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OpportunityAnalyzer:デング熱ワクチンの市場機会分析および市場予測

OpportunityAnalyzer: Dengue Vaccines - Opportunity Analysis and Forecasts to 2020 - Event-Driven Update

発行 GlobalData 商品コード 308244
出版日 ページ情報 英文 211 Pages
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OpportunityAnalyzer:デング熱ワクチンの市場機会分析および市場予測 OpportunityAnalyzer: Dengue Vaccines - Opportunity Analysis and Forecasts to 2020 - Event-Driven Update
出版日: 2014年09月30日 ページ情報: 英文 211 Pages
概要

デング熱とは一本鎖フラビウイルス属のデング熱ウイルス(DENV)を原因とする熱性疾患であり、主にネッタイシマカ(Aedes aegypti)によって媒介されます。毎年1億人以上に感染していると考えられており、世界でもっとも広く流行している節足動物媒介性ウイルスです。

当レポートでは、デング熱ワクチンの市場について調査し、デング熱の概要、発症件数と人口および地理的プロファイル、主要国(ブラジル、インド、メキシコ、シンガポール、タイ)における監視・予防・制御対策の現状、アンメットニーズ、ワクチン開発事業者のR&D戦略、主なパイプライン薬のプロファイル、市場成長への影響因子の分析、市場規模の推移と予測などをまとめています。

機会分析および市場予測

第1章 目次

第2章 イントロダクション

第3章 疾患概要

  • 病因と病態生理
  • 症状
  • 予後

第4章 疫学

  • 疾患の背景
  • リスクファクターと併存症
  • 世界的動向
    • 発症率と地理的分布
    • デング熱の周期的・季節的パターン
    • デング熱の血清型
  • 予測手法
  • デング熱の易学的予測
    • デング熱の検査確認済み報告件数
    • デング熱の検査確認済み報告件数の男女比
    • デング熱の検査確認済み報告件数の年齢分布
    • デング熱の検査確認済み報告件数の年齢調整罹患率
  • ディスカッション
    • 疫学的予測の考察
    • 分析の限界
    • 分析の強み

第5章 現在の監視・予防・制御対策

  • 概要
  • ブラジル
    • 監視と診断
    • ベクターコントロール
    • 免疫化の推奨とインフラ
  • インド
    • 監視と診断
    • ベクターコントロール
    • 免疫化の推奨とインフラ
  • メキシコ
    • 監視と診断
    • ベクターコントロール
    • 免疫化の推奨とインフラ
  • シンガポール
    • 監視と診断
    • ベクターコントロール
    • 免疫化の推奨とインフラ
  • タイ
    • 監視と診断
    • ベクターコントロール
    • 免疫化の推奨とインフラ

第6章 アンメットニーズの評価・市場機会分析

  • 概要
  • アンメットニーズ分析
    • 安全で効果的なワクチン
    • デング熱の免疫に関する理解の周知
    • 信頼できる免疫学的保護の相関因子
    • 国固有の免疫化プログラムの準備体制
    • ベクターコントロールと監視インフラのアップグレード
    • 改良型診断ツール
    • 高品質動物モデル
  • 市場機会分析
    • 単回投与のデング熱ワクチンの開発
    • デング熱の免疫におけるT細胞の役割のさらなる解明
    • 革新的な臨床試験設計によるワクチン開発の合理化
    • 多角的なデング熱防止プログラムにワクチンを統合するための公共医療の関係者との提携
    • 国固有のワクチン開始戦略の確立
    • ワクチンの有効性をアピールする診断の活用

第7章 R&D戦略

  • 概要
  • ワクチン開発への技術的アプローチ
    • ワクチン抗原の選定
    • 4価ワクチンの構成
  • 提携・買収・ライセンシング契約
  • 臨床試験設計
    • 現在の臨床試験設計
    • 代表的な患者人口の臨床試験への投入
    • 予防効果の立証
    • デング熱のヒト感染モデル

第8章 パイプライン分析

  • 概要
  • 臨床開発中の弱毒生ワクチン
    • CYD-TDV
    • DENVax
    • TV-003
  • その他の臨床開発中のワクチン
    • TDENV-PIV
    • DEN-80E
  • 前臨床開発段階のワクチン

第9章 パイプライン評価分析

  • 主なパイプラインワクチンの臨床的ベンチマーキング
  • 主なパイプラインワクチンの商業的ベンチマーキング
  • 競合分析
  • トップライン5カ年予測
    • ブラジル
    • インド
    • メキシコ
    • シンガポール
    • タイ

第10章 付録

図表

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目次
Product Code: GDHC006EPOA

