North America Vagus Nerve Stimulation Market – Industry Trends and Forecast to 2029

North America Vagus Nerve Stimulation Market Analysis and Insights

The vagus nerve is a prominent component of the autonomic nervous system that regulates metabolic homeostasis and functions as a crucial component of the neuroendocrine-immune axis in maintaining homeostasis via its afferent and efferent pathways. Any approach that stimulates the vagus nerve, including manual or electrical stimulation, is referred to as Vagus Nerve Stimulation (VNS). For refractory epilepsy and treatment-resistant depression, left cervical VNS is an approved therapy.

According to the WHO, neurological diseases are responsible for 4.5% to 11% of all illnesses worldwide. Vagus nerve stimulators are also used to treat patients suffering from epilepsy, depression, asthma, and cardiovascular disorders.

The North America vagus nerve stimulation market is expected to grow in the forecast period of 2022 to 2029. Data Bridge Market Research analyzes that the market is growing with a CAGR of 18.0% in the forecast period of 2022 to 2029 and is expected to reach USD 1,052.22 million by 2029 from USD 277.17 million in 2021.

Market Definition: North America Vagus Nerve Stimulation Market

The vagus nerve is a long cranial nerve that runs from a person’s brain stem into the neck, chest, and abdomen. It is a part of the parasympathetic nervous system, which is commonly referred to as the rest-and-digest system because it regulates body functions while a person is at rest. It delivers messages to a person’s brain from their digestive system and organs such as their lungs, heart, and liver. It controls several organ functions, including digestion, heart rate, and respiratory rate. It is responsible for vasomotor activity and reflexes. It also regulates vocalization, mood, and immunity. It influences sensory functions in a person’s ears, sinuses, and esophagus as well.

VNS involves a pulse generator inserted under a person’s skin on their chest. The implantable device, which is similar to a pacemaker, delivers regular electrical pulses to the brain via the vagus nerve. It is possible to provide additional stimulation by placing the provided magnet over the pulse generator. Relaxation techniques such as breathing exercises, yoga, and medication can influence vagus nerve activity, increasing its ability to relieve anxiety and mood-related symptoms. VNS can improve an individual’s physical health and can offer benefits for several conditions such as epilepsy and depression. The treatment has a healing effect on a person’s body due to its ability to promote relaxation and reduce inflammation.

Market Dynamics: North America Vagus Nerve Stimulation Market

Drivers

• Increasing prevalence and incidence of neurological disorders

Neurological disorders cause 4.5% to 11% of all illnesses, whether in low or high-income countries. The impact is greater compared to that of malignancies, gastrointestinal diseases, or respiratory illnesses, and it is expected to grow over the next years. In the U.S., neurological illnesses have also seen a significant rise, and over the next 20 years, this growth tendency is anticipated to continue. The prevalence of these neurological illnesses has been reported to range from 0.9% to 4% (970-4100 per 100,000 population), with an average of roughly 2.3% (2390 per 100,000 population). One of the most common neurological conditions, epilepsy, affects almost every country on earth. Most people with this illness are seen in high-population countries. Due to this rising prevalence, there is a rising demand for a variety of tools and treatments, such as VNS. More neurological problems are being treated with VNS. In addition to other clinical uses, it aids in the treatment of neurological conditions like epilepsy and depression due to the significant prevalence of neurological conditions worldwide.

• Innovative non-invasive vagus nerve stimulation devices introduced to meet demand

Traditional and conventional VNS devices are implanted in the patient's body and leads are placed on the vagus nerves that provide electrical stimulation when required. Growing demand and technological advancement of innovative devices lead to the introduction of small-sized implantable VNS devices in the market. These small-sized implantable devices offer various clinical benefits to patients and healthcare providers. The introduction of innovative devices is anticipated to boost the market growth.

Constant focus by market players to innovate and launch new products had led to the emergence of non-invasive VNS (nVNS) devices in the market. These devices are also known as transcutaneous VNS (tVNS) devices

• Rise in product approvals

The approval for VNS devices is governed by the U.S. FDA and the EU. The FDA issues a final protocol for filing a Pre-market Approval Application (PMA) or a notice of completion of a Product Development Protocol (PDP).

For instance,

• The FDA has approved an implantable vagus nerve stimulator to treat epilepsy and depression. In addition, in North America, new nVNS devices that do not require surgical implantation to treat epilepsy, depression, and pain have been approved.

The approval received for VNS devices would result in the device being declared safe to use and ready for post-marketing approval. It would result in the supply and distribution of MRI machines to the developing markets, situated in the North America region. Hence, the rise in product approvals is expected to propel market growth

• Product development in recent years

Combination Therapies are much more effective than monotherapy, without additional side effects. They are a safe and effective alternative for individuals with refractory bladder conditions. Combining different target therapy strategies is the best approach to relieving patients of bladder disorders. Oral medication and behavioral therapy should be considered for the patients' refractory treatment. Various advanced target therapies are available such as sacral neuromodulation, intradetrusor injection of a botulinum toxin A, and percutaneous tibial nerve stimulation. These are advanced treatments and more effective as compared to oral agents.

Opportunities

• Strategic initiatives by the key market players

The demand for VNS devices is increasing in the market owing to the increased levels of R&D; along with that, the market growth is being aided by the desire for innovative medications. Thus, the top market players have implemented new strategies by developing new devices and equipment as well as collaborating with other players in the market and aimed at improving business operations and profitability.

