SEASONAL INFLUENZA VACCINES - GLOBAL DRUG ...most countries Development of vaccines designed to have improved efficacy in elderly recipients The barriers limiting the growth of the

REFERENCE CODE GDHC67PIDR | PUBLICATION DATE SEPTEMBER 2013

SEASONAL INFLUENZA VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS

TO 2022: EVENT-DRIVEN UPDATE

Seasonal Influenza Vaccines - Global Drug Forecast and Market Analysis to 2022: Event-Driven Update 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.



Executive Summary

Seasonal Influenza: Key Metrics in Nine Major Pharmaceutical Markets

2012 Epidemiology

Target Population 3,308m

Vaccinated Population 303m

2012 Market Sales

US $ 1.28bn

5EU $ 0.39bn

Japan $ 0.70bn

India $ 0.07bn

China $ 0.17bn

Total $ 2.61bn

Pipeline Assessment

Number of vaccines in Phase IIb-III 2

Number of first-in-class vaccines 2

Most Promising Pipeline Vaccines Peak-Year Sales

Influenza VLP Vaccine (Novavax) $49.64m

ASP7374 (Astellas) $34.96m

Key events (2012-2022) Level of Impact

Government initiative (UK) ↑↑↑

Launch of quadrivalent vaccines ↑↑↑

Vaccines indicated for at-risk groups (elderly) ↑

Introduction of recombinant vaccines ↑

2022 Market Sales

US $2.07bn

5EU $0.60bn

Japan $0.73bn

India $0.09bn

China $0.30bn

Total $3.79bn Source: GlobalData 5EU = UK, France, Germany, Spain, Italy

Seasonal Influenza Vaccine Sales Expected to Grow During the Forecast Period

The influenza market generates approximately

$2.61 billion from global sales. Over the next 10

years, this market is expected to grow to reach

$3.79 billion, with major growth occurring in the

main influenza markets, such the US.

Some of the main drivers of growth are expected to

be:

Introduction of quadrivalent influenza vaccines,

which will improve efficacy and immune

coverage against influenza type B infections

Increase in the size of the elderly population in

most countries

Development of vaccines designed to have

improved efficacy in elderly recipients

The barriers limiting the growth of the influenza

market include:

Limited patient awareness regarding the threat

of influenza and the importance of influenza

vaccinations

Concerns over decreasing healthcare costs as

part of government austerity measures

Seasonal Influenza Vaccines - Global Drug Forecast and Market Analysis to 2022 3 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.



Executive Summary

Sales for Seasonal Influenza Vaccines by Region, 2012-2022

Source: GlobalData

Pharma Giants Flex Their R&D and Manufacturing Capabilities to Maintain Their Market Share

Sanofi, the market leader in influenza vaccine

development, has differentiated itself by

developing an intricate portfolio including a diverse

marketing mix under their Fluzone brand that also

include vaccines directed towards the at-risk

populations (e.g., Fluzone High-Dose).

AstraZeneca, having entered the influenza market

through the acquisition of MedImmune, continues

to market FluMist as a premium product, by

focusing upon the benefits of a nasal spray over

existing standard intramuscular injectable

vaccines. Novartis has maintained a strong share

of intramuscular vaccines, but also has one of the

only adjuvanted seasonal influenza vaccines

(Fluad), which has improved efficacy in the elderly

population.

However, quality issues with Novartis vaccines

resulted in a short-lived ban across certain

countries in the EU and in Canada during the fall of

2012.

During this forecast period, GlobalData believes

that other existing and new players, such as

Novartis, Protein Sciences, Astellas and Novavax,

in addition to Sanofi and AstraZeneca, will harness

the use of new cell culture and recombinant protein

manufacturing methods to maintain their market

share and presence.

New companies are unlikely to capture a large

market share from existing players, but out-

licensing opportunities remain viable in this

disease space. These companies realize revenue

primarily from the US and 5EU markets and not the

emerging markets, a pattern which is unlikely to

change over the forecast period.




