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心血管設備

市場調查報告書

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1410261

主動式植入式醫療設備(AIMD) 市場：2023 年至 2028 年預測

Active Implantable Medical Devices (AIMD) Market - Forecasts from 2023 to 2028

出版日期: 2023年12月15日 | 出版商:

Knowledge Sourcing Intelligence | 英文 114 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

全球主動植入醫療設備市場預計將以 7.79% 的複合年成長率成長，從 2021 年的 270.17 億美元成長到 2028 年的 456.86 億美元。

技術突破正在推動主動植入式醫療設備（AIMD）市場的發展，特別是為了應對人口老化中慢性病日益流行的情況。對有源植入式醫療設備的需求是由病人偏好、政府資助和意識提高所推動的。由於正在進行的研發計劃和現有產品的擴大改造，技術創新正在進一步加速。

此外，據美國國家醫學圖書館稱，人工智慧 (AI) 正在醫療保健的許多方面得到應用，包括針對患者的特定診斷。人工智慧醫療設備（AIMD）產業預計在未來幾年將成長。目前，主要國家正在製定框架和法規來引領醫療人工智慧市場。韓國為了促進AIMD的發展，已提案並正在實施一項關於培育醫療設備產業和支持創新醫療設備的法律。

老年人口疾病盛行率上升

主動植入式醫療設備市場受到人口老化導致的慢性病盛行率上升的顯著影響。老化社會與需要先進醫療照護的疾病發生率增加有關，例如糖尿病、神經系統疾病和心血管疾病。 AIMD 在改善老年人的生活品質方面發揮著重要作用，因為它可以監測、管理和治療慢性病。這些人口趨勢正在增加對植入式設備的需求，隨著患者和醫療保健提供者尋求切實可行的方法來解決老化和慢性病的複雜醫療需求，市場正在不斷擴大，發展預期良好。

根據社區生活管理局的數據，2020 年美國65 歲及以上的美國有 5,570 萬人。超過六分之一的美國人，即總人口的 17%，年齡較大。自2010年以來，65歲及以上的美國人數量增加了1,520萬（38%），65歲以下的美國人數量增加了2%。此外，2010 年至 2020 年間，45 歲至 64 歲（將在未來 20 年內年滿 65 歲）的美國人數量增加了 1%，從 8,180 萬增加到 8,280 萬人。 60 歲及以上的美國人數量增加了 33%，從 5,750 萬增加到 7,650 萬。

此外，根據國家醫學圖書館的數據，慢性病是印度老年人口殘疾和過早死亡的主要原因。在印度，據估計 21% 的老年人至少患有一種慢性病。慢性病影響都市區老年人的29%和農村地區老年人的17%。慢性病中，高血壓和糖尿病佔68%以上。喀拉拉邦的慢性病盛行率最高（54%），領先安得拉邦（43%）、西孟加拉邦（36%）和果阿邦（32%）。

根據美國衛生與公共服務部的數據，到 2060 年，近 25% 的美國將年齡在 65 歲或以上。糖尿病、骨質疏鬆症和阿茲海默症慢性健康問題在老年人中更為常見。此外，老年人跌倒佔成年人跌倒的三分之一，是造成傷害的主要原因。從事體育活動的長者可以降低慢性病和跌倒受傷的風險。

北美、美國預計將佔據最大市場佔有率

主動式植入式醫療設備（AIMD）是一種完全或部分植入人體用於治療或診斷目的的醫療設備。該設備使醫生和醫療保健專業人員能夠長時間持續監測患者的身體。此類設備主要用於監測心臟狀況，隨著美國心血管疾病盛行率和死亡人數的增加，預計 AIMD 的市場需求只會增加。根據美國疾病管制與預防中心預測，2022年心臟病死亡人數將達699,659人，比2021年增加4,659人。此外，根據同一消息來源，心臟病是美國女性、男性和族裔群體死亡的主要原因之一，每年約有 605,000 人在美國經歷首次心臟病發作。

此外，美國不斷成長的老年人口預計將進一步增加心臟病的盛行率，並增加對有源植入式醫療設備的需求。根據世界銀行資料，2022年老年人口將占美國的17%。此外，病患監測方面的技術進步以及 AIMD 產品的推出也成為了進一步的推動因素。例如，2023年7月，雅培實驗室宣布其治療心率緩慢或異常的雙腔室心律調節器AVEIR(TM)獲得美國FDA核准。此次核准使該公司能夠為美國數百萬人提供無線起搏服務。

市場開拓的主要進展

2023年10月，FDA核准了Epsila EVTM MRI SureScanTM心臟麻痹去心房顫動和Aurora EV-ICDTM MRI SureScanTM（血管外（植入式心臟整流去顫器））。該核准授予全球醫療保健技術領導者美敦力公司 (Medtronic plc)。 Aurora EV-ICD 系統的引線（細線）放置在胸骨下方，遠離心臟和靜脈，首次提供了傳統經靜脈 ICD 的救生優勢。 Aurora EV-ICD 是一種在尺寸、結構和壽命方面與傳統經靜脈 ICD 相似的裝置。 2022年4月，醫療設備新興企業FineHeart SA開發了FLOWMAKER®，一種完全植入式心摶出量恢復系統（ICOMS），滿足嚴重心臟衰竭患者未滿足的需求，國家知識產權局宣布獲得首批兩項專利。這些新專利涵蓋了創意、心臟衰竭、製造等領域，為該公司強大的全球產品組合增添了 20 個系列和超過 78 項涉及外科植入物的專利。 2021 年 2 月，Abbott 的神經調節臨床醫生程式設計師應用程式和病患控制器應用程式可與相容的 Apple 智慧型手機裝置一起使用，並透過荷蘭公告機構根據醫療設備法規(MDR)（EU 2017/745）獲得BSI 批准，是首款有源植入式應用程式醫療設備產品需獲得合規認證。所有 III 類植入式醫療設備均須遵守最嚴格的法規。這也適用於配件。

Technology breakthroughs are driving the market for active implantable medical devices (AIMDs), which address the growing incidence of chronic diseases, especially in the aging population. The need for active implantable medical devices is driven by patient preference, government funding, and increased awareness. Innovation is further fueled by ongoing R&D projects and extended indications for already-existing products.

Furthermore, according to the National Library of Medicine, numerous aspects of medicine are utilizing artificial intelligence (AI), including patient-specific diagnoses. In the upcoming years, growth in the artificial intelligence medical device (AIMD) industry is anticipated. Major nations are currently setting up frameworks and regulations to take the lead in the market for medical artificial intelligence. The Act on fostering the medical devices industry and supporting innovative medical devices was proposed by the Republic of Korea and is being implemented in anticipation of the development of AIMDs.

The rising prevalence of diseases among the geriatric population

The active implantable medical device market is impacted greatly by the aging population's increasing incidence of chronic diseases. The aging population is associated with an increased incidence of ailments like diabetes, neurological problems, and cardiovascular diseases, all of which call for sophisticated medical care. Since AIMDs can monitor, manage, or treat chronic illnesses, they play a critical role in enhancing the quality of life for older adults. Owing to the growing need for implantable devices brought on by this demographic trend, the market is expected to develop as patients and healthcare providers look for practical ways to handle the complicated healthcare requirements that come with aging and chronic illnesses.

As per the Administration of Community Living, in 2020, there were 55.7 million Americans 65 years of age or older in the United States. More than one in every six Americans, or 17% of the population, was represented by them. Since 2010, the number of Americans over 65 has climbed by 15.2 million (or 38%), while the number of people under 65 has increased by 2%. Additionally, the number of Americans in the 45-64 age group (who will become 65 years old during the next 20 years) grew by 1% from 81.8 million to 82.8 million between 2010 and 2020. The number of Americans sixty years of age and above rose from 57.5 million to 76.5 million, a 33% rise.

Furthermore, according to the National Library of Medicine, the main causes of disability and early mortality among India's senior population are chronic illnesses. In India, it is estimated that 21% of the elderly suffer from at least one chronic illness. Chronic disease affects 29% of older people in urban settings and 17% of senior people in rural areas. Of all chronic disorders, hypertension and diabetes account for over 68%. Kerala has the highest rate of chronic disease prevalence (54%), ahead of Andhra Pradesh (43), West Bengal (36), and Goa (32).

As per the US Department of Health and Human Services, almost 25% of Americans will be 65 years of age or older by 2060. Chronic health issues like diabetes, osteoporosis, and Alzheimer's disease are more common among older people. Furthermore, falls account for one in three adult falls in the older population, making them a major source of injuries. Seniors who engage in physical activity can reduce their risk of developing chronic illnesses and injuries from falls.

The United States in North America is predicted to hold the largest market share in the market

Active implantable medical devices (AIMD) are a type of medical device that is completely or partially implanted in the human body for therapeutics or diagnostic purposes. The devices enable doctors and healthcare professionals to constantly monitor a patient's body for an extended period. Such devices are mainly used for monitoring heart conditions, and with the growing prevalence and deaths via cardiovascular disease in the United States, the market demand for AIMD is anticipated to witness an upward trajectory. According to the Centers for Disease Control and Prevention, in 2022, the number of deaths that occurred via heart disease reached 6,99,659 which signified an increase of 4,659 in comparison to 2021's death count. Moreover, as per the same source, heart disease is one of the major causes of death for women, men, and people of ethnic or racial groups in the United States, and every year nearly 6,05,000 people in America experience their first heart attack.

Moreover, the growing old age population in the United States is further expected to increase the heart disease prevalence rate thereby bolstering the demand for active implantable medical devices. According to the World Bank's data, in 2022, the old age population accounted for 17% of the overall population of the United States. Furthermore, technological advancements in patient monitoring coupled with product launches of AIMDs are also acting as an additional driving factor. For instance, in July 2023, Abbott Laboratories announced that the company received U.S. FDA's approval for its "AVEIR™" dual-chamber pacemaker that would treat people with slow or abnormal heartbeat. The approval had enabled the company to provide its leadless pacing to millions of people across the United States.

