Landscape analysis of NTD diagnostics and considerations on the development of a strategy for regulatory pathways

Access to quality-assured, accurate diagnostics is critical to ensure that the 2021–2030 neglected tropical disease (NTD) road map targets can be achieved. Currently, however, there is limited regulatory oversight and few quality assurance mechanisms for NTD diagnostic tools. In attempting to address such challenges and the changing environment in regulatory requirements for diagnostics, a landscape analysis was conducted, to better understand the availability of NTD diagnostics and inform future regulatory frameworks. The list of commercially available diagnostics was compiled from various sources, including WHO guidance, national guidelines for case detection and management, diagnostic target product profiles and the published literature. The inventory was analyzed according to diagnostic type, intended use, regulatory status, and risk classification. To estimate the global need and size of the market for each type of diagnostic, annual procurement data were collected from WHO, procurement agencies, NGOs and international organizations, where available and global disease prevalence. Expert interviews were also conducted to ensure a better understanding of how diagnostics are procured and used. Of 125 diagnostic tools included in this analysis, rapid diagnostic tools accounted for 33% of diagnostics used for NTDs and very few diagnostics had been subjected to regulatory assessment. The number of tests needed for each disease was less than 1 million units per annum, except in the case of two diseases, suggesting limited commercial value. Despite the nature of the market, and presumed insufficient return on commercial investment, acceptable levels of assurance on performance, quality and safety of diagnostics are still required. Priority actions include setting up an agile, interim, stepwise risk assessment mechanism, in particular for diagnostics of lower risk, in order to support national NTD programmes and their partners with the selection and procurement of the diagnostics needed to control, eliminate and eradicate NTDs.Author summary: Rapidly evolving landscape of in-vitro diagnostics is posing quality assurance challenges for manufacturers and regulators as well as creating product selection dilemmas for procurers, donors, and national programmes. In attempting to address such challenges, a landscape analysis of Neglected Tropical Diseases (NTD) diagnostics was conducted to provide insights for all stakeholders to support a future regulatory framework for NTD diagnostics. The inventory of commercially available diagnostics was compiled and analyzed and the global need and size of the market for each type of diagnostic was estimated. The results showed low commercial value and limited regulatory oversight on NTD diagnostics. Despite the insufficient return on commercial investment, reasonable assurance of product safety, performance and quality is required. One of the priorities is to establish a risk assessment mechanism, in particular for NTD diagnostics of lower risk, in order to support national NTD programmes, procurement agencies, donors and other partners with the selection and procurement of the diagnostics needed to achieve the 2021–2030 NTD road map targets.