This statistic shows the probability of success for new drugs in the U.S. through the various stages of development, from January 1, 2011, to November 30, 2020, by drug classification. It was found that the probability of success from phase I to phase II was quite similar for NMEs, biologics, and vaccines
Probability of success for new drugs in the U.S. by development phase between 2011 and 2020, by drug classification
Characteristic
NME**
Biologic
Vaccine
Phase I to phase II
50.6%
52.5%
52%
Phase II to phase III
25.6%
32.4%
32.2%
Phase III to NDA/BLA*
50.6%
56.7%
58.1%
NDA/BLA to approval*
86.1%
94.6%
100%
0%25%50%75%100%125%
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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.
** NME - New Molecular Entity.
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Biotechnology Innovation Organization, & Pharma Intelligence, & QLS Advisors. (February 26, 2021). Probability of success for new drugs in the U.S. by development phase between 2011 and 2020, by drug classification [Graph]. In Statista. Retrieved April 27, 2025, from https://www.statista.com/statistics/597850/drug-development-phases-probability-of-success-by-drug-classification-modality/
Biotechnology Innovation Organization, und Pharma Intelligence, und QLS Advisors. "Probability of success for new drugs in the U.S. by development phase between 2011 and 2020, by drug classification ." Chart. February 26, 2021. Statista. Accessed April 27, 2025. https://www.statista.com/statistics/597850/drug-development-phases-probability-of-success-by-drug-classification-modality/
Biotechnology Innovation Organization, Pharma Intelligence, QLS Advisors. (2021). Probability of success for new drugs in the U.S. by development phase between 2011 and 2020, by drug classification . Statista. Statista Inc.. Accessed: April 27, 2025. https://www.statista.com/statistics/597850/drug-development-phases-probability-of-success-by-drug-classification-modality/
Biotechnology Innovation Organization, and Pharma Intelligence, and QLS Advisors. "Probability of Success for New Drugs in The U.S. by Development Phase between 2011 and 2020, by Drug Classification ." Statista, Statista Inc., 26 Feb 2021, https://www.statista.com/statistics/597850/drug-development-phases-probability-of-success-by-drug-classification-modality/
Biotechnology Innovation Organization & Pharma Intelligence & QLS Advisors, Probability of success for new drugs in the U.S. by development phase between 2011 and 2020, by drug classification Statista, https://www.statista.com/statistics/597850/drug-development-phases-probability-of-success-by-drug-classification-modality/ (last visited April 27, 2025)
Probability of success for new drugs in the U.S. by development phase between 2011 and 2020, by drug classification [Graph], Biotechnology Innovation Organization, & Pharma Intelligence, & QLS Advisors, February 26, 2021. [Online]. Available: https://www.statista.com/statistics/597850/drug-development-phases-probability-of-success-by-drug-classification-modality/
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