Chronic Hepatitis B Market Insight, Epidemiology And Market Forecast - 2034
Description
Key Highlights
Hepatitis B is a potentially life-threatening and one of the most common liver infection caused by the HBV, which attacks and injures the liver. A hepatitis B infection can result in either an acute or a chronic infection.
Several blood tests are available to diagnose and monitor patients with CHB, such as anti-HBc IgG, HBeAg, HBsAg quantitative, ALT, AST, AFP, and others. For chronic cases, a liver biopsy may be needed.
In 2024, there were approximately 4,970,000 prevalent cases of chronic hepatitis B across the seven major markets (7MM).
In 2024, the total diagnosed cases of Chronic Hepatitis B in the 7MM stood at approximately 1,790,000.
In the 7MM, males accounted for approximately 59% cases and females accounted for almost 41% cases of Chronic Hepatitis B in 2024.
The treatment landscape for CHB is anchored by two primary drug classes approved by major regulatory agencies, including the US FDA, EMA, and PMDA: immunomodulators and nucleotide analogue (NAs).
Immunomodulators, such as conventional IFN-a2 and its PEG-IFN-a2, aim to enhance the host immune response but are limited by significant side effects and variable efficacy. NAs, which directly inhibit HBV DNA polymerase, remain the cornerstone of antiviral therapy.
In 2024, the United States dominated the CHB market among the 7MM, capturing approximately 72% of the total market share.
In 2024, the total market size for CHB in EU4 and the UK was approximately 270 USD million, accounting for almost 17% of market in 7MM.
In November 2024, Vir Biotechnology announced positive end-of-treatment results for tobevibart and elebsiran combinations in CHB from the MARCH Study at AASLD, the Liver Meeting.
In November 2024, GSK presented 12 abstracts at the AASLD, the Liver Meeting 2024, held in San Diego, CA from November 15 to November. The presentations highlighted data from the novel investigational specialty medicine: bepirovirsen, an ASO for CHB.
Meanwhile, the pipeline for Chronic Hepatitis-B therapy continues to expand, with such as Daplusiran/tomligisiran, Imdusiran (AB-729), and others showing promise in clinical development.
Report Summary
The report offers extensive knowledge regarding the epidemiology segments and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
Additionally, an all-inclusive account of the current management techniques and emerging therapies and the elaborative profiles of late-stage (Phase III and Phase II) and prominent therapies that would impact the current treatment landscape and result in an overall market shift has been provided in the report.
The report also encompasses a comprehensive analysis of the Chronic Hepatitis B market, providing an in-depth examination of its historical and projected market size (2020–2034). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The report also includes drug outreach coverage in the 7MM region.
The report includes qualitative insights that provide an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, and treatment preferences that help shape and drive the 7MM Chronic Hepatitis B market.
Chronic Hepatitis B Drug Chapters
The section dedicated to drugs in the Chronic Hepatitis B report provides an in-depth evaluation of late-stage pipeline drugs (Phase III and Phase II) related to Chronic Hepatitis B. The drug chapters section provides valuable information on various aspects related to clinical trials of Chronic Hepatitis B, such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. Furthermore, it presents the most recent news updates and press releases on drugs targeting Chronic Hepatitis B.
Marketed Therapies
VEMLIDY (tenofovir alafenamide): Gilead Sciences
VEMLIDY is an HBV nucleoside analog reverse transcriptase inhibitor and is indicated for treating chronic hepatitis B virus infection in adults and pediatric patients 12 years and older with compensated liver disease
In March 2024, Gilead Sciences announced that the US Food and Drug Administration (FDA) approved the supplemental New Drug pplication (sNDA) for VEMLIDY 25 mg tablets as a once-daily treatment for CHB virus infection in pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease.
In November 2022, the US FDA approved VEMLIDY 25 mg once daily for pediatric patients 12 years and older with chronic HBV infection with compensated liver disease.
In November 2016, the FDA approved VEMLIDY 25 mg for adults with CHB virus infection with compensated liver disease.
In January 2017, Gilead Sciences announced that the EC had granted marketing authorization for VEMLIDY (tenofovir alafenamide, TAF) 25 mg to treat CHB infection in adults and adolescents (aged 12 and older with body weight at least 35 kg).
