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.
A quadrivalent formulation of Intanza Intradermal is anticipated to be launched in the EU, following the launch of quadrivalent Fluzone Intradermal in the US. The sales of quadrivalent Intanza Intradermal are expected to increase to $1.5m in 2025. Its growth will be driven by its improved immunogenicity in elderly patients compared to typical influenza vaccines and the increase in the size of Germany’s elderly population.
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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 5EU including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in 5EU from 2015-2025.
- Analysis of the impact of key events as well the drivers and restraints affecting 5EU 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 5EU.
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1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 12
2 Introduction 13
2.1 Catalyst 13
2.2 Related Reports 14
2.3 Upcoming Related Reports 14
3 Disease Overview 15
3.1 Etiology and Pathophysiology 15
3.1.1 Etiology 15
3.1.2 Pathophysiology 20
3.1.3 Symptoms and Prognosis 21
4 Disease Management 23
4.1 Seasonal Influenza Immunization Policy 23
4.1.1 Immunization Recommendations and Most Frequently Administered Seasonal Influenza Vaccines 24
4.2 France 26
4.2.1 Influenza Immunization Recommendations and Policies 28
4.2.2 Clinical Practice 29
4.3 Germany 31
4.3.1 Influenza Immunization Recommendations and Policies 32
4.3.2 Clinical Practice 34
4.4 Italy 36
4.4.1 Influenza Immunization Recommendations and Policies 38
4.4.2 Clinical Practice 40
4.5 Spain 42
4.5.1 Influenza Immunization Recommendations and Policies 44
4.5.2 Clinical Practice 46
4.6 UK 47
4.6.1 Influenza Immunization Recommendations and Policies 49
4.6.2 Clinical Practice 51
5 Competitive Assessment 53
5.1 Overview 53
5.2 Product Profiles - Major Brands, Inactivated Vaccines 55
5.2.1 Fluzone Quadrivalent 55
5.2.2 Fluzone High-Dose 61
5.2.3 Fluzone Intradermal 68
5.2.4 Vaxigrip 76
5.2.5 Fluarix Tetra 82
5.2.6 Fluvirin 89
5.2.7 Afluria 94
5.2.8 Agrippal 100
5.3 Product Profiles - Major Brands, Inactivated Vaccines (Adjuvanted) 104
5.3.1 Fluad 104
5.4 Product Profiles - Major Brands, Live-Attenuated Vaccines 111
5.4.1 FluMist Quadrivalent 111
5.5 Product Profiles - Major Brands, Cell Cultured Vaccines 119
5.5.1 Flublok 119
5.5.2 Flucelvax 126
5.6 Other Seasonal Influenza Vaccines 133
5.6.1 Influvac 133
5.6.2 Minor Brands 135
6 Unmet Needs and Opportunity Analysis 136
6.1 Overview 136
6.2 Higher Level of Public Awareness and Positive Perception of Influenza Vaccines 140
6.2.1 Unmet Need 140
6.2.2 Gap Analysis 141
6.2.3 Opportunity 144
6.3 Immunization Policies Targeting Children and Adolescents 145
6.3.1 Unmet Need 145
6.3.2 Gap Analysis 146
6.3.3 Opportunity 146
6.4 Enhanced Vaccine Efficacy in High-Risk Groups 148
6.4.1 Unmet Need 148
6.4.2 Gap Analysis 149
6.4.3 Opportunity 151
6.5 Vaccines Leveraging Innovative and Efficient Manufacturing Technologies 152
6.5.1 Unmet Need 152
6.5.2 Gap Analysis 153
6.5.3 Opportunity 154
6.6 Improving the Cost-Effectiveness of Influenza Vaccines 155
6.6.1 Unmet Need 155
6.6.2 Gap Analysis 156
6.6.3 Opportunity 157
6.7 Vaccines with Broader Influenza Strain Coverage 158
6.7.1 Unmet Need 158
6.7.2 Gap Analysis 159
6.7.3 Opportunity 160
6.8 Improved Vaccine Safety Profile 161
6.8.1 Unmet Need 161
6.8.2 Gap Analysis 162
6.8.3 Opportunity 163
7 Pipeline Assessment 164
7.1 Overview 164
7.2 Promising Vaccines in Clinical Development 165
7.2.1 Seasonal Influenza VLP Vaccine 170
7.2.2 VN-100 179
7.2.3 Quadrivalent Seasonal Influenza VLP Vaccine 187
7.3 Promising Vaccines in Early-Stage Development 195
7.3.1 FLU-v 196
7.3.2 M-001 197
7.3.3 TAK-850 198
7.3.4 VAX-2012Q 198
7.4 Other Vaccines in Development Outside the 7MM 199
8 Market Outlook 200
8.1 France 200
8.1.1 Forecast 200
8.1.2 Key Events 204
8.1.3 Drivers and Barriers 204
8.2 Germany 205
8.2.1 Forecast 205
8.2.2 Key Events 209
8.2.3 Drivers and Barriers 209
8.3 Italy 210
