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Datamonitor Healthcare Infectious Diseases Disease Analysis: HIV Pre-Exposure Prophylaxis (HIV PrEP)
August 01, 2025
Following strong early growth after its US and EU approvals, Gilead’s Truvada became the dominant HIV PrEP therapy, reaching peak sales of approximately $2.3bn across the US and major European markets in 2019. Uptake was supported by guideline recommendations and reimbursement decisions; however, sales declined sharply after the launch of generics in 2020 and the introduction of Gilead’s own successor, Descovy. While PrEP use has expanded, it remains underutilized (particularly in Europe) due to limited reimbursement, lower awareness, and social barriers. The US continues to drive the majority of global PrEP revenues, though generics have significantly eroded the market. In Europe, generic Truvada and the injectable option Apretude have kept sales comparatively modest.
To protect market share, Gilead shifted focus from Descovy toward long-acting prevention options. Its twice-yearly injectable, Yeztugo (lenacapavir), has demonstrated strong efficacy across diverse at-risk populations and offers a clear convenience advantage over Apretude’s two-monthly dosing. Recent regulatory approvals and inclusion in WHO guidelines are expected to broaden access and uptake. Competition persists, particularly from ViiV Healthcare’s Apretude and its potential next-generation formulations, as well as Merck’s investigational once-monthly oral agent MK-8527. Overall, long-acting PrEP options represent a critical opportunity to improve adherence and real-world effectiveness, positioning Yeztugo as a potential market leader despite lingering concerns around compliance with extended dosing intervals.
| Indications Covered: | HIV Prevention |