Seasonal Influenza is a respiratory infection caused by influenza virus that results in mild to severe symptoms, such as fever, cold and cough. The market is heavily driven by the sales of prophylactic vaccine treatments to prevent infection. Currently, trivalent intramuscular vaccines such as Sanofi’s Fluzone and Vaxigrip, GlaxoSmithKline’s Fluarix and FluLaval and Novartis’ Fluvirin garner the majority stake of the market. However, with the entrance of vaccines with novel routes of administration, such as AstraZeneca’s intranasal FluMist and Sanofi’s Fluzone IntraDermal, GlobalData projects a dramatic shift favoring the adoption of such vaccines over the traditional intramuscular vaccines. GlobalData also anticipates that manufacturers that launch quadrivalent formulations will steal market share, patient share, and revenue from the trivalent influenza vaccines currently available.

Highlights

Key Questions Answered

• How big an impact will quadrivalent vaccines have on the seasonal influenza market? What do key opinion leaders think of this paradigm shift?

 

• What are the key vaccines for each segment in the population?

 

• Will vaccines with novel routes of administration face adoption challenges in the market? What is the projected uptake of intranasal FluMist or intradermal vaccines, like Fluzone IntraDermal, over the forecast period?

 

• The developmental pipeline consists of cell culture based vaccines. Which of these vaccines will attain high sales revenues during 2012-2022 and in which markets?

 

• What governmental and industry changes are likely to change the vaccination rates in the markets researched? Which is the biggest growth market globally?

 

Key Findings

• Quadrivalent vaccines are expected to cannibalize sales of trivalent vaccines or overtake trivalent vaccine sales.

 

• New market entrants will increase competitiveness in the areas of production, manufacturing, fidelity to circulating influenza strains and strength of immune response elicited.

 

• The initiation of a government initiative in the UK with Fluenz (FluMist) is anticipated to dramatically change market dynamics.

 

Scope

• Overview of seasonal influenza, including epidemiology, etiology, general symptoms from infection, and national vaccination recommendations and guidelines.

 

• Annualized seasonal influenza 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 seasonal influenza market.

 

• Pipeline analysis: comprehensive data split across different phases and emerging trends, specifically cell culture based vaccines and quadrivalent vaccines with novel routes of administration.

 

• Analysis of the current and future market competition in the global seasonal influenza 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 global seasonal influenza vaccine market.

 

• Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global seasonal influenza vaccine market in 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 seasonal influenza 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.

 

Table of Contents

 

1 Table of Contents 7

1.1 List of Tables 14

1.2 List of Figures 19

 

2 Introduction 21

2.1 Catalyst 21

2.2 Related Reports 22

2.3 Upcoming Related Reports 22

 

3 Disease Overview 23

3.1 Etiology and Pathophysiology 23

3.1.1 Etiology 23

3.1.2 Pathophysiology 27

3.2 Symptoms 28

3.3 Prognosis 29

 

4 Epidemiology 30

4.1 Risk Factors and Comorbidities 30

4.2 Global Trends 31

4.2.1 United States 31

4.2.2 France 35

4.2.3 Germany 38

4.2.4 Italy 41

4.2.5 Spain 44

4.2.6 United Kingdom 47

4.2.7 Japan 50

4.2.8 China 53

4.2.9 India 56

4.3 Forecast Methodology 58

4.3.1 Sources Used 63

4.3.2 Forecast Assumptions and Methods 69

4.4 Epidemiological Forecast (2012-2022) 75

4.4.1 Seasonal Influenza Vaccination Coverage, N (%) 75

4.5 Discussion 78

4.5.1 Global Vaccination Coverage Outlook 78

4.5.2 Limitations in Analysis 80

4.5.3 Strengths of Analysis 80

 

