Investment in Child Health Products for HIV/AIDs, Tuberculosis and Malaria: A Research and Development Pipeline Analysis

Abstract

HIV/AIDS, tuberculosis (TB) and malaria remain major morbidity and mortality contributors among children globally. There have been substantial efforts in disease control over the past two decades. However, the development of pediatric-specific health products has lagged behind compared to adult products. Many drugs, diagnostics, biologics and vaccines used in children are adapted from adult formulations, leading to challenges related to safety, dosing and adherence. It is therefore essential to develop sustained financing mechanisms of investing in research and development (R&D) to ensure that children benefit from appropriate health technologies. This study analyzes the current (2025) global pediatric R&D pipeline for four health product archetypes – vaccines, drugs, biologics and diagnostics that target HIV/AIDS, TB and malaria. Using data from the G-FINDER (policy cures) database, and the Portfolio-to-Impact (P2I) modeling tool, the analysis estimates the approximate investment requirements to advance existing product-archetype candidates through clinical development phases to potential product launch, over a 15-year horizon (2025 -2040). Two scenarios are compared: 1). The current (baseline) observed pipeline and 2). A replenished pipeline, that accounts for attrition and estimates the number of candidates per disease product-archetype combination required to yield at least one successful launch. The observed 2025 pipeline comprised of 21 candidates across the three diseases: malaria (n=14), HIV/AIDS (N=2) and TB (n=5). Under this scenario, four potential launches were projected with total clinical development costs of approximately USD 766.68 million. When accounting for attrition, the replenished scenario required 90 candidates and a total investment of approximately USD 3.06 billion. This corresponds to an estimated funding gap of x over the modelling period. Annualized, this would be a funding gap of x. These findings show substantial gaps in the pediatric R&D pipeline for HIV/AIDS, TB and malaria. We see the scale of investment needed to advance the 2025 pediatric R&D pipeline for the development of child-appropriate health products. Therefore, sustaining these investments is necessary to enable equitable access to health products for children affected by these diseases.