Authors :
Aaditya Bansal
Volume/Issue :
Volume 10 - 2025, Issue 10 - October
Google Scholar :
https://tinyurl.com/4uueec7v
Scribd :
https://tinyurl.com/4h5h2yes
DOI :
https://doi.org/10.38124/ijisrt/25oct1460
Note : A published paper may take 4-5 working days from the publication date to appear in PlumX Metrics, Semantic Scholar, and ResearchGate.
Note : Google Scholar may take 30 to 40 days to display the article.
Abstract :
Emerging markets (EMs) are increasingly central to pharmaceutical business development due to growing demand,
evolving regulatory frameworks, and escalating expectations for quality, safety, and innovation. Between 2023-2025, shifts such
as India’s revised Schedule M GMP rules, China’s expanded volume-based procurement, Brazil’s reliance pathways, and
heightened traceability requirements in the GCC have reshaped how pharma companies enter, scale, and compete in EMs. This
paper analyzes why EMs matter now, which business development models are working best, the changing regulatory landscape,
case studies from key markets, and presents a risk/entry evaluation matrix to help companies prioritize. The aim is to guide
strategy in a less formal but evidence-grounded style.
Keywords :
Emerging Markets; Pharmaceutical Business Development; Regulatory Compliance; Schedule M; Volume-Based Procurement; Risk Matrix.
References :
- IQVIA. The Global Use of Medicines 2024: Outlook to 2028. IQVIA
- Bain & Company. “A Roadmap for Making India a Global Pharma Exports Hub.” Bain
- Biospectrum India. “Why New Schedule M Is a Game Changer for Indian Pharma.” BioSpectrum India
- Pharmabiz. “Revised Schedule M to ensure quality of products.” www.pharmabiz.com
- IFPMA. Pharmaceutical Industry Facts & Figures 2025 Report. ifpma.org
- Times of India. “India’s MSME pharma companies get an additional one year to upgrade facilities under Schedule M.
- Maaraf, Nour El Houda, et al. (2025). Drug Development and Regulatory Challenges in Emerging Countries: A Recent Literature Review. This systematic review examines how regulatory policies across EMs affect drug development & commercialisation; looks at preclinical/clinical evaluation variance. uniselinus.us
- Tan, R. et al. (2025). Current Landscape of Innovative Drug Development and Regulation in China (2019-2023). Focuses on regulatory modernization, clinical trial improvements, and the growth of biologics / novel therapies in China. Nature
- „Pharma Companies Still Not Maximising Their Potential to Reach More Patients in Low-and Middle-Income Countries” — Access to Medicine Foundation (2024 Index). Highlights voluntary licensing, technology transfers, and how pharma firms are falling behind in making innovative medicines accessible in LMICs. Access to Medicine Foundation
- Ramagopalan, S. V., et al. (2025). The Need to Consider Market Access for Pharmaceutical Investment Decisions, PMC. Primer on how investment in pharma should factor in regulatory change, reimbursement, and local market access when choosing where / how to launch. PMC
- “Pharmaceutical Legal and Regulatory Trends to Watch in 2024” — Kirkland & Ellis, 2024. Covers several legal/regulatory developments globally in 2023 that are shaping industry behavior (patent / IP, compliance, enablement etc.). Kirkland & Ellis
- Fortune Business Insights. Pharmaceutical Market Size, Share & Growth Report, 2032. Provides projections of global pharma market growth, market size, CAGR etc., which you can use to show how EMs contribute. Fortune Business Insights
- Jairoun, A. A., et al. (2025). Towards Eco-friendly Pharmaceuticals: Regulatory and Industry Trends. Looks at increasing regulatory pushes for sustainability in pharmaceuticals: manufacturing waste, environmental impact, regulatory expectations etc. ScienceDirect
- IFPMA. Pharmaceutical Industry Facts & Figures Report (2025). Industry report with data on R&D intensity, global trends, the share of pharma in health spending, contribution from emerging markets etc. ifpma.org
- Sabogal De La Pava, Martha L., Emily L. Tucker (2023). Effects of Geopolitical Strain on Global Pharmaceutical Supply Chain Design and Drug Shortages. Models how export bans, supply disruptions affect EMs especially, and how firms are redesigning supply chain resilience. arXiv
- Academics: A Model of Triple-Channel Interaction Dynamics in Pharmaceutical Retailing in Emerging Economies (Mondal, Menon, Sahadev; 2025). Theoretical treatment of how organized retail, unorganized (local) pharmacies, and e-pharmacy interplay in EMs; relevant to market access / channel strategy. arXiv
Emerging markets (EMs) are increasingly central to pharmaceutical business development due to growing demand,
evolving regulatory frameworks, and escalating expectations for quality, safety, and innovation. Between 2023-2025, shifts such
as India’s revised Schedule M GMP rules, China’s expanded volume-based procurement, Brazil’s reliance pathways, and
heightened traceability requirements in the GCC have reshaped how pharma companies enter, scale, and compete in EMs. This
paper analyzes why EMs matter now, which business development models are working best, the changing regulatory landscape,
case studies from key markets, and presents a risk/entry evaluation matrix to help companies prioritize. The aim is to guide
strategy in a less formal but evidence-grounded style.
Keywords :
Emerging Markets; Pharmaceutical Business Development; Regulatory Compliance; Schedule M; Volume-Based Procurement; Risk Matrix.
