The global vagus nerve stimulation market is anticipated to expand at a CAGR of 10.5% between 2024 and 2032. The increasing geriatric population, the introduction of technologically advanced products, the escalating product demand as an add-on therapy, the escalating incidence of chronic diseases such as migraine and epilepsy, and the presence of unmet medical needs in these disease segments are among the key factors driving the market growth. The vagus nerve stimulator, also known as the pacemaker of the brain, 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, ensuring the proper function of brain cells. There are 20% efferent fibers and 80% afferent fibers in the vagus nerve. Afferent fibers are sensory in nature and carry information from the body to the brain. Efferent fibers are responsible for transmitting signals from the brain to the body. The vagus nerve is the principal nerve of the parasympathetic nervous system, which controls specific involuntary bodily functions, such as digestion, heart rate, and immunity. Vagus nerve stimulators can be used to treat numerous neurological disorders, including epilepsy, depression, anxiety, cluster headache, migraine, Crohn's disease, and dystonia. Stimulators of the vagus nerve can also be used as a stroke rehabilitation aid.
Depression is a prevalent mental disorder, affecting an estimated 5.0% of adults and 5.7% of adults over the age of 60 worldwide in 2019, according to data published by the World Health Organization (WHO) in September 2021. In 2018-2019, approximately 280 million people worldwide suffered from depression, according to the same source. In addition, an estimated 14,8 million adults aged 18 and older in the United States experienced at least one episode of major depression with severe impairment in 2020. This accounted for 6.0% of all adult Americans. Moreover, according to the American Headache Society, migraine is one of the leading causes of disability in the United States and the third most prevalent disorder globally. Moreover, according to the Migraine Research Foundation, approximately 39 million Americans and 1 billion people worldwide suffer from migraine in 2019.
VNS is widely used as a treatment for epilepsy. Epilepsy can be caused by genetic predisposition, head trauma, stroke, brain tumors, and infectious diseases. According to a study conducted by the International League Against Epilepsy (ILAE), VNS is effective in reducing seizures in a subset of patients with epilepsy. In addition, it may be an effective supplementary treatment for patients who have not responded to other therapies. The aging of the population is anticipated to drive market expansion in the coming years. Epilepsy, head injuries, and strokes are common among people aged 65 and older.
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Technological advances have led to the development of more effective vagus nerve stimulators. The vagus nerve is stimulated precisely and selectively by these devices, which can be customized to meet the needs of individual patients. To increase their market share of vagus nerve stimulators, suppliers are releasing compact and portable products.
Vagus nerve stimulators based on advanced technology enable a more individualized treatment approach. In addition, they may be more effective in reducing the incidence and severity of specific conditions. Manufacturers are incorporating IoT features such as Bluetooth connectivity and smartphone app integration to enable remote monitoring services and stimulation setting adjustments. The availability of IoT-enabled products will likely increase market statistics in the near future. 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, in September 2020.
The focus of key market participants on obtaining regulatory approvals for their vagus nerve stimulators is expected to drive the growth of the global vagus nerve stimulators market over the forecast period. In April 2020, for example, electroCore, Inc., a U.S. medical technology company, announced that the U.S. Food and Drug Administration had approved a migraine prevention indication for gammaCore, a non-invasive vagus nerve stimulator. Previously, gammaCore was recommended as a complementary treatment for cluster headaches and for pain management in cases of episodic cluster headaches and migraine headaches.
It has been observed that implantable VNS is associated with surgically-related infections and abnormal complications such as dysrhythmia, cough, paresthesia, pain, and voice change, the prevalence of which decreases over time. In order to combat the side effects of implantable vagus nerve stimulators, companies such as Cerbomed and Electrocore have made commendable strides in their product research to introduce noninvasivevagus nerve stimulators to the world in this decade. The devices were first introduced in Europe. With recent FDA approvals and clearances for the marketing and licensing of noninvasivevagus nerve stimulator products, the devices have advanced and are gaining worldwide acceptance for the treatment of various neurological conditions. The external vagus nerve stimulator is anticipated to have an advanced hygienic and noninfectious profile because it does not require implantation. Moreover, external VNS devices are more effective as a treatment and more cost-effective for patients.
According to a study, twenty (19%) of 105 patients treated between 1999 and 2008 with a vagus nerve stimulator system experienced device-related technical failures and complications. In eight instances where a device malfunctioned, the device was first removed. Others also experienced device-related complications, such as electrode malfunction, the onset of wound infections and cardiac arrhythmia, and posttraumatic stimulator dysfunction. The use of a vagus nerve stimulator is also associated with a long list of potential side effects. Dislocation and generator malfunctions are additional concurrent technical failures. In children, electrode fracture is the leading cause of the most severe complication, which may result from adolescent growth.
As soon as a neurologist prescribes vagus nerve stimulation therapy as a treatment option for any neurological disorder, the cost of this therapy becomes a concern. Including the implant and surgical procedure, the current cost of vagus nerve stimulator therapy is considerable. The costs of surgery and postoperative care may vary geographically and increase with time. In the West, the vast majority of vagus nerve stimulator therapy expenses are covered by insurance companies, including Medicare and the majority of Medicaid providers. Those who are eligible for vagus nerve stimulator therapy but lack insurance coverage or external funds must pay for the entire implant out of pocket, creating a long-term financial burden for the patient.
The risks of technical failures and the high price of vagus nerve stimulators are anticipated to impede the growth of the global vagus nerve stimulators market over the forecast period. According to a June 2018 article in 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 (United States) male patient with an implanted vagal nerve stimulator for epilepsy complained of neck pain when he turned his head to the right. Investigation revealed that the vagal nerve stimulator implant required replacement due to a partial lead fracture. Moreover, according to an article published in April 2017 in the peer-reviewed medical journal Epilepsia, the use of vagus nerve stimulators is associated with both early- and late-stage complications. Laryngopharyngeal dysfunction affects approximately 66% of patients implanted with vagus nerve stimulators.
Due to an increase in the number of patients suffering from various types of headaches, depression, and epilepsy, the implantable VNS device segment held a revenue share of more than 60% of the market in 2023. The implanted VNS devices are designed to alter nerve activity by sending electrical stimulation to a specific nerve, thereby enhancing the efficacy of the disease treatment. By product, the vagus nerve stimulation market is divided into implantable and external VNS devices.
Those who have not responded to anti-seizure medications and intensive depression treatments like antidepressants, 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 drives the global demand for and adoption of VNS devices. For instance, in August 2021, the FDA approved the MicroTransponderVivistim Paired VNS System, a drug rehabilitation system intended to treat moderate to severe upper extremity motor deficits caused by a chronic ischemic stroke. From 2024 to 2032, the segment of external VNS devices is anticipated to grow at the highest CAGR of 12%. This is due to the increasing number of patients with chronic disorders, the growing demand for non-invasive therapy, and the affordability of the device. The introduction of new devices by market participants and the shift in patient preference toward non-invasive devices are anticipated to fuel demand for these devices and drive market growth over the forecast period.
Implantable VNS devices are frequently associated with adverse events related to surgery and electrical stimulation. As a result, non-invasive VNS (nVNS) devices were created to address the shortcomings of their invasive counterparts. Among the noninvasivevagus nerve stimulators available commercially is the gammaCore Sapphire by electroCore and the Parasym device by Parasym Ltd.
Due to advancements and growth in vagus nerve stimulation therapy research, the metallic biomaterials segment dominated the market in 2023 with a revenue share of more than 50%. Additionally, it is anticipated that the segment's position will persist through 2030. Due to their thermal conductivity and mechanical properties, metallic biomaterials are commonly used in implantable medical devices. Due to their anti-inflammatory properties, electrical implantable devices are coated with 316L stainless steel, titanium-based alloys, gold, tantalum, silver, platinum, and cobalt-chromium alloys.
By biomaterial, the market is divided into polymeric, metallic, and ceramic biomaterials. The polymeric segment is anticipated to grow at the highest rate between 2024 and 2032, at 11.6%, due to its superior flexibility. Worldwide, the prevalence of stress and depression continues to rise. Polymers can regenerate damaged neural tissues and can be fashioned into support structures such as electro-spun matrices, nerve conduits, and scaffolds. Polymers are utilized in implantable medical devices and offer a wide range of shapes and mechanical properties, such as biocompatibility and bioactivity. It is anticipated that these factors will drive segment expansion over the forecast period.
Due to the rising number of regulatory approvals and the prevalence of epilepsy around the world, the epilepsy segment will account for 60% of total revenue by 2023. Epilepsy is diagnosed annually in approximately 49 out of 100,000 people in high-income countries, compared to 139 in low- and middle-income countries, according to the World Health Organization. Similarly, between 100,000 and 120,000 children are hospitalized annually due to epilepsy-related conditions in the United States. This is expected to fuel segment expansion in the years to come. In addition, rising levels of epilepsy treatment awareness, coupled with strategic alliances, are anticipated to stimulate market expansion. The awareness campaigns of epilepsy networks have increased the demand for more precise disease diagnosis and effective treatment. In 2009, the Epilepsy Association of Nova Scotia and the Anita Kaufmann Foundation proclaimed March 26 as "Purple Day" to increase global awareness of epilepsy. By application, the vagus nerve stimulation market is divided into epilepsy, depression, and migraine.
