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Non-Invasive Neurostimulation Devices Market, 2020-2030

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    Report

  • 294 Pages
  • September 2020
  • Region: Global
  • Roots Analysis
  • ID: 5201297

Overview

Over the past few decades, the prevalence of neurological disorders has been increasing at an alarming rate, particularly among the geriatric population across the world. In fact, a Global Burden of Disease study suggested that neurological conditions, which are often associated with serious physical, cognitive and psychosocial impairment, are currently considered among the major threats to public health. Presently, nearly one million Americans are reported to be living with Parkinson’s disease, and approximately 60,000 new cases are reported every year. Chronic pain is another debilitating condition, contributing to the global economic and healthcare burden. According to the Centers for Disease Control and Prevention, around 50 million individuals in the US suffer from some form of pain. This is estimated to account for a financial burden of USD 560 billion per year, including medical expenses and lost productivity. Although, there are several pharmacological options available for symptomatic relief, they are significantly limited in terms of providing long term solutions. For instance, long-term use of opioid drugs is associated with a high risk of addiction, eventually causing many patients to abuse such interventions. There are also some surgical procedures that are recommended in severe cases, but cannot provide permanent relief, often leading to further complications.

Over the years, advances in neurotechnology and neuroimaging, along with the growing understanding of neurocircuitry, have brought about noticeable disruption in this field. Leveraging the aforementioned intellectual capital, a variety of neurostimulation technologies focused on providing therapeutic relief have been developed. The first neurostimulation therapy was introduced in the 1960s. Since then, the benefits of neurostimulation technologies, such as their reversible and minimally invasive nature, targeted and adjustable therapeutic action, integrated safety mechanisms, and almost negligible dependence on opioids/oral medications, have been widely recognized. In fact, many such technologies are presently perceived to be viable alternatives to conventional treatment methods. Although they were initially considered a last resort for treatment, studies have shown neurostimulation devices to be capable of successfully providing therapeutic relief to medication-resistant patients. As a result, the adoption of these non-invasive solutions is on the rise in the US, EU and other parts of the world. Numerous partnerships have been inked amongst stakeholders in this domain, indicative to future growth of the market. Interestingly, start-ups/university spin-offs have been the flagbearers in this upcoming field of therapeutics and are also expected to sustain the research momentum, over the coming years.

Scope Of the Report

The ‘Non-Invasive Neurostimulation Devices Market, 2020-2030’ report features an extensive study of the current market landscape and the future potential of non-invasive neurostimulation devices in treating different chronic conditions. It features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain.

In addition to other elements, the study includes:


  • A detailed assessment of the overall landscape of the non-invasive neurostimulation devices market, highlighting the contribution of industry players and providing information on various types of non-invasive neurostimulation devices (transcutaneous electrical nerve stimulation (TENS), transcranial magnetic stimulation (TMS), electromagnetic stimulation (EMS), non-invasive vagus nerve stimulation (nVNS) and others), target therapeutic areas (pain management, inflammatory disorders, neurological disorders, psychological disorder, movement disorders and others), regulatory/development status (USFDA, CE Mark, Health Canada, TGA Australia, CFDA, MHLW and others), and the key device specifications, including number of stimulation modes, number of electrodes, size, weight, battery type, regulatory stance, professional assistance requirement and regulatory/reimbursement status.
  • An insightful competitiveness analysis of various non-invasive neurostimulation devices, including TENS, TMS, EMS, nVNS and others, taking into consideration the supplier power and product specifications.
  • Elaborate profiles of the key players developing non-invasive neurostimulation devices. Each company profile features an overview of the company, its financial information (if available), a detailed description of the device(s), recent developments and an informed future outlook.
  • An elaborate discussion on the regulatory landscape for market authorization of medical devices, as well as the guidelines related to their reimbursement across different countries.
  • An in-depth analysis of the patents that have been filed/granted for non-invasive neurostimulation devices since 2016, highlighting key trends associated with these patents, across type of patents, publication year, issuing authority/patent offices involved, CPC symbols, emerging focus areas, leading players, patent characteristics and geography. It also includes a detailed patent benchmarking and valuation analysis.
  • An analysis of the partnerships that have been inked by the stakeholders in this domain since 2016, covering distribution agreements, research agreements, clinical trial agreements, commercialization agreements, merger and acquisition, licensing agreements, product development and commercialization and research and development agreements.
  • A discussion on the upcoming opportunities/trends in the field of non-invasive neurostimulation devices that are likely to impact the evolution of this market over the coming years.

One of the key objectives of the report was to estimate the existing market size and potential growth opportunities for non-invasive neurostimulation devices. Based on parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate on the likely evolution of the market over the period 2020-2030. The report also features the likely distribution of the current and forecasted opportunity within the non-invasive neurostimulation devices market across [A] type of stimulation technology (TENS/TMS/nVNS/other types), [B] target indication (chronic pain/epilepsy/major depressive disorder/migraine), and [C] key geographical regions (US/Canada/UK/Germany/France/Spain/Italy/Australia/China/Japan). In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios namely the conservative, base and optimistic scenarios, which represent three different tracks of the industry’s evolution.

The opinions and insights presented in the report were influenced by discussions held with senior stakeholders in the industry.

The report features detailed transcripts of interviews held with the following industry stakeholders:


  • Chip Fisher (Chairman, Fisher Wallace Laboratories)
  • Renee C. Ryan (Chief Executive Officer, Cala Health)
  • Sree N Koneru (Vice President, Product Development, BioElectronics)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.


Table of Contents

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. An Overview of the Nervous system
3.2. Neurological Disorders
3.2.1. Conventional Treatment Methods for neurological Disorders
3.3. An Overview of Neurostimulation Devices
3.3.1. Historical Development
3.4. General Components and Working principle
3.4.1. Types of Neurostimulation Devices
3.4.1.1. Invasive Neurostimulation Devices
3.4.1.1.1. Spinal Cord Neurostimulation (SCS)
3.4.1.1.2. Deep Brain Stimulation (DBS)
3.4.1.1.3. Peripheral Nerve Stimulation
3.4.1.2. Non-Invasive Neurostimulation Devices
3.4.1.2.1. Transcutaneous Electrical Nerve Stimulation (TENS)
3.4.1.2.2. Repetitive Transcranial Magnetic Stimulation (rTMS)
3.4.1.2.3. Transcranial Direct Current Stimulation (tDCS)
3.4.2. Advantages and Limitations of Neurostimulation Devices
3.4.3. Growth Drivers and Roadblocks
4. REGULATORY AND REIMBURSEMENT LANDSCAPE FOR MEDICAL DEVICES
4.1. Chapter Overview
4.2. General Regulatory and Reimbursement Guidelines for Medical Devices
4.3. Regulatory and Reimbursement Landscape in North America
4.3.1. The US Scenario
4.3.1.1. Regulatory Authority
4.3.1.2. Review / Approval Process
4.3.1.3. Reimbursement Landscape
4.3.1.3.1. Payer Mix
4.3.1.3.2. Reimbursement Process
4.3.2. The Canadian Scenario
4.3.2.1. Regulatory Authority
4.3.2.2. Review / Approval Process
4.3.2.3. Reimbursement Landscape
4.3.2.3.1. Payer Mix
4.3.2.3.2. Reimbursement Process
4.4. Regulatory and Reimbursement Landscape in Europe
4.4.1. Overall Scenario
4.4.1.1. Regulatory Authority
4.4.1.2. Review / Approval Process
4.4.2. The UK Scenario
4.4.2.1. Reimbursement Landscape
4.4.2.1.1. Payer Mix
4.4.2.1.2. Reimbursement Process
4.4.3. The German Scenario
4.4.3.1. Reimbursement Landscape
4.4.3.1.1. Payer Mix
4.4.3.1.2. Reimbursement Process
4.4.4. The French Scenario
4.4.4.1. Reimbursement Landscape
