Chronic Hepatitis Delta Virus Infection Market Summary

• Chronic hepatitis D virus infection occurs only in individuals who are already infected with hepatitis B virus, as the hepatitis D virus depends on hepatitis B virus to replicate. It is considered the most severe form of chronic viral hepatitis because it progresses more rapidly to serious liver-related complications, including liver failure and liver cancer.
• The International Agency for Research on Cancer (IARC) Monograph Programme has recently classified hepatitis D virus as a Group I carcinogen, indicating it is carcinogenic to humans, similar to hepatitis B and hepatitis C viruses.
• The chronic hepatitis D market is anticipated to experience steady growth from 2025 to 2034, driven by increasing disease awareness, improved screening for HBV/HDV co-infection, and the rising burden of advanced liver disease. The recent approval of targeted therapies, such as entry inhibitors, along with continued innovation in antiviral research and a growing clinical pipeline, are expected to support sustained market expansion and improved patient outcomes.
• HEPCLUDEX (bulevirtide), developed by Gilead Sciences, is approved for the treatment of chronic hepatitis D virus infection in adults with compensated liver disease. It works by blocking the sodium taurocholate co-transporting polypeptide (NTCP) receptor on liver cells, preventing HDV and HBV from entering and replicating within these cells, thereby reducing viral load and liver inflammation. This approval marks a significant advancement in targeted therapy for HDV.
• Brelovitug (Bluejay Therapeutics) and the Tobevibart + Elebsiran (Vir Biotechnology) represent promising next-generation therapies for chronic HDV. Targeting viral entry and replication through complementary mechanisms, they reflect a shift toward multi-targeted, more effective treatment strategies beyond interferon-based options.
• In July 2025, Vir Biotechnology announced the enrollment of the first participant in the ECLIPSE 2 Phase III clinical trial, which was designed to compare the combination of Tobevibart and Elebsiran to continued Bulevirtide monotherapy in participants with chronic hepatitis D who had not achieved undetectable hepatitis D virus (HDV) RNA despite Bulevirtide treatment.
• In March 2025, Bluejay Therapeutics dosed the first patient in its AZURE-1 global pivotal trial of brelovitug (BJT-778) for chronic hepatitis D.
• Market growth in chronic hepatitis D virus is driven by advanced antiviral therapies and innovative treatment approaches targeting viral replication and liver inflammation. While conventional options like pegylated interferon have shown limited efficacy and tolerability, the high risk of cirrhosis and liver failure underscores the need for more effective, long-lasting solutions. Emerging treatments, including entry inhibitors and combination regimens, aim to improve viral suppression, reduce disease progression, and enhance quality of life through sustained virologic response.

DelveInsight’s comprehensive report titled “Chronic Hepatitis D Virus Market Insights, Epidemiology, and Market Forecast 2034” offers a detailed analysis of chronic hepatitis D virus. The report presents historical and projected epidemiological data covering total prevalent cases of chronic hepatitis D virus, total diagnosed prevalent cases of chronic hepatitis D virus, gender-specific cases of chronic hepatitis D virus, age-specific cases of chronic hepatitis D virus, and treated cases of chronic hepatitis D virus. In addition to epidemiology, the market report encompasses various aspects related to the patient population. These aspects include the diagnosis process, prescription patterns, physician perspectives, market accessibility, treatment options, and prospective developments in the market across seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, spanning from 2020 to 2034.

The report analyzes the existing treatment practices and unmet medical requirements in chronic hepatitis D virus. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the market.

Chronic Hepatitis D Virus Overview

Hepatitis D virus (HDV) was first identified in 1977 in individuals with chronic hepatitis B virus (HBV) infection. Initially mistaken for an HBV antigen, it was later recognized as a distinct pathogen, termed the delta agent. HDV is a hybrid virus that relies on the hepatitis B surface antigen (HBsAg) for its envelope, allowing it to infect only those with HBV. Interestingly, HDV infection suppresses HBV replication through mechanisms that are not yet fully understood. 

