Key Findings

• Chronic Hepatitis B market size projection: As per DelveInsight’s analysis, the total market size of Chronic Hepatitis B in the 7MM is expected to reach significant value driven by novel therapeutic modalities and increasing patient identification rates across global markets.

• Chronic Hepatitis B market drivers: Key market drivers of Chronic Hepatitis B include growing disease prevalence with approximately 254 million people worldwide living with chronic hepatitis B, push toward functional cure through innovative therapeutic approaches, rising awareness and screening programs, favorable regulatory support for breakthrough therapies, and advancements in antiviral therapies including siRNAs, antisense oligonucleotides, and immune checkpoint inhibitors.

• Chronic Hepatitis B epidemiology: The report provides the total Chronic Hepatitis B potential pool of approximately 4.97 million prevalent cases across the 7MM in 2024, with 1.79 million diagnosed cases and 670,000 treated cases. Males account for approximately 59% of cases while females represent 41% of the patient population.

• Key Chronic Hepatitis B companies: Leading Chronic Hepatitis B companies include Gilead Sciences, GSK, Janssen Pharmaceuticals, Arrowhead Pharmaceuticals, Arbutus Biopharma, Vir Biotechnology, Precision BioSciences, Lion TCR, and others driving innovation in this therapeutic area.

• Chronic Hepatitis B pipeline assets: Some of the key Chronic Hepatitis B assets in the pipeline include Daplusiran/tomligisiran (GSK/Janssen/Arrowhead), Imdusiran/AB-729 (Arbutus Biopharma), Bepirovirsen (GSK), PBGENE-HBV (Precision BioSciences), LioCyx-M004 (Lion TCR), Tobevibart and Elebsiran (Vir Biotechnology), and others representing diverse therapeutic modalities.

• Recent developments:

  • September 2025: Precision BioSciences received FDA IND clearance for PBGENE-HBV, marking the first-ever in vivo gene-editing trial for chronic hepatitis B in the United States.

  • September 2025: Lion TCR achieved triple FDA milestones with IND clearance for LioCyx-M004 TCR-T cell therapy, following earlier Fast Track and Orphan Drug designations.

  • July 2025: TherVacB therapeutic vaccine entered its first clinical trial in patients, with the first patient enrolled in June 2025 across multiple European and African sites.

  • May 2025: Arbutus Biopharma reported functional cure in 8 patients with chronic hepatitis B using Imdusiran combination therapy, including 2 patients who received no interferon.

Discover more recent advancements in the Chronic Hepatitis B landscape @ Chronic Hepatitis B Recent Developments.

Chronic Hepatitis B Market Intelligence

The Chronic Hepatitis B market demonstrates robust growth potential with the 7MM market valued at USD 1,603 million in 2025 and projected to grow at a CAGR of 12.3% through 2034. This substantial growth trajectory reflects the convergence of several key factors including significant unmet medical needs, innovative pipeline developments, and supportive regulatory environment.

According to DelveInsight’s comprehensive Chronic Hepatitis B Market Insight, Epidemiology And Market Forecast report, the market size distribution shows the United States commanding the largest share at approximately 72%, followed by Japan at 11%, and EU4 & UK markets representing 17% collectively. Within the European markets, Germany maintains the highest market size at approximately USD 65 million in 2024, while Japan’s market reached approximately USD 160 million. This geographic distribution reflects varying disease prevalence rates, healthcare infrastructure capabilities, and market access dynamics across regions.

The Chronic Hepatitis B market growth projections are primarily driven by the anticipated launch of emerging therapies including Daplusiran/tomligisiran, Imdusiran (AB-729), and other pipeline candidates expected to enter the market during the forecast period. The current treatment landscape remains characterized by limited definitive cure options and only a few FDA-approved treatments, creating substantial opportunities for innovative therapeutic approaches.

Epidemiologically, the 7MM markets demonstrate significant patient populations with 4.97 million prevalent cases and 1.79 million diagnosed cases in 2024. The age-related infection risk patterns show nearly 90% of infected newborns developing chronic infection, up to 50% of infected children (1-5 years), and about 5-10% of infected adults progressing to chronic hepatitis B. This epidemiological profile underscores the critical importance of developing curative therapies that can address the diverse patient populations across different age groups and disease stages.

For a deeper analysis of the evolving Chronic Hepatitis B market, download our free sample report.

Chronic Hepatitis B Competitive Landscape

Key players include Gilead Sciences (VEMLIDY – tenofovir alafenamide), GSK (Bepirovirsen – antisense oligonucleotide), Janssen/Arrowhead Pharmaceuticals (Daplusiran/tomligisiran – siRNA therapeutic), Arbutus Biopharma (Imdusiran/AB-729 – RNAi therapeutic), Vir Biotechnology (Tobevibart and Elebsiran combination), Precision BioSciences (PBGENE-HBV – gene editing therapy), and Lion TCR (LioCyx-M004 – TCR-T cell therapy).

Clinical pipeline activity spans multiple development phases with several breakthrough designations and regulatory milestones achieved in 2025. GSK’s Bepirovirsen received Fast Track designation and is advancing through Phase III B-Well clinical trials. Precision BioSciences’ PBGENE-HBV received both Fast Track designation and IND clearance, marking the first gene-editing therapy to enter clinical trials for chronic hepatitis B. Lion TCR achieved unprecedented triple FDA recognition with Fast Track, Orphan Drug designation, and IND clearance for LioCyx-M004. Arbutus Biopharma reported remarkable functional cure rates with Imdusiran, planning Phase 2b initiation in the first half of 2025.

Furthermore, the Chronic Hepatitis B drug profiles demonstrate diverse mechanisms of action addressing different aspects of HBV pathophysiology. Bepirovirsen operates as a triple-action antisense oligonucleotide designed to recognize and destroy HBV genetic components, potentially enabling immune system recovery. PBGENE-HBV utilizes meganuclease gene-editing technology to eliminate covalently closed circular DNA and inactivate integrated HBV DNA. Imdusiran employs RNAi technology specifically designed to reduce all HBV viral proteins and antigens. Tobevibart functions as a broadly neutralizing monoclonal antibody targeting hepatitis B surface antigen.

Development milestones achieved in 2025 represent unprecedented progress toward functional cure objectives. Precision BioSciences obtained FDA IND clearance for the first gene-editing therapy in chronic hepatitis B, with Phase 1 ELIMINATE-B trials progressing through dose escalation cohorts. Lion TCR received comprehensive FDA recognition including Fast Track, Orphan Drug designation, and IND clearance for its TCR-T cell therapy. Arbutus Biopharma reported functional cure achievement in 8 patients, including 2 without interferon treatment. GSK advanced Bepirovirsen through Phase III development with multiple regulatory designations including Fast Track and SENKU designation in Japan.

Commercial arrangements reflect strategic collaborations and licensing deals shaping market dynamics. GSK’s acquisition of exclusive rights to hepatitis B therapy from Janssen Pharmaceuticals for $1 billion demonstrates significant industry investment in innovative treatment approaches. Vir Biotechnology’s partnerships with Alnylam for elebsiran and ongoing development activities illustrate collaborative approaches to combination therapy development. These strategic arrangements position companies for comprehensive market coverage and accelerated development timelines.

Pipeline development encompasses revolutionary therapeutic approaches including gene editing, TCR-T cell therapy, siRNA technology, antisense oligonucleotides, and immunomodulatory agents, representing the most diverse and promising development landscape in chronic hepatitis B treatment history.

Delve deeper into the major and specialised companies in the Chronic Hepatitis B market @ Chronic Hepatitis B Competitive Landscape.

Chronic Hepatitis B Market Drivers and Barriers

Unmet medical needs remain substantial despite available antiviral therapies, as current treatments achieve functional cure rates of less than 2-8%, which is not clinically meaningful for the 254 million people worldwide living with chronic hepatitis B. The treatment landscape lacks definitive cure options, with existing nucleoside analog therapies requiring lifelong administration to suppress viral replication without addressing hepatitis B surface antigen levels essential for functional cure achievement.

