Hepatitis B and C Therapeutics Market to Reach USD 20.83 Billion by 2033 | CAGR 3.4% | North America Leads with 38% Share | Key Players: Gilead Sciences, AbbVie, Bristol-Myers Squibb, Johnson & Johnson, Dynavax Technologies, VBI Vaccines

Hepatitis B and C Therapeutics Market Size

The global hepatitis B and C therapeutics market reached US$ 17.02 billion in 2024 and is projected to reach US$ 20.83 billion by 2033, growing at a CAGR of 3.4% during the forecast period 2025-2033. Rising awareness of viral hepatitis, large-scale screening initiatives, and government programs promoting early diagnosis and treatment are key factors driving market growth.

Hepatitis B and C infections remain a significant global health concern, with over 350 million people living with chronic infections according to WHO. Many patients remain undiagnosed until the disease progresses, creating a strong need for effective therapeutics. Antiviral therapies, including nucleoside analogues for hepatitis B and direct-acting antivirals (DAAs) for hepatitis C, are increasingly prescribed as part of national and global elimination strategies. Government and health organization programs, such as the WHO Global Health Sector Strategy on Viral Hepatitis (2022-2030), India's National Viral Hepatitis Control Program, and the U.S. CDC Hepatitis Elimination Plan, are strengthening early diagnosis and patient enrollment in treatment, further boosting market demand.

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Recent Developments:

✅ June 2025: The U.S. FDA approved an expanded indication for AbbVie's MAVYRET® (glecaprevir/pibrentasvir), allowing treatment of both adults and pediatric patients (≥3 years) with acute or chronic hepatitis C, achieving 96% cure rates.

✅ January 2025: The FDA granted Breakthrough Therapy designation to brelovitug (BJT‐778) from Bluejay Therapeutics for chronic hepatitis D, based on promising Phase 2 virologic response and liver enzyme normalization.

✅ 2025: Precision BioSciences received FDA clearance of an IND application for PBGENE‐HBV, a gene‐editing therapy targeting the root cause of chronic hepatitis B, enabling Phase 1 clinical studies globally.

✅ 2025: National hepatitis screening and treatment programs across the U.S., Japan, and South Korea expanded access to antivirals, improving early diagnosis and treatment rates.

✅ December 2025: Sanofi announced acquisition of Dynavax Technologies, including its Heplisav‐B hepatitis B vaccine, for US$2.2 billion to strengthen its hepatitis prevention and vaccine portfolio.

Mergers & Acquisitions:

✅ December 2025: Sanofi acquired Dynavax Technologies to expand its hepatitis B vaccine offerings and enhance global access.

✅ October 2025: A European biopharmaceutical company acquired a hepatitis therapeutics-focused startup to strengthen antiviral drug pipelines.

✅ July 2025: A North American biotech firm partnered with a regional government program to co-develop antiviral therapies and expand treatment availability for hepatitis B and C patients.

Key Players:

• Gilead Sciences, Inc. - Holds a 15.3% share, driven by its broad portfolio of antiviral therapies and vaccines targeting hepatitis B and C, supported by ongoing clinical trials and global distribution networks.

• AbbVie Inc. - Holds a 13.7% share, fueled by innovative therapies and strategic collaborations to expand access to hepatitis treatments worldwide.

• Bristol-Myers Squibb Company - Holds a 12.5% share, supported by strong R&D pipelines for novel antiviral drugs and partnerships with healthcare providers to improve patient outreach.

• Merck & Co., Inc. - Holds an 11.8% share, driven by its antiviral therapeutics, vaccination programs, and robust regulatory approvals across multiple regions.

• Johnson & Johnson - Holds a 10.9% share, fueled by its integrated portfolio of hepatitis treatments, global supply chain capabilities, and investment in advanced therapies.

• Roche Holding AG - Holds a 9.6% share, supported by its diagnostic and therapeutic solutions for hepatitis B and C, coupled with innovative biologic treatments.

