Gilead Sciences' newly launched HIV prevention drug Yeztugo (lenacapavir) is significantly outperforming initial market expectations, with the pharmaceutical company reporting strong early sales momentum and industry analysts projecting the therapy to become a major revenue driver worth nearly $5 billion by 2031.
Strong Launch Performance Exceeds Projections
During Gilead's Q2 investor call, Chief Commercial Officer Johanna Mercier revealed that Yeztugo is performing "well ahead of expectations" following its approval in the US and Europe. The twice-yearly pre-exposure prophylaxis (PrEP) therapy has achieved remarkable market awareness, with unaided awareness reaching approximately 72% - "more than double that you'd see in industry at launch," according to Mercier.
The drug's exceptional launch performance stems from its groundbreaking clinical trial results, where it demonstrated 100% efficacy in preventing HIV cases in trials involving South African and Ugandan women. This unprecedented efficacy data contributed to the therapy's approval in June and has generated significant attention within the medical community.
Market Projections and Revenue Potential
GlobalData analysis projects Yeztugo will generate just under $5 billion in global sales by 2031, establishing it as one of Gilead's most lucrative assets. These projections position the drug as a significant contributor to the company's long-term growth strategy in the competitive HIV prevention landscape.
However, some analysts have expressed concerns about potential regulatory challenges that could impact future uptake. The Supreme Court's ruling allowing Robert F. Kennedy Jr. influence over the US Preventive Services Task Force's staffing and decision-making has raised questions about potential changes to HIV prevention guidelines. Despite these concerns, Mercier expressed confidence that Gilead could "work through it" by maintaining close collaboration with payers if regulatory changes occur.
Broader HIV Portfolio Success
Yeztugo's strong performance complements Gilead's overall HIV portfolio success, with the division reporting $4.15 billion in sales during the second quarter. The company's blockbuster antiretroviral therapy Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) achieved "one of its best quarters ever," with sales jumping 9% to $3.5 billion, representing nearly half of Gilead's overall quarterly profits.
Despite Biktarvy's patent expiration scheduled for October 2027, GlobalData's infectious disease analyst Anaelle Tannen noted that no HIV therapy is likely to surpass Biktarvy in terms of commercial success. This assessment is supported by forecasts showing declining sales for Biktarvy's main competitor, ViiV Healthcare's Dovato (dolutegravir and lamivudine), which is projected to drop from $3.4 billion in 2027 to $1.6 billion in 2031.
Market Access and Global Health Initiatives
The World Health Organization recently announced new guidelines shifting focus toward preventive treatments while prioritizing reduced barriers to patient care for HIV management. This regulatory environment supports Yeztugo's market positioning as a preventive therapy.
Addressing global access concerns, Gilead has committed to providing affordable Yeztugo in low- and middle-income countries. This pledge responds to calls from UNAIDS executive director Winnie Byanyima for immediate generic production access, particularly given the drug's $40,000 US price tag that could limit accessibility in lower-income regions.
Competitive Landscape and Future Outlook
The HIV treatment market represents a highly lucrative but increasingly crowded therapeutic area, with GlobalData predicting the market will exceed $32 billion across seven major markets (US, France, Germany, Italy, Spain, UK, and Japan). With more than 40 approved HIV drugs currently available, pharmaceutical companies face significant pressure to differentiate their offerings.
Companies are exploring various differentiation strategies, including HIV vaccine development. While no vaccines have yet demonstrated substantial promise, ongoing Phase I trials by Scripps Research, IAVI, and collaborators across the US and Africa are showing proof of concept, indicating continued innovation in HIV prevention approaches.
