Abstract
This report updates and highlights changes in the malaria diagnostics market since the UNITAID 2014 Malaria diagnostics technology and market landscape.
There has been only a slight change in the malaria burden estimates since the last landscape. While the past decade has seen tremendous reductions in the global burden of malaria, it is increasingly apparent that decreases have been uneven both between and within countries, underscoring the need to strengthen diagnostics capacity and surveillance systems. In terms of access to testing, 197 million slides were read and 319 rapid diagnostic tests (RDTs) were sold in 2013, and for the first time the number of tests performed in the African public sector exceeded artemisinin-based combination therapies (ACTs) distributed. However, compared to the global testing need, which exceeds 1 billion tests annually, significant scale-up is required to achieve universal access to testing. While access has been increasing in the public sector (from 44% tested in 2010 to 64% in 2012), testing in the community and private sector is minimal.
There are a number of changes in malaria policies and practices that shape the malaria agenda and market for diagnostics. Since the 2014 Landscape, the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) completed its replenishment and the New Funding Model (NFM) has been implemented. Although the impact on diagnostic budgets remains to be seen, early indications suggest that countries are likely to maintain the scope and scale of their diagnostics activities in the near term. In 2014, the World Health Organization (WHO) issued new guidance on molecular diagnostics, noting that RDTs and microscopy should be used for clinical malaria in all transmission settings, and recommending that, once diagnostic scale-up is complete, low transmission areas consider more sensitive diagnostics for epidemiological research and surveys. Globally, standardization of molecular methods and development of quality assurance (QA) schemes will be critical to ensuring quality and comparability of results.
With respect to the technology pipeline, several developers report progress although it is not clear that the pipeline will address gaps equitably. Notable progress includes development of positive control wells (PCWs) for RDTs (2015 availability), development of highly sensitive RDTs for use in elimination settings (2017 availability) and a WHO review of evidence on the performance of a new point-of-care (POC) G6PD test.