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 |