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中枢神経系のバイオマーカー

Biomarkers in the Central Nervous System

発行 GlobalData 商品コード 835764
出版日 ページ情報 英文 150 Pages
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中枢神経系のバイオマーカー Biomarkers in the Central Nervous System
出版日: 2019年04月01日 ページ情報: 英文 150 Pages
概要

当レポートでは、主要8ヶ国 (フランス、ドイツ、イタリア、スペイン、英国、米国、日本、中国) における中枢神経系のバイオマーカー市場について調査分析し、アルツハイマー病 (AD) 、統合失調症、多発性硬化症 (MS) などの適応における製品開発に焦点を当てて、現在の臨床・製品開発の動向について、体系的な情報を提供しています。

第1章 序文

第2章 エグゼクティブサマリー

第3章 バイオマーカーのイントロダクションと分類

  • バイオマーカーの定義
  • バイオマーカーの種類
  • 中枢神経系のバイオマーカー
  • KOLの見通し

第4章 中枢神経系のバイオマーカー支援技術

  • 概要
  • ニューロイメージング、ゲノミクス、プロテオミクス
  • エピジェネティック、メタボロミクス、トランスクリプトミクス
  • リピドミクスと免疫システム
  • 中枢神経系のバイオマーカー診断法
  • KOLの見通し

第5章 主要8ヶ国のバイオマーカーに関する臨床試験の評価

  • 8ヶ国のパイプライン概要
  • バイオマーカー試験:主要適応
  • 臨床試験:主要スポンサー

第6章 適応別の概要:アルツハイマー病 (AD)

  • 概要
  • 疫学
  • ADの世界統計バイオマーカー
  • ADのバイオマーカー
  • ADのニューロイメージング
  • アミロイドバイオマーカー
  • ADバイオマーカー製品
  • CSFアミロイドベース検査
  • 血液検査
  • タウバイオマーカー
  • 遺伝子バイオマーカー
  • ADバイオマーカーにおけるアンメットニーズと課題
  • KOLの見通し

第7章 適応別の概要:統合失調症

  • 概要
  • 疫学
  • 統合失調症の世界統計バイオマーカー
  • 統合失調症のバイオマーカー
  • 統合失調症のニューロイメージング
  • 統合失調症の遺伝・後成的バイオマーカー
  • 統合失調症のタンパク質バイオマーカー
  • 統合失調症の代謝・その他のバイオマーカー
  • 統合失調症バイオマーカーにおけるアンメットニーズと課題
  • KOLの見通し

第8章 適応別の概要:多発性硬化症 (MS)

  • 概要
  • 疫学
  • MSの世界統計バイオマーカー
  • MSのバイオマーカー
  • MSの診断バイオマーカー:ニューロイメージング
  • MSの診断バイオマーカー:髄腔内免疫グロブリンG合成
  • MSの遺伝子バイオマーカー
  • 治療選択に対するバイオマーカー
  • MSの有力なバイオマーカー:Neurofilament Light Chain
  • MSのバイオマーカー:Glial Pathology
  • MSバイオマーカーにおけるアンメットニーズと課題
  • KOLの見通し

第9章 市場の機会

  • 概要
  • 市場促進要因
  • 市場の障壁
  • アンメットニーズ
  • 専門家の見解

第10章 市場参入

  • 概要
  • 米国の規制と償還
  • EUの規制と償還
  • 日本の規制と償還
  • 中国の規制と償還

第11章 市場の見通し

  • 専門家の見解

第12章 付録

目次
Product Code: GDHCHT024

Finding a biomarker for Central Nervous System (CNS) disorders that translates into clinical meaningfulness has been a real challenge for the biomarkers space. Biomarkers will be used more in the future, but limitation and lack of reimbursement for these biomarker tests will affect their use. Alzheimer's Disease (AD) is the major indication being targeted for the development of drugs involving biomarkers, with a total of 197 clinical trials conducted in the eight major markets (France, Germany, Italy, Spain, UK, US, Japan, China). Currently, there are three FDA and EMA approved diagnostic tests for AD, all of which are PET neuroimaging scans capable of detecting beta-amyloid plaques in the brains of living patients.

Many biofluid biomarkers, particularly blood-based biomarkers, still face numerous challenges in terms of standardization and measurements of these markers have shown variability and inconsistencies when applied in different settings. These biomarkers are important because they could be widely implemented as diagnostic screens for several diseases, as they would be more cost-effective and less invasive for patients.

Assay technologies are improving and will offer a more convenient and efficient way to test multiple biomarkers, which will become increasingly important as more targeted therapies are approved and the presence of biomarkers impacts clinical decision-making even more widely. Furthermore, physicians would use liquid biopsies more often if they were more reliable, but this is not expected to improve significantly in the next few years.

Biomarkers have a unique set of regulatory challenges and the reimbursement of biomarkers remains a global market barrier as trends across the eight major markets (France, Germany, Italy, Spain, UK, US, Japan, China) are inconsistent. Biomarkers in Central Nervous System (CNS) are used when there is clinical utility and to help decisions regarding a particular drug treatment, and if effective are most likely to receive reimbursement from the regulatory advisor. Reimbursement presents challenges for patients accessing Central Nervous System (CNS) biomarkers, and reforms are crucial to accelerating the adoption of personalized medicine.

Availability of multiple biomarker tests will encourage competition and likely bring prices down, increasing access to biomarker testing. However, one of the major barriers to the widespread use of biomarkers that are available for Central Nervous System (CNS) disorders is the limitation or lack of reimbursement for biomarker tests by public and private health insurance providers.

The report "Biomarkers in the Central Nervous System", provides an overview of current clinical and product development trends for Biomarkers in Central Nervous System (CNS) within the 8MM (France, Germany, Italy, Spain, UK, US, Japan, China), including analysis of the most common targets and molecule types that are being evaluated among the current biomarkers, focus on product development in indications such as AD, Schizophrenia MS, and unmet needs within biomarkers in Central Nervous System (CNS).

Scope

  • Quotes from 6 key opinion leaders (3 US, 1 EU, 2 Japan) and 2 payers (1 US and 1 UK)
  • Summary of biomarkers product definitions and classifications
  • Overview of common targets and molecule types among current biomarkers, with focus on product development in AD, Schizophrenia and MS
  • Trends in ongoing clinical trials in biomarkers in CNS based on sponsor type, and phase of development
  • Call-outs of key information and details
  • Insight from GlobalData's specialist neurology analysts.

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Table of Contents

1. Preface

  • 1.1 Abbreviations
  • 1.2 Related Reports

2. Executive Summary

  • 2.1 Key Findings
  • 2.2 KOL and Payer Insights

3. Introduction and Classification of Biomarkers

  • 3.1 Definition of Biomarker
  • 3.2 Type of Biomarkers
  • 3.3 Biomarkers in CNS
  • 3.4 KOL Perspectives

4. Biomarkers Support Technologies in CNS

  • 4.1 Overview
  • 4.2 Neuroimaging, Genomics and Proteomics
  • 4.3 Epigenetic, Metabolomics and Transcriptomics
  • 4.4 Lipidomics and Immune system
  • 4.5 Biomarkers Diagnosis Methods in CNS
  • 4.6 KOL Perspectives

5. Assessment of Clinical Trials Involving Biomarkers in the 8MM

  • 5.1 Pipeline Overview 8MM
  • 5.2 Biomarkers Trials - Top Indications in CNS in the 8MM
  • 5.3 Clinical Trials - Leading Industry Sponsors in the 8MM

6. Indication-Specific Overview: Alzheimer's Disease

  • 6.1 Overview
  • 6.2 Epidemiology
  • 6.3 Global Statistic Biomarkers in AD
  • 6.4 Biomarkers in AD
  • 6.5 Neuroimaging in AD
  • 6.6 Amyloid Biomarkers
  • 6.7 AD Biomarkers Products
  • 6.8 CSF Amyloid Based Tests
  • 6.9 Blood Tests
  • 6.10 Tau Biomarkers
  • 6.11 Genetic Biomarkers
  • 6.12 Unmet needs and Challenges in AD Biomarkers
  • 6.13 KOL Perspectives

7. Indication-Specific Overview: Schizophrenia

  • 7.1 Overview
  • 7.2 Epidemiology
  • 7.3 Global Statistic Biomarkers in Schizophrenia
  • 7.4 Biomarkers in Schizophrenia
  • 7.5 Neuroimaging in Schizophrenia
  • 7.6 Genetic and Epigenetic Biomarkers in Schizophrenia
  • 7.7 Protein Biomarkers in Schizophrenia
  • 7.8 Metabolic and Other Biomarkers in Schizophrenia
  • 7.9 Unmet needs and Challenges in Schizophrenia Biomarkers
  • 7.10 KOL Perspectives

8. Indication-Specific Overview: Multiple Sclerosis

  • 8.1 Overview
  • 8.2 Epidemiology
  • 8.3 Global Statistic Biomarkers in MS
  • 8.4 Biomarkers in MS
  • 8.5 Diagnostic Biomarkers in MS -Neuroimaging
  • 8.6 Diagnostic Biomarkers in MS -Intrathecal Immunoglobulin G Synthesis
  • 8.7 Genetic Biomarkers in MS
  • 8.8 Biomarkers to Guide Choice of Therapy
  • 8.9 Promising Biomarkers in MS - Neurofilament Light Chain
  • 8.10 Biomarkers in MS - Glial Pathology
  • 8.11 Unmet needs and Challenges in MS Biomarkers
  • 8.12 KOL Perspectives

9. Market Opportunities

  • 9.1 Overview
  • 9.2 Market Drivers
  • 9.3 Market Barriers
  • 9.4 Unmet Needs
  • 9.5 Experts Perspectives

10. Market Access

  • 10.1 Overview
  • 10.2 Regulation and Reimbursement in the US
    • 10.2.1 Payer Perspective
  • 10.3 Regulation and Reimbursement in the EU
    • 10.3.1 Payer Perspective
  • 10.4 Regulation and Reimbursement in Japan
    • 10.4.1 KOL Perspective
  • 10.5 Regulation and Reimbursement in China

11. Market Outlook

  • 11.1 Expert Perspectives

12. Appendix

  • 12.1 Sources
  • 12.2 Methodology
  • 12.3 Primary Research
  • 12.4 About the Authors
  • 12.5 About GlobalData
  • 12.6 Contact Us
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