Neurostimulation Devices Market (2nd Edition), 2018-2030

NEW YORK, Nov. 27, 2018 /PRNewswire/ -- INTRODUCTION
The National Academy of Medicine indicates that as many as 100 million people in the US suffer from some form of pain, which has been shown to be associated with a socioeconomic burden of around USD 600 billion per year, in treatment costs and lost productivity. , Further, it has been estimated that nearly 1 million people in America suffer from Parkinson's disease, with approximately 60,000 new patients being diagnosed every year. Over the past few decades, the prevalence of such chronic disorders has grown at an alarming rate. In fact, a recent World Health Organization's Global Burden of Disease study recognized these chronic conditions as one of the leading causes of deteriorating public health in the world. Such clinical conditions have often been shown to result in serious physical, cognitive and psychosocial consequences in patients. This indicates an urgent need for novel and effective treatment methods as the drawbacks of existing treatment options (such as high risk of addiction / abuse associated with long-term use of oral opioids, and complications due to complex surgical procedures) are substantial.

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Extensive research in the field of neurostimulation has demonstrated the potential of this technique in providing therapeutic relief to a number of patients, who have developed resistance to conventional medication. Since the introduction of the first neurostimulation therapy in 1960s, their numerous observed benefits, such as reversible and minimally invasive nature of the procedures (to administer such treatments), targeted approach to therapeutic relief that can be modulated as well, provisions for integrating various safety mechanisms, and negligible use of opioids / other medications, have captured the interest of several stakeholders in the industry. In fact, since 2010, over 4,000 patents have been published in this domain, indicating the rapid pace at which research is being carried out. It is anticipated that such efforts are likely to boost the overall growth of this market in the coming years.

SCOPE OF THE REPORT
The 'Neurostimulation Devices Market (2nd Edition), 2018-2030' report features an extensive study of the current landscape and future outlook of the growing market for neurostimulation devices. The focus of this study is on invasive neurostimulation devices, such as devices for spinal cord stimulation (SCS), deep brain stimulation (DBS), spinal nerve stimulation (SNS), vagus nerve stimulation (VNS), other cranial nerve stimulation (Other CNS) and other variants of neurostimulation devices.

Amongst other elements, the report features:
• A detailed assessment of the overall landscape of neurostimulation devices market, featuring the contributions of various companies engaged in this domain and highlighting key device specifications (size, weight, battery type, battery life, number of electrodes, type of programming, and MRI compatibility), along with information on different types of neurostimulation devices, target therapeutic areas, and regulatory approvals received across various geographies.
• A comprehensive product competitiveness analysis, taking into consideration the supplier power and specific device-related parameters, such as number of target indications, target nerves, regulatory approvals, and key device specifications.
• Comprehensive profiles of developers of leading neurostimulation devices (shortlisted on the basis of the product competitiveness analysis), featuring an overview of the company, its financial information (if available), and a detailed description of the device(s). Each profile also includes a list of recent developments, highlighting the achievements, partnership activity, and the likely strategies that may be adopted by these players to fuel growth in the foreseen future.
• An elaborate discussion on the regulatory landscape related to medical devices across various geographies, namely North America (the US and Canada), Europe (the UK, Germany, France, Spain and Italy), and Asia-Pacific (Australia, China and Japan). The information covers details on the payer mix, and the reimbursement processes of various public / private organizations across these geographies.
• A detailed brand positioning analysis of leading industry players (shortlisted on the basis of strength of product portfolio), highlighting the current perceptions regarding their proprietary brands across different device types, taking into consideration several aspects, such as strength / diversity of product portfolio, extent of patent portfolio, recent collaborations, number of target indications and regulatory approvals, and the overall market positioning of the players.
• An in-depth analysis of the patents that have been published since 2013. The analysis also highlights the key trends associated with these patents, including patent type, regional applicability, CPC classification, IP litigations, emerging areas, leading industry players (in terms of number of patents filed / granted), and patent benchmarking and valuation.
• A comprehensive clinical trial analysis of completed, ongoing and planned studies of various neurostimulation devices. For the purpose of this analysis, we looked at the clinical studies that have been last updated in 2013, and analyzed them on the basis of various parameters, such as current trial status, regional distribution, leading industry and non-industry players, key indications, and enrolled patient population across different geographies.
• An analysis of the partnerships that have been established in the recent past, covering product development / commercialization agreements, R&D collaborations, technology licensing deals, distribution agreements, mergers / acquisitions, and others.
• An analysis of investments made at various stages of product development / commercialization; these include seed financing, venture capital financing, debt financing and grants / awards received by the companies that are operating in this domain.
• A comprehensive list of non-invasive neurostimulation devices, along with information on their developers, various types of non-invasive technologies used, target therapeutic areas, and development / approval status of the devices.
• An elaborate discussion on the upcoming opportunities / trends in the field of 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 neurostimulation devices. Based on multiple parameters, such as target patient population, likely adoption rates and expected pricing, we have provided an informed estimate on the likely evolution of the market over the period 2018-2030. The report provides sales forecasts for the overall neurostimulation devices market with detailed market segmentation on the basis of type neurostimulation devices (SCS, DBS, VNS, and other types), indication (chronic pain, dystonia, epilepsy, essential tremor, heart failure, major depressive disorder, Parkinson's disease, obsessive compulsive disorder, overactive bladder, sleep apnea), MRI compatibility (MRI compatible and MRI non-compatible), and the geographical distribution of the market (US, Canada, UK, Germany, France, Spain, Italy, Australia, China, and 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 portraying the conservative, base and optimistic tracks of the industry's evolution.

