Non-invasive Intracranial Pressure Monitoring Devices Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Transcranial Doppler Ultrasonography, Tympanic Membrane Displacement (TMD), Optic Nerve Sheath Diameter, MRI/CT, Others), By Application (Traumatic Brain Injury, Intracerebral Hemorrhage, Meningitis, Subarachnoid Hemorrhage, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 414.03 Million
CAGR (2026-2031)	6.16%
Fastest Growing Segment	Meningitis
Largest Market	North America
Market Size (2031)	USD 592.65 Million

Market Overview

The Global Non-invasive Intracranial Pressure Monitoring Devices Market is projected to grow from USD 414.03 Million in 2025 to USD 592.65 Million by 2031 at a 6.16% CAGR. Non-invasive intracranial pressure monitoring devices are diagnostic instruments designed to measure pressure within the cranium without requiring surgical penetration or the insertion of sensors into brain tissue. These systems utilize advanced technologies such as optic nerve sheath diameter ultrasonography and transcranial Doppler to assess cerebrospinal fluid pressure safely and rapidly. The market is fundamentally supported by the critical need to mitigate risks associated with invasive procedures, including infection and hemorrhage, alongside a growing preference for bedside monitoring solutions that allow for early intervention in neurocritical care settings.

Despite these advantages, the sector faces a significant challenge regarding the comparative accuracy and reliability of these devices against invasive external ventricular drains, which remain the clinical gold standard. Inconsistencies in data precision can deter clinicians from relying solely on non-invasive readings for definitive treatment decisions. However, the expanding prevalence of neurological disorders continues to propel development and demand. According to the World Health Organization, in 2025, neurological conditions affected more than 40% of the worldwide population, representing a massive demographic requiring improved neurological management and diagnostics.

Key Market Drivers

The rising global incidence of traumatic brain injuries and stroke acts as a primary catalyst for the Global Non-invasive Intracranial Pressure Monitoring Devices Market. Elevated intracranial pressure requires frequent assessment, yet clinicians increasingly favor non-invasive modalities to avoid the infection risks associated with traditional invasive external ventricular drains. This demand is underscored by the immense economic and clinical burden of neurological conditions; according to the World Stroke Organization, in January 2025, the estimated global cost of stroke exceeded US$890 billion annually, highlighting the critical need for efficient, bedside management solutions. Furthermore, the market is expanding beyond the ICU into pediatric and sports settings where cumulative head trauma is a growing concern. According to the Centers for Disease Control and Prevention, in June 2025, the 12-month prevalence of sports- and recreation-related concussions in youth ranged between 7% and 15%, creating a substantial avenue for portable diagnostic adoption.

Concurrently, the integration of artificial intelligence for predictive analytics is enhancing the clinical viability of these devices. Manufacturers are leveraging machine learning to overcome the precision limitations of earlier optic nerve sheath assessments, creating algorithms that correlate physiological waveforms with intracranial pressure in real-time. This technological leap is essential for bridging the accuracy gap between non-invasive tools and the invasive gold standard. For instance, according to the Society of Vascular and Interventional Neurology, in December 2025, a fully automated non-invasive intracranial pressure diagnostic tool powered by artificial intelligence secured the SVINnovation prize. Such advancements in algorithmic accuracy are pivotal in building clinician confidence and facilitating broader implementation across modern neurocritical care infrastructures.

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Key Market Challenges

The primary impediment to the growth of the Global Non-invasive Intracranial Pressure Monitoring Devices Market is the comparative lack of accuracy and reliability when measured against the clinical gold standard of invasive external ventricular drains (EVDs). In neurocritical care, precise intracranial pressure data is vital for dictating immediate, life-saving interventions. Because non-invasive devices often rely on indirect surrogate markers, they are prone to variances that invasive sensors do not exhibit. Consequently, clinicians frequently regard these non-invasive metrics as insufficient for guiding definitive therapeutic measures, relegating the technology to a preliminary screening role rather than a primary monitoring tool.

This skepticism significantly restricts market penetration, particularly in high-acuity segments where precise management is non-negotiable. The high incidence of complex neurological pathologies underscores the missed market opportunity caused by these performance gaps. According to the 'Central Brain Tumor Registry of the United States', in '2025', 'an estimated 107,100 new cases of malignant and non-malignant brain and other CNS tumors were expected to be diagnosed in the United States'. For this substantial patient population, the inability of non-invasive systems to match the precision of invasive methods effectively excludes them from the core diagnostic workflow, directly limiting market expansion.

Key Market Trends

The emergence of wireless and wearable monitoring technologies is fundamentally reshaping the market by transitioning intracranial pressure assessment from episodic snapshots to continuous, non-invasive surveillance. Unlike traditional methods that require tethering patients to bedside monitors, these novel wearable sensors, such as cranial strain gauges, detect subtle skull expansions correlated with pressure changes, allowing for prolonged observation in diverse clinical environments. This capability is crucial for detecting transient pressure spikes that intermittent checks often miss, thereby enhancing patient safety profiles outside the intensive care unit. Validating this technological shift, according to Brain4Care, April 2025, in the 'Clinical Performance of the Brain4care System' report, their non-invasive wearable platform demonstrated a sensitivity of 92% for detecting intracranial hypertension, effectively ruling out elevated pressure without invasive risks.

