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.
The chronic hepatitis B therapeutics market in the 5EU was valued at $532.1m in 2014. The anticipated arrival of novel branded therapies will be the strongest market driver in the 5EU during the forecast period. These therapies include Gilead’s TAF, a novel NA, along with three adjunct therapies, Arrowhead’s ARC-520, Gilead’s GS-9620, and Gilead’s GS-4774. GlobalData projects these four products will receive licensure in the 5EU in 2017, 2021, 2021, and 2023, respectively.
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Scope
- Overview of HBV including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on the key drugs in 5EU including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in 5EU from 2014-2024.
- Analysis of the impact of key events as well the drivers and restraints affecting 5EU HBV market.
Reasons to buy
- Understand and capitalize by identifying products that are most likely to ensure a robust return
- Stay ahead of the competition by understanding the changing competitive landscape for HBV.
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
- Make more informed business decisions from insightful and in-depth analysis of drug performance
- Obtain sales forecast for drugs from 2014-2024 in 5EU.
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1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Catalyst
2.2 Related Reports
2.3 Upcoming Related Reports
3 Disease Overview
3.1 Overview
3.2 Etiology and Pathophysiology
3.2.1 Etiology
3.2.2 Pathophysiology
3.3 Symptoms
3.4 Prognosis
3.4.1 Phases of Chronic HBV Infection
3.4.2 Complications of Chronic Hepatitis B
3.5 Quality of Life
4 Disease Management
4.1 Diagnosis and Treatment Overview
4.1.1 Diagnosis
4.1.2 Treatment Guidelines and Leading Prescribed Drugs
4.1.3 Clinical Practice
4.2 5EU
4.2.1 Screening and Diagnosis
4.2.2 Clinical Practice
5 Competitive Assessment
5.1 Overview
5.2 Product Profiles - Major Brands
5.2.1 Baraclude (entecavir)
5.2.2 Viread (tenofovir disoproxil fumarate)
5.2.3 Pegasys (peginterferon alfa-2a)
5.2.4 Hepsera (adefovir dipivoxil)
5.2.5 Tyzeka (telbivudine)
5.3 Other Therapeutics
5.3.1 Conventional and Pegylated Interferon alfa
5.3.2 Nucleos(t)ide Analogs
6 Unmet Need and Opportunity
6.1 Overview
6.2 Improvements in Long-Term Clinical Outcomes
6.2.1 Unmet Need
6.2.2 Gap Analysis
6.2.3 Opportunity
6.3 Enhanced Public Awareness and Screening Initiatives to Boost Diagnosis Rates
6.3.1 Unmet Need
6.3.2 Gap Analysis
6.3.3 Opportunity
6.4 Increased Access to Treatment
6.4.1 Unmet Need
6.4.2 Gap Analysis
6.4.3 Opportunity
6.5 Drugs That Effectively Target and Suppress HBV cccDNA
6.5.1 Unmet Need
6.5.2 Gap Analysis
6.5.3 Opportunity
6.6 Safe and Efficacious Therapies for Difficult-to-Treat Patients
6.6.1 Unmet Need
6.6.2 Gap Analysis
6.6.3 Opportunity
6.7 Overcome Unique Barriers Posed by China’s Healthcare System
6.7.1 Unmet Need
6.7.2 Gap Analysis
6.7.3 Opportunity
7 Pipeline Assessment
7.1 Overview
7.2 Clinical Trial Mapping
7.2.1 Clinical Trials by Phase and Status, Therapy Class, and Location
7.3 Promising Drugs in Clinical Development
7.3.1 Tenofovir Alafenamide Fumarate
7.3.2 ARC-520
7.3.3 GS-9620
7.3.4 GS-4774
7.4 Other Drugs in Development
7.4.1 ABX-203
7.4.2 REP 2139-Ca
7.4.3 Besifovir
7.4.4 Hepabulin
7.4.5 Myrcludex-B
7.4.6 Agents in Early Stages of Development
8 Market Outlook
8.1 5EU
8.1.1 Forecast
8.1.2 Key Events
8.1.3 Drivers and Barriers
9 Appendix
9.1 Bibliography
9.2 Abbreviations
9.3 Methodology
9.4 Forecasting Methodology
9.4.1 Total Prevalent Cases of Chronic Hepatitis B
9.4.2 Diagnosed Chronic Hepatitis B Patients
9.4.3 Percent Drug-Treated Chronic Hepatitis B Patients
9.4.4 Drugs Included in Each Therapeutic Class
9.4.5 Launch and Patent Expiry Dates
9.4.6 General Pricing Assumptions
9.4.7 Individual Drug Assumptions
9.4.8 Generic Erosion
9.4.9 Pricing of Pipeline Agents
9.5 Primary Research - KOLs Interviewed for this Report
9.6 Primary Research - Prescriber Survey
9.7 About the Authors
9.7.1 Analyst
9.7.2 Therapy Area Director
9.7.3 Epidemiologists
9.7.4 Global Director of Therapy Analysis and Epidemiology
9.7.5 Global Head of Healthcare
9.8 About GlobalData
9.9 Disclaimer
1.1 List of Tables
Table 1: Modes of HBV Transmission
Table 2: HBV Serological Markers and Test Interpretations
