PharmaPoint: Prophylactic Hepatitis B Virus Vaccines - 5EU 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.

GlobalData’s primary and secondary research has revealed that the reimbursement of Infanrix Hexa, which began in 2008, has helped France’s routine HBV immunization program recover from safety concerns (CTV, 2012; Denis et al., 2013). The adult HBV vaccine market in Germany is also expected to grow during the forecast period, led by the arrival of Dynavax Technologies’ Heplisav in the second half of 2018. GSK dominated Italy’s HBV vaccine market in 2012. Sanofi Pasteur MSD’s monovalent vaccine, HBVaxPro, accounted for the remaining market share. More specifically, GlobalData expects the arrival of Sanofi Pasteur MSD’s Hexyon to be the principal driver of Spain’s market growth, as it should compete with Infanrix Hexa for market share in the routine immunization program. GlobalData’s primary research has revealed that challenging barriers to growth, such as poor funding mechanisms due to government spending concerns, inadequate physician education, and low patient awareness, will limit adult vaccine uptake and growth of this segment of the market in the UK.

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 5EU including product description, safety and efficacy profiles as well as a SWOT analysis.

- Sales forecast for the top drugs in 5EU from 2012-2022.

- Analysis of the impact of key events as well the drivers and restraints affecting the 5EU 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 5EU

Table Of Contents

1 Table of Contents

2 Introduction 14
2.1 Catalyst 14
2.2 Related Reports 15
2.3 Upcoming Related Reports 17
3 Disease Overview 18
3.1 Overview 18
3.2 Etiology and Pathophysiology 19
3.2.1 Etiology 19
3.2.2 Pathophysiology 22
3.3 Symptoms 24
3.4 Prognosis 26
4 Vaccination Recommendations and Coverage Rates 27
4.1 Overview 27
4.2 France 30
4.2.1 Immunization Recommendations and Policies 30
4.2.2 Vaccination Coverage 31
4.2.3 Clinical Practice 33
4.3 Germany 34
4.3.1 Immunization Recommendations and Policies 34
4.3.2 Vaccination Coverage 35
4.3.3 Clinical Practice 37
4.4 Italy 38
4.4.1 Immunization Recommendations and Policies 38
4.4.2 Vaccination Coverage 39
4.4.3 Clinical Practice 40
4.5 Spain 42
4.5.1 Immunization Recommendations and Policies 42
4.5.2 Vaccination Coverage 43
4.5.3 Clinical Practice 44
4.6 UK 46
4.6.1 Immunization Recommendations and Policies 46
