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.

GlobalData expects HPV vaccine coverage rates in Australia to remain relatively high throughout the forecast period, driven by a successful school-based immunization program. The inclusion of males in the school immunization program from 2013 will drive the expansion of the HPV vaccines market over the forecast period. GlobalData expects that following approval Merck’s nine-valent vaccine V503 will be quickly adopted into the Australian school-based immunization program, and this will provide an additional boost to HPV vaccine sales in Australia.

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

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 13
3.1.1 Etiology 13
3.1.2 Pathophysiology 13
3.2 Symptoms 15

4 Vaccination Recommendations and Coverage Rates 17
4.1 Australia 17
4.1.1 Vaccination Recommendations and Policies 17
4.1.2 Vaccination Coverage 17
4.1.3 Clinical Practice 19

5 Competitive Assessment 20
5.1 Overview 20
5.2 Strategic Competitor Assessment 20
5.3 Product Profiles 22
5.3.1 Gardasil 22
5.3.2 Cervarix 28

6 Unmet Need and Opportunity 33
6.1 Overview 33
6.2 Protection against Multiple HPV Types 34
6.2.1 Unmet Need 34
6.2.2 Gap Analysis 35
6.2.3 Opportunity 36
6.3 Vaccine Coverage Rates 36
6.3.1 Unmet Need 36
6.3.2 Gap Analysis 37
6.3.3 Opportunity 37
6.4 Perception of Vaccine Safety 38
6.4.1 Unmet Need 38
6.4.2 Gap Analysis 39
6.4.3 Opportunity 39
6.5 Awareness of HPV Vaccination 40
6.5.1 Unmet Need 40
6.5.2 Gap Analysis 40
6.5.3 Opportunity 41
6.6 Affordability of HPV Vaccines 41
6.6.1 Unmet Need 41
6.6.2 Gap Analysis 42
6.6.3 Opportunity 42
6.7 Coverage of HPV Types Prevalent in Certain Populations 43
6.7.1 Unmet Need 43
6.7.2 Gap Analysis 44
6.7.3 Opportunity 44
6.8 Vaccine Compliance Rates 45
6.8.1 Unmet Need 45
6.8.2 Gap Analysis 45
6.8.3 Opportunity 46
6.9 Lifelong Protection from HPV Infection Not Established 46
6.9.1 Unmet Need 46
6.9.2 Gap Analysis 47
6.9.3 Opportunity 47
6.10 Ongoing Need for Cervical Cancer Screening 48
6.10.1 Unmet Need 48
6.10.2 Gap Analysis 48
6.10.3 Opportunity 49

7 Pipeline Assessment 50
7.1 Overview 50
7.2 Promising Vaccines in Clinical Development 51
7.2.1 V503 52
7.2.2 Xiamen Innovax (Bivalent Vaccine) 58
7.3 Innovative HPV Vaccines in Early Development 61
7.3.1 Low-Cost HPV Vaccines 61
7.3.2 Universal HPV Vaccines 62

8 Market Outlook 64
8.1 Australia 64
8.1.1 Forecast 64
8.1.2 Key Events 65
8.1.3 Drivers and Barriers 66

9 Appendix 68
9.1 Bibliography 68
9.2 Abbreviations 78
9.3 Methodology 80
9.4 Forecasting Methodology 80
9.4.1 Vaccine Coverage 81
9.4.2 Vaccine Approval versus Routine Schedule Inclusion 81
9.4.3 Vaccines Included 82
9.4.4 Vaccine Launch Dates and Patent Expiry Dates 82
9.4.5 General Pricing Assumptions 82
9.4.6 Individual Drug Assumptions 83
9.4.7 Pricing of Pipeline Agents 84
9.5 Physicians and Specialists Included in this Study 85
9.6 About the Author(s) 88
9.6.1 Author(s) 88
9.6.2 Therapy Area Director 88
9.6.3 Global Head of Healthcare 89
9.7 About GlobalData 90
9.8 Disclaimer 90

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 22
Table 4: Product Profile - Gardasil 24
Table 5: Phase III Efficacy Trials - Gardasil 26
Table 6: Safety Profile - Gardasil 27
Table 7: Gardasil SWOT Analysis, 2014 27
Table 8: Product Profile - Cervarix 29
Table 9: Phase III Efficacy Trials - Cervarix 30
Table 10: Safety Profile - Cervarix 31
Table 11: Cervarix SWOT Analysis, 2014 32
Table 12: Overall Unmet Needs - Current and Future Level of Attainment 34
Table 13: HPV Vaccines - Phase Pipeline, 2014 51
Table 14: Product Profile - V503 53
Table 15: V503 SWOT Analysis, 2013 58
Table 16: Bivalent Vaccine (Xiamen Innovax) SWOT Analysis, 2014 61
Table 17: Sales Forecasts ($) for HPV Vaccines in Australia, 2012-2022 64
Table 18: Key Events Impacting Sales for HPV Vaccines in Australia, 2012-2022 66
Table 19: Australia HPV Vaccine Market - Drivers and Barriers, 2013 66
Table 20: Key Launch Dates 82
Table 21: Key Patent Expiries 82
Table 22: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 87

List of Figures

Figure 1: Historical and Projected HPV Vaccination Coverage (%) in Australia among 13-Year-Old Females, 2007-2022 18
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in HPV Vaccines, 2012-2022 52
Figure 3: Sales for HPV Vaccines in Australia by Vaccine Class, 2012-2022 65