CAR T-Cell Neurotoxicity Detection Market Overview and Strategic Developments by Towards Healthcare

This report, published by Towards Healthcare, a sister firm of Precedence Research, provides an in-depth analysis of the CAR T-cell neurotoxicity detection market. It explores key growth drivers, regional insights, and emerging innovations shaping the future of oncology diagnostics.

Ottawa, Nov. 06, 2025 (GLOBE NEWSWIRE) -- The CAR T-cell neurotoxicity detection market is rapidly emerging as a crucial segment in oncology diagnostics, propelled by the growing adoption of CAR T-cell therapies and the need to effectively manage their associated neurotoxic side effects. Between 2024 and 2034, the market is poised for strong growth, driven by advancements in biomarker detection, innovations in neuroimaging technologies, and increasing investments in personalized cancer treatment.

While North America currently leads the market, the Asia Pacific region is expected to experience the fastest expansion. The development of early detection tools and real-time monitoring systems is transforming clinical strategies for addressing CAR T-cell-related neurotoxicity.

This market’s growth is largely fueled by the expanding use of CAR T-cell therapy, supported by the rising demand for personalized medicine and intensive R&D efforts aimed at developing next-generation CAR T-cells. Additionally, the increasing prevalence of hematologic malignancies continues to drive the need for CAR T-cell-based therapies. With continuous progress in genomic technologies and the advancement of the medical device sector, the future of CAR T-cell neurotoxicity detection looks highly promising.

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Key Takeaways

North America held a major revenue share of 52.5% in the market in 2024.
Asia-Pacific is expected to host the fastest-growing market in the coming years.
By detection method, the biomarker-based detection segment contributed the biggest revenue share of approximately 37.6% in the CAR T-cell neurotoxicity detection market in 2024.
By detection method, the AI-based & wearable monitoring segment is expected to grow at the highest CAGR between 2025 and 2034.
By product/service type, the diagnostic kits & reagents segment held the largest revenue share of approximately 52.5% in 2024.
By product/service type, the software & algorithms segment is expected to grow at the fastest CAGR over the projected period.
By biomarker source, the blood-based biomarkers segment registered its dominance over the global market with a share of approximately 60% in 2024.
By biomarker source, the cerebrospinal fluid (CSF) biomarkers segment is expected to witness the fastest growth in the CAR T-cell neurotoxicity detection market over the forecast period.
By end-user, the cancer centres & hospitals segment held a dominant revenue share of 66.6% in the market in 2024.
By end-user, the biotech & CAR-T developers segment is expanding at the fastest CAGR between 2025 and 2034.
By indication, the B-cell malignancies segment led the global market with a share of 54.5% in 2024.
By indication, the solid tumour CAR-T programs segment is expected to expand rapidly in the market in the coming years.

Market Overview & Potential

The market for CAR T-cell neurotoxicity detection encompasses the tools, technologies, and services designed to identify, track, and manage neurotoxic side effects especially ICANS (immune effector cell-associated neurotoxicity syndrome) in patients receiving CAR T-cell therapy. Neurotoxicity is among the most severe and potentially fatal adverse effects of CAR T-cells, emphasising the importance of early detection for patient safety and regulatory adherence. Detection methods include blood tests, MRI, CT scans, EEG, and lumbar puncture.

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What is the Growth Potential Responsible for the CAR T-Cell Neurotoxicity Detection Market?

The CAR T-cell neurotoxicity detection market is driven by the increasing adoption of CAR T-cell therapies, the need to manage their inherent toxicity (specifically ICANS), and the associated rise in research into biomarkers and diagnostic tools to improve patient outcomes. As the use of these advanced therapies expands to more cancers, the development of accurate detection methods for neurotoxicity becomes critical for patient safety and treatment success.

What Are the Growing Trends Associated with the CAR T-Cell Neurotoxicity Detection Market?

Biomarker development: There is a significant focus on identifying and validating biomarkers (e.g., cytokine levels, CAR T-cell expansion kinetics) to predict and monitor neurotoxicity.
Standardisation of methods: Researchers are working to standardise diagnostic techniques such as flow cytometry and PCR, to ensure consistent and comparable results across different institutions.
Early intervention and monitoring: The goal is to utilise early detection through these tools to implement timely interventions, such as corticosteroid use, to manage toxicity and achieve better patient outcomes.
Integration of advanced tools: The market is seeing an increased integration of advanced diagnostic tools into clinical practice. This includes both established methods, such as neurological exams, and newer technologies for real-time analysis.
Focus on risk-benefit balance: As CAR T-cell therapies become more common, the market is focused on finding the right balance between therapeutic efficacy and the management of side effects like neurotoxicity.

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What Is the Growing Challenge in the CAR T-Cell Neurotoxicity Detection Market?

The CAR T-cell neurotoxicity detection market faces challenges, including the need for faster, more sensitive, and standardised detection methods to monitor severe adverse events like immune effector cell-associated neurotoxicity syndrome (ICANS) and cytokine release syndrome (CRS). Key challenges include the rapid and complex nature of these toxicities, a lack of universally standardised diagnostic tools, and difficulties in accurately differentiating between neurotoxicity and other conditions.

Regional Analysis

How Did North America Dominate the CAR T-Cell Neurotoxicity Detection Market in 2024?

North America held a major revenue share of 52.5% in the market in 2024. The North American CAR T-cell neurotoxicity detection market is a significant part of the larger CAR T-cell therapy market, driven by high demand for advanced cancer treatments, robust R&D, and supportive infrastructure. As CAR T-cell therapies become more widely adopted, the need for reliable detection and management of side effects like neurotoxicity is increasing. The market is being shaped by technological advancements in diagnostics and AI, along with regulatory support from agencies like the FDA, which have influenced the growth of the region's dominant position in the global CAR T-cell space.

Asia Pacific CAR T-Cell Neurotoxicity Detection Market Analysis:

The CAR T-cell neurotoxicity detection market in Asia Pacific (APAC) is an emerging sub-segment driven by the rapid growth of the broader CAR T-cell therapy market in the region, particularly in China, Japan, and South Korea. Key drivers include the increasing adoption of CAR T-cell therapies, advancements in gene editing technologies, rising cancer rates, and supportive government initiatives in countries like China and Japan. While the global neurotoxicity detection market focuses on developing biomarkers and managing this potential side effect, the APAC market will be shaped by the region's specific regulatory landscape, local manufacturing capabilities, and growing R&D investments in this area.

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Segmental Insights

By Detection Method,

The biomarker-based detection segment contributed the biggest revenue share of approximately 37.6% in the CAR T-cell neurotoxicity detection market in 2024. Biomarker-based detection methods play a key role in identifying early signs of neurotoxicity associated with CAR-T therapy. The approach supports clinical decision-making by allowing early intervention, reducing adverse events, and improving patient safety and therapy outcomes during CAR-T cell treatments.

The AI-based & wearable monitoring segment is expected to grow at the highest CAGR between 2025 and 2034. AI and wearable-based neurotoxicity monitoring solutions integrate real-time data analytics with physiological tracking to detect early neurological symptoms. These digital tools enhance monitoring accuracy, reduce dependence on invasive procedures, and facilitate proactive neurotoxicity management in CAR-T clinical settings.

By Product/Service Type,

The diagnostic kits & reagents segment held the largest revenue share of approximately 52.5% in 2024. Diagnostic kits and reagents enable laboratory-based detection of CAR-T-induced neurotoxicity by targeting specific biomarkers, cytokines, or immune-related proteins. Increasing demand for precision diagnostics and regulatory emphasis on patient safety are driving adoption among hospitals and CAR-T therapy centres.

The software & algorithms segment is expected to grow at the fastest CAGR over the projected period. Software platforms and analytical algorithms serve as critical components for integrating patient data, biomarker analysis, and imaging results. They utilise machine learning to interpret complex datasets, identify neurotoxicity risk patterns, and guide treatment adjustments. Growing interest in AI-enabled clinical tools is expanding their use in predictive modelling and remote monitoring applications.

By Biomarker Source,

The blood-based biomarkers segment registered its dominance over the global market with a share of approximately 60% in 2024. Blood-based biomarkers such as cytokines, neurofilament light chains, and chemokines provide minimally invasive options for neurotoxicity assessment. This segment is favoured due to ease of sample collection, scalability for longitudinal monitoring, and compatibility with automated detection platforms.

The cerebrospinal fluid (CSF) biomarkers segment is expected to witness the fastest growth in the CAR T-cell neurotoxicity detection market over the forecast period. Cerebrospinal fluid (CSF) biomarkers offer a direct reflection of central nervous system pathology, making them valuable for severe neurotoxicity diagnosis. CSF-based assays detect neuroinflammatory markers and neuronal injury proteins that correlate with immune effector cell-associated neurotoxicity syndrome (ICANS). Despite being invasive, they deliver high diagnostic precision for complex neuroimmune events.

