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, 2020-2030F

 Market Overview

Global Direct-acting Antiviral Drug Market was valued at USD 11.41 Billion in 2024 and is expected to reach USD 23.61 Billion in the forecast period with a CAGR of 12.86% through 2030. The global direct-acting antiviral (DAA) drug market is expanding due to the increasing prevalence of viral infections, particularly hepatitis C. These drugs target specific viral proteins to inhibit replication, offering a highly effective and well-tolerated treatment option. Pharmaceutical advancements have led to the development of next-generation DAAs with improved efficacy and shorter treatment durations. The market is witnessing significant growth as healthcare providers and governments prioritize hepatitis C elimination programs. The introduction of combination therapies has further enhanced treatment outcomes, reducing the risk of drug resistance and increasing sustained virologic response (SVR) rates. Expanding access to diagnostic testing and treatment in developing countries is playing a crucial role in market expansion.

The market is benefiting from increasing awareness of early diagnosis and treatment, supported by government initiatives and non-profit organizations. Rising investments in antiviral drug research are fostering the development of innovative therapies with improved safety profiles. The shift toward personalized medicine is influencing the demand for targeted antiviral therapies, ensuring higher treatment success rates. Breakthroughs in biotechnology and genetic research are enabling pharmaceutical companies to design more precise and potent DAAs. The growing preference for oral therapies over injectable treatments is driving patient adherence, making DAAs a preferred choice in antiviral treatment strategies. Collaborations between research institutions and pharmaceutical firms are expediting drug development, leading to a robust pipeline of next-generation DAAs. Expanding healthcare infrastructure and favorable reimbursement policies in various countries are creating opportunities for market players.

Despite advancements, the market faces challenges related to high treatment costs, limiting accessibility for patients in low-income regions. The emergence of drug-resistant viral strains is a growing concern, requiring continuous research to develop more effective formulations. Regulatory hurdles and lengthy approval processes for new DAAs can delay market entry, impacting innovation cycles. Limited awareness in certain regions about the availability of effective antiviral treatments is slowing adoption rates. The presence of generic alternatives is intensifying market competition, putting pressure on pricing strategies. Addressing these challenges through strategic pricing models, research in resistance management, and increased global treatment outreach will be essential for sustaining market growth.

Key Market Drivers

High Efficacy and Improved Cure Rates

In recent years, the global pharmaceutical landscape has witnessed a transformative shift in the treatment of viral infections, particularly hepatitis C, due to the advent of direct-acting antiviral drugs (DAAs). These innovative medications have demonstrated exceptional efficacy, with cure rates exceeding 95%, redefining the approach to managing viral diseases. 

The high efficacy of DAAs translates into significantly improved patient outcomes. For instance, a study published in JAMA Network Open reported that among patients treated with DAAs, 97.3% achieved sustained virologic response (SVR), indicating a cure. Successful DAA therapy not only clears the virus but also halts disease progression, reducing risks of liver fibrosis, cirrhosis, and hepatocellular carcinoma.

Beyond individual benefits, DAAs contribute to public health by reducing viral transmission. Effective treatment decreases viral load, thereby lowering the likelihood of spreading infections such as hepatitis B and C, which are transmitted through routes like blood contact and sexual intercourse. The World Health Organization highlights that DAAs can cure over 95% of hepatitis C cases, yet access to diagnosis and treatment remains limited globally. 

DAAs also offer shorter treatment durations compared to traditional interferon-based therapies. While older regimens required treatment courses of up to 48 weeks, DAA therapies typically range from 8 to 12 weeks, enhancing patient compliance and reducing healthcare burdens. Furthermore, DAAs are associated with improved tolerability and fewer severe side effects, encouraging patients to complete their treatment regimens.

The success of DAAs has instilled confidence among patients and healthcare providers. For example, the U.S. Department of Health and Human Services notes that new hepatitis C treatments can cure approximately 95% of patients, significantly decreasing the likelihood of severe liver complications and reducing overall healthcare costs. This underscores the importance of expanding access to these life-saving therapies to achieve broader public health benefits.

Shorter Treatment Durations

The global pharmaceutical industry has witnessed a remarkable transformation in recent years, thanks to the advent of direct-acting antiviral drugs (DAAs). One of the most significant factors driving the growth of the global direct-acting antiviral drug market is the shorter treatment durations offered by these medications.

Direct-acting antiviral drugs have ushered in a new era in the management of viral infections, particularly hepatitis C and hepatitis B. Unlike earlier treatments that often-required prolonged regimens extending up to a year or more, DAAs are known for their significantly shorter treatment durations. These durations typically range from 8 to 12 weeks, representing a substantial reduction in the time required for antiviral therapy.

