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Key Takeaways

  • The overall likelihood of approval (LOA) from Phase I for all developmental candidates over 2011–2020 was 7.9%.
  • Phase II development remains the largest hurdle in drug development, with just 28.9% of candidates achieving this critical phase transition.
  • Of the 14 major disease areas, Hematology therapies had the highest LOA from Phase I (23.9%), representing a seven-fold increase over the least successful group, Urology (3.6%).
  • Immuno-oncology therapies provide a rare pocket of success in oncology R&D with an overall LOA of 12.4% vs 5.3% for all oncology approaches.
  • Rare disease therapies were notably successful with an overall LOA of 17.0%.
  • Chronic, high prevalence disease therapies were less successful with an overall LOA of 5.9%.
  • Biological complexity in drug modalities generally leads to higher LOA, with CAR-T and RNA interference achieving the highest LOAs of 17.3% and 13.5%, respectively.
  • Development programs with trials employing patient preselection biomarkers have two-fold higher LOAs (15.9%), driven by a Phase II success rate of nearly one-in-two.
  • The top contributing factors toward phase success are disease indication, target, modality, and drug novelty.
  • On average, it takes 10.5 years for a Phase I asset to progress to regulatory approval. Disease areas with above-average LOAs tend to have the shortest development timelines.
2021 Clinical Development Success Rates

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