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REFERENCE CODE GDHC84PIDR | PUBLICATION DATE MARCH 2014
PROPHYLACTIC HUMAN PAPILLOMAVIRUS VACCINES - GLOBAL DRUG FORECAST AND
MARKET ANALYSIS TO 2022
Prophylactic Human Papillomavirus Vaccines - Global Drug Forecast and Market Analysis to 2022 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
PROPHYLACTIC HUMAN PAPILLOMAVIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
HPV Vaccines: Key Metrics in Nine Major Pharmaceutical Markets 2012 Epidemiology
Target Population 7 million
Vaccinated Population 4.8 million
2012 Market Sales
US $1.1bn
5EU $410m
Japan $135m
Canada $53m
Australia $44m
Total $1.7bn
Pipeline Assessment
Number of drugs in Phase I–II 4
Number of first-in-class drugs (Phase III) 1
Most Promising Pipeline Drugs Peak-Year Sales
V503 (Merck) $2.1bn
Key Events (2012–2022) Level of Impact
Introduction of V503 in US in 2015 ↑
Introduction of V503 in 5EU in 2016 ↑
Inclusion of males in routine vaccination in Australia in 2013 ↑↑
Inclusion of males in routine vaccination in Canada from 2013 ↑↑
Suspension of HPV vaccine recommendations in Japan ↓↓↓
2022 Market Sales
US $1.5bn
5EU $534m
Japan $6m
Canada $130m
Australia $107m
Total $2.2bn Source: GlobalData. 5EU: France, Germany, Italy, Spain, UK
HPV Vaccine Sales Expected to Grow Modestly During the Forecast Period
GlobalData estimates that the global human
papillomavirus (HPV) vaccines market generated
approximately $1.7 billion in sales in 2012. This
market is expected to experience moderate growth
over the next 10 years, with anticipated sales of
over $2.2 billion by 2022. This represents a
compound annual growth rate of 2.6%. HPV
vaccine sales in Canada and Australia are
expected to increase at a CAGR of over 9% during
the forecast period, driven by the inclusion of
males in routine HPV vaccine recommendations.
The US is also expected to make a significant
contribution to market growth, thanks to a large
population and an estimated CAGR of 3%.
GlobalData expects that some of the most
important drivers of global market growth over the
next decade will be:
Increasing inclusion of males in HPV vaccine
recommendations
Introduction of Merck’s nine-valent HPV
vaccine, V503
GlobalData believes that notable barriers to growth
of the global HPV vaccines market will include:
Low HPV vaccine coverage rates among
targeted populations
Fears over the safety of HPV vaccines
Low awareness of HPV and HPV vaccines
among targeted populations
Prophylactic Human Papillomavirus 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.
PROPHYLACTIC HUMAN PAPILLOMAVIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
Pressure on HPV vaccine programs to be cost-
effective
Sales for HPV Vaccines by Region, 2012–2022
62.7%
3.4%
5.2%
6.0%
3.7%
5.4%
7.9%3.1% 2.6%
United States
France
Germany
Italy
Spain
United Kingdom
Japan
Canada
Australia
2012Total: $1.7bn
65.2%3.4%
4.2%
5.6%
4.8%
5.8%0.3%
5.8%4.8%
2022Total: $2.2bn
Source: GlobalData.
Emphasis on HPV Vaccination Shifting from Solely Cervical Cancer Protection
There are only two vaccines currently available for
prophylactic immunization against HPV, Merck’s
quadrivalent vaccine, Gardasil, and
GlaxoSmithKline’s (GSK’s) bivalent vaccine,
Cervarix. Merck’s Gardasil was first to market and
commands a significantly greater share of the HPV
vaccines market globally. Both vaccines were
developed as cervical cancer vaccines and as
such both protect against HPV 16 and 18,
genotypes responsible for up to 70% of cervical
cancer. Recognition of the role of HPV in other
non-cervical cancers and of the benefits of herd
immunity has led to a shift towards a greater
emphasis on vaccinating both males and females.
A shift away from a sole focus on cervical cancer in
females appears to have benefited Merck, as
Gardasil provides protection against two additional
HPV types (6 and 11), responsible for genital warts
in both males and females.
Prophylactic Human Papillomavirus 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.
