PUBLISHER: TechSci Research | PRODUCT CODE: 1881612
PUBLISHER: TechSci Research | PRODUCT CODE: 1881612
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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 1267.29 Million 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.
| Market Overview | |
|---|---|
| Forecast Period | 2026-2030 |
| Market Size 2024 | USD 654.22 Million |
| Market Size 2030 | USD 1267.29 Million |
| CAGR 2025-2030 | 11.65% |
| Fastest Growing Segment | Reagents |
| Largest Market | North America |
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 10% 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.
In this report, the Global Immunoassay for Neurological Biomarkers Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Company Profiles: Detailed analysis of the major companies presents in the Global Immunoassay for Neurological Biomarkers Market.
Global Immunoassay for Neurological Biomarkers Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report: