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시장보고서
상품코드
2088992
인간 면역 결핍 바이러스(HIV) 치료제 시장 : 약제 클래스별, 치료 라인, 투여 경로, 환자 유형, 바이러스 형, 최종 사용자, 유통 채널별 예측(2026-2032년)Human Immunodeficiency Virus Therapeutics Market by Drug Class, Therapy Line, Route of Administration, Patient Type, Virus Type, End User, Distribution Channel - Global Forecast 2026-2032 |
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360iResearch
인간 면역 결핍 바이러스(HIV) 치료제 시장은 2032년까지 연평균 복합 성장률(CAGR) 4.71%로 293억 2,000만 달러 규모로 확대될 것으로 예측됩니다.
| 주요 시장 통계 | |
|---|---|
| 기준 연도 : 2025년 | 212억 3,000만 달러 |
| 추정 연도 : 2026년 | 222억 3,000만 달러 |
| 예측 연도 : 2032년 | 293억 2,000만 달러 |
| CAGR(%) | 4.71% |
인간 면역 결핍 바이러스(HIV) 치료제 시장은 평생 지속되는 항레트로바이러스 요법, 간소화된 치료 요법에 대한 수요 증가, 그리고 전 세계적인 치료 목표에 의해 형성되는 계속해서 우선순위가 높은 의약품 분야입니다. UNAIDS 보고서에 따르면, 2023년 기준 3,990만 명이 HIV에 감염되어 있으며, 이 중 3,070만 명이 항레트로바이러스 치료를 받고 있어, 효과적인 HIV 치료제, 복약 순응도 지원 및 약물 내성 관리에 대한 대규모의 지속적인 수요가 확인되고 있습니다.
현재 치료 현황은 인테그라제 사슬 전이 억제제(IST)를 기반으로 한 요법, 2제 병용 유지 요법, 지속형 주사제를 이용한 HIV 치료, 그리고 다제내성 환자를 위한 구제 요법에 의해 뒷받침되고 있습니다. 업계의 발전은 지속적인 바이러스 억제, 약물 상호작용 감소, 내약성 향상, 차별화된 지적 재산권, 그리고 감염 부담이 높은 지역이나 신생 의료 시스템에서의 접근성 확대와 점점 더 밀접하게 연결되어 있습니다.
HIV 치료의 전망에 있어 획기적인 변화
HIV 치료의 현황은 매일 약을 복용해야 하는 부담에서 벗어나, 환자 중심의 장시간 작용형 치료제로, 약물 내성을 고려한 치료 방식으로 점차 전환되고 있습니다. FDA 및 EMA가 승인한 장시간 작용형 카보테그라비르와 릴피비린 병용 요법은 바이러스학적 억제가 확인된 성인을 대상으로 한 주사제 형태의 유지 요법으로서 그 유효성이 입증되었습니다. 한편, 레나카파비르는 1년에 2회 캡시드 억제제를 투여하는 방식을 통해 다제내성 HIV에 대한 치료 옵션을 확대했습니다.
HIV 치료에서 인공지능이 미치는 누적 영향
인공지능(AI)은 단순한 개별 개입 수단이 아니라, HIV 치료 전반에 걸쳐 점진적인 영향력을 행사하고 있습니다. AI를 활용한 분자 모델링, 바이러스 염기서열 분석 및 임상시험 설계 도구는 표적 식별, 내성 예측 및 병용 요법의 신속한 평가를 지원할 수 있으며, 특히 변이 패턴으로 인해 표준 항레트로바이러스 요법에 대한 반응이 저하된 경우에 그 효과가 두드러집니다.
HIV 치료에 관한 주요 지역별 인사이트
아시아태평양에서는 치료 수요가 큰 반면 의료 접근성에는 편차가 나타나며, 중국, 인도, 일본, 호주, 한국은 각각 서로 다른 보험 급여 제도, 제조 체계, 혁신의 특성을 보이고 있습니다. 인도는 전 세계 제네릭 항레트로바이러스제 공급 및 접근 프로그램에서 여전히 중심적인 역할을 수행하고 있는 반면, 일본, 호주, 한국은 양질의 전문 의료 서비스, 신속한 진단, 그리고 새로운 HIV 치료 요법에 대한 접근성을 중시하고 있습니다. 중국은 공중보건 이니셔티브와 임상 연구 활동의 확대를 바탕으로 치료 적용 범위를 넓히고 국내 제약 혁신을 추진하고 있습니다.
