Chronic Hepatitis B Drugs Market 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Target Population, Revenue, Statistics, MOA, ROA and Companies DelveInsight

In 2024, the US led the Chronic Hepatitis B market among the 7MM, followed by Japan (~USD 160M). In the EU4 and UK, Germany topped at ~USD 65M. Pipeline drugs like Daplusiran, Imdusiran, and others are set to boost market growth through 2034. Numerous promising therapies under investigation signal a bright outlook, with future approvals expected to significantly transform the treatment landscape amid rising global healthcare spending.
(Albany, USA) DelveInsight's "Chronic Hepatitis B Market Insights, Epidemiology, and Market Forecast-2034" report delivers an in-depth understanding of Chronic Hepatitis B, historical and forecasted epidemiology as well as the Chronic Hepatitis B market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

The Chronic Hepatitis B market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Chronic Hepatitis B market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Chronic Hepatitis B treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Chronic Hepatitis B market.

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Some facts of the Chronic Hepatitis B Market Report are:

* According to DelveInsight, Chronic Hepatitis B market size is expected to grow at a decent CAGR by 2034.
* In 2022, the Chronic Hepatitis B market size was highest in the US among the 7MM accounting for approximately USD 1,500 million, is expected to increase by 2034.
* Leading Chronic Hepatitis B companies working in the market are Vedanta Biosciences, Gilead Sciences, Dong-A ST Co, Assembly Biosciences, Arbutus Biopharma, Vir Biotechnology, Antios Therapeutics, Ascletis Pharmaceuticals, Shanghai HEP Pharmaceutical, Romark Laboratories, Qilu Pharmaceutical, Golden Biotechnology, Sunshine Lake Pharma, Ascentage Pharma, GlaxoSmithKline, Janssen Sciences, Henlix, Enyo Pharma, Tasly Tianjin Biopharmaceutical, Brii Biosciences, Vaxine Pty Ltd, Vaccitech Limited, Zhejiang Palo Alto Pharmaceuticals, Suzhou Ribo Life Science, PharmaEssentia, Nucorion Pharmaceuticals, Jiangsu HengRui Medicine, Enanta Pharmaceuticals, Chong Kun Dang Pharmaceutical, Guangzhou Lupeng Pharmaceutical, VenatoRx Pharmaceuticals, Zhimeng Biopharm, among others.
* Key Chronic Hepatitis B Therapies expected to launch in the market are JNJ-3989 (ARO-HBV)/JNJ-6379, VIR-2218 + VIR-3434, ASC22, Hydronidone (F-351), GSK3228836 (bepirovirsen), and others.
* In 2022, the prevalent cases of CHB were ~81,333,350 in the 7MM and China, which might decrease and reach to ~69,308,650 cases by 2034. In the 7MM and China, the highest number of prevalent cases of CHB were observed in China.
* In 2022, the diagnosed cases of CHB in the US were ~863,090 cases. These cases are expected to reach 1,061,670 by 2034.
* In Germany, the gender-specific diagnosed prevalent cases of CHB were ~108,660 and 63,910 cases for males and females, respectively in 2022. These cases are expected to reach ~123,740 and 72,780 cases for males and females, respectively, by 2034.
* In 2022, the age-specific diagnosed prevalent cases of CHB in Japan were ~5,820, 76,560, 91,490, 97,400, 69,920, and 17,603 in the age groups of less than 18 years, 18-34 years, 35-44 years, 45-54 years, 54-64 years, and greater than or equal to 65 years, respectively, which are expected to rise to ~6,410, 84,370, 100,820, 107,330, 77,050, and 19,390 cases, respectively, by 2034.
* In 2022, the type-specific diagnosed prevalent cases of CHB in China were ~2,729,730 and 15,468,470 cases for decompensated and compensated liver, which are expected to rise to ~3,119,320 and 17,676,160 cases, respectively, by 2034.
* In April 2025, Precision BioSciences received FDA Fast Track designation for PBGENE-HBV, its lead in vivo gene editing therapy aimed at curing chronic hepatitis B by targeting and eliminating cccDNA and inactivating integrated HBV DNA in liver cells.
* In March 2025, Precision BioSciences received IND clearance for PBGENE-HBV, the first in vivo gene-editing therapy entering U.S. clinical trials for chronic hepatitis B, targeting cccDNA and integrated HBV DNA untreatable by current therapies.
* In January 2025, Bluejay Therapeutics announced that its lead candidate, brelovitug (BJT-778), a potent human IgG1 monoclonal antibody targeting hepatitis B surface antigen, received FDA Breakthrough Therapy designation for treating chronic hepatitis delta.
* In August 2024, GSK announced that Japan's Ministry of Health granted SENKU designation to bepirovirsen, an investigational antisense oligonucleotide for chronic hepatitis B, enabling expedited review to improve early patient access to this innovative treatment.
* In March 2024, Gilead announced that the FDA had approved a supplemental New Drug Application (sNDA) for VEMLIDY 25 mg, allowing its once-daily use in pediatric patients aged 6 years and older and weighing at least 25 kg who have chronic hepatitis B (CHB) infection with compensated liver disease.

Chronic Hepatitis B Overview

Hepatitis B is a potentially life-threatening and one of the most common liver infections caused by the hepatitis B virus (HBV), which attacks and injures the liver. A hepatitis B infection can result in either an acute or chronic infection.

