biotechnology report

BIOTECHNOLOGY INDUSTRY REPORT

BIOTECHNOLOGY

INDUSTRY REPORT

SUBMITTED BY

TUSHAR PAREEK

MBA BIOTECHNOLOGY

PUMBA


CONTENTS

Topic Page No.

Industry Overview 3

Biopharmaceutical Sector 11

Bioagricultre Sector 27

Bioindustrial Sector 56

Bioservices Sector 76

Biosupplier Sector 101

Bioinformatics Sector 121

SWOT and Conclusion 132

References 136


BIOTECHNOLOGY INDUSTRY OVERVIEW

BIOTECHNOLOGY is an umbrella term that covers a wide spectrum of scientific applications used

in many sectors. It must be seen in the context of a large number of other disciplines and technologies

such as systems biology, synthetic biology, bioinformatics and nanotechnology, whose convergence

will drive new products and technologies in the future. It has been described as a classic example of

‗disruptive technology‘, similar to the steam engine, electricity or information technology. Disruptive

technologies are often initially resisted because their potential is not recognized, even as large

pharmaceutical companies initially dismissed biotechnology in the beginning. The global

biotechnology industry is now at the beginning of a technology curve whose upside potential appears

limitless. Governments around the world are embracing biotechnology as the next driver of

innovation and economic growth. Biotechnology is already beginning to usher in complex, rapidly

emerging and far-reaching new changes in several areas, particularly food and nutrition security,

healthcare and environmental sustainability. It has at the same time sparked-off a number of

controversies. These range from seeking an optimal balance between rewarding innovation and

ensuring the broadest possible access to the benefits of biotechnology, ethical issues related to

‗modifying life‘ and ‗playing God‘, as well as concerns related to environment and health safety.

Society at large has to learn to grapple with these through effective and transparent application of

science-based processes to address these vexing issues. In addition, generation of employment,

creation of intellectual wealth, expansion of entrepreneurial opportunities and augmenting industrial

growth are a few compelling factors that warrant a focused approach for this sector.


The 21st century is witnessing the dawn of biotechnology which is expected to surpass

Information Technology as the new engine of the global economy. Its products will be more

important than the fire the wheel or the car and will generate more knowledge in a short

period of time than history's collective wisdom. Biotechnology is expected to alter healthcare

agriculture commercial and industrial products. It is predicted that by the middle of the 21st

century all companies will become Biotech companies in some form or the other. A key

driver and enabler of this emerging technology is bioinformatics. The biotech industry

developed only within the last twenty-five years. Conventional techniques of producing

biotechnology products such as using traditional microbiological fermentation evolved with

the development of modern technologies. Modern biotechnology entails the use of cell fusion

techniques bio-informatics (use of information technology for documenting bio-diversity and

studying DNA structures) genetic engineering structure based molecular design and

recombinant DNA technology (insertion of foreign gene) and hybridoma technology (fusing

and multiplying cells).

Over the last two decades, world biotechnology has been dominated by the US and Japan.

US-based life sciences companies generate a lion‘s share of over US$ 500 billion in

revenues, followed by Japan. Biotechnology industry continues to grow rapidly, with over

6000 companies engaged in activities related to discovery, consumables and equipment and

the number is increasing at 6% annually. It is noteworthy that in spite of much larger R&D

investments in the pharmaceutical sector, more and more approvals granted by the US FDA

are for bio-drugs.

INDIA & BIOTECHNOLOGY OVERVIEW

The Indian biotech sector is in a unique crossroads. On one hand it is forced to meet the

internal and more public-cantered healthcare objectives of reaching out the right medication

or treatment to the needy and on the other hand it is forced to remain competitive in the

international markets.

India which has earned a name worldwide as the most prefered location for global

information technology outsourcing and software services firms, is gradually making a mark

in another high-tech sector- Biotechnology. The large pool of scientific talent available at a

reasonable cost, a wealth of R & D institutions, a rich and varied bio-diversity, a flourishing

pharmaceutical industry, strong IT skills and an English speaking population have all placed

India favorably in the global market. This sunrise sector which has seen which has seen the

entry of many new players both Indian and International, is poised to take the country to the

big league with investment flowing in from all corners. India has an enormous potential in

becoming a leading player in the global biotechnology industry. The Indian biotech sector

stands 4th in terms of volume and 13th in terms of value. The sector is one of the fastest

growing knowledge-based sectors in India and experts predict that biotechnology is going to

play a key role in shaping India's rapidly developing economy. The country has traditionally

done well in pharmaceutical and drug industry. As a derivative of thepharmaceutical industry

the Biotechnology sector took shape over the last decade with many entrapreneurs making

substantial investment in it. India is ranked among the top-12 biotech destinations in the


world and is the third biggest in the Asia-Pacific region in terms of the number of biotech

companies according to a report by the Confederation of Indian Industry (CII) and the

consultancy firm KPMG. India is also gaining importance as a clinical trial destination. The

global clinical research outsourcing market is projected to touch US$ 23 billion by 2011, with

consultancy firm, KPMG, estimating that India will corner 15 per cent of this in two years.

Also, according to a joint study by FICCI and (E&Y) Ernst and Young, the industry-

sponsored Phase II, Phase III clinical trial study sites in India have grown by 116 per cent

over the last 15 months, with the country moving from rank 18 to 12 across the 60 most

active countries. India participates in 7 per cent of the global Phase III trials and 3.2 per cent

in the Phase II trials with industry-sponsored trials.India has been a recent entrant into the

elite 6 countries group who have successfully decoded the human genome indigenously, the

others being the US, UK, China, Canada and South Korea. India houses about 380 biotech

companies, of which 198 are in Karnataka with 191 in Bangalore alone. Clinical data

management, drug discovery and low-cost production manufacturing are some advantages

that Indian companies enjoy against their global counterparts. Nearly 40 percent of the

biotech companies operate in the biopharma sector, followed by the bioservices (21 percent),

bioagri (19 percent), bioinformatics (14 percent) and lastly the bioindustrial sector (5

percent). Discovery research is leading to new molecules in place of generics. Pre-clinical

development and presence of large animal facilities is set to attract investments in biopharma

and bio-agritech segments. The challenges before the sector are about securing private and

public funding despite risk aversion among VCs (venture capital funds). The industry is

lobbying for the need to improve the regulatory infrastructure, bio-manufacturing standards,

clinical development capabilities, R&D collaborations with US/European Union firms and

acceptance of Indian clinical data by the US Food and Drug Administration and the European

Agency for Evaluation of Medicinal Products of Europe. A number of far reaching changes

are taking place to facilitate growth in the biotech sector further. India is becoming one of the

most favored destinations for collaborative R&D, bioinformatics, contract research and

manufacturing and clinical research as a result of growing compliance with internationally

harmonized standards such as Good Laboratory Practices (GLP), current Good

Manufacturing Practice (cGMP) and Good Clinical Practices (GCP). A well-defined

regulatory framework, along with an emerging stringent IPR regime is also contributing to

this trend.

The Indian Biotechnology Industry can be classified into five different segments, Bio-Pharmaceutical,

Bio-Agriculture, Bio-Services, Bio- Industrial & Bio- informatics with each concentrating on a

particular area.


Bio pharma: deals with the production of vaccines, therapeutics and diagnostics, while the end

products of the biotech industry find two different kinds of buyers, the first type include private

hospitals, governments; patients and the second type include industries like pharmaceutical.

Agri-biotech: deals with hybrid seeds and transgenic crops, bio pesticides and bio fertilizers.

Bio informatics: deals with creation and maintenance of extensive electronic databases on various

biological systems.

Bioservices: market deals with clinical trial, contract research and manufacturing activities.

Bio Industrial: industry deals with enzyme manufacturing and marketing companies and these

enzymes are used in detergent, textile, food, leather, paper and pharmaceutical industry.

At present there are more than 350 biotech companies in India providing employment for over 20,000

scientists. Most of the companies are located in the six major cities of Delhi, Mumbai, Pune, Chennai,

Bangalore, Hyderabad and Ahmadabad. The leading companies in India are Biocon, Serum Institute

of India(in the biopharma space),Mahyco Monsanto, Rasi seeds(in the agribio tech field),Strand

Genomics, GVK Biosciences (in the bioinformatics arena),Syngene and Quintiles in the (in bio

services).

Each sector plays an important role in the growth and development of the Industry. Biopharmaceutical

sector has been the largest contributor to the industries growth with a value contribution of US $ 1.32

billion accounting for a 69.73% contribution in 2006-07 to value contribution of US $ 1.96 billion

accounting to 60% contribution in 2009-2010.

The Indian Biotechnology industry was growing at an astounding 34% growth rate till 2006 and it

was during this period that it was expected to cross the US $ 5billion mark by 2010, but then the

2007-08 recession hit the biotechnology industry growth rate and it came down to 18% in 2008-09


and in 2009-10 the industry grew by 17% and reported a revenue of US $ 3 billion. Even though the

growth rate has slowed down but the industry is recovering from the recession hangover at a good

pace and is expected to reach $ 12 billion by 2017.

The biopharma sector contributed nearly three-fifth to the industry's revenues at US$ 1.9 billion, a rise

of 12 per cent, followed by bioservices at US$ 573 million and bioagri at US$ 420.4 million in the

year 2009-10. The remaining revenue came from the bioindustrials US$ 122.5 million and

bioinformatics US$ 50.2 million segments.

The Indian biotech industry can be broken down in to three clusters Western Cluster, Southern Cluster

and Northern cluster. The Western Biocluster emerged as the biggest contributor to India‘s

Biotech sector revenues followed by the Southern Biocluster contributing US $ 1.23 billion.

Western India continued to dominate India‘s biotech industry with 46% share in the overall

revenues of US $ 1.47 billion from 137 companies in the region. The Northern Biocluster

contributed just about one-seventh of the revenues at US $ 451 million.

West is home to top Bioagri companies such as Monsanto, Mahyco and Ajeet Seeds and

MNCs like GlaxoSmithKline, Roche, Aventis Pharma, Wyeth, Quintiles. Four of India‘s top

10 services companies (CROs) are also based out of West, including the No 1 CRO in the

Indian industry – Quintiles India (Rs 375 crore).

India‘s National Capital Region (NCR), home to the Top 3 companies, Panacea (Rs. 703

crore), Jubilant (Rs. 249 crore) and Eli Lily (Rs. 187 crore), contributed 56% of the revenues

from North. This cluster is better known for its research institutes and of course, government

bodies. Of the three large companies in the North, Panacea is the only one that grew at

17.86%, a growth rate higher than the industry growth rate.

South continues to remain India‘s largest Biotech cluster in terms of the number of

companies adding 9 new biotech companies, highest in the country during the year. The

region has 172 biotech companies which posted revenues of Rs 5537.68 crore during the year

making up 39% of the overall revenues. Eastern India does not add any significant revenues

to the country‘s overall BioTech pie.

Key Biotech clusters in India

Bangalore, in Karnataka is the Biotech capital for India. India houses 380 biotech companies

of which a majority of 198 are in Karnataka and 191 in Bangalore alone. Bangalore and

Karnataka jointly contribute 27% to the revenue of the sector. The other key clusters include

Mumbai and Ahmedabad in the West (Maharashtra and Gujarat respectively), Hyderabad

(Andhra Pradesh) in the South and the area in and around New Delhi in the North. The

Western belt houses companies that are large pharmaceuticals with a prominent

manufacturing and R&D base, who have active interest in pursuing the manufacture of

biogenerics. Hyderabad has several vaccine manufacturers and other large biotech companies

involved in research. The regions in and around New Delhi house several key research

centres and univerisites that are involved in research.


Karnataka –Bangalore Biotechnology, post the ICT success, has emerged as a recent rapidly expanding sector in

Bangalore. The city accounts for over 50% of the 380 biotech companies in India. The city

has revenue of over $550 for 2008-2009 which is over 20% of the total biotech revenue for

the country. Bangalore is the country‘s largest cluster, the city boasts of 198 biotech firms.

Biocon, the nation‘s leading biotech company is headquartered in Bangalore. Some of the

key life science companies to look out for in Bangalore include: Advinus Therapeutics, Astra

Zeneca, Aurigene Discovery services, Biocon India, Jubilant Biosys, Metahelix Life

Sciences, Strand Life Sciences, Strides Arcolab and Xcyton Diagnostics Government of

Karnataka is investing Rs. 5,500 crore in Bangalore Helix Biotech park which is spread over

106 acres at the Electronics City, off Hosur Road in Bangalore. Bangalore can boast of good

Universities like the Indian Institute of Science, JNCASR, NCBS, and University of

Agricultural Sciences. ABLE the Trade association for Biotech Industry is headquartered at

Bangalore. Bangalore has opportunities in Contract Research Space and lot of potential in the

Stem Cell area.

Andhra Pradesh - Hyderabad Biotechnology is an important industry in Andhra Pradesh. There is a high concentration of

biotech companies producing recombinant therapeutics for human consumption. It also has

the second largest recombinant DNA therapeutic production facility in the world, which is

also being used by multi-national companies to produce their own recombinant products.

Andhra Pradesh is called ―Bulk drug Capital of India‖. Andhra Pradesh has a dominant

position in the bulk drugs and pharmaceutical sector with Hyderabad accounting for nearly

one third of India's total bulk drug production. Hyderabad has witnessed infrastructural

development in the biotech domain wherein the Knowledge Park, the Biotech Park, Genome

Valley and other projects have come up giving the city an advantage over others. Hyderabad

is also a house for research and development Centres like Centre for Cellular and Molecular

Biology (CCMB), Indian Institute of Chemical Technology (IICT), International Crop

Research Institute for Semi-arid Tropics (ICRISAT),Central Food Technology Research

Institute (CFTRI) and Institute for Life sciences centre is based out of Hyderabad and have

32 laboratories and 12 research centres. (ILSC) The Government of Andhra Pradesh offers

opportunities in Therapeutics, Diagnostics, Industrial Biotechnology, Inputs to the industry

(hardware suppliers - Instrumentation and Chemicals), and Agricultural Biotechnology in the

biotech space.

TamilNadu - Chennai Tamilnadu is the first state to have introduced a separate Bio Tech

policy. Tamil Nadu presents an attractive market for medical biotechnology products as it

accounts for about 11% of the pharmaceutical market in the country. The Government of

Tamil Nadu has also announced the establishment of Biotechnology Enterprise Zones (Bio-

Valleys) along the lines of Silicon Valley to exploit the bioresources of the State. Chennai has

some of the top pharma companies like Orchid Pharma, Shasun Pharma and Bafna

Pharmaceuticals and few Biotech companies like ABL Biotech and Proalgen Biotech. Tamil

Nadu also has reasearch centres like Centre for Biotechnology, Anna University Centre for

Plant Molecular Biology, Tamil Nadu Agricultural University, Coimbatore, and Centre for

Research in Medical Entomology, Madurai, Department of Biotechnology, School of

Bioengineering, SRM University, Rajiv Gandhi Centre for Biotechnology, School of

Biotechnology, Madurai Kamaraj University, School of Chemical and Biotechnology –

Sastra University. Tamil Nadu has opportunities in the area of Stemcell Research and

Nanotechnology.


Western Region Maharashtra The state accounts for 40 per cent of the country'

pharmaceuticals output. It has strong research capabilities and accounts for over 30 per cent

of country‗s patents. It has a presence of reputed companies focusing on the biotech sector

including Wockhardt, Nicholas Piramal, Cipla and Lupin, among others and state is setting

up biotech parks at Hinjewadi, near Pune. Major opportunities have emerged in the

pharmaceutical sector, primarily in the areas of contract research, contract manufacturing and

clinical trials. State boasts of Low costs, strong manufacturing base, well developed

laboratory and R&D infrastructure, a strong resource pool. The backward linkage with the

well-developed chemicals and petrochemicals sector is an added advantage.

Gujarat: Gujarat accounts for 28 per cent of national pharmaceutical production (2006-

2007). First state to manufacture APIs and finished dosage forms. It is a home to 902

allopathic manufacturing units and 2,122 contract manufacturing units. Gujarat accounts for

exports worth US$ 1.4 billion (2006-2007). It has number of clinical research organisations

in India and over 100 companies with WHO-compliant manufacturing units, academic and

research institutions providing over 4,600 technically-skilled man power per annum. India‘s

largest biotech park of 700 acres is being developed at Savli, Vadodara. Key players are

Zydus Cadila, Torrent Pharma, Sun Pharma, Intas Pharma, Alembic, Dishman Pharma.

Mumbai is home to the two major pharmaceutical associations including Indian Drug

Manufacturers Association (IDMA) and organisation of Pharmaceutical Producers of India

(OPPI).


THE TOPPERS OF THE INDIAN BIOTECH INDUSTRY

The top Indian biotech companies contribute a lot to the overall biotech sector of the country.

The top 30 companies contribute more than 50% of the total revenue of the industry

The top ten biotech companies by revenue for the year 2009-10 are as follows.

Revenue Rank

2010

Company 2009-10

(Revenue

in

Million

US $ )

(Revenue in

Million US $)

% Change over

2008-09

1 Biocon 262.2 202.74 29.34

2 Serum

Institute of

India

188.8 247.55 -23.70

3 Panacea

Biotech

156.2 132.69 17.76

4 Nuziveedu

Seeds

105.9 99.9 6.07

5 Reliance Life

Sciences

100

6 Quintiles 83.3

7 Rasi Seeds 79.7 83.4 -4.48

8 NovoNordisk 76 73.3 3.64

9 Shantha

Biotech

74.2 54.8 35.32

10 Mahyco 69.3 46.9 47.78


BIOPHARMACEUTICAL SECTOR

Biopharmaceuticals are complex macromolecules derived from recombinant DNA

technology, cell fusion, or processes involving genetic manipulation. They include

recombinant proteins, genetically engineered vaccines; therapeutic monoclonal antibodies;

and nucleic acid based therapeutics (i.e. DNA based drugs), including gene therapy vectors.

Unlike orally delivered small molecule drugs that underpin the traditional pharmaceutical

industry, biopharmaceuticals are usually administered by subcutaneous, intravenous, or

intramuscular injection.

BIOPHARMACEUTICAL MARKET OVERVIEW

The biopharmaceutical market has come a long way since 1982 when the first

biopharmaceutical product, recombinant human insulin, was launched. Over 130 such

products are currently being marketed around the world including thirteen blockbuster drugs.

The global market for biopharmaceuticals, currently valued at US$48 billion, has been

growing at an impressive CAGR of 19% over the previous five years. With over one third of

all pipe-line products in active development are biopharmaceuticals, this segment is set to

continue outperforming the total pharmaceutical market and could easily reach US$100

billion by the end of the decade.

Under mounting economic pressures to increase their outputs, pharmaceutical manufacturers

have embraced biopharmaceuticals as a means to maintain flow in their drying pipelines.

Bringing a biopharmaceutical, however, represents a very risky proposition and out of every

ten drugs that enter the clinical phases, only three manage to gain market approval. But the

industry‘s US$ 92 Billion figures and double digit growth rates in the last five years are a

testimonial to the fact that the ones that finally do get approval represent goldmines for

investors. Although factors such as biosimilar entry and cost containment in the developed

markets are likely to restrain the growth of this market in the coming years, it is expected that

the high potency and ability of biopharmaceuticals to attack targets beyond the reach of

traditional small molecule drugs gives the industry a huge scope for future growth. A rich late

stage pipeline and the growth of emerging markets are also expected to be major drivers for

growth in the next five years. The global biopharmaceutical market is estimated to reach

level of sales figures worth more than US$ 167 Billion by 2015.

The development of bio-pharmaceutical industry is in sync with the development of

biotechnology. The technology was quickly applied to new drug development on, and has

achieved great success. Many countries in the world are involved in the development of bio-

pharmaceutical industry, a huge market, but the main focus is in the countries like United

States, Japan and Europe.

AMERICA: Birthplace of modern biotechnology and also the first application of this

technology, the United States in the development of bio-pharmaceutical industry lead the

world. The United States currently has more than 1000 biotechnology companies,

biotechnology market capitalization more than 400 billion dollars, US spends over 50 billion

http://eng.hi138.com/?k=Technology


U.S. dollars in research funding each year. Amgen, Biogen Idec, Genentech, Genzyme, Life

Technologies, and Monsanto are among the major U.S. biotechnology companies in the USA.

US biopharmaceutical market has annual revenue of about $70 Billion USD according to a

Research and Markets report. U.S. has successfully developed more than 30 important drugs.

These drugs are widely used in cancer, diabetes, hepatitis and other diseases treatment.

EUROPE: European Bio-pharmaceuticals market is behind U.S. overall, but is developing

rapidly. Progress of countries like Britain, France, Germany, Russia and other countries in

the developed Europe have been impressive, in the production of biological medicines.

JAPAN: Japan's pharmaceutical industry is also developing rapidly. The country is also

focusing on bio-and nanotechnology, Information technology, disease-related genes and the

resulting protein structure, in order to develop "genetic drugs" as the goal to promote the

biotechnology industry in Japan. Currently, Japan already has 65% of the biotechnology

company engaged in biomedical research; Japanese company's technical strength has been

among the highest in the world.

ASIA PACIFIC: Asia-Pacific countries other than Japan are also developing rapidly in the

field of biopharmaceuticals; especially Australia, China and India, these countries continue to

attract investment in their Biopharmaceutical market.

GLOBAL BIOPHARMACEUTICAL HIGHLIGHT:

Biopharmaceuticals enjoy a higher approval success rate compared to traditional

small molecule drugs. They, however, require higher investments and take longer

development times. Biopharmaceuticals are significantly more expensive than

traditional medications, with the annual cost of therapy of some biopharmaceuticals

touching more than a hundred thousand dollars a year. The cost of these drugs,

however, is expected to be closely scrutinized by payers in the coming years.

Recombinant Proteins represented the biggest biopharmaceutical class in 2009-10,

accounting for more than 65% of the total global biopharmaceutical sales. Growth in

this class is expected to be low in most of the developed markets as a result of

biosimilar entry and increasing cost containment measures.

Monoclonal Antibodies are expected to be the biggest drivers of the

biopharmaceutical market in the next five years. Driven by a rich late stage pipeline

and a strong uptake from both developed and emerging market, Monoclonal

Antibodies are expected to be worth more than US$ 79 Billion by 2015.

Imarc expects the top eight markets (US, Germany, Japan, France, Italy, Spain, UK

and Canada) to account for around 79% of the total global biopharmaceutical sales by

2015. This represents a decline of 4% over their 2009 share.

The market share of emerging markets (Brazil, Russia, India, China, Mexico, Turkey

and South Korea) is likely to increase from less than 5% in 2009 to more than 8% by

2015.


TOP COMPANIES IN THE GLOBAL MARKET:

Top 10 Biopharmaceutical Companies as per revenues - 2009:

01 Roche/Genentech $36,017

02 Amgen $14,642

03 Novo Nordisk $9,566

04 Merck Serono $7,454

05 Baxter BioScience $5,573

06 Biogen Idec $4,247

07 Genzyme $3,562

08 CSL Ltd.* $3,211

09 Allergan $1,310

10 Alexion Pharma $387

Based on 2009 biopharma revenues.*

Note: In all Top Company profiles, dollar amounts are in millions.

* CSL's financial year ran from July 1, 2008 to June 30, 2009

COMPANY PROFILE IN DETAIL:

ROCHE/GENENTECH:

Headquartered in Basel, Switzerland, Roche is one of the world‘s leading research-focused

healthcare groups in the fields of pharmaceuticals and diagnostics. As the world‘s biggest

biotech company and an innovator of products and services for the early detection,

prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of

fronts to improving people‘s health and quality of life. Roche is the world leader in in-vitro

diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is

also active in other major therapeutic areas such as autoimmune diseases, inflammatory and

metabolic disorders and diseases of the central nervous system. In 2010 sales by the

Pharmaceuticals Division totaled 37 billion Swiss francs, and the Diagnostics Division posted

sales of 10.4 billion francs. Roche has R&D agreements and strategic alliances with

http://www.contractpharma.com/articles/2010/07/rochegenentech

http://www.contractpharma.com/articles/2010/07/amgen

http://www.contractpharma.com/articles/2010/07/novonordisk

http://www.contractpharma.com/articles/2010/07/merckserono

http://www.contractpharma.com/articles/2010/07/baxter

http://www.contractpharma.com/articles/2010/07/biogenidec

http://www.contractpharma.com/articles/2010/07/7-10

http://www.contractpharma.com/articles/2010/07/7-10/#csl

http://www.contractpharma.com/articles/2010/07/7-10/#allergan

http://www.contractpharma.com/articles/2010/07/7-10/#alexion


numerous partners, including majority ownership interests in Genentech and Chugai, and

invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about

80, 000 people. With Roche‘s acquisition of Genentech, which closed in April 2009, Roche

supplanted Amgen and moved into the top rank of global biopharma companies.

AMGEN:

Amgen Inc. is an international biotechnology company headquartered in Thousand Oaks,

California. Located in the Conejo Valley Amgen is among the biggest of the biotech

companies. The company uses cellular biology and medicinal chemistry to target cancers,

kidney ailments, inflammatory disorders, and metabolic diseases. Anti-anemia drugs Epogen

and Aranesp account for more than one-third of its sales. Enbrel, another leading drug, treats

rheumatoid arthritis and is one of the best-selling drugs in this multi-billion-dollar market.

The company has a healthy drug pipeline, as well as marketing alliances with Japanese

brewer and drugmaker Kirin, Johnson & Johnson, and other pharmaceutical companies.

Amgen sells its products primarily through wholesale distributors in North America and

Europe. Although Amgen was supplanted as the world‘s biggest biopharma company; the

company got the U.S. and EU approval of Prolia (a.k.a. denosumab), its semi-annual

postmenopausal osteoporosis treatment. Analysts project $1 billion in sales in its first full

year, and $3 billion in annual sales by 2013.

NOVO NORDISK:

Headquartered in Denmark, Novo Nordisk employs approximately 30,000 employees in 76

countries, and markets its products in 179 countries. Novo Nordisk manufactures and markets

pharmaceutical products and services. It is one of the world‘s leading companies in

diabetes care; Novo Nordisk pursues research into pulmonary delivery systems. Novo

Nordisk also commands large sectors of the markets in haemostatic management, growth

hormone therapy and hormone replacement therapy. It controls nearly a quarter of the world

market in diabetes care. Novo Nordisk has continued its dominance in the diabetes market; as

its human insulin sales diminish, its modern insulin products are tearing it up, rising 18% to

$4 billion in revenues.

MERCK

Merck & Co., Inc. (Merck) is a global health care company. Merck delivers health solutions

through its prescription medicines, vaccines, biologic therapies, animal health, and consumer

care products, which it markets directly through its joint ventures. The Company‘s operations

are principally managed on a products basis. Merck‘s operates in four segments: the

Pharmaceutical, Animal Health, Consumer Care and Alliances segments. The Pharmaceutical

segment includes human health pharmaceutical and vaccine products marketed either directly

by the Company or through joint ventures. Human health pharmaceutical products consist of

therapeutic and preventive agents, sold by prescription, for the treatment of human disorders.

http://en.wikipedia.org/wiki/Amgen

http://en.wikipedia.org/wiki/Novo%20Nordisk


The Company sells these human health pharmaceutical products primarily to drug

wholesalers and retailers, hospitals, government agencies and managed health care providers,

such as health maintenance organizations, pharmacy benefit managers and other institutions.

Vaccine products consist of preventative pediatric, adolescent and adult vaccines, primarily

administered at physician offices. Additionally, the Company has consumer health care

operations that develop, manufacture and market Over-the-Counter (OTC), foot care and sun

care products, which are sold through wholesale and retail drug, food chain and mass

merchandiser outlets in the United States and Canada.

BAXTER:

Baxter International Inc., is an American health care company with headquarters in Deerfield,

Illinois. The company primarily focuses on products to treat hemophilia, kidney disease,

immune disorders and other chronic and acute medical conditions. The company has sales of

$12.3 billion, across three manufacturing divisions (BioScience, producing blood plasma

proteins; Medication Delivery producing intravenous therapy products and liquids; and Renal

producing equipment for dialysis and the treatment of kidney disorders). The company is also

involved in the production of a vaccine for the H1N1 influenza. Baxter‘s BioScience

revenues were up 5% to $5.6 billion in 2009.

BIOGEN IDEC:

Biogen Idec, Inc. is a biotechnology company specializing in drugs for neurological

disorders, autoimmune disorders and cancer. The company was formed in 2003 by the

merger of Cambridge, Massachusetts-based Biogen Inc. and San Diego, California-based

IDEC. Biogen, one of the oldest biotechnology companies. Biogen Idec is headquartered in

Weston, Massachusetts. Biogen Idec serves customers in more than 90 countries. Total

revenues of Biogen Idec in 2010 were $4.7 billion, an increase of 8% versus 2009.

GENZYME:

Genzyme Corporation is an American biotechnology company based in Cambridge,

Massachusetts. Genzyme is the world‘s third-largest biotechnology company, employing

more than 11,000 people around the world. The company has a presence in approximately 40

countries, including 17 manufacturing facilities and 9 genetic-testing laboratories, its

products are sold in 90 countries. Genzyme‘s 2009-10 revenue was $4,516 million.

CSL:

CSL Limited is an Australia-based manufacturer of medical products. With major facilities in

Australia, Germany, Switzerland and the US, CSL has over 10,000 employees working in 27

countries. Its products include various blood plasma derivatives, vaccines, antivenin, and cell

http://en.wikipedia.org/wiki/Baxter%20International

http://en.wikipedia.org/wiki/Biogen%20Idec

http://en.wikipedia.org/wiki/Genzyme


culture reagents used in various medical and genetic researches and manufacturing

applications. CSL‗s vaccine for Swine Flu was approved in September 2009 for use in

Australia by people aged 10 and over. The revenue of CSL for 2009-10 was $4456 million.

ALLERGAN:

Allergen Inc. is a global specialty pharmaceutical company. Their product ranges include

ophthalmic pharmaceuticals, dermatology products, and neurological products.

The company‘s most notable neurologic product is Botox, used around the world to treat a

variety of debilitating disorders associated with muscle over activity and also well-known—

under the trade names Botox Cosmetic and Vistabel—for the treatment of facial lines. It‘s

most important manufacturing plants are in Waco, Texas; Westport, Ireland; and San Jose,

Costa Rica.

ALEXION PHARMACEUTICALS:

Alexion Pharmaceuticals, Inc., a biopharmaceutical company, engages in the discovery,

development, and commercialization of biologic therapeutic products in the United States,

Europe, Latin America, Japan, and the Asia Pacific. It focuses on products for severe and

life-threatening disease states, including hematologic, kidney, and neurologic diseases;

transplant rejection; cancer; and autoimmune disorders. The company was founded in 1992

and is headquartered in Cheshire, Connecticut.

INDIAN BIOPHARMACEUTICAL INDUSTRY:

The Biopharma sector makes for a huge part of the Indian biotechnology industry—$1.9

billion in 2009-2010 to be precise, accounting for 60% of the $3 billion revenues of the

biotech industry as a whole. Vaccines are of largest share among biopharma products with

60% contribution. With world class R&D facilities and cost cutting capabilities India is

attracting contract research outsourcing projects which is an add-on to the biopharma sector

growth .The world has understood the value of India as R&D hotspot and they simply cannot

lose the opportunity of being in India.

According to a study undertaken by research firm RNCOS; the biopharmaceuticals industry

in India will grow at a CAGR of about 13% between 2010-2011 and 2012-2013. The

biopharmaceutical sector accounts for 65% of the total industry‘s revenue. Domestic firms

dominate this sector, accounting for fourteen of the top twenty firms. The biopharma sector is

comprised of 200 companies involved mainly in the production of vaccines, therapeutic

drugs, animal biologicals, statins and diagnostics. Vaccine production is the most profitable,

with five of the top ten companies in the biopharma segment dealing primarily in vaccines.

Vaccines account for approximately 60% of total biopharma products. India has a handful of

http://en.wikipedia.org/wiki/CSL%20Limited

http://en.wikipedia.org/wiki/Allergan

http://finance.yahoo.com/q/pr?s=ALXN


dedicated biopharma companies which manufacture monoclonal antibodies (MAbs) which

primarily include cancer drugs, insulin, growth hormones, and cell culture to produce

vaccines. India is one of the largest producers of traditional vaccines in the world comprising

mainly of paediatric vaccines such as Anti Rabies Vaccine, Oral Polio Vaccine, and Hepatitis

B Vaccine.

Vaccines

Vaccines had the largest pie in biopharma with an estimated sale of Rs 2,180 crore over last

year's figure of Rs 2,000 crore. The vaccine segment, human as well as animal

vaccines accounted for approximately 60 percent of the total Biopharma market. Total

estimated sales from the human vaccine business stood at Rs 1,750 crore over the 2008-2009

figure of Rs 1,550 crore. Domestic sales of human vaccines have just crossed Rs 1,000 crore.

In FY 2008-2009 this figure stood at Rs 900 crore. Export sales are estimated to have

generated Rs 750 crore, as compared to Rs 650 crore in FY 2008-09. Animal Vaccines

registered a marginal decline with sales of Rs 430 crore over last year's figure of Rs 450

crore. In animal vaccines, poultry vaccines clocked Rs 220 crore, cattle and sheep vaccines

registered Rs 210 crore. The vaccine market will continue to drive the growth of the

biopharma segment growing in the range of 10-13 percent in the next 5 years. The factors

that will drive this include education and awareness about disease prevention, increase in

disposable income and participation by government.

Major Investments:

Investments, along with outsourcing activities and exports, are key drivers for growth in the

biotech sector. According to data released by the Department of Industrial Policy and

Promotion (DIPP), the drugs and pharmaceuticals sector has attracted foreign direct

investment (FDI) worth US$ 1.82 billion between April 2000 and September 2010.

Some of the major investments in the sector are as follows:

Swiss Pharma company Lonza AG, plans to invest around US$ 55.33 million through its

Indian subsidiary in a phased manner in Genome Valley project, Hyderabad, said Stefan

Borgas, CEO, Lonza.

Biotechnology major Biocon plans to invest around US$ 64 million - US$ 107 million over

the next three years to set up plants that would supply generic biotechnology drugs to Europe

and the United States, said Murali Krishnan K N, President-Group Finance, Biocon.

The Defense Research and Development Organization (DRDO), which caters primarily to the

armed forces, plans to spend US$ 63.5 million to upgrade and custom-make its existing line

of biotech products for civilian use.


The Export vs Domestic Scenario

Biotech Industry Exports vs. Domestic 2009-10

Segment Exports Domestic Total % share

Exports

% share

Domestic

Biopharma 4767.66 4061.34 8829 54 46

BioServices 2507.05 131.95 2639 95 5

BioAgri 58.08 1877.92 1936 3 97

BioIndustrial 124.08 439.92 564 22 78

BioInformatics 73.92 157.08 231 32 68

Total 7530.79 6668.21 14199 53.04 46.96

All figures in Rs. Crore unless indicated otherwise

Growth in India is primarily export-driven.

Export sales of Indian biopharmaceutical products are currently rising at an annual rate of

47%, while domestic sales of Indian biopharmaceutical products have gone up only 4–5% per

annum for each of the past two years. The above data makes it clear that the Indian

Biopharmaceutical sector is an export driven sector

The Indian Biopharma Toppers

The top ten Indian Biopharmaceutical companies based on revenue are as follows

Revenue

Rank 2010

Company 2009-10

(Revenue in

Million $)

2008-09 (Revenue

in Million $)

% Change

Over 2008-09

1 Biocon 262.2 202.74 29.34

2 Serum Institute of

India

188.8 247.55 -23.70

3 Panacea Biotech 156.2 132.69 17.76

4 Reliance Life

Sciences

100 - -


5 NovoNordisk 76 73.3 3.64

6 Shantha Biotech 74.2 54.8 35.32

7 Indian

Immunologicals

60.4 51.4 17.89

8 Bharat Biotech 60.3 53.5 12.7

9 Eli Lilly 41.5 36.4 13.85

10 Bharat Serums 38.8 31.1 25

* BioSpectrum estimates

Biocon:

Biocon is India's leading integrated biotechnology enterprise focused on the development of

biopharmaceuticals. Since its inception Biocon has evolved from an enzyme manufacturing

company to a fully integrated biopharmaceutical enterprise, focused on healthcare. Biocon

has successfully forayed into drug discovery and development. It has developed innovative

and effective bio molecules in diabetology, oncology, cardiology and other therapeutic

segments. Biocon delivers products and solutions to partners and customers in over 50

countries.

Major Achievements of Biocon:

First Indian company to manufacture and export enzymes to USA and Europe.

First Indian Biotech Company to receive US funding for proprietary technologies.

First Indian company to be approved by US FDA for the manufacture of lovastatin, a

cholesterol-lowering molecule.

First company worldwide to develop human insulin on a Pichia expression system.

India's largest producer and exporter of enzymes.

Second Indian company to cross the $ 1 billion mark on the day of listing.

Launched India's first cancer drug BIOMAb EGFR

Serum Institute of India:

Serum Institute of India limited is the largest vaccine and immunobiological manufacturing

company and is at par with world class manufacturing facility. Serum Institute is recognized


as a reliable source of High Quality vaccines and biologicals. Products have been supplied to

International Health Agencies like the WHO, UNICEF, PAHO and also to more than 140

countries across the globe. Serum Institute aims at total indigenization to make India achieve

self-sufficiency in life-saving drugs.

Panacea Biotec:

Panacea Biotec is a research based Health Management Company involved in research,

manufacturing and marketing of branded pharmaceutical formulations, vaccines and natural

products. The product portfolio includes highly innovative prescription products in important

therapeutic areas like pain management, diabetes & cardiovascular management, renal

disease management, osteoporosis management, anti-tubercular, gastro-intestinal care

products and vaccines. The flagship brands of the company- Willgo for pain management;

Glizid & Glizid-M for diabetes; Panimun Bioral & Mycept for kidney transplant occupy

leadership positions in their therapeutic segments. The vaccines portfolio consists of oral

polio vaccines (type I and type III), Enivac-HB (Hepatitis B vaccine), Enivac-HB Safsy,

Ecovac-4 (DTwP+Hep B), Easyfour (DTwP+Hib), Easyfive (DTwP+Hep B+Hib). Vaccines

in the offing are- Anthrax, Dengue, Japanese encephalitis and several others. Panacea Biotec

has earned the distinction of being a WHO pre-qualified supplier of oral polio and Hepatitis-

B vaccines and are in the process of obtaining similar pre-qualifications for other vaccines.

Panacea Biotec is contributing in disease prevention and reducing the child mortality.

Reliance Life Sciences:

Reliance Life Sciences Pvt., Ltd. operates as a research, biotechnology, and life sciences

organization. The company participates in the domains of medical, plant, and industrial

biotechnology opportunities that relate to biopharmaceuticals, molecular diagnostics and

genetics, cell-based therapies, plant tissue culture, plant metabolic engineering, Biofuels,

biopolymers, bio chemicals, contract manufacturing, and clinical research services. It has

facilities in Navi Mumbai and Bangalore, India. The company was incorporated in 2001 and

is based in Navi Mumbai, India. Reliance Life Sciences Pvt., Ltd. operates as a subsidiary of

Reliance Industries, Ltd.

NovoNordisk:

Novo Nordisk is a global healthcare company with 87 years of innovation and leadership in

diabetes care. The company also has leading positions within hemophilia care, growth

hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and

markets pharmaceutical products and services that make a significant difference to patients,

the medical profession and society. With headquarters in Denmark, Novo Nordisk employs

more than 29,000 employees in 81 countries, and markets its products in 179 countries.


Shantha Biotech:

A pioneer in the field of biotechnology, Shantha Biotech is the first Indian company to

develop, manufacture and market a recombinant human healthcare product in India. Shantha

Biotech is currently focusing its R&D efforts in the development of generic biologicals, novel

therapeutic antibodies, proteins and vaccines. Shantha conducts exploratory research in the

fields of Oncology, Infectious Diseases and Platform technologies. Shantha Biotech produced

the first Indian Hepatitis-B vaccine to be pre-qualified by WHO, Geneva, for supplying to

UN agencies globally SHANVAC-B. Today, Shantha caters to major international markets

including Asia-Pacific, Africa, CIS and Latin America in addition to supra nations like

UNICEF and PAHO.

Indian Immunologicals:

The National Dairy Development Board (NDDB) set up Indian Immunologicals Ltd. (IIL) in

1982 with the objective of making Foot and Mouth Disease (FMD) vaccine available to

farmers at an affordable price. The technology for FMD vaccine manufacture was obtained

from M/s. Wellcome Foundation Limited, United Kingdom. The plant in Hyderabad today

has a capacity to make 80 million trivalent doses of FMD vaccine. Following the successful

introduction of Foot &Mouth Disease Vaccine-Raksha, IIL launched the tissue culture

vaccine "Raksharab" in 1989. This was the first Indian tissue culture vaccine in the market.

Subsequently IIL has developed many biologicals through its own R&D efforts and launched

several vaccines in the Indian market at affordable prices. IIL is today the fifth largest animal

health player in the Indian market and the market leader in veterinary biologicals in India. It

operates one of the largest plants in the world for veterinary vaccines and is WHO-GMP and

ISO-9001 certified. IIL exports its products to several countries and exports contributed

substantially to the company's turnover. IIL operates a facility in Ooty to manufacture the

Vero cell culture rabies vaccine for use in human beings.

Bharat Biotech:

Bharat Biotech International Limited (BBIL/Bharat Biotech), Hyderabad, India, is a

multidimensional biotechnology company specializing in product-oriented research,

development and manufacturing of vaccines and biotherapeutics. Bharat Biotech, established

in the year 1996 by Dr. Krishna M. Ella & Mrs. Suchitra K. Ella as the Founder Directors,

is engaged in developing next-generation vaccines and bio-therapeutics through innovative

and collaborative research. BBIL's state-of-the-art manufacturing plant is the largest of its

kind in Asia-Pacific. The first bio-pharma facility in the country to be audited and approved

by Korean Food & Drugs Administration (KFDA), it sprawls over a picturesque campus at

Genome Valley, Hyderabad. Built with an investment of over INR 1000 million, the facility's

Manufacturing, Control Procedures and Protocols, conform to the stringent standards laid

down by internationally recognized institutions such as USFDA, UKMCA and WHO.


Eli Lilly:

Founded in 1876 by Eli Lilly, they are now the 10th largest pharmaceutical company in the

world. They have steadfastly remained independent, but not isolated. Across the globe, Lilly

has developed productive alliances and partnerships that advance their capacity to develop

innovative medicines at lower costs. The Company manufactures and distributes its products

through facilities in the United States, Puerto Rico, and 17 other countries. Its products are

sold in approximately 125 countries. The Company‘s products include neuroscience products,

endocrinology products, oncology products, cardiovascular products, animal health products

and other pharmaceuticals.

Bharat Serums:

Since inception in 1971, BSV develops, manufacture and market specialized biological,

pharmaceutical and biotechnology products.Today, BSV is one of the fast growing Indian

bio-pharmaceutical companies. The product portfolio comprises of a wide range of products

such as plasma derivatives, monoclonals, hormones, equine antitoxins and serums,

antifungals, anaesthetics, cardiovascular and diagnostic products.BSV is managed by an

experianced Board of Directors, who are assisted by a team of dedicated and qualified

professionals drawn from various disciplines. The management team comprises of qualified

doctors, professionals and postgraduates having rich experience and expertise in their

respective fields.

MERGERS AND ACQUISITIONS IN THE INDIAN

BIOPHARMACEUTICAL SECTOR:

Indian market in 2009-10 has seen rise of inbound deals both in volume as well as value.

Inbound deals in India are either due to geographical expansion or through the CRAMS side.

Indian Companies were involved in a total of 356 merger and acquisition deals.

Mergers and Acquisitions by Indian Biopharmaceutical Companies

In the Indian pharmaceutical market there are a number of companies that have entered into

merger and acquisition agreements in the context of the global market scenario. In 2009 there

have been a number of small scale out bound deals but the one deal that stands out as the

blockbuster is the Dr. Reddy‘s Labs acquisition of Beta Pharma a $ 560mn deal which was ap

art of Dr. Reddy‘s Labs inorganic growth strategy. Other deals worth mentioning are as

follows

In the recent times –

Nicholas Piramal has taken the ownership of 17% of Biosyntech that is a major

pharmaceutical packing organization in Canada.

Torrent has got the ownership of Heumann Pharma, a general drug making company and,

formerly, a subsidiary of Pfizer.

Matrix has acquired Docpharma, a major pharmaceutical company of Belgium.

http://www.economywatch.com/mergers-acquisitions/international/pharmaceutical-sector.html


Sun Pharmaceutical Industries is set to make acquisitions in pharmaceutical companies in the

US and has set aside $450 million to execute these plans.

In Bengaluru, Strides Arcolab has aimed at acquiring 70 percent in a pharmaceutical facility

in Italy that is worth $10 million.

Opportunities for Pharmaceutical Companies

There are a number of opportunities for the major pharmaceutical products and services

providers in the Indian pharmaceutical sector as the price controls have been relaxed and

there have been significant changes in the medicinal requirements of the Indians. The

manufacturing base in India is also strong enough to support the major international

pharmaceutical companies from the performance perspective.

This may be said as the Indian pharmaceutical market is varied as well as economical. It is

expected that in the coming years the Indian pharmaceutical companies would be executing

more mergers and acquisitions. It is expected that the regulated pharmaceutical markets in the

United States and Europe would be the main areas of operation.

In the recent years the Indian pharmaceutical companies have been venturing into mergers

and acquisitions so that they can gain access to the big names of the international

pharmaceutical scenario.

Mergers and Acquisitions of Indian companies

The market is set to grow and double by 2015. Higher spending on healthcare, increasing

middle class incomes, and rising penetration in rural areas will help spur growth in the

domestic market. This is also the reason why increasingly global Pharma player are looking

Year Indian Company

taken over

Foreign

Player

Country Deal size ( $

millions)

DEC 10 PARAS PHARMA RECKITT

BENCKISER

UK 726

MAY 10 PIRAMAL

HEALTHCARE

ABBOT Inc US 3720

DEC 09 ORCHID CHEM HOSPIRA US 400

JULY 08 SHANTHA

BIOTECH

SANOFI

AVENTIS

FRANCE 783

JUNE 08 RANBAXY LAB DAIICHI

SANKYO

JAPAN 4600

AUGUST 06 MATRIX LAB MYLAN Inc US 736


at the inorganic route to build a presence in India. According to Mr. Ajay G. Piramal

(Chairman Piramal Healthare) ―Companies across the global are excited about the growth

opportunity in India and the potential to scale up the Indian business models in other

emerging markets. The motivation behind the acquisition is growth and not cost optimization.

Hence they are looking for companies with strong brand and processes.‖

Promoters are asking for higher and higher valuations, and some of them have even realized

their aspiration. In fact there are only getting better with each deal, with a substantial upward

trend in purchase prices - the Daiichi Sankyo transaction was done at 4 times sales, the $783

million Sanofi- Shantha acquisition at 8 times sales while Abott bought Piramal at 9 times

sales .

Patterns of Mergers and Acquisitions in Pharmaceutical Sector

One of the major features of the mergers and acquisitions in the pharmaceutical sector of the

Asia-Pacific region has been the integration of the local pharmaceutical companies. This has

happened especially in India and China. Acquisition has made it convenient for a number of

companies to do business in various pharmaceutical markets.

FUTURE OF BIOPHARMA INDUSTRY:

The pharmaceutical industry comprises establishments primarily engaged in manufacturing

drugs, medicines and related products for human or animal use. Nowadays,

Biopharmaceutical corporations are facing serious inefficiencies in their drug discovery

process. The initial data from the late-stage clinical trials on Biocon‘s oral insulin drug IN-

105 for diabetes did not meet the desired results. In the final-stage trials being conducted in

India, IN-105 failed to comply with its target of lowering HbA1c levels, or haemoglobin

count in patients with type 2 diabetes. These kinds of setbacks can be discouraging to the

industry and other players would be sceptical to enter into a huge budget R&D project.

The biopharma companies are expecting to cut down the drug discovery time line by half and

achieve double-digit growth rates by exploiting the ‗Blockbuster‘ drug/therapy strategy.

Unfortunately Biopharma companies have not been able to fulfil those expectations. The

average time line for a new drug candidate to be on the market is still around 16 to 20 yrs.

Drug discovery is a long journey fraught with risks as well as painstaking research and

testing. Thus, companies are willing to invest in any process that could accelerate the drug

development. The industry is a classic winner-takes-all example as the first-mover with a new

drug usually gets over 75% of the market.

Given that situation, there is no doubt that in biopharma corporations‘ new operating

structures enabling collaborative relationships and cost-effective management are needed.

Global Market

The global market for Biopharmaceuticals is projected to reach US$182.5 billion by 2015,

registering a CAGR of 12.4% during the period 2006-2015. Intense research efforts made


biopharmaceuticals the most successful products in various therapeutic areas such as

Neurology, Infectious Diseases, Cardiovascular, Oncology etc. Undoubtedly, all the major

pharmaceuticals are, now, engaged in doing research for new biopharmaceutical active

ingredients. Biopharma active ingredients are containing in about 50% of the newly approved

drugs. The future of biopharmaceuticals is to be projected bright as the market share is

growing gradually. In terms of market revenue, out of total pharma market the

biopharmaceutical products accounted for about 10% in 2006 and are projected to account for

about 15% 2015. Biopharmaceutical products analyzed in this study comprise Monoclonal

Antibodies, Biotech Vaccines, Erythropoietin, Granulocyte-Colony Stimulating Factor,

Recombinant Human Insulin, Interferon, Human Growth Hormones and Other. India‘s new

Free Trade Agreement with Japan to be in force from April 2011 has increased expectations

of this industry. Thus a new market will developed to compete for the pharma and the

biopharma companies.

Patent Scenario

With the advent of globalization, more Indian biopharma companies started looking at the

western markets in general and the US market in particular as their target for expansion. This

has led to the need for the companies to seek patent protection for their inventions in those

countries besides making a foothold there. The whole perspective of Indian

biopharmaceutical companies changed when the accession of India to WTO brought

obligations to implement the agreement on Trade Related Aspects of Intellectual Property

Rights (TRIPS). For the industry, the critical issue was the (re-) introduction of the product

patent regime and the limitations that this change has imposed on its ability to produce

technologies through reverse engineering.

Considering the biopharma patent scenario in India, the US patent holdings of Indian

companies have been very less. Only 57 Indian biopharma companies have US patents.

Altogether 19 biotech and 425 pharma patents are held by these companies. The pharma and

biotech patents have been obtained since 1990 and 2001 respectively. These patents protect

both the processes and products. The largest number of patents protects pharma inventions.

This reflects the importance of this industry in present scenario.

The number of biotech patents is 19 as compared to 425 pharma patents, which is 20-fold

greater. The interesting fact about the patents granted to Indian biopharma sector is that the

pharma patents are granted to biotech companies whereas the biotech patents have been

granted to companies with pharma background. For example, two-third of the patents granted

to Biocon, are categorized as pharma. Similarly, in case of Reddy U S Therapeutics, there are

three biotech patents. Although the biotech numbers have increased in the past few years, a

consistent year on year increase is not visible yet.

Patents vs. companies

It has been found that out of 424 companies investigated for pharma patents; only 53 have US

patent holdings. That amounts to less than 15 percent of the total home grown Indian


companies. Although the number of patents held are lesser, but the companies indicated a

certain improvement of the capabilities of the biotech and pharma industries. The pharma

sector got first two patents in 1990. Then the number of pharma patents between 1990 and

1995 were only eight. After that, there was tremendous increase in the patent holding of the

Indian pharma companies and 67 patents were awarded in 2007 whereas the biotech sector

registered the first patent in 2001.

The future beckons

The companies looking forward to the new greener pastures abroad will definitely look for

the protection of their products on foreign shores. So, with the increased R&D collaborations

and expanding bases, there will be a surge in the number of US and western country held

patents. As of now, generic biologicals or biosimilars doesn't have a single patent to its credit.

The lack of patents pertaining to biosimilars is due to the lack of a clear regulatory pathway

for such molecules in the US at present. Major Biologics worth $10 billion come off patent in

2009 and there are proposals before US senate to bring in the biosimilars into the US market.

Therefore, the only key that seems to break open this deadlock is innovation. The expression

systems and bio manufacturing processes are expected to have a major share in future

patents. Also, with more and more companies focusing on R&D ventures outside India, the

change in the scenario is likely to happen in the coming years. Therefore, the Indian biotech

companies venturing out for opportunities in western markets are expected to get armed with

lots of new US patents in coming years.


BIOAGRICULTURE

INDUSTRY OVERVIEW

Agriculture continues to be a fundamental instrument for sustainable development and

poverty reduction in India. India resides in its villages and according to the 2001 census 72.2

per cent of the people are in rural areas. The agriculture sector contributes only about 18 per

cent of the total Gross Domestic Product (GDP). Indian agriculture has made rapid strides

from food shortages and imports to self-sufficiency and exports. It has moved from

subsistence farming to intensive and technology led cultivation. Agriculture is at the core of

socio economic development of the country. Growth of other sectors and overall economy

depends on performance of agriculture to a considerable extent. Not only it is a source of

livelihood and food security for a large population of India, but also has a special significance

for low income, poor and vulnerable sections. However, several constraints such as

preponderance of small and marginal holdings accounting for about 82 per cent of total

holdings, imperfect market conditions and lack of backward and forward linkages have

contributed to the stagnation of the sector.

While more specifically the BioAgri sector has come of age in India. In 2004-05, Rasi Seeds

became the second company in India to make commercially available Bt cotton. With the

entry of Rasi, the entire Bt cotton seeds business changed. The release of RCH 2 Bt in 2004

by Rasi has created greater confidence in the farmers about Bt technology. The farmers have

understood that they get maximum benefit using hybrids with Bt technology and there is huge

demand.

Agriculture in India, the pre-eminent sector of the economy, is the source of livelihood of

almost two thirds of the workforce in the country. The contribution of agriculture and allied

activities to India's economic growth in recent years has been no less significant than that of

industry and services. The importance of agriculture to the country is best summed up by this

statement: "If agriculture survives, India survives".

Agri biotech is the third largest contributor to Indian biotech industry in FY 2009-2010 with a

total segment turnover of Rs 1,936 crore, accounting for almost 14.6 percent of the total

biotech revenues. Registering a growth of 37 percent over last year, BioAgri emerged the

industry's fastest growing segment. India is the fourth largest country in the world with

almost 8.4 million hectares of area under Bt cotton.

INDIAN BIOAGRICULTURE MARKET

BioAgri is the third largest contributor to Indian biotech industry in FY 2009-2010 with a

total segment turnover of US$ 427.86 million (Rs 1,936 crore), accounting for almost 14


percent of the total biotech revenues. Registering a growth of 37 percent over last year

BioAgri emerged as industry‘s fastest growing segment.

The BioAgri market, consisting of Bt cotton in the seeds category and bio pesticides and bio

fertilizers, with a total share of 6 percent was Rs 110 crore. The Hybrid seeds were estimated

at about Rs 180 crores. India is the fourth largest country in the world with almost 8.4 million

hectares of area under Bt cotton. The number of companies selling Bt cotton seeds in India

has increased dramatically over the last eight years since the first commercialization in 2002.

Today, there are over 30 companies marketing Bt cotton seeds in the country. Nuziveedu

Seeds is the largest seller with 25 percent of the market share. Rasi Seeds is close second with

19 percent market share of Bt cotton seeds. Other significant players include Ajeet Seeds.

Bio-Agri is sub categorized into three categories they are as follows

1] Tissue Culture

Plant tissue culture is a technique through which cells tissues, organs and even the whole

plant can be grown in the laboratory according to one's will throughout the year without

seasonal constraint. It is a rapid method of multiplication and thus saves time, money and

space. Within very small area large number of plants can be grown. This method is especially

important for propagation of plants in which natural propagation is difficult due to absence of

viable seeds/propagules. Thus, it is a very powerful tool for propagation and conservation of

plants in general and that of rare and endangered species in particular.

The major consumers of tissue culture plants (TCPs) are the State Agriculture Department,

Agri Export Zones (AEZs), sugar industry and private farmers. The paper industry, medicinal

plant industry and State Forest Departments are using TCPs in a limited scale. Nowadays,

PTC is used on various types of fruits, flowers, medicinal plants and even trees.

Here are some examples:

Fruits: Banana, pineapple, strawberry

Cash crops: Sugarcane, potato

Spices: Turmeric, ginger, vanilla, large cardamom, small cardamom

Medicinal plants: Aloe vera, geranium, stevia, patchouli, neem

Ornamentals: Gerbera, carnation, anthurium, lily, syngonium, cymbidium

Woody plants (trees): Teak, bamboo, eucalyptus, populous


Market scenario- For the tissue cultured plants in India

(Volume in thousand nos., Value in Rs. Lakhs)

Crop 2003-04 2004-05 2005-06 2006-07 2007-08

Volume Value Volume Value Volume Value Volume Value Volume Value

Banana 21613 1945 27537 2478 35808 3223 47470 4272 64060 5765

Pineapple 4618 693 5080 762 5588 838 6147 922 6761 1014

Grapes 926 232 975 244 1026 257 1080 270 1137 284

Sugarcane 14791 592 16271 651 18709 748 22449 898 28055 1122

Potato 6 10 22 43 83

Turmeric 634 44 698 49 767 54 844 59 929 65

Vanilla 1000 70 1245 87 1123 79 1123 79 1123 79

Large

Cardamom

2000 140 2000 140 2000 140 2000 140 2000 140

Small

Cardamom

200 18 300 27 400 36 500 45 600 54

Ginger 401 28 441 31 484 34 533 37 586 41

Medicinal

and

aromatic

plants

2100 105 11510 576 11741 587 11995 600 12275 614

Ornamentals 20290 3044 18120 2718 18944 2842 19973 2996 21172 3176

Trees 3000 750 3380 845 3824 956 4342 1086 4951 1238

Total 71579 7660 87567 8607 100436 9793 118499 11404 143731 13592


Benefits of Plant Tissue Culture

Rapid multiplication of plants

Limited requirement of mother plants

Uniformities of properties among the planting material

Disease – free planting material

Increased productivity

Non dependence on environmental conditions

India has a production capacity of 300 million plants per annum, of which around 70 percent

is actually produced by conservative measures; the market size is estimated to be more than

Rs 200 crore with an annual growth of 20 percent. Indian laboratories and companies

currently cater mostly to international markets. However, with increasing awareness about

the advantages of tissue culture raised plants, such as improvement in yield and quality; there

is a noticeable increase in the domestic consumption as well. The major domestic consumers

of tissue culture raised plants include the State Agriculture Department, agri-export zones

(AEZs), Spice Board, the sugar industry and private farmers. Apart from this, the paper

industry, medicinal plant industry and state forest departments also constitute this market.

2). Bio-fertilizers & Bio-pesticides

Bio-fertilizers - Biologically active products or microbial inoculants of bacteria, algae and

fungi either separately or in combination, which may enhance the availability of nutrients for

the benefit of plants are called biofertilizers. They also include organic fertilizers like

manures which are converted to a readily available form due to interaction of microorganisms

or their association with plants. Biofertilizer is a substance which contains living

microorganisms which, when applied to seed, plant surfaces, or soil, colonizes the

rhizosphere or the interior of the plant and promotes growth by increasing the supply or

availability of primary nutrients to the host plant. Some companies involved in production of

biofertilizers are- Pro G Agro Private Limited, Vizien Organics, Bio Organic Industries,

Vardhaman Fertilizers, ADS Agrotech Private Limited, Aksh Bio-Fertilizer, Multimol Micro

Fertilizer Industries etc.

Bio-pesticides- The Biopesticide market is growing very rapidly. This share is grow to about

4.2% by 2010 while the market value is estimated to reach more than US$ 1 billion However,

the overall growth rate of biopesticides is estimated to be about 10% per annum for the next 5

years.

Region wise, North America consumes the largest share (40%) of the global biopesticide

production followed by Europe and Oceanic countries accounting for 20% each.


Trend of global pesticide vis-à-vis biopesticide market

Indian scenario-

Organic cultivation (crops) in India is estimated at 100K hectare; Current supply stands at

approx. 3160 metric ton while estimated demand is approx.1 metric ton. Bio-fertilizer

increases yield by 8-24% to make agriculture a viable proposition. Indian bio-fertilizer and

bio-pesticides industry estimated at approx. $20M in 2008-2009; growing at a CAGR of

approx. 3% and expected to grow at a CAGR of 10%-15% till 2012. Phosphate-solubilising

micro-organisms market witnessed the most growth among bio fertilizers. Leading players

include Biotech International, Excel, and Multiplex. Many research universities and institutes

pursuing research in bio-fertilizers, for example, University of Hyderabad, National Research

Centre for Plant Biotechnology etc.

3] New crop development

Genetically modified plants are plants whose DNA is modified using genetic engineering

techniques. In most cases the aim is to introduce a new trait to the plant which does not occur

naturally in this species.

Market scenario

Global-

Global value of the biotech seed market alone was valued at US$11.2 billion in 2010 with

commercial biotech maize, soybean grain and cotton valued at ~US$150 billion for 2010.


In 2010, the global market value of biotech crops, estimated by Cropnosis, was US$11.2

billion, (up from US$10.6 billion in 2009); this represents 22% of the US$51.8 billion global

crop protection market in 2010, and 33% of the US$34 billion commercial seed market. The

estimated global farm-scale revenues of the harvested commercial ―end product‖, (the biotech

grain and other harvested products) is much greater than the value of the biotech seed alone

(US$11.2 billion) – extrapolating from 2008 data, biotech crop harvested products would be

valued at approximately US$150 billion globally in 2010, and projected to increase at up to

10 - 15% annually.

Indian Scenario-

The Indian Government had promulgated the Rules for dealing with Genetically Modified

Organisms (GMOs) in 1989

In India BT cotton launched in 2002

Indian Bio-Crop Industry estimated at approx $462 per hectare in 2008-2009; growing at a

CAGR of approx 8%.

India is the 4th largest adopter of Biotech crop in the world, outpacing Canada.

Bt crop accounts for approx 3% of total crop harvesting area.

Approx 97% of untapped market representing huge opportunity.

Bt crops improves yield by 31%.

