직접 작용 항바이러스제 시장 : 제품 유형, 약제 클래스별, 유통 채널, 최종사용자별 - 세계 예측(2025-2032년)

The Direct-acting Antiviral Drug Market is projected to grow by USD 33.92 billion at a CAGR of 13.65% by 2032.

Contextualizing the clinical, operational, and commercial foundations of direct-acting antiviral therapies to frame strategic decision-making across healthcare stakeholders

The emergence of direct-acting antiviral therapies has permanently reshaped approaches to viral hepatology and infectious disease management, driving meaningful improvements in patient outcomes and redefining the expectations of curative treatment pathways. This introduction establishes the clinical and commercial context for these therapies, focusing on mechanism-of-action innovations, evolving therapeutic classes, and the broader implications for healthcare systems. It also synthesizes recent trends in clinical development where shorter regimens, improved tolerability, and pan-genotypic activity have shifted treatment paradigms and accelerated adoption among specialist clinicians.

From a supply-chain perspective, manufacturing complexity and active pharmaceutical ingredient sourcing have become central considerations for developers and purchasers alike. As a result, quality-by-design manufacturing, biologics-inspired process controls, and strategic supplier relationships are increasingly important for ensuring predictable product availability. Simultaneously, payer perspectives have evolved to emphasize long-term outcomes and cost-of-care reductions, which in turn influence formulary decisions and contracting strategies.

Looking ahead, integration of diagnostics, linkage-to-care programs, and decentralized treatment models will continue to shape the clinical deployment of direct-acting antivirals. Therefore, this introduction frames subsequent sections by outlining the intersections between clinical efficacy, operational deployment, regulatory oversight, and commercial execution that leaders must reconcile when advancing programs from development into routine clinical practice.

How clinical breakthroughs, distribution innovations, and regulatory adaptation are converging to redefine treatment pathways and commercial strategies for antiviral therapies

Transformative shifts are accelerating across the direct-acting antiviral landscape as clinical advances converge with changes in care delivery and commercial strategy. The therapeutic narrative has transitioned from incremental improvements to fundamentally different expectations around cure rates and treatment simplicity, prompting stakeholders to reevaluate standard-of-care pathways and population-level eradication strategies. Concurrently, advances in pharmacology-particularly combination regimens that enhance potency while minimizing resistance risk-have altered clinical trial designs and endpoint selection, leading to more efficient pathways for regulatory acceptance and label expansion.

In parallel, the distribution environment is undergoing a structural evolution. Digital health platforms and telemedicine have reduced barriers to diagnosis and treatment initiation, enabling earlier intervention and expanding the pool of patients who can be treated outside tertiary centers. These shifts have fostered closer collaboration between diagnostic developers, specialty clinics, and community providers, and they have required manufacturers to adopt more flexible commercialization models that support education, adherence, and monitoring within diverse care settings.

Regulatory frameworks have also adapted, with a stronger emphasis on real-world evidence and post-marketing surveillance to monitor long-term outcomes and safety in broader populations. As these transformative forces continue to interact, they create both opportunities and complexities for manufacturers, payers, and providers; stakeholders that proactively align clinical development with scalable delivery models will be best positioned to capture the full value inherent in the next generation of direct-acting antiviral therapies.

Assessing how recent trade policy and tariff developments have reshaped supply chain resilience, sourcing strategy, and procurement practices across antiviral therapeutics

The introduction of tariffs and trade policy adjustments has a cascading effect on pharmaceutical supply chains, procurement strategies, and transactional economics that extend into clinical access and manufacturing planning. Tariff-related costs influence sourcing choices for active pharmaceutical ingredients and excipients, prompting manufacturers to reassess supplier diversification, regional production footprints, and inventory buffers. These operational responses are not merely tactical; they alter lead times for product launch, constrain responsiveness to demand surges, and increase the complexity of contract negotiations with large institutional purchasers and government buyers.

Moreover, tariffs interact with regulatory and quality requirements in ways that complicate sourcing decisions. When suppliers in tariff-impacted jurisdictions also possess regulatory approvals or specialized manufacturing capabilities, firms face trade-offs between cost, compliance, and speed to market. In response, companies increasingly explore regional manufacturing partnerships, tolling arrangements, and vertical integration to mitigate exposure. At the same time, procurement organizations and payers are re-evaluating contracting structures to protect against price volatility and supply disruptions, favoring multi-year agreements or increased inventory commitments when necessary.

