This statistic shows the probability of success for new rare disease and high prevalence disease drugs in the U.S. through the various stages of development, from January 1, 2011, to November 30, 2020. It was found that while the probability that a new drug for a chronic high prevalence disease makes it from phase I to approval was only 5.9 percent, while it was 17 percent for rare disease drugs.
Probability of success for new rare disease and high prevalence disease drugs in the U.S. by development phase from 2011 to 2020
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 rare disease and high prevalence disease drugs in the U.S. by development phase from 2011 to 2020 [Graph]. In Statista. Retrieved December 21, 2024, from https://www.statista.com/statistics/597822/drug-development-phases-probability-of-success-rare-high-prevalence-disease-drugs/
Biotechnology Innovation Organization, und Pharma Intelligence, und QLS Advisors. "Probability of success for new rare disease and high prevalence disease drugs in the U.S. by development phase from 2011 to 2020." Chart. February 26, 2021. Statista. Accessed December 21, 2024. https://www.statista.com/statistics/597822/drug-development-phases-probability-of-success-rare-high-prevalence-disease-drugs/
Biotechnology Innovation Organization, Pharma Intelligence, QLS Advisors. (2021). Probability of success for new rare disease and high prevalence disease drugs in the U.S. by development phase from 2011 to 2020. Statista. Statista Inc.. Accessed: December 21, 2024. https://www.statista.com/statistics/597822/drug-development-phases-probability-of-success-rare-high-prevalence-disease-drugs/
Biotechnology Innovation Organization, and Pharma Intelligence, and QLS Advisors. "Probability of Success for New Rare Disease and High Prevalence Disease Drugs in The U.S. by Development Phase from 2011 to 2020." Statista, Statista Inc., 26 Feb 2021, https://www.statista.com/statistics/597822/drug-development-phases-probability-of-success-rare-high-prevalence-disease-drugs/
Biotechnology Innovation Organization & Pharma Intelligence & QLS Advisors, Probability of success for new rare disease and high prevalence disease drugs in the U.S. by development phase from 2011 to 2020 Statista, https://www.statista.com/statistics/597822/drug-development-phases-probability-of-success-rare-high-prevalence-disease-drugs/ (last visited December 21, 2024)
Probability of success for new rare disease and high prevalence disease drugs in the U.S. by development phase from 2011 to 2020 [Graph], Biotechnology Innovation Organization, & Pharma Intelligence, & QLS Advisors, February 26, 2021. [Online]. Available: https://www.statista.com/statistics/597822/drug-development-phases-probability-of-success-rare-high-prevalence-disease-drugs/
