색전방지 기기(EPD) 시장 평가(2024-2031년)
색전방지 기기(EPD)의 요구는 몇 가지 변수로 인해 증가하고 있으며, 가장 두드러진 것은 심혈관 질환(CVDs)의 유병률 증가와 저침습 수술의 사용의 확대입니다. 관상동맥질환, 뇌졸중, 말초동맥질환 등 심혈관질환은 전 세계적으로 이환율과 사망률의 주요 원인이 되고 있으며 2024년에는 5억 8,648만 달러의 매출을 돌파하였고 2031년에는 약 10억 2,285만 달러의 평가액에 이를 전망입니다.
의료 현장에서 저침습 수술로의 전환은 색전 방지 시스템 수요를 크게 밀어올리고 있습니다. 경카테테르 대동맥판막치환술(TAVR)이나 경동맥 스텐트 유치술 등의 저침습 수술은 회복시간 단축, 입원기간 단축, 문제발생 확률 저하 등의 관련 장점으로 기존 개복 수술보다 인기를 끌고 있으며 시장은 2024년부터 2031년까지 CAGR 7.20%로 성장할 전망입니다.
색전방지 기기(EPD) 시장 정의 및 개요
색전방지 기기(EPD)는 심장혈관 치료 중, 특히 동맥 내에서 벗어날 수 있는 파편이나 색전 입자를 포착하고 제거하는 데 사용되는 의료기기입니다. 이 기구들은 일반적으로 경동맥 스텐트 유치술(CAS), 경피적 관상동맥인터벤션(PCI) 및 플라크, 혈전 또는 다른 파편이 빠질 위험성이 높은 다른 혈관 수술 등의 손기술에 사용됩니다.
일반적으로 심장혈관 치료는 뇌졸중과 중요한 동맥 폐색과 같은 심각한 문제로 이어지는 색전성 파편의 이동을 피하기 위해 사용됩니다. EPD의 가장 두드러진 용도 중 하나는 경동맥 질환 치료에 이용되는 경동맥 스텐트 유치술(CAS)입니다. 경동맥은 뇌에 혈액을 공급하고 있으며 스텐트 유치 중 플라크나 기타 입자가 빠져 혈류를 타고 뇌졸중과 같은 색전현상을 일으킬 수 있습니다.
색전방지 기기(EPD)의 향후 사용은 심혈관 치료와 의료 기술의 발전에 따라 극적으로 증가할 것으로 예상됩니다. EPD는 통상 경동맥 스텐트 유치술 등 혈관 처치 시 사용되며, 인터벤션 중 빠질 수 있는 파편을 회수 및 제거해 색전성 뇌졸중 위험을 낮춥니다. 세계 인구가 고령화되고 심혈관계 질환 유병률이 상승함에 따라 보다 안전하고 효과적인 인터벤션 기법에 대한 수요가 높아질 것으로 보입니다.
노인 인구의 확대는 색전방지 기기(EPD) 시장의 주요 촉진요인입니다. 고령화가 진행됨에 따라 다양한 심혈관계 질환이나 질병에 걸리기 쉬워져 색전방지 기기(EPD)를 이용한 인터벤션 치료가 필요할 수 있습니다. 세계보건기구(WHO)에 따르면 2015년부터 2050년까지 60세 이상 인구가 차지하는 비율은 12%에서 22%로 거의 두 배가 될 전망입니다. 이는 60세 이상 인구가 9억 명에서 20억 명으로 증가하는 것에 해당합니다. 미국만 해도 2030년까지 베이비붐 세대가 모두 65세 이상이 되고 노인 인구가 5명 중 1명이 될 것으로 인구조사국은 예측하고 있습니다.
이 세대 교체는 색전방지 기기(EPD) 시장에 큰 영향을 미칩니다. 미국 질병예방관리센터(CDC)에 따르면 심장병은 65세 이상 사망원인 1위로 계속 이 연령대 사망원인의 25%를 차지하고 있습니다. 또한 미국 심장 협회에 따르면 뇌졸중 발병률은 55세 이후 10년마다 두 배로 증가합니다. 이러한 통계는 경동맥 스텐트 유치술이나 경카테테르 대동맥판막치환술(TAVR) 등의 치료가 자주 필요한 심혈관계 이벤트의 위험이 고령자층에서 높다는 것을 보여줍니다. Journal of the American College of Cardiology에 게재된 조사에 따르면 TAVR 치료 중 색전보호장치(EPD)를 사용하면 뇌졸중 위험이 57% 감소하는 것으로 나타났습니다.
엄격한 규제 프레임 워크는 색전방지 기기(EPD) 시장의 성장을 현저하게 억제할 수 있습니다. EPD는 특히 경동맥 스텐트 유치술이나 경카테테르 대동맥판막치환술을 받는 환자 등 심혈관계 처치 중 색전 이벤트를 줄이기 위해 매우 중요합니다. 그러나 의료기기 업계는 규제가 엄격하기 때문에 제조사는 복잡한 규제 프로세스를 통과해야 해 신제품 출시 지연의 원인이 되고 있습니다. 미국 식품의약국(FDA)과 유럽의약품청(EMA) 등 규제당국은 이들 기기의 안전성과 유효성을 확보하기 위해 엄격한 요건을 정하고 있습니다. 이러한 규제에는 엄격한 임상시험과 철저한 문서화, 그리고 시간과 비용이 많이 드는 지속적인 시판 후 조사가 필요합니다.
규제는 지역에 따라 다르기 때문에 비즈니스 상황을 복잡하게 만들 수 있습니다. 유럽연합(EU)의 의료기기 규제(MDR)는 임상 에비던스와 시판 후 검사에 대해 보다 강한 기준을 부과하고 있지만 FDA는 시판 전 승인과 지속적 감시에 중점을 두고 있어 해외 진출을 원하는 기업들에게는 어려운 환경을 조성하고 있습니다. 이 미스매치는 제품상시의 지연이나 시장 확대를 제한하는 컴플라이언스 비용의 증가를 일으킬 가능성이 있습니다. 더욱이 변화하는 규칙에 맞춰 지속적으로 업데이트해야 하기 때문에 연구개발에서 자원이 유출돼 기술 혁신이 더욱 제한될 수 있습니다. 이러한 엄격한 기준은 환자의 안전에 필수적이지만, 한편으로 신기하고 구명으로 이어질 가능성이 있는 색전방지 기술의 이용 가능성을 의도치 않게 늦추고 그 채용을 제한하여 전체적인 확대를 늦출 가능성이 있습니다.
The need for embolic protection devices (EPDs) is increasing due to several variables, the most notable of which are the rising prevalence of cardiovascular diseases (CVDs) and the expanding use of minimally invasive surgery. Cardiovascular illnesses such as coronary artery disease, stroke, and peripheral artery disease are major sources of morbidity and mortality globally by enabling the market to surpass a revenue of USD 586.48 Million valued in 2024 and reach a valuation of aroundUSD 1022.85 Million by 2031.
The medical field's shift to minimally invasive procedures has greatly boosted demand for embolic protection systems. Minimally invasive methods such as transcatheter aortic valve replacement (TAVR) and carotid artery stenting are gaining popularity over traditional open surgeries due to their related benefits which include shorter recovery times, shorter hospital stays, and a lower chance of problems by enabling the market to grow at aCAGR of 7.20 % from 2024 to 2031.
Embolic Protection Device Market: Definition/ Overview
Embolic Protection Devices (EPDs) are medical equipment used to catch and remove debris or embolic particles that may become dislodged during cardiovascular treatments, particularly in the arteries. These devices are generally employed in procedures such as carotid artery stenting (CAS), percutaneous coronary interventions (PCI), and other vascular surgeries that have a high risk of dislodging plaque, thrombus, or other debris.
They are generally employed in cardiovascular treatments to avoid the migration of embolic debris which can lead to serious problems such as strokes or blockages in critical arteries. One of the most prominent uses for EPDs is in carotid artery stenting (CAS), a treatment used to treat carotid artery disease. The carotid arteries provide blood to the brain, and during stenting, plaque or other particles can dislodge and travel through the bloodstream, potentially causing an embolic event like a stroke.
