신경계 바이오마커용 면역측정법 시장 규모, 점유율 및 동향 분석 보고서 : 제품별, 질환별 및 부문별 예측(2026-2033년)

Immunoassay For Neurological Biomarkers Market Summary

The global immunoassay for neurological biomarkers market size was estimated at USD 1.08 billion in 2025 and is projected to reach USD 2.12 billion by 2033, growing at a CAGR of 8.91% from 2026 to 2033. Growth is supported by the rising prevalence of neurodegenerative diseases, increasing demand for early diagnostics, wider adoption of minimally invasive blood-based testing, and advancements in high-sensitivity immunoassays.

Furthermore, the expanding use of neurological biomarkers in drug development and precision medicine. The growing demand for early diagnosis of neurological disorders is significantly supporting the immunoassay for neurological biomarkers market, as early-stage detection improves treatment outcomes and enables timely therapeutic intervention. Neurological diseases such as Alzheimer's often remain undiagnosed in early stages, creating a strong need for accessible diagnostic tools. For instance, in October 2025, F. Hoffmann-La Roche received U.S. FDA clearance for its Elecsys pTau181 blood-based immunoassay, designed to aid in the early detection of Alzheimer's disease in clinical and primary care settings. These tests help identify patients at earlier stages, improving referral efficiency, reducing diagnostic delays, and thereby increasing demand for immunoassay-based biomarker testing across healthcare systems.

The transition toward minimally invasive blood-based testing is accelerating the clinical adoption of immunoassays, as these methods offer improved patient compliance, reduced procedural risks, and greater scalability than cerebrospinal fluid (CSF) testing and imaging techniques. Blood-based immunoassays enable routine testing in primary care and laboratory settings, expanding access to neurological diagnostics. Technologies such as high-sensitivity digital immunoassays (e.g., Simoa platforms) enable the detection of low-abundance biomarkers, such as pTau217 and neurofilament light chain, with high diagnostic accuracy. For instance, in May 2025, Fujirebio received U.S. FDA clearance for its Lumipulse G pTau217/B-Amyloid 1-42 plasma ratio test, a blood-based immunoassay designed to detect Alzheimer's pathology. These advancements enhance analytical sensitivity, reproducibility, and throughput, supporting large-scale clinical deployment and broader market adoption.

The increasing integration of neurological biomarkers into drug development and precision medicine is supporting the growth of the immunoassays for neurological biomarkers industry, as biomarkers are critical for patient stratification, treatment monitoring, and clinical trial endpoint evaluation. The development of disease-modifying therapies for Alzheimer's disease has intensified the need for accurate biomarker-based diagnostics to identify eligible patients at early stages. This growing reliance on biomarker-driven approaches is enhancing the clinical utility of immunoassays and reinforcing their role in advancing personalized treatment strategies and improving outcomes in neurological care.

Global Immunoassay for Neurological Biomarkers Market Report Segmentation

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global immunoassays for neurological biomarkers market report based on product, disease, application, and region:

• Product Outlook (Revenue, USD Million, 2021 - 2033)
• Instruments
• Reagents
• Services
• Disease Outlook (Revenue, USD Million, 2021 - 2033)
• Alzheimer's Disease
• Parkinson's Disease
• Multiple Sclerosis
• Others
• Application Outlook (Revenue, USD Million, 2021 - 2033)
• In Vitro Diagnostics Application
• Research Application
• Regional Outlook (Revenue, USD Million, 2021 - 2033)
• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Denmark
  • Sweden
  • Norway
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Thailand
• Latin America
  • Brazil
  • Argentina
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Product
  • 1.2.2. Disease
  • 1.2.3. Application
• 1.3. Estimates and Forecast Timeline
• 1.4. Research Methodology
• 1.5. Information Procurement
  • 1.5.1. Purchased Database
  • 1.5.2. GVR's Internal Database
  • 1.5.3. Secondary Sources
  • 1.5.4. Primary Research
• 1.6. Information Analysis
  • 1.6.1. Data Analysis Models
• 1.7. Market Formulation & Data Visualization
• 1.8. Model Details
  • 1.8.1. Commodity Flow Analysis
• 1.9. List of Secondary Sources
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Snapshot
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. Immunoassays for Neurological Biomarkers Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
  • 3.2.2. Market Restraint Analysis
• 3.3. Business Environment Analysis
  • 3.3.1. Industry Analysis - Porter's Five Forces Analysis
    • 3.3.1.1. Supplier Power
    • 3.3.1.2. Buyer Power
    • 3.3.1.3. Substitution Threat
    • 3.3.1.4. Threat of New Entrants
    • 3.3.1.5. Competitive Rivalry
  • 3.3.2. PESTLE Analysis
  • 3.3.3. Pipeline Analysis
  • 3.3.4. Patent Expiry Analysis
  • 3.3.5. Pricing Analysis

