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, 2020-2030F

Market Overview

Global Neurological Biomarkers Market was valued at USD 8.70 Billion in 2024 and is anticipated to project impressive growth in the forecast period with a CAGR of 8.10% through 2030. The Global Neurological Biomarkers Market is a dynamic and rapidly evolving sector within the broader field of healthcare and life sciences. Neurological biomarkers are crucial tools that enable the diagnosis, monitoring, and research of neurological disorders and conditions affecting the central and peripheral nervous systems. This market has witnessed substantial growth in recent years, driven by various factors that underscore its importance in modern medicine and research. The Global Neurological Biomarkers Market has experienced robust growth and is expected to continue expanding in the coming years. The market size has been influenced by several factors, including the increasing prevalence of neurological disorders, advancements in biomarker discovery and validation techniques, and a growing aging population. As neurological conditions become more prevalent, the demand for accurate and early diagnostic tools has surged, driving market growth.

Key Market Drivers

Rising Prevalence of Neurological Disorders

The Global Neurological Biomarkers Market is significantly influenced by the increasing prevalence of neurological disorders worldwide. As the incidence of conditions such as Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, epilepsy, stroke, and traumatic brain injuries continues to rise, there is a growing demand for advanced diagnostic tools, early disease detection methods, and precision treatment approaches. Neurological biomarkers play a crucial role in addressing these needs, driving market expansion. Neurological disorders are among the leading causes of disability and mortality worldwide. Neurological conditions, the leading cause of global illness and disability, impact more than 1 in 3 individuals worldwide. In 2021, stroke emerged as the most significant contributor to health loss among the top ten neurological disorders. This growing disease burden has heightened the need for early diagnosis and accurate disease monitoring, fueling demand for neurological biomarkers. The aging global population is leading to a surge in neurodegenerative diseases like Alzheimer's. The global dementia population is projected to nearly double every two decades, reaching 78 million by 2030 and 139 million by 2050. A significant portion of this growth will occur in developing economies, where the prevalence of dementia is rising rapidly. Currently, 60% of dementia cases are concentrated in low- and middle-income countries, and this figure is expected to escalate to 71% by 2050, highlighting an urgent need for expanded healthcare infrastructure, diagnostic capabilities, and targeted intervention strategies in these regions. Since biomarkers can help detect Alzheimer’s at pre-symptomatic and early stages, they are increasingly being integrated into diagnostic protocols. In the United States, approximately one million individuals are currently diagnosed with Parkinson’s disease (PD), a figure projected to reach 1.2 million by 2030. As the second-most prevalent neurodegenerative disorder after Alzheimer’s, Parkinson’s presents a growing public health challenge, driving demand for advanced diagnostics, biomarker-based early detection, and innovative treatment solutions. 

Worldwide, one in four adults over 25 is at risk of experiencing a stroke in their lifetime. This year alone, over 12 million people will suffer their first stroke, with 6.5 million fatalities expected as a result. Additionally, more than 100 million individuals globally are living with the long-term effects of a stroke, underscoring the urgent need for enhanced stroke prevention, early detection, and advanced treatment solutions. Neurological biomarkers like glial fibrillary acidic protein (GFAP) and S100B are being widely used for stroke detection and brain injury assessment, further propelling market growth. As more healthcare providers adopt biomarker-based tests for screening, diagnosis, and disease progression tracking, the market continues to expand.

Growing Aging Population

The Global Neurological Biomarkers Market is experiencing significant expansion, largely driven by the growing aging population worldwide. As people live longer, the prevalence of neurodegenerative diseases, cognitive decline, and age-related neurological disorders is rising. This demographic shift is fueling demand for early diagnosis, personalized treatments, and precision medicine solutions, where neurological biomarkers play a critical role. The most extensive study to date reveals that neurological disorders impose a far greater global burden than previously estimated, impacting 43% of the world’s population—equivalent to 3.4 billion individuals in 2021. This finding underscores the urgent need for enhanced neurological research, expanded diagnostic capabilities, and targeted treatment strategies to address the growing prevalence of these conditions. Aging is one of the strongest risk factors for neurological disorders, with conditions such as Alzheimer’s disease, Parkinson’s disease, stroke, dementia, and other neurodegenerative diseases becoming more prevalent among elderly individuals. 

Data from the National Institute on Aging indicates that the risk of developing Alzheimer’s disease doubles every five years after the age of 65. The prevalence escalates significantly beyond age 80, driving increased demand for early diagnostic biomarkers, advanced therapeutic interventions, and long-term cognitive care solutions. Biomarkers such as amyloid-beta (Aβ), tau proteins, and neurofilament light chains (NfL) are increasingly being used for early diagnosis and disease progression tracking. Parkinson’s primarily affects individuals over 60 years old, with cases projected to double by 2040 due to rising life expectancy. Biomarkers such as α-synuclein and dopamine-related markers are essential for diagnosing and managing the disease. Stroke remains one of the leading causes of disability and death among the elderly. Biomarkers such as glial fibrillary acidic protein (GFAP) and S100B are critical for identifying stroke severity, guiding treatment, and predicting recovery outcomes. As the aging population continues to grow, so does the demand for early-stage neurological diagnostic tools, driving the expansion of the neurological biomarkers market. With rising life expectancy, there is an increasing focus on preventative healthcare, early intervention, and proactive disease management. Early detection of neurological disorders allows for better treatment outcomes, reduced healthcare costs, and improved quality of life. Biomarkers enable pre-symptomatic detection, which is critical for conditions like Alzheimer’s, where early intervention can slow disease progression. As part of aging healthcare programs, biomarker-based blood tests, imaging, and cerebrospinal fluid (CSF) analysis are being integrated into routine medical checkups. Governments and healthcare providers are expanding screening programs to detect neurological disorders before they become symptomatic, increasing biomarker adoption. The growing emphasis on early detection and preventative medicine is boosting the neurological biomarkers market as healthcare systems prioritize aging populations.

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Key Market Challenges

Complexity of Neurological Disorders

The complexity of neurological disorders is a fundamental challenge in the development and adoption of neurological biomarkers. Neurological conditions encompass a wide spectrum of diseases, each with its unique characteristics and pathophysiology. Conditions like Alzheimer's disease, Parkinson's disease, and multiple sclerosis exhibit considerable heterogeneity among patients.

Neurological disorders often involve intricate and multifaceted disease mechanisms, making it challenging to identify universal biomarkers that are applicable across all patients. This complexity necessitates the discovery and validation of a diverse set of biomarkers, which can be time-consuming and resource intensive. The concept of precision medicine, which tailor’s treatments to individual patients based on their unique biomarker profiles, further complicates biomarker development. Customized biomarker panels may be needed for each patient, increasing the need for personalized medicine approaches.

Regulatory Hurdles and Validation

Another significant challenge for the Global Neurological Biomarkers Market is navigating the regulatory landscape for biomarker approval. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have stringent requirements for biomarker validation and approval.

Regulatory bodies demand rigorous validation studies to demonstrate the accuracy, specificity, and clinical utility of neurological biomarkers. Meeting these requirements often requires substantial financial investments and extensive clinical trials. Long Approval Timelines: The process of obtaining regulatory approvals can be time-consuming and unpredictable. Delays in approval can hinder the market entry of biomarkers, limiting their accessibility to patients and healthcare providers.

Data Privacy and Security Concerns

In an era of growing data privacy concerns and cybersecurity threats, the collection, storage, and sharing of sensitive patient data for biomarker research and diagnostics pose significant challenges.

Biomarker research often involves the collection of extensive patient data, including genetic information, medical history, and imaging data. Ensuring the privacy and security of this data is essential to comply with regulatory requirements and maintain patient trust. Collaboration among researchers and organizations is critical for biomarker development. However, sharing data securely while protecting patient privacy can be complex. Finding a balance between data sharing and privacy protection is an ongoing challenge.