PROPHYLACTIC HUMAN PAPILLOMAVIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
Company Portfolio Gap Analysis in HPV Vaccines, 2012–2022
Strength of PipelineLow High
Hig
hLo
wS
treng
th o
f Mar
kete
d P
rodu
cts
Stagnant PlayersCurrent and
Future Players
Source: GlobalData.
Physicians Welcome Prospect of Higher-Valency Vaccines, But Significant Barriers to Market Access Must be Overcome
Current HPV vaccines are very effective at
protecting against the included HPV genotypes.
However, the major clinical unmet need with
regards to current HPV vaccines is the limited
number of HPV types against which they protect.
Key opinion leaders (KOLs) from across the
markets identified broader coverage against more
HPV types as the most significant clinical need
associated with current HPV vaccines. GlobalData
believes Merck’s nine-valent pipeline vaccine V503
is well placed to capitalize on this need.
There are a number of non-clinical factors that limit
HPV vaccine uptake; these include low awareness
of HPV vaccination, a poor perception of the safety
of HPV vaccines, and cost-effectiveness concerns.
GlobalData’s primary research indicates that there
is a significant need to overcome such barriers, in
order for pharmaceutical companies to realize the
full potential of the HPV vaccines sector.
Vaccines Protective against all HPV Types Represent Opportunity for New Players
The introduction of Merck’s nine-valent vaccine
V503 will partially address the need to protect
against more HPV types. Despite this, there will
still be some remaining opportunity for new
entrants into the HPV vaccines sector if they can
demonstrate universal protection, against all HPV
types. According to GlobalData’s primary research
insight, such vaccines would be well received by
physicians. A number of biotechnology companies
are currently developing universal HPV vaccines;
these vaccines utilize the minor capsid protein of
HPV (L2), which is conserved across all HPV
types. Such vaccines will need to induce a strong,
durable immune response in order to replace
traditional HPV vaccines.
Prophylactic Human Papillomavirus 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.
PROPHYLACTIC HUMAN PAPILLOMAVIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
Merck’s Nine-Valent Pipeline Vaccine V503 Expected to Garner Significant Market Share
Merck’s nine-valent pipeline vaccine V503 offers
protection against five additional HPV types not
included in current vaccines. GlobalData expects
this vaccine to be quickly adopted following
regulatory approval and subsequent
recommendations by national immunization
committees. KOLs from across the markets
included in this report expected V503 to be widely
used, though it was noted that an inflated price,
relative to current HPV vaccines, could provide
some barrier to uptake. GlobalData anticipates that
by 2017, V503 will be the dominant prophylactic
HPV vaccine globally and will realize sales of $1.4
billion in 2022, representing a 95% market share.
This market share will largely be as a result of the
cannibalization of Merck’s existing vaccine
Gardasil, of which sales are expected to decline
significantly over the forecast period. The only
other prophylactic HPV vaccine in late-stage
clinical development is a low-cost bivalent vaccine,
from Chinese biotechnology company Xiamen
Innovax. This vaccine is primarily being developed
as a low-cost vaccine for use in the domestic
market; as such it is unlikely to have an impact
upon the markets included in this report, and sales
of the vaccine have not been forecast.
Competitive Assessment of Late-Stage Pipeline Agents in HPV Vaccines, 2012–2022
Clinical AttributesLow High
Hig
hLo
wC
omm
erci
al A
ttrib
utes
Merck’s V503
Source: GlobalData.
What do the Physicians Think?
The KOLs interviewed for this report shared their
expert insight into the HPV vaccines market. These
KOLs acknowledged that significant barriers to
HPV vaccine uptake exist, including fears over the
safety of HPV vaccination, low awareness and the
high price of the vaccines. KOLs welcomed the
prospect of higher-valency vaccines, though they
did warn that such vaccines should not be too
expensive.
“HPV vaccination received very, very bad media
attention in the beginning, it was questioned if it’s
useful, they said it is too expensive…it was said
that it may be dangerous.”
Key Opinion Leader, November 2013
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PROPHYLACTIC HUMAN PAPILLOMAVIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
“When I have done surveys and research on this
[barriers to vaccination], it’s all about safety.”
Key Opinion Leader, November 2013
“What I feel is that the industry does not support
this [increasing awareness of HPV vaccination],
they do not give information… positive information,
they are afraid to get again some controversy
starting or criticism, so there is no source of
information for the public.”
