Chronic Hepatitis B Market Size to Reach US$ 3,379.3 Million by 2034, Impelled by Advancements in Early Detection

Chronic Hepatitis B Market Outlook 2024-2034:

The chronic hepatitis B market size reached a value of US$ 2,709.4 Million in 2023. Looking forward, the market is expected to reach US$ 3,379.3 Million by 2034, exhibiting a growth rate (CAGR) of 2.03% during 2024-2034. The market is driven by the emerging popularity of immune modulation strategies, which stimulate the immune system while leading to sustained viral suppression and even serological response, such as hepatitis B surface antigen loss. Additionally, the development of targeted therapies and innovative treatments is further propelling the market growth.

Advances in Early Detection and Diagnostic Technologies: Driving the Chronic Hepatitis B Market 

Advances in early detection and diagnostic technologies are significantly driving the chronic hepatitis B market, improving disease management and expanding treatment opportunities. The development of highly sensitive and specific diagnostic assays has greatly enhanced early detection of hepatitis B virus (HBV) infections. Advanced serological tests, such as enzyme immunoassays (EIAs) and chemiluminescent immunoassays (CLIAs), are now capable of detecting HBV surface antigens (HBsAg) and antibodies with unprecedented accuracy, even in low-resource settings. Additionally, quantitative polymerase chain reaction (qPCR) techniques enable precise measurement of HBV DNA levels, critical for diagnosing chronic infections and monitoring treatment efficacy. Non-invasive diagnostic tools, such as transient elastography and magnetic resonance elastography (MRE), are replacing liver biopsy as the gold standard for assessing liver fibrosis and disease progression. These innovations provide safer, quicker, and more patient-friendly options, encouraging widespread adoption and improving patient outcomes. Molecular and genomic technologies have further revolutionized the landscape. Next-generation sequencing (NGS) is now being utilized to analyze HBV genotypes and resistance-associated mutations, facilitating personalized treatment strategies. These diagnostic advancements not only enhance early detection but also expand the pool of patients eligible for antiviral therapies, boosting demand for innovative treatments. As these technologies continue to evolve, they are shaping the chronic hepatitis B market, ensuring better patient care while driving significant growth opportunities for the industry.

Development of Novel Therapies and Pharmacological Treatments: Contributing to Market Expansion

The development of novel therapies and pharmacological treatments is a key driver in the expansion of the chronic hepatitis B market, offering new hope for patients and transforming the management of this persistent viral infection. One of the most exciting advancements is the development of immune modulators and therapeutic vaccines. These approaches aim to restore or enhance the body's immune response to HBV, potentially leading to a functional cure. For instance, therapeutic vaccines designed to stimulate a stronger immune response are being evaluated in clinical trials, with some showing promise in inducing sustained immune control of the virus after stopping antiviral therapy. Additionally, immune checkpoint inhibitors, which are already making an impact in cancer therapy, are being explored for their potential to activate the immune system against HBV-infected cells. Another promising area is the development of novel small molecules that target different stages of the HBV lifecycle. These include inhibitors of viral entry, capsid assembly, and RNA transcription, which work in synergy with existing antiviral drugs to suppress the virus more effectively. Furthermore, combination therapies are being studied to address viral resistance, improve treatment adherence, and achieve higher rates of virological suppression. As these novel therapies continue to progress through clinical trials, they are expected to expand treatment options for patients, reduce the burden of chronic hepatitis B, and drive significant growth in the market.

Marketed Therapies in Chronic Hepatitis B Market

Pegasys (Peginterferon alfa-2a): Roche 

Pegasys (Peginterferon alfa-2a) is used to treat adults with HBeAg-positive and HBeAg-negative chronic hepatitis B infection who have compensated liver damage, viral replication, and liver inflammation. Peginterferon alfa-2a is a derivative of recombinant human interferon alfa-2a. It interacts with and activates human type 1 interferon receptors, causing them to dimerize. This triggers the JAK/STAT pathway. The JAK/STAT pathway is activated, which raises the expression of many genes in different tissues involved in the innate antiviral response.

Baraclude (Entecavir): Bristol-Myers Squibb

BARACLUDE (entecavir) is used to treat chronic hepatitis B virus infection in people who have active viral replication, persistent elevated serum aminotransferases (ALT or AST), or histologically active illness. Entecavir is a nucleoside analog, specifically a deoxyguanosine analog, that belongs to the carbocyclic nucleoside class. It inhibits reverse transcription, DNA replication, and transcription during viral replication. Entecavir lowers the amount of hepatitis B virus in the blood by inhibiting its capacity to grow and infect new cells.

Viread (Tenofovir disoproxil fumarate): Gilead Sciences

Viread (Tenofovir disoproxil fumarate) is a medicine used to treat chronic hepatitis B infection in adults and pediatric patients aged 2 and above, weighing at least 10 kg. Viread belongs to a class of antiretroviral medications known as nucleotide analog reverse transcriptase inhibitors (NtRTIs), which inhibit reverse transcriptase, an enzyme required for virus generation in HIV patients. This allows for the regulation of HIV viral load through reduced viral replication.

Hepsera (Adefovir dipivoxil): Gilead Sciences 

Hepsera (Adefovir dipivoxil) is a nucleotide analog prescribed to treat chronic hepatitis B. Adefovir dipivoxil is a prodrug of adefovir. Adefovir is an acyclic nucleotide analog of adenosine monophosphate that cellular kinases phosphorylate to produce the active metabolite adefovir diphosphate. Adefovir diphosphate inhibits HBV DNA polymerase (reverse transcriptase) by competing with its natural substrate, deoxyadenosine triphosphate, and causes DNA chain termination upon incorporation into viral DNA.

Epivir HBV (Lamivudine): Takeda

Epivir HBV (Lamivudine) is a reverse transcriptase inhibitor that treats HIV and hepatitis B infections. Lamivudine is a synthetic nucleoside analog that is phosphorylated intracellularly to form the active 5'-triphosphate metabolite lamivudine triphosphate (L-TP). This nucleoside analog is integrated into viral DNA by HIV reverse transcriptase and HBV polymerase, causing DNA chain termination.

Emerging Therapies in Chronic Hepatitis B Market

NUC-1010: Nucorion Pharmaceuticals 

NUC-1010, developed by Nucorion Pharmaceuticals, is an investigational antiviral agent being studied for the treatment of chronic hepatitis B. NUC-1010 is a nucleotide analog that inhibits reverse transcriptase. In HBV, the reverse transcriptase enzyme converts viral RNA into DNA, which is required for virus replication and incorporation into the host genome. NUC-1010 inhibits this enzyme, preventing the synthesis of new viral DNA and terminating the HBV replication cycle. This reduces viral load and, over time, may lead to virus suppression in infected people.

AB-729: Arbutus Biopharma

AB-729 is a subcutaneously delivered RNA interference (RNAi) therapy that is specially designed to lower all HBV viral antigens, including hepatitis B surface antigen (HBsAg), which is regarded to be a necessary condition for a patient's immune system to reactivate and respond to the virus. AB-729 targets hepatocytes via a new covalently attached N-acetylgalactosamine (GalNAc) delivery system. According to clinical evidence produced so far, AB-729 at single and repeated doses is generally safe and well-tolerated, and it also significantly lowers hepatitis B DNA and surface antigen.

Bepirovirsen: Glaxosmithkline

Bepirovirsen is a triple-action experimental antisense oligonucleotide (ASO) that is currently being investigated in the B-Well phase III clinical trial program for the treatment of chronic hepatitis B. Bepirovirsen is intended to identify and eliminate the genetic components (RNA) of the hepatitis B virus that can cause chronic disease, potentially allowing a person's immune system to regain control. Bepirovirsen decreases viral DNA replication in the body, reduces the quantity of hepatitis B surface antigen (HBsAg) in the blood, and boosts the immune system, increasing the likelihood of a long-lasting and sustained response.

VIR-3434: Vir Biotechnology

VIR-3434 is an experimental subcutaneously administered antibody that is intended to prevent hepatitis B and hepatitis delta viruses from entering hepatocytes while also lowering the number of virions and subviral particles in the bloodstream. VIR-3434, which integrates Xencor's Xtend and other Fc technologies, has been developed to act as a T cell vaccination against hepatitis B virus and hepatitis delta virus. It also has a longer half-life. VIR-3434 was discovered utilizing Vir's proprietary monoclonal antibody discovery platform.

