Global Hepatitis B Treatment Market - 2024-2033

The global hepatitis B treatment market size reached US$ 3.57 billion in 2024 and is expected to reach US$ 6.47 billion by 2033, growing at a CAGR of 6.9% during the forecast period 2025-2033.

Hepatitis B is a viral infection that causes inflammation of the liver, which may initially present as mild but, in some cases, can develop into a chronic condition that persists over time. If left untreated, the ongoing inflammation can result in significant liver damage, including cirrhosis and liver failure. The virus can cause substantial harm even without obvious symptoms, making it a silent but serious health threat.

The approach to treating hepatitis B depends on various factors, including the patient's age, overall health, the stage of the infection, and any pre-existing liver issues. The main goals of treatment are to control the virus, prevent further liver damage, and slow the progression of the disease. For those with chronic infections, antiviral medications are often used to manage viral replication, thereby reducing the risk of severe liver complications.

The hepatitis B treatment market has experienced significant growth, fueled by advances in antiviral therapies, rising awareness and the increasing global prevalence of chronic hepatitis B. For instance, hepatitis B remains a major public health concern worldwide. According to the Hepatitis B Foundation, 2 billion people have been infected with the hepatitis B virus (1 out of 3 people). Approximately 1.5 million people become newly infected each year. Almost 300 million people are chronically infected. Approximately 10% of infected individuals are diagnosed. As the disease can lead to serious liver conditions, such as cirrhosis and liver cancer (HCC), the demand for effective treatment options has been on the rise.

Market Dynamics: Drivers & Restraints

Growing combination therapy approaches are significantly driving the hepatitis B treatment market growth

While current antiviral treatments like tenofovir and entecavir effectively suppress HBV replication, they don't eliminate the virus. Combination therapies are being developed to enhance viral suppression and increase the chance of a functional cure. Thus, key market players are focusing on the development of combination therapies for better treatment.

For instance, in November 2024, Barinthus Biotherapeutics plc announced the most significant data so far from the ongoing Phase 2b HBV003 clinical trial. The study is evaluating different dosing regimens of VTP-300 in combination with low-dose nivolumab, an anti-PD-1 monoclonal antibody, and showed that as of the data cut-off, eight participants were reported with complete HBsAg loss, and two participants met the criteria for functional cure.

Additionally, in November 2024, Brii Biosciences Limited released new data from its ongoing Phase 2 ENSURE study. The study excluded HBV patients with low baseline HBsAg levels (<100 IU/mL) to investigate the potential curative benefits in broader patient populations. The ENSURE 48-week end-of-treatment (EOT) data demonstrated that 26.3% (5/19) or 33.3% (6/18) of participants receiving 200 mg or 100 mg elebsiran in combination with PEG-IFNα versus 5.6% (1/18) receiving PEG-IFNα alone achieved HBsAg seroclearance at EOT.

Combination therapies typically combine antiviral agents with other modalities, such as immune modulators, checkpoint inhibitors, or RNA-based therapies. These approaches address the limitations of current treatments and offer a pathway towards curative solutions for chronic HBV infections. As combination therapies provide more effective treatments and reduce the need for long-term therapy, they are expected to improve patient outcomes and reduce the burden of chronic disease. This, in turn, makes treatment more accessible, especially in resource-limited regions.

Side effects and drug resistance hamper the market growth

Side effects and drug resistance are significant challenges in the management of hepatitis B, which are hampering the growth of the hepatitis B treatment market. These issues can lead to treatment failure, reduced patient adherence, and limited therapeutic options, ultimately affecting market expansion.

Long-term use of antiviral therapies, such as nucleoside analogs (NA), such as tenofovir, entecavir, can lead to the emergence of drug-resistant strains of HBV, which limits the efficacy of these treatments and necessitates the development of alternative therapies. For instance, resistance to lamivudine, one of the earliest antiviral drugs used for HBV, became common after prolonged use. Tenofovir and entecavir have shown lower resistance rates, but resistance still occurs in a subset of patients.

Drug-resistant strains of HBV can lead to suboptimal treatment responses, requiring changes in therapy or the addition of new drugs, which complicates treatment regimens. For instance, Gilead Sciences' tenofovir alafenamide (Vemlidy) was developed to address safety concerns related to renal and bone health. As patients develop resistance, alternative treatments like pegylated interferon or combination therapies are required, which are more expensive and less convenient for patients.

Segment Analysis

The global hepatitis B treatment market is segmented based on type, treatment, route of administration, distribution channel, and region.

