Subdural Electrodes Market Size, Share & COVID-19 Impact Analysis, By Material (Platinum, Stainless Steel), By Type (Strip, Grid, Depth, Others), By End-user (Hospitals & ASCs, Specialty Clinics, Others), and Regional Forecast, 2022-2029

The global subdural electrodes market size was valued at USD 32.4 million in 2021. The market is projected to grow from USD 37.4 million in 2022 to USD 66.5 million by 2029, exhibiting a CAGR of 8.6% during the forecast period. The global COVID-19 pandemic has been unprecedented and staggering, with subdural electrodes experiencing lower-than-anticipated demand across all regions compared to pre-pandemic levels. Based on our analysis, the global market exhibited a decline of 14.1% in 2020 as compared to 2019.

These devices are primarily used for intracranial monitoring carried out in patients experiencing seizures and epileptic episodes in the pre-surgical phase of epilepsy. These procedures are carried out in patients who fail to respond to medications and require surgery. It facilitates locating the lobe of origin of seizures, which will help guide the surgical procedure. Based on seizure location, a particular type of electrode is recommended. For instance, if the focus of a seizure is believed to be in the brain, then a depth electrode is recommended for intracranial monitoring.

An increasing number of epilepsy surgeries, the rising adoption of intracranial monitoring, and the prevalence of epilepsy are anticipated to boost the subdural electrodes market growth during the forecast period. For instance, as per a study published in 2022 by ScienceDirect, 65 million people worldwide are affected by epilepsy, and almost 80.0% are from developing countries. Furthermore, a considerable proportion of patients with epilepsy have Drug-Resistant Epilepsy (DRE), affecting 30-40% of epileptic patients. This prevalence represents higher growth for intracranial monitoring, which signifies a higher demand for these products during the forecast period.

COVID-19 IMPACT

Closure of Specialized Epilepsy Care Centers due to COVID-19 has led to Slower Growth of the Global Market

The COVID-19 pandemic has negatively influenced market growth due to a multitude of factors. Some of the factors include the reduction of visits to healthcare professionals for in-person visits, cancellation of elective intracranial monitoring procedures, closure of specialized epilepsy care centers, and the diversion of resources into pandemic-centric procedures. According to the published article in the journal Neurology in May 2022, the total procedure volume in 2020 for intracranial monitoring was lower as compared to 2019. This was attributed to the fact that Epilepsy Monitoring Units (EMUs) were closed for more than 15% of the year in 2020, limiting the demand for these products and leading to a strong adverse impact on the global market.

Furthermore, the pandemic has negatively impacted the sales of these products across the globe. Prominent companies in the market reported strong sales declines in their annual revenues for FY2020. For instance, Natus Medical Incorporated witnessed a decline of -14.8% in its sub-segment of its neuro segment.

However, after the lifting of the COVID-19 restrictions, such as the reopening of EMUs, there was a resurgence in the market’s growth prospects which is expected to return to its pre-pandemic level at a steady rate.

LATEST TRENDS

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Increased Expansion of Pipeline Studies into Newer Application Areas to Determine Market Growth  

The subdural electrodes market trends can be determined by the steadily increasing demand for these products across the globe, which has significantly increased the market growth in the forecast period. As the demand for these technologies is expected to grow over the next few decades, the need for the launch of novel products across diverse clinical indications apart from the primary indication of epilepsy has led to the engagement of several established and emerging companies and institutions to increase R&D initiatives for the development.

For instance, in October 2020, Hospices Civils de Lyon in France initiated clinical trials to implant cortical electrodes in patients with head trauma, subarachnoid hemorrhage, and brain lesions. This study is considered to be an essential step in studying the clinical benefit of individualized management on the basis of such monitoring. The rising number of clinical trials in technologies is expected to strongly move forward the commercialization process of these critical medical devices. Furthermore, the large patient population base who necessitates these technologies and for whom conventional treatment options are not viable are expected to strongly boost the sales of these upcoming products.

DRIVING FACTORS

Increasing Demand for Intracranial Monitoring as Surgical Planning for Epilepsy to Drive Market Growth

The prevalence of epilepsy is growing across the globe leading to the increasing number of surgeries; hence, intracranial monitoring is a pre-surgical planning process for epilepsy surgery. This factor is also driven by the substantial boost in the number of level 3 and level 4 dedicated specialized epilepsy centers, which exclusively provide intracranial monitoring procedures, including the implantation of these products. For instance, according to estimates published by the Centers for Disease Control and Prevention (CDC) in September 2020, in the U.S., the number of adults suffering from epilepsy stood at 3 million in 2015. Furthermore, according to the Centers for Disease Control and Prevention (CDC), the prevalence of epilepsy is increasing, primarily driven by the increase in population growth rates.

