Health System Enablers
Local Manufacturing
Business Planning

Design of an Innovative Path-Breaking Business Model for Pharmaceutical R&D and Manufacturing in Underserved LMIC markets

Kudzai Makomva
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Design of an Innovative Path-Breaking Business Model for Pharmaceutical R&D and Manufacturing in Underserved LMIC markets

Kudzai Makomva

Kudzai specializes in helping public and third sector organizations develop compelling strategies, finance and scale social impact initiatives, and generate rigorous evidence to drive change.

An innovative business model to address the unmet need in diagnostics access and create an ecosystem of healthcare players and investors that will support a pharma R&D model that puts people above profits.

The Soros Economic Development Fund, the impact investment arm of the Open Society Foundations, harnesses the power of private capital to create systematic change in the world. 

The Fund focuses on five themes that it believes are central to advancing Open Society’s values, including provision of access to medicines. One goal of the Fund is to shift manufacturing, distribution, and research and development capacity to the Global South. The fund prioritises engagement with local leaders who can better influence and shape successful outcomes that address the neglected disease conditions of low- and middle-income countries. The result of their work is the generation of path-breaking models that demonstrate to other investors, the opportunities to achieve business viability while enhancing access through low-cost manufacturing and equitable licensing and pricing.

The Problem 

Diagnosis remains one of the weakest links in the care and treatment of the conditions that represent the largest burden of disease in low- and middle-income countries (LMICs), including tuberculosis, malaria, diabetes, and hypertension. Diagnostic tools are also an essential component in the monitoring and detection of outbreaks, and the lack of access to diagnosis undermines surveillance, and epidemic preparedness. When global demand for diagnostics soars, as witnessed with the COVID-19 pandemic, LMICs are further marginalized as they are unable to leverage financial or political influence to secure necessary supplies, in either raw material form or end-products. 

The lack of diagnostics contributes to preventable mortality, and also results in higher healthcare costs. For example, 90% of the 20 largest contributors to life lost in LMICs require a diagnostic test; however, only 1% of primary care facilities in LMICs have the minimum essential diagnostic tools for these conditions. 

Investing in greater access to diagnostics will allow earlier detection of illness, leading to timely and targeted treatment, lives saved, and reduction of spending on inappropriate treatment. 

The Solution 

In an effort to prioritize the unmet need in diagnostics access, the Fund commissioned Market Access Africa to develop a business plan for an innovative model of pharmaceutical R&D and manufacturing. Our analysis involved a thorough examination of factors, such as potential product portfolios, the total addressable market and demand generation, the landscape of other global suppliers, intellectual property arrangements, and strategic partnerships with other industry and non-industry players and input suppliers. The result was the design of a commercially sustainable and socially principled business model for enterprise that produces and delivers affordable quality-assured healthcare products and innovations for LMICs. 

The Outcome

The success of this business model, which is currently being operationalized, will catalyze a series of similar ventures, led by global south institutions and actors. This work will lay the foundation for an ecosystem that will attract other healthcare players and investors to support the development of technologies for neglected disease areas.

Following this successful roll-out, we went on to support the Fund with the design of a governance model to enhance ownership and leadership by Global South actors.

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