In December 2016, Gilead Sciences announced that the MHLW had approved VEMLIDY to suppress viral replication in CHB patients with evidence of hepatitis B virus replication and abnormal liver function.
Note: Detailed assessment will be provided in the final report of CHB …
Emerging Therapies
Daplusiran/tomligisiran: GSK/Janssen/Arrowhead Pharmaceutical
Daplusiran/tomligisiran (formerly JNJ-3989/GSK5637608) is an investigational HBV-targeted siRNA therapeutic being evaluated in a sequential regimen with bepirovirsen for the treatment of adult non-cirrhotic patients with chronic hepatitis B on NA therapy.
In October 2023, GSK and Arrowhead Pharmaceuticals announced that they had reached an agreement with Janssen Pharmaceuticals to transfer exclusive worldwide rights to further develop and commercialise JNJ-3989 to GSK. JNJ-3989 (formerly ARO-HBV) was initially in-licensed by Janssen from Arrowhead in 2018.
Imdusiran (AB-729): Arbutus Biopharma
Imdusiran is an RNAi therapeutic specifically designed to reduce all HBV viral proteins and antigens, including HBsAg, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine (GalNAc) delivery technology, enabling subcutaneous delivery.
In the first-half of 2025, the company is planning to initiate a Phase IIb clinical trial of imdusiran combined with IFN and NA therapy.
Chronic Hepatitis B Market Outlook
Treatment landscape of chronic hepatitis B remains a largely unmet medical need, with no definitive cure and only a few FDA-approved treatments available.
Among the 7MM, the United States accounted for the highest market size in 2024, followed by Japan for Chronic Hepatitis B.
In the EU4 and the UK, Germany has the highest market size of approximately USD 65 million in 2024.
In 2024, the total market size for Chronic Hepatitis B in Japan was approximately 160 USD million.
During the forecast period (2024–2034), pipeline candidates such as Daplusiran/tomligisiran, Imdusiran (AB-729), and others are expected to drive the rise in Chronic Hepatitis B market size.
In a nutshell, many potential therapies are being investigated to manage Chronic Hepatitis B. Even though it is too soon to comment on the above-mentioned promising candidate to enter the market during the forecast period (2025–2034), it is safe to assume that the future of this market is bright. Eventually, these drugs will create a significant difference in the landscape of Chronic Hepatitis B in the coming years. The treatment space is expected to experience a significant positive shift in the coming years owing to the improvement in healthcare spending worldwide.
Further details are provided in the report…
Chronic Hepatitis B (CHB) Disease Understanding and Treatment
Chronic Hepatitis B (CHB) Overview
Hepatitis B is the most common severe liver infection in the world. It is caused by the hepatitis B virus that attacks and injures the liver. Millions of people are living with chronic hepatitis B infection worldwide. The hepatitis B virus (HBV) is transmitted through blood and infected bodily fluids. It can be passed to others through direct contact with blood, unprotected sex, illegal drugs, and unsterilized or contaminated needles.
Most hepatitis B infections clear up within 1–2 months without treatment. When the infection lasts more than 6 months, it can develop into chronic hepatitis B, leading to chronic inflammation of the liver, cirrhosis (scarring of the liver), liver cancer, and/or liver failure.
The symptoms of hepatitis B include fatigue, poor appetite, stomach pain, fever, nausea, vomiting, and occasionally joint pain, hives, or rash. Urine may become darker, and then jaundice (yellowing of the skin and whites of the eyes) may appear. Adults are more likely than children to develop symptoms.
Chronic hepatitis B infection can last for >6 months (after the first blood test result). This means the immune system cannot get rid of the hepatitis B virus, which remains in the blood and liver. The risk of developing a chronic hepatitis B infection is also directly related to the age at which one first becomes exposed to the hepatitis B virus:
Nearly 90% of infected newborns and babies develop a chronic hepatitis B infection.
Up to 50% of infected children (1–5 years) develop a chronic hepatitis B infection.
