Clinical outsourcing drags big pharma out of doldrums
productivity have never been more aggressive, with clinical
outsourcing being one strategy employed by big pharma to lift
itself out of the doldrums.
During 2003-05, clinical trials for new drug candidates carried out by the 10 top selling US drug companies rose by 52 per cent, following a 21 per cent decline from 1993-97 to 1998-02.
The advent of outsourcing clinical trials to specialist companies has been the primary driver, with Almac Services, Kai Research and Mayo at the forefront of such growth.
Indeed, the adoption of outsourcing certain processes in the R&D process has culminated in statistics, which suggest that of the six specific broad therapeutic categories analysed, oncology/immunologic and CNS had the greatest shares of new drugs entering clinical testing during the 1993-02 period.
In addition, respiratory, oncology/immunologic, and systemic anti-infective drugs had the highest clinical approval success rates for the 1993-02 period.
Approximately 20 per cent of self-originated new drugs that enter clinical testing received US marketing approval.
"This 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.
The costs of drug development have increased steadily over the years, with the latest estimates being around $800m. This figure includes a significant contribution from the costs of all compounds that fail during the R&D process.
With the increasing pressure on pharmaceutical and biotech companies to get their drugs successfully through clinical trials, and considering the expense involved, it is not surprising that outsourcing has become the popular option.
That is not to say it is the only option for pharma and biotech. 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 approximately one in seven in 1993-97 to one in four in 2003-05.
"Licensing in compounds to broaden and strengthen development pipelines is one stratagem that complements other efforts, including co-development agreements between large and small firms, clinical outsourcing, and use of web-based and other e-clinical technologies," commented Kaitin.
According to him the fuller picture won't be known for several years, since, average clinical phase time for new drugs receiving market approval in the US is 7 years.
"Clinical approval success rate refers to the share of investigational new compounds entering clinical testing that eventually receive marketing approval from the US Food and Drug Administration," he added.
The results were reported in the May/June >Tufts CSDD Impact Report.