Target for Bt crop seed replacement rate set from 20% to 35% in the ongoing 11th five year

plan

Sr. No. Crop Organization Transgene

1 Birnjal IARI( new Delhi), MAHYCO(Mumbai),

Sungro Seeds Research ltd.(Delhi)

Cry1Aa, Cry1Aabc,

Cry1Ac,

2 Cabbage Nunherms India Pvt.Ltd. Cry1Ba, Cry1Ca

3 Castor Directorate of Oil seed Research Ltd.(

Hydrabad)

Cry1Aa, Cry1Ec

4 Cauliflower Sungro Seeds Research ltd.(Delhi),

Nunherms India Pvt.Ltd.

Cry1Ac

Cry1Ba, Cry1Ca

5 Corn Monsanto India Ltd.(Mumbai) Cry1Ab

6 Groundnut ICRISAT (Hydrabad) Chitinase gene from rice

7 Okra MAHYCO(Mumbai) Cry1Ac, Cry2Ab


8 Potato Central Potato Research Institute(Shimla) RB gene derived from

Solanum bulbocastanum

9 Rice MAHYCO(Mumbai),

Tamil Nadu Agriculture University,

Cry1Ac, Cry2Ab

Rice Chitinase or tobacco

osmotin gene

10 Tomato MAHYCO(Mumbai), IARI Pusa (New

Delhi)

Antisense replicase gene

of tobacco leaf curl virus,

cry2Ab

Positive Impacts of GM crops

For the development of improved food materials, GM has the following advantages over

traditional selective breeding:

Allows a much wider selection of traits for improvement: e.g. not only pest, disease and

herbicide resistance (as achieved to date in plants) but also potentially drought resistance,

improved nutritional content and improved sensory properties

It is faster and lower in cost

Desired change can be achieved in very few generations

Allows greater precision in selecting characteristics

Reduces risk of random occurrence of undesirable traits.

These advantages could, in turn, lead to a number of potential benefits, especially in the

longer term, for the consumer, industry, agriculture and the environment:

Improved agricultural performance (yields) with less labour input and less cost input.

Benefits to the soil of ―notill‖ farming practice. Reduced usage of pesticides and herbicides

Ability to grow crops in previously inhospitable environments (e.g. via increased ability of

plants to grow in conditions of drought, soil salinity, extremes of temperature, consequences

of global warming, etc.). Improved processing characteristics leading to reduced waste and

lower food costs to the consumer. Prevention of loss of species to endemic disease (e.g. the

Cavendish dessert banana which is subject to two fungal diseases that have struck Africa,

South America and Asia, but could be reprieved by GM development of a disease resistant

version).


Negative Impacts of GM crops

There are following unintended impacts on environment, health, markets

1] Environment:

Unintended environmental impacts include harming no target and/or beneficial species in the

case of crops with engineered insecticidal properties, as well as the development of new

strains of resistant pests. Additionally there is concern that pollen from genetically

engineered herbicide resistant crops could reach wild, weedy relatives of the crop and create

so called

superweeds. This is of particular concern in the U.S. with crops such as canola and squash.

2] Health:

At present, there is no evidence to suggest that GM foods are unsafe. However, there are no

absolute guarantees, either. Unintended health impacts from GMOs concern allergens,

antibiotic resistance, decreased nutrients, and toxins.

Allergens Because protein sequences are changed with the addition of new genetic material,

there is concern that the engineered or modified organism could produce known or unknown

allergens. A recent National Research Council committee report on GMOs recommended the

development of improved methods for identifying potential allergens, "specifically focusing

on new tests relevant to the human immune system and on more reliable animal models."

Antibiotic resistance Plant genetic engineers have frequently attached genes they are trying

to insert to antibiotic resistance genes. This allows them to readily select the plants that

acquire the new genes by treating them with the antibiotic. Sometimes these genes remain in

the transgenic crop that has lead critics to charge that the antibiotic resistance genes could

spread to pathogens in the body and render antibiotics less effective. However, several panels

of antibiotic resistance experts have concluded that the risk is miniscule.

Decreased nutrients Because the DNA of genetically engineered plants is altered, there is

concern that some GMOs could have decreased levels of important nutrients, as DNA is the

code for the production of nutrients. However, it must be noted that nutritional differences

also have been documented with traditionally bred crops.

Introduced toxins Residual toxins resulting from introduced genes of the bacteria Bacillus

thuringiensis in so called Bt crops are unlikely to harm humans. This is because the toxin

produced by the bacteria is highly specific to certain types of insects. Prior to its inclusion in

GE/GM crops, Bt has been used as a biological insecticide, causing no adverse effects in

humans consuming treated crops.

Naturally occurring toxins There is concern that genetic engineering could inadvertently

increase naturally occurring plant toxins. However, traditional plant breeding also can result

in higher levels of plant toxins.


4] Bio-diesel

Bio-fuels in India are still in their infancy - about 66 million gallons of ethanol is utilized

in10 Indian states. Domestic and foreign collaborations are expected to boost India‘s bio-

diesel production to 1 million tons per year in the next 2-3 years. India has developed high-

yielding varieties of jatropha seeds. Government has been testing bio-diesel in public

transport locomotives and buses. Commercial bio-diesel production units have been set up by

Southern Online Biotechnologies and Natural Bioenergy Ltd. Bio-diesel companies have

collaborations with companies in the US and Europe. National biofuel policy of India is to

realize 20% blending of petrol and diesel with green-fuels by 2017. Ethanol and Biodiesel

blending requirements estimated to be approx 3.3 metric ton and approx. 17 metric ton by

2016 respectively.

KEY FACTS

Agriculture biotech grew at 37% in FY 2009-10.

Approx 60% of Bioagri revenue owned by top 3 players.

Approx 96% of total revenues from Indian domestic market.

Approx 8% of bioagri market owned by Bio-pesticides and Bio-fertilizers

Bt cotton driving bioagri growth with approx. 81% of total cotton area in India. Has

enabled an increase in farmers‘ income by $2B in 2007 alone

It accounts for 14.6 per cent of the country's gross domestic product (GDP) in 2009-10, and

10.23 per cent (provisional) of the total exports. The sector provided employment to 55 per

cent of the work force (about 50% for males and about 68% for females) is still in agriculture.

The total geographical area of India is 328.7 million hectares of which 140.3 million hectares

is net sown area, while 193.7 million hectares is the gross cropped area, according to the

Annual Report 2009-10 of the Ministry of Agriculture. India's agriculture and allied sector

grew by 3.8 per cent in the first six months of the current fiscal (2010-11), against one per

cent in the year-ago period on the back of better Kharif crop output. According to the GDP

data released by the Central Statistical Organisation (CSO) on November 30, 2010, the

country's farm sector grew by 2.5 per cent and 4.4 per cent each in the first two quarters of

the current fiscal, against 1.9 per cent and 0.9 per cent, respectively, in the same period last

year.

The segment will grow at an average of 26% in the next 5 years. Capital investment in

agriculture has increased from US$ 1.2 billion in 2007-08 to US$ 3.26 billion in 2010-11

(inclusive of State Plan Scheme Rashtriya Krishi Vikas Yojana), as per a Ministry of

Agriculture press release dated August 3, 2010. The total geographical area of India is 328.7

million hectares of which 140.3 million hectares is net sown area, while 193.7 million

hectares is the gross cropped area, according to the Annual Report 2009-10 of the Ministry of

Agriculture.


Production :

India is the largest producer of coconuts, mangoes, bananas, milk and dairy products, cashew

nuts, pulses, ginger, turmeric and black pepper. It is also the second largest producer of rice,

wheat, sugar, cotton, fruits and vegetables. As per the Centre for Monitoring Indian Economy

(CMIE) farm output will grow by 10 per cent to 114 million tonnes (MT) in the 2010 Kharif

season, while Rabi season is expected to report a 2 per cent increase at 116.6 MT. Oilseeds

production is expected to rise by 11.1 per cent during the season to 18.1 per cent, sugarcane

to notch up by 15.6 per cent to 321 MT and cotton to grow by 12.4 per cent to 26.9 million

bales compared to 23.9 million bales in the last season. The agency pegs the overall food

grain output growth up by 5.3 per cent to 229.7 MT. Major agricultural crops, including food

grain, oilseeds, cotton, sugarcane, and fruits and vegetables, are projected to grow by 7.2 per

cent in 2010-11, while production of non-food crops as a whole is projected to grow by 9.7

per cent in the year. There are over 30 companies marketing Bt cotton seeds in India.

Policy and regulatory framework

The various ministries within the Government of India and other agencies responsible for the

development of the agricultural sector include.

Ministry of Food Processing Industries.

Department of Agriculture & Cooperation (National Horticulture Board)

Department of Animal Husbandry, Dairying and Fisheries

Ministry of Commerce and Industry (commodity boards for rubber, coffee, tea and

spices)

National Dairy Development Board (NDDB)

FDI Policy

100 per cent FDI is allowed under the automatic route in floriculture, horticulture,

development of seeds, cultivation of vegetables and mushrooms under uncontrolled conditions

and services related to the agriculture and allied sectors.

100 per cent FDI is allowed in the tea sector, including tea plantations, under the government

route, subject to the following conditions:

Compulsory divestment of 26 per cent equity of the company in favour of an Indian

partner/the public with in a period of 5 years.

Prior approval of the state government, in the event of any future land use change.


TOP GLOBAL COMPANIES FROM VARIOUS BIOAGRICULTURE

SECTORS

1] FLORIGENE

Florigene is a biotechnology company based in Melbourne, Australia, which is principally

involved in the application of in-house genetic modification techniques to develop novel

color expressions in a range of commercial plants.

Florigene has a subsidiary division in the Netherlands and other production operations around

the world.

History

Florigene has long been associated with genetic engineering floriculture. Founded as Calgene

Pacific Ltd in 1986 with institutional backing from Amcor, CP Ventures Ltd and the Japan-

Australia Venture Capital Fund, it was one of Australia's first biotechnology companies.

In 1991, Florigene's research team announced that it had isolated the gene responsible for the

expression of the color blue in petunias, beating out rivals around the globe by a matter of

weeks. This breakthrough paved the way for the acquisition of Dutch rival, Florigene, in

1993. Calgene assumed Florigene's corporate name in 1994 to capitalise on that firm's

international reputation. Since then, Florigene has developed naturally long-life and disease

resistant carnations, new morphologies of gerberas and natural color modifications of the

three main cut flowers - roses, carnations and chrysanthemums, which it exports throughout

the Americas, Europe, the UK and Asia.

Ownership

In 2003, Japanese brewing giant and long term partner Suntory acquired 98.5% equity in

Florigene from Nufarm.

Development and Potential

The significance of Florigene's technology is the brand potential of its novel flower varieties -

a blue rose is a marketer's dream. In 2004, after 20 years and $45 million worth of exhaustive

research and prolific patenting, Florigene and Suntory scientists announced to the world the

development of the first rose in the pipeline to a true blue rose. It is expected to be

commercialized in the coming years.

Products

Florigene - Moon Carnations are an exquisite range of unique carnation varieties. The color

of these flowers is absolutely novel for carnation, and offers the floral industry new uses for

carnation. Always excellent in vase life, carnation can now be a sensational centre piece or

bouquet.


Countries of operation

Australia, Canada, United Arab Emirates, Germany, Holland, Japan, Sweden, United

Kingdom, USA, Russia

Revenues:

(Value in Billion USD)

Year 2010 2009 2008 2007 2006

Revenue 107.8 115.1 119 88.3 75.2

Gross Profit 26.6 24.9 23.1 18.7 15.9

2] BAYER CROP SCIENCES

History:

Bayer AG was founded in Barmen (today a part of Wuppertal), Germany in 1863

by Friedrich Bayer and his partner, Johann Friedrich Weskott. In order to separate operational

and strategic managements, Bayer AG was reorganized into a holding company in December

2003. The group's core businesses were transformed into limited companies, each controlled

by Bayer AG. These companies are: Bayer Crop Science AG; Bayer HealthCare AG; Bayer

Material Science AG and Bayer Chemicals AG, and the three service limited companies

Bayer Technology Services GmbH, Bayer Business Services GmbH and Bayer Industry

Services GmbH & Co. OHG.

Bayer Crop Sciences has products in crop protection and non-agricultural pest control. It also

has activities in seeds and plant traits. In 2002 Bayer AG acquired Aventis Crop Science and

fused it with their own agrochemicals division (Bayer Pflanzenschutz or "Crop Protection")

to form Bayer Crop Science. The company is now one of the world's leading

innovative crop science companies in the areas of crop protection (i.e. pesticides), non-

agricultural pest control, seeds and plant-biotechnology. In addition to conventional

agrochemical business it is involved in genetic engineering of food. The Belgian biotech

company Plant Genetic Systems, became part of the company by the acquisition of Aventis

Crop Science. Also in 2002, Bayer AG acquired the Dutch seed company Nunhems. Bayer

Crop Science is involved in a joint project with Archer Daniels Midland

Company and Daimler AG to develop jatropha as a biofuel.

Products:

In Bayer‘s Bio Science Business Unit growth would be seen in their core crops - canola,

cotton, rice and vegetables. Bayer is also expanding the business to soy and wheat and is

exploring solutions for corn and sugarcane as well. Crop seeds with enhanced yield and

quality properties for the benefit of agriculture, food and fibre manufacturers, consumers and

the environment are developed by Bayer Crop Sciences. Bayer employs modern breeding


methods including plant biotechnology for this. Bayer‘s work is focused on improving the

plant properties, for example their optimized performance under the most varied of

environmental conditions. Bayer therefore creates sustainable, plant-based solutions for

agriculture.

Countries of Operations:

Germany - headquarters of the holding company as well as the subsidiary companies Bayer

Crop Science,

Revenues:

(**Values in $ Billions)

Year 2010 2009 2008 2007

Revenue 50.64 44.98 47.51 67.47

Gross

Profit

25.95 23.14 23.14 23.76

3] DOW AGROSCIENCES

Agricultural sciences- Dow AgroSciences provides 7% of sales of the entire DOW group,

and is responsible for a range of insecticides (such as Lorsban), herbicides and fungicides.

Genetically modified plant seeds are also an important, growing area. Dow AgroSciences

sells seeds commercially under the following brands: Mycogen (grain corn, silage corn,

sunflowers, alfalfa, and sorghum), Atlas (soybean), PhytoGen (cotton) and Hyland Seeds in

Canada (corn, soybean, alfalfa, navy beans and wheat).

Countries of Operation:

Asia- Pacific, Europe, Latin America, North America

Revenues: (Value in Million USD)

Year 2010 2009 2008 2007 2006

Revenue 53,674 44,875 57,361 53,375 49,124

Gross Profit 7,894 5,727 5,448 7,073 7,598


4] MONSANTO

The Monsanto Company is U.S.based multinational agricultural.biotechnology corporation.

It is the world's leading producer of the herbicide glyphosate, marketed as "Roundup".

Monsanto is also the leading producer of genetically engineered (GE) seed. It provides the

technology in 90% of the world's genetically engineered seeds. It is headquartered in Creve

Coeur, Missouri. Agracetus, owned by Monsanto, exclusively produces Roundup

Ready soybean seed for the commercial market. In 2005, it finalized purchase of Seminis Inc,

making it the world's largest conventional seed company.

Monsanto scientists became the first to genetically modify a plant cell in 1982. Five

years later, Monsanto conducted the first field tests of genetically engineered crops.

Products:

Monsanto offers farmers a wide range of corn, soybean, cotton, wheat, canola, sorghum and

sugar cane seeds. We use our elite seed genetics and cutting-edge traits and technologies to

create products that meet farmers‘ wants and needs. These products are offered through

various brands – each of which provides farmers around the world with the solutions that best

fit their farms.

Countries of Operation:

North/ Central America, South America, Europe, Middle East, Asia Pacific, Africa

Revenues: (Values in Million U.S $)

Year 2010

2009

2008

2007

2006

Revenue 10,502 11,724 11,365 8,349 7,065

Gross

Profit

5,086 6,762 6,177 4,230 3,443

5] SYNGENTA

Syngenta is a large global Swiss agribusiness company which notably

markets seeds and pesticides. Syngenta is involved in biotechnology and genomic research.

The company is a leader in crop protection and ranks third in total sales in the commercial

agricultural seeds market. Sales in 2008 were approximately US$ 11.6 billion. Syngenta

employs over 24,000 people in over 90 countries. Syngenta is listed on both the Swiss stock

exchange and in New York.


History:

Based in Basel, Switzerland, Syngenta was formed in 2000 by the merger

of Novartis Agribusiness and Zeneca Agrochemicals. Its roots are considerably older. In

2004, Syngenta Seeds purchased the North American corn and soybean business of Advanta,

as well as Garst and Golden Harvest. In 2005, Syngenta opposed a Swiss ban on genetically

engineered organisms. In 2007, Syngenta's Canadian division was named one of Canada's

Top 100 Employers, as published in Maclean's magazine, one of only a handful of

agribusiness firms to receive this honour.

Products:

Syngenta has eight primary product lines. The company develops markets and sells products

worldwide.

Pesticides: Selective Herbicides, Non-selective Herbicides, Fungicides, Insecticides,

Professional Products

Seeds: Field Crops, Vegetables, Flowers

Countries of Operations: Switzerland, USA, UK, France, China, Brazil, India, Singapore

Revenue: (Values in Million U.S $)

Year 2010 2009 2008 2007

Revenue 11,641 10,992 11,624 9,240

Gross Profit 5,775 5,420 5,918 4,571

TOP INDIAN COMPANIES IN BIOAGRICULTURE SECTOR

Top 10 Agri Companies by Revenue (2009-10)

Sr.

no.

Company 2009-10 (Revenue in

Rs Cr)

2008-09

(Revenue in

Rs Cr)

% Change

Over 2008-09

1 Nuziveedu Seeds 476.86 449.58 6.07

2 Rasi Seeds 358.78 375.59 -4.48

3 Mahyco 312 211.12 47.78

4 Monsanto* 255 345.00 -26.09


5 Krishidhan Seeds 133.23 63.25 110.64

6 Ankur Seeds 109.5 80.35 36.28

7 Ajeet Seeds* 103 - -

8 Nath Seeds 85 48.50 75.26

9 JK Agrigenetics* 35 26.00 34.62

10 Bayer CropScience* 22.5 - -

Revenues of Indian Bioagriculture companies (in Cr Rupees) for the period 2009-2010.

1] AJEET SEEDS

History:

Ajeet Seeds Ltd established in 1986, when the Green Revolution was progressing, Ajeet

seeds participated and shared its role in this. This company is formed by a son of farmer and

industrialist Shri Padmakarrao Mulay, keeping in mind to avail best quality seeds at

reasonable rates to farming community. With the humble beginning the company started

production and marketing of public bred hybrids & varieties. Simultaneously ‗Research wing


established‘ under leadership of veteran agri-scientist and experienced professor, Dr.

Thombre.

Products:

Cereals and crops: jowar, bajra, maize, paddy, wheat, gram, pegion pea, green gram, black

gram,

Fibre and oil crops: cotton, sunflower, mustard.

Vegetable crops: hybrids of okra (bhendi), tomato, chilli, brinjal, bottle gourd and ridge

gourd. Seeds of bitter gourd, cowpea and clusterbean.

Competencies:

Plant Tissue Culture: Mass propagation, Development of novel hybrids and isogenies lines.

Molecular Biology: Gene prospecting, development of DNA based molecular markers,

development of transgenic.

Infrastructure:

State of Art plant tissue culture facility, green houses. Molecular biology facilities for gene

isolation. Diagnostic facilities for all Immunology based and PCR based assays.

Glimpse of current research:

In vitro regeneration of select vegetable crops – A prerequisite to any molecular

intervention is the development of a robust in vitro regeneration and transformation system.

Company has been actively engaged in this area and particularly focused on vegetable and

fruit corps.

Banana Development: The company is involved in vitro propagation of banana on a

commercial scale. Banana breeding is handicapped by the fact that banana is triploid and

sterile. Hence, there is need to develop alternatives. The Plant Biotechnology Centre has

embarked upon a programme of in vitro chemical mutagenesis of banana to develop novel

genotypes with enhanced agronomical characteristics.

Oil Seed Crops: Soybean is of importance both as an oil seed and as a pulse. The crop is,

however, confounded by two major problems, the presence of the antineutrient trypsin

inhibitor in the seed and pod shattering. The plant Biotechnology Centre endeavours to

address both these problems.

Molecular Biology Engineering Resistance to Biotic Stress: Almost all the vegetable crops

grown in tropical climate are invaded by fungal and viral pathogens at one or the other stage

of their life cycle. The Plant Biotechnology Centre is actively involved in the development of

transgenic expressing anti fungal peptides for resistance to fungal pathogens.


ATGC Division: Company has established a separate division by name atgc. Scientist works

to develop robust diagnostic kits, virus indexing kits, molecular diagnostics kits and services

for Indian biotechnology.

DNA Finger Printing: We use DNA finger printing on a regular basis to validate

transformation events. In recent times we are also concentrating on the development of use of

DNA finger printing for MAS breeding programme. The commercial services are available

for SSR microsatellite based DNA fingerprinting.

Development of Diagnostic Tools: Embarked upon the development of DNA and protein

based diagnostic tools and kits for pest and virus disease indexing.

ELISA Kits for Rapid Test: Immunology based ELISA test kits are available for Bt

diagnosis of –

Cry 1 Ac (Bollgard) gene

Cry 1 Ab / AC (Fusion Bt) gene

Cry 2 Ab (Bollgard-II) gene

Cry 1 EC gene

PCR Kits for Rapid Test: PCR kits are available for –

35S promoter.

SSU promoter.

OCS terminator.

SSU terminator.

Cotton SSR micro satellite based DNA finger printing.

Okra SSR micro satellite based DNA finger printing.

2] JK AGRIGENETICS:

The company has two business segments namely 'Seeds, Allied Products & Services' and

'Investments'. JK Agri Genetics has reported a sales turnover of Rs 5.30 crore and a net loss

of Rs 7.82 crore for the quarter ended Dec '10. For the quarter ended Dec 2009 the sales

turnover was Rs 7.72 crore and net loss was Rs 4.22 crore.


Products:

Seeds

Field crops: cotton, bajra, jowar, paddy, castor, mustard, redgram, soyabean, maize,

sunflower, wheat.

Vegetables: tomato, bhendi, chilli, bottle gourd, Watermelon, radish, cabbage, sweet corn,

cucumber, coriander.

Current year (2009-2010)

During the year under review, the Company achieved a turnover of Rs.123.77 Crores with

Operating Profit of Rs. 15.71 Crores and the Profit before Tax of Rs. 10.99 Crores. The sales

turnover increased by 20% over the same period of the previous year. The sale of Cotton,

Maize, and Vegetables & Rice increased while the area under cultivation of Jowar shrunk.

The profitability improved due to increased sales, as well as overall better operational

efficiencies. The Company has launched several new hybrid vegetables which have been

well received by the market. During the year the company also launched number of new Bt.

Cotton hybrids which have started finding good acceptance in the market. Even though some

of these products have been introduced this year these are likely to be major growth drivers of

sales and profitability over the next few years.

Research and development

The Company has intensified its research efforts in developing differentiated superior

products for the major segments in mandate crops. Accordingly, promising products are fast

tracked so as to select the best products whilst ascertaining the performance and stability at

several locations under varying agro climatic conditions. Simultaneously, production is taken

up so as to scale up the volumes rapidly. Various biotech tools are being applied for

introgressing the biotech traits within shortest span of time to bring down the product

development cycle time. The company has widened its collaborative network with national

and international Institutions as well as global agri-biotech companies to source out the latest

technologies/ traits. The company has already started reaping the benefits of this strategy.

Several Bt. cotton hybrids with stacked gene technology were launched during the year. In

addition, several superior virus tolerant hybrids in Tomato and Bhendi were launched.

Similar focused efforts are going on in the other crops which will start showing the results in

the next year or two, to take your company to play significant role in the market.


(Rs. in Lakhs)

Quarter ended

30.12.2010

Quarter ended

30.12.2009

Year ended

30.09.2010

Research &

Development

Expenses

284.51 252.49 1,116.36

Segment

Revenue:

Seeds, Allied

Products &

Services

529.71

631.68 11,590.27

Capital

Employed

Seeds, Allied

Products &

Services

5,229.43 5,984.46 7,665.80

Finished products: Sep 2010 (in Rs. Cr.)

Product Name Sales

Quantity

Sales

Value

Seeds 614.81 105.78

3] NATH BIOGENE (I) LTD.

Company Profile

A Pioneer Indigenous Seed Company established 30 years ago, it is one of the most

experienced seed companies in India. It has strong all India marketing network & brands. It

has strong research & testing facilities all over the country. Also, it has competitive range of

pipeline products in major field and vegetable crops.

Nath-Biogenes (I) Ltd, independently and jointly with the Global Transgenes Ltd(Sister

Concern), have been investing in one of the most intensive product development R & D

programs in the country, using Conventional Breeding Systems as well as GM Technologies.


R and D Pipeline products:

Nath seeds have a very strong product pipeline consisting of:

COTTON:

BAJRA: - NBH-1999

SORGHUM

MAIZE:

NMZ-02

NMZ-03

NMZ-1001

NMZ-1002

CHILLIES:

NCH-748

NCH-791

NCH-886

NCH-861

OKRA

NBO-443

NBO-595

TOMATO

HTM-1144

HTM-1222

4] RASI SEEDS:

History: Rasi Seeds was envisioned by Mr.M.Ramasami, and was initiated in the year 1973

in Attur located in Salem District, India. Rasi Seeds has made rapid advances from seed

production and supply ventures to a commendable position in Research and Development

(R&D) Having excelled in the Research and Development in cotton seeds, it went on to

expand into a multi-crop, multi-location quality research movement and has proved beneficial

to the farming community.

Present: The Company, already well known for its leadership in Bt Cotton is now operating

its vegetable seed business under ‗HyVeg‖ brand. Rasi Group also explores the new trends in

the industry like the corporate and contract farming, which will provide a win-win solution to

Corporate/Farmer, Spinner, Ginner and Seed Company.

R & D:

Rasi Seeds is the 2nd company to obtain regulatory approval for its popular RCH 2 Bt. Well-

maintained Research Farm of 140 acres and about 55000 Sq.Ft. contained Green House. State

of art fibre testing lab (HVI). Well equipped seed testing laboratory. Separate dehumidified

cold storage facility for Germplasm and Breeding lines. A modern high throughput biotech


facility for molecular breeding, transgenic crops production and testing Over 20 million acres

have been covered by our own cotton hybrids. Insect rearing and leaf bio assay facility for

assisting biotechnological research products. RCH 2 is one among the very few proprietary

Research Hybrids that has been notified by the Government of India.

Services Offered-

Contract farming is the best effort they take to fulfill our dream of creating a unique

organization with BREEDING TO BRANDING in house and consultations to large

corporates involved in farming are an end-to-end solution which is also unique.

R&D assistance to required corporate.

Technical services for contract farming.

Identifying, producing and supplying of high quality seeds to marketing companies

Marketing agro based products and inputs

Conducting multilocational trials/testing of hybrids on contract.

The cotton hybrids RCH2, RCH 20, RCH 134 and RCH 138 were among the top

ranking hybrids evaluated in the All India Co-ordinated Cotton Improvement Project

Development of 1405 hybrids of diverse characteristics

Testing centers in various zones for multi-location trials to evaluate hybrids for

suitability

R&D is capable of Breeding intra Hirsutum (H X H), intra Barbadense (B x B) and

inter specific (H X B) hybrids and hybrids with high ginning percentage

5] DUPONT INDIA

It is a subsidiary of US-based $26.1 billion E. I. du Pont de Nemours and Company, a 208 -

years old Science and Technology company. DuPont is a global supplier of products and

services in a variety of industries from transportation and construction to agriculture and

energy

History: DuPont India is a wholly-owned subsidiary of E. I. du Pont de Nemours and

Company. DuPont association with India started in 1802 when the first shipment of raw

materials for black powder to be used in explosives was imported by India from the U.S.

Present: Pioneer Hi-Bred International, a subsidiary of DuPont, is the world's leading

developer and supplier of advanced plant genetics for farmers, livestock producers and grain

and oilseed processors. In 2007, Pioneer entered into an agreement to work with a new seed-

conditioning facility in Medchal, on the outskirts of Hyderabad. This new facility is owned

and operated by Prasad Seeds. The new plant offers much-needed drying and conditioning

capacity for substantial increase in production to accommodate the farmers' growing demand

for seeds. The facility also has the ability to dry hybrid rice seed and condition, treat and

package rice, corn and pearl millet seed.

R&D: The center will support research and development activities in crop and industrial

biotechnology for global markets. Research teams will work together with local farmers and


regional institutions like ICRISAT and Osmania University to develop resources for food,

materials and energy markets. The biotech center will be the first center in the world to have

patent analysts working with Research and Development staff. The technical investment

made by DuPont was $1.7 billion, out of which $1.4 billion was on research and

development. The material research center and the engineering center opened in the summer

of 2008.

6] KF BIOPLANTS

KF Bioplants is India‘s premier producer and exporter in the high-technology field of plant

tissue culture. The Company was established as a joint venture between Kumar Gen Tech &

Tissue Culture Company (KGTC) and Florist de Kwakel b.v., Holland.

Infrastructure

The process begins at the in-vitro stage, and for this purpose, KF Bioplants has a massive

90,000 sq. ft. state-of-art laboratory in Pune. There are separate initiation rooms to safeguard

the quarantine status of the main facility. Rigorous procedures ensure that our contamination

rate is well below the world average. Our 22 growth rooms can store over 10 million plants at

any given time. Highly qualified personnel handle every stage of the process. KF Bioplants

employs over 425 lab technicians to ensure constant production and quality management. For

post in-vitro production, our facilities in Pune have over 4 hectares of completely controlled

greenhouses provided with cooling, heating, benches and energy screens. Finally, KF

Bioplants has world-class grading & packing facilities handling plants for safe, assured

export to the far corners of the world. Plants are sent to customers in agar, ex-agar or fully

hardened, depending on their requirements.

Products

Gerbera

Carnation

Lilium

Zantedeschia

Phalaenopsis

Gypsophila

Pot Plants

Strawberry

7] KRISHIDHAN

Krishidhan Seeds Limited is a pioneer & dynamic agricultural biotech company delivering

high quality seeds for the Indian seeds market. Krishidhan is a research-based organization.

Its R&D activities and research stations are recognized by the Department of Scientific and

Industrial Research (DSIR), Govt. of India. The company is actively involved in research,


production, processing, packing, and marketing of high quality seeds of Cotton, Cereals,

Pulses, Oil seeds and Vegetables. Recently, it has incorporated a separate legal entity as

Krishidhan Vegetable Seeds India Pvt. Ltd (KVSIPL), a company dedicated exclusively for

vegetable seeds business. Krishidhan is one amongst the first three sub-licensees of M.M.B.

India Ltd., which has commercialized Bollgard (BG-I) & Bollgard-II (BG-II) cotton hybrids

in India. With products ranging from Cotton, Cereals, Pulses, Oil seeds, Vegetables, it

command significant market share in Indian commercial seeds. Not only seeds, it also take

care of needs of farmers related to Fertilizers and Nutrients.

RECENT HAPPENINGS

In March 2010, Bharti Walmart Private Limited, the joint venture between Bharti Enterprises

and Walmart Stores Inc, launched the sustainable agricultural programme in Punjab. The

programme provides sanitation and energy-efficient solutions through community toilets and

bio-gas plants that impact the yield and quality of the farm produce. Key domestic deal in

2010: The largest deal in the sector was the acquisition of Agro Dutch Industries Ltd by Penta

Homes Pvt. Ltd., Vishwa Calibre Builders Pvt Ltd, and a private investor for US$ 85.4 million

(INR 3.9 billion).

In March 2010, the Mauritius-based private equity fund, India Agri Business Fund, agreed to

invest US$ 10 million (INR 460 million) in The Global Green Company Limited, the foods

division of the Avantha Group.

In July 2007, Cadbury India Ltd and the Tamil Nadu Horticulture Department entered an

agreement to promote cocoa farming. The five-year agreement aims to bring 50,000 acres

under cocoa farming, which would provide coconut farmers an additional income of US$ 17.4

million (INR 80 million) a year.

In August 2006, Reliance Retail entered an agreement with the Punjab government for

agricultural and retail projects entailing an initial investment of US$ 108.7 million (INR 5.0

billion). The company plans to set up rural hubs for procurement of vegetables, fruits, pulses

and other farm produces.

In 2003, Mahindra Shubhlabh Services Ltd, a subsidiary of Mahindra & Mahindra Ltd, and

Punjab Agro Food grains Corporation, entered an agreement to divert about 100,000 acres of

land from paddy (rice) to maize under contract farming.

Vibha Seeds Group, specializing inprivate crop genetics and plant breeding researches, has

invested ~$43M to setup a multi-crop seed processing facility inA.P.

Bayer CropScience AG, a subsidiary of Germanybased global crop sciences major Bayer AG

and GVK Biosciences Private Limited (GVK Bio) of Hyderabad have entered into a research

cooperation agreementin the area of early discovery chemistry.


Key –state wise contract farming initiatives by private sector

Sr.

No.

State Crop Company/corporate Area/Hectors

1 Maharashtra Soyabean Tinna Oils and Chemicals 134,800

2 Madhya

Pradesh

Wheat Hindustan Lever Ltd 15,000

3 Punjab Rice (Basmati) Satnam Overseas, DD

Intenational Inc, Amira

Foods India Ltd

14,700

4 Punjab Rice (Basmati),

Groundnut,

Potato,tomato ,chilli

PepsiCo India Ltd ~6,000

5 Karnataka Marigold & Caprica Chili AVT Natural Products Ltd 4,000

6 Punjab Rice (Basmati), Maize Maize Satnam Overseas 4,000

7 Punjab Barley United Breweries Ltd. 2,270

Investment

Total investment in the agriculture and allied sectors in 2008–09 amounted to US$ 28.87

billion (INR 1,386 billion), of which the private sector accounted for 82 per cent (US$ 23.78

billion).

Cumulative FDI inflows

Period: April 2000 to September 2010

Sector Amount (US$ million)

Agricultural services 1,540.5

Food-processing industries 1,102.0

Fermentation industries 787.72

Vegetable oils and vanaspati 185.69

Agricultural machinery 150.3


Fertilisers 121.27

Tea and coffee 94.57

Sugar 41.7

Total 4,023.8

Biodiesel

The National Biofuel policy was approved by the Union Cabinet on 11 September, 2008.

Biofuels is in its infancy, with only about 66 million gallons of ethanol utilised in Ten Indian

States. Domestic and foreign collaborations are expected to boost India‘s biodiesel production

to one million tonnes per year in the next two to three years. India has developed high-yielding

varieties of Jatropha seeds. The government has been testing bio-diesel in public transport

locomotives and buses. Commercial bio-diesel production units have been set up by Southern

Online Biotechnologies and Naturol Bioenergy Ltd.

Developments in National Biodiesel Mission.

Date Action Comments

April, 2003 Demonstration phase 2003 to 2007: Ministry

of Rural Development appointed as nodal

ministry to cover 400,000 hectares under

jatropha cultivation. This phase also proposed

nursery development, establishment of seed

procurement and establishment centres,

installation of trans-esterification plants,

blending and marketing of bio-diesel.

Public & private sector, state

government, research institutions

(Indian and foreign) involved in

the program achieved varying

degrees of success.

October,

2005

MoPNG announced bio-diesel purchase policy

in which Oil Marketing Companies (OMC)

would purchase bio-diesel across 20 procure-

ment centres across the country to blend with

high speed diesel w.e.f January 2006. Purchase

price set at Rs 26.5 per liter

Cost of bio-diesel production

higher (20 to 50 percent) than

purchase price. No sale of bio-

diesel.

2008 Self Sustaining Execution phase 2008 to 2012:

Targeted to produce sufficient biodiesel for 20

percent blending by end of XIth (2008-12) five

year plan

Lack of large scale plantations,

seed collection and extraction

infrastructure, buy-back arrange-

ments, capacity and confidence

building measures among

farmers impeded the progress of

this phase.


FUTURE OF THE SECTOR

Projected growth rate and demand for various food commodities towards 2011-12

Commodity Growth Rate

Food grains 2.21

Milk and Milk products 3.18

Meat 4.65

Eggs 4.62

Fish 4.58

Oilseeds 2.94

Vegetables 2.51

Fresh fruits 3.46

Sugar and Gur 1.88

Source: Report of the Steering Committee on Agriculture and Allied Sectors for Formulation

of the 11th Five Year Plan, Planning Commission

New technology

Though modern harvesters and planters will do a better job than their predecessors, the

combine of today still cuts, threshes, and separates grain in essentially the same way it has

always been done. However, technology is changing the way that humans operate the

machines, as computer monitoring systems, GPS locators, and self-steer programs allow the

most advanced tractors and implements to be more precise and less wasteful in the use of

fuel, seed, or fertilizer. In the foreseeable future, some agricultural machines will be capable

of driving themselves, using GPS maps and electronic sensors to become agricultural robots.

Even more esoteric are the new areas of nanotechnology and genetic engineering, where

submicroscopic devices and biological processes may be used as machines to perform

agricultural tasks.

Business wise Growth- The marketing sector suffers from long and fragmented supply

chains resulting in high waste and low efficiency. Within this sector, horticulture and

floriculture is especially sensitive to handling and transport infrastructure and evidence shows

that these costs are particularly high in India. A recent study found that the farm gate price of

horticultural products is less than 15% of the price at the importing destination. This means

improvement in production conditions and decreases in production cost will have minor

impacts on prices and shares in world markets. The major impact will come from addressing

the cost build-up from the farm gate to the world markets. Its f.o.b. prices are in most cases,


well below, international prices. Therefore, if export opportunities are tapped, domestic

demand will not be a constraint to the growth of this sector.

The major public investments in marketing have to do with modernization of existing

markets, creation of new markets, supply chain infrastructure at airports and ports, and the

development and implementation of standards relating to agricultural practices and food

safety.

Road Ahead

The country's demand for horticulture products is expected to grow by over 20 per cent to

touch 360 MT in 2020-21, according to a study conducted by the Horticulture Society of

India. The report said that rising income will create more demand for horticultural products,

which will further push the production of such crops in India.

The horticulture sector encompasses a wide range of commodities, including fruits,

vegetables, potatoes, tuber crops, and ornamentals, medicinal and aromatic crops.

The Indian organic product market, currently pegged at US$ 322.41 million, is expected to

reach US$ 2.15 billion in the next five years, as per Mukesh Gupta, President International

Competence Centre for Organic Agriculture.


Opportunities

Demand side growth alone with government

initiatives expected to help India to become

a leading agro country.

The Indian population is projected to reach

approximately 1.6 billion in 2050, thereby creating

a huge domestic demand for agricultural products.

According to the Organisation for Economic Co-

operation and Development- Food and Agri- culture

Organization, India is estimated to account for 12.1 per

cent and 21.8 per cent of the world‘s wheat and rice

production, respectively by 2015.

From 2021 demand will outstrip supply for cereals, ,

pulses, edible oil and sugar. India need a pluses

revolution in order to meet the demand.

Agricultural inputs expected to grow due to

increased production levels.

With the production levels expected to grow, agricultural

input such as fertilizers, farm equipment and machinery,

irrigation facilities , institutional credit, and research and

development, are expected to be driven towards the

higher target

Private sector involvement expected to

boost Indian agriculture further

Private equity players have invested US$ 300 million in

food processing & agri based companies during Jan-June

2010.

Indian agriculture is in a state of crisis, both from the economic and ecological points of

view. India has to shift from viewing food security at the aggregate level to ensuring

nutrition-security at the level of each individual. This will call for concurrent attention being

paid to availability, access and absorption. In India there is still a gross mismatch between

production and post-harvest technologies. This results in the spoilage of food grains and

missed opportunities for value addition and agro-processing. The use of agricultural biomass

is generally wasteful and does not lead to the creation of jobs or income. Unless attention is

paid to soil health care and enhancement, water conservation and efficient use, adoption of

climate resilient technologies, timely supply of needed inputs at affordable prices, credit and

insurance and producer-oriented marketing, a higher growth rate in agriculture cannot be

realized.


BIOINDUSTRIAL SECTOR

OVERVIEW

Bio industrial sector or Industrial biotechnology, also known as white or even environmental

biotechnology, is the modern use and application of biotechnology for the sustainable

production of industrially useful products like bio chemicals, biomaterials and Biofuels from

renewable resources, using living cells and/or their enzymes. This results generally in cleaner

processes with minimum waste generation and energy use. Enzymes which constitute a major

segment of this sector, are used in industrial processing of starch, distilleries, alcohol, textile

& garments, leather processing as well as for supplementing healthcare products. Current

practice in industrial biotechnology demonstrates that the social (People), Environmental

(Planet) and economic (Profit) benefits of bio-based processes go hand in hand. Substantial

reductions of 17-65% greenhouse gas emissions could potentially account for up to 20% of

the global Kyoto target.

Industrial biotechnology can be differentiated from pharmaceutical (red) biotechnology or

agricultural (green) biotechnology. ―Red‖ biotechnology is confined to the healthcare sector,

whereas ―green‖ biotechnology is applied to the agro-food sector. Industrial biotechnology is

mainly based on fermentation technology and biocatalysis. In a contained environment,

genetically modified or non-GM micro-organisms (e.g. yeast, fungi and bacteria) or cell lines

from animal or human origin are cultivated in closed bioreactors to produce a variety of

goods. Likewise enzymes, which are derived from these microorganisms, are applied to

catalyze a conversion in order to generate the desired products. Activities and opportunities in

this field are rapidly growing due to recent breakthroughs in genomics, molecular genetics,

metabolic engineering, and catalysis.

The Industrial Biotechnology Value Chain.

The above figure shows the industrial biotechnology value chain. Raw materials, including

crops and organic by products from agricultural sources and households, are converted into

The

Industrial

Biotechnolo

gy Value

Chain


sugars, which can be readily converted by tailor-made microorganisms into the desired

products. Typical products include enzymes, vitamins, flavours and fine chemicals such as

chiral building blocks for the pharmaceutical industry. Traditionally, The Netherlands has a

strong foothold in this value chain, given the presence of many important and international

players in the agribusiness, food and chemical industry.

Subsectors in the Bio Industrial Sector

The Textile Sector

Mankind and the environment benefit daily from industrial biotechnology without being

aware of it, for example while doing a load of laundry. Enzymes have been used in detergents

since the 1960s and since then have helped to reduce the amount of detergent released into

the environment as well as decreasing the energy needed to do laundry. In fact detergent

enzymes represent one of the largest and most successful applications of modern Industrial

Biotechnology. In addition to making clothes cleaner, one of the main environmental

advantages of cold water enzymes is that clothes can be washed at a lower temperature.

Washing machines are one of the biggest consumers of household electricity, and 80% of the

electricity for washing Laundry is used to heat the water. With the new generation of cold

water enzymes, washing temperatures can be reduced from 40°C to 30°C, without sacrificing

cleanliness, and saving 30% of the electricity used on the laundry. This one small step has not

only had an impact on electricity bills but has also significantly reduced CO2 emissions.

Studies show that CO2 emissions can be reduced by 100 g per wash by washing at 30°C

rather than 40°C. Enzymes partly replace other, often less desirable, chemicals in detergents

and contribute to reducing both the duration of the washing cycle and water consumption.

Enzymes are biodegradable, do not present risks to aquatic life, and so minimize the

environmental impact of detergents. Use of enzymes in laundering process leads to reduction

of eco-toxic substances by 5% to 60% depending on the product.

Textile bleaching is usually done using hydrogen peroxide followed by at least two rinses in

hot water (80-95°C). With the use of an enzyme that degrades residual peroxide during the

second post-bleach rinse, water heated to 30-40°C can be used and less energy is needed.

Another application of enzymes in the textile industry is in the treatment of cotton fibres.

Traditionally, before cotton can be dyed, it goes through numerous processes including a

series of chemical treatments and rinsing in water. With a biotechnology process, it is

possible to reduce the use of chemicals and therefore the amount of water needed to rinse the

fibres by as much as 30-50%. Compared to the traditional chemical process, the enzymatic

process reduces the pH (acidity) from 14 to 9 (7 = pH neutral) and temperature from 95°C to

55°C, meaning that there are important energy savings. Also, the rinse water required is

reduced by half, which in combination with the energy savings makes the process cheaper.

Finally, fibre strength and softness are improved and, because the process is milder on the

cotton, a higher yield is achieved.


Plastics production

Plastics in general are important materials contributing significantly to environmental

protection: due to their tailor-made properties (e.g. light weight, excellent insulation ability,

tuneable properties for optimum food protection, etc.) they reduce already energy use by 26%

and greenhouse gas emissions (GHG) by 56% across a variety of applications compared to

alternatives. Besides crude oil, natural gas and coal, biomass is an additional raw material

source for plastics. Today, biotech processes allow for the production of bio-based plastics

from renewable resources. Even though today bio-based plastics make up only a small

portion of all plastics produced, they contribute to a reduction of dependency on fossil fuel in

some specific sectors. In many cases, the production of bio-based polymers has a great

potential to reduce greenhouse gases. By using biotechnology processes to produce plastics,

less energy may be expended, few resources are consumed and global greenhouse gas (GHG)

emissions are reduced. Depending on the type of bio-plastic, bio-based polymers may

contribute up to a 50% decrease in terms of energy consumption and up to 67% savings of

CO2 emissions during the production process. In the future, industry expects that less energy

will be needed and GHG emissions will fall as the production processes are optimized and

new feedstock and cheaper energy sources become available.

Pulp and paper production and bleaching

GHG emissions reduction in pulp bleaching

Converting wood into paper is an energy, water and chemical intensive process. The

conventional chemical process requires boiling wood chips at around 160°C before bleaching

the pulp with chlorine dioxide. With the application of biotechnology processes, it is now

possible to reduce the amount of chlorine chemicals by 10-15% and to cut the energy used

during the bleaching process by 40% which means lower emissions during power generation.

Chemicals industry

Biotechnology can be used to produce various bulk and fine chemicals that are currently

produced from fossil fuel based feedstock. Bio-based substances can also act as building

blocks for many other materials provided that they are cost competitive. Since 1990, most

chemical processes have been replaced by fermentation. Producers now use yeasts or fungi in

a single integrated biological process. The move to bio processing for production of vitamin

B2 resulted in a 40% cost reduction and in a drastic reduction of wastes and pollutants.

The energy used in the chemical and the biotechnological processes is about equal: chemical

synthesis uses more steam (energy) which comes from fossil fuels, but fermentation involves

more electricity. However, compared to chemical synthesis, fermentation has reduced the use

of non-renewable resources by 80%, volatile organic compounds by 50% and emissions to

water by 66% while the residuals (34%) are inorganic salt and biomass.

Car engines are not the only way to reduce fuel consumption & the impact of vehicles on the

environment. Tyres can play a crucial role: out of every five full tanks of fuel, one is


consumed by tyre friction on the road. To reduce the energy consumed by the tyres hitting the

road, a technology was developed using corn starch as a polymer filer that reinforces the

tyre‘s compounds & optimizes their properties. Traditional chemical compounds such as

silica & carbon black can be replaced with a renewable & environmentally-friendly additive.

Tyres made using this technology weigh less than traditional tyres & have a 20% reduction to

rolling resistance. Combined, these two advantages have shown a decrease in fuel

consumption of up-to 5 % in tests. Moreover, this new technology decreases CO2 emissions

by 7,7g/km (0,2g/km in the production process of the filter & 7,5g/km as a result of lower

rolling resistance).

Bio-fuels

Several studies have been published on the eco-efficiency of biofuels, reporting CO2 savings

with the present biofuel technologies between 20 and 80% (depending on the feedstock and

conversion process) compared with using conventional petrol. And it is estimated that this

can increase to 90% and higher for second generation biofuels such as cellulosic ethanol.

Further innovation in the biofuel supply chain, such as high energy feedstock, less fuel

intensive cultivation of crops and low carbon conversion processes could help to achieve

further CO2 savings as well as a more sustainable use of biomass.

Food industry

Enzymes have been used in food manufacturing for hundreds of years, mainly based on

fermentation by micro-organisms. The last 10 years in particular has seen an increase in new


enzyme applications in food. Before that, the dominant new enzyme innovations were aimed

at the production of high fructose syrups from corn starch. Today, novel enzyme applications

are also being implemented in baking, fruit and vegetable processing, brewing, wine-making,

processing of vegetable oils, cheese manufacturing, and meat- and fish-processing. There are

different drivers for the use of enzyme technology in the food industry. Enzyme technology

can improve the quality of the food product, for instance, by making juice products that are

more cloud-stable (that stays clear and does not precipitate particles from the pulp) or by

reducing the content of unsaturated fat in fat spreads. The technology can further reduce

processing costs by reducing chemical and energy use and processing time. Finally many

enzymes applications in the food industry are advantageous mainly due to their impact on

processing conditions in food manufacturing plants, where enzyme use may result in savings

of energy and chemicals.

Tanning and leather industry

Enzymes have been used in the tanning industry for centuries because they are efficient in

degrading protein and fat. In early times, the enzymes were derived from animal excrement

and later on from the pancreases of cattle. Today, the enzymes are almost entirely produced

by microbial fermentation. Soaking enzymes reduce the required soaking time, the surfactant

(a molecule that lowers surface tension, e. g. increasing its wetting properties or assisting the

formulation of emulsified liquids) and soda requirements during the tanning process.

Reduced soaking time leads to electricity savings in turning the drum where the hides rest.

Enzymes that remove hair during the tanning process reduce the sulphide requirements for

the process. Comparison of conventional and enzyme-assisted bovine soaking and de-

hairing/liming processes indicates that the application of enzymes in the tanning industry is

justified by considerable energy savings and considerable reductions in the processes‘


contribution to global warming. Assuming that the environmental improvements by

switching from conventional to enzyme-assisted soaking and de-hairing/liming are applicable

worldwide, the global saving potential is in the order of 8 million GJ of energy & 0.7 million

tonnes of CO2 per year.

Dye industry

Enzymes can help to reduce the potential environmental impact of dyes; bioprocesses to

produce bio-based colorants have been developed and recently patented as an alternative to

traditional chemical synthesis. While the creation of chemical-based dyes requires

temperature up to 70-90°C in harsh conditions, the enzymatic synthesis of these colorants can

be obtained at ambient temperature, under mild conditions. A life cycle analysis24 has shown

that on an industrial scale, enzymatic processes could help to reduce CO2 emissions and

toxicity towards the environment.

INDIAN SCENARIO OF BIOINDUSTRIAL SECTOR:

The Bio Industrial market mainly comprising industrial enzymes is estimated to be Rs 564crore in the

year 2009-10 as against Rs 478crore in 2008-09. The Sector is mainly dominated by Enzymes which

constitute around 60% of the market; rest of the market is shared by Bio fuels, Chemicals etc. The

segments revenue percent share was 3.95% in 2009-2010 as compared to 3.94% in 2008-2009.

The segment grew 16 percent in FY 2009-10. Though the overall enzyme consumption figures of

India are comparatively low with respect to other countries and 60-70 percent of domestic demand is

imported, the segment on an average has been growing over 15 percent in the last five years.

In India, the industrial enzyme consumption is predominantly in the detergents market (40 percent),

followed by the starch market (25 percent). The other important segments are food and feed, textiles,


leather, pulp and paper. In recent years, enzymes have found numerous applications in the food,

pharmaceutical, diagnostic and chemical processing industries. The trend for their application in

almost every sector is on increase.

Bio Industrial sector will grow over 15% for next 5 years. The leading players in this segment include

Novozymes which has over 50 percent market share followed by Advanced Enzyme Technologies

holding 25-30 percent market share. Other important players are Maps, Genecor, Lumis and Kerry

Biosciences. Besides, a new entrant Anthem Cellutions, a part of Anthem Biosciences group has

gained significant market share over a short period of time.

Apart from focusing on the local market, companies like Advanced Enzyme Technologies are looking

at other markets such as China. Considering the potential opportunity in the other markets Advanced

Enzyme has registered good growth in its export sales. The Indian companies are reporting a good

growth; a lot of R&D is happening in these companies and new applications are being explored.

Indian companies are looking at technologies from Europe, China and Australia. However, with

respect to global enzyme industry India still needs to do a lot of catching up.

BIO FUELS:

The Indian Bio fuel market has been consistently witnessing growth and developments for

past few years. The Government of India is injecting huge amount of money and resources

into the development of this sector in an attempt to reduce dependency on imported oil. High

volatile oil prices and production levels have further enlightened the need for continuous

developments of this sector.


According to a research report "Emerging Biofuel Market in India", the Indian ethanol

consumption is projected to grow at a CAGR of around 4% during 2009-2018. Besides, the

trend of high consumption will not be limited to ethanol but biodiesel will also register strong

upsurge in consumption in coming years. Thanks to fluctuating oil prices in the international

market and continuously increasing oil import, the Indian bio fuel sector is expected to see

robust growth in coming years. Currently, ethanol dominates the Indian bio fuel sector, but

biodiesel will soon join the commercial stream as the phase one of pilot projects has already

been completed. Being at the initial stage, but with huge potential in terms of production, the

Indian bio fuel industry will prove to be a good option for bio fuel producers.

Industrial biotechnology can address emerging challenges resulting from global population

growth. Bio-based technologies can expand economic opportunities in rural areas while

reducing the burden on the environment. Bio-based technologies are an evolution, not a

revolution Modern uses of biotechnology, including industrial biotechnology, are just starting

and there are vast opportunities to use these tools in new and valuable ways. The world‘s

population will surpass 7 billion later this year and 9 billion by 2050, meaning 150,000 new

people in the world every day and an increasing need for energy. Industrial biotechnology

can provide additional sources of energy and help reduce dependence on fossil fuels.

We recognize that the future of industrial biotechnology will be based on collaborative

partnerships and no one company or country can go it alone given the complexities involved.

That is why companies like DuPont are actively engaged in global partnerships on bio fuels

technologies that produce energy from farm wastes and fuels with unique performance

properties and are delivering products from renewable feed stocks that are enabling

everything from clothing, carpets, car parts and cosmetics to airplane de-icing fluids. To

succeed in world markets, new bio-materials cannot be simple substitutions. They must result

in innovations that are more environmentally sustainable with cost parity and performance

superior to petrochemical-based equivalents. Various DuPont science-powered innovations

will yield products with fuller renewable and recyclable content, and the use of non-food feed

stocks for larger volume technologies. Biotechnology has a great impact on rural

development where renewable feed stocks are abundant. Industry is now increasing its

emphasis on bio fuels and other chemicals i.e. apart from enzymes the industry is trying to

increase its base area from one product dominated to multiproduct line so that the risk

associated with a single product line is reduced and growth prospects are also increased. In

future the share of Bio fuels and chemicals would also become very significant in this sector.

TOP COMPANIES IN INDIAN MARKET

ENZYMES

Novozymes, India:

Novozymes is the largest supplier of industrial enzymes and microorganisms in India,

catering to requirements in the detergent, food, feed, textile, leather, oils & fats, beverage

alcohol, and biofuel industries. The Company‘s enzymes and microorganisms save energy

and raw materials while reducing waste. The result is higher productivity, lower costs, and a


better environment. Novozymes has over 700 products used in 130 countries. Novozymes

has 5,200+ employees working in research, production and sales. The development,

production, distribution, and sale of enzymes form the major part of Novozymes business,

currently accounting for 94% of sales.

Biocon:

Biocon was founded on November 29, 1978 as a joint venture between Biocon Biochemicals

Ltd. of Ireland and an Indian entrepreneur, Kiran Mazumdar Shaw. In 1979, Biocon became

the first Indian company to manufacture and export enzymes to USA and Europe. Biocon is

India's largest producer and exporter of enzymes. It manufactures and markets a broad range

of industrial enzymes, food additives and process aids. Biocon is the first enzyme company

globally to receive the ISO 9001 accreditation. Enzymes manufactured by Biocon are:

Amylases, Amyloglucosidases, Cellulases, Catalase, Lipases, Glucanases, Hemicellulases,

Phytases, Proteases, and Pectinases.

Rossari Biotech Limited:

Recognized one of the industry's premier enzyme & specialty chemicals specialist, The

Company is in the manufacture of Textile, Spinfinish, Coning Oils, Sewing Thread

Lubricants and Knitting Oil, Construction Chemicals, Laundry Chemicals, Animal Health

Care and Nutrition, Pharmaceuticals Products. Manufacturing facility is spread over l0

acres of lush greenery at Village Naroli, Silvassa near Vapi.

Advanced Enzymes Technologies Ltd:

With a history spanning more than half a century, Advanced Enzymes Technologies Ltd

(Advanced Enzymes) has emerged as a worldwide leader in the production of plant,

microbial and animal-based enzymes. In 1957, founder, Mr. L.C. Rathi, pioneered the

extraction of papain, an enzyme complex derived from papaya fruit and widely used for

pharmaceutical and medical purposes. Advanced is the largest manufacturer of Enzymes in

the Indian Sub-Continent.Advanced Enzymes is one of the few manufacturers in the world

that produces a full-spectrum of enzymes derived from all four natural origins: plant, fungal,

bacterial and animal. They also manufacture probiotics, especially Bacillus coagulans and

Saccharomyces boulardii. Their state-of-the-art ISO 9001:2008 certified manufacturing

facilities utilize the most advanced, surface and submerged fermentation technologies

available. Extensive research advances have led to the development of more than 400 unique

enzyme products, making Advanced Enzymes a major value provider to Healthcare and

Processing industries worldwide. With the strength of 42+ enzymes today, Advanced

Enzymes through its technical enzyme experts is able to create value, and provide solutions,

to its clients in 37+ countries globally. Advanced Enzymes operates in four key verticals:

Human Healthcare, Animal Healthcare, Food Processing and Industrial Processing. For each

of these verticals they have created subsidiaries which focus exclusively on delivering

solutions to the industries that operate within that vertical. Advanced Vital Enzymes Ltd

(Advenza) is the human healthcare vertical, while Advanced Bio-Agro Tech Ltd (Bio-Agro)

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focuses on Animal Healthcare. Advanced BioPro Solutions Ltd (BioPro) focuses on the Food

Processing vertical while Advanced EnzyTech Solutions Ltd (EnzyTech) focuses on the

Industrial Processing vertical. Also they have created Advanced Enzyme Far East Ltd. (Far

East) to cater specifically to the large and growing Chinese market. Enzytech, a subsidiary of

Advanced Enzymes, caters solely to the industrial processing vertical consisting of: Textile

Processing, Pulp & Paper Processing and Leather Processing industries. Launched in 2008,

Enzytech is responsible for developing, manufacturing and marketing enzyme based

solutions for these industries. Having developed a dedicated research & development facility,

Enzytech's goal is to innovate, patent and provide sustainable solutions to the major industrial

hubs of Indian sub-continent.

Zytex:

Zytex was established in 1996 starting with textile enzymes; that is how the name Zytex was

coined. Zytex has a world-class R & D research lab & application support lab, which is

approved by DSIR (Department of Science and Industrial Research), Govt. of India. Since the

last decade Zytex has been the leader in India in the textile enzyme business. In 2007, they

made a strategic technical collaboration with Giovanni Bozzetto, Italy, the leading European

textile auxiliaries‘ manufacturer since 1919. Zytex research is based on fermentation

technology and with prime focus on nutraceuticals and cosmoceuticals. Zytex has established

a new manufacturing facility at Savli Biotech Park, Baroda where it will produce products,

which will be sold to Nutraceuticals. Today Zytex products are sold for Nutraceutical,

Cosmetics, Textile, Ethanol, Animal Feed and Baking industry.

BIOFUELS

BIODIESEL TECHNOLOGIES:

Biodiesel Technologies is headquartered in Kolkata. It was conceived in 2002 in response to

the serious environmental and health hazards arising out of the various polluting emissions

casing our environment. The feedstock used is organic in character which produces Biodiesel

as per the ASTM, EN and BIS Standards. Since the operation of the first Biodiesel processing

Plant in Hyderabad, Biodiesel Technologies has built a strong reputation as a leading pioneer

in the manufacturing, fabricating and assembling Biodiesel Processing Plants.

MISSION BIOFUELS INDIA PVT LTD:

Mission Biofuels India Private Limited ("MBIPL") is situated in Bhubneshwar Orissa it is a

subsidiary of Mission NewEnergy Limited was established in March 2007 for the upstream

Jatropha Curcas Feedstock Business and wind energy projects. Mission Biofuels India Private

Limited is involved in a large scale cultivation of Jatropha Curcas as well as nurseries and

procurement centres in several states of India. The company produces Jatropha oil for

production of sustainable biodiesel. Mission Biofuels has a strong network of field

professionals in 6 states of India and agreements in place with micro farming groups and

world class research groups. The company also has Partnerships with the leading Jatropha


research centre - The Energy Resources Institute (TERI), to implement optimum planting

cultivation technologies and ensure highest yields are achieved.

PRAJ INDUSTRIES:

Praj is a global Indian company that offers innovative solutions and adds value in bio-

ethanol, alcohol, brewery plants, process equipment and water and wastewater treatment

systems for customers, worldwide. Praj is a knowledge based company with expertise and

experience in Bioprocesses and engineering. Praj addresses the entire value chain for

processing of alcohol/ethanol as well as beer production, right from feedstock handling to

fermentation, distillation and waste water treatment and re-utilization. The solutions are end-

to-end and comprehensive. Praj also offers water & wastewater treatment solutions for

various applications with a focus on recycle, reuse, reduce and recover. Praj has over 450

references in more than 60 countries across 5 continents with its own offices in Bangkok

(Thailand), Johannesburg (South Africa) and Sharjah (UAE), apart from India. Praj is also

present in USA, The Netherlands, Brazil, Colombia and Guatemala.

TOP COMPANIES IN GLOBAL MARKET

Enzymes

Novozymes:

The company operates in industrial enzymes, microorganisms, and biopharmaceutical

ingredients. Their biological solutions are used in the production of numerous products such

as biofuels, detergents, food, and animal feed. In 2009, they achieved revenue of US $

1635.11 million based on a large portfolio of products and services worldwide. Their

business consists of two segments: Enzyme Business and BioBusiness. Around 14% of their

revenue is spent on research and development, and they currently hold more than 6,000

patents. The number of employees globally is over 5,200. The development, production, and

distribution of enzymes are a major part of the business, currently accounting for 94% of

sales. With a 47% share of the global enzyme market in 2009, they retained the position as

the world leader in enzymes. The enzyme market is divided into four main areas:

Detergent enzymes (32%), Technical enzymes (31%), Food Enzymes (21%), Feed

Enzymes (8%), Microorganisms (5%), Biopharmaceuticals ingredients (3%). 2009

showed a strong earnings development.

Genencor ( A Danisco division):

Genencor discovers, develops, manufactures, and delivers eco-friendly, efficient enzyme

product solutions for the agricultural processing, cleaning and textiles, food and feed,

consumer, and industrial markets. It also develops innovative advancements for the biofuels,

biodefense, and bio safety industries. Genencor is a recognized leader in protein and pathway

engineering. Genencor, Danisco‘s industrial biotech division, posted revenue of US $

881.237 million in the year 2009-10. The division showed broad-based growth in all major

product segments and all key geographies. Throughout the year, growth was particularly

strong in enzymes for Bioethanol production and animal nutrition, and strengthened product

offering and positions in many fields including detergent and food enzymes.


Biofuels

Coskata:

Coskata is a biology-based renewable energy company whose low-cost platform technology

allows for the production of fuels and chemicals from a variety of input material (including

biomass, agricultural and municipal wastes, and other carbonaceous material). Using

proprietary microorganisms and patented bioreactor designs, they are ready today to produce

FlexEthanol™, or feedstock flexible ethanol, to fuel energy security, economic growth, and

environmental sustainability. Coskata is commercializing a proprietary process and related

technologies for the conversion of a wide variety of input materials into ethanol.

Sapphire Energy:

It is a privately held company founded in May 2007. Its headquarters and primary lab are in

San Diego, California; Engineering and project management, Orange County, California;

Research and Development Facility, Las Cruces, New Mexico; Integrated Algal Bio-

Refinery, Columbus, New Mexico.

Virent Energy Systems:

Virent is commercializing an innovative advanced biofuel technology that catalytically

transforms a wide range of soluble plant sugars into hydrocarbon molecules like those

produced at a petroleum refinery. Virent‘s renewable hydrocarbons can be blended

seamlessly to make gasoline, jet fuel, and diesel. Virent made its ground-breaking discoveries

in 2006 and is rapidly advancing its innovative Bio Forming technology platform for the

production of high performance, environmentally superior biofuels. Virent and its

collaborator, Royal Dutch Shell, recently started production at the world‘s first bio gasoline

demonstration plant. The plant proves the ability to scale Virent‘s technology platform to

commercial production volumes. Virent has received significant commercial interest and


counts Cargill, Shell, and Honda among its leading investors. The company has entered into

key strategic industrial collaborations, including with Royal Dutch Shell for the development

and commercialization of bio gasoline and diesel production from plant sugars.

POET, LLC:

It is a privately held company. POET is a leader in biorefining through its efficient, vertically

integrated approach to production. Today, POET has a network of 27 plants in seven states.

POET provides turnkey development, design, engineering, construction, management and

marketing for the plant network. The 27 POET Biorefineries are owned by various investors

most of whom purchased shares in the biorefineries in a private offering. Almost all of the

biorefineries are organized as limited liability companies. Project LIBERTY is POET's large-

scale cellulosic ethanol plant. The Iowa-based company plans on using corn waste -- cobs,

husks, and leaves -- as feedstock for the ethanol plant. The plant is expected to begin

commercial operations in 2012, and POET plans on producing 3.5 billion gallons of

cellulosic ethanol by 2022.

Range Fuels:

Range Fuels is a privately held company funded primarily by greentech venture capital

companies, including Khosla Ventures, LLC, arguably the top venture firm in the U.S.

focusing on alternative, clean energy systems. Range Fuels is one of six companies selected

by the United States Department of Energy (DOE) for financial support in building

commercial cellulosic ethanol plants and is the first to break ground.

World Enzymes Market

Enzyme demand worldwide will reach $7 billion by 2013. Continued strong demand for

specialty enzymes, as well as above average growth in the animal feed and ethanol

production markets, will drive growth. Growth in specialty enzymes, nucleases and

polymerases, along with various other enzyme types, will outpace the more industrially

concentrated lipases, carbohydrases and proteases. From a regional perspective, the

developed economies of North America and Western Europe will achieve healthy gains,

while the fastest growth will continue to come from the more rapidly developing economies

of the Asia/Pacific and Africa/ Mideast regions, as well as Latin America and Eastern

Europe. World enzyme demand grew at a nearly double-digit pace from 2003 to 2008, helped

in large part by the rapid increase in world energy prices (which made enzyme-related

processes and products more cost effective, and facilitated the legislation of a rapid expansion

of the fuel ethanol market, particularly in the United States) and the successful launch of

several enzyme-containing pharmaceuticals. With the world in a global economic downturn

in 2009, however, the market for enzymes has become much more challenging, and growth

will moderate significantly going forward. Pharmaceutical and biocatalyst enzymes will lead

the growth of the global enzyme industry. Through 2013 world enzyme demand is expected

to achieve average annual gains of 6.3 percent per year, led by pharmaceutical and biocatalyst

enzymes. Diagnostics enzyme demand will also fair well due to expanded access to medical

care in developing countries, and the drive to achieve nearly universal health care in the


United States. With pharmaceutical companies having difficulty bringing new small-

molecule drugs to market, biotechnology will continue to gain in importance, helping to

sustain demand for research and biotechnology enzymes.

Among the industrial enzyme markets, animal feed and ethanol production will both achieve

above average advances, while the food and beverage market will grow at a healthy pace.

Animal feed enzymes will achieve their fastest growth in developing markets where rising

per capita incomes will continue to increase demand for meat in the local diets. However,

demand for ethanol production enzymes will slow from the torrid pace of 2003 to 2008 as

countries re-evaluate the use of food-derived raw materials for ethanol production. While the

development of second generation biofuels derived from cellulosic raw materials will help

sustain demand growth, a variety of processes -- including some that do not use enzymes - -

will be employed, restraining advances. Food and beverage enzyme demand growth will

moderate to a below average pace through 2013, reflecting the challenging environment in

North America and Western Europe. Similarly, growth in the cleaning product and other

industrial markets will also be below average.

Global Scenario:

Nowadays, multinational firms dominate the bio industrial market. For example, Monsanto,

Dupont, Syngenta, Novartis, Basf, Pioneer and so forth have jumped into the industry much

earlier than others, absolutely controlling the global market. As for the recently popular

genetically modified seeds, companies from the United States, Switzerland and Germany

account for 96% of the global market. The global market for industrial enzymes is estimated

at $3.3 billion in 2010. This market is expected to reach $4.4 billion by 2015, a compound

annual growth rate (CAGR) of 6% over the 5-year forecast period. Detergents (37%), textiles

(12%), starch (11%), baking (8%) and animal feed (6%) are the main industries, which use

about 75% of industrially, produced enzymes. Technical enzymes are valued at just over $1

billion in 2010. This sector will increase at a 6.6% compound annual growth rate (CAGR) to

reach $1.5 billion in 2015. The highest sales of technical enzymes occurred in the leather

market, followed by the bio ethanol market. The food and beverage enzymes segment is

expected to reach about $1.3 billion by 2015, from a value of $975 million in 2010, rising at a

compound annual growth rate (CAGR) of 5.1%. Within the food and beverage enzymes

segment, the milk and dairy market had the highest sales, with $401.8 million in 2009.

Merger and Acquisitions in Bioindustrial Sector

Start-ups/SMEs have four different growth strategies along the two dimensions

established/new markets and established/new technologies: internal R&D, R&D co-

operations, joint ventures as well as mergers and acquisitions (M&A).

The growth strategies all have their specific advantages and disadvantages, but currently,

most industrial biotech companies only use a very limited set of these strategies. The

preferred strategy is organic growth based on internal R&D for established markets and

technologies. Especially start-ups/SMEs use this strategy to move from a service-oriented to


an IP-oriented business model. This originates from the fact that start-ups/SMEs maintain

very good relationships with universities and research institutions and can rapidly access the

latest research results. However, since start-ups/SMEs have to carry the entire costs of R&D

activities, the number and size of projects is limited.

An option for established companies to access new technologies involves R&D co-operations

with specialized biotech start-ups/SMEs. This growth strategy has often been used in the past

and nearly all industrial biotech companies have such co-operations (e.g. R&D co-operations

of BASF, DSM, Henkel and others with Brain as example from the chemical industry and co-

operations of Shell with Codexis or Total with Gevo in the area of biofuels). They are of

special importance for industrial biotechnology as this ensures the technology transfer of

research results from universities and research institutions to established companies. In

contrast, R&D co-operations between start-ups to realize synergies on the technological as

well as the market side are rare, because of strong competition between start-up companies

for co-operation projects with established companies.

Joint ventures to open new markets are rather seldom in the area of industrial biotechnology

and mainly used to obtain access to emerging markets like China and India. With increasing

maturity of the industrial biotech sector such partnerships will grow in importance and

synergistic risk/reward sharing deal structures will begin to appear. Start-ups/SMEs avoid a

time and cost consuming development of new markets, while the market oriented partner is

able to incorporate innovative and state-of-the-art technologies into their own product

portfolio. Another growth strategy with increasing importance are M&A transactions

between established companies and start-ups/SMEs (e.g. the sale of Biopract by DSM) or

between SMEs (e.g. acquisition of Jlich Fine Chemicals through Codexis).

Followings are some important deals in Bioindustry:

Novozymes

Novozyme is working with leading distributors like Millipore/Celliance and SAFC

Biosciences that specialize in supplying solutions to the biopharmaceutical industry. This will

help to ensure that the products have the best possible access to the pharmaceutical market.

Novozymes Delta Ltd.

In July 2006 Novozymes acquired UK Company Delta Biotechnology Ltd (now Novozymes

Delta Ltd) from the sanofi-aventis group. The Nottingham-based company generated sales of

around DKK 100 million in 2006 and has around 100 employees. The acquisition has brought

additional know-how and technology in the market for recombinant human serum albumin

(rHSA). Novozymes Delta‘s most important product is Recombumin®, an FDA-approved

rHSA product. Its uses include extending the shelf-life of vaccines. As well as several other

rHSA projects, Novozymes Delta has a development project in recombinant transferrin, a

protein which is particularly good at transporting iron. The acquisition has also given


Novozymes a technology called albufuse™

, which can extend a medicine‘s action by fusing it

with albumin, and significant expertise in the production of proteins in yeast cells.

Novozymes Gropep Ltd.

In December 2006 Novozymes acquired Australian listed company GroPep Ltd (now

Novozymes GroPep Ltd). The Adelaide-based company generated sales of around DKK 70

million in the 2005/06 financial year and has around 80 employees. Its most important

product is an insulin-like growth factor (IGF) analogue. Novozymes GroPep Ltd also markets

a number of other recombinant cell culture ingredients for the biopharmaceutical industry and

has a specialist sales organisation which works with the big distributors on marketing these

ingredients to the biopharmaceutical industry. The company has various pharmaceutical

projects under development.

Advanced Enzyme Ltd.

Mumbai-based Advanced Enzyme Technologies Ltd (AETL), the country‘s second largest

natural enzyme manufacturers, set up base in China by acquiring minority stake in two

Chinese technology companies. AETL has earmarked an investment of Rs 10 crore for the

acquisition and has equity collaboration with the Japanese enzyme major-Higuchi. The

company is eyeing China not only market expansion but technology exchange as well,

according to C L Rathi, managing director of AETL. ―China has a well developed enzyme

market and we are scouting for ideal partners to leverage our capabilities both in terms of

market potential as well as technology exchange. However, it is very early to reveal the

details of the investment,‖ he said. The Rs 100 crore company has its research centre and

manufacturing facilities in India and plans to set up three new manufacturing plants in the

country. Rathi said that the additional manufacturing facilities are coming up at Indore in

Punjab, Jalna and Vasinj in Maharshtra. AETL had set up a research centre and a production

plant in US recently

DuPont

On 10 January 2011, American chemical company DuPont had announced that they will

acquire Danisco, a Danish food ingredients and enzymes producer for US$5.8 billion. The

deal is seen by many analysts as a way for DuPont to enter the niche market of chemical food

additives, which has long been dominated by their smaller rival International Flavors and

Fragrances Inc. It is also expected that the deal will see increasing cooperation between the

two firms in the field of technology for advanced bioethanol. The acquisition of Danisco will

be the largest by DuPont since it bought modified seed-maker Pioneer Hi-Bred International

Inc. for US$7.7 billion in 1999. Analysts estimate that during the past year there has been

US$84.8 billion worth of chemical -company takeovers in the past year, with an average

premium on shares of 26%.

Nalco Chemical Company

Nalco Chemical Company is the largest manufacturer and marketer of water treatment and

process chemicals and services in the world. Nalco Chemical Company announced it has

acquired the pulp and paper enzyme business of Ciba Specialty Chemicals Inc., formerly

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known as Ciba-Geigy Ltd., Basel, Switzerland. Nalco will gain worldwide exclusive rights to

this advanced enzyme technology which together with the Company's polymer technology is

used in paper mills to enhance fiber quality and water drainage during the papermaking

process. In addition, Nalco has entered into an exclusive, long-term supply and joint research

agreement with Genencor International, Inc., of Rochester, N.Y., a joint venture company

held by Eastman Chemical Company of Kingsport, Tenn., and Cultor Ltd., of Finland.

Genencor is the sole supplier of these enzyme products for Ciba Specialty Chemicals. The

agreement includes Nalco's exclusive right to use Genencor's pulp and paper enzyme

applications laboratory in Finland to further advance research and development in this area.

The lab will also provide customer support and research. Genencor is the second largest

manufacturer of industrial enzymes in the world. Nalco expects to further advance this

enzyme technology and expand its use to pulp and paper mill customers throughout the

Pacific region, Europe, Latin America and North America. "This new enzyme technology

will greatly enhance what we can offer our customers and allow us to extend our competitive

edge in this dynamic and growing market," said Peter Dabringhausen, Group Vice President

and President of Nalco's Process Chemicals division. Since May 1996, Nalco has completed

acquisitions which total nearly $100 million and add to its core water, wastewater treatment

and process chemicals capabilities.

Codexis

On February 22, 2005 Codexis, Inc., a privately held biosciences company announced it has

acquired Germany's Julich Fine Chemicals GmbH (JFC), a leading supplier of specialty

enzymes (biocatalysts) for organic synthesis and chiral building blocks to pharmaceutical and

chemical companies worldwide. The acquisition has made a positive cash contribution to

Codexis in its first full year of operations. Additional financial terms were not disclosed. JFC

is one of Europe's leading providers of products and services for the biocatalytic production

of chiral pharmaceutical intermediates. JFC will operate as an independent, wholly owned

subsidiary of Codexis. JFC offers a wide range of off-the-shelf specialty enzymes and chiral

intermediates useful in pharmaceutical development. JFC will be an outlet for several of

Codexis' proprietary enzymes, while Codexis will continue to focus on using its Molecular

Breeding(TM) directed molecular evolution technology to provide proprietary, customized

solutions directly to leading pharmaceutical companies worldwide."The acquisition of JFC is

part of Coedix strategic expansion into international markets, in particular Europe. We

believe it will accelerate adoption of Codexis' biocatalytic approach to pharmaceutical

process research and manufacturing, an area historically dominated by synthetic organic

chemistry," said Alan Shaw, Ph.D., President and Chief Executive Officer of Codexis.

Future prospect for Industrial Biotechnology (Bioindustry)

The world is facing many serious challenges. A fast-growing human population and the

consequent growing demand for food, energy and water are the most serious. In addition,

anthropogenic climatic change is a severe threat to mankind and requires that we significantly

reduce our current greenhouse gas (GHG) emissions to avoid detrimental consequences for

the globe. Only the use of new technologies will allow us to bridge the gap between

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economic growth and environmental sustainability in the long run. Over the course of many

multi-stakeholder discussions driven by the Chemicals Industry Community at the World

Economic Forum in 2008 and 2009, industrial biorefineries (bioindustry) were identified as

one potential solution that may help mitigate the threat of climate change and the seemingly

boundless demand for energy, fuels, chemicals and materials. Biorefineries are facilities that

convert biomass – biological materials from living or recently living organisms – into fuels,

energy, chemicals and materials (and feed). To date, the industry is still in a nascent state,

with most second-generation biorefineries plants (using cellulosic material) only expected to

be ready for large-scale commercial production in a few years. The landscape of active

players is rather scattered and fragmented with many relatively small technology players, but

there is an ever increasing number of large players starting to invest. Two of the main

industry drivers, in addition to energy security and environmental concerns, are mandates and

policies. Fuel regulations, such as the Low-carbon Fuel Standard introduced in California in

2007, are examples of potential industry drivers. The Standard requires fuel providers to

reduce GHG emissions of the fuel they sell, to achieve a 10% reduction in the carbon

intensity of transport fuels by 2020. Additionally, the Renewable Fuel Standard introduced in

the US in the same year sets an emissions threshold that includes direct and indirect

emissions from land use changes. Regardless of these legislation-based regional differences

in the status quo of industrial commercialization, generally the markets for bio-based

products are expected to grow very strongly globally over the next few years due to four

underlying, irreversible trends. First, the economics of fossil-based products are deteriorating

since conventional crude oil resources are getting scarce. Second is the growing need for

national energy security and geopolitical security. Third, public pressure for environmental

sustainability is increasing due to an increasing environmental awareness. Last, but not least,

rapid demographic growth will drive demand supported by rising economic aspirations of

developing countries. These fundamental trends triggered a vast interest in bio-based

products and placed them high on the strategic agenda of most players in a variety of

industries. In agriculture, for example, new economic opportunities will emerge from the

rising demand for biomass. In the chemicals industry, bio-based innovative products outside

the conventional petroleum-based product family trees will confer an advantage to players

who manage to find the right molecules and insert them into existing or new value chains. In

the automotive and aviation industries, corporations are looking at bio fuel as an important

means to reduce the GHG emissions of their fleets to comply with regional or national

regulations, while utilities are making high investments in the expansion of their renewable

power generation assets, with biomass coming third after solar and wind investments.

Future Challenges

Despite the great relevance of bio-based products for many industries, experts still see

numerous technical, strategic and commercial challenges that need to be overcome before

any large-scale commercialization of the industry can succeed. Most importantly,

biorefineries will have to employ the best possible technologies (for fermentation,

gasification and chemical conversion, and also for pre-treatment and storage) to ensure that

bio-based products break even. This will require the concerted action of many non-traditional

partners – such as grain processors, chemical companies, and technology players – to cover

all aspects of the complex biomass value chain, from feedstock production to end-user

distribution. Another significant challenge is to establish the necessary infrastructure (supply

chain and distribution infrastructure) and raise the high capital costs required. The latter are

typically beyond the financial reach of individual private companies, and may therefore

require public funding. In the United States, a recent report from Sandia showed that the US


can produce 90 billion gallons of bio fuels to replace oil (total use today is around 110 billion

gallons). With improvements in mileage, that means that US could run solely on bio fuel in

2030-2050. The limitation is not the supply of biomass but, rather, a complete infrastructure

built around oil, expected low oil prices at least between now and 2020 and a lack of political

decisions. To overcome these challenges, various stakeholders need to play different roles in

the industrialization process of biorefineries systems. Governments interested in supporting

biorefineries for reasons of environmental protection and energy security should make

significant investments in R&D, supply chain and distribution infrastructure as well as

conversion capacity, while carefully regulating the implementation process to ensure food

security and avoid land-use change. Companies highly exposed to fossil feedstock and fuels

will need to develop petroleum-replacement strategies to manage their risk, and explore the

new business opportunities created by innovative conversion technologies and novel

molecular outputs. Retail and business consumers need to be better educated about the

benefits of bio-based products both from an environmental sustainability and business

opportunity perspective. Finally, NGOs and public authorities must be involved from an early

stage to ensure development of the industry in a manner compatible with the highest

environmental and social standards. Without the latter, broad public acceptance and the

adoption of bio-based products will be hard to accomplish.

Industrial biotechnology takes the biotech tools developed to fight disease and cure illness

and applies them to the greatest challenges in industrial manufacturing, chemical synthesis,

and renewable energy production. Industrial biotechnology has not gained the recognition it

deserves, but the years ahead will see more acknowledgement of its strength. The future

major thrust area will be fuel and energy, pollution control and enzymes and products derived

from petroleum oil/crude. This area includes polymers such as plastics.

There are two important reasons for increased impetus on bioindustry: first of all, it is a

possible substitute for petroleum/ fossil fuel-based economy: Secondly, it is safe and

environment friendly. The status of bioindustry is limited since, until now, the importance of

biotechnology was mostly attributed to the pharmaceutical segment and, latterly, the

agriculture sector. Industries benefiting from biotechnology include textiles, chemicals,

pollution prevention / bioremediation, pulp and paper and metals. An important development

occurring is the replacing of hydrocarbon-based materials with renewable resources. These

resources are based on both plant and microbes and the estimates suggest that, by 2015, this

will affect the chemical industry to the tune of USD160 billion. This enormous potential

could surpass the revenue generated from the pharmaceutical and agricultural sectors.

The technologies applied in bioindustry are no different to those benefiting healthcare and

agriculture. These technologies include recombinant DNA, genomics, proteomics, gene

shuffling and high-throughput screening and advanced fermentation. An advantage of

biotechnological processes is their ability to occur at normal temperature and pressure in

more neutral conditions. This leads to fewer air emissions and therefore a reduction in plant

pollution. This means that, although bioindustrial processes require significant energy levels,

the economies favor these processes when we consider the following facts:

• Higher energy requirements can be met by generating indigenous energy at the plant using

biomass.

• The elimination/reduction of many pollution-controlling processes resulting in cost


reduction. Similarly the bioremediation sector is showing potential. Earlier approaches (using

microbes for cleaning) are increasing in scope. These days companies experiment with

genetic modification of microbes to produce better microbial species for bioremediation. In

the industrial arena, scientists are combining nanotechnology with biotechnology (bio-

nanotechnology). The research that takes place with the combination of these two advanced

sciences varies from creating smart machines to using DNA as a storage device

Collection and delivery of agricultural residues will require substantial investment in supply

infrastructure, including new planting and one-pass harvest equipment, an enhanced rail

freight network, and greater adoption of no-till cropping. Farmers can expect to recover much

of their necessary investment through residue sales - a 1,000-acre farm could expect to

recover additional costs in as little as 2 years - but government support is also needed to

speed development.

New markets that commoditize the environmental benefits of no-till farming could provide

even greater incentive for farmers to convert to no-till cropping with residue collection. New

mandatory greenhouse gas limits in California and the Northeast could help farmers earn $10

per acre or more from the sale of carbon credits.

Processing just 30 percent of U.S. corn Stover into bio fuels would reduce net U.S.

greenhouse gas emissions by 90 to 150 million metric tons of carbon dioxide equivalent

annually, enough to, Offset the CO2 emissions of 10 typical 1,000-megawatt coal-fired

power plants. More than offset recent annual growth in emissions from all sectors of the U.S.

economy.

A recent study from the University of Tennessee ("25% Renewable Energy for the United

States by 2025: Agricultural and Economic Impacts", Nov. 2006) found that:

Producing 25% of America's energy from agricultural resources would generate in

excess of $700 billion annually in economic activity, create 5.1 million jobs, and add

$180 billion to net farm income by 2025

Improved market prices for corn and other feedstock crops will produce an estimated

cumulative savings in government farm payments of $15 billion.

An analysis by the Natural Resources Defense Council found that an investment of $1 billion

in R&D and demonstration should cut the cost of producing cellulosic ethanol in half by

2015, saving consumers $20 billion per year in fuel costs by 2050 ("Growing Energy",

NRDC 2004).


BIOSERVICES SECTOR

The bioservices sector contributes a total of 22% to Indian Biotech sector and it widely

consists of:

Clinical research

Contract manufacturing

Contract research

Consultancy

With increasing pressures on R&D cost containment across the global pharmaceutical

industry, there is an increased focus on reducing the cost of clinical development, which

accounts for two-thirds of the development costs. This is in addition to the pressure of

accelerating the pace of the entire process of drug development. These challenges have led to

a paradigm shift in the approach of major pharmaceutical companies.

Clinical Research: The process of drug discovery and development takes 14.2 years

(average) and costs $802 million. Clinical trials are the most significant direct costs related to

drug discovery and development. The cost attached is about $282 million and takes about

seven years to complete. These place significant strains on a company‘s resources and

management time and hence significant amounts of these activities are being outsourced.

Besides contract research and manufacturing, India is also emerging as a global hub for

clinical trials. India is being projected to grow in this field on account of adequate patient

population having a wide spectrum of diseases, from common to the rarest, qualified medical

professionals, good communication network and IT capabilities.

Quintiles, Specialty Ranbaxy, Siro Clinpharm, Eli Lilly, Clingene International (a subsidiary

of the Biocon India Group), Lotus labs, Clintec International, Pfizer, Novo Nordisk, Lambda

Therapeutic Labs, Novartis, etc. are some of the companies conducting clinical trials in India.

Contract research: Outsourcing has become the mantra of the industry and contract research

has evolved into a huge market. India is in a unique position to tap this new business

opportunity because of three factors—a large pool of qualified English speaking

professionals, India‘s traditional strength in the pharma business and the cost-effectiveness.

And there are organizations doing contract research and trials for other companies

(independent CRO) like Quintiles Spectral, SIRO Clinpharm and Syngene. Aurigene,

Shantha Biotechnics and Chembiotech. Syngene International, a Biocon Group company, set

up in 1994 was India‘s first integrated CRO in the area of drug discovery

Contract research is very innovative, capital intensive, involving lots of R&D. Further, the

field is not process but product-driven and cannot be operated on a large scale.

Contract manufacturing: Contract manufacturing has become a big industry as India offers

a strong manufacturing base at competitive costs, supported by a well-developed engineering

base and an abundance of scientific talent. Eli Lilly, Bharat Biotech and Shreya Biotech are

some of the important contract manufacturing companies.


The Indian CRO market is currently growing at 20 percent per annum and has excellent

growth opportunities. Market trends indicate that the CRO market is going to experience

rapid growth in the coming years and will become an indispensable part of the drug

development process. The potential is huge and the opportunities exist at every level. As on

date, clinical research is still a sunrise industry in India and contributes just 0.7 percent to the

global clinical research industry but this scenario is soon expected to change.By the year

2011 India would contribute 20 percent to the global clinical research industry revenues.

Clinical Research

Clinical research is a branch of medical science that determines the safety and effectiveness

of medications, devices, diagnostic products and treatment regimens intended for human use.

These may be used for prevention, treatment, diagnosis or for relieving symptoms of a

disease.

The term clinical research refers to the entire biography of a drug from its inception in the lab

to its introduction to the consumer market and beyond. Once the promising candidate or the

molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where

different aspects of the drug (including its efficacy and toxicity) are studied.

These human studies are conducted in four phases in research subjects that give consent to

participate in the clinical trials.

Phase 1 trials: mainly targeted to identify the safety, tolerability and the mechanism of

action of drug. Studied drug investigated in minor number of healthy volunteers.

Phase 2 trials: Goal is to identify appropriate dosage and minimize safety risk for future

research subjects. Trial requires more than 100 patients to demonstrate the relevant results.

Phase 3 trials: Done to study the effectiveness of the studied drug in a variety of

demographic and socioeconomic subjects with variants of disease under study. A comparison

is usually made with standard drug available in the market. More than 1000 subjects are

exposed to the studied drug. Post this stage a New Drug Application (NDA) is filed with the

FDA

Phase 4 trials: Aim is to further characterize the safety of the drug through the identification

of unknown adverse reactions and to potentially research new therapeutic indications.

Further trials: Clinical research continues throughout the lifetime of the drug to include post

marketing surveillance where a periodic 'progress report' is submitted to the regulatory

authorities once every 2 years after the drug is released into the market, and

pharmacovigilance where the safety of marketed drugs, biologics or medical devices are

monitored. The focus of clinical research is wide enough to include important items such as

data management, medical writing, regulatory consultation, and biostatistics.

Clinical trials is the most expensive stage of the drug development chain and India possess

resources that would allow the country to offer clinical research services at very competitive

cost. The international biopharmaceutical sector finds India‘s pool of highly skilled doctors,

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trained medical personnel, investigators, and the support research infrastructure to be highly

attractive and as a result, large numbers of international companies are now viewing India as

a potential centre of knowledge, skills and resources, and are hoping to derive expertise-

based synergies from Indian partners. The foundations for clinical research clearly exist in

India, and the regulatory agency, having issued the Indian GCP guidelines in December 2001

and the Schedule Y in January 2005 (requirements and guidelines for conducting a Clinical

Trial in India), is determined, under the leadership of the new Drug Controller General of

India (DCGI), to enhance the operations of the agency and deliver timely, robust, and quality

medical advice and decisions. In addition, the Indian Council of Medical Research (ICMR)

issued the Ethical Guidelines for Biomedical Research on Human Subjects in 2000 and works

with the DCGI to improve the processes and procedures for clinical research and

development in India.

Global Market

The market for clinical trial services has been expanding rapidly, with impressive revenue

growth and expansion of the sector in recent years. Ageing populations, increasing

prevalence of chronic diseases, growing demand for improved therapies and high growth of

the pharmaceutical and biotechnology markets worldwide are driving the clinical trials sector

and market. The globalization of development programs and the increasing complexity of

trials – with regulatory developments – are heightening the need for larger trials and greater

numbers of trials. Many pharma companies are outsourcing clinical trials to gain cost

savings/efficiencies, greater flexibility and specialist expertise. The emerging clinical trial

destinations, including CEE countries, India and China, are achieving double-digit growth.

Pharmaceutical and biotechnology companies in the US spent approximately $59 billion on

R&D, which equates to roughly 18% of their sales. A significant portion of R&D budgets are

used for the outsourcing services offered by the CRO industry, approximately $15 billion.

This figure is expected to grow at 15% over the next seven years and should increase further

with the broadening of the spectrum of services outsourced to cover the entire value chain. As

outsourced services in developing countries such as China and India move up the value chain

to cover phase 1 and 2 trials, the total contracts value may go up to $20 billion. Further,

certain therapeutic areas within pharmaceutical development are slated for an even greater

growth curve, namely the oncology class, expected to see continued growth of upwards of

21% over the next few years due to the large target market, strong unmet medical need, and

overwhelming number of drugs currently in development (667 for cancer vs. 252 for CNS

disorders, 206 for cardiovascular disorders, and 186 for infections). There are over 1,100

companies in the world. It is a very fragmented industry with the top 10 controlling 56.1% of

the market.

The Indian Market

Over the past decade, there has been a perceptible change from scepticism to acceptance in

how India is viewed for clinical trials; many consider it a core region for global plans. As a

result, many global pharmaceutical players including Pfizer, Novartis, and Roche etc. have


expanded their existing clinical research investment and infrastructure in India. Clinical trials

generated an estimated $70 million in revenues for Indian companies in this sector, and the

number was predicted to grow to $200 million in 2015. Early pharmaceutical pioneers in

India faced a daunting task in operating in a regulatory and ethics environment that was

overtly unfriendly for quality clinical trials. To make matters worse there was a dearth of

experienced investigators and clinical research professionals. However, with patience and

persistence, these organizations and their supporters brought about a change in the quality of

research professionals, increased awareness of good clinical practice (GCP) compliance, and

made efforts to improve ethical aspects of clinical trial operations

.

Regulations

The Central Ethics Committee on Human Research (CECHR) of the Indian Council of

Medical Research (ICMR), New Delhi, issued Ethical Guidelines for Biomedical Research

on Human Subjects in 2000.

