艾昆纬-美国药品短缺和ANDA批准的趋势

Table of Contents©2025 IQVIA and its affiliates. All reproduction rights, quotations, broadcasting, publications reserved. No part of this publication may be reproduced ortransmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, withoutexpress 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 hasbeen provided by the Healthcare Distribution Alliance.Trends in Drug Shortages and ANDA Approvals in the U.S.OverviewCharacteristics of drug shortagesTrends in the launch of ANDA approved generics and drug shortagesDiscussionDefinitionsNotes on sourcesReferencesAbout the authorsAbout the Institute OverviewThe U.S. healthcare system continues to face persistentdrug shortages, particularly affecting genericmedications and sterile injectables. As of June 2024,the FDA reported 102 active shortages, with over halflasting more than two years. These shortages are mostprevalent in pain management and oncology, withinjectables 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-sideissues. On the supply side, manufacturing complexities— especially for sterile injectables — create long leadtimes and high production costs. Market dynamics,such as low profit margins and pricing pressures fromaverage sales price (ASP)-based reimbursement models,discourage manufacturers from entering or remainingin the market. Additionally, fragile supply chainslack the resilience to absorb disruptions, furtherexacerbating shortages.The gap between FDA approval of generics throughAbbreviated New Drug Applications (ANDAs) and theiractual market launch can further impact how quicklythese shortages are addressed. Between 2013 and Q12024, 37% of approved generics had not launched, andit often takes over four years for 70% of generics toreach the market. For drugs currently on the shortageslist, 62% have approved generics, yet 84% of thesehave at least one unlaunched product, and 21% have nogenerics launched at all.Injectables are disproportionately affected, with 75%of shortages involving unlaunched generics in this form.Company size also influences launch behavior. Smallergeneric companies (those companies with less than$500Mn in annual global sales), which accountfor over half of all generic approvals since 2013,are more likely to launch generics than large or mid-sized firms. These smaller generic companiesalso respond more actively to shortages by launchingapproved generics.Economic and operational barriers—such as high setupcosts, low pricing incentives, and uncertainty aroundshortage duration—discourage manufacturers fromlaunching approved generics. These challenges areparticularly acute for injectables, where the risk and costof market entry are highest.Addressing these barriers is essential to improvingdrug availability. Enhancing incentives, streamliningmanufacturing processes, and strengthening supplychain resilience could help ensure that approvedgenerics are brought to market more swiftly, therebymitigating the impact of drug shortages on patient care.iqviainstitute.org | 1Between 2013 and Q1 2024,37% of approved generics had notlaunched, and it often takes overfour years for 70% of generics toreach the market. 2 | Trends in Drug Shortages and ANDA Approvals in the U.S.Characteristics of drug shortagesDrug shortages have been an ongoing issue for theUnited States (U.S.) healthcare system over the past10–15 years, although the number and severity havechanged over time.1The Food and Drug Administration(FDA) defined a drug shortage as “a period of time whenthe demand or projected demand for the drug within theUnited States exceeds the supply of the drug”.2Drug shortages can be supply or demand driven.Supply-driven shortages are often rooted in upstreamdisruptions, including manufacturing and qualityproblems, market dynamics and incentives, delays, anddiscontinuations.3Demand-driven shortages often arisefrom legitimate demand or hoarding practices linkedto medical surges, whether related to disasters or not.4Drug shortages continue to be frequently observed,with the FDA reporting 102 shortages as of June 2024,out of which 57% have been ongoing for over two years(Exhibit 1).Exhibit 1: Current shortages as of June 2024 by timesince initial posting of shortageSource: FDA Drug Shortage Database, June 2024; IQVIA Institute, Oct 2024.Notes: The phrase “shortages” includes shortages of human drug andbiological products as tracked by the FDA’s Center for Drug Evaluation andRe