아세안(ASEAN), GCC, EU, 브릭스(BRICS), G7, 나토(NATO) 내 주요 그룹의 동향
아세안 시장에서는 각국 정부가 검사, 치료 개시, 지역 밀착형 서비스 모델을 확대하고 있어 HIV 치료제의 중요성이 점점 더 커지고 있지만, 접근성은 소득 수준, 낙인 완화, 의료 인프라에 따라 차이가 있습니다. GCC 지역은 보고된 환자 수가 비교적 적고, 전문 의료 체계가 잘 갖춰져 있으며, 공공 자금, 일원화된 조달, 병원 주도의 치료 경로에 힘입어 혁신적인 HIV 치료법에 대한 수요가 높은 특징이 있습니다.
HIV 치료제 우선 시장에서의 주요 국가별 분석
미국은 확립된 전문 약국 유통망과 연방 정부의 HIV 대책 이니셔티브에 힘입어, 브랜드 HIV 치료제, 임상시험, 지침 채택, 그리고 지속형 요법의 급속한 보급에 있어 주도적인 입지를 차지하고 있습니다. 캐나다에서는 국민건강보험 제도와 주·준주별 처방약 목록 결정이 결합되어 체계화되어 있지만, 지역에 따라 접근성에 차이가 있습니다. 멕시코와 브라질은 공공 부문의 치료 프로그램이 주된 원동력이 되고 있으며, 브라질은 국민건강보험제도를 통해 수년에 걸쳐 항레트로바이러스제를 무상으로 제공해 온 점과, HIV 치료를 지원하기 위한 공공 조달을 지속적으로 실시하고 있는 점에서 높이 평가받고 있습니다.
HIV 치료제 업계의 리더을 위한 실질적인 제안
업계 리더는 복약 순응도 향상, 내성 위험 감소, 그리고 치료 경험이 있는 환자 집단에서 충족되지 않은 의료적 요구를 해결할 수 있는 차별화된 치료 요법을 우선시해야 합니다. 투자는 장시간 작용형 제제, 새로운 작용기전, 소아 및 사춘기 환자에게 적합한 제제, 그리고 내성 발생의 문턱을 높게 유지하면서도 복약 부담을 줄여주는 병용 요법에 중점을 두어야 합니다.
증거 기반 HIV 치료제 분석을 위한 조사 기법
본 요약본은 UNAIDS, WHO, CDC, FDA, EMA, 각국의 HIV 치료 지침, 동료 심사를 거친 임상 문헌, 그리고 공공 조달 및 보험 급여 정보 등 공중보건 및 규제 당국의 권위 있는 정보원을 바탕으로 한 2차 조사에 근거하고 있습니다. 시장 분석에 있어서는 검증된 역학 데이터, 승인된 치료제군, 지침에 근거한 치료 경로, 입증된 접근 동향, 그리고 확인 가능한 규제 관련 이정표를 중시하고 있습니다.
결론: HIV 치료제의 미래
인간 면역 결핍 바이러스(HIV) 치료제는 공중보건 측면에서 매우 중요하며, 여전히 회복력이 있고 혁신이 주도하는 분야입니다. 수요의 주요 원동력은 분명합니다. 수백만 명의 사람들이 평생에 걸친 치료가 필요하며, 지속적인 바이러스 억제는 강력하고 내약성이 높으며 사용이 편리하고 가격도 합리적인 항레트로바이러스제에 대한 접근 여부에 달려 있습니다.
