Traumatic Brain Injuries Assessment And Management Devices Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Devices (Imaging Devices (Magnetic Resonance Imaging (MRI) Devices, X-Ray, Computed Tomography, Others), Monitoring Devices), By Technique (Intracranial pressure monitoring, Partial pressure of oxygen in brain tissue (pBrO2)), By End-Use (Hospitals, Diagnostic centers, Others), By Region, and By Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 3.78 Billion
CAGR (2026-2031)	7.27%
Fastest Growing Segment	Imaging Device
Largest Market	North America
Market Size (2031)	USD 5.76 Billion

Market Overview

The Global Traumatic Brain Injuries Assessment And Management Devices Market will grow from USD 3.78 Billion in 2025 to USD 5.76 Billion by 2031 at a 7.27% CAGR. The Global Traumatic Brain Injuries Assessment and Management Devices Market encompasses diagnostic instruments and therapeutic systems designed to evaluate and treat intracranial trauma resulting from external forces. Core products range from intracranial pressure monitors to neuroimaging modalities and targeted temperature management systems. The primary drivers sustaining growth are the rising global incidence of road traffic accidents and the increasing prevalence of fall-related injuries among the expanding geriatric population. Additionally, heightened scrutiny of sports-related concussions and the subsequent demand for precise on-field assessment tools act as critical catalysts for device adoption.

Conversely, the market encounters a significant challenge regarding the widespread underdiagnosis of mild brain injuries, which often prevents timely medical intervention and device utilization. This gap in recognition severely limits the deployment of diagnostic technologies in non-critical settings. According to the Brain Injury Association of America, in 2025, 81% of adults in the United States do not recognize concussions as traumatic brain injuries. This substantial lack of awareness impedes early detection initiatives and remains a formidable barrier to the broader expansion of assessment solutions.

Key Market Drivers

The increasing adoption of neuro-trauma solutions in military and defense sectors acts as a powerful catalyst for market expansion, driven by the critical need for rapid, field-deployable assessment tools in combat and training environments. Defense organizations are prioritizing the deployment of ruggedized handheld devices and serum biomarker tests to manage blast-induced neurotrauma and prevent long-term neurological deficits among service members. This sector's rigorous screening protocols directly stimulate demand for advanced diagnostic technologies that can operate effectively outside traditional clinical settings. According to the Military Health System, August 2025, in the '2024 DOD Worldwide Numbers for TBI' report, the U.S. Department of Defense recorded 18,376 new traumatic brain injury diagnoses among active-duty service members in 2024. Such substantial case volumes underscore the defense sector's continuing role as a key procurement channel for early-detection and management devices.

Supportive government initiatives and public awareness campaigns are simultaneously reshaping the market landscape by improving the recognition of mild traumatic brain injuries that historically went undiagnosed. These educational efforts encourage individuals to identify symptoms and seek medical attention, thereby widening the patient pool eligible for assessment and therapeutic intervention. According to the Brain Injury Association of America, March 2025, in the '2025 Public Perceptions of Brain Injury Report', nearly 4 in 10 U.S. adults reported having experienced symptoms of a brain injury, a finding that highlights the immense potential for market penetration if these latent cases are clinicalized. This shift towards proactive management is further evidenced in professional athletics; according to the NFL, February 2025, enhanced safety mandates contributed to a record low of 182 concussions during the 2024 season, demonstrating how stringent assessment protocols are effectively mitigating injury risks.

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Key Market Challenges

The widespread underdiagnosis of mild brain injuries constitutes a significant impediment to the growth of the Global Traumatic Brain Injuries Assessment and Management Devices Market. This issue creates a substantial gap between the actual prevalence of intracranial trauma and the volume of patients receiving clinical attention. When symptoms are dismissed or not immediately associated with neurological trauma, the pathway to utilizing diagnostic instruments and therapeutic systems is effectively blocked. Consequently, the deployment of assessment tools remains heavily concentrated in high-acuity trauma centers, preventing market expansion into primary care, sports medicine clinics, and outpatient rehabilitation settings where these devices could otherwise see widespread adoption.

This failure to identify patients directly suppresses the demand for diagnostic technologies. According to the Brain Injury Association of America, in 2025, fewer than one in four adults in the United States reported being asked by a healthcare provider about a history of brain injury. This low rate of clinical inquiry suggests that a vast number of potential cases remain uninvestigated. As long as routine screening remains infrequent, the downstream utilization of neuroimaging modalities and monitoring devices will lag behind the actual medical need, directly hampering revenue growth for manufacturers in this sector.

Key Market Trends

The Integration of Artificial Intelligence and Machine Learning for Predictive Analytics is revolutionizing neurotrauma care by automating the detection of critical intracranial anomalies. Advanced algorithms are now being embedded into diagnostic workflows to rapidly identify and quantify brain injuries from imaging data, significantly reducing the time to treatment for time-sensitive conditions. This technological leap enables the simultaneous analysis of multiple biomarkers and imaging modalities, providing clinicians with immediate, data-driven decision support. According to Qure.ai, October 2025, in the 'Qure.ai Earns 19th FDA Clearance' press release, the company received FDA clearance for its qER-CTA algorithm, an AI solution designed to assist in the urgent triage of neurocritical cases, expanding its portfolio of tools that automatically detect intracranial hemorrhages and other acute brain emergencies.