Executive Summary

Company Portfolio Gap Analysis in Seasonal Influenza Vaccines, 2012-2022

Source: GlobalData

Companies Focus Upon New Routes of Administration and Modes of Action

Current influenza vaccines meet satisfactory

standards of efficacy for the majority of the

population. However, as most people forego

immunization against influenza for reasons, such

as a lack of awareness of vaccination benefits, the

market is disconnected between available

prophylactic treatment and true unmet need. This

trend remains characteristic of diseases dominated

by prophylactics over therapeutics. Sanofi’s

approach through the marketing of its ID

(intradermal) vaccine is likely to affect vaccination

rates through patient education initiatives and by

introduction of a novel route of administration

within the United States.

Typical influenza vaccines that are currently on the

market fail to provide adequate protection for

specific patient segments (e.g., young children and

the elderly) with an elevated risk of developing

influenza-induced complications. In the United

States, a recently launched vaccine, Sanofi’s

Fluzone High-Dose, and an adjuvanted vaccine

awaiting FDA approval, Novartis’ Fluad, are

specifically designed to have improved efficacy in

elderly patients.

New Entrants Welcomed in the Market but Face Stiff Uphill Climb to Gain Market Share

Despite the maturity of the influenza vaccine

market, there is still an opportunity for new

vaccines with novel mechanisms of action. The

fierce competition for patient share amongst the

concerned players is driven by developments

towards novel routes of administration and

increasing vaccine efficacy in at-risk patient

populations, such as children less than two years

of age or the elderly. There is also a demand for an

improved vaccine manufacturing process, such as

cell culture or recombinant technology.

These methods will ease capacity constraints and

allow companies to exploit basic economies of

scale to increase revenue while decreasing the

average time for vaccine manufacturing.

Current influenza vaccines use viral subunits,

except for the live, attenuated virus used in FluMist

by AstraZeneca. Subunit vaccines are thought to

only stimulate one of the two branches of the




Executive Summary

immune system. Therefore, there is an opening for

an influenza vaccine that can elicit a stronger

response from the entire immune system, which

may be accomplished via vaccination with the

whole virus or Virus-Like Particles (VLPs). The

early-stage influenza vaccine Influenza VLP

(Novavax) is positioned to take advantage of this

opportunity, but is unlikely to affect the market

during the forecast period.

Quadrivalent Vaccines and Recombinant Technology Will Reinvigorate the Seasonal Influenza Market

Quadrivalent influenza vaccines, which contain

antigens against two influenza type A and two

influenza type B subtypes, will fundamentally

change the composition of influenza vaccines,

which are currently trivalent (two influenza A and a

single influenza B strains). Sanofi,

GlaxoSmithKline, and AstraZeneca will introduce

quadrivalent influenza vaccines in the US and/or

European marketplace within the next two-five

years. Primary research revealed that physicians

are eagerly awaiting quadrivalent vaccines, and

GlobalData forecasts that these newer vaccines

will usurp the position of existing trivalent vaccines,

leading to a quick path to obsolescence for the

latter. While the vaccination rate in most countries

is not anticipated to increase significantly over the

forecast period, the price premium of the

quadrivalent vaccines and other next-generation

immunizations (e.g., Sanofi’s Fluzone High-Dose

and Novartis’ Fluad) is expected to drive market

growth.

Though available in Europe, Novartis’ Fluad is

awaiting FDA approval for the indication of

immunizing individuals ≥65 years of age. Fluad will

be the first adjuvanted influenza vaccine offered in

the United States, which may suggest a change in

consumer preference towards the use of adjuvant-

augmented vaccines. GlobalData projects that

Fluad sales will increase in all markets throughout

the forecast period, while contending with other

quadrivalent vaccines.

Competitive Assessment of Influential Seasonal Influenza, 2012-2022

Source: GlobalData




Executive Summary

What Do the Physicians Think?

The Key Opinion Leaders (KOLs) interviewed for

this report shared their insight into the market

trends within the seasonal influenza market.

Primary concerns within this market remain the

need for vaccines to address the unmet needs in

the at-risk population segments such as the elderly

and young children, the need for adjuvanted

treatments, quadrivalent vaccines and novel routes

of administration (e.g. intradermal vaccines).

“If you’re going to try and protect against influenza

B, you need to have both strains. We are not very

good at predicting which strain to include, so it

really requires a quadrivalent vaccine.”

US key opinion leader, September 2012

“The United States has to get with using adjuvants.

There is no way out. For the future of the vaccine

world you have to use these adjuvants.”

