Presentation (CTI)

OBJECTIVES: To identify structural determinants of successful medicine access in low- and middle-income countries (LMICs) beyond regulatory approval, and to propose a prospective, multi-dimensional market readiness framework applicable to health product market entry decisions.
METHODS: Comparative case analysis of three health products with divergent access trajectories in LMICs: human insulin (chronic disease, persistent access failure despite 47 years of WHO essential medicines listing), HPV vaccine (rapid scale-up across LMICs), and GLP-1 receptor agonists (emerging access failure following 2025 WHO listing). Analysis drew on WHO access reports, UNICEF Supply Division data, World Bank health financing data, and national regulatory authority publications. Cross-case analysis identified recurring dimensions distinguishing successful from unsuccessful access trajectories.
RESULTS: Six dimensions consistently distinguished rapid, sustained access from persistent access failure: financing alignment, procurement capacity, delivery infrastructure, political commitment, pricing strategy, and competitive and regulatory positioning. HPV vaccine addressed all six prospectively through GAVI advance financing, immunization platform integration, and measurable political framing. Human insulin addressed none systematically. GLP-1 receptor agonists are repeating insulin's trajectory — every barrier was identifiable before WHO designation; none was assessed. Applying the framework prospectively alongside regulatory processes would surface implementation gaps at a stage when intervention is feasible.
CONCLUSIONS: Regulatory approval is necessary but insufficient for medicine access in LMICs. A six-dimension market readiness framework, applied prospectively at the point of regulatory submission or essential medicines consideration, enables manufacturers, policymakers, and donors to identify and address implementation gaps before launch. The framework is applicable across therapeutic categories and offers a structured basis for more evidence-based market entry decision-making.