자주 묻는 질문
목차
제1장 서문
제2장 조사 방법
제3장 주요 요약
제4장 시장 개요
제5장 시장 인사이트
제6장 AI의 누적 영향, 2026년
제7장 인간 면역 결핍 바이러스(HIV) 치료제 시장 : 약제 클래스별
제8장 인간 면역 결핍 바이러스(HIV) 치료제 시장 : 치료 라인별
제9장 인간 면역 결핍 바이러스(HIV) 치료제 시장 : 투여 경로별
제10장 인간 면역 결핍 바이러스(HIV) 치료제 시장 : 환자 유형별
제11장 인간 면역 결핍 바이러스(HIV) 치료제 시장 : 바이러스 유형별
제12장 인간 면역 결핍 바이러스(HIV) 치료제 시장 : 최종 사용자별
제13장 인간 면역 결핍 바이러스(HIV) 치료제 시장 : 유통 채널별
제14장 인간 면역 결핍 바이러스(HIV) 치료제 시장 : 지역별
제15장 인간 면역 결핍 바이러스(HIV) 치료제 시장 : 그룹별
제16장 인간 면역 결핍 바이러스(HIV) 치료제 시장 : 국가별
제17장 경쟁 구도
제18장 기업 개요
JHS 26.07.22The Human Immunodeficiency Virus Therapeutics Market is projected to grow by USD 29.32 billion at a CAGR of 4.71% by 2032.
| KEY MARKET STATISTICS | |
|---|---|
| Base Year [2025] | USD 21.23 billion |
| Estimated Year [2026] | USD 22.23 billion |
| Forecast Year [2032] | USD 29.32 billion |
| CAGR (%) | 4.71% |
Human immunodeficiency virus therapeutics remains a high-priority pharmaceutical segment shaped by lifelong antiretroviral therapy, rising demand for simplified regimens, and global treatment targets. UNAIDS reported 39.9 million people living with HIV in 2023, with 30.7 million receiving antiretroviral therapy, confirming a large and durable need for effective HIV drugs, adherence support, and resistance management.
The therapeutic landscape is anchored by integrase strand transfer inhibitor-based regimens, two-drug maintenance therapy, long-acting injectable HIV treatment, and salvage therapies for heavily treatment-experienced patients. Industry progress is increasingly linked to durable viral suppression, fewer drug interactions, improved tolerability, differentiated intellectual property, and broader access across high-burden and emerging healthcare systems.
Transformative Shifts in the HIV Therapeutics Landscape
The HIV therapeutics landscape is shifting from daily pill burden toward patient-centered, long-acting, and resistance-aware care. FDA- and EMA-approved long-acting cabotegravir plus rilpivirine has validated injectable maintenance therapy for virologically suppressed adults, while lenacapavir has expanded options for multidrug-resistant HIV through a twice-yearly capsid inhibitor approach.
Policy and procurement dynamics are also changing. WHO guidance favoring dolutegravir-based first-line regimens, growing adoption of differentiated service delivery, and expanding generic manufacturing have increased treatment coverage in low- and middle-income countries. At the same time, payer scrutiny in mature markets is pushing manufacturers to demonstrate adherence benefits, real-world durability, safety, and value versus lower-cost oral generics.
Cumulative Impact of Artificial Intelligence on HIV Therapeutics
Artificial intelligence is becoming a cumulative force across HIV therapeutics, not a standalone intervention. AI-enabled molecular modeling, viral sequence analysis, and trial design tools can support target identification, resistance prediction, and faster evaluation of combination therapies, especially where mutation patterns reduce response to standard antiretroviral therapy.
Commercial and clinical operations are also benefiting from AI. Predictive analytics can identify adherence risk, care gaps, and potential loss to follow-up, which is critical because sustained viral suppression prevents disease progression and transmission. However, AI adoption must be governed by validated datasets, privacy safeguards, bias monitoring, and clinical oversight to ensure tools improve outcomes rather than widen inequities.
Key Regional Insights for HIV Therapeutics
Asia-Pacific combines large treatment demand with uneven access, with China, India, Japan, Australia, and South Korea representing distinct reimbursement, manufacturing, and innovation profiles. India remains central to global generic antiretroviral supply and access programs, while Japan, Australia, and South Korea emphasize high-quality specialty care, rapid diagnosis, and access to novel HIV regimens. China is expanding treatment coverage and domestic pharmaceutical innovation, supported by public health initiatives and increasing clinical research activity.
North America remains a premium innovation region led by the United States and Canada, where rapid regulatory pathways, specialty pharmacy infrastructure, clinical trial density, and uptake of branded long-acting therapies support high-value therapeutic adoption. Europe benefits from centralized and national health technology assessment processes, broad treatment coverage, and strong clinical guideline alignment, though pricing discipline and comparative effectiveness reviews shape launch sequencing and reimbursement access.
