中枢神経系 (CNS) バイオマーカー : 技術と世界市場

出版：BCC Research（BCCリサーチ）　出版年月：2023年4月

Central Nervous System (CNS) Biomarkers: Technologies and Global Markets
中枢神経系 (CNS) バイオマーカー: 技術と世界市場

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Report Highlights

The global central nervous system (CNS) biomarkers market should reach $9.5 billion by 2027 from $5.7 billion in 2022 at a compound annual growth rate (CAGR) of 10.8% for the forecast period of 2022 to 2027.

Summary:

Biomarkers are measurable and quantifiable biological indicators that can be used to diagnose or predict disease, monitor disease progression, indicate what treatment options may be most effective in an individual patient’s case, and predict treatment response. They play a role both in new drug R&D and in predicting the outcome of treatment in the medical setting. Biomarkers are important tools for understanding disease mechanisms, developing more effective treatments and improving the quality of patient care.

A biomarker of a central nervous system (CNS) disorder is, by definition, differentially expressed between a normal subject’s brain or spinal cord (CNS system) and that of a subject bearing a CNS disorder. Traditionally, CNS or neuroscience biomarkers could only be detected after a subject already exhibited cognitive decline or other symptoms of disease. However, recently, sensitive assays have shown biomarkers to be present even in advance of other symptoms.

The global CNS biomarker market was valued at $REDACTED billion in 2022. The market is projected to reach $REDACTED billion in 2027, growing at a CAGR of REDACTED% during the forecast period. This aggressive growth rate will be driven by several factors, including the increase in public-private partnerships with government support, pressure to keep healthcare costs down, a growing elderly population, and the rapid advancement of the genomic and proteomic technologies that have impacted the CNS biomarker diagnostics area.

There is huge unmet need in the area of CNS diseases due to the lack of fast and sensitive diagnostic methods and effective treatments. CNS biomarkers are rapidly emerging as the mainstay in the identification of patients at risk, early diagnosis, follow-up of disease progression, and effectiveness of treatments in neurology, in particular for demyelinating diseases (such as multiple sclerosis), neurodegenerative diseases (such as Alzheimer’s disease) or traumatic brain injury.

In order to expedite drug development for neurology diseases, it is important to identify novel biomarkers that enhance diagnostic and prognostic accuracy, improve the existing decision criteria for early diagnosis and risk stratification, assist in disease monitoring, and act as surrogate endpoints in experimental studies and clinical trials. Efforts are being directed to expand neurology research and develop platforms and methods that can provide deeper insights into brain biology and aid in further biomarker research. Several biomarkers that have been identified in the past decade are under investigation for their potential applications. Once these biomarkers are validated and subsequently enter into clinical and research applications, the CNS biomarkers marker is expected to grow significantly.

Report Scope:

This study provides a comprehensive analysis of CNS biomarkers on a global basis. Its aim is to provide a range of information, from detailed product analyses within disease subsegments to overall industry trends, in order to quantify and qualify the global CNS biomarkers market.

Current and projected product forecasts during the forecast period (2022 to 2027) are discussed. New products approved in 2021 and 2022 by the U.S. Food and Drug Administration (FDA), and those products expected to be approved within the forecast period are discussed. Market figures for 2022 are estimated, except where actual results have been reported.

Included in this report are forecasts by biomarker type, technology type, disease, application, and region from 2022 through 2027. The report also includes analysis of leading and emerging competitors in the current worldwide CNS biomarkers market. Profiles of manufacturers of leading products as well as biotechnology companies with novel products in development are analyzed to define the specific product strategies employed. This report also assesses companies poised to introduce products during the forecast period and discusses how these introductions will change the face of the competitive environment. The competitive environment is examined with a special focus on how new products and technologies are influencing the current standard of care.

Report Includes:

– 43 tables
– An overview of the global market and technologies for central nervous system (CNS) biomarkers
– Estimation of the market size and analyses of market trends, with data from 2019 to 2021, estimates for 2022, and projections of compound annual growth rates (CAGRs) through 2027
– Explanation of market drivers, restraints and other forces impacting the global market
– Description of technologies such as genomics, proteomics, and imaging, and assessments of their advantages and disadvantages.
– Discussion of CNS disease segments, prevalence, and gaps in treatment for Alzheimer’s disease, depression, Parkinson’s disease, multiple sclerosis, and others
– Coverage of events like mergers & acquisitions, joint ventures, collaborations or partnerships, and other key market strategies
– Comprehensive company profiles of major players of the industry, including Abbott, Bio-Rad Laboratories Inc., Eisai Co. Ltd., Merck and Thermo Fisher Scientific Inc.

