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

Publisher Name :
Date: 01-Sep-2015
No. of pages: 72

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.

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

Table of Contents

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 8

2 Introduction 9
2.1 Classification 9
2.2 Pathophysiology 9
2.3 Etiology 11
2.4 Symptoms 12
2.5 Diagnosis 12
2.6 Epidemiology 13
2.7 Treatment and Management 15
2.8 Prognosis 16
2.9 Co-infection 17
2.9.1 HBV-HIV Co-infection 17
2.9.2 HBV-HDV Co-infection 17
2.9.3 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 Nucleoside-Inhibitor-Naive Subjects with Compensated Liver Disease (Studies AI463022 and AI463027) 20
3.2.2 Lamivudine-Refractory Subjects with Compensated Liver Disease (Study AI463026) 21
3.3 Pegasys (peg interferon α-2a) 23
3.4 Adefovir dipivoxil 25
3.4.1 Study 437 (HBeAg-Positive Chronic Hepatitis B Patients) 25
3.4.2 Study 438 (HBeAg-Negative Chronic Hepatitis B Patients) 25
3.4.3 Adefovir Treatment beyond 48 Weeks 27
3.4.4 Study 435 (Pre- and Post-liver Transplantation Subjects) 27
3.4.5 Study 461 (Clinical Evidence of Lamivudine Resistance Patients) 27
3.5 Tyzeka per Sebivo 28
3.5.1 NV-02B-007 GLOBE Trial 28
3.5.2 HBeAg-Positive Subjects 28
3.5.3 HBeAg-Negative Subjects 28
3.6 Comparative Efficacy and Safety 30

4 Pipeline Analysis 32
4.1 Overall Pipeline 32
4.2 Pipeline Analysis of Therapeutic Vaccines 33
4.3 Clinical Trials 35
4.3.1 Failure Rate 35
4.3.2 Failure Rate by Molecule Type 35
4.3.3 Failure Rate by Mechanism of Action 36
4.3.4 Patient Enrollment and Clinical Trial Size by Molecule Type 37
4.3.5 Duration 38
4.4 Competitive Clinical Trials Metrics Analysis 40
4.5 Promising Drug Candidates in Pipeline 40
4.5.1 GS-7340 (tenofovir alafenamide fumarate) 40
4.6 Therapeutic Vaccines in Pipeline 41
4.6.1 GS-4774 Therapeutic Vaccine with Oral Antiviral Treatment 41
4.6.2 ABX203 Therapeutic Vaccine with Nucleos(t)ide Analogs against HBeAg-Negative Chronic Hepatitis B 41
4.6.3 HB-110E Therapeutic DNA Vaccine 41
4.6.4 INO-1800 with or without INO-9112 in Entecavir/Tenofovir-Treated HBeAg-Positive Chronic Hepatitis B Patients 42
4.6.5 TG1050 Therapeutic Vaccine 43

5 Market Forecast to 2021 44
5.1 Geographical Markets 44
5.2 Global Market 44
5.3 North America 45
5.3.1 Treatment Usage Patterns 45
5.3.2 Annual Cost of Therapy 46
5.3.3 Market Size 47
5.4 Top Five EU Markets 48
5.4.1 Treatment Usage Patterns 48
5.4.2 Annual Cost of Therapy 49
5.4.3 Market Size 50
5.5 Japan 51
5.5.1 Treatment Usage Patterns 51
5.5.2 Annual Cost of Therapy 52
5.5.3 Market Size 53
5.6 Drivers and Barriers in the Disease Market 53
5.6.1 Drivers 53
5.6.2 Barriers 54

6 Deals and Strategic Consolidations 56
6.1 Licensing Deals 56
6.1.1 OnCore Enters into Licensing Agreement with NeuroVive 59
6.1.2 Ligand Enters into Licensing Agreement with Chiva for Pradefovir and MB01733 59
6.2 Co-development Deals 59

7 Appendix 61
7.1 All Pipeline Drugs by Phase of Development 61
7.1.1 Discovery 61
7.1.2 Preclinical 62
7.1.3 Phase I 63
7.1.4 Phase II 64
7.1.5 Phase III 64
7.2 Market Forecasts to 2021 65
7.2.1 Global 65
7.2.2 US 65
7.2.3 Canada 66
7.2.4 UK 66
7.2.5 France 67
7.2.6 Germany 67
7.2.7 Italy 68
7.2.8 Spain 68
7.2.9 Japan 69
7.3 Bibliography 69
7.4 Abbreviations 73
7.5 Research Methodology 74
7.5.1 Secondary Research 74
7.5.2 Marketed Product Profiles 75
7.5.3 Late-Stage Pipeline Candidates 75
7.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 75
7.5.5 Forecasting Model 76
7.5.6 Deals Data Analysis 77
7.6 Expert Panel Validation 78
7.7 Contact Us 78
7.8 Disclaimer 78

List of Tables

Table 1: Hepatitis B Virus Nomenclature 10
Table 2: Chronic Hepatitis B Prevalence in Countries that are Main Sources of Migration to US 14
Table 3: Comparison of Drugs that Treat Hepatitis B 15
Table 4: Histological, Virological, Biochemical and Serological Response at Week 48 in Study 0102 and Study 0103 19
Table 5: Histologic Improvement and Change in Ishak Fibrosis Score at Week 48 in Study AI463022 and Study AI463027 21
Table 6: Selected Virologic, Biochemical and Serologic End Points at Week 48 in Study AI463022 and Study AI463027 21
Table 7: Histologic Improvement and Change in Ishak Fibrosis Score at Week 48 in Study AI463026 22
Table 8: Selected Virologic, Biochemical and Serologic End Points at Week 48 in Study AI463026 22
Table 9: Selected Study End Points at Week 48 in Study AI463048 23
Table 10: Serological, Virological, Biochemical and Histological Response of Subjects in Study 8 and Study 9 24
Table 11: Histologic Response End Points at Week 48 in Study 437 and Study 438 25
Table 12: Changes in Ishak Fibrosis Score End Points at Week 48 in Study 437 and Study 438 26
Table 13: Changes in Serum HBV DNA, ALT Normalization and HBeAg Seroconversion at Week 48 in Study 437 and Study 438 26
Table 14: Pre-and Post-liver Transplantation Subjects with Chronic Hepatitis B at Week 48 in Study 435 27
Table 15: Histological Improvement and Change in Ishak Fibrosis Score at Week 52 in NV-02B-007 GLOBE Trial 29
Table 16: Virological, Biochemical and Serological Response at Week 52 and Week 104 in NV-02B-007 GLOBE Trial 29
Table 17: Immigration from High-Prevalence Regions to US, 2010 and 2013 53
Table 18: Hepatitis B Therapeutics Market, Global, Pipeline Products, Discovery, 2015 61
Table 19: Hepatitis B Therapeutics Market, Global, Pipeline Products, Preclinical, 2015 62
Table 20: Hepatitis B Therapeutics Market, Global, Pipeline Products, Phase I, 2015 63
Table 21: Hepatitis B Therapeutics Market, Global, Pipeline Products, Phase II, 2015 64
Table 22: Hepatitis B Therapeutics Market, Global, Pipeline Products, Phase III, 2015 64
Table 23: Hepatitis B Therapeutics Market, Global, Market Forecast, 2014-2021 65
Table 24: Hepatitis B Therapeutics Market, US, Market Forecast, 2014-2021 65
Table 25: Hepatitis B Therapeutics Market, Canada, Market Forecast, 2014-2021 66
Table 26: Hepatitis B Therapeutics Market, UK, Market Forecast, 2014-2021 66
Table 27: Hepatitis B Therapeutics Market, France, Market Forecast, 2014-2021 67
Table 28: Hepatitis B Therapeutics Market, Germany, Market Forecast, 2014-2021 67
Table 29: Hepatitis B Therapeutics Market, Italy, Market Forecast, 2014-2021 68
Table 30: Hepatitis B Therapeutics Market, Spain, Market Forecast, 2014-2021 68
Table 31: Hepatitis B Therapeutics Market, Japan, Market Forecast, 2014-2021 69
Table 32: Abbreviations 73

List of Figures

Figure 1: Hepatitis B Disease Classification 9
Figure 2: Hepatitis B Virus Life Cycle 11
Figure 3: Management of Hepatitis B Infection 16
Figure 4: Hepatitis B Therapeutics Market, Global, Comparative Efficacy and Safety of Marketed Products Heatmap, 2015 31
Figure 5: Hepatitis B Therapeutics Market, Global, Overview of Pipeline Products 33
Figure 6: Hepatitis B Therapeutics Market, Global, Therapeutic Vaccines in Pipeline by Molecule Type 34
Figure 7: Hepatitis B Market, Global, Clinical Trial Failure Rate (%), 2015 35
Figure 8: Hepatitis B Market, Global, Clinical Trial Failure Rate by Molecule Type (%), 2015 36
Figure 9: Hepatitis B Market, Global, Clinical Trial Failure Rate by Mechanism of Action (%), 2015 37
Figure 10: Hepatitis B Market, Global, Clinical Trial Size by Molecule Type, 2015 38
Figure 11: Hepatitis B Market, Global, Clinical Trial Duration by Molecule Type (months), 2015 39
Figure 12: Multiple Myeloma Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 40
Figure 13: Hepatitis B Therapeutics Market, Vaccine Technology by Genexine 42
Figure 14: Hepatitis B Therapeutics Market, Global, Treatment Patterns (million) and Market Size ($bn), 2014-2021 44
Figure 15: Hepatitis B Therapeutics Market, North America, Treatment Patterns (‘000), 2014-2021 45
Figure 16: Hepatitis B Therapeutics Market, North America, Annual Cost of Therapy ($), 2014-2021 46
Figure 17: Hepatitis B Therapeutics Market, North America, Market Size ($m), 2014-2021 47
Figure 18: Hepatitis B Therapeutics Market, EU, Treatment Patterns (‘000), 2014-2021 48
Figure 19: Hepatitis B Therapeutics Market, EU, Annual Cost of Therapy ($), 2014-2021 50
Figure 20: Hepatitis B Therapeutics Market, EU, Market Size ($), 2014-2021 51
Figure 21: Hepatitis B Therapeutics Market, Japan, Treatment Usage Patterns (‘000), 2014-2021 52
Figure 22: Hepatitis B Therapeutics Market, Japan, Annual Cost of Therapy ($), 2014-2021 52
Figure 23: Hepatitis B Therapeutics Market, Japan, Market Size ($m), 2014-2021 53
Figure 24: Hepatitis B Market, Global, Licensing Deals by Region, 2006-2015 56
Figure 25: Hepatitis B Market, Global, Licensing Deals by Region, Value and Year, 2006-2015 57
Figure 26: Hepatitis B Market, Global, Licensing Deals by Phase and Value, 2006-2015 58
Figure 27: Hepatitis B Market, Global, Co-development Deals by Region and Stage of Development, 2006-2015 60"

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