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市場調查報告書

中樞神經系統的生物標記

Biomarkers in the Central Nervous System

出版商 GlobalData 商品編碼 835764
出版日期 內容資訊 英文 150 Pages
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中樞神經系統的生物標記 Biomarkers in the Central Nervous System
出版日期: 2019年04月01日內容資訊: 英文 150 Pages
簡介

本報告提供主要8個國家 (法國、德國、義大利、西班牙、英國、美國、日本、中國) 的中樞神經系統的生物標記市場相關調查分析,阿茲海默症 (AD) 、思覺失調症,多發性硬化症 (MS) 等的適應中的產品開發為焦點,目前臨床、產品開發趨勢相關的系統性資訊。

第1章 序文

第2章 摘要整理

第3章 生物標記的簡介與分類

  • 生物標記定義
  • 生物標記的種類
  • 中樞神經系統的生物標記
  • KOL預測

第4章 中樞神經系統的生物標記支援技術

  • 概要
  • 神經成像,基因學,蛋白質體學
  • 表觀遺傳,代謝體學,轉錄體學
  • 脂類組學和免疫系統
  • 中樞神經系統的生物標記診斷法
  • KOL預測

第5章 主要8個國家的生物標記相關臨床試驗的評估

  • 8個國家的開發平台概要
  • 生物標記實驗:主要適應
  • 臨床試驗:主要贊助商

第6章 各適應症概要:阿茲海默症 (AD)

  • 概要
  • 流行病學
  • AD的世界統計生物標記
  • AD的生物標記
  • AD的神經成像
  • 澱粉樣蛋白生物標記
  • AD生物標記產品
  • CS基於澱粉樣蛋白的檢驗
  • 血液檢驗
  • Tau生物標記
  • 遺傳基因生物標記
  • AD生物標記的未滿足需求與課題
  • KOL預測

第7章 各適應症概要:思覺失調症

  • 概要
  • 流行病學
  • 思覺失調症的世界統計生物標記
  • 思覺失調症的生物標記
  • 思覺失調症的神經成像
  • 思覺失調症的遺傳、後成性生物標記
  • 思覺失調症的蛋白質生物標記
  • 思覺失調症的代謝、其他生物標記
  • 思覺失調症生物標記的未滿足需求與課題
  • KOL預測

第8章 各適應症概要:多發性硬化症 (MS)

  • 概要
  • 流行病學
  • MS的世界統計生物標記
  • MS的生物標記
  • MS的診斷生物標記:神經成像
  • MS的診斷生物標記:髓腔內免疫球蛋白G合成
  • MS的遺傳基因生物標記
  • 對治療選擇的生物標記
  • MS的有力的生物標記:Neurofilament Light Chain
  • MS的生物標記:Glial Pathology
  • MS生物標記的未滿足需求與課題
  • KOL預測

第9章 市場機會

  • 概要
  • 推動市場要素
  • 市場障礙
  • 未滿足需求
  • 專家的見解

第10章 市場進入

  • 概要
  • 美國的法規與償付
  • EU的法規與償付
  • 日本的法規與償付
  • 中國的法規與償付

第11章 市場預測

  • 專家的見解

第12章 附錄

目錄
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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