The opinions and insights presented in this study were also influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals:
• Dave Rosa (President and Chief Executive Officer, NeuroOne Medical Technologies)
• Deborah Schmalz (Vice President, Regulatory Affairs, Clinical Research and Compliance, ReShape Lifesciences) and Diane Utzman-O'Neill (Vice President, Marketing, ReShape Lifesciences)
• Jan Pieter Heemels (Vice President, Commercial Operations, Mainstay Medical)
• Laura Tyler Perryman (Chief Executive Officer, Stimwave)
• Luca Ravagnan (Chief Executive Officer, WISE)
• Steve Goedeke (President and Chief Executive Officer, Cardionomic)

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.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include
• Annual reports
• Investor presentations
• SEC filings
• Industry databases
• News releases from company websites
• Government policy documents
• Industry analysts' views

While the focus has been on forecasting the market till 2030, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES
Chapter 2 is an executive summary of the insights captured in our research. It offers a high-level view on the likely evolution of the neurostimulation devices market in the mid to long term.

Chapter 3 is an introductory chapter that presents a general overview of the epidemiology and the growing prevalence of chronic clinical conditions, along with information on the limitations of conventional treatment methods. Further, it features a detailed discussion on neurostimulation devices, including a comprehensive history of development, information on their basic components and principle of operation, and associated advantages / challenges. It also features a discussion on the key types of neurostimulation devices, including SCS, DBS, SNS, VNS, Other CNS, and other device types, featuring information on the potential applicability of these devices across different disease indications. Further, the chapter features a discussion on the key growth drivers and road blocks related to neurostimulation and its use in treating various neurological conditions.

Chapter 4 provides a detailed description on the regulatory landscape related to medical devices across various geographies, namely North America (the US and Canada), Europe (the UK, Germany, France, Spain and Italy), and Asia-Pacific (Australia, China and Japan). Further, it provides information on the payer mix, and details of the reimbursement processes of various public / private organizations across different geographies.

Chapter 5 includes information on more than 125 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 key specifications (including size, weight, battery type, battery longevity, number of electrodes, and MRI compatibility), Further, we have provided information on different types of neurostimulation devices, target nerves, target therapeutic areas, and regulatory approvals received across various geographies. 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 provides a detailed review of SCS devices, along with information on their historical evolution and associated surgical procedures (for implantation). The chapter also presents a comprehensive 2 X 2 matrix to compare device competitiveness, by taking into consideration the supplier power (based on size of employee base) and certain device-related parameters, such as number of target indications, target nerves, regulatory approvals, and key specifications of the devices (including size, weight, battery type, battery longevity, number of electrodes, type of programming, and MRI compatibility). In addition, the chapter includes elaborate profiles of the developers of leading SCS devices (shortlisted on the basis of device competitiveness analysis scores); each profile features an overview of the company, its financial information (if available), detailed description of the device(s) and the recent developments and future outlook with respect to the specific device(s) / overall neurostimulation domain.

Chapter 7 provides a detailed review of DBS devices, along with information on their historical evolution and associated surgical procedures (for implantation). The chapter also presents a comprehensive 2 X 2 matrix to compare device competitiveness, by taking into consideration the supplier power (based on size of employee base) and certain device-related parameters. In addition, the chapter includes elaborate profiles of the developers of leading DBS devices (shortlisted on the basis of device competitiveness analysis scores); each profile features an overview of the company, its financial information (if available), detailed description of the device(s) and the recent developments and future outlook with respect to the specific device(s) / overall neurostimulation domain.

