비침습적 두개내압 모니터링 장비 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the non-invasive intracranial pressure monitoring devices market size was valued at USD 372.57 million in 2025 and estimated to grow from USD 389.78 million in 2026 to reach USD 488.69 million by 2031, at a CAGR of 4.62% during the forecast period (2026-2031).

This report is Segmented by Device Type (Transcranial Doppler Ultrasonography, Tympanic Membrane Displacement, and More), Application (Traumatic Brain Injury, Intracerebral Hemorrhage, Meningitis, and More), End User (Hospitals, Neurology Clinics, and More), and Geography (North America, Europe, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Non-Invasive Intracranial Pressure Monitoring Devices Market Trends and Insights

Increasing Incidences of Neurological Disorders

More than 70 million people experience traumatic brain injury each year, and overall stroke rates are climbing in younger cohorts, creating sustained demand for continuous, non-invasive monitoring across acute, rehabilitation and home settings. Baseline cognitive testing for every new U.S. Army recruit since June 2024 highlights how military populations now require lifelong brain-health surveillance. The convergence of longer life expectancy with improved survival after severe events is enlarging the patient pool needing serial intracranial pressure checks without added surgical risk. Health systems consequently channel capital into devices that travel with patients across care environments, reinforcing volume growth for the non-invasive intracranial pressure monitoring devices market.

Rising Preference for Minimally & Non-Invasive Procedures

FDA clearance of the i-STAT TBI cartridge in 2024 exemplifies a regulatory tilt toward bedside diagnostics that bypass surgery while delivering rapid, reliable readings. Studies on Brain4care and similar platforms report mean absolute intracranial pressure errors around 3 mmHg, aligning closely with invasive probes and validating the technology in neurosurgical units. Economically, non-invasive pathways trim infection-related costs and reduce ICU length of stay, forming a persuasive value proposition for payers and clinicians alike. Patient advocacy groups amplify this momentum by challenging invasive use when harm-free substitutes exist. Collectively, these forces enlarge the non-invasive intracranial pressure monitoring devices market well beyond tertiary centers.

Lack of Trained Neuro-Sonographers

Effective transcranial Doppler demands mastery of cerebrovascular anatomy, optimal scale settings and nuanced waveform interpretation, skill sets still scarce outside academic centers. Certification pipelines remain thin, and sustained competence requires exposure to diverse pathologies. Workforce gaps translate into delayed studies, unequal access and, in turn, slower install-base growth for the non-invasive intracranial pressure monitoring devices market. Professional societies have launched standardized curricula, yet emerging economies continue to struggle with limited faculty pools and training equipment shortages.

Other drivers and restraints analyzed in the detailed report include:

1. Wider Adoption of Point-of-Care Ultrasound in ED/ICU
2. AI-Enabled Waveform Analytics Improving Diagnostic Accuracy
3. High Device Acquisition & Maintenance Costs

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Transcranial Doppler held a 37.05% non-invasive intracranial pressure monitoring devices market share in 2025 owing to its established role in vasospasm detection, stroke risk screening and bedside cerebral hemodynamics assessment. Automated waveform storage, portable form factors and protocol standardization have kept adoption robust. The segment benefits from extensive reimbursement coverage and clinician familiarity, anchoring the non-invasive intracranial pressure monitoring devices market size on a solid installed base.

Infrared pupillometry is set for an 11.05% CAGR through 2031 as short-wave infrared cameras deliver touchless readings through closed eyelids, expanding monitoring to sedated or intubated patients. Devices that calculate the Neurological Pupil Index provide objective early warnings of intracranial hypertension, reducing reliance on subjective light-reflex checks. Tympanic membrane displacement and optic-nerve diameter tools serve niche applications where specific anatomic windows or pediatric use dictate alternate approaches. MRI/CT-based estimates remain constrained by cost, radiation exposure and limited repeatability, but may support complex cases requiring multimodal confirmation. Continuous improvements in algorithmic fusion of Doppler and pupillometry promise hybrid platforms that elevate diagnostic confidence while trimming operator training demands.

Complete Report Scope:

• By Device Type
  • Transcranial Doppler Ultrasonography
  • Tympanic Membrane Displacement
  • Optic Nerve Sheath Diameter
  • MRI / CT-based Estimation
  • Infrared Pupillometry
  • Others
• By Application
  • Traumatic Brain Injury
  • Intracerebral Hemorrhage
  • Meningitis
  • Hydrocephalus
  • Stroke
  • Others
• By End User
  • Hospitals
  • Neurology Clinics
  • Ambulatory Surgical Centers
  • Home-care Settings
• Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America accounted for 37.90% of the non-invasive intracranial pressure monitoring devices market in 2025 amid sizable research budgets, robust reimbursement and the Department of Defense's USD 3.2 million grant to refine blast-TBI screening. FDA breakthrough-device pathways shorten time-to-market for innovators, while Level 1 trauma centers set clinical standards that ripple across community hospitals. Canada's single-payer environment supports steady device procurement, and Mexico's public-health expansions are adding advanced neuromonitoring units in select tertiary hubs.

Asia-Pacific is the fastest-growing region with an 8.11% CAGR to 2031, supported by rising traumatic injury rates, aging demographics and expanding critical-care capacity. China's revision of the National Medical Products Administration (NMPA) approval process is creating clearer on-ramps for imported and locally produced monitors. Japan and South Korea drive early adoption of AI-enhanced platforms, while India demonstrates high receptivity to cost-effective handheld Doppler solutions capable of operating in resource-sparse districts. Government health-tech incentives and local manufacturing tie-ups are expected to amplify installed bases.

Europe maintains a steady position, anchored by rigorous evidence-based guidelines and cross-border collaboration on multicenter trials exploring multimodal neuromonitoring. Germany, the United Kingdom and France lead acquisitions, whereas Southern and Eastern European systems embrace shared-service networks to pool capital expenditure. Medical Device Regulation (MDR) compliance has lengthened certification timelines yet boosts clinician confidence once devices clear review. Constrained budgets remain a headwind, but pan-EU research grants and vendor financing schemes help sustain device turnover.

1. Integra LifeSciences
2. Medtronic
3. RAUMEDIC
4. Sophysa
5. Spiegelberg
6. Natus Medical
7. Viasonix
8. NovaSignal
9. Nisonic
10. RIMED
11. Compumedics
12. Dragerwerk
13. Koninklijke Philips
14. Nihon Kohden
15. GE Healthcare
16. Brain4Care
17. HeadSense Medical
18. Luciole Medical
19. IRRAS AB
20. De Cranio Solutions

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Increasing Incidences Of Neurological Disorders
  • 4.2.2 Rising Preference For Minimally- & Non-Invasive Procedures
  • 4.2.3 Wider Adoption Of Point-Of-Care Ultrasound In ED/ICU
  • 4.2.4 Growing Use Of Multimodal Neuromonitoring Bundles
  • 4.2.5 AI-Enabled Waveform Analytics Improving Diagnostic Accuracy
  • 4.2.6 Military R&D Funding For Blast-TBI Screening Devices
• 4.3 Market Restraints
  • 4.3.1 Lack Of Trained Neuro-Sonographers
  • 4.3.2 High Device Acquisition & Maintenance Costs
  • 4.3.3 Variability In Non-Invasive Algorithm Accuracy
  • 4.3.4 Slow Reimbursement Code Expansion For Emergent Settings
• 4.4 Technological Outlook
• 4.5 Porter's Five Forces
  • 4.5.1 Threat of New Entrants
  • 4.5.2 Bargaining Power of Buyers
  • 4.5.3 Bargaining Power of Suppliers
  • 4.5.4 Threat of Substitutes
  • 4.5.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Device Type
  • 5.1.1 Transcranial Doppler Ultrasonography
  • 5.1.2 Tympanic Membrane Displacement
  • 5.1.3 Optic Nerve Sheath Diameter
  • 5.1.4 MRI / CT-based Estimation
  • 5.1.5 Infrared Pupillometry
  • 5.1.6 Others
• 5.2 By Application
  • 5.2.1 Traumatic Brain Injury
  • 5.2.2 Intracerebral Hemorrhage
  • 5.2.3 Meningitis
  • 5.2.4 Hydrocephalus
  • 5.2.5 Stroke
  • 5.2.6 Others
• 5.3 By End User
  • 5.3.1 Hospitals
  • 5.3.2 Neurology Clinics
  • 5.3.3 Ambulatory Surgical Centers
  • 5.3.4 Home-care Settings
• 5.4 Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
  • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 South Korea
    • 5.4.3.5 Australia
    • 5.4.3.6 Rest of Asia-Pacific
  • 5.4.4 Middle East and Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East and Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.3.1 Integra LifeSciences
  • 6.3.2 Medtronic plc
  • 6.3.3 RAUMEDIC
  • 6.3.4 Sophysa
  • 6.3.5 Spiegelberg
  • 6.3.6 Natus Medical
  • 6.3.7 Viasonix
  • 6.3.8 NovaSignal
  • 6.3.9 Nisonic
  • 6.3.10 RIMED
  • 6.3.11 Compumedics
  • 6.3.12 Dragerwerk
  • 6.3.13 Philips Healthcare
  • 6.3.14 Nihon Kohden
  • 6.3.15 GE Healthcare
  • 6.3.16 Brain4Care
  • 6.3.17 HeadSense Medical
  • 6.3.18 Luciole Medical
  • 6.3.19 IRRAS AB
  • 6.3.20 De Cranio Solutions

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment