The growing use of biomarkers in clinical trials will push up worldwide revenues in this segment from $427 million in 2006 to more than $1 billion by 2010, a new report predicts.

Interest in biomarkers has soared due to their proven ability to accelerate pharmaceutical research and development, notes the report by Kalorama Information. This is at a time when pipeline productivity in the industry remains low, despite the significant progress made by key regulators such as the US Food and Drug Administration in streamlining pre-market review processes for new medicines.

In this respect, cutting the time and cost of Phase I and II trials by replacing clinical endpoints should be the most profitable application for biomarkers, Kalorama believes. The segment is already generating revenues of more than US$200 million, a figure that could swell by a factor of five over the next four years, suggests the report, Biomarkers: A Market Briefing.

Central to critical path initiative

The FDA has made biomarkers central to the Critical Path initiative it launched in March 2004 with the aim of modernising and streamlining medical product development. The agency sees a role for the next generation of predictive biomarkers in providing surrogate endpoints for efficacy; identifying safety problems at an early stage of clinical development; evaluating dose ranges; tracking disease progression; facilitating the emergence of novel and more effective clinical trial designs; and supplying new diagnostics that can measure responsiveness to targeted therapies.

The Critical Path Opportunities Report and List, which last March laid down a blueprint for priority research projects to be taken forward under the Initiative, includes Better Evaluation Tools as one of six broad topic areas in which opportunities exist to bridge the gap between biomedical discoveries and development. “FDA’s outreach efforts uncovered a consensus that the two most important areas for improving medical product development are biomarker development and streamlining clinical trials,” the agency pointed out.

Among the activities listed under this heading are developing a concept paper on biomarker qualification that will be the FDA’s “first public statement on clarifying the nature and amount of evidence we will be looking for to support a variety of regulatory uses for biomarkers during medical product development”.

Last year also saw the launch, in October, of The Biomarkers Consortium, a public-private research partnership supported by the Foundation for the National Institutes of Health, Inc (FNIH). This initiative, which already has a first set of projects approved for funding and implementation, involves a variety of stakeholders including the NIH, the FDA, industry, non-profit organisations and advocacy groups. By Peter Mansell