艾昆纬-美国药品短缺和ANDA批准的趋势（英）

JULY2 0 2 5Trends in Drug Shortages and ANDA Approvals in the U.S.RESEARCH BRIEFTable of Contents©2025 IQVIA and its affiliates. All reproduction rights, quotations, broadcasting, publications reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without express written consent of IQVIA and the IQVIA Institute.REFERENCING THIS REPORTPlease use this format when referencing content from this report:Source: IQVIA Institute for Human Data Science. Trends in Drug Shortages and ANDA Approvals in the U.S. July 2025. Available from www.iqviainstitute.orgThis research brief has been developed independently by the IQVIA Institute for Human Data Science. Funding for this research brief has been provided by the Healthcare Distribution Alliance.Trends in Drug Shortages and ANDA Approvals in the U.S.Overview 1Characteristics of drug shortages 2Trends in the launch of ANDA approved generics and drug shortages 5Discussion 11Definitions 12Notes on sources 13References 14About the authors 15About the Institute 16Overview The U.S. healthcare system continues to face persistent drug shortages, particularly affecting generic medications and sterile injectables. As of June 2024, the FDA reported 102 active shortages, with over half lasting more than two years. These shortages are most prevalent in pain management and oncology, with injectables comprising the majority. Generic drugs, which are essential for affordable healthcare access, account for 84% of these shortages.Drug shortages stem from both supply and demand-side issues. On the supply side, manufacturing complexities — especially for sterile injectables — create long lead times and high production costs. Market dynamics, such as low profit margins and pricing pressures from average sales price (ASP)-based reimbursement models, discourage manufacturers from entering or remaining in the market. Additionally, fragile supply chains lack the resilience to absorb disruptions, further exacerbating shortages.The gap between FDA approval of generics through Abbreviated New Drug Applications (ANDAs) and their actual market launch can further impact how quickly these shortages are addressed. Between 2013 and Q1 2024, 37% of approved generics had not launched, and it often takes over four years for 70% of generics to reach the market. For drugs currently on the shortages list, 62% have approved generics, yet 84% of these have at least one unlaunched product, and 21% have no generics launched at all.Injectables are disproportionately affected, with 75% of shortages involving unlaunched generics in this form. Company size also influences launch behavior. Smaller generic companies (those companies with less than $500Mn in annual global sales), which account for over half of all generic approvals since 2013, are more likely to launch generics than large or mid-sized fi