US key opinion leader, September 2012

“If we vaccinated children, we protect them but we

also protect grandparents, other children, and

people who are at high risk.”

OUS key opinion leader, September 2012

“[…] the intradermal route is something that we

need to explore a lot more than we’ve done up to

now, because there may be distinct advantages

[…]”

OUS key opinion leader, September 2012




Table of Contents

1 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




Table of Contents

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 .................................................................................................... 79

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



5.4 Germany............................................................................................................................. 86



5.5 Italy..................................................................................................................................... 87






Table of Contents

5.6 Spain .................................................................................................................................. 89



5.7 United Kingdom .................................................................................................................. 90



5.8 Japan ................................................................................................................................. 91



5.9 China .................................................................................................................................. 92



5.10 India ................................................................................................................................... 93



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




Table of Contents

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 (<2 years old) .............................. 161

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




Table of Contents

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 ........................................................................................................................ 197

9.3.4 GlaxoSmithKline ........................................................................................................... 202

9.3.5 CSL Biotherapies ......................................................................................................... 206

9.3.6 Abbott........................................................................................................................... 209

9.3.7 Protein Sciences Corporation ....................................................................................... 213

9.3.8 Novavax ....................................................................................................................... 217

10 Market Outlook ........................................................................................................................ 221

10.1 Global Markets ................................................................................................................. 221

10.1.1 Forecast ....................................................................................................................... 221

10.1.2 Drivers and Barriers - Global Issues ............................................................................. 224

10.2 United States .................................................................................................................... 228

10.2.1 Forecast ....................................................................................................................... 228

10.2.2 Key Events ................................................................................................................... 231

10.2.3 Drivers and Barriers ..................................................................................................... 232

10.3 France .............................................................................................................................. 236

10.3.1 Forecast ....................................................................................................................... 236




Table of Contents

10.3.2 Key Events ................................................................................................................... 239


10.4 Germany........................................................................................................................... 242

10.4.1 Forecast ....................................................................................................................... 242

10.4.2 Key Events ................................................................................................................... 246


10.5 Italy................................................................................................................................... 248

10.5.1 Forecast ....................................................................................................................... 248

10.5.2 Key Events ................................................................................................................... 252


10.6 Spain ................................................................................................................................ 254

10.6.1 Forecast ....................................................................................................................... 254

10.6.2 Key Events ................................................................................................................... 257


10.7 United Kingdom ................................................................................................................ 259

10.7.1 Forecast ....................................................................................................................... 259

10.7.2 Key Events ................................................................................................................... 263


10.8 Japan ............................................................................................................................... 267

10.8.1 Forecast ....................................................................................................................... 267

10.8.2 Key Events ................................................................................................................... 269


10.9 China ................................................................................................................................ 271

10.9.1 Forecast ....................................................................................................................... 271

10.9.2 Key Events ................................................................................................................... 273





Table of Contents

10.10 India ................................................................................................................................. 275

10.10.1 Forecast ................................................................................................................. 275

10.10.2 Key Events ............................................................................................................. 277

10.10.3 Drivers and Barriers ................................................................................................ 278

11 Appendix.................................................................................................................................. 281

11.1 Bibliography ...................................................................................................................... 281

11.2 Abbreviations .................................................................................................................... 305

11.3 Methodology ..................................................................................................................... 308

11.4 Forecasting Methodology ................................................................................................. 308

11.4.1 Vaccine Coverage ........................................................................................................ 308

11.4.2 Vaccines Included ........................................................................................................ 309

11.4.3 Key Launch Dates ........................................................................................................ 310

11.4.4 Influenza Vaccine Tender System Assumptions ........................................................... 311

11.4.5 General Pricing Assumptions ....................................................................................... 311

11.4.6 Individual Vaccine Assumptions ................................................................................... 312

11.4.7 Pricing of Pipeline Agents............................................................................................. 323

11.5 Physicians and Specialists Included in this Study ............................................................. 324

11.6 Primary Research - Prescriber Survey .............................................................................. 326

11.7 About the Authors ............................................................................................................. 327

11.7.1 Authors......................................................................................................................... 327

11.7.2 Epidemiologists ............................................................................................................ 328

11.7.3 Global Head of Healthcare ........................................................................................... 329

11.8 About GlobalData ............................................................................................................. 330

