Neurological Biomarkers Market – Global Industry Size, Share, Trends, Opportunity, & Forecast, Segmented By Type (Imaging, Proteomic, Genomic, Metabolomic, Others), By Application (Multiple Sclerosis, Alzheimer's Disease, Autism Spectrum Disorder, Parkinson's Disease, Others), By End-User (Research Organizations, Hospital & Hospital Laboratories, Independent Clinical Diagnostic Centers, Others), By Region & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 8.81 Billion
CAGR (2026-2031)	8.18%
Fastest Growing Segment	Imaging
Largest Market	North America
Market Size (2031)	USD 14.12 Billion

Market Overview

The Global Neurological Biomarkers Market will grow from USD 8.81 Billion in 2025 to USD 14.12 Billion by 2031 at a 8.18% CAGR. Neurological biomarkers are biological molecules or imaging indicators found in bodily fluids or tissues that facilitate the diagnosis, monitoring, and prognostic assessment of nervous system disorders. The primary drivers fueling market expansion include the rapidly aging global population and the concurrent rise in the prevalence of neurodegenerative conditions which necessitate effective and noninvasive diagnostic tools. This escalating disease burden creates an urgent need for early intervention strategies and precise patient stratification. According to the Alzheimer's Association, in 2025, an estimated 7.2 million Americans aged 65 and older were living with Alzheimer’s dementia. This substantial patient pool underscores the critical demand for reliable biomarkers to support clinical decision making and therapeutic development.

Despite the robust demand, the market faces a significant impediment regarding the high cost and complexity associated with biomarker development and validation. The physiological barriers protecting the central nervous system often complicate the identification of stable peripheral indicators, leading to prolonged research timelines and stringent regulatory requirements. These financial and technical hurdles can deter investment and delay the commercialization of novel diagnostic assays, thereby restraining the overall pace of market expansion.

Key Market Drivers

Technological advancements in genomics and proteomics are revolutionizing the Global Neurological Biomarkers Market, particularly through the validation of highly sensitive blood-based biomarkers. These non-invasive alternatives to traditional cerebrospinal fluid analysis and PET imaging are rapidly removing barriers to early diagnosis and patient screening. For instance, according to Quest Diagnostics, October 2025, in a study published in 'Neurology Clinical Practice', their novel blood-based test panel for Alzheimer's disease achieved both 91% sensitivity and 91% specificity in identifying amyloid pathology in symptomatic patients. This level of diagnostic precision allows for scalable, accessible testing that can be deployed widely in clinical settings, significantly expanding the addressable market. The operational efficiency of these advancements is further accelerating adoption; according to Quest Diagnostics, in 2025, 94% of physicians surveyed stated that such blood tests would be more cost-effective for the healthcare system compared to invasive detection methods like lumbar punctures.

A substantial surge in public and private funding for neuroscience research serves as the second pivotal driver, providing the necessary capital to navigate the complex pathway from biomarker discovery to commercialization. Developing stable indicators for nervous system disorders requires extensive resources to overcome physiological barriers like the blood-brain barrier and to meet stringent regulatory standards. According to The Transmitter, November 2025, in the 'Establishing a baseline: Trends in NIH neuroscience funding from 2008 to 2024' report, the total amount awarded by the National Institutes of Health for neuroscience-related projects reached $10.5 billion in 2024, more than doubling the funding levels seen in 2008. This sustained financial injection is critical for sustaining robust clinical pipelines, enabling research institutions and diagnostic companies to validate novel targets that drive the long-term expansion of the neurological biomarkers sector.

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Key Market Challenges

The substantial capital requirements and technical intricacies associated with biomarker validation act as a primary restraint on the Global Neurological Biomarkers Market. Identifying stable peripheral indicators is complicated by physiological barriers, necessitating lengthy and capital-intensive clinical studies to meet stringent regulatory standards. These elevated development costs create a high barrier to entry and significantly increase the financial risk for diagnostic companies, often leading to a cautious approach toward new product initiatives. Consequently, the commercialization of novel assays is frequently delayed or abandoned, which directly stifles revenue generation and limits the availability of advanced diagnostic tools. This stagnation in development capability is particularly critical given the escalating economic burden of neurodegenerative conditions that these biomarkers aim to mitigate. According to the Alzheimer's Association, in 2025, the total cost for caring for people with Alzheimer’s and other dementias is projected to reach $384 billion. While this substantial figure highlights the immense market need for efficient early detection tools, the prohibitive financial and technical obstacles in creating them prevent the industry from effectively scaling to meet this urgent requirement, thereby dampening overall market growth.

Key Market Trends

The proliferation of digital biomarkers via wearable technologies and sensors is fundamentally reshaping the Global Neurological Biomarkers Market by enabling continuous, real-world patient monitoring. Unlike episodic clinical assessments which often fail to capture the fluctuation of symptoms in neurodegenerative disorders, sensor-based platforms offer objective, longitudinal data streams that enhance disease management and clinical trial efficiency. This trend is driving the adoption of precision neurology solutions that integrate passive monitoring with care management workflows, significantly improving patient outcomes. For instance, according to Rune Labs, March 2025, in a press release regarding the launch of their StrivePD Guardian platform, the technology demonstrated a 50% reduction in emergency room visits for Parkinson’s disease patients by facilitating proactive symptom management. Such quantifiable clinical utility is accelerating the commercial uptake of digital biomarkers, positioning them as essential tools for both therapeutic development and value-based care models.