One of the most significant advantages of shorter treatment durations is improved patient compliance. Traditional therapies, characterized by long and often grueling courses of treatment, posed significant challenges for patients. The extended duration of treatment could lead to treatment fatigue, missed doses, and treatment discontinuation. With DAAs, patients are more likely to adhere to the prescribed regimen due to the relatively short timeframe, resulting in better treatment outcomes.

Shorter treatment durations not only benefit patients but also alleviate the burden on healthcare systems. Prolonged treatments require more frequent medical visits, monitoring, and healthcare resources. In contrast, DAAs, with their abbreviated treatment schedules, reduce the demand on healthcare infrastructure, making it easier for healthcare providers to manage a larger volume of patients.

The cost-effectiveness of DAAs is closely tied to their shorter treatment durations. While these drugs may be relatively expensive, the overall cost of treatment is reduced when considering factors such as fewer medical visits, laboratory tests, and the potential avoidance of complications associated with prolonged illness. This cost-efficiency is an essential driver for both healthcare systems and patients.

Shorter treatment durations not only save time but also contribute to an improved quality of life for patients. Traditional antiviral treatments often came with debilitating side effects that could persist for months. In contrast, DAAs are known for their improved tolerability, reducing the impact of treatment on patients' daily lives and overall well-being.

The shorter treatment durations offered by DAAs often result in faster viral suppression. This rapid reduction in viral load can provide patients with symptomatic relief sooner, improving their overall health and reducing the risk of disease progression. Additionally, faster viral suppression can contribute to the prevention of further transmission of the virus.

Fewer Side Effect

In the ever-evolving landscape of pharmaceuticals, direct-acting antiviral drugs (DAAs) have emerged as a game-changer in the treatment of viral infections, particularly hepatitis C and hepatitis B. Among the various factors driving the growth of the global direct-acting antiviral drug market, the significantly fewer side effects associated with these medications stand out as a critical catalyst.

The hallmark of direct-acting antiviral drugs is their superior tolerability profile compared to traditional antiviral treatments. Previous therapies often came with a host of debilitating side effects, including flu-like symptoms, fatigue, depression, and anemia. In contrast, DAAs are known for their mild and manageable side effect profiles, significantly improving the overall treatment experience for patients.

Fewer side effects translate to improved patient adherence to prescribed treatment regimens. Patients are more likely to adhere to a therapy that does not disrupt their daily lives with severe and unpleasant side effects. This enhanced adherence contributes to higher cure rates and better long-term outcomes for individuals living with viral infections.

The reduced side effect burden associated with DAAs results in an improved quality of life for patients undergoing treatment. Traditional antiviral therapies could lead to a significant deterioration in the patient's well-being, affecting their ability to work, socialize, and engage in daily activities. DAAs offer a reprieve from these adverse effects, allowing patients to maintain a better overall quality of life during treatment.

Fewer side effects also have a positive economic impact on healthcare systems. The management of side effects often necessitates additional medical visits, medications, and laboratory tests, which can contribute to higher healthcare costs. With DAAs, the reduced need for supportive care and monitoring results in cost savings for both patients and healthcare providers.

The improved tolerability of DAAs has led to greater patient acceptance of antiviral treatment. Patients who may have been hesitant to pursue therapy in the past due to fear of side effects are now more willing to seek treatment. This expanded patient pool contributes to the growth of the DAA market.

The milder side effects associated with DAAs enable patients to recover more quickly from the adverse effects of viral infections. This faster recovery not only alleviates the patient's suffering but also contributes to shorter overall treatment durations, reducing the burden on healthcare systems.

Rising Prevalence of Viral Infections

The global healthcare landscape is confronting a significant challenge with the rising prevalence of viral infections, notably hepatitis B and hepatitis C. According to the World Health Organization (WHO), as of 2022, approximately 254 million people are living with chronic hepatitis B, and nearly 50 million with chronic hepatitis C. These infections can lead to severe liver diseases, including cirrhosis and hepatocellular carcinoma, if left untreated, underscoring the urgency for effective treatment strategies.

Direct-acting antiviral drugs (DAAs) have revolutionized the treatment landscape for these infections. DAAs have demonstrated cure rates exceeding 95% for hepatitis C, offering a highly effective solution for a significant portion of those affected by the virus. Improved awareness and diagnostics have been pivotal in identifying more cases of viral infections. Enhanced screening and diagnostic capabilities have led to an increasing number of individuals being diagnosed with hepatitis B and C, thereby expanding the pool of patients seeking treatment.

In response to this global health concern, numerous countries and health organizations have initiated ambitious programs aimed at eliminating viral hepatitis as a public health threat. The WHO's Global Health Sector Strategy on Viral Hepatitis, endorsed by all member states, aims to reduce new hepatitis infections by 90% and deaths by 65% between 2016 and 2030. Such initiatives have significantly increased the demand for effective antiviral medications like DAAs. Furthermore, governments and non-governmental organizations worldwide are implementing measures to expand access to these life-saving drugs. Efforts include access programs, subsidies, and negotiations with pharmaceutical companies to make DAAs more affordable and accessible, particularly in low- and middle-income countries.

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Key Market Challenges

High Treatment Costs

One of the most significant challenges is the high cost of direct-acting antiviral drugs. While these medications are highly effective, their price tags can be prohibitive for many patients, especially in low- and middle-income countries. Striking a balance between recouping research and development costs and ensuring affordable access is a persistent challenge.

Drug Resistance

Over time, the development of drug-resistant strains of viruses is a concern. While direct-acting antiviral drugs have shown remarkable efficacy, the risk of resistance remains, particularly if patients do not adhere to prescribed treatment regimens. Pharmaceutical companies must continually invest in research to develop new drugs that combat resistant strains.

Key Market Trends

Expanded Indications

One significant trend in the DAA market is the exploration of expanded indications. While DAAs have been predominantly used to treat hepatitis C and B, researchers are investigating their efficacy against other viral infections. This could lead to the development of new DAA therapies targeting a broader range of viruses.

Combination Therapies

Combination therapies, which involve the use of multiple direct-acting antiviral drugs simultaneously, are gaining traction. These regimens aim to improve treatment efficacy, reduce the risk of drug resistance, and offer more options for patients with complex medical histories or co-infections.

Generic Competition

As patents expire for some DAA medications, the market is seeing increased competition from generic versions. This trend has the potential to enhance accessibility and affordability for patients globally, particularly in lower-income regions.

Segmental Insights

Route Insights

Based on the Route, Intravenous emerged as the dominant segment in the Global Direct-acting Antiviral Drug Market in 2024. This is due to its superior efficacy, rapid drug delivery, and high bioavailability. Many direct-acting antiviral drugs, particularly those used for severe viral infections such as hepatitis C, HIV, and emerging viral threats, require immediate and precise dosing, which intravenous administration effectively ensures. The ability of IV DAAs to achieve optimal therapeutic drug concentrations in the bloodstream faster than oral alternatives makes them the preferred choice for critically ill patients and hospital settings. Healthcare providers favor IV antiviral drugs for patients with advanced-stage infections, compromised liver function, or co-morbidities that hinder the absorption of oral medications. Moreover, the increasing adoption of IV antivirals in intensive care units and emergency treatment protocols has further strengthened the segment’s dominance. Pharmaceutical companies are also investing in IV formulations to enhance drug stability, controlled release, and patient compliance in hospital settings.

Distribution Channel Insights

Based on Distribution Channel, Hospital Pharmacies are poised to dominate the Global Direct-acting Antiviral Drug Market and maintain their leadership in the forecast years for several compelling reasons. Firstly, hospital pharmacies offer a centralized and controlled environment for the storage and distribution of critical antiviral drugs, ensuring their availability to patients in need. This centralized approach simplifies inventory management and minimizes the risk of drug shortages, a key concern in the healthcare sector. Furthermore, hospitals often serve as the primary point of care for patients with complex medical conditions, including viral infections, making them the natural hub for dispensing these specialized medications. Additionally, the increasing prevalence of viral diseases and the need for prompt and accurate diagnosis and treatment further solidify the role of hospital pharmacies in the market. Their close collaboration with healthcare professionals and access to cutting-edge research and clinical trials also position hospital pharmacies as the go-to source for the latest and most effective antiviral treatments. In conclusion, the pivotal role that hospital pharmacies play in patient care and their ability to provide comprehensive solutions make them the dominant force in the Global Direct-acting Antiviral Drug Market, with a strong likelihood of maintaining this position in the forecasted years.

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Regional Insights

North America emerged as the dominant region in the Global Direct-acting Antiviral Drug Market in 2024. Firstly, the region benefits from a robust healthcare infrastructure and a well-established pharmaceutical industry that actively drives research, development, and distribution of cutting-edge antiviral medications. Secondly, North America faces a significant burden of viral diseases, including hepatitis C and HIV, which has led to substantial investments in antiviral drug research and development. Moreover, the region's regulatory agencies maintain stringent standards, ensuring the safety and efficacy of drugs, which instills confidence among healthcare professionals and patients alike. Additionally, the region's high healthcare expenditure and insurance coverage contribute to greater accessibility to advanced antiviral treatments, fostering market growth. Furthermore, North America has a strong presence of key pharmaceutical companies, fostering innovation and competition, ultimately bolstering its dominant position in the Global Direct-acting Antiviral Drug Market. In summary, the combination of a robust healthcare ecosystem, disease prevalence, regulatory rigor, and industry innovation makes North America a formidable force in this market, poised to maintain its dominance in the years to come.

