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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.
SEASONAL INFLUENZA VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS
TO 2022: EVENT-DRIVEN UPDATE
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.
SEASONAL INFLUENZA VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS
TO 2022: EVENT-DRIVEN UPDATE
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.
Seasonal Influenza Vaccines - Global Drug Forecast and Market Analysis to 2022 4 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
SEASONAL INFLUENZA VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS
TO 2022: EVENT-DRIVEN UPDATE
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
Seasonal Influenza Vaccines - Global Drug Forecast and Market Analysis to 2022 5 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
SEASONAL INFLUENZA VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS
TO 2022: EVENT-DRIVEN UPDATE
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
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SEASONAL INFLUENZA VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS
TO 2022: EVENT-DRIVEN UPDATE
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
Seasonal Influenza Vaccines - Global Drug Forecast and Market Analysis to 2022: Event-Driven Update 7 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
SEASONAL INFLUENZA VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS
TO 2022: EVENT-DRIVEN UPDATE
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
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TO 2022: EVENT-DRIVEN UPDATE
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
5.3.1 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..................................................................................................................................... 87
5.5.1 Influenza Vaccination Recommendations and Policies ................................................... 87
5.5.2 Clinical Practice .............................................................................................................. 88
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TO 2022: EVENT-DRIVEN UPDATE
Table of Contents
5.6 Spain .................................................................................................................................. 89
5.6.1 Influenza Vaccination Recommendations and Policies ................................................... 89
5.6.2 Clinical Practice .............................................................................................................. 89
5.7 United Kingdom .................................................................................................................. 90
5.7.1 Influenza Vaccination Recommendations and Policies ................................................... 90
5.7.2 Clinical Practice .............................................................................................................. 91
5.8 Japan ................................................................................................................................. 91
5.8.1 Influenza Vaccination Recommendations and Policies ................................................... 91
5.8.2 Clinical Practice .............................................................................................................. 92
5.9 China .................................................................................................................................. 92
5.9.1 Influenza Vaccination Recommendations and Policies ................................................... 92
5.9.2 Clinical Practice .............................................................................................................. 93
5.10 India ................................................................................................................................... 93
5.10.1 Influenza Vaccination Recommendations and Policies ................................................... 93
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
Seasonal Influenza Vaccines - Global Drug Forecast and Market Analysis to 2022: Event-Driven Update 10 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
SEASONAL INFLUENZA VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS
TO 2022: EVENT-DRIVEN UPDATE
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
Seasonal Influenza Vaccines - Global Drug Forecast and Market Analysis to 2022: Event-Driven Update 11 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
SEASONAL INFLUENZA VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS
TO 2022: EVENT-DRIVEN UPDATE
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
Seasonal Influenza Vaccines - Global Drug Forecast and Market Analysis to 2022: Event-Driven Update 12 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
SEASONAL INFLUENZA VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS
TO 2022: EVENT-DRIVEN UPDATE
Table of Contents
10.3.2 Key Events ................................................................................................................... 239
10.3.3 Drivers and Barriers ..................................................................................................... 240
10.4 Germany........................................................................................................................... 242
10.4.1 Forecast ....................................................................................................................... 242
10.4.2 Key Events ................................................................................................................... 246
10.4.3 Drivers and Barriers ..................................................................................................... 246
10.5 Italy................................................................................................................................... 248
10.5.1 Forecast ....................................................................................................................... 248
10.5.2 Key Events ................................................................................................................... 252
10.5.3 Drivers and Barriers ..................................................................................................... 252
10.6 Spain ................................................................................................................................ 254
10.6.1 Forecast ....................................................................................................................... 254
10.6.2 Key Events ................................................................................................................... 257
10.6.3 Drivers and Barriers ..................................................................................................... 258
10.7 United Kingdom ................................................................................................................ 259
10.7.1 Forecast ....................................................................................................................... 259
10.7.2 Key Events ................................................................................................................... 263
10.7.3 Drivers and Barriers ..................................................................................................... 264
10.8 Japan ............................................................................................................................... 267
10.8.1 Forecast ....................................................................................................................... 267
10.8.2 Key Events ................................................................................................................... 269
10.8.3 Drivers and Barriers ..................................................................................................... 269
10.9 China ................................................................................................................................ 271
10.9.1 Forecast ....................................................................................................................... 271
10.9.2 Key Events ................................................................................................................... 273
10.9.3 Drivers and Barriers ..................................................................................................... 274
Seasonal Influenza Vaccines - Global Drug Forecast and Market Analysis to 2022: Event-Driven Update 13 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
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TO 2022: EVENT-DRIVEN UPDATE
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
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SEASONAL INFLUENZA VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS
TO 2022: EVENT-DRIVEN UPDATE
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 ($m) for Vaxigrip, 2012-2022..................................................107
Table 22: Product Profile - Fluarix ..............................................................................................108
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Table of Contents
Table 23: Fluarix SWOT Analysis, 2013 .....................................................................................110
Table 24: Global Sales Forecasts ($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
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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
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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
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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
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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
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Table of Contents
Figure 23: Sales for Influenza Vaccines in India by Route of Administration, 2012-2022 .............277
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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.
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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
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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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