Furthermore, there is a gradual shift in the preference of epileptic patients from Anti-Epileptic Drugs (AEDs) to epilepsy surgery. According to the World Health Organization, in 2022, around 30.0% of patients on anti-epileptic medications across the globe will fail to get desired treatment outcomes for epilepsy seizure control. The failure of AEDs for seizure control is leading to an increasing number of epilepsy surgeries, which is expected to result in increased intracranial monitoring procedures for epilepsy.

Superior Procedural Outcomes of Subdural Electrodes for Locating Seizure Focus in Epilepsy to Drive Adoption

Intracranial monitoring is recommended for patients failing to get seizure control by anti-epileptic medications. To locate seizure focus and perform brain mapping, these devices are implanted in the patient's brain. Subdural electrodes enable visual mapping of seizure patterns which surgeons analyze. Moreover, they allow detailed mapping of several areas in the brain to accomplish superior procedural outcomes, eventually leading to greater adoption of intracranial monitoring and driving market growth.

There is a gradual shift in preference for depth electrodes from strip & grid electrodes. Certain benefits offered by depth electrodes, such as minimal invasion, superior visualizations, and lower postoperative complications, are expected to fuel the growth of depth electrodes, which is expected to boost the growth of the global market during the forecast period. For instance, according to a study conducted by the majority of the Epilepsy Centers in Europe in 2018, the complication rates for depth electrodes ranged between 0.5% to 5.0% during the course of intracranial monitoring.

RESTRAINING FACTORS

Lack of Product Awareness in Emerging Countries to Impede Market Growth Prospects

Despite the higher prevalence of epilepsy in emerging nations, there is a huge treatment gap due to the lack of infrastructure and product availability in emerging nations. Moreover, certain factors, such as lack of awareness about surgical planning of epilepsy, social stigma about epilepsy, widespread misconceptions, and the reluctance of government authorities to promote treatment programs in emerging nations, are expected to restrain the market growth during the forecast period.

For instance, according to a study published in a Brain Science journal in 2018, in Sub-Saharan countries and Latin America, an estimated 90% of the patients don’t get access to any kind of epilepsy treatment or intracranial monitoring facility. Such limiting factors are anticipated to restrict the market growth in the forecast period.

SEGMENTATION

By Material Analysis

Higher Bio-Compatibility to Boost the Adoption of Platinum Electrode

By material, the global market can be bifurcated into platinum and stainless steel.

The platinum segment is estimated to dominate the market due to various benefits it offers such as better compatibility with the organic environment, low risk of infection among patients, and better electrical conductivity over stainless steel. The stainless steel segment is expected to lose market share from 2022-2029 due to changing preference of healthcare professionals from stainless steel to platinum. Some factors of stainless steel material, such as oxidation properties and high infection rate, have impacted the segment's growth during the forecast period. Hence, healthcare professionals' preference for subdural electrodes is shifting from stainless steel to platinum.

By Type Analysis

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Better Safety and Patient Comfort Offered by Depth Electrode to Drive the Segment Growth

Based on type, the global market can be segmented into strip, grid, depth, and others.

The depth electrode segment dominated the market in 2021 due to certain factors, such as comprehensive recording of deep brain structures, minimal invasion, improved patient comfort, and superior quality of brain mapping, which are attributable to the segment’s growth during the forecast period.

The grid and strip segments are anticipated to witness a decline in their market share during the forecast period. Their current market share is attributable to the strong adoption of grid and strip electrodes due to their lower costs and robust usage in low and middle-income countries where a large patient populace resides.

The others segment is estimated to grow at a lower CAGR due to a comparatively limited number of product offerings in this segment.

By End-user Analysis

Growing Demand for Advanced Healthcare Facilities is Projected to Drive Hospitals & ASCs

By end-user, the global market can be classified into hospitals & ASCs, specialty clinics, and others.

The hospitals & ASCs segment generated the highest revenue in the global market in 2021 as the majority of the implant procedures are carried out in these settings. Furthermore, the increased utilization of these healthcare facilities, such as hospitals for epilepsy care in emerging nations, and the rising awareness about intracranial monitoring is anticipated to drive the market growth with the highest CAGR during the forecast period.

The specialty clinics segment accounted for a substantial market share in 2021 and is estimated to grow with a considerable CAGR during the forecast period due to the increasing number of epilepsy centers across the globe. According to the National Association of Epilepsy Centers (NAEC), the number of accredited epilepsy centers increased by 60.0%, from 161 in 2012 to 256 in 2019. The others segment is anticipated to witness a decline in its market share from 2022-2029.

REGIONAL INSIGHTS

On the basis of region, the global market can be segmented into the U.S., Europe, Japan, and the rest of the world.

