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Chronic Hepatitis B market

The Chronic Hepatitis B (CHB) market across the seven major markets (7MM), the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, is projected to experience strong growth over the next decade. Valued at approximately USD 1,603 million in 2025, the market is expected to expand at a robust CAGR of 12.3% during the forecast period (2025–2034).

The United States is anticipated to remain the largest contributor, capturing around 72% of the total 7MM market share in 2024. The EU4 and the United Kingdom collectively represented nearly USD 270 million in 2024, accounting for approximately 17% of the total market, while Japan also contributes notably to the overall market landscape.

In 2024, there were approximately 4.97 million prevalent cases of Chronic Hepatitis B across the 7MM, with 1.79 million diagnosed cases. The disease shows a gender skew, with males accounting for around 59% of cases and females 41%.

Diagnosis and monitoring of CHB rely on a range of blood tests, including anti-HBc IgG, HBeAg, HBsAg quantitative, ALT, AST, and AFP. For chronic or complex cases, a liver biopsy may be required to assess the degree of liver damage.

Current treatment options for CHB primarily involve immunomodulators such as conventional IFN-α2 and PEG-IFN-α2, which aim to boost immune response but are often limited by side effects and variable efficacy. Nucleos(t)ide analogs (NAs), which directly inhibit HBV DNA polymerase, continue to serve as the cornerstone of antiviral therapy, effectively controlling viral replication but rarely achieving a functional cure.

The future outlook for the Chronic Hepatitis B market appears highly promising, with an expanding pipeline featuring novel and combination approaches. Candidates such as Daplusiran (tomligisiran) and Imdusiran (AB-729) are demonstrating encouraging data in clinical trials. Recent updates from leading developers highlight significant momentum—Vir Biotechnology reported positive end-of-treatment results from the MARCH Study for tobevibart and elebsiran, while GSK showcased data from its bepirovirsen program, an antisense oligonucleotide (ASO) targeting HBV, at AASLD 2024 in San Diego.

Overall, the Chronic Hepatitis B market is poised for rapid and sustained growth through 2034, driven by continued innovation, improved understanding of HBV pathophysiology, and the pursuit of a functional cure.

DelveInsight’s report, “Chronic Hepatitis B Market Insights, Epidemiology, and Market Forecast-2034” provides a detailed overview of the disease landscape. The report offers comprehensive insights into historical and forecasted epidemiology, market dynamics, treatment patterns, and emerging therapies across the 7MM, equipping stakeholders with strategic intelligence to navigate the evolving CHB market landscape.

Some of the key facts of the Chronic Hepatitis B Market Report:

• The leading Chronic Hepatitis B Companies developing therapies include Gilead Sciences, GlaxoSmithKline, Ionis Pharma, Janssen Sciences Ireland, Assembly Biosciences, Janssen and Arrowhead Pharmaceuticals, Roche, Vir Biotechnology, and others.

• Potential future therapies for Chronic Hepatitis B include RG6346, Pradefovir, VIR-3434, SBT8230, and others.

• The future of Chronic Hepatitis B treatment holds promise, driven by ongoing research and the development of innovative therapies. Current management strategies, such as symptomatic medications, physical therapy, and supportive care, remain essential.

Chronic Hepatitis B Overview

Hepatitis B is one of the most prevalent and serious liver infections globally, caused by the hepatitis B virus (HBV), which targets and damages liver cells. Millions of individuals around the world live with chronic hepatitis B infection. The virus spreads through contact with infected blood or bodily fluids, sharing of contaminated needles, or exposure to unsterilized medical equipment.

In most cases, hepatitis B infection resolves naturally within one to two months without the need for treatment. However, when the virus persists for more than six months, it progresses to chronic hepatitis B, potentially resulting in long-term liver inflammation, cirrhosis (liver scarring), liver cancer, or liver failure.

Typical symptoms of hepatitis B include fatigue, loss of appetite, abdominal pain, fever, nausea, vomiting, and sometimes joint pain, rashes, or hives. Dark-colored urine and jaundice (yellowing of the skin and eyes) may also occur. Adults are more likely than children to experience noticeable symptoms.

A chronic hepatitis B infection is defined as one lasting longer than six months after the initial positive blood test. This indicates that the immune system has been unable to clear the virus, allowing it to remain in the bloodstream and liver. The likelihood of developing chronic infection depends heavily on the age of exposure to HBV:

• Around 90% of infants infected at birth or during early infancy develop chronic infection.

• Up to 50% of children infected between ages 1 and 5 progress to chronic hepatitis B.

• Only 5–10% of infected adults develop a chronic infection.

Learn more about Chronic Hepatitis B treatment algorithms in different geographies, and patient journeys. Contact to receive a sample @ Chronic Hepatitis B Treatment Market

Key Factors Driving Growth in the Chronic Hepatitis B Market

• Advances in Antiviral Treatments: The introduction of potent antiviral agents, such as nucleos(t)ide analogs and emerging next-generation therapies, has enhanced viral suppression rates and improved patient outcomes, thereby accelerating market expansion.

• Increasing Awareness and Diagnostic Efforts: Growing education among healthcare providers and patients about chronic hepatitis B (CHB) and its severe complications—like cirrhosis and hepatocellular carcinoma—has led to earlier diagnosis and wider adoption of treatment.