From 2024 to 2032, the depression market segment is anticipated to grow at the highest CAGR. Worldwide, the prevalence of stress and depression continues to rise. According to the National Institute of Mental Health (NIMH), over 2.7 million American adults suffer from difficult-to-treat depression. In addition, the WHO estimates that more than 300 million adults worldwide suffer from depression, and approximately one-third of patients with major depressive disorder (MDD) have treatment-resistant depression (TRD). It has been shown that vagus nerve stimulators play an important role in providing therapeutic solutions for difficult-to-treat depression; therefore, an increase in the prevalence of such diseases is expected to drive segment growth over the forecast period. The introduction of technologically advanced products also enhances the quality of therapy. In 2017, electroCore launched gammaCore, the world's first non-invasive vagus nerve stimulation therapy product. These developments are likely to stimulate segment growth further.
In 2023, hospitals held a 52% share of the end-use market for vagus nerve stimulation. The expansion is primarily caused by an increase in the number of VNS surgeries performed in hospitals and the prevalence of neurological disorders. In addition, favorable reimbursement policies and the availability of technologically advanced devices are anticipated to boost the hospital segment during the forecast period. Medtronic, for instance, offers comprehensive services for securing and maintaining coverage and payment for a variety of DBS devices. In addition, hospitals are currently advancing technologically, and sophisticated medical devices are widely used to enhance patient care. These devices not only simplify treatment procedures, but also contribute to improved, more rapid, and more accurate outcomes. All neurological disorders, including epilepsy, are typically diagnosed and treated with cutting-edge technology by neurologists in specialized hospitals.
Comparatively, the Ambulatory Surgical Centers (ASC) segment is anticipated to experience the highest CAGR between 2023 and 2030. This is due to the lower cost of procedures relative to hospitals, the ease of access to patient care, the reduction in waiting time, and the low infection rate relative 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, contributing to the expansion of the segment.
Due to the advanced and minimally invasive nature of the surgical procedures carried out in ASCs, the majority of neuro surgeries can now be performed there. Consequently, the segment's growth is primarily attributable to shorter procedure times and ongoing innovations in minimally invasive surgical techniques.
North America dominated the vagus nerve stimulation market in 2023, with a 60% share, due to an increase in government funding and initiatives to raise 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 anticipated to generate substantial market growth opportunities. The Centers for Medicare & Medicaid Services (CMS) projects that between 2018 and 2027, health expenditures in the United States will increase by 5.5% annually, reaching USD 6 trillion by 2027. In addition, the large market share of the North American region is partially attributable to the availability of skilled professionals and the high discretionary income in developed economies.
In contrast, Asia-Pacific is anticipated to grow at a CAGR of 12% between 2024 and 2032. This is due to the increasing prevalence of neurodegenerative disorders in the region and the unmet demand for effective and durable solutions. Rising awareness of neurological disease treatment options and improvements to the clinical development framework of emerging economies is expected to drive market growth in this region. In addition, the presence of high-growth opportunities in developing nations like Japan, China, and India is likely to contribute to the market's expansion. In addition, the establishment of organizations such as the Asia-Pacific Centre for Neuromodulation (APCN), which was founded to conduct research and raise awareness about the advantages of vagus nerve stimulation, is anticipated to stimulate regional growth.
Industry leaders are increasingly focusing on product launches, technological advances, and other growth strategies, such as mergers and acquisitions, to strengthen their market position. In March 2020, for example, LivaNova received CE Mark approval for their VNS Therapy System, Symmetry, to treat difficult-to-treat depression. Market participants are conducting a number of clinical trials in collaboration with research institutions 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 the treatment of epilepsy in developed nations, are expected to create substantial opportunities for market participants.
Newcomers to the market for vagus nerve stimulation, such as electroCore, MicroTransponder, Inc., and Parasym, are regarded as innovators. These businesses provide products with a favorable price-to-performance ratio, competitive functionality, and innovative technology. These individuals prioritize product commercialization and fundraising to support the expansion of research and development. In November 2017, for instance, 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 most prominent companies on the global market for vagus nerve stimulation:
electroCore, Cerebral Rx, MicroTransponder, Inc., Parasym, LivaNova LLC (formerly Cyberonics) and Other Notable Players.
