What's killing biopharma's R&D success rate?

Timothy Anderson, Sanford C. Bernstein analyst

A new report from a top biopharma analyst at Bernstein Research maps out an alarming slide in clinical trial success rates in recent years. 

Tim Anderson tells Medical Marketing & Media that the Phase II success rate for experimental drugs plunged from 34% in 2003-2007 to 25% in the 2005 to 2009 era and 22% from 2007 to 2011. Phase III has performed on a more even keel, but still tracked downward, from 70% to 65%. The number of preclinical programs needed to produce a single new drug, meanwhile, soared from 12 during the first four-year stage to 30 in the most recent grouping. Anderson based his report on numbers from consultants at the KMR Group.

Anderson tells MM&M that any recent turnaround in the data would have been hidden behind the report's method of reviewing the trend in four-year stages over the past decade. And he put the erosion of productivity down to a slate of events: from the pipeline disruption triggered by megamergers to an insistence from payers and regulators that drug companies abandon the me-too drug development approach and focus on new treatments for serious unmet medical needs.

The greater the unmet need, the bigger the clinical risk.

"FDA has raised the bar on me-too drugs for the past five to seven years," 

Anderson told the trade journal: "They have gotten more cautious in their approach to safety. That and the payer dynamic are pushing [the industry] into the territory of unmet need. And with that, the risk of failure goes up."  

Anecdotally, Anderson says he's been seeing a spate of novel drug approvals that could portend a turnaround. But the industry clearly has dug itself a deep hole that it needs to climb out of. And that won't come as a surprise to a group of top pharma CEOs at companies like AstraZeneca ($AZN), Eli Lilly ($LLY), Pfizer ($PFE) and Sanofi ($SNY).

- here's the story from Medical Marketing & Media

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