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PharmaPoint: Prophylactic Hepatitis B Virus Vaccines - Canada Drug Forecast and Market Analysis to 2022

Summary

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.

In 2012, the Canadian HBV vaccine market was estimated to be worth almost $18m, with the majority of vaccine sales occurring within the routine childhood immunization program. ). Twinrix has enjoyed success largely due to its use in school-based immunization programs in Quebec and other Canadian provinces that universally vaccinate preteens instead of infants. The adult vaccine market in Canada represented a small percentage of total sales in 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 the key drugs in Canada including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in Canada from 2012-2022.
- Analysis of the impact of key events as well the drivers and restraints affecting the Canada Hepatitis B disease market.

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 disease
- 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 drug performance
- Obtain sales forecast for drugs from 2012-2022 in Canada

Table Of Contents

PharmaPoint: Prophylactic Hepatitis B Virus Vaccines - Canada Drug Forecast and Market Analysis to 2022
1 Table of Contents

2 Introduction 11
2.1 Catalyst 11
2.2 Related Reports 12
2.3 Upcoming Related Reports 14
3 Disease Overview 15
3.1 Overview 15
3.2 Etiology and Pathophysiology 16
3.2.1 Etiology 16
3.2.2 Pathophysiology 19
3.3 Symptoms 21
3.4 Prognosis 23
4 Vaccination Recommendations and Coverage Rates 24
4.1 Overview 24
4.2 Canada 27
4.2.1 Immunization Recommendations and Policies 27
4.2.2 Vaccination Coverage 29
4.2.3 Clinical Practice 30
5 Competitive Assessment 32
5.1 Overview 32
5.2 Strategic Competitor Assessment 32
5.3 Product Profiles - Monovalent Vaccines 35
5.3.1 Engerix-B 35
5.3.2 Recombivax HB 40
5.4 Product Profiles - Combination Vaccines 44
5.4.1 Infanrix Hexa 45
5.4.2 Hexyon 49
5.4.3 Twinrix 53
6 Opportunity and Unmet Need 59
6.1 Overview 59
6.2 Increased Vaccine Immunogenicity 61
6.2.1 Unmet Need 61
6.2.2 Gap Analysis 63
6.2.3 Opportunity 64
6.3 Increased Vaccination Coverage Rates 64
6.3.1 Unmet Need 64
6.3.2 Gap Analysis 65
6.3.3 Opportunity 66
6.4 Increased Patient Awareness 67
6.4.1 Unmet Need 67
6.4.2 Gap Analysis 68
6.4.3 Opportunity 68
6.5 Improved Physician Education 69
6.5.1 Unmet Need 69
6.5.2 Gap Analysis 70
6.5.3 Opportunity 70
6.6 More Cost-Effective Vaccines 72
6.6.1 Unmet Need 72
6.6.2 Gap Analysis 72
6.6.3 Opportunity 73
7 Pipeline Assessment 74
7.1 Overview 74
7.2 Promising Vaccines in Late-Stage Clinical Development 75
7.2.1 Heplisav 77
7.3 Promising Vaccines in Early-Stage Clinical Development 87
8 Market Outlook 88
8.1 Canada 88
8.1.1 Forecast 88
8.1.2 Key Events 91
8.1.3 Drivers and Barriers 92
9 Appendix 96
9.1 Bibliography 96
9.2 Abbreviations 110
9.3 Methodology 114
9.4 Forecasting Methodology 114
9.4.1 Patient Populations Targeted for Vaccination 114
9.4.2 Vaccination Coverage Rates 116
9.4.3 Vaccinated Patients 117
9.4.4 Regulatory Approval vs. Advisory Committee Recommendation 117
9.4.5 Vaccines Included 117
9.4.6 Key Launch Dates 118
9.4.7 General Pricing Assumptions 118
9.4.8 Individual Vaccine Assumptions 119
9.4.9 Pricing of Pipeline Vaccines 123
9.5 Physicians and Specialists Included in this Study 124
9.5.1 Interviews of Key Opinion Leaders (KOLs) 124
9.5.2 Online Survey of High-Prescribing Physicians (non-KOLs) 125
9.6 About the Authors 126
9.6.1 Analyst 126
9.6.2 Therapy Area Director 126
9.6.3 Global Head of Healthcare 127
9.7 About GlobalData 128
9.8 Disclaimer 128

1.1 List of Tables

Table 1: Modes of HBV Transmission 20
Table 2: HBV Serological Markers and Test Interpretations 21
Table 3: Symptoms of HBV Infection 22
Table 4: HBV Vaccination Advisory Committees by Country 25
Table 5: HBV Immunization Recommendations by Country 26
Table 6: Targeted Age Group(s) for Routine Immunization and Most Administered HBV Vaccines by Country in the Global Markets, 2014 27
Table 7: Targeted Age Group(s) for Routine HBV Immunization in Canada, by Province or Territory, 2014 29
Table 8: Leading Vaccines for HBV, 2014 34
Table 9: Product Profile - Engerix-B 36
Table 10: Immunogenicity Profile - Engerix-B 37
Table 11: Safety Profile - Engerix-B 38
Table 12: Engerix-B SWOT Analysis, 2014 39
Table 13: Product Profile - Recombivax HB 41
Table 14: Immunogenicity Profile - Recombivax HB 42
Table 15: Safety Profile - Recombivax HB 43
Table 16: Recombivax HB SWOT Analysis, 2014 44
Table 17: Product Profile - Infanrix Hexa 46
Table 18: Immunogenicity Profile - Infanrix Hexa 47
Table 19: Safety Profile - Infanrix Hexa 48
Table 20: Infanrix Hexa SWOT Analysis, 2014 48
Table 21: Product Profile - Hexyon 50
Table 22: Immunogenicity Profile - Hexyon 51
Table 23: Safety Profile - Hexyon 52
Table 24: Hexyon SWOT Analysis, 2014 53
Table 25: Product Profile - Twinrix 55
Table 26: Immunogenicity Profile - Twinrix 56
Table 27: Safety Profile - Twinrix 57
Table 28: Twinrix SWOT Analysis, 2014 58
Table 29: Unmet Need and Opportunity in Prophylactic HBV Vaccines 61
Table 30: HBV Vaccines - Phase Pipeline, 2014 75
Table 31: Comparison of Vaccines in Development for HBV, 2014 76
Table 32: Product Profile - Heplisav 79
Table 33: Immunogenicity Profile - Heplisav 80
Table 34: Safety Profile - Heplisav 82
Table 35: Heplisav SWOT Analysis, 2014 86
Table 36: Sales Forecasts ($) for HBV Vaccines in Canada, 2012-2022 89
Table 37: Key Events Impacting Sales for HBV Vaccines in Canada, 2014 91
Table 38: Canada HBV Vaccine Market - Drivers and Barriers, 2014 92
Table 39: Patient Population(s) Targeted for HBV Vaccination in the Pediatric Market, Canada 115
Table 40: Patient Population(s) Targeted for HBV Vaccination in the Adult Market, Canada 116
Table 41: Key Launch Dates 118
Table 42: High-Prescribing Physicians (non-KOLs) Surveyed, Canada 125

1.2 List of Figures

Figure 1: HBV Structure and the Recombinant Vaccine Development Process 17
Figure 2: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in Canada, 2014 31
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents and Marketed Products in HBV Vaccines, 2012-2022 76
Figure 4: Sales for HBV Vaccines in Canada, 2012-2022 90

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