gdhc84pidr prophylactic human papillomavirus … in this report expected v503 to be widely used,...

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



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.



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.



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



Executive Summary

“When I have done surveys and research on this

[barriers to vaccination], it’s all about safety.”


“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.”


“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.”


“Future vaccines covering more types [of HPV] will

be really beneficial.”


“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.”



Table of Contents


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




Table of Contents



4.4 Germany ........................................................................................................................... 35




4.5 Italy ................................................................................................................................... 38




4.6 Spain ................................................................................................................................ 42




4.7 UK..................................................................................................................................... 45




4.8 Japan ................................................................................................................................ 48




4.9 Australia ............................................................................................................................ 51



Table of Contents




4.10 Canada ............................................................................................................................. 54




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


Table of Contents


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


Table of Contents


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


Table of Contents


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


9.4 Germany ......................................................................................................................... 130

9.4.1 Forecast ...................................................................................................................... 130

9.4.2 Key Events .................................................................................................................. 132


9.5 Italy ................................................................................................................................. 134

9.5.1 Forecast ...................................................................................................................... 134

9.5.2 Key Events .................................................................................................................. 136


9.6 Spain .............................................................................................................................. 138

9.6.1 Forecast ...................................................................................................................... 139

9.6.2 Key Events .................................................................................................................. 140


9.7 UK................................................................................................................................... 143


Table of Contents


9.7.1 Forecast ...................................................................................................................... 143

9.7.2 Key Events .................................................................................................................. 144


9.8 Japan .............................................................................................................................. 147

9.8.1 Forecast ...................................................................................................................... 147

9.8.2 Key Events .................................................................................................................. 148


9.9 Australia .......................................................................................................................... 151

9.9.1 Forecast ...................................................................................................................... 151

9.9.2 Key Events .................................................................................................................. 153


9.10 Canada ........................................................................................................................... 155

9.10.1 Forecast ...................................................................................................................... 155

9.10.2 Key Events .................................................................................................................. 156


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


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


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



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.



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


Appendix


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.

gdhc84pidr prophylactic human papillomavirus … in this report expected v503 to be widely used,...

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