• Expanded Vaccination Coverage: Comprehensive hepatitis B immunization initiatives have significantly curtailed new infections. However, the substantial existing population of chronic HBV carriers continues to sustain demand for long-term therapeutic management.

• Aging and High-Risk Patient Base: The rising proportion of elderly individuals and high-risk groups, such as immunocompromised patients, faces greater vulnerability to CHB-related complications, underscoring the growing need for consistent monitoring and effective treatment options.

Recent Developments in Chronic Hepatitis B Clinical Trials:

• In September 2025, Lion TCR, a clinical-stage biotechnology company, announced that it had obtained Investigational New Drug (IND) clearance from the U.S. FDA to initiate Phase 1b/2 clinical trials of its proprietary TCR-T cell therapy, LioCyx-M004, in patients with chronic hepatitis B (CHB). This clearance represents the third major regulatory milestone for LioCyx-M004, following its earlier Fast Track and Orphan Drug Designations for the treatment of hepatitis B virus–related hepatocellular carcinoma (HBV-HCC).

• In July 2025, TherVacB, an innovative therapeutic vaccine for chronic hepatitis B developed by Helmholtz Munich in collaboration with the German Center for Infection Research (DZIF), entered its first patient-based clinical trial. Following a successful Phase Ia study in healthy volunteers that demonstrated a strong safety profile and promising immune activation, the program has advanced into a multi-center Phase Ib/IIa trial, with the first patient enrolled in June 2025.

• In May 2025, Interim findings from a Phase 2b clinical trial of Ausperbio’s investigational therapy AHB-137 revealed that the candidate effectively and safely suppressed hepatitis B virus (HBV) in individuals with chronic hepatitis B. These results, consistent with previous data from an ongoing Phase 1/2a trial (NCT06115993), were presented at the European Association for the Study of the Liver (EASL) Congress 2025.

• In May 2025, Vir Biotechnology’s Phase II MARCH study (NCT04856085) evaluating the combination therapy of tobevibart and elebsiran—aimed at achieving a “functional cure” for chronic hepatitis B—did not meet its primary efficacy endpoints. At the 24-week analysis, 17% of patients treated with tobevibart and elebsiran alone and 21% of those receiving the combination with peginterferon achieved undetectable hepatitis B surface antigen (HBsAg) levels among those with measurable baseline HBsAg.

Learn more about the recent advancements in Chronic Hepatitis B treatment landscape @ Chronic Hepatitis B Recent Developments

Chronic Hepatitis B Epidemiology

• In 2024, the United States recorded an estimated 2.25 million prevalent cases of chronic hepatitis B, with approximately 635,000 individuals diagnosed with the condition.

Chronic Hepatitis B Epidemiology Segmentation

• Total Prevalent Cases of Chronic Hepatitis B

• Total Diagnosed Cases of Chronic Hepatitis B

• Chronic Hepatitis B cases by Age group

• Chronic Hepatitis B cases by Gender

• Treated cases of Chronic Hepatitis B

• Chronic Hepatitis B cases by impact on Liver

Chronic Hepatitis B Marketed Drugs

• VEMLIDY (tenofovir alafenamide): Gilead Sciences

Chronic Hepatitis B Emerging Drugs

• Daplusiran/tomligisiran: GSK/Janssen/Arrowhead Pharmaceutical

• Imdusiran (AB-729): Arbutus Biopharma

Chronic Hepatitis B Market Barriers

• Lack of a Functional Cure: Current antiviral treatments, including nucleos(t)ide analogs (NAs) and interferon-based therapies, primarily suppress HBV replication rather than eliminating the virus. The persistence of covalently closed circular DNA (cccDNA) in hepatocytes remains a major scientific and clinical hurdle, preventing complete viral eradication and functional cure.

• Long-Term Treatment Burden: Most patients with chronic hepatitis B require lifelong therapy to maintain viral suppression. This extended treatment duration increases healthcare costs, risks of drug resistance, and adherence challenges, particularly in resource-limited regions.

• Limited Access and Affordability: Despite the availability of effective antivirals, high drug costs and limited healthcare infrastructure in low- and middle-income countries hinder widespread access to diagnosis and treatment, leading to under-treated populations and ongoing disease transmission.

• Low Diagnosis and Screening Rates: A significant proportion of HBV-infected individuals remain undiagnosed due to asymptomatic disease progression and inadequate screening programs. This delays timely intervention and contributes to the progression toward cirrhosis and hepatocellular carcinoma (HCC).

Request a free sample copy or view report summary: Chronic Hepatitis B Market Report

Scope of the Chronic Hepatitis B Market Report:

• Study Period: 2020–2034

• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

• Key Chronic Hepatitis B Companies: Gilead Sciences, GlaxoSmithKline, Ionis Pharma, Janssen Sciences Ireland, Assembly Biosciences, Janssen and Arrowhead Pharmaceuticals, Roche, Vir Biotechnology, and others

• Key Chronic Hepatitis B Therapies: RG6346, Pradefovir, VIR-3434, SBT8230, and others

• Chronic Hepatitis B Therapeutic Assessment: Chronic Hepatitis B current marketed and Chronic Hepatitis B emerging therapies

• Chronic Hepatitis B Market Dynamics: Chronic Hepatitis B market drivers and Chronic Hepatitis B market barriers

• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies

• Chronic Hepatitis B Unmet Needs, KOL’s views, Analyst’s views, Chronic Hepatitis B Market Access and Reimbursement

About DelveInsight

DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

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