Current Global Pharma Developments-Challenges and

Opportunities

P.U.M.Rao Retd. Addl. Industrial

Adviser(Pharma), Govt. Of

India

The Race for Quality

has no

finishing Line………

Global Pharma Industry 2008-09

• Global drug sales projected at $ 773 Bn with low growth of 4.8% in 2008.Further slowdown expected in 2009

• North America sales- $ 312 Bn, • Europe sales $ 247 Bn, Japan $ 76 Bn,

• Latin America $ 47 Bn growing +12%, • Asia/Africa/Australia together $ 91 Bn growing

+15%

• patent expiries, slowdown in new product launches, hurdles imposed by payers on market access, world financial crisis are some reasons for reduced growth

Global Pharma(contd)

• Oncology top therapeutic class $ 48 Bn sales growing at 11%. To reach $75 - 80 Bn by 2012.

• Aggregate value of biotechnology drugs sales +$ 75 Billion in 2007 are estimated to grow to $169 billion in 2014.

• Lipid Regulators($ 34 Bn),Respiratory($ 31 Bn), Antidiabetics($ 27 Bn), Antiulcers( $ 26 Bn), CVD($ 23 Bn)

are the other top groups

• U.S. Prescription drug Sales which grew 1.3 Percent in 2008 to $ 291 Billion is expected to decline by 1-2 percent in 2009

Global Pharma Highlights

• Top 50 pharmaceutical companies accounted for prescription drug sales of

$ 558 billion in 2008.• New Drugs in development gone up to 9605( 2009) from 5930 (1998) • Currently there are 100 blockbuster drugs,

22 biotech products are part of this.• 32 NCEs launched in 2008 compared to 25

in 2007.

Top Product Sales 2008($ Bn)

Lipitor (atorvastatin) 13.6

Plavix (clopidogrel) 8.6

Nexium (esomeprazole) 7.8

Seretide (fluticasone+salmeterol

7.7

Enbrel (etanercept) 5.7

Seroquel (quetiapine ) 5.4

Zyprexa (olanzapine ) 5.0

Remicade ((infliximab) 4.9

Singulair (montelukast) 4.6

Lovenox (enoxaparin) 4.4

Global Pharma Developments

● Serious profit setbacks • Mergers & Acquisitions.• Prohibitive R&D costs• Changing Regulatory environment• Threat from generics• More outsourcing• Emergence of new players

• ICH-quality risk management Q8, Q9 and Q10

guidelines.

Drug Patent Expiry

2009 2010Lansoprazole (Prevacid/Takepron/Zoton) Duloxetine (Cymbalta/XeriStar) Tamsulosin (Flomax/Omnic/Harnal) Perindopril erbumine (Coversyl/Aceon) Escitalopram oxalate (Lexapro/Cipralex) Anastrozole (Arimidex)

Losartan potassium (Cozaar/Hyzaar)

Atorvastatin calcium (Lipitor)

Docetaxel (Taxotere)

Gemcitabine (Gemzar)

Lamivudine and zidovudine (Combivir)

Pantoprazole (Protonix/Pantozol)

Donepezil (Aricept)

Levofloxacin Levaquin/Cravit/Tavanec)

Big Pharma M & A

Acquirer Acquired Value $ Mil Year

Pfizer Warner 8880 1999

Glaxo SKB 7880 2000

Sanofi Aventis 6570 2004

Pfizer Wyeth 6800 2009

Roche Genentech 4700 2009

Merck Schering 4110 2009

AstraZeneca Medimmune 1520 2007

Indian Pharma Profile

Current Indian pharma export profile

Exports of Drugs, Pharma and Finechem amounted to Rs 32051 Crores during 2008-09 (Apr -_Jan)

The Biopharma exports touched Rs 3999 Crores in 2007-08

Exports to over 200 destinations including small islands like Kiribati

Europe, North America together account for half of exports

Share of dosage exports 52% - a noteworthy achievement

World’s No. 1 Pharma market USA also India’s top destination

Africa is biggest with 54 destinations Global presence of India in the critical antiretroviral supply is now part of history.

