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V503 (Prophylactic Human Papillomavirus Vaccines) - Forecast and Market Analysis to 2022

Summary

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.

Merck is developing V503, a nine-valent HPV vaccine; like Gardasil, this vaccine is being developed in partnership with CSL, from which Merck is licensing VLP technology. Both V503 and Merck’s current vaccine Gardasil have a similar mechanism of action, consisting of VLPs combined with aluminum salt adjuvant, delivered as an IM injection over a three-dose course. Merck has recently registered a Phase III trial to assess the immunogenicity of V503 given over a two-dose course (Merck, NCT01984697).

Scope

- Overview of HPV, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on V503 including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for V503 for the top eight countries from 2012 to 2022.
- Sales information covered for the US, France, Germany, Italy, Spain, the UK, Canada and Australia

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 HPV
- 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 V503 performance
- Obtain sales forecast for V503 from 2012-2022 in top eight countries (the US, France, Germany, Italy, Spain, the UK, Canada and Australia)

Table Of Contents

V503 (Prophylactic Human Papillomavirus Vaccines) - Forecast and Market Analysis to 2022
1 Table of Contents

2 Introduction 8
2.1 Catalyst 8
2.2 Related Reports 9
2.3 Upcoming Related Reports 10
3 Disease Overview 11
3.1 Etiology and Pathophysiology 12
3.1.1 Etiology 12
3.1.2 Pathophysiology 12
3.2 Symptoms 14
4 Vaccination Recommendations and Coverage Rates 16
4.1 Vaccination Recommendations Overview 16
5 Competitive Assessment 18
5.1 Overview 18
5.2 Strategic Competitor Assessment 18
6 Unmet Need and Opportunity 21
6.1 Overview 21
6.2 Protection against Multiple HPV Types 22
6.2.1 Unmet Need 22
6.2.2 Gap Analysis 23
6.2.3 Opportunity 24
6.3 Vaccine Coverage Rates 24
6.3.1 Unmet Need 24
6.3.2 Gap Analysis 25
6.3.3 Opportunity 25
6.4 Perception of Vaccine Safety 26
6.4.1 Unmet Need 26
6.4.2 Gap Analysis 27
6.4.3 Opportunity 27
6.5 Awareness of HPV Vaccination 28
6.5.1 Unmet Need 28
6.5.2 Gap Analysis 28
6.5.3 Opportunity 29
6.6 Affordability of HPV Vaccines 29
6.6.1 Unmet Need 29
6.6.2 Gap Analysis 30
6.6.3 Opportunity 30
6.7 Coverage of HPV Types Prevalent in Certain Populations 31
6.7.1 Unmet Need 31
6.7.2 Gap Analysis 32
6.7.3 Opportunity 32
6.8 Vaccine Compliance Rates 33
6.8.1 Unmet Need 33
6.8.2 Gap Analysis 33
6.8.3 Opportunity 34
6.9 Lifelong Protection from HPV Infection Not Established 34
6.9.1 Unmet Need 34
6.9.2 Gap Analysis 35
6.9.3 Opportunity 35
6.10 Ongoing Need for Cervical Cancer Screening 36
6.10.1 Unmet Need 36
6.10.2 Gap Analysis 36
6.10.3 Opportunity 37
7 Pipeline Assessment 38
7.1 Overview 38
7.2 Promising Vaccines in Clinical Development 39
8 V503 41
8.1 Overview 41
8.2 Immunogenicity 42
8.3 Safety 43
8.4 Dosing and Formulation 44
8.5 Potential Clinical Positioning 44
8.6 Potential Commercial Positioning 45
8.7 Pricing and Reimbursement 45
8.8 SWOT Analysis 46
8.9 Forecast 47
9 Appendix 48
9.1 Bibliography 48
9.2 Abbreviations 57
9.3 Methodology 59
9.4 Forecasting Methodology 59
9.4.1 Vaccine Coverage 60
9.4.2 Vaccine Approval versus Routine Schedule Inclusion 60
9.4.3 General Pricing Assumptions 61
9.4.4 Individual Drug Assumptions 61
9.4.5 Pricing of Pipeline Agents 62
9.5 Physicians and Specialists Included in this Study 63
9.6 About the Author(s) 66
9.6.1 Author(s) 66
9.6.2 Therapy Area Director 66
9.6.3 Global Head of Healthcare 67
9.7 About GlobalData 68
9.8 Disclaimer 68

1.1 List of Tables

Table 1: Histological Progression Towards Cervical Cancer 13
Table 2: Diseases Associated with HPV Infection and Their Associated Symptoms 15
Table 3: HPV Vaccine Recommendation Agencies by Country 17
Table 4: Targeted Group(s) for Recommended Immunization and Most-Administered HPV Vaccine by Country in the Global Markets, 2014 17
Table 5: Marketed Vaccines for HPV, 2014 20
Table 6: Overall Unmet Needs - Current and Future Level of Attainment 22
Table 7: HPV Vaccines - Phase Pipeline, 2014 39
Table 8: Product Profile - V503 42
Table 9: V503 SWOT Analysis, 2013 46
Table 10: Global Sales Forecasts ($m) for V503, 2012-2022 47
Table 11: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 65

1.2 List of Figures

Figure 1: Competitive Assessment of Late-Stage Pipeline Agents in HPV Vaccines, 2012-2022 40

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