The future use of embolic protection devices (EPDs) is expected to grow dramatically as advances in cardiovascular care and medical technology progress. EPDs are generally utilized during vascular procedures such as carotid artery stenting to collect and remove debris that may become dislodged during the intervention lowering the risk of an embolic stroke. As the world population ages and cardiovascular disease prevalence rises, there will be a greater demand for safer and more effective interventional methods.
The expanding geriatric population is a primary driver of the embolic protection device market. As people age, they become increasingly vulnerable to a variety of cardiovascular diseases and ailments that may necessitate interventional procedures involving embolic protection devices. According to the World Health Organization (WHO), the share of the world's population over 60 will nearly double between 2015 and 2050 from 12% to 22%. This equates to an increase of 900 million to 2 billion persons over the age of 60. In the United States alone, the Census Bureau predicts that by 2030, all baby boomers will be above the age of 65 growing the elder population to one in every five individuals.
This generational transition has major consequences for the embolic protection device market. According to the Centers for Disease Control and Prevention (CDC), heart disease continues to be the top cause of death among persons aged 65 and older accounting for 25% of all fatalities in this age range. Furthermore, the American Heart Association reports that the incidence of stroke doubles with each decade of life after the age of 55. These statistics show the senior population's higher risk of cardiovascular events which frequently require treatments such as carotid artery stenting or transcatheter aortic valve replacement (TAVR). Research published in the Journal of the American College of Cardiology discovered that using embolic protection devices during TAVR treatments decreased the risk of stroke by 57%.
Stringent regulatory frameworks can significantly impede the growth of the embolic protection device (EPD) market. EPDs are crucial for reducing embolic events during cardiovascular procedures, especially in patients having carotid artery stenting or transcatheter aortic valve replacement. However, due to the highly regulated nature of the medical device industry, manufacturers must navigate complex regulatory processes which can cause new product release delays. Regulatory authorities such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) set stringent requirements to ensure the safety and efficacy of these devices. These restrictions necessitate rigorous clinical trials thorough documentation, and ongoing post-market surveillance which can be time-consuming and expensive.
Regulations vary among regions which can complicate the business situation. While the European Union's Medical Device Regulation (MDR) has imposed stronger standards for clinical evidence and post-market inspection, the FDA's emphasis on pre-market approval and continuing monitoring creates a difficult environment for companies wanting to expand abroad. This mismatch might cause product launch delays and increased compliance costs limiting market expansion. Furthermore, the necessity for continual updates to suit changing rules might tap resources away from R&D restricting innovation even further. While these tight standards are vital for patient safety, they can unintentionally slow down the availability of novel and potentially life-saving embolic protection technologies limiting their adoption and slowing the overall expansion.
Distal filter devices are currently the most dominant product type due to their broad use and effectiveness in a variety of cardiovascular treatments. Distal filter devices are intended to trap embolic debris downstream from the intervention site preventing it from reaching essential organs such as the brain or heart where it could cause catastrophic problems including strokes or myocardial infarctions. Their appeal arises from their capacity to maintain continuous blood flow while filtering out debris which is especially useful in complicated procedures such as carotid artery stenting. These devices are less invasive and easier to use than other types of EPDs making them popular among interventional cardiologists and vascular surgeons.
Furthermore, the form and functionality of distal filter devices help to explain their supremacy. They are frequently more adaptive and versatile allowing for usage in a variety of anatomical situations and procedural scenarios. This versatility is especially useful in the medical industry where patient diversity and procedural complexity necessitate flexible solutions. These devices are suited for a broader spectrum of patients including those with difficult vascular anatomy due to their ease of use and capacity to maintain perfusion throughout the surgery. Furthermore, the rising global frequency of cardiovascular illnesses has increased the demand for effective embolic protection during interventions and distal filter devices are well positioned to address this demand.
