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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

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.

Table Of Contents

Hepatitis B Therapeutics in Major Developed Markets to 2021 - Increasing Number of Migrants from High-Prevalence Regions to Drive Market Growth
1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 7
2 Introduction 8
2.1 Disease Introduction 8
2.2 Epidemiology 8
2.3 Etiology and Pathophysiology 10
2.3.1 Viral Genome 10
2.3.2 Viral life cycle 11
2.3.3 Genotypes and Global Distribution 12
2.4 Symptoms 13
2.5 Diagnosis 13
2.6 Prognosis 14
2.7 Treatment and Management 14
2.7.1 First-Line Treatment 15
2.7.2 Second-Line Treatment 16
2.8 Co-infection 17
2.8.1 HBV-HIV Co-infection 17
2.8.2 HBV-HDV Co-infection 17
2.8.3 HBV-HCV Co-infection 17
3 Marketed Products 18
3.1 Viread 18
3.1.1 Study 0102 18
3.1.2 Study 0103 18
3.2 Entecavir 19
3.2.1 Study AI463022 (HBeAg-Positive Subjects) 19
3.2.2 Study AI463027 (HBeAg-Negative Subjects) 19
3.2.3 Study AI463026 20
3.2.4 Study AI463048 20
3.3 Pegasys (peg interferon ?-2a) 21
3.4 Adefovir dipivoxil 22
3.4.1 Study 437 (HBeAg-Positive) 22
3.4.2 Study 438 (HBeAg-Negative) 22
3.4.3 Adefovir Treatment beyond 48 Weeks 22
3.4.4 Study 435 23
3.4.5 Study 461 23
3.5 Tyzeka/Sebivo 23
3.5.1 NV-02B-007 GLOBE Trial 23
3.5.2 HBeAg-Positive Subjects 24
3.5.3 HBeAg-Negative Subjects 24
3.6 Comparative Efficacy and Safety 24
4 Pipeline Analysis 26
4.1 Overview 26
4.2 Pipeline Analysis of Therapeutic Vaccines 27
4.3 Clinical Trials 29
4.3.1 Failure Rate 29
4.3.2 Clinical Trial Duration 31
4.3.3 Clinical Trial Size 32
4.4 Competitive Clinical Trials Metrics Analysis 33
4.5 Promising Drug Candidates in Pipeline 33
4.5.1 Tenofovir Alafenamide Fumarate (GS-7340) 33
4.6 Therapeutic Vaccines in Pipeline 34
4.6.1 GS-4774 Therapeutic Vaccine with Oral Antiviral Therapy 34
4.6.2 ABX203 Therapeutic Vaccine with Nucleos(t)ide Analogs against HBeAg-Negative Chronic Hepatitis B 34
4.6.3 HB-110E Therapeutic DNA Vaccine 34
4.6.4 INO-1800 with or without INO-9112 in Entecavir/Tenofovir-Treated HBeAg-Positive Chronic Hepatitis B Patients 35
4.6.5 TG1050 Therapeutic Vaccine 36
5 Market Forecast to 2021 37
5.1 Geographical Markets 37
5.2 Global Market 37
5.3 North America 38
5.3.1 Treatment Usage Patterns 38
5.3.2 Annual Cost of Therapy 39
5.3.3 Market Size 40
5.4 Top Five EU Markets 41
5.4.1 Treatment Usage Patterns 41
5.4.2 Annual Cost of Therapy 42
5.4.3 Market Size 43
5.5 Japan 44
5.5.1 Treatment Usage Patterns 44
5.5.2 Annual Cost of Therapy 45
5.5.3 Market Size 46
5.6 Drivers and Barriers in the Disease Market 46
5.6.1 Drivers 46
5.6.2 Barriers 47
6 Deals and Strategic Consolidations 49
6.1 Licensing Deals 49
6.1.1 OnCore Enters into Licensing Agreement with NeuroVive 52
6.1.2 Ligand Enters into Licensing Agreement with Chiva for Pradefovir and MB01733 52
6.1.3 Cytos Biotech Enters into Licensing Agreement with OnCore Biopharma 52
6.1.4 NeuroVive Pharma Enters into Licensing Agreement with OnCore Biopharma for NVP018 52
6.2 Co-development Deals 53
6.2.1 Research agreement between OnCore Biopharma and Baruch S. Blumberg 53
6.2.2 Vaccine Development Agreement between Artes Biotech and Bio Farma 54
7 Appendix 55
7.1 All Pipeline Drugs by Phase of Development 55
7.1.1 Discovery 55
7.1.2 Preclinical 56
7.1.3 Phase I 57
7.1.4 Phase II 58
7.1.5 Phase III 58
7.2 Market Forecasts to 2021 59
7.2.1 Global 59
7.2.2 US 59
7.2.3 Canada 60
7.2.4 UK 60
7.2.5 France 61
7.2.6 Germany 61
7.2.7 Italy 62
7.2.8 Spain 62
7.2.9 Japan 63
7.3 Bibliography 63
7.4 Abbreviations 67
7.5 Research Methodology 67
7.5.1 Secondary Research 68
7.5.2 Marketed Product Profiles 68
7.5.3 Late-Stage Pipeline Candidates 69
7.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 69
7.5.5 Forecasting Model 70
7.5.6 Deals Data Analysis 71
7.6 Contact Us 72
7.7 Disclaimer 72

