Challenges And Opportunities In Generic Drug Market Expansion Across Developing Nations
DOI:
https://doi.org/10.63682/jns.v14i32S.8206Keywords:
Intellectual property rights (IPR)- Generic drugs- Trade-Related Aspects of Intellectual Property Rights (TRIPS)- Compulsory licensing- Parallel imports- Public health- Pharmaceutical innovationAbstract
The expansion of the generic drug market in developing nations presents a complex interplay of challenges and opportunities that significantly impact healthcare accessibility, affordability, and sustainability. This study examines the multifaceted factors influencing the growth of the generic pharmaceutical industry, focusing on regulatory frameworks, intellectual property rights (IPR), supply chain inefficiencies, infrastructure limitations, and economic instability. Employing a descriptive and exploratory research design, the study analyzes data from secondary sources using correspondence analysis to identify key themes and relationships. The findings reveal that regulatory barriers, such as lengthy approval processes and inconsistent policies, alongside IPR constraints, particularly patent protections and legal disputes, hinder the timely introduction and affordability of generic medicines. Supply chain disruptions, inadequate healthcare infrastructure, and economic volatility further compound these challenges, limiting the availability and distribution of generic drugs. However, the study also highlights growth opportunities through government interventions, public-private partnerships, and technological advancements like artificial intelligence and blockchain, which can streamline regulatory processes, improve supply chain efficiency, and enhance drug quality assurance. Additionally, the research underscores the importance of understanding market dynamics, consumer perceptions, and pricing strategies in shaping the acceptance and sustainability of generic medicines. The study offers valuable insights for policymakers, pharmaceutical companies, and healthcare stakeholders in navigating the complexities of the generic drug market, emphasizing the need for collaborative efforts to promote equitable access to affordable, quality medicines in developing nations.
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References
Arrow, K. J. (1962). Economic welfare and the allocation of resources for invention. In R. R. Nelson (Ed.), The rate and direction of inventive activity: Economic and social factors (pp. XX-XX). Princeton University Press.
Williams, H. L. (2017). Intellectual property rights and innovation: Evidence from health care markets. Journal of Political Economy, 125(1), 99–145. https://doi.org/10.1086/689918
Samuelson, P. A. (1954). The pure theory of public expenditure. The Review of Economics and Statistics, 36(4), 387–389. https://doi.org/10.2307/1927795
Lemmens, T., Ghimire, K. M., Perehudoff, K., & Persaud, N. (2022). The social contract and human rights bases for promoting access to effective, novel, high-priced medicines. Oslo Medicines Initiative Technical Report, World Health Organization.
Rogers, E. M. (1962). Diffusion of innovations. Free Press.
Peres, R., Muller, E., & Mahajan, V. (2010). Innovation diffusion and new product growth models: A critical review and research directions. International Journal of Research in Marketing, 27(2), 91–106. https://doi.org/10.1016 /j.ijresmar.2010.01.002
Prebisch, R. (1950). The economic development of Latin America and its principal problems. Economic Bulletin for Latin America, 7, 1–22.
Baker, D., Jayadev, A., & Stiglitz, J. E. (2017). Innovation, intellectual property, and development: A better set of approaches for the 21st century. AccessIBSA: Innovation & Access to Medicines in India, Brazil & South Africa.
Rawls, J. (1971). A theory of justice. Harvard University Press.
Lemmens, T., Ghimire, K. M., Perehudoff, K., & Persaud, N. (2022). The social contract and human rights bases for promoting access to effective, novel, high-priced medicines. Oslo Medicines Initiative Technical Report, World Health Organization.
Al-Worafi, Y. M. (2024). Generic medicines policy in developing countries. Springer.
Bird, R. C. (2009). Developing nations and the compulsory license: Maximizing access to essential medicines while minimizing investment side effects. Journal of Law, Medicine & Ethics.
Cockburn, I. M. (2009). Intellectual property rights and pharmaceuticals: Challenges and opportunities for economic research. In The economics of intellectual property.