Concurrent with AI advancements, the Proliferation of Handheld and Point-of-Care Diagnostic Devices is expanding the reach of TBI assessment into non-hospital environments. These portable systems allow for the immediate evaluation of intracranial bleeding in resource-limited settings, such as remote field locations or ambulances, where access to standard computed tomography is restricted. By utilizing technologies like near-infrared spectroscopy, these devices enable reliable on-site screening that aids in the rapid triaging of patients. According to the University of Cambridge, July 2025, in the 'Performance of the InfraScanner' research publication, the handheld InfraScanner 2000 demonstrated a negative predictive value of 94.2% for detecting intracranial bleeding in trauma patients, underscoring its efficacy as a frontline triage tool when comprehensive neuroimaging is unavailable.

Segmental Insights

The Imaging Device segment represents the fastest-growing vertical in the Global Traumatic Brain Injuries Assessment And Management Devices Market, driven by the escalating need for precise, real-time diagnostic capabilities. Market expansion is fueled by the transition towards portable computed tomography and magnetic resonance imaging systems, which allow for immediate assessment in critical care scenarios. Furthermore, the incorporation of artificial intelligence algorithms is enhancing the sensitivity of these devices in detecting subtle brain injuries. Continuous approvals of such advanced technologies by regulatory bodies, including the U.S. Food and Drug Administration, play a pivotal role in accelerating their clinical adoption.

Regional Insights

North America maintains a leading position in the traumatic brain injury assessment and management devices market due to a high incidence of head trauma from sports and vehicle accidents. The region benefits from established healthcare infrastructure and substantial government support for neurological research. Additionally, the presence of major medical device manufacturers allows for wider product availability and distribution. The U.S. Food and Drug Administration facilitates market growth through clear pathways for device clearance, which encourages consistent product adoption. This combination of strong industry presence and regulatory support cements North America’s status as the primary regional market.

Recent Developments

• In June 2025, BrainScope launched a next-generation deep learning platform designed to enhance the analysis of brain electrical activity for neurological assessments. This advanced technology was integrated into the company's FDA-cleared EEG-based medical device to improve the detection and evaluation of brain health conditions, including concussions and structural brain injuries. The new platform aimed to deliver faster, more objective insights at the point of care by leveraging artificial intelligence to interpret complex EEG data. This launch was intended to eliminate the need for specialized interpretation and support more precise clinical decision-making in emergency and military environments.
• In February 2025, Sway Medical announced that it received U.S. FDA 510(k) clearance for its mobile platform as a Computerized Cognitive Assessment Aid for Concussion. This regulatory milestone recognized the system as a fully integrated tool combining both cognitive and balance testing capabilities into a single product for concussion management. The clearance validated the platform's utility in detecting subtle changes in patient performance following a head injury. This approval provided healthcare professionals and athletic trainers with a comprehensive, clinically validated solution to assess and track concussion recovery using standard mobile devices, aligning with modern multi-modal testing protocols.
• In May 2024, bioMérieux announced that it received U.S. FDA 510(k) clearance for its VIDAS TBI (GFAP, UCH-L1) assay. This serum-based diagnostic test was designed to measure specific biomarkers associated with brain injury to aid in the assessment of patients with suspected mild traumatic brain injury. By measuring the concentration of these proteins, the test helped clinicians predict the absence of acute intracranial lesions, thereby potentially reducing the number of unnecessary head CT scans performed in emergency departments. This development represented a significant expansion of the company's immunoassay portfolio and aimed to improve patient management workflows in acute care environments.
• In April 2024, Abbott obtained U.S. Food and Drug Administration (FDA) clearance for its i-STAT Traumatic Brain Injury (TBI) cartridge to be used with whole blood samples. This approval allowed healthcare providers to assess patients with suspected mild traumatic brain injuries, or concussions, directly at the bedside without needing plasma separation in a laboratory. The portable test delivered lab-quality results in approximately 15 minutes, enabling clinicians to quickly evaluate patients up to 24 hours after an injury. By providing rapid objective data, the device helped medical staff determine the need for CT scans and facilitated faster triage decisions in urgent care settings.

Key Market Players

• Integra LifeSciences Corp
• BioDirection Inc
• Nihon Kohden Tokyo Corp
• Compumedics Ltd
• InfraScan Inc
• Oculogica Inc
• RAUMEDIC AG

By Devices	By Technique	By End-Use	By Region
Imaging Devices (Magnetic Resonance Imaging (MRI) Devices, X-Ray, Computed Tomography, Others) Monitoring Devices	Intracranial pressure monitoring Partial pressure of oxygen in brain tissue (pBrO2)	Hospitals Diagnostic centers Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Traumatic Brain Injuries Assessment And Management Devices Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Traumatic Brain Injuries Assessment And Management Devices Market, By Devices:

• Imaging Devices (Magnetic Resonance Imaging (MRI) Devices, X-Ray, Computed Tomography, Others)
• Monitoring Devices

• Traumatic Brain Injuries Assessment And Management Devices Market, By Technique:

• Intracranial pressure monitoring
• Partial pressure of oxygen in brain tissue (pBrO2)

• Traumatic Brain Injuries Assessment And Management Devices Market, By End-Use:

• Hospitals
• Diagnostic centers
• Others

• Traumatic Brain Injuries Assessment And Management Devices Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE