缓解药品短缺：弹性药品供应链的策略

Mitigating Drug Shortages:Strategies for ResilientPharmaceutical Supply Chains IQVIA Chemical Intelligence/IQVIA MIDAS® CHANDANA D, Senior Global data Associate, Chemical Intelligence, IQVIAGURPREET KAUR, Senior Global data Analyst, MIDAS Table of contents Introduction1Manufacturing facilities of drugs in shortage in 20231Trends in new drug shortages over time2Main causes of drug shortages3The high cost of scarcity: Understanding drug shortage impacts3Mitigation strategies4Case study: Drug shortage trends by region (2023–2025 YTD)6Case study: Evolving causes of drug shortages (2019–present)7Conclusion8References9About the authors9 Manufacturing facilities ofdrugs in shortage in 2023 Introduction Healthcare depends significantly on medicines andensuring that all individuals have access to them is awidely accepted human right. According to theWorld Health Organization (WHO), essential medicinesare those that meet the priority healthcare needs ofthe population. However, ongoing drug shortagespose serious challenges to healthcare systemsaround the world. In 2023, drug shortages continued to be a significantchallenge globally, and understanding where thesedrugs are manufactured sheds light on potentialsupply chain vulnerabilities, as highlighted byUS FDA data.4 Finished dosage form manufacturing Nearly half (49%) of the drugs in shortage are producedin the USA, making it the dominant location for finaldrug formulation. India follows as the second-largestmanufacturer, responsible for 17% of these drugs.Germany contributes 8%, while smaller sharescome from Canada, China, and the Czech Republic.Collectively, other countries account for 18% of theproduction.4 The issue of medication scarcity dates to the early1920s, with the first recorded case being the shortageof insulin. Since then, drug shortages have becomeincreasingly common, disrupting patient care,compromising treatment outcomes, and threateningpublic health on a global scale.1 To better understand the scope of the issue, it isimportant to consider how major health authoritiesdefine drug shortages. The World Health Organization(WHO) describes a drug shortage as a situation wherethe supply of essential medicines is insufficient tomeet public health and patient needs. This definitionhighlights the impact of shortages on both healthcaresystems and patient care.2 Active Pharmaceutical Ingredient (API)manufacturing The manufacturing of APIs, the key components indrugs, is more geographically diversified. The USAleads with 28%, but its share is smaller compared tofinal dosage manufacturing. Germany (14%) and India(11%) are also significant producers of APIs. Otherimportant contributors include Finland, Spain, Mexico,and China, each holding smaller percentages. Variousother countries make up the remaining 16%.4 Similarly, the US Food and Drug Administration (FDA)defines a drug shortage as a period when the demandor projected demand for a medically necessarydrug exceeds its supply at the patient care level.3Together, these definitions reflect the diverse factorscontributing to drug shortages, includinglogistical disruptions, and increasingdemand for medications. In 2023, drug shortages continued tobe a significant challenge globally,and understanding where these drugsare manufactured sheds light onpotential supply chain vulnerabilities. persistent challenge for over two decades. Beginningwith 120 new shortages in 2001, the numbersgradually increased, reaching a peak of 267 newshortages in 2011. Since then, the annual count hasfluctuated but remained relatively high, with severalspikes above 150 shortages in years including 2012,2014, 2018, and 2022. The lowest point recorded wasin 2004, with only 58 new shortages. Implications The concentration of drug manufacturing in a fewcountries, especially the USA and India, highlightspotential risks for drug shortages if disruptions occurin these regions. The relatively diverse locations for APIproduction may provide some resilience, but overall,this concentration calls for a strategic approach todiversify and strengthen global pharmaceutical supplychains to reduce future shortages.4 Early data for 2025 shows 48 new shortages butis incomplete for the full year. Overall, this trendhighlights the ongoing complexities in pharmaceuticalsupply chains and emphasizes the critical need forrobust monitoring systems and proactive strategies toaddress and mitigate drug shortages.5 Trends in new drug shortagesover time Data from the University of Utah Drug InformationService reveal that new drug shortages have been a 4.Geopolitical tensions and trade conflicts Main causes of drugshortages — Trade wars, export bans, and political conflictshave increasingly disrupted global drug distribution. Drug shortages typically result from a combination ofsupply-related, demand-driven, and regulatory factors.These can be categorized as follows: •Heavy Dependence on Few Countries: APIs andfinished drugs are mainly sourced fr