Biomarkers in the Central Nervous System

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Biomarkers in CNS are expected to be an area that will witness strong growth in the future due to factors such as deeper understanding of the underlying disease pathology, advancements in technologies, and potential of these biomarkers that can contribute to targeted therapy. Biomarkers in CNS targeting a number of neurology indications are being developed; however, the most common ones are Alzheimer’s disease (AD), Schizophrenia and Multiple Sclerosis (MS).
This report provides an overview of current clinical and product development trends for Biomarkers in 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 CNS.

Scope

GlobalData’s Biomarkers in the Central Nervous System report combines primary research from a cross-specialty panel of neurology experts with in-house analyst expertise to provide an assessment of the development landscape.

Components of the slide deck include primary and secondary research:

• 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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Sanofi
InviCRO
Lunbeck
Eisai
F. Hoffmann- La Roche
J&J
Biogen
GSK
Eli Lilly
Brystol-Myers Squibb
Regenera Pharma
Araclon Biotech
EIP Pharma
Sunnybrook Health Sciences Centre
AstraZeneca
Boehringer Ingelheim
Les Laboratoires Servier
GE Healthcare
Piramal
Forest Laboratories
Alkermes
Sunovion Pharmaceuticals
Intra-Cellular Therapies
GW Pharmaceuticals
Novartis
Merck
Teva
Genzyme
AbbVie
Pfizer

Table of Contents

1 Table of Contents (PowerPoint Deck)

1 Preface

1.1 Table of Contents

1.2 Abbreviations

1.3 Related Reports

2 Executive Summary

2.1 Key Findings

2.2 KOL and Payer Insight

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

12.7 Disclaimer

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