4.6.2 Vaccination Coverage 47
4.6.3 Clinical Practice 47
5 Competitive Assessment 49
5.1 Overview 49
5.2 Strategic Competitor Assessment 49
5.3 Product Profiles - Monovalent Vaccines 51
5.3.1 Engerix-B 52
5.3.2 Recombivax HB 57
5.3.3 Fendrix 62
5.4 Product Profiles - Combination Vaccines 65
5.4.1 Infanrix Hexa 66
5.4.2 Hexyon 70
5.4.3 Twinrix 74
5.4.4 Ambirix 79
6 Opportunity and Unmet Need 83
6.1 Overview 83
6.2 Increased Vaccine Immunogenicity 85
6.2.1 Unmet Need 85
6.2.2 Gap Analysis 87
6.2.3 Opportunity 88
6.3 Increased Vaccination Coverage Rates 88
6.3.1 Unmet Need 88
6.3.2 Gap Analysis 89
6.3.3 Opportunity 90
6.4 Increased Patient Awareness 91
6.4.1 Unmet Need 91
6.4.2 Gap Analysis 92
6.4.3 Opportunity 92
6.5 Improved Physician Education 93
6.5.1 Unmet Need 93
6.5.2 Gap Analysis 94
6.5.3 Opportunity 94
6.6 More Cost-Effective Vaccines 96
6.6.1 Unmet Need 96
6.6.2 Gap Analysis 96
6.6.3 Opportunity 97
7 Pipeline Assessment 98
7.1 Overview 98
7.2 Promising Vaccines in Late-Stage Clinical Development 99
7.2.1 Heplisav 101
7.3 Promising Vaccines in Early-Stage Clinical Development 111
8 Market Outlook 112
8.1 France 112
8.1.1 Forecast 112
8.1.2 Key Events 115
8.1.3 Drivers and Barriers 116
8.2 Germany 119
8.2.1 Forecast 119
8.2.2 Key Events 123
8.2.3 Drivers and Barriers 124
8.3 Italy 127
8.3.1 Forecast 127
8.3.2 Key Events 131
8.3.3 Drivers and Barriers 132
8.4 Spain 135
8.4.1 Forecast 135
8.4.2 Key Events 138
8.4.3 Drivers and Barriers 139
8.5 UK 141
8.5.1 Forecast 141
8.5.2 Key Events 144
8.5.3 Drivers and Barriers 146
8.5.4 Alternative Market Scenario 149
9 Appendix 150
9.1 Bibliography 150
9.2 Abbreviations 167
9.3 Methodology 171
9.4 Forecasting Methodology 171
9.4.1 Patient Populations Targeted for Vaccination 171
9.4.2 Vaccination Coverage Rates 173
9.4.3 Vaccinated Patients 174
9.4.4 Regulatory Approval vs. Advisory Committee Recommendation 174
9.4.5 Vaccines Included 175
9.4.6 Key Launch Dates 176
9.4.7 General Pricing Assumptions 176
9.4.8 Individual Vaccine Assumptions 177
9.4.9 Pricing of Pipeline Vaccines 183
9.5 Physicians and Specialists Included in this Study 185
9.5.1 Interviews of Key Opinion Leaders (KOLs) 185
9.5.2 Online Survey of High-Prescribing Physicians (non-KOLs) 187
9.6 About the Authors 188
9.6.1 Analyst 188
9.6.2 Therapy Area Director 188
9.6.3 Global Head of Healthcare 189
9.7 About GlobalData 190
9.8 Disclaimer 190

