Recent HIV RDT market landscape report aims for healthier, more sustainable markets

The global testing and treatment targets of the Joint United Nations Programme on HIV/AIDS (UNAIDS) were not met in 2021 and the world is off-track in its efforts to reach the 2030 95-95-95 goals. For testing, the global target is to ensure that 95% of people with HIV know their status; however, in 2022 only 86% were aware. Testing has a cascading effect on other HIV response targets as it directly affects the number of people who may access treatment and prevention. This is clearly reflected in the data from 2022 which estimates that 76% of people living with HIV were receiving antiretroviral therapy and 71% of people living with HIV had suppressed viral loads.

A newly released report on the integrated HIV Rapid Diagnostic Test (RDT) market has highlighted how market factors can affect availability and access to essential diagnostic services. The report was released shortly after the WHA resolution to strengthen diagnostic capacity, which calls for the WHO to collect data on affordability, availability and access to essential diagnostics, and seeks to answer the question: From a market perspective, what could get in the way of achieving global HIV testing targets? The report provides a common understanding of forces impacting the HIV RDT market, visibility around key market challenges, and potential ways to address those challenges.

It is an opportune time to consider the HIV RDT market holistically given that the HIV epidemic is evolving and new products like dual HIV/syphilis RDTs (dual tests), and HIV self-tests (HIVST) are being widely scaled up. For the first time, this report takes an integrated approach across 3 market segments and models how potential changes in the provision of HIV testing services may impact the market and the future availability of HIV testing. 

The 4 product mix scenarios modeled considerable variation in the volumes of each test type to be procured by low- and middle-income countries (LMICs) over the next 5 years within the context of continuing demand and sustained market growth. Across the 4 scenarios, HIV RDT volumes range from 592m to 838m, dual HIV/syphilis test volumes range from 154 to 197m and HIVST volumes range from 133m to 283m over the projected time period of 2022–2027. 

A diverse group of global health stakeholders provided input into the report and forecast via a technical working group and from the joint WHO/UNAIDS Annual Health Commodity Forecasting meeting. “Against the backdrop of competing priorities, funding for testing in many settings has declined. We know that without testing we cannot treat and prevent infections, achieve global goals, sustain low HIV incidence, and save lives. This report offers a timely and comprehensive analysis of opportunities that can increase efficiencies in the RDT market,” said Dr Meg Doherty, Director, Global HIV, Hepatitis and STI Programmes.

Key characteristics and challenges in the HIV professional RDT (i.e. HIV-only professional use RDTs and dual HIV/syphilis RDTs) and HIVST markets are highlighted by the report, reflecting differences between the role these tests play in reaching people and delivering HIV testing, diagnosis and prevention services. While the conditions for competition and equitable access exist, and several new products such as dual tests and HIVSTs have recently entered the market, structural factors have contributed to higher prices for professional use HIV RDTs than can be observed in comparable products. Furthermore, there are concerns regarding the need to balance quality with supply risk, concentration, and affordability in professional use test selection and the sometimes higher price of HIVST.

Through the exploration and analysis of these challenges, a course of action is proposed based on market health frameworks. These include but are not limited to, refreshing policy and procurement approaches for professional use HIV tests to drive price competition and improve supply security, supporting counties to update their algorithm to allow new tests to enter in their market, continuing to promote and facilitate the adoption of WHO policy recommendations, addressing affordability by increasing new test market penetration, and revitalizing support for strategic programmatic implementation. 

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