APIIC launches National Fragility Index for US drug supply chains
The API Innovation Center (APIIC) has launched what it describes as the first standardised benchmark for measuring structural vulnerability in US pharmaceutical supply chains. The National Fragility Index (NFI), unveiled at a Washington policy event on 6 October, assigns fragility scores to individual drug product codes and is intended to give federal agencies, manufacturers and investors a consistent framework for tracking supply chain risk over time.
The initial analysis covers more than 400 medicines across 131 treatment categories. Fourteen medicines received the highest rating of Severe and 71 were rated High, meaning roughly one in five medicines scored fell into the two most vulnerable categories. APIIC said those medicines together accounted for more than 550 million prescriptions dispensed in 2023. A fuller report is expected at a later date; the launch release does not disclose the index's full scoring methodology.
What the data shows
Two case studies illustrate the scale of the problem. Pantoprazole, a proton pump inhibitor with 34 million prescriptions filled in 2024, rated Severe on the index. APIIC found its active pharmaceutical ingredient (API) is sourced from 36 suppliers across 12 countries, with no US manufacturer among them. Only 5.6% of domestically dispensed pantoprazole comes from a US-based finished-dose site, and the drug has gone into shortage five times since 2015.
Metoprolol, the most prescribed systemic beta-blocker in the US at more than 58 million prescriptions annually, rated High. It has no domestic API source and has experienced two recorded shortages since 2015, with a median duration of nearly five years. APIIC is working to address the gap through its federally supported BioMaP Consortium, a public-private partnership with the HHS Administration for Strategic Preparedness and Response.
The NFI draws on supply chain intelligence from QYOBO, a data provider with visibility into global manufacturing networks, API origins, key starting materials, quality risks and shortage histories. Natalie de Graaf, APIIC's vice president and general manager for data analytics and AI solutions, said the index was designed to answer a practical question that policymakers have so far lacked tools to address. "We cannot know whether our investments are strengthening the drug supply unless we can measure the risks they are meant to address," she said. "The National Fragility Index gives decision-makers a starting point."
Market and regulatory context
US pharmaceutical supply chain resilience has become a sustained policy priority following the disruptions exposed during the COVID-19 pandemic and, more recently, by geopolitical tensions affecting API manufacturing concentrated in China and India. The ASPR already maintains a list of 86 essential medicines, but APIIC's data highlight a telling gap: at least 11 of those medicines have a US API manufacturer yet none of those manufacturers are actively supplying domestic drug makers. That suggests the problem is not solely one of manufacturing capacity, but of commercial and procurement incentives.
The NFI arrives as a number of federal and state-level initiatives are directing capital toward domestic API production, including provisions in recent defence and health security legislation. Having a publicly available, longitudinal benchmark could help legislators and regulators evaluate whether those investments are producing measurable improvements in supply resilience, or whether funding is flowing to lower-risk categories where domestic production is commercially attractive but strategically less critical. For generic drug manufacturers and healthcare group purchasing organisations, the index also offers a structured basis for sourcing diversification decisions that go beyond immediate cost considerations.
APIIC is a St. Louis-based nonprofit supported by Missouri state grants and a federal HHS award. Its model of combining data analytics with active API development programmes positions it as both an assessment body and a participant in the supply chain it aims to strengthen, a dual role that stakeholders should weigh when interpreting the index's findings.