February 21, 2018

Pharma R&D failure and success

Clinical Development Success Rates 2006-2015

In the russian rulette as a lethal game of chance you may have 1/6 chance of being shot. If the chamber of the revolver holds 6, a 16,6%.
In drug industry the probability of R&D failure is 90.4%. We all know that in the drug cost we are paying also for failures, but we forget the figure.

These are the key takeaways of the report:
  • The overall likelihood of approval (LOA) from Phase I for all developmental candidates was 9.6%, and 11.9% for all indications outside of Oncology.
  • Rare disease programs and programs that utilized selection biomarkers had higher success rates at each phase of development vs. the overall dataset.
  • Chronic diseases with high populations had lower LOA from Phase I vs. the overall dataset.
  • Of the 14 major disease areas, Hematology had the highest LOA from Phase I (26.1%) and Oncology had the lowest (5.1%).Sub-indication analysis within Oncology revealed hematological cancers had 2x higher LOA from Phase I than solid tumors.
  • Oncology drugs had a 2x higher rate of first cycle approval than Psychiatric drugs, which had the lowest percent of first-cycle review approvals. Oncology drugs were also approved the fastest of all 14 disease areas.
  • Phase II clinical programs continue to experience the lowest success rate of the four development phases, with only 30.7% of developmental candidates advancing to Phase III.
PS. The growth in R&D expenses was 14% in 2016, while revenues grew 4% (p.36).