USP Report: Drug Shortages Decline 23% in 2025, But Average Duration Stretches to 5.3 Years
核心洞察
The number of year-end drug shortages in the U.S. fell 23% in 2025, dropping from 98 to 75, marking the lowest level since 2017.
The average drug shortage now lasts 5.3 years, up from 4.3 years in 2024, with 39% of shortages persisting for more than five years.
Sterile injectable drugs account for 71% of current shortages, and pediatric drugs are the most affected therapeutic category with 16 drugs in short supply.
The number of prescription drug shortages in the United States declined by 23% in 2025, falling from 98 at the end of 2024 to 75, according to the latest annual report from the U.S. Pharmacopeia (搜索) (USP). This marks the second consecutive year of declines and the lowest year-end total since 2017. Yet beneath the headline improvement, the analysis reveals deepening structural problems: the average shortage now lasts 5.3 years, and nearly two-thirds of out-of-stock medicines have been unavailable for more than three years.
The 2025 USP Annual Drug Shortage Report, which examines shortages reported by the U.S. Food and Drug Administration (FDA) as of December 31, 2025, integrates data from the USP Medicines Supply Chain Map for the first time, offering new visibility into the geographic origins of key starting materials (KSMs) and active pharmaceutical ingredients (APIs).
Shortages Are Becoming More Entrenched
The duration of current drug shortages increased to 5.3 years on average in 2025, up from 4.3 years in 2024 and approximately two years in 2019. More than 64% of drugs currently in shortage have been unavailable for over three years, and 39% have been in shortage for more than five years.
Matthew Christian, director of supply chain insights at USP, noted that "ninety-five percent of the drug shortages from 2024 made it to 2025," underscoring the persistence of the problem. He also highlighted a notable spike in discontinuations, which rose 60% from the prior year. "Sixty-five percent of the discontinued drugs had a price point below $1 per unit, so a lot of these older low-cost generic drugs, they don't have enough incentive to invest in resilience," Christian said.
Dosage Forms and Therapeutic Categories Affected
Sterile injectable drugs dominated the shortage landscape, accounting for 71% of all drugs in short supply. Oral solid drugs represented 16%, while other dosage forms comprised the remaining 13%. The 75 drugs in shortage spanned 130 therapeutic categories, indicating that supply disruptions affected a broad range of diseases and patient populations.
Pediatric drugs were the most affected category, with 16 drugs in shortage. Six of these are intravenous (IV) fluids and additives, such as dextrose for injection. The report emphasizes that IV fluid shortages pose significant challenges because these products serve as both medications and diluents for other drugs, forcing clinicians to ration them. "A child experiencing a hypoglycemic crisis will take priority over patients with less urgent needs," the report states, noting that pediatric patients face greater risk due to smaller body mass, narrower therapeutic windows, and immature renal and hepatic clearance systems.
Other heavily impacted categories include gastroenterology with 11 drugs in shortage, anesthesia with 10, endocrinology/metabolism with 10, and oncology with 6.
Supply Chain Concentration and Geographic Vulnerabilities
USP attributed the shortages to a combination of low prices, manufacturing complexity, geographic concentration, and quality concerns. "Together, these factors create overlapping vulnerabilities that increase the risk of supply chain disruption," the organization stated.
Among the 75 drugs currently in shortage, 33 depend on at least one KSM that is produced exclusively in a single country. Analysis of APIs reveals that the European Union serves as the primary API supplier for 15 of the 75 drugs in shortage, with over 50% of their API volume sourced from the EU. India is the primary API supplier for seven drugs in shortage.
The report highlights cefotaxime injection, a third-generation cephalosporin antibiotic, as a case study. The drug has been in short supply for over a decade. According to USP's analysis, the cefotaxime API supplied to the U.S. is produced entirely in India, while nearly all of its KSMs are manufactured in China.
Policy Implications and Potential Solutions
Christian emphasized that visibility into supply chain vulnerabilities is an essential starting point for policymakers. "You can't fix what you can't see," he said. "Something like key starting materials [data] we are able to publicize and talk about … this allows policymakers to make medicine-specific decisions as opposed to a generic onshoring program."
He also pointed to procurement reform as a critical lever: "A lot of the contract or procurement mechanisms have this race-to-the-bottom pricing concept, so if you really want to make a difference there needs to be procurement incentives that value resilience, and this is not something we have today."