The US FDA approved 131 drugs last year through its New Drug Application (NDA), Biologics License Application (BLA), and biosimilar pathways, leading to a steady 4.8% year-on-year increase in approvals. After an uneven decade in which new drug approvals fluctuated widely, the number approved by US regulators in 2025 exceeded the 10-year average, according to GlobalData, a leading intelligence and productivity platform.
GlobalData’s New Drug Approvals and Their Contract Manufacture: 2026 Edition reveals that this recovery, which put 2025’s total comfortably above the annual average of 123 approvals for the decade from 2016, was driven by non-new molecular entity (NME) approvals and biosimilar approvals that were consistent with the high levels seen in 2024.
Katia Djebbar, Pharma Analyst at GlobalData, comments: “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.”
From a longer-term perspective, data from 2016–25 show the market is defined by the balance between innovative therapies, such as biologic NMEs and small-molecule NMEs, and higher-volume biosimilars. Successfully maintaining that balance will be of prime importance for the industry over the next five years as it manages an unfolding and seismic patent cliff.
Djebbar concludes: “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.”
New Drug Approvals and Their Contract Manufacture is an annual analysis of approval trends affecting pharmaceutical contract manufacturing organisations. The report lists the latest players, FDA NDA approvals, sponsor trends, special products, outsourced API approvals, ANDA approvals, value chain and CMO performance.
