Implantable neurostimulation systems typically consist of three implantable components (the extension, lead, and power source) and two external components (the control magnet and a handheld programmer). The extension is used to connect the lead to the power source, and the lead is used to deliver the electrical stimulation to the targeted nerve(s).
For the purposes of this report, the total U.S. market for implantable neurostimulation devices includes sales derived from systems for 8 therapy segments, including the 5 core, established areas of deep brain stimulation (DBS), gastric nerve stimulation (GNS), spinal cord stimulation (SCS), sacral nerve stimulation (SNS), and vagus nerve stimulation (VNS), as well as neural prostheses (cochlear and recently launched retinal implants) and newly FDA-approved Vagal Blocking (VBLOC) therapy, for the treatment of obesity.
The large and burgeoning market for implantable neurostimulation devices in the U.S. has reached nearly $2.3 billion in 2014. Despite the lingering economic uncertainty and financial constraints that have affected many other medical device markets, this market is undergoing significant technological advancement due to heavy R&D and investment efforts by dozens of startups and leading medical device companies. The market is expected to experience high single-digit growth over the next half-decade, with many industry experts expecting its value to rival the multibillion-dollar markets for implantable defibrillators and coronary stents. A major reason for such optimism is not only the products' clinical and commercial success thus far, but also the need for more effective treatments for the large population of patients who suffer from debilitating, chronic, incurable conditions that require the long-term management of symptoms.
This dynamic, new report from Medtech Insight includes analyses of dozens of selected products, current/forecast markets (from 2014-2019), disease prevalence, competitors, market share by supplier, and opportunities in the U.S. Neurostimulation Devices Market. Specifically, this report covers leading and emerging implantable neurostimulation devices and next-generation technologies, as well as increasingly competitive less invasive or nonsurgical therapies, such as transcutaneous electrical nerve stimulation (TENS), peripheral nerve stimulation (PNS), transcutaneous magnetic stimulation (TMS), and external trigeminal nerve stimulation (eTNS).
EXECUTIVE SUMMARY i. Implantable Neurostimulation Devices Market ii. Methodology Exhibit ES-1: Estimated U.S. Prevalence of Selected Neurological Conditions Exhibit ES-2: 2014, Implantable Neurostimulation Devices Market, Estimated Percentage of Sales, by Type of Therapy Exhibit ES-3: 2015, Leading Competitors and Products in the Implantable Neurostimulation Devices Market 1. NEUROSTIMULATION TECHNOLOGIES OVERVIEW 1.1 Implantable Neurostimulators 1.1.1 Deep Brain Stimulators 1.1.2 Gastric Nerve Stimulators 1.1.3 Sacral Nerve Stimulators 1.1.4 Spinal Cord Stimulators 1.1.5 Vagus Nerve Stimulators 1.1.6 Vagal Blocking for Obesity 1.1.7 Cochlear Implants 1.1.8 Retinal Implants 1.2 Noninvasive Peripheral Nerve Stimulation 1.3 Transcutaneous Electrical Nerve Stimulation 1.4 Closed-Loop Stimulation 1.5 Hypoglossal Nerve Stimulation 1.6 Transcutaneous Magnetic Stimulation 1.7 External Trigeminal Nerve Stimulation Exhibit 1-1: Estimated U.S. Prevalence of Selected Neurological Conditions Exhibit 1-2: Selected Advantages and Disadvantages of Neurostimulation Therapy Exhibit 1-3: Estimated Number of Neurostimulation Implants, by Selected Neurological Condition Exhibit 1-4: Schematic Illustration of Deep Brain Stimulation 2. NEUROSTIMULATION DEVICES 2.1.1 Alzheimer's Disease 22.214.171.124 Beijing Pins Medical Co., Ltd. 126.96.36.199 The Magstim Company 188.8.131.52 Functional Neuromodulation Ltd. 2.1.2 Attention-Deficit/Hyperactivity Disorder 184.108.40.206 Brainsway 220.127.116.11 NeuroSigma 2.1.3 Autism 18.104.22.168 Brainsway 22.214.171.124 MagVenture A/S 2.1.4 Blindness 126.96.36.199 Bionic Vision Australia 188.8.131.52 Pixium Vision 184.108.40.206 Retina Implant AG 