Whether looking at Phase III success, drug launches or product sales, biopharma is hitting its stride in R&D, according to new analysis from Thomson Reuters. And, as the industry evolves its approach to research and regulators speed up the review process, the latest upswing could be a sign of better days ahead for drug developers.
Last year was a banner campaign for the world's drugmakers, per Thomson Reuters' latest CMR International factbook. The FDA approved 41 novel candidates--the most in more than a decade--in a year with 44 filings, suggesting a 93% success rate for applicants. That led to 46 drug launches in the developed world, a 17-year high, and 2014 saw global pharma sales cross $1 trillion for the first time, according to the report.
And while it's entirely possible 2014 is an outlier propped up by major new products in hepatitis C and oncology, Thomson Reuters points to some upstream factors suggesting biopharma R&D may have turned a corner.
Across the board, early-stage activity has declined while Phase III work has increased, a trend the report sees as evidence that biopharmas have learned to kill low-probability projects in Phase I before they become costly failures in larger trials. And that has had an effect on success rates: The number of terminated Phase III trials has steadily declined over the last 6 years, according to Thomson Reuters.
And while those trends point to biopharma learning the lessons of late-stage failures past, they also reflect the ongoing specialization of drug R&D, the report notes. The industry is increasingly seeing the benefit of focusing on rare diseases and unmet needs among small patient populations, as trials for such indications can be done speedily and with fewer volunteers, and global regulators give priority attention to niche medicines.
- read the report