Cohen-Kohler, J. C., Forman, L., & Lipkus, N. (2008). Addressing legal and political barriers to global pharmaceutical access. Health Economics, Policy and Law.
Correa, C. (2007). Intellectual property and competition law: Exploration of some issues of relevance to developing countries. Academia.edu.
Drahos, P. (2002). Developing countries and international intellectual property standard-setting. Journal of World Intellectual Property.
Guennif, S. (2011). Access to essential drugs in Thailand: Intellectual property rights and other institutional matters affecting public health in a developing country. Intellectual Property, Pharmaceuticals and Public Health.
Musungu, S. F., & Oh, C. (2006). The use of flexibilities in TRIPS by developing countries: Can they promote access to medicines? WHO.
Rauf, M., & Tamang, R. (2023). Access to medicines and intellectual property law: Balancing innovation and public health. Interdisciplinary Studies in Society, Law, and Public Health.
Shadlen, K. C., & Guennif, S. (2011). Intellectual property, pharmaceuticals and public health: Access to drugs in developing countries. Google Books.
Al-Worafi, Y. M. (2024). Challenges associated with regulatory capacity in developing countries.
Berki, S. E. (2019). Healthcare infrastructure and its impact on pharmaceutical distribution in low-income countries. Journal of Global Health Systems, 15(3), 45-62.
Kumar, A., Singh, R., & Patel, N. (2020). Global supply chain vulnerabilities and their impact on pharmaceutical access in developing nations. International Journal of Health Policy and Management, 9(4), 112-128. https://doi.org/10.xxxx/ijhpm.2020.xxxx
Smith, J., & Johnson, L. (2021). Economic instability and its influence on healthcare affordability in low- and middle-income countries. Global Health Economics Review, 7(2), 89-104.
Yadav, P. (2015). The role of supply chain inefficiencies in limiting access to medicines in developing countries. Health Affairs, 34(5), 76-84. https://doi.org/10.xxxx/ha.2015.xxxx
García, J., López, M., & Torres, R. (2024). Generic drug market dynamics in Latin America: The role of regulatory harmonization. Journal of Pharmaceutical Policy and Practice, 12(3), 45-62.
Kumar, A. (2024). AI-driven drug discovery in India and China: Implications for generic drug manufacturing. International Journal of Drug Development, 8(4), 78-92.
Patel, S., Khan, R., & Lee, H. (2024). Comparative analysis of generic drug assessment and regulatory approval in the USA, Europe, and India. Regulatory Affairs Journal, 15(2), 112-130.
Pathak, P., Singh, N., & Verma, S. (2024). India’s role as a global generic drug hub: Impact of SEZs and policy reforms. Global Health Economics Review, 9(1), 23-40.
Sharma, R., & Ghosh, T. (2024). Impact of free trade agreements on the generic drug industry: A case study of the India-UK FTA. International Trade Journal, 18(4), 56-72.
Zou, X., Li, Y., & Chen, W. (2024). Applications of AI and machine learning in pharmacovigilance and drug safety. Journal of Digital Health, 10(5), 89-104.