Latin America, the Middle East, and Africa show rising demand tied to public-sector procurement, donor-supported programs, and national HIV strategies. Brazil has a mature public HIV treatment program and established domestic policy commitment to antiretroviral access, while GCC countries are expanding specialty care through public funding and centralized purchasing. Africa remains the global epidemiological center of HIV, with UNAIDS reporting that eastern and southern Africa carry the highest burden, making affordability, supply security, differentiated service delivery, and regimen simplification essential to treatment continuity.
Key Group Insights Across ASEAN, GCC, EU, BRICS, G7, and NATO
ASEAN markets are increasingly important for HIV therapeutics as governments expand testing, treatment initiation, and community-based service models, though access varies by income level, stigma reduction, and health infrastructure. The GCC is characterized by smaller reported patient populations, higher specialty-care capacity, and demand for innovative HIV therapies supported by public funding, centralized purchasing, and hospital-led treatment pathways.
The European Union and G7 remain influential because they shape HIV clinical standards, pricing benchmarks, pharmacovigilance expectations, health technology assessment requirements, and intellectual property strategies. NATO membership does not directly determine HIV demand, but overlapping high-income health systems often prioritize medicine security, supply-chain resilience, emergency preparedness, and continuity of care for chronic infectious diseases.
BRICS countries represent a strategic mix of scale, manufacturing capability, and epidemiological need. Brazil, India, China, Russia, and South Africa influence generic availability, public procurement, local production, clinical access negotiations, and national HIV program design, making the group central to long-term HIV treatment affordability, supply diversification, and patient access in both domestic and export-oriented markets.
Key Country Insights for Priority HIV Therapeutics Markets
The United States leads in branded HIV therapeutics, clinical trials, guideline adoption, and rapid uptake of long-acting regimens, supported by established specialty pharmacy channels and federal HIV initiatives. Canada combines universal health coverage with provincial and territorial formulary decision-making, creating structured but regionally varied access. Mexico and Brazil are driven by public-sector treatment programs, with Brazil recognized for longstanding free antiretroviral access through its national health system and continued use of public procurement to support HIV care.
The United Kingdom, Germany, France, Italy, and Spain have mature treatment networks, high viral suppression goals, routine guideline-based care, and rigorous reimbursement evaluation. Germany and France are key early-access and clinical adoption markets, while the United Kingdom emphasizes national guideline alignment and centralized health technology assessment. Italy and Spain maintain strong specialist HIV care networks. Russia faces substantial treatment need and distinct procurement dynamics, while China is expanding domestic innovation and treatment coverage. India remains pivotal as a global supplier of generic antiretroviral medicines and a major contributor to affordable HIV treatment access.
Japan, Australia, and South Korea represent advanced Asia-Pacific HIV therapeutics markets with strong clinical infrastructure, aging treated populations, and demand for therapies with favorable safety, interaction, renal, bone, metabolic, and adherence profiles. Australia also benefits from robust public health systems and prevention-oriented HIV policy, while South Korea and Japan continue to prioritize high-quality specialty care and access to clinically differentiated regimens.
Actionable Recommendations for HIV Therapeutics Leaders
Industry leaders should prioritize differentiated regimens that improve adherence, reduce resistance risk, and address unmet needs in treatment-experienced populations. Investment should focus on long-acting delivery, novel mechanisms, pediatric and adolescent-friendly formulations, and combinations that lower pill burden while preserving high barriers to resistance.
Commercial strategy must align innovation with access. Manufacturers should support voluntary licensing, regional manufacturing partnerships, pharmacovigilance capacity, and real-world evidence programs that demonstrate viral suppression, persistence, safety, and quality-of-life benefits. Payers and providers should integrate adherence analytics, community-based delivery, stigma-reduction initiatives, and resistance surveillance to maximize treatment impact.
Research Methodology for Evidence-Based HIV Therapeutics Analysis
This executive summary is grounded in secondary research from authoritative public health and regulatory sources, including UNAIDS, WHO, CDC, FDA, EMA, national HIV treatment guidelines, peer-reviewed clinical literature, and public procurement and reimbursement information. Market interpretation emphasizes validated epidemiology, approved therapeutic classes, guideline-supported care pathways, documented access trends, and observable regulatory milestones.
The analysis applies triangulation across disease burden, treatment coverage, regulatory approvals, clinical adoption, payer behavior, health-system capacity, and regional access mechanisms. No unsupported market-size, market-share, or forecasting claims are used; conclusions are based on verified evidence, approved products, published guidance, and consistent signals from public health programs and pharmaceutical activity.
