Gilead Sciences and the Global Expansion of Lenacapavir for HIV Prevention: Strategic Partnerships and Market Access in Emerging Markets

Gilead Sciences’ lenacapavir (Yeztugo), the first and only FDA-approved twice-yearly injectable pre-exposure prophylaxis (PrEP) for HIV prevention, represents a paradigm shift in global health. With clinical trials demonstrating ≥99.9% efficacy in preventing HIV infection [1], the drug’s potential to address adherence and stigma challenges is unmatched. However, its true transformative power lies in Gilead’s strategic public-private partnerships and scalable market access models, which are critical to ensuring equitable distribution in emerging markets.

Strategic Public-Private Partnerships: A Cornerstone of Global Access

Gilead’s collaboration with PEPFAR and the Global Fund has positioned lenacapavir as a cornerstone of HIV prevention in low- and lower-middle-income countries (LLMICs). Under this partnership, Gilead provides the drug at no profit until generic versions are available, targeting up to two million individuals in high-burden regions by 2028 [1]. This initiative is bolstered by royalty-free licensing agreements with six generic manufacturers, covering 120 countries, which will drive down costs and ensure regulatory approvals are streamlined [1].

The Global Fund’s procurement agreement marks a historic milestone: lenacapavir will be introduced in low- and middle-income countries simultaneously with high-income nations—a first for an HIV prevention product [4]. Early shipments are expected by late 2025, with the Global Fund aiming to scale access to two million people over three years [4]. Such partnerships not only accelerate distribution but also mitigate financial barriers in regions where healthcare infrastructure is fragmented.

Scalable Market Access: Innovation and Challenges

Gilead’s market access strategy combines tiered pricing, at-risk manufacturing, and early regulatory filings in Africa and Latin America to ensure scalability. For instance, in Latin America, where PrEP uptake remains low, lenacapavir is poised to address gaps in adherence among populations like young men who have sex with men and transgender women [3]. Similarly, in sub-Saharan Africa, the drug’s long-acting formulation could overcome logistical challenges associated with daily oral PrEP.

However, challenges persist. In the U.S., the annual cost of lenacapavir exceeds $28,000, raising concerns about affordability [2]. While generic production could reduce costs to as low as $25 per person annually, patent barriers and legal uncertainties—such as a pending Supreme Court case on health plan coverage requirements—threaten to delay broader access [2][4]. Additionally, structural stigma and weak healthcare systems in emerging markets may hinder implementation, even with cost reductions [4].

Future Outlook: Balancing Innovation and Equity

Gilead’s approach underscores the importance of aligning commercial incentives with public health goals. By prioritizing no-profit pricing and voluntary licensing, the company has set a precedent for equitable access to breakthrough therapies. However, sustained success will depend on navigating regulatory and legal hurdles, particularly in the U.S., where policy shifts could impact funding for public health programs [4].

For investors, Gilead’s partnerships and market access strategies present both opportunities and risks. The potential to capture a significant share of the $1.2 billion PrEP market [3] is tempered by the need for continued collaboration with global health organizations. As lenacapavir scales, its impact on reducing HIV incidence in high-burden regions could translate into long-term revenue growth and enhanced corporate reputation.

Conclusion

Gilead Sciences’ expansion of lenacapavir exemplifies how strategic public-private partnerships can drive scalable market access in emerging markets. By addressing structural barriers through innovative licensing and tiered pricing, the company is not only advancing global health equity but also positioning itself as a leader in the evolving HIV prevention landscape. For investors, the key takeaway is clear: the intersection of public health impact and commercial viability will define the future of lenacapavir—and Gilead’s role in it.

**Source:[1] Gilead Announces Partnership With PEPFAR to Deliver Twice-Yearly Lenacapavir for HIV Prevention for up to Two Million People in Primarily Low--and Lower-Middle-Income Countries [https://www.businesswire.com/news/home/20250903204152/en/Gilead-Announces-Partnership-With-PEPFAR-to-Deliver-Twice-Yearly-Lenacapavir-for-HIV-Prevention-for-up-to-Two-Million-People-in-Primarily-Low--and-Lower-Middle-Income-Countries][2] New Analysis Exposes Path to Affordable Lenacapavir for HIV Prevention [https://itpcglobal.org/2025/07/15/new-analysis-exposes-path-to-affordable-lenacapavir-for-hiv-prevention/][3] Lenacapavir Injection Market Update; Opportunity Of The Lenacapavir Injection Market [https://www.htfmarketintelligence.com/report/global-lenacapavir-injection-market][4] Global Fund Secures Access to Breakthrough HIV Prevention Drug Lenacapavir for Low- and Middle-Income Countries [https://www.theglobalfund.org/en/news/2025/2025-07-09-global-fund-secures-access-breakthrough-hiv-prevention-drug-lenacapavir/]