Risk Management Strategies in Global Supply Chains of Active Pharmaceutical Ingredients
Abstract
The article examines risk management strategies in global supply chains of active pharmaceutical ingredients (APIs), which underpin the availability and affordability of generic and branded medicines. The study addresses the growing instability in API sourcing caused by the geographical concentration of production, geopolitical tensions, regulatory heterogeneity, and recurrent quality failures. The research objective is to systematise vulnerabilities in API supply chains and to evaluate managerial and policy tools that strengthen resilience without undermining cost efficiency. The work relies on a structured review of recent empirical and analytical studies on pharmaceutical supply chains, complemented by a comparative analysis of regulatory and industrial initiatives. Special attention is paid to risk assessment frameworks, resilience and criticality metrics, and strategic options such as diversification, reshoring, strategic stockpiling, and collaborative governance. The conclusions highlight combinations of operational and institutional measures that reduce the probability and impact of disruptions. The article is intended for scholars and practitioners in pharmaceutical management, health economics, supply chain governance, and quality systems, as well as regulators designing interventions for strategically significant medicines.
References
2. BenAmor, W. D., Labella, Á., Frikha, H. M., & Martínez, L. M. (2022). Pharmaceutical supply chain risk assessment during COVID-19 Epidemic. IFAC-PapersOnLine, 55(10), 2203–2208. https://doi.org/10.1016/j.ifacol.2022.10.035
3. Ciceri, C., Borsani, C., Guida, M., Farinelli, M., & Caniato, F. (2025). Impact pathways: Navigating risks in the pharmaceutical supply chain – A multi-actor perspective. International Journal of Operations & Production Management, 45(13), 53–62. https://doi.org/10.1108/IJOPM-06-2024-0458
4. Goswami, A., Baveja, A., Ding, X., Melamed, B., & Roberts, F. (2024). An integrated framework for modeling pharmaceutical supply chains with disruptions and risk mitigation. Annals of Operations Research. Advance online publication. https://doi.org/10.1007/s10479-024-06381-y
5. Kashif, M. (2024). Analysis of the supply chain risk management in pharmaceutical industry. South Asian Journal of Operations and Logistics, 3(2), 382–413. https://doi.org/10.57044/sajol.2024.3.2.2442
6. Keeton, V. F. (2024). Pharmaceutical supply chains: A structural determinant of health for children with ADHD. Journal of Pediatric Health Care, 39(2), 297–302. https://doi.org/10.1016/j.pedhc.2024.11.001
7. Machta, R., et al. (2025). Defining and measuring the resilience, criticality, and vulnerability of medical product supply chains. U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation & Mathematica. URL: https://aspe.hhs.gov/sites/default/files/documents/ebf67ed4c543fc5fa249ccbdd7a14391/MeasuringSupplyChainResilience.pdf
8. Postma, D. J., De Smet, P. A. G. M., Mantel-Teeuwisse, A. K., Leufkens, H. G. M., & Notenboom, K. (2025). Upstream pharmaceutical supply chains of 10 high-use pharmaceuticals in the Netherlands: A cohort study. BMJ Open, 15(4), e099697. https://doi.org/10.1136/bmjopen-2025-099697
9. Socal, M. P., Ahn, K., Greene, J. A., & Anderson, G. F. (2023). Competition and vulnerabilities in the global supply chain for US generic active pharmaceutical ingredients. Health Affairs, 42(3), 407–415. https://doi.org/10.1377/hlthaff.2022.01120
10. Takawira, B., & Mutambara, E. (2023). COVID-19 and emerging markets: A strategic framework for pharmaceutical supply chains. Corporate and Business Strategy Review, 4(4, Special Issue), 346–358. https://doi.org/10.22495/cbsrv4i4siart15
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