Key Opinion Leader, November 2013
“We should try to get the price reduced because
then the penetration of the market is much easier
to do.”
Key Opinion Leader, November2013
“We need bigger coverage, that’s for sure.”
Key Opinion Leader, November 2013
“Future vaccines covering more types [of HPV] will
be really beneficial.”
Key Opinion Leader, November 2013
“Adoption of nine-valent HPV vaccines depends on
a number of factors, one of which I presume will be
the price and impact on the federal budget.”
Key Opinion Leader, November 2013
Prophylactic Human Papillomavirus Vaccines - Global Drug Forecast and Market Analysis to 2022 7 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
PROPHYLACTIC HUMAN PAPILLOMAVIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
1 Table of Contents
1 Table of Contents ....................................................................................................................... 7
1.1 List of Tables .................................................................................................................... 15
1.2 List of Figures ................................................................................................................... 18
2 Introduction ............................................................................................................................... 20
2.1 Catalyst ............................................................................................................................. 20
2.2 Related Reports ................................................................................................................ 21
2.3 Upcoming Related Reports ............................................................................................... 21
3 Disease Overview ..................................................................................................................... 22
3.1 Etiology and Pathophysiology ........................................................................................... 23
3.1.1 Etiology ......................................................................................................................... 23
3.1.2 Pathophysiology ............................................................................................................ 23
3.2 Symptoms ......................................................................................................................... 25
4 Vaccination Recommendations and Coverage Rates ............................................................... 27
4.1 Vaccination Recommendations Overview ......................................................................... 27
4.2 US..................................................................................................................................... 29
4.2.1 Vaccination Recommendations and Policies ................................................................. 29
4.2.2 Vaccination Coverage ................................................................................................... 29
4.2.3 Clinical Practice ............................................................................................................. 31
4.3 France .............................................................................................................................. 32
4.3.1 Vaccination Recommendations and Policies ................................................................. 32
4.3.2 Vaccination Coverage ................................................................................................... 33
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PROPHYLACTIC HUMAN PAPILLOMAVIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
4.3.3 Clinical Practice ............................................................................................................. 34
4.4 Germany ........................................................................................................................... 35
4.4.1 Vaccination Recommendations and Policies ................................................................. 35
4.4.2 Vaccination Coverage ................................................................................................... 36
4.4.3 Clinical Practice ............................................................................................................. 37
4.5 Italy ................................................................................................................................... 38
4.5.1 Vaccination Recommendations and Policies ................................................................. 38
4.5.2 Vaccination Coverage ................................................................................................... 39
4.5.3 Clinical Practice ............................................................................................................. 41
4.6 Spain ................................................................................................................................ 42
4.6.1 Vaccination Recommendations and Policies ................................................................. 42
4.6.2 Vaccination Coverage ................................................................................................... 43
4.6.3 Clinical Practice ............................................................................................................. 45
4.7 UK..................................................................................................................................... 45
4.7.1 Vaccination Recommendations and Policies ................................................................. 45
4.7.2 Vaccination Coverage ................................................................................................... 46
4.7.3 Clinical Practice ............................................................................................................. 47
4.8 Japan ................................................................................................................................ 48
4.8.1 Vaccination Recommendations and Policies ................................................................. 48
4.8.2 Vaccination Coverage ................................................................................................... 49
4.8.3 Clinical Practice ............................................................................................................. 50
4.9 Australia ............................................................................................................................ 51
4.9.1 Vaccination Recommendations and Policies ................................................................. 51
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PROPHYLACTIC HUMAN PAPILLOMAVIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
4.9.2 Vaccination Coverage ................................................................................................... 51
4.9.3 Clinical Practice ............................................................................................................. 53
4.10 Canada ............................................................................................................................. 54
4.10.1 Vaccination Recommendations and Policies ................................................................. 54
4.10.2 Vaccination Coverage ................................................................................................... 55
4.10.3 Clinical Practice ............................................................................................................. 56
