Central Nervous System (CNS) Biomarker Market 2025-2035

Description

List of Tables

Central Nervous System (CNS) Biomarker Market Size, Share & Trends Analysis Report by Application (Drug Discovery & Development, Personalized Medicine, Disease Risk Assessment, and Others) by Type (Safety Biomarker, Efficacy Biomarker, Predictive Biomarker, Prognostic Biomarker, and Validation Biomarker) and by End User (Diagnostic Labs, Hospitals and Clinics, and Research Centers) Forecast Period (2025-2035)

Industry Overview

Central nervous system (CNS) biomarker market was valued at $6.5 billion in 2024 and is projected to reach $16.1 billion by 2035, growing at a CAGR of 8.6% during the forecast period. The market is primarily driven by the rising prevalence of neurological disorders such as Alzheimer's disease, Parkinson's disease, and multiple sclerosis, coupled with increasing demand for early diagnosis, disease monitoring, and personalized treatment approaches. Among applications, drug discovery & development hold the largest market share, while personalized medicine is witnessing the fastest growth. By type, predictive biomarkers are gaining significant traction, and research centers are emerging as key end users driving adoption. North America, led by the United States, dominates the market due to advanced healthcare infrastructure, strong R&D investments, and the presence of leading pharmaceutical and biotechnology companies. Continuous technological advancements and regulatory support are further fueling market expansion globally.

Market Dynamics

Rising Prevalence of Neurological Disorders

The increasing incidence of neurological diseases such as Alzheimer's, Parkinson's, and multiple sclerosis is a significant driver for the CNS biomarker market. According to the World Health Organization (WHO), neurological disorders are the second leading cause of death globally and the leading cause of disability-adjusted life years (DALYs). Conditions like Alzheimer's disease currently affect over 55 million people worldwide and are expected to triple by 2050.

This surge in prevalence underscores the urgent need for effective diagnostic and monitoring tools, propelling the demand for CNS biomarkers. These biomarkers facilitate early detection, disease progression monitoring, and evaluation of therapeutic responses, thereby improving patient outcomes and advancing personalized treatment approaches.

Advancements in Genomic and Proteomic Technologies

Technological innovations in genomics, proteomics, and metabolomics have revolutionized the identification and validation of CNS biomarkers. These advancements enable the discovery of novel biomarkers with unprecedented precision and efficiency, enhancing the accuracy of diagnosing and treating neurological conditions.

The integration of these technologies into clinical practice has led to more reliable and non-invasive diagnostic methods, reducing the need for invasive procedures and improving patient comfort. Moreover, they support the development of targeted therapies, aligning with the growing trend towards personalized medicine in neurology.

Increasing Investment in Research and Development

There is a significant rise in research and development (R&D) activities focused on CNS biomarkers, driven by both public and private sector investments. For instance, the National Institute of Neurological Disorders & Stroke is particularly interested in methods that might speed up identifying and validating reliable biomarkers. These investments are fostering innovation in biomarker discovery, leading to the development of new diagnostic tools and therapeutic strategies. Collaborations between pharmaceutical companies, research institutions, and healthcare providers are accelerating the translation of biomarker research into clinical applications, thereby expanding the market and improving patient care.

Market Segmentation

Based on the application, the market is segmented into drug discovery & development, personalized medicine, disease risk assessment, and others.
Based on the Type, the market is segmented into safety biomarker, efficacy biomarker, predictive biomarker, prognostic biomarker, and validation biomarker.
Based on the end user, the market is segmented into diagnostic labs, hospitals and clinics, research centers, and others.

Drug Discovery & Development Is the Largest Segment in the Global CNS Biomarker Market

Among the various segments in the global CNS biomarker market, the drug discovery & development segment is the largest and holds the major market share. CNS biomarkers are extensively used during the drug development process to identify potential therapeutic targets, evaluate the safety and efficacy of candidate drugs, and monitor biological responses during preclinical and clinical trials. Their application accelerates the development of new therapies for neurological disorders, reduces attrition rates in clinical trials, and helps in optimizing dosing and treatment strategies. Pharmaceutical and biotechnology companies increasingly rely on CNS biomarkers to streamline drug development pipelines and minimize the risk of late-stage failures. The dominance of this segment is further supported by the growing prevalence of neurological disorders globally, increasing demand for innovative therapies, and the rising investment in research and clinical trials for CNS-related drugs.

Predictive Biomarker: A Key Segment in Market Growth

The predictive biomarker segment is expected to witness the fastest growth among all biomarker types. Predictive biomarkers are critical tools in modern neurology as they help forecast a patient's likely response to a specific therapy or drug. This capability is particularly valuable for complex neurological disorders, such as Alzheimer's disease, Parkinson's disease, and multiple sclerosis, where treatment responses vary significantly across patients. By enabling clinicians and researchers to anticipate therapeutic outcomes, predictive biomarkers reduce the trial-and-error approach in treatment selection, improve patient outcomes, and optimize healthcare resource utilization. Advances in molecular diagnostics, genomics, and artificial intelligence are enhancing the accuracy, reliability, and applicability of predictive biomarkers, further accelerating their adoption in both clinical and research settings. Moreover, the growing focus on personalized medicine is driving demand for predictive biomarkers, as they allow therapies to be tailored to individual molecular and genetic profiles, improving efficacy while minimizing side effects.

Regional Outlook

The global central nervous system (CNS) biomarker industry is further divided by region, including North America (the US and Canada), Europe (the UK, Germany, France, Italy, Spain, Russia, and the Rest of Europe), Asia-Pacific (India, China, Japan, South Korea, Australia and New Zealand, ASEAN Countries, and the Rest of Asia-Pacific), and the Rest of the World (the Middle East & Africa, and Latin America).

North America Maintains Strong Market Position

North America, particularly the United States, dominates the global Central Nervous System (CNS) biomarker market, holding the largest market share. The region's leadership is driven by several critical factors, including advanced healthcare infrastructure, high R&D expenditure, and the presence of major pharmaceutical and biotechnology companies. The United States has a well-established ecosystem for neurological research, supported by leading academic institutions, government agencies such as the National Institutes of Health (NIH), and private research organizations. This ecosystem facilitates the discovery, validation, and commercialization of novel CNS biomarkers, positioning the country at the forefront of innovation in neurology diagnostics and therapeutics.

The high prevalence of neurological disorders in North America further strengthens demand for CNS biomarkers. Conditions such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, and other neurodegenerative disorders are increasingly prevalent due to the aging population, lifestyle factors, and improved disease awareness. Biomarkers play a pivotal role in early diagnosis, monitoring disease progression, and evaluating treatment efficacy, which is critical in a region where patient care standards are high and early intervention is prioritized. Additionally, regulatory support from agencies like the U.S. Food and Drug Administration (FDA) encourages the development and adoption of novel biomarkers. The United States has also witnessed significant investment from private and public sectors in biomarker-based research and personalized medicine initiatives, further accelerating market growth.

The presence of key market players such as Thermo Fisher Scientific, Bio-Rad Laboratories, Merck KGaA, Siemens Healthineers, and F. Hoffmann-La Roche AG ensures continuous innovation and reinforces North America's dominance. Furthermore, collaboration between research centers, hospitals, and diagnostic labs facilitates rapid clinical translation of CNS biomarker discoveries into practice. This integration of research, clinical applications, and technological advancements positions the United States as a leader in the CNS biomarker market, contributing to its substantial share globally and driving the overall expansion of the market in the forecast period.

Market Players Outlook

The major companies operating in the global central nervous system (CNS) biomarker market include Bio-Rad Laboratories, F. Hoffmann-La Roche AG, Merck KGaA, Siemens Healthineers, Thermo Fisher Scientific, among others. Market players are leveraging partnerships, collaborations, mergers, and acquisition strategies for business expansion and innovative product development to maintain their market positioning.

Recent Developments

In July 2025, Thermo Fisher Scientific announced the launch of a new platform for high-throughput screening of CNS biomarkers, aimed at accelerating drug discovery processes.
In August 2025, Merck KGaA entered into a collaboration with a leading AI diagnostics company to develop machine learning algorithms for the analysis of CNS biomarker data, enhancing diagnostic accuracy and efficiency.
In September 2025, Bio-Rad Laboratories expanded its portfolio with the introduction of a novel biomarker assay for early detection of neurodegenerative diseases, addressing the unmet need for early diagnostic tools.

The Report Covers:

Market value data analysis of 2024 and forecast to 2035.
Annualized market revenues ($ million) for each market segment.
Country-wise analysis of major geographical regions.
Key companies operating in the global central nervous system (CNS) biomarker market. Based on the availability of data, information related to new products and relevant news is also available in the report.
Analysis of business strategies by identifying the key market segments positioned for strong growth in the future.
Analysis of market-entry and market expansion strategies.
Competitive strategies by identifying 'who-stands-where' in the market.

