Neuromodulation devices are used for regulating the nervous system, either to correct an abnormality in the system or to treat a condition. The devices consist of a pulse generator, leads and electrodes. The electrodes are connected to the desired stimulation area on one end and the pace generator on the other using leads. The pulse generator delivers small pulses of electricity from an internal battery to regulate the activity of the indicated nerve. This report covers the markets for spinal cord stimulators (SCSs), vagus nerve stimulators (VNSs), deep brain stimulators (DBSs), gastric electric stimulators (GESs) and sacral nerve stimulators (SNSs).
Market growth will be propelled by wider acceptance of neuromodulation products, allowing them to be used on a larger proportion of potential patients. In addition, many neuromodulation patients require multiple devices over their lifetimes because the battery life of neuromodulation devices are limited, ranging from three to ten years. Furthermore, the neuromodulation market had a relatively low penetration rate in 2016 and therefore has excellent growth potential. The GES market will be the slowest growing segment in the neuromodulation device market because the procedure has not gained widespread acceptance and the device only has humanitarian device exemption (HDE) status, limiting its usage to 4,000 units per year. The fastest growing segment is projected to be the DBS market. This market will benefit from the expected entry of new competitors into the market, which will lead to increasing ASP and unit sales through the established sales network of St. Jude Medical and potentially Boston Scientific.
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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 Neuromodulation Devices 48
3.1.1.1 Introduction 48
3.1.1.2 Spinal Cord Stimulators 48
3.1.1.3 Vagus Nerve Stimulators 49
3.1.1.4 Deep Brain Stimulators 50
3.1.1.5 Gastric Electric Stimulators 52
3.1.1.6 Sacral Nerve Stimulators 52
3.1.1.7 Product Matrix for Neuromodulation Device Market: Core Companies 54
3.2 REGULATORY ISSUES AND RECALLS 55
3.2.1 Neuromodulation Devices 55
3.3 CLINICAL TRIALS 57
3.3.1 Neuromodulation Devices 57
NEUROMODULATION DEVICE MARKET 59
4.1 INTRODUCTION 59
4.1.1 Spinal Cord Stimulators 59
4.1.2 Vagus Nerve Stimulators 60
4.1.3 Deep Brain Stimulators 62
4.1.4 Gastric Electric Stimulators 63
4.1.5 Sacral Nerve Stimulators 64
4.2 MARKET OVERVIEW 66
4.3 MARKET ANALYSIS AND FORECAST 70
4.3.1 Total Neuromodulation Device Market 70
4.3.2 Spinal Cord Stimulator Market 72
4.3.2.1 Spinal Cord Stimulator Implants by Application 75
4.3.3 Vagus Nerve Stimulator Market 76
4.3.4 Deep Brain Stimulator Market 79
4.3.5 Gastric Electric Stimulator Market 82
4.3.6 Sacral Nerve Stimulator Market 85
4.4 DRIVERS AND LIMITERS 88
4.4.1 Spinal Cord Stimulator Market 88
4.4.1.1 Market Drivers 88
4.4.1.2 Market Limiters 89
4.4.2 Vagus Nerve Stimulator Market 92
4.4.2.1 Market Drivers 92
4.4.2.2 Market Limiters 92
4.4.3 Deep Brain Stimulator Market 94
4.4.3.1 Market Drivers 94
4.4.3.2 Market Limiters 94
4.4.4 Gastric Electric Stimulator Market 96
4.4.4.1 Market Drivers 96
4.4.4.2 Market Limiters 96
4.4.5 Sacral Nerve Stimulator Market 98
4.4.5.1 Market Drivers 98
4.4.5.2 Market Limiters 98
4.5 COMPETITIVE MARKET SHARE ANALYSIS 100
ABBREVIATIONS 106
APPENDIX: COMPANY PRESS RELEASES 109
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: Neuromodulation Device Market by Segment, U.S., 2013 – 2023 68
Chart 4 2: Neuromodulation Device Market Breakdown, U.S., 2016 69
Chart 4 3: Neuromodulation Device Market Breakdown, U.S., 2023 69
Chart 4 4: Total Neuromodulation Device Market, U.S., 2013 – 2023 71
Chart 4 5: Spinal Cord Stimulator Market, U.S., 2013 – 2023 74
Chart 4 6: Vagus Nerve Stimulator Market, U.S., 2013 – 2023 78
Chart 4 7: Deep Brain Stimulator Market, U.S., 2013 – 2023 81
Chart 4 8: Gastric Electric Stimulator Market, U.S., 2013 – 2023 84
Chart 4 9: Sacral Nerve Stimulator Market, U.S., 2013 – 2023 87
Chart 4 10: Leading Competitors, Neuromodulation Device Market, U.S., 2016 105
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: RestoreSensor and RestoreSensor SureScan, Medtronic Neuromodulation 55
Figure 3 2: Class 2 Device Recall: DBS Pocket Adaptor, Medtronic Neuromodulation 55
Figure 3 3: Class 2 Device Recall: Specify neurostimulation leads, Medtronic Neuromodulation 55
Figure 3 4: Class 2 Device Recall: Itrel 3 IPG; InterStim II INS: InterStim INS ; Enterra INS 56
Figure 3 5: Class 2 Device Recall: Percutaneous Trial Lead Kits, St. Jude Medical, Inc. 56
Figure 3 6: Class 2 Device Recall: Brio DBS System, Advanced Neuromodulation Systems Inc. 56
Figure 3 7: Class 2 Device Recall: RestoreUltra and RestoreSensor, Medtronic Neuromodulation 56
Figure 3 8: Neuromodulation device: The Motor Network in Essential Tremor: Mechanisms of Therapy 57
Figure 3 9: Neuromodulation device: Treatment of Bipolar Depression With H1-Coil Deep Brain rTMS 57
Figure 3 10: Neuromodulation device: A Pilot Study of Deep Brain Stimulation of the Amygdala 58
Figure 3 11: Neuromodulation device: MAPS Trial: Matrix And Platinum Science (MAPS) 58
Figure 4 1: Neuromodulation Device by Segment, U.S., 2013 – 2023 (US$M) 67
Figure 4 2: Total Neuromodulation Device Market, U.S., 2013 – 2023 70
Figure 4 3: Spinal Cord Stimulator Market, U.S., 2013 – 2023 73
Figure 4 4: Spinal Cord Stimulator Implants by Application, U.S., 2016 75
Figure 4 5: Vagus Nerve Stimulator Market, U.S., 2013 – 2023 77
Figure 4 6: Deep Brain Stimulator Market, U.S., 2013 – 2023 80
Figure 4 7: Gastric Electric Stimulator Market, U.S., 2013 – 2023 83
Figure 4 8: Sacral Nerve Stimulator Market, U.S., 2013 – 2023 86
Figure 4 9: Drivers and Limiters, Spinal Cord Stimulator Market, U.S., 2016 91
Figure 4 10: Drivers and Limiters, Vagus Nerve Stimulator Market, U.S., 2016 93
Figure 4 11: Drivers and Limiters, Deep Brain Stimulator Market, U.S., 2016 95
Figure 4 12: Drivers and Limiters, Gastric Electric Stimulator Market, U.S., 2016 97
Figure 4 13: Drivers and Limiters, Sacral Nerve Stimulator Market, U.S., 2016 99
Figure 4 14: Leading Competitors, Neuromodulation Device Market, U.S., 2016 104
Figure 6 1: Press Release Summary 109
Medtronic
Boston Scientific
St. Jude Medical
Cyberonics
Codman & Shurtleff
Stryker
Integra LifeSciences
InoMed
Mizuho America
RauMedic