5 Competitive Assessment .......................................................................................................... 58
5.1 Overview ........................................................................................................................... 58
5.2 Strategic Competitor Assessment ..................................................................................... 58
5.3 Product Profiles ................................................................................................................. 60
5.3.1 Gardasil......................................................................................................................... 60
5.3.2 Cervarix......................................................................................................................... 66
6 Unmet Need and Opportunity ................................................................................................... 72
6.1 Overview ........................................................................................................................... 72
6.2 Protection against Multiple HPV Types ............................................................................. 73
6.2.1 Unmet Need .................................................................................................................. 73
6.2.2 Gap Analysis ................................................................................................................. 74
6.2.3 Opportunity ................................................................................................................... 75
6.3 Vaccine Coverage Rates .................................................................................................. 75
6.3.1 Unmet Need .................................................................................................................. 75
6.3.2 Gap Analysis ................................................................................................................. 76
6.3.3 Opportunity ................................................................................................................... 76
6.4 Perception of Vaccine Safety ............................................................................................ 77
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PROPHYLACTIC HUMAN PAPILLOMAVIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
6.4.1 Unmet Need .................................................................................................................. 77
6.4.2 Gap Analysis ................................................................................................................. 78
6.4.3 Opportunity ................................................................................................................... 78
6.5 Awareness of HPV Vaccination ......................................................................................... 79
6.5.1 Unmet Need .................................................................................................................. 79
6.5.2 Gap Analysis ................................................................................................................. 79
6.5.3 Opportunity ................................................................................................................... 80
6.6 Affordability of HPV Vaccines ............................................................................................ 80
6.6.1 Unmet Need .................................................................................................................. 80
6.6.2 Gap Analysis ................................................................................................................. 81
6.6.3 Opportunity ................................................................................................................... 81
6.7 Coverage of HPV Types Prevalent in Certain Populations ................................................ 82
6.7.1 Unmet Need .................................................................................................................. 82
6.7.2 Gap Analysis ................................................................................................................. 83
6.7.3 Opportunity ................................................................................................................... 83
6.8 Vaccine Compliance Rates ............................................................................................... 84
6.8.1 Unmet Need .................................................................................................................. 84
6.8.2 Gap Analysis ................................................................................................................. 84
6.8.3 Opportunity ................................................................................................................... 85
6.9 Lifelong Protection from HPV Infection Not Established .................................................... 85
6.9.1 Unmet Need .................................................................................................................. 85
6.9.2 Gap Analysis ................................................................................................................. 86
6.9.3 Opportunity ................................................................................................................... 86
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PROPHYLACTIC HUMAN PAPILLOMAVIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
6.10 Ongoing Need for Cervical Cancer Screening ................................................................... 87
6.10.1 Unmet Need .................................................................................................................. 87
6.10.2 Gap Analysis ................................................................................................................. 87
6.10.3 Opportunity ................................................................................................................... 88
7 Pipeline Assessment................................................................................................................. 89
7.1 Overview ........................................................................................................................... 89
7.2 Clinical Trial Mapping ........................................................................................................ 90
7.2.1 Clinical Trials by Country ............................................................................................... 90
7.2.2 Clinical Trials by Phase and Trial Status ....................................................................... 91
7.3 Promising Vaccines in Clinical Development ..................................................................... 92
7.3.1 V503 ............................................................................................................................. 94
7.3.2 Xiamen Innovax (Bivalent Vaccine) ............................................................................. 100
7.4 Innovative HPV Vaccines in Early Development ............................................................. 103
7.4.1 Low-Cost HPV Vaccines ............................................................................................. 103
7.4.2 Universal HPV Vaccines ............................................................................................. 104
8 Current and Future Players ..................................................................................................... 105
