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PharmaPoint:B型肝炎ウイルス(HBV)予防ワクチン−−欧州主要5ヶ国での医薬品の予測と市場分析

PharmaPoint: Prophylactic Hepatitis B Virus Vaccines - 5EU Drug Forecast and Market Analysis to 2022

発行 GlobalData 商品コード 298833
出版日 ページ情報 英文 191 Pages
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PharmaPoint:B型肝炎ウイルス(HBV)予防ワクチン−−欧州主要5ヶ国での医薬品の予測と市場分析 PharmaPoint: Prophylactic Hepatitis B Virus Vaccines - 5EU Drug Forecast and Market Analysis to 2022
出版日: 2014年01月31日 ページ情報: 英文 191 Pages
概要

全世界で20億人の人々がB型肝炎ウイルス(HBV)に感染しており、毎年60万人がB型肝炎関連の肝疾患で死亡しています。混合HBsAgワクチンの登場以来20年間で疾患負荷は大幅に軽減されましたが、成人へのワクチン摂取と有効性(特にニッチな疾患の場合)についてはまだ疑問が残っています。今後は、高リスク成人患者に対する高いセロコンバージョン率の達成や、各国ごとの政策的取り組み−−欧州各国における成人向けワクチンの新規認可や、定期的な予防接種プログラムの施行など−−が、市場成長を促進していくものと思われます。一方で英国では、資金供給メカニズムの不備や医師教育の不足、患者側の意識の低さなどが、成人のワクチン接種率上昇の制約となっています。

当レポートでは、EU主要5ヶ国(フランス・ドイツ・イタリア・スペイン・英国)におけるB型肝炎ウイルス(HBV)予防ワクチンに関する最新の研究・開発状況と、関連市場の将来展望とを分析し、疾患の概要や治療法、市場機会とアンメットニーズ、市場規模の動向(今後10年間分)、現在発売中および治験中の主なワクチンのプロファイル、各国市場の現状と今後の方向性などの情報を盛り込んで、概略以下の構成でお届けします。

第1章 目次

第2章 イントロダクション

第3章 疾患の概要

  • 概要
  • 病因と病態
    • 病因
    • 病態
  • 症状
  • 予後

第4章 ワクチンの摂取勧告と摂取率

  • 概要
  • フランス
    • 予防摂取の勧告と政策
    • 摂取率
    • 臨床診療
  • ドイツ
  • イタリア
  • スペイン
  • 英国

第5章 競争環境

  • 概要
  • 競合企業の戦略的評価
  • 製品のプロファイル:単価ワクチン
    • Engerix-B
    • Recombivax HB
    • Fendrix
  • 製品のプロファイル:混合ワクチン
    • Infanrix Hexa
    • Hexyon
    • Twinrix
    • Ambirix

第6章 市場機会とアンメットニーズ

  • 概要
  • ワクチンの免疫原性の増大
    • アンメットニーズ
    • ギャップの分析
    • 市場機会
  • ワクチン接種率の上昇
  • 患者の意識の高まり
  • 医師教育の改善
  • 費用対効果の高いワクチン

第7章 パイプライン分析

  • 概要
  • 治験の後期段階にある有望なワクチン
    • Heplisav
  • 治験の初期段階にある有望なワクチン

第8章 市場の見通し

  • フランス
    • 市場予測
    • 主要動向
    • 市場促進・阻害要因
  • ドイツ
  • イタリア
  • スペイン
  • 英国

第9章 付録

図表一覧

目次
Product Code: GDHC215CFR

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.

GlobalData's primary and secondary research has revealed that the reimbursement of Infanrix Hexa, which began in 2008, has helped France's routine HBV immunization program recover from safety concerns (CTV, 2012; Denis et al., 2013). The adult HBV vaccine market in Germany is also expected to grow during the forecast period, led by the arrival of Dynavax Technologies' Heplisav in the second half of 2018. GSK dominated Italy's HBV vaccine market in 2012. Sanofi Pasteur MSD's monovalent vaccine, HBVaxPro, accounted for the remaining market share. More specifically, GlobalData expects the arrival of Sanofi Pasteur MSD's Hexyon to be the principal driver of Spain's market growth, as it should compete with Infanrix Hexa for market share in the routine immunization program. GlobalData's primary research has revealed that challenging barriers to growth, such as poor funding mechanisms due to government spending concerns, inadequate physician education, and low patient awareness, will limit adult vaccine uptake and growth of this segment of the market in the UK.