Chapter 4. Global Immunoassays for Neurological Biomarkers Market, by Product Business Analysis

• 4.1. Product Market Share, 2025 & 2033
• 4.2. Product Segment Dashboard
• 4.3. Market Size & Forecasts and Trend Analysis, by Product, 2021 to 2033 (USD Million)
• 4.4. Instruments
  • 4.4.1. Instruments Market, 2021 - 2033 (USD Million)
• 4.5. Reagents
  • 4.5.1. Reagents Market, 2021 - 2033 (USD Million)
• 4.6. Services
  • 4.6.1. Services Market, 2021 - 2033 (USD Million)

Chapter 5. Immunoassays for Neurological Biomarkers Market: Segment Analysis, by Disease Business Analysis

• 5.1. Disease Market Share, 2025 & 2033
• 5.2. Disease Segment Dashboard
• 5.3. Market Size & Forecasts and Trend Analysis, by Disease, 2021 to 2033 (USD Million)
• 5.4. Alzheimer's Disease
  • 5.4.1. Alzheimer's Disease Market, 2021 - 2033 (USD Million)
• 5.5. Parkinson's Disease
  • 5.5.1. Parkinson's Disease Market, 2021 - 2033 (USD Million)
• 5.6. Multiple Sclerosis
  • 5.6.1. Multiple Sclerosis Market, 2021 - 2033 (USD Million)
• 5.7. Others
  • 5.7.1. Others Market, 2021 - 2033 (USD Million)

Chapter 6. Immunoassays for Neurological Biomarkers Market: Segment Analysis, by Application Business Analysis

• 6.1. Application Market Share, 2025 & 2033
• 6.2. Application Segment Dashboard
• 6.3. Market Size & Forecasts and Trend Analysis, by Application, 2021 to 2033 (USD Million)
• 6.4. In Vitro Diagnostics Application
  • 6.4.1. In Vitro Diagnostics Application Market, 2021 - 2033 (USD Million)
• 6.5. Research Application
  • 6.5.1. Research Application Market, 2021 - 2033 (USD Million)

Chapter 7. Immunoassays for Neurological Biomarkers Market: Regional Estimates & Trend Analysis