8.1 Overview ......................................................................................................................... 105
8.2 Trends in Corporate Strategy .......................................................................................... 107
8.3 Company Profiles ............................................................................................................ 108
8.3.1 Merck .......................................................................................................................... 108
8.3.2 GSK ............................................................................................................................ 111
9 Market Outlook ....................................................................................................................... 114
9.1 Global Markets ................................................................................................................ 114
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PROPHYLACTIC HUMAN PAPILLOMAVIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
9.1.1 Forecast ...................................................................................................................... 114
9.1.2 Drivers and Barriers – Global Issues ........................................................................... 116
9.2 US................................................................................................................................... 121
9.2.1 Forecast ...................................................................................................................... 121
9.2.2 Key Events .................................................................................................................. 122
9.2.3 Drivers and Barriers .................................................................................................... 123
9.3 France ............................................................................................................................ 126
9.3.1 Forecast ...................................................................................................................... 126
9.3.2 Key Events .................................................................................................................. 128
9.3.3 Drivers and Barriers .................................................................................................... 128
9.4 Germany ......................................................................................................................... 130
9.4.1 Forecast ...................................................................................................................... 130
9.4.2 Key Events .................................................................................................................. 132
9.4.3 Drivers and Barriers .................................................................................................... 132
9.5 Italy ................................................................................................................................. 134
9.5.1 Forecast ...................................................................................................................... 134
9.5.2 Key Events .................................................................................................................. 136
9.5.3 Drivers and Barriers .................................................................................................... 137
9.6 Spain .............................................................................................................................. 138
9.6.1 Forecast ...................................................................................................................... 139
9.6.2 Key Events .................................................................................................................. 140
9.6.3 Drivers and Barriers .................................................................................................... 141
9.7 UK................................................................................................................................... 143
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PROPHYLACTIC HUMAN PAPILLOMAVIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
9.7.1 Forecast ...................................................................................................................... 143
9.7.2 Key Events .................................................................................................................. 144
9.7.3 Drivers and Barriers .................................................................................................... 145
9.8 Japan .............................................................................................................................. 147
9.8.1 Forecast ...................................................................................................................... 147
9.8.2 Key Events .................................................................................................................. 148
9.8.3 Drivers and Barriers .................................................................................................... 149
9.9 Australia .......................................................................................................................... 151
9.9.1 Forecast ...................................................................................................................... 151
9.9.2 Key Events .................................................................................................................. 153
9.9.3 Drivers and Barriers .................................................................................................... 153
9.10 Canada ........................................................................................................................... 155
9.10.1 Forecast ...................................................................................................................... 155
9.10.2 Key Events .................................................................................................................. 156
9.10.3 Drivers and Barriers .................................................................................................... 157
10 Appendix................................................................................................................................. 160
10.1 Bibliography .................................................................................................................... 160
10.2 Abbreviations .................................................................................................................. 176
10.3 Methodology ................................................................................................................... 178
10.4 Forecasting Methodology ................................................................................................ 178
10.4.1 Vaccine Coverage ....................................................................................................... 179
10.4.2 Vaccine Approval versus Routine Schedule Inclusion ................................................. 179
10.4.3 Vaccines Included ....................................................................................................... 180
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PROPHYLACTIC HUMAN PAPILLOMAVIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
