Access to quality-assured, efficacious and safe health products is critical to ensure that the 2021–2030 neglected tropical disease (NTD) road map targets can be achieved. However, it is challenging due to various factors such as lack of funding, little interest from the pharmaceutical industry, limited regulatory oversight and few quality assurance mechanisms and uncoordinated procurement with uncertain forecasting.
Aiming to shed light on the current market landscape for leishmaniasis, one of NTDs, and develop a regulatory framework for NTD diagnostics, we conducted an analysis of 1) global procurement of leishmaniasis medicines for the past 5 years and 2) the availability of commercially available NTD diagnostics. For historical procurement analysis, we estimated the global demand of each leishmaniasis medicines based on the number of cases reported to WHO and the treatment regimen used in each country. Procurement data were obtained from procurement agencies, international organizations, WHO, national leishmaniasis programmes and manufacturers. Expert interviews were conducted to have a better understanding of how medicines were procured and used. For the development of a strategy for regulatory pathways for NTD diagnostics, the list of commercially available diagnostics was compiled from various sources and 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 procurement agencies.
The comparison of estimated need and procurement data indicated discrepancies in supply and demand at global level as well as in the leishmaniasis endemic countries. The extent of the gap in supply was up to 80% of the needs for one of the leishmaniasis medicines. Mismatch between supply and demand was much wider for cutaneous leishmaniasis than visceral leishmaniasis. 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.
Addressing improved access and supply and regulatory barriers requires multidimensional, collaborative and concerted efforts at the global and national levels. Priority actions proposed to improve access to leishmaniasis medicines include (i) setting up the procurement coordination mechanism with major partners for the development of joint forecasting and market shaping interventions, (ii) proactive engagement of manufacturers to secure uninterrupted supply of quality-assured medicines and (iii) promoting high-level advocacy. Despite the nature of the market, and presumed insufficient return on commercial investment, acceptable levels of assurance on performance, quality and safety of NTD 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.
