From 2024 to 2032, the global vagus nerve stimulation market is projected to expand at a CAGR of 10.5%. The rising geriatric population, the introduction of technologically advanced products, the escalating product demand as an add-on therapy, the rising incidence of chronic diseases such as migraine and epilepsy, and the presence of unmet medical needs in these disease segments are some of the key factors driving the market growth. The vagus nerve stimulator, also known as the brain's pacemaker, is a device that generates electrical impulses to stimulate the vagus nerve. These electric impulses travel to the brain and are dispersed to various regions to alter the activity of nerves, thereby ensuring that brain cells function properly. The vagus nerve contains 20% efferent fibers and 80% afferent fibers. Efferent fibers are responsible for transmitting signals from the brain to the body, whereas afferent fibers are sensory and carry information from the body to the brain. The vagus nerve is the principal nerve of the parasympathetic nervous system, which regulates specific involuntary bodily functions including digestion, heart rate, and immunity. Vagus nerve stimulators can be used to treat a variety of neurological conditions, including epilepsy, depression, anxiety, cluster headache, migraine, Crohn's disease, and dystonia. Vagus nerve stimulators can also be utilized as a stroke rehabilitation aid.
The Increasing Prevalence of Neurological Disorders
According to data published by the World Health Organization (WHO) in September 2021, depression is a prevalent mental disorder, affecting an estimated 5.0% of adults and 5.7% of adults older than 60 years worldwide in 2019. According to the same source, approximately 280 million people worldwide suffered from depression in 2018-2019. In addition, an estimated 14.8 million adults aged 18 and older in the United States experienced at least one major depressive episode with severe impairment in 2020. This represented 6.0% of all American adults. In addition, according to the American Headache Society, migraine is one of the leading causes of disability in the United States and the third most common disorder worldwide. In addition, according to the Migraine Research Foundation, migraine affects approximately 39 million Americans and 1 billion people worldwide in 2019.
Widespread use of VNS for the treatment of epilepsy. Genealogical factors, head injuries, strokes, brain tumors, and infectious diseases can all contribute to the onset of epilepsy. A study conducted by the International League Against Epilepsy (ILAE) indicates that VNS is effective in reducing seizures in a subset of patients with epilepsy. In addition, it may be an effective adjunctive therapy for patients who have not responded to other treatments. In the coming years, the market expansion is anticipated to be fueled by the aging of the population. Epilepsy, head injuries, and strokes are prevalent among individuals over 65 years old.
Development of Innovative and Efficient Vagus Nerve Stimulators
Technological advancements have led to the creation of vagus nerve stimulators that are more effective. The vagus nerve is stimulated precisely and selectively by these devices, which can be adapted to specific patient needs. To increase their vagus nerve stimulator market share, industry suppliers are launching compact and portable products.
Advanced technology-based vagus nerve stimulators enable a more individualized treatment approach. Additionally, they may be more effective in reducing the frequency and severity of particular conditions. To enable remote monitoring services and stimulation setting adjustments, manufacturers are incorporating IoT features such as Bluetooth connectivity and smartphone app integration. Shortly, the availability of IoT-enabled products will likely boost market statistics.
In September 2020, for instance, ReShape Lifesciences Inc., a U.S. weight-loss and metabolic health solutions company, announced a positive pre-clinical result for its Diabetes Bloc-Stim Neuromodulation (DBSN) device, a dual vagus nerve stimulator for the treatment of type 2 diabetes mellitus.
Key market participants are concentrating on obtaining regulatory approvals for their vagus nerve stimulators, which is anticipated to drive the growth of the global vagus nerve stimulators market during the forecast period.
In April 2020, for instance, electroCore, Inc., a U.S. medical technology company, announced that the U.S. Food and Drug Administration had approved an expanded indication for gammaCore, a non-invasive vagus nerve stimulator, to include migraine prevention in adult patients. Previously, gammaCore was recommended as an adjunctive therapy for cluster headaches and pain management in cases of episodic cluster headaches and migraine headaches.
