Hepatitis B Therapeutics in Major Developed Markets to 2021 - Increasing Number of Migrants from High-Prevalence Regions to Drive Market Growth - GBI Research Reports

Hepatitis B Therapeutics in Major Developed Markets to 2021 - Increasing Number of Migrants from High-Prevalence Regions to Drive Market Growth

Hepatitis B Therapeutics in Major Developed Markets to 2021 - Increasing Number of Migrants from High-Prevalence Regions to Drive Market Growth - GBI Research Reports
Hepatitis B Therapeutics in Major Developed Markets to 2021 - Increasing Number of Migrants from High-Prevalence Regions to Drive Market Growth
Published Sep 01, 2015
72 pages — Published Sep 01, 2015
Price US$ 4,995.00  |  Buy this Report Now

About This Report

  
Abstract:

Summary

Hepatitis B is an infectious liver disease caused by the Hepatitis B Virus (HBV) and characterized by acute or chronic inflammation of the liver. Despite its status as a vaccine-preventable disease, it remains a serious global health concern. Incidence tends to be higher in countries with a significant number of migrants from medium and high-prevalence countries. Approximately 350 million people worldwide are infected with chronic hepatitis B, which causes significant morbidity and mortality. Around 780,000 patients die from hepatitis B each year, of which 650,000 deaths are due to complications such as cirrhosis and liver cancer. Despite this, diagnosis and treatment rates are poor, stemming from its asymptomatic nature.

Globally, the hepatitis B therapeutics market is served moderately well by the available products, of which Baraclude and Viread are the most frequently prescribed. However, both have received black-box warnings from the US Food and Drug Administration (FDA), meaning that the market has a high level of unmet need.

Scope

The current hepatitis B market contains mainly nucleoside analog reverse transcriptase inhibitors, nucleotide analogs, and interferons.
- Will these drugs continue to dominate hepatitis B treatment?
With 81 active pipeline molecules, most of the investigational drug candidates are small molecules and vaccines, comprising 64% of the pipeline.
- What are the most prominent small molecules and vaccines in the pipeline?
- Do the pipeline molecules offer advantages over commercially proven mechanisms?
Analysis of clinical trials since 2006 has identified a high rate of attrition in hepatitis B products.
- How do failure rates vary by product stage of development, molecule type, and mechanism of action?
- How do other factors such as average trial duration and trial size influence the costs and risks associated with product development?
Over the 20142021 forecast period, the hepatitis B market in the eight major markets is expected to increase in value at a CAGR of 2.3% from $2.9 billion to $3.5 billion.
- Which markets make the most significant contribution to the current market size?
- What are the epidemiology trends in these markets?
- Which factors will influence growth rates in the different major markets?
Despite generic sales erosion resulting from patent expirations, the uptake of premium therapies tenofovir and entecavir will contribute to significant market growth over the forecast period.
- Will patent expirations or emerging pipeline molecules threaten the commercial success of existing drugs?
- Which patent expirations will have the most significant impact on the market?

Reasons to buy

This report will enable you to -
- Understand the clinical context of hepatitis B by considering symptoms, etiology, pathophysiology, epidemiology, diagnosis, and treatment options.
- Identify the therapeutic strategies, products, and companies that dominate the current marketed products landscape and recognize gaps and areas of unmet need.
- Appreciate key pipeline trends by molecule type, route of administration, mechanism of action, and novelty.
- Consider market opportunities and potential risks by looking at trends in clinical trial size, duration, and failure rate by stage of development, molecule type, and mechanism of action.
- Recognize the late-stage pipeline molecules that have demonstrated strong therapeutic potential by examining clinical trial data and multi-scenario product forecast projections.
- Compare treatment usage patterns, annual therapy costs, and market growth projections for the US, Canada, the UK, France, Germany, Italy, Spain, and Japan.&

  
Source:
Document ID
GBIHC368MR
Industry
Format:
PDF Adobe Acrobat
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Sections

TitleStarting PageNumber of Pages
1 Table of Contents44
  1.1 List of Tables71
  1.2 List of Figures71
2 Introduction810
  2.1 Disease Introduction81
  2.2 Epidemiology82
  2.3 Etiology and Pathophysiology101
    2.3.1 Viral Genome101
      2.3.1.1 Surface22T Gene111
      2.3.1.2 22TCore Gene111
      2.3.1.3 22TX Gene111
      2.3.1.4 P Gene111
    2.3.2 Viral life cycle111
    2.3.3 Genotypes and Global Distribution121
  2.4 Symptoms131
  2.5 Diagnosis131
  2.6 Prognosis141
  2.7 Treatment and Management141
    2.7.1 First-Line Treatment151
    2.7.2 Second-Line Treatment161
  2.8 Co-infection171
    2.8.1 HBV-HIV Co-infection171
    2.8.2 HBV-HDV Co-infection171
    2.8.3 HBV HCV Co-infection171
3 Marketed Products188
  3.1 Viread181
    3.1.1 Study 0102181
    3.1.2 Study 0103181
  3.2 Entecavir191
    3.2.1 Study AI463022 (HBeAg-Positive Subjects)191
    3.2.2 Study AI463027 (HBeAg-Negative Subjects)191
    3.2.3 Study AI463026201
    3.2.4 Study AI463048201
   211
  3.4 Adefovir dipivoxil221
    3.4.1 Study 437 (HBeAg-Positive)221
    3.4.2 Study 438 (HBeAg-Negative)221
    3.4.3 Adefovir Treatment beyond 48 Weeks221
    3.4.4 Study 435231
    3.4.5 Study 461231
  3.5 Tyzeka/Sebivo231
    3.5.1 NV-02B-007 GLOBE Trial231
    3.5.2 HBeAg-Positive Subjects241
    3.5.3 HBeAg-Negative Subjects241
  3.6 Comparative Efficacy and Safety242
4 Pipeline Analysis2611
  4.1 Overview261
  4.2 Pipeline Analysis of Therapeutic Vaccines272
  4.3 Clinical Trials291
    4.3.1 Failure Rate292
    4.3.2 Clinical Trial Duration311
    4.3.3 Clinical Trial Size321
  4.4 Competitive Clinical Trials Metrics Analysis331
  4.5 Promising Drug Candidates in Pipeline331
    4.5.1 Tenofovir Alafenamide Fumarate (GS-7340)331
  4.6 Therapeutic Vaccines in Pipeline341
    4.6.1 GS-4774 Therapeutic Vaccine with Oral Antiviral Therapy341
    4.6.2 ABX203 Therapeutic Vaccine with Nucleos(t)ide Analogs against HBeAg-Negative Chronic Hepatitis B341
    4.6.3 HB-110E Therapeutic DNA Vaccine341
    4.6.4 INO-1800 with or without INO-9112 in Entecavir/Tenofovir-Treated HBeAg-Positive Chronic Hepatitis B Patients351
    4.6.5 TG1050 Therapeutic Vaccine361
5 Market Forecast to 20213712
  5.1 Geographical Markets371
  5.2 Global Market371
  5.3 North America381
    5.3.1 Treatment Usage Patterns381
    5.3.2 Annual Cost of Therapy391
    5.3.3 Market Size401
  5.4 Top Five EU Markets411
    5.4.1 Treatment Usage Patterns411
    5.4.2 Annual Cost of Therapy421
    5.4.3 Market Size431
  5.5 Japan441
    5.5.1 Treatment Usage Patterns441
    5.5.2 Annual Cost of Therapy451
    5.5.3 Market Size461
  5.6 Drivers and Barriers in the Disease Market461
    5.6.1 Drivers461
      5.6.1.1 Increasing Immigration and Overseas Travel461
      5.6.1.2 Expected Launch of GS-7340 (tenofovir alafenamide fumarate)471
    5.6.2 Barriers471
      5.6.2.1 Universal Prophylactic Vaccination471
      5.6.2.2 Patent Expiries and Weak Late-Stage Pipeline481
      5.6.2.3 Social Stigma and Asymptomatic Nature of the disease481
6 Deals and Strategic Consolidations496
  6.1 Licensing Deals493
    6.1.1 OnCore Enters into Licensing Agreement with NeuroVive521
    6.1.2 Ligand Enters into Licensing Agreement with Chiva for Pradefovir and MB01733521
    6.1.3 Cytos Biotech Enters into Licensing Agreement with OnCore Biopharma521
    6.1.4 NeuroVive Pharma Enters into Licensing Agreement with OnCore Biopharma for NVP018521
  6.2 Co-development Deals531
    6.2.1 Research agreement between OnCore Biopharma and Baruch S. Blumberg531
    6.2.2 Vaccine Development Agreement between Artes Biotech and Bio Farma541
7 Appendix5518
  7.1 All Pipeline Drugs by Phase of Development554
    7.1.1 Discovery551
    7.1.2 Preclinical561
    7.1.3 Phase I571
    7.1.4 Phase II581
    7.1.5 Phase III581
  7.2 Market Forecasts to 2021595
    7.2.1 Global591
    7.2.2 US591
    7.2.3 Canada601
    7.2.4 UK601
    7.2.5 France611
    7.2.6 Germany611
    7.2.7 Italy621
    7.2.8 Spain621
    7.2.9 Japan631
  7.3 Bibliography634
  7.4 Abbreviations671
  7.5 Research Methodology675
    7.5.1 Secondary Research681
    7.5.2 Marketed Product Profiles681
    7.5.3 Late-Stage Pipeline Candidates691
    7.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products691
      7.5.4.1 Overall Pipeline691
      7.5.4.2 Clinical Trials701
        7.5.4.2.1 Failure Rate701
        7.5.4.2.2 Clinical Trial Size701
        7.5.4.2.3 Clinical Trial Duration701
        7.5.4.2.4 Clinical trial Endpoint Analysis701
    7.5.5 Forecasting Model701
    7.5.6 Deals Data Analysis711
  7.6 Contact Us721
  7.7 Disclaimer721

Table Of Contents

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Cite this Report

  
MLA:
GBI Research Reports. "Hepatitis B Therapeutics in Major Developed Markets to 2021 - Increasing Number of Migrants from High-Prevalence Regions to Drive Market Growth" Sep 01, 2015. Alacra Store. May 03, 2025. <http://www.alacrastore.com/storecontent/GBI-Research-Reports/Hepatitis-B-Therapeutics-in-Major-Developed-Markets-to-2021-Increasing-Number-of-Migrants-from-High-Prevalence-Regions-to-Drive-Market-Growth-2115-698>
  
APA:
GBI Research Reports. (2015). Hepatitis B Therapeutics in Major Developed Markets to 2021 - Increasing Number of Migrants from High-Prevalence Regions to Drive Market Growth Sep 01, 2015. New York, NY: Alacra Store. Retrieved May 03, 2025 from <http://www.alacrastore.com/storecontent/GBI-Research-Reports/Hepatitis-B-Therapeutics-in-Major-Developed-Markets-to-2021-Increasing-Number-of-Migrants-from-High-Prevalence-Regions-to-Drive-Market-Growth-2115-698>
  
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