塞栓保護デバイス（EPD）市場：製品タイプ、用途、エンドユーザー、地域別、2024年～2031年

塞栓保護デバイス（EPD）市場評価、2024年～2031年

塞栓保護デバイス（EPD）のニーズは、いくつかの変数のために増加している、最も顕著なのは、心血管疾患（CVDs）の有病率の上昇と低侵襲手術の使用の拡大です。冠動脈疾患、脳卒中、末梢動脈疾患などの心血管疾患は、世界的に罹患率や死亡率の主な原因となっており、2024年には5億8,648万米ドルの売上を突破し、2031年には約10億2,285万米ドルの評価額に達する見込みです。

医療現場における低侵襲手術へのシフトは、塞栓防止システムの需要を大きく押し上げています。経カテーテル大動脈弁置換術（TAVR）や頸動脈ステント留置術などの低侵襲手術は、回復時間の短縮、入院期間の短縮、問題の発生確率の低下などの関連メリットにより、従来の開腹手術よりも人気を集めており、市場は2024年から2031年にかけてCAGR 7.20%で成長します。

塞栓保護デバイス（EPD）市場定義/概要

塞栓保護デバイス（EPD）は、心臓血管治療中、特に動脈内で外れる可能性のある破片や塞栓粒子を捕捉・除去するために使用される医療機器です。これらの器具は一般に、頸動脈ステント留置術（CAS）、経皮的冠動脈インターベンション（PCI）、およびプラーク、血栓、または他の破片が外れる危険性の高い他の血管手術などの手技で使用されます。

一般に心臓血管の治療では、脳卒中や重要な動脈の閉塞といった重大な問題につながる塞栓性破片の移動を避けるために使用されます。EPDの最も顕著な用途の一つは、頸動脈疾患の治療に用いられる頸動脈ステント留置術（CAS）です。頸動脈は脳に血液を供給しており、ステント留置中にプラークやその他の粒子が外れて血流に乗り、脳卒中のような塞栓事象を引き起こす可能性があります。

塞栓保護デバイス（EPD）の今後の使用は、心血管系治療と医療技術の進歩に伴って劇的に増加すると予想されます。EPDは通常、頸動脈ステント留置術などの血管処置の際に使用され、インターベンション中に外れる可能性のある破片を回収・除去し、塞栓性脳卒中のリスクを低下させる。世界の人口が高齢化し、心血管系疾患の有病率が上昇するにつれて、より安全で効果的なインターベンション手法に対する需要が高まると思われます。

高齢者の増加は塞栓保護デバイス（EPD）市場を牽引するか？

高齢人口の拡大は塞栓保護デバイス（EPD）市場の主要な促進要因です。高齢化が進むにつれ、さまざまな心血管系疾患や病気にかかりやすくなり、塞栓保護デバイス（EPD）を用いたインターベンション治療が必要になる可能性があります。世界保健機関（WHO）によると、2015年から2050年の間に60歳以上の人口が占める割合は12%から22%へとほぼ倍増します。これは、60歳以上の人口が9億人から20億人に増加することに相当します。米国だけでも、2030年までにベビーブーム世代がすべて65歳以上になり、高齢者人口が5人に1人になると国勢調査局は予測しています。

この世代交代は、塞栓保護デバイス（EPD）市場に大きな影響を与えます。米国疾病予防管理センター（CDC）によれば、心臓病は65歳以上の死亡原因のトップであり続け、この年齢層の死亡原因の25％を占めています。さらに、米国心臓協会によると、脳卒中の発症率は55歳以降10年ごとに倍増します。これらの統計は、頸動脈ステント留置術や経カテーテル大動脈弁置換術（TAVR）などの治療が頻繁に必要となる心血管系イベントのリスクが高齢者層で高いことを示しています。Journal of the American College of Cardiologyに掲載された調査によると、TAVR治療中に塞栓保護デバイス（EPD）を使用することで、脳卒中のリスクが57％減少することが判明しました。

厳しい規制の枠組みは塞栓保護デバイス（EPD）市場の妨げになるか？

厳しい規制の枠組みは、塞栓保護デバイス（EPD）市場の成長を著しく阻害する可能性があります。EPDは、特に頸動脈ステント留置術や経カテーテル大動脈弁置換術を受ける患者など、心血管系処置中の塞栓イベントを減らすために極めて重要です。しかし、医療機器業界は規制が厳しいため、メーカーは複雑な規制プロセスを通過しなければならず、新製品発売の遅れの原因となっています。米国食品医薬品局（FDA）や欧州医薬品庁（EMA）などの規制当局は、これらの機器の安全性と有効性を確保するために厳しい要件を定めています。これらの規制には、厳格な臨床試験と徹底した文書化、そして時間と費用のかかる継続的な市販後調査が必要です。

規制は地域によって異なるため、ビジネスの状況を複雑にする可能性があります。欧州連合（EU）の医療機器規制（MDR）は、臨床エビデンスと市販後検査についてより強い基準を課しているが、FDAは市販前承認と継続的監視に重点を置いており、海外進出を望む企業にとっては難しい環境を作り出しています。このミスマッチは、製品上市の遅延や市場拡大を制限するコンプライアンスコストの増加を引き起こす可能性があります。さらに、変化する規則に合わせて継続的に更新する必要があるため、研究開発からリソースが流出し、技術革新がさらに制限される可能性があります。このような厳しい基準は患者の安全にとって不可欠であるが、その一方で、新奇で救命につながる可能性のある塞栓防止技術の利用可能性を意図せず遅らせ、その採用を制限し、全体的な拡大を遅らせる可能性があります。

目次

第1章 イントロダクション

• 市場の定義
• 市場セグメンテーション
• 調査手法

第2章 エグゼクティブサマリー

• 主な調査結果
• 市場概要
• 市場ハイライト

第3章 市場概要

• 市場規模と成長の可能性
• 市場動向
• 市場促進要因
• 市場抑制要因
• 市場機会
• ポーターのファイブフォース分析

第4章 塞栓保護デバイス（EPD）市場：製品タイプ別

• 遠位フィルターデバイス
• 近位閉塞デバイス
• 遠位閉塞デバイス
• バルーン閉塞デバイス

第5章 塞栓保護デバイス（EPD）市場、用途別

• 心血管疾患
• 神経血管疾患
• 末梢血管疾患

第6章 塞栓保護デバイス（EPD）市場：エンドユーザー別

• 病院
• 外来手術センター
• 専門クリニック
• その他

第7章 地域別分析

• 北米
• 米国
• カナダ
• メキシコ
• 欧州
• 英国
• ドイツ
• フランス
• イタリア
• アジア太平洋
• 中国
• 日本
• インド
• オーストラリア
• ラテンアメリカ
• ブラジル
• アルゼンチン
• チリ
• 中東・アフリカ
• 南アフリカ
• サウジアラビア
• アラブ首長国連邦

第8章 市場力学

• 市場促進要因
• 市場抑制要因
• 市場機会
• COVID-19の市場への影響

第9章 競合情勢

• 主要企業
• 市場シェア分析

第10章 企業プロファイル

• Abbott Laboratories
• Boston Scientific Corporation
• Medtronic Plc
• Edwards Lifesciences Corporation
• W. L. Gore & Associates（Gore Medical）
• Transverse Medical, Inc.
• Innovative Cardiovascular Solutions, LLC
• Allium Medica
• Cardinal Health
• Contego Medical, LLC
• Keystone Heart
• Metactive Medical

第11章 市場の展望と機会

• 新興技術
• 今後の市場動向
• 投資機会

第12章 付録

• 略語リスト
• 出典と参考文献

Embolic Protection Device Market Valuation - 2024-2031

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.

Will the Growing Geriatric Population Drive the Embolic Protection Device Market?

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%.

Will Stringent Regulatory Framework Hamper the Embolic Protection Device Market?

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.

Category-Wise Acumens

Will Adoption and Effectiveness in Various Cardiovascular Procedures Drive Growth in the Product Type Segment?

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.

Will High Prevalence of Cardiovascular Conditions Drive the Application Segment?

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.

Country/Region-wise Acumens

Will Rising Cases of Coronary Heart Disease Drive the Market in the North American Region?

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.

Will Improving Healthcare Infrastructure Drive the Market in the Asia Pacific Region?

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.

Competitive Landscape

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.

Latest Developments

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).

TABLE OF CONTENTS

1. Introduction

• Market Definition
• Market Segmentation
• Research Methodology

2. Executive Summary

• Key Findings
• Market Overview
• Market Highlights

3. Market Overview

• Market Size and Growth Potential
• Market Trends
• Market Drivers
• Market Restraints
• Market Opportunities
• Porter's Five Forces Analysis

4. Embolic Protection Device Market, By Product Type

• Distal Filter Devices
• Proximal Occlusion Devices
• Distal Occlusion Devices
• Balloon Occlusion Devices

5. Embolic Protection Device Market, By Application

• Cardiovascular Diseases
• Neurovascular Diseases
• Peripheral Vascular Diseases

6. Embolic Protection Device Market, By End-User

• Hospitals
• Ambulatory Surgical Centers
• Specialty Clinics
• Others

7. Regional Analysis

• North America
• United States
• Canada
• Mexico
• Europe
• United Kingdom
• Germany
• France
• Italy
• Asia-Pacific
• China
• Japan
• India
• Australia
• Latin America
• Brazil
• Argentina
• Chile
• Middle East and Africa
• South Africa
• Saudi Arabia
• UAE

8. Market Dynamics

• Market Drivers
• Market Restraints
• Market Opportunities
• Impact of COVID-19 on the Market

9. Competitive Landscape

• Key Players
• Market Share Analysis

10. Company Profiles

• Abbott Laboratories
• Boston Scientific Corporation
• Medtronic Plc
• Edwards Lifesciences Corporation
• W. L. Gore & Associates (Gore Medical)
• Transverse Medical, Inc.
• Innovative Cardiovascular Solutions, LLC
• Allium Medica
• Cardinal Health
• Contego Medical, LLC
• Keystone Heart
• Metactive Medical

11. Market Outlook and Opportunities

• Emerging Technologies
• Future Market Trends
• Investment Opportunities

12. Appendix

• List of Abbreviations
• Sources and References