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

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

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Publication ID
GDA01143234
Publication Date
January 31, 2014
Pages
303
Regions Covered
Publisher
PharmaPoint: Prophylactic Hepatitis B Virus Vaccines Global Drug Forecast and Market Analysis to 2022
Prophylactic Hepatitis B Virus Vaccines Global sales to reach over $1.1 billion by 2022.
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.
 

Highlights

Key Questions Answered

  • How large an impact will Hexyon and Heplisav have on the HBV vaccine market? What do key opinion leaders think of these vaccines?
  • What are the key HBV vaccines for each age segment and country?
  • Which HBV vaccines will face adoption challenges in the market? What is the projected uptake of new vaccines, such as Dynavax’s Heplisav, over the forecast period?
  • The developmental pipeline consists of vaccines that address immunogenicity and coverage rate concerns. Which of these vaccines will attain high sales revenues during 2012-2022 and in which markets?
  • What governmental and industry developments are likely to affect the vaccination rates in the markets researched? Which is the largest growth market globally?
 

Key Findings

  • Country-specific immunization recommendations heavily influence HBV vaccine uptake in the pediatric and adult segments of the marketplace.
  • The potential impact of Dynavax Technologies’ Heplisav on the marketplace will be determined by its level of uptake in at-risk adults targeted for vaccination.
  • Major players will leverage their R&D, manufacturing, and distribution networks to maintain their stakes in the market.
  • Government endorsements of new and existing vaccines, in particular pediatric combination vaccines and novel adult vaccines, are anticipated to dramatically influence market growth.
 

Scope

  • Overview of hepatitis B virus (HBV), including etiology, general symptoms from infection, and country-specific immunization recommendations and vaccination coverage data. 
  • Annualized HBV vaccine market revenue, annual cost of vaccination and treatment usage pattern data from 2012 and forecast for ten years to 2022.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the HBV vaccine market.
  • Pipeline analysis: comprehensive data split across different phases and emerging trends, specifically Dynavax Technologies’ Heplisav and Sanofi Pasteur MSD’s Hexyon.
  • Analysis of the current and future market competition in the global HBV vaccine market. Insightful review of the key industry and governmental drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
 

Reasons to buy

  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the HBV vaccine market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global HBV vaccine market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Track drug sales in the global HBV vaccine market from 2012-2022.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
 

1 Table of Contents 8

1.1 List of Tables 14
1.2 List of Figures 18

2 Introduction 20

2.1 Catalyst 20
2.2 Related Reports 21
2.3 Upcoming Related Reports 22

3 Disease Overview 23

3.1 Overview 23
3.2 Etiology and Pathophysiology 24
3.2.1 Etiology 24
3.2.2 Pathophysiology 28
3.3 Symptoms 30
3.4 Prognosis 32

4 Vaccination Recommendations and Coverage Rates 33

4.1 Overview 33
4.2 US 36
4.2.1 Immunization Recommendations and Policies 36
4.2.2 Vaccination Coverage 38
4.2.3 Clinical Practice 39
4.3 France 41
4.3.1 Immunization Recommendations and Policies 41
4.3.2 Vaccination Coverage 42
4.3.3 Clinical Practice 44
4.4 Germany 45
4.4.1 Immunization Recommendations and Policies 45
4.4.2 Vaccination Coverage 46
4.4.3 Clinical Practice 47
4.5 Italy 49
4.5.1 Immunization Recommendations and Policies 49
4.5.2 Vaccination Coverage 50
4.5.3 Clinical Practice 51
4.6 Spain 53
4.6.1 Immunization Recommendations and Policies 53
4.6.2 Vaccination Coverage 54
4.6.3 Clinical Practice 55
4.7 UK 57
4.7.1 Immunization Recommendations and Policies 57
4.7.2 Vaccination Coverage 58
4.7.3 Clinical Practice 59
4.8 Japan 60
4.8.1 Immunization Recommendations and Policies 60
4.8.2 Vaccination Coverage 61
4.8.3 Clinical Practice 63
4.9 Canada 64
4.9.1 Immunization Recommendations and Policies 64
4.9.2 Vaccination Coverage 66
4.9.3 Clinical Practice 67

5 Competitive Assessment 69

5.1 Overview 69
5.2 Strategic Competitor Assessment 70
5.3 Product Profiles - Monovalent Vaccines 73
5.3.1 Engerix-B 73
5.3.2 Recombivax HB 79
5.3.3 Fendrix 85
5.3.4 Bimmugen 89
5.4 Product Profiles - Combination Vaccines 91
5.4.1 Infanrix Hexa 92
5.4.2 Pediarix 97
5.4.3 Hexyon 101
5.4.4 Comvax 107
5.4.5 Twinrix 112
5.4.6 Ambirix 117

