U.S. NEUROSTIMULATION DEVICES MARKET

277 Pages | 67 Exhibits | 2015 Analysis | Forecasts Through 2019

OVERVIEW:
An estimated 200 million people in the United States (U.S.) experience some degree of neurological impairment over the course of a lifetime. Among the many neurological disorders are chronic pain (including migraine headache), epilepsy, hearing loss, incontinence, major depression, Parkinson's disease, sleep apnea, and visual impairment/blindness. Typically, the initial treatment option for these conditions is standard pharmacotherapy or surgery; however, neurostimulation is gaining in popularity as a viable alternative among many people in the U.S. and worldwide. The estimated number of neurostimulation implant procedures has more than doubled over the past decade, reaching more than 1 million worldwide.

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).

TABLE OF CONTENTS:
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
		2.1.1.1 Beijing Pins Medical Co., Ltd.
		2.1.1.2 The Magstim Company
		2.1.1.3 Functional Neuromodulation Ltd.
	2.1.2 Attention-Deficit/Hyperactivity Disorder
		2.1.2.1 Brainsway
		2.1.2.2 NeuroSigma
	2.1.3 Autism
		2.1.3.1 Brainsway
		2.1.3.2 MagVenture A/S
	2.1.4 Blindness
		2.1.4.1 Bionic Vision Australia
		2.1.4.2 Pixium Vision
		2.1.4.3 Retina Implant AG
		2.1.4.4 Second Sight Medical Products
	2.1.5 Chronic Depression
		2.1.5.1 Brainsway Ltd.
		2.1.5.2 Cyberonics/Sorin Group
		2.1.5.3 Fisher Wallace
		2.1.5.4 MagVenture A/S
		2.1.5.5 Medtronic
		2.1.5.6 Neuronetics
		2.1.5.7 NeuroSigma
		2.1.5.8 St. Jude Medical
		2.1.5.9 Others
	2.1.6 Chronic Heart Failure
		2.1.6.1 BioControl Medical
		2.1.6.2 Cyberonics/Sorin Group
		2.1.6.3 Medtronic
		2.1.6.4 St. Jude Medical
	2.1.7  Chronic Migraine Headache
		2.1.7.1 Boston Scientific
		2.1.7.2 Medtronic
		2.1.7.3 St. Jude Medical
		2.1.7.4 Others (Cluster Headache/Migraine)
 			2.1.7.4.1 Autonomic Technologies, Inc.
			2.1.7.4.2 ElectroCore, LLC
	2.1.8 Chronic Pain
		2.1.8.1 Boston Scientific
		2.1.8.2 Medtronic
		2.1.8.3 St. Jude Medical
			2.1.8.3.1 Spinal Modulation/St. Jude Medical
			2.1.8.3.2 Neurotherm/St. Jude Medical
		2.1.8.4 Others
			2.1.8.4.1 Bioness, Inc.
			2.1.8.4.2 Mainstay Medical
			2.1.8.4.3 NeuroMetrix
			2.1.8.4.4 Neuros Medical
			2.1.8.4.5 Nevro Corp.
			2.1.8.4.6 Saluda Medical
			2.1.8.4.7 SPR Therapeutics
			2.1.8.4.8 Stimwave Technologies, Inc.
	2.1.9 Dystonia, Essential Tremor, and Parkinson's Disease
		2.1.9.1 Boston Scientific
		2.1.9.2 Medtronic
		2.1.9.3 St. Jude Medical
	2.1.10 Epilepsy
		2.1.10.1 Beijing Pins Medical Co., Ltd
		2.1.10.2 Cerbomed GmbH
		2.1.10.3 CerebralRx/BioControl Medical
		2.1.10.4 Cyberonics/Sorin Group
		2.1.10.5 Electrical Geodesics, Inc.
		2.1.10.6 Medtronic plc
		2.1.10.7 NeuroPace
		2.1.10.8 NeuroSigma
		2.1.10.9 NeuroVista/Cyberonics
	2.1.11 Foot Drop
		2.1.11.1 Bioness, Inc.
	2.1.12 Gastro-Esophageal Reflux Disease
		2.1.12.1 EndoStim
	2.1.13 Gastroparesis
		2.1.13.1 Medtronic
	2.1.14 Hearing Loss
		2.1.14.1 Advanced Bionics AG/Sonova Group
		2.1.14.2 Cochlear, Ltd.
		2.1.14.3 MED-EL
	2.1.15 Incontinence
		2.1.15.1 Medtronic
		2.1.15.2 Advanced Uro-Solutions/Medtronic
		2.1.15.3 Bioness, Inc.
		2.1.15.4 Cogentix Medical (Uroplasty/Vision-Sciences)
	2.1.16 Obesity
		2.1.16.1 EnteroMedics
		2.1.16.2 MetaCure
	2.1.17 Obsessive-Compulsive Disorder
		2.1.17.1 Medtronic
	2.1.18 Sleep Apnea
		2.1.18.1 ImThera Medical
		2.1.18.2 Inspire Medical Systems
		2.1.18.3 Respicardia
		2.1.18.4 Others
	2.1.19 Spinal Cord Injury/Paralysis
		2.1.19.1 BrainGate Research Team
		2.1.19.2 Synapse Biomedical
	2.1.20 Stroke
		2.1.20.1 MicroTransponder
	2.1.21  Tinnitus
		2.1.21.1 Brainsway
		2.1.21.2 Medtronic
		2.1.21.3 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
		3.2.1.1 Medtronic plc
		3.2.1.2 Boston Scientific
		3.2.1.3 St. Jude Medical
		3.2.1.4 Cyberonics/Sorin Group
3.3 Emerging Neurostimulation Technologies
	3.3.1 Nevro Corp.
	3.3.2 Stimwave
	3.3.3 Peripheral Nerve Stimulation
		3.3.3.1 Bioness
		3.3.3.2 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


COMPANIES COVERED:

  1. Advanced Bionics Corporation/Sonova Group
  2. Autonomic Technologies, Inc.
  3. Beijing PINS Medical Co., Ltd
  4. BioControl Medical, Inc.
  5. Bioness, Inc.
  6. Bionic Vision Australia
  7. Boston Scientific Corporation
  8. BrainGate Research Team
  9. Brainsway Ltd.
  10. Cerbomed GmbH
  11. CerebralRX/BioControl Medical LTD
  12. Cochlear, LTD
  13. Cogentix Medical
  14. Cyberonics, Inc.
  15. Electrical Geodesics, Inc.
  16. ElectroCore, LLC
  17. EndoStim
  18. EnteroMedics, Inc.
  19. Epimed
  20. Fisher Wallace
  21. Functional Neuromodulation, Ltd.
  22. ImThera Medical, Inc.
  23. Inspire Medical Systems, Inc.
  24. The Magstim Company LTD
  25. MagVenture A/S
  26. Mainstay Medical
  27. MED-EL Corporation
  28. Medtronic plc
  29. MetaCure LTD
  30. MicroTransponder, Inc.
  31. NeuroMetrix, Inc.
  32. Neuronetics, Inc.
  33. NeuroPace, Inc.
  34. Neuros Medical, Inc.
  35. NeuroSigma, Inc.
  36. NeuroTherm, Inc.
  37. NeuroVista Corporation
  38. Nevro Corp.
  39. Pixium Vision
  40. Respicardia, Inc.
  41. Retina Implant AG
  42. Saluda Medical
  43. Second Sight Medical Products, Inc.
  44. Spinal Modulation, Inc.
  45. SPR Therapeutics LLC
  46. St. Jude Medical, Inc.
  47. Stimwave Technologies, Incorporated
  48. Synapse Biomedical, Inc.
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