• 7.1. Regional Market Share Analysis, 2025 & 2033
• 7.2. Regional Market Dashboard
• 7.3. Market Size & Forecasts Trend Analysis, 2021 to 2033:
• 7.4. North America
  • 7.4.1. North America Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, By Country, 2021 - 2033 (USD Million)
  • 7.4.2. U.S.
    • 7.4.2.1. Key Country Dynamics
    • 7.4.2.2. Target Disease Prevalence
    • 7.4.2.3. Regulatory Framework
    • 7.4.2.4. Reimbursement Framework
    • 7.4.2.5. U.S. Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.4.3. Canada
    • 7.4.3.1. Key Country Dynamics
    • 7.4.3.2. Target Disease Prevalence
    • 7.4.3.3. Regulatory Framework
    • 7.4.3.4. Reimbursement Framework
    • 7.4.3.5. Canada Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.4.4. Mexico
    • 7.4.4.1. Key Country Dynamics
    • 7.4.4.2. Target Disease Prevalence
    • 7.4.4.3. Regulatory Framework
    • 7.4.4.4. Reimbursement Framework
    • 7.4.4.5. Mexico Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.5. Europe
  • 7.5.1. Europe Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.2. UK
    • 7.5.2.1. Key Country Dynamics
    • 7.5.2.2. Target Disease Prevalence
    • 7.5.2.3. Regulatory Framework
    • 7.5.2.4. Reimbursement Framework
    • 7.5.2.5. UK Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.3. Germany
    • 7.5.3.1. Key Country Dynamics
    • 7.5.3.2. Target Disease Prevalence
    • 7.5.3.3. Regulatory Framework
    • 7.5.3.4. Reimbursement Framework
    • 7.5.3.5. Germany Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.4. France
    • 7.5.4.1. Key Country Dynamics
    • 7.5.4.2. Target Disease Prevalence
    • 7.5.4.3. Regulatory Framework
    • 7.5.4.4. Reimbursement Framework
    • 7.5.4.5. France Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.5. Italy
    • 7.5.5.1. Key Country Dynamics
    • 7.5.5.2. Target Disease Prevalence
    • 7.5.5.3. Regulatory Framework
    • 7.5.5.4. Reimbursement Framework
    • 7.5.5.5. Italy Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.6. Spain
    • 7.5.6.1. Key Country Dynamics
    • 7.5.6.2. Target Disease Prevalence
    • 7.5.6.3. Regulatory Framework
    • 7.5.6.4. Reimbursement Framework
    • 7.5.6.5. Spain Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.7. Denmark
    • 7.5.7.1. Key Country Dynamics
    • 7.5.7.2. Target Disease Prevalence
    • 7.5.7.3. Regulatory Framework
    • 7.5.7.4. Reimbursement Framework
    • 7.5.7.5. Denmark Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.8. Sweden
    • 7.5.8.1. Key Country Dynamics
    • 7.5.8.2. Target Disease Prevalence
    • 7.5.8.3. Regulatory Framework
    • 7.5.8.4. Reimbursement Framework
    • 7.5.8.5. Sweden Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.9. Norway
    • 7.5.9.1. Key Country Dynamics
    • 7.5.9.2. Target Disease Prevalence
    • 7.5.9.3. Regulatory Framework
    • 7.5.9.4. Reimbursement Framework
    • 7.5.9.5. Norway Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.6. Asia Pacific
  • 7.6.1. Asia Pacific Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.2. Japan
    • 7.6.2.1. Key Country Dynamics
    • 7.6.2.2. Target Disease Prevalence
    • 7.6.2.3. Regulatory Framework
    • 7.6.2.4. Reimbursement Framework
    • 7.6.2.5. Japan Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.3. China
    • 7.6.3.1. Key Country Dynamics
    • 7.6.3.2. Target Disease Prevalence
    • 7.6.3.3. Regulatory Framework
    • 7.6.3.4. Reimbursement Framework
    • 7.6.3.5. China Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.4. India
    • 7.6.4.1. Key Country Dynamics
    • 7.6.4.2. Target Disease Prevalence
    • 7.6.4.3. Regulatory Framework
    • 7.6.4.4. Reimbursement Framework
    • 7.6.4.5. India Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.5. Australia
    • 7.6.5.1. Key Country Dynamics
    • 7.6.5.2. Target Disease Prevalence
    • 7.6.5.3. Regulatory Framework
    • 7.6.5.4. Reimbursement Framework
    • 7.6.5.5. Australia Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.6. South Korea