Dengue is a febrile illness caused by the dengue virus (DENV), a single-stranded flavivirus most commonly transmitted by the Aedes aegypti (A. aegypti) mosquito. Thought to be responsible for upwards of 100 million infections each year, DENV is the most prevalent arthropod-borne virus in the world. Individuals infected with DENV can present with a wide spectrum of symptoms, including fevers, retro-orbital pain, severe headache, muscle and joint pain, and rash. The severity of dengue fever ranges from asymptomatic cases, to classic dengue fever, and to dengue hemorrhagic fever (DHF) or dengue shock syndrome (DSS) that have a mortality rate of 5%-15%. Because there are no marketed dengue-specific vaccines or therapeutics, current treatment strategies are limited to supportive care for those already infected with the virus, and vector control to reduce DENV transmission. The near-universal failure of these measures to curtain transmission and reduce disease burden across the global marketplace - which for the purposes of this report is comprised of Brazil, India, Mexico, Singapore, and Thailand - has further enhanced the need for safe and effective vaccines. GlobalData expects the launch of the first dengue vaccines, led by Sanofi Pasteur's CYD-TDV and Takeda's TAK-003, to revolutionize the treatment and prevention paradigm.

Highlights

Key Questions Answered

  • Based on interviews with key opinion leaders (KOLs), GlobalData has identified the major unmet needs in the dengue vaccine marketplace. Will the leading pipeline agents fulfil these unmet needs during the forecast period (2015-2020)?
  • What research and development (R&D) strategies will companies leverage to compete in the future dengue vaccine marketplace?
  • Which patient population(s) are most likely to be targeted for routine and catch-up immunization?
  • What clinical and environmental factors are likely to influence dengue vaccine uptake in Brazil, India, Mexico, Singapore, and Thailand? Which of these markets will experience the strongest growth from 2015-2020?

Key Findings

  • GlobalData projects the dengue vaccine market in Brazil, India, Mexico, Singapore, and Thailand to grow from $50.8m in 2015 to $486.2m in 2020, at a compound annual growth rate (CAGR) of 57.1%. This rapid growth will be driven by the expected incorporation of newly-launched dengue vaccines into routine and catch-up immunization programs.
  • KOLs interviewed by GlobalData expect the live-attenuated dengue vaccines - led by Sanofi Pasteur's CYD-TDV and Takeda's TAK-003 - to dominate the marketplace for the duration of the forecast period.
  • GlobalData anticipates that firms will increasingly turn to innovative R&D strategies, in particular the exploration of alternative approaches to early-stage clinical trial design - such as the dengue human infection model (DHIM) - in order to increase developmental efficiency, minimize upfront risk, and gain a competitive advantage over rivals.
  • Domestically-supplied vaccines, most notably Butantan Institute's TV-003 in Brazil and Panacea Biotech's/Biological E's TV-003 in India, are projected to limit market growth due to their low price relative to vaccines produced by privately-held foreign companies.

Scope

  • Overview of dengue virus (DENV), including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current disease surveillance and prevention measures.
  • Topline dengue vaccine market revenue from 2015-2020. Annual cost of therapy (ACOT) and major pipeline vaccine sales in this forecast period are included.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, and clinical trial design for the dengue vaccine market.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline vaccines. An interactive clinical and commercial analyzer tool is available.
  • Analysis of the current and future market competition in the global dengue vaccine market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the global dengue vaccine market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the dengue vaccine market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

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
  • 4.3. Global Trends
    • 4.3.1. Incidence and Geographic Distribution
    • 4.3.2. Dengue Periodic and Seasonal Patterns
    • 4.3.3. Dengue Serotypes
  • 4.4. Forecast Methodology
    • 4.4.1. Sources Used
    • 4.4.2. Sources Not Used
    • 4.4.3. Forecast Assumptions and Methods
  • 4.5. Epidemiological Forecast for Dengue (2013-2023)
    • 4.5.1. Reported Laboratory-Confirmed Dengue Cases
    • 4.5.2. Sex-Specific Distribution of Reported Laboratory-Confirmed Dengue Cases
    • 4.5.3. Age-Specific Distribution of Reported Laboratory-Confirmed Dengue Cases
    • 4.5.4. Age-Standardized Incidence of Reported Laboratory-Confirmed Dengue
  • 4.6. Discussion
    • 4.6.1. Epidemiological Forecast Insight
    • 4.6.2. Limitations of the Analysis
    • 4.6.3. Strengths of the Analysis

5. Current Surveillance, Prevention, and Control Measures

  • 5.1. Overview
  • 5.2. Brazil
    • 5.2.1. Surveillance and Diagnosis
    • 5.2.2. Vector Control
    • 5.2.3. Immunization Recommendations and Infrastructure
  • 5.3. India
    • 5.3.1. Surveillance and Diagnosis
    • 5.3.2. Vector Control
    • 5.3.3. Immunization Recommendations and Infrastructure
  • 5.4. Mexico
    • 5.4.1. Surveillance and Diagnosis
    • 5.4.2. Vector Control
    • 5.4.3. Immunization Recommendations and Infrastructure
  • 5.5. Singapore
    • 5.5.1. Surveillance and Diagnosis
    • 5.5.2. Vector Control
    • 5.5.3. Immunization Recommendations and Infrastructure
  • 5.6. Thailand
    • 5.6.1. Surveillance and Diagnosis
    • 5.6.2. Vector Control
    • 5.6.3. Immunization Recommendations and Infrastructure

