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PharmaPoint:髄膜炎菌ワクチン - 世界の医薬品の予測と市場分析

PharmaPoint: Meningococcal Vaccines - Global Drug Forecast and Market Analysis to 2022

発行 GlobalData 商品コード 289835
出版日 ページ情報 英文 290 Pages
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PharmaPoint:髄膜炎菌ワクチン - 世界の医薬品の予測と市場分析 PharmaPoint: Meningococcal Vaccines - Global Drug Forecast and Market Analysis to 2022
出版日: 2015年12月01日 ページ情報: 英文 290 Pages
概要

当レポートでは、全世界の髄膜炎菌ウイルス市場の現状と将来展望について分析し、疾患の概要や今後の疫学的予測、主要国での予防体性、主要企業のプロファイルと代表的製品、市場のアンメットニーズと将来的な機会、現在治験中のパイプライン製品の情報、今後の市場規模と影響要因などを調査しています。

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

  • 病因と病態
  • 症状
  • 予後

第4章 疫学

  • 疾患の背景
  • リスク要因と共存症
    • 乳幼児・児童の発症リスクが最も高い
    • 直接接触・混雑:主な感染要因
    • アフリカの「髄膜炎ベルト」に旅行した場合、曝露リスクが最大となる
  • 世界的な傾向
    • 米国
    • 欧州主要5ヶ国
    • オーストラリア
    • ブラジル
  • 予測手法
    • 利用した情報源
    • 予測の前提条件と手法
    • 利用しなかった情報源
  • 髄膜炎菌性疾患の疫学的予測(今後11年間分)
    • 髄膜炎菌性疾患の発症件数
    • 年齢調整済みの発症件数
    • 血清群(セログループ)別の発症件数
  • 議論
    • 疫学的傾向の結論
    • 分析の限界
    • 分析の強み

第5章 疾患の管理

  • 髄膜炎菌の予防政策
  • 米国
    • 髄膜炎菌の予防接種に関する予防と政策
    • 臨床診療
  • フランス
  • ドイツ
  • イタリア
  • スペイン
  • 英国
  • 日本
  • オーストラリア
  • ブラジル

第6章 競争環境

  • 概要
  • 競合企業の戦略的評価
  • 製品プロファイル:主要ブランド
    • Menactra
    • Menveo
    • Nimenrix
    • MenHibrix
    • Menitorix
    • Meningitec
    • Menjugate
    • NeisVac-C
    • Menomune
    • Bexsero

第7章 市場機会とアンメットニーズ

  • 概要
  • アンメットニーズ
    • 血清群B疾患に対する保護
    • 五価(MenABCWY)ワクチン
    • よりコスト効率的なワクチン
    • 児童・青年の免疫期間の延長
    • 乳幼児向け免疫原性ワクチン
    • ワクチン接種率の改善
    • 患者の認知度改善と教育
  • アンメットニーズのギャップの分析
  • 市場機会
    • 新規・既存の抗体の組み合わせによる、治療対象の血清群の拡大
    • アジュバント(補助剤)による、免疫反応の持続期間の改善
    • 新興国市場のメーカーとの提携による、よりコスト効率的なワクチンの開発

第8章 パイプライン評価

  • 概要
  • 治験マッピング
    • 国別の動向
  • 相別・治験段階別の治験進行状況
  • 治験中の有望なワクチン
    • MnB rLP2086
  • 治験の初期段階にある有望なワクチン
    • Meninge ACYW conj.
    • MenABCWY
    • MenC conjugate
    • Heptavalent DTP-Hib-HepB-IPV-MenC

第9章 現在・将来の市場参入企業

  • 概要
  • 企業戦略の概要
  • 企業プロファイル
    • Sanofi
    • Novartis
    • GlaxoSmithKline
    • Baxter
    • Nuron Biotech
    • Pfizer

第10章 市場の見通し

  • 世界市場
    • 市場予測
    • 市場促進・阻害要因:世界的課題
  • 米国
    • 市場予測
    • 近年の主な出来事
    • 市場促進・阻害要因
  • フランス
  • ドイツ
  • イタリア
  • スペイン
  • 英国
  • 日本
  • オーストラリア
  • ブラジル

第11章 付録

図表一覧

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目次
Product Code: GDHC013EPIDR

Meningococcal disease is an acute infection caused by the bacterium Neisseria meningitidis, an aerobic, gram-negative diplococcal microbe that is only pathogenic in humans. Different N. meningitides strains are typically classified into serotypes based on the structure of the polysaccharide capsule surrounding the outer membrane, with five serotypes (A, B, C, W-135, and Y) being responsible for the majority of invasive infections. The meningococci are spread primarily by the exchange of bodily fluids (i.e. saliva) and enter the body by attaching to the epithelial cells of the nasopharynx. Upon adhesion, the bacteria then begin to proliferate and form micro-colonies on the surface of the epithelial cells. Symptoms of systemic infection develop rapidly and include flu-like symptoms (headache, fever, sore throat, nausea, and vomiting), sensitivity to light, and a stiff neck. If left untreated, meningococcal disease progresses rapidly and is often fatal, and a significant population of survivors (10-20%) are left with complications such as loss of a limb, deafness, epilepsy, and mental retardation. Due to the rapid onset and severity of symptoms, vaccination remains the preferred approach to meningococcal disease management and prevention. Currently available vaccines protect against all serotypes A, B, C, W-135, and Y and utilize the polysaccharide as antigens although no single vaccine can protect against all serogroups simultaneously. GlobalData expects growth in the meningococcal vaccines market to be driven by the recent launch of serotype B vaccines, which address a critical unmet need in the treatment landscape, and an increase in the coverage rates of existing routine vaccination programs.

Highlights

Key Questions Answered

  • Based on interviews with key opinion leaders (KOLs), GlobalData has identified the major unmet needs in the meningococcal vaccine marketplace.
  • What will be the effect of recent acquisitions be on the meningococcal vaccine marketplace?
  • How will the new first-in class-vaccines against serogroup B be received in the different markets?
  • What research and development (R&D) strategies will companies leverage to compete in the future meningococcal vaccine marketplace?
  • Which patient population(s) are most likely to be targeted for vaccines against serogroup B?

Key Findings

  • GlobalData projects the meningococcal vaccine market in the US, 5EU, Brazil and Australia to grow from approximately $1.1bn in 2012 to $1.5bn in 2022, at a compound annual growth rate (CAGR) of 3.0%. This growth across the 8MM will primarily be driven by the 5EU due to implementation of serogroup B vaccines in the routine infant vaccination schedule. Further growth will be the result of adolescents, including college students, in US receiving the newly approved vaccines against serogroup B while the commercial meningococcal vaccine market in Brazil will experience a decline at a negative CAGR of 16.3%.
  • With full implementation of serogroup B vaccines only realized in the UK, the routine application of these vaccines is seen as the major unmet need to be addressed in the oncoming years.
  • GlobalData anticipates that opportunities will center on the improvement of vaccine efficacy, in particular in the emerging field of vaccines against serogroup B whilst addressing the cost effectiveness concerns voiced by various governmental institutions.

Scope

  • Overview of meningococcal disease, including epidemiology, etiology, pathophysiology, regional serogroup distribution as well current meningococcal vaccine recommendation of all 8MM covered.
  • Topline meningococcal vaccine market revenue from 2012-2022. Recent acquisitions, approvals and governmental recommendations are included in the forecast model.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, and clinical trial design for the meningococcal vaccine market.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and analysis of late-stage pipeline products. An interactive clinical and commercial analyzer tool is available.
  • Analysis of the current and future market competition in the global meningococcal vaccine market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

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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. Etiology and Pathophysiology
    • 3.1.1. Etiology
    • 3.1.2. Pathophysiology
  • 3.2. Symptoms
  • 3.3. Prognosis

