Big Pharma may be emerging from R&D doldrums, says Tufts

Leading US pharmaceutical companies have increased the number of new clinical trials more than 50% since 2002, signaling a possible resurgence in R&D productivity, according to a new study released today by the Tufts Center for the Study of Drug Development. During the 2003-05 period, the rate at which the 10 top selling US drugmakers initiated clinical trials for new drug candidates rose by 52%, following a 21% decline from 1993-97 to 1998-2002, the analysis found.

"This robust improvement could be the start of a break-out from the R&D productivity doldrums that has plagued the major research-based pharmaceutical companies in recent years," said Tufts Center for the Study of Drug Development director Kenneth Kaitin.

"The real proof will be in the ability of companies to avoid late-stage development terminations and boost overall clinical success rates. Prior to the 2003-05 period, clinical approval success rates increased modestly. It remains to be seen whether further improvement in success rates will apply to the recent crop of products entering clinical testing." he added. However, that fuller picture will not be known for several years because, according to Mr Kaitin, average clinical phase time for new drugs receiving market approval in the USA is seven years. Coincident with the increase in new clinical trials, the largest drug companies expanded their reliance on licensed-in compounds. According to the study, the share of licensed compounds in the development portfolios of leading firms increased from about one in seven in 1993-97 to one in four in 2003-05.