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 18.104.22.168 Beijing Pins Medical Co., Ltd. 22.214.171.124 The Magstim Company 126.96.36.199 Functional Neuromodulation Ltd. 2.1.2 Attention-Deficit/Hyperactivity Disorder 188.8.131.52 Brainsway 184.108.40.206 NeuroSigma 2.1.3 Autism 220.127.116.11 Brainsway 18.104.22.168 MagVenture A/S 2.1.4 Blindness 22.214.171.124 Bionic Vision Australia 126.96.36.199 Pixium Vision 188.8.131.52 Retina Implant AG 184.108.40.206 Second Sight Medical Products 2.1.5 Chronic Depression 220.127.116.11 Brainsway Ltd. 18.104.22.168 Cyberonics/Sorin Group 22.214.171.124 Fisher Wallace 126.96.36.199 MagVenture A/S 188.8.131.52 Medtronic 184.108.40.206 Neuronetics 220.127.116.11 NeuroSigma 18.104.22.168 St. Jude Medical 22.214.171.124 Others 2.1.6 Chronic Heart Failure 126.96.36.199 BioControl Medical 188.8.131.52 Cyberonics/Sorin Group 184.108.40.206 Medtronic 220.127.116.11 St. Jude Medical 2.1.7 Chronic Migraine Headache 18.104.22.168 Boston Scientific 22.214.171.124 Medtronic 126.96.36.199 St. Jude Medical 188.8.131.52 Others (Cluster Headache/Migraine) 184.108.40.206.1 Autonomic Technologies, Inc. 220.127.116.11.2 ElectroCore, LLC 2.1.8 Chronic Pain 18.104.22.168 Boston Scientific 22.214.171.124 Medtronic 126.96.36.199 St. Jude Medical 188.8.131.52.1 Spinal Modulation/St. Jude Medical 184.108.40.206.2 Neurotherm/St. Jude Medical 220.127.116.11 Others 18.104.22.168.1 Bioness, Inc. 22.214.171.124.2 Mainstay Medical 126.96.36.199.3 NeuroMetrix 188.8.131.52.4 Neuros Medical 184.108.40.206.5 Nevro Corp. 220.127.116.11.6 Saluda Medical 18.104.22.168.7 SPR Therapeutics 22.214.171.124.8 Stimwave Technologies, Inc. 2.1.9 Dystonia, Essential Tremor, and Parkinson's Disease 126.96.36.199 Boston Scientific 188.8.131.52 Medtronic 184.108.40.206 St. Jude Medical 2.1.10 Epilepsy 220.127.116.11 Beijing Pins Medical Co., Ltd 18.104.22.168 Cerbomed GmbH 22.214.171.124 CerebralRx/BioControl Medical 126.96.36.199 Cyberonics/Sorin Group 188.8.131.52 Electrical Geodesics, Inc. 184.108.40.206 Medtronic plc 220.127.116.11 NeuroPace 18.104.22.168 NeuroSigma 22.214.171.124 NeuroVista/Cyberonics 2.1.11 Foot Drop 126.96.36.199 Bioness, Inc. 2.1.12 Gastro-Esophageal Reflux Disease 188.8.131.52 EndoStim 2.1.13 Gastroparesis 184.108.40.206 Medtronic 2.1.14 Hearing Loss 220.127.116.11 Advanced Bionics AG/Sonova Group 18.104.22.168 Cochlear, Ltd. 22.214.171.124 MED-EL 2.1.15 Incontinence 126.96.36.199 Medtronic 188.8.131.52 Advanced Uro-Solutions/Medtronic 184.108.40.206 Bioness, Inc. 220.127.116.11 Cogentix Medical (Uroplasty/Vision-Sciences) 2.1.16 Obesity 18.104.22.168 EnteroMedics 22.214.171.124 MetaCure 2.1.17 Obsessive-Compulsive Disorder 126.96.36.199 Medtronic 2.1.18 Sleep Apnea 188.8.131.52 ImThera Medical 184.108.40.206 Inspire Medical Systems 220.127.116.11 Respicardia 18.104.22.168 Others 2.1.19 Spinal Cord Injury/Paralysis 22.214.171.124 BrainGate Research Team 126.96.36.199 Synapse Biomedical 2.1.20 Stroke 188.8.131.52 MicroTransponder 2.1.21 Tinnitus 184.108.40.206 Brainsway 220.127.116.11 Medtronic 18.104.22.168 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 22.214.171.124 Medtronic plc 126.96.36.199 Boston Scientific 188.8.131.52 St. Jude Medical 184.108.40.206 Cyberonics/Sorin Group 3.3 Emerging Neurostimulation Technologies 3.3.1 Nevro Corp. 3.3.2 Stimwave 3.3.3 Peripheral Nerve Stimulation 220.127.116.11 Bioness 18.104.22.168 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