Summary
Influenza, often referred to as the flu, is an acute infection caused by one of the three closely related viruses, designated as influenza Type A, B, and C. The infection’s rapid onset and potential for high morbidity and mortality, particularly in high-risk patient populations such as the elderly and young children, make prompt and effective treatment with antiviral medication very difficult. For these reasons, prophylactic vaccination is the preferred intervention for seasonal influenza.
The US will experience solid growth in seasonal influenza vaccine sales during the forecast period, and this growth will be driven by a significant shift in the market share distribution of the different vaccine types. The US market will experience the largest nominal change of any country in the 7MM.
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Scope
- Overview of Seasonal Influenza Vaccines 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 the US including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the US from 2015-2025.
- Analysis of the impact of key events as well the drivers and restraints affecting the US Seasonal Influenza Vaccines 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 Seasonal Influenza Vaccines.
- 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 2015-2025 in the US.
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1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 6
1.2 List of Figures 10
2 Introduction 11
2.1 Catalyst 11
2.2 Related Reports 12
2.3 Upcoming Related Reports 12
3 Disease Overview 13
3.1 Etiology and Pathophysiology 13
3.1.1 Etiology 13
3.1.2 Pathophysiology 18
3.1.3 Symptoms and Prognosis 19
4 Disease Management 21
4.1 Seasonal Influenza Immunization Policy 21
4.1.1 Immunization Recommendations and Most Frequently Administered Seasonal Influenza Vaccines 22
4.2 US 24
4.2.1 Influenza Immunization Recommendations and Policies 25
4.2.2 Clinical Practice 28
5 Competitive Assessment 30
5.1 Overview 30
5.2 Product Profiles - Major Brands, Inactivated Vaccines 32
5.2.1 Fluzone Quadrivalent 32
5.2.2 Fluzone High-Dose 38
5.2.3 Fluzone Intradermal 45
5.2.4 Vaxigrip 53
5.2.5 Fluarix Tetra 59
5.2.6 Fluvirin 66
5.2.7 Afluria 71
5.2.8 Agrippal 77
5.3 Product Profiles - Major Brands, Inactivated Vaccines (Adjuvanted) 81
5.3.1 Fluad 81
5.4 Product Profiles - Major Brands, Live-Attenuated Vaccines 88
5.4.1 FluMist Quadrivalent 88
5.5 Product Profiles - Major Brands, Cell Cultured Vaccines 96
5.5.1 Flublok 96
5.5.2 Flucelvax 103
5.6 Other Seasonal Influenza Vaccines 110
5.6.1 Influvac 110
5.6.2 Minor Brands 112
6 Unmet Needs and Opportunity Analysis 113
6.1 Overview 113
6.2 Higher Level of Public Awareness and Positive Perception of Influenza Vaccines 117
6.2.1 Unmet Need 117
6.2.2 Gap Analysis 118
6.2.3 Opportunity 121
6.3 Immunization Policies Targeting Children and Adolescents 122
6.3.1 Unmet Need 122
6.3.2 Gap Analysis 123
6.3.3 Opportunity 123
6.4 Enhanced Vaccine Efficacy in High-Risk Groups 125
6.4.1 Unmet Need 125
6.4.2 Gap Analysis 126
6.4.3 Opportunity 128
6.5 Vaccines Leveraging Innovative and Efficient Manufacturing Technologies 129
6.5.1 Unmet Need 129
6.5.2 Gap Analysis 130
6.5.3 Opportunity 131
6.6 Improving the Cost-Effectiveness of Influenza Vaccines 132
6.6.1 Unmet Need 132
6.6.2 Gap Analysis 133
6.6.3 Opportunity 134
6.7 Vaccines with Broader Influenza Strain Coverage 135
6.7.1 Unmet Need 135
6.7.2 Gap Analysis 136
6.7.3 Opportunity 137
6.8 Improved Vaccine Safety Profile 138
6.8.1 Unmet Need 138
6.8.2 Gap Analysis 139
6.8.3 Opportunity 140
7 Pipeline Assessment 141
7.1 Overview 141
7.2 Promising Vaccines in Clinical Development 142
7.2.1 Seasonal Influenza VLP Vaccine 147
7.2.2 VN-100 156
7.2.3 Quadrivalent Seasonal Influenza VLP Vaccine 164
7.3 Promising Vaccines in Early-Stage Development 172
7.3.1 FLU-v 173
7.3.2 M-001 174
7.3.3 TAK-850 175
7.3.4 VAX-2012Q 175
7.4 Other Vaccines in Development Outside the 7MM 176
8 Market Outlook 177
8.1 US 177
8.1.1 Forecast 177
8.1.2 Key Events 184
8.1.3 Drivers and Barriers 185
9 Appendix 186
9.1 Bibliography 186
9.2 Abbreviations 224
9.3 Methodology 228
9.4 Forecasting Methodology 228
9.4.1 Vaccine Coverage 228
9.4.2 Vaccines Included 229
9.4.3 Key Launch Dates 229
9.4.4 Influenza Vaccine Tender System Assumptions 230
9.4.5 General Pricing Assumptions 231
9.4.6 Individual Vaccine Assumptions 232
9.4.7 Pricing of Pipeline Agents 240
9.5 Primary Research - KOLs Interviewed for this Report 241
9.6 Primary Research - Prescriber Survey 244
9.7 About the Authors 245
9.7.1 Analyst 245
9.7.2 Therapy Area Director 245
9.7.3 Epidemiologists 246
9.7.4 Director of Epidemiology 247
9.7.5 Global Director of Therapy Analysis and Epidemiology 247
9.8 About GlobalData 248
9.9 Disclaimer 248
1.1 List of Tables
Table 1: Notable Influenza Pandemics 18
Table 2: Influenza Symptoms 20
Table 3: Seasonal Influenza Immunization Recommendation Agencies by Country, 2016 22
Table 4: Immunization Recommendations and Most Frequently Administered Seasonal Influenza Vaccines, 2016 24
Table 5: Country Profile - US 25
Table 6: Leading Seasonal Influenza Vaccines, 2016 31
Table 7: Product Profile - Fluzone Quadrivalent 33
Table 8: Immunogenicity Profile of Fluzone Quadrivalent 34
Table 9: Local and Systemic AEs of Fluzone Quadrivalent 35
Table 10: Fluzone Quadrivalent SWOT Analysis, 2016 36
Table 11: Global Sales Forecast ($m) for Fluzone Quadrivalent, 2015-2025 38
Table 12: Product Profile - Fluzone High-Dose 39
Table 13: Immunogenicity of Fluzone High-Dose Compared with Fluzone 41
Table 14: Local and Systemic AEs of Fluzone High-Dose 42
Table 15: Fluzone High-Dose SWOT Analysis, 2016 43
Table 16: Global Sales Forecast ($m) for Fluzone High-Dose, 2015-2025 45
Table 17: Product Profile - Fluzone Intradermal 47
Table 18: Comparison of Fluzone Intradermal Quadrivalent Versus Fluzone Intradermal Trivalent 49
Table 19: Local andsystemic AEs of Fluzone Intradermal Quadrivalent 50
Table 20: Fluzone Intradermal Quadrivalent SWOT Analysis, 2016 51
Table 21: Global Sales Forecast ($m) for Fluzone/Intanza Intradermal, 2015-2025 53
Table 22: Product Profile - Vaxigrip 55
Table 23: Cumulative Incidence of Influenza Infection in Children 56
Table 24: Local and Systemic AEs of Vaxigrip 57
Table 25: Vaxigrip SWOT Analysis, 2016 57
Table 26: Global Sales Forecast ($m) for Vaxigrip, 2015-2025 59
Table 27: Product Profile - Fluarix Tetra 61
Table 28: Immunogenicity Profile of Fluarix Tetra 62
Table 29: Local and Systemic AEs of Fluarix Tetra 63
Table 30: Fluarix Tetra SWOT Analysis, 2016 64
Table 31: Global Sales Forecast ($m) for Fluarix Tetra, 2015-2025 66
Table 32: Product Profile - Fluvirin 67
Table 33: Immunogenicity of Fluvirin in Adults 68
Table 34: Local and Systemic AEs of Fluvirin 69
Table 35: Fluvirin SWOT Analysis, 2016 70
Table 36: Global Sales Forecast ($m) for Fluvirin, 2015-2025 71
Table 37: Product Profile - Afluria 72
