1 Table of Contents
1 Table of Contents 10
1.1 List of Tables 17
1.2 List of Figures 24
2 Introduction 26
2.1 Catalyst 26
2.2 Related Reports 27
2.3 Upcoming Related Reports 27
3 Disease Overview 28
3.1 Etiology and Pathophysiology 28
3.1.1 Etiology 28
3.1.2 Pathophysiology 33
3.1.3 Symptoms and Prognosis 34
4 Epidemiology 36
4.1 Disease Background 36
4.2 Risk Factors and Comorbidities 38
4.3 Global Trends 38
4.3.1 Historical Perspective of Vaccination Coverage 39
4.3.2 Laboratory Confirmed Influenza Cases 42
4.3.3 Hospitalization Due to Influenza 42
4.3.4 Influenza Averted Cases 43
4.4 Forecast Methodology 43
4.4.1 Sources Used Tables 44
4.4.2 Forecast Assumptions and Methods 48
4.4.3 Sources Not Used 62
4.5 Epidemiological Forecast for Seasonal Influenza (2015-2025) 63
4.5.1 Seasonal Influenza Vaccination 63
4.5.2 Seasonal Influenza Vaccination Rates 69
4.5.3 Diagnosed Outpatient Influenza-Like Illness Incident Cases 72
4.5.4 Lab Confirmed Incident Cases of Seasonal Influenza 79
4.5.5 Influenza-Related Hospitalized Incident Cases 85
4.5.6 Cases Averted by Seasonal Influenza Vaccinations 91
4.6 Discussion 95
4.6.1 Epidemiological Forecast Insight 95
4.6.2 Limitations of Analysis 96
4.6.3 Strengths of Analysis 97
5 Disease Management 98
5.1 Seasonal Influenza Immunization Policy 98
5.1.1 Immunization Recommendations and Most Frequently Administered Seasonal Influenza Vaccines 99
5.2 US 101
5.2.1 Influenza Immunization Recommendations and Policies 102
5.2.2 Clinical Practice 105
5.3 France 107
5.3.1 Influenza Immunization Recommendations and Policies 108
5.3.2 Clinical Practice 110
5.4 Germany 111
5.4.1 Influenza Immunization Recommendations and Policies 113
5.4.2 Clinical Practice 115
5.5 Italy 117
5.5.1 Influenza Immunization Recommendations and Policies 119
5.5.2 Clinical Practice 121
5.6 Spain 123
5.6.1 Influenza Immunization Recommendations and Policies 124
5.6.2 Clinical Practice 126
5.7 UK 127
5.7.1 Influenza Immunization Recommendations and Policies 129
5.7.2 Clinical Practice 131
5.8 Japan 133
5.8.1 Influenza Immunization Recommendations and Policies 134
5.8.2 Clinical Practice 135
6 Competitive Assessment 138
6.1 Overview 138
6.2 Product Profiles – Major Brands, Inactivated Vaccines 140
6.2.1 Fluzone Quadrivalent 140
6.2.2 Fluzone High-Dose 146
6.2.3 Fluzone Intradermal 153
6.2.4 Vaxigrip 161
6.2.5 Fluarix Tetra 167
6.2.6 Fluvirin 174
6.2.7 Afluria 179
6.2.8 Agrippal 185
6.3 Product Profiles – Major Brands, Inactivated Vaccines (Adjuvanted) 189
6.3.1 Fluad 189
6.4 Product Profiles – Major Brands, Live-Attenuated Vaccines 196
6.4.1 FluMist Quadrivalent 196
6.5 Product Profiles – Major Brands, Cell Cultured Vaccines 204
6.5.1 Flublok 204
6.5.2 Flucelvax 211
6.6 Other Seasonal Influenza Vaccines 218
6.6.1 Influvac 218
6.6.2 Minor Brands 220
7 Unmet Needs and Opportunity Analysis 221
7.1 Overview 221
7.2 Higher Level of Public Awareness and Positive Perception of Influenza Vaccines 225
7.2.1 Unmet Need 225
7.2.2 Gap Analysis 226
7.2.3 Opportunity 229
