Neuro-autoimmune Disease Diagnostics Market
By Diagnostics Test;
Antinuclear Antibodies (ANA) Test, Autoantibodies Test, Blood Test: Immunoglobulin A (IgA) Test, C-Reactive Protein (CRP) Test, Complement Test, ESR (erythrocyte sedimentation rate) Test, and Protein Electrophoresis Test Or Immunofixation Electrophoresis TestBy End User;
Hospitals, Neurological Diagnostics Test Centers, and OthersBy Geography;
North America, Europe, Asia Pacific, Middle East & Africa, and Latin America - Report Timeline (2021 - 2031)Neuro-Auto-Immune Disease Diagnostics Market Overview
Neuro-Auto-Immune Disease Diagnostics Market (USD Million)
Neuro-Auto-Immune Disease Diagnostics Market was valued at USD 1,824.79 million in the year 2024. The size of this market is expected to increase to USD 3,017.17 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 7.4%.
Neuro-autoimmune Disease Diagnostics Market
*Market size in USD million
CAGR 7.4 %
Study Period | 2025 - 2031 |
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Base Year | 2024 |
CAGR (%) | 7.4 % |
Market Size (2024) | USD 1,824.79 Million |
Market Size (2031) | USD 3,017.17 Million |
Market Concentration | Medium |
Report Pages | 344 |
Major Players
- Bio-Rad Laboratories, Inc
- Crescendo Bioscience
- Roche Diagnostics
- Quest Diagnostics
- Abbott Diagnostics
- Beckman Coulter, Inc
- SQI Diagnostic and Euroimmun
Market Concentration
Consolidated - Market dominated by 1 - 5 major players
Neuro-autoimmune Disease Diagnostics Market
Fragmented - Highly competitive market without dominant players
The Neuro‑Autoimmune Disease Diagnostics Market is expanding rapidly as disorders such as multiple sclerosis and neuromyelitis optica become more frequently identified. Diagnostic utilization has surged by over 41% in neurology and immunology labs due to enhanced detection needs. Diagnostic firms are establishing clear strategies to distribute assay kits and platforms across hospitals and specialty clinics. Strong collaboration between diagnostics innovators and clinical centers is supporting sustained market expansion.
Strategic Partnerships Driving Product Launches
Over 38% of new diagnostic offerings are being introduced through strategic collaborations among biotech firms, assay manufacturers, and academic research programs. These alliances streamline validation and regulatory readiness. Mergers and joint ventures help broaden distribution networks and reinforce product reliability. This collaborative approach underpins continual market growth.
Wider Integration Across Lab and Clinical Settings
Adoption of neuro‑autoimmune diagnostic tools has risen by more than 43% in hospital labs, clinical trial facilities, and neurologic clinics. Providers now integrate these diagnostics into protocols for screening, monitoring, and treatment response assessment. Companies support this through growth strategies including bundled panels, operator training, and service contracts. Partnerships with clinical networks support better access and scalable expansion.
Future Outlook Defined by Smart, Multiplex Platforms
More than 45% of upcoming diagnostic platforms deliver multiplex biomarker detection, automated analysis, and connectivity with clinical digital systems—defining the market’s future outlook. These solutions enable personalized neuro‑immunological diagnostics and real‑time monitoring. Continued innovation, combined with multidisciplinary collaboration, is shaping next‑gen diagnostics and long‑term market expansion.
Neuro-Auto-Immune Disease Diagnostics Market Recent Developments
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According to reports from the International Diabetes Federation (2021), over 1.2 million children and adolescents under 19 are affected by Type 1 diabetes, with the prevalence steadily rising. The American Diabetes Association (2019) also reported that over 1.9 million Americans suffer from this condition. The increasing rates of Type 1 diabetes are linked to significant health consequences, comorbidities, and rising mortality rates.
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In May 2022, Thermo Fisher Scientific announced the availability of the Phadia 2500+ Instrument in the U.S. for autoimmune testing. This device aids in the diagnosis of autoimmune diseases including celiac disease, rheumatoid arthritis, autoimmune liver disease and autoimmune thyroid disease among others. This strategic launch helped the company gain business revenue along with an enhanced customer base.
Neuro-Auto-Immune Disease Diagnostics Market Segment Analysis
In this report, the Neuro-Auto-Immune Disease Diagnostics Market has been segmented by Diagnostics Test, End User and Geography.
Neuro-Auto-Immune Disease Diagnostics Market, Segmentation by Diagnostics Test
The Neuro-Auto-Immune Disease Diagnostics Market has been segmented by Diagnostics Test into Antinuclear Antibodies (ANA) Test, Autoantibodies Test, Blood Test: Immunoglobulin A (IgA) Test, C-Reactive Protein (CRP) Test, Complement Test, ESR (erythrocyte sedimentation rate) Test and Protein Electrophoresis Test Or Immunofixation Electrophoresis Test.
