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Hepatitis B Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2024-2034

May 2024 | 134 pages | ID: H9E6F1F9DB16EN
IMARC Group

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The hepatitis B market reached a value of US$ 3.3 Billion across the top 7 markets (US, EU4, UK, and Japan) in 2023. Looking forward, IMARC Group expects the top 7 markets to reach US$ 4.9 Billion by 2034, exhibiting a growth rate (CAGR) of 3.83% during 2024-2034.

The hepatitis B market has been comprehensively analyzed in IMARC's new report titled "Hepatitis B Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2024-2034". Hepatitis B refers to a viral infection that severely affects the liver and is caused by the hepatitis B virus (HBV). The virus can cause acute and chronic conditions, with the latter being more serious and fatal. The symptoms of acute hepatitis B infection can range from mild to severe and include muscle and joint pain, fever, fatigue, nausea, vomiting, abdominal pain, loss of appetite, etc. As the disease progresses, several other indications, such as jaundice, dark urine, pale stools, etc., may also develop. Chronic hepatitis B infection often has no symptoms in its early stages, but over time it can lead to cirrhosis, liver damage, liver cancer, and even liver failure. The diagnosis of the ailment typically involves a blood test to check for the presence of hepatitis B virus (HBV) antigens and antibodies, as well as liver function tests to assess the level of liver enzymes and proteins in the blood. If the blood tests suggest an active HBV infection, further procedures, such as a hepatitis B viral load test, may be done to evaluate the amount of virus in the blood. Additionally, a liver biopsy may also be performed to determine the extent of liver damage in cases of chronic hepatitis B infection.

The rising cases of infections from the hepatitis B virus, which is transmitted through contact with infected blood or bodily fluids like semen and vaginal secretions, are primarily driving the hepatitis B market. Furthermore, the widespread adoption of antiviral medications, including entecavir, tenofovir, lamivudine, etc., for suppressing the replication of the virus in the body and preventing liver damage is also creating a positive outlook for the market. Apart from this, the emerging popularity of interferon therapy among patients with chronic hepatitis B who have not responded to other therapeutic procedures is acting as another significant growth-inducing factor. Additionally, the introduction of new treatment modalities for hepatitis B, including gene therapy and RNA interference (RNAi), which hold the potential to provide more effective and durable treatments for patients with chronic hepatitis B infection, is further propelling the market growth. Moreover, the inflating demand for immune modulators, such as pegylated interferon and thymosin alpha-1, since they boost the immune response and enhance the effectiveness of antiviral medications, is expected to drive the hepatitis B market in the coming years.

IMARC Group's new report provides an exhaustive analysis of the hepatitis B market in the United States, EU4 (Germany, Spain, Italy, and France), United Kingdom, and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report, the United States has the largest patient pool for hepatitis B and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario, unmet medical needs, etc., have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the hepatitis B market in any manner.

Recent Developments:
In March 2024, Gilead Sciences, Inc. revealed that the U.S. FDA has granted the supplemental new drug application for Vemlidy (tenofovir alafenamide) tablets at a dosage of 25 mg once daily for chronic hepatitis B infection in pediatric patients aged ? 6 years and weighing no less than 25 kg with compensated liver disease.
In February 2024, TherVacB, a new therapeutic vaccine to address chronic hepatitis B, began its first clinical trial. The vaccine was developed and designed under the leadership of Helmholtz Munich. It aims to cure the disease by boosting the body’s innate system to fight against the infection.
In February 2024, GSK declared that the U.S. FDA approved Fast Track designation for bepirovirsen, an experimental antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B. Bepirovirsen decreases viral DNA replication in the body, reduces the quantity of hepatitis B surface antigen in the blood, and boosts the immune system, thereby increasing the likelihood of a long-lasting and sustained response.
In February 2024, Chula researchers devised a unique wireless hepatitis B virus test kit that screens for infection and collects data for an online database in a single step. This innovative diagnostic kit for targeting Hepatitis B surface antigen (HBsAg) uses an electrochemical biosensor based on the distinctive interaction of antigens and antibodies.

Key Highlights:
It is estimated that more than 2 billion people are infected with hepatitis B worldwide.
As per the Centers for Disease Control and Prevention (CDC), hepatitis B contributes to an estimated 820,000 deaths every year.
The rate of acute hepatitis B infection cases reduced by 32% after 2019, possibly due to the disruptions caused by the COVID-19 pandemic.
25% of chronic hepatitis B infections progress to liver cancer.
In the U.S., an estimated 880,000 to 1.89 million persons are chronically infected with the hepatitis B virus.

Drugs:
Baraclude (entecavir) is an oral antiviral drug used to manage chronic hepatitis B virus infection in people who have active viral replication, persistently elevated serum aminotransferases (ALT or AST), or histologically active illness. It is designed to specifically inhibit the hepatitis B virus by blocking all three steps in the replication process.

VIR-2218 is an experimental subcutaneously administered hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) that stimulates an immunological response and has effective antiviral action against hepatitis B and hepatitis delta viruses. It works by targeting the hepatitis B virus (HBV) genome, particularly HBsAg.

NCO-48 fumarate is a novel tenofovir liver-targeted prodrug (LTP). The liver-targeting ability of oral NCO-48 fumarate relies on the chemical change of tenofovir into an inactive prodrug form that is quickly absorbed and efficiently converted to tenofovir diphosphate in the liver. This results in high tenofovir diphosphate levels in the liver, where viral replication occurs, and low levels of tenofovir in the systemic circulation and kidney, which are susceptible to toxicity.


Time Period of the Study

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

Competitive Landscape:
This report also provides a detailed analysis of the current 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

*Kindly note that the drugs in the above table only represent a partial list of marketed/pipeline drugs, and the complete list has been provided in the report.


Key Questions Answered in this Report:
Market Insights

How has the hepatitis B market performed so far and how will it perform in the coming years?
What are the markets shares of various therapeutic segments in 2023 and how are they expected to perform till 2034?
What was the country-wise size of the hepatitis B market across the seven major markets in 2023 and what will it look like in 2034?
What is the growth rate of the hepatitis B market across the seven major markets and what will be the expected growth over the next ten years?
What are the key unmet needs in the market?

Epidemiology Insights

What is the number of prevalent cases (?2018-2034?) of hepatitis B across the seven major markets?
What is the number of prevalent cases (?2018-2034?) of hepatitis B by age across the seven major markets?
What is the number of prevalent cases (?2018-2034?) of hepatitis B by gender across the seven major markets?
What is the number of prevalent cases (?2018-2034?) of hepatitis B by type across the seven major markets?
How many patients are diagnosed (?2018-2034?) with hepatitis B across the seven major markets?
What is the size of the hepatitis B patient pool (2018-2023) across the seven major markets?
What would be the forecasted patient pool (2024-2034) across the seven major markets?
What are the key factors driving the epidemiological trend of hepatitis B?
What will be the growth rate of patients across the seven major markets?

Hepatitis B: Current Treatment Scenario, Marketed Drugs and Emerging Therapies

What are the current marketed drugs and what are their market performance?
What are the key pipeline drugs and how are they expected to perform in the coming years?
How safe are the current marketed drugs and what are their efficacies?
How safe are the late-stage pipeline drugs and what are their efficacies?
What are the current treatment guidelines for hepatitis B drugs across the seven major markets?
Who are the key companies in the market and what are their market shares?
What are the key mergers and acquisitions, licensing activities, collaborations, etc. related to the hepatitis B market?
What are the key regulatory events related to the hepatitis B market?
What is the structure of clinical trial landscape by status related to the hepatitis B market?
What is the structure of clinical trial landscape by phase related to the hepatitis B market?
What is the structure of clinical trial landscape by route of administration related to the hepatitis B market?
1 PREFACE

2 SCOPE AND METHODOLOGY

2.1 Objectives of the Study
2.2 Stakeholders
2.3 Data Sources
  2.3.1 Primary Sources
  2.3.2 Secondary Sources
2.4 Market Estimation
  2.4.1 Bottom-Up Approach
  2.4.2 Top-Down Approach
2.5 Forecasting Methodology

3 EXECUTIVE SUMMARY

4 HEPATITIS B - INTRODUCTION

4.1 Overview
4.2 Regulatory Process
4.3 Epidemiology (2018-2023) and Forecast (2024-2034)
4.4 Market Overview (2018-2023) and Forecast (2024-2034)
4.5 Competitive Intelligence