About 5–10% of infected adults develop a chronic hepatitis B infection
Further details are provided in the report…
Chronic Hepatitis B (CHB) Diagnosis
Screening for HBV involves a simple, low-cost blood test to detect hepatitis B surface antigen (HBsAg) and antibodies to HBsAg (anti-HBs) in serum. HBsAg-negative patients who do not have antibodies are given the hepatitis B vaccine. Those who are HBsAg-negative and have detectable anti-HBs are immune (generally from prior vaccination or recovery from an acute infection) and do not require further intervention or testing. A patient who tests positive for HBsAg has an active HBV infection, and further testing is needed to determine the phase of the disease and course of action.
Recommended initial follow-up testing includes serum ALT and HBV DNA levels, serology for hepatitis B e antigen (HBeAg), and antibody to HBeAg (anti-HBe). Individuals with chronic HBV infection have persistently circulating HBsAg in their serum for more than 6 months.
Further details related to country-based variations are provided in the report…
Chronic Hepatitis B (CHB) Treatment
Hepatitis B infection can result in either an acute or chronic infection. CHB is a blood born virus that primarily affects the liver. When the infection starts to progress after being in the body for 6 months, it is termed “Development or Advancement of Acute Hepatitis B infection into Chronic Hepatitis B infection.” To date, there is no cure for this infection; with the help of antivirals and interferon injections, the virus can be suppressed, or the patient might feel relieved of the symptoms for a specific period; however, there is no permanent solution.
When the hepatitis B virus does not get washed off the body after 6 months, the infection has progressed into the chronic stage, which makes a patient eligible for drug therapy. Usually, drug therapy is used if only one has active liver disease. The US FDA has approved seven drugs to treat hepatitis B. Out of seven, two are given in injectable forms of interferon, while the five other antivirals are tablets. The medications will have to be taken every day without fail; these medicines help suppress the virus’s growth and capability to multiply in the system, followed by a reduction in swelling and liver damage.
Further details related to treatment and management are provided in the report…
Chronic Hepatitis B (CHB) Epidemiology
The Chronic Hepatitis B (CHB) epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by 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 in the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034.
In 2024, the total prevalent cases of Chronic Hepatitis B was approximately 2,250,000 in the US.
In 2024, the total diagnosed cases of Chronic Hepatitis B was approximately 635,000 in the US.
In 2024, the age group-specific cases of CHB were approximately 10,000, 135,000, 160,000, 170,000, 125,000 and 31,000 cases for <18 years, 18–34 years, 35–44 years, 45–54 years, 55–64 years and =65 years, respectively, in the US.
In 2024, the compensated liver cases of CHB accounted 85% of all cases and decompensated liver cases of CHB accounted for 15% of the cases in the 7MM.
In 2024, the treated Cases of Chronic Hepatitis B was approximately 670,000 in the 7MM.
KOL Views
To stay abreast of the latest trends in the market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.
We have reached out to industry experts to gather insights on various aspects of Chronic Hepatitis B (CHB), including the evolving treatment landscape, patients’ reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts we contacted included medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan.
Our team of analysts at Delveinsight connected with more than 15 KOLs across the 7MM. We contacted institutions such as the University of Munich, the University of Tokyo, and The Blumberg Institute, University of Minnesota, etc., among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the Chronic Hepatitis B (CHB) market, which will assist our clients in analyzing the overall epidemiology and market scenario.
Qualitative Analysis
We perform Qualitative and Market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in trials for Chronic Hepatitis B (CHB), one of the most important primary endpoints was achieving hemolysis control, LDH normalization, etc. Based on these, the overall efficacy is evaluated.
Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Market Access and Reimbursement
Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.
The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Chronic Hepatitis B (CHB) Report Insights
Patient Population
Therapeutic Approaches
Chronic Hepatitis B (CHB) Market Size and Trends
Existing Market Opportunity
Chronic Hepatitis B (CHB) Report Key Strengths
Ten-year Forecast
The 7MM Coverage
Chronic Hepatitis B (CHB) Epidemiology Segmentation
Key Cross Competition
Chronic Hepatitis B (CHB) Report Assessment
Current Treatment Practices
Reimbursements
Market Attractiveness
Qualitative Analysis (SWOT, Conjoint Analysis, Unmet needs)
Key Questions
Would there be any changes observed in the current treatment approach?
