만성 B형 간염 시장 평가 : 약물 종류별, 성별, 유통 채널별, 지역별, 기회 및 예측(2017-2031년)

Global chronic hepatitis B market is projected to witness a CAGR of 3.46% during the forecast period, 2024-2031, growing from USD 5.01 billion in 2023 to USD 6.58 billion in 2031F. The expansion of the market is supported by increasing investments in the pharmaceutical sector, rising research and development activities to evaluate the safety and efficacy of various treatments available for chronic hepatitis B, and growing accessibility to healthcare facilities.

According to a StatPearls' article published by researchers of University of Kentucky and Mayo Clinic stated that approximately 350-400 million individuals across the globe suffer from chronic hepatitis B. Early detection of the infection can aid in management of the condition and prevention of complications. Due to the increasing prevalence of chronic hepatitis B, the market is expected to witness significant growth in the coming years. Increasing investments towards the development of novel treatment and diagnostic solutions is further supporting the market expansion.

As per the Centers for Disease Control and Prevention, 25% of cases of chronic hepatitis B progress into liver cancer. Due to the severity of chronic infection, various research and development activities are underway across the globe. For instance, National Taiwan University Hospital is conducting an interventional, randomized, active control study to compare P1101 to entecavir in subjects with HBeAg-negative chronic hepatitis B. The subjects of the study were randomized in 2:1 ratio for P1101: entecavir with the help of a computer-generated permuted block randomization scheme. The study is expected to conclude in December 2024.

Deployment of Advanced Diagnostic Solutions to Boost the Market

The increasing development of convenient diagnostic solutions for hepatitis B is supporting the growth of the market. A team of researchers from Chulalongkorn University developed a wireless-based detection system using innovative electrochemical card sensors that can be controlled by a smartphone for targeting hepatitis B surface antigens. The simple label-free electrochemical platform will aid in convenient operation for point of care diagnosis. Point of care testing is a system that is designed for complete diagnostic platforms to enhance patient outcomes by significantly reducing sample-to-answer time. The device is based on a novel electrochemical sensor architecture. The analytical performance of the system was evaluated with the help of a dilution series of hepatitis B surface antigen titers. The electrochemical card sensor was engineered as a portable potentiostat that was controlled using a wireless Near Field Communication (NFC) network connection of smartphone.

Increasing Research and Development Activities Support Market Growth

Research and development activities play a crucial role in the development of treatments for diseases including chronic hepatitis B. They allow researchers to understand how new medicines work in patients and compare them to the already available treatments. They can aid in understanding the pathways of various treatments. For instance, an observational study is being conducted by the Chinese University of Hong Kong to evaluate the fast-track treatment pathways under primary care for patients suffering from chronic hepatitis B. The analyses will be performed before and after the introduction of pathways in the retrospective-prospective longitudinal cohort study, with comparisons made to unexposed controls. The novel fast-track treatment pathway for patients under primary care will bridge the gap and provide pivotal data to the Steering Committee and the Government for guiding the strategies to achieve the goals set by the World Health Organization (WHO). Various clinical trials are being initiated to determine potential treatment solutions for people living with chronic hepatitis B infection. GlaxoSmithKline is about to launch two new phase 3 trails namely, B Well-1 and B Well-2. The trials will test an experimental drug as a potential treatment option for hepatitis B.

North America Anticipated to Account Significant Market Share

The presence of several leading market players in the region along with a well-established healthcare infrastructure is supporting the market expansion in North America. Furthermore, the increasing prevalence of the disease in the United States is bolstering the demand for treatment solutions for chronic hepatitis B. According to the US Department of Health and Human Services, approximately 880,000 to 1.89 million individuals in the United States are chronically infected with the hepatitis B virus.

Growing efforts of regional market players are further supporting the market expansion in North America. For instance, in October 2023, Virion Therapeutics dosed the first patients in their Phase Ib trial that will investigate VRON-0200 as the functional cure for chronic hepatitis B. VRON-0200 will use Virion's checkpoint modifiers for broadening and amplifying the patient's T cell response against hepatitis B virus infection. Over the course of the preclinical studies, the drug showcased the ability to switch on T cells that are generally not activated during chronic hepatitis B infection. The program is being conducted with the help of Ocean Biomedical, their joint venture partner.

Antivirals to Account for Significant Market Share

The segment held a major share of the market during the historical period and is expected to generate similar results over the forecast period owing to the increasing prevalence of the disease and rapid improvements in the healthcare infrastructure. Various studies are underway to determine the safety and effectiveness of antiviral therapies on patients with chronic hepatitis B. For instance, a phase 2 interventional study is being conducted by Sun Yat-sen University to determine the effectiveness and safety of entecavir, in combination with tenofovir amibufenamide. Over the course of the study, the investigators plan to divide the patients randomly into two groups. Group A will be treated with entecavir whereas group B will be treated with tenofovir amibufenamide and entecavir. The patients in both groups will be followed up for ninety-six weeks. The primary endpoint of the study involves the comparison of the inhibition rate of HBV-DNA between both groups. The secondary endpoint of the study includes a comparison of adverse side effects, a comparison in decrease of HBV DNA at forty-eight weeks, changes of HBsAg at fort-eight and ninety-six weeks and comparison of HBeAg seroconversion rates between the two groups.

Retail Pharmacies to Dominate the Market Share

The increasing popularity of retail pharmacies in various regions across the globe can be attributed to the availability of both branded and generic drugs across these distribution channels. The pharmacists play a crucial role in providing counseling to the patients and explaining various side-effects associated with the consumption of the medication. These pharmacies play a significant role in the healthcare ecosystem in various countries.

On the contrary, online pharmacies are expected to witness significant growth in the coming years. As per a survey funded by Sanofi Consumer Healthcare, respondents highlighted the various advantages associated with shopping across online pharmacies including convenience and reduced costs for patients. The growing acceptance of the distribution channels due to increasing awareness about legitimate and verified online pharmacies is further supporting the expansion of the segment.

Future Market Scenario

Several clinical trials are underway to evaluate novel drugs with different mechanisms of action, with promising results. There is an emerging multitude of new molecules individually and in combination, that can act as future treatment strategies. Investments are increasing toward the development of novel treatment solutions. For instance, in December 2023, Tune Therapeutics, a Duke Capital Partners portfolio company and Duke University start-up announced that they were working on a potentially curative and new approach to treating chronic hepatitis B infection. The Tune HBV program was unveiled in November 2023, at the University of Auckland at the American Association for the Study of Liver Diseases (AASLD) conference in Boston. Tune Therapeutics aims to dose their first patient in 2024, with Dr Gane Professor of Medicine at the University of Auckland serving as the lead investigator.

Key Players Landscape and Outlook

Increasing investments towards research and development activities by the key players of the market along with the provision of fast-track status by FDA is supporting the market expansion.

In 2024, FDA granted fast track status to bepirovirsen, a triple action investigational antisense oligonucleotide, developed by GlaxoSmithKline for treating chronic hepatitis B. Developed jointly with Ionis Pharmaceuticals, the drug is intended to stimulate the immune system, curb viral DNA replication and reduce the levels of hepatitis B surface antigens to boost the chances of a sustained and durable response.

Table of Contents

1. Research Methodology

2. Project Scope & Definitions

3. Executive Summary

4. Global Chronic Hepatitis B Market Outlook, 2017-2031F

• 4.1. Market Size & Forecast
  • 4.1.1. By Value
  • 4.1.2. By Volume
• 4.2. By Drug Class
  • 4.2.1. Immune Modulators
  • 4.2.2. Antivirals
• 4.3. By Gender
  • 4.3.1. Male
  • 4.3.2. Female
• 4.4. By Distribution Channel
  • 4.4.1. Hospital Pharmacies
  • 4.4.2. Retail Pharmacies
  • 4.4.3. Online Pharmacies
• 4.5. By Region
  • 4.5.1. North America
  • 4.5.2. South America
  • 4.5.3. Europe
  • 4.5.4. Asia-Pacific
  • 4.5.5. Middle East & Africa
• 4.6. By Company Market Share (%), 2023

5. Global Chronic Hepatitis B Market Outlook, By Region, 2017-2031F

• 5.1. North America*
  • 5.1.1. Market Size & Forecast
    • 5.1.1.1. By Value
    • 5.1.1.2. By Volume
  • 5.1.2. By Drug Class
    • 5.1.2.1. Immune Modulators
    • 5.1.2.2. Antivirals
  • 5.1.3. By Gender
    • 5.1.3.1. Male
    • 5.1.3.2. Female
  • 5.1.4. By Distribution Channel
    • 5.1.4.1. Hospital Pharmacies
    • 5.1.4.2. Retail Pharmacies
    • 5.1.4.3. Online Pharmacies
  • 5.1.5. United States*
    • 5.1.5.1. Market Size & Forecast
    • 5.1.5.1.1. By Value
    • 5.1.5.1.2. By Volume
    • 5.1.5.2. By Drug Class
    • 5.1.5.2.1. Immune Modulators
    • 5.1.5.2.2. Antivirals
    • 5.1.5.3. By Gender
    • 5.1.5.3.1. Male
    • 5.1.5.3.2. Female
    • 5.1.5.4. By Distribution Channel
    • 5.1.5.4.1. Hospital Pharmacies
    • 5.1.5.4.2. Retail Pharmacies
    • 5.1.5.4.3. Online Pharmacies
  • 5.1.6. Canada
  • 5.1.7. Mexico

All segments will be provided for all regions and countries covered

• 5.2. Europe
  • 5.2.1. Germany
  • 5.2.2. France
  • 5.2.3. Italy
  • 5.2.4. United Kingdom
  • 5.2.5. Russia
  • 5.2.6. Netherlands
  • 5.2.7. Spain
  • 5.2.8. Turkey
  • 5.2.9. Poland
• 5.3. Asia-Pacific
  • 5.3.1. India
  • 5.3.2. China
  • 5.3.3. Japan
  • 5.3.4. Australia
  • 5.3.5. Vietnam
  • 5.3.6. South Korea
  • 5.3.7. Indonesia
  • 5.3.8. Philippines
• 5.4. South America
  • 5.4.1. Brazil
  • 5.4.2. Argentina
• 5.5. Middle East & Africa
  • 5.5.1. Saudi Arabia
  • 5.5.2. UAE
  • 5.5.3. South Africa

6. Market Mapping, 2023

• 6.1. By Drug Class
• 6.2. By Gender
• 6.3. By Distribution Channel
• 6.4. By Region

7. Macro Environment and Industry Structure

• 7.1. Supply Demand Analysis
• 7.2. Import Export Analysis
• 7.3. Value Chain Analysis
• 7.4. PESTEL Analysis
  • 7.4.1. Political Factors
  • 7.4.2. Economic System
  • 7.4.3. Social Implications
  • 7.4.4. Technological Advancements
  • 7.4.5. Environmental Impacts
  • 7.4.6. Legal Compliances and Regulatory Policies (Statutory Bodies Included)
• 7.5. Porter's Five Forces Analysis
  • 7.5.1. Supplier Power
  • 7.5.2. Buyer Power
  • 7.5.3. Substitution Threat
  • 7.5.4. Threat from New Entrant
  • 7.5.5. Competitive Rivalry

8. Market Dynamics

• 8.1. Growth Drivers
• 8.2. Growth Inhibitors (Challenges and Restraints)

9. Regulatory Framework and Innovation

• 9.1. Patent Landscape
• 9.2. Regulatory Approvals
• 9.3. Innovations/Emerging Technologies

10. Key Players Landscape

• 10.1. Competition Matrix of Top Five Market Leaders
• 10.2. Market Revenue Analysis of Top Five Market Leaders (in %, 2023)
• 10.3. Mergers and Acquisitions/Joint Ventures (If Applicable)
• 10.4. SWOT Analysis (For Five Market Players)
• 10.5. Patent Analysis (If Applicable)

11. Pricing Analysis

12. Case Studies

13. Key Players Outlook

• 13.1. Gilead Sciences, Inc.
  • 13.1.1. Company Details
  • 13.1.2. Key Management Personnel
  • 13.1.3. Products & Services
  • 13.1.4. Financials (As reported)
  • 13.1.5. Key Market Focus & Geographical Presence
  • 13.1.6. Recent Developments
• 13.2. GlaxoSmithKline Pharmaceuticals Ltd.
• 13.3. F. Hoffmann-La Roche AG
• 13.4. Novartis AG
• 13.5. Bristol Myers Squibb Co.
• 13.6. Vir Biotechnology
• 13.7. Virion Therapeutics, LLC
• 13.8. Beijing Continent Pharmaceutical Co. Ltd.
• 13.9. GlobeImmune, Inc.
• 13.10. Viatris Inc.

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work

14. Strategic Recommendations

15. About Us & Disclaimer