Demand for contract clinical research services continues to grow rapidly and underscores the integral role that outsourcing
plays in drug development. Additionally, usage of full-service and niche-services contract research organizations (CROs) is
evolving as sponsors react to changing portfolio requirements, operating needs, and global economic conditions.1
This year, biopharmaceutical companies are expected to spend in excess of $10 billion (US) worldwide on contract clinical
service providers—net of pass through costs such as central lab fees and investigator grants. Annual growth in spending on
CRO services—13.4% since 2001—has well outpaced the 9.1% annual growth rate in total global development spending during that
period.2
Figure 1. The factors respondents said were behind their increased use of CROs in 2009.
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A number of factors are driving the growth in outsourcing: Global clinical trial volume and scope is increasing while drug
developers face significant capacity constraints (see Figure 1). The number of projects in worldwide development has grown
6% annually since 2002, yet many major pharmaceutical and biotechnology companies have not increased their internal clinical
research headcount. These capacity constraints are expected to worsen as sponsors reduce and consolidate their R&D infrastructure
in response to a global economic downturn.3Between 2000 and 2008, the proliferation of small and mid-sized companies conducting clinical research programs also stimulated
demand for outsourcing. Smaller companies, many of them biotechnology firms, outsource a higher relative proportion of their
total clinical research portfolio in order to obtain expertise that falls outside their core capabilities. This year, however,
facing tight access to capital, many smaller companies have been forced to downsize and divest their development operations
resulting in a strong reduction in their demand for outsourcing. CRO contribution to development performance has also helped stimulate demand. Many sponsor companies have found that CROs
can provide faster cycle times at comparable quality, when they are used effectively. These findings were confirmed in a study
conducted by the Tufts Center for the Study of Drug Development in 2006.4
As global economic conditions continue to challenge the drug development enterprise, a rising number of sponsors—large, medium,
and small—are looking for new ways to better leverage the performance of their CRO partners while addressing intensifying
capacity, quality, and cycle time requirements.
With this as a backdrop, and as a follow-up to CRO usage surveys that we have conducted in collaboration with Applied Clinical Trials during the past decade, we conducted a new survey among biopharmaceutical companies to understand how their outsourcing practices
and partnerships continue to evolve. It is our hope that the results will inform drug developers and service providers alike
about how CROs are being used and the future direction of sponsor–CRO collaborations.
Survey methods
A 32-item survey was emailed to a targeted subgroup of subscribers to Applied Clinical Trials—biopharmaceutical (i.e., pharmaceutical and biotechnology) companies—during February and March 2009. In total, 392 individuals
responded to the questionnaire.
Fifty-two percent of respondents described their primary job function as middle management/operational. Senior management
accounted for 29%, and the remaining 19% chose "other." Female (52%) and male (48%) respondents were nearly equally represented,
and two-thirds of the respondents were between the ages of 30 and 49.
Overall, respondents reported a high level of experience in clinical research. Fifty-five percent of respondents have three
or more years of experience in drug development. Most respondents (83%) reported being directly involved in outsourcing. The
majority (70%) said they were involved in managing sponsor-provider relationships; 61% report they are responsible for selecting
providers and 55% for deciding whether to outsource a study, function or specific activity.
Respondents represented a cross-section of small, medium, and large pharmaceutical, specialty pharmaceutical, biologics, and
medical device companies. The proportion of respondents from smaller companies (<$100 million annual R&D spending) in the
2009 survey was greater than the proportion in our 2005 survey, where small, medium, and large companies were equally represented.
In the present survey, smaller companies comprised nearly half of the respondents (56%). One-out-of five responses came from
large (>$500 million) sponsors and one-out-of-four from mid-size sponsors.
The majority of respondents were from the United States (65%), with one-third based in the Northeast (36%), and one-fourth
based in each southern region: the Southeast (24%) and Southwest (24%). Western Europe accounted for (16%). Fewer respondents
were from Central/Eastern Europe (9%), Canada (3%), and Asia (4%).
