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PharmaPoint: Hepatitis B Virus (HBV) Therapeutics - Global Drug Forecast and Market Analysis to 2024

Summary

Chronic hepatitis B virus (HBV) infection is a serious chronic liver disease caused by the failure of viral clearance following acute HBV infection. Despite the availability of effective prophylactic vaccines, the disease remains a serious global health concern, with estimated over 350 million people worldwide currently living with this condition. In addition, patients with chronic hepatitis B are at a high risk of developing life-threatening complications including liver cirrhosis and hepatocellular carcinoma (HCC). In 2010, an estimated 786,000 HBV-related deaths occurred worldwide.

Available treatment for chronic hepatitis B focuses on viral suppression, and include oral nucleos(t)ide analogues (NAs) and pegylated interferon (PEG-IFN). The two therapy classes have distinctive strengths and weaknesses. Nevertheless, most patients are using long-term NA treatment, and suffer from issues such as high accumulated treatment cost and low compliance.

For the purposes of this report, GlobalData defines the HBV infection therapeutics market to include sales of HBV-specific medication in patients 18 years and older in the eight major pharmaceutical markets (8MM; US, France, Germany, Italy, Spain, UK, Japan, and China). GlobalData expects the market to experience moderate growth that will be primarily driven by the uptake of therapies with novel mechanisms of action (MOAs).

Highlights

Key Questions Answered

- How good is the management of chronic HBV infection with marketed therapies?
- Which drugs and players are important in the current management landscape?
- Which pipeline agents will enter the market during the forecast period (2014-2024)?
- Will the leading pipeline agents fulfil the unmet needs of current management landscape?
- What clinical and commercial factors are likely to influence HBV therapeutic uptake in the US, 5EU, Japan and China?

Key Findings

- GlobalData projects the HBV therapeutics market in the 8MM to grow from approximately $2.4 billion in 2014 to $3.0 billion in 2024, at a compound annual growth rate (CAGR) of 2.4%. This growth across the 8MM will primarily be driven by the launch of pipeline agents, especially those with novel MOAs, while steep generic erosion across the 8MM is expected to curtail market growth over the forecast period.
- While pipeline agents have the potential to address some of the unmet needs in the HBV treatment landscape, more clinical data are required to demonstrate their advantage over available therapies, according to interviewed KOLs. In addition, these agents are pioneers of novel therapies, which retain substantial room for future development.
- GlobalData anticipates that opportunities centered on the development of antivirals with novel MOAs, which can improve the efficacy of existing drugs, will exist for current and future players in the HBV therapeutic marketplace for the duration of the forecast period.

Scope

- Overview of chronic HBV infection, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current treatment options.
- Topline HBV therapeutics market revenue from 2014-2024. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.
- Key topics covered include strategic competitor assessment, unmet needs, pipeline assessment, and market outlook for the HBV therapeutics market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.
- Analysis of the current and future market competition in the global HBV therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the global HBV therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the HBV therapeutics market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table Of Contents