Conclusion: The Future of HIV Therapeutics
Human immunodeficiency virus therapeutics remains a resilient, innovation-led field with significant public health importance. The core demand driver is clear: millions of people require lifelong therapy, and sustained viral suppression depends on access to potent, tolerable, convenient, and affordable antiretroviral options.
Future competitiveness will be defined by long-acting HIV treatment, resistance solutions, equitable access, AI-supported care optimization, and credible real-world outcomes. Organizations that combine scientific differentiation with affordability, supply reliability, and delivery innovation will be best positioned to support global HIV control objectives and create durable therapeutic value.
Table of Contents
1. Preface
- 1.1. Objectives of the Study
- 1.2. Market Definition
- 1.3. Market Segmentation & Coverage
- 1.4. Years Considered for the Study
- 1.5. Currency Considered for the Study
- 1.6. Language Considered for the Study
- 1.7. Key Stakeholders
2. Research Methodology
- 2.1. Introduction
- 2.2. Research Design
- 2.2.1. Primary Research
- 2.2.2. Secondary Research
- 2.3. Research Framework
- 2.3.1. Qualitative Analysis
- 2.3.2. Quantitative Analysis
- 2.4. Market Size Estimation
- 2.4.1. Top-Down Approach
- 2.4.2. Bottom-Up Approach
- 2.5. Data Triangulation
- 2.6. Research Outcomes
- 2.7. Research Assumptions
- 2.8. Research Limitations
3. Executive Summary
- 3.1. Introduction
- 3.2. CXO Perspective
- 3.3. Market Size & Growth Trends
- 3.4. Market Share Analysis, 2025
- 3.5. FPNV Positioning Matrix, 2025
- 3.6. New Revenue Opportunities
- 3.7. Next-Generation Business Models
- 3.8. Industry Roadmap
4. Market Overview
- 4.1. Introduction
- 4.2. Industry Ecosystem & Value Chain Analysis
- 4.2.1. Supply-Side Analysis
- 4.2.2. Demand-Side Analysis
- 4.2.3. Stakeholder Analysis
- 4.3. Market Dynamics
- 4.3.1. Key Drivers
- 4.3.2. Key Restraints
- 4.3.3. Key Opportunities
- 4.3.4. Key Challenges
- 4.4. Porter's Five Forces Analysis
- 4.5. PESTLE Analysis
- 4.6. Market Outlook
- 4.6.1. Near-Term Market Outlook (0-2 Years)
- 4.6.2. Medium-Term Market Outlook (3-5 Years)
- 4.6.3. Long-Term Market Outlook (5-10 Years)
- 4.7. Go-to-Market Strategy
5. Market Insights
- 5.1. Consumer Insights & End-User Perspective
- 5.2. Consumer Experience Benchmarking
- 5.3. Opportunity Mapping
- 5.4. Distribution Channel Analysis
- 5.5. Pricing Trend Analysis
- 5.6. Regulatory Compliance & Standards Framework
- 5.7. ESG & Sustainability Analysis
- 5.8. Disruption & Risk Scenarios
- 5.9. Return on Investment & Cost-Benefit Analysis
6. Cumulative Impact of Artificial Intelligence 2026
7. Human Immunodeficiency Virus Therapeutics Market, by Drug Class
- 7.1. Entry Inhibitors
- 7.1.1. Enfuvirtide
- 7.1.2. Maraviroc
- 7.2. Integrase Strand Transfer Inhibitors
- 7.2.1. Bictegravir
- 7.2.2. Dolutegravir
- 7.2.3. Elvitegravir
- 7.2.4. Raltegravir
- 7.3. Non-Nucleoside Reverse Transcriptase Inhibitors
- 7.3.1. Efavirenz
- 7.3.2. Etravirine
- 7.3.3. Nevirapine
- 7.3.4. Rilpivirine
- 7.4. Nucleoside Reverse Transcriptase Inhibitors
- 7.4.1. Abacavir
