Toxicogenomics and Predictive Toxicology: Market and Business Outlook addresses the
significant need and potential for predictive toxicology in drug development.
The report evaluates a number of novel approaches to toxicology research that
have become available over the past five years that are raising optimism for
dramatic improvements in the field. A detailed and insightful business outlook
on the strategic, regulatory, and marketplace issues driving growth of
toxicogenomic and predictive toxicology applications completes the analysis.
The ability to predict the toxic effects of potential
new drugs is crucial to prioritizing compound pipelines and eliminating costly
failures in drug development. The inability to accurately predict toxicity early
in drug development cost the pharmaceutical industry $8 billion in 2003,
approximately one-third the cost of all drug failures. Primarily, this is
because safety problems are often detected late in the drug development pathway,
after hundreds of millions of dollars have already been invested in potential
therapeutics. Even when drugs successfully obtain FDA approval and reach the
market, they remain vulnerable to costly safety issues. A recent example is
Mercks withdrawal of the blockbuster drug Vioxx from the market due to safety
concerns which caused the companys stock to plunge 25% in one day. Indeed,
predictive toxicology and toxicogenomics technologies are of growing interest to
government regulators, who have issued several reports recently calling for more
predictive toxicology and toxicogenomics approaches to be used in assessing drug
safety.
Toxicogenomics and Predictive Toxicology: Market and Business Outlook examines new
predictive toxicology approaches including in vivo, in vitro, and in silico
technologies such as toxicogenomics, metabolomics, new animal models, and
computational methods. Predictive toxicology differs from traditional toxicology
testing primarily by having a greater emphasis on low-cost, high through-put
assays, anticipating toxic responses rather than measuring them after they
occur; and by having a greater emphasis on understanding the underlying
mechanisms of action rather than just monitoring toxic response.
Predictive toxicology is still in its early stages,characterized by the use of gene expression profiles to gain a basic
understanding of whether a compound has a "clean" or "messy" profile. It
is still some way off from replacing traditional toxicology testing. However,
the tremendous advantages of these approaches, as well as pressure from the FDA
to improve toxicology testing in drug development, indicate that advancements in
predictive toxicology will play an increasing and accelerating role in drug
development. This report is crucial reading for companies that are exploring the
potential benefits of these methods and that wish to realize a maximum return on
their R&D spending.
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