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.

Comvax [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine] is Merck’s bivalent combination vaccine that offers protection against infections caused by Hib and all known subtypes of HBV. Comvax contains the antigenic components used in Merck’s PedvaxHIB and Recombivax HB vaccines. Upon receiving FDA approval for use in infants six weeks to 15 months of age in 1996, Comvax became the first combination vaccine in the US to protect its recipients against HBV infection. Currently, Comvax is only marketed in the US, as its EU market authorization, under the name Procomvax, was not renewed in 2009.

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 Comvax including product description, safety and efficacy profiles as well as a SWOT analysis.
• Sales forecast for Comvax for the US from 2012 to 2022.
• Sales information covered for the US

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 Comvax performance
• Obtain sales forecast for Comvax from 2012-2022 in the US.

Table of Contents

1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 7

2 Introduction 8
2.1 Catalyst 8
2.2 Related Reports 9
2.3 Upcoming Related Reports 11

3 Disease Overview 12
3.1 Overview 12
3.2 Etiology and Pathophysiology 13
3.2.1 Etiology 13
3.2.2 Pathophysiology 16
3.3 Symptoms 18
3.4 Prognosis 20

4 Vaccination Recommendations and Coverage Rates 21
4.1 Overview 21

5 Competitive Assessment 25
5.1 Overview 25
5.2 Strategic Competitor Assessment 25

6 Comvax 28
6.1 Overview 28
6.2 Immunogenicity 29
6.3 Safety 30
6.4 SWOT Analysis 31
6.5 Forecast 31

7 Appendix 33
7.1 Bibliography 33
7.2 Abbreviations 47
7.3 Methodology 50
7.4 Forecasting Methodology 50
7.4.1 Patient Populations Targeted for Vaccination 51
7.4.2 Vaccination Coverage Rates 54
7.4.3 Vaccinated Patients 55
7.4.4 Regulatory Approval vs. Advisory Committee Recommendation 55
7.4.5 General Pricing Assumptions 56
7.4.6 Individual Vaccine Assumptions 57
7.5 Physicians and Specialists Included in this Study 58
7.5.1 Interviews of Key Opinion Leaders (KOLs) 58
7.5.2 Online Survey of High-Prescribing Physicians (non-KOLs) 60
7.6 About the Authors 61
7.6.1 Analyst 61
7.6.2 Therapy Area Director 61
7.6.3 Global Head of Healthcare 62
7.7 About GlobalData 63
7.8 Disclaimer 63

List of Tables

Table 1: Modes of HBV Transmission 17
Table 2: HBV Serological Markers and Test Interpretations 18
Table 3: Symptoms of HBV Infection 19
Table 4: HBV Vaccination Advisory Committees by Country 22
Table 5: HBV Immunization Recommendations by Country 23
Table 6: Targeted Age Group(s) for Routine Immunization and Most Administered HBV Vaccines by Country in the Global Markets, 2014 24
Table 7: Leading Vaccines for HBV, 2014 27
Table 8: Product Profile - Comvax 29
Table 9: Immunogenicity Profile - Comvax 30
Table 10: Safety Profile - Comvax 30
Table 11: Comvax SWOT Analysis, 2014 31
Table 12: Global Sales Forecasts ($m) for Comvax, 2012-2022 32
Table 13: Patient Population(s) Targeted for HBV Vaccination in the Pediatric Market, by Country 52
Table 14: Patient Population(s) Targeted for HBV Vaccination in the Adult Market, by Country 53
Table 15: High-Prescribing Physicians (non-KOLs) Surveyed, by Country 60

List of Figures

Figure 1: HBV Structure and the Recombinant Vaccine Development Process 14