Market Insight report on ADME/Tox Technologies

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RITMIR001: ADME/Tox Technologies – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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I. SCOPE AND METHODOLOGY 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

RITMIR001: ADME/Tox Technologies – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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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.

RITMIR001: ADME/Tox Technologies – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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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.

RITMIR001: ADME/Tox Technologies – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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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

RITMIR001: ADME/Tox Technologies – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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ADME/Tox Technologies – Global Market Analysis Growing at a healthy compounded annual growth rate (CAGR) of XX.XX % during the analysis period (20052020), 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 ADME/Tox Technologies – Global Value Market Estimations and Predictions (2005-2020) in US$ Million Year

Value

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© RIT Figures, 2013

RITMIR001: ADME/Tox Technologies – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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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.

RITMIR001: ADME/Tox Technologies – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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Exhibit 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 Year/Region

United States

Europe

Asia-Pacific

Canada

RoW

Total

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XX.XX

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%CAGR

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© RIT Figures, 2013

RITMIR001: ADME/Tox Technologies – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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Exhibit List of Major Global In Vivo Companies* Company

Country

Website

ABC Laboratories, Inc.

USA

www.abclabs.com

ADMET Group

USA

www.admetgroup.com

Caliper Life Sciences, Inc.

USA

www.caliperls.com

Charles River Laboratories, Inc.

USA

www.criver.com

Comparative Biosciences, Inc.

USA

www.compbio.com

Eurofins ADME BIOANALYSES

France

www.eurofinsadmebioanalyses.com

GenPharmTox BioTech AG

Germany

www.genpharmtox.de

Gwathmey, Inc.

USA

www.gwathmey.com

Harlan Laboratories, Inc.

USA

www.harlan.com

Nerviano Medical Sciences srl

Italy

www.nervianoms.com

NoAb BioDiscoveries, Inc.

Canada

www.noabbiodiscoveries.com

Pharmaron

USA

www.pharmaron.com

SRI International

USA

www.sri.com

Tetra Q

Australia

www.tetraq.com.au

WuXi AppTec Co., Ltd.

China

www.wuxiapptec.com

Xceleron Ltd.

UK

www.xceleron.com

*Companies Engaged In In Vivo Screening or Products/Services © RIT Figures, 2013

RITMIR001: ADME/Tox Technologies – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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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. Exhibit ADME/Tox Technologies – Global Value Market Shares (2010, 2015 & 2020) for United States, Europe, Asia-Pacific, Canada and Rest of World Year/Region

United States

Europe

Asia-Pacific

Canada

RoW

Total

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XX.XX

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100

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100

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100

© RIT Figures, 2013

RITMIR001: ADME/Tox Technologies – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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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 Pharmaceutical Cell-Based Screening – Global Value Market Estimations and Predictions (20052020) in US$ Billion Year

Value (US$ Billions)

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© RIT Figures, 2013

RITMIR001: ADME/Tox Technologies – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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Exhibit Pharmaceutical Contract Research – United States Value Market Estimations and Predictions (2005-2020) in US$ Billion Year

Value (US $ Billion)

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© RIT Figures, 2013

RITMIR001: ADME/Tox Technologies – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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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 ADME/Tox Technologies – German Value Market Estimations and Predictions (2005-2020) in US$ Million for In Vivo, In Vitro and In Silico Year/Technology

In Vivo

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© RIT Figures, 2013

RITMIR001: ADME/Tox Technologies – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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IV. PRODUCT/TECHNOLOGY RESEARCH Time and Money – both can be 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.

RITMIR001: ADME/Tox Technologies – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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

Pre-Clinical

Phase I

Phase II

Phase III

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© RIT Figures, 2013

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

RITMIR001: ADME/Tox Technologies – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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Exhibit 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) © RIT Figures, 2013

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

RITMIR001: ADME/Tox Technologies – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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Analysis by Segment Exhibit 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

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© RIT Figures, 2013

RITMIR001: ADME/Tox Technologies – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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RITMIR001: ADME/Tox Technologies – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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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……………………………...

RITMIR001: ADME/Tox Technologies – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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