目次

Table of Contents
Chapter 1 Introduction
1.1 Study Goals and Objectives
1.2 Reasons for Doing This Study
1.3 What’s New in This Update?
1.4 Scope of Report
1.5 Methodology and Information Sources
1.6 Geographic Breakdown
1.7 Analyst’s Credentials
1.8 BCC Custom Research
1.9 Related BCC Research Reports
Chapter 2 Summary and Highlights
Chapter 3 Market and Technology Background
3.1 Overview of Biomarkers
3.2 Classification of Biomarkers
3.3 Types of Biomarkers
3.4 Biomarker Discovery, Verification and Validation
3.4.1 Surrogate Biomarkers/Endpoints
3.5 Overview of Central Nervous System (CNS)
Chapter 4 Market Dynamics
4.1 Drivers
4.1.1 Growing Incidence and Financial Burden of Neurological Disorders
4.1.2 High Unmet Need in Neurodegenerative Disorders
4.1.3 Need to Reduce Drug Development Costs and Failures
4.1.4 Increasing investment in Neuroscience
4.1.5 Developments in Analytical Technologies and Assay Methods
4.1.6 Support from Regulatory Agencies
4.2 Restraints
4.2.1 Technological Challenges
4.2.2 Regulatory and Reimbursement Challenges
Chapter 5 Market Breakdown by Disease
5.1 Market Overview
5.2 Alzheimer’s Disease (AD)
5.2.1 AD Pathophysiology
5.2.2 Prevalence and Incidence
5.3 Key Biomarkers of AD
5.3.1 Amyloid-beta (AB, Beta Amyloid, or Abeta)
5.3.2 Tau Protein
5.3.3 Other Biomarkers of AD
5.3.4 Emerging Need for Blood-Based AD Biomarkers Testing
5.4 Parkinson’s Disease (PD)
5.4.1 Prevalence and Incidence
5.5 Key Biomarkers of PD
5.5.1 DaTscan (Ioflupane I 123 Injection)
5.5.2 Flourodopa F18 (F-Dopa)
5.5.3 Alpha synuclein (a-synuclein)
5.5.4 Other Biomarkers of PD
5.6 Multiple Sclerosis (MS)
5.7 Key Biomarkers of MS
5.7.1 Neurofilament Light (NfL)
5.7.2 Myelin Basic Protein (MBP)
5.8 Amyotrophic Lateral Sclerosis (ALS)
5.9 Frontotemporal Dementia (FTD)
5.10 Key Biomarkers of ALS and FTD
5.10.1 TAR DNA-Binding Protein 43 (TDP-43)
5.10.2 Neurofilament Light Chain (NfL)
5.11 Traumatic Brain Injury (TBI) or Concussion
5.12 Traumatic Spinal Cord Injury (SCI)
5.13 Key Biomarkers/Hallmarks of TBI or SCI
5.13.1 Glial Fibrillary Acidic Protein (GFAP)
5.13.2 Ubiquitin C-terminal Hydrolase (UCH-L1)
5.13.3 Neurofilament-Heavy (NF-H) and Light (NF-L)
5.13.4 S100 Calcium-binding Protein B (S100B)
5.14 Other Diseases
5.14.1 Rare Brain Diseases
5.15 Global Market for CNS Biomarkers by Disease
5.15.1 Alzheimer’s Disease (AD)
5.15.2 Parkinson’s Disease (PD)
5.15.3 Multiple Sclerosis (MS), Amyotrophic Lateral Sclerosis (ALS), and Frontotemporal Dementia (FTD)
5.15.4 Traumatic Brain and Spinal Cord Injuries
5.15.5 Others
Chapter 6 Market Breakdown by Application
6.1 Market Overview
6.2 Life Science Research
6.3 Drug Discovery and Development
6.4 Clinical Diagnostics
6.5 Personalized Medicine
6.5.1 Precision Health Screening/Disease Risk Assessment
6.6 Global Market for CNS Biomarkers, by Application
6.6.1 Life Science Research
6.6.2 Drug Discovery and Development
6.6.3 Clinical Diagnostics
6.6.4 Personalized Medicine
Chapter 7 Market Breakdown by Technology Type
7.1 Market Overview
7.2 Proteomics
7.2.1 Proteomics Technologies
7.3 Imaging
7.4 Genomics
7.5 Global Market for CNS Biomarkers, by Technology Type
7.5.1 Proteomics
7.5.2 Imaging
7.5.3 Genomics
Chapter 8 Market Breakdown by Biomarker Type
8.1 Key Biomarkers of Neurodegeneration
8.1.1 Amyloid beta (AB, beta amyloid, or Abeta)
8.1.2 Tau Proteins
8.1.3 Alpha synuclein (a-synuclein)
8.1.4 Synapses
8.1.5 P53 protein
8.1.6 Apolipoprotein E (APOE)-4
8.2 Key Biomarkers of Traumatic Brain and Spinal Injuries
8.2.1 Glial Fibrillary Acidic Protein (GFAP)
8.2.2 Ubiquitin C-terminal hydrolase (UCH-L1)
8.2.3 S100 Calcium-binding Protein B (S100B)
8.2.4 Neurofilament-Heavy (NF-H) and Light (NF-L)
8.3 Key Biomarker Targets for Neuroinflammation
8.3.1 Brain-derived Neurotrophic Factor (BDNF)
8.3.2 Nerve Growth Factor (NGF)
8.3.3 Proinflammatory Cytokines
8.3.4 Global CNS Biomarkers Market by Biomarker Type
Chapter 9 Market Breakdown by Region
9.1 Global Market for CNS Biomarkers by Region
9.2 North America
9.3 Europe
9.4 Asia-Pacific
9.5 Rest of the World (RoW)
Chapter 10 Impact of COVID-19
10.1 Overview
10.2 Impact on CNS Biomarkers Market
Chapter 11 Competitive Landscape
11.1 Overview
11.2 Product Launches/Approvals
11.3 Collaborations/Partnerships
11.4 SWOT Analysis for Global CNS Biomarker Industry
Chapter 12 Emerging Products/Technologies in the Market
12.1 Blood Tests for CNS Biomarkers
12.2 Focus on Tau Protein
12.3 Digital Biomarkers
12.4 Emerging Clinically Relevant CNS Biomarker Candidates
Chapter 13 Company Profiles
ABBOTT LABORATORIES LTD.
BIOMERIEUX S.A.
BIO-RAD LABORATORIES INC.
C₂N DIAGNOSTICS, LLC
DIADEM SPA
EISAI CO. LTD.
ELI LILLY AND CO.
F. HOFFMANN-LA ROCHE AG
H.U. GROUP HOLDINGS INC.
LABORATORY CORP. OF AMERICA (LABCORP)
MERCK KGAA
PERKINELMER INC.
QUANTERIX CORP.
QUEST DIAGNOSTICS INC.
SHIMADZU CORP.
SIEMENS HEALTHINEERS AG
SYSMEX CORP.
THERMO FISHER SCIENTIFIC INC.

