Though drug development will never be an odds-on favorite, the chances of a compound moving from Phase I clinical trials to approval are no longer so low, according to the consulting firm McKinsey & Co.
The firm tracked the progress of more than 9,200 novel compounds between 1996 and 2015 (Nat. Rev. Drug Discovery 2016, DOI: 10.1038/nrd.2016.85). During 2012–15, 11.9% of drug candidates made it through development. This rate is a sharp uptick from a 15-year low of 7.5% reached during 2008–11, when pharmaceutical companies were restructuring their R&D organizations.
Those corporate makeovers “seem to have resulted in an improvement in the overall pipeline quality, leading to a gradual increase in Phase II and Phase III success rates,” the analysis concludes. A higher number of Phase I failures, it suggests, might reflect drug firms’ “increasingly thorough early evaluation in order to prevent costly late-stage failures.”
In addition, the number of candidates in development reached a high of 5,558 during 2012–15, up from 2,603 in 1996–99. Hot areas such as immunotherapies, antivirals, and biologics contributed to this growth. And, since 2008, biologics have been twice as likely as small molecules to succeed in development.