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

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).

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?

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.

Key Highlights

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.

Companies mentioned

Gilead Science

GlaxoSmithKline

Bristol-Myers Squibb

Novartis

F. Hoffmann-La Roche

Merck &Co.

Arrowhead Research

GlobeImmune

Aspen Pharmacare

Enzon Pharmaceuticals

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

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.3Global Trends

4.4Forecast Methodology

4.4.1Sources Used

4.4.2Sources Not Used

4.4.3Forecast Assumptions and Methods

4.5Epidemiological Forecast of Chronic Hepatitis B (2014–2024)

4.5.1Diagnosed Prevalent Cases of Chronic Hepatitis B

4.5.2Age-Specific Diagnosed Prevalent Cases of Chronic Hepatitis B

4.5.3Sex-Specific Diagnosed Prevalent Cases of Chronic Hepatitis B

4.5.4Age-Standardized Diagnosed Prevalence of Chronic Hepatitis B

4.5.5Diagnosed Prevalent Cases of Chronic Hepatitis B Segmented by HBV DNA Level

4.5.6Diagnosed Prevalent Cases of Chronic Hepatitis B Segmented by ALT Level

4.5.7Diagnosed Prevalent Cases of Chronic Hepatitis B Segmented by HBeAg Status

4.5.8Diagnosed Prevalent Cases of Chronic Hepatitis B Segmented by Cirrhosis Status

4.5.9Diagnosed Prevalent Cases of Chronic Hepatitis B with Co-infection of HIV and Hepatitis C

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

5Disease Management

5.1Diagnosis and Treatment Overview

5.1.1Diagnosis

5.1.2Treatment Guidelines and Leading Prescribed Drugs

5.1.3Clinical Practice

5.2US

5.2.1Screening and Diagnosis

5.2.2Clinical Practice

5.35EU

5.3.1Screening and Diagnosis

5.3.2Clinical Practice

5.4Japan

5.4.1Screening and Diagnosis

5.4.2Clinical Practice

5.5China

5.5.1Screening and Diagnosis

5.5.2Clinical Practice

6Competitive Assessment

6.1Overview

6.2Product Profiles – Major Brands

6.2.1Baraclude (entecavir)

6.2.2Viread (tenofovir disoproxil fumarate)

6.2.3Pegasys (peginterferon alfa-2a)

6.2.4Hepsera (adefovir dipivoxil)

6.2.5Tyzeka (telbivudine)