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 5EU including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for the top drugs in 5EU from 2012-2022.
  • Analysis of the impact of key events as well the drivers and restraints affecting the 5EU 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 5EU

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Catalyst
  • 2.2. Related Reports
  • 2.3. Upcoming Related Reports

3. Disease Overview

  • 3.1. Overview
  • 3.2. Etiology and Pathophysiology
    • 3.2.1. Etiology
    • 3.2.2. Pathophysiology
  • 3.3. Symptoms
  • 3.4. Prognosis

4. Vaccination Recommendations and Coverage Rates

  • 4.1. Overview
  • 4.2. France
    • 4.2.1. Immunization Recommendations and Policies
    • 4.2.2. Vaccination Coverage
    • 4.2.3. Clinical Practice
  • 4.3. Germany
    • 4.3.1. Immunization Recommendations and Policies
    • 4.3.2. Vaccination Coverage
    • 4.3.3. Clinical Practice
  • 4.4. Italy
    • 4.4.1. Immunization Recommendations and Policies
    • 4.4.2. Vaccination Coverage
    • 4.4.3. Clinical Practice
  • 4.5. Spain
    • 4.5.1. Immunization Recommendations and Policies
    • 4.5.2. Vaccination Coverage
    • 4.5.3. Clinical Practice
  • 4.6. UK
    • 4.6.1. Immunization Recommendations and Policies
    • 4.6.2. Vaccination Coverage
    • 4.6.3. Clinical Practice

5. Competitive Assessment

  • 5.1. Overview
  • 5.2. Strategic Competitor Assessment
  • 5.3. Product Profiles - Monovalent Vaccines
    • 5.3.1. Engerix-B
    • 5.3.2. Recombivax HB
    • 5.3.3. Fendrix
  • 5.4. Product Profiles - Combination Vaccines
    • 5.4.1. Infanrix Hexa
    • 5.4.2. Hexyon
    • 5.4.3. Twinrix
    • 5.4.4. Ambirix

6. Opportunity and Unmet Need

  • 6.1. Overview
  • 6.2. Increased Vaccine Immunogenicity
    • 6.2.1. Unmet Need
    • 6.2.2. Gap Analysis
    • 6.2.3. Opportunity
  • 6.3. Increased Vaccination Coverage Rates
    • 6.3.1. Unmet Need
    • 6.3.2. Gap Analysis
    • 6.3.3. Opportunity
  • 6.4. Increased Patient Awareness
    • 6.4.1. Unmet Need
    • 6.4.2. Gap Analysis
    • 6.4.3. Opportunity
  • 6.5. Improved Physician Education
    • 6.5.1. Unmet Need
    • 6.5.2. Gap Analysis
    • 6.5.3. Opportunity
  • 6.6. More Cost-Effective Vaccines
    • 6.6.1. Unmet Need
    • 6.6.2. Gap Analysis
    • 6.6.3. Opportunity

7. Pipeline Assessment

  • 7.1. Overview
  • 7.2. Promising Vaccines in Late-Stage Clinical Development
    • 7.2.1. Heplisav
  • 7.3. Promising Vaccines in Early-Stage Clinical Development

8. Market Outlook

  • 8.1. France
    • 8.1.1. Forecast
    • 8.1.2. Key Events
    • 8.1.3. Drivers and Barriers
  • 8.2. Germany
    • 8.2.1. Forecast
    • 8.2.2. Key Events
    • 8.2.3. Drivers and Barriers
  • 8.3. Italy
    • 8.3.1. Forecast
    • 8.3.2. Key Events
    • 8.3.3. Drivers and Barriers
  • 8.4. Spain
    • 8.4.1. Forecast
    • 8.4.2. Key Events
    • 8.4.3. Drivers and Barriers
  • 8.5. UK
    • 8.5.1. Forecast
    • 8.5.2. Key Events
    • 8.5.3. Drivers and Barriers
    • 8.5.4. Alternative Market Scenario

9. Appendix

  • 9.1. Bibliography
  • 9.2. Abbreviations
  • 9.3. Methodology
  • 9.4. Forecasting Methodology
    • 9.4.1. Patient Populations Targeted for Vaccination
    • 9.4.2. Vaccination Coverage Rates
    • 9.4.3. Vaccinated Patients
    • 9.4.4. Regulatory Approval vs. Advisory Committee Recommendation
    • 9.4.5. Vaccines Included
    • 9.4.6. Key Launch Dates
    • 9.4.7. General Pricing Assumptions
    • 9.4.8. Individual Vaccine Assumptions
    • 9.4.9. Pricing of Pipeline Vaccines
  • 9.5. Physicians and Specialists Included in this Study
    • 9.5.1. Interviews of Key Opinion Leaders (KOLs)
    • 9.5.2. Online Survey of High-Prescribing Physicians (non-KOLs)
  • 9.6. About the Authors
    • 9.6.1. Analyst
    • 9.6.2. Therapy Area Director
    • 9.6.3. Global Head of Healthcare
  • 9.7. About GlobalData
  • 9.8. Disclaimer

List of Tables

  • Table 1: Modes of HBV Transmission
  • Table 2: HBV Serological Markers and Test Interpretations
  • Table 3: Symptoms of HBV Infection
  • Table 4: HBV Vaccination Advisory Committees by Country
  • Table 5: HBV Immunization Recommendations by Country
  • Table 6: Targeted Age Group(s) for Routine Immunization and Most Administered HBV Vaccines by Country in the Global Markets, 2014
  • Table 7: Leading Vaccines for HBV, 2014
  • Table 8: Product Profile - Engerix-B
  • Table 9: Immunogenicity Profile - Engerix-B
  • Table 10: Safety Profile - Engerix-B
  • Table 11: Engerix-B SWOT Analysis, 2014
  • Table 12: Product Profile - Recombivax HB
  • Table 13: Immunogenicity Profile - Recombivax HB
  • Table 14: Safety Profile - Recombivax HB
  • Table 15: Recombivax HB SWOT Analysis, 2014
  • Table 16: Product Profile - Fendrix
  • Table 17: Immunogenicity Profile - Fendrix
  • Table 18: Safety Profile - Fendrix
  • Table 19: Fendrix SWOT Analysis, 2014
  • Table 20: Product Profile - Infanrix Hexa
  • Table 21: Immunogenicity Profile - Infanrix Hexa
  • Table 22: Safety Profile - Infanrix Hexa
  • Table 23: Infanrix Hexa SWOT Analysis, 2014
  • Table 24: Product Profile - Hexyon
  • Table 25: Immunogenicity Profile - Hexyon
  • Table 26: Safety Profile - Hexyon
  • Table 27: Hexyon SWOT Analysis, 2014
  • Table 28: Product Profile - Twinrix
  • Table 29: Immunogenicity Profile - Twinrix
  • Table 30: Safety Profile - Twinrix
  • Table 31: Twinrix SWOT Analysis, 2014
  • Table 32: Product Profile - Ambirix
  • Table 33: Immunogenicity Profile - Ambirix
  • Table 34: Safety Profile - Ambirix
  • Table 35: Ambirix SWOT Analysis, 2014
  • Table 36: Unmet Need and Opportunity in Prophylactic HBV Vaccines
  • Table 37: HBV Vaccines - Phase Pipeline, 2014
  • Table 38: Comparison of Vaccines in Development for HBV, 2014
  • Table 39: Product Profile - Heplisav
  • Table 40: Immunogenicity Profile - Heplisav
  • Table 41: Safety Profile - Heplisav
  • Table 42: Heplisav SWOT Analysis, 2014
  • Table 43: Sales Forecasts ($m) for HBV Vaccines in France, 2012-2022
  • Table 44: Key Events Impacting Sales for HBV Vaccines in France, 2014
  • Table 45: France HBV Vaccine Market - Drivers and Barriers, 2014
  • Table 46: Sales Forecasts ($m) for HBV Vaccines in Germany, 2012-2022
  • Table 47: Key Events Impacting Sales for HBV Vaccines in Germany, 2014
  • Table 48: Germany HBV Vaccine Market - Drivers and Barriers, 2014
  • Table 49: Sales Forecasts ($m) for HBV Vaccines in Italy, 2012-2022
  • Table 50: Key Events Impacting Sales for HBV Vaccines in Italy, 2014
  • Table 51: Italy HBV Vaccine Market - Drivers and Barriers, 2014
  • Table 52: Sales Forecasts ($m) for HBV Vaccines in Spain, 2012-2022
  • Table 53: Key Events Impacting Sales for HBV Vaccines in Spain, 2014
  • Table 54: Spain HBV Vaccine Market - Drivers and Barriers, 2014
  • Table 55: Sales Forecasts ($m) for HBV Vaccines in the United Kingdom, 2012-2022
  • Table 56: Key Events Impacting Sales for HBV Vaccines in the United Kingdom, 2014
  • Table 57: United Kingdom HBV Vaccine Market - Drivers and Barriers, 2014
  • Table 58: Patient Population(s) Targeted for HBV Vaccination in the Pediatric Market, by Country
  • Table 59: Patient Population(s) Targeted for HBV Vaccination in the Adult Market, by Country
  • Table 60: Key Launch Dates
  • Table 61: High-Prescribing Physicians (non-KOLs) Surveyed, by Country

List of Figures

  • Figure 1: HBV Structure and the Recombinant Vaccine Development Process
  • Figure 2: Routine HBV Vaccination Coverage (%) in France
  • Figure 3: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in France, 2014
  • Figure 4: Routine HBV Vaccination Coverage (%) in Germany
  • Figure 5: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in Germany, 2014
  • Figure 6: Routine HBV Vaccination Coverage (%) in Italy
  • Figure 7: High-Prescriber Estimation of Pediatric HBV Patient Share in Italy, 2014
  • Figure 8: Routine HBV Vaccination Coverage (%) in Spain
  • Figure 9: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in Spain, 2014
  • Figure 10: High-Prescriber Estimation of Pediatric HBV Vaccine Patient Share in the United Kingdom, 2014
  • Figure 11: Competitive Assessment of Late-Stage Pipeline Agents and Marketed Products in HBV Vaccines, 2012-2022
  • Figure 12: Sales for HBV Vaccines in France, 2012-2022
  • Figure 13: Sales for HBV Vaccines in Germany, 2012-2022
  • Figure 14: Sales for HBV Vaccines in Italy, 2012-2022
  • Figure 15: Sales for HBV Vaccines in Spain, 2012-2022
  • Figure 16: Sales for HBV Vaccines in the United Kingdom, 2012-2022
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