6 Opportunity and Unmet Need 122

6.1 Overview 122
6.2 Increased Vaccine Immunogenicity 124
6.2.1 Unmet Need 124
6.2.2 Gap Analysis 126
6.2.3 Opportunity 127
6.3 Increased Vaccination Coverage Rates 128
6.3.1 Unmet Need 128
6.3.2 Gap Analysis 129
6.3.3 Opportunity 130
6.4 Increased Patient Awareness 131
6.4.1 Unmet Need 131
6.4.2 Gap Analysis 131
6.4.3 Opportunity 132
6.5 Improved Physician Education 133
6.5.1 Unmet Need 133
6.5.2 Gap Analysis 134
6.5.3 Opportunity 134
6.6 More Cost-Effective Vaccines 136
6.6.1 Unmet Need 136
6.6.2 Gap Analysis 136
6.6.3 Opportunity 137

7 Pipeline Assessment 138

7.1 Overview 138
7.2 Clinical Trial Mapping 139
7.2.1 Clinical Trials by Country 139
7.2.2 Clinical Trials by Phase and Trial Status 140
7.3 Promising Vaccines in Late-Stage Clinical Development 142
7.3.1 Heplisav 144
7.4 Promising Vaccines in Early-Stage Clinical Development 155

8 Current and Future Players 157

8.1 Overview 157
8.2 Trends in Corporate Strategy 161
8.3 Company Profiles 163
8.3.1 GSK 163
8.3.2 Merck 167
8.3.3 Sanofi 170
8.3.4 Kaketsuken 173
8.3.5 Dynavax Technologies 174

9 Market Outlook 177

9.1 Global Markets 177
9.1.1 Forecast 177
9.1.2 Drivers and Barriers - Global Issues 181
9.2 US 187
9.2.1 Forecast 187
9.2.2 Key Events 191
9.2.3 Drivers and Barriers 192
9.3 France 201
9.3.1 Forecast 201
9.3.2 Key Events 204
9.3.3 Drivers and Barriers 205
9.4 Germany 208
9.4.1 Forecast 208
9.4.2 Key Events 212
9.4.3 Drivers and Barriers 213
9.5 Italy 217
9.5.1 Forecast 217
9.5.2 Key Events 220
9.5.3 Drivers and Barriers 221
9.6 Spain 224
9.6.1 Forecast 224
9.6.2 Key Events 228
9.6.3 Drivers and Barriers 229
9.7 UK 231
9.7.1 Forecast 231
9.7.2 Key Events 235
9.7.3 Drivers and Barriers 236
9.7.4 Alternative Market Scenario 239
9.8 Japan 239
9.8.1 Forecast 239
9.8.2 Drivers and Barriers 242
9.9 Canada 245
9.9.1 Forecast 245
9.9.2 Key Events 248
9.9.3 Drivers and Barriers 249

10 Appendix 253

10.1 Bibliography 253
10.2 Abbreviations 273
10.3 Methodology 277
10.4 Forecasting Methodology 277
10.4.1 Patient Populations Targeted for Vaccination 278
10.4.2 Vaccination Coverage Rates 281
10.4.3 Vaccinated Patients 282
10.4.4 Regulatory Approval vs. Advisory Committee Recommendation 282
10.4.5 Vaccines Included 283
10.4.6 Key Launch Dates 284
10.4.7 General Pricing Assumptions 285
10.4.8 Individual Vaccine Assumptions 286
10.4.9 Pricing of Pipeline Vaccines 296
10.5 Physicians and Specialists Included in this Study 297
10.5.1 Interviews of Key Opinion Leaders (KOLs) 297
10.5.2 Online Survey of High-Prescribing Physicians (non-KOLs) 299
10.6 About the Authors 300
10.6.1 Analyst 300
10.6.2 Therapy Area Director 300
10.6.3 Global Head of Healthcare 301
10.7 About GlobalData 302
10.8 Disclaimer 302
 

