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

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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...
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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.

Additional Information

Additional Information

Publisher name GlobalData.
Format PDF
Page count 323
Publication date 1 Jan 2016
Table of contents 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

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