Chapter 8 provides a detailed review of PNS devices (including SNS, VNS and Other CNS devices), along with information on their historical evolution and associated surgical procedures (for implantation). The chapter also presents three comprehensive 2 X 2 matrices to compare device competitiveness within each type of PNS devices, by taking into consideration the supplier power (based on size of employee base) and certain device-related parameters. In addition, the chapter includes elaborate profiles of the developers of leading devices within each type (shortlisted on the basis of respective device competitiveness analysis scores); each profile features an overview of the company, its financial information (if available), detailed description of the device(s) and the recent developments and future outlook with respect to the specific device(s) / overall neurostimulation domain.

Chapter 9 provides an elaborative brand positioning analysis of the leading industry players (shortlisted on the basis of strength of product portfolio) highlighting the current perceptions regarding their proprietary brands across different device types. The analysis takes into consideration several aspects, such as strength / diversity of product portfolio, strength of patent portfolio, recent collaborations, number of target indications and regulatory approvals, and the overall market positioning of the companies.

Chapter 10 provides an in-depth patent analysis to provide an overview of how the industry is evolving from the R&D perspective. For the purpose of this analysis, we considered those patents that have been published since 2013 related to the neurostimulation domain. The analysis also highlights the key trends associated with these patents, including patent type, regional applicability, CPC classification, IP litigations, emerging areas, leading industry players, and patent benchmarking and valuation.

Chapter 11 provides a comprehensive clinical trial analysis of completed, ongoing and planned studies of various neurostimulation devices. For the purpose of this analysis, we looked at the clinical studies that have been last updated in 2013, and analyzed them on the basis of various parameters, such as current trial status, regional distribution, leading industry and non-industry players, key indications, and enrolled patient population across different geographies.

Chapter 12 features an elaborate discussion and analysis of the various partnerships / collaborations that have been inked amongst 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 employed by stakeholders in this domain, and analysis on the trend of partnerships inked since 2015. It also consists of a schematic representation showcasing the players that have established the maximum number of alliances related to 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 13 provides information on the funding instances and investments that have been made in the neurostimulation domain. The chapter includes details on various types of investments (such as seed financing, venture funding, debt financing and grants) received by companies between 2015 and mid-2018, highlighting the growing interest of the venture capital community and other strategic investors in this domain.

Chapter 14 features a comprehensive market forecast, highlighting the future potential of neurostimulation devices till 2030 based on multiple parameters, such as prices of devices, indication / region specific adoption trends, and competitive landscape. We have segmented the market on the basis of type of neurostimulation devices (SCS, DBS, VNS, and other types), indication (chronic pain, dystonia, epilepsy, essential tremor, heart failure, major depressive disorder, Parkinson's disease, obsessive compulsive disorder, overactive bladder, and sleep apnea), MRI compatibility (MRI compatible and MRI non-compatible), and the geographical distribution of the market (US, Canada, UK, Germany, France, Spain, Italy, Australia, China, and Japan). We have adopted a bottom up approach, backed by robust data and credible inputs from primary research, to estimate the likely size of the market, both in terms of value (USD billion) and volume (number of devices).

Chapter 15 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 16 is a collection of executive insights of the discussions that were held key stakeholders in this market. The chapter provides a brief overview of the companies and details of interviews held with Dave Rosa (President and Chief Executive Officer, NeuroOne Medical Technologies), Deborah Schmalz (Vice President, Regulatory Affairs, Clinical Research and Compliance, ReShape Lifesciences) and Diane Utzman-O'Neill (Vice President, Marketing, ReShape Lifesciences), Jan Pieter Heemels (Vice President, Commercial Operations, Mainstay Medical), Laura Tyler Perryman (Chief Executive Officer, Stimwave), Luca Ravagnan (Chief Executive Officer, WISE), and Steve Goedeke (President and Chief Executive Officer, Cardionomic)

Chapter 17 is an appendix, which provides a comprehensive list of non-invasive neurostimulation devices, along with information on their developers, types of non-invasive neurostimulation technologies, target therapeutic areas, and development / approval status of the devices.

Chapter 18 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 19 is an appendix, which provides the list of companies and organizations mentioned in the report.