HepTcell: Altimmune

HepTcell, an experimental immunotherapy created by Altimmune, eliminates hepatitis B infection by restoring dormant T cells. HepTcell is a peptide-based treatment that includes nine synthetic peptides and an adjuvant, IC31. The peptides are intended to elicit T-cell responses to all hepatitis B virus genotypes. HepTcell aims to produce a functional cure by reactivating the T cell immune response and overcoming immunological resistance.

Detailed list of emerging therapies in Chronic Hepatitis B is provided in the final report.

Leading Companies in the Chronic Hepatitis B Market:

The market research report by IMARC encompasses a comprehensive analysis of the competitive landscape in the market. Across the global chronic hepatitis B market, several leading companies are at the forefront of developing integrated platforms to enhance the management of chronic hepatitis B. Some of the major players include Roche, Gilead Sciences, and Takeda. These companies are driving innovation in the chronic hepatitis B market through continuous research, diagnostic tools, and expanding their product offerings to meet the growing demand for the illness.

​In May 2024, Roche stated that the U.S. FDA had approved Pegasys(R) (peginterferon alfa-2a), the most prescribed hepatitis C medicine in the United States, for treating chronic hepatitis B. Pegasys is the first and only pegylated interferon that has been authorized for the treatment of chronic hepatitis B, which includes both HBeAg-positive and HBeAg-negative cases.

Key Players in Chronic Hepatitis B Market:

The key players in the Chronic Hepatitis B market who are in different phases of developing different therapies are Roche, Bristol-Myers Squibb, Gilead Sciences, Takeda, Nucorion Pharmaceuticals, Arbutus Biopharma, GlaxoSmithKline, Vir Biotechnology, Altimmune, and Others.

Regional Analysis:

The major markets for chronic hepatitis B include the United States, Germany, France, the United Kingdom, Italy, Spain, and Japan. According to projections by IMARC, the United States has the largest patient pool for chronic hepatitis B while also representing the biggest market for its treatment. This can be attributed to favorable regulatory pathways, such as the FDA’s Fast Track and Breakthrough Therapy Designation, which are accelerating the availability of innovative treatments.

Moreover, advancements in diagnostic technologies, such as more sensitive serological tests, PCR assays for viral load measurement, and non-invasive liver monitoring techniques, are improving early detection and disease management. This encourages greater patient engagement and facilitates timely treatment, reducing the risk of severe liver complications like cirrhosis and liver cancer.

Besides this, the development of novel antiviral therapies and immunotherapies, including next-generation nucleos(t)ide analogs, immune modulators, and therapeutic vaccines, is fueling market growth. These treatments offer better outcomes and address unmet needs, such as achieving sustained viral suppression and potential functional cures​.

Recent Developments in Chronic Hepatitis B Market:

• In November 2024, Arbutus Biopharma Corporation presented new preliminary findings from the Phase 2a IM-PROVE II clinical trial (AB-729-202) of persons with chronic hepatitis B virus at the American Association for the Study of Liver Diseases (AASLD).
• In February 2024, GSK stated that the U.S. FDA had granted Fast Track designation to bepirovirsen, an experimental antisense oligonucleotide for the treatment of chronic hepatitis B. The application was supported by data from the phase IIb trials B-Clear and B-Sure, which assessed the effectiveness, safety, and long-term response of bepirovirsen in persons with chronic hepatitis B.
• In November 2023, Vir Biotechnology announced that it would present new data from its ongoing Phase 2 MARCH trials evaluating the potential clinical impact that VIR-3434, an investigational monoclonal antibody (mAb), could have for chronic hepatitis B patients at the American Association for the Study of Liver Diseases.
   

Key information covered in the report.

• Base Year: 2023
• Historical Period: 2018-2023
• Market Forecast: 2024-2034
   

Countries Covered

• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
• Japan
   

 Analysis Covered Across Each Country

• Historical, current, and future epidemiology scenario
• Historical, current, and future performance of the chronic hepatitis B market
• Historical, current, and future performance of various therapeutic categories in the market
• Sales of various drugs across the chronic hepatitis B market
• Reimbursement scenario in the market
• In-market and pipeline drugs
   

Competitive Landscape:

This report offers a comprehensive analysis of current chronic hepatitis B marketed drugs and late-stage pipeline drugs.

In-Market Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance
   

 Late-Stage Pipeline Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance
   

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