Simultaneously, the technological evolution of optical and ultrasound-based methods is establishing standardized, rapid diagnostic protocols that rival invasive gold standards. Advanced ultrasonography of the optic nerve sheath diameter (ONSD) has matured into a reliable point-of-care tool, providing immediate, actionable data for triage in neurocritical care and emergency settings where invasive procedures are contraindicated or unavailable. This maturation is driving broader clinical adoption by replacing subjective assessments with quantified metrics. According to the World Federation of Neurosurgical Societies, March 2025, in the 'Insights from the B-ICONIC Consensus' report, a definitive optic nerve sheath diameter threshold of 6 mm was established as indicative of raised intracranial pressure, offering a unified metric to guide immediate therapeutic decisions.

Segmental Insights

The meningitis segment is identified as the fastest-growing category within the Global Non-invasive Intracranial Pressure Monitoring Devices Market due to the rising incidence of infectious brain diseases. Meningitis causes acute inflammation of the meninges, leading to critical elevations in intracranial pressure that require continuous assessment. Data from the World Health Organization regarding the persistent global burden of this condition underscores the urgent need for safer diagnostic tools. Consequently, medical professionals are prioritizing non-invasive monitoring to assess neurological status and guide treatment without the complications of infection or hemorrhage inherent in invasive catheterization.

Regional Insights

North America holds the leading position in the Global Non-invasive Intracranial Pressure Monitoring Devices Market, driven by established healthcare infrastructure and comprehensive trauma care protocols. This dominance is largely attributed to the significant incidence of traumatic brain injuries and neurological disorders, as indicated by data from the Centers for Disease Control and Prevention. Furthermore, the U.S. Food and Drug Administration maintains rigorous approval processes that foster clinical confidence and device reliability. This structured regulatory environment, alongside favorable reimbursement frameworks, accelerates the integration of non-invasive monitoring solutions into hospitals and specialized clinics throughout the region.

Recent Developments

• In November 2025, ClearPoint Neuro, Inc. completed the acquisition of IRRAS, a medical technology company specializing in neurocritical care. The transaction, valued at approximately $5.0 million in cash plus stock, integrated the IRRAflow active fluid-exchange system into ClearPoint Neuro’s portfolio. This acquisition expanded the company's capabilities in the management of intracranial bleeding and pressure monitoring, positioning it to offer a broader range of solutions in the neurocritical care market. The move consolidated the competitive landscape for intracranial pressure monitoring technologies, influencing the strategic environment for both invasive and non-invasive device developers.
• In February 2025, Children's National Hospital entered into a strategic collaboration with Compremium AG, a Swiss medical device company, to co-develop and commercialize non-invasive diagnostic technologies for pediatric patients. The partnership focuses on leveraging Compremium’s platform technology, which utilizes ultrasound and pressure sensing to diagnose pressure-related physiologies, including intracranial pressure, without invasive catheters. This initiative aims to establish the hospital as a pediatric innovation hub for the company, facilitating clinical studies and the development of non-invasive monitoring solutions tailored specifically for vulnerable pediatric populations with conditions such as congenital heart disease.
• In August 2024, Aesculap, Inc., in partnership with Christoph Miethke GmbH & Co. KG, announced that the U.S. FDA granted Breakthrough Device Designation for the M.scio System. This device is described as a non-invasive telemetric pressure measurement system designed to provide continuous, long-term monitoring of intracranial pressure for patients with hydrocephalus. The designation recognizes the system's potential to offer a more effective treatment or diagnosis for life-threatening conditions by enabling pressure measurement through a telemetric interface, thereby reducing the need for repeated invasive procedures to assess cerebrospinal fluid pressure dynamics.
• In July 2024, Brain4Care received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new sensor model compatible with its non-invasive intracranial pressure monitoring system. This regulatory milestone allowed the company to introduce an additional piezoelectric pressure sensor, model BcSs-PICNIW-2000, which is designed to detect skull deformations and provide surrogate intracranial pressure waveforms. The system, which includes a headband and mobile software application, is intended to monitor variations in intracranial pressure and compliance in patients with suspected neurological alterations, offering a non-invasive alternative to traditional invasive monitoring methods.

Key Market Players

• Medtronic plc
• Raumedic AG
• Integra LifeSciences Holdings Corporation
• Spiegelberg GmbH & Co. KG
• Natus Medical Incorporated
• Siemens Healthineers AG
• Sophysa SA
• NeuroWave Systems Inc.
• HeadSense Medical Ltd.
• BrainScope Company, Inc.

By Type	By Application	By Region
Transcranial Doppler Ultrasonography Tympanic Membrane Displacement (TMD) Optic Nerve Sheath Diameter MRI/CT Others	Traumatic Brain Injury Intracerebral Hemorrhage Meningitis Subarachnoid Hemorrhage Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Non-invasive Intracranial Pressure Monitoring Devices Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Non-invasive Intracranial Pressure Monitoring Devices Market, By Type:

• Transcranial Doppler Ultrasonography
• Tympanic Membrane Displacement (TMD)
• Optic Nerve Sheath Diameter
• MRI/CT
• Others

• Non-invasive Intracranial Pressure Monitoring Devices Market, By Application:

• Traumatic Brain Injury
• Intracerebral Hemorrhage
• Meningitis
• Subarachnoid Hemorrhage
• Others

• Non-invasive Intracranial Pressure Monitoring 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