Africa has made significant strides toward strengthening health security. Diagnostic manufacturing capacity is expanding, and hundreds of products have received regulatory approval. Yet a critical question remains: are Africa’s diagnostic systems ready to deliver when and where they are needed most?

The latest report in the Blindspots series from PATH and Impact Global Health reveals a complex picture. Drawing on data on approved diagnostics, global R&D investment trends, manufacturing capacity, and regulatory systems, the report examines how well Africa’s diagnostic ecosystem is aligned with the diseases prioritized by the Africa Centres for Disease Control and Prevention (Africa CDC).

The findings reveal a persistent gap between progress and preparedness:

• 577 diagnostics have received regulatory approval, reflecting growing product availability.
• Diagnostic manufacturing capacity is expanding, creating new opportunities for regional production.
• R&D investment continues to decline, limiting innovation and the development of future-ready tools.
• Nearly half of approved diagnostics remain inaccessible at the primary care level, where most people first seek healthcare.

This gap highlights a critical blindspot: diagnostic readiness cannot be achieved through political commitments alone. It requires sustained investment, fit-for-purpose regulatory pathways, and financing and procurement systems that enable African manufacturers to produce and deliver the diagnostics communities need.

The report identifies priority actions to strengthen Africa’s diagnostic ecosystem, including:

• reversing declining investment in diagnostic research and development;
• establishing diagnostics as a distinct regulatory category within the African Medicines Agency framework; and
• creating sustainable demand, financing, and market-shaping mechanisms to support African manufacturers.

The diagnostics deficit is the second publication in the Blindspots series, jointly produced by Impact Global Health and PATH, examining overlooked barriers that stand between health commitments and real-world impact.