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.

Engerix-B [Hepatitis B Vaccine (Recombinant)] is GSK’s monovalent vaccine that protects children, adolescents, and adults against acute and chronic infections caused by all known strains of HBV. Following the 1986 debut of Merck’s hepatitis B offering, Recombivax HB, Engerix-B was the second recombinant HBV vaccine to receive FDA approval. Engerix-B also received market authorization in Canada in 1991 and the 5EU in 2000. It is marketed under the names Engerix-B Kinder/Engerix-B Erwachsene in Germany.

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 Engerix-B including product description, safety and efficacy profiles as well as a SWOT analysis.
• Sales forecast for Engerix-B for top seven countries from 2012 to 2022.
• Sales information covered for the US, Canada, France, Germany, Italy, Spain and the UK

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

Table of Contents

1 Table of Contents 6
1.1 List of Tables 7
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 Engerix-B 29
6.1 Overview 29
6.2 Immunogenicity 31
6.3 Safety 32
6.4 SWOT Analysis 33
6.5 Forecast 34

7 Appendix 35
7.1 Bibliography 35
7.2 Abbreviations 49
7.3 Methodology 52
7.4 Forecasting Methodology 52
7.4.1 Patient Populations Targeted for Vaccination 53
7.4.2 Vaccination Coverage Rates 56
7.4.3 Vaccinated Patients 57
7.4.4 Regulatory Approval vs. Advisory Committee Recommendation 57
7.4.5 General Pricing Assumptions 58
7.4.6 Individual Vaccine Assumptions 59
7.5 Physicians and Specialists Included in this Study 61
7.5.1 Interviews of Key Opinion Leaders (KOLs) 61
7.5.2 Online Survey of High-Prescribing Physicians (non-KOLs) 63
7.6 About the Authors 64
7.6.1 Analyst 64
7.6.2 Therapy Area Director 64
7.6.3 Global Head of Healthcare 65
7.7 About GlobalData 66
7.8 Disclaimer 66

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: Product Profile - Engerix-B 30
Table 9: Immunogenicity Profile - Engerix-B 31
Table 10: Safety Profile - Engerix-B 32
Table 11: Engerix-B SWOT Analysis, 2014 33
Table 12: Global Sales Forecasts ($m) for Engerix-B, 2012-2022 34
Table 13: Patient Population(s) Targeted for HBV Vaccination in the Pediatric Market, by Country 54
Table 14: Patient Population(s) Targeted for HBV Vaccination in the Adult Market, by Country 55
Table 15: High-Prescribing Physicians (non-KOLs) Surveyed, by Country 63

List of Figures

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