PharmaPoint: Prophylactic Human Papillomavirus Vaccines – Global Drug Forecast and Market Analysis to 2022

Pages: 190 Published: March 01, 2014 Report Code: GDHC84PIDR

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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.

Scope

Overview of the latest advances in prophylactic vaccination.

Analysis of the future potential for novel and existing HPV vaccines.

Key topics covered include unmet needs, opportunities, and drivers and barriers specific to prophylactic HPV vaccines.

Key Highlights

What environmental factors limit the uptake of current HPV vaccines?

What opportunities exist to overcome these environmental factors?

What are the main unmet needs of current HPV vaccines?

What technologies are positioned to address these unmet needs?

What opportunities will remain for the development of new HPV vaccines?

What environmental factors will influence the introduction of novel HPV vaccines?

Reasons to Buy

Understand the dynamics of the prophylactic HPV vaccines market, and the unique barriers to market access.

Identify opportunities for the development and delivery of HPV vaccines, and to identify emerging players with potentially strong product portfolios

Develop business strategies by understanding the trends shaping and driving the future of prophylactic HPV vaccination.

Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.

Gain insight on the challenges associated with delivering prophylactic HPV vaccines and the impact of novel vaccines.

Track vaccine sales in the global HPV vaccines market from 2012-2022

Table of Contents

1Table of Contents1

1.1List of Tables8

1.2List of Figures10

2Executive Summary12

2.1HPV Vaccine Sales Expected to Grow Modestly During the Forecast Period13

2.2Emphasis on HPV Vaccination Shifting from Solely Cervical Cancer Protection14

2.3Physicians Welcome Prospect of Higher-Valency Vaccines, But Significant Barriers to Market Access Must be Overcome15

2.4Vaccines Protective against all HPV Types Represent Opportunity for New Players16

2.5Merck’s Nine-Valent Pipeline Vaccine V503 Expected to Garner Significant Market Share16

