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VIROLOGY
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0 This HIV RDT market landscape
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People living with HIV who know their status
People living with HIV who are on treatment
People living with HIV who are virally suppressed Fig 1. HIV testing and treatment cascade, women (aged 15+) compared to men (aged 15+), global, 2021.
and potential ways to address those challenges.
The HIV testing market is at an inflection point driven by: n the increasing uptake of new test types (HIV self-tests and dual HIV/Syphilis professional use tests)
n progress towards testing goals resulting in shifting programmatic approaches
n the expansion of testing to expand access to prevention in addition to treatment
n stagnant funding. These factors have increased the complexity of the HIV testing market, making a holistic look at the market timely. For the first time, this report considers what factors from a market perspective stand in the way of reaching global testing targets. 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,” commented Dr Meg Doherty, Director, Global HIV, Hepatitis and STI Programmes.
A slowing of progress HIV testing services are a critical intervention in the global HIV response: 1. Knowledge of status is the critical first step in ensuring that people living with HIV (PLHIV) are linked to treatment services.
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2. For people who are HIV negative, testing provides access to key prevention services, reducing risk of future infection; and when focused on those with high ongoing risk it enables early diagnosis and treatment which is important to preventing new infections and improving health outcomes. 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. Because testing affects the number of people who access treatment and prevention services, testing programme implementation has a cascading effect on progress towards other HIV programme targets. In the current environment of flat or declining funding, programmes are challenged to devise solutions that will allow them to maintain the levels of testing required. There is an equally important need for programmes to identify means to provide equitable access to testing services for those with low knowledge of status. RDTs are the foundation of HIV diagnosis that have expanded the reach of testing among adults in low- and middle-income countries (LMICs). While laboratory-based methods are used in some countries, they are mostly complementary to RDTs which are used in the majority of settings.
89% 82% 80% 70% 74% 65%
Women (aged 15+ years) living with HIV Men (aged 15+ years) living with HIV
report seeks to answer the question: From a market perspective, what could get in the way of achieving global HIV testing targets? The aim of the report is to provide a common understanding of factors impacting the HIV RDT market, visibility around key market challenges, and initial views on how those challenges might be addressed by identifying market solutions. This report primarily focuses on LMIC
donor-funded RDT markets; therefore, it does not cover the global market, ie high-income country markets are excluded, and several LMIC countries that fund their HIV testing programmes domestically are excluded. Specifically, China, Brazil, and India are largely excluded; Kenya and South Africa are only partially represented. There is also limited focus on the private sector, except for nascent self-testing retail markets. This report focuses on RDTs, the backbone of HIV testing in LMICs; as such, it excludes EIAs and other laboratory-based assays, recency tests, and molecular diagnostics for infants under 18 months of age. Because the focus is on donor-funded markets, the report focuses primarily on WHO prequalified (PQ-ed) tests.
Professional-use HIV RDT market Professional-use HIV RDTs include traditional HIV-only RDTs and dual HIV/ syphilis RDTs that test for both diseases using one sample. These tests are performed by healthcare workers and are always part of a testing algorithm wherein multiple tests are needed to diagnose HIV infection. HIV RDTs or dual tests can be used as the first test in an algorithm (A1), in which case they are used in high volumes. HIV-only RDTs in the second and third spots of an algorithm are used in low volumes, because only A1 reactive results are tested, and the vast majority of A1 tests will be non-reactive. Self-tests are not part of the algorithm for diagnosing HIV. They are ‘tests for triage’ and are usually designated as ‘Assay 0’ (A0). The self-test market differs from professional RDTs in several fundamental ways, including different
Generally, HIV self-testing (HIVST) thrived during the pandemic as populations accepted and manufacturers gained experience with self-tests. WHO anticipates an expansion of self-testing for HIV and other diseases as part of its broader self-care initiatives
FEBRUARY 2024
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Source: UNAIDS special analysis, 2022, Figure 1.11 percentage
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