Are low- and middle-income countries the next frontier for biopharma?

By Drew Wilkins, managing director, Deloitte Consulting, LLP, and Sarah Shier, senior manager, Deloitte Consulting LLP

Biopharmaceutical companies may be overlooking significant opportunities by not entering the diverse and rapidly evolving markets in low- and middle-income countries (LMICs). Many US and European organizations have historically avoided these regions due to pricing constraints, regulatory considerations, fragmented health care systems, limited clinical workforce capacity, and other challenges.¹ However, as LMIC economies strengthen and health systems mature—and as populations become more prosperous—demand for health care and prescription drugs will likely grow.² This shift can be accompanied by increased local pharmaceutical research and development (R&D) and manufacturing.³

Tropical and communicable diseases tend to be disproportionately prevalent in LMICs due to poverty, inadequate sanitation, and limited access to health care. And, as prosperity in these countries increases, the rates of noncommunicable chronic diseases (e.g., diabetes and cardiovascular disease) can increase as well.⁴ Biopharma companies that prioritize R&D and focus on sustainable access solutions could be well positioned to capture value while improving health outcomes.⁵ However, challenges remain. These include infrastructure limitations, country-specific regulatory considerations, and drug-reimbursement rates.⁶

Consider this: About 60% of life sciences and health care organizations expect to see some impact from tariffs, according to a recent report from the Deloitte Center for Health Solutions. In response, some US biopharma companies have announced plans to boost domestic manufacturing, update existing facilities, and/or build new ones. At the same time, emerging LMICs could be an additional—and potentially lucrative—opportunity.⁷ Moreover, LMICs can provide biopharma companies with the potential to address unmet medical needs and improve population health in those countries. Companies might consider tailored approaches for each country or subregions of a country (e.g., urban vs. rural). This could involve collaborating with local stakeholders, adopting digital technologies to enhance supply chains and health care delivery, implementing flexible pricing and reimbursement models, supporting local clinical trials, and investing in local manufacturing.

Conventional thinking vs. evolving LMIC strategies
While there appeared to be some interest in exploring LMICs a decade ago, the markets were sometimes more challenging than expected. As a result, many companies opted to focus on existing major markets rather than nurture new ones.⁸ That line of thinking appears to be changing, especially as austerity measures rise in developed markets and as health care budgets face new scrutiny. The topic of potential opportunities in LMICs has been coming up frequently in our conversations, particularly when discussing new growth markets.⁹ Along with opening new markets, LMICs also offer unique opportunities for clinical trials.¹⁰ This can be particularly important in the development of therapies to treat rare diseases. Some clinical trials might not be able to attract enough patients who have a rare disease if they are limited to developed markets.

Here is a look at some of the conventional thinking around LMICs and evolving strategies that could help biopharma companies take advantage of potential markets.

Conventional thinking: Ensuring that products are accessible and affordable means they cannot be profitable.

• Evolving LMIC strategy: Go-to-market mechanisms can be used to adapt commercial access models to LMIC contexts (e.g., second brands when a single product is marketed under two different brand names due to different dosages, indications, or formulations to target a new market).¹¹

Conventional thinking: Only products that address infectious diseases or small molecules are suited for launch in LMICs.

• Evolving LMIC strategy: About 80% of deaths from noncommunicable diseases occur in LMICs, making them a higher priority to focus on in comparison to the traditional focus on infectious diseases.¹²

Conventional thinking: LMIC regulatory frameworks and processes are too complex, unharmonized, and lengthy; they cannot be adapted to innovative specialty drugs.

• Evolving LMIC strategy: Many processes are becoming more structured, and regulators are increasingly collaborating across LMICs.¹² For example, the Africa Centres for Disease Control and Prevention has announced the creation of a pooled African medicines procurement mechanism. The proposed African Medicines Agency aims to create a more unified regulatory market across the African Union.^{13, 14} Another example is the Caribbean Regulatory System (CRS), which serves as the regulatory body for 15 Caribbean countries.¹⁵ The CRS provides recommendations on authorization, rational use, and the quality and safety monitoring of medical products.

Conventional thinking: Pharmaceuticals, especially complex innovations, will not reach patients in LMICs due to poor infrastructure and limited health care infrastructure.

• Evolving LMIC strategy: While there might be some infrastructure gaps, biopharma companies can work with local governments to develop innovative solutions to bridge them.¹⁶ Existing initiatives like Project Last Mile bring together donors, ministries of health, and the private sector to translate supply chain and marketing best practices into solutions that improve the availability of life-saving medicines and health services in Africa.¹⁷ In addition, the International Finance Corporation is working to strengthen local manufacturing of pharmaceuticals by partnering with stakeholders and local governments.¹⁸

Conventional thinking: Products will not reach patients because LMIC markets cannot afford innovative medicines.