6. Unmet Needs Assessment and Opportunity Analysis

  • 6.1. Overview
  • 6.2. Unmet Needs Analysis
    • 6.2.1. Unmet Need: Safe and Efficacious Vaccines
    • 6.2.2. Unmet Need: An Improved Understanding of Dengue Immunity
    • 6.2.3. Unmet Need: Reliable Immunological Correlates of Protection
    • 6.2.4. Unmet Need: Country-Specific Immunization Program Preparedness
    • 6.2.5. Unmet Need: Upgraded Vector Control and Surveillance Infrastructures
    • 6.2.6. Unmet Need: Improved Diagnostic Tools
    • 6.2.7. Unmet Need: High-Quality Animal Models
  • 6.3. Opportunity Analysis
    • 6.3.1. Opportunity: Develop a Single-Dose Dengue Vaccine
    • 6.3.2. Opportunity: Further Elucidate the Role(s) of T Cells in Dengue Immunity
    • 6.3.3. Opportunity: Streamline Vaccine Development with Innovative Clinical Trial Design
    • 6.3.4. Opportunity: Partner with Public Health Stakeholders to Integrate Vaccines into Multifaceted Dengue Prevention Programs
    • 6.3.5. Opportunity: Establish Country-Specific Vaccine Launch Strategies
    • 6.3.6. Opportunity: Leverage Diagnostics to Demonstrate Vaccine Effectiveness Post-Licensure

7. Research and Development Strategies

  • 7.1. Overview
  • 7.2. Technological Approaches to Vaccine Development
    • 7.2.1. Vaccine Antigen Selection
    • 7.2.2. Tetravalent Vaccine Construction
  • 7.3. Partnerships, Acquisitions, and Licensing Agreements
  • 7.4. Clinical Trial Design
    • 7.4.1. Current Clinical Trial Design
    • 7.4.2. Inclusion of Representative Patient Populations in Clinical Trials
    • 7.4.3. Demonstration of Protective Efficacy
    • 7.4.4. Dengue Human Infection Model

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Live-Attenuated Vaccines in Clinical Development
    • 8.2.1. CYD-TDV
    • 8.2.2. TAK-003
    • 8.2.3. TV-003
  • 8.3. Other Vaccines in Clinical Development
    • 8.3.1. TDENV-PIV
    • 8.3.2. DEN-80E
  • 8.4. Vaccines in Preclinical Development

9. Pipeline Valuation Analysis

  • 9.1. Clinical Benchmarking of Key Pipeline Vaccines
  • 9.2. Commercial Benchmarking of Key Pipeline Vaccines
  • 9.3. Competitive Assessment
  • 9.4. Top-Line Five-Year Forecast
    • 9.4.1. Brazil
    • 9.4.2. India
    • 9.4.3. Mexico
    • 9.4.4. Singapore
    • 9.4.5. Thailand

10. Appendix

  • 10.1. Bibliography
  • 10.2. Abbreviations
  • 10.3. Methodology
  • 10.4. Forecasting Methodology
    • 10.4.1. Vaccinated Patients
    • 10.4.2. Vaccination Coverage Rates
    • 10.4.3. Vaccines Included in Each Class
    • 10.4.4. Vaccine Launch Dates
    • 10.4.5. General Pricing Assumptions
    • 10.4.6. Individual Vaccine Assumptions
    • 10.4.7. Pricing of Pipeline Vaccines
  • 10.5. Physicians and Specialists Included in this Study
  • 10.6. About the Authors
    • 10.6.1. Analyst
    • 10.6.2. Epidemiologist
    • 10.6.3. Therapy Area Director
    • 10.6.4. Global Head of Healthcare
  • 10.7. About GlobalData
  • 10.8. Disclaimer

List of Tables

  • Table 1: Symptoms and WHO Case Definitions of Dengue
  • Table 2: Risk Factors for DENV Transmission and Severe Dengue (DHF and DSS)
  • Table 3: Periodicity and Seasonality of Dengue Fever in the 5MM, 2003-2013
  • Table 4: 5MM, Circulating DENV Serotypes and Predominant Serotype, 2003-2013
  • Table 5: 5MM, Sources of Reported Laboratory-Confirmed Dengue Fever Data
  • Table 6: 5MM, Reported Laboratory-Confirmed Dengue Cases, N (Col %), Men and Women, All Ages, Selected Years, 2009-2023
  • Table 7: 5MM, Sex-Specific Distribution of Reported Laboratory-Confirmed Dengue Cases, All Ages, Annual Average, 2009-2013
  • Table 8: 5MM, Age-Specific Distribution of Reported Laboratory-Confirmed Dengue Cases, All Ages, Annual Average, 2009-2013
  • Table 9: Routine Immunization Recommendations in Brazil, 2014
  • Table 10: Routine Immunization Recommendations in India, 2014
  • Table 11: Routine Immunization Recommendations in Mexico, 2014
  • Table 12: Routine Immunization Recommendations in Singapore, 2014
  • Table 13: Routine Immunization Recommendations in Thailand, 2014
  • Table 14: Unmet Need and Opportunity in Dengue Vaccines
  • Table 15: Acquisitions and Licensing Agreements in the Dengue Vaccine Market, 2014
  • Table 16: Design of Selected Dengue Vaccine Clinical Trials
  • Table 17: Dengue Vaccines - Clinical Development Pipeline, 2014
  • Table 18: Comparison of Dengue Vaccine Classes in Clinical Development, 2014
  • Table 19: Product Profile - CYD-TDV
  • Table 20: Phase III Efficacy Profile - CYD-TDV
  • Table 21: Exploratory Intent-to-Treat Efficacy Analyses - CYD-TDV
  • Table 22: Phase IIb Efficacy Profile - CYD-TDV
  • Table 23: Safety Profile - CYD-TDV
  • Table 24: CYD-TDV SWOT Analysis, 2014
  • Table 25: Product Profile - TAK-003
  • Table 26: Efficacy Profile - TAK-003
  • Table 27: Safety Profile - TAK-003
  • Table 28: TAK-003 SWOT Analysis, 2014
  • Table 29: Product Profile - TV-003
  • Table 30: Efficacy Profile - TV-003
  • Table 31: Safety Profile - TV-003
  • Table 32: TV-003 SWOT Analysis, 2014
  • Table 33: Product Profile - TDENV-PIV
  • Table 34: TDENV-PIV SWOT Analysis, 2014
  • Table 35: Product Profile - DEN-80E
  • Table 36: Efficacy Profile - DEN-80E
  • Table 37: DEN-80E SWOT Analysis, 2014
  • Table 38: Dengue Vaccines - Innovative Vaccines in Preclinical Development, 2014
  • Table 39: Clinical Benchmarking of Key Pipeline Vaccines
  • Table 40: Commercial Benchmarking of Key Pipeline Vaccines
  • Table 41: Top-Line Sales Forecast ($m) for Dengue Vaccines, 2015-2020
  • Table 42: Key Events Impacting Sales for Dengue Vaccines, 2015-2020
  • Table 43: Dengue Vaccines Market - Drivers and Barriers, 2015-2020
  • Table 44: Key Launch Dates

List of Figures

  • Figure 1: DENV Structure and Genome
  • Figure 2: Laboratory Methods for Dengue Diagnosis
  • Figure 3: 5MM, Incidence Rate (Cases per 100,000 Population) of Reported Laboratory-Confirmed Dengue Cases (Including Classic Dengue Fever and DHF), Men and Women, All Ages, 2003-2013
  • Figure 4: 5MM, Reported Laboratory-Confirmed Dengue Cases, Men and Women, All Ages, 2014-2023
  • Figure 5: 5MM, Sex-Specific Distribution of Reported Laboratory-Confirmed Dengue Cases, All Ages, Annual Average, 2009-2013
  • Figure 6: 5MM, Age-Specific Distribution of Reported Laboratory-Confirmed Dengue Cases, Men and Women, Annual Average, 2009-2013
  • Figure 7: 5MM, Age-Standardized Incidence of Reported Laboratory-Confirmed Dengue Cases, All Ages, Annual Average, 2009-2013
  • Figure 8: Competitive Assessment of Pipeline Dengue Vaccines, 2015-2020
  • Figure 9: Global Dengue Vaccine Uptake, by Routine or Catch-up Immunization, 2015-2020
  • Figure 10: Global Sales for Pipeline Dengue Vaccines by Country, 2015-2020
  • Figure 11: Brazil Dengue Vaccine Uptake, by Routine or Catch-up Immunization, 2015-2020
  • Figure 12: India Dengue Vaccine Uptake, by Routine or Catch-up Immunization, 2015-2020
  • Figure 13: Mexico Dengue Vaccine Uptake, by Routine or Catch-up Immunization, 2015-2020
  • Figure 14: Singapore Dengue Vaccine Uptake, by Routine or Catch-up Immunization, 2015-2020
  • Figure 15: Thailand Dengue Vaccine Uptake, by Routine or Catch-up Immunization, 2015-2020
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