Hepatitis B, which is caused by the hepatitis B virus (HBV), is characterized by acute or chronic inflammation of the liver. Researchers and healthcare experts have estimated that roughly two billion people are infected with HBV worldwide, with roughly 600,000 people dying each year from HBV-related liver diseases. While the arrival of recombinant HBsAg vaccines has greatly reduced disease burden over the past two decades, questions surrounding vaccine uptake and effectiveness in adults, particularly in niche patient populations, still remain. GlobalData expects that the growing popularity of pediatric combination vaccines, along with the arrival of vaccines that achieve higher seroconversion rates in high-risk adults, will serve to stimulate growth in the marketplace over the forecast period. Country-specific immunization recommendations and policy implementation will be an essential metric for determining future vaccine uptake in the 7MM (US, France, Germany, Italy, Spain, UK, and Japan) and Canada.

Heplisav [Hepatitis B vaccine, 1018 ISS immunostimulatory oligonucleotide with HBsAg (HBsAg-1018)] is Dynavax Technologies’ adjuvanted pipeline vaccine candidate that guards adults against acute and chronic infections caused by all known strains of HBV, with a particular emphasis on protecting adults that have failed to achieve seroconversion from the currently licensed HBV vaccines. With Heplisav, Dynavax hopes to address a key clinical unmet need in the treatment landscape while simultaneously improving HBV vaccination coverage in adults.

Scope

• Overview of Hepatitis B disease, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
• Detailed information on Heplisav including product description, safety and efficacy profiles as well as a SWOT analysis.
• Sales forecast for Heplisav for top eight countries from 2012 to 2022.
• Sales information covered for the US, France, Germany, Italy, Spain, UK, Japan and Canada.

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 Hepatitis B
• 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 Heplisav performance
• Obtain sales forecast for Heplisav from 2012-2022 in the top eight countries (the US, France, Germany, Italy, Spain, UK, Japan and Canada).

Table of Contents

1 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 8

2 Introduction 9
2.1 Catalyst 9
2.2 Related Reports 10
2.3 Upcoming Related Reports 12

3 Disease Overview 13
3.1 Overview 13
3.2 Etiology and Pathophysiology 14
3.2.1 Etiology 14
3.2.2 Pathophysiology 17
3.3 Symptoms 19
3.4 Prognosis 21

4 Vaccination Recommendations and Coverage Rates 22
4.1 Overview 22

5 Competitive Assessment 26
5.1 Overview 26
5.2 Strategic Competitor Assessment 26

6 Opportunity and Unmet Need 29
6.1 Overview 29
6.2 Increased Vaccine Immunogenicity 31
6.2.1 Unmet Need 31
6.2.2 Gap Analysis 33
6.2.3 Opportunity 34
6.3 Increased Vaccination Coverage Rates 34
6.3.1 Unmet Need 34
6.3.2 Gap Analysis 36
6.3.3 Opportunity 36
6.4 Increased Patient Awareness 37
6.4.1 Unmet Need 37
6.4.2 Gap Analysis 38
6.4.3 Opportunity 38
6.5 Improved Physician Education 39
6.5.1 Unmet Need 39
6.5.2 Gap Analysis 40
6.5.3 Opportunity 41
6.6 More Cost-Effective Vaccines 42
6.6.1 Unmet Need 42
6.6.2 Gap Analysis 42
6.6.3 Opportunity 43

7 Pipeline Assessment 44
7.1 Overview 44

8 Heplisav 45
8.1 Overview 45
8.2 Immunogenicity 47
8.3 Safety 49
8.4 Dosing and Formulation 50
8.5 Potential Clinical Positioning 51
8.6 Potential Commercial Positioning 52
8.7 Pricing and Reimbursement 52
8.8 SWOT Analysis 54
8.9 Forecast 55

9 Appendix 57
9.1 Bibliography 57
9.2 Abbreviations 73
9.3 Methodology 77
9.4 Forecasting Methodology 77
9.4.1 Patient Populations Targeted for Vaccination 78
9.4.2 Vaccination Coverage Rates 81
9.4.3 Vaccinated Patients 82
9.4.4 Regulatory Approval vs. Advisory Committee Recommendation 82
9.4.5 Vaccines Included 83
9.4.6 General Pricing Assumptions 83
9.4.7 Pricing of Pipeline Vaccines 84
9.5 Physicians and Specialists Included in this Study 85
9.5.1 Interviews of Key Opinion Leaders (KOLs) 85
9.5.2 Online Survey of High-Prescribing Physicians (non-KOLs) 87
9.6 About the Authors 88
9.6.1 Analyst 88
9.6.2 Therapy Area Director 88
9.6.3 Global Head of Healthcare 89
9.7 About GlobalData 90
9.8 Disclaimer 90

List of Tables

Table 1: Modes of HBV Transmission 18
Table 2: HBV Serological Markers and Test Interpretations 19
Table 3: Symptoms of HBV Infection 20
Table 4: HBV Vaccination Advisory Committees by Country 23
Table 5: HBV Immunization Recommendations by Country 24
Table 6: Targeted Age Group(s) for Routine Immunization and Most Administered HBV Vaccines by Country in the Global Markets, 2014 25
Table 7: Leading Vaccines for HBV, 2014 28
Table 8: Unmet Need and Opportunity in Prophylactic HBV Vaccines 31
Table 9: Product Profile - Heplisav 47
Table 10: Immunogenicity Profile - Heplisav 48
Table 11: Safety Profile - Heplisav 50
Table 12: Heplisav SWOT Analysis, 2014 54
Table 13: Global Sales Forecasts ($m) for Heplisav, 2012-2022 56
Table 14: Patient Population(s) Targeted for HBV Vaccination in the Pediatric Market, by Country 79
Table 15: Patient Population(s) Targeted for HBV Vaccination in the Adult Market, by Country 80
Table 16: High-Prescribing Physicians (non-KOLs) Surveyed, by Country 87

List of Figures

Figure 1: HBV Structure and the Recombinant Vaccine Development Process 15