The U.S. was solely responsible for 61% of medicines approved by the Food & Drug Administration (FDA) between 2011 and 2020, with a majority developed by small biotechs, says a new report published by Vital Transformation (with support from BIO).
Small biopharmas lead the way: 55% of all therapies the U.S. originated were developed by small biopharmaceutical companies with less than $500 million in annual revenue, and 45% were fully discovered by small biopharmas on their own without an academic or government transfer of IP.
Partnerships go both ways: 1/3 of therapies originating in large firms are later sublicensed to small firms for production, especially for rare-disease treatments serving smaller patient cohorts.
The private sector does most drug development. NIH’s Cooperative Research and Development Agreements and intermural grants produced four of the 363 new drugs developed between 2011 and 2020, while “U.S. academic institutions created 10% of all indigenously originated IP.”
But U.S. dominance is being challenged by competitors around the world. Data shows venture-backed biopharmaceutical startups in Asia—predominantly driven by China—now equal the annual total of the U.S., with 93 startups. Europe was relatively flat, with 44 biopharma startups.
BIO’s take: The study shows “remarkable overall R&D productivity of U.S.-based biopharmaceutical enterprises” and “interdependence of the various large and small, public, and private actors that contribute to this flexible ecosystem,” says Hans Sauer, BIO’s VP for IP. “We shouldn’t take such successes for granted. It is critical that we maintain rational policies” that enable successful research, development, and market entry of new medicines.
Read the full study.
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