Will there be any improvements in Chronic Hepatitis B (CHB) management recommendations?
Would research and development advances pave the way for future tests and therapies for Chronic Hepatitis B (CHB)?
Would the diagnostic testing space experience a significant impact and lead to a positive shift in the treatment landscape of Chronic Hepatitis B (CHB)?
What kind of uptake will the new therapies witness in the coming years in Chronic Hepatitis B (CHB) patients?
Hepatitis B is a potentially life-threatening and one of the most common liver infection caused by the HBV, which attacks and injures the liver. A hepatitis B infection can result in either an acute or a chronic infection.
Several blood tests are available to diagnose and monitor patients with CHB, such as anti-HBc IgG, HBeAg, HBsAg quantitative, ALT, AST, AFP, and others. For chronic cases, a liver biopsy may be needed.
In 2024, there were approximately 4,970,000 prevalent cases of chronic hepatitis B across the seven major markets (7MM).
In 2024, the total diagnosed cases of Chronic Hepatitis B in the 7MM stood at approximately 1,790,000.
In the 7MM, males accounted for approximately 59% cases and females accounted for almost 41% cases of Chronic Hepatitis B in 2024.
The treatment landscape for CHB is anchored by two primary drug classes approved by major regulatory agencies, including the US FDA, EMA, and PMDA: immunomodulators and nucleotide analogue (NAs).
Immunomodulators, such as conventional IFN-a2 and its PEG-IFN-a2, aim to enhance the host immune response but are limited by significant side effects and variable efficacy. NAs, which directly inhibit HBV DNA polymerase, remain the cornerstone of antiviral therapy.
In 2024, the United States dominated the CHB market among the 7MM, capturing approximately 72% of the total market share.
In 2024, the total market size for CHB in EU4 and the UK was approximately 270 USD million, accounting for almost 17% of market in 7MM.
In November 2024, Vir Biotechnology announced positive end-of-treatment results for tobevibart and elebsiran combinations in CHB from the MARCH Study at AASLD, the Liver Meeting.
In November 2024, GSK presented 12 abstracts at the AASLD, the Liver Meeting 2024, held in San Diego, CA from November 15 to November. The presentations highlighted data from the novel investigational specialty medicine: bepirovirsen, an ASO for CHB.
Meanwhile, the pipeline for Chronic Hepatitis-B therapy continues to expand, with such as Daplusiran/tomligisiran, Imdusiran (AB-729), and others showing promise in clinical development.
Report Summary
The report offers extensive knowledge regarding the epidemiology segments and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
Additionally, an all-inclusive account of the current management techniques and emerging therapies and the elaborative profiles of late-stage (Phase III and Phase II) and prominent therapies that would impact the current treatment landscape and result in an overall market shift has been provided in the report.
The report also encompasses a comprehensive analysis of the Chronic Hepatitis B market, providing an in-depth examination of its historical and projected market size (2020–2034). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The report also includes drug outreach coverage in the 7MM region.
The report includes qualitative insights that provide an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, and treatment preferences that help shape and drive the 7MM Chronic Hepatitis B market.
Chronic Hepatitis B Drug Chapters
The section dedicated to drugs in the Chronic Hepatitis B report provides an in-depth evaluation of late-stage pipeline drugs (Phase III and Phase II) related to Chronic Hepatitis B. The drug chapters section provides valuable information on various aspects related to clinical trials of Chronic Hepatitis B, such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. Furthermore, it presents the most recent news updates and press releases on drugs targeting Chronic Hepatitis B.
Marketed Therapies
VEMLIDY (tenofovir alafenamide): Gilead Sciences
VEMLIDY is an HBV nucleoside analog reverse transcriptase inhibitor and is indicated for treating chronic hepatitis B virus infection in adults and pediatric patients 12 years and older with compensated liver disease
In March 2024, Gilead Sciences announced that the US Food and Drug Administration (FDA) approved the supplemental New Drug pplication (sNDA) for VEMLIDY 25 mg tablets as a once-daily treatment for CHB virus infection in pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease.
