For all diseases and modalities. Only company-sponsored, FDA registration-enabling development
programs were included in this analysis. Investigator-sponsored studies and combinations with other
investigational drugs were excluded.
* NDA - New Drug Application/ BLA - Biologic License Application.
Citation formats
U.S. drug development phase success rates 2011-2020
This statistic shows the probability of success for new drugs in the U.S. through the various stages of development, within the period from January 1, 2011, to November 30, 2020. It was found that the probability that a new drug makes it from phase I to phase II was ** percent.
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Biotechnology Innovation Organization, & Pharma Intelligence, & QLS Advisors. (February 26, 2021). Probability of success for drugs in the U.S. in different development phases between 2011 and 2020 [Graph]. In ÌÇÐÄÆƽâ°æ. Retrieved July 24, 2026, from /statistics/597642/drug-development-phases-probability-of-success/
Biotechnology Innovation Organization, und Pharma Intelligence, und QLS Advisors. "Probability of success for drugs in the U.S. in different development phases between 2011 and 2020." Chart. February 26, 2021. ÌÇÐÄÆƽâ°æ. Accessed July 24, 2026. /statistics/597642/drug-development-phases-probability-of-success/
Biotechnology Innovation Organization, Pharma Intelligence, QLS Advisors. (2021). Probability of success for drugs in the U.S. in different development phases between 2011 and 2020. ÌÇÐÄÆƽâ°æ. ÌÇÐÄÆƽâ°æ Inc.. Accessed: July 24, 2026. /statistics/597642/drug-development-phases-probability-of-success/
Biotechnology Innovation Organization, and Pharma Intelligence, and QLS Advisors. "Probability of Success for Drugs in The U.S. in Different Development Phases between 2011 and 2020." ÌÇÐÄÆƽâ°æ, ÌÇÐÄÆƽâ°æ Inc., 26 Feb 2021, /statistics/597642/drug-development-phases-probability-of-success/
Biotechnology Innovation Organization & Pharma Intelligence & QLS Advisors, Probability of success for drugs in the U.S. in different development phases between 2011 and 2020 ÌÇÐÄÆƽâ°æ, /statistics/597642/drug-development-phases-probability-of-success/ (last visited July 24, 2026)
Probability of success for drugs in the U.S. in different development phases between 2011 and 2020 [Graph], Biotechnology Innovation Organization, & Pharma Intelligence, & QLS Advisors, February 26, 2021. [Online]. Available: /statistics/597642/drug-development-phases-probability-of-success/
