직접 작용형 항바이러스제 시장 : 약제 클래스별, 투여 경로별, 치료 요법별, 유통 채널별, 최종 사용자별 예측(2026-2032년)

The Direct Acting Antivirals Market was valued at USD 48.91 billion in 2025 and is projected to grow to USD 52.37 billion in 2026, with a CAGR of 8.13%, reaching USD 84.56 billion by 2032.

A strategic introduction to the direct acting antivirals ecosystem highlighting therapeutic breakthroughs, access dynamics, regulatory milestones and stakeholder priorities

Direct acting antivirals (DAAs) have redefined the clinical approach to chronic hepatitis C and established a paradigm for targeted, infection-curing therapeutics. Over the past decade clinical outcomes have transitioned from incremental viral suppression to high sustained virologic response rates, enabling short-course, well-tolerated regimens that minimize long-term disease burden. Alongside clinical efficacy, regulatory agencies have evolved approval pathways for combination regimens, fostering both originator and generic entries while increasing treatment accessibility in diverse health systems.

From a strategic perspective, stakeholders now operate at the intersection of clinical optimization and systems-level delivery. Payers and providers are refining formulary placement and access criteria to balance clinical benefit with budgetary constraints. Manufacturers focus on formulation innovation, real-world evidence generation, and lifecycle management to sustain differentiated value. These converging forces frame the current DAA ecosystem and set the priorities for innovation, commercialization, and policy engagement going forward.

How therapeutic innovation, delivery decentralization, digital enablement and supply chain realignment are reshaping the DAA landscape and stakeholder strategies

The DAA landscape is experiencing transformative shifts driven by therapeutic innovation, supply chain reconfiguration, and evolving care delivery models. Clinically, the emergence of pan-genotypic regimens and fixed-dose combinations has simplified treatment algorithms and reduced the need for extensive genotype testing. Shorter treatment durations and improved tolerability have widened the candidate pool for therapy, enabling decentralization of care into primary and community settings. At the same time, real-world evidence and post-approval safety data have informed iterative regimen adjustments and strengthened payer confidence in curative outcomes.

Commercially, manufacturers are responding with differentiated product strategies that emphasize adherence-friendly dosing and simplified logistics. The rise of online and specialty distribution channels complements traditional hospital and retail pharmacies, offering convenience and continuity for patients. Concurrently, digital health tools and telemedicine have accelerated remote monitoring and adherence support, enabling clinicians to manage therapy outside tertiary centers. These shifts collectively reposition DAAs from specialized hospital treatments to accessible, community-delivered cures that require integrated commercial and clinical strategies.

Assessment of how the 2025 United States tariff actions have shifted procurement, manufacturing footprints and commercial contracting dynamics across the DAA supply chain

The cumulative impact of the United States tariffs introduced in 2025 has reverberated across procurement practices, supplier sourcing, and manufacturing footprints for antiviral therapies. Increased tariffs on certain pharmaceutical inputs elevated the near-term cost base for active pharmaceutical ingredients and complex excipients, prompting procurement teams to reassess supplier contracts and logistics routes. In response, many manufacturers accelerated diversification of API and finished-dose manufacturing across multiple jurisdictions to mitigate tariff exposure and shipping bottlenecks, thereby increasing emphasis on regionalization of supply chains and dual-sourcing strategies.

Beyond direct cost implications, tariff-driven adjustments altered negotiation dynamics with distributors and payers. Contracting teams sought greater clarity on landed cost and total cost of therapy, while policymakers and regulators engaged with industry to preserve therapeutic access. For product teams and commercial leaders, the tariffs underscored the importance of supply chain transparency, localized manufacturing investments, and scenario planning to avoid disruption to patient access. Ultimately, the policy environment catalyzed a shift from single-source efficiency to resilient supply architectures that prioritize continuity of supply and price stability.