Importantly, tariffs also reshape strategic investment decisions. Firms planning capacity expansions, new product rollouts, or geographic entry must incorporate the altered cost dynamics into scenario planning and capital allocation. Through careful supply-chain redesign, proactive regulatory engagement, and contractual innovation, stakeholders can reduce exposure and preserve patient access, although these adjustments require deliberate cross-functional alignment to implement effectively and sustainably.

Multidimensional segmentation insights that illuminate how product type, therapeutic class, channels, and end-user dynamics uniquely influence strategy and deployment

Segmentation insight reveals how demand drivers, clinical profiles, and distribution dynamics differ across key dimensions of the direct-acting antiviral space. Based on Product Type, market is studied across Branded Drugs and Generic Drugs, and this distinction influences pricing dynamics, channel support, and the nature of commercial partnerships required to ensure uptake and adherence. Branded products often require heavier investments in education, real-world evidence generation, and specialty distribution, while Generic Drugs emphasize cost competitiveness, scale manufacturing, and efficient channel penetration.

Based on Therapeutic Class, market is studied across Combination Therapy, Ns5A Inhibitor, Ns5B Inhibitor, and Protease Inhibitor, and each class carries unique clinical positioning, resistance considerations, and regimen complexity that shape prescribing patterns. Combination Therapy often addresses multi-genotype coverage and resistance suppression, whereas class-specific agents may be prioritized where monotherapy still offers clinical advantage or where tolerability is paramount. This therapeutic segmentation has direct consequences for clinical trial design, labeling strategies, and post-approval lifecycle management.

Based on Distribution Channel, market is studied across Hospital Pharmacy, Online Pharmacy, and Retail Pharmacy, which affects how products are accessed, how adherence is monitored, and how patient support programs are deployed. Hospital Pharmacy channels typically handle more complex cases and institutional contracting, while Online Pharmacy platforms enable broader patient reach and convenience. Based on End User, market is studied across Home Healthcare, Hospitals, and Specialty Clinics, and the end-user mix shapes training requirements, monitoring protocols, and the design of ancillary services required to ensure optimal outcomes. Taken together, these segmentation lenses provide a multidimensional view that informs product positioning, commercialization tactics, and partnership priorities.

Comparative regional dynamics and strategic implications across the Americas, Europe Middle East and Africa, and Asia-Pacific that drive differentiated access and deployment approaches

Regional dynamics have become a decisive factor in shaping development priorities, regulatory engagement strategies, and commercialization planning for direct-acting antivirals. In the Americas, payer-driven contracting, outcomes-based agreements, and robust specialty care networks influence how manufacturers approach formulary access and patient support programs. Regulatory agencies and public health initiatives often prioritize elimination goals, which creates collaborative opportunities between manufacturers and public-sector purchasers to align supply and demand for high-impact interventions.

In Europe, Middle East & Africa, healthcare systems exhibit a breadth of procurement models and budgetary constraints that require nuanced market access strategies. Countries with centralized healthcare procurement may favor negotiated pricing and volume guarantees, whereas regions with heterogeneous payers necessitate adaptable contracting and evidence generation to meet divergent reimbursement thresholds. Meanwhile, supply-chain complexity and capacity variability across parts of Europe, the Middle East, and Africa underscore the need for regional manufacturing partnerships and tailored distribution solutions.

In Asia-Pacific, rapid scale-up of diagnostic and treatment programs, coupled with strong manufacturing capabilities in several countries, creates both competitive and collaborative opportunities. Diverse regulatory pathways and varying degrees of local production capacity make it critical to align product registrations, technology transfers, and commercial launches with country-specific requirements. Across all regions, successful strategies will integrate local clinical engagement, regionally appropriate pricing models, and resilient distribution networks to ensure broad and equitable access to antiviral therapies.

Corporate positioning and competitive dynamics driven by innovation leadership, manufacturing scale, and strategic partnerships that determine sustainable advantage in antiviral therapeutics

Company-level dynamics reflect a mix of innovation leadership, manufacturing scale, and strategic collaborations that collectively determine competitive positioning within the direct-acting antiviral space. Innovative pharmaceutical and biotech companies focus on advancing mechanism-of-action differentiation, expanding pan-genotypic indications, and generating robust safety and real-world effectiveness evidence to sustain clinical preference. These organizations typically invest in integrated ecosystem capabilities-combining clinical affairs, pharmacovigilance, and digital adherence tools-to support durable market access and physician confidence.

Meanwhile, manufacturers with strong generic capabilities emphasize operational excellence, cost optimization, and rapid scale-up to meet demand in price-sensitive markets. Contract manufacturing organizations and tolling partners play a pivotal role in enabling agility, allowing brand and generic players to adjust output in response to procurement cycles and supply shocks. Partnership strategies, including licensing agreements, co-promotion deals, and public-private collaborations, continue to shape the competitive landscape and accelerate treatment uptake in public health initiatives.

Across the corporate landscape, mid-size specialty companies and larger pharma firms differentiate through strategic investments in diagnostics integration, patient support programs, and targeted distribution partnerships. Leadership teams that align clinical differentiation with pragmatic commercialization models and resilient manufacturing networks will be better equipped to navigate regulatory complexity and sustain long-term value creation in this therapeutic area.

Practical strategic actions for industry leaders to align clinical evidence, supply-chain resilience, and channel-specific commercialization to accelerate access and sustain value

Leaders seeking to capitalize on the evolving direct-acting antiviral landscape should adopt a set of pragmatic, high-impact actions that balance clinical credibility with operational resilience. First, integrate clinical development and commercialization planning early so that trial designs generate evidence relevant to payers, guideline committees, and real-world practice. By aligning endpoints, patient populations, and health-economic evidence needs from the outset, organizations can shorten the pathway from approval to meaningful uptake.

Second, strengthen supply-chain resilience through supplier diversification, selective regional manufacturing partnerships, and flexible contract manufacturing arrangements. Scenario planning that incorporates potential trade-policy shifts, raw-material constraints, and demand volatility will enable more adaptive sourcing decisions. Third, tailor distribution and patient-support models to channel realities: design differentiated approaches for Hospital Pharmacy, Online Pharmacy, and Retail Pharmacy that reflect variations in access, adherence, and monitoring requirements. Complement these channel strategies with robust diagnostic linkages and provider education initiatives to ensure appropriate patient selection and follow-through.

Finally, pursue collaborative pricing and contracting approaches with payers, including outcomes-based agreements where appropriate, and invest in data infrastructure to demonstrate value in routine practice. By combining these actions-evidence-aligned development, supply-chain robustness, channel-specific commercialization, and payer collaboration-industry leaders can enhance access, reduce variability in outcomes, and create defensible commercial positions.

A reproducible mixed-methods research design combining primary expert interviews, literature synthesis, supply-chain mapping, and scenario stress testing to ensure robust insights

This research employed a mixed-methods approach that integrates primary qualitative interviews, secondary literature synthesis, and supply-chain and regulatory analysis to produce a comprehensive view of the direct-acting antiviral environment. Primary insights were derived from structured interviews with experienced clinicians, formulary decision-makers, procurement specialists, and industry executives, enabling triangulation of clinical practice patterns, contracting dynamics, and operational challenges. Secondary analysis synthesized peer-reviewed literature, regulatory guidance documents, and publicly available clinical trial outcomes to contextualize therapeutic efficacy, safety profiles, and regulatory trends.

In addition, supply-chain mapping and policy analysis were used to assess sourcing risks, manufacturing dependencies, and the implications of trade-policy shifts. Scenario-based stress testing helped illuminate how different tariff and procurement outcomes could affect operational decisions and stakeholder incentives. Evidence quality checks and cross-validation between internal sources and external subject-matter experts were implemented to ensure the robustness of conclusions.

Transparency in methodology supports reproducibility and allows stakeholders to appraise the fit of insights to their specific contexts. Where appropriate, the research highlights data limitations and recommends areas for targeted follow-up research or bespoke analysis to address organization-specific questions related to access, pricing strategies, and manufacturing expansion planning.

