The number of small biotechs scoring major FDA approvals has surged in recent years, outpacing their larger pharmaceutical counterparts.
A stark contrast can be seen between the FDA new drug approval lists for 2023 and 2024. While large companies dominated the 2023 list with 43 (63%) of its approvals sponsored or co-sponsored by companies generating at least $3 billion in revenue, the 2024 list tells a different story.
In 2024, only two of the 55 FDA nods were gained by companies that had lined up a commercial partner. The remaining approvals came from small biotechs and mid-sized pharmaceutical firms. This shift towards smaller players has significant implications for the industry, as it marks a return to an era where innovation and success are more evenly distributed among all sizes of pharma companies.
Pfizer’s FDA nods, including gene therapy Beqvez priced at $3.5 million, and Roche’s approvals for treatments that project peak sales of 2 billion Swiss francs ($2.3 billion) highlight the growing importance of cell and gene therapies. However, these high-priced treatments are often outpacing traditional small molecule drugs in terms of development timelines.
In contrast, companies like Merck and Bristol Myers Squibb secured key approvals for neurological conditions such as Alzheimer’s disease and schizophrenia. These major breakthroughs underscore the industry’s ongoing commitment to addressing some of the world’s most pressing health challenges.
With prices escalating across the board, from $4.25 million for Kyowa Kirin’s Lenmeldy, to $727,000 for Adaptimmune’s Tecelra, it appears that small biotechs are gaining an edge in terms of pricing and innovation.
Overall, the 2024 FDA approval landscape paints a picture of an industry where innovation is spread across different size categories. As more companies emerge as front runners in treatment development, there’s likely to be significant change on the horizon for pharmaceuticals.
Source: https://www.fiercepharma.com/pharma/2024-drug-approvals