1.1 List of Tables

Table 1: Modes of HBV Transmission 29
Table 2: HBV Serological Markers and Test Interpretations 30
Table 3: Symptoms of HBV Infection 31
Table 4: HBV Vaccination Advisory Committees by Country 34
Table 5: HBV Immunization Recommendations by Country 35
Table 6: Targeted Age Group(s) for Routine Immunization and Most Administered HBV Vaccines by Country in the Global Markets, 2014 36
Table 7: Targeted Age Group(s) for Routine HBV Immunization in Canada, by Province or Territory, 2014 66
Table 8: Leading Vaccines for HBV, 2014 72
Table 9: Product Profile - Engerix-B 74
Table 10: Immunogenicity Profile - Engerix-B 75
Table 11: Safety Profile - Engerix-B 76
Table 12: Engerix-B SWOT Analysis, 2014 77
Table 13: Global Sales Forecasts ($m) for Engerix-B, 2012-2022 78
Table 14: Product Profile - Recombivax HB 80
Table 15: Immunogenicity Profile - Recombivax HB 81
Table 16: Safety Profile - Recombivax HB 82
Table 17: Recombivax HB SWOT Analysis, 2014 83
Table 18: Global Sales Forecasts ($m) for Recombivax HB, 2012-2022 84
Table 19: Product Profile - Fendrix 86
Table 20: Immunogenicity Profile - Fendrix 87
Table 21: Safety Profile - Fendrix 87
Table 22: Fendrix SWOT Analysis, 2014 88
Table 23: Global Sales Forecasts ($m) for Fendrix, 2012-2022 89
Table 24: Product Profile - Bimmugen 90
Table 25: Bimmugen SWOT Analysis, 2014 90
Table 26: Global Sales Forecasts ($m) for Bimmugen, 2012-2022 91
Table 27: Product Profile - Infanrix Hexa 93
Table 28: Immunogenicity Profile - Infanrix Hexa 94
Table 29: Safety Profile - Infanrix Hexa 95
Table 30: Infanrix Hexa SWOT Analysis, 2014 95
Table 31: Global Sales Forecasts ($m) for Infanrix Hexa, 2012-2022 96
Table 32: Product Profile - Pediarix 98
Table 33: Immunogenicity Profile - Pediarix 99
Table 34: Safety Profile - Pediarix 99
Table 35: Pediarix SWOT Analysis, 2014 100
Table 36: Global Sales Forecasts ($m) for Pediarix, 2012-2022 101
Table 37: Product Profile - Hexyon 103
Table 38: Immunogenicity Profile - Hexyon 104
Table 39: Safety Profile - Hexyon 105
Table 40: Hexyon SWOT Analysis, 2014 105
Table 41: Global Sales Forecasts ($m) for Hexyon, 2012-2022 107
Table 42: Product Profile - Comvax 108
Table 43: Immunogenicity Profile - Comvax 109
Table 44: Safety Profile - Comvax 110
Table 45: Comvax SWOT Analysis, 2014 110
Table 46: Global Sales Forecasts ($m) for Comvax, 2012-2022 111
Table 47: Product Profile - Twinrix 113
Table 48: Immunogenicity Profile - Twinrix 114
Table 49: Safety Profile - Twinrix 115
Table 50: Twinrix SWOT Analysis, 2014 116
Table 51: Global Sales Forecasts ($m) for Twinrix, 2012-2022 117
Table 52: Product Profile - Ambirix 118
Table 53: Immunogenicity Profile - Ambirix 119
Table 54: Safety Profile - Ambirix 120
Table 55: Ambirix SWOT Analysis, 2014 120
Table 56: Global Sales Forecasts ($m) for Ambirix, 2012-2022 121
Table 57: Unmet Need and Opportunity in Prophylactic HBV Vaccines 124
Table 58: HBV Vaccines - Clinical Trials by Phase and Status, 2014 141
Table 59: HBV Vaccines - Phase Pipeline, 2014 142
Table 60: Comparison of Vaccines in Development for HBV, 2014 143
Table 61: Product Profile - Heplisav 146
Table 62: Immunogenicity Profile - Heplisav 147
Table 63: Safety Profile - Heplisav 149
Table 64: Heplisav SWOT Analysis, 2014 153
Table 65: Global Sales Forecasts ($m) for Heplisav, 2012-2022 155
Table 66: Key Companies in the HBV Vaccine Market, 2014 159
Table 67: GSK’s HBV Vaccine Portfolio Assessment, 2014 165
Table 68: GSK SWOT Analysis, 2014 166
Table 69: Merck’s HBV Vaccine Portfolio Assessment, 2014 168
Table 70: Merck SWOT Analysis, 2014 169
Table 71: Sanofi’s HBV Vaccine Portfolio Assessment, 2014 171
Table 72: Sanofi SWOT Analysis, 2014 172
Table 73: Kaketsuken’s HBV Vaccine Portfolio Assessment, 2014 173
Table 74: Kaketsuken SWOT Analysis, 2014 174
Table 75: Dynavax Technologies’ HBV Vaccine Portfolio Assessment, 2014 175
Table 76: Dynavax Technologies SWOT Analysis, 2014 176
Table 77: Global Sales Forecasts ($m) for HBV Vaccines, 2012-2022 179
Table 78: Global HBV Vaccine Market - Drivers and Barriers, 2014 181
Table 79: Sales Forecasts ($m) for HBV Vaccines in the United States, 2012-2022 189
Table 80: Key Events Impacting Sales for HBV Vaccines in the United States, 2014 191
Table 81: United States HBV Vaccine Market - Drivers and Barriers, 2014 192
Table 82: Sales Forecasts ($m) for HBV Vaccines in France, 2012-2022 202
Table 83: Key Events Impacting Sales for HBV Vaccines in France, 2014 204
Table 84: France HBV Vaccine Market - Drivers and Barriers, 2014 205
Table 85: Sales Forecasts ($m) for HBV Vaccines in Germany, 2012-2022 210
Table 86: Key Events Impacting Sales for HBV Vaccines in Germany, 2014 212
Table 87: Germany HBV Vaccine Market - Drivers and Barriers, 2014 213
Table 88: Sales Forecasts ($m) for HBV Vaccines in Italy, 2012-2022 218
Table 89: Key Events Impacting Sales for HBV Vaccines in Italy, 2014 220
Table 90: Italy HBV Vaccine Market - Drivers and Barriers, 2014 221
Table 91: Sales Forecasts ($m) for HBV Vaccines in Spain, 2012-2022 226
Table 92: Key Events Impacting Sales for HBV Vaccines in Spain, 2014 228
Table 93: Spain HBV Vaccine Market - Drivers and Barriers, 2014 229
Table 94: Sales Forecasts ($) for HBV Vaccines in the United Kingdom, 2012-2022 233
Table 95: Key Events Impacting Sales for HBV Vaccines in the United Kingdom, 2014 235
Table 96: United Kingdom HBV Vaccine Market - Drivers and Barriers, 2014 236
Table 97: Sales Forecasts ($) for HBV Vaccines in Japan, 2012-2022 240
Table 98: Japan HBV Vaccine Market - Drivers and Barriers, 2014 242
Table 99: Sales Forecasts ($) for HBV Vaccines in Canada, 2012-2022 246
Table 100: Key Events Impacting Sales for HBV Vaccines in Canada, 2014 248
Table 101: Canada HBV Vaccine Market - Drivers and Barriers, 2014 249
Table 102: Patient Population(s) Targeted for HBV Vaccination in the Pediatric Market, by Country 279
Table 103: Patient Population(s) Targeted for HBV Vaccination in the Adult Market, by Country 280
Table 104: Key Launch Dates 284
Table 105: High-Prescribing Physicians (non-KOLs) Surveyed, by Country 299
 