    • 7.6.6.1. Key Country Dynamics
    • 7.6.6.2. Target Disease Prevalence
    • 7.6.6.3. Regulatory Framework
    • 7.6.6.4. Reimbursement Framework
    • 7.6.6.5. South Korea Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.7. Thailand
    • 7.6.7.1. Key Country Dynamics
    • 7.6.7.2. Target Disease Prevalence
    • 7.6.7.3. Regulatory Framework
    • 7.6.7.4. Reimbursement Framework
    • 7.6.7.5. Thailand Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.7. Latin America
  • 7.7.1. Latin America Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.7.2. Brazil
    • 7.7.2.1. Key Country Dynamics
    • 7.7.2.2. Target Disease Prevalence
    • 7.7.2.3. Regulatory Framework
    • 7.7.2.4. Reimbursement Framework
    • 7.7.2.5. Brazil Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.7.3. Argentina
    • 7.7.3.1. Key Country Dynamics
    • 7.7.3.2. Target Disease Prevalence
    • 7.7.3.3. Regulatory Framework
    • 7.7.3.4. Reimbursement Framework
    • 7.7.3.5. Argentina Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.8. Middle East and Africa
  • 7.8.1. Middle East and Africa Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8.2. South Africa
    • 7.8.2.1. Key Country Dynamics
    • 7.8.2.2. Target Disease Prevalence
    • 7.8.2.3. Regulatory Framework
    • 7.8.2.4. Reimbursement Framework
    • 7.8.2.5. South Africa Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8.3. Saudi Arabia
    • 7.8.3.1. Key Country Dynamics
    • 7.8.3.2. Target Disease Prevalence
    • 7.8.3.3. Regulatory Framework
    • 7.8.3.4. Reimbursement Framework
    • 7.8.3.5. Saudi Arabia Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8.4. UAE
    • 7.8.4.1. Key Country Dynamics
    • 7.8.4.2. Target Disease Prevalence
    • 7.8.4.3. Regulatory Framework
    • 7.8.4.4. Reimbursement Framework
    • 7.8.4.5. UAE Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8.5. Kuwait
    • 7.8.5.1. Key Country Dynamics
    • 7.8.5.2. Target Disease Prevalence
    • 7.8.5.3. Regulatory Framework
    • 7.8.5.4. Reimbursement Framework
    • 7.8.5.5. Kuwait Immunoassays for Neurological Biomarkers Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Participant Overview
• 8.2. Company Market Position Analysis
• 8.3. Company Categorization
• 8.4. Strategy Mapping
• 8.5. Company Profiles/Listing
  • 8.5.1. QIAGEN
    • 8.5.1.1. Overview
    • 8.5.1.2. Financial Performance
    • 8.5.1.3. Product Benchmarking
    • 8.5.1.4. Strategic Initiatives
  • 8.5.2. Abbott
    • 8.5.2.1. Overview
    • 8.5.2.2. Financial Performance
    • 8.5.2.3. Product Benchmarking
    • 8.5.2.4. Strategic Initiatives
  • 8.5.3. Merck & Co., Inc.
    • 8.5.3.1. Overview
    • 8.5.3.2. Financial Performance
    • 8.5.3.3. Product Benchmarking
    • 8.5.3.4. Strategic Initiatives
  • 8.5.4. Johnson & Johnson Services, Inc.
    • 8.5.4.1. Overview
    • 8.5.4.2. Financial Performance
    • 8.5.4.3. Product Benchmarking
    • 8.5.4.4. Strategic Initiatives
  • 8.5.5. Thermo Fisher Scientific, Inc.
    • 8.5.5.1. Overview
    • 8.5.5.2. Financial Performance
    • 8.5.5.3. Product Benchmarking
    • 8.5.5.4. Strategic Initiatives
  • 8.5.6. Bio-Rad Laboratories, Inc.
    • 8.5.6.1. Overview
    • 8.5.6.2. Financial Performance
    • 8.5.6.3. Product Benchmarking
    • 8.5.6.4. Strategic Initiatives
  • 8.5.7. Sysmex Corporation
    • 8.5.7.1. Overview
    • 8.5.7.2. Financial Performance
    • 8.5.7.3. Product Benchmarking
    • 8.5.7.4. Strategic Initiatives
  • 8.5.8. Merck KGaA.
    • 8.5.8.1. Overview
    • 8.5.8.2. Financial Performance
    • 8.5.8.3. Product Benchmarking
    • 8.5.8.4. Strategic Initiatives
  • 8.5.9. F. Hoffmann-La Roche Ltd.
    • 8.5.9.1. Overview
    • 8.5.9.2. Financial Performance
    • 8.5.9.3. Product Benchmarking
    • 8.5.9.4. Strategic Initiatives
  • 8.5.10. Nimble Therapeutics
    • 8.5.10.1. Overview
    • 8.5.10.2. Financial Performance
    • 8.5.10.3. Product Benchmarking
    • 8.5.10.4. Strategic Initiatives