Hepatitis B Treatment Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Acute, Chronic), By Treatment (Immune Modulator Drugs, Antiviral Drugs, Vaccines, Surgery), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 5.11 Billion
CAGR (2026-2031)	4.14%
Fastest Growing Segment	Surgery
Largest Market	North America
Market Size (2031)	USD 6.52 Billion

Market Overview

The Global Hepatitis B Treatment Market will grow from USD 5.11 Billion in 2025 to USD 6.52 Billion by 2031 at a 4.14% CAGR. The Global Hepatitis B Treatment Market involves the provision of antiviral drugs and immune modulators intended to inhibit viral replication and mitigate liver damage. The primary drivers fueling this sector are the rising global prevalence of chronic infections and expanded government initiatives for screening and immunization, which underscore the critical need for effective therapeutic interventions. According to the World Health Organization, in 2024, approximately 254 million people worldwide were estimated to be living with chronic hepatitis B infection.

Conversely, a major challenge hindering market growth is the substantial rate of underdiagnosis, particularly in developing regions. High costs associated with lifelong treatment and inadequate healthcare infrastructure prevent a significant portion of the infected population from accessing necessary care. This disconnect between high disease prevalence and the low number of diagnosed patients limits the commercially addressable market, creating a formidable barrier for pharmaceutical companies aiming to expand their global footprint.

Key Market Drivers

Accelerated R&D investments in functional cure therapeutics are fundamentally reshaping the Global Hepatitis B Treatment Market, shifting the paradigm from lifelong viral suppression to finite-duration regimens that restore immune control. Pharmaceutical developers are aggressively pursuing novel modalities, such as small interfering RNAs and capsid assembly modulators, which target specific stages of the viral lifecycle to achieve sustained seroclearance. This innovation is yielding promising clinical data; according to Vir Biotechnology, in May 2025, preliminary results from a phase 2 study demonstrated that its investigational combination therapy achieved a functional cure rate of 15% in a specific subgroup of participants. Such advancements underscore the industry’s strategic pivot toward curative solutions, aiming to address the limitations of current nucleoside analogues and capture a larger share of the therapeutic landscape.

Concurrently, the expansion of government-sponsored screening and vaccination programs is increasing patient identification and linkage to care, particularly in high-prevalence regions. National health policies are increasingly aligning with viral elimination goals, supported by international alliances that facilitate access to preventative measures. According to the Hepatitis B Foundation's 2024 Annual Report, the Gavi alliance launched a campaign in June 2024 to introduce the hepatitis B birth dose vaccine across 32 African countries. These public health initiatives are expanding the diagnosed population, thereby strengthening the commercial foundation for antiviral manufacturers. Reflecting this sector's robust trajectory, according to Gilead Sciences, in February 2025, the company reported an 8% increase in full-year 2024 product sales (excluding Veklury), with its liver disease portfolio identified as a primary growth driver.

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Key Market Challenges

The primary constraint preventing the hepatitis B treatment market from reaching its full economic potential is the high rate of underdiagnosis. Although the global prevalence of the disease suggests a large volume of potential users for antiviral drugs, the actual addressable market is significantly smaller because most individuals remain unaware of their infection status. This lack of awareness creates a fundamental disconnect between the number of existing cases and the number of patients actively seeking medical intervention, thereby limiting revenue streams for manufacturers of therapeutic agents.

This diagnostic gap directly restricts the volume of prescriptions and impedes the uptake of available medications. Even with available inventory, pharmaceutical companies face a ceiling on growth as long as the majority of the infected population remains outside the healthcare system. According to the World Health Organization, in 2024, only 13 percent of people living with chronic hepatitis B infection had been diagnosed. This statistic highlights that the industry is currently accessing a small fraction of the total patient population, resulting in a market environment where potential demand far exceeds realized sales.

Key Market Trends

The clinical evaluation of therapeutic vaccines is gaining momentum as a strategic priority to establish sustained viral control by reinvigorating the host's exhausted T-cell response. Unlike standard antivirals that primarily suppress replication, these investigational vaccines aim to induce specific immunity, potentially enabling patients to discontinue lifelong therapy. This approach is showing tangible progress in clinical settings; according to Barinthus Biotherapeutics, November 2024, in the 'Barinthus Bio Announces Results From Ongoing Phase 2b Chronic Hepatitis B Trial' press release, eight participants treated with the candidate VTP-300 achieved HBsAg loss at any time, with two meeting the criteria for a functional cure. This data highlights the growing potential of vaccination strategies to successfully address the immune tolerance that characterizes chronic infection.

