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U.S. development phase success rates for drugs with and without biomarkers 2006-2015

Probability of success for new drugs in the U.S. with and without selection biomarkers by development phase between 2006 and 2015

The data displays the probability of success for new drugs with and without biomarkers in the United States through the various stages of development, in the period from January 1, 2006 to December 31, 2015. It was found that while the probability that a new drug without biomarkers makes it from Phase I to approval was only 8.4 percent, those with selection biomarkers had a probability of success of 25.9%.

Phase I to phase II 63 76
Phase II to phase III 28 46
Phase III to NDA/BLA 55 76
NDA/BLA to approval 83 94
Phase I to approval 8.4 25.9