4. Epidemiology

  • 4.1. Disease Background
  • 4.2. Risk Factors and Comorbidities
    • 4.2.1. Infants and Young Children are at Greatest Risk for Developing Meningococcal Disease
    • 4.2.2. Direct Contact and Overcrowding are the Primary Risk Factors for Infection
    • 4.2.3. Exposure is Highest for Those Traveling to the African "Meningitis Belt"
  • 4.3. Global Trends
    • 4.3.1. US
    • 4.3.2. 5EU
    • 4.3.3. Australia
    • 4.3.4. Brazil
  • 4.4. Forecast Methodology
    • 4.4.1. Sources Used
    • 4.4.2. Forecast Assumptions and Methods
    • 4.4.3. Sources Not Used
  • 4.5. Epidemiology Forecast of Meningococcal Disease (2012-2022)
    • 4.5.1. Incident Cases of Meningococcal Disease
    • 4.5.2. Age-Specific Incident Cases of Meningococcal Disease
    • 4.5.3. Incident Cases of Meningococcal Disease by Serogroup
  • 4.6. Discussion
    • 4.6.1. Conclusions on Epidemiological Trends
    • 4.6.2. Limitations of the Analysis
    • 4.6.3. Strengths of the Analysis

5. Disease Management

  • 5.1. Meningococcal Immunization Policy
  • 5.2. US
    • 5.2.1. Meningococcal Immunization Recommendations and Policies
    • 5.2.2. Clinical Practice
  • 5.3. France
    • 5.3.1. Meningococcal Immunization Recommendations and Policies
    • 5.3.2. Clinical Practice
  • 5.4. Germany
    • 5.4.1. Meningococcal Immunization Recommendations and Policies
    • 5.4.2. Clinical Practice
  • 5.5. Italy
    • 5.5.1. Meningococcal Immunization Recommendations and Policies
    • 5.5.2. Clinical Practice
  • 5.6. Spain
    • 5.6.1. Meningococcal Immunization Recommendations and Policies
    • 5.6.2. Clinical Practice
  • 5.7. UK
    • 5.7.1. Meningococcal Immunization Recommendations and Policies
    • 5.7.2. Clinical Practice
  • 5.8. Japan
    • 5.8.1. Meningococcal Immunization Recommendations and Policies
    • 5.8.2. Clinical Practice
  • 5.9. Australia
    • 5.9.1. Meningococcal Immunization Recommendations and Policies
    • 5.9.2. Clinical Practice
  • 5.10. Brazil
    • 5.10.1. Meningococcal Immunization Recommendations and Policies
    • 5.10.2. Clinical Practice

6. Competitive Assessment

  • 6.1. Overview
  • 6.2. Strategic Competitor Assessment
  • 6.3. Product Profiles - Serogroup A,C,W,Y vaccines
    • 6.3.1. Menactra
    • 6.3.2. Menveo
    • 6.3.3. Nimenrix
    • 6.3.4. Menomune
  • 6.4. Product Profiles - Serogroup B Vaccines
    • 6.4.1. Bexsero
    • 6.4.2. Trumenba
  • 6.5. Product Profiles - Serogroup C Vaccines
    • 6.5.1. Meningitec
    • 6.5.2. Menjugate
    • 6.5.3. NeisVac-C
    • 6.5.4. Menitorix
    • 6.5.5. MenHibrix

7. Opportunity and Unmet Need

  • 7.1. Overview
  • 7.2. Unmet Needs
    • 7.2.1. Unmet Need: Protection Against Serogroup B Disease
    • 7.2.2. Unmet Need: A Pentavalent (MenABCWY) Vaccine
    • 7.2.3. Unmet Need: More Cost-Effective Vaccines
    • 7.2.4. Unmet Need: Improved Duration of Immunity in Children and Adolescents
    • 7.2.5. Unmet Need: Immunogenic Infant Vaccines
    • 7.2.6. Unmet Need: Improved Vaccination Coverage Rates
    • 7.2.7. Unmet Need: Increased Patient Awareness and Education
  • 7.3. Unmet Needs Gap Analysis
  • 7.4. Opportunities
    • 7.4.1. Opportunity: Broadening Serogroup Protection with New and Existing Antigen Combinations
    • 7.4.2. Opportunity: Improving Immune Response Duration with Adjuvants
    • 7.4.3. Opportunity: Developing More Cost-Effective Vaccines by Partnering with Manufacturers in Emerging Markets
    • 7.4.4. Opportunity: Reducing the Overall Vaccination Burden by Combining Meningococcal Vaccine with Other Routine Vaccinations

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Clinical Trials Mapping
    • 8.2.1. Clinical Trials by Country
    • 8.2.2. Clinical Trials by Phase and Trial Status
  • 8.3. Promising Vaccines in Clinical Development
    • 8.3.1. Meninge ACYW conj.
    • 8.3.2. MenABCWY
    • 8.3.3. MenC Conjugate
    • 8.3.4. Heptavalent DTP-Hib-HepB-IPV-MenC

9. Current and Future Players

  • 9.1. Overview
  • 9.2. Trends in Corporate Strategy
  • 9.3. Company Profiles
    • 9.3.1. Sanofi
    • 9.3.2. Pfizer
    • 9.3.3. GlaxoSmithKline
  • 9.4. Former Players
    • 9.4.1. Novartis
    • 9.4.2. Baxter
    • 9.4.3. Nuron Biotech

10. Market Outlook

  • 10.1. Global Markets
    • 10.1.1. Forecast
    • 10.1.2. Drivers and Barriers - Global Issues
  • 10.2. United States
    • 10.2.1. Forecast
    • 10.2.2. Key Events
    • 10.2.3. Drivers and Barriers
  • 10.3. France
    • 10.3.1. Forecast
    • 10.3.2. Key Events
    • 10.3.3. Drivers and Barriers
  • 10.4. Germany
    • 10.4.1. Forecast
    • 10.4.2. Key Events
    • 10.4.3. Drivers and Barriers
  • 10.5. Italy
    • 10.5.1. Forecast
    • 10.5.2. Key Events
    • 10.5.3. Drivers and Barriers
  • 10.6. Spain
    • 10.6.1. Forecast
    • 10.6.2. Key Events
    • 10.6.3. Drivers and Barriers
  • 10.7. United Kingdom
    • 10.7.1. Forecast
    • 10.7.2. Key Events
    • 10.7.3. Drivers and Barriers
  • 10.8. Japan
    • 10.8.1. Drivers and Barriers
  • 10.9. Australia
    • 10.9.1. Forecast
    • 10.9.2. Key Events
    • 10.9.3. Drivers and Barriers
  • 10.10. Brazil
    • 10.10.1. Forecast
    • 10.10.2. Key Events
    • 10.10.3. Drivers and Barriers

11. Appendix

  • 11.1. Bibliography
  • 11.2. Abbreviations
  • 11.3. Methodology
  • 11.4. Forecasting Methodology
    • 11.4.1. Vaccine Coverage
    • 11.4.2. Vaccine Approval vs. Routine Schedule Inclusion
    • 11.4.3. Vaccines Included
    • 11.4.4. Key Launch Dates
    • 11.4.5. General Pricing Assumptions
    • 11.4.6. Individual Vaccine Assumptions
    • 11.4.7. Pricing of Pipeline agents
  • 11.5. Physicians and Specialists Included in This Study
  • 11.6. About the Authors
    • 11.6.1. Authors
    • 11.6.2. Reviewers
    • 11.6.3. Epidemiologists
    • 11.6.4. Therapy Area Director
    • 11.6.5. Global Director of Therapy Analysis and Epidemiology
    • 11.6.6. Global Head of Healthcare
  • 11.7. About GlobalData
  • 11.8. Disclaimer