1.1 List of Tables

Table 1: Modes of HBV Transmission 23
Table 2: HBV Serological Markers and Test Interpretations 24
Table 3: Symptoms of HBV Infection 25
Table 4: HBV Vaccination Advisory Committees by Country 28
Table 5: HBV Immunization Recommendations by Country 29
Table 6: Targeted Age Group(s) for Routine Immunization and Most Administered HBV Vaccines by Country in the Global Markets, 2014 30
Table 7: Leading Vaccines for HBV, 2014 51
Table 8: Product Profile - Engerix-B 53
Table 9: Immunogenicity Profile - Engerix-B 54
Table 10: Safety Profile - Engerix-B 55
Table 11: Engerix-B SWOT Analysis, 2014 56
Table 12: Product Profile - Recombivax HB 58
Table 13: Immunogenicity Profile - Recombivax HB 59
Table 14: Safety Profile - Recombivax HB 60
Table 15: Recombivax HB SWOT Analysis, 2014 61
Table 16: Product Profile - Fendrix 63
Table 17: Immunogenicity Profile - Fendrix 64
Table 18: Safety Profile - Fendrix 64
Table 19: Fendrix SWOT Analysis, 2014 65
Table 20: Product Profile - Infanrix Hexa 67
Table 21: Immunogenicity Profile - Infanrix Hexa 68
Table 22: Safety Profile - Infanrix Hexa 69
Table 23: Infanrix Hexa SWOT Analysis, 2014 69
Table 24: Product Profile - Hexyon 71
Table 25: Immunogenicity Profile - Hexyon 72
Table 26: Safety Profile - Hexyon 73
Table 27: Hexyon SWOT Analysis, 2014 74
Table 28: Product Profile - Twinrix 76
Table 29: Immunogenicity Profile - Twinrix 77
Table 30: Safety Profile - Twinrix 78
Table 31: Twinrix SWOT Analysis, 2014 79
Table 32: Product Profile - Ambirix 80
Table 33: Immunogenicity Profile - Ambirix 81
Table 34: Safety Profile - Ambirix 82
Table 35: Ambirix SWOT Analysis, 2014 82
Table 36: Unmet Need and Opportunity in Prophylactic HBV Vaccines 85
Table 37: HBV Vaccines - Phase Pipeline, 2014 99
Table 38: Comparison of Vaccines in Development for HBV, 2014 100
Table 39: Product Profile - Heplisav 103
Table 40: Immunogenicity Profile - Heplisav 104
Table 41: Safety Profile - Heplisav 106
Table 42: Heplisav SWOT Analysis, 2014 110
Table 43: Sales Forecasts ($m) for HBV Vaccines in France, 2012-2022 113
Table 44: Key Events Impacting Sales for HBV Vaccines in France, 2014 115
Table 45: France HBV Vaccine Market - Drivers and Barriers, 2014 116
Table 46: Sales Forecasts ($m) for HBV Vaccines in Germany, 2012-2022 121
Table 47: Key Events Impacting Sales for HBV Vaccines in Germany, 2014 123
Table 48: Germany HBV Vaccine Market - Drivers and Barriers, 2014 124
Table 49: Sales Forecasts ($m) for HBV Vaccines in Italy, 2012-2022 129
Table 50: Key Events Impacting Sales for HBV Vaccines in Italy, 2014 131
Table 51: Italy HBV Vaccine Market - Drivers and Barriers, 2014 132
Table 52: Sales Forecasts ($m) for HBV Vaccines in Spain, 2012-2022 136
Table 53: Key Events Impacting Sales for HBV Vaccines in Spain, 2014 138
Table 54: Spain HBV Vaccine Market - Drivers and Barriers, 2014 139
Table 55: Sales Forecasts ($m) for HBV Vaccines in the United Kingdom, 2012-2022 143
Table 56: Key Events Impacting Sales for HBV Vaccines in the United Kingdom, 2014 145
Table 57: United Kingdom HBV Vaccine Market - Drivers and Barriers, 2014 146
Table 58: Patient Population(s) Targeted for HBV Vaccination in the Pediatric Market, by Country 172
Table 59: Patient Population(s) Targeted for HBV Vaccination in the Adult Market, by Country 173
Table 60: Key Launch Dates 176
Table 61: High-Prescribing Physicians (non-KOLs) Surveyed, by Country 187

1.2 List of Figures

Figure 1: HBV Structure and the Recombinant Vaccine Development Process 20
Figure 2: Routine HBV Vaccination Coverage (%) in France 33
Figure 3: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in France, 2014 34
Figure 4: Routine HBV Vaccination Coverage (%) in Germany 36
Figure 5: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in Germany, 2014 38
Figure 6: Routine HBV Vaccination Coverage (%) in Italy 40
Figure 7: High-Prescriber Estimation of Pediatric HBV Patient Share in Italy, 2014 41
Figure 8: Routine HBV Vaccination Coverage (%) in Spain 44
Figure 9: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in Spain, 2014 45
Figure 10: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in the United Kingdom, 2014 48
Figure 11: Competitive Assessment of Late-Stage Pipeline Agents and Marketed Products in HBV Vaccines, 2012-2022 100
Figure 12: Sales for HBV Vaccines in France, 2012-2022 114
Figure 13: Sales for HBV Vaccines in Germany, 2012-2022 122
Figure 14: Sales for HBV Vaccines in Italy, 2012-2022 130
Figure 15: Sales for HBV Vaccines in Spain, 2012-2022 137
Figure 16: Sales for HBV Vaccines in the United Kingdom, 2012-2022 144

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