1.2 List of Figures

Figure 1: HBV Structure and the Recombinant Vaccine Development Process 25
Figure 2: Routine HBV Vaccination Coverage (%) in the United States 39
Figure 3: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in the United States, 2014 40
Figure 4: Routine HBV Vaccination Coverage (%) in France 43
Figure 5: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in France, 2014 45
Figure 6: Routine HBV Vaccination Coverage (%) in Germany 47
Figure 7: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in Germany, 2014 48
Figure 8: Routine HBV Vaccination Coverage (%) in Italy 51
Figure 9: High-Prescriber Estimation of Pediatric HBV Patient Share in Italy, 2014 52
Figure 10: Routine HBV Vaccination Coverage (%) in Spain 55
Figure 11: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in Spain, 2014 56
Figure 12: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in the United Kingdom, 2014 60
Figure 13: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in Japan, 2014 64
Figure 14: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in Canada, 2014 68
Figure 15: HBV Vaccines - Clinical Trials by Country, 2014 140
Figure 16: Competitive Assessment of Late-Stage Pipeline Agents and Marketed Products in HBV Vaccines, 2012-2022 143
Figure 17: Global Sales for HBV Vaccines by Company, 2012-2022 160
Figure 18: Company Portfolio Gap Analysis in HBV Vaccines, 2012-2022 161
Figure 19: Global Sales for HBV Vaccines by Country, 2012-2022 180
Figure 20: Sales for HBV Vaccines in the United States by Vaccine, 2012-2022 190
Figure 21: Sales for HBV Vaccines in France by Vaccine, 2012-2022 203
Figure 22: Sales for HBV Vaccines in Germany by Vaccine, 2012-2022 211
Figure 23: Sales for HBV Vaccines in Italy by Vaccine, 2012-2022 219
Figure 24: Sales for HBV Vaccines in Spain by Vaccine, 2012-2022 227
Figure 25: Sales for HBV Vaccines in the United Kingdom by Vaccine, 2012-2022 234
Figure 26: Sales for HBV Vaccines in Japan by Vaccine, 2012-2022 241
Figure 27: Sales for HBV Vaccines in Canada by Vaccine, 2012-2022 247
  1. GSK
  2. Merck
  3. Sanofi
  4. Kaketsuken
  5. Dynavax Technologies
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