- 7.4.2. Emtricitabine
- 7.4.3. Lamivudine
- 7.4.4. Tenofovir
- 7.4.5. Zidovudine
- 7.5. Protease Inhibitors
- 7.5.1. Atazanavir
- 7.5.2. Darunavir
- 7.5.3. Fosamprenavir
- 7.5.4. Lopinavir
8. Human Immunodeficiency Virus Therapeutics Market, by Therapy Line
- 8.1. Combination Therapy
- 8.1.1. Single Tablet Regimen
- 8.1.2. Multi Tablet Regimen
- 8.2. Monotherapy
- 8.3. Highly Active Antiretroviral Therapy
- 8.3.1. First-Line Therapy
- 8.3.2. Second-Line Therapy
- 8.4. Pre-Exposure Prophylaxis
- 8.5. Post-Exposure Prophylaxis
9. Human Immunodeficiency Virus Therapeutics Market, by Route of Administration
- 9.1. Injectable
- 9.1.1. Intramuscular
- 9.1.2. Subcutaneous
- 9.1.3. Intravenous
- 9.2. Oral
- 9.2.1. Tablets
- 9.2.2. Capsules
- 9.2.3. Solutions
- 9.3. Topical
10. Human Immunodeficiency Virus Therapeutics Market, by Patient Type
- 10.1. Adult
- 10.2. Pediatric
- 10.3. Geriatric
11. Human Immunodeficiency Virus Therapeutics Market, by Virus Type
- 11.1. HIV-1
- 11.2. HIV-2
12. Human Immunodeficiency Virus Therapeutics Market, by End User
- 12.1. Hospitals
- 12.2. Homecare Settings
- 12.3. Specialty HIV Clinics
- 12.4. Research Institutes
13. Human Immunodeficiency Virus Therapeutics Market, by Distribution Channel
- 13.1. Hospital Pharmacy
- 13.2. Online Pharmacy
- 13.3. Retail Pharmacy
14. Human Immunodeficiency Virus Therapeutics Market, by Region
- 14.1. Asia-Pacific
- 14.2. North America
- 14.3. Latin America
- 14.4. Europe
- 14.5. Middle East
- 14.6. Africa
15. Human Immunodeficiency Virus Therapeutics Market, by Group
- 15.1. ASEAN
- 15.2. GCC
- 15.3. European Union
- 15.4. BRICS
- 15.5. G7
- 15.6. NATO
16. Human Immunodeficiency Virus Therapeutics Market, by Country
- 16.1. United States
- 16.2. Canada
- 16.3. Mexico
- 16.4. Brazil
- 16.5. United Kingdom
- 16.6. Germany
- 16.7. France
- 16.8. Russia
- 16.9. Italy
- 16.10. Spain
- 16.11. China
- 16.12. India
- 16.13. Japan
- 16.14. Australia
- 16.15. South Korea
17. Competitive Landscape
- 17.1. Market Concentration Analysis, 2025
- 17.1.1. Concentration Ratio (CR)
- 17.1.2. Herfindahl Hirschman Index (HHI)
- 17.2. Recent Developments & Impact Analysis, 2025
- 17.3. Product Portfolio Analysis, 2025
- 17.4. Benchmarking Analysis, 2025
18. Company Profiles
- 18.1. AbbVie Inc
- 18.2. Aspen Pharmacare Holdings Limited
- 18.3. Aurobindo Pharma Limited
- 18.4. Boehringer Ingelheim International GmbH
- 18.5. Bristol-Myers Squibb Company
- 18.6. Cipla Limited
- 18.7. CytoDyn Inc
- 18.8. Dr Reddy's Laboratories Limited
- 18.9. Emcure Pharmaceuticals Limited
- 18.10. F Hoffmann-La Roche AG
- 18.11. Gilead Sciences Inc
- 18.12. GlaxoSmithKline plc
- 18.13. Glenmark Pharmaceuticals Limited
- 18.14. Hetero Labs Limited
- 18.15. Johnson & Johnson Services Inc
- 18.16. Lupin Limited
- 18.17. Macleods Pharmaceuticals Limited
- 18.18. Merck & Co Inc
- 18.19. Pfizer Inc
- 18.20. Strides Pharma Science Limited
- 18.21. Sun Pharmaceutical Industries Limited
- 18.22. TaiMed Biologics Inc
- 18.23. Teva Pharmaceutical Industries Ltd
- 18.24. Theratechnologies Inc
- 18.25. Viatris Inc
- 18.26. ViiV Healthcare Limited
- 18.27. Zydus Lifesciences Limited
