United States Central Nervous System Biomarkers Market to hit US$ 3.3 Billion by 2033 | Major Compnies 2026 - Quanterix, Alamar Biosciences Inc., Thermo Fisher Scientific Inc. | Exclusive report by DataM Intelligence

Leander, Texas and Tokyo, Japan - Jan.08.2026
As per DataM intelligence research report" The global central nervous system (CNS) biomarkers market reached US$ 5.00 billion in 2023, with a rise to US$ 5.41 billion in 2024, and is expected to reach US$ 11.00 billion by 2033, growing at a CAGR of 8.2% during the forecast period 2025-2033." Early neurological diagnosis and drug development needs are driving biomarker research.

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United States Recent Industry Developments

✅ In November 2025, Quanterix launched a new high-sensitivity assay for p-Tau 217 in blood The test detects Alzheimer's pathology years before symptoms appear It accelerates patient screening for new disease-modifying therapies in the U.S.

✅ In October 2025, C2N Diagnostics received FDA breakthrough designation for a Parkinson's blood test The test measures alpha-synuclein aggregates to confirm diagnosis It offers a non-invasive alternative to spinal taps for U.S. patients

✅ In September 2025, Biogen partnered with a diagnostics firm to develop a companion biomarker for ALS The biomarker tracks neurofilament light chain (NfL) levels to monitor treatment response It guides personalized care for ALS patients in the U.S.

✅ In August 2025, The NIH launched a study on digital biomarkers for depression using smartphone data The study analyzes typing patterns and voice tone to predict mood episodes It explores objective measures for mental health in the U.S.

Japan Recent Industry Developments

✅ In December 2025, Fujirebio launched the "Lumipulse" blood test for Alzheimer's in Japan The automated assay is now available for routine health checkups It supports Japan's national strategy for early dementia detection

✅ In November 2025, Shimadzu Corporation released a mass spec system for analyzing amyloid beta ratios The system provides high-throughput screening for large populations It enables scalable preventative care in Japan's aging society

✅ In October 2025, Sysmex Corporation collaborated with Eisai to promote blood-based amyloid testing The partnership aims to identify patients eligible for "Leqembi" therapy It streamlines the patient journey in Japanese memory clinics

✅ In September 2025, A Japanese research institute identified a salivary biomarker for stress The non-invasive test allows for easy monitoring of occupational stress It addresses mental health management in the Japanese workplace

Central Nervous System Biomarkers Market: Drivers
The CNS biomarkers market is expanding due to rising neurological disease prevalence. Demand for early diagnosis and monitoring drives adoption. Technological advancements improve detection accuracy. Expansion of neuroscience research supports growth. Pharmaceutical R&D investments accelerate biomarker development. Regulatory approvals strengthen market confidence.

Market growth is reinforced by use in drug development and clinical trials. Emerging markets invest in neurological care. AI integration enhances data interpretation. Partnerships between biotech firms and research institutions drive innovation. Focus on precision medicine boosts adoption. CNS biomarkers are critical for neurological healthcare.

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Central Nervous System Biomarkers Market: Major Players
Quanterix, Alamar Biosciences, Inc., Thermo Fisher Scientific Inc., F. Hoffmann-La Roche Ltd, Siemens Healthineers AG and Sysmex Corporation, among others.

Segment Covered in the Central Nervous System Biomarkers Market:
By Type
The market is segmented into kits 35%, assays 30%, reagents 25%, and others 10%. Kits dominate due to ready-to-use solutions for biomarker detection, offering standardization, reliability, and time efficiency. Assays are widely adopted in research and clinical diagnostics for high-throughput and sensitive detection. Reagents are essential for laboratory workflows, supporting custom assays and experimental flexibility.

By Application
Applications include drug discovery & development 35%, disease risk assessment 25%, diagnostics 30%, and others 10%. Drug discovery and development dominate due to the growing focus on CNS-targeted therapeutics and biomarker-guided clinical trials. Diagnostics and risk assessment are expanding with increasing prevalence of neurodegenerative and neurological disorders worldwide.

By Disease
Disease segmentation comprises Alzheimer's disease 35%, Parkinson's disease 25%, multiple sclerosis 15%, traumatic brain injury 10%, and others 15%. Alzheimer's disease dominates due to high prevalence, extensive research funding, and the need for early diagnostic and therapeutic biomarkers. Parkinson's disease and multiple sclerosis are growing areas for biomarker development and clinical monitoring.

By End-User
End-users include diagnostic labs 40%, hospitals 25%, research centers 20%, clinics 10%, and others 5%. Diagnostic labs dominate due to high throughput testing capabilities, regulatory compliance, and adoption of standardized biomarker panels. Hospitals and research centers are growing adopters for clinical trials, patient monitoring, and translational research.

Regional Analysis
North America - 35% Share
North America leads with 35% share driven by high R&D investment in CNS disorders, presence of leading biotech and pharmaceutical companies, and advanced clinical and research infrastructure in the U.S. and Canada.

Europe - 25% Share
Europe accounts for 25% share supported by government-funded CNS research initiatives, growing prevalence of neurodegenerative diseases, and established healthcare and diagnostic infrastructure in Germany, the UK, and France.

Asia Pacific - 25% Share
Asia Pacific holds 25% share with rising awareness of CNS diseases, expanding research and diagnostic facilities, and increasing healthcare expenditure in China, India, Japan, and South Korea.

Latin America - 8% Share
Latin America represents 8% share driven by adoption of biomarker testing in clinical diagnostics and research centers in Brazil, Mexico, and Argentina.

Middle East & Africa - 7% Share
Middle East & Africa accounts for 7% share, supported by growing investments in healthcare infrastructure, research initiatives, and increasing focus on neurodegenerative disease management in UAE, Saudi Arabia, and South Africa.

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