低收入和中等收入国家药品的关键准入途径和瓶颈：对新上市和已确立药品的数据洞察

JUNE Access to medicines is a cornerstone of equitable healthcare and a criticaldeterminant of health outcomes, particularly in low- and middle-income countries(LMICs), which are home to over 80% of the global population. These countriesface a disproportionate burden of both communicable and non-communicablediseases, making timely access to effective treatments essential for improvingpopulation health, reducing mortality, and addressing health disparities.Ensuring the availability of both recently launchedmedicines and established essential medicines inLMICs is a matter of public health and a key factor inachieving global health equity and meeting nationalhealth targets and international development goals,such as Universal Health Coverage (UHC) and theUnited Nations Sustainable Development Goals (SDGs).However, significant barriers — ranging from regulatorychallenges and reimbursement to supply chaininefficiencies and national infrastructure and capacity— often limit access to these medicines, delaying ordenying treatment to millions of patients. Addressingthese challenges and bottlenecks is vital for fosteringhealthier, more resilient communities worldwide.This report evaluates select access pathways for twotypes of medicines in 18 LMICs. One, the “recentlylaunched” analyses focus on medicines first launchedglobally between 2013 and 2022. Two, the “established”analyses focus on a selection of medicines from the2023 version of the WHO Essential Medicines List (EML)excluding - among others - the “recently launched”entries. The analysis examines several factors thatinfluence drug availability and accessibility: whetherthese medicines are registered locally, included onnational essential medicines lists, reimbursed byIntroduction©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.Key Access Pathways and Bottlenecks for Medicines in LMICs: Data Insights into Recently Launched and Established MedicinesREFERENCING THIS REPORTPlease use this format when referencing content from this report:Source: IQVIA Institute for Human Data Science. Key Access Pathways and Bottlenecks for Medicines in LMICs: Data Insights into Recently Launchedand Established Medicines. May 2025. Available from www.iqviainstitute.org healthcare systems, or sold in-country. The number ofcountries with quality data varies for each measure.By identifying gaps in these areas, the study highlightspotential bottlenecks in the drug access process thatmay contribute to inequities both within and acrossnations. These findings aim to provide key data tosupport discussions around these bottlenecks as well assuccess stories and inform strategies to improve accessto essential and recently launched medicines.This study was conducted independently by the IQVIAInstitute for Human Data Science, with funding providedby the International Federation of PharmaceuticalManufacturers and Associations (IFPMA). Thecontributions to this report by Ralphael Nduka andVibhu Tewary are gratefully acknowledged.Find Out MoreIf you wish to receive future reports from the IQVIAInstitute for Human Data Science or join our mailing list,visit iqviainstitute.org.MURRAY AITKENExecutive DirectorIQVIA Institute for Human Data Science Table of ContentsOverviewReview of recently launched medicines globallyInsights into global procurement organizations and the WHO EMLAnalysis of lists of registered drugs in select LMICsAnalysis of National Essential Medicines Lists (NEMLs)Analysis of national reimbursement listsAnalysis of number of medicines sold in-countryCombined view of sales, reimbursement and national EML inclusionMethodologiesSources of dataAbout the authorsAbout the Institute 2456810121516212729 OverviewLow- and middle-income countries (LMICs) comprise 82%of the world’s population, highlighting the importanceof addressing their healthcare needs to reduce globalhealth disparities and improve outcomes.Access to medicines varies widely across LMICs. Thisis the case for both recently launched medicines—defined as novel active substances (NAS) first launchedbetween 2013 and 2022 (n=593)—and establishedmedicines, represented by a selection of drugs from the2023 version of the WHO essential medicines list (EML)(n=477). Understanding this variation in access canhelp identify barriers that hinder timely delivery ofthe right treatments to patients. Recently launchedmedicines specifically can drive innovation, enhancinghealthcare in LMICs by expanding treatment options,addressing unmet needs, and increasing overalleffectiveness and efficiency; however, data on accessto both recently launched and established medicines inLMICs remains limited.Low- and middle-income countries(LMICs