Regional manufacturing

The manufacturing of diagnostic tests is currently highly centralized, concentrated among a small number of companies primarily based in Asia, North America, and Europe. While these centralized manufacturing facilities have realized important economies of scale and other benefits, the lack of complementary facilities in other regions has meant that many countries have solely depended on a limited set of global suppliers and manufacturers.

Globalization has meant that the specific health needs of low- and middle-income countries (LMICs) are frequently underserved, with diagnostic tests not adapted for use in LMICs, which limits countries’ capacity to achieve universal health coverage (UHC). For example, only two of the 20 diseases in the WHO Roadmap for Neglected Tropical Diseases have adequate and accessible diagnostic tools, and only one of 21 rapid diagnostic tests for HIV with WHO prequalification status have shown stability at temperatures higher than 30 degrees Celsius. Centralization also exacerbates fragility during global crises and outbreaks, as regional import/export restrictions can impact many manufacturing sites.

This, too, disproportionately affects LMICs, where sufficient production capacity is lacking, and there is no possibility to compete with high-income countries for limited supply – resulting in inequities in the public health response. A more distributed manufacturing of diagnostics across the globe is critical to achieve pandemic preparedness and UHC. Although the international community “recognizes the need for strengthening local and regional health product manufacturing, especially in developing countries”, the implementation and sustainability of these facilities are extremely challenging and require coordination among all global health stakeholders.

Our vision

Our vision at FIND is to foster sustainable redistribution of global manufacturing capacity for increased access to affordable high-quality products that meet local and regional needs, aiming to achieve UHC, strengthen global health security and foster self-reliance. We collaborate with manufacturers, countries, regional and global agencies, and acknowledges that efforts are required at all steps of the diagnostic value chain.

What we do

We manage projects across the value chain, across the world. Examples include:

• Providing investments and technical assistance to LMIC-based diagnostic innovators and manufacturers, to enable and accelerate their ability to deliver quality-assured products adapted to local needs at affordable prices.
• In collaboration with regional and global partners and countries, advocating for and supporting an ecosystem essential for the sustainability of regional manufacturing in LMICs.

Geographic spread of regional manufacturing activities

Regional manufacturing preparedness

• During the COVID-19 response, in partnership with Unitaid, we supported regional manufacturers in Brazil, India and Senegal with investments, technology transfer and technical assistance to ensure supply security in these regions. As the world transitions from the COVID-19 pandemic, we are working closely with manufacturers to adapt their portfolio of tests needed in their region, to keep facilities functioning and ready to expand, to make tests for other diseases when another local outbreak or potential global pandemic occurs.
• In Africa: We are in the process of selecting 1 or 2 African-based manufacturers that are developing their regional RDT businesses, and expanding manufacturing to respond to regional needs. The long-term vision for this initiative is to enable African suppliers of rapid diagnostic tests (RDTs) to meet regional demand for quality-assured, affordable RDTs in a financially sustainable manner, thereby contributing to the development of robust regional diagnostics markets and supporting UHC and pandemic preparedness.
• In Indonesia: FIND is helping to grow the country’s ability to develop, produce and deliver high-quality, affordable diagnostic tests that meet regional health needs. By fostering technology transfers and providing technical assistance to local manufacturers for quality systems, regulatory authorization, and market entry, FIND is supporting Indonesia in building better capacity to respond to current and future health threats both in Indonesia and regionally.
• In India: FIND is working to deliver a multi-pronged programme to build India’s manufacturing capacity and capability for Indian diagnostic manufacturing, and international regulatory approval submissions, with a focus on TB diagnostic tests.
• Looking forward and beyond RDTs, FIND and Unitaid have published an Expression of Interest to seek an advanced understanding of potential projects, partnerships and stakeholders that could meaningfully strengthen the in-vitro diagnostic (IVD) supply base in priority regions. This critical information will guide FIND’s and Unitaid’s future investments and efforts to accelerate and strengthen IVD supply in LMICs.

Building a resilient ecosystem essential for the sustainability of regional manufacturing in LMICs

We are also actively involved in advocating the need for a coherent and strong ecosystem favourable for implementation of regional manufacturing of diagnostics in collaboration with countries, and regional and global partners. FIND is notably engaged with the G20 Health Working Group (HWG), notably under the presidency of Indonesia, India and Brazil, contributing our experience in diagnostics and regional manufacturing.

• FIND and Unitaid organized a 2-day convening of diagnostics manufacturers (22 global and regional manufacturers from 13 countries, representing Asia, Africa, Latin America, Europe and North America) ahead of the 2nd HWG in 2023. The goal of this convening was to catalyse potential partnerships for technology transfer between global and regional manufacturers, and to gather, across six priority areas, recommendations by manufacturers to provide concrete actions that should be considered for establishing an enabling ecosystem that supports the sustainable regional production of diagnostics in LMICs.
• FIND subsequently co-hosted a G20 side-event with the Department of Pharmaceuticals, Government of India and Unitaid during the 2nd HWG in 2023, to present manufacturers’ recommendations collected in the 2-day convening, to the delegates of the G20 countries.
• We are also supporting the harmonization of regulatory and registration pathways, including strengthening capacity in national regulatory authorities, to accelerate access to quality-assured products manufactured regionally.