The U.S. market was valued at USD 13.1 million in 2021 and is likely to remain dominant throughout the forecast period. There is a high adoption rate of these devices for intracranial monitoring in the U.S. as the number of epilepsy centers is increasing, coupled with the rising prevalence of drug resistance amongst the epileptic patient population. These factors are boosting the market growth during the forecast period.

Europe is anticipated to be the second leading region in revenue, which is attributable to improved healthcare facilities for epilepsy, higher adoption of depth electrodes, and higher awareness of intracranial monitoring and its benefits among epileptic patients & healthcare resources. For instance, according to the NeuroOne Medical Technologies Corporation FY2021 report, it is estimated that there are 18,000 craniotomies performed for epilepsy cases each year in Europe. Such instances are expected to lead to comparatively higher market growth in the region.

Japan is projected to witness strong growth during the forecast period with the second-highest CAGR in the global market. Japan has witnessed a higher prevalence of epilepsy coupled with a significant number of research and development activities carried out by the major market players. Furthermore, there is a higher probability of the penetration of the Japan market by the U.S. and Europe-based players along with certain government initiatives, which are expected to boost the adoption of these products in the Japan market. For instance, in early 2020, the Japan Ministry of Health, Labor and Welfare approved reimbursement as insurance coverage for robot-assisted placement of depth electrodes for SEEG.

The rest of the world includes India, China, Australia, South Africa, Brazil, and others that made remarkable improvements in terms of epilepsy surgeries and pre-surgical planning for epilepsy. The unmet requirement in South Africa and Brazil could provide lucrative opportunities for leading market players to capture a higher subdural electrodes market share in these regions.

KEY INDUSTRY PLAYERS

Ad-Tech Medical Instrument Corporation, CorTec GmbH, and Integra LifeSciences Corporation to Ensure Competitive Dominance by Providing Unique Technology

Introducing new products and focusing on mergers and acquisitions have been the key driving factors for the key industry players to capture higher market revenue. Combined with this, the companies are reinforcing its strategic position in the global market owing to their hold on unique technology, a wide range of product offerings, robust distribution network, key industry developments, mergers, and strong brand presence. The growth strategies adopted by the dominating companies of the global market have facilitated in leading the competition in the market. For instance, in October 2021, Ad-Tech Medical Instrument Corporation received investment from ArchiMed intending to scale up its business operations in North America and Europe.

CorTec GmbH is considered to be a second leading player in the global market due to its strong presence in the European market. Other key players, such as Natus Medical Incorporated, PMT Corporation, Unique Medical Ltd, and inomed Medizintechnik GmbH, are focusing on collaborations with healthcare institutions and strengthening their supply chain network to maintain their position in the market.

LIST OF KEY COMPANIES PROFILED:

• CorTech GmbH (Germany)


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


• DIXI MEDICAL (Dixi) (France)


• PMT Corporation (U.S.)


• UNIQUE MEDICAL Co., LTD (Japan)


• inomed Medizintechnik GmbH (Germany)


• Integra LifeSciences Corporation (U.S.)


• Natus Medical Incorporated (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• May 2022: NeuroOne Medical Technologies Corporation received the U.S. FDA clearance for its Evo sEEG Electrode for less than 30-day use.


• October 2021: Ad-Tech Medical Instrument Corporation received investment from ArchiMed with an aim to scale up its business operations in the North American and European markets.


• May 2020: Natus Medical Incorporated partnered with Holberg EEG AS to automate and improve the diagnosis and critical care of epilepsy patients around the globe.


• January 2020: Ad-Tech Medical Instrument Corporation received the FDA approval for its subdural strip/intraoperative strip electrode, subdural grid/intraoperative grid electrode, dual-sided interhemispheric subdural electrodes, multi-strip, and split grid subdural electrodes, and intraoperative mapping grid subdural electrodes.


• March 2019: CorTec GmbH got FDA approval for its AirRay electrodes. The newly FDA-approved electrodes are equipped with CortiQ technology, enabling real-time automated brain mapping, leading to superior seizure detection in intracranial monitoring for epilepsy.

REPORT COVERAGE

An Infographic Representation of Subdural Electrode Market

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The report provides qualitative and quantitative insights into the global market and a detailed analysis of the global market size & growth rate for all possible segments in the market. The report also provides an elaborative analysis of the global market dynamics and competitive landscape. Various key insights presented in the report are the prevalence of epilepsy in key countries, key recent industry developments – mergers, acquisitions, and partnerships; key industry developments – new product launches, approvals, recalls; regulatory scenario, overview of applications of subdural electrodes in cranial nerves & others, trends of usage of these products and intracranial monitoring in epilepsy surgeries, the impact of COVID-19 on the market, and market volume data.

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