Diagnostics are fundamental to accurate detection of disease and critical to informing effective clinical care and selection of treatment. Yet access to diagnostic testing has remained poor and inequitable in many parts of the world. Approximately 47 percent of the global population has little to no access to diagnostics. This challenge is particularly evident in low- and middle-income countries (LMICs), where only 19 percent of patients have access to appropriate diagnostics at the primary health care level. This represents the single largest gap in the health care pathway (Fleming et al. 2021).

The COVID-19 pandemic continues to illustrate the criticality of appropriate and accessible diagnostics for a rapid response to new and existing diseases. At the same time, the pandemic has also highlighted the challenges in accessing quality-assured diagnostics, particularly for LMICs.

The 2021 Lancet Commission on Diagnostics analyzed existing gaps and barriers to appropriate diagnosis in LMICs. One major finding from this Lancet Commission is that local research and development (R&D), manufacturing, and distribution of diagnostics is limited, contributing to their lack of affordability in LMICs (Fleming et al. 2021).

To build on the Lancet Commission’s body of work, PATH collaborated with Accenture to investigate access challenges within the diagnostics ecosystems in Latin America, Africa, and Southeast Asia. Market failures and market-shaping interventions needed for LMICs to close the existing diagnostics gap were identified through extensive desk research, one-on-one interviews with global health experts, and engagement with diagnostics manufacturers. This report aims to call attention to existing market failures across the diagnostics value chain, which includes R&D, manufacturing, procurement and distribution, and service delivery and user adoption.

Nine market failures were identified as key threats to diagnostic supply security: limited investment, insufficient workforce, deterring regulations, inefficient purchasing and procurement, operational inefficiencies, limited infrastructure and technology, high costs, low trust, and limited government and policy support.

Through the consistent and collaborative action of cross-sectoral stakeholders and players within this ecosystem, as outlined in the recommendations in this report, access to quality diagnostics in LMICs can be sustainably improved and expanded.