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PharmaPoint: Prophylactic Hepatitis B Virus Vaccines - Japan 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.

Similar to the situation in the UK, sales in the Japanese market are severely constrained by the absence of a routine HBV immunization program. Furthermore, Japan also does not target adult risk groups for HBV immunization, an approach that is unique among the eight markets discussed in this report. While Japanese policymakers have hinted at a more pro-vaccine stance, GlobalData does not expect HBV immunization recommendations to be expanded in Japan during the forecast period, which poses a serious barrier to market growth.

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

Table Of Contents

PharmaPoint: Prophylactic Hepatitis B Virus Vaccines - Japan Drug Forecast and Market Analysis to 2022
1 Table of Contents

2 Introduction 10
2.1 Catalyst 10
2.2 Related Reports 11
2.3 Upcoming Related Reports 13
3 Disease Overview 14
3.1 Overview 14
3.2 Etiology and Pathophysiology 15
3.2.1 Etiology 15
3.2.2 Pathophysiology 18
3.3 Symptoms 20
3.4 Prognosis 22
4 Vaccination Recommendations and Coverage Rates 23
4.1 Overview 23
4.2 Japan 26
4.2.1 Immunization Recommendations and Policies 26
4.2.2 Vaccination Coverage 27
4.2.3 Clinical Practice 28
5 Competitive Assessment 30
5.1 Overview 30
5.2 Strategic Competitor Assessment 30
5.3 Product Profiles - Monovalent Vaccines 32
5.3.1 Recombivax HB 33
5.3.2 Bimmugen 38
5.4 Product Profiles - Combination Vaccines 39
6 Opportunity and Unmet Need 40
6.1 Overview 40
6.2 Increased Vaccine Immunogenicity 42
6.2.1 Unmet Need 42
6.2.2 Gap Analysis 44
6.2.3 Opportunity 45
6.3 Increased Vaccination Coverage Rates 45
6.3.1 Unmet Need 45
6.3.2 Gap Analysis 46
6.3.3 Opportunity 47
6.4 Increased Patient Awareness 48
6.4.1 Unmet Need 48
6.4.2 Gap Analysis 49
6.4.3 Opportunity 49
6.5 Improved Physician Education 50
6.5.1 Unmet Need 50
6.5.2 Gap Analysis 51
6.5.3 Opportunity 51
6.6 More Cost-Effective Vaccines 53
6.6.1 Unmet Need 53
6.6.2 Gap Analysis 53
6.6.3 Opportunity 54
7 Market Outlook 55
7.1 Japan 55
7.1.1 Forecast 55
7.1.2 Drivers and Barriers 57
8 Appendix 61
8.1 Bibliography 61
8.2 Abbreviations 73
8.3 Methodology 77
8.4 Forecasting Methodology 77
8.4.1 Patient Populations Targeted for Vaccination 77
8.4.2 Vaccination Coverage Rates 78
8.4.3 Vaccinated Patients 79
8.4.4 Regulatory Approval vs. Advisory Committee Recommendation 79
8.4.5 Vaccines Included 79
8.4.6 Key Launch Dates 80
8.4.7 General Pricing Assumptions 80
8.4.8 Individual Vaccine Assumptions 81
8.5 Physicians and Specialists Included in this Study 83
8.5.1 Interviews of Key Opinion Leaders (KOLs) 83
8.5.2 Online Survey of High-Prescribing Physicians (non-KOLs) 85
8.6 About the Authors 86
8.6.1 Analyst 86
8.6.2 Therapy Area Director 86
8.6.3 Global Head of Healthcare 87
8.7 About GlobalData 88
8.8 Disclaimer 88

1.1 List of Tables

Table 1: Modes of HBV Transmission 19
Table 2: HBV Serological Markers and Test Interpretations 20
Table 3: Symptoms of HBV Infection 21
Table 4: HBV Vaccination Advisory Committees by Country 24
Table 5: HBV Immunization Recommendations by Country 25
Table 6: Targeted Age Group(s) for Routine Immunization and Most Administered HBV Vaccines by Country in the Global Markets, 2014 26
Table 7: Leading Vaccines for HBV, 2014 32
Table 8: Product Profile - Recombivax HB 34
Table 9: Immunogenicity Profile - Recombivax HB 35
Table 10: Safety Profile - Recombivax HB 36
Table 11: Recombivax HB SWOT Analysis, 2014 37
Table 12: Product Profile - Bimmugen 38
Table 13: Bimmugen SWOT Analysis, 2014 39
Table 14: Unmet Need and Opportunity in Prophylactic HBV Vaccines 42
Table 15: Sales Forecasts ($) for HBV Vaccines in Japan, 2012-2022 56
Table 16: Japan HBV Vaccine Market - Drivers and Barriers, 2014 57
Table 17: Patient Population(s) Targeted for HBV Vaccination in the Pediatric Market, Japan 78
Table 18: Key Launch Dates 80
Table 19: High-Prescribing Physicians (non-KOLs) Surveyed, Japan 85

1.2 List of Figures

Figure 1: HBV Structure and the Recombinant Vaccine Development Process 16
Figure 2: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in Japan, 2014 29
Figure 3: Sales for HBV Vaccines in Japan, 2012-2022 56

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