1.1 List of Tables
Table 1: Chronic Hepatitis B Prevalence in Countries that are Main Sources of Migration to US 9
Table 2: Comparison of Drugs that Treat Hepatitis B 15
Table 3: Immigration from High-Prevalence Regions to US, 2010 and 2013 46
Table 4: Hepatitis B Therapeutics Market, Global, Pipeline Products, Discovery, 2015 55
Table 5: Hepatitis B Therapeutics Market, Global, Pipeline Products, Preclinical, 2015 56
Table 6: Hepatitis B Therapeutics Market, Global, Pipeline Products, Phase I, 2015 57
Table 7: Hepatitis B Therapeutics Market, Global, Pipeline Products, Phase II, 2015 58
Table 8: Hepatitis B Therapeutics Market, Global, Pipeline Products, Phase III, 2015 58
Table 9: Hepatitis B Therapeutics Market, Global, Market Forecast, 2014-2021 59
Table 10: Hepatitis B Therapeutics Market, US, Market Forecast, 2014-2021 59
Table 11: Hepatitis B Therapeutics Market, Canada, Market Forecast, 2014-2021 60
Table 12: Hepatitis B Therapeutics Market, UK, Market Forecast, 2014-2021 60
Table 13: Hepatitis B Therapeutics Market, France, Market Forecast, 2014-2021 61
Table 14: Hepatitis B Therapeutics Market, Germany, Market Forecast, 2014-2021 61
Table 15: Hepatitis B Therapeutics Market, Italy, Market Forecast, 2014-2021 62
Table 16: Hepatitis B Therapeutics Market, Spain, Market Forecast, 2014-2021 62
Table 17: Hepatitis B Therapeutics Market, Japan, Market Forecast, 2014-2021 63
Table 18: Abbreviations 67

1.2 List of Figures
Figure 1: Hepatitis B Disease Classification 8
Figure 2: Hepatitis B Virus Life Cycle 12
Figure 3: Management of Hepatitis B Infection 16
Figure 4: Hepatitis B Therapeutics Market, Global, Comparative Efficacy and Safety of Marketed Products Heatmap, 2015 25
Figure 5: Hepatitis B Therapeutics Market, Global, Overview of Pipeline Products 27
Figure 6: Hepatitis B Therapeutics Market, Global, Therapeutic Vaccines in Pipeline by Molecule Type 28
Figure 7: Hepatitis B Market, Global, Clinical Trial Failure Rate (%), 2015 29
Figure 8: Hepatitis B Market, Global, Clinical Trial Failure Rate by Molecule Type (%), 2015 30
Figure 9: Hepatitis B Market, Global, Clinical Trial Failure Rate by Molecular Target (%), 2015 30
Figure 10: Hepatitis B Market, Global, Clinical Trial Duration by Molecule Type (months), 2015 31
Figure 11: Hepatitis B Market, Global, Clinical Trial Size by Molecule Type, 2015 32
Figure 12: Multiple Myeloma Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 33
Figure 13: Hepatitis B Therapeutics Market, Vaccine Technology by Genexine 35
Figure 14: Hepatitis B Therapeutics Market, Global, Treatment Patterns (million) and Market Size ($bn), 2014-2021 37
Figure 15: Hepatitis B Therapeutics Market, North America, Treatment Patterns (‘000), 2014-2021 38
Figure 16: Hepatitis B Therapeutics Market, North America, Annual Cost of Therapy ($), 2014-2021 39
Figure 17: Hepatitis B Therapeutics Market, North America, Market Size ($m), 2014-2021 40
Figure 18: Hepatitis B Therapeutics Market, EU, Treatment Patterns (‘000), 2014-2021 41
Figure 19: Hepatitis B Therapeutics Market, EU, Annual Cost of Therapy ($), 2014-2021 43
Figure 20: Hepatitis B Therapeutics Market, EU, Market Size ($), 2014-2021 44
Figure 21: Hepatitis B Therapeutics Market, Japan, Treatment Usage Patterns (‘000), 2014-2021 45
Figure 22: Hepatitis B Therapeutics Market, Japan, Annual Cost of Therapy ($), 2014-2021 45
Figure 23: Hepatitis B Therapeutics Market, Japan, Market Size ($m), 2014-2021 46
Figure 24: Hepatitis B Market, Global, Licensing Deals by Region, 2006-2015 49
Figure 25: Hepatitis B Market, Global, Licensing Deals by Region, Value and Year, 2006-2015 50
Figure 26: Hepatitis B Market, Global, Licensing Deals by Phase and Value, 2006-2015 51
Figure 27: Hepatitis B Market, Global, Co-development Deals by Region and Stage of Development, 2006-2015 53

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