In June 2026, the United States Pharmacopeia (USP) released their 2025 Annual Drug Shortages Report, reviewing trends in drug shortages affecting the United States. The general trend observed was that the total number of drug shortages is declining, however, those that persist are experiencing lengthier shortage durations. Data was sourced from the Center for Drug Evaluation and Research (CDER) Drug Shortages Database and alongside data from the USP Medicine Supply Map (MSM), USP’s drug-shortage intelligence platform.
The report stated that the total number of drug shortages decreased by 23% in 2025, in which 71% of the shortages were sterile injectable drugs. The 75 drugs in shortage span across 130 therapeutic categories, with paediatrics being the most affected, though the report notes that the shortages are not confined to one particular area of care. The majority of shortages in 2025 were carried over from the previous year (95%, to be exact), with only four new drug shortages reported in 2025, down from 11 the year prior. While the number of shortages decreased, the average duration of a shortage increased to 5.3 years, up from 4.3 years, indicating that medicines currently experiencing a shortage are being prolonged, in addition to discontinuations rising by 60% compared to 2024.
Regarding the rationale behind these trends, USP details four major drivers behind drug shortages: low prices, manufacturing complexity, geographical concentration and quality concerns. The data suggests a fragility in the supply chain, with a significant concentration of manufacturing in specific geographical regions and significant single-country sourcing for Key Starting Materials (KSMs) and Active Pharmaceutical Ingredients (APIs), both of represent single points of failure that could affect the availability of medicines to patients. The data also suggests that many drugs in shortage have low price points and the facilities producing drugs on the shortage list were more likely to receive the FDA’s ‘Official Action Indicated’ inspection determination, a pattern USP attributes to the misaligned incentive structure for generics, where pressure of maintaining low prices can lead to a lack of investment in quality systems.
Amid ongoing geopolitical tension in the Middle East, which has once again exposed the fragility of supply chains in an interconnected world, the conversation around drug shortages is becoming increasingly urgent. USP has also released a policy position regarding identifying and addressing vulnerabilities in the medicines supply chain, proposing measures such as the establishment of a Vulnerable Medicines list and the creation of payment and purchasing models that build supply chain resilience.
