This report presents findings from a review of the market landscape conducted from December 2013 to February 2014 as part of PATH’s Project DIAMETER (Diagnostics for Malaria Elimination Toward Eradication). To date, evaluation of malaria diagnostics markets has been relatively limited, and where it is available, it is largely focused on passive case detection and on higher-burden countries. This report aims to build on existing malaria diagnostics market work and to complement it by delving deeper into elimination and active use scenarios for malaria diagnostics.

The report is structured as follows:

• Malaria elimination and diagnostics use: This section provides information on elimination countries and the role of diagnostics, including a review of current World Health Organization (WHO) guidance and trends shaping the research agenda.
• The current malaria diagnostics market: This section summarizes relevant aspects of the current microscopy and rapid diagnostic test (RDT) markets, drawing on existing work about the malaria diagnostics market.
• Country use of diagnostics for elimination and active use scenarios: This section considers use of and demand for diagnostics in elimination settings, with a focus on active use scenarios. It includes both qualitative and quantitative analyses.
• The potential market for a new rapid infection detection test: This section describes a marketsizing exercise that was undertaken for a new rapid infection detection test (IDT).
• Promoting investment and development of a healthy market: This section describes challenges and risks along the product development and market access pathway and describes some potential interventions to promote investment and development of a healthy market.
• Several annexes provide additional detail of the analyses conducted for this report and a list of experts interviewed.

The methodology undertaken is described at the start of each section. Generally, given the limited data available on malaria diagnostics markets, the methods for this report included identifying potential sources of data for analysis, desk review, and expert interviews. The available data on malaria diagnostics are limited (relative to other product categories, such as medicines), and even more limited for eliminating countries. Therefore, for this report, we primarily relied on national malaria control program reporting to the WHO (published and unpublished information). Although many national programs do not completely or reliably report to the WHO, the assumption was made that, by definition, surveillance systems in countries pursuing elimination should be robust enough to produce reliable data. Given the time frame for this report, validation of the data and analyses with countries and experts was not possible. When reviewing the analyses and data in this report, it is important to keep in mind that many of the analyses presented are for a subset of countries, and therefore may not be completely representative of the global markets. Attempts were also made to identify analogous products and markets; however, none were identified.

From an operational research perspective, malaria elimination is a rapidly evolving area, and currently many unanswered questions about optimal strategies are being explored. Likewise, WHO guidance on elimination is expected to be updated in 2014. The lack of consensus and guidance on optimal approaches makes analyzing the market and making predictions about the market size for a new diagnostic challenging. Evidence gaps and research questions that would impact the market have been highlighted in this report.

Lastly, a note about defining elimination countries: The WHO characterizes all countries by program phase using a combination of epidemiological and operational criteria. In 2013, the WHO classified 19 countries as in the elimination or pre-elimination phase, with an additional seven countries in the prevention of reintroduction phase. The Malaria Elimination Group (MEG) at the University of California, San Francisco (UCSF) has a broader definition of “malaria-eliminating countries,” which is based on whether a country has adopted a strategy for elimination. Currently, this is a set of 38 countries. For this report, the UCSF MEG definition and set of countries is used, unless otherwise noted.