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Immunoassay for Neurological Biomarkers Market - Global Industry Size, Share, Trends, Opportunity, & Forecast, 2020-2030

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  • 185 Pages
  • November 2025
  • Region: Global
  • TechSci Research
  • ID: 5941745
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The Global Immunoassay for Neurological Biomarkers Market, valued at USD 654.22 Million in 2024, is projected to experience a CAGR of 11.65% to reach USD 1.26 billion by 2030. Immunoassays for neurological biomarkers encompass protein-based tests designed to detect and quantify specific molecular interactions indicative of neurological disorders within biological samples. The global market for these diagnostics is primarily driven by the escalating prevalence of neurodegenerative conditions and the increasing demand for early and precise diagnostic tools.

Key Market Drivers

The increasing prevalence of neurological disorders globally constitutes a primary impetus for the immunoassay market for neurological biomarkers. The increasing longevity of the global population, coupled with environmental and lifestyle factors, contributes to a rising burden of neurodegenerative conditions. For instance, according to a study published in The Lancet in March 2024, the Global Burden of Disease, Injuries, and Risk Factors study 2021 revealed that 3.4 billion people, representing 43% of the world's population, were affected by neurological conditions in 2021. This widespread occurrence underscores an urgent clinical need for accurate and accessible diagnostic and monitoring tools, driving demand for advanced biomarker detection and effective therapeutic intervention development.

Key Market Challenges

The market for immunoassays in neurological biomarkers faces significant impedance due to stringent regulatory hurdles and the inherent complexity of standardizing biomarker panels. These obstacles directly constrain the introduction of novel assays and complicate their widespread clinical adoption. For instance, according to MedTech Europe's 2024 survey results, which includes data up to October 2023, certification and maintenance costs for in vitro diagnostic (IVD) devices under the new European IVD Regulation (IVDR) have escalated by 100% or more compared to previous directives, diverting substantial personnel and financial resources away from innovation and market expansion. This increase in regulatory burden and cost creates unpredictable timelines for manufacturers, particularly impacting smaller and medium-sized enterprises.

Key Market Trends

The integration of Artificial Intelligence for enhanced biomarker detection and analysis significantly impacts the immunoassay market for neurological biomarkers. AI algorithms process complex multimodal data, including imaging and clinical records, identifying subtle biomarker patterns crucial for diagnosing neurological disorders. This capability enables precise disease stratification and personalized therapeutic approaches. According to AdvaMed, in 2022, at least 91 new algorithms gained FDA approval in the first ten months, impacting diagnostic markets. Illustrating this, the University of Liverpool announced in October 2025 the development of a low-cost, handheld AI-powered blood test for early Alzheimer's detection. This innovation highlights AI's role in advancing accurate diagnostic tools.

Key Market Players Profiled:

  • QIAGEN NV
  • Abbott Laboratories Inc.
  • Merck & Co., Inc.
  • Johnson & Johnson Services, Inc.
  • Thermo Fisher Scientific, Inc.
  • Bio-Rad Laboratories, Inc.
  • Sysmex Corporation
  • F. Hoffmann La-Roche Ltd.
  • Nimble Therapeutics Inc.
  • HD Biosciences Co., Ltd.

Report Scope:

In this report, the Global Immunoassay for Neurological Biomarkers Market has been segmented into the following categories:

By Product:

  • Instruments
  • Reagents
  • Services

Immunoassay for Neurological Biomarkers Market, ¬By Disease:

  • Alzheimer's Disease
  • Parkinson's Disease
  • Multiple Sclerosis
  • Others

By Application:

  • In Vitro Diagnostics
  • Research

By Region:

  • North America
  • Europe
  • Asia Pacific
  • South America
  • Middle East & Africa

Competitive Landscape

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

Available Customizations:

With the given market data, the publisher offers customizations according to a company's specific needs. The following customization options are available for the report:
  • Detailed analysis and profiling of additional market players (up to five).

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Table of Contents

1. Product Overview
1.1. Market Definition
1.2. Scope of the Market
1.2.1. Markets Covered
1.2.2. Years Considered for Study
1.2.3. Key Market Segmentations
2. Research Methodology
2.1. Objective of the Study
2.2. Baseline Methodology
2.3. Key Industry Partners
2.4. Major Association and Secondary Sources
2.5. Forecasting Methodology
2.6. Data Triangulation & Validation
2.7. Assumptions and Limitations
3. Executive Summary
3.1. Overview of the Market
3.2. Overview of Key Market Segmentations
3.3. Overview of Key Market Players
3.4. Overview of Key Regions/Countries
3.5. Overview of Market Drivers, Challenges, Trends
4. Voice of Customer
5. Global Immunoassay for Neurological Biomarkers Market Outlook
5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Product (Instruments, Reagents, Services)
5.2.2. ¬By Disease (Alzheimer's Disease, Parkinson's Disease, Multiple Sclerosis, Others)
5.2.3. By Application (In Vitro Diagnostics, Research)
5.2.4. By Region
5.2.5. By Company (2024)
5.3. Market Map
6. North America Immunoassay for Neurological Biomarkers Market Outlook
6.1. Market Size & Forecast
6.1.1. By Value
6.2. Market Share & Forecast
6.2.1. By Product
6.2.2. ¬By Disease
6.2.3. By Application
6.2.4. By Country
6.3. North America: Country Analysis
6.3.1. United States Immunoassay for Neurological Biomarkers Market Outlook
6.3.1.1. Market Size & Forecast
6.3.1.1.1. By Value
6.3.1.2. Market Share & Forecast
6.3.1.2.1. By Product
6.3.1.2.2. ¬By Disease
6.3.1.2.3. By Application
6.3.2. Canada Immunoassay for Neurological Biomarkers Market Outlook
6.3.2.1. Market Size & Forecast
6.3.2.1.1. By Value
6.3.2.2. Market Share & Forecast
6.3.2.2.1. By Product
6.3.2.2.2. ¬By Disease
6.3.2.2.3. By Application
6.3.3. Mexico Immunoassay for Neurological Biomarkers Market Outlook
6.3.3.1. Market Size & Forecast
6.3.3.1.1. By Value
6.3.3.2. Market Share & Forecast
6.3.3.2.1. By Product
6.3.3.2.2. ¬By Disease
6.3.3.2.3. By Application
7. Europe Immunoassay for Neurological Biomarkers Market Outlook
7.1. Market Size & Forecast
7.1.1. By Value
7.2. Market Share & Forecast
7.2.1. By Product
7.2.2. ¬By Disease
7.2.3. By Application
7.2.4. By Country
7.3. Europe: Country Analysis
7.3.1. Germany Immunoassay for Neurological Biomarkers Market Outlook
7.3.1.1. Market Size & Forecast
7.3.1.1.1. By Value
7.3.1.2. Market Share & Forecast
7.3.1.2.1. By Product
7.3.1.2.2. ¬By Disease
7.3.1.2.3. By Application
7.3.2. France Immunoassay for Neurological Biomarkers Market Outlook
7.3.2.1. Market Size & Forecast
7.3.2.1.1. By Value
7.3.2.2. Market Share & Forecast
7.3.2.2.1. By Product
7.3.2.2.2. ¬By Disease
7.3.2.2.3. By Application
7.3.3. United Kingdom Immunoassay for Neurological Biomarkers Market Outlook
7.3.3.1. Market Size & Forecast
7.3.3.1.1. By Value
7.3.3.2. Market Share & Forecast
7.3.3.2.1. By Product
7.3.3.2.2. ¬By Disease
7.3.3.2.3. By Application
7.3.4. Italy Immunoassay for Neurological Biomarkers Market Outlook
7.3.4.1. Market Size & Forecast
7.3.4.1.1. By Value
7.3.4.2. Market Share & Forecast
7.3.4.2.1. By Product
7.3.4.2.2. ¬By Disease
7.3.4.2.3. By Application
7.3.5. Spain Immunoassay for Neurological Biomarkers Market Outlook
7.3.5.1. Market Size & Forecast
7.3.5.1.1. By Value
7.3.5.2. Market Share & Forecast
7.3.5.2.1. By Product
7.3.5.2.2. ¬By Disease
7.3.5.2.3. By Application
8. Asia Pacific Immunoassay for Neurological Biomarkers Market Outlook
8.1. Market Size & Forecast
8.1.1. By Value
8.2. Market Share & Forecast
8.2.1. By Product
8.2.2. ¬By Disease
8.2.3. By Application
8.2.4. By Country
8.3. Asia Pacific: Country Analysis
8.3.1. China Immunoassay for Neurological Biomarkers Market Outlook
8.3.1.1. Market Size & Forecast
8.3.1.1.1. By Value
8.3.1.2. Market Share & Forecast
8.3.1.2.1. By Product
8.3.1.2.2. ¬By Disease
8.3.1.2.3. By Application
8.3.2. India Immunoassay for Neurological Biomarkers Market Outlook
8.3.2.1. Market Size & Forecast
8.3.2.1.1. By Value
8.3.2.2. Market Share & Forecast
8.3.2.2.1. By Product
8.3.2.2.2. ¬By Disease
8.3.2.2.3. By Application
8.3.3. Japan Immunoassay for Neurological Biomarkers Market Outlook