7.3 Immunization Policies Targeting Children and Adolescents 230
7.3.1 Unmet Need 230
7.3.2 Gap Analysis 231
7.3.3 Opportunity 231
7.4 Enhanced Vaccine Efficacy in High-Risk Groups 233
7.4.1 Unmet Need 233
7.4.2 Gap Analysis 234
7.4.3 Opportunity 236
7.5 Vaccines Leveraging Innovative and Efficient Manufacturing Technologies 237
7.5.1 Unmet Need 237
7.5.2 Gap Analysis 238
7.5.3 Opportunity 239
7.6 Improving the Cost-Effectiveness of Influenza Vaccines 240
7.6.1 Unmet Need 240
7.6.2 Gap Analysis 241
7.6.3 Opportunity 242
7.7 Vaccines with Broader Influenza Strain Coverage 243
7.7.1 Unmet Need 243
7.7.2 Gap Analysis 244
7.7.3 Opportunity 245
7.8 Improved Vaccine Safety Profile 246
7.8.1 Unmet Need 246
7.8.2 Gap Analysis 247
7.8.3 Opportunity 248
8 Pipeline Assessment 249
8.1 Overview 249
8.2 Promising Vaccines in Clinical Development 250
8.2.1 Seasonal Influenza VLP Vaccine 255
8.2.2 VN-100 264
8.2.3 Quadrivalent Seasonal Influenza VLP Vaccine 272
8.3 Promising Vaccines in Early-Stage Development 280
8.3.1 FLU-v 281
8.3.2 M-001 282
8.3.3 TAK-850 283
8.3.4 VAX-2012Q 283
8.4 Other Vaccines in Development Outside the 7MM 284
9 Current and Future Players 285
9.1 Overview 285
9.2 Trends in Corporate Strategy 289
9.3 Company Profiles – Major Players 292
9.3.1 Sanofi 292
9.3.2 CSL Limited (Seqirus) 294
9.3.3 GlaxoSmithKline 296
9.3.4 AstraZeneca (MedImmune) 297
9.3.5 Protein Sciences Corporation 300
9.3.6 Mitsubishi Tanabe Pharma 302
9.3.7 Novavax 303
9.4 Other Companies 305
9.4.1 Mylan 305
9.4.2 Daiichi Sankyo 306
10 Market Outlook 307
10.1 Global Markets 307
10.1.1 Forecast 307
10.1.2 Drivers and Barriers – Global Issues 313
10.2 US 314
10.2.1 Forecast 314
10.2.2 Key Events 321
10.2.3 Drivers and Barriers 322
10.3 France 323
10.3.1 Forecast 323
10.3.2 Key Events 327
10.3.3 Drivers and Barriers 327
10.4 Germany 328
10.4.1 Forecast 328
10.4.2 Key Events 332
10.4.3 Drivers and Barriers 332
10.5 Italy 333
10.5.1 Forecast 333
10.5.2 Key Events 337
10.5.3 Drivers and Barriers 338
10.6 Spain 339
10.6.1 Forecast 339
10.6.2 Key Events 343
10.6.3 Drivers and Barriers 343
10.7 United Kingdom 344
10.7.1 Forecast 344
10.7.2 Key Events 348
10.7.3 Drivers and Barriers 349
10.8 Japan 349
10.8.1 Forecast 349
10.8.2 Key Events 354
10.8.3 Drivers and Barriers 355
11 Appendix 356
11.1 Bibliography 356
11.2 Abbreviations 394
11.3 Methodology 398
11.4 Forecasting Methodology 398
11.4.1 Vaccine Coverage 398
11.4.2 Vaccines Included 399
11.4.3 Key Launch Dates 399
11.4.4 Influenza Vaccine Tender System Assumptions 400
11.4.5 General Pricing Assumptions 401
11.4.6 Individual Vaccine Assumptions 402
11.4.7 Pricing of Pipeline Agents 410
11.5 Primary Research – KOLs Interviewed for this Report 411
11.6 Primary Research – Prescriber Survey 414
11.7 About the Authors 415
11.7.1 Analyst 415
11.7.2 Therapy Area Director 415
11.7.3 Epidemiologists 416
11.7.4 Director of Epidemiology 417
11.7.5 Global Director of Therapy Analysis and Epidemiology 417
11.8 About GlobalData 418
11.9 Disclaimer 418