Hepatitis B Virus Infection - Global Drug Forecast and Market Analysis to 2029

Chronic hepatitis B (CHB) is a serious liver disease caused by the failure of viral clearance following acute hepatitis B virus (HBV) infection. The global disease burden is high in the nine major markets (9MM: US, France, Germany, Italy, Spain, UK, Japan, Brazil, and China); it is especially high in China. For most patients, CHB is a lifelong disease that cannot be cured, with only a very small number of patients entering remission each year. Patients with CHB have a 20% risk of developing life-threatening liver disease, such as cirrhosis and hepatocellular carcinoma (HCC) as a result of their condition. Guidelines by the American Association of the Study of Liver Diseases (AASLD) and the European Association for the Study of Liver (EASL) have recommended CHB to be treated with nucleotide analogs (NA).

Gilead Sciences and Bristol Myers Squibb (BMS) are the major players within the CHB market with their nucleotide analogs Viread (TDF, Gilead), Vemlidy (TAF, Gilead) and Baraclude (entecavir, BMS). However, generic versions of TDF and entecavir dominate the 9MM. The CHB treatment pipeline is predominantly in early stages. Gilead’s TLR-8 agonist selgantolimod, J&J’s capsid assembly modulator JNJ-6379, and antisense nucleotide JNJ-3898 could significantly impact the CHB market across the 9MM. Also Replicor, Assembly Biosciences, and Ionis Pharmaceuticals are developing CHB therapies. A major unmet for CHB treatment remains the potential to achieve functional cure.

Key Highlights

During the 10-year forecast period, there are six major pipeline products that are on track to launch, driving a forecast growth in the 9MM from $3.8B in 2019 to $5.2B in 2029, which represents a CAGR of 3.1%.
To combat the unmet need of a functional cure, companies such as Gilead, J&J, Replicor, Ionis, and Assembly Biosciences are developing pipeline products with novel mechanism of action, with the potential of being used as a combination therapy either with current nucleotide analogs or with emerging products.
The pipeline products are expected to launch in the second half of the forecast period in 2029. Antisense nucleotides are expected to gain a market share of 14.7% and sales of $761M in the 9MM by 2029. However, capsid assembly modulators from J&J and a toll-like receptor 8 agonist from Gilead are expected to compete with antisense nucleotides for market shares in the 9MM by the end of the forecast period.

Key Questions Answered

How will the CHB market landscape in the 9MM (US, France, Germany, Italy, Spain, UK, Japan, Brazil, China) change from 2019-2029?
What are the most promising late-stage pipeline products for CHB treatment?
How do the clinical and commercial attributes of late-stage pipeline products compare with one another, and against existing CHB treatment options?
What are the remaining unmet needs in CHB treatment?
What drivers and barriers will affect CHB treatment sales in the 9MM over the forecast period?

Scope

Overview of CHB, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.
Topline CHB treatment market revenue from 2019-2029. Annual cost of therapy and major pipeline product sales in this forecast period are included.
Key topics covered include current CHB treatment, unmet needs and opportunities, and the drivers and barriers affecting CHB treatment sales in the 9MM.
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 CHB treatment market. Insightful review of the key industry drivers, constraints, 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 Hepatitis B Virus Infection market.
Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the Hepatitis B Virus Infection 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.

1 Chronic Hepatitis B: Executive Summary

1.1 Chronic Hepatitis B Treatment to Experience Modest Market Growth over the Forecast Period from 2019-2029
1.2 Hepatitis B Therapies with Novel MOAs Will Supplement Existing NA Treatment
1.3 Pipeline Therapies with Novel MOAs Are Aiming to Increase CHB Cure Rates
1.4 Current CHB Treatment Pipeline Includes Agents with Novel MOAs
1.5 What Do Physicians Think?

2 Introduction

2.1 Catalyst
2.2 Related Reports
2.3 Upcoming Reports

3 Disease Overview

3.1 Etiology and Pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology

4 Epidemiology

4.1 Disease Background
4.2 Risk Factors and Comorbidities
4.3 Global and Historical Trends
4.4 Forecast Methodology
4.4.1 Sources
4.4.2 Forecast Assumptions and Methods
4.5 Epidemiological Forecast for CHB (2019-2029)
4.5.1 Diagnosed Prevalent Cases of CHB
4.5.2 Age-Specific Diagnosed Prevalent Cases of CHB
4.5.3 Sex-Specific Diagnosed Prevalent Cases of CHB
4.5.4 Diagnosed Prevalent Cases of CHB by HBeAg Status
4.5.5 Diagnosed Prevalent Cases of CHB by HBV DNA Level
4.5.6 Diagnosed Prevalent Cases of CHB by ALT Level
4.5.7 Diagnosed Prevalent Cases of CHB by Type of Liver Cirrhosis
4.6 Discussion
4.6.1 Epidemiological Forecast Insight
4.6.2 COVID-19 Impacts
4.6.3 Limitations of Analysis
4.6.4 Strengths of Analysis

5 Disease Management

5.1 Diagnosis and Treatment Overview
5.1.1 Treatment Guidelines and Leading Prescribed Drugs
5.1.2 Clinical Practice
5.2 KOL Insights on Disease Management

6 Competitive Assessment

6.1 Overview

7 Unmet Needs and Opportunity Assessment

7.1 Overview
7.2 The Need for a Functional Cure
7.3 Reduction in Drug Administration
7.4 Reduction in Treatment Time Frame
7.5 Discovery of Biomarkers
7.6 Improve Access to Diagnostics

8 R&D Strategies

8.1 Overview
8.1.1 R&D Strategy 1 - Mechanism of Action
8.1.2 R&D Strategy 2 - Combination Therapy
8.1.3 R&D Strategy 3 - Company Partnerships
8.2 Clinical Trials Design
8.2.1 Clinical Trials Design - Primary Endpoints
8.2.2 Clinical Trials Design - Combination Therapies
8.2.3 Clinical Trials Design - Focused on Phase II

9 Pipeline Assessment

9.1 Overview
9.2 Promising Drugs in Clinical Development

10 Pipeline Valuation Analysis

10.1 Overview
10.2 Competitive Assessment

11 Current and Future Players

11.1 Overview
11.2 Trends in Corporate Strategy
11.3 Deal-Making Trends

12 Market Outlook

12.1 Global Markets
12.1.1 Forecast
12.1.2 Drivers and Barriers - Global Issues
12.2 US
12.2.1 Forecast
12.2.2 Key Events
12.2.3 Drivers and Barriers
12.3 5EU
12.3.1 Forecast
12.3.2 Key Events
12.3.3 Drivers and Barriers
12.4 Japan
12.4.1 Forecast
12.4.2 Key Events
12.4.3 Drivers and Barriers
12.5 Brazil
12.5.1 Forecast
12.5.2 Key Events
12.5.3 Drivers and Barriers
12.6 China
12.6.1 Forecast
12.6.2 Key Events
12.6.3 Drivers and Barriers

13 Appendix

List of Tables

Table 1: Key Metrics for CHB in the 9MM
Table 2: Phases of CHB Infection
Table 3: Risk Factors and Comorbidities for Chronic Hepatitis B
Table 4: Treatment Guidelines for CHB
Table 5: Country Profile - US
Table 6: Country Profile - 5EU
Table 7: Country Profile - Japan
Table 8: Country Profile - Brazil
Table 9: Country Profile - China
Table 10: Chronic Hepatitis B Market - Global Drivers and Barriers, 2019-2029
Table 11: Key Events Impacting Sales for Chronic Hepatitis B Treatment in the US, 2019-2029
Table 12: Chronic Hepatitis B Market - Drivers and Barriers in the US, 2019-2029
Table 13: Key Events Impacting Sales for Chronic Hepatitis B Treatment in the 5EU, 2019-2029
Table 14: Chronic Hepatitis B Market - Drivers and Barriers in the 5EU, 2019-2029
Table 15: Key Events Impacting Sales for Chronic Hepatitis B Treatment in Japan, 2019-2029
Table 16: Chronic Hepatitis B Market - Drivers and Barriers in Japan, 2019-2029
Table 17: Key Events Impacting Sales for Chronic Hepatitis B Treatment in Brazil, 2019-2029
Table 18: Chronic Hepatitis B Market - Drivers and Barriers in Brazil, 2019-2029
Table 19: Key Events Impacting Sales for Chronic Hepatitis B Treatment in China, 2019-2029
Table 20: Chronic Hepatitis B Market - Drivers and Barriers in China, 2019-2029
Table 21: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Global Sales Forecast by Country for CHB in 2019 and 2029
Figure 2: Analysis of the Company Portfolio Gap in CHB During the Forecast Period
Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to Be Licensed for the Treatment of CHB During the Forecast Period
Figure 4: Hepatitis B Virus Structure
Figure 5: Key Steps in HBV Replication and Potential Therapeutic Targets
Figure 6: 9MM, Diagnosed Prevalence of CHB (%), Both Sexes, All Ages, 2009-2019.
Figure 7: 9MM, Sources Used and Not Used for Diagnosed Prevalence of CHB (%)
Figure 8: 9MM, Sources Used for Diagnosed Prevalent Cases of CHB by HBeAg Status (N)
Figure 9: 9MM, Sources Used and Not Used for Diagnosed Prevalent Cases of CHB by HBV DNA Level (N)
Figure 10: 9MM, Sources Used for Diagnosed Prevalent Cases of CHB by ALT Level (N)
Figure 11: 9MM, Sources Used for Diagnosed Prevalent Cases of CHB by Type of Liver Cirrhosis (N)
Figure 12: 9MM, Diagnosed Prevalent Cases of CHB, Men and Women, All Ages, N, 2019
Figure 13: 9MM, Age-Specific Diagnosed Prevalent Cases of CHB, 9MM, Men and Women, All Ages, N, 2019
Figure 14: 9MM, Sex-Specific Diagnosed Prevalent Cases of CHB, All Ages, N, 2019
Figure 15: 9MM, Diagnosed Prevalent Cases of CHB by HBeAg Status, Men and Women, All Ages, N, 2019
Figure 16: 9MM, Diagnosed Prevalent Cases of CHB by HBV DNA Level, Men and Women, All Ages, N, 2019
Figure 17: 9MM, Diagnosed Prevalent Cases of CHB by ALT Level, Men and Women, All Ages, N, 2019
Figure 18: 9MM, Diagnosed Prevalent Cases of CHB by Type of Liver Cirrhosis, Men and Women, All Ages, N, 2019
Figure 19: Unmet Needs and Opportunities in CHB
Figure 20: Overview of the Development Pipeline in Chronic Hepatitis B
Figure 21: Key Late-Stage Trials for the Promising Pipeline Agents that GlobalData Expects be Licensed for CHB in the 9MM During the Forecast Period
Figure 22: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of CHB During the Forecast Period
Figure 23: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the Standard of Care (SOC), entecavir, TDF, and TAF
Figure 24: Analysis of the Company Portfolio Gap in CHB During the Forecast Period
Figure 25: Global (9MM) Sales Forecast by Country for Chronic Hepatitis B in 2019 and 2029
Figure 26: Sales Forecast by Class for Chronic Hepatitis B in the US in 2019 and 2029
Figure 27: Sales Forecast by Class for Chronic Hepatitis B in the 5EU in 2019 and 2029
Figure 28: Sales Forecast by Class for Chronic Hepatitis B in Japan in 2019 and 2029
Figure 29: Sales Forecast by Class for Chronic Hepatitis B in Brazil in 2019 and 2029
Figure 30: Sales Forecast by Class for Chronic Hepatitis B in China in 2019 and 2029

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

Gilead Sciences
Johnson & Johnson
Assembly Biosciences
Ionis Pharmaceuticals/GlaxoSmithKline
Replicor
HEC Pharma
Ligand Pharmaceuticals
Jiangsu Hansoh Pharmaceutical Group
Bristol-Myers Squibb Co
GlaxoSmithKline
Merck & Co
F. Hoffmann-La Roche

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Table of Contents

Companies Mentioned (Partial List)

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