4.4.4.1.1. Payer Mix
4.4.4.1.2. Reimbursement Process
4.4.5. The Spanish Scenario
4.4.5.1. Reimbursement Landscape
4.4.5.1.1. Payer Mix
4.4.5.1.2. Reimbursement Process
4.4.6. The Italian Scenario
4.4.6.1. Reimbursement Landscape
4.4.6.1.1 Payer Mix
4.4.6.1.2. Reimbursement Process
4.5. Regulatory and Regulatory Landscape in Asia-Pacific
4.5.1. The Australian Scenario
4.5.1.1. Regulatory Authority
4.5.1.2. Review / Approval Process
4.5.1.3. Reimbursement Landscape
4.5.1.3.1. Payer Mix
4.5.1.3.2. Reimbursement Process
4.5.2. The Chinese Scenario
4.5.2.1. Regulatory Authority
4.5.2.2. Review / Approval Process
4.5.2.3. Reimbursement Landscape
4.5.2.3.1. Payer Mix
4.5.2.3.2. Reimbursement Process
4.5.3. The Japanese Scenario
4.5.3.1. Regulatory Authority
4.5.3.2. Review / Approval Process
4.5.3.3. Reimbursement Landscape
4.5.3.3.1. Payer Mix
4.5.3.3.2. Reimbursement Process
5. CURRENT MARKET LANDSCAPE
5.1. Chapter Overview
5.2. Non-Invasive Neurostimulation Devices: Overall Market Landscape
5.2.1. Analysis by Type of Stimulation Technology
5.2.2. Analysis by Target Nerve / Physiological Region
5.2.3. Analysis by Therapeutic Area
5.2.4. Analysis by Status of Development
5.2.5. Analysis by Number of Stimulation Modes
5.2.6. Analysis by Number of Electrodes
5.2.7. Analysis by Size
5.2.8. Analysis by Weight
5.2.9. Analysis by Battery Type
5.2.10. Analysis by Regulatory Stance
5.2.11. Analysis by Professional Assistance Requirement
5.2.12. Analysis by Reimbursement / Insurance Coverage
5.3. Non-Invasive Neurostimulation Devices: Analysis of Developers
5.3.1. Analysis by Year of Establishment
5.3.2. Analysis by Company Size
5.3.3. Analysis by Geographical Location
5.4. Non-Invasive Neurostimulation Devices: List of Additional Devices
6. PRODUCT COMPETITIVENESS ANALYSIS
6.1. Chapter Overview
6.2. Assumptions and Key Parameters
6.3. Methodology
6.4. Competitiveness Analysis: TENS devices
6.5. Competitiveness Analysis: TMS devices
6.6. Competitiveness Analysis: EMS devices
6.7. Competitiveness Analysis: nVNS devices
6.8. Competitiveness Analysis: Other devices
7. COMPANY PROFILES
7.1. Chapter Overview
7.2. Non-Invasive Neurostimulation Devices Developers in North America
7.2.1. AcuKnee
7.2.1.1. Company Overview
7.2.1.2. Product Portfolio
7.2.1.3. Recent Developments and Future Outlook
7.2.2. AxioBionics
7.2.2.1. Company Overview
7.2.2.2. Product Portfolio
7.2.2.3. Recent Developments and Future Outlook
7.2.3. BioMedical Life Systems
7.2.3.1. Company Overview
7.2.3.2. Product Portfolio
7.2.3.3. Recent Developments and Future Outlook
7.2.4. HiDow
7.2.4.1. Company Overview
7.2.4.2. Product Portfolio
7.2.4.3. Recent Developments and Future Outlook
7.3. Non-Invasive Neurostimulation Devices Developers in Europe
7.3.1. CEFALY Technology
7.3.1.1. Company Overview
7.3.1.2. Financial Information
7.3.1.3. Product Portfolio
7.3.1.4. Recent Developments and Future Outlook
7.3.2. Natures Gate Tens
7.3.2.1. Company Overview
7.3.2.2. Financial Information
7.3.2.3. Product Portfolio
7.3.2.4. Recent Developments and Future Outlook
7.3.3. neuroCare
7.3.3.1. Company Overview
7.3.3.2. Financial Information
7.3.3.3. Product Portfolio
7.3.3.4. Recent Developments and Future Outlook
7.3.4. Neuroelectrics
7.3.4.1. Company Overview
7.3.4.2. Financial Information
7.3.4.3. Product Portfolio
7.3.4.4. Recent Developments and Future Outlook
7.4. Non-Invasive Neurostimulation Devices Developers in Asia-Pacific and Rest of the World
7.4.1. Johari Medtech / Johari Digital Healthcare Limited
7.4.1.1. Company Overview
7.4.1.2. Financial Information
7.4.1.3. Product Portfolio
7.4.1.4. Recent Developments and Future Outlook
7.4.2. OMRON Healthcare
7.4.2.1. Company Overview
7.4.2.2. Financial Information
7.4.2.3. Product Portfolio
7.4.2.4. Recent Developments and Future Outlook
7.4.3. RITM
7.4.3.1. Company Overview
7.4.3.2. Financial Information
7.4.3.3. Product Portfolio
7.4.3.4. Recent Developments and Future Outlook
7.4.4. SUNMAS
7.4.4.1. Company Overview
7.4.4.2. Financial Information
7.4.4.3. Product Portfolio
7.4.4.4. Recent Developments and Future Outlook
8. PATENT ANALYSIS
8.1. Chapter Overview
8.2. Scope and Methodology
8.3. Non-Invasive Neurostimulation Devices: Patent Analysis
8.3.1. Analysis by Publication Year
8.3.2. Analysis by Issuing Authority / Patent Offices Involved
8.3.3. Analysis by CPC Symbols
8.3.4. Emerging Focus Areas
8.3.5. Leading Players: Analysis by Number of Patents
8.4. Non-Invasive Neurostimulation Devices: Patent Benchmarking Analysis
8.4.1. Analysis by Patent Characteristics
8.5. Non-Invasive Neurostimulation Devices: Patent Valuation Analysis
8.6. Leading Patents by Number of Citations
9. PARTNERSHIP AND COLLABORATIONS
9.1. Chapter Overview
9.2. Scope and Methodology
9.3. Non-Invasive Neurostimulation Devices: List of Partnerships and Collaborations
9.3.1. Analysis by Year of Partnership
9.3.2. Analysis by Type of Partnership
9.3.3. Analysis by Type of Partner
9.3.4. Analysis by Year of Partnership and Type of Partner
9.3.5. Analysis by Type of Stimulation Technology
9.3.6. Analysis by Target Therapeutic Area
9.3.7. Most Active Players: Analysis by Number of Partnerships
9.3.8. Regional Analysis
9.3.9. Intercontinental and Intracontinental Agreements
10. MARKET FORECAST
10.1. Chapter Overview
10.2. Scope and Methodology
10.3. Forecast Methodology and Key Assumptions
10.4. Global Non-Invasive Neurostimulation Devices Market
10.4.1. Global Non-Invasive Neurostimulation Devices Market, 2020-2030 (By Value)
10.4.2. Global Non-Invasive Neurostimulation Devices Market, 2020-2030 (By Volume)
10.5. Global Non-Invasive Neurostimulation Devices Market, 2020-2030: Distribution by Type of Device and Indication
10.5.1. Global TENS Devices Market, 2020-2030 (By Value)
10.5.1.1. Global TENS Devices Market for Chronic Pain, 2020-2030 (By Value)
10.5.2. Global TENS Devices Market, 2020-2030 (By Volume)
10.5.2.1. Global TENS Devices Market for Chronic Pain, 2020-2030 (By Volume)
10.5.3. Global TMS Devices Market, 2020-2030 (By Value)
10.5.3.1. Global TMS Devices Market for Chronic Pain, 2020-2030 (By Value)
10.5.3.2. Global TMS Devices Market for Migraine, 2020-2030 (By Value)
10.5.3.3. Global TMS Devices Market for Major Depressive Disorder, 2020-2030 (By Value)
10.5.4. Global TMS Devices Market, 2020-2030 (By Volume)
10.5.4.1. Global TMS Devices Market for Chronic Pain, 2020-2030 (By Volume)
10.5.4.2. Global TMS Devices Market for Migraine, 2020-2030 (By Volume)
10.5.4.3. Global TMS Devices Market for Major Depressive Disorder, 2020-2030 (By Volume)
10.5.5. Global nVNS Devices Market, 2020-2030 (By Value)
10.5.5.1. Global nVNS Devices Market for Epilepsy, 2020-2030 (By Value)
10.5.5.2. Global nVNS Devices Market for Migraine, 2020-2030 (By Value)
10.5.5.3. Global nVNS Devices Market for Major Depressive Disorder, 2020-2030 (By Value)
10.5.6. Global nVNS Devices Market, 2020-2030 (By Volume)
10.5.6.1. Global nVNS Devices Market for Epilepsy, 2020-2030 (By Volume)
10.5.6.2. Global nVNS Devices Market for Migraine, 2020-2030 (By Volume)
10.5.6.3. Global nVNS Devices Market for Major Depressive Disorder, 2020-2030 (By Volume)
10.5.7. Global Other Non-Invasive Neurostimulation Devices Market, 2020-2030 (By Value)
10.5.7.1. Global Other Non-Invasive Neurostimulation Devices Market for Epilepsy, 2020-2030 (By Value)
10.5.7.2. Global Other Non-Invasive Neurostimulation Devices Market for Migraine, 2020-2030 (By Value)
10.5.7.3. Global Other Non-Invasive Neurostimulation Devices Market for Major Depressive Disorder, 2020-2030 (By Value)
10.5.8. Global Other Devices Market, 2020-2030 (By Volume)
10.5.8.1. Global Other Non-Invasive Neurostimulation Devices Market for Epilepsy, 2020-2030 (By Volume)
10.5.8.2. Global Other Non-Invasive Neurostimulation Devices Market for Migraine, 2020-2030 (By Volume)
10.5.8.3. Global Other Non-Invasive Neurostimulation Devices Market for Major Depressive Disorder, 2020-2030 (By Volume)
10.6. Global Non-Invasive Neurostimulation Devices Market, 2020-2030: Distribution by Geography
10.6.1. Non-Invasive Neurostimulation Devices Market in the US, 2020-2030
10.6.2. Non-Invasive Neurostimulation Devices Market in Canada, 2020-2030
10.6.3. Non-Invasive Neurostimulation Devices Market in the UK, 2020-2030
10.6.4. Non-Invasive Neurostimulation Devices Market in Germany, 2020-2030
10.6.5. Non-Invasive Neurostimulation Devices Market in France, 2020-2030
10.6.6. Non-Invasive Neurostimulation Devices Market in Spain, 2020-2030
10.6.7. Non-Invasive Neurostimulation Devices Market in Italy, 2020-2030
10.6.8. Non-Invasive Neurostimulation Devices Market in Australia, 2020-2030
10.6.9. Non-Invasive Neurostimulation Devices Market in China, 2020-2030
10.6.10. Non-Invasive Neurostimulation Devices Market in Japan, 2020-2030
11. EXECUTIVE INSIGHTS
11.1. Chapter Overview
11.2. Cala Health
11.2.1. Company Snapshot
11.2.2. Interview Transcript: Renee Ryan, Chief Executive Officer
11.3. BioElectronics
11.3.1. Company Snapshot
11.3.2. Interview Transcript: Sree N Koneru, Vice President, Product Development
11.4. Fisher Wallace Laboratories
11.4.1. Company Snapshot
11.4.2. Interview Transcript: Chip Fisher, Chairman
12. FUTURE GROWTH OPPORTUNITIES
12.1. Chapter Overview
12.2. Development of Devices to Address the Needs of Unexplored Therapeutic Areas
12.3. Integration of Novel and Advanced Features in Devices
12.4. Launch / Commercialization of Devices Across Different Geographies
12.5. Increased Utilization of Real World Data Based Insights to Optimize Device Performance and Support Regulatory / Reimbursement Decisions
12.6. Implementation of Cybersecurity Measures to Tackle Device Hacks
13. APPENDIX 1: TABULATED DATA