Other drivers include growing disease prevalence with 12 million new infections annually, novel therapeutic modalities revolutionizing treatment approaches, favorable regulatory support demonstrated by multiple Fast Track and breakthrough designations, rising awareness and screening programs improving patient identification, and push toward functional cure driving innovation in siRNAs, antisense oligonucleotides, capsid assembly modulators, and immune checkpoint inhibitors. The anticipated launch of emerging therapies including Imdusiran (AB-729), GSK3228836 (Bepirovirsen), and PBGENE-HBV creates substantial market expansion opportunities during the forecast period.

Download the Chronic Hepatitis B Market report to understand which other factors are driving the therapeutic market @ Chronic Hepatitis B Market Trends.

Conclusion

The Chronic Hepatitis B treatment market stands at a pivotal transformation point, with DelveInsight’s analysis revealing unprecedented growth prospects driven by breakthrough therapeutic innovations and supportive regulatory environment. The market’s projected 12.3% CAGR through 2034 reflects the convergence of significant unmet medical needs, revolutionary pipeline developments, and strategic industry investments positioning this therapeutic area for substantial expansion and improved patient outcomes.

Scope of the Chronic Hepatitis B Market Report

• Comprehensive market analysis covering key events, executive summary, descriptive overview explaining chronic hepatitis B causes, signs and symptoms, pathogenesis, and currently available therapies

• Detailed epidemiology segments and forecasts providing future growth potential of diagnosis rates and disease progression, along with country-specific treatment guidelines across 7MM markets

• All-inclusive account of current and emerging therapies with elaborate profiles of late-stage and prominent therapies impacting the Chronic Hepatitis B Treatment Market Landscape

• Detailed review of historical and forecasted Chronic Hepatitis B Treatment Market size, market share by therapies, detailed assumptions, and rationale behind analytical approach covering 7MM drug outreach

• Business strategy development insights through SWOT analysis, expert insights/KOL views, patient journey understanding, and treatment preferences shaping 7MM Chronic Hepatitis B Drugs Market

• Ten-year forecast period with comprehensive 7MM coverage including the United States, EU4 countries (Germany, France, Italy, Spain), the United Kingdom, and Japan

• Chronic Hepatitis B epidemiology segmentation, including total prevalent cases, total diagnosed cases, cases by age group, cases by gender, treated cases, and cases by liver impact

• Key cross-competition analysis and market opportunity assessment for existing and emerging therapeutic approaches

• Market drivers and barriers analysis encompassing unmet medical needs, regulatory landscape, and competitive dynamics influencing market evolution

Table of Contents

1. Key Insights

2. Executive Summary of Chronic Hepatitis B

3. Competitive Intelligence Analysis for Chronic Hepatitis B

4. Chronic Hepatitis B Market Overview at a Glance

5. Chronic Hepatitis B: Disease Background and Overview

6. Chronic Hepatitis B Patient Journey

7. Chronic Hepatitis B Epidemiology and Patient Population

8. Treatment Algorithm, Current Treatment, and Medical Practices

9. Chronic Hepatitis B Unmet Needs

10. Key Endpoints of Chronic Hepatitis B Treatment

11. Chronic Hepatitis B Marketed Products

12. Chronic Hepatitis B Emerging Therapies

13. Chronic Hepatitis B: Seven Major Market Analysis

14. Attribute analysis

15. 7MM: Market Outlook

16. Access and Reimbursement Overview of Chronic Hepatitis B

17. KOL Views

18. Chronic Hepatitis B Market Drivers

19. Chronic Hepatitis B Market Barriers

20. Appendix

21. DelveInsight Capabilities

22. Disclaimer

23. About DelveInsight

About DelveInsight

DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.

Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Arpit Anand
Email: Send Email
Phone: +14699457679
Address:304 S. Jones Blvd #2432
City: Las Vegas
State: Nevada
Country: United States
Website: https://www.delveinsight.com/consulting/due-diligence-services