8.3.3.1. Market Size & Forecast
8.3.3.1.1. By Value
8.3.3.2. Market Share & Forecast
8.3.3.2.1. By Product
8.3.3.2.2. ¬By Disease
8.3.3.2.3. By Application
8.3.4. South Korea Immunoassay for Neurological Biomarkers Market Outlook
8.3.4.1. Market Size & Forecast
8.3.4.1.1. By Value
8.3.4.2. Market Share & Forecast
8.3.4.2.1. By Product
8.3.4.2.2. ¬By Disease
8.3.4.2.3. By Application
8.3.5. Australia Immunoassay for Neurological Biomarkers Market Outlook
8.3.5.1. Market Size & Forecast
8.3.5.1.1. By Value
8.3.5.2. Market Share & Forecast
8.3.5.2.1. By Product
8.3.5.2.2. ¬By Disease
8.3.5.2.3. By Application
9. Middle East & Africa Immunoassay for Neurological Biomarkers Market Outlook
9.1. Market Size & Forecast
9.1.1. By Value
9.2. Market Share & Forecast
9.2.1. By Product
9.2.2. ¬By Disease
9.2.3. By Application
9.2.4. By Country
9.3. Middle East & Africa: Country Analysis
9.3.1. Saudi Arabia Immunoassay for Neurological Biomarkers Market Outlook
9.3.1.1. Market Size & Forecast
9.3.1.1.1. By Value
9.3.1.2. Market Share & Forecast
9.3.1.2.1. By Product
9.3.1.2.2. ¬By Disease
9.3.1.2.3. By Application
9.3.2. UAE Immunoassay for Neurological Biomarkers Market Outlook
9.3.2.1. Market Size & Forecast
9.3.2.1.1. By Value
9.3.2.2. Market Share & Forecast
9.3.2.2.1. By Product
9.3.2.2.2. ¬By Disease
9.3.2.2.3. By Application
9.3.3. South Africa Immunoassay for Neurological Biomarkers Market Outlook
9.3.3.1. Market Size & Forecast
9.3.3.1.1. By Value
9.3.3.2. Market Share & Forecast
9.3.3.2.1. By Product
9.3.3.2.2. ¬By Disease
9.3.3.2.3. By Application
10. South America Immunoassay for Neurological Biomarkers Market Outlook
10.1. Market Size & Forecast
10.1.1. By Value
10.2. Market Share & Forecast
10.2.1. By Product
10.2.2. ¬By Disease
10.2.3. By Application
10.2.4. By Country
10.3. South America: Country Analysis
10.3.1. Brazil Immunoassay for Neurological Biomarkers Market Outlook
10.3.1.1. Market Size & Forecast
10.3.1.1.1. By Value
10.3.1.2. Market Share & Forecast
10.3.1.2.1. By Product
10.3.1.2.2. ¬By Disease
10.3.1.2.3. By Application
10.3.2. Colombia Immunoassay for Neurological Biomarkers Market Outlook
10.3.2.1. Market Size & Forecast
10.3.2.1.1. By Value
10.3.2.2. Market Share & Forecast
10.3.2.2.1. By Product
10.3.2.2.2. ¬By Disease
10.3.2.2.3. By Application
10.3.3. Argentina Immunoassay for Neurological Biomarkers Market Outlook
10.3.3.1. Market Size & Forecast
10.3.3.1.1. By Value
10.3.3.2. Market Share & Forecast
10.3.3.2.1. By Product
10.3.3.2.2. ¬By Disease
10.3.3.2.3. By Application
11. Market Dynamics
11.1. Drivers
11.2. Challenges
12. Market Trends & Developments
12.1. Merger & Acquisition (If Any)
12.2. Product Launches (If Any)
12.3. Recent Developments
13. Global Immunoassay for Neurological Biomarkers Market: SWOT Analysis
14. Porter's Five Forces Analysis
14.1. Competition in the Industry
14.2. Potential of New Entrants
14.3. Power of Suppliers
14.4. Power of Customers
14.5. Threat of Substitute Products
15. Competitive Landscape
15.1. QIAGEN NV
15.1.1. Business Overview
15.1.2. Products & Services
15.1.3. Recent Developments
15.1.4. Key Personnel
15.1.5. SWOT Analysis
15.2. Abbott Laboratories Inc.
15.3. Merck & Co., Inc.
15.4. Johnson & Johnson Services, Inc.
15.5. Thermo Fisher Scientific, Inc.
15.6. Bio-Rad Laboratories, Inc.
15.7. Sysmex Corporation
15.8. F. Hoffmann La-Roche Ltd.
15.9. Nimble Therapeutics Inc.
15.10. HD Biosciences Co., Ltd.
16. Strategic Recommendations17. About the Publisher & Disclaimer

Companies Mentioned

  • QIAGEN NV
  • Abbott Laboratories Inc.
  • Merck & Co., Inc.
  • Johnson & Johnson Services, Inc.
  • Thermo Fisher Scientific, Inc.
  • Bio-Rad Laboratories, Inc.
  • Sysmex Corporation
  • F. Hoffmann La-Roche Ltd.
  • Nimble Therapeutics Inc.
  • HD Biosciences Co., Ltd.

Table Information

Report AttributeDetails
No. of Pages185
PublishedNovember 2025
Forecast Period2024 - 2030
Estimated Market Value ( USD ) in 2024 $ 654.22 Million
Forecasted Market Value ( USD ) by 2030 $ 1260 Million
Compound Annual Growth Rate11.6%
Regions CoveredGlobal
No. of Companies Mentioned10

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