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.

In the US the total number of HPV vaccine doses delivered annually is likely to grow steadily over the next few years, as more males receive vaccination and Merck’s nine-valent vaccine V503 becomes available in 2015. US market growth will contribute to global growth in the HPV vaccines sector. There is no indication that coverage rates for adolescent girls will increase dramatically over the forecast period, as they have been relatively stable over the past few years. However, a modest increase will likely be achieved following the introduction of V503, which will be accompanied by a marketing and awareness campaign.

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

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 9
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 US 17
4.1.1 Vaccination Recommendations and Policies 17
4.1.2 Vaccination Coverage 17
4.1.3 Clinical Practice 19

5 Competitive Assessment 21
5.1 Overview 21
5.2 Strategic Competitor Assessment 21
5.3 Product Profiles 23
5.3.1 Gardasil 23
5.3.2 Cervarix 29

6 Unmet Need and Opportunity 34
6.1 Overview 34
6.2 Protection against Multiple HPV Types 35
6.2.1 Unmet Need 35
6.2.2 Gap Analysis 36
6.2.3 Opportunity 37
6.3 Vaccine Coverage Rates 37
6.3.1 Unmet Need 37
6.3.2 Gap Analysis 38
6.3.3 Opportunity 38
6.4 Perception of Vaccine Safety 39
6.4.1 Unmet Need 39
6.4.2 Gap Analysis 40
6.4.3 Opportunity 40
6.5 Awareness of HPV Vaccination 41
6.5.1 Unmet Need 41
6.5.2 Gap Analysis 41
6.5.3 Opportunity 42
6.6 Affordability of HPV Vaccines 42
6.6.1 Unmet Need 42
6.6.2 Gap Analysis 43
6.6.3 Opportunity 43
6.7 Coverage of HPV Types Prevalent in Certain Populations 44
6.7.1 Unmet Need 44
6.7.2 Gap Analysis 45
6.7.3 Opportunity 45
6.8 Vaccine Compliance Rates 46
6.8.1 Unmet Need 46
6.8.2 Gap Analysis 46
6.8.3 Opportunity 47
6.9 Lifelong Protection from HPV Infection Not Established 47
6.9.1 Unmet Need 47
6.9.2 Gap Analysis 48
6.9.3 Opportunity 48
6.10 Ongoing Need for Cervical Cancer Screening 49
6.10.1 Unmet Need 49
6.10.2 Gap Analysis 49
6.10.3 Opportunity 50

7 Pipeline Assessment 51
7.1 Overview 51
7.2 Promising Vaccines in Clinical Development 52
7.2.1 V503 53
7.2.2 Xiamen Innovax (Bivalent Vaccine) 59
7.3 Innovative HPV Vaccines in Early Development 62
7.3.1 Low-Cost HPV Vaccines 62
7.3.2 Universal HPV Vaccines 63

8 Market Outlook 65
8.1 US 65
8.1.1 Forecast 65
8.1.2 Key Events 66
8.1.3 Drivers and Barriers 67

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: Marketed Vaccines for HPV, 2014 23
Table 4: Product Profile - Gardasil 25
Table 5: Phase III Efficacy Trials - Gardasil 27
Table 6: Safety Profile - Gardasil 28
Table 7: Gardasil SWOT Analysis, 2014 28
Table 8: Product Profile - Cervarix 30
Table 9: Phase III Efficacy Trials - Cervarix 31
Table 10: Safety Profile - Cervarix 32
Table 11: Cervarix SWOT Analysis, 2014 33
Table 12: Overall Unmet Needs - Current and Future Level of Attainment 35
Table 13: HPV Vaccines - Phase Pipeline, 2014 52
Table 14: Product Profile - V503 54
Table 15: V503 SWOT Analysis, 2013 59
Table 16: Bivalent Vaccine (Xiamen Innovax) SWOT Analysis, 2014 62
Table 17: Sales Forecasts ($m) for HPV Vaccines in the United States, 2012-2022 65
Table 18: Key Events Impacting Sales for HPV Vaccines in the United States, 2012-2022 67
Table 19: United States HPV Vaccine Market - Drivers and Barriers, 2014 67
Table 20: Key Launch Dates 85
Table 21: Key Patent Expiries 85
Table 22: High-Prescribing Physicians (non-KOLs) Surveyed, in US 90

List of Figures

Figure 1: Historical and Projected HPV Vaccination Coverage (%) in the United States among 12-Year-Old Females, 2007-2022 19
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in HPV Vaccines, 2012-2022 53
Figure 3: Sales for HPV Vaccines in the US by Vaccine Class, 2012-2022 66