U.S. development phase success rates for drugs with and without biomarkers 2011-2020

Published by
Matej Mikulic,
Jun 3, 2022
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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Release date

February 2021

Region

United States

Survey time period

January 1, 2011, to November 30, 2020

Supplementary notes

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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