"The lawsuits, expense, and negative publicity have been costly to their suppliers," says Jack Gardner, a pharmaceutical market analyst with
Kalorama Information. "The toxicity problems with these drugs should have been caught before they reached clinical trials, but they weren't. This was not because of ineptitude of the companies involved, it was because better tools for determining toxicity were not available."
In his June 2007 report Early Toxicology: Markets and Approaches, Gardner suggests the market for early toxicology, which currently sits around $947 million, can expect significant growth in the next couple of years and will likely surpass $1.5 billion by 2010. These numbers include in vitro, in vivo, and in silico platforms, as well as services.
"Ten years ago, nobody would have considered outsourcing early tox services," Gardner says. "Now many pharmas and biotechs are doing it routinely. The change started with the mega-mergers of the late '90s. Newly formed, merged pharmas didn't have enough resources to do all their optimization work in-house."
In particular, he sees pharma looking increasingly to toxicology outsourcing to solve their problems. Outsourcing, he says, allows companies to explore new technologies without making significant capital investments and truly focus their efforts on drug candidates without having to alter their R&D processes.
Using small and mid-sized CROs as a barometer of future growth in the early toxicology service sector markets, he adds, "Many of these companies are innovative, dynamic, and growing rapidly. This indicates a healthy marketplace, where one can expect annual growth rates in the 15 percent range over the next five years."
