U.S. Subdural Electrode Market Size, Share & COVID-19 Impact Analysis, By Material (Platinum and Stainless Steel), By Type (Strip, Grid, Depth, and Others), By End-user (Hospitals & ASCs, Specialty Clinics, and Others), and Country Forecast, 2023-2030

The U.S. subdural electrode market size was worth USD 15.0 million in 2022 and is projected to grow at a CAGR of 8.4% during the forecast period. 

In the U.S., there is a significant rise in the prevalence of epilepsy. Intracranial monitoring is commonly recommended for patients with epilepsy whose seizures cannot be controlled with medication. This test helps physicians pinpoint where seizures start in the brain. Subdural electrodes are placed inside the skull of the patient in intracranial monitoring. The growing prevalence of epilepsy has led to more patients opting for intracranial monitoring tests. This scenario has increased the demand for subdural electrodes. In addition, a strong surge in the number of epileptic surgeries in which these electrodes are widely used is augmenting the U.S. subdural electrode market growth rate during the forecast period.

• For instance, according to the Centers for Disease Control and Prevention (CDC), in 2020, an estimated 3 million adults and 470,000 children had active epilepsy in the U.S. in 2015.

Various pipeline studies for diverse clinical indications and the growing focus of major players to provide advanced diagnostic products will propel the market expansion in the U.S. The COVID-19 pandemic negatively impacted the market growth due to reduced in-person visits, cancellation of elective intracranial monitoring procedures, and closure of specialized epilepsy care centers.

LATEST TRENDS

Increasing Pipeline Studies for Diverse Clinical Indications to Augment Market Growth

Over the past few decades, the market witnessed strong demand for advanced healthcare facilities and products across the U.S. There are established as well as emerging players who are emphasizing increasing R&D activities to develop novel products. In addition, several institutions are working to diversify the clinical applications of these products apart from their prime indication for epilepsy.

• In June 2021, CorTec GmbH entered into a transatlantic strategic partnership with Blackrock Neurotech, LLC to provide a more comprehensive portfolio of solutions to address various neurological disorders, including peripheral nerve application, and enter the U.S. market.

The commercialization process of these critical medical devices is expected to move forward strongly due to the rising number of clinical trials in technologies. Further, the growing disposable income has augmented the adoption of technologically advanced products. Such factors are projected to propel the sales of these upcoming products intensely.

DRIVING FACTORS

Robust Demand for Intracranial Monitoring for Epileptic Surgeries to Drive Market Growth

One of the most significant drivers promoting market growth is the increasing prevalence and number of epileptic surgeries across the U.S. Intracranial monitoring is done by placing electrodes inside the patient's brain to monitor brain activity for several days/weeks. This factor is driving the robust utilization of subdural electrodes in epileptic surgeries.

Furthermore, the augmenting cases of Anti-Epileptic Drugs (AEDs) for controlling seizures are expected to propel the number of epileptic surgeries. This will enhance demand for substantial subdural electrodes and growth of the market.

• For instance, according to an article published by WebMD in 2021, about 30% of epileptic patients taking anti-epileptic drugs to control seizures cannot tolerate the side effects and opt for brain surgery. Such a scenario is expected to increase intracranial monitoring procedures for epilepsy.

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According to an article published by Medical News Today in 2023, the Centers for Disease Control and Prevention reported that about 1.2% of people have active epilepsy in the U.S.

RESTRAINING FACTORS

Product Recalls and Relative Side Effects to Deter the Product Adoption

One of the factors limiting the adoption of these devices is the concerns associated with the risks of their implantation during surgery. Surgical procedures can lead to adverse complications such as bleeding, infection, and post-operative trauma.

Product recalls can create a crisis for key players as it creates concerns and doubts in the minds of the end-users about a product. The market has witnessed certain product recalls due to health hazards, and product quality issues can deter the U.S. subdural electrode market growth.

• For instance, in January 2022, DIXI Medical recalled its products, Microdeep Depth Electrode and MicroDeep SEEG Depth Electrode, distributed in the U.S. The reason for the recall was the internal packaging deformation that could compromise the medical device's sterile barrier when removed from the Tyvek bag.