6.3Other Therapeutics

6.3.1Conventional and Pegylated Interferon alfa

6.3.2Nucleos(t)ide Analogs

7Unmet Needs and Opportunities

7.1Overview

7.2Improvements in Long-Term Clinical Outcomes

7.2.1Unmet Need

7.2.2Gap Analysis

7.2.3Opportunity

7.3Enhanced Public Awareness and Screening Initiatives to Boost Diagnosis Rates

7.3.1Unmet Need

7.3.2Gap Analysis

7.3.3Opportunity

7.4Increased Access to Treatment

7.4.1Unmet Need

7.4.2Gap Analysis

7.4.3Opportunity

7.5Drugs That Effectively Target and Suppress HBV cccDNA

7.5.1Unmet Need

7.5.2Gap Analysis

7.5.3Opportunity

7.6Safe and Efficacious Therapies for Difficult-to-Treat Patients

7.6.1Unmet Need

7.6.2Gap Analysis

7.6.3Opportunity

7.7Overcome Unique Barriers Posed by China’s Healthcare System

7.7.1Unmet Need

7.7.2Gap Analysis

7.7.3Opportunity

8Pipeline Assessment

8.1Overview

8.2Clinical Trial Mapping

8.2.1Clinical Trials by Phase and Status, Therapy Class, and Location

8.3Promising Drugs in Clinical Development

8.3.1Tenofovir Alafenamide Fumarate

8.3.2ARC-520

8.3.3GS-9620

8.3.4GS-4774

8.4Other Drugs in Development

8.4.1ABX-203

8.4.2REP 2139-Ca

8.4.3Besifovir

8.4.4Hepabulin

8.4.5Myrcludex-B

8.4.6Agents in Early Stages of Development

9Current and Future Players

9.1Overview

9.2Trends in Corporate Strategy

9.3Company Profiles

9.3.1Gilead

9.3.2Bristol-Myers Squibb

9.3.3Roche

9.3.4Merck

9.3.5GSK

9.3.6Novartis

9.3.7Arrowhead Research

9.3.8GlobeImmune

10Market Outlook

10.1Global Markets

10.1.1Forecast

10.1.2Drivers and Barriers – Global Issues

10.2US

10.2.1Forecast

10.2.2Key Events

10.2.3Drivers and Barriers

10.35EU

10.3.1Forecast

10.3.2Key Events

10.3.3Drivers and Barriers

10.4Japan

10.4.1Forecast

10.4.2Key Events

10.4.3Drivers and Barriers

10.5China

10.5.1Forecast

10.5.2Key Events

10.5.3Drivers and Barriers

11Appendix

11.1Bibliography

11.2Abbreviations

11.3Methodology

11.4Forecasting Methodology

11.4.1Total Prevalent Cases of Chronic Hepatitis B

11.4.2Diagnosed Chronic Hepatitis B Patients

11.4.3Percent Drug-Treated Chronic Hepatitis B Patients

11.4.4Drugs Included in Each Therapeutic Class

11.4.5Launch and Patent Expiry Dates

11.4.6General Pricing Assumptions

11.4.7Individual Drug Assumptions

11.4.8Generic Erosion

11.4.9Pricing of Pipeline Agents

11.5Primary Research – KOLs Interviewed for this Report

11.6Primary Research – Prescriber Survey

11.7About the Authors

11.7.1Analyst

11.7.2Therapy Area Director

11.7.3Epidemiologists

11.7.4Global Director of Therapy Analysis and Epidemiology

11.7.5Global Head of Healthcare

11.8About GlobalData

11.9Disclaimer

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: Risk Factors and Comorbidities for Chronic Hepatitis B

Table 7: 8MM, Sources Used for the Diagnosed Prevalent Cases Forecast of Chronic Hepatitis B

Table 8: 8MM, Sources Used for HBV DNA Level

Table 9: 8MM, Sources Used for Chronic Hepatitis B by ALT Level

Table 10: 8MM, Sources Used for Chronic Hepatitis B HBeAg Status

Table 11: 8MM, Sources Used for Cirrhosis Status

Table 12: 8MM, Sources Used for HIV Co-infection

Table 13: 8MM, Sources Used for Hepatitis C Co-infection

Table 14: 8MM, Diagnosed Prevalent Cases of Chronic Hepatitis B, Both Sexes, All Ages, Select Years, 2014–2024

Table 15: 8MM, Age-Specific Diagnosed Prevalent Cases of Chronic Hepatitis B, Ages =18 Years, N (Row %), 2014

Table 16: 8MM, Sex-Specific Diagnosed Prevalent Cases of Chronic Hepatitis B, Ages =18 Years, N, 2014

Table 17: US and 5EU, Diagnosed Prevalent Cases of Chronic Hepatitis B Segmented by HBV DNA, Ages =18 Years, N, Both Sexes, 2014

Table 18: Japan and China, Diagnosed Prevalent Cases of Chronic Hepatitis B Segmented by HBV DNA, Ages =18 Years, N, Both Sexes, 2014

Table 19: 8MM, Diagnosed Prevalent Cases of Chronic Hepatitis B Segmented by ALT Level, Ages =18 Years, N, Both Sexes, 2014

Table 20: 8MM, Diagnosed Prevalent Cases of Chronic Hepatitis B Segmented by HBeAg Status, Ages =18 Years, N, Both Sexes, 2014

Table 21: 8MM, Diagnosed Prevalent Cases of Chronic Hepatitis B Segmented Cirrhosis Status, Ages =18 Years, N, Both Sexes, 2014

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

Table 23: Treatment Guidelines for Chronic Hepatitis B

Table 24: Most Prescribed Drugs for Chronic Hepatitis B by Class in the 8MM, 2014