10.4.4 Vaccine Launch Dates and Patent Expiry Dates ......................................................... 180
10.4.5 General Pricing Assumptions ...................................................................................... 180
10.4.6 Individual Drug Assumptions ....................................................................................... 181
10.4.7 Pricing of Pipeline Agents............................................................................................ 183
10.5 Physicians and Specialists Included in this Study ........................................................... 184
10.6 About the Author(s) ......................................................................................................... 187
10.6.1 Author(s) ..................................................................................................................... 187
10.6.2 Therapy Area Director ................................................................................................. 187
10.6.3 Global Head of Healthcare .......................................................................................... 188
10.7 About GlobalData ............................................................................................................ 189
10.8 Disclaimer ....................................................................................................................... 189
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PROPHYLACTIC HUMAN PAPILLOMAVIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
1.1 List of Tables
Table 1: Histological Progression Towards Cervical Cancer ......................................................................... 24
Table 2: Diseases Associated with HPV Infection and Their Associated Symptoms ..................................... 26
Table 3: HPV Vaccine Recommendation Agencies by Country .................................................................... 28
Table 4: Targeted Group(s) for Recommended Immunization and Most-Administered HPV Vaccine by
Country in the Global Markets, 2014 .............................................................................................. 28
Table 5: Routine HPV Vaccine Programs by Region, Italy ............................................................................ 39
Table 6: Routine HPV Vaccine Programs by Region, Spain ......................................................................... 43
Table 7: Routine HPV Vaccine Programs by Province, Canada ................................................................... 54
Table 8: Marketed Vaccines for HPV, 2014.................................................................................................. 60
Table 9: Product Profile – Gardasil .............................................................................................................. 62
Table 10: Phase III Efficacy Trials – Gardasil ................................................................................................. 64
Table 11: Safety Profile – Gardasil ................................................................................................................. 65
Table 12: Gardasil SWOT Analysis, 2014 ...................................................................................................... 65
Table 13: Global Sales Forecasts ($m) for Gardasil, 2012–2022 .................................................................... 66
Table 14: Product Profile – Cervarix............................................................................................................... 68
Table 15: Phase III Efficacy Trials – Cervarix ................................................................................................. 69
Table 16: Safety Profile – Cervarix ................................................................................................................. 70
Table 17: Cervarix SWOT Analysis, 2014 ...................................................................................................... 70
Table 18: Global Sales Forecasts ($m) for Cervarix, 2012–2022 .................................................................... 71
Table 19: Overall Unmet Needs – Current and Future Level of Attainment ..................................................... 73
Table 20: HPV Vaccines – Clinical Trials by Phase and Status, 2014 ............................................................. 92
Table 21: HPV Vaccines – Phase Pipeline, 2014 ........................................................................................... 93
Table 22: Product Profile – V503 ................................................................................................................... 95
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PROPHYLACTIC HUMAN PAPILLOMAVIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
Table 23: V503 SWOT Analysis, 2013 ........................................................................................................... 99
Table 24: Global Sales Forecasts ($m) for V503, 2012–2022 ....................................................................... 100
Table 25: Bivalent Vaccine (Xiamen Innovax) SWOT Analysis, 2014 ........................................................... 102
Table 26: Key Companies in the HPV Vaccine Market, 2014 ....................................................................... 106
Table 27: Merck’s HPV Vaccine Portfolio Assessment, 2014 ....................................................................... 110
Table 28: Merck SWOT Analysis, 2014 ........................................................................................................ 110
Table 29: GSK’s HPV Vaccine Portfolio Assessment, 2014.......................................................................... 112
Table 30: GSK SWOT Analysis, 2014 .......................................................................................................... 113
Table 31: Global Sales Forecasts ($m) for HPV Vaccines, 2012–2022 ......................................................... 114
Table 32: Global HPV Vaccine Market – Drivers and Barriers, 2014 ............................................................. 116
Table 33: Sales Forecasts ($m) for HPV Vaccines in the United States, 2012–2022 .................................... 121
Table 34: Key Events Impacting Sales for HPV Vaccines in the United States, 2012–2022 .......................... 123
Table 35: United States HPV Vaccine Market – Drivers and Barriers, 2014 .................................................. 123
Table 36: Sales Forecasts ($m) for HPV Vaccines in France, 2012–2022 .................................................... 127
Table 37: Key Events Impacting Sales for HPV Vaccines in France, 2012–2022 .......................................... 128
Table 38: France HPV Vaccine Market – Drivers and Barriers, 2014 ............................................................ 128
Table 39: Sales Forecasts ($m) for HPV Vaccines in Germany, 2012–2022 ................................................. 131
Table 40: Key Events Impacting Sales for HPV Vaccines in Germany, 2014 ................................................ 132
Table 41: Germany HPV Vaccine Market – Drivers and Barriers, 2014 ........................................................ 132
Table 42: Sales Forecasts ($m) for HPV Vaccines in Italy, 2012–2022 ......................................................... 135
Table 43: Key Events Impacting Sales for HPV Vaccines in Italy, 2014 ........................................................ 137
Table 44: Italy HPV Vaccine Market – Drivers and Barriers, 2014 ................................................................ 137
