Long-acting PrEP Market - Global Forecast 2026-2032

The Long-acting PrEP Market size was estimated at USD 452.06 million in 2025 and expected to reach USD 475.10 million in 2026, at a CAGR of 4.76% to reach USD 626.06 million by 2032.

The global fight against HIV has reached a pivotal juncture as new prevention modalities redefine the landscape of public health interventions. Although daily oral pre-exposure prophylaxis (PrEP) demonstrated substantial efficacy when widely adopted, real-world utilization lags behind potential; only about one-third of individuals eligible for PrEP accessed it in 2022, underscoring persistent barriers to effective prevention. Concurrently, HIV incidence remains stubbornly high, with approximately 1.3 million new infections reported in 2024, disproportionately affecting key populations such as men who have sex with men, sex workers, and adolescents. These trends highlight critical gaps in adherence, stigma reduction, and equitable access that daily regimens alone cannot bridge.

In response, regulatory authorities have approved a new generation of long-acting PrEP products that promise to transform prevention strategies. The U.S. Food and Drug Administration granted approval to cabotegravir long-acting (Apretude) in December 2021, marking the first injectable option that reduced administration frequency to as few as six injections per year. More recently, lenacapavir (Yeztugo) received FDA clearance in June 2025, offering a twice-yearly dosing schedule that could dramatically enhance adherence among populations facing challenges with daily oral pills.

Beyond injectables, subdermal implants are advancing through clinical development, leveraging biodegradable and non-biodegradable polymer matrices to deliver sustained antiretroviral release over extended durations. These implantable devices aim to further diversify options and address preferences for minimal clinical visits and reduced stigma.

In this executive summary, we explore how these innovations, alongside evolving service delivery models and shifting policy frameworks, are driving a new era of HIV prevention. This overview lays the foundation for strategic insights that inform stakeholders across the public and private sectors as they plan to scale long-acting PrEP adoption.

Over the past two years, the long-acting PrEP landscape has undergone fundamental shifts driven by breakthroughs in pharmaceutical formulation and evolving delivery paradigms. Injectable and implantable technologies now harness advanced drug delivery platforms; cabotegravir and lenacapavir formulations utilize extended-release nanosuspension and polymer-based depot methods to maintain therapeutic drug levels for months with a single administration. These technological advances reduce the frequency of clinical appointments and align with patient preferences for discretion and convenience.

Simultaneously, healthcare ecosystems are integrating long-acting PrEP into decentralized and community-based models of care. Community health centers and mobile clinics have expanded capacity to administer injections and implants outside traditional hospital settings, enabling outreach to underserved urban and rural populations. Certified online pharmacies are augmenting telehealth services by facilitating home delivery of oral lead-in medications and nurse-assisted administration kits, while chain and independent retail pharmacies collaborate with healthcare networks to offer ‘‘hub-and-spoke’’ support for long-acting PrEP initiation and follow-up.

Clinical guidelines and policy frameworks have adapted accordingly. The World Health Organization’s July 2025 guidelines recommend twice-yearly lenacapavir and bimonthly cabotegravir as additional PrEP choices, endorsing simplified HIV testing protocols to support community delivery. In parallel, national programs have begun revising reimbursement pathways and training clinicians to ensure safe implementation. Altogether, these transformative shifts are dismantling traditional barriers of stigma and adherence, paving the way for more resilient and patient-centered HIV prevention strategies.

Policy changes in 2025 have introduced new tariff structures that reverberate through pharmaceutical supply chains, affecting both raw materials and finished long-acting PrEP products imported into the United States. Negotiations between the U.S. and European Union are poised to establish 15% tariffs on EU medical device imports, including key injectable delivery systems, while potential reciprocal measures could escalate duties to as high as 30% if no agreement is reached by the stipulated deadline. These tariffs risk increasing costs for syringes, needles, and polymer-based implant delivery kits, which rely on specialized components sourced globally.

At the same time, Section 301 tariff measures on Chinese imports have been finalized, raising additional duties on medical gloves to 50% and applying a 100% tariff on syringes and needles beginning September 2024, with temporary exclusions set to expire in early 2026. The combination of steel and aluminum derivative tariffs further escalates the cost base for manufacturing injection apparatus and implantable device components domestically and abroad.

These cumulative tariff impacts could constrain manufacturers’ pricing flexibility, potentially passing increased costs to payers and patients. Device and supply shortages may arise if importers seek to avoid punitive tariffs, creating disruptions in distribution channels spanning hospital pharmacies, public health programs, and community clinics. As stakeholders navigate this complex trade environment, strategic sourcing and localized production initiatives become essential to sustaining reliable access to long-acting PrEP modalities.

A nuanced understanding of market segmentation is critical to tailoring long-acting PrEP strategies and optimizing resource allocation. When evaluating product types, stakeholders must consider both implantable devices-available in biodegradable polymer formulations that gradually dissolve within the body and non-biodegradable matrices requiring removal-and injectable suspensions administered via intramuscular or subcutaneous injection, each offering distinct pharmacokinetic profiles and patient acceptability dynamics. These variations influence clinical preferences and supply chain logistics.

Distribution channels likewise exhibit heterogeneous characteristics. Community health centers operate through fixed clinics and mobile units that reach remote or marginalized populations, while hospital pharmacies in private and public institutions anchor broader health systems. Certified online pharmacies have emerged to facilitate seamless access to oral lead-in medication and support remote counseling, complemented by retail pharmacies-both chain and independent-that provide critical touchpoints for patient education and adherence reinforcement.

End users span a spectrum of care settings. Hospitals must integrate long-acting PrEP protocols into existing inpatient and outpatient services, whereas international and local non-governmental organizations deploy specialized programs in resource-constrained environments. Private clinics, including sexual health and STD-focused facilities, often lead in adopting innovative PrEP delivery, while public health programs leverage community outreach and government-funded initiatives to scale preventive services across diverse demographics.

Target populations present further segmentation. Adolescents aged 15 to 19 and those aged 20 to 24 have unique developmental and psychosocial considerations, while heterosexual adults aged 25 to 49 and those over 50 navigate different risk profiles and healthcare touchpoints. Among men who have sex with men, adult and young cohorts demonstrate varying levels of PrEP awareness and stigma-related concerns.

Enrollment pathways also diverge by administration setting. Clinical venues-encompassing both clinics and hospitals-offer professional supervision, contrasted with home-based models enabling nurse-assisted or fully self-administered injections and implant management. Understanding these multidimensional segments guides targeted outreach and user-centric program design.

Regional dynamics significantly influence long-acting PrEP adoption, shaped by local healthcare infrastructure, regulatory environments, and cultural factors. In the Americas, robust healthcare systems in the United States and Canada facilitate rapid uptake of approved injectables and pilot implant programs, supported by established private and public payer mechanisms. Meanwhile, Latin American countries are expanding community-based delivery through non-governmental partnerships and mobile clinics, addressing geographical barriers and stigma-related challenges.

In Europe, Middle East, and Africa (EMEA), the landscape is equally dynamic but heterogeneous. High-income European nations are integrating long-acting PrEP into national health services, negotiating pricing agreements with manufacturers and piloting decentralized dispensing models. Conversely, many African and Middle Eastern countries rely on donor-funded public health programs and international NGO efforts to extend access, often constrained by supply chain complexities and tariff-driven cost pressures. Mobile outreach and telehealth solutions are emerging to reach key and priority populations in resource-limited settings.

In Asia-Pacific, countries such as Australia and New Zealand lead in regulatory approvals and clinical guideline adoption, embedding long-acting PrEP within sexual health frameworks. Elsewhere across Southeast Asia and the Pacific Islands, governments and private providers are forging public–private partnerships to introduce injectable and implantable options, leveraging community pharmacies and telemedicine platforms to overcome infrastructural gaps. Across all regions, local epidemiology and cultural factors continue to drive tailored program designs that address unique barriers to access and adherence.

Leading pharmaceutical companies are strategically positioning their portfolios to capture opportunities within the long-acting PrEP market. ViiV Healthcare has established an early advantage through cabotegravir long-acting, securing regulatory approvals across several markets and furnishing real-world evidence that demonstrates zero HIV transmissions in diverse implementation studies presented at CROI 2025. The company’s collaborative initiatives with government programs and community organizations reinforce its commitment to equity-driven access.

Gilead Sciences, following the June 2025 approval of lenacapavir, is scaling manufacturing capabilities to ensure supply resilience while negotiating reimbursement pathways to align pricing with existing PrEP options. Its strategic alliances with academic institutions and public health agencies aim to generate robust real-world adherence data and inform digital adherence tools.

Emerging biotech firms and medical device companies are advancing subdermal implant technologies, engaging in partnerships to co-develop biodegradable polymer platforms optimized for sustained drug release. These alliances reflect a trend toward platform-based collaborations that combine antiretroviral expertise with delivery system innovation.

