PharmaPoint: Prophylactic Hepatitis B Virus Vaccines - US Drug Forecast and Market Analysis to 2022

Summary

Hepatitis B, which is caused by the hepatitis B virus (HBV), is characterized by acute or chronic inflammation of the liver. Researchers and healthcare experts have estimated that roughly two billion people are infected with HBV worldwide, with roughly 600,000 people dying each year from HBV-related liver diseases. While the arrival of recombinant HBsAg vaccines has greatly reduced disease burden over the past two decades, questions surrounding vaccine uptake and effectiveness in adults, particularly in niche patient populations, still remain. GlobalData expects that the growing popularity of pediatric combination vaccines, along with the arrival of vaccines that achieve higher seroconversion rates in high-risk adults, will serve to stimulate growth in the marketplace over the forecast period. Country-specific immunization recommendations and policy implementation will be an essential metric for determining future vaccine uptake in the 7MM (US, France, Germany, Italy, Spain, UK, and Japan) and Canada.

The drivers and barriers that GlobalData projects to most heavily influence growth of the US HBV vaccine market during the forecast period. In the pediatric segment of the marketplace, where annual coverage rates consistently reach 90%, this growth will be driven primarily by the increased use of combination vaccines for routine immunization, as these vaccines are looked upon favorably by both parents and physicians due to their ability to protect infants against multiple diseases with a single series of shots.

Scope

- Overview of Hepatitis B disease 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 Hepatitis B 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 Hepatitis B disease

- 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

2 Introduction 11
2.1 Catalyst 11
2.2 Related Reports 12
2.3 Upcoming Related Reports 14
3 Disease Overview 15
3.1 Overview 15
3.2 Etiology and Pathophysiology 16
3.2.1 Etiology 16
3.2.2 Pathophysiology 19
3.3 Symptoms 21
3.4 Prognosis 23
4 Vaccination Recommendations and Coverage Rates 24
4.1 Overview 24
4.2 US 27
4.2.1 Immunization Recommendations and Policies 27
4.2.2 Vaccination Coverage 28
4.2.3 Clinical Practice 30
5 Competitive Assessment 32
5.1 Overview 32
5.2 Strategic Competitor Assessment 32
5.3 Product Profiles - Monovalent Vaccines 35
5.3.1 Engerix-B 35
5.3.2 Recombivax HB 40
5.4 Product Profiles - Combination Vaccines 44
5.4.1 Pediarix 45
5.4.2 Hexyon 48
5.4.3 Comvax 53
5.4.4 Twinrix 56
6 Opportunity and Unmet Need 62
6.1 Overview 62
6.2 Increased Vaccine Immunogenicity 64
6.2.1 Unmet Need 64
6.2.2 Gap Analysis 66
6.2.3 Opportunity 67
6.3 Increased Vaccination Coverage Rates 67
6.3.1 Unmet Need 67
6.3.2 Gap Analysis 68
6.3.3 Opportunity 69
6.4 Increased Patient Awareness 70
6.4.1 Unmet Need 70
6.4.2 Gap Analysis 71
6.4.3 Opportunity 71
6.5 Improved Physician Education 72
6.5.1 Unmet Need 72
6.5.2 Gap Analysis 73
6.5.3 Opportunity 73
6.6 More Cost-Effective Vaccines 75
6.6.1 Unmet Need 75
6.6.2 Gap Analysis 75
6.6.3 Opportunity 76
7 Pipeline Assessment 77
7.1 Overview 77
7.2 Promising Vaccines in Late-Stage Clinical Development 78
7.2.1 Heplisav 80
7.3 Promising Vaccines in Early-Stage Clinical Development 90
8 Market Outlook 91
8.1 US 91
8.1.1 Forecast 91
8.1.2 Key Events 93
8.1.3 Drivers and Barriers 94
9 Appendix 103
9.1 Bibliography 103
9.2 Abbreviations 116
9.3 Methodology 120
9.4 Forecasting Methodology 120
9.4.1 Patient Populations Targeted for Vaccination 120
9.4.2 Vaccination Coverage Rates 122
9.4.3 Vaccinated Patients 123
9.4.4 Regulatory Approval vs. Advisory Committee Recommendation 123
9.4.5 Vaccines Included 123
9.4.6 Key Launch Dates 124
9.4.7 General Pricing Assumptions 124
9.4.8 Individual Vaccine Assumptions 125
9.4.9 Pricing of Pipeline Vaccines 129
9.5 Physicians and Specialists Included in this Study 130
9.5.1 Interviews of Key Opinion Leaders (KOLs) 130
9.5.2 Online Survey of High-Prescribing Physicians (non-KOLs) 132
9.6 About the Authors 133
9.6.1 Analyst 133
9.6.2 Therapy Area Director 133
9.6.3 Global Head of Healthcare 134
9.7 About GlobalData 135
9.8 Disclaimer 135

1.1 List of Tables

Table 1: Modes of HBV Transmission 20
Table 2: HBV Serological Markers and Test Interpretations 21
Table 3: Symptoms of HBV Infection 22
Table 4: HBV Vaccination Advisory Committees by Country 25
Table 5: HBV Immunization Recommendations by Country 26
Table 6: Targeted Age Group(s) for Routine Immunization and Most Administered HBV Vaccines by Country in the Global Markets, 2014 27
Table 7: Leading Vaccines for HBV, 2014 34
Table 8: Product Profile - Engerix-B 36
Table 9: Immunogenicity Profile - Engerix-B 37
Table 10: Safety Profile - Engerix-B 38
Table 11: Engerix-B SWOT Analysis, 2014 39
Table 12: Product Profile - Recombivax HB 41
Table 13: Immunogenicity Profile - Recombivax HB 42
Table 14: Safety Profile - Recombivax HB 43
Table 15: Recombivax HB SWOT Analysis, 2014 44
Table 16: Product Profile - Pediarix 46
Table 17: Immunogenicity Profile - Pediarix 47
Table 18: Safety Profile - Pediarix 47
Table 19: Pediarix SWOT Analysis, 2014 48
Table 20: Product Profile - Hexyon 50
Table 21: Immunogenicity Profile - Hexyon 51
Table 22: Safety Profile - Hexyon 52
Table 23: Hexyon SWOT Analysis, 2014 52
Table 24: Product Profile - Comvax 54
Table 25: Immunogenicity Profile - Comvax 55
Table 26: Safety Profile - Comvax 55
Table 27: Comvax SWOT Analysis, 2014 56
Table 28: Product Profile - Twinrix 58
Table 29: Immunogenicity Profile - Twinrix 59
Table 30: Safety Profile - Twinrix 60
Table 31: Twinrix SWOT Analysis, 2014 61
Table 32: Unmet Need and Opportunity in Prophylactic HBV Vaccines 64
Table 33: HBV Vaccines - Phase Pipeline, 2014 78
Table 34: Comparison of Vaccines in Development for HBV, 2014 79
Table 35: Product Profile - Heplisav 82
Table 36: Immunogenicity Profile - Heplisav 83
Table 37: Safety Profile - Heplisav 85
Table 38: Heplisav SWOT Analysis, 2014 89
Table 39: Sales Forecasts ($m) for HBV Vaccines in the United States, 2012-2022 92
Table 40: Key Events Impacting Sales for HBV Vaccines in the United States, 2014 94
Table 41: United States HBV Vaccine Market - Drivers and Barriers, 2014 95
Table 42: Patient Population(s) Targeted for HBV Vaccination in the Pediatric Market, US 121
Table 43: Patient Population(s) Targeted for HBV Vaccination in the Adult Market, US 122
Table 44: Key Launch Dates 124
Table 45: High-Prescribing Physicians (non-KOLs) Surveyed, US 132

1.2 List of Figures

Figure 1: HBV Structure and the Recombinant Vaccine Development Process 17
Figure 2: Routine HBV Vaccination Coverage (%) in the United States 30
Figure 3: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in the United States, 2014 31
Figure 4: Competitive Assessment of Late-Stage Pipeline Agents and Marketed Products in HBV Vaccines, 2012-2022 79
Figure 5: Sales for HBV Vaccines in the US, 2012-2022 93

View This Report »

Find all the market research you need - instantly, in one place.

+1.2 Million Research Documents & Statistics +200,000 Trusted Public Sources 350 Industries With Global Coverage

24/7 Customer Support

Talk to Amrita

+1 718 303 2019

Purchase Reports From Reputable Market Research Publishers

PharmaPoint: Asthma - Global Drug Forecast and Market Analysis to 2023

PharmaPoint: Asthma - Global Drug Forecast and Market Analysis to 2023

  • $ 10 995
  • Industry report
  • August 2014
  • by Global Data

PharmaPoint: Asthma - Global Drug Forecast and Market Analysis to 2023 Summary Asthma accounts for approximately 250,000 deaths around the world annually, deaths that otherwise could be easily prevented ...

PharmaPoint: Ulcerative Colitis - Global Drug Forecast and Market Analysis to 2022 - Event-Driven Update

PharmaPoint: Ulcerative Colitis - Global Drug Forecast and Market Analysis to 2022 - Event-Driven Update

  • $ 10 995
  • Industry report
  • September 2014
  • by Global Data

PharmaPoint: Ulcerative Colitis - Global Drug Forecast and Market Analysis to 2022 - Event-Driven Update Summary During the forecast period from 2012-2022, the growth of the UC market will be driven largely ...

Cancer Vaccines: Technologies and Global Markets

Cancer Vaccines: Technologies and Global Markets

  • $ 6 650
  • Industry report
  • Dec 2014
  • by BCC Research

REPORT HIGHLIGHTS The global market for cancer vaccines was about $4.5 billion in 2013. This market reached about $4.0 billion in 2014 and is expected to reach $4.3 billion in 2019, registering a compound ...


ReportLinker is an award-winning market research solution that finds, filters and organizes the latest industry data so you get all the market research you need - quickly, in one place.