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September 2025
The global HIV PrEP market is on an upward trajectory, poised to generate substantial revenue growth, potentially climbing into the hundreds of millions over the forecast years from 2025 to 2034. This surge is attributed to evolving consumer preferences and technological advancements reshaping the industry.
Due to the growing incidence of HIV, the demand for HIV PrEP is increasing, which in turn is increasing their innovation. New government guidelines are promoting their launch and access, and the funding is enhancing their development, where AI is also being used to accelerate their development, drug candidate screening, and personalized treatment development. Their growing adoptions and HIV burden are increasing their demand in various regions. The companies are also developing, collaborating, and launching new products along with government support, where these advancements are promoting market growth.
The HIV PrEP market is driven by growing oral formulation and long-acting injectables, providing more options to enhance patient adherence and shift the market away from the use of daily pills. The HIV PrEP covers pharmaceutical and device-based prevention options given to HIV-negative people at substantial risk of acquiring HIV to reduce their infection risk. PrEP products include daily oral antivirals, on-demand oral regimens, long-acting injectables, topical/vaginal rings, implants, as well as experimental biologics (e.g., broadly neutralizing antibodies, bNAbs). The market is shaped by clinical efficacy, safety, convenience, cost, programmatic delivery (community vs clinic), regulatory approvals, donor funding (Global Fund, PEPFAR), and local scale-up strategies in high-burden regions.
Growth in HIV cases: There is a rise in the incidence of HIV, which is increasing the demand for HIV PrEP solutions. At the same time, due to growing awareness programs and their screening, their recommendations are also increasing. These growing advancements are being supported by the governments with their new guidelines and funding.
For instance,
AI plays an important role in predicting and analyzing the HIV infection risk and datasets. AI chatbots are also being used to provide personalized treatment plans and reminders for the same, enhancing patient counseling and outreach. At the same time, it is also being used to accelerate drug discovery and development as it helps in analyzing a vast amount of drug candidates and optimizing them depending on their safety, efficacy, and stability. It also helps in predicting the HIV outbreaks or their hotspots, as well as with their integration with telehealth, they are enhancing their accessibility, encouraging the use of HIV PrEP.
Growing Innovation
To tackle the growing HIV incidences, different types of HIV PrEP, such as daily pills, long-acting injectables, and vaginal rings, are being developed. At the same time, personalized treatments are also being developed, such as topical formulations, depending on the patient demand and need. They are also focusing on enhancing their effectiveness and reducing their dosing frequencies to reduce the patient stigmas, which is promoting the development of implants. Thus, these innovations, along with R&D funding and investments, are driving the HIV PrEP market growth.
Low Awareness and Stigma
Due to a lack of awareness and education about the effectiveness of the HIV PrEP solution, its demand is often low. Moreover, they also believe there is no proper prevention medication for HIV, thinking that PrEP is only a treatment. Similarly, due to the fear of being judged or discriminated the use of HIV PrEP is reduced. Thus, these factors are acting as barriers to the use of HIV PrEP.
Advancements in the Long-Acting Injectable PrEP
The use of long-acting PrEP is increasing due to its enhanced efficacy, which in turn is increasing its adherence as well as demand. At the same time, the growing HIV awareness is also increasing their use, shifting from daily pills to these injectables, which is increasing their accessibility. Similarly, their simplified dosing and reduced frequency are helping in minimizing the burden on the healthcare system and patients, which is attracting patients. This, in turn, is also encouraging their development and innovations, promoting the development of long-acting inhibitors with repeated doses after 6 months and implants. Thus, this is promoting the HIV PrEP market growth.
For instance,
By product/modality type, the daily oral PrEP segment held the dominating share of approximately 60% share in the market in 2024, due to its convenience. At the same time, due to the growth in awareness and FDA approvals, their use increased. Similarly, their affordability and accessibility also enhanced their use.
By product/modality type, the long-acting injectable PrEP segment is expected to show the highest growth during the upcoming years. Rather than the daily use of the HIV PrEP pills, these injectables helped in minimizing the dosing frequency, enhancing patient adherence to the treatment. Additionally, due to their high efficacy, their use in the high-risk population is increasing.
