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.

Recombivax HB [Hepatitis B Vaccine (Recombinant)] is Merck’s monovalent vaccine that protects children, adolescents, and adults against acute and chronic infections caused by all identified strains of HBV. Merck’s vaccine was the first recombinant vaccine for HBV to be widely commercialized. Upon its approval and launch in the US in 1986, Recombivax HB began to replace the first-generation, human plasma-derived HBV vaccines as the preferred treatment option for active immunization against acute and chronic HBV infection (CDC, 2012a; FDA, 1987).

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 Recombivax HB including product description, safety and efficacy profiles as well as a SWOT analysis.
• Sales forecast for Recombivax HB 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 Recombivax HB performance
• Obtain sales forecast for Recombivax HB 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 6
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 Recombivax HB 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 50
7.3 Methodology 53
7.4 Forecasting Methodology 53
7.4.1 Patient Populations Targeted for Vaccination 54
7.4.2 Vaccination Coverage Rates 57
7.4.3 Vaccinated Patients 58
7.4.4 Regulatory Approval vs. Advisory Committee Recommendation 58
7.4.5 General Pricing Assumptions 59
7.4.6 Individual Vaccine Assumptions 60
7.5 Physicians and Specialists Included in this Study 62
7.5.1 Interviews of Key Opinion Leaders (KOLs) 62
7.5.2 Online Survey of High-Prescribing Physicians (non-KOLs) 64
7.6 About the Authors 65
7.6.1 Analyst 65
7.6.2 Therapy Area Director 65
7.6.3 Global Head of Healthcare 66
7.7 About GlobalData 67
7.8 Disclaimer 67

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 - Recombivax HB 30
Table 9: Immunogenicity Profile - Recombivax HB 31
Table 10: Safety Profile - Recombivax HB 32
Table 11: Recombivax HB SWOT Analysis, 2014 33
Table 12: Global Sales Forecasts ($m) for Recombivax HB, 2012-2022 34
Table 13: Patient Population(s) Targeted for HBV Vaccination in the Pediatric Market, by Country 55
Table 14: Patient Population(s) Targeted for HBV Vaccination in the Adult Market, by Country 56
Table 15: High-Prescribing Physicians (non-KOLs) Surveyed, by Country 64

List of Figures

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