adme tox market

RITMIR001: ADME/Tox Technologies – A Market Insight Report, Jan 2014

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Adme/Tox Technologies Global Market Size Scope of the Study

This report gives an insight into ADME/Tox technologies. The report covers introduction to ADME/Tox

methods including High Throughput Screening and Predictive Technologies such as In vivo, In vitro and In

silico.

The study includes estimates and projections for the total global ADME/Tox market. Projections and

estimates are also illustrated by region and by technology.

The report serves as a guide to ADME/Tox industry, as it covers more than 540 companies that are engaged

in ADME/Tox studies/screening, products and services.

Major Contract Research Organizations serving ADME/Tox industry are also covered in the corporate

directory section of this report.

Information related to recent product releases, product developments, partnerships, collaborations, and

mergers and acquisitions is also covered in the report.

This report covers both products and services used in the ADME/Tox industry.

Since ADME/Tox is an essential tool in drug discovery procedures, the drug discovery markets are also

discussed in brief. Related technologies such as High Throughput Screening (HTS), and cell based assays are

also analyzed.

This report also attempts a glance at biotechnology industry.

ADME/Tox Technologies report is an ideal research tool providing strategic business intelligence to the

corporate sector.

This report may help strategists, investors, laboratories, pharmaceutical companies, contract research

organizations, biotechnology companies and drug approval authorities in understanding the following

market factors:

Comprehending Key Market Drivers

Gauging Competitive Intelligence

Identifying Key Growth Areas and Opportunities

Understanding Geographic Relevance to Product

Knowing Regional Market Sizes and Growth Opportunities and Restraints

Keeping Tab on Emerging Technologies

Equity Analysis

Tapping New Markets



Analytics and data presented in this report pertain to several parameters such as –

Global And Regional Market Sizes, Market Shares, Market Trends

Product (Global And Regional) Market Sizes, Market Shares, Market Trends

Technology Trends

Corporate Intelligence

Key Companies By Sales, Brands, Products

Consumer Behavioral Patterns

Other Strategic Business Affecting Data



Research Methodology

RI Technologies publishes business intelligence reports by going through a cycle of diligent research and

analysis activity.

Research is done using both online and offline resources. The study outline of this report is sketched on the

following lines – global market analysis, regional market analysis, product segmentation,

Global and regional market analysis by product segment, market trends, M&A, R&D, competitive

landscape, technology trends, and other key drivers.

Current data helps in analyzing the future of the industry and is also helpful for doing market evaluations,

and estimating the market size for the future.

This report is uniquely researched and the methodology includes:

Need and Scope of Study

Product Definitions

Segmental Analysis

Regional Analysis

Exclusive Data Analytics

Corporate Intelligence

Feedback

Right from concept to final compilation of this report, both primary and secondary research methods are

applied.

We have provided exclusive feedback forms/pre-release questionnaires for this report to use the

information for authentication of our own findings.

Secondary research includes government publications, investment research reports, web based surveys,

website information of both companies and markets, and other offline resources such as print publications

and CDs.

Our compilation of easy to navigate PDF reports are essential value addition resources for leading and

growing companies.



II. REPORT SYNOPSIS

ADMET technologies play an important role in determining pharmacokinetic and toxicology properties of a

new drug candidate in preclinical stage of the drug discovery process.

ADME is at present a confirmed and indispensable part of coordinated drug discovery and development

programs. It furnishes important data to facilitate iterative chemistry, target discovery and biological

procedures on which pipelines are dependent upon.

ADME-toxicology is also known as ADMET or ADME/Tox. It is an instrument for drug discovery. It is used for

assessing the pharmacological activity or pharmacological toxicity of a drug. It could be performed either in

vitro or in vivo.

To obtain ADME analysis, the detection systems and assay kits are immensely useful. Presently ADME

analysis can also be performed by high throughput automated workstations.

Typically ADME/Tox (Absorption, Distribution, Metabolism, Excretion and Toxicology) is defined as follows:

Absorption

Absorption determines the compound’s bioavailability. Oral delivery is the most desirable route of drug

administration.

The effective gastrointestinal absorption of an orally administered drug is one of the key factors for its

bioavailability, and the rate of Absorption mainly depends upon the surface area of the intestine.

Distribution

Distribution refers to the passage of the drug to the every tissue of the body depending upon the particle

size by the process of filtration, diffusion and osmosis.

The extent of drug distributed in the body is referred to as Volume of Distribution.

Metabolism

The definition of metabolism is the processing of a particular substance inside the living body. Compounds

start to disintegrate immediately after entering the living body.

A substantial part of the small-molecule drug metabolism is performed within the liver by redox enzymes.

These redox enzymes are known as cytochrome P450 enzymes.

When the process of metabolism takes place, the original compound which has entered the body, gets

transformed into new compounds.



The new compounds are called metabolites. The metabolites soon become pharmacologically inactive. At

that point in time, metabolism inhibits the dose of the original drug that was dispensed.

As this deactivation process advances there is a reduction of the effects on the body. Intermittently, it will

be observed, that the metabolites could be pharmacologically active.

