It now costs more than $1 billion and takes more than seven years, on average, to conduct clinical trials and win regulatory approval to market a new drug. Not only are development costs high and rising steadily, but also only one out of every six self-originated drugs developed successfully completes clinical testing and obtains marketing approval.
New Drug Development Still Risky
This 16% overall success rate—gleaned from the portfolios of the top 50 largest global pharmaceutical companies—has remained relatively constant despite efforts on the part of sponsors to improve the overall quality, predictability, and scope of their clinical research data. Although overall success rates have not changed substantially during the past decade, some trends in phase transition probabilities have been observed: Clinical transition probabilities between Phase i and Phase II and between Phase II and Phase III have gotten lower, suggesting that drug sponsors are becoming more aggressive about terminating unpromising candidates, enabling them to redirect increasingly scarce R&D resources to more promising drug development programs.—Tufts Center for Drug Development,