DelveInsight’s “Chronic Hepatitis B Market Insight, Epidemiology and Market Forecast–2034” report delivers an in-depth analysis of Chronic Hepatitis B epidemiology, market, and clinical development understanding of, addition to this report provides historical and forecasted epidemiology and market data as well as a detailed analysis on the Chronic Hepatitis B market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

 

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Key Takeaways from Chronic Hepatitis B Market Report

• June 2024:- GlaxoSmithKline- Phase 3 Multicenter, Randomized, Double-Blind, Study to Assess the Efficacy and Safety of Treatment With Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B Virus (B-Well 1).
• June 2024:- Arbutus Biopharma Corporation- A Randomized, Open-Label, Multicenter Study Investigating AB-729, Nucleos(t)Ide Analogue and Pegylated Interferon Alfa-2a Treatment in Subjects With Chronic Hepatitis B Infection. This is a randomized, open label, multicenter Phase 2 study investigating the safety and antiviral activity of AB-729 in combination with ongoing NA therapy and short courses of Peg-IFNα-2a in subjects with CHB.
• June 2024:- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.- This study is divided into two parts. Phase Ib is a randomized, double-blind, placebo-controlled trial, designed to evaluate the safety, tolerability, pharmacokinetic characteristics, preliminary efficacy, and immunogenicity of TQA3038 injection in patients with chronic hepatitis B. It is expected to include 72 subjects.
• June 2024:- Daewoong Pharmaceutical Co. LTD.- The Efficacy and Safety of Switching to Vemliver Tab (Tenofovir Alafenamide Hemitartrate) From Entecavir in Chronic Hepatitis B Patients Who Pretreated With Entecavir; A Multi-Center, Randomized, Open-Label, Active-Controlled, Non-Inferiority, Phase IV Clinical Trial.
• The United States accounted for the highest number of prevalent cases. There were approximately 2 million cases of Chronic Hepatitis B in the US in 2023.
• Among EU4 and the UK, Germany accounted for the highest number of diagnosed prevalent cases followed by Italy, whereas Spain accounted for the least number of cases.
• In type-specific cases, compensated liver cases were higher in number as compared to decompensated liver
• The leading Chronic Hepatitis B Companies such as Gilead Sciences, GlaxoSmithKline, Ionis Pharma, Janssen Sciences Ireland, Assembly Biosciences, Janssen and Arrowhead Pharmaceuticals, Roche, Vir Biotechnology and other.
• Promising Chronic Hepatitis B Therapies such as APG-1387, Bepirovirsen, Entecavir 0.5 mg, VIR-3434, VIR-2218, BRII-835, AB-729, and others.

 

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Chronic Hepatitis B Overview

Chronic Hepatitis B is a long-term liver infection caused by the hepatitis B virus (HBV). It occurs when the body’s immune system fails to clear the virus after the initial acute infection, leading to the virus remaining in the liver. Over time, chronic hepatitis B can cause serious liver damage, including cirrhosis (scarring of the liver), liver failure, and an increased risk of liver cancer.

 

Chronic Hepatitis B Epidemiology Segmentation

• Chronic Hepatitis B prevalent cases
• Chronic Hepatitis B diagnosed prevalent cases
• Chronic Hepatitis B gender-specific diagnosed prevalent cases
• Chronic Hepatitis B age-specific diagnosed prevalent cases
• Chronic Hepatitis B type-specific diagnosed prevalent cases
• Total Chronic Hepatitis B treated cases

 

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Chronic Hepatitis B Marketed Drugs

• VEMLIDY (tenofovir alafenamide): Gilead Sciences

Tenofovir alafenamide is an antiviral drug against the hepatitis B virus; it is a phosphonamidate prodrug of tenofovir. Tenofovir alafenamide is a lipophilic cell-permeate compound that enters primary hepatocytes by passive diffusion and hepatic uptake transporters OATP1B1 and OATP1B3. It is then converted to tenofovir through hydrolysis, primarily by carboxylesterase 1 (CES1) in primary hepatocytes. Intracellular tenofovir is subsequently phosphorylated by cellular kinases to the pharmacologically active metabolite tenofovir diphosphate. Tenofovir diphosphate inhibits HBV replication through incorporation into viral DNA by the HBV reverse transcriptase, which results in DNA chain termination. Tenofovir diphosphate is a weak inhibitor of mammalian DNA polymerases, including mitochondrial DNA polymerase γ, and there is no evidence of toxicity to mitochondria in cell culture.