Segment-driven insights revealing clinical, commercial and operational implications across drug classes, channels, administration routes and regimen architectures

Segmentation analysis reveals nuanced clinical and commercial opportunities across drug class, distribution channel, end user, route of administration, and treatment regimen. Based on drug class, the market divides into Ns3/4A Protease Inhibitors, Ns5A Inhibitors, and Ns5B Polymerase Inhibitors, with the Ns3/4A Protease Inhibitors further distinguished by agents such as Glecaprevir and Voxilaprevir, the Ns5A Inhibitors explored through combinations like Ledipasvir Sofosbuvir and Velpatasvir Sofosbuvir, and the Ns5B Polymerase Inhibitors represented by Dasabuvir and Sofosbuvir. Each class carries distinct resistance profiles, drug-drug interaction considerations, and formulary positioning, which informs regimen selection and clinical pathway design.

Based on distribution channel, comparisons among hospital pharmacy, online pharmacy, and retail pharmacy reveal divergent fulfillment models and patient touchpoints that affect adherence support and post-prescription services. Based on end user, hospitals, retail pharmacies, and specialty clinics each present different engagement models for prescribers and patients, with hospitals often handling complex cases and specialty clinics enabling focused treatment pathways. Based on route of administration, fixed dose combinations and single agent tablets-and their once-daily versus twice-daily dosing variants-shape adherence dynamics and patient preference. Finally, based on treatment regimen, combination therapy and monotherapy split into dual and triple therapy permutations, with dual therapy combinations such as Ns3/4A plus Ns5A or Ns5A plus Ns5B and triple therapy across Ns3/4A, Ns5A and Ns5B offering options for treatment-experienced or resistant populations. These segmentation lenses together guide portfolio prioritization, clinical positioning, and channel strategy for maximizing patient reach and therapeutic impact.

Regional clinical, regulatory and commercial dynamics that determine access strategies, manufacturing decisions and payer engagement across key global territories

Regional dynamics shape access, manufacturing strategy, and payer engagement across distinct geographies. In the Americas, a combination of advanced payer frameworks and concentrated manufacturing capacity drives rapid uptake of simplified regimens, while disparities in access across subnational systems demand targeted pricing and access programs. In Europe, Middle East & Africa, regulatory heterogeneity and variable procurement mechanisms create both barriers and opportunities: centralized purchasing in some jurisdictions contrasts with fragmented markets in others, necessitating tailored market access strategies and public-private collaborations. In Asia-Pacific, high prevalence pockets coexist with a strong generics manufacturing base and progressive public health programs, which together create a complex environment of competitive pricing, volume-driven tendering, and innovation adoption.

These regional contours influence strategic decisions around manufacturing localization, licensing and partnership models, and patient support infrastructure. Regulatory pathways and reimbursement criteria differ by region, so lifecycle planning must account for varied registration timelines and health technology assessment requirements. Furthermore, regional digital health adoption and telemedicine penetration affect how providers engage patients, while localized patient assistance programs and community outreach remain essential to expand treatment uptake in underserved populations.

How originator strategies, generic competition and strategic partnerships are reshaping portfolio priorities, manufacturing alliances and commercial stewardship

Company-level behavior in the DAA landscape reflects a mix of originator stewardship, generic competition, and strategic alliances. Originator firms have prioritized intellectual property management, lifecycle extensions through formulation enhancements, and comprehensive evidence generation to preserve premium positioning. Concurrently, generic manufacturers and authorized generic programs have expanded access in price-sensitive settings, leveraging local manufacturing and streamlined regulatory pathways to deliver affordable alternatives. Strategic alliances, licensing agreements, and co-marketing arrangements have become common mechanisms to reconcile global regulatory requirements with local commercialization capabilities.

Commercial leaders must balance investment in brand-differentiating activities-such as adherence support, physician education, and real-world outcome tracking-with pragmatic pricing and access initiatives in markets where generics predominate. Manufacturing partnerships and contract development and manufacturing organizations play a pivotal role in scaling supply while maintaining quality standards. Portfolio managers should monitor competitor lifecycle activities, regulatory exclusivity timelines, and partnership opportunities to optimize launch sequencing and post-launch support for combination regimens and new formulations.

