Clinical outsourcing market set to skyrocket, says Kalorama

By Gareth Macdonald

- Last updated on GMT

Related tags European medicines agency Food and drug administration Pharmacology

Cost pressure and the increasing complexity of trials is forcing drugmakers to increasingly turn to outsourcing experts for clinical development, according to a Kalorama Information report.

The study reveals that spending on contract research in 2007 was $26bn (€20.2bn), equivalent to 34 per cent of global R&D spending up from the 22 per cent it made up in 2002.

The report argues that because developing and bringing a drug to market costs an average of $1.5bn and can take as long as 15 years, drugmakers are increasingly seeking ways to reduce R&D costs. It identifies patient recruitment as a key factor driving the increasing move towards outsourced trials.

The authors explain that the stricter safety regulations being put in place by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) has made it increasingly difficult to enrol trial participants in either continent.

In contrast, recruitment rates in contracting hubs like India and China are much higher, according to data released at this year’s World Economic Forum meeting.

According to another recent report by KPMG the Indian trial sector, which was worth $200m (€157.7m) in 2007, will generate $500-600m by 2010, equivalent to 15 per cent of the global market.

As a result, the outsourcing trend has begun to shift offshore as drugmakers seek to recruit in large populations of people eager to take part in clinical trial research. These regions can often produce the required number of participants in half the time, with better compliance and cheaper medical professionals.

"Pharmaceutical marketing is truly global right now​," commented Kalorama's Bruce Carlson adding that "Developers need to submit new drugs for approval in multiple countries simultaneously, rather than in succession, in order to maximise revenue and reduce costs. Recruiting volunteers in multiple countries is essential​."

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