5 Disease Management 81

5.1 Influenza Vaccination Policy 81

5.2 United States 82

5.2.1 Influenza Vaccination Recommendations and Policies 82

5.2.2 Clinical Practice 84

5.3 France 85

5.3.1 Influenza Vaccination Recommendations and Policies 85

5.3.2 Clinical Practice 85

5.4 Germany 86

5.4.1 Influenza Vaccination Recommendations and Policies 86

5.4.2 Clinical Practice 87

5.5 Italy 88

5.5.1 Influenza Vaccination Recommendations and Policies 88

5.5.2 Clinical Practice 89

5.6 Spain 89

5.6.1 Influenza Vaccination Recommendations and Policies 89

5.6.2 Clinical Practice 90

5.7 United Kingdom 90

5.7.1 Influenza Vaccination Recommendations and Policies 90

5.7.2 Clinical Practice 91

5.8 Japan 92

5.8.1 Influenza Vaccination Recommendations and Policies 92

5.8.2 Clinical Practice 92

5.9 China 93

5.9.1 Influenza Vaccination Recommendations and Policies 93

5.9.2 Clinical Practice 93

5.10 India 94

5.10.1 Influenza Vaccination Recommendations and Policies 94

5.10.2 Clinical Practice 94

 

6 Competitive Assessment 95

6.1 Overview 95

6.2 Strategic Competitor Assessment 95

6.3 Product Profiles - Major Brands 97

6.3.1 Fluzone 97

6.3.2 Vaxigrip/Mutagrip 102

6.3.3 Fluarix/FluLaval 107

6.3.4 FluMist 112

6.3.5 Fluzone High-Dose 116

6.3.6 Fluad 122

6.3.7 Fluzone ID (Intradermal)/Intanza 126

6.3.8 Optaflu/Flucelvax 132

6.3.9 Flublok 138

6.3.10 Fluvirin 143

6.3.11 Afluria 147

6.3.12 Influvac 151

6.3.13 Agrippal 155

 

7 Opportunity and Unmet Need 160

7.1 Overview 160

7.2 Unmet Needs 160

7.2.1 Higher level of patient awareness 160

7.2.2 Increased efficacy in the elderly and young children ( 7.2.3 Improved vaccine side-effect profiles 161

7.2.4 More efficient vaccine manufacturing process 162

7.2.5 More cost-effective vaccines 162

7.3 Gap Analysis 163

7.4 Opportunities 164

7.4.1 Expanded breadth of protection against viral strains 164

7.4.2 Increased duration of protection 165

7.4.3 T-cell involvement 165

 

8 Pipeline Assessment 167

8.1 Overview 167

8.2 Clinical Trial Mapping 168

8.2.1 Clinical Trials by Country 168

8.3 Clinical Trials by Phase and Trial Status 169

8.4 Promising vaccines in clinical development 171

8.4.1 ASP7374 (UMN-0502) 173

8.4.2 Influenza VLP Vaccine 178

 

9 Current and Future Players 185

9.1 Overview 185

9.2 Trends in Corporate Strategy 188

9.3 Company Profiles 190

9.3.1 Sanofi 190

9.3.2 AstraZeneca (MedImmune) 194

9.3.3 Novartis 198

9.3.4 GlaxoSmithKline 203

9.3.5 CSL Biotherapies 207

9.3.6 Abbott 210

9.3.7 Protein Sciences Corporation 214

9.3.8 Novavax 218

 

10 Market Outlook 222

10.1 Global Markets 222

10.1.1 Forecast 222

10.1.2 Drivers and Barriers - Global Issues 225

10.2 United States 229

10.2.1 Forecast 229

10.2.2 Key Events 232

10.2.3 Drivers and Barriers 233

10.3 France 237

10.3.1 Forecast 237

10.3.2 Key Events 240

10.3.3 Drivers and Barriers 241

10.4 Germany 243

10.4.1 Forecast 243

10.4.2 Key Events 247

10.4.3 Drivers and Barriers 247

10.5 Italy 249

10.5.1 Forecast 249

10.5.2 Key Events 253

10.5.3 Drivers and Barriers 253

10.6 Spain 255

10.6.1 Forecast 255

10.6.2 Key Events 258

10.6.3 Drivers and Barriers 259

10.7 United Kingdom 261

10.7.1 Forecast 261

10.7.2 Key Events 264

10.7.3 Drivers and Barriers 265

10.8 Japan 268

10.8.1 Forecast 268

10.8.2 Key Events 270

10.8.3 Drivers and Barriers 270

10.9 China 272

10.9.1 Forecast 272

10.9.2 Key Events 274

10.9.3 Drivers and Barriers 275

10.10 India 276

10.10.1 Forecast 276

10.10.2 Key Events 278

10.10.3 Drivers and Barriers 279

 

