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.

There are very low HPV vaccine coverage rates in France and GlobalData expects this to continue throughout the forecast period, especially while the burden of vaccine cost falls partially on the patient. GlobalData anticipates that the low coverage rates for HPV vaccination in Germany will persist throughout the forecast period. Although lower than for other vaccines, coverage rates for HPV vaccination in Italy are higher than for many European countries. Compared with other countries Spain has relatively high coverage rates for HPV vaccination, which GlobalData expects will persist throughout the forecast period. Due to the comprehensive nature of its school-based immunization program, the UK has high HPV vaccine coverage rates.

Scope

• Overview of Prophylactic Human Papillomavirus Vaccines including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
• Detailed information on the key drugs in the 5EU including product description, safety and efficacy profiles as well as a SWOT analysis.
• Sales forecast for the top drugs in the 5EU from 2012-2022.
• Analysis of the impact of key events as well the drivers and restraints affecting the 5EU Prophylactic Human Papillomavirus Vaccines disease market.

Reasons to buy

• Understand and capitalize by identifying products that are most likely to ensure a robust return
• Stay ahead of the competition by understanding the changing competitive landscape for Prophylactic Human Papillomavirus Vaccines
• Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
• Make more informed business decisions from insightful and in-depth analysis of drug performance
• Obtain sales forecast for drugs from 2012-2022 in the 5EU

Table of Contents

1 Table of Contents 4
1.1 List of Tables 9
1.2 List of Figures 11

2 Introduction 12
2.1 Catalyst 12
2.2 Related Reports 13
2.3 Upcoming Related Reports 14

3 Disease Overview 15
3.1 Etiology and Pathophysiology 16
3.1.1 Etiology 16
3.1.2 Pathophysiology 16
3.2 Symptoms 18

4 Vaccination Recommendations and Coverage Rates 20
4.1 France 20
4.1.1 Vaccination Recommendations and Policies 20
4.1.2 Vaccination Coverage 20
4.1.3 Clinical Practice 22
4.2 Germany 23
4.2.1 Vaccination Recommendations and Policies 23
4.2.2 Vaccination Coverage 23
4.2.3 Clinical Practice 25
4.3 Italy 25
4.3.1 Vaccination Recommendations and Policies 25
4.3.2 Vaccination Coverage 27
4.3.3 Clinical Practice 28
4.4 Spain 29
4.4.1 Vaccination Recommendations and Policies 29
4.4.2 Vaccination Coverage 30
4.4.3 Clinical Practice 32
4.5 UK 32
4.5.1 Vaccination Recommendations and Policies 32
4.5.2 Vaccination Coverage 33
4.5.3 Clinical Practice 34

5 Competitive Assessment 36
5.1 Overview 36
5.2 Strategic Competitor Assessment 36
5.3 Product Profiles 38
5.3.1 Gardasil 38
5.3.2 Cervarix 44

6 Unmet Need and Opportunity 49
6.1 Overview 49
6.2 Protection against Multiple HPV Types 50
6.2.1 Unmet Need 50
6.2.2 Gap Analysis 51
6.2.3 Opportunity 52
6.3 Vaccine Coverage Rates 52
6.3.1 Unmet Need 52
6.3.2 Gap Analysis 53
6.3.3 Opportunity 53
6.4 Perception of Vaccine Safety 54
6.4.1 Unmet Need 54
6.4.2 Gap Analysis 55
6.4.3 Opportunity 55
6.5 Awareness of HPV Vaccination 56
6.5.1 Unmet Need 56
6.5.2 Gap Analysis 56
6.5.3 Opportunity 57
6.6 Affordability of HPV Vaccines 57
6.6.1 Unmet Need 57
6.6.2 Gap Analysis 58
6.6.3 Opportunity 58
6.7 Coverage of HPV Types Prevalent in Certain Populations 59
6.7.1 Unmet Need 59
6.7.2 Gap Analysis 60
6.7.3 Opportunity 60
6.8 Vaccine Compliance Rates 61
6.8.1 Unmet Need 61
6.8.2 Gap Analysis 61
6.8.3 Opportunity 62
6.9 Lifelong Protection from HPV Infection Not Established 62
6.9.1 Unmet Need 62
6.9.2 Gap Analysis 63
6.9.3 Opportunity 63
6.10 Ongoing Need for Cervical Cancer Screening 64
6.10.1 Unmet Need 64
6.10.2 Gap Analysis 64
6.10.3 Opportunity 65

7 Pipeline Assessment 66
7.1 Overview 66
7.2 Promising Vaccines in Clinical Development 67
7.2.1 V503 68
7.2.2 Xiamen Innovax (Bivalent Vaccine) 74
7.3 Innovative HPV Vaccines in Early Development 77
7.3.1 Low-Cost HPV Vaccines 77
7.3.2 Universal HPV Vaccines 78

8 Market Outlook 80
8.1 France 80
8.1.1 Forecast 80
8.1.2 Key Events 81
8.1.3 Drivers and Barriers 82
8.2 Germany 84
8.2.1 Forecast 84
8.2.2 Key Events 85
8.2.3 Drivers and Barriers 86
8.3 Italy 88
8.3.1 Forecast 88
8.3.2 Key Events 90
8.3.3 Drivers and Barriers 91
8.4 Spain 93
8.4.1 Forecast 93
8.4.2 Key Events 94
8.4.3 Drivers and Barriers 95
8.5 UK 97
8.5.1 Forecast 97
8.5.2 Key Events 99
8.5.3 Drivers and Barriers 99

