Global Anti-retroviral Protease Inhibitors Market Size, Forecast, and Trend Highlights Over 2025-2037
Anti-retrovial Protease Inhibitors Market size was valued at USD 3.7 billion in 2024 and is projected to reach USD 7.3 billion by the end of 2037, rising at a CAGR of 7.5 % during the forecast period, i.e., from 2025 to 2037. In 2025, the industry size of anti-retroviral protease inhibitors is estimated at USD 3.9 billion.
The demand for the market is remarkably stimulated by the increasing occurrence of HIV, AIDS, fruitful innovations in combination therapies, and expanding access to advanced treatment procedures in developing nations. For instance, in 2023, UNAIDS reported nearly 40 million people were affected by HIV or AIDS, out of which 25.9 million were getting treated through antiretroviral therapy. Besides, Sub-Saharan Africa alone accounted for 68% of global HIV cases, which draws the interest of domestic players to invest in this sector. Due to this rising burden, the demand for anti-retroviral protease inhibitors expands at a rapid pace.
Focus for improved patient outcomes initiated several funding activities with USD 20.4 billion being invested in 2022 for HIV responses in developing countries. Additionally, the U.S. Bureau of Labor Statistics reported a surge in PPI for these products of about 3% to 5% in a year due to the increased ingredient costs. Furthermore, NMPA reports that more than 50% of APIs for anti-retroviral protease inhibitors are being supplied from China, and India converts them into a final product for exports. Besides, FDA trade data reported that the U.S. imports nearly 40% of these drugs from India. Hence, these factors significantly contribute to the market expansion during the forecast timeline.
Anti-retroviral Protease Inhibitors Sector: Growth Drivers and Challenges
Growth Drivers
- Government investments: One of the fueling factors for the anti-retroviral protease inhibitors market is the ever-increasing government and in-person expenditures in PI-based treatments. In this regard CDC report in 2023 states that in the U.S., the medical expenditure on protease inhibitors reached a substantial amount of USD 2.9 billion. Besides, in 2023, the global funding initiatives assigned USD 4.3 billion for HIV treatment 2023 out of which 45% was particularly allocated for ARV procurement. Hence, this is the evidence for a wider scope, thereby driving business in this sector.
- Rising burden of chronic diseases: Another major driver for the market is the large consumer base, which is the expanding patient pool of HIV and AIDS. For instance, in 2025, Germany reported a total of 91,500 cases of HIV, which is a 9% increase since 2018, out of which 89% of people rely on ART-based treatment measures. Besides the CDC data 2024, which unveiled that 1.2 million people in the U.S. are affected by HIV, out of which 15% remain undiagnosed. Hence, these rising instances necessitate the demand for PIs across all nations.
Manufacturer Strategies Shaping the Anti-retroviral Protease Inhibitors Market
Global manufacturers involved in the market are emphasizing various sorts of tactical strategies to strengthen their ecosystems in the industry. Pharmaceutical firms are focusing on innovative product launches, collaborations, and expansions to enhance their product portfolio. In this regard, UNAIDS reported that in 2024, ViiVHealthcare captured a huge value of USD 86.9 billion by developing next-generation, heat-stable HIV medicines in the PI market. Besides, the global fund in 2024 reported that Cipla and Mylan gained an optimum consumer base focusing on affordability, which is reducing PI costs by 36%. Hence, these strategies are anticipated to shape the market, demonstrating lucrative growth opportunities.
Revenue Opportunities for PI Manufacturers (2023-2027)
|
Company |
Strategy |
Revenue Impact |
|
ViiV Healthcare |
Long-acting injectables (Cabenuva) |
+$1.6 billion |
|
Gilead Sciences |
Heat-stable PIs for tropical markets |
+$910 million |
|
Merck & Co. |
Pediatric PI formulations |
+$620 million |
|
Cipla |
Low-cost generics for LMICs |
+$1.3 billion |
|
Mylan |
Biosimilar Darunavir |
+$760 million |
Expansion Models Shaping the Future of Anti-retroviral Protease Inhibitors Market
There is a limitless exposure for the market, which is inspiring the global leaders to emphasize several expansion strategies. The transformative growth in this sector is pushing both public and private organizations to invest in this sector, followed by meaningful partnerships, pricing, and digital health collaborations. For instance, UNAIDS reported that access to these products rose by 25% in developing countries from 2020 to 2023, which highlights the improved medical penetration. Thus, these factors underscore the global shift towards affordable and consumer-friendly therapeutics.
