Immunoassay for Neurological Biomarkers Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Instruments, Reagents, Services), By Disease (Alzheimer's Disease, Parkinson's Disease, Multiple Sclerosis, Others), By Application (In Vitro Diagnostics, Research), By Region and Competition, 2020-2030F

Market Overview

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. For instance, according to the Alzheimer's Association, an estimated 7.2 million Americans aged 65 and older are living with Alzheimer's in 2025, underscoring the substantial need for advanced diagnostic methods. Furthermore, considerable investments in neurological disease research and development, alongside continuous technological advancements in immunoassay platforms, actively support market expansion.

Despite robust growth drivers, the market faces a significant challenge in the form of regulatory hurdles and the complex process of standardizing biomarker panels. These obstacles can impede the rapid introduction of novel assays and complicate their widespread clinical adoption, thereby constraining overall market expansion.

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.

Complementing this disease burden, continuous advancements in immunoassay technologies significantly propel market growth. Innovations have led to highly sensitive and specific assays capable of detecting minute concentrations of neurological biomarkers in readily available biological samples. A notable example is Fujirebio's announcement in May 2025 that the U. S. Food and Drug Administration granted 510(k) clearance for their Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic test, the first FDA-cleared blood-based IVD test in the U. S. to identify amyloid pathology associated with Alzheimer's disease. Such breakthroughs enhance diagnostic capabilities and facilitate the shift towards less invasive testing, improving patient acceptance. Moreover, sustained investment reinforces innovation; according to the National Institute of Neurological Disorders and Stroke 2024 Congressional Budget Justification, Research Project Grants for neurological disorders experienced an increase of $27.6 million in fiscal year 2024. This financial backing ensures continued development and broader adoption of immunoassay-based diagnostics.

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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.

Furthermore, the lack of harmonization and varying interpretations of compliance requirements across different regulatory bodies contribute to delays in bringing new neurological biomarker assays to patients. According to a 2023 survey by the European Federation of Pharmaceutical Industries and Associations (EFPIA), a significant number of clinical trials were expected to be delayed, affecting up to 42,200 patients over a three-year period due to the unforeseen effects of new medical device and IVD regulations. Such delays restrict timely access to advanced diagnostics, thereby hampering market growth and limiting the availability of tools crucial for early and precise identification of neurological disorders.

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.

Growth in point-of-care and portable diagnostic solutions is a key trend, decentralizing neurological biomarker testing. These solutions allow diagnostics outside traditional laboratories in settings like clinics, rural offices, or homes, increasing accessibility and reducing delays for conditions requiring frequent monitoring. According to the American Society for Clinical Laboratory Science, as of January 2022, 96% of CLIA-licensed facilities performing testing operated outside a hospital setting, signifying existing infrastructure for decentralized diagnostics. Notably, Stanford Medicine researchers published in Nature in August 2025 on a portable device paired with a smartphone for at-home monitoring of Parkinson's disease symptoms. Such advancements facilitate remote patient management and convenience for immunoassay technologies.

Segmental Insights

The Reagents segment is experiencing rapid growth in the Global Immunoassay for Neurological Biomarkers Market due to several interconnected factors. A key driver is the continuous advancement in immunoassay technologies, leading to the development of ultrasensitive and highly specific reagents capable of detecting subtle changes in neurological biomarkers. Furthermore, ongoing research and development efforts are uncovering novel biomarkers for various neurological conditions, necessitating the creation and approval of new diagnostic reagents to accurately quantify these markers. The increasing global prevalence of neurodegenerative disorders, coupled with a growing emphasis on early and precise diagnosis for effective disease management and personalized medicine approaches, further fuels the demand for specialized and reliable immunoassay reagents.

Regional Insights

North America dominates the Global Immunoassay for Neurological Biomarkers Market due to a confluence of factors. The region benefits from a well-established clinical research infrastructure, high awareness regarding advanced diagnostics, and rapid adoption of biomarker-based testing in neurology. Specifically, the United States plays a significant role with its progress in implementing Alzheimer's biomarker panels, numerous Food and Drug Administration (FDA)-approved diagnostic tools, and National Institutes of Health (NIH)-sponsored programs emphasizing brain health. This robust ecosystem, coupled with substantial research funding and favorable reimbursement policies, drives the widespread application of immunoassays in both research and clinical settings, further solidifying North America's leading position.

Recent Developments

• In July 2025, Spear Bio commercially launched its SPEAR UltraDetect™ immunoassay solution. This innovative platform utilized a homogeneous, ultrasensitive technology for biomarker measurement. The initial launch featured four assays specifically targeting critical neurology biomarkers, including phosphorylated tau 231 (pTau231), phosphorylated tau 217 (pTau217), glial fibrillary acidic protein (GFAP), and neurofilament light (NfL). This development aimed to provide academic and clinical researchers worldwide with enhanced capabilities for discovering new insights and advancing therapeutic strategies for various neurological conditions.

• In May 2025, Fujirebio Diagnostics obtained 510(k) clearance from the FDA for its Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test. This blood test marked a significant development as the first of its kind to receive such clearance, intended to assist in the early detection of amyloid plaques associated with Alzheimer's disease. The test targeted individuals aged 55 and older who exhibited signs and symptoms of cognitive impairment, providing a more accessible and less invasive diagnostic alternative to traditional methods.

• In December 2024, Fujirebio and Eisai entered into a Memorandum of Understanding to conduct joint research on blood-based biomarkers in the field of neurodegenerative diseases. This non-exclusive collaboration aimed to establish advanced diagnostic technologies and accelerate their global implementation for various neurodegenerative conditions with high unmet medical needs. The initiative sought to improve diagnosis and treatment by facilitating the selection and provision of appropriate therapies, thereby contributing to advancements in neurological patient care.

• In June 2024, Siemens Healthineers received the CE mark in Europe for a lab-based blood test designed to measure neurofilament light chain (NfL) levels in adults with relapsing forms of multiple sclerosis (MS). This immunoassay, developed in collaboration with Novartis, aimed to predict new or worsening disease activity when used alongside clinical and imaging data. The test was intended for deployment on the company's Atellica IM Analyzer and ADVIA Centaur XP/XPT automated immunoassay systems, offering an accessible and cost-effective method for the early identification of neuronal injury in MS management.

Key Market Players

• 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, in addition to the industry trends which have also been detailed below:

• Immunoassay for Neurological Biomarkers Market, By Product:

o   Instruments

o   Reagents

o   Services

• Immunoassay for Neurological Biomarkers Market, ­By Disease:

o   Alzheimer's Disease

o   Parkinson's Disease

o   Multiple Sclerosis

o   Others

• Immunoassay for Neurological Biomarkers Market, By Application:

o   In Vitro Diagnostics

o   Research

• Immunoassay for Neurological Biomarkers Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

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

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Company Information

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