2.6What do the Physicians Think?17

3Introduction18

3.1Catalyst18

3.2Related Reports20

3.3Upcoming Related Reports20

4Disease Overview21

4.1Etiology and Pathophysiology22

4.1.1Etiology22

4.1.2Pathophysiology22

4.2Symptoms24

5Vaccination Recommendations and Coverage Rates25

5.1Vaccination Recommendations Overview25

5.2US28

5.2.1Vaccination Recommendations and Policies28

5.2.2Vaccination Coverage28

5.2.3Clinical Practice30

5.3France31

5.3.1Vaccination Recommendations and Policies31

5.3.2Vaccination Coverage32

5.3.3Clinical Practice33

5.4Germany34

5.4.1Vaccination Recommendations and Policies34

5.4.2Vaccination Coverage34

5.4.3Clinical Practice36

5.5Italy37

5.5.1Vaccination Recommendations and Policies37

5.5.2Vaccination Coverage38

5.5.3Clinical Practice40

5.6Spain41

5.6.1Vaccination Recommendations and Policies41

5.6.2Vaccination Coverage42

5.6.3Clinical Practice44

5.7UK44

5.7.1Vaccination Recommendations and Policies44

5.7.2Vaccination Coverage45

5.7.3Clinical Practice46

5.8Japan47

5.8.1Vaccination Recommendations and Policies47

5.8.2Vaccination Coverage47

5.8.3Clinical Practice49

5.9Australia50

5.9.1Vaccination Recommendations and Policies50

5.9.2Vaccination Coverage50

5.9.3Clinical Practice52

5.10Canada53

5.10.1Vaccination Recommendations and Policies53

5.10.2Vaccination Coverage54

5.10.3Clinical Practice55

6Competitive Assessment56

6.1Overview56

6.2Strategic Competitor Assessment56

6.3Product Profiles58

6.3.1Gardasil58

6.3.2Cervarix64

7Unmet Need and Opportunity69

7.1Overview69

7.2Protection against Multiple HPV Types71

7.2.1Unmet Need71

7.2.2Gap Analysis72

7.2.3Opportunity72

7.3Vaccine Coverage Rates73

7.3.1Unmet Need73

7.3.2Gap Analysis73

7.3.3Opportunity74

7.4Perception of Vaccine Safety74

7.4.1Unmet Need74

7.4.2Gap Analysis76

7.4.3Opportunity76

7.5Awareness of HPV Vaccination77

7.5.1Unmet Need77

7.5.2Gap Analysis77

7.5.3Opportunity78

7.6Affordability of HPV Vaccines78

7.6.1Unmet Need78

7.6.2Gap Analysis79

7.6.3Opportunity79

7.7Coverage of HPV Types Prevalent in Certain Populations80

7.7.1Unmet Need80

7.7.2Gap Analysis80

7.7.3Opportunity81

7.8Vaccine Compliance Rates82

7.8.1Unmet Need82

7.8.2Gap Analysis82

7.8.3Opportunity83

7.9Lifelong Protection from HPV Infection Not Established83

7.9.1Unmet Need83

7.9.2Gap Analysis84

7.9.3Opportunity84

7.10Ongoing Need for Cervical Cancer Screening85

7.10.1Unmet Need85

7.10.2Gap Analysis85

7.10.3Opportunity86

8Pipeline Assessment86

8.1Overview86

8.2Clinical Trial Mapping87

8.2.1Clinical Trials by Country87

8.2.2Clinical Trials by Phase and Trial Status89

8.3Promising Vaccines in Clinical Development90

8.3.1V50392

8.3.2Xiamen Innovax (Bivalent Vaccine)98

8.4Innovative HPV Vaccines in Early Development101

8.4.1Low-Cost HPV Vaccines101

8.4.2Universal HPV Vaccines102

9Current and Future Players102

9.1Overview102

9.2Trends in Corporate Strategy105

9.3Company Profiles106

9.3.1Merck106

9.3.2GSK109

10Market Outlook111

10.1Global Markets111

10.1.1Forecast111

10.1.2Drivers and Barriers – Global Issues114

10.2US118

10.2.1Forecast118

10.2.2Key Events121

10.2.3Drivers and Barriers121

10.3France124

10.3.1Forecast124

10.3.2Key Events126

10.3.3Drivers and Barriers126

10.4Germany128

10.4.1Forecast128

10.4.2Key Events130

10.4.3Drivers and Barriers130

10.5Italy132

10.5.1Forecast132

10.5.2Key Events134

10.5.3Drivers and Barriers135

10.6Spain137

10.6.1Forecast137

10.6.2Key Events138

10.6.3Drivers and Barriers139

10.7UK141

10.7.1Forecast141

10.7.2Key Events142

10.7.3Drivers and Barriers143

10.8Japan145

10.8.1Forecast145

10.8.2Key Events146

10.8.3Drivers and Barriers147

10.9Australia149

10.9.1Forecast149

10.9.2Key Events151

10.9.3Drivers and Barriers151

10.10Canada153

10.10.1Forecast153

10.10.2Key Events154

10.10.3Drivers and Barriers155

11Appendix157

11.1Bibliography157

11.2Abbreviations171

11.3Methodology173

11.4Forecasting Methodology173

11.4.1Vaccine Coverage174

11.4.2Vaccine Approval versus Routine Schedule Inclusion174

11.4.3Vaccines Included175

11.4.4Vaccine Launch Dates and Patent Expiry Dates175

11.4.5General Pricing Assumptions175

11.4.6Individual Drug Assumptions176

11.4.7Pricing of Pipeline Agents178

11.5Physicians and Specialists Included in this Study179

11.6About the Author(s)182

11.6.1Author(s)182

11.6.2Therapy Area Director182

11.6.3Global Head of Healthcare183

11.7About GlobalData184

11.8Contact Us184

11.9Disclaimer184

List of Tables

Table 1: HPV Vaccines: Key Metrics in Nine Major Pharmaceutical Markets12

Table 2: Histological Progression Towards Cervical Cancer23

Table 3: Diseases Associated with HPV Infection and Their Associated Symptoms25

Table 4: HPV Vaccine Recommendation Agencies by Country27

Table 5: Targeted Group(s) for Recommended Immunization and Most-Administered HPV Vaccine by Country in the Global Markets, 201427

Table 6: Routine HPV Vaccine Programs by Region, Italy38

Table 7: Routine HPV Vaccine Programs by Region, Spain42

Table 8: Routine HPV Vaccine Programs by Province, Canada53

Table 9: Marketed Vaccines for HPV, 201458

Table 10: Product Profile – Gardasil60

Table 11: Phase III Efficacy Trials – Gardasil61

Table 12: Safety Profile – Gardasil62

Table 13: Gardasil SWOT Analysis, 201463

Table 14: Global Sales Forecasts ($m) for Gardasil, 2012–202264

Table 15: Product Profile – Cervarix66

Table 16: Phase III Efficacy Trials – Cervarix67

Table 17: Safety Profile – Cervarix68

Table 18: Cervarix SWOT Analysis, 201468

Table 19: Global Sales Forecasts ($m) for Cervarix, 2012–202269

Table 20: Overall Unmet Needs – Current and Future Level of Attainment70

Table 21: HPV Vaccines – Clinical Trials by Phase and Status, 201490

Table 22: HPV Vaccines – Phase Pipeline, 201491

Table 23: Product Profile – V50393

Table 24: V503 SWOT Analysis, 201397

Table 25: Global Sales Forecasts ($m) for V503, 2012–202298

Table 26: Bivalent Vaccine (Xiamen Innovax) SWOT Analysis, 2014100

Table 27: Key Companies in the HPV Vaccine Market, 2014104

Table 28: Merck’s HPV Vaccine Portfolio Assessment, 2014108

Table 29: Merck SWOT Analysis, 2014108

Table 30: GSK’s HPV Vaccine Portfolio Assessment, 2014110

Table 31: GSK SWOT Analysis, 2014111

Table 32: Global Sales Forecasts ($m) for HPV Vaccines, 2012–2022112

Table 33: Global HPV Vaccine Market – Drivers and Barriers, 2014114

Table 34: Sales Forecasts ($m) for HPV Vaccines in the United States, 2012–2022119

Table 35: Key Events Impacting Sales for HPV Vaccines in the United States, 2012–2022121