Table 25: Country Profile – US

Table 26: Country Profile – 5EU

Table 27: Country Profile – Japan

Table 28: Country Profile – China

Table 29: Leading Treatments for Chronic Hepatitis B, 2015

Table 30: Product Profile – Baraclude

Table 31: Antiviral Efficacy of Baraclude Compared with Epivir-HBV

Table 32: Antiviral Efficacy of Baraclude in Epivir-HBV-Refractory Patients

Table 33: Baraclude SWOT Analysis, 2015

Table 34: Global Sales Forecasts ($m) for Baraclude, 2014–2024

Table 35: Product Profile – Viread

Table 36: Antiviral Efficacy of Viread Compared with Hepsera

Table 37: Viread SWOT Analysis, 2015

Table 38: Global Sales Forecasts ($m) for Viread, 2014–2024

Table 39: Product Profile – Pegasys

Table 40: Antiviral Efficacy of Pegasys Monotherapy Compared with Epivir-HBV Monotherapy or the Combination of the Two

Table 41: Pegasys SWOT Analysis, 2015

Table 42: Global Sales Forecasts ($m) for Pegasys, 2014–2024

Table 43: Product Profile – Hepsera

Table 44: Antiviral Efficacy of Hepsera in HBeAg-positive patients

Table 45: Long-term Antiviral Efficacy of Hepsera in HBeAg-negative patients

Table 46: Hepsera SWOT Analysis, 2015

Table 47: Global Sales Forecasts ($m) for Hepsera, 2014–2024

Table 48: Product Profile – Tyzeka

Table 49: Antiviral Efficacy of Tyzeka Compared with Epivir-HBV

Table 50: Tyzeka SWOT Analysis, 2015

Table 51: Global Sales Forecasts ($m) for Tyzeka, 2014–2024

Table 52: Summary of Minor Therapeutics for Chronic HBV Infection, 2015

Table 53: Unmet Needs and Opportunities in Chronic HBV Infection

Table 54: HBV – Clinical Trials by Phase and Status, 2015

Table 55: Key Late-Stage Pipeline Agents for Chronic Hepatitis B Treatment, 2015

Table 56: Product Profile – TAF

Table 57: TAF SWOT Analysis, 2015

Table 58: Global Sales Forecasts ($m) for TAF, 2014–2024

Table 59: Product Profile – ARC-520

Table 60: Safety of ARC-520 from a Phase I Clinical Trial

Table 61: ARC-520 SWOT Analysis, 2015

Table 62: Global Sales Forecasts ($m) for ARC-520, 2014–2024

Table 63: Product Profile – GS-9620

Table 64: GS-9620 SWOT Analysis, 2015

Table 65: Global Sales Forecasts ($m) for GS-9620, 2014–2024

Table 66: Product Profile – GS-4774

Table 67: Phase I Clinical Trial Efficacy Results of GS-4774 in Healthy Participants

Table 68: Phase I Clinical Trial Safety Results of GS-4774 in Healthy Participants

Table 69: GS-4774 SWOT Analysis, 2015

Table 70: Global Sales Forecasts ($m) for GS-4774, 2014–2024

Table 71: Other Agents in Clinical Development for Chronic Hepatitis B Treatment, 2015

Table 72: Agents in Phase I or early Phase II Clinical Development for Chronic Hepatitis B Treatment, 2015

Table 73: Agents in Preclinical Development for Chronic Hepatitis B Treatment, 2015

Table 74: Key Companies in the Chronic Hepatitis B Therapeutics Market, 8MM, 2015

Table 75: Gilead’s Chronic Hepatitis B Portfolio Assessment, 2015

Table 76: BMS’s Chronic Hepatitis B Portfolio Assessment, 2015

Table 77: Roche’s Chronic Hepatitis B Portfolio Assessment, 2015

Table 78: Merck’s Chronic Hepatitis B Portfolio Assessment, 2015

Table 79: GSK’s Chronic Hepatitis B Portfolio Assessment, 2015

Table 80: Novartis’ Chronic Hepatitis B Portfolio Assessment, 2015

Table 81: Arrowhead’s Chronic Hepatitis B Portfolio Assessment, 2015

Table 82: GlobeImmune’s Chronic Hepatitis B Portfolio Assessment, 2015

Table 83: Global Sales Forecasts ($m) for Chronic Hepatitis B Therapeutics, 2014–2024