HDV requires the presence of hepatitis B virus (HBV) to establish a productive infection, as it cannot replicate independently. Co-infection with HDV not only significantly accelerates the progression to advanced liver disease, including cirrhosis and hepatocellular carcinoma, but also markedly increases the risk of hepatic decompensation. Compared to HBV infection alone, HDV co-infection is associated with a higher likelihood of liver-related complications and serves as an independent risk factor for both liver-related and overall mortality in individuals with chronic hepatitis B. 

Chronic Hepatitis D Virus Diagnosis and Treatment Algorithm 

The diagnosis of chronic hepatitis D virus (HDV) infection involves a two-step process: first, serological testing is used to confirm exposure to the virus, indicating either past or current infection, typically through the detection of anti-HDV antibodies. Second, molecular testing is required to identify the presence of HDV RNA in the blood, which confirms active viral replication and ongoing infection. This molecular assessment is also critical for monitoring a patient’s response to antiviral therapy over time.

Despite its importance, HDV testing is limited. A major challenge is the lack of standardized HDV RNA assays, which hinders accurate detection of active infection and monitoring of treatment response. This contributes to underdiagnosis and delays in clinical management.

Until recently, pegylated interferon alpha (PEG-IFNα) was the only available treatment for chronic hepatitis D virus infection. However, its clinical utility has been limited due to modest efficacy, a high rate of side effects, and several contraindications. Only few of patients achieve a complete virological response during therapy, and relapses are common following treatment cessation.

The treatment landscape for chronic HDV is now progressing, with new therapies demonstrating promising outcomes. In 2023, bulevirtide, a once-daily subcutaneous entry inhibitor was approved by the European Medicines Agency for use in adults with chronic HDV. Ongoing multicenter studies are investigating optimal dosing, treatment duration, and the potential benefits of combining bulevirtide with PEG-IFNα. Meanwhile, nucleoside analogues used to manage hepatitis B have shown no direct antiviral effect on HDV, though they remain important for concurrent HBV infection management.

Chronic Hepatitis D Virus Epidemiology

The epidemiology section of the chronic hepatitis D virus market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.

This section also presents the data with relevant tables and graphs, offering a clear and concise view of the prevalence of chronic hepatitis D virus. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.

Key Findings

• According to secondary sources, over 12 million people globally are chronically infected with hepatitis D virus (HDV), which is recognized as the most severe form of viral hepatitis.
• According to WHO, it is estimated that hepatitis D virus affects ~5% of individuals with chronic hepatitis B.
• According to secondary sources, in the US, up to 2.4 million people are hepatitis B surface antigen (HBsAg)-positive. Among them, 3–6% test positive for HDV antibodies, and 50–70% of those have active HDV infection based on RNA testing, translating to an estimated 70,000 to 150,000 active HDV cases in the US. 
• The epidemiology of chronic hepatitis D virus is expected to change during the forecast period (2025-2034).

Chronic hepatitis D virus Market Outlook

The chronic hepatitis D virus therapeutics market is further expected to increase by the major drivers, such as the rising prevalence population, technological advancements, and upcoming therapies in the forecast period (2025–2034).

With ongoing research and continued dedication, the future holds hope for even more effective treatments and, ultimately, a cure for this challenging condition. According to DelveInsight, the chronic hepatitis D virus market in the 7MM is expected to change significantly during the forecast period 2025–2034.

Chronic Hepatitis D Virus Drug Chapters

Marketed Chronic Hepatitis D Virus Drugs

HEPCLUDEX (Bulevirtide): Gilead Sciences

HEPCLUDEX is an antiviral medicine used to treat chronic hepatitis D virus (HDV) infection in adults and children from 3 years of age and weighing at least 10 kg who have compensated liver disease. It is used when the presence of HDV RNA has been confirmed by blood tests. HEPCLUDEX (bulevirtide) blocks the receptor used by hepatitis D and B viruses to enter liver cells, limiting HDV replication and reducing liver inflammation.

In May 2023, Gilead Sciences announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for HEPCLUDEX (bulevirtide) for the treatment of adults with chronic HDV and compensated liver disease, and recommended granting full marketing authorisation that is no longer subject to specific obligations. Bulevirtide was initially granted conditional marketing authorisation in July 2020 to provide people living with HDV urgent access to treatment. 

