Global Human Immunodeficiency Virus Type-1 (HIV-1) Treatment Market to reach US$ 62,752.56 million by 2031, North America led 46% of global market share | key Players:- Gilead Sciences, Inc., ViiV Healthcare, Janssen Global Services, LLC.

Global Human Immunodeficiency Virus Type-1 (HIV-1) Treatment Market reached US$ 39,670.14 million in 2023 and is expected to reach US$ 62,752.56 million by 2031, growing at a CAGR of 5.9% during the forecast period 2025-2031.

HIV-1 is a retrovirus, belonging to a group of heterogeneous, lipid-enveloped RNA viruses. HIV-1 is the most common type of HIV (Human Immunodeficiency Virus) accounting for nearly 95% of the cases. The virus attacks the patient's immune system by destroying CD4 cells, which play a key role in fighting infections. This can lead to AIDS (Acquired Immune Deficiency Syndrome). The most common treatment option for HIV-1 infection is anti-retroviral therapy (ART) which is a combination of antiretroviral drugs. The major goal of ART therapy is to suppress the HIV replication and delay the progression of the condition into AIDS.

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Key Industry Development-
✅ June 2025: Gilead Sciences received FDA approval for Yeztugo (lenacapavir) as the first and only twice-yearly injectable PrEP option to prevent sexually acquired HIV-1 in adults and adolescents, marking a major shift toward long‐acting HIV‐1 prevention in the U.S.​

✅ March 2025: At the Conference on Retroviruses and Opportunistic Infections (CROI 2025), Gilead presented late‐breaking Phase 2 data on a lenacapavir‐based long‐acting combination regimen that showed promising efficacy signals and supported continued development of biannual HIV‐1 treatment options.​

✅ February 2025: Industry analyses highlighted accelerating adoption and pipeline investment in injectable and long‐acting HIV‐1 regimens in the U.S., including cabotegravir/rilpivirine and emerging capsid inhibitor combinations, reflecting payer and provider interest in reduced‐frequency dosing models.​

✅ June 2025: Gilead launched Yeztugo (lenacapavir) commercially in the U.S. as a twice‐yearly subcutaneous PrEP injection, expanding the HIV‐1 treatment and prevention market with a first‐in‐class long‐acting capsid inhibitor option for high‐risk populations.​

✅ Early 2025: U.S. specialty pharmacy and payer reports described roll‐outs of updated HIV‐1 treatment packs and service models built around long‐acting injectables, bundling clinical monitoring and adherence support to optimize outcomes and differentiate offerings in the HIV‐1 care market.

Recent FDA Approvals:-

→ In 2025, the key U.S. FDA action relevant to the HIV‐1 treatment/prevention landscape is the approval of lenacapavir (Yeztugo) as a twice‐yearly injectable pre‐exposure prophylaxis (PrEP) to prevent sexually acquired HIV‐1 in adults and adolescents at risk. This is a prevention (PrEP) indication, not treatment of people already living with HIV‐1.

Report Objectives

To visualize the global human immunodeficiency virus type-1 (HIV-1) treatment market segmentation based on type, treatment type, route of administration, distribution channel, and region as well as understand key commercial assets and players.
Identify commercial opportunities by analyzing trends and co-development
Excel data sheet with numerous data points of human immunodeficiency virus type-1 (HIV-1) treatment market-level with all segments.
PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
Product mapping available as Excel consisting of key products of all the major players.
The global human immunodeficiency virus type-1 (HIV-1) treatment market report would provide approximately 70 tables,67 figures, and 187 Pages.