SEGMENTATION

By Material Analysis

By material, the market is divided into platinum and stainless steel.

The platinum segment held the largest U.S. subdural electrode market share in 2022. Platinum electrode offers benefits such as better conductivity over other materials and limited risk of patient infections. These benefits, coupled with the affirmative results of clinical cases performed by these electrodes, contribute to the product adoption. Thus, superior procedural outcomes of these electrodes for locating seizure focus in epilepsy and an increase in the number of epileptic surgeries are projected to drive the platinum segment’s growth.

• For instance, according to the 2021 annual report of NeuroOne Technologies Medical Corporation, only 16,000 craniotomies are estimated to be performed for epilepsy cases each year in the U.S.

By Type Analysis

Based on type, the market is segmented into strip, grid, depth, and others.

The depth segment was dominant in the U.S. market. The benefits offered by depth electrodes, such as comprehensive recording of deep brain structures, minimal invasion, superior brain mapping quality, and improved patient comfort, are the primary reasons for adopting depth subdural electrodes. Thus, the surge in responsive neurostimulation (RNS) implantation and intracranial monitoring procedures has increased the preference for depth subdural electrodes for locating seizure focus in epilepsy, further augmenting the segment growth.

• As per a research article published in 2021 by the American Academy of Neurology, there has been a growth in procedures such as responsive neurostimulation (RNS) implantation (114%) and intracranial monitoring without resection (152%) from 2012 to 2019 in the U.S.

By End-user Analysis

Based on end-user, the market is segmented into hospitals & ASCs, specialty clinics, and others.

The hospitals & ASCs segment held a major share in 2022. The dominance of this segment is attributed to the rise in utilization of these healthcare facilities for epilepsy care and strong awareness of intracranial monitoring. Factors, such as advanced brain mapping, increase in healthcare expenditure, and improved services at hospitals, are expected to boost the growth of the hospitals & ASCs segment. Furthermore, certain key players are focusing on clinical research initiatives to expand their space in the market.

• According to the Cure Epilepsy 2021 statistics, the U.S. spends approximately USD 15.5 billion on epilepsy each year.

KEY INDUSTRY PLAYERS

The market's competitive landscape comprises various established and emerging subdural electrode companies. Ad-Tech Medical Instrument Corporation, CorTec GmbH, and Integra LifeSciences Corporation held a substantial market share in 2022. The factors attributed to the dominance of these companies are their product offerings, robust distribution network, strategic activities, and brand presence.

• In January 2020, Ad-Tech Medical Instrument Corporation received the U.S. FDA approval for its Subdural Strip/Intraoperative Strip Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Split Grid Electrode, and Intraoperative Mapping Grid Electrode.

Some other key players include Natus Medical Incorporated, PMT Corporation, and inomed Medizintechnik GmbH. These companies are focusing on strengthening the supply chain and distribution network to enhance their market presence.

LIST OF KEY COMPANIES PROFILED:

• CorTech GmbH (Germany)


• Ad-Tech Medical Instrument Corporation (ArchiMed) (U.S.)


• DIXI MEDICAL (Dixi) (France)


• PMT Corporation (U.S.)


• inomed Medizintechnik GmbH (Germany)


• Integra LifeSciences Corporation (U.S.)


• Natus Medical Incorporated (U.S.)

KEY INDUSTRY DEVELOPMENTS: 

• September 2021 – Natus Medical Incorporated received a five-year contract from the U.S. government healthcare systems. Natus Patient Monitoring and Capital Equipment (PMCE) was included in the Electronic Catalog (ECAT) as a medical equipment source and preferred purchasing source for the U.S. government.


• October 2021 – DIXI Medical received the U.S. FDA approval for its Intraoperative Subdural Electrodes (strips and grids).

REPORT COVERAGE

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The market research report depicts a qualitative and quantitative market analysis. It emphasizes key segments such as type, material, and end-user. Moreover, it highlights the key industry developments, regulatory scenarios, a summary of product applications in cranial nerves & others, trends of usage of these products, and key players in the market. Additionally, it includes market dynamics, the impact of COVID-19, and the contributing factors for the market growth.

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