In November 2022, the US FDA approved VEMLIDY 25 mg once daily for pediatric patients 12 years and older with chronic HBV infection with compensated liver disease.
In November 2016, the FDA approved VEMLIDY 25 mg for adults with CHB virus infection with compensated liver disease.
In January 2017, Gilead Sciences announced that the EC had granted marketing authorization for VEMLIDY (tenofovir alafenamide, TAF) 25 mg to treat CHB infection in adults and adolescents (aged 12 and older with body weight at least 35 kg).
In December 2016, Gilead Sciences announced that the MHLW had approved VEMLIDY to suppress viral replication in CHB patients with evidence of hepatitis B virus replication and abnormal liver function.
Note: Detailed assessment will be provided in the final report of CHB …
Emerging Therapies
Daplusiran/tomligisiran: GSK/Janssen/Arrowhead Pharmaceutical
Daplusiran/tomligisiran (formerly JNJ-3989/GSK5637608) is an investigational HBV-targeted siRNA therapeutic being evaluated in a sequential regimen with bepirovirsen for the treatment of adult non-cirrhotic patients with chronic hepatitis B on NA therapy.
In October 2023, GSK and Arrowhead Pharmaceuticals announced that they had reached an agreement with Janssen Pharmaceuticals to transfer exclusive worldwide rights to further develop and commercialise JNJ-3989 to GSK. JNJ-3989 (formerly ARO-HBV) was initially in-licensed by Janssen from Arrowhead in 2018.
Imdusiran (AB-729): Arbutus Biopharma
Imdusiran is an RNAi therapeutic specifically designed to reduce all HBV viral proteins and antigens, including HBsAg, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine (GalNAc) delivery technology, enabling subcutaneous delivery.
In the first-half of 2025, the company is planning to initiate a Phase IIb clinical trial of imdusiran combined with IFN and NA therapy.
Chronic Hepatitis B Market Outlook
Treatment landscape of chronic hepatitis B remains a largely unmet medical need, with no definitive cure and only a few FDA-approved treatments available.
Among the 7MM, the United States accounted for the highest market size in 2024, followed by Japan for Chronic Hepatitis B.
In the EU4 and the UK, Germany has the highest market size of approximately USD 65 million in 2024.
In 2024, the total market size for Chronic Hepatitis B in Japan was approximately 160 USD million.
During the forecast period (2024–2034), pipeline candidates such as Daplusiran/tomligisiran, Imdusiran (AB-729), and others are expected to drive the rise in Chronic Hepatitis B market size.
In a nutshell, many potential therapies are being investigated to manage Chronic Hepatitis B. Even though it is too soon to comment on the above-mentioned promising candidate to enter the market during the forecast period (2025–2034), it is safe to assume that the future of this market is bright. Eventually, these drugs will create a significant difference in the landscape of Chronic Hepatitis B in the coming years. The treatment space is expected to experience a significant positive shift in the coming years owing to the improvement in healthcare spending worldwide.
Further details are provided in the report…
Chronic Hepatitis B (CHB) Disease Understanding and Treatment
Chronic Hepatitis B (CHB) Overview
Hepatitis B is the most common severe liver infection in the world. It is caused by the hepatitis B virus that attacks and injures the liver. Millions of people are living with chronic hepatitis B infection worldwide. The hepatitis B virus (HBV) is transmitted through blood and infected bodily fluids. It can be passed to others through direct contact with blood, unprotected sex, illegal drugs, and unsterilized or contaminated needles.
Most hepatitis B infections clear up within 1–2 months without treatment. When the infection lasts more than 6 months, it can develop into chronic hepatitis B, leading to chronic inflammation of the liver, cirrhosis (scarring of the liver), liver cancer, and/or liver failure.
The symptoms of hepatitis B include fatigue, poor appetite, stomach pain, fever, nausea, vomiting, and occasionally joint pain, hives, or rash. Urine may become darker, and then jaundice (yellowing of the skin and whites of the eyes) may appear. Adults are more likely than children to develop symptoms.