If an individual suffers from an HBV infection that lasts more than 6 months, the infection becomes chronic. Chronic hepatitis B (CHB) increases the risk of developing liver failure, liver cancer, or cirrhosis. The risk of developing a CHB infection is also directly related to the age at which one first becomes exposed to the hepatitis B virus.

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Chronic Hepatitis B Market

The Chronic Hepatitis B market outlook of the report helps to build a detailed comprehension of the historical, current, and forecasted Chronic Hepatitis B market trends by analyzing the impact of current Chronic Hepatitis B therapies on the market and unmet needs, and drivers, barriers, and demand for better technology.

Key drivers include the high disease burden and persistent prevalence of chronic hepatitis B infections despite widespread vaccination efforts. Advances in diagnostics and increased screening initiatives have improved early detection rates, leading to higher treatment uptake. Additionally, ongoing R&D and the emergence of novel therapeutics, such as RNA interference agents and core inhibitors, promise to address unmet needs by offering functional cures beyond existing nucleos(t)ide analogs and interferon therapies. Favorable reimbursement frameworks and growing awareness among patients and healthcare professionals further stimulate market expansion.

However, the market faces notable barriers. Chief among them is the virus's complex biology, which makes complete eradication challenging and prolongs dependence on long-term antiviral therapy. Safety concerns and suboptimal tolerability of some regimens can affect adherence.

Furthermore, limited patient awareness in certain regions, social stigma associated with HBV infection, and disparities in healthcare access act as hurdles. Regulatory hurdles and the high costs of developing innovative therapies also constrain the pace of pipeline progression. Overall, while the CHB market holds significant growth potential, these barriers must be strategically addressed to optimize patient outcomes and market opportunities.

According to DelveInsight, the Chronic Hepatitis B market in 7MM is expected to witness a major change in the study period 2020-2034.

Chronic Hepatitis B Epidemiology

The Chronic Hepatitis B epidemiology section provides insights into the historical and current Chronic Hepatitis B patient pool and forecasted trends for seven individual major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the Chronic Hepatitis B market report also provides the diagnosed patient pool, trends, and assumptions.

The chronic hepatitis B market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:

* 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

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Chronic Hepatitis B Drugs Uptake

This section focuses on the uptake rate of the potential Chronic Hepatitis B drugs recently launched in the Chronic Hepatitis B market or expected to be launched in 2020-2034. The analysis covers the Chronic Hepatitis B market uptake by drugs, patient uptake by therapies, and sales of each drug.

Chronic Hepatitis B Drugs Uptake helps in understanding the drugs with the most rapid uptake and the reasons behind the maximal use of new drugs and allows the comparison of the drugs based on Chronic Hepatitis B market share and size, which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Chronic Hepatitis B Pipeline Development Activities

The Chronic Hepatitis B report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses Chronic Hepatitis B key players involved in developing targeted therapeutics. Some of the drugs in the pipeline include Imdusiran (AB-729) (Arbutus Biopharma), GSK3228836 (bepirovirsen) (GlaxoSmithKline), Tobevibart (VIR-3434) + elebsiran (VIR-2218) plus-minus PEG-IFN-a (Vir Biotechnology), and others.

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Chronic Hepatitis B Therapeutics Assessment

Major key companies are working proactively in the Chronic Hepatitis B Therapeutics market to develop novel therapies which will drive the Chronic Hepatitis B treatment markets in the upcoming years are Vedanta Biosciences, Gilead Sciences, Dong-A ST Co, Assembly Biosciences, Arbutus Biopharma, Vir Biotechnology, Antios Therapeutics, Ascletis Pharmaceuticals, Shanghai HEP Pharmaceutical, Romark Laboratories, Qilu Pharmaceutical, Golden Biotechnology, Sunshine Lake Pharma, Ascentage Pharma, GlaxoSmithKline, Janssen Sciences, Henlix, Enyo Pharma, Tasly Tianjin Biopharmaceutical, Brii Biosciences, Vaxine Pty Ltd, Vaccitech Limited, Zhejiang Palo Alto Pharmaceuticals, Suzhou Ribo Life Science, PharmaEssentia, Nucorion Pharmaceuticals, Jiangsu HengRui Medicine, Enanta Pharmaceuticals, Chong Kun Dang Pharmaceutical, Guangzhou Lupeng Pharmaceutical, VenatoRx Pharmaceuticals, Zhimeng Biopharm, among others.

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Chronic Hepatitis B Report Key Insights

1. Chronic Hepatitis B Patient Population

2. Chronic Hepatitis B Market Size and Trends

3. Key Cross Competition in the Chronic Hepatitis B Market

4. Chronic Hepatitis B Market Dynamics (Key Drivers and Barriers)

5. Chronic Hepatitis B Market Opportunities

6. Chronic Hepatitis B Therapeutic Approaches

7. Chronic Hepatitis B Pipeline Analysis

8. Chronic Hepatitis B Current Treatment Practices/Algorithm

9. Impact of Emerging Therapies on the Chronic Hepatitis B Market

Table of Contents

1. Key Insights

2. Executive Summary

3. Chronic Hepatitis B Competitive Intelligence Analysis

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. Chronic Hepatitis B 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. Chronic Hepatitis B Market Outlook (7 major markets)

16. Chronic Hepatitis B Access and Reimbursement Overview

17. KOL Views on the Chronic Hepatitis B Market

18. Chronic Hepatitis B Market Drivers

19. Chronic Hepatitis B Market Barriers

20. Appendix

21. DelveInsight Capabilities

22. Disclaimer

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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