Table 45: Sales Forecasts ($m) for HPV Vaccines in Spain, 2012–2022 ...................................................... 139
Table 46: Key Events Impacting Sales for HPV Vaccines in Spain, 2012–2022 ............................................ 141
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PROPHYLACTIC HUMAN PAPILLOMAVIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
Table 47: Spain HPV Vaccine Market – Drivers and Barriers, 2014 .............................................................. 141
Table 48: Sales Forecasts ($) for HPV Vaccines in the United Kingdom, 2012–2022 ................................... 143
Table 49: Key Events Impacting Sales for HPV Vaccines in the United Kingdom, 2012–2022 ...................... 145
Table 50: United Kingdom HPV Vaccine Market – Drivers and Barriers, 2014 .............................................. 145
Table 51: Sales Forecasts ($) for HPV Vaccines in Japan, 2012–2022 ........................................................ 147
Table 52: Key Events Impacting Sales for HPV Vaccines in Japan, 2012–2022 ........................................... 149
Table 53: Japan HPV Vaccine Market – Drivers and Barriers, 2014 ............................................................. 149
Table 54: Sales Forecasts ($) for HPV Vaccines in Australia, 2012–2022 .................................................... 152
Table 55: Key Events Impacting Sales for HPV Vaccines in Australia, 2012–2022 ....................................... 153
Table 56: Australia HPV Vaccine Market – Drivers and Barriers, 2013 ......................................................... 153
Table 57: Sales Forecasts ($) for HPV Vaccines in Canada, 2012–2022 ...................................................... 155
Table 58: Key Events Impacting Sales for HPV Vaccines in Canada, 2012–2022 ......................................... 157
Table 59: Canada HPV Vaccine Market – Drivers and Barriers, 2014........................................................... 157
Table 60: Key Launch Dates ........................................................................................................................ 180
Table 61: Key Patent Expiries ...................................................................................................................... 180
Table 62: High-Prescribing Physicians (non-KOLs) Surveyed, By Country ................................................... 186
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Table of Contents
PROPHYLACTIC HUMAN PAPILLOMAVIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
1.2 List of Figures
Figure 1: Historical and Projected HPV Vaccination Coverage (%) in the United States among 12-Year-Old
Females, 2007–2022 .................................................................................................................... 31
Figure 2: Historical and Projected HPV Vaccination Coverage (%) in France among 14-Year-Old Females,
2007–2022 ................................................................................................................................... 34
Figure 3: Historical and Projected HPV Vaccination Coverage (%) in Germany among 17-Year-Old Females,
2009–2022 ................................................................................................................................... 37
Figure 4: Historical and Projected HPV Vaccination Coverage (%) in Italy among 12-Year-Old Females,
2009–2022 ................................................................................................................................... 41
Figure 5: Historical and Projected HPV Vaccination Coverage (%) in Spain among 14-Year-Old Females,
2008–2022 ................................................................................................................................... 44
Figure 6: Historical and Projected HPV Vaccination Coverage (%) in the United Kingdom among 12-Year-Old
Females, 2008–2022 .................................................................................................................... 47
Figure 7: Historical and Projected HPV Vaccination Coverage (%) in Japan among 16-Year-Old Females,
2012–2022 ................................................................................................................................... 50
Figure 8: Historical and Projected HPV Vaccination Coverage (%) in Australia among 13-Year-Old Females,
2007–2022 ................................................................................................................................... 53
Figure 9: Historical and Projected HPV Vaccination Coverage (%) in Canada among 12-Year-Old Females,
2007–2022 ................................................................................................................................... 56
Figure 10: HPV Vaccines – Clinical Trials by Country, 2014 ........................................................................... 90
Figure 11: Competitive Assessment of Late-Stage Pipeline Agents in HPV Vaccines, 2012–2022 .................. 93
Figure 12: Company Portfolio Gap Analysis in HPV Vaccines, 2012–2022 ................................................... 106
Figure 13: Global Sales for HPV Vaccines by Region, 2012–2022 ............................................................... 115
Figure 14: Sales for HPV Vaccines in the US by Vaccine Class, 2012–2022 ................................................ 122
Figure 15: Sales for HPV Vaccines in France by Vaccine Class, 2012–2022 ................................................ 127
Figure 16: Sales for HPV Vaccines in Germany by Vaccine Class, 2012–2022 ............................................ 131
Figure 17: Sales for HPV Vaccines in Italy by Vaccine Class, 2012–2022 .................................................... 136
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PROPHYLACTIC HUMAN PAPILLOMAVIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
Figure 18: Sales for HPV Vaccines in Spain by Vaccine Class, 2012–2022 .................................................. 140
Figure 19: Sales for HPV Vaccines in the United Kingdom by Vaccine Class, 2012–2022 ............................ 144
Figure 20: Sales for HPV Vaccines in Japan by Vaccine Class, 2012–2022 ................................................. 148
Figure 21: Sales for HPV Vaccines in Australia by Vaccine Class, 2012–2022 ............................................. 152
Figure 22: Sales for HPV Vaccines in Canada by Vaccine Class, 2012–2022 .............................................. 156
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PROPHYLACTIC HUMAN PAPILLOMAVIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
Introduction
2 Introduction
2.1 Catalyst
The first prophylactic vaccine for immunization against human papillomavirus (HPV) became
available in 2006. The global HPV vaccines market is now well established, yet vaccine coverage
rates among the traditional target population of adolescent girls remain persistently low. Initially
HPV vaccines were developed and marketed solely to protect against cervical cancer. In recent
years the role of HPV in other cancers has been increasingly recognized, which has facilitated a
shift towards vaccinating a wider population; most significant has been the inclusion of males in
routine vaccine recommendations in some countries. The current HPV vaccines market is
dominated by one major player, Merck’s Gardasil, with GlaxoSmithKline’s (GSK’s) HPV vaccine
Cervarix providing the only competition. However, the introduction of Merck’s nine-valent vaccine is
set to change the future landscape of the HPV vaccines sector.