By delivery channel type, the clinical/hospital pharmacy segment led the market in 2024, because of physician-prescribed PrEP via sexual health clinics and primary care. Moreover, they also provided regular HIV testing and monitoring. Similarly, the presence of specialist and advanced therapies enhanced patient adherence to them.
By delivery channel type, the community & NGO distribution segment is expected to show the fastest growth rate during the predicted time. The presence of community delivery, peer distribution, and mobile clinics is enhancing their use. At the same time, due to their flexible delivery and expanding reach, their accessibility is increasing. This is promoting the market growth.
By payer/funding source type, the private insurance & out-of-pocket segment held the dominating share in the market in 2024, due to limited public funding. At the same time, the presence of patents protecting the branded drugs also increased their use. Additionally, they were also used by private clinics or clinics that wanted to maintain the insurance privacy.
By payer/funding source type, the donor funding segment is expected to show the highest growth during the upcoming years. They enable large volume procurement and scale-up in high-burden countries. Moreover, they are also providing support to the low and middle-income countries. Additionally, they also help to enhance their affordability and accessibility of the drugs.
North America dominated the HIV PrEP market with approximately 30-35% revenue share in 2024. Due to the early adoption of the HIV PrEP in North America, their demand increased, which enhanced their clinical access. At the same time, their use increased among the high-risk and MSM population, which increased their demand as an HIV prevention option. Additionally, their growing innovations are being supported by the private payer coverage, which contributed to the market growth.
The use of HIV PrEP oral formulations is increasing in the U.S. due to the growing HIV burden, which in turn is driving their innovations and adoption rates. The companies are actively participating, promoting their development and launch to deal with this growing burden. At the same time, the presence of specialty clinics and labs are increasing the HIV early diagnosis, promoting the use of HIV PrEP.
Various HIV PrEP solutions are being approved by the government of Canada and are supported by the healthcare funding, which is increasing their access and affordability. The growing awareness is also encouraging their use to deal with the stigma and HIV incidence. Therefore, this is increasing their use among the high-risk population.
The Middle East and Africa (MEA) is expected to host the fastest-growing HIV PrEP market during the forecast period, due to the growing HIV burden driving the demand for HIV PrEP for their effective prevention. The growing awareness campaigns and funding from various sources are enhancing their use and innovations. Sub-Saharan Africa is showing the fastest growth by dealing with the unmet needs of patients, where they are focusing on public health by conducting donor programs. This is enhancing the use of oral PrEP and is accelerating the launch of pilots for rings and long-acting options. This is promoting the market growth.
The development of long-acting and convenient formulations with reduced dosing frequency, such as twice a month or twice a year, to enhance patient adherence to the treatment and provide them with more HIV prevention options is the main focus of the R&D of HIV PrEP.
Key Players: ViiV Healthcare, Gilead Sciences, Merck & Co. Inc., Aurobindo Pharma, Cipla, Viatris/Mylan.
The clinical trials and regulatory approvals of HIV PrEP focus on their safety and efficacy.
Key Players: ViiV Healthcare, Gilead Sciences, Janssen/Johnson & Johnson, Merck & Co. Inc., Cipla, Viatris/Mylan, Teva Pharmaceutical Industries.
To enhance the accessibility of the HIV PrEP, the patient support and services of the HIV PrEP provide telehealth appointments, adherence programs, counseling, and financial assistance.
Key Players: ViiV Healthcare, Gilead Sciences, Merck & Co. Inc., Aurobindo Pharma, Cipla, Viatris/Mylan, Teva Pharmaceutical Industries, Janssen/Johnson & Johnson.
In September 2025, after announcing the collaboration between the U.S President’s Emergency Plan for AIDS Relief (PEPFAR), the U.S. State Department, and Gilead Sciences, for the prevention of HIV as pre-exposure prophylaxis (PrEP), the chairman and chief executive officer of Gilead Sciences, Daniel O’Day, stated that, they will be able to take a step closer to ending the HIV epidemic with this collaboration as it will accelerate the access to lenacapavir. Moreover, to support the US government in providing life-saving programs to meet the urgent need, they will be providing the medication with no profit in this collaboration.
By Product/Modality
By Delivery Channel
By Payer/Funding Source
By Region
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