Central Nervous System (CNS) Biomarkers Market Size, Share, Industry, Forecast and outlook (2024-2031)

Global Central Nervous System (CNS) Biomarkers Market is Segmented  By Type (Safety Biomarker, Efficacy Biomarker, Validation Biomarker, Others), By Application (Drug Discovery & Development, Drug Discovery & Development, Personalized Medicines, Disease Risk Assessment, Diagnostics, Others), By Disease(Multiple Sclerosis, Alzheimer's disease, Parkinson's Disease, Traumatic Brain Injury, Others), By End-user(Diagnostic Labs, Clinics, Hospitals, Research Centers, Others)and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2024-2031

Central Nervous System (CNS) Biomarkers Market Overview

The Global Central Nervous System Biomarkers Market size reached US$ 4,790.8 million in 2022 and is projected to witness lucrative growth by reaching up to US$ 9,852.7 million by 2031. The market is exhibiting at a CAGR of 9.7% during the forecast period (2024-2031).  The global central nervous system biomarkers market is anticipated to rise throughout the forecast period due to the increased demand for imaging technologies and the development of novel biomarkers.

Biomarkers can indicate various aspects of biological processes in healthy and pathological states, or as a response to drug therapy. They are classified into predictive, diagnostic, monitoring, and safety biomarkers. Some nerve injury markers, humoral markers, cytokines, and immune cells in serum or cerebrospinal fluid have potential roles in disease severity and prognosis in autoimmune diseases occurring in the CNS, providing a promising approach for clinicians to early intervention and prevention of future disability. 

Central Nervous System (CNS) Biomarkers Market Scope

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Central Nervous System (CNS) Biomarkers Market Dynamics

Rising Demand For Novel Biomarkers

Novel potential biomarkers include the tau protein, neurofilament light chain (NFL), glial fibrillary acidic protein (GFAP), and ubiquitin C-terminal hydrolase-L1 (UCH-L1). The tau protein is a neuroaxonal marker located mainly in the white matter of the central nervous system and is reported to be increased in ischemic stroke and cardiac arrest. 

Novel biomarkers for CNS disorders hold promise for addressing existing shortcomings in diagnosis and disease monitoring and the discovery and development of new targets and therapeutics. Technological advances have increased the pace of biomarker discovery, but most are yet to be validated. Incorporating biomarkers into clinical trials and practice will help improve study efficiency and inform advancements in personalized neurology.

Development of Imaging Technologies

Imaging biomarkers are one of the most commonly utilized approaches in clinical settings due to their availability, cost-effectiveness, and non-invasiveness. They have three subtypes: positron emission tomography (PET), computed tomography (CT), and magnetic resonance imaging (MRI). 

PET is used to assess the efficacy of oncologic treatments, CT is used to monitor tumor status, and MRI is used to understand neurodegenerative diseases. The development of imaging technologies in the CNS biomarkers market holds opportunities in the coming future.

High Cost of CNS Biomarker Testing and Diagnostics

The high cost of CNS biomarker testing and diagnostics and their related issues with regulatory and reimbursement systems are hindering market growth.

With the high cost of the validation process, such as sample collection & storage, government rules and policies are changing since reimbursements do not cover biomarker-mediated therapies that are not considered standard of care. Even though biomarkers add significant value to tests, refunds are limited.

Central Nervous System (CNS) Biomarkers Market Segment Analysis

The global central nervous system biomarkers market is segmented by type, application, disease, end-user, and by region

Based on Type, Safety Biomarkers Segment Is Expected To Dominate The Market Share 

The safety biomarkers segment accounted for the highest market stake accounting for approximately 35.5% of the central nervous system biomarkers market in 2022 due to increased awareness of health issues such as depression, Parkinson’s, and multiple sclerosis. 

Safety biomarkers play a crucial role in preclinical and clinical research trials, with rapid changes in growth measurement, computation, and analysis leading to the explosive growth of the translational research field. For instance, in patients with Alzheimer’s disease, Donanemab improved cognition and ability to perform activities of daily living in patients with early Alzheimer's disease at 76 weeks.

Source: DataM Intelligence Analysis (2024)

Central Nervous System (CNS) Biomarkers Market Geographical Penetration

North America Is Estimated to Hold The Highest Revenue Share During The Forecast Period 

North America is estimated to hold around 42.7% of the total market share throughout the forecast period due to rising CNS cancer cases and increased R&D expenditure. For instance, based on the American Cancer Society, brain malignancy is the second most common cancer in children and adolescents, where CNS biomarkers are used.

Source: DataM Intelligence Analysis (2024)

Central Nervous System (CNS) Biomarkers Companies

The major global players include Acumen Pharmaceuticals Inc., Biogen Inc., Alseres Pharmaceuticals, Aposense, Avacta Life Sciences, Banyan Biomarkers, Bio-Rad Laboratories, DiaGenic ASA, G-Biosciences, and Thermo Fisher Scientific.

COVID-19 Impact on Central Nervous System (CNS) Biomarkers Market

Russia-Ukraine Conflict Analysis

Russia and Ukraine war significantly impacted the central nervous system biomarkers market growth. The situation in Ukraine will have a variety of effects on performing clinical trials, but it mainly affects the closure of treatment facilities, internal displacement, and forced migration. The war is expected to have an effect on the contribution of Russian clinical trial sites. Because resources and manpower are not allocated according to priority, CNS care in these nations has worsened. 

By Type

• Safety Biomarkers
• Efficacy Biomarkers
• Validation Biomarkers
• Others 

By Application

• Drug Discovery & Development
• Personalized Medicines
• Disease Risk Assessment
• Diagnostics
• Others

By Disease

• Multiple Sclerosis
• Alzheimer's Disease
• Parkinson's Disease
• Traumatic Brain Injury
• Others

By End-User 

• Diagnostic Labs
• Clinics
• Hospitals
• Research Centers
• Others

By Region

• North America
  • The U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • The U.K.
  • France
  • Italy
  • Spain
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific
• Middle East and Africa

Key Developments

• In April 2023, Biogen and Denali Therapeutics announced that Biogen exercised the option to license Denali's Antibody Transport Vehicle (ATV): Amyloid beta program (ATV:A). ATV:A is designed to increase brain exposure and target engagement of antibody therapeutics directed against A, which may enable improved plaque clearance and/or reduced amyloid-related imaging abnormalities (ARIA). 
• In April 2023, Athira Pharma (ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, announced the presentation of new data from its small molecule programs enhancing the HGF/MET neurotrophic system.
• In May 2023, Gate Neurosciences, a clinical-stage biotechnology company using precision medicine approaches to develop next-generation neuroscience therapies, announced it increased its R&D capabilities with new expanded research operations and lab facilities in Evanston.

Why Purchase the Report?

• To visualize the global central nervous system biomarkers market segmentation based on type, application, disease, end-user, and region and understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development. 
• Excel data sheet with numerous data points of central nervous system biomarkers market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as Excel consisting of key products of all the major players.

The global central nervous system biomarkers market report would provide approximately 54 tables, 46 figures, and 195 Pages.