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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

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 2014–2021 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.
  • Discover trends in licensing and co-development deals concerning hepatitis B products and identify the major strategic consolidations that have shaped the commercial landscape.


1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Disease Introduction
2.2 Epidemiology
2.3 Etiology and Pathophysiology
2.3.1 Viral Genome
2.3.2 Viral life cycle
2.3.3 Genotypes and Global Distribution
2.4 Symptoms
2.5 Diagnosis
2.6 Prognosis
2.7 Treatment and Management
2.7.1 First-Line Treatment
2.7.2 Second-Line Treatment
2.8 Co-infection
2.8.1 HBV-HIV Co-infection
2.8.2 HBV-HDV Co-infection
2.8.3 HBV-HCV Co-infection
3 Marketed Products
3.1 Viread
3.1.1 Study 0102
3.1.2 Study 0103
3.2 Entecavir
3.2.1 Study AI463022 (HBeAg-Positive Subjects)
3.2.2 Study AI463027 (HBeAg-Negative Subjects)
3.2.3 Study AI463026
3.2.4 Study AI463048
3.3 Pegasys (peg interferon α-2a)
3.4 Adefovir dipivoxil
3.4.1 Study 437 (HBeAg-Positive)
3.4.2 Study 438 (HBeAg-Negative)
3.4.3 Adefovir Treatment beyond 48 Weeks
3.4.4 Study 435
3.4.5 Study 461
3.5 Tyzeka/Sebivo
3.5.1 NV-02B-007 GLOBE Trial
3.5.2 HBeAg-Positive Subjects
3.5.3 HBeAg-Negative Subjects
3.6 Comparative Efficacy and Safety
4 Pipeline Analysis
4.1 Overview
4.2 Pipeline Analysis of Therapeutic Vaccines
4.3 Clinical Trials
4.3.1 Failure Rate
4.3.2 Clinical Trial Duration
4.3.3 Clinical Trial Size
4.4 Competitive Clinical Trials Metrics Analysis
4.5 Promising Drug Candidates in Pipeline
4.5.1 Tenofovir Alafenamide Fumarate (GS-7340)
4.6 Therapeutic Vaccines in Pipeline
4.6.1 GS-4774 Therapeutic Vaccine with Oral Antiviral Therapy
4.6.2 ABX203 Therapeutic Vaccine with Nucleos(t)ide Analogs against HBeAg-Negative Chronic Hepatitis B
4.6.3 HB-110E Therapeutic DNA Vaccine
4.6.4 INO-1800 with or without INO-9112 in Entecavir/Tenofovir-Treated HBeAg-Positive Chronic Hepatitis B Patients
4.6.5 TG1050 Therapeutic Vaccine
5 Market Forecast to 2021
5.1 Geographical Markets
5.2 Global Market
5.3 North America
5.3.1 Treatment Usage Patterns
5.3.2 Annual Cost of Therapy
5.3.3 Market Size
5.4 Top Five EU Markets
5.4.1 Treatment Usage Patterns
5.4.2 Annual Cost of Therapy
5.4.3 Market Size
5.5 Japan
5.5.1 Treatment Usage Patterns
5.5.2 Annual Cost of Therapy
5.5.3 Market Size
5.6 Drivers and Barriers in the Disease Market
5.6.1 Drivers
5.6.2 Barriers
6 Deals and Strategic Consolidations
6.1 Licensing Deals
6.1.1 OnCore Enters into Licensing Agreement with NeuroVive
6.1.2 Ligand Enters into Licensing Agreement with Chiva for Pradefovir and MB01733
6.1.3 Cytos Biotech Enters into Licensing Agreement with OnCore Biopharma
6.1.4 NeuroVive Pharma Enters into Licensing Agreement with OnCore Biopharma for NVP018
6.2 Co-development Deals
6.2.1 Research agreement between OnCore Biopharma and Baruch S. Blumberg
6.2.2 Vaccine Development Agreement between Artes Biotech and Bio Farma
7 Appendix
7.1 All Pipeline Drugs by Phase of Development
7.1.1 Discovery
7.1.2 Preclinical
7.1.3 Phase I
7.1.4 Phase II
7.1.5 Phase III
7.2 Market Forecasts to 2021
7.2.1 Global
7.2.2 US
7.2.3 Canada
7.2.4 UK
7.2.5 France
7.2.6 Germany
7.2.7 Italy
7.2.8 Spain
7.2.9 Japan
7.3 Bibliography
7.4 Abbreviations
7.5 Research Methodology
7.5.1 Secondary Research
7.5.2 Marketed Product Profiles
7.5.3 Late-Stage Pipeline Candidates
7.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products
7.5.5 Forecasting Model
7.5.6 Deals Data Analysis
7.6 Contact Us
7.7 Disclaimer
1.1 List of Tables