Table 38: Immunogenicity of Afluria in Adults 73
Table 39: Local and Systemic AEs of Afluria 74
Table 40: Afluria SWOT Analysis, 2016 75
Table 41: Global Sales Forecast ($m) for Afluria, 2015-2025 76
Table 42: Product Profile - Agrippal 78
Table 43: Immunogenicity of Agrippal 79
Table 44: Local and Systemic AEs of Agrippal 79
Table 45: Agrippal SWOT Analysis, 2016 80
Table 46: Global Sales Forecast ($m) for Agrippal, 2015-2025 81
Table 47: Product Profile - Fluad 83
Table 48: Immunogenicity Comparison of Fluad Versus Agriflu 84
Table 49: Local and Systemic AEs of Fluad 85
Table 50: Fluad SWOT Analysis, 2016 86
Table 51: Global Sales Forecast ($m) for Fluad, 2015-2025 88
Table 52: Product Profile - FluMist Quadrivalent 90
Table 53: Noninferiority of FluMist Quadrivalent Compared with FluMist Trivalent 92
Table 54: AEs of FluMist Quadrivalent 93
Table 55: FluMist Quadrivalent SWOT Analysis, 2016 93
Table 56: Global Sales Forecast ($m) for FluMist Quadrivalent, 2015-2025 95
Table 57: Product Profile - Flublok 97
Table 58: Immunogenicity of Flublok compared with Fluzone and Fluzone High-Dose 99
Table 59: Local and Systemic AEs of Flublok 100
Table 60: Flublok SWOT Analysis, 2016 101
Table 61: Global Sales Forecast ($m) for Flublok, 2015-2025 103
Table 62: Product Profile - Flucelvax 105
Table 63: Immunogenicity of Flucelvax 106
Table 64: Local and Systemic AEs of Flucelvax 107
Table 65:Flucelvax SWOT Analysis, 2016 108
Table 66: Global Sales Forecast ($m) for Flucelvax, 2015-2025 110
Table 67: Summary of Other Marketed Seasonal Influenza Vaccines, 2016 112
Table 68: Unmet Need and Opportunity in Seasonal Influenza Vaccines, 2016 116
Table 69: Seasonal Influenza Vaccines - Late-Stage Pipeline, 2016 143
Table 70: Quadrivalent Versions of Marketed Vaccines 146
Table 71: Product Profile - Seasonal Influenza VLP Vaccine 149
Table 72: Seasonal Influenza VLP Vaccine SWOT Analysis, 2016 154
Table 73: Global Sales Forecast ($m) for Seasonal Influenza VLP Vaccine, 2015-2025 156
Table 74: Product Profile - VN-100 158
Table 75: Comparison of Immunogenicity Profile of VN-100 and Subcutaneous Standard Vaccine 159
Table 76: Frequency of Local and Systemic AEs of VN-100 Compared with a Comparator Subcutaneous Vaccine 160
Table 77: VN-100 SWOT Analysis, 2016 163
Table 78: Global Sales Forecast ($m) for VN-100, 2015-2025 164
Table 79: Product Profile - Quadrivalent Seasonal Influenza VLP Vaccine 166
Table 80: Quadrivalent Seasonal Influenza VLP Vaccine SWOT Analysis, 2016 170
Table 81: Global Sales Forecast ($m) for Quadrivalent Seasonal Influenza VLP Vaccine, 2015-2025 172
Table 82: Promising Vaccines in Early-Stage Development, 2016 173
Table 83: Summary of Seasonal Influenza Vaccines in Development Outside the 7MM, 2016 176
Table 84: Sales Forecasts ($m) for Seasonal Influenza Vaccines in the US, 2015-2025 182
Table 85: Key Events Impacting Sales for Seasonal Influenza in the US, 2015‒2025 184
Table 86: US Seasonal Influenza Vaccines Market - Drivers and Barriers, 2015‒2025 185
Table 87: Key Launch Dates 230
Table 88: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 244
1.2 List of Figures
Figure 1: Influenza Virus Structure 15
Figure 2: Seasonal Influenza Vaccines - Phase II/Phase III Pipeline, 2016 143
Figure 3: Competitive Assessment of the Late-Stage Pipeline Vaccines for Seasonal Influenza, 2015-2025 144
Figure 4: Sales of Seasonal Influenza Vaccines by Class in the US, 2015 and 2025 183