PharmaPoint: Hepatitis B Virus (HBV) Therapeutics - Global Drug Forecast and Market Analysis to 2024
1 Table of Contents
1 Table of Contents 10
1.1 List of Tables 16
1.2 List of Figures 20
2 Introduction 22
2.1 Catalyst 22
2.2 Related Reports 23
2.3 Upcoming Related Reports 24
3 Disease Overview 25
3.1 Overview 25
3.2 Etiology and Pathophysiology 26
3.2.1 Etiology 26
3.2.2 Pathophysiology 33
3.3 Symptoms 35
3.4 Prognosis 36
3.4.1 Phases of Chronic HBV Infection 37
3.4.2 Complications of Chronic Hepatitis B 41
3.5 Quality of Life 43
4 Epidemiology 45
4.1 Disease Background 45
4.2 Risk Factors and Comorbidities 46
4.3 Global Trends 47
4.4 Forecast Methodology 49
4.4.1 Sources Used 50
4.4.2 Sources Not Used 58
4.4.3 Forecast Assumptions and Methods 59
4.5 Epidemiological Forecast of Chronic Hepatitis B (2014-2024) 65
4.5.1 Diagnosed Prevalent Cases of Chronic Hepatitis B 65
4.5.2 Age-Specific Diagnosed Prevalent Cases of Chronic Hepatitis B 67
4.5.3 Sex-Specific Diagnosed Prevalent Cases of Chronic Hepatitis B 70
4.5.4 Age-Standardized Diagnosed Prevalence of Chronic Hepatitis B 72
4.5.5 Diagnosed Prevalent Cases of Chronic Hepatitis B Segmented by HBV DNA Level 74
4.5.6 Diagnosed Prevalent Cases of Chronic Hepatitis B Segmented by ALT Level 75
4.5.7 Diagnosed Prevalent Cases of Chronic Hepatitis B Segmented by HBeAg Status 76
4.5.8 Diagnosed Prevalent Cases of Chronic Hepatitis B Segmented by Cirrhosis Status 77
4.5.9 Diagnosed Prevalent Cases of Chronic Hepatitis B with Co-infection of HIV and Hepatitis C 79
4.6 Discussion 80
4.6.1 Epidemiological Forecast Insight 80
4.6.2 Limitations of the Analysis 80
4.6.3 Strengths of the Analysis 81
5 Disease Management 82
5.1 Diagnosis and Treatment Overview 82
5.1.1 Diagnosis 82
5.1.2 Treatment Guidelines and Leading Prescribed Drugs 83
5.1.3 Clinical Practice 85
5.2 US 90
5.2.1 Screening and Diagnosis 91
5.2.2 Clinical Practice 92
5.3 5EU 95
5.3.1 Screening and Diagnosis 96
5.3.2 Clinical Practice 97
5.4 Japan 101
5.4.1 Screening and Diagnosis 101
5.4.2 Clinical Practice 103
5.5 China 106
5.5.1 Screening and Diagnosis 107
5.5.2 Clinical Practice 109
6 Competitive Assessment 113
6.1 Overview 113
6.2 Product Profiles - Major Brands 117
6.2.1 Baraclude (entecavir) 117
6.2.2 Viread (tenofovir disoproxil fumarate) 122
6.2.3 Pegasys (peginterferon alfa-2a) 130
6.2.4 Hepsera (adefovir dipivoxil) 137
6.2.5 Tyzeka (telbivudine) 141
6.3 Other Therapeutics 147
6.3.1 Conventional and Pegylated Interferon alfa 147
6.3.2 Nucleos(t)ide Analogs 148
7 Unmet Needs and Opportunities 150
7.1 Overview 150
7.2 Improvements in Long-Term Clinical Outcomes 153
7.2.1 Unmet Need 153
7.2.2 Gap Analysis 156
7.2.3 Opportunity 160
7.3 Enhanced Public Awareness and Screening Initiatives to Boost Diagnosis Rates 163
7.3.1 Unmet Need 163
7.3.2 Gap Analysis 167
7.3.3 Opportunity 167
7.4 Increased Access to Treatment 168
7.4.1 Unmet Need 168
7.4.2 Gap Analysis 171
7.4.3 Opportunity 172
7.5 Drugs That Effectively Target and Suppress HBV cccDNA 173
7.5.1 Unmet Need 173
7.5.2 Gap Analysis 173
7.5.3 Opportunity 174
7.6 Safe and Efficacious Therapies for Difficult-to-Treat Patients 175
7.6.1 Unmet Need 175
7.6.2 Gap Analysis 176
7.6.3 Opportunity 177
7.7 Overcome Unique Barriers Posed by China's Healthcare System 178
7.7.1 Unmet Need 178
7.7.2 Gap Analysis 179
7.7.3 Opportunity 179
8 Pipeline Assessment 181
8.1 Overview 181
8.2 Clinical Trial Mapping 182
8.2.1 Clinical Trials by Phase and Status, Therapy Class, and Location 182
8.3 Promising Drugs in Clinical Development 184
8.3.1 Tenofovir Alafenamide Fumarate 187
8.3.2 ARC-520 194
8.3.3 GS-9620 201
8.3.4 GS-4774 206
8.4 Other Drugs in Development 212
8.4.1 ABX-203 213
8.4.2 REP 2139-Ca 214
8.4.3 Besifovir 215
8.4.4 Hepabulin 215
8.4.5 Myrcludex-B 215
8.4.6 Agents in Early Stages of Development 216
9 Current and Future Players 219
9.1 Overview 219
9.2 Trends in Corporate Strategy 222
9.3 Company Profiles 225
9.3.1 Gilead 225
9.3.2 Bristol-Myers Squibb 227
9.3.3 Roche 229
9.3.4 Merck 230
9.3.5 GSK 233
9.3.6 Novartis 234
9.3.7 Arrowhead Research 235
9.3.8 GlobeImmune 236
10 Market Outlook 237
10.1 Global Markets 237
10.1.1 Forecast 237
10.1.2 Drivers and Barriers - Global Issues 243
10.2 US 245
10.2.1 Forecast 245
10.2.2 Key Events 249
10.2.3 Drivers and Barriers 250
10.3 5EU 252
10.3.1 Forecast 252
10.3.2 Key Events 256
10.3.3 Drivers and Barriers 257
10.4 Japan 260
10.4.1 Forecast 260
10.4.2 Key Events 264
10.4.3 Drivers and Barriers 265
10.5 China 266
10.5.1 Forecast 266
10.5.2 Key Events 270
10.5.3 Drivers and Barriers 271
11 Appendix 274
11.1 Bibliography 274
11.2 Abbreviations 296
11.3 Methodology 302
11.4 Forecasting Methodology 302
11.4.1 Total Prevalent Cases of Chronic Hepatitis B 302
11.4.2 Diagnosed Chronic Hepatitis B Patients 303
11.4.3 Percent Drug-Treated Chronic Hepatitis B Patients 303
11.4.4 Drugs Included in Each Therapeutic Class 304
11.4.5 Launch and Patent Expiry Dates 304
11.4.6 General Pricing Assumptions 305
11.4.7 Individual Drug Assumptions 307
11.4.8 Generic Erosion 314
11.4.9 Pricing of Pipeline Agents 315
11.5 Primary Research - KOLs Interviewed for this Report 316
11.6 Primary Research - Prescriber Survey 319
11.7 About the Authors 320
11.7.1 Analyst 320
11.7.2 Therapy Area Director 320
11.7.3 Epidemiologists 321
11.7.4 Global Director of Therapy Analysis and Epidemiology 321
11.7.5 Global Head of Healthcare 321
11.8 About GlobalData 322
11.9 Disclaimer 322