• Evolving LMIC strategy: The work of some organizations is helping to mitigate affordability challenges. Pfizer's Accord for a Healthier World initiative, for example, made about 500 products available in 45 LMICs, using a tiered-pricing-like approach to maximize global access.¹⁹ The Financing Accelerator Network for NCDs brings together biopharma companies, the World Bank, and other organizations to support government and local stakeholders in building sustainable health care financing systems.²⁰ And while affordability challenges persist in some markets, it is important to note the range of incomes and wealth demographics in LMICs. Many markets within these countries continue to experience prosperity and a growing number of health care consumers, which could drive demand for biopharma products.²¹ A rising segment of more affluent individuals may prefer to access advanced treatments within their own region, rather than traveling to developed markets for care.²²

Conventional thinking: Licensing puts intellectual property at risk if local manufacturers gain access to technology platforms.

• Evolving LMIC strategy: Licensing puts intellectual property at risk if local manufacturers gain access to technology platforms. By licensing local generic manufacturers, originators can leverage established distribution networks and local knowledge to increase product availability and penetration. Some organizations offer support and facilitation of licensing arrangements to help mitigate risks. For example, the Medicines Patent Pool has broadened its model of negotiating public-health driven licenses with patent holders of essential medicines to those with biotherapeutics targeting cancer, diabetes, and other noncommunicable diseases. The main goal is to facilitate early entry of biosimilars through voluntary licensing agreements in LMICs.²³ In May, the World Health Organization and Medicines Patent Pool announced a sublicensing agreement with a Nigerian health technology company to develop rapid diagnostic tests using technology from a global diagnostics company.²⁴

Conclusion
Biopharma companies have historically relied on philanthropy to address health needs in LMICs but sustained economic growth and an increasingly prosperous middle class is transforming these markets.²⁵ Moreover, as prosperity increases, non-communicable and preventable diseases (e.g., obesity, diabetes, heart disease) are becoming more prevalent.²⁶ In response, societies, governments, and consumers are placing greater value on health and preventive care.²⁷ By expanding access in LMICs, biopharma companies have an opportunity to become leaders in new and emerging markets, and to establish local relationships in markets that can provide the next wave of growth for innovative therapies.

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Endnotes:

¹Drug development in LMICs: Opportunity or exploitation?, ACCO Publications, June 3, 2022
²Health, economic growth, and jobs, World Bank Group, April 17, 2025
³Achieving universal health coverage in LMICs, International Longevity Centre UK, February 18, 2025
⁴Poverty and infectious disease come together far too often, World Economic Forum, March 15, 2023
⁵The local production of essential drugs, University of Virginia School of Engineering and Applied Sciences, May 2024
⁶The net effect of wealth on health, National Library of Medicine/PLoS One, November 6, 2023
⁷As tariffs loom over pharma manufacturing, a reshoring effort is underway, Supply Chain Dive, March 18, 2025
⁸Challenges in clinical research in LMICs, National Library of Medicine/Global Heart, January 25, 2024
⁹Pharma companies are taking steps to address access in LMICs, Access to Medicine Foundation, November 19, 2024;
¹⁰New global guidance puts forward recommendations for more effective and equitable clinical trials, World Health Organization, September 25, 2024
¹¹Two brands, one drug: The potential benefits and challenges of dual branding, Brand Insights, April 6, 2023
¹²Noncommunicable diseases prevention In LMICs, Sage Journals, August 23, 2021
¹³Big pharma ramps up expansion to emerging markets, Contract Pharma Magazine, June 22, 2024
¹⁴An African polled procurement mechanism will enhance quality and safe medical supplies for a resilient continent, United Nations Economic Commission for Africa, May 15, 2024
¹⁵Caribbean Regulatory System, Caribbean Public Health Agency
¹⁶African Medicines Agency, African Union Development Agency
¹⁷Project Last Mile
¹⁸Boosting local production of pharmaceuticals, International Finance Corporation, September 2024
¹⁹Accord for a Healthier World, Pfizer
²⁰The Financing Accelerator Network for NCDs, World Bank Group
²¹Microestimates of wealth for all low- and middle-income countries, July 24, 2021
²²Why health care firms in LMICs will challenge market leaders, William Davidson Institute at the University of Michigan, October 9, 2019
²³Biotherapeutics, Medicines Patent Pool, April 2024
²⁴WHO and Medicines Patent Pool announce sublicensing agreement for rapid diagnostic test technology, World Health Organization, May 9, 2025
²⁵Pharma companies are taking steps to address access in LMIC, but significant gaps remain, Access to Medicine Foundation, November 19, 2024
²⁶The impact of non-communicable diseases in LMIC countries, Springer Nature, October 22, 2024
²⁷Global preventive health care market $485B by 2030, iHealthcareAnalyst, Inc., August 21, 2025

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