By End-User,

The cancer centres & hospitals segment held a dominant revenue share of 66.6% in the market in 2024. Cancer centres and hospitals represent the largest end-user segment, implementing neurotoxicity detection protocols alongside CAR-T treatment programs. They integrate biomarker assays, imaging, and digital monitoring within multidisciplinary clinical workflows. The increasing number of CAR-T therapy approvals and specialised oncology infrastructure support market growth in this category.

The biotech & CAR-T developers segment is expanding at the fastest CAGR between 2025 and 2034. Biotech firms and CAR-T developers utilise neurotoxicity detection tools during preclinical and clinical studies to assess therapy safety. They invest in biomarker validation, algorithm development, and assay integration to meet regulatory expectations. Growing collaborations with diagnostic and digital health companies further enhance precision neurotoxicity monitoring capabilities.

By Indication,

The B-cell malignancies segment led the global market with a share of 54.5% in 2024. Neurotoxicity detection solutions are widely used in CAR-T therapies targeting B-cell malignancies, such as leukaemia and lymphoma, where immune-related neurological side effects are common. Clinical trials and post-market monitoring continue to strengthen neurotoxicity risk stratification in this indication.

The solid tumour CAR-T programs segment is expected to expand rapidly in the market in the coming years. In solid tumour CAR-T applications, neurotoxicity monitoring is crucial due to emerging evidence of systemic immune activation. The growing development of CAR-T therapies for solid tumours increases demand for advanced neurotoxicity detection platforms.

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Recent Developments

In March 2025, researchers from Kyushu University determined specific proteins associated with a damaging immune response that can affect the CNS after CAR T-cell therapy by analysing cerebrospinal fluid. Their study found that immunotherapy cancer treatment could be safer by helping healthcare professionals identify high-risk patients in advance.
In June 2023, researchers in Germany and the U.S. found that a simple blood test identifying serum neurofilament light chain (NfL) can help detect the risk of developing ICANS following CAR T-cell therapy. NfL is a protein in the blood indicative of neuroaxonal injury, and its level increases, causing ICANS complications.

CAR T-Cell Neurotoxicity Detection Market Key Players List

Diagnostic & Biotech Companies
Thermo Fisher Scientific
Bio-Techne (R&D Systems, ProteinSimple)
Quanterix Corporation
BD Biosciences
Olink Proteomics
Siemens Healthineers
Roche Diagnostics
PerkinElmer
Merck KGaA (MilliporeSigma)
Biognosys AG
Neuromonitoring & Imaging
Neuroelectrics
GE Healthcare
Natus Medical
Compumedics Neuroscan
Philips Healthcare
AI, Software & Platform Developers
Owkin
Tempus AI
CureMetrix
Blackfynn (Neuroscience Data Integration)
NeuroPace Inc.

Segments Covered in The Report

By Detection Method

Biomarker-based Detection
- Cytokine levels (e.g. IL-6, IFN-γ, TNF-α)
- S100B, GFAP (glial damage markers)
- Neurofilament light chain (NfL)
- Endothelial markers (ANG2, VWF)
AI-based & Wearable Monitoring
- Eye-tracking, reaction time apps
- Wearable EEG/neuromonitors
Neuroimaging
- MRI (contrast-enhanced)
- PET-CT
Electrophysiology
- EEG for seizure or encephalopathy detection
Cognitive & Behavioural Assessment Tools
- Mini-Mental State Exam (MMSE)
- NIH Cognitive Test Battery

By Product/Service Type

Diagnostic Kits & Reagents
Software & Algorithms
- AI platforms for ICANS risk prediction
Imaging Equipment
Monitoring Devices
- EEG caps, wearable biosensors
Clinical & Laboratory Services

By Biomarker Source

Blood-based Biomarkers
Cerebrospinal Fluid (CSF) Biomarkers
Saliva/Plasma Proteomic Markers
Neuroimaging Markers

By End-User

Cancer Centers & Hospitals
Biotech & CAR-T Developers
Academic & Research Institutes
Diagnostic Laboratories
Clinical Trial Sponsors & CROs

By Indication

B-cell Malignancies
- Diffuse Large B-cell Lymphoma (DLBCL)
- Acute Lymphoblastic Leukaemia (ALL)
Solid Tumour CAR-T Programs
Multiple Myeloma
Pediatric CAR T Recipients

By Region

North America
- U.S.
- Canada
Asia Pacific
- China
- Japan
- India
- South Korea
- Thailand
Europe
- Germany
- UK
- France
- Italy
- Spain
- Sweden
- Denmark
- Norway
Latin America
- Brazil
- Mexico
- Argentina
Middle East and Africa (MEA)
- South Africa
- UAE
- Saudi Arabia
- Kuwait

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