Table 3: Symptoms of HBV Infection
Table 4: Phases of Chronic Hepatitis B Infection
Table 5: Key Complications of Chronic HBV infection
Table 6: Treatment Guidelines for Chronic Hepatitis B
Table 7: Most Prescribed Drugs for Chronic Hepatitis B by Class in the 8MM, 2014
Table 8: Country Profile - 5EU
Table 9: Leading Treatments for Chronic Hepatitis B, 2015
Table 10: Product Profile - Baraclude
Table 11: Antiviral Efficacy of Baraclude Compared with Epivir-HBV
Table 12: Antiviral Efficacy of Baraclude in Epivir-HBV-Refractory Patients
Table 13: Baraclude SWOT Analysis, 2015
Table 14: Global Sales Forecasts ($m) for Baraclude, 2014-2024
Table 15: Product Profile - Viread
Table 16: Antiviral Efficacy of Viread Compared with Hepsera
Table 17: Viread SWOT Analysis, 2015
Table 18: Global Sales Forecasts ($m) for Viread, 2014-2024
Table 19: Product Profile - Pegasys
Table 20: Antiviral Efficacy of Pegasys Monotherapy Compared with Epivir-HBV Monotherapy or the Combination of the Two
Table 21: Pegasys SWOT Analysis, 2015
Table 22: Global Sales Forecasts ($m) for Pegasys, 2014-2024
Table 23: Product Profile - Hepsera
Table 24: Antiviral Efficacy of Hepsera in HBeAg-positive patients
Table 25: Long-term Antiviral Efficacy of Hepsera in HBeAg-negative patients
Table 26: Hepsera SWOT Analysis, 2015
Table 27: Global Sales Forecasts ($m) for Hepsera, 2014-2024
Table 28: Product Profile - Tyzeka
Table 29: Antiviral Efficacy of Tyzeka Compared with Epivir-HBV
Table 30: Tyzeka SWOT Analysis, 2015
Table 31: Global Sales Forecasts ($m) for Tyzeka, 2014-2024
Table 32: Summary of Minor Therapeutics for Chronic HBV Infection, 2015
Table 33: Unmet Needs and Opportunities in Chronic HBV Infection
Table 34: HBV - Clinical Trials by Phase and Status, 2015
Table 35: Key Late-Stage Pipeline Agents for Chronic Hepatitis B Treatment, 2015
Table 36: Product Profile - TAF
Table 37: TAF SWOT Analysis, 2015
Table 38: Global Sales Forecasts ($m) for TAF, 2014-2024
Table 39: Product Profile - ARC-520
Table 40: Safety of ARC-520 from a Phase I Clinical Trial
Table 41: ARC-520 SWOT Analysis, 2015
Table 42: Global Sales Forecasts ($m) for ARC-520, 2014-2024
Table 43: Product Profile - GS-9620
Table 44: GS-9620 SWOT Analysis, 2015
Table 45: Global Sales Forecasts ($m) for GS-9620, 2014-2024
Table 46: Product Profile - GS-4774
Table 47: Phase I Clinical Trial Efficacy Results of GS-4774 in Healthy Participants
Table 48: Phase I Clinical Trial Safety Results of GS-4774 in Healthy Participants
Table 49: GS-4774 SWOT Analysis, 2015
Table 50: Global Sales Forecasts ($m) for GS-4774, 2014-2024
Table 51: Other Agents in Clinical Development for Chronic Hepatitis B Treatment, 2015
Table 52: Agents in Phase I or early Phase II Clinical Development for Chronic Hepatitis B Treatment, 2015
Table 53: Agents in Preclinical Development for Chronic Hepatitis B Treatment, 2015
Table 54: Sales Forecasts ($m) for Chronic Hepatitis B Therapeutics in the 5EU, 2014-2024
Table 55: Key Events Impacting Sales for Chronic Hepatitis B Therapeutics in the 5EU, 2014-2024
Table 56: Chronic Hepatitis B Therapeutics Market - Drivers and Barriers in the 5EU, 2014
Table 57: National Healthcare Authorities and Governmental Drug Pricing Authorities in the 5EU
Table 58: Key Historical and Projected Launch Dates
Table 59: Key Historical and Projected Patent Expiry Dates
Table 60: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country
1.2 List of Figures
Figure 1: Key Steps in HBV Replication and Potential Therapeutic Targets
Figure 2: HBV Structure
Figure 3: Prognosis of Chronic HBV infection
Figure 4: Treatment Algorithm for Chronic HBV Infection in Non-cirrhotic, HBeAg-Positive Patients
Figure 5: Treatment Algorithm for Chronic HBV Infection in Non-cirrhotic, HBeAg-Negative Patients
Figure 6: Chronic hepatitis B Therapeutics - Therapy Class and Trial Location, 2014
Figure 7: HBV Phase II/Phase III Pipeline, 2014
Figure 8: Competitive Assessment of Late-Stage Pipeline Agents for Chronic Hepatitis B, 2015
Figure 9: Clinical and Commercial Positioning of TAF
Figure 10: Clinical and Commercial Positioning of ARC-520
Figure 11: Clinical and Commercial Positioning of GS-9620
Figure 12: Clinical and Commercial Positioning of GS-4774
Figure 13: Sales for Chronic Hepatitis B Therapeutics in the 5EU by Therapy Class, 2014-2024
