Following its initial US and EU approvals for HIV pre-exposure prophylaxis (PrEP) in 2012 and 2016, respectively, PrEP-specific sales for Gilead’s Truvada steadily rose to a peak in 2019, with estimated PrEP sales of $2.3bn in the US and five major European markets (France, Germany, Italy, Spain, and the UK). This strong performance was driven by its status as the only approved therapy for PrEP until Descovy’s US approval in October 2019, the favorable recommendations for its use in US Centers for Disease Control and Prevention and WHO guidelines, and reimbursement by the healthcare systems of four of the five major European markets in either national or pilot programs. However, PrEP-specific sales tumbled to an estimated $1.3bn in 2020, driven by the launch of Teva’s generic in the US market in October 2020 and rapid cannibalization by Gilead’s own successor product, Descovy (emtricitabine/tenofovir alafenamide). Since then, PrEP-specific sales have fallen further, to approximately $51m in 2023. 

Despite Truvada’s and Descovy’s commercial success, PrEP remains underutilized due to poor awareness and lack of/limited reimbursement in some European countries, though uptake is increasing due to favorable reimbursement decisions in Germany, Spain, England, Wales, and Northern Ireland, as well as due to Gilead’s marketing efforts. The US has the highest rate of uptake (estimated at 34.5% of at-risk individuals in 2023) and generates the majority of global PrEP revenues, though the October 2020 launch of generic versions of Truvada triggered a steep decline in sales. Within the EU and UK, Truvada is the only approved agent for PrEP but generates minimal sales due to generic competition since July 2017. PrEP uptake is also estimated to be much lower in the five major European markets (9.3% in 2023), due partially to a historical lack of reimbursement in some countries and a continued lack of reimbursement in Italy, but also due to social factors. 

This Datamonitor Healthcare report contains a Disease Analysis module.