11.9 Disclaimer......................................................................................................................... 330




Table of Contents

1.1 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 of Contents

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 of Contents

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 of Contents

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 ..............................199

Table 74: Novartis SWOT Analysis, 2013 ...................................................................................202

Table 75: GlaxoSmithKline’s Seasonal Vaccine Portfolio Assessment, 2013 ..............................204

Table 76: GlaxoSmithKline’s SWOT Analysis, 2013....................................................................206

Table 77: CSL Biotherapies’ Seasonal Vaccine Portfolio Assessment, 2013 ...............................207

Table 78: CSL Biotherapies SWOT Analysis, 2013 .....................................................................209

Table 79: Abbott’s Seasonal Vaccine Portfolio Assessment, 2013 ..............................................211

Table 80: Abbott SWOT Analysis, 2013 ......................................................................................213

Table 81: Protein Science’s Seasonal Vaccine Portfolio Assessment, 2013 ................................215

Table 82: Protein Sciences SWOT Analysis, 2013 ......................................................................217

Table 83: Novavax’s Seasonal Vaccine Portfolio Assessment, 2013 ...........................................218

Table 84: Novavax SWOT Analysis, 2013 ..................................................................................220

Table 85: Global Sales Forecasts ($m) for Influenza Vaccines, 2012-2022 .................................223

Table 86: Influenza Vaccine Market - Drivers and Barriers, 2013 ................................................225

Table 87: Sales Forecasts ($m) for Influenza Vaccines in the United States, 2012-2022 .............230

Table 88: Key Events Impacting Sales of Influenza Vaccines in US, 2013 ..................................232

Table 89: US Influenza Vaccine Market - Drivers and Barriers, 2013 ..........................................233

Table 90: Sales Forecasts ($m) for Influenza Vaccines in France, 2012-2022.............................238

Table 91: Key Events Impacting Sales of Influenza Vaccines in France, 2013 ............................240

Table 92: French Influenza Vaccine Market - Drivers and Barriers, 2013 ....................................240

Table 93: Sales Forecasts ($m) for Influenza Vaccines in Germany, 2012-2022 .........................244

Table 94: Key Events Impacting Sales of Influenza Vaccines in Germany, 2013 .........................246




Table of Contents

Table 95: German Influenza Vaccine Market - Drivers and Barriers, 2013 ..................................247

Table 96: Sales Forecasts ($m) for Influenza Vaccines in Italy, 2012-2022 .................................250

Table 97: Key Events Impacting Sales of Influenza Vaccines in Italy, 2013 .................................252

Table 98: Italian Influenza Vaccine Market - Drivers and Barriers, 2013 ......................................253

Table 99: Sales Forecasts ($m) for Influenza Vaccines in Spain, 2012-2022 ..............................256

Table 100: Key Events Impacting Sales of Influenza Vaccines in Spain, 2013 ............................258

Table 101: Spanish Influenza Vaccine Market - Drivers and Barriers, 2013.................................258

Table 102: Sales Forecasts ($m) for Influenza Vaccines in the United Kingdom, 2012-2022 .......262

Table 103: Key Events Impacting Sales for Influenza Vaccines in UK, 2013 ...............................264

Table 104: UK Influenza Vaccine Market - Drivers and Barriers, 2013 ........................................264

Table 105: British Influenza Vaccine Uptake Scenarios for Childhood Influenza Vaccination Program, 2012-2022 (in millions) .............................................................................265

Table 106: Sales Forecasts ($m) for Influenza Vaccines in Japan, 2012-2022 ............................269

Table 107: Key Events Impacting Sales of Influenza Vaccines in Japan, 2013 ............................269

Table 108: Japanese Influenza Vaccine Market - Drivers and Barriers, 2013 ..............................270

Table 109: Sales Forecasts ($m) for Influenza Vaccines in China, 2012-2022 ............................272

Table 110: Key Events Impacting Sales of Influenza Vaccines in China, 2013 ............................274

Table 111: Chinese Influenza Vaccine Market - Drivers and Barriers, 2013 ................................274

Table 112: Sales Forecasts ($m) for Influenza Vaccines in India, 2012-2022 ..............................276

Table 113: Key Events Impacting Sales of Influenza Vaccines in India, 2013 ..............................278