Key Market Trends

Rise of Personalized Medicine

One of the prominent trends in the Global Neurological Biomarkers Market is the shift towards personalized medicine. Personalized medicine involves tailoring medical treatment to individual patients based on their unique genetic, biomarker, and clinical profiles. This trend is driven by several key factors:

The sequencing of the human genome and the development of high-throughput genomics technologies have enabled the identification of genetic variations associated with neurological disorders. These genetic biomarkers can be used to predict disease risk and guide personalized treatment plans. Biomarker panels that incorporate genetic, proteomic, and imaging data are being developed to provide more precise diagnoses. These panels allow healthcare providers to differentiate between various subtypes of neurological disorders and customize treatment strategies accordingly.

Personalized medicine allows for the selection of treatments that are most likely to be effective for an individual patient, reducing the risk of adverse effects and optimizing therapeutic outcomes.

Technological Advancements in Biomarker Discovery

Technological advancements are driving rapid progress in biomarker discovery for neurological disorders. The integration of cutting-edge technologies into biomarker research and development is a key trend in the market:

High-resolution imaging modalities, such as functional magnetic resonance imaging (fMRI) and positron emission tomography (PET), enable the visualization of brain structures and functions with unprecedented clarity. This aids in the identification of structural and functional biomarkers for neurological conditions. Genomics, proteomics, and metabolomics are being employed to identify molecular biomarkers associated with neurological disorders. These technologies allow for the comprehensive profiling of biological molecules and pathways, leading to the discovery of novel biomarkers.

AI and machine learning algorithms are increasingly utilized to analyze complex datasets and identify patterns and correlations that may not be apparent to human researchers. AI-driven biomarker discovery accelerates the identification of diagnostic and prognostic biomarkers.

Growing Emphasis on Early Detection and Prevention

There is a growing emphasis on early detection and prevention in the field of neurological biomarkers. Detecting neurological disorders at an early stage can significantly impact patient outcomes, and this trend is supported by several factors:

Healthcare systems are increasingly focused on preventive measures to reduce the burden of neurological disorders. Biomarkers that can detect preclinical disease stages or risk factors are instrumental in preventive healthcare strategies.

Biomarkers are being developed not only for disease diagnosis but also for screening individuals at risk and monitoring disease progression. This facilitates early intervention and personalized care plans. Patient-centric care models prioritize early detection and proactive management of neurological conditions. Biomarkers play a pivotal role in these models by enabling patient-specific risk assessment and tailored interventions.

Segmental Insights

Type Insights

Based on the category of Type, Imaging segment is emerging as the fastest-growing category within the Global Neurological Biomarkers Market, driven by advancements in neuroimaging technologies, rising demand for early disease detection, and the increasing adoption of precision diagnostics. Imaging-based biomarkers are transforming how neurological disorders are diagnosed, monitored, and treated, fueling rapid market expansion. Continuous technological innovations in neuroimaging tools have significantly improved the accuracy, resolution, and efficiency of biomarker-based diagnostics, making imaging a preferred choice for neurological assessments. AI-Driven Imaging Analysis: Artificial intelligence (AI) and machine learning (ML) are transforming imaging-based biomarker analysis, enabling automated detection of disease-specific patterns with greater accuracy. High-Resolution PET & MRI Scanners: Innovations such as 7T MRI scanners and amyloid PET tracers are improving the visualization of brain abnormalities at microscopic levels, facilitating early and precise disease characterization. Hybrid Imaging Modalities: The integration of PET-MRI, PET-CT, and multimodal imaging techniques provides a comprehensive assessment of neurological biomarkers, enhancing diagnostic accuracy. These advancements are boosting the adoption of imaging biomarkers and accelerating the segment’s market growth These factors are expected to drive the growth of this segment.

Application Insight

Based on the category of Application, the Alzheimer's disease segment emerged as the dominant segment in the global market for Neurological Biomarkers in 2024. Alzheimer's disease is one of the most prevalent and devastating neurological disorders worldwide. Its high prevalence among the elderly population, coupled with its substantial societal impact, places Alzheimer's disease at the forefront of neurological biomarker research. As a result, considerable resources and attention are directed towards developing biomarkers for early diagnosis, prognosis, and monitoring of Alzheimer's disease.

Early detection of Alzheimer's disease is crucial for timely intervention and management. Alzheimer's is characterized by a long preclinical phase during which pathological changes occur in the brain before clinical symptoms manifest. Biomarkers that can identify these preclinical stages are essential for initiating interventions that may slow disease progression. Alzheimer's disease is characterized by complex and multifaceted pathophysiological mechanisms, including the accumulation of beta-amyloid plaques and tau tangles in the brain. Biomarkers are indispensable tools for unraveling these complexities and understanding disease progression. They enable researchers to monitor changes in these pathological markers and evaluate the effectiveness of potential treatments. These factors are expected to drive the growth of this segment.

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Regional Insights

North America emerged as the largest market in the global Neurological Biomarkers market in 2024, holding the largest market share in terms of value. North America boasts a highly developed healthcare infrastructure, with state-of-the-art hospitals, research centers, and diagnostic laboratories. This infrastructure facilitates the extensive utilization of neurological biomarkers in clinical practice, research, and drug development. The region is a global leader in neurological research and innovation. Renowned academic institutions, such as Harvard, Johns Hopkins, and the Mayo Clinic, continuously contribute to groundbreaking research in neurology. These institutions drive the development and adoption of neurological biomarkers. North America has a relatively high prevalence of neurological disorders, including Alzheimer's disease, Parkinson's disease, and multiple sclerosis. The rising aging population contributes to the increased incidence of these conditions, creating a strong demand for biomarkers for early diagnosis and management.

Recent Developments

• In February 2024, Quanterix has established its first collaborations with five leading health networks to advance the diagnosis and clinical management of individuals with Alzheimer’s disease. These partnerships aim to integrate ultrasensitive biomarker detection technologies into clinical practice, enabling earlier and more precise identification of Alzheimer’s-related pathology. By working closely with healthcare providers, Quanterix is driving innovation in neurodegenerative disease diagnostics, improving patient care pathways, treatment decisions, and long-term disease management.
• In October 2023, Lucent Diagnostics, the diagnostics brand of Quanterix Corporation, has expanded its LucentAD product line with the launch of LucentAD p-Tau 217, a highly accurate blood test for Alzheimer’s disease. This lab-developed test represents a significant advancement in scalable immunoassay-based biomarker detection, offering enhanced precision in assessing amyloid pathology in individuals experiencing memory-related cognitive concerns. By leveraging p-Tau 217, a critical biomarker linked to Alzheimer’s, this innovation supports earlier and more accessible detection of neurodegenerative changes, improving clinical decision-making and patient outcomes.
• In September 2023, C2N Diagnostics, a leading innovator in brain health diagnostics, is leveraging World Alzheimer’s Day to spotlight the expanding global availability of its PrecivityAD2 blood test. This advanced clinical assay enables healthcare providers to detect amyloid plaques in the brain, a critical biomarker for Alzheimer’s disease. Studies confirm that PrecivityAD2 delivers results comparable to PET scans and cerebrospinal fluid (CSF) tests, which, despite their diagnostic reliability, remain costly, invasive, and less accessible. By offering a scalable, non-invasive alternative, C2N Diagnostics is enhancing early detection and patient access to Alzheimer’s diagnostics worldwide.
• In July 2023, Quanterix Corporation, a leader in ultrasensitive biomarker detection for scientific research and advanced diagnostics, has announced the launch of LucentAD—a cutting-edge test designed to aid in the assessment of patients exhibiting cognitive symptoms associated with early-stage Alzheimer’s disease (AD). This innovation enhances clinical decision-making by providing precise biomarker insights, supporting earlier and more accurate detection of Alzheimer’s-related cognitive decline.

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.

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:

o   Imaging

o   Proteomic

o   Genomic

o   Metabolomic

o   Others

• Neurological Biomarkers Market, By Application:

o   Multiple Sclerosis

o   Alzheimer's Disease

o   Autism Spectrum Disorder

o   Parkinson's Disease

o   Others

• Neurological Biomarkers Market, By End-User:

o   Research Organizations

o   Hospital & Hospital Laboratories

o   Independent Clinical Diagnostic Centers

o   Others

• Neurological Biomarkers Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia-Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Neurological Biomarkers Market.

Available Customizations:

Global Neurological Biomarkers market report with the given market data, Tech Sci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).