Market Needs

In recent years, the costs of new drug development have skyrocketed. The average cost of developing a new approved drug is estimated to be $1.3 billion (DiMasi and Grabowski, 2007). At the same time, each year fewer new molecular entities (NMEs) are approved.

DiMasi and Grabowski report that only 21.5 percent of the candidate drugs that enter phase I clinical testing actually make it to market. US FDA approvals in 2008 totalled 21 NMEs and 3 biologic licence applications (BLAs). 

In addition to the slowing rate of drug development and approval, recent years have seen a number of drugs withdrawn from the market for safety reasons. According to the Government Accountability Office (GAO), 10 drugs were withdrawn because of safety concerns between 2000 and March 2006 (GAO, 2006).

Finding ways to select successful drug candidates earlier in development could save millions or even billions of dollars, reduce the costs of drugs on the market, and increase the number of new drugs with improved safety profiles that are available to patients.¹

¹ Emerging Safety Science: Workshop Summary. Sally Robinson, Robert Pool, and Robert Giffin, Forum on Drug Discovery, Development, and Translation (2008)