Direct-acting Antiviral Drug Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (NS3/4A Protease, NS5A Protein, NS5B RNA-Dependent RNA polymerase), By Indication (Hepatitis C Virus, HIV Infection/ AIDS, Influenza, Prophylaxis), By Route (Intravenous, Oral, Subcutaneous, Topical), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 11.91 Billion
CAGR (2026-2031)	12.16%
Fastest Growing Segment	NS3/4A Protease
Largest Market	North America
Market Size (2031)	USD 23.71 Billion

Market Overview

The Global Direct-acting Antiviral Drug Market will grow from USD 11.91 Billion in 2025 to USD 23.71 Billion by 2031 at a 12.16% CAGR. Direct-acting antiviral drugs are a distinct class of pharmaceutical agents designed to target specific non-structural proteins within the viral replication cycle, effectively disrupting the virus's ability to multiply and offering high cure rates for infections such as Hepatitis C. The expansion of this market is primarily supported by the escalating global prevalence of chronic viral diseases and the intensified efforts by international health organizations to achieve disease elimination targets, which necessitate the widespread deployment of efficacious therapies. According to the American Association for the Study of Liver Diseases, in 2025, approximately 50 million people globally were estimated to be living with Hepatitis C, highlighting the critical and substantial demand for these therapeutic interventions.

Despite the strong clinical demand, the market encounters a significant challenge related to the high cost of branded therapies which limits patient accessibility in resource-constrained regions. This economic barrier often forces healthcare systems to implement strict reimbursement criteria or rationing of care, thereby impeding the broader adoption of these treatments and restricting the overall market potential in low- and middle-income countries where the disease burden is often highest.

Key Market Drivers

The rising global incidence of Hepatitis C and HIV infections serves as the primary catalyst for the Global Direct-acting Antiviral Drug Market, creating a sustained necessity for therapeutic intervention. As viral transmission rates persist, healthcare systems are compelled to procure advanced antiviral regimens to manage the disease burden and prevent progression to chronic stages. This demand is quantified by the volume of new cases requiring immediate medical attention and long-term viral suppression. According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), July 2024, in the 'Global HIV & AIDS Statistics — Fact Sheet', approximately 1.3 million people globally were newly infected with HIV in 2024. This continuous patient influx drives market expansion as manufacturers scale production to meet the needs of this growing population, particularly in regions where effective viral suppression is a public health priority.

Robust clinical pipelines and continued R&D investment are further propelling market growth through the development of long-acting and highly efficacious therapeutics. Pharmaceutical developers are aggressively pursuing next-generation direct-acting antivirals that offer superior clinical outcomes and reduced dosing frequencies, which significantly enhances patient adherence. A prime example of this innovation is evident in recent clinical breakthroughs for HIV prevention. According to Gilead Sciences, September 2024, in the 'Gilead: Lenacapavir Reduces HIV Infections By 96% In PURPOSE 2 Trial' press release, the investigational twice-yearly injectable lenacapavir reduced HIV infections by 96% compared to background incidence, demonstrating the market-shifting potential of new therapeutic classes. This focus on superior efficacy directly translates into substantial commercial performance for key market players. According to Gilead Sciences, in 2024, HIV product sales increased by 9% to reach $5.1 billion in the third quarter, reflecting the strong economic conversion of clinical demand into revenue.

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Key Market Challenges

The high cost of branded therapies constitutes a formidable economic barrier that directly impedes the expansion of the Global Direct-acting Antiviral Drug Market. In many regions, particularly low- and middle-income countries where the disease burden is most concentrated, national healthcare budgets are unable to sustain the premium pricing associated with these patented regimens. This financial strain forces public health systems to implement strict rationing protocols, often limiting drug access solely to patients with advanced liver damage while deferring treatment for the wider infected population. Consequently, the market volume is artificially suppressed, preventing the conversion of high clinical prevalence into actual pharmaceutical sales.

This affordability gap creates a disconnect between the availability of effective cures and their adoption. When healthcare infrastructure cannot support widespread procurement due to pricing prohibitive to local economies, the scalable growth of the market is stifled. According to the World Hepatitis Alliance, in 2024, data indicated that only 15 percent of individuals diagnosed with Hepatitis C globally had received necessary treatment, reflecting the profound impact of these access barriers. Such restrictions ensure that a vast majority of the addressable market remains untapped, thereby hampering the industry's ability to realize its full revenue potential globally.

Key Market Trends

The strategic focus on functional cures for Hepatitis B prioritizes finite-duration therapies over lifelong suppression. This trend is driving the development of novel antisense oligonucleotides designed to clear viral surface antigens, addressing a massive unmet need in a landscape dominated by maintenance drugs. Recent clinical milestones validate this trajectory. According to GSK, January 2026, in the 'Positive phase 3 data for GSK's bepirovirsen' announcement, the company's investigational antisense oligonucleotide bepirovirsen achieved a statistically significant functional cure rate in pivotal trials, marking a decisive improvement over the approximately 1 percent cure rate historically seen with standard nucleoside analogue regimens.

The expansion into acute respiratory viral indications is establishing a resilient secondary revenue stream, extending beyond chronic pathogens. Pharmaceutical developers are successfully commercializing oral direct-acting antivirals for endemic respiratory infections, ensuring sustained market activity even as pandemic urgency subsides. This segment's durability is evidenced by robust financial performance. According to Pfizer, November 2025, in the 'Pfizer Reports Solid Third-Quarter 2025 Results' press release, the oral antiviral Paxlovid generated $1.23 billion in revenue during the third quarter of 2025 alone, confirming the economic relevance of acute viral therapeutics.

Segmental Insights

The NS3/4A protease inhibitor segment represents the fastest-growing category within the global direct-acting antiviral drug market. This expansion is primarily driven by the critical role these inhibitors play in pangenotypic combination therapies, which effectively treat multiple Hepatitis C genotypes. Regulatory endorsements from entities such as the US Food and Drug Administration for regimens containing these agents have further validated their clinical utility and safety. As healthcare providers increasingly prioritize treatments offering high cure rates and shorter durations, the demand for NS3/4A protease inhibitors continues to rise, solidifying their status as a central driver of market development.

Regional Insights

North America leads the Global Direct-acting Antiviral Drug Market, driven by a well-established healthcare infrastructure and the presence of key pharmaceutical manufacturers. The region benefits from favorable reimbursement policies that enhance patient access to treatments for viral infections like Hepatitis C. Additionally, regulatory bodies such as the U.S. Food and Drug Administration support market expansion through structured approval pathways for new therapeutics. This regulatory efficiency, coupled with high diagnosis rates and strong research initiatives, solidifies North America’s position as the dominant region in this sector.

Recent Developments

• In December 2024, Pfizer Inc. initiated a Phase 3 clinical trial to evaluate the safety and efficacy of ibuzatrelvir, a next-generation oral direct-acting antiviral for COVID-19. The study focused on high-risk adults and adolescents with symptomatic SARS-CoV-2 infection. Unlike existing protease inhibitors that require co-administration with ritonavir, this novel candidate was designed as a stand-alone treatment to potentially minimize drug-drug interactions and improve patient adherence. This development represented a significant continuation of the company's research into advanced antiviral therapies aimed at reducing the burden of COVID-19 progression and hospitalization in vulnerable patient groups.
• In October 2024, Gilead Sciences presented breakthrough research data from the pivotal Phase 3 PURPOSE 2 clinical trial at IDWeek. The study evaluated lenacapavir, an injectable HIV-1 capsid inhibitor and direct-acting antiviral, for pre-exposure prophylaxis. The results indicated that the twice-yearly injection reduced HIV infections by 96% compared to background HIV incidence and demonstrated superiority over daily oral antiviral regimens. These findings underscored the transformative potential of long-acting direct-acting antivirals in preventing HIV transmission and supported the company's regulatory submissions to expand access to this innovative prevention option for diverse populations globally.
• In September 2024, Roche announced positive topline results from the Phase III CENTERSTONE study evaluating Xofluza, a potent direct-acting antiviral drug. The trial met its primary endpoint, demonstrating that a single oral dose of the cap-dependent endonuclease inhibitor significantly reduced the transmission of influenza viruses from infected patients to their household contacts. This study represented the first time an antiviral medication showed a benefit in reducing the spread of a respiratory viral illness in a global Phase III trial. The findings highlighted the drug's potential to provide broader public health benefits beyond symptom management by interrupting the chain of infection.
• In September 2024, Enanta Pharmaceuticals reported positive data from a Phase 2a human challenge study of EDP-323, a novel direct-acting antiviral candidate for respiratory syncytial virus. The oral L-protein inhibitor achieved a significant reduction in viral load and clinical symptoms in healthy adults infected with the virus compared to a placebo. These results supported the safety and potent antiviral activity of the drug, positioning it as a promising once-daily treatment option. The successful trial outcome marked a key step in the company's efforts to develop effective therapeutics for populations at high risk of severe respiratory syncytial virus complications.

Key Market Players

• Natco Pharma Ltd
• Vertex Pharmaceuticals Inc
• Dr Reddy's Laboratories Ltd
• Johnson & Johnson
• Merck & Co Inc
• Gilead Sciences Inc
• AbbVie Inc
• Bristol-Myers Squibb Co

By Type	By Indication	By Route	By Distribution Channel	By Region
NS3/4A Protease NS5A Protein NS5B RNA-Dependent RNA polymerase	Hepatitis C Virus HIV Infection/ AIDS Influenza Prophylaxis	Intravenous Oral Subcutaneous Topical	Hospital Pharmacies Retail Pharmacies Online Pharmacies	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Direct-acting Antiviral Drug Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Direct-acting Antiviral Drug Market, By Type:

• NS3/4A Protease
• NS5A Protein
• NS5B RNA-Dependent RNA polymerase

• Direct-acting Antiviral Drug Market, By Indication:

• Hepatitis C Virus
• HIV Infection/ AIDS
• Influenza
• Prophylaxis

• Direct-acting Antiviral Drug Market, By Route:

• Intravenous
• Oral
• Subcutaneous
• Topical

• Direct-acting Antiviral Drug Market, By Distribution Channel:

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

• Direct-acting Antiviral Drug Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE