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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

Published: Aug 31, 2015 | Pages: Publisher: GBI Research | Industry: Therapeutic Area | Report Format: Electronic (PDF)

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
 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 a-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 36
4.3.3 Failure Rate by Mechanism of Action 37
4.3.4 Patient Enrollment and Clinical Trial Size by Molecule Type 38
4.3.5 Duration 39
4.4 Competitive Clinical Trials Metrics Analysis 41
4.5 Promising Drug Candidates in Pipeline 41
4.5.1 GS-7340 (tenofovir alafenamide fumarate) 41
4.6 Therapeutic Vaccines in Pipeline 42
4.6.1 GS-4774 Therapeutic Vaccine with Oral Antiviral Treatment 42
4.6.2 ABX203 Therapeutic Vaccine with Nucleos(t)ide Analogs against HBeAg-Negative Chronic Hepatitis B 42
4.6.3 HB-110E Therapeutic DNA Vaccine 42
4.6.4 Therapeutic (Synthesized Peptide) HBV Vaccine (ePA-44) 43
4.6.5 INO-1800 with or without INO-9112 in Entecavir/Tenofovir-Treated HBeAg-Positive Chronic Hepatitis B Patients 44
4.6.6 TG1050 Therapeutic Vaccine 45

5 Market Forecast to 2021 46
5.1 Geographical Markets 46
5.2 Global Market 46
5.3 North America 47
5.3.1 Treatment Usage Patterns 47
5.3.2 Annual Cost of Therapy 48
5.3.3 Market Size 49
5.4 Top Five EU Markets 50
5.4.1 Treatment Usage Patterns 50
5.4.2 Annual Cost of Therapy 51
5.4.3 Market Size 52
5.5 Japan 53
5.5.1 Treatment Usage Patterns 53
5.5.2 Annual Cost of Therapy 54
5.5.3 Market Size 55
5.6 Drivers and Barriers in the Disease Market 55
5.6.1 Drivers 55
5.6.2 Barriers 56

6 Deals and Strategic Consolidations 58
6.1 Licensing Deals 58
6.1.1 OnCore Enters into Licensing Agreement with NeuroVive 61
6.1.2 Dynavax Enters into Licensing Agreement with Merck for Heplisav 61
6.1.3 Ligand Enters into Licensing Agreement with Chiva for Pradefovir and MB01733 61
6.2 Co-development Deals 61

7 Appendix 63
7.1 All Pipeline Drugs by Phase of Development 63
7.1.1 Discovery 63
7.1.2 Preclinical 64
7.1.3 Phase I 65
7.1.4 Phase II 66
7.1.5 Phase III 66
7.2 Market Forecasts to 2021 67
7.2.1 Global 67
7.2.2 US 67
7.2.3 Canada 68
7.2.4 UK 68
7.2.5 France 69
7.2.6 Germany 69
7.2.7 Italy 70
7.2.8 Spain 70
7.2.9 Japan 71
7.3 Bibliography 71
7.4 Abbreviations 75
7.5 Research Methodology 76
7.5.1 Secondary Research 76
7.5.2 Marketed Product Profiles 77
7.5.3 Late-Stage Pipeline Candidates 77
7.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 77
7.5.5 Forecasting Model 78
7.5.6 Deals Data Analysis 79
7.6 Expert Panel Validation 80
7.7 Contact Us 80
7.8 Disclaimer 80
List of Table

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 55
Table 18: Hepatitis B Therapeutics Market, Global, Pipeline Products, Discovery, 2015 63
Table 19: Hepatitis B Therapeutics Market, Global, Pipeline Products, Preclinical, 2015 64
Table 20: Hepatitis B Therapeutics Market, Global, Pipeline Products, Phase I, 2015 65
Table 21: Hepatitis B Therapeutics Market, Global, Pipeline Products, Phase II, 2015 66
Table 22: Hepatitis B Therapeutics Market, Global, Pipeline Products, Phase III, 2015 66
Table 23: Hepatitis B Therapeutics Market, Global, Market Forecast, 2014–2021 67
Table 24: Hepatitis B Therapeutics Market, US, Market Forecast, 2014–2021 67
Table 25: Hepatitis B Therapeutics Market, Canada, Market Forecast, 2014–2021 68
Table 26: Hepatitis B Therapeutics Market, UK, Market Forecast, 2014–2021 68
Table 27: Hepatitis B Therapeutics Market, France, Market Forecast, 2014–2021 69
Table 28: Hepatitis B Therapeutics Market, Germany, Market Forecast, 2014–2021 69
Table 29: Hepatitis B Therapeutics Market, Italy, Market Forecast, 2014–2021 70
Table 30: Hepatitis B Therapeutics Market, Spain, Market Forecast, 2014–2021 70
Table 31: Hepatitis B Therapeutics Market, Japan, Market Forecast, 2014–2021 71
Table 32: Abbreviations 75 


List of Chart

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 35
Figure 7: Hepatitis B Market, Global, Clinical Trial Failure Rate (%), 2015 36
Figure 8: Hepatitis B Market, Global, Clinical Trial Failure Rate by Molecule Type (%), 2015 37
Figure 9: Hepatitis B Market, Global, Clinical Trial Failure Rate by Mechanism of Action (%), 2015 38
Figure 10: Hepatitis B Market, Global, Clinical Trial Size by Molecule Type, 2015 39
Figure 11: Hepatitis B Market, Global, Clinical Trial Duration by Molecule Type (months), 2015 40
Figure 12: Multiple Myeloma Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 41
Figure 13: Hepatitis B Therapeutics Market, Vaccine Technology by Genexine 43
Figure 14: Hepatitis B Therapeutics Market, Global, Treatment Patterns (million) and Market Size ($bn), 2014–2021 46
Figure 15: Hepatitis B Therapeutics Market, North America, Treatment Patterns (‘000), 2014–2021 47
Figure 16: Hepatitis B Therapeutics Market, North America, Annual Cost of Therapy ($), 2014–2021 48
Figure 17: Hepatitis B Therapeutics Market, North America, Market Size ($m), 2014–2021 49
Figure 18: Hepatitis B Therapeutics Market, EU, Treatment Patterns (‘000), 2014–2021 50
Figure 19: Hepatitis B Therapeutics Market, EU, Annual Cost of Therapy ($), 2014–2021 52
Figure 20: Hepatitis B Therapeutics Market, EU, Market Size ($), 2014–2021 53
Figure 21: Hepatitis B Therapeutics Market, Japan, Treatment Usage Patterns (‘000), 2014–2021 54
Figure 22: Hepatitis B Therapeutics Market, Japan, Annual Cost of Therapy ($), 2014–2021 54
Figure 23: Hepatitis B Therapeutics Market, Japan, Market Size ($m), 2014–2021 55
Figure 24: Hepatitis B Market, Global, Licensing Deals by Region, 2006–2015 58
Figure 25: Hepatitis B Market, Global, Licensing Deals by Region, Value and Year, 2006–2015 59
Figure 26: Hepatitis B Market, Global, Licensing Deals by Phase and Value, 2006–2015 60
Figure 27: Hepatitis B Market, Global, Co-development Deals by Region and Stage of Development, 2006–2015 62

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