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 amongst 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. The introduction of Merck’s nine-valent vaccine (V503) is set to change the future landscape of the HPV vaccines sector.

Highlights

Key Questions Answered

• What environmental factors limit the uptake of current HPV vaccines?
• What opportunities exist to overcome these environmental factors?
• What are the main unmet needs of current HPV vaccines?
• What technologies are positioned to address these unmet needs?
• What opportunities will remain for the development of new HPV vaccines?
• What environmental factors will influence the introduction of novel HPV vaccines?

Key Findings

• New nine-valent HPV vaccines are expected to be widely adopted following market approval, stealing market share from existing vaccines. Though a high price represents a potential barrier to market access.
• Significant environmental barriers to HPV vaccination exist, which currently serve to limit vaccine uptake.
• The emphasis of HPV vaccination is shifting away from an initial focus on cervical cancer prevention in females, towards prevention of a range of cancers in both males and females.
• The inclusion of males in routine HPV vaccine recommendations will expand the size of the HPV vaccines market

Scope

• Overview of the latest advances in prophylactic vaccination.
• Analysis of the future potential for novel and existing HPV vaccines.
• Key topics covered include unmet needs, opportunities, and drivers and barriers specific to prophylactic HPV vaccines.

Reasons to buy

• Understand the dynamics of the prophylactic HPV vaccines market, and the unique barriers to market access.
• Identify opportunities for the development and delivery of HPV vaccines, and to identify emerging players with potentially strong product portfolios.
• Develop business strategies by understanding the trends shaping and driving the future of prophylactic HPV vaccination.
• Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
• Gain insight on the challenges associated with delivering prophylactic HPV vaccines and the impact of novel vaccines.
• Track vaccine sales in the global HPV vaccines market from 2012-2022

Table of Contents

1 Table of Contents 7
1.1 List of Tables 13
1.2 List of Figures 16

2 Introduction 18
2.1 Catalyst 18
2.2 Related Reports 19
2.3 Upcoming Related Reports 19

3 Disease Overview 20
3.1 Etiology and Pathophysiology 21
3.1.1 Etiology 21
3.1.2 Pathophysiology 21
3.2 Symptoms 23

4 Vaccination Recommendations and Coverage Rates 25
4.1 Vaccination Recommendations Overview 25
4.2 US 27
4.2.1 Vaccination Recommendations and Policies 27
4.2.2 Vaccination Coverage 27
4.2.3 Clinical Practice 29
4.3 France 30
4.3.1 Vaccination Recommendations and Policies 30
4.3.2 Vaccination Coverage 31
4.3.3 Clinical Practice 32
4.4 Germany 33
4.4.1 Vaccination Recommendations and Policies 33
4.4.2 Vaccination Coverage 34
4.4.3 Clinical Practice 35
4.5 Italy 36
4.5.1 Vaccination Recommendations and Policies 36
4.5.2 Vaccination Coverage 37
4.5.3 Clinical Practice 39
4.6 Spain 40
4.6.1 Vaccination Recommendations and Policies 40
4.6.2 Vaccination Coverage 41
4.6.3 Clinical Practice 43
4.7 UK 43
4.7.1 Vaccination Recommendations and Policies 43
4.7.2 Vaccination Coverage 44
4.7.3 Clinical Practice 45
4.8 Japan 46
4.8.1 Vaccination Recommendations and Policies 46
4.8.2 Vaccination Coverage 47
4.8.3 Clinical Practice 48
4.9 Australia 49
4.9.1 Vaccination Recommendations and Policies 49
4.9.2 Vaccination Coverage 49
4.9.3 Clinical Practice 51
4.10 Canada 52
4.10.1 Vaccination Recommendations and Policies 52
4.10.2 Vaccination Coverage 53
4.10.3 Clinical Practice 54

5 Competitive Assessment 56
5.1 Overview 56
5.2 Strategic Competitor Assessment 56
5.3 Product Profiles 58
5.3.1 Gardasil 58
5.3.2 Cervarix 64