Market Key Developments

In October 2023, the FDA approved the Epsila EVTM MRI SureScanTM defibrillation lead and the Aurora EV-ICDTM MRI SureScanTM (Extravascular Implantable Cardioverter-Defibrillator) for use in treating dangerously fast heart rhythms that may result in sudden cardiac arrest (SCA). Medtronic plc, a leader in healthcare technology globally, was the recipient of this approval. The lead, or thin wire, for the Aurora EV-ICD system, is positioned beneath the breastbone, away from the heart and veins, and it offers the life-saving advantages of conventional transvenous ICDs for the first time. The Aurora EV-ICD is a device that resembles conventional transvenous ICDs in terms of size, structure, and longevity.
In April 2022, the medical device startup FineHeart S.A., which is creating the completely implantable cardiac output restoration system (ICOMS) FLOWMAKER® to meet the unmet requirements of patients with severe heart failure, announced that the CNIPA has awarded its first two patents. These new patents add to the company's robust global portfolio of 20 families and over 78 patents that cover the idea, development, manufacturing, and surgical implantation of the FLOWMAKER®, the world's first physiological heart assist device created by French cardiologists specializing in rhythm and electrophysiology that treats severe heart failure.
In February 2021, Abbott's neuromodulation clinician programmer app and its patient controller app, which can be used on compatible Apple smartphone devices, became the first Active Implantable Medical Devices products that BSI has certified to comply with the Medical Devices Regulation (MDR) (EU 2017/745) through its Notified Body in the Netherlands. All Class III Active Implantable Medical Devices are governed by the strictest regulations. This also applies to their accessories.

Segmentation:

By Product

Ventricular Assist Devices
Neurostimulators
Implantable Cardiac Pacemakers
Cochlear Implants
Others

By End-User

Hospitals & Clinics
Ambulatory Surgical Centers

By Geography

North America
United States
Canada
Mexico
South America
Brazil
Argentina
Others
Europe
United Kingdom
Germany
France
Spain
Others
Middle East and Africa
Saudi Arabia
UAE
Israel
Others
Asia Pacific
Japan
China
India
South Korea
Indonesia
Thailand
Others

1. INTRODUCTION

1.1. Market Overview
1.2. Market Definition
1.3. Scope of the Study
1.4. Market Segmentation
1.5. Currency
1.6. Assumptions
1.7. Base, and Forecast Years Timeline

2. RESEARCH METHODOLOGY

2.1. Research Data
2.2. Research Process

3. EXECUTIVE SUMMARY

3.1. Research Highlights

4. MARKET DYNAMICS

4.1. Market Drivers
4.2. Market Restraints
4.3. Porter's Five Forces Analysis
- 4.3.1. Bargaining Power of Suppliers
- 4.3.2. Bargaining Power of Buyers
- 4.3.3. Threat of New Entrants
- 4.3.4. Threat of Substitutes
- 4.3.5. Competitive Rivalry in the Industry
4.4. Industry Value Chain Analysis

5. GLOBAL ACTIVE IMPLANTABLE MEDICAL DEVICES MARKET BY PRODUCT

5.1. Introduction
5.2. Ventricular Assist Devices
5.3. Neurostimulators
5.4. Implantable Cardiac Pacemakers
5.5. Cochlear Implants
5.6. Others

6. GLOBAL ACTIVE IMPLANTABLE MEDICAL DEVICES MARKET BY END-USER

6.1. Introduction
6.2. Hospitals & Clinics
6.3. Ambulatory Surgical Centers

7. GLOBAL ACTIVE IMPLANTABLE MEDICAL DEVICES MARKET BY GEOGRAPHY

7.1. Introduction
7.2. North America
- 7.2.1. By Product
- 7.2.2. By End-user
- 7.2.3. By Country
- 7.2.3.1. United States
- 7.2.3.2. Canada
- 7.2.3.3. Mexico
7.3. South America
- 7.3.1. By Product
- 7.3.2. By End-user
- 7.3.3. By Country
- 7.3.3.1. Brazil
- 7.3.3.2. Argentina
- 7.3.3.3. Others
7.4. Europe
- 7.4.1. By Product
- 7.4.2. By End-user
- 7.4.3. By Country
- 7.4.3.1. UK
- 7.4.3.2. Germany
- 7.4.3.3. France
- 7.4.3.4. Italy
- 7.4.3.5. Others
7.5. Middle East and Africa
7.6. Asia Pacific
- 7.6.1. By Product
- 7.6.2. By End-user
- 7.6.3. By Country
- 7.6.3.1. Japan
- 7.6.3.2. China
- 7.6.3.3. India
- 7.6.3.4. Thailand
- 7.6.3.5. Taiwan
- 7.6.3.6. Indonesia
- 7.6.3.7. Others