5 HEPATITIS B - DISEASE OVERVIEW

5.1 Introduction
5.2 Symptoms and Diagnosis
5.3 Pathophysiology
5.4 Causes and Risk Factors
5.5 Treatment

6 PATIENT JOURNEY

7 HEPATITIS B - EPIDEMIOLOGY AND PATIENT POPULATION

7.1 Epidemiology - Key Insights
7.2 Epidemiology Scenario - Top 7 Markets
  7.2.1 Epidemiology Scenario (2018-2023)
  7.2.2 Epidemiology Forecast (2024-2034)
  7.2.3 Epidemiology by Age (?2018-2034?)
  7.2.4 Epidemiology by Gender (?2018-2034?)
  7.2.5 Epidemiology by Type (?2018-2034?)
  7.2.6 Diagnosed Cases (?2018-2034?)
  7.2.7 Patient Pool/Treated Cases (?2018-2034?)
7.3 Epidemiology Scenario - United States
  7.3.1 Epidemiology Scenario (2018-2023)
  7.3.2 Epidemiology Forecast (2024-2034)
  7.3.3 Epidemiology by Age (?2018-2034?)
  7.3.4 Epidemiology by Gender (?2018-2034?)
  7.3.5 Epidemiology by Type (?2018-2034?)
  7.3.6 Diagnosed Cases (?2018-2034?)
  7.3.7 Patient Pool/Treated Cases (?2018-2034?)
7.4 Epidemiology Scenario - Germany
  7.4.1 Epidemiology Scenario (2018-2023)
  7.4.2 Epidemiology Forecast (2024-2034)
  7.4.3 Epidemiology by Age (?2018-2034?)
  7.4.4 Epidemiology by Gender (?2018-2034?)
  7.4.5 Epidemiology by Type (?2018-2034?)
  7.4.6 Diagnosed Cases (?2018-2034?)
  7.4.7 Patient Pool/Treated Cases (?2018-2034?)
7.5 Epidemiology Scenario - France
  7.5.1 Epidemiology Scenario (2018-2023)
  7.5.2 Epidemiology Forecast (2024-2034)
  7.5.3 Epidemiology by Age (?2018-2034?)
  7.5.4 Epidemiology by Gender (?2018-2034?)
  7.5.5 Epidemiology by Type (?2018-2034?)
  7.5.6 Diagnosed Cases (?2018-2034?)
  7.5.7 Patient Pool/Treated Cases (?2018-2034?)
7.6 Epidemiology Scenario - United Kingdom
  7.6.1 Epidemiology Scenario (2018-2023)
  7.6.2 Epidemiology Forecast (2024-2034)
  7.6.3 Epidemiology by Age (?2018-2034?)
  7.6.4 Epidemiology by Gender (?2018-2034?)
  7.6.5 Epidemiology by Type (?2018-2034?)
  7.6.6 Diagnosed Cases (?2018-2034?)
  7.6.7 Patient Pool/Treated Cases (?2018-2034?)
7.7 Epidemiology Scenario - Italy
  7.7.1 Epidemiology Scenario (2018-2023)
  7.7.2 Epidemiology Forecast (2024-2034)
  7.7.3 Epidemiology by Age (?2018-2034?)
  7.7.4 Epidemiology by Gender (?2018-2034?)
  7.7.5 Epidemiology by Type (?2018-2034?)
  7.7.6 Diagnosed Cases (?2018-2034?)
  7.7.7 Patient Pool/Treated Cases (?2018-2034?)
7.8 Epidemiology Scenario - Spain
  7.8.1 Epidemiology Scenario (2018-2023)
  7.8.2 Epidemiology Forecast (2024-2034)
  7.8.3 Epidemiology by Age (?2018-2034?)
  7.8.4 Epidemiology by Gender (?2018-2034?)
  7.8.5 Epidemiology by Type (?2018-2034?)
  7.8.6 Diagnosed Cases (?2018-2034?)
  7.8.7 Patient Pool/Treated Cases (?2018-2034?)
7.9 Epidemiology Scenario - Japan
  7.9.1 Epidemiology Scenario (2018-2023)
  7.9.2 Epidemiology Forecast (2024-2034)
  7.9.3 Epidemiology by Age (?2018-2034?)
  7.9.4 Epidemiology by Gender (?2018-2034?)
  7.9.5 Epidemiology by Type (?2018-2034?)
  7.9.6 Diagnosed Cases (?2018-2034?)
  7.9.7 Patient Pool/Treated Cases (?2018-2034?)

8 HEPATITIS B - TREATMENT ALGORITHM, GUIDELINES, AND MEDICAL PRACTICES

8.1 Guidelines, Management and Treatment
8.2 Treatment Algorithm

9 HEPATITIS B - UNMET NEEDS

10 HEPATITIS B - KEY ENDPOINTS OF TREATMENT

11 HEPATITIS B - MARKETED PRODUCTS

11.1 List of Hepatitis B Marketed Drugs Across the Top 7 Markets
  11.1.1 Heplisav B (Adjuvanted Hepatitis B vaccine (Recombinant)) - Dynavax Technologies
    11.1.1.1 Drug Overview
    11.1.1.2 Mechanism of Action
    11.1.1.3 Regulatory Status
    11.1.1.4 Clinical Trial Results
    11.1.1.5 Sales Across Major Markets
  11.1.2 PreHevbrio (Hepatitis B vaccine recombinant) - VBI Vaccines
    11.1.2.1 Drug Overview
    11.1.2.2 Mechanism of Action
    11.1.2.3 Regulatory Status
    11.1.2.4 Clinical Trial Results
    11.1.2.5 Sales Across Major Markets
  11.1.3 Baraclude (Entecavir) - Bristol-Myers Squibb
    11.1.3.1 Drug Overview
    11.1.3.2 Mechanism of Action
    11.1.3.3 Regulatory Status
    11.1.3.4 Clinical Trial Results
    11.1.3.5 Sales Across Major Markets
  11.1.4 Hepsera (Adefovir dipivoxil) - Gilead Sciences
    11.1.4.1 Drug Overview
    11.1.4.2 Mechanism of Action
    11.1.4.3 Regulatory Status
    11.1.4.4 Clinical Trial Results
    11.1.4.5 Sales Across Major Markets
  11.1.5 Vemlidy (Tenofovir alafenamide) - Gilead Sciences
    11.1.5.1 Drug Overview
    11.1.5.2 Mechanism of Action
    11.1.5.3 Regulatory Status
    11.1.5.4 Clinical Trial Results
    11.1.5.5 Sales Across Major Markets
Kindly note that the above only represents a partial list of marketed drugs, and the complete list has been provided in the report.

12 HEPATITIS B - PIPELINE DRUGS

12.1 List of Hepatitis B Pipeline Drugs Across the Top 7 Markets
  12.1.1 VIR-2218 - Vir Biotechnology
    12.1.1.1 Drug Overview
    12.1.1.2 Mechanism of Action
    12.1.1.3 Clinical Trial Results
    12.1.1.4 Safety and Efficacy
    12.1.1.5 Regulatory Status
  12.1.2 EYP001a - ENYO Pharma
    12.1.2.1 Drug Overview
    12.1.2.2 Mechanism of Action
    12.1.2.3 Clinical Trial Results
    12.1.2.4 Safety and Efficacy
    12.1.2.5 Regulatory Status
  12.1.3 NCO48 Fumarate - Nucorion Pharmaceuticals
    12.1.3.1 Drug Overview
    12.1.3.2 Mechanism of Action
    12.1.3.3 Clinical Trial Results
    12.1.3.4 Safety and Efficacy
    12.1.3.5 Regulatory Status
  12.1.4 APG1387 - Ascentage Pharma
    12.1.4.1 Drug Overview
    12.1.4.2 Mechanism of Action
    12.1.4.3 Clinical Trial Results
    12.1.4.4 Safety and Efficacy
    12.1.4.5 Regulatory Status
  12.1.5 GSK3965193 - GlaxoSmithKline
    12.1.5.1 Drug Overview
    12.1.5.2 Mechanism of Action
    12.1.5.3 Clinical Trial Results
    12.1.5.4 Safety and Efficacy
    12.1.5.5 Regulatory Status
Kindly note that the above only represents a partial list of pipeline drugs, and the complete list has been provided in the report.