6 Unmet Need and Opportunity 70
6.1 Overview 70
6.2 Protection against Multiple HPV Types 71
6.2.1 Unmet Need 71
6.2.2 Gap Analysis 72
6.2.3 Opportunity 73
6.3 Vaccine Coverage Rates 73
6.3.1 Unmet Need 73
6.3.2 Gap Analysis 74
6.3.3 Opportunity 74
6.4 Perception of Vaccine Safety 75
6.4.1 Unmet Need 75
6.4.2 Gap Analysis 76
6.4.3 Opportunity 76
6.5 Awareness of HPV Vaccination 77
6.5.1 Unmet Need 77
6.5.2 Gap Analysis 77
6.5.3 Opportunity 78
6.6 Affordability of HPV Vaccines 78
6.6.1 Unmet Need 78
6.6.2 Gap Analysis 79
6.6.3 Opportunity 79
6.7 Coverage of HPV Types Prevalent in Certain Populations 80
6.7.1 Unmet Need 80
6.7.2 Gap Analysis 81
6.7.3 Opportunity 81
6.8 Vaccine Compliance Rates 82
6.8.1 Unmet Need 82
6.8.2 Gap Analysis 82
6.8.3 Opportunity 83
6.9 Lifelong Protection from HPV Infection Not Established 83
6.9.1 Unmet Need 83
6.9.2 Gap Analysis 84
6.9.3 Opportunity 84
6.10 Ongoing Need for Cervical Cancer Screening 85
6.10.1 Unmet Need 85
6.10.2 Gap Analysis 85
6.10.3 Opportunity 86

7 Pipeline Assessment 87
7.1 Overview 87
7.2 Clinical Trial Mapping 88
7.2.1 Clinical Trials by Country 88
7.2.2 Clinical Trials by Phase and Trial Status 89
7.3 Promising Vaccines in Clinical Development 90
7.3.1 V503 92
7.3.2 Xiamen Innovax (Bivalent Vaccine) 98
7.4 Innovative HPV Vaccines in Early Development 101
7.4.1 Low-Cost HPV Vaccines 101
7.4.2 Universal HPV Vaccines 102

8 Current and Future Players 103
8.1 Overview 103
8.2 Trends in Corporate Strategy 105
8.3 Company Profiles 106
8.3.1 Merck 106
8.3.2 GSK 109

9 Market Outlook 112
9.1 Global Markets 112
9.1.1 Forecast 112
9.1.2 Drivers and Barriers - Global Issues 114
9.2 US 119
9.2.1 Forecast 119
9.2.2 Key Events 121
9.2.3 Drivers and Barriers 121
9.3 France 124
9.3.1 Forecast 124
9.3.2 Key Events 126
9.3.3 Drivers and Barriers 126
9.4 Germany 128
9.4.1 Forecast 128
9.4.2 Key Events 130
9.4.3 Drivers and Barriers 130
9.5 Italy 132
9.5.1 Forecast 132
9.5.2 Key Events 134
9.5.3 Drivers and Barriers 135
9.6 Spain 137
9.6.1 Forecast 137
9.6.2 Key Events 138
9.6.3 Drivers and Barriers 139
9.7 UK 141
9.7.1 Forecast 141
9.7.2 Key Events 142
9.7.3 Drivers and Barriers 143
9.8 Japan 145
9.8.1 Forecast 145
9.8.2 Key Events 146
9.8.3 Drivers and Barriers 147
9.9 Australia 149
9.9.1 Forecast 149
9.9.2 Key Events 151
9.9.3 Drivers and Barriers 151
9.10 Canada 153
9.10.1 Forecast 153
9.10.2 Key Events 154
9.10.3 Drivers and Barriers 155