11 Appendix 282

11.1 Bibliography 282

11.2 Abbreviations 306

11.3 Methodology 309

11.4 Forecasting Methodology 309

11.4.1 Vaccine Coverage 309

11.4.2 Vaccines Included 310

11.4.3 Key Launch Dates 311

11.4.4 Influenza Vaccine Tender System Assumptions 312

11.4.5 General Pricing Assumptions 312

11.4.6 Individual Vaccine Assumptions 313

11.4.7 Pricing of Pipeline Agents 324

11.5 Physicians and Specialists Included in this Study 325

11.6 Primary Research - Prescriber Survey 327

11.7 About the Authors 328

11.7.1 Authors 328

11.7.2 Epidemiologists 329

11.7.3 Global Head of Healthcare 330

11.8 About GlobalData 331

11.9 Disclaimer 331

 

List of Tables

 

Table 1: Notable Influenza Pandemics 27

Table 2: Symptoms of Influenza 29

Table 3: United States, Sources of Vaccination Coverage Data 58

Table 4: France, Sources of Vaccination Coverage Data 59

Table 5: Germany, Sources of Vaccination Coverage Data 59

Table 6: Italy, Sources of Vaccination Coverage Data 60

Table 7: Spain, Sources of Vaccination Coverage Data 61

Table 8: United Kingdom, Sources of Vaccination Coverage Data 62

Table 9: Japan, Sources of Vaccination Coverage Data 63

Table 10: India and China, Sources of Vaccination Coverage Data 63

Table 11: Nine Markets, Seasonal Vaccination Coverage, N (%), 2012-2022 76

Table 12: Influenza Vaccination Recommendation Committees by Country 81

Table 13: Most Administered Influenza Vaccines by Country in the Global Markets, 2013 82

Table 14: Leading Influenza Vaccines, 2013 97

Table 15: Product Profile - Fluzone 98

Table 16: Fluzone SWOT Analysis, 2013 101

Table 17: Global Sales Forecasts ($m) for Fluzone, 2012-2022 102

Table 18: Product Profile - Vaxigrip 103

Table 19: Laboratory-Confirmed Influenza Infection Rates in Vaccine or Placebo Recipients and their Household Contacts 104

Table 20: Vaxigrip SWOT Analysis, 2013 106

Table 21: Global Sales Forecasts ($m) for Vaxigrip, 2012-2022 107

Table 22: Product Profile - Fluarix 108

Table 23: Fluarix SWOT Analysis, 2013 110

Table 24: Global Sales Forecasts ($m) for Fluarix, 2012-2022 111

Table 25: Product Profile - FluMist 113

Table 26: FluMist SWOT Analysis, 2013 115

Table 27: Global Sales Forecasts ($m) for FluMist, 2012-2022 116

Table 28: Product Profile - Fluzone High-Dose 117

Table 29: Non-inferiority comparison of Fluzone High-Dose and Standard-Dose Vaccines 119

Table 30: Fluzone High-Dose SWOT Analysis, 2013 121

Table 31: Global Sales Forecasts ($m) for Fluzone High-Dose, 2012-2022 122

Table 32: Product Profile - Fluad 123

Table 33: Fluad SWOT Analysis, 2013 125

Table 34: Global Sales Forecasts ($m) for Fluad, 2012-2022 126

Table 35: Product Profile - Fluzone ID/Intanza 127

Table 36: Non-inferiority Comparison of Fluzone ID and IM Vaccines 128

Table 37: Fluzone ID/Intanza SWOT Analysis, 2013 131

Table 38: Global Sales Forecasts ($m) for Fluzone ID/Intanza, 2012-2022 132

Table 39: Product Profile - Optaflu/Flucelvax 134

Table 40: Optaflu/Flucelvax SWOT Analysis, 2013 137

Table 41: Global Sales Forecasts ($m) for Optaflu/Flucelvax, 2012-2022 138

Table 42: Product Profile - Flublok 139

Table 43: Flublok SWOT Analysis, 2013 142

Table 44: Global Sales Forecasts ($m) for Flublok, 2012-2022 143

Table 45: Product Profile - Fluvirin 144

Table 46: Immunogenicity of Agrippal and Fluvirin 145

Table 47: Fluvirin SWOT Analysis, 2013 146

Table 48: Global Sales Forecasts ($m) for Fluvirin, 2012-2022 147

Table 49: Product Profile - Afluria 148

Table 50: Afluria SWOT Analysis, 2013 150

Table 51: Global Sales Forecasts ($m) for Afluria, 2012-2022 151

Table 52: Product Profile - Influvac 152

Table 53: Influvac SWOT Analysis, 2013 154

Table 54: Global Sales Forecasts ($m) for Influvac, 2012-2022 155

Table 55: Product Profile - Agrippal 156

Table 56: Agrippal SWOT Analysis, 2013 158

Table 57: Global Sales Forecasts ($m) for Agrippal, 2012-2022 159

Table 58: Overall Unmet Needs - Current Level of Attainment, 2013 160

Table 59: Clinical Unmet Needs - Gap Analysis, 2013 164

Table 60: Seasonal Influenza - Clinical Trials by Phase and Status, 2013 171

Table 61: Seasonal Influenza Vaccines - Phase Pipeline, 2013 172

Table 62: Product Profile - ASP7374 (UMN-0502) 173

Table 63: ASP7374 (UMN-0502) SWOT Analysis, 2013 177

Table 64: Global Sales Forecasts ($m) for ASP7374 (UMN-0502), 2012-2022 177

Table 65: Product Profile - Influenza VLP Vaccine 179

Table 66: Influenza VLP Vaccine SWOT Analysis, 2013 183

Table 67: Global Sales Forecasts ($m) for Influenza VLP Vaccine, 2012-2022 184

Table 68: Key Companies in the Seasonal Influenza Vaccine Market, 2013 187

Table 69: Sanofi's Seasonal Influenza Vaccine Portfolio Assessment, 2013 192

Table 70: Sanofi SWOT Analysis, 2013 194

Table 71: AstraZeneca's Seasonal Influenza Vaccine Portfolio Assessment, 2013 195

Table 72: AstraZeneca SWOT Analysis, 2013 197

Table 73: Novartis' Seasonal Influenza Vaccine Portfolio Assessment, 2013 200

Table 74: Novartis SWOT Analysis, 2013 203

Table 75: GlaxoSmithKline's Seasonal Vaccine Portfolio Assessment, 2013 205

Table 76: GlaxoSmithKline's SWOT Analysis, 2013 207

Table 77: CSL Biotherapies' Seasonal Vaccine Portfolio Assessment, 2013 208

Table 78: CSL Biotherapies SWOT Analysis, 2013 210

Table 79: Abbott's Seasonal Vaccine Portfolio Assessment, 2013 212

Table 80: Abbott SWOT Analysis, 2013 214

Table 81: Protein Science's Seasonal Vaccine Portfolio Assessment, 2013 216

Table 82: Protein Sciences SWOT Analysis, 2013 218

Table 83: Novavax's Seasonal Vaccine Portfolio Assessment, 2013 219

Table 84: Novavax SWOT Analysis, 2013 221

Table 85: Global Sales Forecasts ($m) for Influenza Vaccines, 2012-2022 224

Table 86: Influenza Vaccine Market - Drivers and Barriers, 2013 226

Table 87: Sales Forecasts ($m) for Influenza Vaccines in the United States, 2012-2022 231

Table 88: Key Events Impacting Sales of Influenza Vaccines in US, 2013 233

Table 89: US Influenza Vaccine Market - Drivers and Barriers, 2013 234

Table 90: Sales Forecasts ($m) for Influenza Vaccines in France, 2012-2022 239

Table 91: Key Events Impacting Sales of Influenza Vaccines in France, 2013 241

Table 92: French Influenza Vaccine Market - Drivers and Barriers, 2013 241

Table 93: Sales Forecasts ($m) for Influenza Vaccines in Germany, 2012-2022 245

Table 94: Key Events Impacting Sales of Influenza Vaccines in Germany, 2013 247

Table 95: German Influenza Vaccine Market - Drivers and Barriers, 2013 248

Table 96: Sales Forecasts ($m) for Influenza Vaccines in Italy, 2012-2022 251

Table 97: Key Events Impacting Sales of Influenza Vaccines in Italy, 2013 253

Table 98: Italian Influenza Vaccine Market - Drivers and Barriers, 2013 254

Table 99: Sales Forecasts ($m) for Influenza Vaccines in Spain, 2012-2022 257

Table 100: Key Events Impacting Sales of Influenza Vaccines in Spain, 2013 259

Table 101: Spanish Influenza Vaccine Market - Drivers and Barriers, 2013 259

Table 102: Sales Forecasts ($m) for Influenza Vaccines in the United Kingdom, 2012-2022 263

