VIROLOGY
value propositions, distribution channels, product selection processes, and market maturity.
HIV self-test market 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. WHO recommended HIVST for the first time in 2016 to increase testing uptake, especially to reach those who may not otherwise be reached. Since then, the effectiveness has been demonstrated in many populations primarily through public health system delivery models. The self-test market remains relatively small but is dynamic and evolving. Several questions around optimal use, impact, and product differentiation will influence the market in the near term. Developing self-testing distribution outside of the health systems (retail, on-line) requires new capabilities, investment and time to develop; these will be essential if WHO’s self-care goals are to be realised beyond public health systems.
Professional test algorithms HIV testing is governed by an algorithm
Market-related priorities for supply security and healthy competition require developing policy and procurement strategies that diversify the professional use HIV test market
designed to support test quality. Three tests are required to diagnose HIV, and each country establishes a national algorithm, (specifying the product brands and sequence of testing) to improve testing accuracy and standardized testing across thousands of sites. An algorithm verification study primarily ensures each test in the algorithm is different. Although many quality-assured
products are available, the market is dominated by one company. The Abbott products (Determine, Bioline, Bioline HIV/ syphilis, and Determine Early detect), were among the first to market and frequently occupy the A1 position, the largest market segment. Programmes seldom review their algorithms or consider switching products; this limits opportunities for new competitive products to enter the market. New product adoption requires an algorithm review, which occurs infrequently. Programmes are reluctant
to switch professional use RDTs because of programmatic costs (retraining users, updating registers, and supply chain issues). Infrequent algorithm reviews combined with high programmatic costs of switching slow the adoption of new lower-cost tests or higher-efficacy products.
Supply security risk exists at the local and global levels. The need for three specific tests, specified in the algorithm, creates a supply risk. Disruption in the supply of any one product impacts the ability to diagnose HIV. While WHO recommends that countries verify alternative tests, the uptake of this recommendation is unknown and likely limited. At the global level, relying on one company to serve most LMIC professional HIV RDT demand also contributes to supply risk. Affordability could improve with
procurement of different products. HIV test prices have been affordable enough
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