Prophylactic Human Papillomavirus Vaccines – US Drug Forecast and Market Analysis to 2022

Pages: 95 Published: March 01, 2014 Report Code: GDHC230CFR

  • Overview
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  • Figures
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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. 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.

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Table of Contents

1Table of Contents1

1.1List of Tables4

1.2List of Figures5

2Executive Summary6

2.1Sales for Prophylactic Human PapillomaVirus (HPV) Vaccines in the US6

2.2What do the Physicians Think?7

3Introduction8

3.1Catalyst8

3.2Related Reports9

3.3Upcoming Related Reports11

4Disease Overview11

4.1Etiology and Pathophysiology11

4.1.1Etiology11

4.1.2Pathophysiology12

4.2Symptoms14

5Vaccination Recommendations and Coverage Rates15

5.1US15

5.1.1Vaccination Recommendations and Policies15

5.1.2Vaccination Coverage16

5.1.3Clinical Practice17

6Competitive Assessment19

6.1Overview19

6.2Strategic Competitor Assessment19

6.3Product Profiles21

6.3.1Gardasil21

6.3.2Cervarix27

7Unmet Need and Opportunity31

7.1Overview31

7.2Protection against Multiple HPV Types33

7.2.1Unmet Need33

7.2.2Gap Analysis34

7.2.3Opportunity34

7.3Vaccine Coverage Rates35

7.3.1Unmet Need35

7.3.2Gap Analysis35

7.3.3Opportunity36

7.4Perception of Vaccine Safety36

7.4.1Unmet Need36

7.4.2Gap Analysis38

7.4.3Opportunity38

7.5Awareness of HPV Vaccination39

7.5.1Unmet Need39

7.5.2Gap Analysis39

7.5.3Opportunity40

7.6Affordability of HPV Vaccines40

7.6.1Unmet Need40

7.6.2Gap Analysis41

7.6.3Opportunity41

7.7Coverage of HPV Types Prevalent in Certain Populations42

7.7.1Unmet Need42

7.7.2Gap Analysis42

7.7.3Opportunity43

7.8Vaccine Compliance Rates44

7.8.1Unmet Need44

7.8.2Gap Analysis44

7.8.3Opportunity45

7.9Lifelong Protection from HPV Infection Not Established45

7.9.1Unmet Need45

7.9.2Gap Analysis46

7.9.3Opportunity46

7.10Ongoing Need for Cervical Cancer Screening47

7.10.1Unmet Need47

7.10.2Gap Analysis47

7.10.3Opportunity48

8Pipeline Assessment48

8.1Overview48

8.2Promising Vaccines in Clinical Development49

8.2.1V50351

8.2.2Xiamen Innovax (Bivalent Vaccine)57

8.3Innovative HPV Vaccines in Early Development60

8.3.1Low-Cost HPV Vaccines60

8.3.2Universal HPV Vaccines61

9Market Outlook62

9.1US62

9.1.1Forecast62

9.1.2Key Events63

9.1.3Drivers and Barriers64

10Appendix67

10.1Bibliography67

10.2Abbreviations77

10.3Methodology79

10.4Forecasting Methodology79

10.4.1Vaccine Coverage80

10.4.2Vaccine Approval versus Routine Schedule Inclusion80

10.4.3Vaccines Included80

10.4.4Vaccine Launch Dates and Patent Expiry Dates80

10.4.5General Pricing Assumptions81

10.4.6Individual Drug Assumptions81

10.4.7Pricing of Pipeline Agents83

10.5Physicians and Specialists Included in this Study84

10.6About the Author(s)87

10.6.1Author(s)87

10.6.2Therapy Area Director87

10.6.3Global Head of Healthcare88

10.7About GlobalData89

10.8Contact Us89

10.9Disclaimer89

List of Tables

Table 1: Histological Progression Towards Cervical Cancer13

Table 2: Diseases Associated with HPV Infection and Their Associated Symptoms15

Table 3: Marketed Vaccines for HPV, 201421

Table 4: Product Profile – Gardasil23

Table 5: Phase III Efficacy Trials – Gardasil24

Table 6: Safety Profile – Gardasil25

Table 7: Gardasil SWOT Analysis, 201426

Table 8: Product Profile – Cervarix28

Table 9: Phase III Efficacy Trials – Cervarix29

Table 10: Safety Profile – Cervarix30

Table 11: Cervarix SWOT Analysis, 201431

Table 12: Overall Unmet Needs – Current and Future Level of Attainment32

Table 13: HPV Vaccines – Phase Pipeline, 201449

Table 14: Product Profile – V50352

Table 15: V503 SWOT Analysis, 201357

Table 16: Bivalent Vaccine (Xiamen Innovax) SWOT Analysis, 201460

Table 17: Sales Forecasts ($m) for HPV Vaccines in the United States, 2012–202262

Table 18: Key Events Impacting Sales for HPV Vaccines in the United States, 2012–202264

Table 19: United States HPV Vaccine Market – Drivers and Barriers, 201464

Table 20: Key Launch Dates80

Table 21: Key Patent Expiries81

Table 22: High-Prescribing Physicians (non-KOLs) Surveyed, in US86

List of Figures

Figure 1: Sales for HPV Vaccines in the US by Vaccine Class, 2012–20227

Figure 2: Historical and Projected HPV Vaccination Coverage (%) in the United States among 12-Year-Old Females, 2007–202217

Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in HPV Vaccines, 2012–202251

Figure 4: Sales for HPV Vaccines in the US by Vaccine Class, 2012–202263

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