9 Appendix 102
9.1 Bibliography 102
9.2 Abbreviations 114
9.3 Methodology 116
9.4 Forecasting Methodology 116
9.4.1 Vaccine Coverage 117
9.4.2 Vaccine Approval versus Routine Schedule Inclusion 117
9.4.3 Vaccines Included 118
9.4.4 Vaccine Launch Dates and Patent Expiry Dates 118
9.4.5 General Pricing Assumptions 118
9.4.6 Individual Drug Assumptions 119
9.4.7 Pricing of Pipeline Agents 120
9.5 Physicians and Specialists Included in this Study 121
9.6 About the Author(s) 124
9.6.1 Author(s) 124
9.6.2 Therapy Area Director 124
9.6.3 Global Head of Healthcare 125
9.7 About GlobalData 126
9.8 Disclaimer 126

List of Tables

Table 1: Histological Progression Towards Cervical Cancer 17
Table 2: Diseases Associated with HPV Infection and Their Associated Symptoms 19
Table 3: Routine HPV Vaccine Programs by Region, Italy 26
Table 4: Routine HPV Vaccine Programs by Region, Spain 30
Table 5: Marketed Vaccines for HPV, 2014 38
Table 6: Product Profile - Gardasil 40
Table 7: Phase III Efficacy Trials - Gardasil 42
Table 8: Safety Profile - Gardasil 43
Table 9: Gardasil SWOT Analysis, 2014 43
Table 10: Product Profile - Cervarix 45
Table 11: Phase III Efficacy Trials - Cervarix 46
Table 12: Safety Profile - Cervarix 47
Table 13: Cervarix SWOT Analysis, 2014 48
Table 14: Overall Unmet Needs - Current and Future Level of Attainment 50
Table 15: HPV Vaccines - Phase Pipeline, 2014 67
Table 16: Product Profile - V503 69
Table 17: V503 SWOT Analysis, 2013 74
Table 18: Bivalent Vaccine (Xiamen Innovax) SWOT Analysis, 2014 77
Table 19: Sales Forecasts ($m) for HPV Vaccines in France, 2012-2022 80
Table 20: Key Events Impacting Sales for HPV Vaccines in France, 2012-2022 82
Table 21: France HPV Vaccine Market - Drivers and Barriers, 2014 82
Table 22: Sales Forecasts ($m) for HPV Vaccines in Germany, 2012-2022 84
Table 23: Key Events Impacting Sales for HPV Vaccines in Germany, 2014 86
Table 24: Germany HPV Vaccine Market - Drivers and Barriers, 2014 86
Table 25: Sales Forecasts ($m) for HPV Vaccines in Italy, 2012-2022 89
Table 26: Key Events Impacting Sales for HPV Vaccines in Italy, 2014 91
Table 27: Italy HPV Vaccine Market - Drivers and Barriers, 2014 91
Table 28: Sales Forecasts ($m) for HPV Vaccines in Spain, 2012-2022 93
Table 29: Key Events Impacting Sales for HPV Vaccines in Spain, 2012-2022 95
Table 30: Spain HPV Vaccine Market - Drivers and Barriers, 2014 95
Table 31: Sales Forecasts ($) for HPV Vaccines in the United Kingdom, 2012-2022 97
Table 32: Key Events Impacting Sales for HPV Vaccines in the United Kingdom, 2012-2022 99
Table 33: United Kingdom HPV Vaccine Market - Drivers and Barriers, 2014 99
Table 34: Key Launch Dates 118
Table 35: Key Patent Expiries 118
Table 36: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 123

List of Figures

Figure 1: Historical and Projected HPV Vaccination Coverage (%) in France among 14-Year-Old Females, 2007-2022 21
Figure 2: Historical and Projected HPV Vaccination Coverage (%) in Germany among 17-Year-Old Females, 2009-2022 24
Figure 3: Historical and Projected HPV Vaccination Coverage (%) in Italy among 12-Year-Old Females, 2009-2022 28
Figure 4: Historical and Projected HPV Vaccination Coverage (%) in Spain among 14-Year-Old Females, 2008-2022 31
Figure 5: Historical and Projected HPV Vaccination Coverage (%) in the United Kingdom among 12-Year-Old Females, 2008-2022 34
Figure 6: Competitive Assessment of Late-Stage Pipeline Agents in HPV Vaccines, 2012-2022 68
Figure 7: Sales for HPV Vaccines in France by Vaccine Class, 2012-2022 81
Figure 8: Sales for HPV Vaccines in Germany by Vaccine Class, 2012-2022 85
Figure 9: Sales for HPV Vaccines in Italy by Vaccine Class, 2012-2022 90
Figure 10: Sales for HPV Vaccines in Spain by Vaccine Class, 2012-2022 94
Figure 11: Sales for HPV Vaccines in the United Kingdom by Vaccine Class, 2012-2022 98