Practical strategic moves to enhance supply chain resilience, accelerate patient-centric formulations and align commercial models with payer and health system priorities

Industry leaders can take specific, actionable steps to protect patient access while preserving commercial viability. First, strengthen supply chain resilience by diversifying API and finished-dose manufacturing across multiple regions and by qualifying secondary suppliers to minimize disruption. Second, prioritize fixed-dose combination development and adherence-enhancing formulations that reduce clinical complexity and support decentralized care models. Third, engage proactively with payers and health systems to demonstrate long-term value through real-world evidence, health economic modeling, and outcome-based contracting that align clinical benefit with budgetary priorities.

Additionally, invest in digital adherence solutions and telehealth-enabled care pathways to support decentralized treatment and improve cure rates. Forge targeted partnerships with local manufacturers and procurement agencies to address pricing sensitivities in lower-resource settings while protecting intellectual property through structured licensing or voluntary agreements. Finally, embed scenario planning and policy monitoring into commercial planning to respond rapidly to trade policy changes, tariff shifts, or regulatory reforms that could affect access and pricing dynamics.

A transparent, multi-method research approach combining clinical literature, regulatory review, expert interviews and supply chain mapping to underpin actionable insights

This research synthesized diverse sources and applied a multi-method approach to ensure rigorous, actionable insights. The methodology combined systematic review of clinical literature, analysis of regulatory approvals and label changes, review of product formularies and distribution channel structures, and mapping of manufacturing footprints and supply chain flows. In addition, structured interviews with clinical experts, supply chain managers, and commercial leaders supplemented secondary data to contextualize real-world adoption patterns, access barriers, and payer incentives.

Data validation included cross-referencing regulatory documents, clinical trial registries, and published safety and effectiveness studies, as well as triangulation against industry press releases and procurement announcements. Where uncertainty existed, sensitivity analyses and scenario planning informed interpretive conclusions. Limitations of the approach include reliance on publicly available documentation for certain operational details and the lag inherent in published data compared with rapid policy or contract changes, which the methodology mitigated through targeted expert consultations and continuous update checks.

Concise synthesis of DAA opportunities and strategic imperatives emphasizing access, manufacturing resilience and evidence-driven commercialization

In summary, direct acting antivirals represent a maturing therapeutic area where clinical efficacy, simplified regimens, and improved tolerability converge to enable population-level disease control. The confluence of pan-genotypic therapies, fixed-dose combinations, and expanding distribution channels supports broader treatment access, yet commercial success requires careful alignment of manufacturing strategy, payer engagement, and differentiated product features. Trade policy changes and regional access dynamics further complicate the strategic environment, making agility and evidence-driven decision-making imperative.

For stakeholders across industry, healthcare delivery, and policy, the priority is to translate clinical opportunity into sustainable access. That requires coordinated efforts to shore up supply chains, invest in formulations and adherence supports that fit decentralized care, and forge commercial agreements that reflect long-term clinical and economic value. When executed coherently, these steps will ensure the full therapeutic promise of DAAs is realized across diverse health systems.

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. Porter's Five Forces Analysis
• 4.4. PESTLE Analysis
• 4.5. Market Outlook
  • 4.5.1. Near-Term Market Outlook (0-2 Years)
  • 4.5.2. Medium-Term Market Outlook (3-5 Years)
  • 4.5.3. Long-Term Market Outlook (5-10 Years)
• 4.6. 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 United States Tariffs 2025

7. Cumulative Impact of Artificial Intelligence 2025

8. Direct Acting Antivirals Market, by Drug Class

• 8.1. Ns3/4A Protease Inhibitors
  • 8.1.1. Glecaprevir
  • 8.1.2. Voxilaprevir
• 8.2. Ns5A Inhibitors
  • 8.2.1. Ledipasvir Sofosbuvir
  • 8.2.2. Velpatasvir Sofosbuvir
• 8.3. Ns5B Polymerase Inhibitors
  • 8.3.1. Dasabuvir
  • 8.3.2. Sofosbuvir

9. Direct Acting Antivirals Market, by Route Of Administration

• 9.1. Fixed Dose Combinations
  • 9.1.1. Once Daily Dosing
  • 9.1.2. Twice Daily Dosing
• 9.2. Single Agent Tablets
  • 9.2.1. Once Daily Dosing
  • 9.2.2. Twice Daily Dosing

10. Direct Acting Antivirals Market, by Treatment Regimen

• 10.1. Combination Therapy
  • 10.1.1. Dual Therapy
    • 10.1.1.1. Ns3 4A Ns5A
    • 10.1.1.2. Ns5A Ns5B
  • 10.1.2. Triple Therapy
• 10.2. Monotherapy

11. Direct Acting Antivirals Market, by Distribution Channel

• 11.1. Hospital Pharmacy
• 11.2. Online Pharmacy
• 11.3. Retail Pharmacy

12. Direct Acting Antivirals Market, by End User

• 12.1. Hospitals
• 12.2. Retail Pharmacies
• 12.3. Specialty Clinics

13. Direct Acting Antivirals Market, by Region

• 13.1. Americas
  • 13.1.1. North America
  • 13.1.2. Latin America
• 13.2. Europe, Middle East & Africa
  • 13.2.1. Europe
  • 13.2.2. Middle East
  • 13.2.3. Africa
• 13.3. Asia-Pacific

14. Direct Acting Antivirals Market, by Group

• 14.1. ASEAN
• 14.2. GCC
• 14.3. European Union
• 14.4. BRICS
• 14.5. G7
• 14.6. NATO

15. Direct Acting Antivirals Market, by Country

• 15.1. United States
• 15.2. Canada
• 15.3. Mexico
• 15.4. Brazil
• 15.5. United Kingdom
• 15.6. Germany
• 15.7. France
• 15.8. Russia
• 15.9. Italy
• 15.10. Spain
• 15.11. China
• 15.12. India
• 15.13. Japan
• 15.14. Australia
• 15.15. South Korea

16. United States Direct Acting Antivirals Market

17. China Direct Acting Antivirals Market

18. Competitive Landscape

• 18.1. Market Concentration Analysis, 2025
  • 18.1.1. Concentration Ratio (CR)
  • 18.1.2. Herfindahl Hirschman Index (HHI)
• 18.2. Recent Developments & Impact Analysis, 2025
• 18.3. Product Portfolio Analysis, 2025
• 18.4. Benchmarking Analysis, 2025
• 18.5. AbbVie Inc.
• 18.6. Amgen Inc.
• 18.7. AstraZeneca plc
• 18.8. Aurobindo Pharma Limited
• 18.9. Bayer AG
• 18.10. Biogen Inc.
• 18.11. Boehringer Ingelheim International GmbH
• 18.12. Bristol-Myers Squibb Company
• 18.13. Cipla Limited
• 18.14. Dr. Reddy's Laboratories Ltd.
• 18.15. Eli Lilly and Company
• 18.16. Gilead Sciences, Inc.
• 18.17. GlaxoSmithKline plc
• 18.18. Hetero Labs Limited
• 18.19. Johnson & Johnson
• 18.20. Laurus Labs Limited
• 18.21. Lupin Limited
• 18.22. Merck & Co., Inc.
• 18.23. Natco Pharma Limited
• 18.24. Novartis AG
• 18.25. Pfizer Inc.
• 18.26. Pharco Pharmaceuticals
• 18.27. Regeneron Pharmaceuticals, Inc.
• 18.28. Roche Holding AG
• 18.29. Sanofi S.A.
• 18.30. Strides Pharma Science Limited
• 18.31. Takeda Pharmaceutical Company Limited
• 18.32. Teva Pharmaceutical Industries Ltd.
• 18.33. Vertex Pharmaceuticals Incorporated
• 18.34. Viatris Inc.
• 18.35. Zydus Lifesciences Limited