Subsequently in 2001, a central expert committee was set up by the Central Drugs Standard

Control Organization (CDSCO) to develop Indian GCP guidelines in line with the latest

WHO, ICH, FDA, and MHRA guidelines. A continuation of this regulatory revolution has

been revision of Schedule Y.

Schedule Y deals with regulations relating to clinical trial requirements for the import,

manufacture, and of obtaining marketing approval for a new drug in India. The procedure for

applying for marketing approval depends on the status of the new drug. When the revised

Schedule Y fully comes into force, it will confirm India‘s image as a reliable clinical research

destination.


Top global clinical research companies

In the international scene there are several clinical research companies that are making their

mark.

Dar Pharma: Mexican company which offers services (clinical trials as well as research), for

development of the new products.

Euromedex: manufactures medicines for human as well as veterinian use, health products

and medical equipment.

Gastroenterology research consultants. This organisation is totally integrated, clinical

centre comprising of nine board certified professionals in Gastroenterology as well as in

internal remedies.

Matrix contract limited is also a leading service CRO having abundance experience in

paper-based project (research projects) and e-process development in clinics.

Rostrum is also known for designing as well as delivering training for different

pharmaceuticals companies.

Cetero Research is an industry leading CRO in clinical pharmacology, bio analytical, and

specialty Phase II-IV services.

Rules-Based Medicine (RBM) is a CLIA-certified biomarker testing laboratory specializing

in cost-effective, high-quality multiplexing services.

Diteba is a research and testing laboratory that provides GMP analytical services and GLP

bioanalytical services to the pharmaceutical, biotechnology and natural health products

industries.

PRA International conducts clinical trials in more than 75 countries across 6 continents and

provides services through all phases of clinical development.

Pacific BioLabs: offers testing and research support services in the medical device,

pharm/biopharm, and other industries.

Indian Clinical research companies

Clinigene

Established in the year 2000 as a Biocon subsidiary, Clinigene became India's first CAP

(College of American Pathologists) accredited Central Laboratory. Clinigene's services now

span a broad spectrum of activities including human pharmacology, bio analytical research,


central laboratory, clinical operations, medical writing, medical monitoring, safety

management, pharmacovigilance, clinical data management & biostatistics and regulatory

services supporting early-phase through late-phase clinical development programs. Clinigene

has extensive working knowledge of a wide range of products such as biologics,

biotechnology products, vaccines, devices and small molecules. Clinigene has, in a short span

of time, earned a reputation for maintaining internationally benchmarked standards in clinical

research.

Jubilant Clinsys

Jubilant Clinsys, Inc., a Jubilant Life Sciences company, is a therapeutically focused clinical

research organization headquartered in Bedminster, New Jersey. It provides pharmaceutical,

biotechnology and medical device companies with a broad range of clinical research services

in support of Phase I-IV drug and device development, including project management,

clinical monitoring, scientific and medical support, investigator and patient recruitment, site

management, biostatistics, data management, drug safety, quality assurance, regulatory

affairs, and medical writing. Clinsys has expertise in a wide range of highly specialized

therapeutic areas, including oncology, cardiovascular, central nervous system, dermatology,

respiratory and allergy/immunology. The company has operations in Bedminster, New

Jersey; Raleigh, North Carolina; Ottawa, Ontario Canada; Düsseldorf, Germany; and Noida

and Bangalore, India.

Kendle India

Kendle International Inc. is a leading global clinical research organization providing the full

range of early- to late-stage clinical development services for the world's biopharmaceutical

industry. Kendle focuses is on innovative solutions that reduce cycle times for the customers

and accelerate the delivery of life-enhancing products to market for the benefit of patients

worldwide. As one of the world‘s largest global providers of Phase I-IV services, it offers

experience spanning more than 100 countries, along with industry-leading patient access and

retention capabilities and broad therapeutic expertise.

Other companies worth mentioning are.

Ace Biomed Private Limited

Actimus Biosciences Private Limited

Bharat Biotech International Limited

BioArc Research Solutions

Bioserve Clinical Research Private Limited

Cadila Pharmaceuticals Limited

Chembiotek Research International

Lupin Limited

Johnson and Johnson

Manipal Acunova

Lambda Therapeutic Research Limited

Novartis and Novo Nordisk India Private Ltd.


Future of clinical research

India is clearly on course to become a major centre for clinical trials, and is routinely

considered by international sponsors for their global trials. The involvement of regulatory

agencies, such as the FDA, should be seen as a beneficial step to ensure that the clinical trials

environment evolves in an appropriate fashion and that standards used to protect patients in

other markets are also applied in India. Although companies face continuing pressure to

reduce clinical development timelines and costs, it is important that these factors do not

encourage staff to let standards slip in particular markets. It is in the pharmaceutical

industry‘s interest to fully engage with Indian patients in their work. Patient participation is

essential if future drugs are to be developed successfully in India. If the public have

confidence in the industry, then rapid patient recruitment will be enhanced.

Ensuring ethical evolution - With so much attention focused on the financial aspects of the

clinical trials market in India, it is important that issues such as ethics do not take second

place. There have been occasional allegations that poor and illiterate patients in India are

being used, often unknowingly, by some CROs in India as ―human guinea pigs‖ to test new

drugs. This, of course, is unacceptable and the industry must send a clear message to its staff

about the high standards it expects for the conduct of clinical trials. All those involved in

drug development must ensure that they adhere to international and local regulations in order

to protect patients. Sponsors must verify, and not just assume, that investigators completely

understand and respect ICH–GCP, the consent process and the need for documentation of the

consent process, and the ethics process. There should also be a formal training of clinical

trials staff so that the required standards can be upheld.

CONTRACT MANUFACTURING

“Businesses today thrive by focusing on what they do best and leaving the rest to others.”

Contract manufacturing seems to fit neatly into this practice. In addition to allowing

companies to focus on core competencies, contract manufacturers offer numerous other

advantages over in-house manufacturing, including lower costs, flexibility, access to external

expertise and reduced capital. In most cases, the manufacturer will also handle the ordering

and shipment processes for the client. As a result, the client does not have to maintain

manufacturing facilities, purchase raw materials, or hire labour in order to produce the

finished goods. In manufacturing, much of the cost competitiveness comes from the

manufacturing process yield. This yield can be increased through an accurate control and

handling of the manufacturing equipment, careful selection of materials and their proper

handling on the product line. The general concept of contract manufacturing is not limited to

the production of goods. Services such as telecommunications, Internet access, and cellular

services can also be supplied by a central vendor and private branded for other customers who

wish to sell those services. Doing so allows the customer to establish a buy rate from the

vendor, and then resell the services at a profit to their own client base.

Contract manufacturing is a process that established a working agreement

between two companies. As part of the agreement, one company will custom

produce parts or other materials on behalf of their client.

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In order to secure contract manufacturing jobs, the contract manufacturer usually initiates

discussions with the potential client. The task is to convince the prospective customer that the

manufacturer can use their facilities to produce quality goods that will meet or exceed the

expectations of the customer. At the same time, the manufacturer will demonstrate how the

overall unit cost of production to the customer will be less than any current production

strategies in use, thus increasing the amount of profit that will be earned from each unit sold.

The success of contract manufacturing depends on the mutual understanding between the

contract manufacturer and the customers. The former must know how to service the latter,

and must make clear his requirements (to the customer) in advance. The relationship depends

on mutual trust, and hence the communication between the two parties must remain open.

This will help both the sides to understand the requirements of maintaining the partnership.

History/Trend

Contract manufacturing became popular in many industries during the 1990s as a way to

counter rising costs and to reinvestment. The pharmaceutical industry has been slow to adopt

this practice because of its absolute need for secrecy.

With the onset of global economic recession, several countries in the developed world began

scouting for ways to minimize expenditure on drugs. Resultantly, pharmaceutical companies

were compelled to seek ways of minimizing cost of drugs, which in turn forced them to

evaluate opportunities for manufacturing outsourcing. Despite tough times faced by

companies in the pharmaceutical contract manufacturing industry during the recession,

overall market maintained a positive growth posting only a moderate slowdown in growth.

However, a drop in venture capital funding due to the recession has compelled many

pharmaceutical and biotechnology companies to cut down on spending, affecting the fortunes

of contract manufacturers worldwide. As a result, several projects were kept on hold and new

project starts were delayed, cascading the impact of the pharmaceutical industry to the

outsourcing industry as well.

Global pharma industry has been witnessing drastic changes such as increasing competition

in generic markets, declining research and development (R&D) productivity, shrinking

average patent life, and mounting governmental pressure to reduce drug prices. Further, the

drug development process is known to extend over a period ranging from 8 to 15 years, and

the cost of bringing out a single new molecule into the market is more than US$800 million.

With limited new blockbuster drugs, the decisive factors for growth and sustainability are

faster new drug development and cost containment. When the drug gets regulatory approval,

Pharma companies will require large quantities of product supplies for marketing and

distribution. Given the considerable timelines of drug development, it is not only difficult to

project a company's manufacturing needs but also challenging to procure extensive capital

requirements. As a result, Pharmaceutical Contract Manufacturing (PCM) outsourcing

emerged to bail out Pharma companies from these manufacturing uncertainties. Initially, it

gained popularity in the US and Western Europe. Over the years, PCM outsourcing shifted its

base to low-cost nations. Today, manufacturing capacity constraints are only one of the

reasons for outsourcing. Pharmaceutical manufacturing entails sophisticated technology

(cGMP synthesis and scale up, impurity profiling, lyophilization) and strict regulatory

compliance (good manufacturing practices - GMP). Outsourcing such activities to Contract

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Manufacturing Organizations (CMOs) enables a Pharma company to expedite its R&D, and

thus realize the potential revenues. Moreover, CMOs are increasingly offering a wide range

of value-added services, which make PCMO an indispensable opportunity to Pharma

companies.

Winning Factors in Contract Manufacturing

Product Quality: Perhaps the most important thing in contract manufacturing is to produce

high-quality products.

Delivery Schedule: As All Contract manufacturer demand that their products be delivered

within contractual time frames. Maintaining a Consistent and strict delivery schedule

involves close planning of the entire production.

Cost Competitiveness: By assisting pharmaceutical companies with approval procedures, by

evaluating the safety, efficacy and quality of new medicines prior to authorization and by

constantly monitoring them once they are on the market.

CM/Customers Relationship: In CM, mutual trust plays a crucial role, Hence Customer

relations is important

Managing the Manufacturing Shop Floor: In manufacturing, obtaining a better yield

through controlling the process, process optimization, understanding and implementing new

technologies, and providing training and motivation to the production floor personnel is

important to deliver high end results.

Win- Win situation to a contract manufacturing arrangement

For the manufacturer

There is the guarantee of steady work. Having contracts in place that commit to certain levels

of production for one, two and even five year periods makes it much easier to forecast the

future financial stability of the company

For the client

There is no need to purchase or rent production facilities, buy equipment, purchase raw

materials, or hire and train employees to produce the goods. There are also no headaches

from dealing with employees who fail to report to work, equipment that breaks down, or any

of the other minor details that any manufacturing company must face daily. All the client has

to do is generate sales, forward orders to the manufacturer, and keep accurate records of all

income and expenses associated with the business venture.

Global Scenario

Global Pharmaceutical Contract Manufacturing Market to Reach US$40.7 Billion by 2015,

the pharmaceutical contract manufacturing market is expected to grow at a CAGR of around

12% during 2010-2012.

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The US represents the largest regional market for Pharmaceutical Contract Manufacturing

worldwide. Europe trails behind the US. However, future growth in the market is expected to

emanate from developing regions, such as Asia-Pacific. Japanese market for Pharmaceutical

Contract Manufacturing alone is projected to register a compounded annual growth rate of

12.8% in 1 year.

Countries like India, Brazil, Ukraine, Mexico, China and Singapore have been emerging as

the key destination for contract manufacturing. Several factors like low cost of manufacturing

and highly developed infrastructure have boosted growth in the contract manufacturing

industry. It has been observed that pharmaceutical companies are increasingly adopting the

concept of ‘virtual pharma’, wherein they retain the marketing rights while outsourcing all

manufacturing activities and related processes. This allows companies to deliver goods at a

faster rate than an internal plant would allow.

Global Manufacturing Outsourcing pie

The global market for pharmaceutical contract manufacturing witnessed robust growth in

recent years, and the future continues to hold tremendous prospects for the industry.

Some Global Players

Nycomed Abbott, US B. Braun OEM, Germany

Wockhardt, UK Laboratoria Smeets, Belgium DPT Laboratories, US

IDT Biologika GmbH,

Germany

Symyx, US Vetter Pharma International,

Germany


Indian Scenario

With an increase in the number of off-patent drugs available, the competition, both domestic

and MNCs, are tapping custom manufacturing outsourcing in a big way. India is the fastest

growing custom manufacturing outsourcing (CMO) destination with a growth rate of 43

percent, which is thrice the global market rate. India, currently the third largest active

pharmaceutical ingredient (API) player after China and Italy, is expected to be the second

largest after China by 2010. API exports from India were to the tune of $3.75 billion and are

expected to reach $12.75 billion by 2012.

Contract manufacturing market size

The Indian contract manufacturing segment is expected to reach up to $1 billion in 2011.

Factors that have led to the establishment of several CMOs in India and Reasons for high

growth in this sector:

This is driven by its ability to create a differentiating cost value proposition powered by its

lower manufacturing costs, as the cost of secondary manufacturing in India is around 13%-

15% of the cost in the US, the UK and Germany

Skilled manpower- India has more than four times the total drug manufacturing staff

than the US and more than 12 times that in the UK

Strong technical capabilities- The existence of more than 80 US FDA approved

manufacturing facilities makes India the only country outside the US to have the

highest FDA-certified manufacturing facilities.

Reliability of suppliers

Improvements in IP policy are in line with world standards, and are factors that have

led to the establishment of several CMOs in India.

Indian Companies

Ranbaxy Dr Reddy's

Laboratories

Divi's Laboratories Zydus Cadila

Cipla Alkem Dishman Alembic

Piramal

Healthcare

Lupin Shasun Chemicals Torrent Pharma

Sun Pharma Aristo Jubilant Organosys IndocoRemedies


Contract Manufacturing in India – A backgrounder

API costs account for around 30 per cent of the total cost of a generic drug. This does

not impact patented products as much as cost competitive generic medications. The price of a

generic formulation is highly dependent upon the cost of APIs and companies attempt to

determine firms, which can provide APIs with stable costs. This has resulted in a growing

demand for contract manufacturers who produce pre-determined products at prices fixed in

advance.

The contract manufacturing market comprises of bulk drugs as well as formulations.

However, the bulk drug contract manufacturing contributes to 77 per cent of the total

contract manufacturing market. India has emerged as one of the prime destinations for

contract manufacturing due to its low cost and high efficient manufacturing processes

India has a cost advantage unrivalled by many countries, while offering state-of-the-art

manufacturing facilities.

The US Senate has approved the Healthcare Bill, which entails expanding the insurance

coverage to citizens either employed with smaller companies or unemployed. It is estimated

that around 3.2Cr US citizens would now receive additional healthcare access. This

development augurs well for Indian CMO industry

India Contract Manufacturing Pie


Indian CMO – Strengths

Cost advantage: Indian companies are able to reduce the upfront capital cost of setting up a

project by 25-50 percent due to access to locally fabricated equipment and high quality local

technology/engineering skills. This benefit can be passed on to customers. Labor cost in India

is typically in the range of 10-15 percent of similar costs in the US.

Resource: India has the world's second biggest pool of English speakers and a strong system

of higher education 115,000 scientists with Masters degrees and 12,000 with PhDs every year

Regulatory & FDA: India has recorded 1,671 DMF filings, China shows a tally of 520, the

second largest number of DMF filings after India

Market Economics: The industry received investments worth Rs 21.4 bn in the form of FDI

between April 2007 and April 2009. Out of 36 countries that contributed to FDI in India, 5

countries, led by Mauritius (56.4%), Singapore (11.2%), USA (5.8%), UAE (4.7%) and

Canada (4.0%), accounted for over 82% of FDI in drugs and pharmaceuticals. According to

the Ministry of Commerce and Industry, domestic investment in the industry is estimated at

Rs 31.34 bn.

Indian CMO – Weakness

Quality practices & compliance

Recently major bulk drug companies of India have come under FDA scanner Examples:

Ranbaxy's Paonta Sahib & Manesar Mfg unit were under the FDA scan & 30 drugs banned in

US. Sun Pharma's Carcao Mfg. unit (Detroit) - was the victim of FDA rage. Cipla has been

questioned for deviation from US FDA Mfg. process

Logistics

Logistics and distribution has been Outsourcing companies‘ most perceived risk area. The

market size of Indian pharmaceutical logistics has been growing at an average annual growth

rate of four percent Latent information asymmetry; loss of logistics innovative capacity;

hidden costs; dependence on the third party logistics (3PL) providers; loss of control over the

3PL providers.

Recent Contract Manufacturing News

Global consolidation hits Indian contract drug manufacturing companies

Mergers & acquisitions in the global pharmaceutical industry that have led to reduction in

outsourced research work have hit Indian contract drug manufacturing and research services

or CRAMS companies. The impact is being felt by both large firms such as Jubilant Life

Sciences as also mid-sized firms such as Dishman Pharmaceuticals and Shasun

Pharmaceuticals. Analysts say global consolidation poses a challenge for Indian CRAMS

firm‘s revenues for the future.


The impact is visible in the financial performance of CRAMS firms:

Ahmedabad-based Dishman Pharmaceuticals & Chemicals faced a loss of Rs. 33 crore.

Another large CRAMS company Shasun Pharmaceuticals that also has bulk drug business

saw consolidated loss increase almost fivefold to 9.7 crore for the third quarter.

The country's largest CRAMs firm Jubilant Life Sciences saw its revenues from its research

services drop almost by a third shrinking its profit more than half to 44 crore for the third

quarter.

Future of Indian Contract Manufacturing

Indian CMO – Opportunities

Early Mover Advantage

Estimated USD 103 bn worth of global generic drugs are at the risk of losing their patents by

2012 India is significantly ahead in chemistry services such as analogue preparation,

analytical chemistry and structural drug design, which will provide the country with ample

avenues in the field of contract manufacturing approved facilities and 200 cGMP

manufacturing facilities

TRIPS agreement

The introduction of the new patent regime in India from January 2005 has boosted the

confidence of multinational companies looking to outsource the manufacturing of branded

drugs with the protection of intellectual property rights (IPRs). Amendment to Schedule Y to

allow parallel phase clinical trails

Government Subsidy

15 per cent capital subsidy for manufacturing facility investment and equipment projects.

SEZ – Pharmaceutical exclusive setups : Vizag and Himachal Pradesh

Domestic Market

The growing domestic market with TRIPS agreement in place presents opportunity for direct

investments of Pharma MNCs in India

Indian CMO – Threats

China and India together account for 7% of world pharmaceutical industry in value terms

with revenues of US$28 billion.FDI in pharmaceutical sector in China is more than 20 times

than in Indian sector 18 of world top 20 companies have setup their manufacturing and R&D

facilities in China China competing as bulk drug-sourcing base for MNC‘s and global

generic majors, by developing patent non-infringing processes for drugs on which the patent

is set to expire


Contract Manufacturing: Leading Players, Global Moves

Adding capacities and capabilities

Partnerships: For example: Ranbaxy – Eli Lilly, Lupin –Cynamid, Cadila –Byk Gulden,

Aurobindo – Pfizer, Dr. Reddy‘s – GSK Plc, Strides Arcolabs – Pfizer, Claris Lifescience –

Pfizer

Mergers and acquisitions: For example: Dr Reddy's Laboratories (DRL) acquired

betapharm from Germany for €480 million.

CONTRACT RESEARCH ORGANIZATIONS

A contract research organization (CRO) is a service organization that provides support to

the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical

research services (for both drugs and medical devices). CROs range from large, international

full service organizations to small, niche specialty groups and can offer their clients the

experience of moving a new drug or device from its conception to FDA marketing approval

without the drug sponsor having to maintain a staff for these services. In the Code of Federal

Regulations (CFR), the U.S. Food and Drug Administration regulations state that a CRO is "a

person [i.e., a legal person, which may be a corporation] that assumes, as an independent

contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a

protocol, selection or monitoring of investigations, evaluation of reports, and preparation of

materials to be submitted to the Food and Drug Administration."

Global Market Scenario

Despite cutbacks caused by a drop in early-stage research, a new report finds that the global

CRO market is poised to grow 14 percent per year over the next three years. That would

make contract research a $35 billion industry by 2013. The pharmaceutical and biotech

industries are facing cost containment and regulatory pressures, which drive R&D

outsourcing across the globe. Additionally, drug makers also have to jump over higher

regulatory hurdles, which have increased the complexity of clinical research. This, the

Business Insight report claims, will lead to the CRO industry's growth as drug companies

choose to outsource expensive and difficult research projects. Of the 1,100-plus CRO

companies the top 10 players only accounted for 56.1 percent of the global market (Quintiles

is the largest, with a market share of almost 17 percent). That means many smaller and mid-

sized contractors could be buyout or merger bait.


Strategies used by CROs to increase the market share

Top Companies in Global Market

Rank

2009

Company Revenue in 2009-10

1 Quintiles $ 2.5 bn

2 Covance $ 1.8 bn

3 Pharmaceutical Product Development (PPD) $ 1.4 bn

4 Charles River Laboratories (CRL) $ 1.2 bn

5 Parexel $ 930 mn

6 ICON $ 887 mn

7 Kendle $ 590 mn

8 Pharmanet $ 470 mn

9 PRA International $ 410 mn

10 Aptuit $ 370 mn

Indian Market Scenario

Contract Research activities for global Clinical Research Industry is becoming one of the

major contributors in booming Indian economy. The Top 10 CROs make up 60 percent of the

total segment revenue of Rs 2,639 crore. The segment is growing on account of the growing

requirements of the multinational companies that are looking at India as an outsourcing

destination with high-skill, low cost advantage. Besides, due to business model evolutions

driven by market forces, even the domestic companies are outsourcing various portions of the

drug discovery chain. With India offering 10-year tax concessions on revenue to local


companies making Research & Development (R&D) investments, a substantial increase in

R&D activities of both multinational and domestic biopharmaceutical companies is

inevitable. Clinical Research spending in India will increase by more than 30% annually

through 2010. Following are the factors which determine India to become a preferred

destination for contract research activities:

• Cost effectiveness (economical manpower, shorter timelines etc.).

• Large and diverse patient pool.

• World class medical infrastructures.

• Familiarity with western medical facilities.

• Succeeding with latest trends.

• Technical Support.

• Data Credibility.

• English speaking qualified professionals.

• Central lab facilities (Internationally, Nationally accredited).

• ICH/GCP guidelines implementation.

The cost of trials in India may be just 20-60 percent of the cost in western countries. At

present, about 20-30 percent of the clinical development activity is outsourced to developing

countries like India. Indian clinical trials market is expected to grow at a CAGR of nearly

36% between 2006 and 2011 to register revenues worth US$ 546 Million in future. India by

2011 will be conducting more than 15% of the total global clinical trials.


Top Companies in Indian Market

Rank

2010

Company 2009-10

(Revenue $

Million)

1 Quintiles India 83.3

2 Syngene International 56

3 Jubilant Organosys 55.4

4 Siro Clinpharm 33.3

5 Lambda Therapeutic

Research

32.2

6 Veeda Clinpharm 24.4

7 Ecron Acunova 21.5

8 Vimta Labs 19.6

9 Anthem Biosciences 11.7

10 Max Neeman

International

8.8

Quintiles India

Quintiles helps pharmaceutical, biotechnology and medical device companies develop and

market innovative therapies. It is the largest pharmaceutical contract research organization

(CRO) in the world. As the global pioneer in pharmaceutical services, Quintiles helps deliver

new drugs and cures for the world‘s most challenging diseases. For more than 25 years,

Quintiles has built its work on scientific rigor, therapeutic expertise and unparalleled service.

With offices in more than 50 countries, Quintiles is positioned to accelerate new therapies to

market — ensuring a higher level of healthcare for the people all over the world. Quintiles

has helped develop or commercialize all of the top 30 best-selling drugs. Quintiles is the only

fully integrated bio and pharmaceutical services provider offering clinical, commercial,

consulting and capital solutions. It has 22,000 employees in 60 countries that have helped to

develop or commercialize all of the top 30 best-selling drugs.


Syngene International

Established in 1994, in Bangaluru Syngene was India‘s first Contract Research Organization

(CRO). Over the past 16 years, Syngene has successfully partnered with the leading players

in global pharmaceutical, biotechnology, chemical and agrochemical industries across a wide

range of discovery and development programs. Syngene is an internationally reputed

contract research and manufacturing organisation with multidisciplinary skills in chemistry

and biology services. From early stage discovery and process development through to cGMP

manufacturing, Syngene provides customised services to pharmaceutical and biotechnology

majors, on a strong platform of confidentiality and intellectual property protection.

Siro Clinpharm

SIRO Clinpharm is a leading full service Clinical Research Organization that specializes in

providing solutions to the twin challenges of speed and cost in clinical drug development.

SIRO Clinpharm is among one of the leading global Clinical Research Organizations

(CROs), offering full scope services, conducting clinical trials in the pharmaceutical,

biotechnology and medical devices sectors in compliance with international standards. The

company has offices in India, USA, Israel and in Europe at Germany, Romania, Estonia,

Greece, Czech Republic and Spain.

Recent Happenings

Due to the tremendous growth shown by this sector, many new global companies have been

born. Also recently many mergers and acquisitions have taken place. Some of them are as

follows:

SIRO Clinpharm having presence in India, Western & Central Eastern Europe, and

US has now entered into an alliance with DreamCIS Inc., a leading CRO based out of

Seoul in South Korea. The company has also signed an agreement with Virginia

Contract Research Organization (VCRO), a Taiwan-based CRO to offer a range of

services to Taiwan companies. And, it is not just Asia Pacific market that the

company is looking at. SIRO is expanding operations in the developed markets like

USA and Europe as well. It has entered an alliance with Advanced Clinical Trial

Solutions, Flemington, NJ, USA

Syngene International, a subsidiary of Biocon Group, has partnered with Sapient

Discovery, a US-based biotechnology company. Both the companies intend to provide

a highly integrated platform for structure-based drug discovery. It also signed a pact

with another US company, Endo Pharma, to jointly discover and develop novel

biological drug molecules to fight cancer.


Bangalore-based Ecron Acunova has tied-up with a Japanese CRO and expects this

alliance to trigger a trend and set off 40-50 clinical trials between India and Japan in

the next two-to-three years. Japan is the second biggest pharma market after the US.

This apart, the Indo-German clinical research major with its established presence in

India and Europe is scouting for more market share in clinical research in these

countries and other parts of the globe.

Veeda Clinical Research, which has completed five years of existence in January

2010, has opened its office in South East Asia by signing a collaborative agreement

with the Malaysian Ministry Health to open a Phase I and Early Clinical Development

Unit in the Ampang Hospital in Kuala Lumpur.

Future of CROs

Firstly, it is unlikely that the drug development industry and process will change in any

radical fashion within the next three to five years. CROs must be mindful of these technology

advances and be prepared to mine the benefits of proven approaches. And this must be done

without either destroying the CRO‘s current infrastructure or mortgaging its future by

investing in any and all related technologies. One approach to ensure that clients have access

to the latest discovery and development technologies is to weave together a number of world-

class providers of different technologies under one service offering. Secondly, CROs must

get the ‗service‘ aspect of their business right. They have proven that they can deliver a

quality product, now they must convince the client (through actions, not words) that they can

do it consistently. Consistency in the CRO industry service starts with the staff. This means

that they must focus on developing an environment that allows staff to develop personally

and professionally, reducing the high turnover that has plagued particularly the clinical

research side of the business. Clients will reward such consistency with increased loyalty and,

ultimately, a willingness to develop closer, deeper and more strategic relationships.

Lastly, once they address the ‗service‘ issue mentioned above, CROs need to find ways to

develop and solidify more strategic (ie, deep and long-lasting) relationships with sponsors

(notably Pharma). In order to accomplish this they will have to engage senior executives

within Pharma and Biotech. These are the people who have the appropriate holistic view of

the R&D process within their respective companies and understand the value/benefits that a

more strategic, broad-based approach to outsourcing can bring – particularly to a company

that is vertically integrated. If sponsors feel comfortable that their chosen strategic CRO

partner is capable of delivering on its promise of performance – routinely and consistently –

they will invest the time required to define, negotiate and develop a close strategic

relationship.

Having made significant strides in the areas of quality and scientific expertise, CROs have

legitimately established themselves as a) alternatives to Pharma‘s internal resources, and b)

expert drug development resources for Biotech that have (rightfully so) little internal


infrastructure. Pressure on the Pharma and Biotech industries to control R&D costs while

improving the yield of new, approvable drugs points to an even greater reliance on

outsourcing. Overall, industry growth rates should remain strong. However, those CROs that

embrace their role as ‗service providers‘ and take concrete steps to improve the consistency

of the delivery of their service will be in the best position to forge stronger and more strategic

ties with their sponsors – and capture a greater share of the industry‘s growth. Success

moving forward will not be measured by how many services a CRO can deliver, but by how

well it delivers the services it offers and by how well these services can be integrated across

the continuum of drug discovery and development needs of its clients.

CROs provide services that form the pharmaceutical R&D value chain, including drug

discovery, product development and formulation, pre-clinical and clinical trial management

spanning phase I–IV. The share of CROs in the industry‘s research operations is 27%. Indian

CROs provide substantial global capacity to drug developers with full-service and specialised

CROs taking the biggest pieces of the pie. The present CRO market size is estimated at $10

billion and growing, with revenue increasing at an annual rate of 14-16%. An extensive

evaluation of the current scenario and incorporating the necessary improvisation has become

the need of the hour for making the Indian CRO sector emerge as a forerunner amongst the

highly competitive global CRO market. India has to cross the critical path with proactive risk

management approach in this world of innovations and new technology. India with its

strength will be able to outweigh inherent weakness. The opportunities are appealing and

attractive and the threats are manageable. Thus, Indian industry can carve out a niche for

itself in the global market place. Then the time is not far when India will be CRO

superpower.


CONSULTANCY

Services play a crucial role in our economy by contributing around 50% of the GDP. Among

services, consultancy profession assumes significance as a catalyst of change in the ever

expanding industrial and infrastructure scenario. Consultants help in optimizing use of

resources to enhance efficiency and overall returns from a project. Consulting is a diversified

industry that encompasses diverse trades, disciplines, services and straddles almost all the

sectors of economic activity. Consultants provide key inputs from conceptualization,

planning to implementation stages. The growth of this industry is closely linked to economic

performance and development Indian consulting industry has been in existence for some time

and has matured over a period. In last few decades, the development of consulting profession

in India has been quite significant. A large number of consultants offer a multiplicity of

consulting services in various sectors such as agriculture and rural development,

construction, manufacturing, social development, tourism, transportation, urban

development, and water supply & sanitation. Indian consultants are gaining recognition

globally for their technical prowess and capabilities.

The number of consulting firms has increased manifolds in a short span of time. It has

resulted in large number of Consulting Organization, Consultants / Domain Experts available

in India offering consulting services in almost all sectors of economic growth. With a view to

identify the key capabilities and expertise of the Indian Consulting industry and also make it

available to prospective clients both within and outside India, it is felt that a comprehensive

database of Consultancy organizations and Consultants/ Domain experts in India need to be

developed. Department of Scientific and Industrial Research (DSIR), Ministry of Science and

Technology, Govt. of India has taken initiative to prepare Industry Specific Sectoral National

Online Database of Consultants and Consultancy organizations

and has commissioned this assignment to Consultancy Development Centre (CDC), an

autonomous institution of DSIR.

Global Scenario

Global Consulting Industry Revenues (including HR, IT, strategy, operations management &

business advisory services) reached US$ 345 billion in 2010

Global Consultancies

McKinsey & Company

McKinsey is a privately held leading management consulting firm with over 80 offices

around the globe. McKinsey specializes in delivering thoughtful solutions to challenging

strategic and operational problems. The company has approximately 15,600 employees and

booked revenue in 2009 of US $6.60 Billion. McKinsey groups its practices into seven main

areas: business technology, corporate finance, marketing and sales, operations, organization,

risk, and strategy. McKinsey serves clients in numerous industry sectors, from automotive to

high tech to telecommunications


Bain & Company

Bain and Company is a global privately held management consulting company. Bain focuses

on consulting aimed at increasing efficiency, creation of value and determination of strategy.

The firm gets involved in a wide variety of corporate issues including marketing,

performance and information technology. Bain is heavily involved in mergers and

acquisitions, private equity investments and transformation plans. Bain has over 4,000

employees. Bain is also affiliated with Bain Capital, an elite private equity firm, with a record

for outstanding large investments.

Booz Allen Hamilton (not present in India)

Founded in 1914, Booz & Company is the oldest management consulting firm still in

business and the first to use the term ―management consultant". Booz is a top-tier provider of

consulting services in both the public and private sectors around the world. Booz has 3200

employees. The company has 57 offices in 33 countries. In 2008, Booz & Co separated its

operations from its U.S. Government consulting business, which retains the name Booz Allen

Hamilton.

Boston Consulting Group

The Boston Consulting Group (BCG) is a privately held management consulting company

founded in 1968 by Bruce Henderson. The company looks for insightful innovation solutions

to corporate problems. They focus on driving tangible results while making their clients more

capable. BCG has approximately 6,000 employees. BCG has more than 65 offices around the

globe.

Ernst & Young

Ernst & Young is a global leader in assurance, tax, transaction and advisory services.

Worldwide, the 141,000 people are united by the company‘s shared values and an

unwavering commitment to quality.

Deloitte

Deloitte Consulting is the consulting arm of Deloitte & Touche. Deloitte Consulting has 15,000

professionals in 33 countries and serves more than one-third of the companies in the Global Fortune®

500. Deloitte provides strategic and operational management consulting, tax advisory and financial

advisory services to many of the world's largest companies. Managing consulting practice areas

include human capital, technology/systems integration, and strategy and operations management. The

consulting practice focuses on nine industry groups: aviation and transport services; consumer

business; energy and resources; financial services; life sciences and health care; manufacturing; the

public sector; real estate; and technology, media, and communications.

KPMG

KPMG operates as an international network of member firms offering audit, tax and advisory

services. The company works closely with its clients, helping them to mitigate risks and grasp

opportunities.


Accenture

Accenture is a global management consulting, technology services and outsourcing company.

Combining unparalleled experience, comprehensive capabilities across all industries and

business functions, and extensive research on the world's most successful companies,

Accenture collaborates with clients to help them become high-performance businesses and

governments.

PwC

PwC is one of the world‘s largest providers of assurance, tax, and business consulting

services. They believe that the best outcomes are achieved through close collaboration with

the clients and the many stakeholder communities. 161,000 PwC people in 154 countries

work hard to build strong relationships with others and understand the issues and aspirations

that drive them.

IBM Global Services

IBM integrates hardware, software, business consulting and IT services into business

solutions to meet the goals. IBM also has strong alliances with partners to deliver business

solutions.

Asia Pacific Scenario

APAC- Asia Pacific consulting generated $33.5 billion as revenues in 2008 and is expected

to reach $ 39.2 billion by 2012. The consulting industry overall is growing at a CAGR of

4.1% since 2001. India contributed to 5.4% of the total revenues in Asia Pacific as compared

to Japan which contributes 67.2%. Corporate strategy, Outsourcing Services, Human

Resource Management and Operations Management have been some of the prominent

business divisions in the consulting market in the Asia Pacific Region.

Indian Scenario

India's Outsourcing & Consulting Industry Revenues contributed to US$ 47 billion in the

year 2009. The rising opportunities and growing consultancy spectrum as a result of high

demand, consulting industry in India is well poised to grow at CAGR of about 30% to carry

forward its size to over Rs. 22,000 crores as against current size of nearly Rs. 16,500 crores.

It also holds that the consultancy opportunities for domestic project managers would enhance

engagements and occupation, numbering over 3.5 lakhs in next three years in nearly 9500 to

11000 consultancy firms in the field of projects management including turned key projects,

engineering, designing, financing & auditing consultancy, besides consultancies in medical

services, travel & hospitality. Currently, approximately 7000 consultancy firms are in

operations in major cities like Delhi, Bangalore, Hyderabad, Chennai, Cochin, Ahmedabad,

Mumbai, Pune, Chandigarh and even Dehradun.


Distribution of consultancies in the Indian Metros

The future prospects for consultancies particularly in project consultancy on turned key basis

are emerging to be more exciting as India is one of the largest economies in the world with its

strategic location giving access to vast domestic and South Asian market. The presence of

skilled manpower and professional managers are available at competitive cost as India‘s

manufacturing sectors providing ample opportunities for assimilation of consultancy in

variety of sectors. Other than economies of scale, the other countries that are looking for

Indian consultancy firms to provide them innovative ways for projects execution in the field

textile and garments, energy, geology & mining, agriculture, rural development,

transportation and tourism. In case of Indonesia, Uganda and Ethiopia, the most sought after

consultancy areas from India oil & gas, education, infrastructure, IT enabled services,

mining, water management, telecommunications, construction & health, information

technology, agriculture & petrochemicals and transportation, besides power.


BIOSUPPLIERS

INDUSTRY OVERVIEW

2.1 Indian Scenario Of Biosupplier Industry

One of the main components that sustains the life sciences businesses globally are the

Biosuppliers that make components of everyday use at labs and manufacturing units. A

growing life science business, increased investment and pro active government have made

Biosuppliers take notice of the potential of Asian countries. This has, in turn, led to the

growth of a massive Biosupplier industry. This has also led to a huge windfall in terms of

investments in R&D and expansion. Top Biosupplier companies such as Pall Life Sciences,

Shimadzu, Millipore, Agilent Technologies, GE Healthcare, Thermofisher, Waters, BioTek

and Sartorius have already started business in the Asian region to meet the increasing

demands and they are investing huge amounts in building own facilities in the region.

The recession has affected Biosuppliers significantly. In FY 2009-10 they were hit hard with

the industry growth sliding to 7.5 percent, even though the overall scenario remains positive.

The overall supplier industry revenues stood at $ 865.11million as against $ 804.6 million in

2008-09. The downward trend of 2008-09, when the industry growth slipped to 16 percent

from earlier levels of 40 percent, continued in 2009-10 on account of number of MNCs

reporting flat or negative growth. However, the home-grown companies have done well-

posting healthy double digit growth. Waters India is the top biosupplier in country with a

growth of 21 percent. Top 20 bio supplier companies contributed 70 percent of the overall

supplier revenues of $ 865.11 million while the Top 20 Principals contributed about 60

percent of the revenues. Home-grown suppliers have seen stable year-on-year growth,.

Companies like Spinco Biotech, Imperial Life Sciences, and DSS Imagetech are worth a

mention. Backed by strong teams and a good strategy these have managed to grow in double

digits.

Biosupplier Industry registered 7.5% growth with a revenue of $ 865.11 million.Top 20

companies contributed 70% of this revenue. A number of MNCs reported flat or negative

growth. Fastest growing companies tally was led by small distributors. Most of the domestic

companies grew at healthy double digitsIndian

Bio Suppliers- The Challenges faced

Bio-suppliers provide the critical ingredients for Biotech research. Bio-Suppliers are under

constant pressure from their customers to offer better quality materials, at competitive pricing

and to provide for a more flexible ordering system. The challenges faced by this segment

include:

Ensure that customers make use of their products to the optimal extent, by packaging

experiment design and data analysis tool.


Offer flexible and customized order fulfilment to customers who have varied needs driven by

usage of disparate high throughout and combination of technologies

Continuous introduction of new products that meet the ever increasing high quality and low

price demands of customers while having to beat well entrenched & ―industry standard‖

competition.

2.2 Indian Biosupplier industry- Revenue and Growth Rate for 2002-10


From above two graphs we can see that though the industry is growing each year, the rate of

the growth has slowed down during last few years. The industry registered only 16 percent

growth in 2008-09, compared to last year's 30 percent growth. The Bio suppliers were hit

primarily as the Indian biotech sector deferred some of their infrastructure investments owing

to the recessionary trends. The rate of growth in Asia for most of the companies was also

slow compared to that in 2007-08 and the growth there was around 6 percent mark for most

companies considering the foreign currency movement.

70.15%

47.75%

29.74%

19.72%

Company % Share in Total Revenue(2010)

Top 20 Companies Top 10 Companies

Top 5 Companies Top 3 Companies

Total Revenue= $ 865.11 million


►Top 3 companies make up 28 percent of the total Top 20 revenues of $ 606.66 million

►Top 10 companies contribute 68 percent of the Top 20 revenue

►8 of the fastest growing supplier companies were between $ 11.11 million- $ 17.77 million

in revenues

►Top 10 companies from the North contributed 26 percent to the overall revenues.

►Top 10 companies from the South contributed 35 percent to the overall revenues.

►Top 10 companies from the West contributed 21 percent to the overall revenues.

MAJOR GLOBAL AND INDIAN BIOSUPPLIERS

3.1 Top 20 Global Biosuppliers

The table given below shows the top 20 global Bio suppliers along with their

revenues from 2005 to 2010.

Rank

2009

Company 2005-06

($

millions)

2006-07

($

millions)

2007-08

($

millions)

2008-09

($

millions)

2009-10

($

millions)

%

Change

2009-

10

1 Waters India 40.8 47.33 58.6 74 58.2 -21.43

2 Agilent

Technologies

30.8 43.1 61.5 - 56.6 -

3 Thermo

Fisher

38.2 54.6 70 41.1 46.6 13.03

North 31%

South 44%

West 25%

Region % Share in Total Revenue(2010)

Total Revenue = $ 865.11 million


Scientific

4 BD 25.1 29.5 39.5 51.5 40 -22.41

5 Millipore

India

20.2 30.2 38.4 35.5 39.3 10.43

6 Invitrogen

Bioservices

India

- - - - 33.3 -

7 Shimadzu

Analytical

(India)

21.3 24.4 28.4 34.2 31.3 -8.44

8 GE

Healthcare

10.8 13.5 17.7 26.6 26.6 0.00

9 Sigma

Aldrich India

- - - - 22.2 -

10 Merck - - - - 21.5 -

3.2 Major Global Companies

WATERS US:

Waters Corporation, founded in 1958 by James L. Waters and headquartered in Milford,

Massachusetts, U.S.A., is the world's leading supplier of ultra performance liquid

chromatography, high performance liquid chromatography, mass spectrometry, thermal

analysis and rheology instrumentation and consumables. Around the world, Waters products

are used by pharmaceutical, biotechnology, industrial, university, and government research &

development, quality assurance, and environmental testing laboratories. For these customers,

they provide technology that gives scientists fundamental data on the composition of natural

products and synthetic chemical mixtures and the physical properties of materials. An

independent company since 1994, Waters and its subsidiaries employ 4,500+ persons around

the world each with an average of 10 years service with the company. The company is

Operating in 27 countries, including 11 manufacturing facilities, with products available in

more than 50 countries.Exports account for nearly two-thirds of Waters' sales while the

company's largest single market is the pharmaceutical industry. Waters is a member of the

Standard and Poors 500 Index.

Its main product areas are-

Chromatography Consumables & Columns

Analytical & Preparative Columns


Sample Preparation Products

Bio Separation Products and Columns

SFC Columns

Sample Vials & Plates

GPC & GFC Columns and Standards

AGILENT TECHNOLOGIES

As the world's premier measurement company, Agilent offers the broadest range of

innovative measurement solutions in the industry. The company's three businesses --

Chemical Analysis, Life Sciences and Electronic Measurement -- provide customers with

products and services that make a real difference in the lives of people everywhere. Agilent is

committed to providing innovative measurement solutions that enable its customers and

partners to deliver the products and services that make a measurable difference in the lives of

people everywhere. The company has 18,500 employees and serves customers in more than

100 countries. Agilent had net revenues of $5.4 billion in fiscal year 2010.

Market Leadership

Agilent holds many product and market leadership positions, including being first worldwide

in overall test and measurement products, as well as in gas chromatographs and liquid

chromatography/mass spectrometry.

Within life sciences, their solutions are focused in the following markets:

Pharmaceutical Companies

Biotechnology Companies

Academic and Government Laboratories

Contract Research Organizations

Contract Marketing Organizations

Within chemical analysis, Agilent focuses on the following markets:

Energy & Fuels

Environmental

Food Safety

Forensics

Bioagriculture

Homeland Security

Product areas

Gas Chromatography

Liquid Chromatography

Mass Spectrometry

ICP-MS

Magnetic resonance

Reagents


Microarrays

Sequencing Target Enrichment

Microfluidics

Consumables and Services

Capillary Electrophoresis

Lab Automation

Software and Informatics

Vacuum Technology

Thermo Fischer Scientific

Thermo Fisher Scientific is the world leader in serving science. The company enables its

customers to make the world healthier, cleaner and safer by providing analytical instruments,

equipment, reagents and consumables, software and services for research, analysis, discovery

and diagnostics. With annual sales of more than $11 billion, Thermo Fisher Scientific has

approximately 37,000 employees and serves more than 350,000 customers in pharmaceutical

and biotech companies, hospitals and clinical diagnostic labs, universities, research

institutions and government agencies, as well as environmental, industrial quality and process

control settings.

The company delivers the industry‘s broadest selection of analytical instruments, equipment,

consumables and laboratory supplies. Its growing portfolio of products includes innovative

technologies for mass spectrometry, elemental analysis, molecular spectroscopy, sample

preparation, informatics, fine and high-purity chemistry production, cell culture, RNA

interference analysis and immunodiagnostic testing, as well as air and water quality

monitoring and process control.

Markets Served

Thermo Fisher Scientific offers a complete and integrated portfolio of solutions and services

for laboratory research and analysis, healthcare and clinical science and manufacturing and

the field.

A. Laboratory Research and Analysis

Thermo Fisher Scientific serves the pharmaceutical, biotechnology, academic, government

and other research and industrial laboratory markets. Its products and integrated solutions are

used by pharmaceutical companies for drug discovery and development, by biotechnology

companies and universities for life science research to discover new cures and preventions for

disease and in laboratories focused on elemental analysis of liquids and solids. This includes-

Analytical instrumentation

Lab equipment

Research consumables

Fine and high-purity chemistry


Propriety protein, nucleic acid, cell biology and cell-culture

Software and Laboratory Information Management Systems

B. Healthcare and Clinical Science

Thermo Fisher Scientific healthcare solutions include a full range of supplies for hospitals,

clinical laboratories, reference laboratories and physician‘s offices. Its clinical diagnostic

products and services are used by healthcare facilities and independent laboratories to analyze

patient samples, such as blood. It includes-Clinical testing systems and supplies Diagnostic

products and services Clinical trial support services

C. Manufacturing and the Field

Thermo Fisher Scientific provides products, solutions and services for process control and

optimization and for environmental monitoring, safety and security. Offerings include a

complete range of fixed and portable instruments for detecting radiation, explosives and

chemicals and instrumentation used in manufacturing to ensure quality control through

precise monitoring, measurement and analysis. It includes-Process instruments

Environmental analysis instrumentation Security and detection devices.

Brands

Thermo Fisher Scientific is the world leader in serving science supporting customers through

two premier brands - Thermo Scientific and Fisher Scientific - along with a family of

specialty product brands.

Thermo Scientific

The Thermo Scientific brand encompasses a complete range of high-end analytical

instruments as well as laboratory equipment, software, services, consumables and reagents to

enable integrated laboratory workflow solutions.

Fisher Scientific

Fisher Scientific is our premier customer channel and services brand providing a complete

portfolio of laboratory equipment, chemicals, supplies and services used in healthcare,

scientific research, safety and education through the most convenient purchasing options

from a single purchase to a supply chain solution

Becton-Dickinson

BD is a leading global medical technology company that develops, manufactures and sells

medical devices, instrument systems and reagents. BD is focused on improving drug delivery,

enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing


research, discovery and production of new drugs and vaccines. Founded in 1897 and

headquartered in Franklin Lakes, New Jersey, BD employs approximately 29,000 associates

in more than 50 countries throughout the world. The Company serves healthcare institutions,

life science researchers, clinical laboratories, the pharmaceutical industry and the general

public.BD Worldwide fetched revenues around US $ 7.37 billion in 2010.

BD Worldwide segments:

A.BD MEDICAL:

This segment deals with the supply of Medical Surgical Systems, Anaesthesia Products,

Infusion Therapy Products, Injection Products, Sharps Disposal Products, and Diabetes Care

Pharmaceutical Systems like:

Needles and syringes

Intravenous catheters

Safety-engineered and auto-disable devices

Prefillable drug delivery systems

Prefilled IV flush syringes

Insulin syringes and pen needles

Regional anesthesia needles and trays

Sharps disposal containers

B.BD DIAGNOSTICS:

BD Diagnostics deals in Diagnostic Systems and Preanalytical Systems like:

Integrated systems for specimen collection

Safety-engineered blood collection products and systems

Automated blood culturing systems

Molecular testing systems for sexually transmitted diseases and HAIs

Microorganism identification and drug susceptibility systems

Liquid-based cytology systems for cervical cancer screening

Rapid diagnostic assays

Plated media

C.BD BIOSCIENCES:

The Biosciences Division deals with Cell Analysis and Discovery Lab ware products some of

which are:

Fluorescence-activated cell sorters and analyzers

Monoclonal antibodies and kits for cell analysis

Reagent systems for life science research

Cell imaging systems


Laboratory products for tissue culture and fluid handling

Cell culture media and supplements for biopharmaceutical manufacturing

The revenues generated by each segment were US $ 3.796 billion, US $ 2.319 billion and US

$ 1.257 billion respectively.

Millipore

As scientists and engineers pioneering new cures to mankind's most challenging health

issues, they relied more on Millipore as a trusted partner who for more than 50 years has

supported them with a continuum of cutting edge tools, technologies and application

solutions to ensure success in research, development and production. Merck Millipore is part

of the Merck Group, a company with 40,000 employees in 64 countries that was generating

total revenues of US $ 11.11 billion in 2009. Merck Millipore, a division of Merck Group,

offers solutions that enable scientists to conduct life science research easily, efficiently and

economically. With a range of more than 40,000 products, Merck Millipore is one of the top

three suppliers of tools to the life science industry. The division comprises three business

units: Bioscience, Lab Solutions and Process Solutions.

A.Biosciences:

The Bioscience business unit is focused on helping customers in the pharmaceutical and

biotechnology industries, as well as academia, understand complete biological systems and

identify new therapeutic targets. It provides an increasing number of tools and services to

support researchers seeking to understand complex biological systems. The products help to

advance life science research in a wide variety of areas ranging from neuroscience, infectious

disease, oncology, and metabolic disorders to stem cells, cell signalling, nuclear function, and

chromatin biology. Bioscience products and services simplify the work flow for researchers,

offering consolidated and validated solutions.

B. Lab Solutions:

The Lab Solutions business unit supplies products for research, analytical and clinical

laboratories in a wide variety of industries. The company is one of the leading suppliers of

laboratory chemicals, lab water equipment and consumables. For inorganic chemistry, they

offer reagents of high purity such as salts, acids, caustics, volumetric solutions, buffers,

reference materials for instrumental analysis and products for inorganic trace analysis. For

organic chemistry, they supply a full range of basic products for synthesis; including building

blocks, reagents and solvents most commonly used in organic synthesis from laboratory scale

to bulk production. As a leading supplier of chromatography products, Merck Millipore is

also advancing the development of analytical separation technologies. The product focus is

on analytical high performance liquid chromatography (HPLC) and innovations to the

monolithic ChromolithÂ® HPLC columns for ultrafast separations.


C. Process Solutions:

The Process Solutions business unit supplies products used by pharmaceutical and

biotechnology companies to develop and manufacture biopharmaceutical drugs safely and

efficiently. Millipore provides fully integrated solutions to biopharmaceutical customers and

an attractive range of development and regulatory services to biopharmaceutical

manufacturers.

Invitrogen Scientific

Invitrogen Corporation is a large, multinational biotechnology company headquartered in

Carlsbad, California. In November 2008, a merger between Applied Bio systems and

Invitrogen was finalized. The new company is called Life Technologies. Invitrogen

Corporation develops, manufactures, and markets more than 10,000 products for customers

involved in life sciences research and the commercial manufacture of genetically engineered

products. The company‘s research kits are used to simplify and improve gene cloning, gene

expression, and gene analysis. Invitrogen also is involved in cell structure activities, which

provides customers with the material to grow cells in the laboratory and to produce

pharmaceutical and other materials made by cultured cells.

Key products and technologies include

Dynabeads magnetic separation technology,

GIBCO cell culture media and reagents,

SuperScript reverse transcriptase,

Platinum Taq polymerase

TOPO cloning and expression products

Novex protein electrophoresis products

Numerous fluorescent reagents such as Qdot nanocrystals and Alexa Fluor and SYBR

dyes.

Invitrogen currently offers more than 25,000 products and services to support research in

cellular analysis, genomics, proteomics, and drug discovery, and has sought to leverage their

extensive technology portfolio to address research problems in developing fields, including

biodefense and environmental diagnostics, bioinformatics, epigenetics, and stem cell

research.


The popular brands of Invitrogen are as follows:

1. Ambion: RNA sample preparation

2. Dynal: magnetic beads for separation

3. Gateway- for cloning and protein expression

4. Gibco: Cell culture media

5. Lipofectamine- transfection reagents

6. Molecular probes- fluorescent dyes and probes

7. Novex-protein separation and blotting

8. SuperScript- Cdna synthesis reagents

9. TaqMan- Real time PCR kit

10. TOPO- PCR cloning kits

3.3 Top 10 Indian Biosuppliers

Top 10 Indian Bio supplier companies and their revenues from 2005-2010 are given below.

Rank

2009

Company 2005-06

($

millions

)

2006-07

($

millions

)

2007-08

($

millions

)

2008-09

($

millions

)

2009-10

($

millions

)

%

Change

2009-10

1 Spinco Biotech 30.6 34.6 46.6 50 55.5 11.40

2 Imperial Life

Sciences

5.3 8.6 19.5 22.6 24.8 9.67

3 RFCL 3.7 4.8 7.5 20.4 20.6 1.11

4 Genetix Biotech

Asia

8.8 11.3 15.5 17.7 20 12.50

5 DSS Imagetech 9.1 12 15.1 17.3 19.5 12.05

6 Toshvin

Analytical

— — — 16.6 18.8 12.12


The pie diagram above shows the percent share of top 10 Indian bio supplier companies in

total revenue generate in year 2009-10

7 Nishotech — — — — 15.5 —

8 Towa Optics — 8.8 10.2 12.4 13.7 11.43

9 Advanced

Microdevices

— — 8.2 10 12.4 24.44

10 HiMedia

Laboratories*

26.6 33.3 40 — 10 —


Major Indian Companies:

SPINCO BIOTECH PVT.LTD

It is ranked No. 1 Bio-suppliers in India with a proven track record of 29 years in Analytical

& Life Science Instrumentation. The revenue of Spinco Biotech during the financial year

2009-10 was US $ 55.7 million, and the percentage change was 11.40. Spinco has been able

to cross many milestones like maximum number of HPLC in India, highest capacity

lyophiliser in India, largest field support team with more than 28 branches. Headquartered in

Chennai, and has more than 28 branches spanning north, south, east and west of India.

Some of the major product line includes:

Chromatography-

Mass Spectrometry

Life Science

Lab Products

Chemistry and Consumables

IMPERIAL LIFESCIENCES PVT. LTD.

Imperial has grown by leaps and bounds since inception in 1992 and the growth has been

consistent and well defined through these years. The revenue of Imperial Life sciences Pvt.

Ltd. during the financial year 2009-10 was US $ 25.07 million, and the percentage change

was 9.67. Its key customers include companies in the biopharma, biotech, agriculture,

veterinary sciences segment along with universities, medical colleges, drug discovery labs,

clinical trial and contract research facilities and research institutes.

Automated Liquid Handling

Benchtop Instruments

Microarray Scanner

Reagents & Consumables

Bioanalyzer

Lab chip Systems

RANBAXY FINE CHEMICALS LIMITED

Ranbaxy Fine Chemicals Limited is owned by ICICI Venture Funds Management Company

Limited, and is managed by a highly dynamic group of professionals which accounts for

approx. US $ 533.3 million business group. The revenue of RFCL during the financial year

2009-10 was US $ 20.71 million and the percentage change was 1.11. RFCL is soon going to

launch new reagents - JSB Stain-I & JSB Stain-II. It is headquartered at Delhi, and has

branch offices in Hyderabad, Bangalore, Ahmadabad, Mohali, Mumbai, Ghaziabad, Indore,

Kolkata, Pune, and Chennai. Recently Avantor has completed acquisition of RFCL Limited.


Avantor and New Mountain Capital will provide RFCL with significant financial and

strategic resources to support their growth initiatives

It has four different SBUs as follows

‗Rankem‘ dealing in total scientific laboratory solutions;

‗Ventex‘ dealing with next generation veterinary solution for livestock, poultry and

pets;

‗Diagnova‘ dealing with in vitro diagnostics; and

‗Neosynth‘ which deals with custom synthesis

GENETIX BIOTECH ASIA

Genetix Asia is a retailer & Supplier of pharmaceuticals, health care, herbal, diagnostic

products, animal care products, finished pharmaceutical products, perfume, herb, skincare,

medical devices, bio pharmaceuticals, etc. The revenue of Genetix Biotech Asia during the

financial year 2009-10 was US $ 20 million, and the percentage change was 12.50. Genetix is

a world leader for supply of Kits, Reagents, Laboratory Plasticware and Filterware for use

within Molecular Biology, Genomics, Proteomics, Immunology and Cell Culture. It is

headquartered at Delhi, with branch offices at Chandigarh, Lucknow, Bhopal, Kolkata,

Mumbai, Pune, Hyderabad, Bangalore, Chennai.

The product range of Genetix Biotech Asia includes:

Diagnostic

Medical devices

Laboratory products

Molecular diagnostics

Filtration Products

Molecular Biology / Industrial Enzymes

PCR Machine

DSS IMAGETECH

With the capital of $ 995,268 (Rs 4.5 crore) and 25 employees, the DSS IMAGETECH

engages into the manufacturing and sales of research reagents and kits. DSS Imagetech is

based on providing cutting edge technology solutions to Researchers and Clinicians in the

field of Life Sciences including Genetics, ART, Drug Discovery, Biotechnology etc. Products

and application areas include microscopy, image analysis software/systems, Genetic

workstation, ICSI workstation, DNA probes, Thermal Cyclers, Micro Array Readers etc. The

revenue of DSS Imagetech during the financial year 2009-10 was US $ 19.5 million, and the

percentage change was 12.05. Headquartered at New Delhi, with branch offices in Bangalore,

Chandigarh, Chennai, Hyderabad, Mumbai, Kolkata, Pune, Trivandaram,


The areas it caters to are:

Microscopy

Image analysis software / systems,

Genetic workstation,

ICSI workstation,

DNA probes,

Micro array readers,

TOSHVIN ANALYTICAL

It is the sixth largest company in biosuppliers and its revenue generation for year 2009-10

was US $ 18.9 million. Toshvin Analytical Pvt. Ltd. is one of the leading companies in India

in the field of analytical and laboratory instrumentation. Since 1948, Toshvin has been at the

forefront of bringing the latest, most sophisticated range of instruments to Indian companies

from leading manufacturers around the world. Its products range from analytical instrument,

water purification system, Chromatography Accessories to Consumables. It has a partnership

with Shimadzu Japan Company since from 1970. They offer the following range of product

like

Laboratory Instruments

Testing and Inspection

Balances and Scales

Life Science Lab Instruments

Medical Systems and Equipment

Industrial Equipment

NISHOTECH

Nishotech is well known in the Pharma, Food Processing and Biotech world for its Sterile

Process Piping Systems. With its vast experience in executing prestigious projects and a

highly skilled workforce, it uses latest techniques particularly in orbital welding technology

to integrate pipe work installation and end results are checked using Boroscopy with still /

video rendering. It also has partnership with Novasep process SAS. Novasep Process SAS

primarily concentrates on purification needs of pharmaceutical, food, cosmetic, agrochemical

and specialty chemical industries; using industrial processes. Novasep Process offers

solutions for producing pure products, from process development to optimization, from the

supply of laboratory purification equipment to the delivery of industrial turn-key purification

plants. Through synergies with Novasep Synthesis, Novasep Process technologies enable

straightforward and cost efficient global synthesis of new molecules, while helping to reduce

time to market. Novasep Process‘ core technologies are Chromatography, Crystallization, Ion

exchange, Membranes, Evaporation. DrM is a technology partner for Nishotech system for

their patented candle filtration design. There are over 1500 Filters in operation worldwide and

about 80 new systems are put in place every year; most of them in the chemical industry but

also in petrochemical, pharmaceutical, food and industrial waste water applications.

http://www.toshvin.com/chromatography.asp


The clients of Nishotech are Cipla, Claris, Intas Biopharma, Biocon, Emcure, Dr.Reddy‘s,

Ipca, Pfizer, Torrent and many more.

TOWA OPTICS

Towa Optics (I) Pvt. Ltd. is the authorized distributor of many reputable international

companies such as NIKON (Japan), Andor (UK) , Linkam (UK), Thermo Fischer Scientific (

USA & UK), Genikon (Italy) and Spectro Inc (USA). It manufactures various instruments

and equipment like Biological Microscopes, Imaging Systems, Cooled/UnCooled Scientific

Cameras, Semi-Conductor Inspection Equipment, Controlled Environment Equipment,

Histopathology /Cytology Products etc. It is a dedicated company in the field of Bio

science/Industrial and now expanded its activities into analytical products. With ten dedicated

offices, in different cities of India Towa provides the most prompt attention to the customers

for sales and service.

HIMEDIA LABORATORIES

Hi- Media Laboratories was founded in 1973 as a small, regional manufacturer of prepared

culture media. Over the past 28 years, it has added many diverse products, moving into a

current position as a full-service supplier for several disciplines in the laboratory. Its catalog

now includes microbial identification systems, quality control organisms, stains, reagents,

dehydrated culture media, prepared media and diagnostic test kits, including EIA test kits and

slide agglutination kits. It also encourages inquiries for products not listed in the catalog. It is

a leading manufacturer of products for microbiology, parasitological, immunology, serology

and virology. Their customers include clinical, industrial, research and academic laboratories

around the world.