The companies operating in the North America region in this market are adopting collaboration as a strategy to increase their product portfolio with advanced technology-rich products to boost their business in various dimensions. Thus, increasing strategic initiatives by key market players are expected to offer significant opportunities for market players operating in the market

• Rising government initiatives for neurological disease

The purpose of funding for VNS devices is to encourage applications seeking to develop devices for various neurological disorders. Novel devices should move beyond existing electrical or magnetic stimulation and develop new stimulation techniques capable of increased spatiotemporal precision as well as multi-focal, closed-loop approaches. Therefore, the funding by the government would result in the safety of the patient and cost savings. In addition, hospitals and healthcare agencies would administer this treatment at a lower price through collaboration with government organizations. Hence, the advancements in R&D activities and funding by the government will act as an opportunity for this market growth.

Restraint/Challenge

• High maintenance and device costs to restrain adoption of vagus nerve stimulators

The rise in the cost of VNS devices is due to technological development and increased demand for nVNS devices by neurologists in hospitals, clinics, nursing facilities, and ambulatory surgical centers. Overhead costs can help explain why hospitals charge so much for stimulation devices. The increased intricacy and cost of VNS devices, technological innovations, and robust investments would increase the costs. The increased cost would result in delayed treatment of patients in hospitals and clinics. Hence, the increased cost of VNS devices is expected to restrain market growth.

Post-COVID-19 Impact on North America Vagus Nerve Stimulation Market

The COVID-19 outbreak had a drastic effect on North America healthcare with the U.S. being amongst the countries most severely impacted. The pandemic had a negative impact on the market growth, on account of a temporary halt in research activities in this field, coupled with the low influx of patients in hospitals and diagnostic centers.

Manufacturers are making various strategic decisions to bounce back post-COVID-19. The players are conducting multiple R&D activities, product launches, and strategic partnerships to improve the technology and test results involved in the pharmacogenetics testing market.

Recent Development

• In May 2022, electroCore, Inc. announced that the gammaCore Sapphire non-invasive Vagus Nerve Stimulator will be available in 130 National Spine and Pain Centers (NSPC) affiliated locations across the U.S. for patients suffering from pain associated with different forms of primary headache. This would help the organization to develop more revenue.

North America Vagus Nerve Stimulation Market Scope

North America vagus nerve stimulation market is segmented into product type, biomaterial, application, patient type, end user, and distribution channel. The growth amongst these segments will help you analyze meager growth segments in the industries and provide the users with a valuable market overview and market insights to make strategic decisions to identify core market applications.

Product Type

• Implantable VNS Devices
• External VNS Devices

Based on product type, the market is segmented into implantable VNS devices and external VNS devices.

Biomaterial

• Ceramics
• Metallic
• Polymeric

Based on biomaterial, the market is segmented into ceramics, metallic, and polymeric.

Application

• Pain Management
• Epileptic Seizures
• Obesity Management
• Depression and Anxiety
• Others

Based on application, the market is segmented into pain management, epileptic seizures, obesity management, depression and anxiety, and others.

Patient Type

• Adults
• Pediatric
• Geriatric

Based on patient type, the market is segmented into adults, pediatric, and geriatric.

End User

• Hospital
• Ambulatory Surgery Centers
• Specialty Centers
• Others

Based on end users, the market is segmented into hospitals, ambulatory surgery centers, specialty centers, and others.

Distribution Channel

• Direct Tender
• Retail Sales
• Others

Based on distribution channel, the market is segmented into direct tender, retail sales, and others.

North America Vagus Nerve Stimulation Market Regional Analysis/Insights  

The North America vagus nerve stimulation market is analyzed and market size insights and trends are provided by country, product type, biomaterial, application, patient type, end user, and distribution channel as referenced above.

The U.S. dominates the North America vagus nerve stimulation market in terms of market share and revenue and will continue to flourish its dominance during the forecast period. This is due to the high prevalence and incidence of neurological disorders in the region, and growing R&D investments and the launch of new products are boosting market growth.

The country section of the report also provides individual market impacting factors and changes in regulations in the market that impact the current and future trends of the market. Data points, such as new and replacement sales, country demographics, disease epidemiology, and import-export tariffs, are some of the major pointers used to forecast the market scenario for individual countries. In addition, the presence and availability of North America brands and their challenges faced due to competition from local and domestic brands and the impact of sales channels are considered while providing forecast analysis of the country data.

Competitive Landscape and North America Vagus Nerve Stimulation Market Share Analysis

The North America vagus nerve stimulation market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in R&D, new market initiatives, North America presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, and application dominance. The above data points provided are only related to the companies' focus related to the market.

Some of the major players operating in the market are Medtronic, LivaNova PLC, electroCore, Inc., Cirtec, Brain Control Co. Limited, Soterix Medical Inc., SetPoint Medical, MicroTransponder Inc, Parasym Ltd, and tVNS Technologies GmbH among others.

Research Methodology

Data collection and base year analysis are done using data collection modules with large sample sizes. The market data is analyzed and estimated using market statistical and coherent models. In addition, market share analysis and key trend analysis are the major success factors in the market report. The key research methodology used by the DBMR research team is data triangulation which involves data mining, analysis of the impact of data variables on the market, and primary (industry expert) validation. Data models include Vendor Positioning Grid, Market Time Line Analysis, Market Overview and Guide, Company Positioning Grid, Company Market Share Analysis, Standards of Measurement, North America vs. Regional, and Vendor Share Analysis. Please request an analyst call in case of further inquiry.

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