Hepatitis B Virus (HBV) Therapeutics – China Drug Forecast and Market Analysis to 2024

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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. In 2014, the Chinese chronic hepatitis B therapeutic market was the largest among the 8MM in terms of total sales. Generic erosion of key brands occurred in China earlier than in the rest of the 8MM, with Baraclude, Hepsera, and Epivir-HBV having faced generic competition for some years. As a consequence, GlobalData estimates that over 30% of the total therapeutics sales in this market arose from generic sales. *This is an on-demand report and will be delivered within 24 hrs. (excluding weekends) of the purchase.

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 China including product description, safety and efficacy profiles as well as a SWOT analysis.

Sales forecast for the top drugs in China from 2014-2024.

Analysis of the impact of key events as well the drivers and restraints affecting China 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 China.

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

2.3Upcoming Related Reports

3Disease Overview

3.1Overview

3.2Etiology and Pathophysiology

3.2.1Etiology

3.2.2Pathophysiology

3.3Symptoms

3.4Prognosis

3.4.1Phases of Chronic HBV Infection

3.4.2Complications of Chronic Hepatitis B

3.5Quality of Life

4Disease Management

4.1Diagnosis and Treatment Overview

4.1.1Diagnosis

4.1.2Treatment Guidelines and Leading Prescribed Drugs

4.1.3Clinical Practice

4.2China

4.2.1Screening and Diagnosis

4.2.2Clinical Practice

5Competitive Assessment

5.1Overview

5.2Product Profiles – Major Brands

5.2.1Baraclude (entecavir)

5.2.2Viread (tenofovir disoproxil fumarate)

5.2.3Pegasys (peginterferon alfa-2a)

5.2.4Hepsera (adefovir dipivoxil)

5.2.5Tyzeka (telbivudine)

5.3Other Therapeutics

5.3.1Conventional and Pegylated Interferon alfa

5.3.2Nucleos(t)ide Analogs

6Unmet Need and Opportunity

6.1Overview

6.2Improvements in Long-Term Clinical Outcomes

6.2.1Unmet Need

6.2.2Gap Analysis

6.2.3Opportunity

6.3Enhanced Public Awareness and Screening Initiatives to Boost Diagnosis Rates

6.3.1Unmet Need

6.3.2Gap Analysis

6.3.3Opportunity

6.4Increased Access to Treatment

6.4.1Unmet Need

6.4.2Gap Analysis

6.4.3Opportunity

6.5Drugs That Effectively Target and Suppress HBV cccDNA

6.5.1Unmet Need

6.5.2Gap Analysis

6.5.3Opportunity

6.6Safe and Efficacious Therapies for Difficult-to-Treat Patients

6.6.1Unmet Need

6.6.2Gap Analysis

6.6.3Opportunity

6.7Overcome Unique Barriers Posed by China’s Healthcare System

6.7.1Unmet Need

6.7.2Gap Analysis

6.7.3Opportunity

7Pipeline Assessment

7.1Overview

7.2Clinical Trial Mapping

7.2.1Clinical Trials by Phase and Status, Therapy Class, and Location

7.3Promising Drugs in Clinical Development

7.3.1Tenofovir Alafenamide Fumarate

7.3.2ARC-520

7.3.3GS-9620

7.3.4GS-4774

7.4Other Drugs in Development

7.4.1ABX-203

7.4.2REP 2139-Ca

7.4.3Besifovir

7.4.4Hepabulin

7.4.5Myrcludex-B

7.4.6Agents in Early Stages of Development

8Market Outlook

8.1China

8.1.1Forecast

8.1.2Key Events

8.1.3Drivers and Barriers

9Appendix

9.1Bibliography

9.2Abbreviations

9.3Methodology

9.4Forecasting Methodology

9.4.1Total Prevalent Cases of Chronic Hepatitis B

9.4.2Diagnosed Chronic Hepatitis B Patients

9.4.3Percent Drug-Treated Chronic Hepatitis B Patients

9.4.4Drugs Included in Each Therapeutic Class

9.4.5Launch and Patent Expiry Dates

9.4.6General Pricing Assumptions

9.4.7Individual Drug Assumptions

9.4.8Generic Erosion

9.4.9Pricing of Pipeline Agents

9.5Primary Research – KOLs Interviewed for this Report

9.6Primary Research – Prescriber Survey

9.7About the Authors

9.7.1Analyst

9.7.2Therapy Area Director

9.7.3Epidemiologists

9.7.4Global Director of Therapy Analysis and Epidemiology

9.7.5Global Head of Healthcare

9.8About GlobalData

9.9Disclaimer

Table

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 – China

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 China, 2014–2024

Table 55: Key Events Impacting Sales for Chronic Hepatitis B Therapeutics in China, 2014-2024

Table 56: Chronic Hepatitis B Therapeutics Market – Drivers and Barriers in China, 2014

Table 57: Key Historical and Projected Launch Dates

Table 58: Key Historical and Projected Patent Expiry Dates

Table 59: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country

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 China by Therapy Class, 2014–2024

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