Type:

The chronic hepatitis B from the type segment is expected to dominate the hepatitis B treatment market with the highest market share

There is a direct relationship between the risk of developing a chronic hepatitis B infection and the age of first exposure to hepatitis B virus: 90% of infected newborns and infants will become chronic hepatitis B carriers, Between 30% and 50% of infected children (aged 1-5 years) will develop chronic infection, 5-10% of infected adults will develop chronic hepatitis B (i.e. 90% would recover).

The chronic hepatitis B segment is expected to grow during the forecast period owing to factors like, rise in the incidence of chronic hepatitis B, which is leading to liver cancer and cirrhosis, advances in drug development, including novel antivirals and immunomodulators and other factors that helps the segment to grow during the forecast period.

For instance, according to an NCBI-published article, it is estimated that each year, chronic hepatitis B infection in the United States ranges from 700,000 to more than 2 million persons. As the chronic condition rises, market players are developing effective therapies for better treatment. For instance, in August 2024, the Japanese Ministry of Health, Labour and Welfare (MHLW) assigned the SENKU (previously known as SAKIGAKE) designation for bepirovirsen, an experimental antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B (CHB), by GSK Plc.

Additionally, in February 2024, GSK plc announced that Fast Track designation for bepirovirsen, an experimental antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B (CHB), has been awarded by the US Food and Drug Administration (FDA).

Treatment:

The vaccines from the treatment segment is expected to dominate the hepatitis B treatment market with the highest market share

The hepatitis B vaccine is a medication used to prevent infection, which can lead to chronic liver failure and hepatocellular carcinoma. It reviews its indications, action, and contraindications, highlighting its mechanism of action, adverse event profile, and other crucial factors for healthcare team members to reduce the burden of hepatitis B on patients and communities.

Two different vaccines are used to treat hepatitis B: combination vaccine and single antigen vaccine. The vaccines segment in hepatitis B treatment is expected to grow by various factors like the prevalence of the hepatitis B disease, increased awareness, government immunization programs and vaccine development advancements are driving demand, while investments in R&D and public-private partnerships are expanding vaccine accessibility and market growth.

For instance, in February 2024, TherVacB, a novel therapeutic vaccine designed by Helmholtz Munich, entered its first clinical trial. The Phase Ia trial, conducted at LMU University Hospital Munich's Division of Infectious Diseases and Tropical Medicine, will investigate the vaccine's safety and immunogenicity in healthy volunteers. The first clinical trial in patients with chronic hepatitis B is set to begin in 2024.

Geographical Analysis

North America is expected to hold a significant position in the global hepatitis B treatment market with the highest market share

With the increased incidence of hepatitis B infection and the rising prevalence in the region, there is a growing demand for treatment. For instance, according to the report by the Centers for Disease Control and Prevention (CDC), in 2024, an estimated 850,000 to 2.2 million individuals in the United States are living with chronic hepatitis B virus (HBV) infection.

One of the major driving forces is the ongoing investment in research and development by both pharmaceutical companies and government bodies. North America includes the largest pharmaceutical companies, which are continuously working on improving existing treatments and developing new therapies for Hepatitis B. This includes advancements in antiviral medications, immune therapies, and potential cures.

For instance, in November 2024, the Coalition for Global Hepatitis Elimination launched the Center for Operational Research on Hepatitis B (COR-HEPB), a global center dedicated to catalyzing investments and coordinating research to expand access to hepatitis B care and treatments in low- and middle-income countries (LMICs). The center aims to prevent disability and premature mortality from hepatitis B, with generous support from Open Philanthropy.

Furthermore, in October 2024, Precision BioSciences received Clinical Trial Application (CTA) approval in Moldova for its lead candidate, PBGENE-HBV. The in vivo gene editing program aims to cure chronic hepatitis B by eliminating cccDNA, the key source of replicating HBV and inactivating integrated HBV DNA in hepatocytes. The company has opened its Phase 1 clinical program and is now moving towards dosing patients.

Competitive Landscape

Top companies in the hepatitis B treatment market include Gilead Sciences, Inc., Merck & Co. Inc., GSK plc, Accord Healthcare Limited, APOTEX INC, Dynavax Technologies Corporation, Bharat Biotech, Serum Institute of India Pvt. Ltd, Sanofi S.A., VBI Vaccines Inc., and among others.

Why Purchase the Report?

• Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.

• Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.

• Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.

• Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.

• Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.

• Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.

• Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.

• Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.

• Regional Growth & Investment: Highlights high-growth regions and investment opportunities.

• Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.

• Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.

• Post-market Surveillance: Uses post-market data to enhance product safety and access.

• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global Hepatitis B Treatment market report delivers a detailed analysis with 70 key tables, more than 60 visually impactful figures and 172 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

• Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.

• Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.

• Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.

• Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.

• Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.

• Supply Chain: Distribution and Supply Chain Managers.

• Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.

• Academic & Research: Academic Institutions.