220.127.116.11 Second Sight Medical Products 2.1.5 Chronic Depression 18.104.22.168 Brainsway Ltd. 22.214.171.124 Cyberonics/Sorin Group 126.96.36.199 Fisher Wallace 188.8.131.52 MagVenture A/S 184.108.40.206 Medtronic 220.127.116.11 Neuronetics 18.104.22.168 NeuroSigma 22.214.171.124 St. Jude Medical 126.96.36.199 Others 2.1.6 Chronic Heart Failure 188.8.131.52 BioControl Medical 184.108.40.206 Cyberonics/Sorin Group 220.127.116.11 Medtronic 18.104.22.168 St. Jude Medical 2.1.7 Chronic Migraine Headache 22.214.171.124 Boston Scientific 126.96.36.199 Medtronic 188.8.131.52 St. Jude Medical 184.108.40.206 Others (Cluster Headache/Migraine) 220.127.116.11.1 Autonomic Technologies, Inc. 18.104.22.168.2 ElectroCore, LLC 2.1.8 Chronic Pain 22.214.171.124 Boston Scientific 126.96.36.199 Medtronic 188.8.131.52 St. Jude Medical 184.108.40.206.1 Spinal Modulation/St. Jude Medical 220.127.116.11.2 Neurotherm/St. Jude Medical 18.104.22.168 Others 22.214.171.124.1 Bioness, Inc. 126.96.36.199.2 Mainstay Medical 188.8.131.52.3 NeuroMetrix 184.108.40.206.4 Neuros Medical 220.127.116.11.5 Nevro Corp. 18.104.22.168.6 Saluda Medical 22.214.171.124.7 SPR Therapeutics 126.96.36.199.8 Stimwave Technologies, Inc. 2.1.9 Dystonia, Essential Tremor, and Parkinson's Disease 188.8.131.52 Boston Scientific 184.108.40.206 Medtronic 220.127.116.11 St. Jude Medical 2.1.10 Epilepsy 18.104.22.168 Beijing Pins Medical Co., Ltd 22.214.171.124 Cerbomed GmbH 126.96.36.199 CerebralRx/BioControl Medical 188.8.131.52 Cyberonics/Sorin Group 184.108.40.206 Electrical Geodesics, Inc. 220.127.116.11 Medtronic plc 18.104.22.168 NeuroPace 22.214.171.124 NeuroSigma 126.96.36.199 NeuroVista/Cyberonics 2.1.11 Foot Drop 188.8.131.52 Bioness, Inc. 2.1.12 Gastro-Esophageal Reflux Disease 184.108.40.206 EndoStim 2.1.13 Gastroparesis 220.127.116.11 Medtronic 2.1.14 Hearing Loss 18.104.22.168 Advanced Bionics AG/Sonova Group 22.214.171.124 Cochlear, Ltd. 126.96.36.199 MED-EL 2.1.15 Incontinence 188.8.131.52 Medtronic 184.108.40.206 Advanced Uro-Solutions/Medtronic 220.127.116.11 Bioness, Inc. 18.104.22.168 Cogentix Medical (Uroplasty/Vision-Sciences) 2.1.16 Obesity 22.214.171.124 EnteroMedics 126.96.36.199 MetaCure 2.1.17 Obsessive-Compulsive Disorder 188.8.131.52 Medtronic 2.1.18 Sleep Apnea 184.108.40.206 ImThera Medical 220.127.116.11 Inspire Medical Systems 18.104.22.168 Respicardia 22.214.171.124 Others 2.1.19 Spinal Cord Injury/Paralysis 126.96.36.199 BrainGate Research Team 188.8.131.52 Synapse Biomedical 2.1.20 Stroke 184.108.40.206 MicroTransponder 2.1.21 Tinnitus 220.127.116.11 Brainsway 18.104.22.168 Medtronic 22.214.171.124 MicroTransponder Exhibit 2-1: Functional Neuromodulation's DBS-f Technology and Early Clinical Results Exhibit 2-2: NeuroSigma's Monarch eTNS system Exhibit 2-3: MagVenture's MagPro100x System Utilized in Repetitive Transcranial Magnetic Stimulation Exhibit 2-4: Bionic Vision Australia's Retinal Stimulation Technology Exhibit 2-5: Pixium Vision's Bio-Mimetic Camera Exhibit 2-6: Retina Implant's Subretinal Implant Technology Exhibit 2-7: Second Sight Medical Product's Argus II Retinal Prosthesis System Exhibit 2-8: The Fisher Wallace Stimulator Exhibit 2-9: MagVenture's MagVita TMS Therapy system for the Treatment of Depression Exhibit 2-10: Neuronetic's NeuroStar TMS Therapy System for the Treatment of Depression Exhibit 2-11: BioControl Medical's CardioFit Stimulator Exhibit 2-12: Autonomic Technologies' ATI Neurostimulation System Exhibit 2-13: ElectroCore's Self-Administered gammaCore nVNS System for Treatment of Chronic Cluster Headache and Migraine Exhibit 2-14: Boston Scientific's Precision Spectra SCS System Exhibit 2-15: Medtronic's RestoreSensor with SureScan MRI Technology for the Treatment of Chronic Pain Exhibit 2-16: St. Jude Medical's New Prodigy System with Burst Technology for Improved Pain Management Exhibit 2-17: St. Jude Medical's Eon Neurostimulators for the Treatment of Chronic Pain Exhibit 2-18: St. Jude Medical's Constant Current Circuitry Technology Exhibit 2-19: Clinical Results: a 50% Reduction in Back and Leg Pain after 2 Years in Patients Receiving St. Jude Medical's Rechargeable Eon