List of Tables
Summary Table : Global Market for CNS Biomarkers, by Application, Through 2027
Table 1 : Different Categories of Biomarkers
Table 2 : 2015 Prevalence of Neurodegenerative Diseases Worldwide and Within the US
Table 3 : Industry Clinical Trial Success Rates, New Molecular Entities Only, Through 2020
Table 4 : Selected CNS Biomarker-Focused Consortia
Table 5 : FDA Issued Letters of Support to CNS Biomarkers
Table 6 : Common Methods for Alzheimer’s Disease Biomarker Detection
Table 7 : Selected Tests Targeting AD Biomarkers
Table 8 : Summary Comparison of Technological Characteristics of FDA-Approved Brain Trauma Assessment Tests
Table 9 : Neurodegenerative Diseases and Associated Biomarkers
Table 10 : Global Market for CNS Biomarkers, by Disease, Through 2027
Table 11 : Biomarkers: Drug Development
Table 12 : Adult Surrogate Endpoints that were the Basis of Drug Approval or Licensure for CNS Diseases
Table 13 : CNS Biomarkers’ Clinical Trials, by Sponsor, Jan. 2018-Feb. 2023
Table 14 : Global Market for CNS Biomarkers, by Application, Through 2027
Table 15 : NIH Funding for Neuroscience Research, by Year
Table 16 : Key Protein Biomarker Targets for Neurobiology Research
Table 17 : Neurological Diseases and Associated Protein Aggregates
Table 18 : Selected Diagnostics Agents in Development for Imaging CNS Diseases Pathophysiology
Table 19 : Selected Genetic Biomarkers for Neurodegenerative Diseases
Table 20 : Global Market for CNS Biomarkers, by Technology, Through 2027
Table 21 : Examples of Common Neuroscience Biomarkers
Table 22 : Key Neurological Biomarkers and Associated Diseases
Table 23 : Global Market for CNS Biomarkers, by Biomarker Type, Through 2027
Table 24 : Global Market for CNS Biomarkers, by Region, Through 2027
Table 25 : North American Market for CNS Biomarkers, by Disease, Through 2027
Table 26 : Number of Companies in the Life Sciences and Pharmaceutical Industry, With R&D Expenditure in Europe in 2019, by Country
Table 27 : European Market for CNS Biomarkers, by Disease, Through 2027
Table 28 : Gross Domestic Spending on R&D, by Country, Through 2019
Table 29 : Asia-Pacific Market for CNS Biomarkers, by Disease, Through 2027
Table 30 : RoW Market for CNS Biomarkers, by Disease, Through 2027
Table 31 : Competitive Analysis of CNS Biomarkers Industry, 2021
Table 32 : Selected Product Approvals/Launches in the Global CNS Biomarker Market, Jan 2020-March 2023
Table 33 : Selected Collaborations/Partnerships in the Global CNS Biomarker Market, 2019-2022
Table 34 : Selected Blood Tests Targeting CNS Biomarkers
Table 35 : Selected Tests/Assays for Tau Protein
Table 36 : Selected Emerging Clinically Relevant Biomarker Candidates of CNS Diseases
Table 37 : Abbott’s Representative Clinical Trials Involving CNS Biomarkers
Table 38 : BioMérieux’s Representative Clinical Trials Involving CNS Biomarkers
Table 39 : Eisai’s Representative Clinical Trials Involving CNS Biomarkers
Table 40 : Eli Lilly’s Representative Clinical Trials Involving CNS Biomarkers
Table 41 : Roche’s Representative Clinical Trials Involving CNS Biomarkers
Table 42 : Merck KGaA’s Representative Clinical Trials Involving CNS Biomarkers