Antinuclear Antibodies (ANA) Test
The Antinuclear Antibodies (ANA) Test is essential in detecting autoimmune conditions that affect the nervous system. It identifies autoantibodies targeting cell nuclei and returns positive in approximately 35% of neuro-autoimmune cases. This test plays a vital role in diagnosing systemic lupus and related disorders.
Autoantibodies Test
Autoantibodies Tests help identify disease-specific antibodies associated with neuro-autoimmune diseases such as multiple sclerosis and autoimmune encephalitis. With a 42% positivity rate, they offer valuable insights for accurate diagnosis and personalized treatment.
Blood Test: Immunoglobulin A (IgA) Test
The IgA Test measures levels of Immunoglobulin A to detect immune system irregularities, especially in mucosal immunity. Roughly 28% of neuro-autoimmune patients show abnormal IgA values, assisting in differentiating systemic from localized immune dysfunctions.
C-Reactive Protein (CRP) Test
The CRP Test is a marker for inflammation and is commonly elevated during active autoimmune responses. Around 46% of patients with neuro-autoimmune disorders exhibit raised CRP levels, making it an effective tool for monitoring inflammatory status.
Complement Test
Complement Tests evaluate components of the immune system that play a key role in inflammation and defense. Abnormalities are observed in 30–40% of patients, supporting diagnosis of diseases like lupus cerebritis and Guillain-Barré syndrome.
ESR (Erythrocyte Sedimentation Rate) Test
The ESR Test measures how quickly red blood cells settle at the bottom of a test tube, a marker of systemic inflammation. Elevated ESR values are found in nearly 50% of neuro-autoimmune cases, making it a standard part of diagnostic protocols.
Protein Electrophoresis Test or Immunofixation Electrophoresis TestThese tests detect abnormal protein patterns in the blood or spinal fluid, helping diagnose neurological autoimmune conditions. Around 33% of patients show irregular results, indicating diseases such as multiple myeloma and inflammatory neuropathies.
Neuro-Auto-Immune Disease Diagnostics Market, Segmentation by End User
The Neuro-Auto-Immune Disease Diagnostics Market has been segmented by End User into Hospitals, Neurological Diagnostics Test Centers and Others.
Hospitals
Hospitals lead the neuro-auto-immune disease diagnostics market with an estimated 55% share. Their comprehensive infrastructure, multidisciplinary medical teams and access to advanced diagnostic equipment make them the primary choice for autoimmune neurological testing. Hospitals also facilitate immediate treatment decisions based on test outcomes.
Neurological Diagnostics Test Centers
Neurological Diagnostics Test Centers hold a 30% market share and are preferred for their specialized capabilities in detecting complex neuro-autoimmune disorders. These centers offer advanced imaging, autoantibody panels and faster result delivery. Their precision-focused approach attracts both patients and referring physicians.
Others
The Others segment comprises outpatient clinics, academic labs and emerging home-based diagnostic solutions, contributing about 15% to the market. This segment is growing due to rising demand for affordable and accessible diagnostic services. It plays a crucial role in reaching patients in remote and non-urban areas.
Neuro-Auto-Immune Disease Diagnostics Market, Segmentation by Geography
In this report, the Neuro-Auto-Immune Disease Diagnostics Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East & Africa and Latin America.
Regions and Countries Analyzed in this Report
Global Neuro-Auto-Immune Disease Diagnostics Market Share (%), by Geographical Region
North America
North America leads the neuro-auto-immune disease diagnostics market, holding around 38% of the global share. This is driven by the presence of advanced healthcare infrastructure, high disease awareness and strong R&D investments. The United States contributes significantly due to its early adoption of innovative diagnostic technologies.
Europe
Europe accounts for approximately 27% of the global market, supported by public healthcare systems, growing emphasis on early disease detection and strong government backing for autoimmune disease research. Key contributors include Germany, France and the United Kingdom.
Asia Pacific
Asia Pacific represents about 20% of the market and is the fastest-growing region. Rapid expansion is attributed to increasing healthcare access, rising autoimmune disease prevalence and growing diagnostic awareness. India and China are key players, backed by large populations and government health initiatives.
Middle East & Africa
Middle East & Africa contribute around 8% to the global market. Growth in this region is fueled by improving diagnostic infrastructure and increased investment in urban healthcare systems, particularly in countries like the UAE, Saudi Arabia and South Africa.
Latin America
Latin America holds a market share of nearly 7%, with major contributions from Brazil and Mexico. While adoption of neuro-auto-immune diagnostics is increasing, the region faces challenges such as regulatory delays and limited access to advanced healthcare facilities in rural areas.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Neuro-Auto-Immune Disease Diagnostics Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Drivers, Restraints and Opportunity Analysis
Drivers :
- Rising prevalence of neuro-autoimmune diseases
- Increased awareness and early diagnosis
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Growing geriatric population - The growth of the global neuro-auto-immune disease diagnostics market is significantly influenced by the increasing geriatric population worldwide. As populations age, there is a higher prevalence of neurodegenerative diseases and autoimmune disorders, which often overlap or exacerbate each other. The elderly are more susceptible to conditions such as multiple sclerosis, Parkinson's disease, Alzheimer's disease, and various autoimmune neuropathies. This demographic shift is driving the demand for advanced diagnostic tools and techniques to accurately diagnose and manage these complex conditions.
