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.

Infanrix Hexa [Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), inactivated poliovirus, Hib conjugate vaccine (adsorbed)] is GSK’s hexavalent combination vaccine that offers protection against infections caused by diphtheria, tetanus, pertussis, three subtypes of poliovirus, Hib, and all known subtypes of HBV. Infanrix Hexa contains the antigenic components used in GSK’s Pediarix [diphtheria toxoid, tetanus toxoid, inactivated pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin, and inactivated poliovirus subtypes Mahoney, MEF-1, and Saukett, and yeast-derived HBsAg] and Hiberix (Hib capsular polysaccharide PRP) vaccines (Hiberix package insert, 2012; Pediarix package insert, 2012).

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 Infanrix Hexa including product description, safety and efficacy profiles as well as a SWOT analysis.
• Sales forecast for Infanrix Hexa for top six countries from 2012 to 2022.
• Sales information covered for the US, France, Germany, Italy, Spain 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 Infanrix Hexa performance
• Obtain sales forecast for Infanrix Hexa from 2012-2022 in the top six countries (the US, France, Germany, Italy, Spain and Canada).

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 Infanrix Hexa 28
6.1 Overview 28
6.2 Immunogenicity 30
6.3 Safety 30
6.4 SWOT Analysis 31
6.5 Forecast 32

7 Appendix 33
7.1 Bibliography 33
7.2 Abbreviations 48
7.3 Methodology 51
7.4 Forecasting Methodology 51
7.4.1 Patient Populations Targeted for Vaccination 52
7.4.2 Vaccination Coverage Rates 55
7.4.3 Vaccinated Patients 56
7.4.4 Regulatory Approval vs. Advisory Committee Recommendation 56
7.4.5 General Pricing Assumptions 57
7.4.6 Individual Vaccine Assumptions 58
7.5 Physicians and Specialists Included in this Study 59
7.5.1 Interviews of Key Opinion Leaders (KOLs) 59
7.5.2 Online Survey of High-Prescribing Physicians (non-KOLs) 61
7.6 About the Authors 62
7.6.1 Analyst 62
7.6.2 Therapy Area Director 62
7.6.3 Global Head of Healthcare 63
7.7 About GlobalData 64
7.8 Disclaimer 64

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 - Infanrix Hexa 29
Table 9: Immunogenicity Profile - Infanrix Hexa 30
Table 10: Safety Profile - Infanrix Hexa 31
Table 11: Infanrix Hexa SWOT Analysis, 2014 31
Table 12: Global Sales Forecasts ($m) for Infanrix Hexa, 2012-2022 32
Table 13: Patient Population(s) Targeted for HBV Vaccination in the Pediatric Market, by Country 53
Table 14: Patient Population(s) Targeted for HBV Vaccination in the Adult Market, by Country 54
Table 15: High-Prescribing Physicians (non-KOLs) Surveyed, by Country 61

List of Figures

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