The cardiovascular diseases segment is the most dominant application field owing to the high frequency of cardiovascular illnesses and the important necessity for embolic protection during interventional treatments. Cardiovascular diseases such as coronary artery disease and heart valve problems are major sources of morbidity and mortality worldwide. As a result, there is a high demand for procedures like angioplasty and stenting which are required to treat these problems. While these operations are lifesaving, there is a risk of embolic events which occur when debris dislodges and causes blockages in other sections of the circulatory system.
Furthermore, developments in interventional cardiology have increased the quantity and complexity of cardiovascular treatments driving up demand for EPDs. To avoid complications, innovations like transcatheter aortic valve replacement (TAVR) and sophisticated coronary operations require highly effective embolic protection. The increased use of these advanced procedures, particularly in elderly populations with significant cardiovascular risk highlights the importance of EPDs in this application area. Furthermore, the cardiovascular market benefits from significant investments in research and development resulting in the ongoing advancement of EPD technology.
The rising prevalence of coronary heart disease (CHD) in North America is driving the market for embolic protection devices. The United States dominates this market because of its advanced healthcare infrastructure, high healthcare spending, and expanding elderly population.
The increasing prevalence of coronary heart disease is a major driver of the embolic protection device market in North America. According to the Centers for Disease Control and Prevention (CDC), approximately 18.2 million adults aged 20 and up in the United States have CHD, accounting for 6.7% of the adult population.
The American Heart Association says that coronary heart disease is the top cause of mortality in the United States accounting for around 13% of all fatalities in 2019. According to the National Heart, Lung, and Blood Institute, the risk of getting coronary heart disease increases with age, especially beyond the age of 55 for women and 45 for men. With North America's aging population, this risk factor is likely to help drive market expansion. According to the United States Census Bureau, by 2030, all baby boomers will be over the age of 65 bringing the total elder population to 73 million people.
The Asia Pacific region is seeing the highest growth in the embolic protection device market owing to significant improvements in healthcare infrastructure and increased investments in medical technology. This trend is especially noticeable in rising markets such as China and India. Governments around the Asia Pacific are dramatically expanding their healthcare budgets to enhance access to high-quality medical treatment. According to the World Health Organization, Chinese healthcare spending increased from 5.03% of GDP in 2010 to 6.57% in 2018. Similarly, India's healthcare spending increased from 3.27% to 3.54% of GDP over the same period.
This increasing funding allows hospitals and clinics to invest in modern medical technologies such as embolic protection devices. The Asia Pacific region is experiencing an increase in cardiovascular disease owing to changing lifestyles and an aging population. According to the World Heart Federation, cardiovascular disease accounts for 35% of all deaths in the Asia-Pacific area. Between 2010 and 2030, the number of persons suffering from cardiovascular disease in China is expected to increase by 50%. This increased disease burden is driving up demand for sophisticated therapeutic options such as embolic protection devices.
The Embolic Protection Device Market is a dynamic and competitive space, characterized by a diverse range of players vying for market share. These players are on the run for solidifying their presence through the adoption of strategic plans such as collaborations, mergers, acquisitions, and political support. The organizations are focusing on innovating their product line to serve the vast population in diverse regions.
Some of the prominent players operating in the embolic protection device market include:
Boston Scientific Corporation
Edwards Lifesciences Corporation.
Abott.
Medtronic
Cardinal Health
Innovative Cardiovascular Solutions, LLC
Transverse Medical, Inc.
L. Gore & Associates, Inc.
In September 2022, Boston Scientific Corporation revealed the results of a clinical trial on the PROTECTED TAVR to evaluate the SENTINEL Cerebral Protection System, which is designed to capture and eliminate embolic debris from transcatheter aortic valve replacement before it reaches the brain and potentially causes a stroke. Such advances served to maintain the company's brand image while also expanding its consumer base.
In April 2024, Emboline, Inc. announced the acquisition of SWAT Medical's Intellectual Property Portfolio for embolic protection. This acquisition is expected to broaden Emboline's existing portfolio of platform solutions for lowering the risk of stroke caused by the release of embolic debris into the bloodstream during operations like Transcatheter Aortic Valve Replacement (TAVR).