 

Chronic Hepatitis B Emerging Drugs

• GSK3228836 (bepirovirsen): GlaxoSmithKline/Ionis Pharma

GSK3228836 (bepirovirsen) was discovered by and jointly developed with Ionis Pharmaceuticals. Bepirovirsen is one of the ASO HBV programme assets in-licensed by GSK from Ionis Pharmaceuticals in August 2019. It is an investigational antisense oligonucleotide (ASO) designed to specifically recognize the RNA that the hepatitis B virus uses to replicate itself in the infected liver cells (hepatocytes) and make the viral antigens (proteins) that facilitate chronicity of the disease by helping to avoid clearance by the immune system.

Currently, it is being evaluated in Phase III (NCT05630820) and two Phase II (NCT04544956; NCT04676724) clinical trials for this drug in patients with active CHB. Recently, it has completed a Phase II (NCT04449029) study. The results showed that treatment with bepirovirsen resulted in sustained clearance of HBsAg and HBV DNA in patients on concurrent nucleoside/nucleotide analogs (NA) and patients not-on-NA therapy.

• VIR-2218 and VIR-3434: Vir Biotechnology

VIR-2218 is an investigational subcutaneously administered HBV-targeting siRNA that can stimulate an effective immune response and have direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include enhanced stabilization chemistry plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index.

 

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Chronic Hepatitis B Market Outlook

CHB infection results in progressive liver disease ranging from asymptomatic to severe disease with complications including cirrhosis, liver failure, and the development of HCC. Despite the availability of prophylactic vaccines, hepatitis B remains a global public health threat. The main objective of the currently available therapy is to reduce the risk of complications. Treatment can help prevent cirrhosis, liver failure, and liver cancer by reducing hepatitis B viral load and the loss of HBeAg (either with or without detection of anti-HBe) while improving liver enzyme levels.

 

Chronic Hepatitis B Treatment Landscape

The existing Chronic Hepatitis B treatment is mainly dominated by antiviral drugs such as entecavir, VEMLIDY, VIREAD, telbivudine, adefovir dipivoxil, and lamivudine. Lamivudine was the first NA to be given the go-ahead by US FDA for treating Chronic hepatitis B. The drug was given adult approval in 1998, while pediatric approval for children aged 2–17 was given in 2001. But since 1995, this drug has been used and licensed for treating HIV infection. With few side effects, it can be used successfully in various patients. However, lamivudine therapy for a prolonged time is linked to significant rates of drug resistance, which cause virological relapse and biochemical flare. Lamivudine is suggested as a second-line therapy for managing Hepatitis B.

 

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Scope of the Chronic Hepatitis B Market Report

• Coverage- 7MM
• Chronic Hepatitis B Companies- Gilead Sciences, GlaxoSmithKline, Ionis Pharma, Janssen Sciences Ireland, Assembly Biosciences, Janssen and Arrowhead Pharmaceuticals, Roche, Vir Biotechnology and other.
• Chronic Hepatitis B Therapies- APG-1387, Bepirovirsen, Entecavir 0.5 mg, VIR-3434, VIR-2218, BRII-835, AB-729, and others.
• Chronic Hepatitis B Market Dynamics: Chronic Hepatitis B Market drivers and Chronic Hepatitis B Market Barriers
• Chronic Hepatitis B 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

 

Table of Content

1. Key Insights

2. Report Introduction

3. CHB Market Overview at a Glance

4. Executive Summary of CHB

5. Epidemiology and Market Methodology

6. Disease Background and Overview

7. Diagnosis of Hepatitis B Infection

8. Current Treatment Practices

9. Epidemiology and Patient Population

10. Patient Journey

11. Key Endpoints in CHB Clinical Trials

12. Marketed Therapies

13. Emerging Therapies

14. Discontinued Drugs

15. Chronic Hepatitis B: The 7MM

16. Market Access and Reimbursement

17. KOL Views

18. SWOT Analysis

19. Unmet Needs

20. Appendix

21. DelveInsight Capabilities

22. Disclaimer

23. About DelveInsight

 

About DelveInsight

DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

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