The US FDA has approved 131 drugs in the past year through its New Drug Application (NDA), Biologics License Application (BLA), and biosimilar pathways, marking a steady 4.8% year-on-year rise in approvals.
After a volatile decade in which approvals swung sharply from year to year, 2025’s total pushed past long-term norms, exceeding the 10-year average, according to GlobalData, a leading intelligence and productivity platform.
The findings come from GlobalData’s New Drug Approvals and Their Contract Manufacture: 2026 Edition, which shows the rebound lifted total approvals comfortably above the 2016–2025 annual average of 123. The uptick was driven largely by non-new molecular entity (NME) approvals and biosimilars, which held steady at the elevated levels seen in 2024.
Commenting on the sector’s performance, Katia Djebbar, Pharma Analyst at GlobalData, said: “Pharma innovation proved relatively resilient in 2025 despite a high degree of uncertainty across the industry, as a series of systemic challenges to the sector unfolded.
"In particular, companies had to contend with considerable US regulatory uncertainty, including major shakeups in FDA personnel and leadership, as well as shifting perspectives on some drug classes and clinical trial requirements.”
Over the longer term, data spanning 2016–2025 highlights a market shaped by the balance between innovative therapies—including biologic NMEs and small-molecule NMEs—and higher-volume biosimilars. That equilibrium, analysts say, will be critical over the next five years as the industry confronts a looming and “seismic” patent cliff.
Looking ahead, Djebbar added: “By 2030, only 4% of global drug sales will remain under patent protection, focusing industry attention on pharma innovation and the way it is manufactured.”
The annual New Drug Approvals and Their Contract Manufacture report tracks approval trends shaping pharmaceutical contract manufacturing organizations, including NDA approvals, sponsor activity, biosimilars, outsourced API approvals, ANDA trends, value chain shifts, and CMO performance.
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