Service providers, including certified online pharmacies and specialty injectables distributors, are forging relationships with payers and healthcare networks to integrate telehealth and home-based administration models. Collectively, these strategic moves and collaborations underscore a competitive landscape defined by integration, evidence generation, and patient-centric execution.

To capitalize on the momentum in long-acting PrEP adoption, industry leaders should prioritize scalable implementation frameworks that align with segmented population needs. First, forging partnerships with community health centers and mobile clinics can enhance reach among adolescents and underserved demographics, leveraging fixed and mobile platforms to deliver injections and implants directly within communities. Complementary collaborations with certified online pharmacies can extend support for oral lead-in regimens and facilitate nurse-assisted home administration, bridging gaps between clinical and home-based models.

Second, proactive engagement with payers is essential to secure favorable reimbursement terms for both injectable and implantable products. Transparent value dossiers that articulate cost-effectiveness gains through improved adherence and reduced HIV acquisition can inform formulary inclusion and co-pay assistance strategies. Working with government-funded programs and NGOs to integrate long-acting PrEP into broader HIV prevention bundles can further catalyze uptake.

Third, investing in digital adherence solutions and telehealth infrastructure will optimize patient support. Mobile applications, remote monitoring, and targeted SMS reminders can sustain adherence across bimonthly or biannual dosing intervals, while data analytics can inform personalized intervention triggers. Integration of these digital tools into product launches will differentiate offerings and drive patient engagement.

Finally, diversifying manufacturing and sourcing strategies is critical in navigating the evolving tariff environment. Establishing localized manufacturing partnerships, qualifying alternate API suppliers, and evaluating in-region assembly for delivery systems will mitigate supply chain risks and stabilize pricing amid fluctuating trade policies.

This report’s insights are grounded in a rigorous, mixed-method research process. Secondary research encompassed a detailed review of peer-reviewed literature, regulatory filings, clinical trial registries, and policy documents from leading health organizations. Key sources included WHO guidelines on injectable cabotegravir and lenacapavir, FDA approval announcements, and international trade publications on 2025 tariff measures. Market intelligence databases and published white papers provided contextual understanding of pharmaceutical supply chain dynamics.

Primary research involved in-depth interviews with industry experts, including clinicians, formulary decision-makers, payer executives, and implementation partners across community health centers, NGOs, and retail pharmacy networks. Surveys and structured questionnaire-based engagements with target end users-adolescents, heterosexual adults, and men who have sex with men-explored attitudinal drivers influencing product selection and administration setting preferences.

Data triangulation techniques ensured reliability, whereby insights from primary interviews were validated against secondary data and real-world evidence from implementation studies presented at CROI 2025. Analytical frameworks employed include segmentation analysis, SWOT assessments for key stakeholders, and scenario planning to evaluate tariff impact and distribution strategies. This multi-source, iterative methodology underpins the strategic recommendations and regional insights detailed herein.

The advent of long-acting PrEP marks a watershed moment in HIV prevention, offering potent, user-friendly alternatives to daily oral regimens. Regulatory endorsements for cabotegravir and lenacapavir have catalyzed a transformation in service delivery, with decentralized and community-based models expanding access. However, emerging tariff policies pose headwinds to supply chain stability, necessitating strategic sourcing and localized production efforts.

Segmentation insights reveal the importance of tailoring approaches across product types, distribution channels, end users, target populations, and administration settings to maximize market penetration. Regional analyses underscore the heterogeneity of adoption drivers and highlight opportunities for public–private partnerships in each geography. Competitive intelligence highlights that collaborative, platform-based alliances between pharmaceutical innovators and device specialists will define market leadership, as will integration of digital adherence solutions.

Moving forward, industry stakeholders must align reimbursement strategies with demonstrable health-economic value, invest in telehealth infrastructure, and strengthen community partnerships to overcome structural barriers. By executing targeted, data-driven initiatives, organizations can accelerate uptake, improve equity of access, and ultimately contribute to global HIV prevention goals. The insights and recommendations presented form a comprehensive blueprint for stakeholders seeking to navigate the evolving long-acting PrEP ecosystem with agility and impact.

For tailored guidance or to discuss how this comprehensive report can support your decision-making, connect directly with Associate Director Ketan Rohom. Leverage his expertise in aligning market insights with strategic sales and marketing initiatives to drive adoption of long-acting PrEP solutions. Engage today to explore customized packages, licensing options, and advisory services that will empower your team to navigate the evolving HIV prevention landscape with confidence and precision.