10 Appendix 158
10.1 Bibliography 158
10.2 Abbreviations 174
10.3 Methodology 176
10.4 Forecasting Methodology 176
10.4.1 Vaccine Coverage 177
10.4.2 Vaccine Approval versus Routine Schedule Inclusion 177
10.4.3 Vaccines Included 178
10.4.4 Vaccine Launch Dates and Patent Expiry Dates 178
10.4.5 General Pricing Assumptions 178
10.4.6 Individual Drug Assumptions 179
10.4.7 Pricing of Pipeline Agents 181
10.5 Physicians and Specialists Included in this Study 182
10.6 About the Author(s) 185
10.6.1 Author(s) 185
10.6.2 Therapy Area Director 185
10.6.3 Global Head of Healthcare 186
10.7 About GlobalData 187
10.8 Disclaimer 187

List of Tables

Table 1: Histological Progression Towards Cervical Cancer 22
Table 2: Diseases Associated with HPV Infection and Their Associated Symptoms 24
Table 3: HPV Vaccine Recommendation Agencies by Country 26
Table 4: Targeted Group(s) for Recommended Immunization and Most-Administered HPV Vaccine by Country in the Global Markets, 2014 26
Table 5: Routine HPV Vaccine Programs by Region, Italy 37
Table 6: Routine HPV Vaccine Programs by Region, Spain 41
Table 7: Routine HPV Vaccine Programs by Province, Canada 52
Table 8: Marketed Vaccines for HPV, 2014 58
Table 9: Product Profile - Gardasil 60
Table 10: Phase III Efficacy Trials - Gardasil 62
Table 11: Safety Profile - Gardasil 63
Table 12: Gardasil SWOT Analysis, 2014 63
Table 13: Global Sales Forecasts ($m) for Gardasil, 2012-2022 64
Table 14: Product Profile - Cervarix 66
Table 15: Phase III Efficacy Trials - Cervarix 67
Table 16: Safety Profile - Cervarix 68
Table 17: Cervarix SWOT Analysis, 2014 68
Table 18: Global Sales Forecasts ($m) for Cervarix, 2012-2022 69
Table 19: Overall Unmet Needs - Current and Future Level of Attainment 71
Table 20: HPV Vaccines - Clinical Trials by Phase and Status, 2014 90
Table 21: HPV Vaccines - Phase Pipeline, 2014 91
Table 22: Product Profile - V503 93
Table 23: V503 SWOT Analysis, 2013 97
Table 24: Global Sales Forecasts ($m) for V503, 2012-2022 98
Table 25: Bivalent Vaccine (Xiamen Innovax) SWOT Analysis, 2014 100
Table 26: Key Companies in the HPV Vaccine Market, 2014 104
Table 27: Merck's HPV Vaccine Portfolio Assessment, 2014 108
Table 28: Merck SWOT Analysis, 2014 108
Table 29: GSK's HPV Vaccine Portfolio Assessment, 2014 110
Table 30: GSK SWOT Analysis, 2014 111
Table 31: Global Sales Forecasts ($m) for HPV Vaccines, 2012-2022 112
Table 32: Global HPV Vaccine Market - Drivers and Barriers, 2014 114
Table 33: Sales Forecasts ($m) for HPV Vaccines in the United States, 2012-2022 119
Table 34: Key Events Impacting Sales for HPV Vaccines in the United States, 2012-2022 121
Table 35: United States HPV Vaccine Market - Drivers and Barriers, 2014 121
Table 36: Sales Forecasts ($m) for HPV Vaccines in France, 2012-2022 125
Table 37: Key Events Impacting Sales for HPV Vaccines in France, 2012-2022 126
Table 38: France HPV Vaccine Market - Drivers and Barriers, 2014 126
Table 39: Sales Forecasts ($m) for HPV Vaccines in Germany, 2012-2022 129
Table 40: Key Events Impacting Sales for HPV Vaccines in Germany, 2014 130
Table 41: Germany HPV Vaccine Market - Drivers and Barriers, 2014 130
Table 42: Sales Forecasts ($m) for HPV Vaccines in Italy, 2012-2022 133
Table 43: Key Events Impacting Sales for HPV Vaccines in Italy, 2014 135
Table 44: Italy HPV Vaccine Market - Drivers and Barriers, 2014 135
Table 45: Sales Forecasts ($m) for HPV Vaccines in Spain, 2012-2022 137
Table 46: Key Events Impacting Sales for HPV Vaccines in Spain, 2012-2022 139
Table 47: Spain HPV Vaccine Market - Drivers and Barriers, 2014 139
Table 48: Sales Forecasts ($) for HPV Vaccines in the United Kingdom, 2012-2022 141
Table 49: Key Events Impacting Sales for HPV Vaccines in the United Kingdom, 2012-2022 143
Table 50: United Kingdom HPV Vaccine Market - Drivers and Barriers, 2014 143
Table 51: Sales Forecasts ($) for HPV Vaccines in Japan, 2012-2022 145
Table 52: Key Events Impacting Sales for HPV Vaccines in Japan, 2012-2022 147
Table 53: Japan HPV Vaccine Market - Drivers and Barriers, 2014 147
Table 54: Sales Forecasts ($) for HPV Vaccines in Australia, 2012-2022 150
Table 55: Key Events Impacting Sales for HPV Vaccines in Australia, 2012-2022 151
Table 56: Australia HPV Vaccine Market - Drivers and Barriers, 2013 151
Table 57: Sales Forecasts ($) for HPV Vaccines in Canada, 2012-2022 153
Table 58: Key Events Impacting Sales for HPV Vaccines in Canada, 2012-2022 155
Table 59: Canada HPV Vaccine Market - Drivers and Barriers, 2014 155
Table 60: Key Launch Dates 178
Table 61: Key Patent Expiries 178
Table 62: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 184