8.3.1 Forecast 210
8.3.2 Key Events 214
8.3.3 Drivers and Barriers 215
8.4 Spain 216
8.4.1 Forecast 216
8.4.2 Key Events 220
8.4.3 Drivers and Barriers 220
8.5 United Kingdom 221
8.5.1 Forecast 221
8.5.2 Key Events 225
8.5.3 Drivers and Barriers 226
9 Appendix 227
9.1 Bibliography 227
9.2 Abbreviations 265
9.3 Methodology 269
9.4 Forecasting Methodology 269
9.4.1 Vaccine Coverage 269
9.4.2 Vaccines Included 270
9.4.3 Key Launch Dates 270
9.4.4 Influenza Vaccine Tender System Assumptions 271
9.4.5 General Pricing Assumptions 272
9.4.6 Individual Vaccine Assumptions 273
9.4.7 Pricing of Pipeline Agents 281
9.5 Primary Research - KOLs Interviewed for this Report 282
9.6 Primary Research - Prescriber Survey 285
9.7 About the Authors 286
9.7.1 Analyst 286
9.7.2 Therapy Area Director 286
9.7.3 Epidemiologists 287
9.7.4 Director of Epidemiology 288
9.7.5 Global Director of Therapy Analysis and Epidemiology 288
9.8 About GlobalData 289
9.9 Disclaimer 289
1.1 List of Tables
Table 1: Notable Influenza Pandemics 20
Table 2: Influenza Symptoms 22
Table 3: Seasonal Influenza Immunization Recommendation Agencies by Country, 2016 24
Table 4: Immunization Recommendations and Most Frequently Administered Seasonal Influenza Vaccines, 2016 26
Table 5: Country Profile - France 27
Table 6: Country Profile - Germany 32
Table 7: Country Profile - Italy 38
Table 8: Country Profile - Spain 44
Table 9: Country Profile - UK 48
Table 10: Leading Seasonal Influenza Vaccines, 2016 54
Table 11: Product Profile - Fluzone Quadrivalent 56
Table 12: Immunogenicity Profile of Fluzone Quadrivalent 57
Table 13: Local and Systemic AEs of Fluzone Quadrivalent 58
Table 14: Fluzone Quadrivalent SWOT Analysis, 2016 59
Table 15: Global Sales Forecast ($m) for Fluzone Quadrivalent, 2015-2025 61
Table 16: Product Profile - Fluzone High-Dose 62
Table 17: Immunogenicity of Fluzone High-Dose Compared with Fluzone 64
Table 18: Local and Systemic AEs of Fluzone High-Dose 65
Table 19: Fluzone High-Dose SWOT Analysis, 2016 66
Table 20: Global Sales Forecast ($m) for Fluzone High-Dose, 2015-2025 68
Table 21: Product Profile - Fluzone Intradermal 70
Table 22: Comparison of Fluzone Intradermal Quadrivalent Versus Fluzone Intradermal Trivalent 72
Table 23: Local andsystemic AEs of Fluzone Intradermal Quadrivalent 73
Table 24: Fluzone Intradermal Quadrivalent SWOT Analysis, 2016 74
Table 25: Global Sales Forecast ($m) for Fluzone/Intanza Intradermal, 2015-2025 76
Table 26: Product Profile - Vaxigrip 78
Table 27: Cumulative Incidence of Influenza Infection in Children 79
Table 28: Local and Systemic AEs of Vaxigrip 80
Table 29: Vaxigrip SWOT Analysis, 2016 80
Table 30: Global Sales Forecast ($m) for Vaxigrip, 2015-2025 82
Table 31: Product Profile - Fluarix Tetra 84
Table 32: Immunogenicity Profile of Fluarix Tetra 85
Table 33: Local and Systemic AEs of Fluarix Tetra 86
Table 34: Fluarix Tetra SWOT Analysis, 2016 87
Table 35: Global Sales Forecast ($m) for Fluarix Tetra, 2015-2025 89
Table 36: Product Profile - Fluvirin 90
Table 37: Immunogenicity of Fluvirin in Adults 91
Table 38: Local and Systemic AEs of Fluvirin 92
Table 39: Fluvirin SWOT Analysis, 2016 93
Table 40: Global Sales Forecast ($m) for Fluvirin, 2015-2025 94
Table 41: Product Profile - Afluria 95
Table 42: Immunogenicity of Afluria in Adults 96
Table 43: Local and Systemic AEs of Afluria 97
Table 44: Afluria SWOT Analysis, 2016 98
Table 45: Global Sales Forecast ($m) for Afluria, 2015-2025 99
Table 46: Product Profile - Agrippal 101
Table 47: Immunogenicity of Agrippal 102
Table 48: Local and Systemic AEs of Agrippal 102
Table 49: Agrippal SWOT Analysis, 2016 103
Table 50: Global Sales Forecast ($m) for Agrippal, 2015-2025 104
Table 51: Product Profile - Fluad 106
Table 52: Immunogenicity Comparison of Fluad Versus Agriflu 107
Table 53: Local and Systemic AEs of Fluad 108
Table 54: Fluad SWOT Analysis, 2016 109
Table 55: Global Sales Forecast ($m) for Fluad, 2015-2025 111
Table 56: Product Profile - FluMist Quadrivalent 113
Table 57: Noninferiority of FluMist Quadrivalent Compared with FluMist Trivalent 115