The metabolites may become more active than the original drug that was administered.

Excretion

Excretion or elimination may be described as the process of discharging metabolic waste from the organs,

tissues or blood.

The compounds and the metabolites of the compounds have to be necessarily eliminated from the body.

The process is termed as excretion. The excretion via kidneys is through urine.

The waste matter eliminated via the bowels is feces. It is imperative that excretion is thorough. If not, the

aggregation of foreign substances tends to negatively affect regular and functional metabolism.

Drug excretion takes place via three sites. They are as follows:

1. The most essential site is the kidneys through which drug excretion occurs. The waste matter is

eliminated through the urine.

2. Fecal excretion and biliary excretion, that is, relating to bile, is initiated in the liver. The waste matter

then is transported through the guts and the last part of the process is the excretion through the feces.

3. The third method of excretion is via the lungs. The lungs are used by the body to eliminate organic

anesthetic gases.

Toxicity

Toxicity refers to the degree to what extent a substance or matter or the combination of matter can

endanger humans.

There are two basic toxicities - chronic toxicity and acute toxicity. Chronic toxicity harms over an extended

period, is generally repeated and continues. Acute toxicity causes harmful effects over a short period of

time.



Significant Methods for ADME/Tox

Predictive Technologies

Predictive ADME/Tox technologies include:

In Vivo

In Vitro

In Silico

Related ADME/Tox Methods

High Throughput Screening (HTS)

Primary Screening

Secondary Screening

Biochemical Assays

Cell-based Assays

High Content Screening



ADME/Tox Technologies – Global Market Analysis

Growing at a healthy compounded annual growth rate (CAGR) of XX.XX % during the analysis period (2005-

2020), global ADME/Tox Technologies market is projected to reach US$ XX.XX billion by 2020 from an

estimated US$ XX.XX billion in 2012.

Exhibit 1. ADME/Tox Technologies – Global Value Market Estimations and Predictions (2005-2020)

in US$ Million



In Vitro ADME/Tox – An Emerging Technology

In vitro ADME/Tox technologies are likely to have slow development as they have to rely on innovative and

new ideas.

In vivo methods that have well developed In vivo alternatives are easiest to replace. Other In vivo

techniques that provide toxicity information, not easily comprehensible, will be more difficult to replace.

The mapping of the human genome and the oncoming of computational techniques has greatly increased

the utility of In vitro methods.

In vitro technology is largely used to predict whole body kinetics and drug to drug interactions.

Factors such as genotypes, age, ethnicity, disease, etc. are taken into consideration to root out potential

drug compound failures. Early In vitro toxicity screening helps in eradication of failure compounds very

early.

Global Market Analysis

The worldwide In vitro ADME/Tox market is estimated at US$ XX.XX million in 2012. Registering a CAGR of

XX.XX % during the analysis period, the market is projected to be worth US$ XX.XX million by 2020.

With an estimated market share of XX.XX % in 2012, the US represents the largest market for In vitro

ADME/Tox with market worth US$ XX.XX million.

The US is projected to reach US$ XX.XX million by 2020 by growing at a CAGR of XX.XX % during 2005-2020

to retain the leadership. Canada is expected to be the fastest growing market, while Europe represents

second fastest growing as well as second largest market with a share of XX.XX % in 2010.



Exhibit 2. In Vitro ADME/Tox Technologies – Global Value Market Estimations and Predictions (2005-

2020) in US$ Million for United States, Europe, Asia-Pacific, Canada and Rest of World



Exhibit 3. List of Major Global In Vivo Companies*



III. MARKET DYNAMICS

New technologies in ADME/Tox have evolved from diverse scientific disciplines. The toughest challenge is

to integrate several successful features and enable pharmaceutical companies to benefit and reap profits in

the future.

Though some of the concepts in this industry are still in infant stages, the data generated from other

relevant sources can be used to close the gaps.

Pharmaceutical companies realize the potential of ADME/Tox technologies and are trying more than before

to incorporate innovative procedures to reduce drug attrition rates and lessen the burden of costs and save

precious time.

Strategic partnerships between pharmaceutical and biotechnology companies are the order of the day, and

the trend is increasing globally.

Another significant trend is the alliance between Pharma and Biotech companies and information

technology companies such as Microsoft, IBM, Oracle, Sun, and Infosys, etc.

The computer platforms generated by such companies help managing and analyzing the huge amounts of

data produced from ADME/Tox technologies such as High Throughput Screening (HTS) and other

computational techniques.

Effective R&D strategy involves efficient data management and implementation plans. The new

technologies promise improved efficacy, decreased toxicity in patients, and reduced time frames and

expenditures.



Global Pharmaceutical Cell Based Screening Market

The size of pharmaceutical cell-based screening market was an estimated US$ XX.XX billion in 2012. This

market is expected to reach US$ XX.XX billion by the year 2020 at a CAGR of XX.XX %.