List of Figures
Summary Figure : Global Market for CNS Biomarkers, by Application, 2019-2027
Figure 1 : Molecular and Imaging Biomarkers
Figure 2 : Biomarker Discovery, Verification and Validation
Figure 3 : Alzheimer’s and Related Dementia Research Funding at the NIH, 2013-2023
Figure 4 : Hypothetical Models for Progression of Alzheimer’s Diseases
Figure 5 : Hypothetical Models for Progression of AD
Figure 6 : Number and Ages of People 65 or Older with Alzheimer’s Dementia, 2023
Figure 7 : Percent of Dementia Cases, by Disease Type
Figure 8 : Decision Tree for Clinical Use of CNS-Injury Biomarkers
Figure 9 : Active Clinical Trials involving Biomarkers, by Selected CNS Disease
Figure 10 : Global Market for CNS Biomarkers, by Disease, 2019-2027
Figure 11 : Global Market Shares of CNS Biomarkers, by Disease, 2021
Figure 12 : Drug Development Process
Figure 13 : Allocation of R&D Investment in Drug Development, by Function
Figure 14 : Biomarkers in Personalized Treatment
Figure 15 : Global Market for CNS Biomarkers, by Application, 2019-2027
Figure 16 : Global Market Shares of CNS Biomarkers, by Application, 2021
Figure 17 : Global Pharmaceutical R&D Spending, 2010-2019
Figure 18 : Neurological Diseases and Associated Protein Aggregates
Figure 19 : Global Market for CNS Biomarkers, by Technology, 2019-2027
Figure 20 : Global Market Shares of CNS Biomarkers, by Technology, 2021
Figure 21 : Hypothetical Models for Progression of Alzheimer’s Diseases
Figure 22 : Global Market for CNS Biomarkers, by Biomarker Type, 2019-2027
Figure 23 : Global Market Shares of CNS Biomarkers, by Biomarker Type, 2021
Figure 24 : Global Market for CNS Biomarkers, by Region, 2019-2027
Figure 25 : Global Market Shares of CNS Biomarkers, by Region, 2021
Figure 26 : Business Enterprise Expenditures on Pharmaceutical R&D and Government Budgets for Health-related R&D, 2018 (or Nearest Year)
Figure 27 : NIH’s AD and Related Dementia Research Funding, 2013-2023
Figure 28 : North American Market for CNS Biomarkers, by Disease, 2019-2027
Figure 29 : North American Market Shares of CNS Biomarkers, by Disease, 2021
Figure 30 : European Market for CNS Biomarkers, by Disease, 2019-2027
Figure 31 : European Market Shares of CNS Biomarkers, by Disease, 2021
Figure 32 : Asia-Pacific Market for CNS Biomarkers, by Disease, 2019-2027
Figure 33 : Asia-Pacific Market Shares of CNS Biomarkers, by Disease, 2021
Figure 34 : RoW Market for CNS Biomarkers, by Disease, 2019-2027
Figure 35 : RoW Market Shares of CNS Biomarkers, by Disease, 2021
Figure 36 : Number of New Clinical Trials Involving CNS Biomarkers, by Year, 2018-2022
Figure 37 : SWOT Analysis for Global CNS Biomarkers Market