Product Code: OMR2024005

1. Report Summary

Current Industry Analysis and Growth Potential Outlook
Global Central Nervous System (CNS) Biomarker Market Sales Analysis - Application | Type | End User $ Million)
Central Nervous System (CNS) Biomarker Market Sales Performance of Top Countries
1.1. Research Methodology
Primary Research Approach
Secondary Research Approach
1.2. Market Snapshot

2. Market Overview and Insights

2.1. Scope of the Study
2.2. Analyst Insight & Current Market Trends
- 2.2.1. Key Central Nervous System (CNS) Biomarker Market Trends
- 2.2.2. Market Recommendations

3. Market Determinants

3.1. Market Drivers
- 3.1.1. Drivers For Global Central Nervous System (CNS) Biomarker Market: Impact Analysis
3.2. Market Pain Points and Challenges
- 3.2.1. Restraints For Global Central Nervous System (CNS) Biomarker Market: Impact Analysis
3.3. Market Opportunities
- 3.3.1. Opportunities For Global Central Nervous System (CNS) Biomarker Market: Impact Analysis

4. Competitive Landscape

4.1. Competitive Dashboard - Central Nervous System (CNS) Biomarker Market Revenue and Share by Manufacturers
Central Nervous System (CNS) Biomarker Comparison Analysis
Top Market Player Ranking Matrix
4.2. Key Company Analysis
- 4.2.1. Bio-Rad Laboratories
  - 4.2.1.1. Overview
  - 4.2.1.2. Product Portfolio
  - 4.2.1.3. Financial Analysis (Subject to Data Availability)
  - 4.2.1.4. SWOT Analysis
  - 4.2.1.5. Business Strategy
- 4.2.2. F. Hoffmann-La Roche AG
  - 4.2.2.1. Overview
  - 4.2.2.2. Product Portfolio
  - 4.2.2.3. Financial Analysis (Subject to Data Availability)
  - 4.2.2.4. SWOT Analysis
  - 4.2.2.5. Business Strategy
- 4.2.3. Merck KGaA
  - 4.2.3.1. Overview
  - 4.2.3.2. Product Portfolio
  - 4.2.3.3. Financial Analysis (Subject to Data Availability)
  - 4.2.3.4. SWOT Analysis
  - 4.2.3.5. Business Strategy
- 4.2.4. Siemens Healthineers
  - 4.2.4.1. Overview
  - 4.2.4.2. Product Portfolio
  - 4.2.4.3. Financial Analysis (Subject to Data Availability)
  - 4.2.4.4. SWOT Analysis
  - 4.2.4.5. Business Strategy
- 4.2.5. Thermo Fisher Scientific
  - 4.2.5.1. Overview
  - 4.2.5.2. Product Portfolio
  - 4.2.5.3. Financial Analysis (Subject to Data Availability)
  - 4.2.5.4. SWOT Analysis
  - 4.2.5.5. Business Strategy
4.3. Top Winning Strategies by Market Players
- 4.3.1. Merger and Acquisition
- 4.3.2. Product Launch
- 4.3.3. Partnership And Collaboration

5. Global Central Nervous System (CNS) Biomarker Market Sales Analysis By Application ($ Million)

5.1. Drug Discovery & Development
5.2. Personalized Medicine
5.3. Disease Risk Assessment
5.4. Others

6. Global Central Nervous System (CNS) Biomarker Market Sales Analysis By Type ($ Million)

6.1. Safety Biomarker
6.2. Efficacy Biomarker
6.3. Predictive Biomarker
6.4. Prognostic Biomarker
6.5. Validation Biomarker

7. Global Central Nervous System (CNS) Biomarker Market Sales Analysis By End User ($ Million)

7.1. Diagnostic Labs
7.2. Hospitals and Clinics
7.3. Research Centers

8. Regional Analysis

North American Central Nervous System (CNS) Biomarker Market Sales Analysis - Application | Type | End User $ Million)
Macroeconomic Factors for North America
- 8.1.1. United States
- 8.1.2. Canada
European Central Nervous System (CNS) Biomarker Market Sales Analysis - Application | Type | End User $ Million)
Macroeconomic Factors for Europe
- 8.1.3. UK
- 8.1.4. Germany
- 8.1.5. Italy
- 8.1.6. Spain
- 8.1.7. France
- 8.1.8. Russia
- 8.1.9. Rest of Europe
Asia-Pacific Central Nervous System (CNS) Biomarker Market Sales Analysis - Application | Type | End User $ Million)
Macroeconomic Factors for Asia-Pacific
- 8.1.10. China
- 8.1.11. Japan
- 8.1.12. South Korea
- 8.1.13. India
- 8.1.14. Australia & New Zealand
- 8.1.15. ASEAN Countries (Thailand, Indonesia, Vietnam, Singapore, And Other)
- 8.1.16. Rest of Asia-Pacific
Rest of the World Central Nervous System (CNS) Biomarker Market Sales Analysis - Application | Type | End User $ Million)
Macroeconomic Factors for the Rest of the World
- 8.1.17. Latin America
- 8.1.18. Middle East and Africa

9. Company Profiles

9.1. Abbott Laboratories
- 9.1.1. Quick Facts
- 9.1.2. Company Overview
- 9.1.3. Product Portfolio
- 9.1.4. Business Strategies
9.2. Agilent Technologies Inc.
- 9.2.1. Quick Facts
- 9.2.2. Company Overview
- 9.2.3. Product Portfolio
- 9.2.4. Business Strategies
9.3. Atlas Genetics Ltd.
- 9.3.1. Quick Facts
- 9.3.2. Company Overview
- 9.3.3. Product Portfolio
- 9.3.4. Business Strategies
9.4. Becton Dickinson & Co.
- 9.4.1. Quick Facts
- 9.4.2. Company Overview
- 9.4.3. Product Portfolio
- 9.4.4. Business Strategies
9.5. bioMerieux SA
- 9.5.1. Quick Facts
- 9.5.2. Company Overview
- 9.5.3. Product Portfolio
- 9.5.4. Business Strategies
9.6. Bio-Rad Laboratories, Inc.
- 9.6.1. Quick Facts
- 9.6.2. Company Overview
- 9.6.3. Product Portfolio
- 9.6.4. Business Strategies
9.7. Danaher Corp.
- 9.7.1. Quick Facts
- 9.7.2. Company Overview
- 9.7.3. Product Portfolio
- 9.7.4. Business Strategies
9.8. Epigenomics AG
- 9.8.1. Quick Facts
- 9.8.2. Company Overview
- 9.8.3. Product Portfolio
- 9.8.4. Business Strategies
9.9. F. Hoffmann-La Roche AG
- 9.9.1. Quick Facts
- 9.9.2. Company Overview
- 9.9.3. Product Portfolio
- 9.9.4. Business Strategies
9.10. GE Healthcare
- 9.10.1. Quick Facts
- 9.10.2. Company Overview
- 9.10.3. Product Portfolio
- 9.10.4. Business Strategies
9.11. Hologic, Inc.
- 9.11.1. Quick Facts
- 9.11.2. Company Overview
- 9.11.3. Product Portfolio
- 9.11.4. Business Strategies
9.12. Illumina Inc.
- 9.12.1. Quick Facts
- 9.12.2. Company Overview
- 9.12.3. Product Portfolio
- 9.12.4. Business Strategies
9.13. Merck KGaA
- 9.13.1. Quick Facts
- 9.13.2. Company Overview
- 9.13.3. Product Portfolio
- 9.13.4. Business Strategies
9.14. Myriad Genetics
- 9.14.1. Quick Facts
- 9.14.2. Company Overview
- 9.14.3. Product Portfolio
- 9.14.4. Business Strategies
9.15. PerkinElmer Inc.
- 9.15.1. Quick Facts
- 9.15.2. Company Overview
- 9.15.3. Product Portfolio
- 9.15.4. Business Strategies
9.16. QIAGEN N.V.
- 9.16.1. Quick Facts
- 9.16.2. Company Overview
- 9.16.3. Product Portfolio
- 9.16.4. Business Strategies
9.17. Quanterix Corp.
- 9.17.1. Quick Facts
- 9.17.2. Company Overview
- 9.17.3. Product Portfolio
- 9.17.4. Business Strategies
9.18. Roche Diagnostics
- 9.18.1. Quick Facts
- 9.18.2. Company Overview
- 9.18.3. Product Portfolio
- 9.18.4. Business Strategies
9.19. Siemens Healthineers
- 9.19.1. Quick Facts
- 9.19.2. Company Overview
- 9.19.3. Product Portfolio
- 9.19.4. Business Strategies
9.20. Sysmex Corp.
- 9.20.1. Quick Facts
- 9.20.2. Company Overview
- 9.20.3. Product Portfolio
- 9.20.4. Business Strategies
9.21. Thermo Fisher Scientific Inc.
- 9.21.1. Quick Facts
- 9.21.2. Company Overview
- 9.21.3. Product Portfolio
- 9.21.4. Business Strategies