List of Figures

Figure 1: Historical and Projected HPV Vaccination Coverage (%) in the United States among 12-Year-Old Females, 2007-2022 29
Figure 2: Historical and Projected HPV Vaccination Coverage (%) in France among 14-Year-Old Females, 2007-2022 32
Figure 3: Historical and Projected HPV Vaccination Coverage (%) in Germany among 17-Year-Old Females, 2009-2022 35
Figure 4: Historical and Projected HPV Vaccination Coverage (%) in Italy among 12-Year-Old Females, 2009-2022 39
Figure 5: Historical and Projected HPV Vaccination Coverage (%) in Spain among 14-Year-Old Females, 2008-2022 42
Figure 6: Historical and Projected HPV Vaccination Coverage (%) in the United Kingdom among 12-Year-Old Females, 2008-2022 45
Figure 7: Historical and Projected HPV Vaccination Coverage (%) in Japan among 16-Year-Old Females, 2012-2022 48
Figure 8: Historical and Projected HPV Vaccination Coverage (%) in Australia among 13-Year-Old Females, 2007-2022 51
Figure 9: Historical and Projected HPV Vaccination Coverage (%) in Canada among 12-Year-Old Females, 2007-2022 54
Figure 10: HPV Vaccines - Clinical Trials by Country, 2014 88
Figure 11: Competitive Assessment of Late-Stage Pipeline Agents in HPV Vaccines, 2012-2022 91
Figure 12: Company Portfolio Gap Analysis in HPV Vaccines, 2012-2022 104
Figure 13: Global Sales for HPV Vaccines by Region, 2012-2022 113
Figure 14: Sales for HPV Vaccines in the US by Vaccine Class, 2012-2022 120
Figure 15: Sales for HPV Vaccines in France by Vaccine Class, 2012-2022 125
Figure 16: Sales for HPV Vaccines in Germany by Vaccine Class, 2012-2022 129
Figure 17: Sales for HPV Vaccines in Italy by Vaccine Class, 2012-2022 134
Figure 18: Sales for HPV Vaccines in Spain by Vaccine Class, 2012-2022 138
Figure 19: Sales for HPV Vaccines in the United Kingdom by Vaccine Class, 2012-2022 142
Figure 20: Sales for HPV Vaccines in Japan by Vaccine Class, 2012-2022 146
Figure 21: Sales for HPV Vaccines in Australia by Vaccine Class, 2012-2022 150
Figure 22: Sales for HPV Vaccines in Canada by Vaccine Class, 2012-2022 154