EXAMPLE HIGHLIGHTS
1. Over 120 implantable neurostimulation devices are presently available / under development for the treatment of chronic disorders. Of these, close to 31% are spinal cord stimulating (SCS) products indicated for managing different forms of chronic pain. Examples include (in alphabetical order, no specific selection criteria) Algovita®, Altius® System, Intellis™, Precision Spectra™, Proclaim™ Elite, Senza®, and StimRouter®. These are followed by deep brain stimulation (DBS) devices (20%) that are designed to stimulate globus pallidus / subthalamic nucleus, ventral intermediate of the thalamus and other portions of the brain for the treatment of neurological / movement-related disorders. Other therapeutic areas for which such devices are available / under evaluation include urological disorders, respiratory disorders, cardiovascular disorders, gastrointestinal disorders, sleep disorders and metabolic disorders.
2. Around 75% of the companies that are involved in the development of neurostimulation devices are small-sized firms / start-ups (less than 200 employees). Examples of such players include (in alphabetical order, no specific selection criteria) Cardionomic, Lungpacer Medical, Neuros Medical, Nyxoah, Respicardia, SPR Therapeutics and Stimwave. However, the overall market is currently dominated by a few well-established players that are actively developing / improving their proprietary technologies in order to further increase their footprint in this competitive domain. Examples of such players include (in alphabetical order, no specific selection criteria) Abbott (St. Jude Medical), Boston Scientific, LivaNova, Medtronic and Nevro.
3. It is worth highlighting that more than 45% approvals have been granted to various neurostimulation devices in the EU, followed by approvals granted by the US FDA, Australian TGA and Health Canada for the treatment of different chronic clinical conditions. In fact, close to 65 marketing approvals have been granted to these devices across different regions since 2015. Examples of devices approved in the year 2018 include (in alphabetical order, no specific selection criteria) Axonics® r-SNM™ System (TGA approval for overactive bladder), SenTiva® (CE Mark for epilepsy), Senza II™ (CE Mark for chronic pain), Spectra WaveWriter™ (US FDA approval for chronic pain), StimGuard's SNS system (CE Mark for overactive bladder), StimRouter® (Health Canada approval for chronic peripheral nerve pain), and TransAeris™ System (CE Mark for ventilator-induced diaphragm dysfunction).
4. Close to 45% of the neurostimulation devices feature magnetic resonance (MR) conditional labeling, allowing patients to undergo safe magnetic resonance imaging (MRI) of full body / specific body parts. Further, around 40% of neurostimulation devices utilize rechargeable batteries in their implantable pulse generators (IPGs), while close to 15% of devices have battery-free IPGs in order to deliver minimally invasive therapies to the patients.
5. Extensive research efforts in this domain have resulted in the publication of over 4,000 patents since 2010. Stakeholders that have filed / been granted the maximum number of patents related to neurostimulation devices in the last 8-10 years include (in decreasing order of number of patents) Boston Scientific, Medtronic, LivaNova, Abbott (St. Jude Medical), NeuroPace, and Metavention.
6. Further, close to 1,000 clinical studies have been registered (completed / ongoing / planned) across different geographies. Based on the number of trials, North America (~380 trials) has emerged as a major research / innovation hub in this domain; about 55% of the total number of patients enrolled in the aforementioned trials were reported to have been recruited in centers in this region, followed by Europe and Asia-Pacific. Further, the maximum number (150) of trials evaluating neurostimulation devices were observed to be associated with chronic pain.
7. Capital investments, totaling USD 1.8 billion have been made across over 100 instances in this domain since 2015. Examples of companies that have received relatively more funding include (in reverse chronological order) Inspire Medical Systems (USD 108 million), Metavention (USD 65 million in 2018), NeuroPace (USD 74 million in 2017), ReShape Lifesciences (USD 61 million in 2017), and CVRx (USD 93 million in 2016), and Nevro (USD 173 million in 2016). Examples of prominent venture capital investors that have actively purchased equity in this domain include (in decreasing order of the number of instances) Action Potential Venture Capital, Atlante Ventures, Gilde Healthcare Partners, Cormorant Asset Management, Andera Partners, F3F, and KCK Group.
8. The market for neurostimulation devices is expected to grow at an annualized rate of 10.9% between 2018 and 2030. While SCS devices, intended primarily for pain management, are expected to occupy majority of the share (close to 57%) in the market, DBS devices (utilized for the treatment of neuropsychological disorders) are anticipated to grow at a relatively faster rate (14.8%) in the forecast period. Further, the major share (over 75%) of revenues is anticipated to be distributed between North America and Europe; however, we believe that certain Asian countries, such as China, are likely to grow at a faster rate as compared to other regions over the coming decade; this is attributed to the increasing awareness about the nature of these therapies and a less stringent regulatory environment.

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