1.1 List of Tables
Table 1: Modes of HBV Transmission 32
Table 2: HBV Serological Markers and Test Interpretations 35
Table 3: Symptoms of HBV Infection 36
Table 4: Phases of Chronic Hepatitis B Infection 38
Table 5: Key Complications of Chronic HBV infection 41
Table 6: Risk Factors and Comorbidities for Chronic Hepatitis B 47
Table 7: 8MM, Sources Used for the Diagnosed Prevalent Cases Forecast of Chronic Hepatitis B 50
Table 8: 8MM, Sources Used for HBV DNA Level 51
Table 9: 8MM, Sources Used for Chronic Hepatitis B by ALT Level 51
Table 10: 8MM, Sources Used for Chronic Hepatitis B HBeAg Status 52
Table 11: 8MM, Sources Used for Cirrhosis Status 52
Table 12: 8MM, Sources Used for HIV Co-infection 53
Table 13: 8MM, Sources Used for Hepatitis C Co-infection 54
Table 14: 8MM, Diagnosed Prevalent Cases of Chronic Hepatitis B, Both Sexes, All Ages, Select Years, 2014-2024 66
Table 15: 8MM, Age-Specific Diagnosed Prevalent Cases of Chronic Hepatitis B, Ages ?18 Years, N (Row %), 2014 68
Table 16: 8MM, Sex-Specific Diagnosed Prevalent Cases of Chronic Hepatitis B, Ages ?18 Years, N, 2014 71
Table 17: US and 5EU, Diagnosed Prevalent Cases of Chronic Hepatitis B Segmented by HBV DNA, Ages ?18 Years, N, Both Sexes, 2014 74
Table 18: Japan and China, Diagnosed Prevalent Cases of Chronic Hepatitis B Segmented by HBV DNA, Ages ?18 Years, N, Both Sexes, 2014 75
Table 19: 8MM, Diagnosed Prevalent Cases of Chronic Hepatitis B Segmented by ALT Level, Ages ?18 Years, N, Both Sexes, 2014 76
Table 20: 8MM, Diagnosed Prevalent Cases of Chronic Hepatitis B Segmented by HBeAg Status, Ages ?18 Years, N, Both Sexes, 2014 77
Table 21: 8MM, Diagnosed Prevalent Cases of Chronic Hepatitis B Segmented Cirrhosis Status, Ages ?18 Years, N, Both Sexes, 2014 78
Table 22: 8MM, Diagnosed Prevalent Chronic Hepatitis B Cases Segmented by Co-infection with HIV and Hepatitis C, Both Sexes, Ages ?18 Years, N (% of Diagnosed Chronic Hepatitis B Cases), 2014 79
Table 23: Treatment Guidelines for Chronic Hepatitis B 84
Table 24: Most Prescribed Drugs for Chronic Hepatitis B by Class in the 8MM, 2014 85
Table 25: Country Profile - US 90
Table 26: Country Profile - 5EU 95
Table 27: Country Profile - Japan 101
Table 28: Country Profile - China 106
Table 29: Leading Treatments for Chronic Hepatitis B, 2015 113
Table 30: Product Profile - Baraclude 118
Table 31: Antiviral Efficacy of Baraclude Compared with Epivir-HBV 119
Table 32: Antiviral Efficacy of Baraclude in Epivir-HBV-Refractory Patients 120
Table 33: Baraclude SWOT Analysis, 2015 121
Table 34: Global Sales Forecasts ($m) for Baraclude, 2014-2024 122
Table 35: Product Profile - Viread 125
Table 36: Antiviral Efficacy of Viread Compared with Hepsera 127
Table 37: Viread SWOT Analysis, 2015 128
Table 38: Global Sales Forecasts ($m) for Viread, 2014-2024 129
Table 39: Product Profile - Pegasys 132
Table 40: Antiviral Efficacy of Pegasys Monotherapy Compared with Epivir-HBV Monotherapy or the Combination of the Two 133
Table 41: Pegasys SWOT Analysis, 2015 135
Table 42: Global Sales Forecasts ($m) for Pegasys, 2014-2024 136
Table 43: Product Profile - Hepsera 138
Table 44: Antiviral Efficacy of Hepsera in HBeAg-positive patients 139
Table 45: Long-term Antiviral Efficacy of Hepsera in HBeAg-negative patients 139
Table 46: Hepsera SWOT Analysis, 2015 140
Table 47: Global Sales Forecasts ($m) for Hepsera, 2014-2024 141
Table 48: Product Profile - Tyzeka 143
Table 49: Antiviral Efficacy of Tyzeka Compared with Epivir-HBV 144
Table 50: Tyzeka SWOT Analysis, 2015 145
Table 51: Global Sales Forecasts ($m) for Tyzeka, 2014-2024 146
Table 52: Summary of Minor Therapeutics for Chronic HBV Infection, 2015 147
Table 53: Unmet Needs and Opportunities in Chronic HBV Infection 153
Table 54: HBV - Clinical Trials by Phase and Status, 2015 183
Table 55: Key Late-Stage Pipeline Agents for Chronic Hepatitis B Treatment, 2015 185
Table 56: Product Profile - TAF 189
Table 57: TAF SWOT Analysis, 2015 193
Table 58: Global Sales Forecasts ($m) for TAF, 2014-2024 194
Table 59: Product Profile - ARC-520 196
Table 60: Safety of ARC-520 from a Phase I Clinical Trial 198
Table 61: ARC-520 SWOT Analysis, 2015 200
Table 62: Global Sales Forecasts ($m) for ARC-520, 2014-2024 201
Table 63: Product Profile - GS-9620 203
Table 64: GS-9620 SWOT Analysis, 2015 205
Table 65: Global Sales Forecasts ($m) for GS-9620, 2014-2024 206
Table 66: Product Profile - GS-4774 207
Table 67: Phase I Clinical Trial Efficacy Results of GS-4774 in Healthy Participants 209
Table 68: Phase I Clinical Trial Safety Results of GS-4774 in Healthy Participants 209
Table 69: GS-4774 SWOT Analysis, 2015 211
Table 70: Global Sales Forecasts ($m) for GS-4774, 2014-2024 212
Table 71: Other Agents in Clinical Development for Chronic Hepatitis B Treatment, 2015 213
Table 72: Agents in Phase I or early Phase II Clinical Development for Chronic Hepatitis B Treatment, 2015 216
Table 73: Agents in Preclinical Development for Chronic Hepatitis B Treatment, 2015 217
Table 74: Key Companies in the Chronic Hepatitis B Therapeutics Market, 8MM, 2015 221
Table 75: Gilead's Chronic Hepatitis B Portfolio Assessment, 2015 227
Table 76: BMS's Chronic Hepatitis B Portfolio Assessment, 2015 228
Table 77: Roche's Chronic Hepatitis B Portfolio Assessment, 2015 230
Table 78: Merck's Chronic Hepatitis B Portfolio Assessment, 2015 232
Table 79: GSK's Chronic Hepatitis B Portfolio Assessment, 2015 234
Table 80: Novartis' Chronic Hepatitis B Portfolio Assessment, 2015 234
Table 81: Arrowhead's Chronic Hepatitis B Portfolio Assessment, 2015 236
Table 82: GlobeImmune's Chronic Hepatitis B Portfolio Assessment, 2015 236
Table 83: Global Sales Forecasts ($m) for Chronic Hepatitis B Therapeutics, 2014-2024 240
Table 84: Chronic Hepatitis B Therapeutics Market - Drivers and Barriers, 2014-2024 243
Table 85: Sales Forecasts ($m) for Chronic Hepatitis B Therapeutics in the US, 2014-2024 247
Table 86: Key Events Impacting Sales for Chronic Hepatitis B Therapeutics in the US, 2014-2024 249
Table 87: Chronic Hepatitis B Therapeutics Market - Drivers and Barriers in the US, 2014-2024 250
Table 88: Sales Forecasts ($m) for Chronic Hepatitis B Therapeutics in the 5EU, 2014-2024 254
Table 89: Key Events Impacting Sales for Chronic Hepatitis B Therapeutics in the 5EU, 2014-2024 256
Table 90: Chronic Hepatitis B Therapeutics Market - Drivers and Barriers in the 5EU, 2014 257
Table 91: National Healthcare Authorities and Governmental Drug Pricing Authorities in the 5EU 259
Table 92: Sales Forecasts ($m) for Chronic Hepatitis B Therapeutics in Japan, 2014-2024 262
Table 93: Key Events Impacting Sales for Chronic Hepatitis B Therapeutics in Japan, 2014-2024 264
Table 94: Chronic Hepatitis B Therapeutics Market - Drivers and Barriers in Japan, 2014 265
Table 95: Sales Forecasts ($m) for Chronic Hepatitis B Therapeutics in China, 2014-2024 268
Table 96: Key Events Impacting Sales for Chronic Hepatitis B Therapeutics in China, 2014-2024 270
Table 97: Chronic Hepatitis B Therapeutics Market - Drivers and Barriers in China, 2014 271
Table 98: Key Historical and Projected Launch Dates 304
Table 99: Key Historical and Projected Patent Expiry Dates 305
Table 100: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 319