Synthesis of strategic imperatives emphasizing alignment between clinical innovation, operational resilience, and collaborative access models to secure sustainable therapeutic impact

This final synthesis reiterates the central themes that should guide executive decision-making in the direct-acting antiviral domain: therapeutic innovation must be matched with pragmatic strategies for access, delivery, and supply assurance. Clinical advances have created opportunities to rethink treatment pathways and public-health approaches, but capturing the benefits requires careful coordination across development, manufacturing, and market-access functions. Operational resilience-particularly around supplier diversification and manufacturing flexibility-remains essential to protecting product availability and upholding public-health commitments.

Moreover, segmentation and regional nuance matter. Decisions about product type, therapeutic class, distribution channel, and end-user settings will determine the traction a therapy achieves in different healthcare systems and will inform the investments needed across evidence generation, education, and logistics. Finally, collaborative arrangements-whether with payers, public-health agencies, or manufacturing partners-can accelerate access while sharing risk and aligning incentives around long-term outcomes. As organizations translate these conclusions into operational plans, they should prioritize alignment between clinical objectives and commercial realities, ensuring that strategy execution remains patient-centered and resilience-focused.

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Segmentation & Coverage
• 1.3. Years Considered for the Study
• 1.4. Currency & Pricing
• 1.5. Language
• 1.6. Stakeholders

2. Research Methodology

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Expanding pan-genotypic direct-acting antiviral regimens addressing hepatitis C genotype diversity
• 5.2. Integration of real-world evidence demonstrating cost-effectiveness of combination DAA therapies
• 5.3. Increasing emphasis on shortened DAA treatment durations to improve patient adherence rates
• 5.4. Regulatory approvals for all-oral DAA therapies in paediatric patient populations worldwide
• 5.5. Adoption of point-of-care diagnostics to enable immediate linkage to direct-acting antiviral treatment
• 5.6. Development of next-generation NS5A inhibitors to overcome resistance-associated HCV variants
• 5.7. Collaborations between biotech firms and global health agencies to expand DAA access in LMICs

6. Cumulative Impact of United States Tariffs 2025

7. Cumulative Impact of Artificial Intelligence 2025

8. Direct-acting Antiviral Drug Market, by Product Type

• 8.1. Branded Drugs
• 8.2. Generic Drugs

9. Direct-acting Antiviral Drug Market, by Therapeutic Class

• 9.1. Combination Therapy
• 9.2. Ns5A Inhibitor
• 9.3. Ns5B Inhibitor
• 9.4. Protease Inhibitor

10. Direct-acting Antiviral Drug Market, by Distribution Channel

• 10.1. Hospital Pharmacy
• 10.2. Online Pharmacy
• 10.3. Retail Pharmacy

11. Direct-acting Antiviral Drug Market, by End User

• 11.1. Home Healthcare
• 11.2. Hospitals
• 11.3. Specialty Clinics

12. Direct-acting Antiviral Drug Market, by Region

• 12.1. Americas
  • 12.1.1. North America
  • 12.1.2. Latin America
• 12.2. Europe, Middle East & Africa
  • 12.2.1. Europe
  • 12.2.2. Middle East
  • 12.2.3. Africa
• 12.3. Asia-Pacific

13. Direct-acting Antiviral Drug Market, by Group

• 13.1. ASEAN
• 13.2. GCC
• 13.3. European Union
• 13.4. BRICS
• 13.5. G7
• 13.6. NATO

14. Direct-acting Antiviral Drug Market, by Country

• 14.1. United States
• 14.2. Canada
• 14.3. Mexico
• 14.4. Brazil
• 14.5. United Kingdom
• 14.6. Germany
• 14.7. France
• 14.8. Russia
• 14.9. Italy
• 14.10. Spain
• 14.11. China
• 14.12. India
• 14.13. Japan
• 14.14. Australia
• 14.15. South Korea

15. Competitive Landscape

• 15.1. Market Share Analysis, 2024
• 15.2. FPNV Positioning Matrix, 2024
• 15.3. Competitive Analysis
  • 15.3.1. Gilead Sciences, Inc.
  • 15.3.2. AbbVie Inc.
  • 15.3.3. Merck & Co., Inc.
  • 15.3.4. Janssen Pharmaceuticals, Inc.
  • 15.3.5. Bristol-Myers Squibb Company
  • 15.3.6. Roche Holding AG
  • 15.3.7. Teva Pharmaceutical Industries Ltd.
  • 15.3.8. Mylan N.V.
  • 15.3.9. Cipla Limited
  • 15.3.10. Aurobindo Pharma Limited