In November 2021, Gilead Sciences filed a BLA with the US FDA for bulevirtide, a first-in-class HDV treatment with Breakthrough and Orphan Drug status. In October 2022, the FDA issued a Complete Response Letter (CRL) over manufacturing and delivery issues, with no new safety or efficacy studies requested. Bulevirtide remains unapproved in the US.

Note: Detailed marketed therapies assessment will be provided in the final report

Emerging Chronic hepatitis D virus Drugs

The chronic hepatitis D virus market is expected to evolve gradually, driven by the limited number of emerging therapies currently in development. Key players such as Brelovitug, by Bluejay therapeutics, Tobevibart + Elebsiran by Vir Biotechnology among others are showing active commitment to addressing this unmet need, with ongoing efforts to advance novel treatment options for this complex condition.

Brelovitug (BJT-778): Bluejay therapeutics

Brelovitug (BJT-778) is a high potency, fully human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets the surface antigen (anti-HBsAg) of the hepatitis B virus with pan-genotypic activity. It is being investigated as a potential monotherapy for adults with chronic hepatitis D and as the foundation of a combination strategy for the functional cure of chronic hepatitis B. Brelovitug neutralizes and removes hepatitis B and hepatitis D virions and depletes HBsAg-containing subviral particles. In addition, brelovitug has shown it has the potential to be a potent immunomodulator.

In January 2025, Bluejay Therapeutics received US FDA Breakthrough Therapy Designation for Brelovitug (BJT-778) for the treatment of chronic hepatitis D. Brelovitug is currently being evaluated in a Phase III clinical trial, with the first patient dosed in the AZURE-1 study.

Tobevibart + Elebsiran: Vir Biotechnology 

Tobevibart is a subcutaneously administered investigational monoclonal antibody that targets the hepatitis B surface antigen to block hepatitis B and D virus entry into liver cells and reduce circulating viral particles. It features extended half-life technologies and is in clinical development for chronic hepatitis B and D. Elebsiran is a subcutaneous investigational siRNA therapy designed to degrade hepatitis B virus RNA, reducing surface antigen production. It shows potential antiviral activity against both hepatitis B and D viruses and is in clinical development through a collaboration between Vir Biotechnology and Alnylam Pharmaceuticals. 

In December 2024, Vir Biotechnology received FDA Breakthrough Therapy Designation and EMA PRIME Designation for Tobevibart and Elebsiran in chronic hepatitis D.

Note: Detailed emerging therapies assessment will be provided in the final report.

Chronic Hepatitis D Virus Market Segmentation

DelveInsight’s ‘Chronic Hepatitis D Virus Market Insights, Epidemiology, and Market Forecast – 2034’ report provides a detailed outlook of the current and future chronic hepatitis D virus market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies. 

Chronic Hepatitis D Virus Market Size by Countries

The chronic hepatitis D virus market size is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. In 2024, the United States held a significant share of the overall 7MM (Seven Major Markets) chronic hepatitis D virus market, primarily attributed to the country’s higher prevalence of the condition and the elevated cost of the available treatments. This dominance is projected to persist, especially with the potential early introduction of new products.

Chronic Hepatitis D Virus Market Size by Therapies

Chronic Hepatitis D Virus Market Size by Therapies is categorized into current and emerging markets for the study period 2020–2034. 

Note: Detailed market segment assessment will be provided in the final report.

Chronic Hepatitis D Virus Drugs Uptake

This section focuses on the sales uptake of potential chronic hepatitis D virus drugs that have recently been launched or are anticipated to be launched in the chronic hepatitis D virus market between 2020 and 2034. It estimates the market penetration of chronic hepatitis D virus drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the chronic hepatitis D virus market.

The emerging chronic hepatitis D virus therapies are analyzed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the chronic hepatitis D virus market.

Note: Detailed assessment of drug uptake and attribute analysis will be provided in the full report on chronic hepatitis D virus.

Chronic Hepatitis D Virus Market Access and Reimbursement

DelveInsight’s ‘Chronic Hepatitis D Virus– Market Insights, Epidemiology, and Market Forecast – 2034’ report provides a descriptive overview of the market access and reimbursement scenario of chronic hepatitis D virus.

This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments. 

Latest KOL Views

To keep up with current chronic hepatitis D virus market trends and fill gaps in secondary findings, we interview KOLs and SMEs’ working in the chronic hepatitis D virus domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or chronic hepatitis D virus market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the chronic hepatitis D virus unmet needs.

Chronic Hepatitis D Virus KOL Insights

• DelveInsight’s analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as Upstate Medical University, US, Hannover Medical School, Germany universitat de barcelona, Barcelona, Spain, Université Paris-Saclay, France, Cambridge University, UK, and Hokkaido University, Sapporo, Japan, among others.
• As per the KOLs from the US “There is an urgent need for effective antiviral therapies to halt the progression of HDV toward serious complications. Pegylated interferon alpha has been used off-label for decades to treat HDV, but its use is limited by significant side effects and modest efficacy, with less than one-third of patients achieving a complete virological and biochemical response 24 weeks after treatment ends.”
• As per the KOLs from the UK “Implementing targeted quality improvement measures, such as electronic medical record (EMR) alerts and reflex testing, can help increase screening rates, similar to established hepatitis C virus screening programs. In fact, the use of reflex testing for hepatitis D antibodies in all individuals who tested positive for hepatitis B surface antigen (HBsAg) led to improved detection of hepatitis D infection.”
• As per the KOLs from the US “Chronic HDV infection is associated with higher rates of liver-related complications, including increased risk of liver failure, liver transplantation, and death. Additionally, individuals with chronic HDV may show ongoing elevation of ALT levels even when HBV DNA is suppressed with nucleos(t)ide analog (NA) therapy.”

Note: Detailed assessment of KOL Views will be provided in the full report chronic hepatitis D virus.

Competitive Intelligence Analysis

We conduct a Competitive and Market Intelligence analysis of the chronic hepatitis D virus Market, utilizing various Competitive Intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.

Chronic Hepatitis D Virus Pipeline Development Activities

The report offers an analysis of therapeutic candidates in Phase II and III stages and examines companies involved in developing targeted therapeutics for chronic hepatitis D virus. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.

Pipeline Development Activities

The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging chronic hepatitis D virus therapies.

Chronic Hepatitis D Virus Report Insights

• Chronic Hepatitis D Virus Patient Population
• Therapeutic Approaches
• Chronic Hepatitis D Virus Pipeline Analysis
• Chronic Hepatitis D Virus Market Size and Trends
• Chronic Hepatitis D Virus Market Opportunities
• Impact of Upcoming Therapies

Chronic Hepatitis D Virus Report Key Strengths

• 10 Years Forecast
• The 7MM Coverage
• Chronic Hepatitis D Virus Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Chronic Hepatitis D Virus Market
• Chronic Hepatitis D Virus Drugs Uptake

Chronic Hepatitis D Virus Report Assessment

• Chronic Hepatitis D Virus Current Treatment Practices
• Unmet Needs
• Chronic Hepatitis D Virus Pipeline Product Profiles
• Chronic Hepatitis D Virus Market Attractiveness

Key Questions answered through our chronic hepatitis D virus market report:

• How common is chronic hepatitis D virus?
• What are the key findings of chronic hepatitis D virus epidemiology across the 7MM, and which country will have the highest number of patients during the study period (2020–2034)?
• What are the currently available treatments for chronic hepatitis D virus?
• What are the disease risk, burden, and unmet needs of chronic hepatitis D virus?
• At what CAGR is the chronic hepatitis D virus market and its epidemiology is expected to grow in the 7MM during the forecast period (2025–2034)?
• How would the unmet needs impact the chronic hepatitis D virus market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of chronic hepatitis D virus in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?
• Among EU4 and the UK, which country will have the highest number of patients during the forecast period (2025–2034)?
• How many companies are currently developing therapies for the treatment of chronic hepatitis D virus? 

Reasons to buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the chronic hepatitis D virus Market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of current treatment in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future. 
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.