List of Tables

  • Table 1: Symptoms of Meningococcal Disease
  • Table 2: Risk Factors for Meningococcal Disease
  • Table 3: Sources of Incidence Data Used in the Epidemiology Forecast
  • Table 4: 8MM, Incident Cases of Meningococcal Disease, N, Select Years, 2012-2022
  • Table 5: 8MM, Incident Cases of Meningococcal Disease, By Age, N (Row %), 2012
  • Table 6: 8MM, Incident Cases of Meningococcal Disease, By Serogroup, N (Row %), 2012
  • Table 7: Meningococcal Immunization Recommendation Agencies by Country
  • Table 8: Recommended Routine Coverage and Most Administered Meningococcal Vaccines by Country in the Global Markets, 2015
  • Table 9: Leading Vaccines for Meningococcal Disease, 2012
  • Table 10: Product Profile - Menactra
  • Table 11: Menactra SWOT Analysis, 2012
  • Table 12: Global Sales Forecasts ($m) for Menactra, 2012-2022
  • Table 13: Product Profile - Menveo
  • Table 14: Menveo SWOT Analysis, 2012
  • Table 15: Global Sales Forecasts ($m) for Menveo, 2012-2022
  • Table 16: Product Profile - Nimenrix
  • Table 17: Nimenrix SWOT Analysis, 2012
  • Table 18: Global Sales Forecasts ($m) for Nimenrix, 2012-2022
  • Table 19: Product Profile - Menomune
  • Table 20: Menomune SWOT Analysis, 2012
  • Table 21: Global Sales Forecasts ($m) for Menomune, 2012-2022
  • Table 22: Product Profile - Bexsero
  • Table 23: Bexsero SWOT Analysis, 2015
  • Table 24: Global Sales Forecasts ($m) for Bexsero, 2012-2022
  • Table 25: Product Profile - Trumenba
  • Table 26: Trumenba SWOT Analysis, 2015
  • Table 27: Global Sales Forecasts ($m) for Trumenba, 2012-2022
  • Table 28: Product Profile - Meningitec
  • Table 29: Meningitec SWOT Analysis, 2012
  • Table 30: Global Sales Forecasts ($m) for Meningitec, 2012-2022
  • Table 31: Product Profile - Menjugate
  • Table 32: Menjugate SWOT Analysis, 2012
  • Table 33: Global Sales Forecasts ($m) for Menjugate, 2012-2022
  • Table 34: Product Profile - NeisVac-C
  • Table 35: NeisVac-C SWOT Analysis, 2012
  • Table 36: Global Sales Forecasts ($m) for NeisVac-C, 2012-2022
  • Table 37: Product Profile - Menitorix
  • Table 38: Menitorix SWOT Analysis, 2012
  • Table 39: Global Sales Forecasts ($m) for Menitorix, 2012-2022
  • Table 40: Product Profile - MenHibrix
  • Table 41: MenHibrix SWOT Analysis, 2012
  • Table 42: Global Sales Forecasts ($m) for MenHibrix, 2012-2022
  • Table 43: Overall Unmet Needs - Current Level of Attainment
  • Table 44: Clinical Unmet Needs - Gap Analysis, 2012
  • Table 45: Meningococcal Vaccines - Clinical Trials by Phase and Status, 2012
  • Table 46: Meningococcal Vaccines - Phase Pipeline, 2012
  • Table 47: Comparison of Vaccines in Development for Meningococcal Disease, 2015
  • Table 48: Product Profile - Meninge ACYW conj.
  • Table 49: Meninge ACYW conj. SWOT Analysis, 2015
  • Table 50: Product Profile - MenABCWY
  • Table 51: MenABCWY SWOT Analysis, 2015
  • Table 52: Product Profile - MenC conjugate
  • Table 53: MenC conjugate SWOT Analysis, 2012
  • Table 54: Product Profile - Heptavalent DTP-Hib-HepB-IPV-MenC
  • Table 55: Heptavalent DTP-Hib-HepB-IPV-MenC SWOT Analysis, 2012
  • Table 56: Key Companies in the Meningococcal Vaccines Market, 2015
  • Table 57: Sanofi's Meningococcal Vaccines Portfolio Assessment, 2015
  • Table 58: Sanofi SWOT Analysis, 2015
  • Table 59: Pfizer's Meningococcal Vaccines Portfolio Assessment, 2015
  • Table 60: Pfizer SWOT Analysis, 2015
  • Table 61: GSK's Meningococcal Vaccines Portfolio Assessment, 2015
  • Table 62: GSK SWOT Analysis, 2015
  • Table 63: Global Sales Forecasts ($m) for Meningococcal Vaccines, 2012-2022
  • Table 64: Global Meningococcal Vaccines Market - Drivers and Barriers, 2012-2022
  • Table 65: Sales Forecasts ($m) for Meningococcal Vaccines in the United States, 2012-2022
  • Table 66: Key Events Impacting Sales for Meningococcal Vaccines in US, 2012-2022
  • Table 67: United States Meningococcal Vaccines Market - Drivers and Barriers, 2012-2022
  • Table 68: Sales Forecasts ($m) for Meningococcal Vaccines in France, 2012-2022
  • Table 69: Key Events Impacting Sales for Meningococcal Vaccines in France, 2012-2022
  • Table 70: France Meningococcal Vaccines Market - Drivers and Barriers, 2012-2022
  • Table 71: Sales Forecasts ($m) for Meningococcal Vaccines in Germany, 2012-2022
  • Table 72: Key Events Impacting Sales for Meningococcal Vaccines in Germany, 2012-2022
  • Table 73: Germany Meningococcal Vaccines Market - Drivers and Barriers, 2012-2022
  • Table 74: Sales Forecasts ($m) for Meningococcal Vaccines in Italy, 2012--2022
  • Table 75: Key Events Impacting Sales for Meningococcal Vaccines in Italy, 2012-2022
  • Table 76: Italy Meningococcal Vaccines Market - Drivers and Barriers, 2012-2022
  • Table 77: Sales Forecasts ($m) for Meningococcal Vaccines in Spain, 2012-2022
  • Table 78: Key Events Impacting Sales for Meningococcal Vaccines in Spain, 2012-2022
  • Table 79: Spain Meningococcal Vaccines Market - Drivers and Barriers, 2012-2022
  • Table 80: Sales Forecasts ($m) for Meningococcal Vaccines in the United Kingdom, 2012-2022
  • Table 81: Key Events Impacting Sales for Meningococcal Vaccines in UK, 2012-2022
  • Table 82: United Kingdom Meningococcal Vaccines Market - Drivers and Barriers, 2012-2022
  • Table 83: Japan Meningococcal Vaccines Market - Drivers and Barriers, 2012-2022
  • Table 84: Sales Forecasts ($m) for Meningococcal Vaccines in Australia, 2012-2022
  • Table 85: Key Events Impacting Sales for Meningococcal Vaccines in Australia, 2012-2022
  • Table 86: Australia Meningococcal Vaccines Market - Drivers and Barriers, 2012-2022
  • Table 87: Sales Forecasts ($m) for Meningococcal Vaccines in Brazil, 2012-2022
  • Table 88: Key Events Impacting Sales for Meningococcal Vaccines in Brazil, 2012-2022
  • Table 89: Brazil Meningococcal Vaccines Market - Drivers and Barriers, 2012-2022
  • Table 90: Key Launch Dates
  • Table 91: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

