The data displays the probability of success for new rare disease and high prevalence disease drugs in the United States through the various stages of development, from January 1, 2006 to December 31, 2015. 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 8.7 percent, it was 25.3% for rare disease drugs.
Phase I to phase II | 63 | 58 | 76 |
Phase II to phase III | 30 | 27 | 50 |
Phase III to NDA/BLA | 58 | 61 | 73 |
NDA/BLA to approval | 85 | 87 | 89 |
Phase I to approval | 9.6 | 8.7 | 25.3 |