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 52 percent.
Probability of success for drugs in the U.S. in different development phases between 2011 and 2020
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Probability of success for drugs in the U.S. in different development phases between 2011 and 2020
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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.
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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 Statista. Retrieved March 02, 2025, from https://www.statista.com/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. Statista. Accessed March 02, 2025. https://www.statista.com/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. Statista. Statista Inc.. Accessed: March 02, 2025. https://www.statista.com/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." Statista, Statista Inc., 26 Feb 2021, https://www.statista.com/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 Statista, https://www.statista.com/statistics/597642/drug-development-phases-probability-of-success/ (last visited March 02, 2025)
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: https://www.statista.com/statistics/597642/drug-development-phases-probability-of-success/
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