Simultaneously, the market is witnessing a distinct focus on immunomodulatory drug candidates, particularly monoclonal antibodies designed to rapidly reduce viral antigen burdens. Developers are prioritizing agents that can deplete circulating hepatitis B surface antigen (HBsAg), thereby removing a primary suppression mechanism of the host's immune system to facilitate recovery. This trend is exemplified by recent clinical successes; according to Bluejay Therapeutics, November 2024, in the 'Bluejay Therapeutics Reports Best-in-Class Monoclonal Antibody BJT-778' press release, 100% of participants in the 300 mg weekly dose group achieved a virologic response by Week 44. These advancements reflect a broader industry shift towards immunotherapies that complement direct-acting antivirals to achieve higher functional cure rates.

Segmental Insights

Based on current market analysis, the Surgery segment is identified as the fastest-growing category within the Global Hepatitis B Treatment Market. This rapid expansion is primarily driven by the escalating progression of chronic Hepatitis B infections into severe complications, such as liver cirrhosis and hepatocellular carcinoma, which often require liver transplantation as a life-saving measure. While antiviral drugs manage the virus, they rarely provide a complete cure, making surgical intervention necessary for end-stage liver disease. Furthermore, the World Health Organization highlights the rising burden of these liver-related conditions, which, combined with improving healthcare infrastructure and surgical access in emerging economies, significantly fuels the demand for this segment.

Regional Insights

North America holds a dominant position in the global hepatitis B treatment market driven by established healthcare infrastructure and favorable reimbursement policies. The region benefits from the concentrated presence of key pharmaceutical companies that facilitate wide accessibility to therapeutics. Additionally, proactive initiatives by organizations such as the Centers for Disease Control and Prevention encourage higher diagnosis rates through comprehensive screening programs. This high diagnostic rate directly correlates with increased demand for therapeutics. Furthermore, streamlined drug approval processes by the U.S. Food and Drug Administration support the continuous introduction of effective treatments, cementing the region's market leadership.

Recent Developments

• In November 2024, Arbutus Biopharma and Barinthus Biotherapeutics presented new preliminary data from their Phase 2a IM-PROVE II clinical trial at The Liver Meeting. The study evaluated a combination of imdusiran, an RNA interference therapeutic, and VTP-300, an immunotherapeutic candidate, in patients with chronic hepatitis B. The results indicated that adding low-dose nivolumab to the treatment regimen significantly increased the rates of hepatitis B surface antigen loss compared to other cohorts. These findings supported the belief that lowering surface antigen levels is crucial for reawakening the immune system and achieving a functional cure for the disease.
• In November 2024, Vir Biotechnology announced positive end-of-treatment data from its Phase 2 MARCH study evaluating a novel combination regimen for chronic hepatitis B. The trial assessed the efficacy of tobevibart, an investigational monoclonal antibody, and elebsiran, a small interfering RNA, administered with or without pegylated interferon alfa. The results demonstrated that a substantial percentage of participants achieved hepatitis B surface antigen loss at the end of the treatment period. These findings, presented at the American Association for the Study of Liver Diseases annual meeting, highlighted the potential of this regimen to serve as a functional cure for the chronic condition.
• In March 2024, Gilead Sciences received approval from the U.S. FDA for a supplemental new drug application regarding its antiviral medication, Vemlidy. The approval expanded the indication to include the treatment of chronic hepatitis B virus infection in pediatric patients aged six years and older weighing at least 25 kilograms with compensated liver disease. Previously, the treatment was authorized only for patients aged 12 and older. This label expansion addressed a significant unmet medical need for younger children requiring effective management of the viral infection to prevent long-term liver complications such as cirrhosis and liver cancer.
• In February 2024, GSK announced that the U.S. Food and Drug Administration granted Fast Track designation for bepirovirsen, its investigational antisense oligonucleotide for treating chronic hepatitis B. This regulatory milestone was intended to expedite the review of the therapy, addressing an unmet medical need for this serious condition. The designation was supported by promising data from Phase IIb clinical trials, which evaluated the drug's efficacy and safety. GSK highlighted that bepirovirsen demonstrated the potential to achieve a clinically meaningful functional cure when used in combination with oral nucleoside/nucleotide analogues, marking a significant advancement in the company’s liver disease pipeline.

Key Market Players

• Bristol-Myers Squibb
• Gilead Sciences, Inc.
• GlaxoSmithKline PLC
• Accord Healthcare Inc.
• Apotex Corp.
• Arbutus Biopharma Corp
• Arrowhead Pharma Inc
• Aurobindo Pharma Limited
• Lupin Pharmaceuticals Inc.
• Merck & Co. Inc.

By Type	By Treatment	By Distribution Channel	By Region
Acute Chronic	Immune Modulator Drugs Antiviral Drugs Vaccines Surgery	Hospital Pharmacies Retail Pharmacies Online Pharmacies	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Hepatitis B Treatment Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Hepatitis B Treatment Market, By Type:

• Acute
• Chronic

• Hepatitis B Treatment Market, By Treatment:

• Immune Modulator Drugs
• Antiviral Drugs
• Vaccines
• Surgery

• Hepatitis B Treatment Market, By Distribution Channel:

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

• Hepatitis B Treatment 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