Today’s drug pipeline is in an interesting spot. In 2022, there were only 44 novel new drugs approved, down from 58 in 2020 and 60 in 2021. The decrease is due to several reasons beyond a regulatory COVID lag: a constricted approval pathway, the natural ebb and flow of the industry, and manufacturer funding issues. As the industry grows, it’s becoming harder for companies to go public and raise money like they once could.
But these challenges are no reason to fret. The market is strong and gaining momentum. There are currently more than 6,000 products in active clinical trials, which is about 67% more than in 2016. Cell and gene therapies are an exciting new frontier, especially for traditionally hard-to-treat indications like oncology, neurology, and rare disease.
In this white paper by Kimberly Cline and Jen Moran, with a note from Two Labs CEO Howard Miller, we review our top insights from 280+ launches, including how to set the stage for launch, connect the dots to form a seamless strategy, and what to expect in the years to come.