Asia-Pacific emerged as the fastest growing region in the Global Direct-acting Antiviral Drug Market during the forecast period. This is due to increasing prevalence of viral infections and government-led healthcare initiatives. The region has witnessed a rising burden of hepatitis B and C, HIV, and other viral infections, necessitating advanced antiviral treatments. Countries such as China, India, and Japan have significantly expanded their healthcare infrastructure, improving patient access to screening, diagnostics, and antiviral therapies. Additionally, government-backed vaccination and disease management programs have created a favorable environment for the adoption of DAAs. Pharmaceutical companies are increasingly focusing on the Asia-Pacific market, launching cost-effective antiviral therapies tailored to the region’s diverse patient population. Moreover, partnerships between international organizations and local governments are facilitating large-scale awareness campaigns, ensuring that more individuals receive timely diagnosis and treatment. The rapid expansion of healthcare insurance coverage in several Asia-Pacific countries has further contributed to the affordability and accessibility of DAAs, driving market growth.

Recent Developments

• In November 2024, Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio) announced the completion of enrollment and dosing in its Phase 1 clinical trial for AK0610, a fully human monoclonal antibody aimed at preventing respiratory syncytial virus (RSV) infection. This milestone strengthens ArkBio’s RSV portfolio, offering a potential new preventive option for vulnerable infants.
• In October 2024, Gilead Sciences, Inc. announced new research to be presented at The Liver Meeting 2024, hosted by AASLD from November 15-19 in San Diego. Over 40 abstracts will be featured, including 11 on primary biliary cholangitis (PBC). Key data from the RESPONSE trial will highlight the efficacy and safety of Livdelzi (seladelpar) in PBC patients with compensated cirrhosis. Additional findings will cover Livdelzi’s impact on pruritus and interim long-term efficacy and safety results from the ongoing ASSURE study.
• In October 2024, the INTREPID Alliance released its latest Antiviral Clinical and Preclinical Development Landscape report, adding preclinical compounds to its analysis of 13 viral families with pandemic potential, including mpox. The report shows most of the 64 clinical-stage and 96 preclinical direct-acting antivirals target SARS-CoV-2 and Influenza. No preclinical activity exists for Nairoviridae, Peribunyaviridae, and Picornaviridae, while no clinical development is found for Hantaviridae, Peribunyaviridae, Paramyxoviridae, and Togaviridae.
• In September 2024, Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio) announced the publication of its Phase 3 clinical trial results for ziresovir, an oral treatment for respiratory syncytial virus (RSV) in infants and young children, in The New England Journal of Medicine (NEJM). This marks the first time NEJM has published Phase 3 trial results for a direct-acting antiviral drug for RSV. Led by Professors Xin Ni and Shunying Zhao from Beijing Children's Hospital, the study highlights a major breakthrough in RSV antiviral development, addressing the lack of effective treatments worldwide. NEJM also featured an editorial by Professor Edward Walsh, recognizing the findings as promising for RSV therapy.
• In September 2023, Via Nova Therapeutics, Inc. announced that the U.S. FDA has cleared its Investigational New Drug (IND) application for VNT-101, an influenza A nucleoprotein inhibitor. CEO Don Ganem called it a key milestone in developing a novel flu antiviral. VNT-101 is an investigational small molecule targeting influenza A nucleoprotein. It has shown in vitro efficacy against seasonal influenza A, highly pathogenic avian influenza (H5N1, H7N9), and drug-resistant strains, positioning it as a potential breakthrough in flu treatment.

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

 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:

o   NS3/4A Protease

o   NS5A Protein

o   NS5B RNA-Dependent RNA polymerase

• Direct-acting Antiviral Drug Market, By Indication:

o   Hepatitis C Virus

o   HIV Infection/ AIDS

o   Influenza

o   Prophylaxis

• Direct-acting Antiviral Drug Market, By Route:

o   Intravenous

o   Oral

o   Subcutaneous

o   Topical

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

o   Hospital Pharmacies

o   Retail Pharmacies

o   Online Pharmacies

• Direct-acting Antiviral Drug Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  Germany

§  United Kingdom

§  France

§  Italy

§  Spain

o   Asia-Pacific

§  China

§  Japan

§  India

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Direct-acting Antiviral Drug Market.

Available Customizations:

Global Direct-acting Antiviral Drug market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).