Major export destinations(value Rs Mil)

Country 2007- 08 2008- 09 (Apr- Jan) Share %dosage forms(2007-08)

USA 58393 56686 65

Germany 14489 11773 31

Russia 11990 11977 94

UK 11465 9835 70

China 8794 4653 10

Brazil 7716 8645 47

Canada 7380 9217 16

South Africa 6843 9353 72

Nigeria 6441 8607 87

Netherlands 5227 5500 42

Major API Exports(2007-08)

Product group Rs. CroresMenthol 640

Amoxycillin 562

Cephalexin 196

Erythromycin 173

Ibuprofen 149

Ciprofloxacin 123

Ampicillin 138

Ranitidine 131

Ephedrines 90

Major Dosage Form exports(2007-08)

Product Group Rs. Crores

All Antiinfectives 4600

Vitamins 798

Analgesics,Antipyretics 791

Cardiovasculars 645

Antiulcers 452

Antiasthamatics 347

Hormonals+Insulin 315

Anticancers 251

Veg. Alkaloids 157

Government Initiatives for Pharma sector

• 100 % FDI permitted through Automatic route• Technology freely importable both Lumpsum, Royalty

applicable• Foreign Trade policy instruments-Advance Authorisation,

DEPB, EPCG• Export facilitation- MAI, MDI• New moves - Focus Markets, • R&D initiatives – funding• In house R&D recognition• Modernisation• Registration system streamlined for import of drugs -

both site and product registration• product patents for drugs, food and agrochemicals since

2005

Global Generic industry • Global generics Sale $78 billion as per

IMSH. Growth down to 3.6 % from 11.4 % in 2007

• top eight global markets – the U.S., Germany, France, the U.K., Canada, Italy, Spain and Japan account for 84 percent of total generics sales .

• Generics growth 10.2 % in Japan, 16.9 % in France, 12.5 % in Italy and 10.5 % in Spain.

• Top 10 generics companies 47 percent share of the generics market worldwide.

• Three leading generics manufacturers – Teva ( 11 % market share), Sandoz ( 9 %) and Mylan ( 8 %).

• Generics companies to benefit as products generating $139 billion in branded sales in the top eight world markets lose their patent protection through 2012

Country $ Billion

USA 33

Top 5 Europe 22

EU 31

Japan 3

Australia 2

generic medicine policies of European governments

I. Countries with a coherent generic

medicines policySweden, UK, Denmark, France

II. Generic medicines competition within existing regulatory frameworks

Poland, Netherlands, Denmark

Germany, UK, Sweden

III. Countries with incentives for physicians to prescribe generic medicines

Germany, France, UK, Sweden

IV. Countries with incentives for

pharmacists to dispense generic

medicines

Netherlands, Denmark, UK, Italy

France, Poland, Sweden

V. Countries with incentives for patients to demand generic medicines

Italy, Denmark, Germany

Sweden, France, Poland

Source- EGA

Opportunities

• Why New Markets - what’s happening in US, Europe

• Outsourcing opportunities. Collaboration, Tie ups

• BT Acquisitions

• Prevalence of Different Strategies –

• Growth Areas for products

• Eco-innovation driving greener product development

• Cooperate not compete model

• FTAs- Setting up JVs to access new markets.

Concept to Goal of ASEAN pharmaceutical harmonization

• $ 13 Billion ASEAN pharma market presents growing opportunities

• 10 ASEAN member countries formed PPWG in 1999 – A Partnership of Indonesia, Malaysia, Singapore, Thailand, Philippines, South Korea, Vietnam, Laos, Mynamar, Brunei

• Studied harmonization of procedures and regulatory system towards achieving MRA

• ASEAN CTD and other regulatory parameters like BA adopted

• Implementation through Working Group based on consultations and consensus

• Resources, Training taken care off

• ASEAN GMP finally in place through a decade of dedicated exercise

• Implementation January 2011

Impediments Non Tariff Barriers Effect of Free trade agreements Growing imports. Absence of regulatory cooperation Pricing pressures in US. New approach by overseas API Mfrs - risk

strategy Take over Blues Authorized Generics REACH Increased FDA scrutiny of overseas API

facilities Lack of Accreditation of Indian testing labs

by vendors

Thank you