Chronic hepatitis B infection can last for >6 months (after the first blood test result). This means the immune system cannot get rid of the hepatitis B virus, which remains in the blood and liver. The risk of developing a chronic hepatitis B infection is also directly related to the age at which one first becomes exposed to the hepatitis B virus:
Nearly 90% of infected newborns and babies develop a chronic hepatitis B infection.
Up to 50% of infected children (1–5 years) develop a chronic hepatitis B infection.
About 5–10% of infected adults develop a chronic hepatitis B infection
Further details are provided in the report…
Chronic Hepatitis B (CHB) Diagnosis
Screening for HBV involves a simple, low-cost blood test to detect hepatitis B surface antigen (HBsAg) and antibodies to HBsAg (anti-HBs) in serum. HBsAg-negative patients who do not have antibodies are given the hepatitis B vaccine. Those who are HBsAg-negative and have detectable anti-HBs are immune (generally from prior vaccination or recovery from an acute infection) and do not require further intervention or testing. A patient who tests positive for HBsAg has an active HBV infection, and further testing is needed to determine the phase of the disease and course of action.
Recommended initial follow-up testing includes serum ALT and HBV DNA levels, serology for hepatitis B e antigen (HBeAg), and antibody to HBeAg (anti-HBe). Individuals with chronic HBV infection have persistently circulating HBsAg in their serum for more than 6 months.
Further details related to country-based variations are provided in the report…
Chronic Hepatitis B (CHB) Treatment
Hepatitis B infection can result in either an acute or chronic infection. CHB is a blood born virus that primarily affects the liver. When the infection starts to progress after being in the body for 6 months, it is termed “Development or Advancement of Acute Hepatitis B infection into Chronic Hepatitis B infection.” To date, there is no cure for this infection; with the help of antivirals and interferon injections, the virus can be suppressed, or the patient might feel relieved of the symptoms for a specific period; however, there is no permanent solution.
When the hepatitis B virus does not get washed off the body after 6 months, the infection has progressed into the chronic stage, which makes a patient eligible for drug therapy. Usually, drug therapy is used if only one has active liver disease. The US FDA has approved seven drugs to treat hepatitis B. Out of seven, two are given in injectable forms of interferon, while the five other antivirals are tablets. The medications will have to be taken every day without fail; these medicines help suppress the virus’s growth and capability to multiply in the system, followed by a reduction in swelling and liver damage.
Further details related to treatment and management are provided in the report…
Chronic Hepatitis B (CHB) Epidemiology
The Chronic Hepatitis B (CHB) epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by 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 in the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034.
In 2024, the total prevalent cases of Chronic Hepatitis B was approximately 2,250,000 in the US.
In 2024, the total diagnosed cases of Chronic Hepatitis B was approximately 635,000 in the US.
In 2024, the age group-specific cases of CHB were approximately 10,000, 135,000, 160,000, 170,000, 125,000 and 31,000 cases for <18 years, 18–34 years, 35–44 years, 45–54 years, 55–64 years and =65 years, respectively, in the US.
In 2024, the compensated liver cases of CHB accounted 85% of all cases and decompensated liver cases of CHB accounted for 15% of the cases in the 7MM.
In 2024, the treated Cases of Chronic Hepatitis B was approximately 670,000 in the 7MM.
KOL Views
To stay abreast of the latest trends in the market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.
We have reached out to industry experts to gather insights on various aspects of Chronic Hepatitis B (CHB), including the evolving treatment landscape, patients’ reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts we contacted included medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan.
Our team of analysts at Delveinsight connected with more than 15 KOLs across the 7MM. We contacted institutions such as the University of Munich, the University of Tokyo, and The Blumberg Institute, University of Minnesota, etc., among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the Chronic Hepatitis B (CHB) market, which will assist our clients in analyzing the overall epidemiology and market scenario.
Qualitative Analysis
We perform Qualitative and Market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in trials for Chronic Hepatitis B (CHB), one of the most important primary endpoints was achieving hemolysis control, LDH normalization, etc. Based on these, the overall efficacy is evaluated.
Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Market Access and Reimbursement
Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.