The shift in Focus to Minimally Invasive VNS Procedures
Implantable VNS has been observed to be associated with surgically-related infections and abnormal complications such as dysrhythmia, cough, paresthesia, pain, and voice alteration, the prevalence of which decreases over time. In this decade, companies such as Cerbomed and Electrocore have made commendable strides in their product research to introduce noninvasive vagus nerve stimulators to the world to combat the side effects of implantable vagus nerve stimulators. Initially, the devices were introduced in Europe. With recent FDA approvals and clearances for the marketing and licensing of noninvasive vagus nerve stimulator products, the devices have made progress and are gaining acceptance worldwide for various neurological treatments. As it does not require implantation, the external vagus nerve stimulator is anticipated to provide an advanced hygienic and noninfectious profile. In addition, external VNS devices are more effective as a treatment and more affordable for patients.
Vagus Nerve Stimulators' adoption will be hindered by their expensive upkeep and devices
Twenty (19%) of 105 patients treated with a vagus nerve stimulator system between 1999 and 2008 experienced device-related technical failures and complications, according to a study. In eight instances of device failure, the device was removed first. Others also experienced complications associated with the device, including electrode malfunction, the onset of wound infections and cardiac arrhythmia, and posttraumatic stimulator dysfunction. Vagus nerve stimulator therapy is also associated with an extensive list of potential side effects. Other concurrent technical failures include dislocation and generator malfunctions. In children, electrode fracture is the leading cause of the most serious complication, which may be caused by growth during adolescence.
As soon as the neurologist prescribes vagus nerve stimulation therapy as a treatment option for any neurological disorder, the question of how much this therapy cost arises. The current cost of vagus nerve stimulator therapy, including the implant and surgical procedure, is high. The costs of surgery and postoperative care may vary across regions of the globe and rise over time. In the West, many insurance companies, including Medicare and the majority of Medicaid providers, cover nearly all costs associated with vagus nerve stimulator therapy. Those who qualify for vagus nerve stimulator therapy but lack insurance coverage or external funds must pay the entire cost of the implant out of pocket, creating a long-term financial burden for the patient.
Global Market for Vagus Nerve Stimulators - Restriction
The risks of technical failures and the high cost of vagus nerve stimulators are expected to restrain the growth of the global vagus nerve stimulators market during the forecast period. According to an article published in June 2018 by the World Neurosurgery Journal, a monthly peer-reviewed medical journal, complications associated with vagus nerve stimulators can include lead fracture, disconnection, battery displacement, and device malfunction. A 25-year-old male patient (United States) with an implanted vagal nerve stimulator for epilepsy complained of neck pain whenever he turned his head to the right. Investigation revealed that the vagal nerve stimulator had a partial lead fracture, necessitating the replacement of the implant. Furthermore, according to an April 2017 article published in the peer-reviewed medical journal Epilepsia, the use of vagus nerve stimulators is associated with both early and late-stage complications. Approximately 66% of patients with implanted vagus nerve stimulators experience laryngopharyngeal dysfunction.
VNS Devices Dominated the Product Market
Due to an increase in the number of patients suffering from various types of headaches, depression, and epilepsy, the implantable VNS device segment dominated the market in 2023 with a revenue share of more than 60%. The implanted VNS devices are designed to act directly on the pain site and alter nerve activity by sending electrical stimulation to a specific nerve, thereby making the disease treatment more effective. The market for vagus nerve stimulation is segmented by product into implantable and external VNS devices.
Those who have not responded to anti-seizure medications and intensive depression treatments, such as antidepressant medications, psychotherapy, and electroconvulsive therapy, may benefit from an implantable VNS device (ECT). In addition, the introduction of new and innovative products by leading market participants is driving the demand for and adoption of VNS devices in the global market. In August 2021, for instance, the FDA approved the MicroTransponderVivistim Paired VNS System, a drug rehabilitation system designed to treat moderate to severe upper extremity motor deficits caused by a chronic ischemic stroke. From 2024 to 2032, the external VNS device segment is expected to grow at the highest CAGR of 12%. This is due to the growing number of patients with chronic disorders, the rising demand for non-invasive therapy, and the device's affordability. During the forecast period, the introduction of new devices by market participants and the shift in patient preference toward non-invasive devices are expected to fuel demand for these devices and drive market growth.
Implantable VNS devices are frequently associated with both surgical and electrical stimulation-related adverse events. Consequently, non-invasive VNS (nVNS) devices were developed to address the deficiencies of their invasive counterparts. Among the commercially available noninvasive vagus nerve stimulators is the gammaCore Sapphire by electroCore and the Parasym device by Parasym Ltd.
Metallic Biomaterials Dominated the Market
The metallic biomaterials segment dominated the market with a revenue share of over 50% in 2023, due to advances and growth in vagus nerve stimulation therapy research and development. It is also anticipated that the segment will maintain its position through 2030. Due to their thermal conductivity and mechanical properties, metallic biomaterials are widely used in medical devices such as implantable devices. Due to their anti-inflammatory properties, 316L stainless steel, titanium-based alloys, gold, tantalum, silver, platinum, and cobalt-chromium alloys are used to coat electrical implantable devices.
The market is segmented by biomaterial into polymeric, metallic, and ceramic biomaterials. The polymeric segment is anticipated to grow at the highest rate from 2024 to 2032, at 11.6%, due to its flexibility advantages. The prevalence of stress and depression continues to rise worldwide. Polymers are capable of regenerating damaged neural tissues and can be fashioned into support structures such as electro-spun matrices, nerve conduits, and scaffolds. Polymers are utilized in medical implantable devices and offer a wide variety of shapes and mechanical properties, including biocompatibility and bioactivity. These factors are anticipated to drive segment expansion over the forecast period.
Epilepsy Segment Remains the Dominant Application Market
As of 2023, the epilepsy segment holds a 60% revenue share, owing to the increasing number of regulatory approvals and the high prevalence of epilepsy around the world. According to the WHO, approximately 49 out of 100,000 people in high-income countries are diagnosed annually with epilepsy, compared to 139 in low- and middle-income countries. Similarly, between 100,000 and 120,000 children are hospitalized annually in the United States due to epilepsy-related conditions. This is anticipated to fuel segment expansion in the coming years. In addition, increasing levels of awareness regarding epilepsy treatment, combined with strategic alliances, are anticipated to stimulate market expansion. Epilepsy networks' awareness campaigns have increased the demand for more accurate disease diagnosis and effective treatment. In 2009, for instance, the Epilepsy Association of Nova Scotia and the Anita Kaufmann Foundation jointly proclaimed March 26 as "Purple Day" to raise global awareness about epilepsy. The vagus nerve stimulation market is segmented by application into epilepsy, depression, and migraine.
From 2024 to 2032, the depression segment is anticipated to grow at the highest compound annual growth rate. The prevalence of stress and depression continues to rise worldwide. According to the National Institute of Mental Health (NIMH), more than 2.7 million American adults are burdened by depression which is difficult to treat. In addition, according to the WHO, more than 300 million adults worldwide suffer from depression, and roughly one-third of patients with major depressive disorder (MDD) have depression that is resistant to treatment (TRD). It has been demonstrated that vagus nerve stimulators play an important role in providing therapeutic solutions for difficult-to-treat depression; thus, an increase in the prevalence of such diseases is anticipated to drive segment growth over the forecast period. In addition, the introduction of technologically advanced products improves the quality of therapy. In 2017, electroCore introduced gammaCore, the first non-invasive vagus nerve stimulation therapy product. These developments are likely to further stimulate segment expansion.
Hospitals Dominated the End User Segment
In 2023, hospitals dominated the end-use segment of the vagus nerve stimulation market with 52%. The expansion is primarily attributable to a rise in the number of VNS surgeries performed in hospitals and the incidence of neurological disorders. In addition, the availability of technologically advanced devices and favorable reimbursement policies are anticipated to boost the hospital segment during the forecast period. For example, Medtronic provides comprehensive services to secure and maintain coverage and payment for a variety of DBS devices. In addition, hospitals are currently advancing in terms of technology, and advanced medical devices are widely used to improve patient care. These devices not only simplify treatment procedures, but also contribute to better, faster, and more precise outcomes. All neurological disorders, including epilepsy, are typically diagnosed and treated by neurologists in specialized hospitals using cutting-edge technology.
In contrast, the Ambulatory Surgical Centers (ASC) segment is anticipated to grow at the fastest CAGR between 2023 and 2030. This is due to the lower cost of procedures compared to hospitals, the ease of access to patient care, the reduction in waiting time, and the low infection rate in comparison to neurology clinics and hospitals. Moreover, according to a study conducted by Advancing Surgical Care, 92% of patients were satisfied with the medical care and service provided by ASCs, thereby contributing to the segment's growth.
In addition, the majority of neuro surgeries can now be performed in ASCs due to the advanced and minimally invasive nature of the surgical procedures performed there. Thus, the segment's growth is primarily attributable to shorter procedure times and ongoing developments in minimally invasive surgical techniques.
North America Remained the Global Leader
North America dominated the vagus nerve stimulation market with a 60% share in 2023, due to an increase in government funding and initiatives for raising awareness about epilepsy and difficult-to-treat depression. In addition, rapid technological advancements, the presence of major manufacturers in the region, an increase in R&D investments, and an increase in government funding and initiatives are expected to create significant growth opportunities in the market. According to the Centers for Medicare & Medicaid Services (CMS), health spending in the United States is projected to increase by 5.5% annually between 2018 and 2027, reaching USD 6 trillion by 2027. In addition, the large market share of the North American region is due in part to the availability of skilled professionals and the high disposable income in developed economies.
Asia-Pacific, on the other hand, is anticipated to grow at a 12% CAGR between 2023 and 2031. This is due to the increasing prevalence of neurodegenerative disorders in the region, as well as the unmet demand for effective and long-lasting solutions. Rising awareness of neurological disease treatment options and enhancements to the clinical development framework of emerging economies are anticipated to drive market expansion in this region. In addition, the presence of high-growth opportunities in developing nations such as Japan, China, and India is likely to contribute to the expansion of the market. In addition, the establishment of organizations such as the Asia-Pacific Centre for Neuromodulation (APCN), which has been established to conduct research and raise awareness about the benefits of vagus nerve stimulation, is anticipated to stimulate regional growth.
Product Launches and Technological Advancements to Enhance Market Share
To strengthen their market position, industry leaders are increasingly focusing on product launches, technological advances, and other growth strategies, such as mergers and acquisitions. For instance, LivaNova received CE Mark approval for their VNS Therapy System - Symmetry - for difficult-to-treat depression in March 2020.
In collaboration with research institutions, market participants are conducting several clinical trials to investigate and expand the applications of VNS devices. However, the demonstrated efficacy of VNS in the treatment of epilepsy and treatment-resistant depression (TRD), as well as the increased prevalence of these devices for epilepsy treatment in developed nations, are anticipated to create significant opportunities for market participants.
On the market for vagus nerve stimulation, newcomers such as electroCore, MicroTransponder, Inc., and Parasym are considered innovators. These companies offer products with a favorable price-to-performance ratio, competitive functionality, and cutting-edge technology. These participants prioritize product commercialization and fundraising to support the expansion of R&D. For example, in November 2017, electroCore completed its Series B Funding round with more than USD 70 million for the commercialization of gammaCore and the continued clinical development of nVNS. The following are some of the leading companies in the global vagus nerve stimulation market: electroCore, Cerebral Rx, MicroTransponder, Inc., Parasym, LivaNova LLC (formerly Cyberonics), and Other Notable Players.
Historical & Forecast Period
This study report represents analysis of each segment from 2022 to 2032 considering 2023 as the base year. Compounded Annual Growth Rate (CAGR) for each of the respective segments estimated for the forecast period of 2024 to 2032.
The current report comprises of quantitative market estimations for each micro market for every geographical region and qualitative market analysis such as micro and macro environment analysis, market trends, competitive intelligence, segment analysis, porters five force model, top winning strategies, top investment markets, emerging trends and technological analysis, case studies, strategic conclusions and recommendations and other key market insights.
Research Methodology
The complete research study was conducted in three phases, namely: secondary research, primary research, and expert panel review. key data point that enables the estimation of Vagus Nerve Stimulators market are as follows:
Market forecast was performed through proprietary software that analyzes various qualitative and quantitative factors. Growth rate and CAGR were estimated through intensive secondary and primary research. Data triangulation across various data points provides accuracy across various analyzed market segments in the report. Application of both top down and bottom-up approach for validation of market estimation assures logical, methodical and mathematical consistency of the quantitative data.
| ATTRIBUTE | DETAILS |
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| Research Period | 2022-2032 |
| Base Year | 2023 |
| Forecast Period | 2024-2032 |
| Historical Year | 2022 |
| Unit | USD Million |
| Segmentation | |
Product
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Application
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Biomaterial
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End-use
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Region Segment (2022-2032; US$ Million)
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Key questions answered in this report