Table 58: AEs of FluMist Quadrivalent 116
Table 59: FluMist Quadrivalent SWOT Analysis, 2016 116
Table 60: Global Sales Forecast ($m) for FluMist Quadrivalent, 2015-2025 118
Table 61: Product Profile - Flublok 120
Table 62: Immunogenicity of Flublok compared with Fluzone and Fluzone High-Dose 122
Table 63: Local and Systemic AEs of Flublok 123
Table 64: Flublok SWOT Analysis, 2016 124
Table 65: Global Sales Forecast ($m) for Flublok, 2015-2025 126
Table 66: Product Profile - Flucelvax 128
Table 67: Immunogenicity of Flucelvax 129
Table 68: Local and Systemic AEs of Flucelvax 130
Table 69:Flucelvax SWOT Analysis, 2016 131
Table 70: Global Sales Forecast ($m) for Flucelvax, 2015-2025 133
Table 71: Summary of Other Marketed Seasonal Influenza Vaccines, 2016 135
Table 72: Unmet Need and Opportunity in Seasonal Influenza Vaccines, 2016 139
Table 73: Seasonal Influenza Vaccines - Late-Stage Pipeline, 2016 166
Table 74: Quadrivalent Versions of Marketed Vaccines 169
Table 75: Product Profile - Seasonal Influenza VLP Vaccine 172
Table 76: Seasonal Influenza VLP Vaccine SWOT Analysis, 2016 177
Table 77: Global Sales Forecast ($m) for Seasonal Influenza VLP Vaccine, 2015-2025 179
Table 78: Product Profile - VN-100 181
Table 79: Comparison of Immunogenicity Profile of VN-100 and Subcutaneous Standard Vaccine 182
Table 80: Frequency of Local and Systemic AEs of VN-100 Compared with a Comparator Subcutaneous Vaccine 183
Table 81: VN-100 SWOT Analysis, 2016 186
Table 82: Global Sales Forecast ($m) for VN-100, 2015-2025 187
Table 83: Product Profile - Quadrivalent Seasonal Influenza VLP Vaccine 189
Table 84: Quadrivalent Seasonal Influenza VLP Vaccine SWOT Analysis, 2016 193
Table 85: Global Sales Forecast ($m) for Quadrivalent Seasonal Influenza VLP Vaccine, 2015-2025 195
Table 86: Promising Vaccines in Early-Stage Development, 2016 196
Table 87: Summary of Seasonal Influenza Vaccines in Development Outside the 7MM, 2016 199
Table 88: Sales Forecasts ($m) for Seasonal Influenza Vaccines in France, 2015 -2025 202
Table 89: Key Events Impacting Sales for Seasonal Influenza in France, 2015‒2025 204
Table 90: France Seasonal Influenza Vaccines Market - Drivers and Barriers, 2015‒2025 204
Table 91: Sales Forecasts ($m) for Seasonal Influenza Vaccines in Germany, 2015 -2025 207
Table 92: Key Events Impacting Sales for Seasonal Influenza in Germany, 2015‒2025 209
Table 93: Germany Seasonal Influenza Vaccines Market - Drivers and Barriers, 2015‒2025 209
Table 94: Sales Forecasts ($m) for Seasonal Influenza Vaccines in Italy, 2015-2025 212
Table 95: Key Events Impacting Sales for Seasonal Influenza in Italy, 2015‒2025 214
Table 96: Italy Seasonal Influenza Vaccines Market - Drivers and Barriers, 2015‒2025 215
Table 97: Sales Forecasts ($m) for Seasonal Influenza Vaccines in Spain, 2015 -2025 218
Table 98: Key Events Impacting Sales for Seasonal Influenza in Spain, 2015‒2025 220
Table 99: Spain Seasonal Influenza Vaccines Market - Drivers and Barriers, 2015‒2025 220
Table 100: Sales Forecasts ($m) for Seasonal Influenza Vaccines in the UK, 2015-2025 223
Table 101: Key Events Impacting Sales for Seasonal Influenza in the UK, 2015‒2025 225
Table 102: UK Seasonal Influenza Vaccines Market - Drivers and Barriers, 2015‒2025 226
Table 103: Key Launch Dates 271
Table 104: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 285
1.2 List of Figures
Figure 1: Influenza Virus Structure 17
Figure 2: Seasonal Influenza Vaccines - Phase II/Phase III Pipeline, 2016 166
Figure 3: Competitive Assessment of the Late-Stage Pipeline Vaccines for Seasonal Influenza, 2015-2025 167
Figure 4: Sales of Seasonal Influenza Vaccines by Class in France, 2015 and 2025 203
Figure 5: Sales of Seasonal Influenza Vaccines by Class in Germany, 2015 and 2025 208
Figure 6: Sales of Seasonal Influenza Vaccines by Class in Italy, 2015 and 2025 213
Figure 7: Sales of Seasonal Influenza Vaccines by Class in Spain, 2015 and 2025 219
Figure 8: Sales of Seasonal Influenza Vaccines by Class in the UK, 2015 and 2025 224