Table 103: Key Events Impacting Sales for Influenza Vaccines in UK, 2013 265

Table 104: UK Influenza Vaccine Market - Drivers and Barriers, 2013 265

Table 105: British Influenza Vaccine Uptake Scenarios for Childhood Influenza Vaccination Program, 2012-2022 (in millions) 266

Table 106: Sales Forecasts ($m) for Influenza Vaccines in Japan, 2012-2022 270

Table 107: Key Events Impacting Sales of Influenza Vaccines in Japan, 2013 270

Table 108: Japanese Influenza Vaccine Market - Drivers and Barriers, 2013 271

Table 109: Sales Forecasts ($m) for Influenza Vaccines in China, 2012-2022 273

Table 110: Key Events Impacting Sales of Influenza Vaccines in China, 2013 275

Table 111: Chinese Influenza Vaccine Market - Drivers and Barriers, 2013 275

Table 112: Sales Forecasts ($m) for Influenza Vaccines in India, 2012-2022 277

Table 113: Key Events Impacting Sales of Influenza Vaccines in India, 2013 279

Table 114: Indian Influenza Vaccine Market - Drivers and Barriers, 2013 279

Table 115: Epidemiology and Market Forecast Chinese Influenza Vaccination Rates (%), 2012-2022 310

Table 116: Key Launch Dates 311

Table 117: Physicians Surveyed, By Country 327

 

List of Figures

 

Figure 1: Influenza Virus Structure 24

Figure 2: United States, Seasonal Influenza Vaccination Coverage, 2001-2022 34

Figure 3: France, Seasonal Influenza Vaccination Coverage, 2001-2022 37

Figure 4: Germany, Seasonal Influenza Vaccination Coverage, 2001-2022 40

Figure 5: Italy, Seasonal Influenza Vaccination Coverage, 2001-2022 43

Figure 6: Spain, Seasonal Influenza Vaccination Coverage, 2001-2022 46

Figure 7: United Kingdom, Seasonal Influenza Vaccination Coverage, 2001-2022 49

Figure 8: Japan, Seasonal Influenza Vaccination Coverage, 2001-2022 52

Figure 9: China, Seasonal Influenza Vaccination Coverage, 2001-2022 55

Figure 10: India, Seasonal Influenza Vaccination Coverage, 2001-2022 57

Figure 11: All Markets, Seasonal Influenza Vaccination Coverage (N), 2012-2022 78

Figure 12: Seasonal Influenza Vaccines - Clinical Trials by Country, 2013 169

Figure 13: Competitive Assessment of Influential Seasonal Influenza Vaccines, 2012-2022 172

Figure 14: Company Portfolio Gap Analysis in Seasonal Influenza Vaccines, 2012-2022 188

Figure 15: Global Sales of Influenza Vaccines by Region, 2012-2022 225

Figure 16: Sales for Influenza Vaccines in the United States by Route of Administration, 2012-2022 232

Figure 17: Sales for Influenza Vaccines in France by Route of Administration, 2012-2022 240

Figure 18: Sales for Influenza Vaccines in Germany by Route of Administration, 2012-2022 246

Figure 19: Sales for Influenza Vaccines in Italy by Route of Administration, 2012-2022 252

Figure 20: Sales for Influenza Vaccines in Spain by Route of Administration, 2012-2022 258

Figure 21: Sales for Influenza Vaccines the United Kingdom by Route of Administration, 2012-2022 264

Figure 22: Sales for Influenza Vaccine in China by Route of administration, 2012-2022 274

Figure 23: Sales for Influenza Vaccines in India by Route of Administration, 2012-2022 278