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PharmaPoint: Prophylactic Hepatitis B Virus Vaccines - Global Drug Forecast and Market Analysis to 2022
Publication Date Feb 2014
Publisher GlobalData
Product Type Report
Pages 301
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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.

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.

Market Model Features
An interactive excel forecast model based on primary research interviews and surveys with KOLs and high-prescribing physicians is included in this report*. This patient based model provides diagnosis rates, patient segmentation, treatment rates, annual costs of therapy , and indication-specific drug sales for the 10 year forecast period. The forecast model is robust, fully transparent, and easy to navigate. Moreover, our models support data presented in the reports and the complete methodology is outlined in the report and the model.

*Model only available with site and global license purchases.

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.

Key Questions Answered in this Report

   -  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 Benefits
- 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.

Companies Mentioned
GlaxoSmithKline
Merck
Sanofi
Kaketsuken
Dynavax Technologies Corporation
SciGen Ltd.

Report at a Glance
Number of Pages – 300+
Number of Tables – 106
Number of Figures – 30
Number of Companies Mentioned – 6
Number of Marketed and Pipeline Vaccines Mentioned – 14
Pipeline Vaccine Mentioned – 1 Phase III vaccine, 1 Phase II vaccines
Companies Covered – GlaxoSmithKline, Merck, Sanofi, Kaketsuken, Dynavax Technologies Corporation
Markets Covered – US, France, Germany, Italy, Spain, UK, Japan, and Canada
KOL’s Interviewed – 9
High Prescribers Surveyed – 101
 

