The Global Market for ADME-Toxicology Testing is Projected to Reach US$16.2 Billion by 2024
Growing Number of New Drugs Failing Phase II and III
Clinical Trials Due to Toxicity Issues Drives the Focus on ADME-Toxicology
Testing, According to a New Report by Global Industry Analysts, Inc.
GIA launches comprehensive
analysis of industry segments, trends, growth drivers, market size, and demand
forecasts on the global ADME-Toxicology Testing market. The global market for ADME-Toxicology Testing is
projected to reach US$16.2 billion by 2024, driven by the growing losses and writedowns related to drug failure in
developmental stages due to unchecked and unaddressed toxicity issues and the
resulting emphasis on integrating ADME-Toxicology Testing in early preclinical drug development stage.
Predicting the safety
profile of drugs during all stages of clinical development has been a major
endeavor of pharmaceutical companies for decades. Yet, despite spending
billions of dollars, non-clinical and clinical studies continue to show
substantial variation in results on drug behavior, leading to significantly
high attrition rate of drugs in clinical trials. While drug development costs
have increased substantially over the years, the number of drugs newly approved
has virtually stagnated – an apparent result of high drug attrition rate in
development. The growing focus on minimizing costs while improving hit rates
have elevated the importance of ADME-Toxicology testing, which help companies
assess the pharmacological effect of the drug and the potential of the drug to
induce toxicity in humans, respectively. Drug failures in late stage clinical
development compelled pharmaceutical companies to focus on pushing toxicology
testing further upstream in drug development process to drug discovery
alongside ADME testing for preventing costly down the lane failures. Increasing
number of potential drug targets, dearth of detailed information on these
targets, increasing focus on reducing drug developmental costs, growing intent
to detect potential ADME and Toxicological issues earlier in clinical
development and growing number of drugs under development are the major factors
driving growth in the market. With the testing moving towards early clinical
development, such drug discovery and lead optimization stages, in-vitro toxicology testing is fast gaining prominence.
Technological advancements
have contributed significantly to the changing paradigm in the ADME-Toxicology
testing market. Increasing human comprehension of factors affecting drug
behavior, driven in turn by advancements in genetics and other areas, has
constantly driven evolution in ADME-Tox assays. The deployment of in-silico technologies, computational technologies, advanced informatics and
sophisticated software solutions are further improving ADME-Tox testing. Technological
breakthroughs have enabled use of cell lines, such as those of liver, for
targeted hepatotoxicity testing, an approach unavailable until recent years.
Further advancements in this direction are allowing the development of novel
cell lines, and means to developing them, resembling the indications in humans.
Use of cell systems based microtiters is beginning to blur the lines between
ADME testing and toxicology testing. Drawbacks in cell lines-based ADME-Tox testing are leading to
development of various other strategies, including co-culture, 3D and
suspension, and immortalization. Emergence of three-dimensional cell cultures is,
however, driving demand for advanced liquid-handling instruments. Focus is also
gaining on developing cultures that can sustain longer durations are important
to simulate chronic exposure of drugs. Acquisition and analysis software
solutions that assist correlating structures with metabolism are fast gaining
importance, and are witnessing considerable developments. However, there is
still significant room for further technological developments for better human
models in screening and assessing biotransformation of drugs in humans.
As stated by the new
market research report on ADME-Toxicology Testing, the United States represents the largest market worldwide
supported by stringent adherence to regulatory toxicology and pharmacology
guidelines. Asia-Pacific ranks as the fastest growing market with a CAGR of 12%
through the analysis period led by increased outsourcing of drug discovery, and
clinical trials to low-cost countries particularly China and India; increasing
partnerships between international pharma companies with research laboratories
in the region along with rising support from regional governments.
Major players in the market
include ACEA Biosciences Inc., ADMEcell Inc., Agilent Technologies Inc., Albany
Molecular Research Inc., Beckman Coulter Inc., Cerep SA, CompuDrug
International Inc., Cyprotex PLC., CeeTox Inc., Dassault Systèmes Biovia Corp.,
Eurofins ADME BIOANALYSES SAS, Galapagos NV, Molecular Discovery Ltd.,
MultiCASE Inc., Optivia Biotechnology, PerkinElmer Inc., Promega Corporation,
Qualyst Inc., Simulations Plus Inc., Takara Bio Europe AB, Tecan Group Ltd. and
Thermo Fisher Scientific Inc. among others.
The
research report titled “ADME-Toxicology Testing: A Global Strategic Business
Report” announced by Global Industry
Analysts Inc., provides a comprehensive
review of market trends, issues, drivers, mergers, acquisitions and other
strategic industry activities of global companies. The report provides market
estimates and projections for ADME-Toxicology Testing in value terms for all
major geographic markets such as United States, Canada, Japan, Europe (France,
Germany, Italy, UK, Spain and Rest of Europe), Asia-Pacific and Rest of World. Global
and regional market analytics are further analyzed by the following testing
categories/types: Toxicology Testing (In-Vivo and In-Vitro) and ADME Testing.
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