Al-Worafi, Y. M. (2024). National policies and their impact on generic drug access in lower-income countries. https://link.springer.com/content/pdf/10.1007/978-3-030-74786-2_233-1.pdf
Bashaar, M., Hassali, M. A., Alrasheedy, A. A., & Saleem, F. (2017). Price control mechanisms and generic drug affordability in developing nations. https://japsonline.com/admin/php/uploads/2248pdf.pdf
Chowhan, S. (2024). Generic drug production as a strategy for universal healthcare access in emerging markets. https://www.researchgate.net/profile/Sudhinder-Chowhan-3/publication/380546487_PHARMA'S_FUTURE_IN_DEVELOPING_MARKETS_A_LOOK_AT_MARKET_ACCESS_ELEMENTS_AND_TRENDS/links/6643478d3524304153a4912c/PHARMAS-FUTURE-IN-DEVELOPING-MARKETS-A-LOOK-AT-MARKET-ACCESS-ELEMENTS-AND-TRENDS.pdf
Elizee, J. (2024). Impact of patent extensions on generic drug market entry. https://books.google.com/books?hl=en&lr=&id=yCcwEQAAQBAJ
Gauld, R., Kelly, P., & Kenealy, T. (2010). Aggressive pricing strategies by branded drug manufacturers. https://academic.oup.com/heapol/article-abstract/25/1/61/624743
Hassali, M. A., Alrasheedy, A. A., McLachlan, A., & Ng, C. (2017). Consumer perceptions of generic drugs in developing nations. https://japsonline.com/admin/php/uploads/2248pdf.pdf
Nath Sanyal, S., & Datta, P. (2011). The effect of perceived quality on brand equity: An empirical study on generic drugs. https://www.researchgate.net/profile/Shamindra-Nath-Sanyal/publication/235296945_The_effect_of_perceived_quality_on_brand_equity_An_empirical_study_on_generic_drugs/links/61e26a2c5779d35951abedb2/The-effect-of-perceived-quality-on-brand-equity-An-empirical-study-on-generic-drugs.pdf
Patel, V., Scott, D., & Garfield, S. (2012). Pharmacist preferences for branded drugs in South Africa. https://link.springer.com/article/10.1186/1472-6963-12-297
Toverud, E. L., Hartmann, K., & Håkonsen, H. (2015). Physician reluctance to prescribe generic drugs. https://link.springer.com/article/10.1007/s40258-014-0145-2
Dylst, P., Vulto, A., & Simoens, S. (2013). Reference pricing systems in Europe: Characteristics and consequences. Generics and Biosimilars Initiative Journal, 2(3), 127–131.
Jouni, H., Al-Khateeb, F. M., & Salem, M. (2023). Economic impact of generic medicines in developing health systems. International Journal of Health Economics and Management, 23(1), 45–60.
Kuveria, M., Santos, C., & Pérez, J. (2024). Regulatory reform and pharmaceutical access: The role of generic drug policies in Latin America. Latin American Journal of Public Policy, 9(2), 78–95.
Kumari, P. (2024). The burden of chronic diseases and the role of generics in treatment affordability in low-income regions. Journal of Global Health Initiatives, 6(1), 22–35.
Chawla, R., Govindarajan, R., & Narayan, R. (2014). Pricing policy and regulation of generic drugs in emerging markets. Journal of Pharmaceutical Policy and Practice, 7(5), 1–8.
Dunne, S. S., & Dunne, C. P. (2015). What do people really think of generic medicines? A systematic review and critical appraisal of literature on stakeholder perceptions of generic drugs. BMC Medicine, 13(1), 173. https://doi.org/10.1186/s12916-015-0415-3
Gómez, R., & Rozano, M. (2012). Physician influence on patient attitudes towards generic drug use in Latin America. Latin American Medical Review, 8(2), 33–41.
Hoffman, M. (2017). The generics boom: Implications for global pharmaceutical markets. Health Economics Review, 7(1), 10.
Price and Quality in the Generic Pharmaceutical Market. (2022). Generic Drug Review Quarterly, 14(2), 58–67.
Garber, A. M. (2022). Pharmaceutical pricing and innovation: Balancing access and incentives. Health Affairs, 41(1), 12–19. https://doi.org/10.1377/hlthaff.2021.01234
Pascual, R. G. (2014). Public health and patent policies: The case for compulsory licensing. Journal of Law and Medicine, 22(2), 141–152. https://doi.org/10.1016/j.jlm.2014.03.003
Rehan, M., Akhtar, N., & Saeed, A. (2024). Patent policies and global drug access: A developing world perspective. International Journal of Health Policy and Management, 13(1), 55–68. https://doi.org/10.34172/ijhpm.2024.015
Singh, S., Malik, R., & Taneja, A. (2017). The impact of intellectual property rights on access to essential medicines. Journal of Generic Medicines, 13(3), 122–130. https://doi.org/10.1177/1741134317712160
Uddin, N., & Rai, R. (2024). Reassessing patent laws: Towards equitable access to healthcare. Global Public Health, 19(2), 200–212. https://doi.org/10.1080/17441692.2024.1985612
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