Table of Contents
1    Table of Contents    9

1.1    List of Tables    16

1.2    List of Figures    20

2    Introduction    22

2.1    Catalyst    22

2.2    Related Reports    23

2.3    Upcoming Related Reports    24

3    Disease Overview    25

3.1    Overview    25

3.2    Etiology and Pathophysiology    26

3.2.1    Etiology    26

3.2.2    Pathophysiology    30

3.3    Symptoms    32

3.4    Prognosis    34

4    Vaccination Recommendations and Coverage Rates    35

4.1    Overview    35

4.2    US    38

4.2.1    Immunization Recommendations and Policies    38

4.2.2    Vaccination Coverage    40

4.2.3    Clinical Practice    41

4.3    France    43

4.3.1    Immunization Recommendations and Policies    43

4.3.2    Vaccination Coverage    44

4.3.3    Clinical Practice    46

4.4    Germany    47

4.4.1    Immunization Recommendations and Policies    47

4.4.2    Vaccination Coverage    48

4.4.3    Clinical Practice    49

4.5    Italy    51

4.5.1    Immunization Recommendations and Policies    51

4.5.2    Vaccination Coverage    52

4.5.3    Clinical Practice    53

4.6    Spain    55

4.6.1    Immunization Recommendations and Policies    55

4.6.2    Vaccination Coverage    56

4.6.3    Clinical Practice    57

4.7    UK    59

4.7.1    Immunization Recommendations and Policies    59

4.7.2    Vaccination Coverage    60

4.7.3    Clinical Practice    61

4.8    Japan    62

4.8.1    Immunization Recommendations and Policies    62

4.8.2    Vaccination Coverage    63

4.8.3    Clinical Practice    64

4.9    Canada    65

4.9.1    Immunization Recommendations and Policies    65

4.9.2    Vaccination Coverage    67

4.9.3    Clinical Practice    68

5    Competitive Assessment    70

5.1    Overview    70

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    200

9.3.1    Forecast    200

9.3.2    Key Events    203

9.3.3    Drivers and Barriers    204

9.4    Germany    207

9.4.1    Forecast    207

9.4.2    Key Events    211

9.4.3    Drivers and Barriers    212

9.5    Italy    216

9.5.1    Forecast    216

9.5.2    Key Events    219

9.5.3    Drivers and Barriers    220

9.6    Spain    223

9.6.1    Forecast    223

9.6.2    Key Events    227

9.6.3    Drivers and Barriers    228

9.7    UK    230

9.7.1    Forecast    230

9.7.2    Key Events    234

9.7.3    Drivers and Barriers    235

9.7.4    Alternative Market Scenario    238

9.8    Japan    238

9.8.1    Forecast    238

9.8.2    Drivers and Barriers    241

9.9    Canada    244

9.9.1    Forecast    244

9.9.2    Key Events    247

9.9.3    Drivers and Barriers    248

10    Appendix    252

10.1    Bibliography    252

10.2    Abbreviations    272

10.3    Methodology    276

10.4    Forecasting Methodology    276

10.4.1    Patient Populations Targeted for Vaccination    277

10.4.2    Vaccination Coverage Rates    280

10.4.3    Vaccinated Patients    281

10.4.4    Regulatory Approval vs. Advisory Committee Recommendation    281

10.4.5    Vaccines Included    282

10.4.6    Key Launch Dates    283

10.4.7    General Pricing Assumptions    284

10.4.8    Individual Vaccine Assumptions    285

10.4.9    Pricing of Pipeline Vaccines    295

10.5    Physicians and Specialists Included in this Study    296

10.5.1    Interviews of Key Opinion Leaders (KOLs)    296

10.5.2    Online Survey of High-Prescribing Physicians (non-KOLs)    298

10.6    About the Authors    299

10.6.1    Analyst    299

10.6.2    Therapy Area Director    299

10.6.3    Global Head of Healthcare    300

10.7    About GlobalData    301

10.8    Disclaimer    301

List Of Tables
Table 1: Modes of HBV Transmission    31

Table 2: HBV Serological Markers and Test Interpretations    32

Table 3: Symptoms of HBV Infection    33

Table 4: HBV Vaccination Advisory Committees by Country    36

Table 5: HBV Immunization Recommendations by Country    37

Table 6: Targeted Age Group(s) for Routine Immunization and Most Administered HBV Vaccines by Country in the Global Markets, 2014    38

Table 7: Targeted Age Group(s) for Routine HBV Immunization in Canada, by Province or Territory, 2014    67

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    201

Table 83: Key Events Impacting Sales for HBV Vaccines in France, 2014    203

Table 84: France HBV Vaccine Market – Drivers and Barriers, 2014    204

Table 85: Sales Forecasts ($m) for HBV Vaccines in Germany, 2012–2022    209

Table 86: Key Events Impacting Sales for HBV Vaccines in Germany, 2014    211

Table 87: Germany HBV Vaccine Market – Drivers and Barriers, 2014    212

Table 88: Sales Forecasts ($m) for HBV Vaccines in Italy, 2012–2022    217

Table 89: Key Events Impacting Sales for HBV Vaccines in Italy, 2014    219

Table 90: Italy HBV Vaccine Market – Drivers and Barriers, 2014    220

Table 91: Sales Forecasts ($m) for HBV Vaccines in Spain, 2012–2022    225

Table 92: Key Events Impacting Sales for HBV Vaccines in Spain, 2014    227

Table 93: Spain HBV Vaccine Market – Drivers and Barriers, 2014    228

Table 94: Sales Forecasts ($) for HBV Vaccines in the United Kingdom, 2012–2022    232

Table 95: Key Events Impacting Sales for HBV Vaccines in the United Kingdom, 2014    234

Table 96: United Kingdom HBV Vaccine Market – Drivers and Barriers, 2014    235

Table 97: Sales Forecasts ($) for HBV Vaccines in Japan, 2012–2022    239

Table 98: Japan HBV Vaccine Market – Drivers and Barriers, 2014    241

Table 99: Sales Forecasts ($) for HBV Vaccines in Canada, 2012–2022    245

Table 100: Canada HBV Vaccine Market – Drivers and Barriers, 2014    248

Table 101: Patient Population(s) Targeted for HBV Vaccination in the Pediatric Market, by Country    278

Table 102: Patient Population(s) Targeted for HBV Vaccination in the Adult Market, by Country    279

Table 103: Key Launch Dates    283

Table 104: High-Prescribing Physicians (non-KOLs) Surveyed, by Country    298

List Of Figures
Figure 1: HBV Structure and the Recombinant Vaccine Development Process    28

Figure 2: Routine HBV Vaccination Coverage (%) in the United States    42

Figure 3: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in the United States, 2014    43

Figure 4: Routine HBV Vaccination Coverage (%) in France    46

Figure 5: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in France, 2014    48

Figure 6: Routine HBV Vaccination Coverage (%) in Germany    50

Figure 7: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in Germany, 2014    51

Figure 8: Routine HBV Vaccination Coverage (%) in Italy    54

Figure 9: High-Prescriber Estimation of Pediatric HBV Patient Share in Italy, 2014    55

Figure 10: Routine HBV Vaccination Coverage (%) in Spain    58

Figure 11: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in Spain, 2014    59

Figure 12: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in the United Kingdom, 2014    63

Figure 13: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in Japan, 2014    66

Figure 14: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in Canada, 2014    70

Figure 15: HBV Vaccines – Clinical Trials by Country, 2014    141

Figure 16: Competitive Assessment of Late-Stage Pipeline Agents and Marketed Products in HBV Vaccines, 2012–2022    144

Figure 17: Global Sales for HBV Vaccines by Company, 2012–2022    161

Figure 18: Company Portfolio Gap Analysis in HBV Vaccines, 2012–2022    162

Figure 19: Global Sales for HBV Vaccines by Country, 2012–2022    181

Figure 20: Sales for HBV Vaccines in the United States by Vaccine, 2012–2022    191

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

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