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.

The anticipated addition of boys to routine HPV vaccine recommendations by different Canadian provinces is expected to serve as a significant driver to growth within the HPV vaccines market in Canada over the forecast period. In addition, from primary research insight, GlobalData projects Merck’s nine-valent vaccine V503 to be widely adopted in the country. This will also significantly enhance the size of the HPV vaccines sector in Canada.

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 Canada including product description, safety and efficacy profiles as well as a SWOT analysis.
• Sales forecast for the top drugs in the Canada from 2012-2022.
• Analysis of the impact of key events as well the drivers and restraints affecting the Canada 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 Canada

Table of Contents

1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 8

2 Introduction 9
2.1 Catalyst 9
2.2 Related Reports 10
2.3 Upcoming Related Reports 11

3 Disease Overview 12
3.1 Etiology and Pathophysiology 12
3.1.1 Etiology 12
3.1.2 Pathophysiology 13
3.2 Symptoms 15

4 Vaccination Recommendations and Coverage Rates 17
4.1 Canada 17
4.1.1 Vaccination Recommendations and Policies 17
4.1.2 Vaccination Coverage 18
4.1.3 Clinical Practice 20

5 Competitive Assessment 22
5.1 Overview 22
5.2 Strategic Competitor Assessment 22
5.3 Product Profiles 24
5.3.1 Gardasil 24
5.3.2 Cervarix 30

6 Unmet Need and Opportunity 35
6.1 Overview 35
6.2 Protection against Multiple HPV Types 36
6.2.1 Unmet Need 36
6.2.2 Gap Analysis 37
6.2.3 Opportunity 38
6.3 Vaccine Coverage Rates 38
6.3.1 Unmet Need 38
6.3.2 Gap Analysis 39
6.3.3 Opportunity 39
6.4 Perception of Vaccine Safety 40
6.4.1 Unmet Need 40
6.4.2 Gap Analysis 41
6.4.3 Opportunity 41
6.5 Awareness of HPV Vaccination 42
6.5.1 Unmet Need 42
6.5.2 Gap Analysis 42
6.5.3 Opportunity 43
6.6 Affordability of HPV Vaccines 43
6.6.1 Unmet Need 43
6.6.2 Gap Analysis 44
6.6.3 Opportunity 44
6.7 Coverage of HPV Types Prevalent in Certain Populations 45
6.7.1 Unmet Need 45
6.7.2 Gap Analysis 46
6.7.3 Opportunity 46
6.8 Vaccine Compliance Rates 46
6.8.1 Unmet Need 46
6.8.2 Gap Analysis 47
6.8.3 Opportunity 47
6.9 Lifelong Protection from HPV Infection Not Established 48
6.9.1 Unmet Need 48
6.9.2 Gap Analysis 49
6.9.3 Opportunity 49
6.10 Ongoing Need for Cervical Cancer Screening 50
6.10.1 Unmet Need 50
6.10.2 Gap Analysis 50
6.10.3 Opportunity 51

7 Pipeline Assessment 52
7.1 Overview 52
7.2 Promising Vaccines in Clinical Development 53
7.2.1 V503 54
7.2.2 Xiamen Innovax (Bivalent Vaccine) 60
7.3 Innovative HPV Vaccines in Early Development 63
7.3.1 Low-Cost HPV Vaccines 63
7.3.2 Universal HPV Vaccines 64

8 Market Outlook 66
8.1 Canada 66
8.1.1 Forecast 66
8.1.2 Key Events 67
8.1.3 Drivers and Barriers 68

9 Appendix 71
9.1 Bibliography 71
9.2 Abbreviations 81
9.3 Methodology 83
9.4 Forecasting Methodology 83
9.4.1 Vaccine Coverage 84
9.4.2 Vaccine Approval versus Routine Schedule Inclusion 84
9.4.3 Vaccines Included 84
9.4.4 Vaccine Launch Dates and Patent Expiry Dates 85
9.4.5 General Pricing Assumptions 85
9.4.6 Individual Drug Assumptions 85
9.4.7 Pricing of Pipeline Agents 87
9.5 Physicians and Specialists Included in this Study 88
9.6 About the Author(s) 91
9.6.1 Author(s) 91
9.6.2 Therapy Area Director 91
9.6.3 Global Head of Healthcare 92
9.7 About GlobalData 93
9.8 Disclaimer 93

List of Tables

Table 1: Histological Progression Towards Cervical Cancer 14
Table 2: Diseases Associated with HPV Infection and Their Associated Symptoms 16
Table 3: Routine HPV Vaccine Programs by Province, Canada 18
Table 4: Marketed Vaccines for HPV, 2014 24
Table 5: Product Profile - Gardasil 26
Table 6: Phase III Efficacy Trials - Gardasil 28
Table 7: Safety Profile - Gardasil 29
Table 8: Gardasil SWOT Analysis, 2014 29
Table 9: Product Profile - Cervarix 31
Table 10: Phase III Efficacy Trials - Cervarix 32
Table 11: Safety Profile - Cervarix 33
Table 12: Cervarix SWOT Analysis, 2014 34
Table 13: Overall Unmet Needs - Current and Future Level of Attainment 36
Table 14: HPV Vaccines - Phase Pipeline, 2014 53
Table 15: Product Profile - V503 55
Table 16: V503 SWOT Analysis, 2013 60
Table 17: Bivalent Vaccine (Xiamen Innovax) SWOT Analysis, 2014 63
Table 18: Sales Forecasts ($) for HPV Vaccines in Canada, 2012-2022 66
Table 19: Key Events Impacting Sales for HPV Vaccines in Canada, 2012-2022 68
Table 20: Canada HPV Vaccine Market - Drivers and Barriers, 2014 68
Table 21: Key Launch Dates 85
Table 22: Key Patent Expiries 85
Table 23: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 90

List of Figures

Figure 1: Historical and Projected HPV Vaccination Coverage (%) in Canada among 12-Year-Old Females, 2007-2022 20
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in HPV Vaccines, 2012-2022 54
Figure 3: Sales for HPV Vaccines in Canada by Vaccine Class, 2012-2022 67