The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Chronic Hepatitis B (CHB) Report Insights
Patient Population
Therapeutic Approaches
Chronic Hepatitis B (CHB) Market Size and Trends
Existing Market Opportunity
Chronic Hepatitis B (CHB) Report Key Strengths
Ten-year Forecast
The 7MM Coverage
Chronic Hepatitis B (CHB) Epidemiology Segmentation
Key Cross Competition
Chronic Hepatitis B (CHB) Report Assessment
Current Treatment Practices
Reimbursements
Market Attractiveness
Qualitative Analysis (SWOT, Conjoint Analysis, Unmet needs)
Key Questions
Would there be any changes observed in the current treatment approach?
Will there be any improvements in Chronic Hepatitis B (CHB) management recommendations?
Would research and development advances pave the way for future tests and therapies for Chronic Hepatitis B (CHB)?
Would the diagnostic testing space experience a significant impact and lead to a positive shift in the treatment landscape of Chronic Hepatitis B (CHB)?
What kind of uptake will the new therapies witness in the coming years in Chronic Hepatitis B (CHB) patients?
Table of Contents
210 Pages
- 1. Key Insights
- 2. Report Introduction
- 3. CHB Market Overview at a Glance
- 3.1. Market Share (%) Distribution of CHB by Country in 2024 in the 7MM
- 3.2. Market Share (%) Distribution of CHB by Country in 2034 in the 7MM
- 4. Epidemiology and Market Methodology
- 5. Executive Summary of CHB
- 6. Key Events
- 7. Disease Background and Overview
- 7.1. Introduction
- 7.2. Acute and Chronic Hepatitis B Infection
- 7.3. Signs and Symptoms
- 7.4. Risk Factors and Causes
- 7.5. Transmission of Hepatitis B Virus
- 7.6. Pathophysiology
- 7.7. Stages of HBV Infection
- 7.8. Complications of Hepatitis B Virus Infection
- 7.9. Diagnosis of Hepatitis B Infection
- 7.9.1. Screening Tests for Hepatitis B Infection
- 7.9.2. Liver Related Blood Tests
- 7.1. Tests to Diagnose Hepatitis B Virus
- 7.10.1. Medical History and Physical Exam
- 7.10.2. Imaging Tests
- 7.10.3. MRI and CT Scans
- 7.10.4. Liver Biopsy for Hepatitis B Virus
- 7.11. Diagnostic Guidelines of Hepatitis B Infection
- 7.11.1. World Health Organization (WHO) Diagnostic Guidelines
- 7.11.2. Disease Control and Prevention (CDC) Recommendations for Onetime Universal Screening of Adults Aged 18 years and Older for HBV Infection, 2023
- 7.11.3. American Association for the Study of Liver Diseases (AASLD) Diagnostic Guidelines, 2018
- 7.11.4. European Association for the Study of the Liver (EASL) Diagnostic Guidelines, 2017
- 7.12. Diagnosis Algorithm
- 8. Treatment and Management
- 8.1. Prevention of Hepatitis B Infection
- 8.2. Treatment Guidelines
- 8.2.1. World Health Organization Guidelines for the management and treatment of CHB
- 8.2.2. AASLD 2018 Practice Guidelines for Treatment of Chronic Hepatitis
- 8.2.3. European Association for the Study of the Liver (EASL) 2017 Clinical Practice Guidelines for Hepatitis
- 8.2.4. Hepatitis B management: Guidance for the primary care provider
- 8.3. Treatment Algorithm
- 9. Epidemiology and Patient Population
- 9.1. Key Findings
- 9.2. Assumptions and Rationale: The 7MM
- 9.3. Prevalent Cases of CHB in the 7MM
- 9.4. United States
- 9.4.1. Prevalent Cases of CHB in the US
- 9.4.2. Diagnosed Prevalent Cases of CHB in the US
- 9.4.3. Gender-specific Diagnosed Prevalent Cases of CHB in the US