13. HEPATITIS B - ATTRIBUTE ANALYSIS OF KEY MARKETED AND PIPELINE DRUGS

14. HEPATITIS B – CLINICAL TRIAL LANDSCAPE

14.1 Drugs by Status
14.2 Drugs by Phase
14.3 Drugs by Route of Administration
14.4 Key Regulatory Events

15 HEPATITIS B - MARKET SCENARIO

15.1 Market Scenario - Key Insights
15.2 Market Scenario - Top 7 Markets
  15.2.1 Hepatitis B - Market Size
    15.2.1.1 Market Size (2018-2023)
    15.2.1.2 Market Forecast (2024-2034)
  15.2.2 Hepatitis B - Market Size by Therapies
    15.2.2.1 Market Size by Therapies (2018-2023)
    15.2.2.2 Market Forecast by Therapies (2024-2034)
15.3 Market Scenario - United States
  15.3.1 Hepatitis B - Market Size
    15.3.1.1 Market Size (2018-2023)
    15.3.1.2 Market Forecast (2024-2034)
  15.3.2 Hepatitis B - Market Size by Therapies
    15.3.2.1 Market Size by Therapies (2018-2023)
    15.3.2.2 Market Forecast by Therapies (2024-2034)
  15.3.3 Hepatitis B - Access and Reimbursement Overview
15.4 Market Scenario - Germany
  15.4.1 Hepatitis B - Market Size
    15.4.1.1 Market Size (2018-2023)
    15.4.1.2 Market Forecast (2024-2034)
  15.4.2 Hepatitis B - Market Size by Therapies
    15.4.2.1 Market Size by Therapies (2018-2023)
    15.4.2.2 Market Forecast by Therapies (2024-2034)
  15.4.3 Hepatitis B - Access and Reimbursement Overview
15.5 Market Scenario - France
  15.5.1 Hepatitis B - Market Size
    15.5.1.1 Market Size (2018-2023)
    15.5.1.2 Market Forecast (2024-2034)
  15.5.2 Hepatitis B - Market Size by Therapies
    15.5.2.1 Market Size by Therapies (2018-2023)
    15.5.2.2 Market Forecast by Therapies (2024-2034)
  15.5.3 Hepatitis B - Access and Reimbursement Overview
15.6 Market Scenario - United Kingdom
  15.6.1 Hepatitis B - Market Size
    15.6.1.1 Market Size (2018-2023)
    15.6.1.2 Market Forecast (2024-2034)
  15.6.2 Hepatitis B - Market Size by Therapies
    15.6.2.1 Market Size by Therapies (2018-2023)
    15.6.2.2 Market Forecast by Therapies (2024-2034)
  15.6.3 Hepatitis B - Access and Reimbursement Overview
15.7 Market Scenario - Italy
  15.7.1 Hepatitis B - Market Size
    15.7.1.1 Market Size (2018-2023)
    15.7.1.2 Market Forecast (2024-2034)
  15.7.2 Hepatitis B - Market Size by Therapies
    15.7.2.1 Market Size by Therapies (2018-2023)
    15.7.2.2 Market Forecast by Therapies (2024-2034)
  15.7.3 Hepatitis B - Access and Reimbursement Overview
15.8 Market Scenario - Spain
  15.8.1 Hepatitis B - Market Size
    15.8.1.1 Market Size (2018-2023)
    15.8.1.2 Market Forecast (2024-2034)
  15.8.2 Hepatitis B - Market Size by Therapies
    15.8.2.1 Market Size by Therapies (2018-2023)
    15.8.2.2 Market Forecast by Therapies (2024-2034)
  15.8.3 Hepatitis B - Access and Reimbursement Overview
15.9 Market Scenario - Japan
  15.9.1 Hepatitis B - Market Size
    15.9.1.1 Market Size (2018-2023)
    15.9.1.2 Market Forecast (2024-2034)
  15.9.2 Hepatitis B - Market Size by Therapies
    15.9.2.1 Market Size by Therapies (2018-2023)
    15.9.2.2 Market Forecast by Therapies (2024-2034)
  15.9.3 Hepatitis B - Access and Reimbursement Overview

16 HEPATITIS B - RECENT EVENTS AND INPUTS FROM KEY OPINION LEADERS

17 HEPATITIS B MARKET - SWOT ANALYSIS

17.1 Strengths
17.2 Weaknesses
17.3 Opportunities
17.4 Threats

18 HEPATITIS B MARKET – STRATEGIC RECOMMENDATIONS

19 APPENDIX


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