Table 84: Chronic Hepatitis B Therapeutics Market – Drivers and Barriers, 2014–2024

Table 85: Sales Forecasts ($m) for Chronic Hepatitis B Therapeutics in the US, 2014–2024

Table 86: Key Events Impacting Sales for Chronic Hepatitis B Therapeutics in the US, 2014–2024

Table 87: Chronic Hepatitis B Therapeutics Market – Drivers and Barriers in the US, 2014–2024

Table 88: Sales Forecasts ($m) for Chronic Hepatitis B Therapeutics in the 5EU, 2014–2024

Table 89: Key Events Impacting Sales for Chronic Hepatitis B Therapeutics in the 5EU, 2014–2024

Table 90: Chronic Hepatitis B Therapeutics Market – Drivers and Barriers in the 5EU, 2014

Table 91: National Healthcare Authorities and Governmental Drug Pricing Authorities in the 5EU

Table 92: Sales Forecasts ($m) for Chronic Hepatitis B Therapeutics in Japan, 2014–2024

Table 93: Key Events Impacting Sales for Chronic Hepatitis B Therapeutics in Japan, 2014–2024

Table 94: Chronic Hepatitis B Therapeutics Market – Drivers and Barriers in Japan, 2014

Table 95: Sales Forecasts ($m) for Chronic Hepatitis B Therapeutics in China, 2014–2024

Table 96: Key Events Impacting Sales for Chronic Hepatitis B Therapeutics in China, 2014-2024

Table 97: Chronic Hepatitis B Therapeutics Market – Drivers and Barriers in China, 2014

Table 98: Key Historical and Projected Launch Dates

Table 99: Key Historical and Projected Patent Expiry Dates

Table 100: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country

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: 8MM, Diagnosed Prevalent Cases of Chronic Hepatitis B, Both Sexes, Ages =18 Years, Select Years, 2014–2024

Figure 5: 8MM, Age-Specific Diagnosed Prevalent Cases of Chronic Hepatitis B, Ages =18 Years, Both Sexes, N, 2014

Figure 6: 8MM, Sex-Specific Diagnosed Prevalent Cases of Chronic Hepatitis B, Ages =18 Years, N, 2014

Figure 7: 8MM, Age-Standardised Diagnosed Prevalence of Chronic Hepatitis B, Ages =18 Years, 2014

Figure 8: Treatment Algorithm for Chronic HBV Infection in Non-cirrhotic, HBeAg-Positive Patients

Figure 9: Treatment Algorithm for Chronic HBV Infection in Non-cirrhotic, HBeAg-Negative Patients

Figure 10: Chronic hepatitis B Therapeutics – Therapy Class and Trial Location, 2014

Figure 11: HBV Phase II/Phase III Pipeline, 2014

Figure 12: Competitive Assessment of Late-Stage Pipeline Agents for Chronic Hepatitis B, 2015

Figure 13: Clinical and Commercial Positioning of TAF

Figure 14: Clinical and Commercial Positioning of ARC-520

Figure 15: Clinical and Commercial Positioning of GS-9620

Figure 16: Clinical and Commercial Positioning of GS-4774

Figure 17: Company Portfolio Gap Analysis in the Chronic Hepatitis B Therapeutic Market, 2014–2024

Figure 18: Sales for Chronic Hepatitis B Therapeutics by Country, 2014–2024

Figure 19: Sales for Chronic Hepatitis B Therapeutics by Therapy Class, 2014–2024

Figure 20: Sales for Chronic Hepatitis B Therapeutics in the US by Therapy Class, 2014–2024

Figure 21: Sales for Chronic Hepatitis B Therapeutics in the 5EU by Therapy Class, 2014–2024

Figure 22: Sales for Chronic Hepatitis B Therapeutics in Japan by Therapy Class, 2014–2024

Figure 23: Sales for Chronic Hepatitis B Therapeutics in China by Therapy Class, 2014–2024

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