1.2 List of Figures
Figure 1: Key Steps in HBV Replication and Potential Therapeutic Targets 28
Figure 2: HBV Structure 30
Figure 3: Prognosis of Chronic HBV infection 39
Figure 4: 8MM, Diagnosed Prevalent Cases of Chronic Hepatitis B, Both Sexes, Ages ?18 Years, Select Years, 2014-2024 67
Figure 5: 8MM, Age-Specific Diagnosed Prevalent Cases of Chronic Hepatitis B, Ages ?18 Years, Both Sexes, N, 2014 69
Figure 6: 8MM, Sex-Specific Diagnosed Prevalent Cases of Chronic Hepatitis B, Ages ?18 Years, N, 2014 72
Figure 7: 8MM, Age-Standardised Diagnosed Prevalence of Chronic Hepatitis B, Ages ?18 Years, 2014 73
Figure 8: Treatment Algorithm for Chronic HBV Infection in Non-cirrhotic, HBeAg-Positive Patients 87
Figure 9: Treatment Algorithm for Chronic HBV Infection in Non-cirrhotic, HBeAg-Negative Patients 88
Figure 10: Chronic hepatitis B Therapeutics - Therapy Class and Trial Location, 2014 184
Figure 11: HBV Phase II/Phase III Pipeline, 2014 186
Figure 12: Competitive Assessment of Late-Stage Pipeline Agents for Chronic Hepatitis B, 2015 187
Figure 13: Clinical and Commercial Positioning of TAF 192
Figure 14: Clinical and Commercial Positioning of ARC-520 199
Figure 15: Clinical and Commercial Positioning of GS-9620 204
Figure 16: Clinical and Commercial Positioning of GS-4774 210
Figure 17: Company Portfolio Gap Analysis in the Chronic Hepatitis B Therapeutic Market, 2014-2024 222
Figure 18: Sales for Chronic Hepatitis B Therapeutics by Country, 2014-2024 241
Figure 19: Sales for Chronic Hepatitis B Therapeutics by Therapy Class, 2014-2024 242
Figure 20: Sales for Chronic Hepatitis B Therapeutics in the US by Therapy Class, 2014-2024 248
Figure 21: Sales for Chronic Hepatitis B Therapeutics in the 5EU by Therapy Class, 2014-2024 255
Figure 22: Sales for Chronic Hepatitis B Therapeutics in Japan by Therapy Class, 2014-2024 263
Figure 23: Sales for Chronic Hepatitis B Therapeutics in China by Therapy Class, 2014-2024 269

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