This statistic shows the probability of success for new drugs with and without biomarkers in the U.S. through the various stages of development, in the period from January 1, 2011, to November 30, 2020. It was found that while the probability that a new drug without biomarkers makes it from phase I to approval was only 7.6 percent, those with selection biomarkers had a probability of success of 15.9 percent.
Probability of success for new drugs in the U.S. with and without selection biomarkers by development phase between 2011 and 2020
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Probability of success for new drugs in the U.S. with and without selection biomarkers by development phase between 2011 and 2020
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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.
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Biotechnology Innovation Organization, & Pharma Intelligence, & QLS Advisors. (February 26, 2021). Probability of success for new drugs in the U.S. with and without selection biomarkers by development phase between 2011 and 2020 [Graph]. In Statista. Retrieved April 09, 2025, from https://www.statista.com/statistics/597826/drug-development-phases-probability-of-success-with-without-biomarkers/
Biotechnology Innovation Organization, und Pharma Intelligence, und QLS Advisors. "Probability of success for new drugs in the U.S. with and without selection biomarkers by development phase between 2011 and 2020." Chart. February 26, 2021. Statista. Accessed April 09, 2025. https://www.statista.com/statistics/597826/drug-development-phases-probability-of-success-with-without-biomarkers/
Biotechnology Innovation Organization, Pharma Intelligence, QLS Advisors. (2021). Probability of success for new drugs in the U.S. with and without selection biomarkers by development phase between 2011 and 2020. Statista. Statista Inc.. Accessed: April 09, 2025. https://www.statista.com/statistics/597826/drug-development-phases-probability-of-success-with-without-biomarkers/
Biotechnology Innovation Organization, and Pharma Intelligence, and QLS Advisors. "Probability of Success for New Drugs in The U.S. with and without Selection Biomarkers by Development Phase between 2011 and 2020." Statista, Statista Inc., 26 Feb 2021, https://www.statista.com/statistics/597826/drug-development-phases-probability-of-success-with-without-biomarkers/
Biotechnology Innovation Organization & Pharma Intelligence & QLS Advisors, Probability of success for new drugs in the U.S. with and without selection biomarkers by development phase between 2011 and 2020 Statista, https://www.statista.com/statistics/597826/drug-development-phases-probability-of-success-with-without-biomarkers/ (last visited April 09, 2025)
Probability of success for new drugs in the U.S. with and without selection biomarkers by development phase between 2011 and 2020 [Graph], Biotechnology Innovation Organization, & Pharma Intelligence, & QLS Advisors, February 26, 2021. [Online]. Available: https://www.statista.com/statistics/597826/drug-development-phases-probability-of-success-with-without-biomarkers/
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