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Trends in clinical success rates

Nature Reviews Drug Discovery volume 15, pages 379–380 (2016)Cite this article

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To update our research, we conducted an outside-in analysis of pharmaceutical development success rates from 1996 until 2014. Using Informa's Pharmaprojects database, we tracked the clinical and regulatory phase progression of more than 9,200 novel compounds in development (see Supplementary information S1 (box) for details). Our methodology enables success rates for individual development phases to be determined based on the proportion of successful drugs among all compounds exiting that phase in a given time period. Here, we summarize the key trends we observed.

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Figure 1: Trends in clinical success rates for all therapeutic areas over the past two decades.
Figure 2: Trends in clinical success rates for biologics compared with small molecules.
Figure 3: Trends in clinical success rates for partnered compounds compared with non-partnered compounds.

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Authors and Affiliations

  1. McKinsey & Company, Ved Stranden 14, Copenhagen K, DK-1061, Denmark

    Katarzyna Smietana

  2. McKinsey & Company, Plac Grunwaldzki 23, Wroclaw, 50-365, Poland

    Marcin Siatkowski & Martin Møller

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  1. Katarzyna Smietana
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  2. Marcin Siatkowski
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  3. Martin Møller
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Correspondence to Katarzyna Smietana.

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Competing interests

The authors of this article are employees of McKinsey & Company, a management consultancy that works with the world's leading biopharmaceutical companies on R&D productivity issues. The analysis in this study was funded by McKinsey's Pharmaceuticals and Medical Products practice and undertaken independently of any other organizations.

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Supplementary information S1 (box)

Data and analysis methods (PDF 126 kb)

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Smietana, K., Siatkowski, M. & Møller, M. Trends in clinical success rates. Nat Rev Drug Discov 15, 379–380 (2016). https://doi.org/10.1038/nrd.2016.85

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