Investing in Late-Stage Clinical Trials and Manufacturing of Neglected Disease Product Candidates – Modeling the Benefits and Costs of Investments for Three Middle-Income Countries

Background: Investing in late-stage clinical trials, trial sites and production capacity for neglected disease products could improve access to vaccines, therapeutics, and diagnostics in middle-income countries (MICs). This study assesses the case for such investment in three MICs: India, Kenya, and South Africa. Methods: We modeled how many cases, deaths, and disability-adjusted life years (DALYs) could be averted from the development and manufacturing of new technologies (therapeutics and vaccines) in these countries. We also estimated the economic benefits that might accrue from making these investments and we develop benefit-cost ratios (BCRs) for each of the three MICs. Findings: From 2021-2036, product development and manufacturing in Kenya could avert 4.4 million deaths and 206.3 million DALYs in the Common Market for Eastern and Southern Africa (COMESA) region. In South Africa, it could prevent 5.2 million deaths and 253.8 million DALYs in the South African Development Community (SADC) region. In India, it could avert almost 9.8 million deaths and 374.4 million DALYs in Southeast Asia. Economic returns would be especially high if new tools were produced for regional markets rather than for domestic markets only. Under a societal perspective, regional returns outweigh investments by a factor of 21 in Kenya, 33 in South Africa, and 68 in India. Interpretation: Our study supports the creation of regional hubs for clinical trials and product manufacturing compared to narrow national efforts. Funding: This study was funded by a grant from the Bill & Melinda Gates Foundation. Declaration of Interest: This study was approved by Duke University’s institutional review board (IRB). Ethical Approval: All authors report grants from Bill & Melinda Gates Foundation during the conduct of the study.Robert Karanja also serves as Chairman of Steering Committee of the Coalition for Health Research & Development (CHReaD), a policy and advocacy coalition that is funded by BMGF - that also funded this study.