With new and novel medicines launched the last couple of years for diseases like cancer, hepatitis C virus and multiple sclerosis, to name a few, one would think that pharmaceutical pipelines are gradually improving. Think again.
A hot-off-the-press Bernstein Research report shows that, essentially, "Pipeline success rates across all phases of development have been slowly worsening or at best staying flat, depending on the phase (preclinical through registration)."
Drawing on data from consultancy KMR Group in areas like success rate across development phases and product-cycle metrics, the report by Bernstein analyst Dr. Tim Anderson illuminates what appear to be some potentially disturbing trends: across all phases, success rates more often have declined, while it's taking longer for products to go from discovery to market.
One reason: regulators and payers are prompting pharma to take more risks. "What you're seeing is a function of [the industry] pursuing more novel drugs—pushing into disease areas with unmet medical need," Anderson told MM&M in an exclusive interview. "FDA is forcing folks, and payers are forcing folks, to get into these areas."
The drug industry's two main problems the last decade have been lagging R&D and the patent cliff, says Anderson. Recent R&D wins—like Boehringer Ingelheim's Pradaxa and Johnson & Johnson's Xarelto in the oral anticoagulant category; Novartis' Gilenya for MS; and Bristol-Myers Squibb's Yervoy and Genentech's Zelboraf and Perjeta for various forms of cancer—suggest a productivity renaissance. . .View Full Article