While product launch and commercialization has largely been the province of big biotech and big pharma, with smaller companies partnering to get their products over the finish line, BioCentury’s analysis of recent FDA approvals finds that smaller biotechs are increasingly going the distance alone.
Over the past three years, an increasing proportion of new drug launches are the first for a given company, particularly in Orphan indications and other niche areas.
In 2016, 14 of the 54 (26%) drugs approved by FDA represented the first U.S. launches for their developers, up from 11% in 2014 and 12% in 2015. The momentum has continued -- in 2018, a record year for FDA approvals, this figure rose to 27%, while the number of new launches by commercially-seasoned companies has remained flat (see Figure: “First U.S. Product Launches”).