Over the past three years, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved around 200 novel drugs for human use (1,2). Not a large number considering the Pharmaceutical Research and Manufacturers of America (PhRMA) citation that for every 5,000 to 10,000 compounds that enter the pipeline, only one receives approval (3)
BioPharma and CROs are riding the latest wave – discovery research – together with a vigour and gusto that might have seemed implausible five years ago. How these collaborations are structured, and how well they function, can vary widely, though.
R&D outsourcing continues to rise sharply to meet the demands of life sciences organisations’ growing pipelines, but CROs have to keep evolving or more nimble competitors will take their place.
The biopharmaceutical industry is currently facing significant headwinds. The blockbuster era is over, development costs are skyrocketing, uncertainty exists around regulatory and reimbursement, patent cliffs, generic erosion and a sluggish global economy all have industry executives losing sleep at night.