Simultaneously, the expansion of companion diagnostics for neurodegenerative therapies is creating a new paradigm in market growth, driven by the approval of disease-modifying treatments that require precise patient identification. As pharmaceutical companies introduce novel therapies targeting specific pathologies like amyloid-beta and tau, the demand for accessible, regulatory-cleared screening tools in primary care settings is surging. This shift moves high-complexity testing from specialized centers to broader community practice, ensuring that eligible patients are rapidly identified for treatment. According to Roche, October 2025, in a press release, the FDA cleared the company’s Elecsys pTau181 assay, becoming the first blood-based biomarker test indicated for use in primary care to aid in ruling out Alzheimer’s pathology in symptomatic patients. This regulatory milestone underscores the critical role of companion diagnostics in operationalizing new neurological drugs and expanding the addressable patient population.

Segmental Insights

The Imaging segment is recognized as the fastest-growing category in the Global Neurological Biomarkers Market due to an increasing preference for non-invasive diagnostics. This trend is accelerated by the ability of MRI and PET technologies to provide precise visual evidence of neurological conditions such as Alzheimer’s disease. Furthermore, the US Food and Drug Administration has approved specific radiopharmaceuticals that function as reliable biomarkers, validating their clinical utility. These regulatory milestones facilitate earlier detection of neurodegenerative pathologies and enable pharmaceutical companies to accurately monitor disease progression and therapeutic efficacy during complex clinical trials.

Regional Insights

North America holds the leading position in the Global Neurological Biomarkers Market, driven by extensive research initiatives and a well-established healthcare infrastructure. The dominance of this region is largely attributed to substantial funding for neurological studies from institutions like the National Institutes of Health. Additionally, the presence of major industry players accelerates the development of diagnostic solutions. Supportive regulatory environments, particularly those maintained by the U.S. Food and Drug Administration, facilitate the approval and commercialization of new biomarker technologies. This combination of investment and regulatory support ensures the continued expansion of the regional market.

Recent Developments

• In May 2025, Fujirebio Diagnostics received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Lumipulse G pTau 217/beta-Amyloid 1-42 Plasma Ratio in-vitro diagnostic test. This clearance represented the first FDA-authorized blood-based diagnostic test intended to aid in the assessment of amyloid pathology in patients being evaluated for Alzheimer's disease. The assay runs on the fully automated LUMIPULSE G1200 instrument system and measures the specific ratio of phosphorylated tau 217 to beta-amyloid 1-42. This approval provided healthcare professionals with a minimally invasive and accessible tool to support the diagnosis of neurodegenerative conditions in patients with cognitive impairment.
• In September 2024, Quanterix Corporation announced the commercial launch of its Simoa p-Tau 217 Planar Kit, significantly expanding its portfolio of blood-based biomarkers for Alzheimer's disease. The new research-use-only test kit utilized proprietary antibody technology licensed from Eli Lilly and Company and was optimized for the company’s SP-X platform. This release aimed to provide researchers and pharmaceutical developers with broad access to high-sensitivity p-Tau 217 testing, a critical biomarker for assessing amyloid status. The launch highlighted the company's strategy to support scientific discovery and the development of non-invasive diagnostic solutions for early detection and monitoring of neurological disorders.
• In July 2024, Biogen Inc., Beckman Coulter, and Fujirebio announced a strategic collaboration to develop and validate novel blood-based biomarkers for tau pathology in Alzheimer's disease. The joint effort focused on creating advanced diagnostic tools capable of measuring brain tau burden to better stratify patients for clinical trials and monitor treatment efficacy. By integrating Biogen’s drug development insights with the diagnostic platforms of Beckman Coulter and Fujirebio, the alliance aimed to accelerate the availability of tau-specific assays. This cooperation was intended to support the commercialization of next-generation therapies and enhance the precision of neurodegenerative disease management in clinical practice.
• In June 2024, ALZpath, Inc. finalized a strategic licensing agreement with Roche to integrate its proprietary pTau217 antibody into a blood-based diagnostic test on the Roche Elecsys platform. This collaboration aimed to develop and commercialize a widely accessible, high-performance immunoassay for the detection of Alzheimer's disease biomarkers in blood plasma. By leveraging Roche’s extensive global network of diagnostic instruments, the partnership sought to facilitate early diagnosis and improve patient management. The initiative focused on providing a scalable and accurate alternative to invasive testing methods, thereby supporting the identification of patients eligible for emerging disease-modifying therapies.

Key Market Players

• PERKINELMER INC.
• Abbott Laboratories Inc
• Thermo Fisher Scientific, Inc.
• Banyan Biomarkers, Inc.
• Bio-Rad Laboratories, Inc.
• F. HOFFMANN-LA ROCHE LTD.
• Merck & Co., Inc.
• DiaGenic ASA
• Johnson & Johnson Services, Inc.
• Myriad Genetics, Inc.

By Type	By Application	By End-User	By Region
Imaging Proteomic Genomic Metabolomic Others	Multiple Sclerosis Alzheimer's Disease Autism Spectrum Disorder Parkinson's Disease Others	Research Organizations Hospital & Hospital Laboratories Independent Clinical Diagnostic Centers Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Neurological Biomarkers Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Neurological Biomarkers Market, By Type:

• Imaging
• Proteomic
• Genomic
• Metabolomic
• Others

• Neurological Biomarkers Market, By Application:

• Multiple Sclerosis
• Alzheimer's Disease
• Autism Spectrum Disorder
• Parkinson's Disease
• Others

• Neurological Biomarkers Market, By End-User:

• Research Organizations
• Hospital & Hospital Laboratories
• Independent Clinical Diagnostic Centers
• Others

• Neurological Biomarkers Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE