skip to main content
Close Icon We use cookies to improve your website experience.  To learn about our use of cookies and how you can manage your cookie settings, please see our Cookie Policy.  By continuing to use the website, you consent to our use of cookies.
Global Search Configuration
  • Close Icon

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

お問い合わせ&レポートストア

専任スタッフによるデモンストレーションを兼ねたサービスの詳しいご説明、または無料トライアルを常時受け付けています。ご希望の場合は下記のフォームよりお気軽にお申し込みください。

*一部のサービスでは無料トライアルをご利用になれません。

新型コロナウイルス感染拡大防止のため在宅勤務を実施しています。お問い合わせの際は下記のフォームまたはメールアドレスをご利用下さい。

Eメール:inquiry.jp@informa.com


オンラインショップのレポートストアでは、医療用医薬品の市場調査・分析レポートを常時1000本以上販売しています。レポート1本単位で購入でき、オンラインでご提供いたします。

お探しの情報が見つからない場合はお問い合わせ先までお気軽にご連絡ください。