- 9.4.4. Age-specific diagnosed prevalent cases of CHB in the US
- 9.4.5. CHB Cases by Impact on Liver in the US
- 9.4.6. Total Treated Cases of CHB in the US
- 9.5. Epidemiology Scenario in EU4 and the UK
- 9.5.1. Prevalent Cases of CHB in EU4 and the UK
- 9.5.2. Diagnosed Prevalent Cases of CHB in EU4 and the UK
- 9.5.3. Gender-specific Diagnosed Prevalent Cases of CHB in EU4 and the UK
- 9.5.4. Age-specific Diagnosed Prevalent Cases of CHB in EU4 and the UK
- 9.5.5. CHB Cases by Impact on Liver in EU4 and the UK
- 9.5.6. Total Treated Cases of CHB in EU4 and the UK
- 9.6. Japan
- 9.6.1. Prevalent Cases of CHB in Japan
- 9.6.2. Diagnosed Prevalent Cases of CHB in Japan
- 9.6.3. Gender-specific Diagnosed Prevalent Cases of CHB in Japan
- 9.6.4. Age-specific Diagnosed Prevalent Cases of CHB in Japan
- 9.6.5. CHB Cases by Impact on Liver in Japan
- 9.6.6. Total Treated Cases of CHB in Japan
- 10. Patient Journey
- 11. Marketed Therapies
- 11.1. Key Cross of Marketed Therapies
- 11.2. VEMLIDY (tenofovir alafenamide): Gilead Sciences
- 11.2.1. Product description
- 11.2.2. Regulatory Milestones
- 11.2.3. Other developmental activities
- 11.2.4. Clinical Developmental Activities
- 11.2.5. Safety and Efficacy
- 12. Emerging Therapies
- 12.1. Key Cross of Emerging Therapies
- 12.2. Imdusiran (AB-729): Arbutus Biopharma
- 12.2.1. Product description
- 12.2.2. Other developmental activities
- 12.2.3. Clinical Developmental Activities
- 12.2.4. Safety and Efficacy
- 12.2.5. Analyst View
- 12.3. GSK3228836 (bepirovirsen): GlaxoSmithKline
- 12.3.1. Product description
- 12.3.2. Other developmental activities
- 12.3.3. Clinical Developmental Activities
- 12.3.4. Safety and efficacy
- 12.3.5. Analyst View
- 12.4. Tobevibart (VIR-3434) + elebsiran (VIR-2218) ± PEG-IFN-a: Vir Biotechnology
- 12.4.1. Product Description
- 12.4.2. Other developmental activities
- 12.4.3. Clinical Developmental Activities
- 12.4.4. Safety and efficacy
- 12.4.5. Analyst View
- 13. CHB: 7 Major Market Analysis
- 13.1. Key Findings
- 13.2. Market Outlook
- 13.3. Conjoint Analysis
- 13.4. Key Market Forecast Assumptions
- 13.5. Total Market Size of CHB in the 7MM
- 13.6. Total Market Size of CHB by Therapies in the 7MM
- 13.7. The United States Market Size
- 13.7.1. Total Market Size of CHB in the US (2020–2034)
- 13.7.2. Market Size of CHB by Therapies in the United States (2020-2034)
- 13.8. EU4 and the UK Market Size
- 13.8.1. Total Market Size of CHB in EU4 and the UK (2020-2034)
- 13.8.2. Market Size of CHB by Therapies in EU4 and the UK (2020-2034)
- 13.9. Japan Market Size
- 13.9.1. Total Market Size of CHB in Japan (2020-2034)
- 13.9.2. Market Size of CHB by Therapies
- 14. KOL Views
- 15. SWOT Analysis
- 16. Unmet Needs
- 17. Market Access and Reimbursement
- 17.1. United States
- 17.1.1. Centre for Medicare and Medicaid Services (CMS)
- 17.2. EU4 and the UK
- 17.2.1. Germany
- 17.2.2. France
- 17.2.3. Italy
- 17.2.4. Spain
- 17.2.5. United Kingdom
- 17.3. Japan
- 17.3.1. MHLW
- 17.4. Market Access and Reimbursement Senario in CHB
- 17.4.1. Patient access programs
- 17.4.2. Key HTA decisions for CHB
- 17.4.3. Japan
- 18. Appendix
- 18.1. Bibliography
- 18.2. Report Methodology
- 19. DelveInsight Capabilities
- 20. Disclaimer
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