As drug candidates have become increasingly complex, the risk of failure down the line appears to be greater than ever. Robert Harris, director – Early Development, Molecular Profiles, looks at the challenges with early phase development and the benefits offered by CROs.
According to data from IMS Health, the world pharmaceutical market was worth an estimated €579,510m at ex-factory prices in 2009 and Europe accounted for 30.6% of the world pharmaceutical sales. As the European Federation of Pharmaceutical Industries and Associations (EFPIA) reports, the research-based pharmaceutical industry is a key asset of the European economy, representing 17% of the total EU business r&d investment and 3.5% of the total EU manufacturing value added.1
Pharmaceutical r&d is a particularly lengthy, expensive and risky process, requiring increasing investment efforts. The chances of new compounds becoming marketable and profitable medicines are relatively small. It is not uncommon for seemingly promising new compounds to reach an advanced stage within clinical research before trial results reveal that these substances offer no potential. This incurs extremely high costs. And while the cost of producing new drugs continues to escalate, drug sales are declining due to patent expirations. In this era of shrinking pipelines and revenues, the industry is looking for ways to bring new drugs to market more efficiently.
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