Its range of products include

Dehydrated Culture Media

Animal Tissue Culture Media

Plant Tissue Culture Media Bacteriological

Differentiation Aids

Antimicrobial Sensitivity Single Discs 50 discs

Antimicrobial Sensitivity Octo Discs 10 discs

Standardized Chemicals & Ingredients Various Fields of HiMedia product applications and

company's customers:

Academic Fields: Research Institutes and Education Institutes including Veterinary and

Medical Colleges.

Public Health Care: Water supply, Waste water disposal, Pollution control, Hospitals and

Clinical Laboratories.


Industries:

Pharmaceutical & Cosmetics

Vaccine, Toxin and Antibiotics

Food and Dairy Products

Agriculture such as Biofertilizers and

Hotels, Catering and Flight Kitchens Biopesticides

RECENT HAPPENINGS- MERGERS AND ACQUISITIONS

Acquisitions are common in the life-science tools sector as large companies seek to fill gaps

in their product portfolios and broaden geographical reach by buying-out smaller peers. An

acquisition is the purchase of one company by another company. The combination of two or

more organizations is a merger.

Agilent Technologies acquired Varian Inc for $1.5 billion

Transformational transaction establishes Agilent‘s position as a leading provider of analytical

instrumentation to the applied and life sciences markets. Varian had annual revenue of $1

billion in its fiscal year 2008 in a product portfolio that includes lab instrumentation and

consumables. Transaction expanded Agilent product and application breadth in industrial and

life sciences markets; establishes entry into nuclear magnetic resonance (NMR), imaging and

vacuum technology markets. Price reflects a premium of approximately 35% to Varian

shareholders. The acquisition broadened Agilent‘s applications and solutions offerings in Life

Sciences, Environmental, and Energy and Materials. It also expanded Agilent‘s product

portfolio into atomic and molecular spectroscopy; establishes a leading position in NMR,

imaging and vacuum technologies; and strengthens its consumables portfolio.

Merck-Millipore merger-A $2.9 billion.

The Merck-Millipore deal is an important step in the transformation of Merck as it adds a

high-growth business that is not vulnerable to patent expiry.

Crux of the deal

1. Merck acquired all outstanding Millipore shares for $107 per share in cash, creating a

world-class partner for the life science sector.

2. Agreed transaction is valued at approximately $7.2 billion.

3. Combination created a $2.9 billion partner for the life sciences sector and transform Merck

Chemicals.


4. Combined business has significant scale in high-growth bioresearch and bioproduction

segments.

Together, Millipore and Merck created a $2.9 billion world-class partner for the life sciences

sector, achieving significant scale in high-margin specialty products with an attractive growth

profile.

4.3 Danaher will acquire Beckman Coulter for $6.8 Billion

Danaher Corporation, in February of this year, announced that it has entered into a definitive

merger agreement with Beckman Coulter, Inc. Danaher will acquire Beckman Coulter by

making a cash tender offer to acquire all of the outstanding shares of common stock of

Beckman Coulter at a purchase price of $83.50 per share, for a total enterprise value of

approximately $6.8 billion, including debt assumed and net of cash acquired.

With annual revenues of approximately $3.7 billion, Beckman Coulter develops,

manufactures and markets products that simplify, automate and innovate complex biomedical

testing. Its diagnostic systems are found in hospitals and other clinical settings around the

world and produce information used by physicians to diagnose disease, make treatment

decisions and monitor patients. Scientists use its life science research instruments to study

complex biological problems including causes of disease and potential new therapies or

drugs. Beckman Coulter would become part of Danaher‘s Life Sciences & Diagnostics

segment, joining Danaher‘s Leica, AB Sciex, Radiometer and Molecular Devices businesses.

Danaher is a diversified technology leader that designs, manufactures, and markets

innovative products and services to professional, medical, industrial, and commercial

customers. Its portfolio of premier brands is among the most highly recognized in each of the

markets they serve. Driven by a foundation provided by the Danaher Business System, its

48,000 associates serve customers in more than 125 countries and generated $13.2 billion of

revenue in 2010.

BIO SUPPLY MANAGEMENT ALLIANCE

The Bio Supply Management Alliance has launched an industry initiative to meet the risk

management challenges in the emerging global market.

About the Bio Supply Management Alliance

The Bio Supply Management Alliance was born of the need to create a worldwide

community of operations and supply chain management leaders and professionals in the

biotechnology industry. Based in the San Francisco Bay Area, home to more than 600 biotech


firms, the Alliance provides a forum for collaboration, learning and best practice sharing of

practitioners, executives and thought leaders in these uniquely demanding industry sectors.

Founders Tim Salaver and Devendra Mishra have forged relationships with key industry

leaders and defined initiatives with a vision to create process, people, and policy

improvements in this vital sector. The Bio Supply Management Alliance supports B2B

networking, continuous learning and career improvement of bio supply management

professionals.


Bioinformatics Sector

Introduction

Bioinformatics is the application of statistics and computer science to the field of molecular

biology. The primary goal of bioinformatics is to increase the understanding of biological

processes. What sets it apart from other approaches, however, is its focus on developing and

applying computationally intensive techniques (e.g., pattern recognition, data mining,

machine learning algorithms, and visualization) to achieve this goal. Major research efforts in

the field include sequence alignment, gene finding, genome assembly, drug design, drug

discovery, protein structure alignment, protein structure prediction, prediction of gene

expression and protein-protein interactions, genome-wide association studies and the

modelling of evolution.

The major research areas of bioinformatics are Sequence analysis, Genome Annotation,

computational evolutionary biology, analysis of gene expression, analysis of regulation,

analysis of protein expression, analysis of mutation in cancer, comparative genomics,

Modelling Biological systems, high throughput image analysis, structural bioinformatics

approaches etc.

Bioinformatics involves the application of computer technology for analysis and management

of biological data. The computers are used to collect, analyze, store and merge the biological

data. The aim of bioinformatics is to collect the wealth of biological information and use it to

improve the living standards of human beings. Bioinformatics is applied in various fields like

human health, environment, agriculture, biotechnology and energy to advance the biomedical

research and development. It is used in the field of molecular medicine to produce the

customized medicines for the prevention or cure of the disease. Bioinformatics is today

rapidly growing field all over the world. Therefore one can start a career in Bioinformatics

and find employment opportunities in biotechnology, biomedical and pharmaceutical

sciences, in industries, hospitals and research institutions.

The scope of bioinformatics is in areas like database design and maintenance, sequence

assembly, proteomics, clinical pharmacologist, sequence analysis, informatics developer and

bio-analytics. Excellent job opportunities are available in Biotech and Pharmaceutical

companies in India. Indian companies like Wipro, Reliance, Satyam, TCS and companies like

Accelrys and IBM Life Sciences Pubgene, Silicon Genetics and Tessella offer good

employments to the bioinformatics candidates. Due to increasing demand of bioinformatics

candidates, a career in bioinformatics offer good prospects.

The Bioinformatics tools are the software programs for the saving, retrieving and analysis of

Biological data and extracting the information from them.

Factors that must be taken into consideration when designing these tools are:

The end user (the biologist) may not be a frequent user of computer technology and thus it

should be very user friendly.


These software tools must be made available over the internet given the global distribution of

the scientific research community.

The Bioinformatics Tools may be categorized into following categories:

Homology and Similarity Tools

Protein Function Analysis

Structural Analysis

Sequence Analysis

Homology and Similarity Tools:

The term homology implies a common evolutionary relationship between two traits -whether

they are DNA sequences or bristle patterns on a fly's nose. Homologous sequences are

sequences that are related by divergence from a common ancestor. Thus the degree of

similarity between two sequences can be measured while their homology is a case of being

either true of false. This set of tools can be used to identify similarities between novel query

sequences of unknown structure and function and database sequences whose structure and

function have been elucidated.

Protein Function Analysis

Function Analysis is Identification and mapping of all functional elements (both coding and

non-coding) in a genome. This group of programs allow you to compare your protein

sequence to the secondary (or derived) protein databases that contain information on motifs,

signatures and protein domains. Highly significant hits against these different pattern

databases allow you to approximate the biochemical function of your query protein.

Structural Analysis

These sets of tools allow you to compare structures with the known structure databases. The

function of a protein is more directly a consequence of its structure rather than its sequence

with structural homologs tending to share functions. The determination of a protein's 2D/3D

structure is crucial in the study of its function.

Sequence Analysis

This set of tools allows you to carry out further, more detailed analysis on your query

sequence including evolutionary analysis, identification of mutations, hydropathy regions,

CpG islands and compositional biases. The identification of these and other biological

properties are all clues that aid the search to elucidate the specific function of your sequence.


Bioinformatics Tools

BLAST:

The Basic Local Alignment Search Tool (BLAST) for comparing gene and protein sequences

against others in public databases now comes in several types including PSI-BLAST, PHI-

BLAST, and BLAST 2 sequences. Specialized BLASTs are also available for human,

microbial, malaria, and other genomes, as well as for vector contamination,

immunoglobulins, and tentative human consensus sequences.

FASTA

A database search tool used to compare a nucleotide or peptide sequence to a sequence

database. The program is based on the rapid sequence algorithm described by Lipman and

Pearson. It was the first widely used algorithm for database similarity searching. The program

looks for optimal local alignments by scanning the sequence for small matches called

"words". Initially, the scores of segments in which there are multiple word hits are calculated

("init1"). Later the scores of several segments may be summed to generate an "initn" score.

An optimized alignment that includes gaps is shown in the output as "opt". The sensitivity

and speed of the search are inversely related and controlled by the "k-tup" variable which

specifies the size of a "word".

EMBOSS EMBOSS (The European Molecular Biology Open Software Suite) is a new, free open source

software analysis package specially developed for the needs of the molecular biology user

community. Within EMBOSS you will find around 100 programs (applications) for sequence

alignment, database searching with sequence patterns, protein motif identification and

domain analysis, nucleotide sequence pattern analysis, codon usage analysis for small

genomes, and much more.

Clustalw ClustalW is a general purpose multiple sequence alignment program for DNA or proteins. It

produces biologically meaningful multiple sequence alignments of divergent sequences,

calculates the best match for the selected sequences, and lines them up so that the identities,

similarities and differences can be seen.

RasMol

It is a powerful research tool to display the structure of DNA, proteins, and smaller

molecules. Protein Explorer, a derivative of RasMol, is an easier to use program.

Application Programs

JAVA in Bioinformatics:

Due to Platform independence nature of Java, it is emerging as a key player in

bioinformatics. Physiome Sciences' computer-based biological simulation technologies and

Bioinformatics Solutions' PatternHunter are two examples of the growing adoption of Java in

bioinformatics.


Perl in Bioinformatics:

Perl is also being used in the processing of biological data. One example of perl project is

BioPerl project.

Bioinformatics Projects:

BioJava: The Bio-Java Project is providing the Java tool for the processing of data in Java

BioPerl: The BioPerl project many modules for biological data processing.

BioXML: A part of the BioPerl project, this is a resource to gather XML documentation,

DTDs and XML aware tools for biology in one location.

Industry overview

The industry comprises of players in areas such as contract research and development (R and

D) services, clinical and proof of concept clinical investigation, clinical trials, contract

research, bio-engineering, stem cell research, contract manufacturing, bioinformatics and

drug development. We are also witnessing activity in the field of research and development

in biotechnology with companies like Ranbaxy, Dr Reddy‘s Laboratories and Nicholas

Piramal have been working on licensed molecules, clinical trials of drugs already formulated,

and bioprospecting from Ayurveda, which is India‘ s traditional medicine. The Indian

software companies have come up with the software tools to capture, manage and analyse the

voluminous amount of genetic data. India‘s skilled but low cost manpower is the reason why

MNCs are sending their genomic and proteomic data to India for analysis. A key advantage

of India is the availability of skilled but low cost manpower. Unlike IT, bioinformatics

requires a highly skilled work force with knowledge of IT, molecular biology, protein

separation chemistry, instrument control, data acquisition and data analysis tools. India is on

the verge of taking the global leadership in genomic studies. Analysis shows that pure cost

benefits for biotech companies will drive the bioinformatics industry in the country. Slated as

the next big opportunity for India in the global arena after the success of IT Services,

Bioinformatics and Life Science research is gaining attention from government, industry and

the academia. In today‘s fast paced scientific innovations, Bioinformatics plays a very crucial

role in the areas of contemporary biomedical research. With the introduction of

Bioinformatics, the focus of the pharmaceutical companies has shifted from the trial and error

process of drug discovery to a rational structure based drug design. India has several ethnic

populations that are valuable in providing information about disease predisposition and

susceptibility, which in turn will help in drug discovery. Many eminent research and

development institutes are in the process of developing a database of genetic profiles among

diverse Indian population in terms of ethnicity, demographics and ancestral roots. However,

as there is lack of records and data management capabilities, the biotech and pharma

companies need tremendous software support. With computers biological problems that can

be addressed are in the areas of DNA / Protein sequence characterization, Protein Structure


Predictions, Protein Interaction Prediction, i.e., Drug Discovery and Pathway Modeling. The

need for the hour is High Performance Computing Infrastructure by development of new

advanced software and optimization of existing software.

History of the sector

The start of bioinformatics sector was from the time George Mendel experimented with cross

fertilization. He carefully recorded the data and analyzed the data. Mendel illustrated that the

inheritance of traits could be more easily explained if it was controlled by factors passed

down from generation to generation.

The understanding of genetics has advanced remarkably in the last thirty years. In 1972, Paul

berg made the first recombinant DNA molecule using ligase. In that same year, Stanley

Cohen, Annie Chang and Herbert Boyer produced the first recombinant DNA organism. In

1973, two important things happened in the field of genomics. The advancement of

computing in 1960-70s resulted in the basic methodology of bioinformatics. However, it is

the 1990s when the INTERNET arrived when the full fledged bioinformatics field was born.

Bioinformatics Network

India was one of the first countries in the world to establish a nationwide bioinformatics

network. The Department of Biotechnology (DBT) initiated a program on bioinformatics in

1986. The Biotechnology Information System Network (BTIS), a division of DBT, now

connects 57 key research centers, covering the entire country. More than 100 databases for

biotechnology have been developed. Two databases, namely one that covers data regarding

biotechnology research on coconuts and another that contains the complete genome of the

white spota syndrome of shrimp, have been released for public use. In addition, several major

international databases with applications for genomics and proteomics have been established

under the National Jai Vigyan Mission. BTIS also has decided to establish five advanced

research and training centers. These Centers of Excellence (COE) in Bioinformatics

undertake advanced research in bioinformatics, provide PhD and postdoctoral training,

develop new solutions to support the Indian Bioinformatics industry and its academic

institutions in India, help in solving complex biological problems, and retain required high-

end manpower.


TOP INDIAN COMPANIES IN BIOINOFORMATIC SECTOR

The Indian BioInformatics segment grew at 5%. Domestic market contributed to 68% of

BioInformatics revenue. The top two Indian companies in the Bioinformatics sector are

RANK COMPANY 2009-10

Revenue in

Million USD

2008-09

Revenue in

Million USD

Percentage

Change over

2008-09

1 Ocimum

Biosolutions

9.2 10.5 -12.97

2 Strand Life

Sciences

7.7 7.7 0.0

Company Profile

Ocimum Biosolutions

Ocimum Biosolutions is a leading integrated global genomics company providing GLP-

compliant microarray services, comprehensive genomic reference databases, life science lab

information management solutions and essential research consumables. Ocimum‘s services

span across key priority areas including Biopharmaceutical, Diagnostics, Agriculture, and

Food & Nutrition. Diverse research and development efforts in such key areas have benefited

from our unique range of integrated services. Ocimum provides multi-platform GLP-

compliant gene expression, SNP genotyping and other Microarray based services. It also

provides full biorepository and genomic services support for the Genetic Alliance, which is

an umbrella organization representing ~600 genetic advocacy groups. Besides providing the

physical infrastructure for storing thousands of biological samples, we provide services to

assist sample accrual, IRB approvals, CRO training, sample collection, clinical data capture

and management. Ocimum has created the world‘s largest commercial gene expression

databases – BioExpress® and ToxExpress®,

Strand Life Sciences

Strand Life Sciences – Pioneers in Discovery Research Informatics, is a premier life science

informatics innovation company. Strand leverages its core strengths and intellectual property

in data mining, predictive modelling, bioinformatics, and computational chemistry to develop

products and solutions for drug discovery. Five of the top ten pharmaceutical companies,

three of the top six biotechnology companies, and numerous academic institutions across the

globe, are part of Strand's customer profile. Using its award-winning application

development platform, AVADIS®, Strand has built innovative products that enable cutting-

edge analysis, relationship building, modelling and accurate predicting, and building and


deploying of systems biology models. Strand products are very user-friendly and adept at

dealing with complexity. They help users conduct virtual experiments and use the results in

an intuitive manner

Products

GeneSpring GX : It is a cutting-edge analysis tool for gene expression, genotyping, exon and

tiling microarrays. It has a database of over 1.5 million biological interactions extracted by

the powerful Natural Language Processing (NLP) - based text mining engine developed by

Strand. GeneSpring is developed on Strand's AVADIS platform and marketed worldwide by

Agilent Technologies, USA.

Sarchitect: It is meant for Quantitative Structure Activity Relationship (QSAR) studies

and modeling of ADME / Tox properties. Sarchitect allows model builders to build best

possible models of their data and equally importantly, monitor and improve the models over a

period of usage. It allows users of the models to optimize complex multi-dimensional

ADME/Tox properties of molecules while retaining their biological activity. The Sarchitect

platform empowers computational and medicinal chemists, modelers, DMPK scientists and

other users with: QSAR modeling and deployment platform. Powerful algorithms, interactive

views, single click model building, intuitive workflows for chemists and customized

scripting.

BioLego: It is an interactive modelling and simulation platform built on Strand's award

winning AVADIS® technology. It has following features

Transparent and comprehensive knowledge-base

Handling Complexity

Reliable solvers

Large scale data handling and sharing

BioLego helps in

Building Own Models

Accessing, modifying and customizing dynamic systems models built at Strand

Generating and/or Testing Hypothesis in silico

Visualizing, Storing, Retrieving and Comparing Results

WebChemistry: It is Strand's proprietary web-based analysis and reporting tool to explore

and learn about compounds, their structures and properties. WebChemistry enables medicinal

chemists and DMPK Scientists to carry out HTS, Lead generation and Lead optimization

activities more efficiently, while enabling Research IT to deploy these functions easily and

integrate them seamlessly.

http://www.strandls.com/childpages.php?param=2&param1=5


Global Scenario

Growth Rate and Market Size

The product lines, software tools and other biometric applications were projected at an annual

market growth of 15.8% or US $3 billion for the year 2010. As it stands the bioinformatics

market is at stability where 20% of the applications discovered are based on genomics and

proteomics, which boosts growth of bioinformatics tools. A greater number of R&D centers

across the world are seeking a common base for transfer of data, information and knowledge

to enable an informatics-based decision support system. Given the said market structure there

is an emerging need to develop breakthrough drugs while shortening the discovery time and

costs. There is also need for forming mergers and partnerships of companies both at local and

international levels. Leading biotech firms like Compugen, DoubleTwist have come forward

with novel drug programs. Interestingly, India and South East Asian countries have

comparative advantage in terms of cheap labor, which can offer database solutions and

genome research for biotech companies globally.

Future of the Bioinformatics Sector (Global)

The global market for bioinformatics is forecast to reach US$5.0 billion by the year 2015.

Key factors driving market growth are:-

Substantial development in the area of genomics

Increasing application of genomics in R&D processes

Availability of huge genomic information

Continuing demand for new drugs

Bioinformatics, one of the most vibrant industries in the current scenario, is at the forefront of

the biotech revolution. The market is projected to transform into a major industry within the

next few years. Driving the revolution is genomics, a set of advanced tools designed for large

data acquisition and analysis. New tools are not only pushing the development of drug

discovery, but also fundamentally changing the nature of biological research. The success of

Human Genome Project and breakthrough technologies in drug discovery initiatives spells

significant investment opportunities for the industry. As new players enter the market, and

existing companies grow in size and revenue, competition in the bioinformatics industry is

likely to intensify significantly.

Globally, pharmaceutical companies are increasingly seeking help from biotechnology to

alleviate concerns related to increasing number of blockbuster drugs going off-patent, narrow

product pipelines, and high drug development costs. Bioinformatics can be applied in every

stage of the R&D processes in biotechnology as well as the pharmaceutical sectors. The

emergence of genomics and its ever-growing application in the research and development

processes have created soaring amount of data, creating significant opportunities for

bioinformatics. Data management tools based on bioinformatics have helped companies in

easing the task of R&D analysis, thereby enhancing their productivity by way of identifying

new biomarkers for toxicity and drug efficacy, diagnostic biomarkers as well as new drug


targets. Bioinformatics help utilization of the gene and protein data and construct interactive

models that aid in identifying disease pathways and effects of compounds.

Going forwards, the penetration of genomics in drug discovery is expected to increase

further, which bodes tremendous market prospects for bioinformatics. In addition, more and

more spending is expected to be made in research and development from pharmaceutical

companies, of which a major chunk is expected to end up in the area of bioinformatics.

Bioinformatics is a multifaceted market, characterized by a host of licensing and research and

development collaborations. Worldwide bioinformatics market is primarily concentrated in

the United States and Europe. The industry represents one of the fastest growing fields

offering economic opportunities in various areas.

The US represents the largest regional market for bioinformatics worldwide, followed by

Europe, as stated by the new market research report on Bioinformatics. However, Asia-

Pacific is projected to record the fastest growth over the analysis period. Japanese market is

projected to post a CAGR of 13.5% during the analysis period. Segment wise, Biocontent

represents the largest product segment in the global bioinformatics market. Bioinformatics

Software represents the fastest growing product segment. Demand for Bioinformatics

hardware is projected to rise by 9.5% during the analysis period. The global bioinformatics

industry is highly fragmented, with several companies offering only specific services and a

very few companies delivering comprehensive solutions for their clients‘ R&D needs. Large-

scale presence of smaller companies and high fragmentation is due to lower entry barriers and

existence of large IT companies in the sector.

Major players include

3rd Millennium Inc

Accelrys, Inc.,

Affymetrix

Agilent Technologies

BioWisdom Ltd

Celera Group

Gene Logic

IBM Life Sciences

Life Technologies Corporation

Rosetta Inpharmatics.

Bioinformatics in India

Bioinformatics will be a potential star in bioscience field in the coming years after

considering the factors like bio-diversity, human resources, infrastructure facilities and

government initiatives. It has been reported that the pharmaceutical firms and research

institutes in India are looking forward for cost-effective, high-quality research development,

Bioinformatics has emerged out of the inputs from several different areas such as biology,

biochemistry, biophysics, molecular biology, biostatics, and computer science. Specially

designed algorithms and organized databases is the core of all informatics operations. The

requirements for such an activity make heavy and high level demands on both the hardware

and software capabilities.


The Bioinformatics revenue change (in Rs. Crore) over the recent years can be seen in the

following table:-

Segment 2007-08 2008-09 2009-10 % change

over 2007-

08

% change

over 2008-

09

Bioinformatics 190 220 231 16 5

Current Market Status

Bioinformatics is one of the fastest-expanding fields in India's biotechnology sector today.

There are over 200 companies in Bangalore, Hyderabad, Pune, Chennai, and Delhi that are in

some way involved in bioinformatics. Large IT organizations such as Intel, IBM, and Wipro

are also getting into this sector in India. Just as important, over 300 college-level institutes

across India now offer degrees in biotechnology, bioinformatics, and biological sciences.

These facilities are educating millions of students annually. This educational base is creating

a solid future for India's bioinformatics industry. Although a fast expanding Sector the

smallest segment of the Industry, BioInformatics which has just about 2 percent segment

share in the overall industry, has been sluggish in FY 2009-10. It registered a 5 percent

growth over 2008-09, clocking Rs 231 crore in revenues last year as compared to Rs 220

crore in FY 2008-09, when it recorded a growth of 16 percent

Segregation of companies according to region:

Region No. of Bioinformatics

Companies

%Share of Sector in the

Regions

NORTH 5 12%

SOUTH 32 78%

WEST 4 10%

South based companies generate almost 55 percent of the total CRO business in the country.

The biggest of number of Bioinformatics companies headquartered in a region is the South as

it accounts for 77 percent share of the total number of companies in the country. Northen

region accounted for 15 percent share of the total base. This field has generated such high

revenues mainly because it is home to almost all the top diagnostics companies.

Bioinformatics applications in drug discovery and development are expected to reduce the

annual cost of developing a new drug by 33%, and the time for drug discovery by 30%.

The pure-play BioInformatics companies in India include Strand Genomics, Ocimum

Biosolutions, SysArris, CytoGenomics and Molecular Connections. These companies have

come out with products that cater mainly to the needs of the pharmaceutical and

biotechnology companies. Most of these companies are small and medium enterprises based

at locations such as Bangalore, Hyderabad, and Pune. Much of this growth is because of the

linkages between IT and biotechnology. India's software engineers are established around the

globe. This breadth of expertise is, in turn, creating an engine for global biopharmaceutical

growth. In fact, because of India's global presence in bioinformatics, Indian scientists and


bioinformatics professionals are in high demand. Today, the country's talented software

engineers are establishing themselves as more than just inexpensive. As a result, salary

differentials today are shrinking quickly. Engineers in India today command salaries of

around half of those in the US.

INDIA'S ADVANTAGES

The core R&D strength in Indian biotechnology is its relatively well-educated and trained

labor force, with a strong base of English-speaking scientists who are well versed in

mathematics, physics, and chemistry. Thus, the country has the scientific skills that

encompass capabilities for handling all aspects of biological information acquisition,

processing, analysis, and interpretation. India's well-known software skills are, of course,

another key advantage in global bioinformatics.

ON THE CONTRARY

Venture capital and other funding sources are still needed, though. This may require

concurrent support from government agencies, in the form of building infrastructure and

funding of small- and medium-sized entrepreneurs. Foreign companies can offer knowledge

Indian companies may lack, so partnering will likely become an important element in this

segment's growth, as Indian companies increasingly recognize that expertise in

bioinformatics is not enough without expertise in areas such as lead generation, toxicology

studies, regulatory affairs, and patenting.


SWOT ANALYSIS AND CONCLUSION: BIOTECHNOLOGY INDIAN INDUSTRY

The importance of India in the field of Biotechnology is manifold. In addition to generating

trained manpower and a knowledge base, India is proving to be an ideal setting for

manufacturing activities and high-level biotechnology research programmes. With the

initiatives taken by the government, Indian Biotechnology is poised for a tremendous growth.

Government Initiatives

In recognition of the need of training and education for generating interdisciplinary human

resource relevant to biotechnology, the Government of India and UNESCO, have taken a

joint decision to establish the Regional Centre for research, training and education in

biotechnology under the auspices of UNESCO. The UNESCO Regional Centre for

Biotechnology is scheduled to come up in Faridabad, Haryana by the end of 2010. Further,

the Department of Biotechnology (DBT), Government of India, has also decided to set up a

unique Health Biotech Science Cluster (HBSC) at Faridabad. Moreover, the government will

fast forward the process of setting up a National Biotechnology Regulatory Authority, to

stimulate public and private investment in biotechnology. Besides the central government

initiatives, individual states are also doing their bit to promote the biotechnology industry.

Karnataka takes the lead and the state's revised biotech policy offers many fiscal incentives

and concession to prospective investors in the industry. According to the Mr. B S

Yeddurappa, Chief Minister of Karnataka, a bio-venture fund with a seed capital of US$ 10

million will be set up to incubate start-ups by young entrepreneurs. Moreover, the state

government is setting up 10 biotech finishing schools in association with the industry and

academia to create a steady talent pool. Sector specific biotech parks are expected to be set up

at Mysore, Mangalore, Dharwad and Bidar in north Karnataka. Similarly, a bio-cluster will

be set up in the Bangalore Biotech Park on a public-private partnership mode.

Incentives for investing in Indian Biotech Sector

DBT provides a single window processing mechanism for all mega Biotechnology

projects involving FDI of $ 22 million or more under the FIIA with its Fast Track

Committee (FTC)

150% weighted tax deduction on R&D expenditure

3 year excise duty waiver on patented products

100% rebate on own R&D expenditure

125% rebate if research in contracted to public funded R&D institutes

Joint R&D projects provided special fiscal benefits


MAJOR STENGTHS OF INDIA

AVAILABILTY OF SKILLED MANPOWER

India has the largest English speaking population after US

Sciences and Engineering streams produce 3 million graduated, 700,000 post

graduates and 1500 PhDs every year

Manpower costs much lower as compared to other nation

HIGHEST QUALITY STANDARDS IN MANUFACTURING

Outside the US, India has the highest number of FDA approvals in the world

World class facilities for manufacturing that comply with GLPs, cGMPs and GCP

standards

Well recognized for low-cost fermentation technology and generics biologicals

GENETIC PROFILE OF INDIAN POPULATION

Clinical trials can be outsourced to India as the Indian population has the similar

genetic profile as the US and European population, due to joint Aryan descent.

NEW BUSINESS MODELS:

COLABORATIVE R&D: Indian companies partnering with foreign players to enter into

collaborative R&D efforts as an initial step towards focusing on R&D.

NEW REVENUE STREAMS: Revenues from patent licensing and litigation can redefine

existing business models completely and shift them to a higher value generation plan.

EMERGING BUSINESS OPPORTUNITIES: India will become a highly lucrative option

for contract research once stronger IP protection legistation

CAPTURING THE INDIAN: Indian companies can introduce entry barriers foreign players

in the Indian market by using IP to protect their own innovation.


STRENGTH

TRAINED MANPOWER AND KNOWLEDGE

BASE

GOOD NETWORK OF

RESEARCH LABORATORIES

RICH BIODIVERSITY

WELL DEVELOPED BASE

INDUSTRIES (PHARMACEUTICAL AND

SEEDS)

EXTENSIVE CLINICAL TRIALS AND

RESEARCH

ACCESS TO VAST AND DIVERSE DISEASE

POPULATION

WEAKNESS

MISSING LINK BETWEEN RESEARCH

AND COMMERCIALIZATION

LACK OF VENTURE CAPITAL

RELATIVELY LOW R&D EXPENDITURE

BY THE INDUSTRY

DOUBTSABOUT INDIAN PRODUCTS TO

MEET INTERNATIONAL QUALITY

ADMINISTRATION OF RESOURCES

SUPPORTING BIOTECH RESERACH

AND DEVELOPMENT


OPPORTUNITY

THE LARGE INDIAN MARKET CAN BE

CAPTURED BY GAINING PROPER IP

PROTECTION`

THERE WILL EMERGE NEW REVENUE

STREAMS FROM PATENT LICENSING

ANDLITIGATION

STRONG IP PROTECTION INCREASES

THE LUCRATIVNESS OF INDIA AS A

CLINICAL RESERACH DESTINATION

ACCLERATED GROWTH OF BIOTECH

INDUSTRY

INCREASED OPPORTUNITY FOR

ENTRAPRENURIAL ACTIVITY

THREAT

DANGER OF ANTIBIOTECH

PROPAGANDA GAINING GROUND

IPR POLICIES

BRAIN DRAIN

ENHANCED LEVEL OF POLITICS IN THE

SYSTEM


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http://www3.ocimumbio.com/about/corporate-overview/

http://www.strandls.com/Company





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www.adm.com

www.dow.com

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www.ajeetseed.co.in

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www.rasiseeds.com

www.nathseeds.com

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biotechnology report

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