Below are some key factors affecting market growth over the forecast period:
Globally HPV vaccine coverage rates have remained persistently low over recent years. There
are a number of factors that contribute to these low coverage rates, including fears over
vaccine safety and lack of awareness. Overcoming barriers to vaccination and increasing
coverage rates would have a significant impact on the HPV vaccines market over the forecast
period.
There is increasing recognition of the benefits of vaccinating males against HPV. A number of
countries have included males in recommendations for routine immunization, which will expand
the patient population and drive growth in HPV vaccine sales in these countries.
Following introduction of V503, GlobalData expects Merck’s nine-valent vaccine to dominate
the HPV vaccines sector. The introduction of this vaccine is likely to drive expansion in the size
of the HPV vaccines sector over the forecast period.
The current HPV vaccines market is dominated by one major player, Merck’s Gardasil, with GlaxoSmithKline’s (GSK’s) HPV vaccine Cervarix providing the only competition.
Prophylactic Human Papillomavirus Vaccines - Global Drug Forecast and Market Analysis to 2022 21 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
PROPHYLACTIC HUMAN PAPILLOMAVIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
Introduction
2.2 Related Reports
GlobalData (2013). PharmaPoint: HIV Therapeutics – Global Drug Forecast and Market
Analysis to 2022: Event-Driven Update, March, 2013, GDHC41PIDR
GlobalData (2013). PharmaFocus: Vaccine Adjuvants in Infectious Disease, March, 2013,
GDHC001PFR
GlobalData (2013). PharmaPoint: Pediatric Respiratory Syncytial Virus Prophylactics – United
States Drug Forecast and Market Analysis to 2022, April, 2013, GDHC102PIDR
GlobalData (2013). PharmaPoint: HCV Therapeutics – Global Drug Forecast and Market
Analysis to 2022, May, 2013, GDHC42PIDR
GlobalData (2013). PharmaPoint: Dermatophytic Onychomycosis – United States Drug
Forecast and Market Analysis to 2022, June, 2013, GDHC101PIDR
GlobalData (2013). PharmaPoint: Meningococcal Vaccines – Global Drug Forecast and Market
Analysis to 2022, June 2013, GDHC51PIDR
GlobalData (2013). PharmaFocus: Market Access Strategies for Antibiotics Targeting
Multidrug-Resistant Gram-Negative Bacteria, August 2013, GDHC004PFR
GlobalData (2013). PharmaFocus: HIV – R&D Strategies Towards Cure and Prevention,
August 2013, GDHC003PFR
GlobalData (2013). PharmaPoint: Meningococcal Vaccines – Global Drug Forecast and Market
Analysis to 2022: Event-Driven Update, August 2013, GDHC61PIDR
GlobalData (2013). PharmaPoint: Seasonal Influenza Vaccines – Global Drug Forecast and
Market Analysis to 2022: Event-Driven Update, September 2013, GDHC67PIDR
GlobalData (2013). Prophylactic Hepatitis B Vaccines – Global Drug Forecast and Market
Analysis to 2022, January 2014, GDHC68PIDR
2.3 Upcoming Related Reports
GlobalData (2013). Asthma Therapeutics – Global Drug Forecast and Market Analysis to 2022,
April 2014, GDHC75PIDR
Prophylactic Human Papillomavirus Vaccines - Global Drug Forecast and Market Analysis to 2022 189 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Appendix
PROPHYLACTIC HUMAN PAPILLOMAVIRUS VACCINES - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022
10.7 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 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, San Francisco, London, India and Singapore.
10.8 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.