• Dynavax Technologies Corporation - Holds a 9.2% share, driven by its novel adjuvant technologies and partnerships enhancing hepatitis vaccine efficacy.

• VBI Vaccines - Holds a 7.0% share, fueled by its development of next-generation hepatitis vaccines and strategic collaborations with biotech firms and healthcare organizations.

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Market Segmentation:

➥By indication, hepatitis B (HBV) accounts for approximately 56% of the market, driven by its high prevalence in Asia-Pacific and ongoing vaccination and antiviral therapy programs. Hepatitis C (HCV) represents around 44% of the market, fueled by increasing diagnosis rates, government screening initiatives, and the widespread adoption of direct-acting antivirals (DAAs).

➥By route of administration, oral therapies hold a dominant share of about 62%, supported by the convenience of oral antiviral drugs and improved patient adherence for long-term treatment regimens. Injectable therapies account for 38% of the market, primarily driven by vaccines and specialized therapeutic biologics requiring parenteral administration. In terms of distribution channels, hospital pharmacies lead with a 54% share, due to the high concentration of chronic hepatitis patients in hospitals and specialized treatment centers. Retail pharmacies hold 46% of the market, supported by ease of access, increasing availability of complementary therapies, and outpatient treatment programs.
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Market Dynamics:

Drivers:
The global hepatitis B and C therapeutics market is primarily driven by the rising prevalence of chronic hepatitis infections worldwide. Approximately 254 million people live with chronic Hepatitis B and nearly 50 million with chronic Hepatitis C, with millions of new cases reported annually. Regions such as Asia-Pacific and Sub-Saharan Africa account for over 70% of global Hepatitis B cases, largely due to inadequate vaccination coverage, unsafe medical practices, and limited access to screening programs. In contrast, in developed countries such as the United States and Europe, increasing cases linked to intravenous drug use and blood transfusion-related transmission sustain the disease burden. This growing patient population has fueled the demand for effective antiviral therapies, combination regimens, and emerging curative treatments, prompting pharmaceutical companies and governments to invest heavily in research, treatment infrastructure, and vaccination programs, thereby strengthening market growth.

Restraints:
However, the market faces significant restraints from high treatment costs and limited access to care. Branded antiviral therapies for Hepatitis B and C can be prohibitively expensive, with a 12-week sofosbuvir-based therapy ranging from USD 25,000 to USD 90,000 in developed markets, while chronic Hepatitis B treatments cost between USD 300 and USD 1,200 per year. Although generic versions are available in emerging regions, their distribution is often restricted by regulatory hurdles and limited healthcare infrastructure. These financial and logistical barriers restrict patient access, delay treatment initiation, and negatively impact market expansion, particularly in low- and middle-income countries across Asia and Africa.

Regional Insights:

North America is expected to hold the largest share of the global hepatitis B and C therapeutics market, accounting for approximately 38% in 2024. This dominance is driven by well-established healthcare infrastructure, widespread access to advanced antiviral therapies, strong government and private investment in disease management programs, and early adoption of innovative treatments. The United States, in particular, benefits from extensive screening initiatives, robust reimbursement policies, and active research and development efforts.

Europe follows with an estimated 28% market share, supported by government-led screening campaigns, high awareness of hepatitis management, and growing adoption of combination therapies for chronic hepatitis infections.

The Asia-Pacific region is expected to register the fastest growth, holding roughly 22% of the market by 2024, due to a high prevalence of hepatitis B, large untreated patient populations, and improving healthcare infrastructure in countries such as China, India, and Japan. Government initiatives focused on vaccination, early diagnosis, and subsidized treatment further drive adoption in this region.

Latin America and the Middle East & Africa collectively account for about 15% of the global market. While these regions are gradually expanding due to improving healthcare infrastructure and awareness campaigns, affordability, limited access, and regulatory hurdles continue to restrict full market potential.

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