Table 1: Chronic Hepatitis B Prevalence in Countries that are Main Sources of Migration to US
Table 2: Comparison of Drugs that Treat Hepatitis B
Table 3: Immigration from High-Prevalence Regions to US, 2010 and 2013
Table 4: Hepatitis B Therapeutics Market, Global, Pipeline Products, Discovery, 2015
Table 5: Hepatitis B Therapeutics Market, Global, Pipeline Products, Preclinical, 2015
Table 6: Hepatitis B Therapeutics Market, Global, Pipeline Products, Phase I, 2015
Table 7: Hepatitis B Therapeutics Market, Global, Pipeline Products, Phase II, 2015
Table 8: Hepatitis B Therapeutics Market, Global, Pipeline Products, Phase III, 2015
Table 9: Hepatitis B Therapeutics Market, Global, Market Forecast, 2014-2021
Table 10: Hepatitis B Therapeutics Market, US, Market Forecast, 2014-2021
Table 11: Hepatitis B Therapeutics Market, Canada, Market Forecast, 2014-2021
Table 12: Hepatitis B Therapeutics Market, UK, Market Forecast, 2014-2021
Table 13: Hepatitis B Therapeutics Market, France, Market Forecast, 2014-2021
Table 14: Hepatitis B Therapeutics Market, Germany, Market Forecast, 2014-2021
Table 15: Hepatitis B Therapeutics Market, Italy, Market Forecast, 2014-2021
Table 16: Hepatitis B Therapeutics Market, Spain, Market Forecast, 2014-2021
Table 17: Hepatitis B Therapeutics Market, Japan, Market Forecast, 2014-2021
Table 18: Abbreviations
1.2 List of Figures
Figure 1: Hepatitis B Disease Classification
Figure 2: Hepatitis B Virus Life Cycle
Figure 3: Management of Hepatitis B Infection
Figure 4: Hepatitis B Therapeutics Market, Global, Comparative Efficacy and Safety of Marketed Products Heatmap, 2015
Figure 5: Hepatitis B Therapeutics Market, Global, Overview of Pipeline Products
Figure 6: Hepatitis B Therapeutics Market, Global, Therapeutic Vaccines in Pipeline by Molecule Type
Figure 7: Hepatitis B Market, Global, Clinical Trial Failure Rate (%), 2015
Figure 8: Hepatitis B Market, Global, Clinical Trial Failure Rate by Molecule Type (%), 2015
Figure 9: Hepatitis B Market, Global, Clinical Trial Failure Rate by Molecular Target (%), 2015
Figure 10: Hepatitis B Market, Global, Clinical Trial Duration by Molecule Type (months), 2015
Figure 11: Hepatitis B Market, Global, Clinical Trial Size by Molecule Type, 2015
Figure 12: Multiple Myeloma Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type
Figure 13: Hepatitis B Therapeutics Market, Vaccine Technology by Genexine
Figure 14: Hepatitis B Therapeutics Market, Global, Treatment Patterns (million) and Market Size ($bn), 2014-2021
Figure 15: Hepatitis B Therapeutics Market, North America, Treatment Patterns (‘000), 2014-2021
Figure 16: Hepatitis B Therapeutics Market, North America, Annual Cost of Therapy ($), 2014-2021
Figure 17: Hepatitis B Therapeutics Market, North America, Market Size ($m), 2014-2021
Figure 18: Hepatitis B Therapeutics Market, EU, Treatment Patterns (‘000), 2014-2021
Figure 19: Hepatitis B Therapeutics Market, EU, Annual Cost of Therapy ($), 2014-2021
Figure 20: Hepatitis B Therapeutics Market, EU, Market Size ($), 2014-2021
Figure 21: Hepatitis B Therapeutics Market, Japan, Treatment Usage Patterns (‘000), 2014-2021
Figure 22: Hepatitis B Therapeutics Market, Japan, Annual Cost of Therapy ($), 2014-2021
Figure 23: Hepatitis B Therapeutics Market, Japan, Market Size ($m), 2014-2021
Figure 24: Hepatitis B Market, Global, Licensing Deals by Region, 2006-2015
Figure 25: Hepatitis B Market, Global, Licensing Deals by Region, Value and Year, 2006-2015
Figure 26: Hepatitis B Market, Global, Licensing Deals by Phase and Value, 2006-2015
Figure 27: Hepatitis B Market, Global, Co-development Deals by Region and Stage of Development, 2006-2015

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