Neurological Disorder Diagnostics Market – Global Industry Size, Share, Trends, Opportunity, & Forecast Segmented By Product (Imaging, In Vitro Diagnostics), By Disease Indication (Genetic Neurological Disorders, Immunological Neurological Disorders, Paraneoplastic Syndrome, Paraproteinemic Neuropathies), By End User (Hospitals and Specialty Clinics, Diagnostic Centres, Ambulatory Care Centers), By Region & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 10.91 Billion
CAGR (2026-2031)	8.01%
Fastest Growing Segment	Genetic Neurological Disorders
Largest Market	North America
Market Size (2031)	USD 17.32 Billion

Market Overview

The Global Neurological Disorder Diagnostics Market will grow from USD 10.91 Billion in 2025 to USD 17.32 Billion by 2031 at a 8.01% CAGR. The Global Neurological Disorder Diagnostics Market consists of the medical industry sector dedicated to developing technologies and tests, such as neuroimaging systems and in vitro assays, designed to identify and monitor pathologies affecting the central and peripheral nervous systems. The primary drivers fueling this market include the rapidly aging global population and the concurrent rise in the prevalence of chronic neurodegenerative diseases, which necessitate precise tools for early clinical intervention. This growing disease burden is substantiated by recent statistics. According to the Alzheimer's Association, in 2025, an estimated 7.2 million Americans aged 65 and older are living with Alzheimer's dementia, a figure that underscores the urgent and escalating demand for effective diagnostic capabilities.

Despite the strong clinical need, a significant challenge impeding market expansion is the high cost associated with advanced diagnostic procedures and equipment. The substantial capital required for imaging infrastructure, combined with inadequate reimbursement frameworks in many developing regions, creates a financial barrier that limits accessibility for a large patient demographic. Consequently, these economic constraints restrict the widespread adoption of comprehensive diagnostic solutions in emerging markets and negatively impact the overall growth trajectory of the industry.

Key Market Drivers

The Rising Global Prevalence of Neurological and Neurodegenerative Disorders acts as the primary catalyst for the diagnostics market, creating an urgent imperative for scalable testing. As conditions like stroke and dementia accelerate, healthcare systems must prioritize early identification to mitigate the compounding burden. This demographic shift is highlighted by recent analysis; according to The Lancet Neurology, March 2024, in the 'Global Burden of Disease Study 2021', approximately 3.4 billion individuals globally were living with a neurological condition. This pervasive morbidity translates into immense financial strain, driving the adoption of tools for timely intervention. Underscoring this economic weight, according to the Alzheimer's Association, in 2024, the total cost for caring for people with Alzheimer's and other dementias in the United States was projected to reach $360 billion, reinforcing the need for effective diagnostic capabilities.

Technological Breakthroughs in Neuroimaging and Diagnostic Modalities are simultaneously reshaping the market by enhancing precision and accessibility. Innovations in biomarker profiling now offer non-invasive alternatives to capital-intensive scans, effectively reducing adoption barriers. The integration of high-performance assays is pivotal for accurately ruling out pathologies. For instance, according to Roche, October 2024, in data presented at the 'Clinical Trials in Alzheimer's Disease' congress, the Elecsys Amyloid Plasma Panel demonstrated a negative predictive value of 96.2% in a prospective study. Such advancements streamline patient stratification and encourage market uptake by offering cost-effective solutions that address the infrastructural limitations of traditional neuroimaging.

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Key Market Challenges

The substantial capital required for advanced diagnostic procedures and equipment presents a significant barrier to the growth of the neurological disorder diagnostics market. Healthcare providers often face high acquisition and maintenance costs for essential infrastructure, such as magnetic resonance imaging and computed tomography systems. This financial burden is frequently compounded by inadequate reimbursement structures, particularly in developing regions. These economic factors effectively prevent many medical facilities from purchasing or upgrading to modern diagnostic tools, thereby stalling market penetration and reducing the availability of early detection services for a wide demographic of patients.

The immense economic pressure placed on healthcare systems by neurological conditions further restricts the allocation of funds toward expensive diagnostic testing. According to the Alzheimer's Association, in 2024, the total national cost of caring for individuals with Alzheimer's and other dementias was projected to reach $360 billion. This staggering financial obligation forces budget constraints that often limit coverage for high-cost imaging and assay technologies. Consequently, the high cost of care creates a restrictive environment that hampers the widespread adoption of comprehensive diagnostic solutions and negatively impacts industry expansion.

Key Market Trends

Integration of Artificial Intelligence and Machine Learning for Automated Image Analysis is fundamentally altering the diagnostic landscape by enhancing the speed and accuracy of interpreting complex neuroimaging data. These algorithms assist radiologists by automating the segmentation of pathological findings, such as white matter lesions or amyloid burden, thereby addressing the critical issue of clinician burnout and reducing diagnostic variability. This trend is rapidly commercializing, as evidenced by the increasing regulatory approval of such software. According to GE HealthCare, July 2025, in the press release 'GE HealthCare drives growth with investment in AI-enabled medical devices', the company reported topping the FDA's list of AI-enabled medical device authorizations with 100 clearances to date, reflecting the massive industry push toward automated diagnostic support systems.

Shift Towards Portable and Point-of-Care Diagnostic Devices is expanding the reach of neurological assessment beyond traditional radiology suites into critical care units and emergency departments. By utilizing low-field magnetic resonance imaging and miniaturized hardware, providers can now perform bedside scans for stroke and brain injury, eliminating the risks associated with transporting unstable patients to central imaging facilities. This adoption is supported by growing clinical validation of these compact systems in acute settings. According to Hyperfine, Inc., December 2024, in the press release 'Hyperfine Announces Extensive Clinical Study Coverage at RSNA 2024', a featured study from Washington University School of Medicine presented data from over 350 exams using the portable Swoop system, demonstrating its increasing utility in routine neurocritical care workflows.

Segmental Insights

The Genetic Neurological Disorders segment is currently recognized as the fastest-growing category within the Global Neurological Disorder Diagnostics Market. This rapid expansion is primarily driven by significant breakthroughs in genomic analysis, particularly next-generation sequencing, which have improved the accuracy and accessibility of genetic testing. The shift toward personalized medicine further accelerates this growth, as clinicians increasingly rely on specific genetic markers to tailor treatments for hereditary conditions like Alzheimer’s and Parkinson’s disease. Additionally, regulatory bodies such as the U.S. Food and Drug Administration (FDA) have supported this trend by streamlining approvals for companion diagnostics, enabling earlier detection and more effective patient management strategies.

Regional Insights

North America maintains a leading position in the global neurological disorder diagnostics market due to the rising prevalence of chronic conditions such as Alzheimer’s disease and Parkinson’s disease. The region benefits from a well-established healthcare infrastructure and significant funding for medical research. Additionally, consistent product approvals by the U.S. Food and Drug Administration (FDA) facilitate the timely availability of diagnostic technologies. High healthcare expenditure and favorable reimbursement policies further support market expansion by ensuring broader patient access to testing services. This combination of regulatory support and clinical demand secures the region's market dominance.

Recent Developments

• In October 2024, Roche presented late-breaking data regarding its Elecsys Amyloid Plasma Panel at the Clinical Trials on Alzheimer's Disease (CTAD) conference. The research highlighted the diagnostic performance of the blood-based test, which measures phosphorylated Tau 181 and Apolipoprotein E4 to rule out amyloid pathology in patients with cognitive impairment. The study demonstrated that the assay could effectively identify patients who were unlikely to have Alzheimer's disease, potentially reducing the need for invasive confirmatory testing like PET scans or cerebrospinal fluid analysis. This development underscored the company's progress in delivering accessible tools for early Alzheimer's diagnosis.
• In April 2024, Abbott received U.S. FDA clearance for its i-STAT TBI cartridge to be used with whole blood samples, marking a significant advancement in the Global Neurological Disorder Diagnostics Market. This point-of-care test aids in the rapid assessment of patients with suspected mild traumatic brain injuries, including concussions, directly at the bedside. By eliminating the need to separate plasma or serum, the test streamlines the diagnostic process and provides lab-quality results within 15 minutes. This development is expected to improve triage efficiency in emergency departments and urgent care clinics by quickly ruling out the need for CT scans in negative cases.
• In April 2024, Labcorp announced the nationwide commercial availability of a new blood-based test for glial fibrillary acidic protein (GFAP), a key biomarker for neurodegenerative diseases and neurological injuries. This diagnostic tool utilizes sensitive immunoassay technology to detect GFAP levels from a standard blood draw, aiding physicians in the assessment of conditions such as Alzheimer’s disease, multiple sclerosis, glioblastoma, and traumatic brain injury. The launch expanded the company's neurology portfolio, offering a less invasive and more accessible alternative to traditional methods for evaluating the presence and progression of neurological damage in patients.
• In March 2024, Beckman Coulter Diagnostics and Fujirebio entered into an expanded partnership to develop and commercialize new blood-based assays for neurodegenerative diseases. The collaboration focused on creating diagnostic tests for recently identified biomarkers, specifically a pTau217 plasma assay and a Beta Amyloid 1-42 plasma assay, adapted for use on Beckman Coulter's high-throughput immunoassay analyzers. This strategic alliance aimed to increase global access to critical neurological diagnostics, supporting the clinical adoption of emerging Alzheimer's disease therapies by providing scalable and accurate testing solutions for laboratories and healthcare providers.

Key Market Players

• Siemens Healthineers AG
• Koninklijke Philips N.V.
• Esaote SPA
• NeuroLogica Corp.
• Masimo Corp
• Neusoft Corporation
• CANON MEDICAL SYSTEMS CORPORATION
• Abbott Laboratories Inc

By Product	By Disease Indication	By End User	By Region
Imaging In Vitro Diagnostics	Genetic Neurological Disorders Immunological Neurological Disorders Paraneoplastic Syndrome Paraproteinemic Neuropathies	Hospitals and Specialty Clinics Diagnostic Centres Ambulatory Care Centers	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

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

• Neurological Disorder Diagnostics Market, By Product:

• Imaging
• In Vitro Diagnostics

• Neurological Disorder Diagnostics Market, By Disease Indication:

• Genetic Neurological Disorders
• Immunological Neurological Disorders
• Paraneoplastic Syndrome
• Paraproteinemic Neuropathies

• Neurological Disorder Diagnostics Market, By End User:

• Hospitals and Specialty Clinics
• Diagnostic Centres
• Ambulatory Care Centers

• Neurological Disorder Diagnostics 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