As the aging population presents unique diagnostic challenges, including comorbidities and atypical disease presentations, necessitating more precise and comprehensive diagnostic approaches. Healthcare providers are increasingly focusing on early detection and intervention to improve patient outcomes and quality of life. Consequently, there is a growing emphasis on research and development in neuro-auto-immune disease diagnostics, leading to innovations in diagnostic technologies and tests tailored to the needs of the elderly population. This demographic trend underscores the importance of addressing the specific diagnostic requirements of the aging population within the broader context of the global neuro-auto-immune disease diagnostics market.
Restraints :
- High cost of diagnostics
- Lack of specific biomarkers
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Regulatory hurdles - Navigating regulatory hurdles is a significant challenge in the Global Neuro-Auto-Immune Disease Diagnostics Market. Regulatory frameworks vary across different regions, requiring companies to comply with stringent requirements for product approval, manufacturing standards, and marketing authorization. Obtaining regulatory clearance or approval for neuro-auto-immune disease diagnostic products often involves extensive clinical trials, rigorous testing, and documentation to demonstrate safety, efficacy, and quality standards. Additionally, the classification of diagnostic tests and devices by regulatory agencies can impact market entry strategies and timelines. Keeping pace with evolving regulatory landscapes and ensuring compliance with changing requirements pose ongoing challenges for companies operating in this market. Consequently, effective regulatory strategies, proactive engagement with regulatory authorities, and meticulous adherence to compliance standards are imperative for navigating regulatory hurdles and facilitating market access for neuro-auto-immune disease diagnostics.
Opportunities :
- Development of point-of-care diagnostics
- Personalized medicine
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Increased focus on minimally invasive techniques - The Global Neuro-Auto-Immune Disease Diagnostics Market has witnessed a significant trend towards the adoption of minimally invasive techniques. This shift reflects a growing preference among patients and healthcare providers for diagnostic methods that minimize patient discomfort, reduce recovery times, and offer greater precision in diagnosis. Minimally invasive techniques in neuro-auto-immune disease diagnostics often involve procedures such as blood tests, cerebrospinal fluid analysis, and advanced imaging modalities like magnetic resonance imaging (MRI) and positron emission tomography (PET) scans.
These techniques not only aid in the early detection and accurate diagnosis of neuro-auto-immune diseases but also contribute to improving patient outcomes by enabling prompt initiation of treatment. Moreover, the rise in minimally invasive diagnostics aligns with broader healthcare trends emphasizing value-based care and cost-effectiveness, as these methods typically require fewer resources and hospital stays compared to traditional diagnostic approaches. As a result, there's a growing emphasis on the development and adoption of innovative minimally invasive diagnostic technologies within the neuro-auto-immune disease diagnostics market, driving advancements in both clinical practice and patient care.
Competitive Landscape Analysis
Key players in Global Neuro-Auto-Immune Disease Diagnostics Market include,
- Bio-Rad Laboratories, Inc
- Crescendo Bioscience
- Roche Diagnostics
- Quest Diagnostics
- Abbott Diagnostics
- Beckman Coulter, Inc
- SQI Diagnostic and Euroimmun
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Diagnostics Test
- Market Snapshot, By End User
- Market Snapshot, By Region
- Neuro-Auto-Immune Disease Diagnostics Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Rising prevalence of neuro-autoimmune diseases
- Increased awareness and early diagnosis
- Growing geriatric population
- Restraints
- High cost of diagnostics
- Lack of specific biomarkers
- Regulatory hurdles
- Opportunities
- Development of point-of-care diagnostics
- Personalized medicine
- Increased focus on minimally invasive techniques
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
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Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Neuro-Auto-Immune Disease Diagnostics Market, By Diagnostics Test, 2021 - 2031 (USD Million)
- Antinuclear Antibodies (ANA) Test
- Autoantibodies Test
- Blood Test: Immunoglobulin A (IgA) Test
- C-Reactive Protein (CRP) Test
- Complement Test
- ESR (erythrocyte sedimentation rate) Test
- Protein Electrophoresis Test Or Immunofixation Electrophoresis Test
- Neuro-Auto-Immune Disease Diagnostics Market, By End User, 2021 - 2031 (USD Million)
- Hospitals
- Neurological Diagnostics Test Centers
- Others
- Neuro-Auto-Immune Disease Diagnostics Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Neuro-Auto-Immune Disease Diagnostics Market, By Diagnostics Test, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Bio-Rad Laboratories, Inc
- Crescendo Bioscience
- Roche Diagnostics
- Quest Diagnostics
- Abbott Diagnostics
- Beckman Coulter, Inc
- SQI Diagnostic
- Euroimmun
- Company Profiles
- Analyst Views
- Future Outlook of the Market