U.S. drug development Phase success rates, by drug classification 2006-2015

Probability of success for new drugs in the U.S. by development phase between 2006 and 2015, by drug classification

U.S. drug development Phase success rates, by drug classification 2006-2015 This statistic shows the probability of success for new drugs in the U.S. through the various stages of development, from January 1, 2006 to December 31, 2015, by drug classification. It was found that while non-new molecular entities had a 22.6 percent probability of success from Phase I to approval, new molecular entities had only a 6.2 percent probability of success.
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Probability of success for new drugs in the U.S. by development phase between 2006 and 2015, by drug classification

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NME**BiologicNon-NME
Phase I to phase II61%66%70%
Phase II to phase III26%34%48%
Phase III to NDA/BLA*49%57%74%
NDA/BLA to approval*78%88%90%
Phase I to approval6.2%11.5%22.6%
NME**BiologicNon-NME
Phase I to phase II61%66%70%
Phase II to phase III26%34%48%
Phase III to NDA/BLA*49%57%74%
NDA/BLA to approval*78%88%90%
Phase I to approval6.2%11.5%22.6%
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This statistic shows the probability of success for new drugs in the U.S. through the various stages of development, from January 1, 2006 to December 31, 2015, by drug classification. It was found that while non-new molecular entities had a 22.6 percent probability of success from Phase I to approval, new molecular entities had only a 6.2 percent probability of success.
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