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Report Description
The current market for non-invasive neurostimulation devices is expected to be worth $1.0 billion, and is expected to grow at a compounded annual growth rate (CAGR) of 11.0% during the forecast period. 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.
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:
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:
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.
Contents
Chapter 2 is an executive summary of the insights captured in our research. The summary offers a high-level view on the likely evolution of the non-invasive neurostimulation devices market in the mid to long term.
Chapter 3 is an introductory chapter that presents a general view of the growing prevalence of neurological impairment, along with information on the limitations associated with conventional treatment methods. Further, it features a detailed discussion on neurostimulation devices, their historical development, basic components and principle of operation, and the advantages / challenges associated with them. It also provides information on different types of neurostimulation devices, including invasive devices (spinal cord stimulation devices, deep brain stimulation devices, sacral nerve stimulation devices, vagus nerve stimulation devices and other invasive neurostimulation devices) and non-invasive devices (TENS, repetitive transcranial magnetic stimulation and transcranial direct current stimulation), their potential applicability across different indications, and the key growth drivers and road blocks to the overall neurostimulation domain.
Chapter 4 provides a comprehensive overview of regulatory landscape for the market authorization of medical devices across different geographies, such as North America (the US and Canada), Europe (the UK, Germany, France, Spain and Italy), and Asia-Pacific (Australia, China and Japan). In addition, the chapter provides information on the payer mix, and detailed reimbursement processes of medical devices by different public / private organizations within various geographies.
Chapter 5 includes information on more than 170 non-invasive neurostimulation devices that are either commercialized or under development for the treatment of different disorders. It features detailed analyses of these devices based on different types of non-invasive neurostimulation devices (TENS, TMS, EMS, nVNS and others), target therapeutic areas (pain management, inflammatory disorders, neurological disorders, psychological disorder, movement disorders and others), and regulatory / development status (USFDA, CE Mark, Health Canada, TGA Australia, CFDA, MHLW and others). Further, we have provided information on key specifications (including size, weight, battery type, number of electrodes, number of stimulation modes and regulatory / reimbursement status). The chapter also highlights the contributions of various companies engaged in this domain, presenting a detailed analysis based on their year of establishment, size of employee base and geographical presence.
Chapter 6 presents a detailed competitiveness analysis of non-invasive neurostimulation devices based on the supplier power and key product specifications. The analysis was designed to enable stakeholder companies to compare their existing capabilities within and beyond their respective peer groups and identify opportunities to achieve a competitive edge in the industry.
Chapter 7 provides detailed profiles of the key players that are engaged in developing non-invasive neurostimulation devices domain. Each profile features a brief overview of the company, its financial information (if available), detailed description of the device(s) and the recent developments and an informed future outlook.
Chapter 8 provides an in-depth patent analysis presenting an overview of how the industry is evolving from the R&D perspective. For this analysis, we considered those 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, geographical location, type of applicants, issuing authority / patent offices involved, CPC symbols, emerging focus areas, leading players (in terms of number of patents granted / filed in the given time period), patent characteristics and geography. It also includes a detailed patent benchmarking and an insightful valuation analysis.
Chapter 9 features a detailed analysis of the partnerships / collaborations that have been inked amongst the players in this market. It includes a brief description on the various types of partnership models (such as product development / commercialization agreements, R&D collaborations, technology licensing deals, distribution agreements, mergers / acquisitions, and others) that have been adopted by stakeholders in this domain, and analysis on the trend of partnerships inked since 2016. It also consists of a schematic representation highlighting the players that have established the maximum number of alliances related to non-invasive neurostimulation devices. Furthermore, we have provided a world map representation of all the deals inked in this field, highlighting those that have been established within and across different continents.
Chapter 10 presents an insightful market forecast analysis, highlighting the future potential of non-invasive neurostimulation devices, till the year 2030. We have segregated the opportunity on the basis of [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 (the US / Canada / the UK / Germany / France / Spain / Italy / Australia / China / Japan). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.
Chapter 11 is a collection of executive insights of the discussions that were held with various key stakeholders in this market. The chapter provides a brief overview of the companies and details of interviews held with and Renee C. Ryan (Chief Executive Officer, Cala Health), Sree N Koneru (Vice President, Product Development, BioElectronics), Chip Fisher (Chairman, Fisher Wallace Laboratories).
Chapter 12 presents a discussion on the upcoming opportunities / trends in the field of neurostimulation devices that are likely to impact the future evolution of this market over the coming years. These include (but not limited to) development of devices against unexplored therapeutic areas, integration of novel and advanced features, launch in different geographies, increased utilization of real world evidence-based insights, and implementation of cybersecurity measures in the devices.
Chapter 13 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.
Chapter 14 is an appendix, which provides the list of companies and organizations mentioned in the report.
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
14. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
The following companies / institutes / government bodies and organizations have been mentioned in this report.
Source 1: www.ncbi.nlm.nih.gov/pmc/articles/PMC3405884/
Source 2: www.washingtonpost.com/national/health-science/the-big-number-50-million-adults-experience-chronic-pain/2018/10/19/30831828-d2e0-11e8-83d6-291fcead2ab1_story.html
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