Feasibility Model for Global ARV-PI Market Expansion (2024–2026)
|
Model |
Adoption Rate (2024) |
Projected Revenue Growth (2026) |
Key Driver |
|
Voluntary Licensing |
73% (Developing countries) |
22% |
Generic competition |
|
Long-Acting Formulations |
46% (High-Income) |
27% |
Improved adherence |
|
Telehealth Dispensing |
39% (Global) |
16% |
Digital health policy |
Challenge
- Price controls by government: One of the major bottlenecks hindering growth in the market is the price controls and reimbursement barriers imposed by governments across the world. In this regard, BMG Germany reported that the AMNOG law in the country reduced prices for the next-generation therapies by 20% to 30%, making it challenging for manufacturers to develop these PI inhibitors. Additionally, Health Canada reported reduced launch prices by 15%, further creating a major hurdle for the firms leveraging PI inhibitors.
Anti-retroviral Protease Inhibitors Market: Key Insights
| Report Attribute | Details |
|---|---|
|
Base Year |
2024 |
|
Forecast Year |
2025-2037 |
|
CAGR |
7.5% |
|
Base Year Market Size (2024) |
USD 3.7 billion |
|
Forecast Year Market Size (2037) |
USD 7.3 billion |
|
Regional Scope |
|
Anti-retroviral Protease Inhibitors Segmentation
Application (HIV Treatment, Hepatitis C Treatment)
Based on application, the HIV treatment segment is expected to garner the highest share of 85.4% in the anti-retroviral protease inhibitors market by the end of 2037. The dominance of the segment is attributable to the crucial role of anti-retroviral therapy in HIV treatment. As there is an increasing burden of HIV cases across the world, the demand for these therapies increases owing to their higher efficacy in mitigating the multiplication of HIV cells in the body. This has further created a heightened awareness among the global health reforms, such as UNICEF and WHO, that are focusing on expansion across all nations, thereby contributing to the segment’s growth.
Drug Class (First-generation Protease Inhibitors, Second-generation Protease Inhibitors)
Based on drug class, the second-generation protease inhibitors segment is projected to account for a lucrative share of 60.5% in the anti-retroviral protease inhibitors market during the forecast period. The growth in the segment is subject to the growing preference for PIs such as Darunavir, Atazanavir, when compared to the first generation, due to their enhanced efficacy and lowered side effects, high resistance, and convenience offered. Besides, they are widely used in modern HIV treatment procedures, hence denoting a positive outlook for market development.
Our in-depth analysis of the global anti-retroviral protease inhibitors market includes the following segments:
|
Application |
|
|
Drug Class |
|
|
Distribution Channel |
|
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Customize this ReportAnti-retroviral Protease Inhibitors Industry - Regional Synopsis
North America Market Analysis
The North America anti-retroviral protease inhibitors market is poised to capture the largest share of 48.8% during the forecast period. The dominance of the region is attributable to the high disease prevalence, advanced medical infrastructure, and funding initiatives from the government. Besides, public and private healthcare systems in the region are focusing on improved patient outcomes for which the long-acting injectable therapies were introduced, further enhancing the management of therapies. Government initiatives, such as the U.S. Department of Health & Human Services' funding and Canada's Public Health Agency's programs, further boost business in this sector.
Canada's market is growing exponentially, driven by substantial government-backed funding and growing awareness of prevention and care. It is reported that nearly 75,500 people in Canada are affected by HIV, which is a 9.8% increase from 2011. In this context federal government assigned an annual budget of USD 42.4 million in the last decade, followed by British Columbia and Alberta, providing optimal coverage for anti-retrovirals to mitigate health disparities. Hence, these factors significantly contribute to the market expansion during the forecast timeline.