Table 114: Indian Influenza Vaccine Market - Drivers and Barriers, 2013 ....................................278

Table 115: Epidemiology and Market Forecast Chinese Influenza Vaccination Rates (%), 2012- 2022 .........................................................................................................................309

Table 116: Key Launch Dates ....................................................................................................310

Table 117: Physicians Surveyed, By Country .............................................................................326




Table of Contents

1.2 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 .........................................224

Figure 16: Sales for Influenza Vaccines in the United States by Route of Administration, 2012- 2022 ..........................................................................................................................231

Figure 17: Sales for Influenza Vaccines in France by Route of Administration, 2012-2022 ..........239

Figure 18: Sales for Influenza Vaccines in Germany by Route of Administration, 2012-2022.......245

Figure 19: Sales for Influenza Vaccines in Italy by Route of Administration, 2012-2022 ..............251

Figure 20: Sales for Influenza Vaccines in Spain by Route of Administration, 2012-2022 ............257

Figure 21: Sales for Influenza Vaccines the United Kingdom by Route of Administration, 2012- 2022 ..........................................................................................................................263

Figure 22: Sales for Influenza Vaccine in China by Route of administration, 2012-2022 ..............273




Table of Contents

Figure 23: Sales for Influenza Vaccines in India by Route of Administration, 2012-2022 .............277




Introduction

2 Introduction

2.1 Catalyst

Despite its maturity, the influenza market is expected to undergo significant change over the next

decade.

The 2009 H1N1 (swine flu) influenza outbreak emphasized the need for novel technologies to

decrease the time required to manufacture and produce influenza vaccines, which has resulted

in the development of cell culture-based and recombinant protein vaccines.

The introduction of quadrivalent influenza vaccines will fundamentally change vaccine

composition in markets where trivalent inactivated virus-based vaccines are currently the norm.

The market size for influenza vaccines is growing. The reasons for this increase are more

complex than the growth of the elderly population, who are at an elevated risk of developing

influenza-associated complications. Government initiatives to encourage influenza vaccination,

such as a new government initiative in the UK to immunize all children between the ages of two

and seventeen, will increase influenza vaccine demand.

Concerns over the effectiveness of current vaccines in high-risk patients (e.g., the elderly and

young children) have created an opportunity for entrants with improved efficacy, such as

vaccines that contain more antigen (i.e., high-dose), or an adjuvant.

The short-lived ban on Novartis vaccines during the fall of 2012 highlights the outstanding

concerns governmental agencies and the end consumer may have in this market. This ban is

likely to affect the projected sales of Novartis during the forecast period and thereby alter

Novartis’ share of the seasonal influenza market.

The launch of novel influenza vaccine production techniques (i.e., cell-culture and recombinant

methodologies) will introduce competition for egg-based vaccines. Novartis’ Flucelvax and

Protein Sciences Corporation’s gained FDA approval in December 2012 and January 2013,

respectively.




Introduction

2.2 Related Reports

GlobalData (2013) PharmaPoint: HIV Therapeutics Global Market Forecast and Market

Analysis. GDHC41PIDR

GlobalData (2013) PharmaPoint: HCV Therapeutics Global Market Forecast and Market

Analysis. GDHC42PIDR

GlobalData (2013) PharmaPoint: Meningococcal Meningitis Global Market Forecast and

Market Analysis. GDHC61PIDR

2.3 Upcoming Related Reports

GlobalData (2013) PharmaPoint: PharmaPoint: Prophylactic Hepatitis B Vaccines Global

Market Forecast and Market Analysis. GDHC68PIDR

GlobalData (2013) PharmaPoint: Prophylactic Human Papillomavirus Vaccines Global Market

Forecast and Market Analysis. GDHC69PIDR




Appendix

11.8 About GlobalData

GlobalData is a leading global provider of business intelligence in the healthcare industry.

GlobalData provides its clients with up-to-date information and analysis on the latest developments

in drug and vaccine research, disease analysis, and clinical research and development. Our

integrated business intelligence solutions include a range of interactive online databases, analytical

tools, reports, and forecasts. Our analysis is supported by a 24/7 client support and analyst team.

GlobalData has offices in New York, Boston, London, India, and Singapore.

11.9 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any

form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior

permission of the publisher, GlobalData.

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