Exhibit 4. Pharmaceutical Cell-Based Screening – Global Value Market Estimations and

Predictions (2005-2020) in US$ Billion



Exhibit 5. Pharmaceutical Contract Research – United States Value Market Estimations and Predictions

(2005-2020) in US$ Billion



Europe trails behind in biotechnology after the United States due to the continent’s several systemic

causes, rather than simply institutional failures. Though Europe has many research institutes and

universities, the region does not attract foreign investments. European biotechnology industry relies

heavily on research done in the US.

Exhibit 6. ADME/Tox Technologies – German Value Market Estimations and Predictions (2005-2020) in

US$ Million for In Vivo, In Vitro and In Silico



IV. PRODUCT/TECHNOLOGY RESEARCH

Time and Money – both can be saved by applying ADME/Tox technologies in the early drug discovery

processes. ADME/Tox studies determine dosage and toxicity issues for any new drug before human trials.

Prediction of potential human risks of a new drug candidate is crucial in early stages of the drug

discovery/development process. Even 10%-12% increase in identifying failures before a drug candidate

entering the clinical trial stage could save the company over US$100 million.

ADME/Tox or ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) is widely accepted

preclinical testing system of a new drug candidate.

ADME/Tox is applied in various tests to determine the candidate’s characteristics such as absorption,

distribution, metabolism, and excretion respectively by intestine, liver, kidney, and other target organs.

ADME/Tox is also applied in determining toxicity profile of the drug candidate.

Biotechnology methods for screening new drug candidates are becoming important and the technology

needs to provide latest screening tools at the pace of discovery of numerous new drug candidates.

Improvements in molecular biology made it possible to clone express proteins that are expected to play a

key role in disease trial and combinatorial chemistry helped in creating large libraries of chemical

compounds.

This phenomenon helped in discovering/identifying huge number of drug candidates.

Though animal studies, considered as gold standard in confirming adequate drug exposure limits in human

are essentially used in tests, non animal models such as In vitro and in silico techniques are rapidly making

their ground.

Most of the drugs fail in the clinical development phase due to their poor ADME/Tox properties.

Companies are making robust efforts in eliminating poor elements before they enter into clinical trials.

Drug failure in or post clinical trial phase may lead the company into economic disasters.



Exhibit 7. Drug Development Cost - Estimations and Predictions (2005-2020) in US$ Million

Year Pre-Clinical Phase I Phase II Phase III Total

2005 XX.XX XX.XX XX.XX XX.XX XX.XX
















CAGR% XX.XX XX.XX XX.XX XX.XX XX.XX

© RIT Figures, 2013

(Pre-Clinical Includes Discovery to Pre-Clinical Development)

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

US$ Million

Pre-Clinical Phase I Phase II Phase III



Exhibit 8. Reasons for Drug Failure in Clinical Trials in Phase I –III

Reason Phase I Phase II Phase III

Pharmacokinetics 15% 18% 6%

Human Toxicity 40% 27% 32%

Efficacy Not Proven 32% 38% 49%

Economic 2% 4% 5%

Other 11% 13% 8%

Total 100% 100% 100%

(Other Includes Chemistry (Unknown), Improved Candidate, Commercial)


(Other Includes Chemistry (Unknown), Improved Candidate, Commercial)



Analysis by Segment

Exhibit 9. In Silico ADME/Tox – Global Value Market Estimations and Predictions (2005-2020) in US$

Million for Organ and Tissue Cells, Cellular Networks, and Whole Cells

Year/Segment Organ & Tissue Cells Cellular Networks Whole Cells Total

2005 XX.XX XX.XX XX.XX XX.XX
















%CAGR XX.XX XX.XX XX.XX XX.XX


2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

US$ Million

Organ & Tissue Cells Cellular Networks Whole Cells



ADME/TOX TECHNOLOGIES – THE OUTLOOK

Global ADME/Tox Technologies market is projected to grow at a robust rate of XX.XX % compounded

annually from 2005 through 2020. This growth is mainly driven by the efforts of pharmaceutical and

biotech companies for reducing time and cost of drug discovery.

ADME/Tox profiling of a drug candidate plays a key role in reducing clinical trials cost and time of drug

launch to the market.

ADME/Tox assays eliminate compounds with lack of bioavailability, lower efficacy and toxicity in early

stages, in order to save time and costs in expensive later stages of drug discovery.

Due to ethical issues and growing trend towards decrease in using animals in clinical trials, there is a

gradual decline in market for In vivo predictive technology.

Though In vivo accounts for about three- fourth of total ADME/Tox Technologies market currently, non-

animal technologies- In vitro and In silico are projected to peg more than 40% of the market by 2015.

In particular, In silico is projected grow at a high CAGR of XX.XX % during the period 2005-2020. In terms of

technology, In silico is projected to register the fastest growth rate in all geographic

markets……………………………...

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Identifying Key Growth Areas and Opportunities

Understanding Geographic Relevance to Product

Knowing Regional Market Sizes and Growth Opportunities and Restraints

Keeping Tab on Emerging Technologies

Equity Analysis

Tapping New Markets



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