APAC Market Statistics
Anti-retroviral protease inhibitors market in the Asia Pacific is unfolding remarkable growth opportunities, fueled by the expanding access to treatment procedures. Due to the rising disposable income, the region is witnessing tremendous growth coupled with government support, generic drug formulations, and technological advancements in the development of next-generation protease inhibitors with lowered side effects. In this context, in 2023, nearly 6.6 million people were living with HIV in the Asia Pacific, which is 25% of global new infections. Hence, these rising instances drive demand for advanced PIs in the region.
China is a global leader in the market due to the presence of key market players and government disbursement of funding. Besides, in 2023, the country reported that approximately 1.4 million people were diagnosed with HIV due to sexual transmission rather than blood transfusion. Government initiatives, such as the National Free Antiretroviral Treatment Program, are expanding treatment access for HIV patients in China. This is the evidence for a wider scope positioning China as an emerging player in the market by the end of 2037.
Companies Dominating the Anti-retroviral Protease Inhibitors Landscape
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
Companies involved in the market are emphasizing several expansion models to strengthen their ecosystem in the global market landscape. Key leaders such as Gilead, ViiV, and Merck are focusing on research activities to bring innovations and enhance patient outcomes in the field. Key players in Africa and Asia, such as Aurobindo, Cipla, and Mylan, are focusing on affordable medical solutions to reach a vast consumer base in rural areas. Besides, organizations are gaining traction in the development of biosimilars, further contributing to market upliftment during the forecast period.
Here is a list of key players operating in the global market:
|
Company |
Headquarters |
Market Share |
Key Products |
|
Gilead Sciences |
USA |
~27% |
Darunavir (Prezista) |
|
ViiV Healthcare |
UK |
~22% |
Atazanavir (Reyataz) |
|
Merck & Co. |
USA |
~17% |
Ritonavir (Norvir) |
|
AbbVie |
USA |
~12% |
Lopinavir/Ritonavir |
|
Bristol-Myers Squibb |
USA |
~10% |
Atazanavir |
|
Roche |
Switzerland |
xx% |
HIV formulations |
|
Boehringer Ingelheim |
Germany |
xx% |
Tipranavir (Aptivus) |
|
Johnson & Johnson |
USA |
xx% |
Darunavir |
|
Aurobindo Pharma |
India |
xx% |
Generic protease inhibitors |
|
Cipla |
India |
xx% |
Affordable generics |
|
Hetero Drugs |
India |
xx% |
Generic HIV drugs |
|
Mylan (Viatris) |
USA |
xx% |
Generic HIV treatments |
|
Teva Pharmaceuticals |
Israel |
xx% |
Generic & specialty HIV meds |
|
Lupin |
India |
xx% |
Affordable HIV drugs |
|
Sun Pharmaceutical |
India |
xx% |
Generic protease inhibitors |
|
Daiichi Sankyo |
Japan |
xx% |
Novel HIV therapies (R&D) |
|
Takeda Pharmaceutical |
Japan |
xx% |
Antiviral drug development |
|
CSL Limited |
Australia |
xx% |
Biotech-based HIV treatments |
|
Dong-A ST |
South Korea |
xx% |
Regional HIV drug supplier |
|
Pharmaniaga |
Malaysia |
xx% |
Government-backed HIV distribution |
Below are the areas covered for each company under the top global manufacturers:
In the News
- In December 2024, Gilead Sciences launched Lenacapavir, a long-acting injectable HIV prevention drug administered every six months to prevent HIV in women and adolescent girls.
- In December 2024, GSK reported a major commercial milestone with Apretude, its long-acting injectable PrEP medication that generated £126 million in sales in H1 2024, more than doubling year-over-year.
Author Credits: Radhika Pawar
- Report ID: 2553
- Published Date: May 29, 2025
- Report Format: PDF, PPT
