The cerebrospinal fluid (CSF) acts as a cushion between the brain and the skull. In healthy individuals, it is circulated though the brain and its ventricles, the spine and the circulatory system. However, there are cases where the amount of CSF surrounding the brain changes significantly. As a result, intracranial pressure (ICP) can increase to damaging levels. ICP monitoring devices can be used to monitor the ICP of patients that have hydrocephalus, head trauma, brain surgery, intracranial tumors, increased venous pressure, hepatic encephalopathy and cerebral edema. Elevated ICP carries a mortality rate of around 20% therefore the rapid recognition of elevated ICP is important so therapies to lower this pressure can be initiated. ICP is monitored to ensure maintenance of an ideal pressure level.
The market value for this segment includes external and internal transducers for ICP monitoring and advanced sensors for measuring other parameters as well as their monitors. It also includes disposals such as the catheters used for external drainage and ICP monitoring and cranial access kits. The total value does not include research-based sales revenue or pole mount assemblies and other accessories. In the United States, it is still more common to measure ICP with external transducers in conjunction with external drainage systems. The ASP for internal sensors and monitors is significantly more and any move towards that technology will drive growth in the market and lead to an appreciation in ASP. Internal and external transducers are expected to experience steady growth over the projected period. There will be slight growth in the use of advanced sensors and their monitors as well. The ASP on the advanced sensors and monitors with additional parameters will increase as they become more technologically advanced and the ASP on the basic ICP monitors will decline slightly over the forecast period.
'
TABLE OF CONTENTS I
LIST OF FIGURES X
LIST OF CHARTS XII
EXECUTIVE SUMMARY 1
U.S. NEUROMODULATION, NEUROVASCULAR, NEUROSURGICAL AND MONITORING DEVICE MARKET OVERVIEW 1
COMPETITIVE ANALYSIS 4
MARKET TRENDS 8
MARKET DEVELOPMENTS 11
PROCEDURE NUMBERS 12
PROCEDURE CODES INVESTIGATED 13
MARKETS INCLUDED 15
KEY REPORT UPDATES 17
VERSION HISTORY 17
RESEARCH METHODOLOGY 18
1.1 RESEARCH SCOPE 18
1.2 IDATA’S 9-STEP METHODOLOGY 18
Step 1: Project Initiation & Team Selection 18
Step 2: Prepare Data Systems and Perform Secondary Research 20
Step 3: Preparation for Interviews & Questionnaire Design 21
Step 4: Performing Primary Research 22
Step 5: Research Analysis: Establishing Baseline Estimates 24
Step 6: Market Forecast and Analysis 25
Step 7: Identify Strategic Opportunities 27
Step 8: Final Review and Market Release 28
Step 9: Customer Feedback and Market Monitoring 29
DISEASE OVERVIEW 30
2.1 BASIC ANATOMY 30
2.2 DISEASE PATHOLOGY AND DISORDERS 32
2.2.1 Introduction 32
2.2.2 General Diagnostics and Neurosurgery 34
2.2.3 Tumor and Brain Cancer 36
2.2.4 Brain Arteriovenous Malformations 38
2.2.5 Ischemic Stroke 39
2.2.6 Brain Aneurysm 40
2.2.7 Disorders Related to Cerebrospinal Fluids and Intracranial Pressure 42
2.2.7.1 Hydrocephalus and Intracranial Pressure Disorder 42
2.2.7.2 Cerebral Edema 43
2.2.8 Indication for Neuromodulation 45
2.2.9 Traumatic brain injury 47
PRODUCT ASSESSMENT 48
3.1 PRODUCT PORTFOLIOS 48
3.1.1 Intracranial Pressure Monitoring 48
3.1.1.1 Introduction 48
3.1.1.2 Product Matrix for ICP Monitoring Market: Core Companies (1 of 2) 50
3.1.1.3 Product Matrix for ICP Monitoring Market: Core Companies (2 of 2) 51
3.2 REGULATORY ISSUES AND RECALLS 52
3.2.1 Intracranial Pressure (ICP) Monitoring 52
3.3 CLINICAL TRIALS 54
3.3.1 Intracranial Pressure Monitoring 54
INTRACRANIAL PRESSURE MONITORING DEVICE MARKET 59
4.1 INTRODUCTION 59
4.1.1 Common Indications 60
4.1.1.1 Hydrocephalus 60
4.1.1.2 Cerebral Edema 61
4.1.1.3 Head Trauma 61
4.1.2 Applications 61
4.1.3 Complications 62
4.2 MARKET OVERVIEW 63
4.3 MARKET ANALYSIS AND FORECAST 67
4.3.1 Total Intracranial Pressure Transducer System Market 67
4.3.1.1 Internal Intracranial Pressure Transducer System Market 70
4.3.1.2 External Intracranial Pressure Transducer System Market 72
4.3.2 Total Advanced ICP Monitoring Market 74
4.3.2.1 Advanced ICP Monitor Market 77
4.3.2.2 Monitor with Tissue O2 Saturation Market 79
4.3.2.3 Advanced ICP Sensor Market 81
4.3.3 Total Universal ICP Disposables Market 83
4.3.3.1 ICP Cranial Access Kit Market 85
4.3.3.2 ICP Catheter Market 87
4.4 DRIVERS AND LIMITERS 90
4.4.1 Market Drivers 90
4.4.2 Market Limiters 91
4.5 COMPETITIVE MARKET SHARE ANALYSIS 93
ABBREVIATIONS 97
APPENDIX: COMPANY PRESS RELEASES 100
Chart 1 1: Neurological Device Market by Segment, U.S., 2013 – 2023 3
Chart 1 2: Neurological Device Market Overview, U.S., 2016 & 2023 3
Chart 4 1: Intracranial Pressure Monitoring Device Market by Segment, U.S., 2013 – 2023 65
Chart 4 2: Intracranial Pressure Monitoring Device Market Breakdown, U.S., 2016 66
Chart 4 3: Intracranial Pressure Monitoring Device Market Breakdown, U.S., 2023 66
Chart 4 4: Total Intracranial Pressure Transducer System Market, U.S., 2013 – 2023 69
Chart 4 5: Internal Intracranial Pressure Transducer System Market, U.S., 2013 – 2023 71
Chart 4 6: External Intracranial Pressure Transducer System Market, U.S., 2013 – 2023 73
Chart 4 7: Total Intracranial Pressure Monitor Market, U.S., 2013 – 2023 76
Chart 4 8: Basic Intracranial Pressure Monitor Market, U.S., 2013 – 2023 78
Chart 4 9: Advanced Intracranial Pressure Monitor Market, U.S., 2013 – 2023 80
Chart 4 10: Advanced ICP Sensor Market, U.S., 2013 – 2023 82
Chart 4 11: Total Universal ICP Disposables Market, U.S., 2013 – 2023 84
Chart 4 12: ICP Cranial Access Kit Market, U.S., 2013 – 2023 86
Chart 4 13: ICP Catheter Market, U.S., 2013 – 2023 89
Figure 1 1: Neurological Device Market Share Ranking by Segment, U.S., 2016 (1 of 3) 5
Figure 1 2: Neurological Device Market Share Ranking by Segment, U.S., 2016 (2 of 3) 5
Figure 1 3: Neurological Device Market Share Ranking by Segment, U.S., 2016 (3 of 3) 6
Figure 1 4: Companies Researched in this Report, U.S., 2016 7
Figure 1 5: Factors Impacting the Neurological Device Market by Segment, U.S. (1 of 3) 8
Figure 1 6: Factors Impacting the Neurological Device Market by Segment, U.S. (2 of 3) 9
Figure 1 7: Factors Impacting the Neurological Device Market by Segment, U.S. (3 of 3) 10
Figure 1 8: Recent Events in the Neurological Device Market, U.S., 2014 – 2016 11
Figure 1 9: Neurological Device Markets Covered, U.S., 2016 12
Figure 1 10: Procedural Codes Investigated, U.S., 2016 (1 of 2) 13
Figure 1 11: Procedural Codes Investigated, U.S., 2016 (2 of 2) 14
Figure 1 12: Neurological Device Markets Covered, U.S., 2016 (1 of 2) 15
Figure 1 13: Neurological Device Markets Covered, U.S., 2016 (2 of 2) 16
Figure 1 14: Key Report Updates 17
Figure 1 15: Version History 17
Figure 2 1: Neurology Disease Overview 33
Figure 2 2: Brain/Other Nervous System Cancer Statistics by Type and Gender, U.S., 2016 37
Figure 3 1: Class 2 Device Recall: Intracranial pressure monitor 52
Figure 3 2: Class 2 Device Recall: Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting 52
Figure 3 3: Class 2 Device Recall: Integra Camino 1104 Intracranial Pressure (ICP) Monitoring 52
Figure 3 4: Class 2 Device Recall: Integra 53
Figure 3 5: Class 2 Device Recall: Integra Camino 1104 ICP Monitoring 53
Figure 3 6: Class 2 Device Recall: Codman 53
Figure 3 7: ICP Monitoring: Assessing the Accuracy and the Impact of Standard-practice Ventricular Drainage on ICP Measurements 54
Figure 3 8: ICP Monitoring: Non Invasive Measurements of Intracranial Pressure in Patients With Malignant Glioma (GMaPIC) 54
Figure 3 9: ICP Monitoring: Non-invasive Intracranial Pressure (ICP) Monitoring in Pediatric Patients 55
Figure 3 10: ICP Monitoring: Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion 55
Figure 3 11: ICP Monitoring: An Evaluation of Non-invasive ICP Monitoring 56
Figure 3 12: ICP Monitoring: An Evaluation of Non-Invasive ICP Monitoring 56
Figure 3 13: ICP Monitoring: Prospective Evaluation of the Non-invasive ICP HeadSense Monitor 57
Figure 3 14: ICP Monitoring: Non-invasive Brain Pressure Monitoring After Trauma or Hemorrhage 57
Figure 3 15: ICP Monitoring: NIMI-NICU: Non Invasive Monitoring of the Intracranial Pressure - NeuroIntensive Care Unit 58
Figure 4 1: Intracranial Pressure Monitoring Device Market by Segment, U.S., 2013 – 2023 (US$M) 64
Figure 4 2: Total Intracranial Pressure Transducer System Market, U.S., 2013 – 2023 68
Figure 4 3: Internal Intracranial Pressure Transducer System Market, U.S., 2013 – 2023 70
Figure 4 4: External Intracranial Pressure Transducer System Market, U.S., 2013 – 2023 72
Figure 4 5: Intracranial Pressure Monitor Market by Segment, U.S., 2013 – 2023 75
Figure 4 6: Advanced ICP Monitor Market, U.S., 2013 – 2023 77
Figure 4 7: Monitor with Tissue O2 Saturation Market, U.S., 2013 – 2023 79
Figure 4 8: Advanced ICP Sensor Market, U.S., 2013 – 2023 81
Figure 4 9: Universal ICP Disposables Market by Segment, U.S., 2013 – 2023 84
Figure 4 10: Leading Competitors, Intracranial Pressure Monitoring Device Market, U.S., 2016 95
Figure 6 1: Press Release Summary 100
Medtronic
Boston Scientific
St. Jude Medical
Cyberonics
Codman & Shurtleff
Stryker
Integra LifeSciences
InoMed
Mizuho America
RauMedic
