항레트로바이러스약 시장 : 시장 점유율 분석, 산업 동향, 통계, 성장 예측(2025-2030년)

The anti-retroviral drugs market size reached USD 31.64 billion in 2025 and is forecast to rise to USD 38.92 billion by 2030, reflecting a 4.23% CAGR over the period.

This measured pace marks a transition from earlier rapid scale-up to a mature phase where innovation, differentiated access strategies and supply-chain resilience steer growth. Long-acting injectables, once-weekly oral regimens and ultra-durable prophylaxis strengthen adherence and open new prevention segments, while integrated primary care delivery and digital adherence tools broaden therapeutic reach. Competitive intensity is rising as blockbuster patents approach expiry, prompting both branded lifecycle extensions and aggressive generic positioning. At the same time, donor financing, tiered-pricing frameworks and local manufacturing investments continue to anchor demand in low- and middle-income countries, which account for almost all new infections.

Global Anti-retroviral Drugs Market Trends and Insights

Rising Global HIV Prevalence and Treatment Coverage Expansion

HIV programmes now target the 33% of people living with the virus who remain untreated, a cohort concentrated in emerging Europe, Central Asia and parts of Latin America. Growing middle-income country budgets, combined with tiered-pricing structures, push the anti-retroviral drugs market into regions where per-capita spending potential is higher than historical Sub-Saharan averages. As more adults age with HIV, comorbidity-tolerant regimens with fewer renal and bone risks gain traction, sustaining volume even where incidence is falling. Universal test-and-treat policies, championed by WHO, keep first-line demand resilient, while scaled viral-load monitoring identifies failure earlier and lifts second-line uptake. These dynamics collectively reinforce a broad base of recurring demand across all lines of therapy.

Enhanced Public and Donor Funding for Universal ART Access

The Global Fund's USD 9.2 billion 2024-2026 allocation underwrites multi-year procurement and strengthens supply chains in 70 countries, anchoring predictable demand for suppliers. PEPFAR's pivot toward country co-financing spurs national budget lines and invites direct manufacturer-government contracts that shorten cash-flow cycles. Advance purchase commitments and voluntary licences, such as Gilead's lenacapavir agreement covering 120 countries, encourage earlier generic ramp-up while protecting inventor margins through royalty structures. Collectively, blended finance mechanisms shield the anti-retroviral drugs market from donor fatigue in the medium term, although future macroeconomic stress in high-income donor nations remains a watch-list risk.

Persistent Drug Resistance and Viral Mutations

WHO surveillance shows dolutegravir resistance of 3.9-8.6% in treatment-naive patients and 19.6% in those previously exposed, pushing payers toward higher-cost salvage regimens. Resistance testing gaps in low-resource settings mask emerging multi-class failures and complicate guideline updates. The additional laboratory and second-line drug costs strain donor budgets and national insurance schemes, while patent-protected rescue therapies further elevate spend. For suppliers, rising resistance reshapes portfolio priorities toward agents with higher genetic barriers and multimodal modes of action, thereby raising R&D budgets and trial complexity.

Other drivers and restraints analyzed in the detailed report include:

1. Ongoing Research and Development of Novel Long-Acting Therapies
2. Growing Integration of ART With Primary Healthcare Delivery Platforms
3. Long-Term Safety Concerns and Adverse Effects

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Multi-class combination pills preserved 38.45% revenue in 2024 through simplified dosing and high resistance barriers that support first-line durability. Integrase inhibitor-anchored regimens posted a 6.53% CAGR, the strongest within this class, propelled by once-daily bictegravir- or dolutegravir-based backbones that maintain >=85% suppression in heavily pre-treated cohorts. Nucleoside reverse transcriptase inhibitors remain a mainstay despite historic bone and renal signals; reformulated tenofovir alafenamide mitigates these risks and extends franchise life. Protease inhibitors continue niche use for boosted salvage regimens but decline as metabolic concerns prompt clinician preference shifts. Novel entry inhibitors and broadly neutralising antibodies, including China's pending albuvirtide, add pipeline diversity but must demonstrate cost-effectiveness to gain guideline prominence.

Integrase-driven durability and once-daily simplicity help this class capture incremental share from NNRTIs, whose vulnerability to single-point mutations curtails uptake. The anti-retroviral drugs market size for integrase-based combinations is projected to surpass USD 18 billion by 2030, reflecting sustained clinical confidence and expanding label indications. Yet, manufacturers must prepare for generic erosion after 2031 as key patents lapse, pressuring them to introduce next-generation boosters or ultra-long-acting depot versions to protect value.

Single-tablet regimens dominated 2024 sales but face heightened competition from depot injections that eliminate daily adherence barriers. The anti-retroviral drugs market share of single-tablet regimens is supported by broad payer familiarity and streamlined distribution, yet their growth moderates to low-single digits as adherence-challenged cohorts pivot to injectables. Long-acting CAB-RPV posted initial uptake in high-income settings, and lenacapavir's six-month dosing interval sets a new convenience benchmark that could shift payer mix toward specialty pharmacy channels.

Implant technologies remain investigational but present disruptive potential, especially for prevention in high-burden youth populations. Manufacturing scale-up for injectables introduces supply-chain fragilities-cold-chain breaks, device shortages-that suppliers must mitigate through dual-site production and buffer inventory. The anti-retroviral drugs market size dedicated to long-acting modalities is expected to register USD 5.4 billion by 2030 at a 6.99% CAGR, with early commercial success hinging on provider training incentives and reimbursement codes for administration services.

The Anti-Retroviral Drugs Market Report is Segmented by Drug Class (Protease Inhibitors, and More), Regimen Type (STRs, Multi-Pill Oral, Long-Acting Injectables, Implants & Depot), Patient Age Group (Adults (>=15 Yrs), and More), Line of Therapy (First-Line, and More), Distribution Channel (Hospital, Retail, and More), and Geography (North America, and More). Market Forecasts are Provided in Terms of Value (USD).

Geography Analysis

North America commanded 42.43% of anti-retroviral drugs market revenue in 2024, benefiting from early access to breakthrough designations and insurance coverage that routinely reimburses USD 25,000-30,000 per patient-year. Lenacapavir's FDA approval underscores the region's innovative pull, yet looming patent cliffs for bictegravir (2036) and dolutegravir (2031) invite price erosion and generic challenges. Payer negotiations emphasise outcomes-based discounts, pushing innovators to supply real-world evidence of sustained suppression and improved adherence.

Europe follows with a robust albeit slower growth trajectory. Harmonised HTA frameworks foster simultaneous multi-country launches, while manufacturing investments such as Eli Lilly's USD 2.5 billion German injectable complex highlight the continent's role in global supply security. Cost-effectiveness thresholds drive aggressive tendering, particularly in Central and Eastern Europe, where lenacapavir may compete against lower-cost generics post-2028. EU pandemic-era joint procurement experience informs regional pooled purchasing that could reshape seller pricing power.

Asia-Pacific delivers the fastest regional CAGR at 7.12%, led by China and India, which together house 3.6 million people living with HIV. China's epidemiology now skews toward heterosexual transmission and older age groups, boosting demand for comorbidity-compatible regimens. Domestic champions scale up antibody and long-acting injectables, while the Belt and Road "health silk road" fosters exports across Africa. India leverages its dominant generic base; companies such as Laurus Labs expanded HIV API capacity 27% CAGR in FY23, supporting both local therapy scale-up and international donor tenders.

Sub-Saharan Africa remains volume-centric, absorbing more than half of global treatment courses, yet donor reliance flattens value growth. Enhanced primary-care integration and six-month multi-dispensing blunt per-patient revenue, but expanding coverage lifts absolute market size. South America and Eastern Europe experience resurgent incidence, offering niche growth but confronting diverse reimbursement and IP landscapes, as demonstrated by Colombia's compulsory dolutegravir licence that sliced procurement costs by 90%.

1. Gilead Sciences
2. ViiV Healthcare (GlaxoSmithKline plc, Pfizer, Shionogi)
3. Janssen Pharmaceuticals (Johnson & Johnson)
4. Merck
5. Abbvie
6. Bristol-Myers Squibb
7. Roche
8. Boehringer Ingelheim Intl. GmbH
9. Cipla
10. Viatris
11. Teva Pharmaceutical Industries
12. Aurobindo Pharma
13. Sun Pharmaceuticals Industries
14. Hetero Drugs Ltd
15. Lupin
16. Natco Pharma Ltd
17. Mylan Laboratories Ltd (Generics)
18. Shanghai Desano Pharmaceuticals
19. Vistin Pharma ASA
20. ViiV Healthcare-s Cabotegravir Partnership Network

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Global HIV Prevalence and Treatment Coverage Expansion
  • 4.2.2 Enhanced Public and Donor Funding for Universal ART Access
  • 4.2.3 Ongoing Research and Development of Novel Long-Acting Therapies
  • 4.2.4 Growing Integration of ART With Primary Healthcare Delivery Platforms
  • 4.2.5 Expansion of Digital Adherence Technologies and Remote Monitoring
  • 4.2.6 Accelerated Regulatory Pathways for Pediatric ART Formulations
• 4.3 Market Restraints
  • 4.3.1 Persistent Drug Resistance and Viral Mutations
  • 4.3.2 Long-Term Safety Concerns and Adverse Effects
  • 4.3.3 Supply Chain Vulnerabilities in Active Pharmaceutical Ingredient Sourcing
  • 4.3.4 Price Erosion from Generic Competition and Reference Pricing
• 4.4 Regulatory Landscape
• 4.5 Porter's Five Forces Analysis
  • 4.5.1 Threat of New Entrants
  • 4.5.2 Bargaining Power of Buyers
  • 4.5.3 Bargaining Power of Suppliers
  • 4.5.4 Threat of Substitutes
  • 4.5.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Drug Class
  • 5.1.1 Protease Inhibitors
  • 5.1.2 Integrase Inhibitors
  • 5.1.3 Multi-class Combination Products
  • 5.1.4 Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
  • 5.1.5 Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)
  • 5.1.6 Entry & Fusion Inhibitors
  • 5.1.7 Other Drug Class
• 5.2 By Regimen Type
  • 5.2.1 Single-Tablet Regimens (STRs)
  • 5.2.2 Multi-pill Oral Regimens
  • 5.2.3 Long-Acting Injectables
  • 5.2.4 Implants & Depot Formulations
• 5.3 By Line of Therapy
  • 5.3.1 First-Line
  • 5.3.2 Second-Line
  • 5.3.3 Salvage / Third-Line
• 5.4 By Patient Age Group
  • 5.4.1 Adults (>=15 yrs)
  • 5.4.2 Adolescents (10-14 yrs)
  • 5.4.3 Pediatrics (<10 yrs)
• 5.5 By Distribution Channel
  • 5.5.1 Hospital Pharmacies
  • 5.5.2 Retail Pharmacies
  • 5.5.3 Online Pharmacies
  • 5.5.4 NGO / Donor Supply Chains
• 5.6 Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 Australia
    • 5.6.3.5 South Korea
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East & Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East & Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Business Segments, Financials, Headcount, Key Information, Market Rank, Market Share, Products and Services, and analysis of Recent Developments)
  • 6.3.1 Gilead Sciences, Inc.
  • 6.3.2 ViiV Healthcare (GlaxoSmithKline plc, Pfizer, Shionogi)
  • 6.3.3 Janssen Pharmaceuticals (Johnson & Johnson)
  • 6.3.4 Merck & Co., Inc.
  • 6.3.5 AbbVie Inc.
  • 6.3.6 Bristol-Myers Squibb Company
  • 6.3.7 F. Hoffmann-La Roche Ltd
  • 6.3.8 Boehringer Ingelheim Intl. GmbH
  • 6.3.9 Cipla Ltd
  • 6.3.10 Viatris Inc.
  • 6.3.11 Teva Pharmaceutical Industries Ltd
  • 6.3.12 Aurobindo Pharma Ltd
  • 6.3.13 Sun Pharmaceutical Industries Ltd
  • 6.3.14 Hetero Drugs Ltd
  • 6.3.15 Lupin Ltd
  • 6.3.16 Natco Pharma Ltd
  • 6.3.17 Mylan Laboratories Ltd (Generics)
  • 6.3.18 Shanghai Desano Pharmaceuticals
  • 6.3.19 Vistin Pharma ASA
  • 6.3.20 ViiV Healthcare-s Cabotegravir Partnership Network

7 Market Opportunities & Future Outlook

• 7.1 White-Space & Unmet-Need Assessment