Neurostimulator Exhibit 2-20: Neurotherm's Radiofrequency Ablation Technology Application to the Facet Joint in the Spine Exhibit 2-21: NeuroMetrix's SENSUS Pain Management System for the Treatment of Chronic Intractable Pain Exhibit 2-22: Neuros Medical's Altius System High Frequency Nerve Block Technology for the Treatment of Chronic, Peripheral Pain Exhibit 2-23: Nevro's Senza SCS System Exhibit 2-24: SPR Therapeutic's Smartpatch PNS System for the Treatment of Chronic Shoulder Pain Exhibit 2-25: Stimwave Technologies' FREEDOM SCS System Wireless Pain Relief Technology Exhibit 2-26: Medtronic's Activa Neurostimulator for the Treatment of Parkinson's Disease and Essential Tremor Exhibit 2-27: Cerbomed's Noninvasive NEMOS t-VNS Device for Treatment of Refractory Epilepsy Exhibit 2-28: Cyberonic's/Sorin Group's VNS Therapy System for the Treatment of Epilepsy Exhibit 2-29: NeuroPace's RNS/Responsive Neurostimulation for the Suppression of Epileptic Seizures Exhibit 2-30: NeuroVista/Cyberonic's Seizure Advisory System for the Prediction of Epileptic Seizures Exhibit 2-31: Bioness' L300 Foot Drop FES System Exhibit 2-32: The Enterra II Gastric Neurostimulator for the Treatment of Gastroparesis Exhibit 2-33: Advanced Bionic's HiRes 90K Implant System for the Treatment of Hearing Loss Exhibit 2-34: Cochlear Ltd.'s Nucleus 6 Sound Processor and Function of Cochlear Implant System Exhibit 2-35: MED-EL's MAESTRO and SYNCHRONY Cochlear Implant Systems Exhibit 2-36: Medtronic's InterStim Therapy System for the Treatment of Incontinence Exhibit 2-37: Cogentix Medical's Urgent PC System for the Treatment of Overactive Bladder Exhibit 2-38: EnteroMedics' Maestro System Exhibit 2-39: Overview of EnteroMedics' VBLOC Therapy and Vagus Nerve Function Exhibit 2-40: Potential Benefits and Risks of VBLOC Therapy Exhibit 2-41: Comparison of VBLOC Therapy, Laparoscopic Banding, and Gastric Bypass Exhibit 2-42: MetaCure's DIAMOND (TANTALUS) Gastric Stimulation System Exhibit 2-43: The aura6000 System for the Treatment of Obstructive Sleep Apnea Exhibit 2-44: Inspire Medical System's Inspire II System for the Treatment of Obstructive Sleep Apnea Exhibit 2-45: An Illustration of Normal and Abnormal Breathing Patterns in Patients with Central Sleep Apnea Exhibit 2-46: Synapse Biomedical's NeuRx Diaphragm Pacing System Exhibit 2-47: MicroTransponder's Serenity System for the Treatment of Tinnitus 3. IMPLANTABLE NEUROSTIMULATION DEVICES MARKET 3.1 Market Forecast 3.2 Competitive Analysis 3.2.1 Market Share 126.96.36.199 Medtronic plc 188.8.131.52 Boston Scientific 184.108.40.206 St. Jude Medical 220.127.116.11 Cyberonics/Sorin Group 3.3 Emerging Neurostimulation Technologies 3.3.1 Nevro Corp. 3.3.2 Stimwave 3.3.3 Peripheral Nerve Stimulation 18.104.22.168 Bioness 22.214.171.124 Autonomic Technologies, Inc. Exhibit 3-1: Selected Market Drivers and Limiters for Implantable Neurostimulation Devices Exhibit 3-2: Implantable Neurostimulation Devices, Combined Market Forecast, 2014-2019 Exhibit 3-3: 2014, Implantable Neurostimulation Devices Market, Estimated Percentage of Sales, by Type of Therapy Exhibit 3-4: U.S. Neurostimulation Devices Market Forecast, by Therapy Segment, 2014-2019 Exhibit 3-5: 2015, Leading Competitors and Products in the Implantable Neurostimulation Devices Market Exhibit 3-6: 2015-2019, Next-Generation Implantable Neurostimulation Systems Pending FDA Approval for Core Indications Exhibit 3-7: 2014, Combined Implantable Neurostimulation Devices Market, Share by Supplier Exhibit 3-8: 2014, Implantable Neurostimulation Devices Market (DBS/GNS/SCS/SNS/VNS Market, Excluding Cochlear & Retinal Implants), Share by Supplier Exhibit 3-9: 2014, Implantable SCS Devices Market, Share by Supplier Exhibit 3-10: 2014, Cochlear Implants Market, Share by Supplier Exhibit 3-11: Selected Recently FDA-Approved (Implantable/External) Neurostimulation Devices, 2013-2015 Exhibit 3-12: Selected Implantable Neurostimulation Devices Expected to Launch in 2015-2016 Exhibit 3-13: Selected (Implantable/External) Neurostimulation Devices Expected to Launch in 2017-2019 APPENDIX A: COMPANY LISTING APPENDIX B: BIBLIOGRAPHY