Companies Mentioned

  • AcuKnee
  • Alan Neuromedical Technologies
  • Arizona State University
  • Aucta Technologies
  • Axiobionics
  • AZOVA
  • Banner Alzheimer’s Institute
  • Banner Sun Health Research Institute
  • Bayer
  • BioElectronics
  • Bioinduction
  • BioMedical Life Systems
  • Bioness
  • BioWave
  • BrainsWay
  • Cala Health
  • California Electronic Asset Recovery
  • Calmare Therapeutics
  • CEFALY Technology
  • Cerbomed
  • Cereset
  • Cerevast Medical
  • Chattem,
  • Cove
  • Desitin Pharma
  • DEYMED Diagnostic
  • Doctor’s Medical Center
  • Dolphin Neurostim
  • DyAnsys
  • electroCore
  • Electronic waveform lab
  • Elvation
  • Endonovo Therapeutics
  • eNeura
  • Eyetronic (formerly known as EBS Technologies)
  • Firstkind
  • Fisher Wallace Laboratories
  • Flow Neuroscience
  • Forschungszentrum Jülich
  • Galen Data
  • GiMer Medical
  • Gradient Medical
  • GlaxoSmithKline
  • GTX Medical
  • Halo Neuro
  • HealthyWomen
  • Helius Medical Technologies
  • Hellius Medical
  • HiDow International
  • Hollywog
  • HoMedics
  • HRL Laboratories
  • ImThera Medical
  • Innovative Health Solutions
  • Interx Technologies
  • iTENS
  • Johari Medtech / Johari Digital Healthcare
  • Laboratoires Expanscience
  • MAG & More
  • Magstim
  • MagVenture
  • Massachusetts General Hospital
  • Massachusetts Institute of Technology
  • Metavention
  • Multisana
  • MyndTec
  • National Association of County Veterans Service Officers (NACVSO)
  • Nature’s Gate
  • neuroCare
  • Neuroelectrics
  • NeuroEM Therapeutics
  • NeuroMetrix
  • Neuromod
  • Neuronetics
  • Neuropace
  • NeuroQore
  • NeuroRecovery Technologies (acquired by GTX Medical)
  • NeuroSigma
  • Neurova
  • Neurowave Medical Technologies
  • Nevro
  • Nexeon MedSystems
  • Nexstim
  • Oculeve (acquired by Allergan)
  • OMRON Healthcare
  • Options Medical Center
  • Oregon Health & Science University
  • Orthofix
  • Ottobock
  • Pain Management Technologies
  • PainPod BioTechnology
  • Parasym Health
  • Partners HealthCare Innovation
  • PathMaker Neurosystems
  • Platoscience
  • Premera Blue Cross
  • Prizm Medical
  • QB Medical
  • Quick Care Pharmacy
  • Relaxis (also known as Sensory NeuroStimulation)
  • Renewal Technologies
  • RITM Australia
  • Scion NeuroStim
  • Second Hospital
  • Solio Therapy
  • Soterix Medical
  • Spark Medical
  • Stanford University
  • SUBLIMED
  • SUNMAS
  • SunMED Medical
  • Tal Medical
  • Teijin Pharma
  • TENS Rx
  • Theranica Bio-Electronics
  • Thync
  • Ultra Care Systems
  • University of California
  • University of Minnesota
  • University of South Florida Health
  • University of Texas
  • University of Toronto
  • UpScript
  • US Army Medical Research and Materiel Command
  • Veterans Healthcare Supply Solutions
  • Virility Medical
  • Vital Motion
  • Xavant Technology
  • Zynex Medical

Methodology

 

 

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