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A report on the fragility of the U.S. pharmaceutical supply chain published by the API Innovation Center (APIIC) provides new insights into the vulnerabilities affecting the availability of medicines in the United States. Based on the newly developed National Fragility Index (NFI), the analysis found that, in 2023, more than 550 million prescriptions were linked to medicines associated with high or severe supply chain fragility.
The NFI was designed to identify vulnerabilities at the level of individual marketing authorizations across more than 400 products spanning over 130 therapeutic categories. According to Natalie de Graaf, Vice President and General Manager for Data Analytics, AI and ML Solutions for National Security and Health Outcomes, the index provides decision-makers with a practical tool to determine which supply chains require immediate attention and to evaluate whether ongoing mitigation efforts are producing tangible results.
Key Findings from the NFI
According to data released so far by APIIC, 14 medicines have been classified as facing a severe level of supply chain fragility, while approximately 70 additional products require heightened attention. The report also highlights that at least 11 active pharmaceutical ingredients (APIs) included in the U.S. Administration for Strategic Preparedness and Response (ASPR) list of essential medicines have a manufacturer located in the United States. However, none of these manufacturers currently appears to supply U.S.-based pharmaceutical companies.
Furthermore, nearly three-fifths of the medicines analyzed have experienced at least one drug shortage, with an average shortage duration exceeding two years.
The NFI incorporates data from multiple sources and evaluates a broad range of risk factors, including geopolitical considerations, regulatory compliance, financial stability, manufacturing site location and the clinical importance of the products involved. The ultimate goal is to help both public and private investors assess the impact of investments aimed at strengthening domestic manufacturing capacity and reducing supply risks. Cases classified as “severe” require immediate assessment and action, while those rated as “high” call for short-term mitigation measures. APIIC also emphasizes that no pharmaceutical supply chain is entirely risk-free, although vulnerability decreases progressively among products receiving medium or low fragility scores.
Pantoprazole and Metoprolol as Illustrative Cases
Among the examples highlighted in the report is pantoprazole, which received a severe NFI rating. The analysis found that the API was sourced from 36 suppliers across 12 different countries, with no U.S.-based manufacturers involved. At the finished-product level, only 5.6% of the pantoprazole dispensed in the United States was domestically produced.
A similar situation was observed for the beta-blocker metoprolol, for which no U.S. manufacturers were identified. The product has also been affected by two separate shortage events since 2015, each lasting nearly five years.
The National Fragility Index therefore aims to provide a clearer picture of pharmaceutical supply chain vulnerabilities and to support evidence-based investments designed to improve resilience across the U.S. medicines supply network.