  • Figure 1: Membrane Structure of N. meningitidis
  • Figure 2: 8MM, Incident Cases of Meningococcal Disease, N, Select Years, 2012-2022
  • Figure 3: 8MM, Incident Cases of Meningococcal Disease, By Age, N, 2012
  • Figure 4: 8MM, Incident Cases of Meningococcal Disease, By Serogroup, %, 2012
  • Figure 5: Meningococcal Vaccines - Clinical Trials by Country, 2012
  • Figure 6: Competitive Assessment of Late-Stage Pipeline Agents in Meningococcal Vaccines, 2012-2022
  • Figure 7: Company Portfolio Gap Analysis in Meningococcal Vaccines, 2012-2022
  • Figure 8: Global Sales for Meningococcal Vaccines by Region, 2012-2022
  • Figure 9: Sales for Meningococcal Vaccines in the United States by Vaccine Class, 2012-2022
  • Figure 10: Sales for Meningococcal Vaccines in France by Vaccine Class, 2012-2022
  • Figure 11: Sales for Meningococcal Vaccines in Germany by Vaccine Class, 2012-2022
  • Figure 12: Sales for Meningococcal Vaccines in Italy by Vaccine Class, 2012-2022
  • Figure 13: Sales for Meningococcal Vaccines in Spain by Vaccine Class, 2012-2022
  • Figure 14: Sales for Meningococcal Vaccines in the United Kingdom by Vaccine Class, 2012-2022
  • Figure 15: Sales for Meningococcal Vaccines in Australia by Vaccine Class, 2012-2022
  • Figure 16: Sales for Meningococcal Vaccines in Brazil by Vaccine Class, 2012-2022
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