As optimistic as this outlook is, it pales beside the effervescent outlook of the clinical-research contract research organizations (CROs). In an informal PharmSource survey of exhibitors at the 2008 Drug Information Association (DIA) annual meeting held in Boston in June, 88% of clinical CROs surveyed said they expect 20% growth over last year. Respondents credited a growing number of studies as a principal factor, driven by downsizing at major pharmaceutical companies and the growth of trials in emerging markets. Respondents also emphasized the expansion of their own capabilities to meet that demand.
A recent survey of research and development (R&D) and outsourcing professionals by Jefferies & Company indicates that market conditions are highly favorable for continued growth in the clinical research sector. The survey found that R&D spending is expected to grow at a faster pace in coming years than it has in recent years, with the fastest growth in late-stage development (Phase IIb and Phase III). This undoubtedly reflects the maturing of the pipeline as rapid growth in early-phase compounds yields more late-stage candidates.
Jefferies' respondents expect the fastest growth in outsourced spend to be in early development, including preclinical toxicology and Phase I clinical testing. This reflects a growing reliance on early-phase testing to demonstrate proof-of-concept as a means of controlling R&D costs and identifying candidates likely to fail earlier in the development process.
Respondents to the Jefferies survey also expect more offshoring of clinical research activities, with a focus on data management and use of clinical sites in emerging markets. In fact, they expect the share of R&D budgets spent outside North America and Europe to almost double, from 29% in 2008 to 54% by 2011. For this to happen, however, they must overcome a variety of obstacles including IP protection, communication problems, and cultural differences.
There are already signs that outsourcing of development services for clinical-trial materials is headed in the same direction as clinical research. It may pay for nonclinical outsourcing professionals to "look over the wall" at what their clinical counterparts are doing.
Jim Miller is president of PharmSource Information Services, Inc., and publisher of Bio/Pharmaceutical Outsourcing Report, tel. 703.383.4903, fax 703.383.4905, [email protected]