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Market Segment Analysis

→ By Type (Group M, N, O, P)
In practice, nearly all commercial HIV‐1 treatment demand is associated with Group M viruses, with Groups N, O, and P remaining vanishingly rare in clinical practice.​

Group M: Group M-associated infections account for essentially the whole treated HIV‐1 population; assigning about 99.8% of the 2025 market, this corresponds to roughly USD 38.4 billion.​

Group N: Group N is extremely rare; for modeling, an assumption around 0.05% share (about USD 19 million) captures its negligible but non‐zero treated volume.​

Group O: Group O is more prevalent than N in a few West‐Central African pockets but still very rare globally; allocating about 0.1% share (around USD 38 million) is reasonable.​

Group P: Group P cases are extraordinarily rare; a working assumption of 0.05% (about USD 19 million) reflects effectively negligible commercial weight while keeping your type segmentation exhaustive.​

→ By Treatment Type
Published HIV therapeutics segmentation shows nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) as the largest single drug class, with substantial roles for NNRTIs, PIs, and INSTIs; combination regimens (fixed‐dose combinations and multi‐class ART) dominate actual prescribing. Mapping that to your structure and normalizing to 100% for 2025:​

Combination therapies: Fixed‐dose and regimen‐level combinations are the backbone of modern ART and command the largest revenue pool when treated as a distinct "treatment type"; a pragmatic assumption is about 45% share, or USD 17.3 billion.​

Protease inhibitors: PI‐based regimens are now more niche but remain important in certain patient segments; a share around 12% (≈USD 4.6 billion) aligns with their declining but still material contribution.​

Integrase strand transfer inhibitors (INSTIs): INSTIs are the fastest‐growing class and widely used in first‐line and switch regimens; a working share of about 20% (USD 7.7 billion) reflects this strong uptake.​

Nucleoside reverse transcriptase inhibitors (NRTIs): NRTIs underpin most ART backbones and hold the single largest class share in many reports; assigning 18% (USD 6.9 billion) to NRTI‐specific revenues fits with reported dominance once combination‐therapy revenues are separated out.​

Non‐nucleoside reverse transcriptase inhibitors (NNRTIs): NNRTIs have lost share to INSTIs but remain widely used, particularly in resource‐limited settings; a modeled share of about 5% (USD 1.9 billion) is consistent with their shrinking yet persistent role.

Regional insights:-

• North America: 46% share . Driving factors include advanced healthcare infrastructure, widespread access to antiretroviral therapy (ART), high levels of awareness, and strong R&D plus government initiatives.

• Europe: 24% share . Growth supported by strong public health systems, early diagnosis/treatment initiatives, and ready access to modern HIV therapies.

• Asia-Pacific: 20% share . Growth driven by increasing HIV burden in populous countries, rising healthcare investment, improving access to ART, and growing treatment uptake.

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Market Major Players
→ The major players in the human immunodeficiency virus type-1 (HIV-1) treatment market include Gilead Sciences, Inc., ViiV Healthcare, Janssen Global Services, LLC, Viatris Inc., Merck & Co., Inc., GSK plc., Bristol-Myers Squibb Company, Boehringer Ingelheim International GmbH, AbbVie. and CELLTRION INC. among others.

Key Developments:

→ In January 2025, the HIV-1 treatment market saw advancements in integrase strand transfer inhibitors (INSTIs) as preferred first-line therapies, with fixed-dose combinations gaining traction for improved patient adherence and reduced resistance risks. Market projections indicated growth from USD 39.1 billion in 2025, driven by simplified dosing regimens and public health initiatives expanding access in developing regions.​

→ In September 2025, AI integration accelerated HIV-1 therapy development through machine learning for personalized treatments and drug discovery, with the broader HIV therapy market valued at around USD 36.4 billion amid rising adoption of automation in clinical trials. Future Market Insights highlighted sustained demand for novel antiretroviral combinations amid global efforts to curb transmission.​

→ In November 2025, the Clinton Health Access Initiative's HIV Market Report revealed crisis-level disruptions in pediatric HIV services across 14 countries, with 26,000 children losing treatment in six months due to funding cuts, impacting overall HIV-1 treatment dynamics. This underscored challenges in maintaining market stability for vulnerable populations.

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