Only company-sponsored, FDA registration-enabling development
programs were included in this analysis. Investigator-sponsored studies and combinations with other
investigational drugs were excluded.
Citation formats
U.S. drug development phase III success rates 2011-2020, by disease area
This statistic shows the probability of phase III success for new drugs in the U.S., in the period from January 1, 2011, to November 30, 2020, by disease area. It was found that drugs in hematology had the highest phase III success rates.
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Biotechnology Innovation Organization, & Pharma Intelligence, & QLS Advisors. (February 26, 2021). The probability of phase III success for new drugs in select disease areas in the U.S. between 2011 and 2020 [Graph]. In ÌÇÐÄÆƽâ°æ. Retrieved July 23, 2026, from /statistics/597742/drug-development-phase-three-probability-of-success/
Biotechnology Innovation Organization, und Pharma Intelligence, und QLS Advisors. "The probability of phase III success for new drugs in select disease areas in the U.S. between 2011 and 2020." Chart. February 26, 2021. ÌÇÐÄÆƽâ°æ. Accessed July 23, 2026. /statistics/597742/drug-development-phase-three-probability-of-success/
Biotechnology Innovation Organization, Pharma Intelligence, QLS Advisors. (2021). The probability of phase III success for new drugs in select disease areas in the U.S. between 2011 and 2020. ÌÇÐÄÆƽâ°æ. ÌÇÐÄÆƽâ°æ Inc.. Accessed: July 23, 2026. /statistics/597742/drug-development-phase-three-probability-of-success/
Biotechnology Innovation Organization, and Pharma Intelligence, and QLS Advisors. "The Probability of Phase Iii Success for New Drugs in Select Disease Areas in The U.S. between 2011 and 2020." ÌÇÐÄÆƽâ°æ, ÌÇÐÄÆƽâ°æ Inc., 26 Feb 2021, /statistics/597742/drug-development-phase-three-probability-of-success/
Biotechnology Innovation Organization & Pharma Intelligence & QLS Advisors, The probability of phase III success for new drugs in select disease areas in the U.S. between 2011 and 2020 ÌÇÐÄÆƽâ°æ, /statistics/597742/drug-development-phase-three-probability-of-success/ (last visited July 23, 2026)
The probability of phase III success for new drugs in select disease areas in the U.S. between 2011 and 2020 [Graph], Biotechnology Innovation Organization, & Pharma Intelligence, & QLS Advisors, February 26, 2021. [Online]. Available: /statistics/597742/drug-development-phase-three-probability-of-success/
