The U.S. Biopharmaceutical Innovation Ecosystem at Risk: The 20-Year Threat to U.S. Innovation and Cures

The United States has long been a global leader in biopharmaceutical innovation. That leadership depends on a stable ecosystem that supports early scientific discovery, predictable regulatory pathways, long-term investment, and continued development of new treatments for patients.

Our analysis examines how interacting pressures across research funding, regulatory capacity, and drug pricing policy may compound over time and affect the future pipeline of medicines. The analysis estimates that combined pressures, including NIH funding instability, FDA capacity challenges, IRA price negotiations, and potential Most-Favored Nation-style pricing, could reduce the number of novel drugs approved by up to 55% over the next two decades.

Why it matters

Drug development often takes 10 to 15 years, which means the effects of today’s policy decisions may shape the treatments available to patients for decades.

When research funding becomes less stable, regulatory pathways become less predictable, and investment incentives weaken, the impact can extend across the full innovation lifecycle. These pressures may be especially significant in areas with high unmet need, including rare diseases, oncology, small-molecule development, and other complex therapeutic areas where innovation is already difficult, costly, and uncertain.