Table 36: United States HPV Vaccine Market – Drivers and Barriers, 2014121

Table 37: Sales Forecasts ($m) for HPV Vaccines in France, 2012–2022125

Table 38: Key Events Impacting Sales for HPV Vaccines in France, 2012–2022126

Table 39: France HPV Vaccine Market – Drivers and Barriers, 2014126

Table 40: Sales Forecasts ($m) for HPV Vaccines in Germany, 2012–2022129

Table 41: Key Events Impacting Sales for HPV Vaccines in Germany, 2014130

Table 42: Germany HPV Vaccine Market – Drivers and Barriers, 2014130

Table 43: Sales Forecasts ($m) for HPV Vaccines in Italy, 2012–2022133

Table 44: Key Events Impacting Sales for HPV Vaccines in Italy, 2014135

Table 45: Italy HPV Vaccine Market – Drivers and Barriers, 2014135

Table 46: Sales Forecasts ($m) for HPV Vaccines in Spain, 2012–2022137

Table 47: Key Events Impacting Sales for HPV Vaccines in Spain, 2012–2022139

Table 48: Spain HPV Vaccine Market – Drivers and Barriers, 2014139

Table 49: Sales Forecasts ($) for HPV Vaccines in the United Kingdom, 2012–2022141

Table 50: Key Events Impacting Sales for HPV Vaccines in the United Kingdom, 2012–2022143

Table 51: United Kingdom HPV Vaccine Market – Drivers and Barriers, 2014143

Table 52: Sales Forecasts ($) for HPV Vaccines in Japan, 2012–2022145

Table 53: Key Events Impacting Sales for HPV Vaccines in Japan, 2012–2022147

Table 54: Japan HPV Vaccine Market – Drivers and Barriers, 2014147

Table 55: Sales Forecasts ($) for HPV Vaccines in Australia, 2012–2022150

Table 56: Key Events Impacting Sales for HPV Vaccines in Australia, 2012–2022151

Table 57: Australia HPV Vaccine Market – Drivers and Barriers, 2013151

Table 58: Sales Forecasts ($) for HPV Vaccines in Canada, 2012–2022153

Table 59: Key Events Impacting Sales for HPV Vaccines in Canada, 2012–2022155

Table 60: Canada HPV Vaccine Market – Drivers and Barriers, 2014155

Table 61: Key Launch Dates175

Table 62: Key Patent Expiries175

Table 63: High-Prescribing Physicians (non-KOLs) Surveyed, By Country181

List of Figures

Figure 1: Sales for HPV Vaccines by Region, 2012–202214

Figure 2: Company Portfolio Gap Analysis in HPV Vaccines, 2012–202215

Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in HPV Vaccines, 2012–202217

Figure 4: Historical and Projected HPV Vaccination Coverage (%) in the United States among 12-Year-Old Females, 2007–202230

Figure 5: Historical and Projected HPV Vaccination Coverage (%) in France among 14-Year-Old Females, 2007–202233

Figure 6: Historical and Projected HPV Vaccination Coverage (%) in Germany among 17-Year-Old Females, 2009–202236

Figure 7: Historical and Projected HPV Vaccination Coverage (%) in Italy among 12-Year-Old Females, 2009–202240

Figure 8: Historical and Projected HPV Vaccination Coverage (%) in Spain among 14-Year-Old Females, 2008–202243

Figure 9: Historical and Projected HPV Vaccination Coverage (%) in the United Kingdom among 12-Year-Old Females, 2008–202246

Figure 10: Historical and Projected HPV Vaccination Coverage (%) in Japan among 16-Year-Old Females, 2012–202248

Figure 11: Historical and Projected HPV Vaccination Coverage (%) in Australia among 13-Year-Old Females, 2007–202251

Figure 12: Historical and Projected HPV Vaccination Coverage (%) in Canada among 12-Year-Old Females, 2007–202255

Figure 13: HPV Vaccines – Clinical Trials by Country, 201488

Figure 14: Competitive Assessment of Late-Stage Pipeline Agents in HPV Vaccines, 2012–202291

Figure 15: Company Portfolio Gap Analysis in HPV Vaccines, 2012–2022104

Figure 16: Global Sales for HPV Vaccines by Region, 2012–2022113

Figure 17: Sales for HPV Vaccines in the US by Vaccine Class, 2012–2022120

Figure 18: Sales for HPV Vaccines in France by Vaccine Class, 2012–2022125

Figure 19: Sales for HPV Vaccines in Germany by Vaccine Class, 2012–2022129

Figure 20: Sales for HPV Vaccines in Italy by Vaccine Class, 2012–2022134

Figure 21: Sales for HPV Vaccines in Spain by Vaccine Class, 2012–2022138

Figure 22: Sales for HPV Vaccines in the United Kingdom by Vaccine Class, 2012–2022142

Figure 23: Sales for HPV Vaccines in Japan by Vaccine Class, 2012–2022146

Figure 24: Sales for HPV Vaccines in Australia by Vaccine Class, 2012–2022150

Figure 25: Sales for HPV Vaccines in Canada by Vaccine Class, 2012–2022154

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