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主动式植入式医疗设备(AIMD) 市场：2023 年至 2028 年预测
市场调查报告书
商品编码
1410261

主动式植入式医疗设备(AIMD) 市场：2023 年至 2028 年预测

Active Implantable Medical Devices (AIMD) Market - Forecasts from 2023 to 2028
出版日期: | 出版商: Knowledge Sourcing Intelligence | 英文 114 Pages | 商品交期: 最快1-2个工作天内

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简介目录

全球主动植入医疗设备市场预计将以 7.79% 的复合年增长率成长，从 2021 年的 270.17 亿美元成长到 2028 年的 456.86 亿美元。

技术突破正在推动主动植入式医疗设备（AIMD）市场的发展，特别是为了应对人口老化中慢性病日益流行的情况。对有源植入式医疗设备的需求是由病人偏好、政府资助和意识提高所推动的。由于正在进行的研发计划和现有产品的扩大改造，技术创新正在进一步加速。

此外，据美国国家医学图书馆称，人工智慧 (AI) 正在医疗保健的许多方面得到应用，包括针对患者的特定诊断。人工智慧医疗设备（AIMD）产业预计在未来几年将成长。目前，主要国家正在製定框架和法规来引领医疗人工智慧市场。韩国为了促进AIMD的发展，已提案并正在实施一项关于培育医疗设备产业和支持创新医疗设备的法律。

老年人口疾病盛行率上升

主动植入式医疗设备市场受到人口老化导致的慢性病盛行率上升的显着影响。老化社会与需要先进医疗照护的疾病发生率增加有关，例如糖尿病、神经系统疾病和心血管疾病。 AIMD 在改善老年人的生活品质方面发挥着重要作用，因为它可以监测、管理和治疗慢性病。这些人口趋势正在增加对植入式设备的需求，随着患者和医疗保健提供者寻求切实可行的方法来解决老化和慢性病的复杂医疗需求，市场正在不断扩大，发展预期良好。

根据社区生活管理局的数据，2020 年美国65 岁及以上的美国有 5,570 万人。超过六分之一的美国人，即总人口的 17%，年龄较大。自2010年以来，65岁及以上的美国人数量增加了1,520万（38%），65岁以下的美国人数量增加了2%。此外，2010 年至 2020 年间，45 岁至 64 岁（将在未来 20 年内年满 65 岁）的美国人数量增加了 1%，从 8,180 万增加到 8,280 万人。 60 岁及以上的美国人数量增加了 33%，从 5,750 万增加到 7,650 万。

此外，根据国家医学图书馆的数据，慢性病是印度老年人口残疾和过早死亡的主要原因。在印度，据估计 21% 的老年人至少患有一种慢性病。慢性病影响都市区老年人的29%和农村地区老年人的17%。慢性病中，高血压和糖尿病占68%以上。喀拉拉邦的慢性病盛行率最高（54%），领先安得拉邦（43%）、西孟加拉邦（36%）和果阿邦（32%）。

根据美国卫生与公共服务部的数据，到 2060 年，近 25% 的美国将年龄在 65 岁或以上。糖尿病、骨质疏鬆症和阿兹海默症慢性健康问题在老年人中更为常见。此外，老年人跌倒占成年人跌倒的三分之一，是造成伤害的主要原因。从事体育活动的长者可以降低慢性病和跌倒受伤的风险。

北美、美国预计将占据最大市场份额

主动式植入式医疗设备（AIMD）是一种完全或部分植入人体用于治疗或诊断目的的医疗设备。该设备使医生和医疗保健专业人员能够长时间持续监测患者的身体。此类设备主要用于监测心臟状况，随着美国心血管疾病盛行率和死亡人数的增加，预计 AIMD 的市场需求只会增加。根据美国疾病管制与预防中心预测，2022年心臟病死亡人数将达699,659人，比2021年增加4,659人。此外，根据同一消息来源，心臟病是美国女性、男性和族裔群体死亡的主要原因之一，每年约有 605,000 人在美国经历首次心臟病发作。

此外，美国不断增长的老年人口预计将进一步增加心臟病的盛行率，并增加对有源植入式医疗设备的需求。根据世界银行资料，2022年老年人口将占美国的17%。此外，病患监测方面的技术进步以及 AIMD 产品的推出也成为了进一步的推动因素。例如，2023年7月，雅培实验室宣布其治疗心率缓慢或异常的双腔室心律调节器AVEIR(TM)获得美国FDA核准。此次核准使该公司能够为美国数百万人提供无线起搏服务。

市场开拓的主要进展

2023年10月，FDA核准了Epsila EVTM MRI SureScanTM心臟麻痹去心房颤动和Aurora EV-ICDTM MRI SureScanTM（血管外（植入式心臟整流去颤器））。该核准授予全球医疗保健技术领导者美敦力公司 (Medtronic plc)。 Aurora EV-ICD 系统的引线（细线）放置在胸骨下方，远离心臟和静脉，首次提供了传统经静脉 ICD 的救生优势。 Aurora EV-ICD 是一种在尺寸、结构和寿命方面与传统经静脉 ICD 相似的装置。 2022年4月，医疗设备新兴企业FineHeart SA开发了FLOWMAKER®，一种完全植入式心抟出量恢復系统（ICOMS），满足严重心臟衰竭患者未满足的需求，国家知识产权局宣布获得首批两项专利。这些新专利涵盖了创意、心臟衰竭、製造等领域，为该公司强大的全球产品组合增添了 20 个系列和超过 78 项涉及外科植入物的专利。 2021 年 2 月，Abbott 的神经调节临床医生程式设计师应用程式和病患控制器应用程式可与相容的 Apple 智慧型手机装置一起使用，并透过荷兰公告机构根据医疗设备法规(MDR)（EU 2017/745）获得BSI 批准，是首款有源植入式应用程式医疗设备产品需获得合规认证。所有 III 类植入式医疗设备均须遵守最严格的法规。这也适用于配件。

目录

第一章简介

  • 市场概况
  • 市场定义
  • 调查范围
  • 市场区隔
  • 货币
  • 先决条件
  • 基准年和预测年时间表

第二章调查方法

  • 调查资料
  • 调查过程

第三章执行摘要

  • 研究亮点

第四章市场动态

  • 市场驱动因素
  • 市场抑制因素
  • 波特五力分析
  • 产业价值链分析

第五章全球有源植入式医疗设备市场：依产品

  • 介绍
  • 心室辅助装置
  • 神经刺激设备
  • 植入式心臟节律器
  • 人工电子耳
  • 其他的

第六章全球活跃植入式医疗设备市场：依最终用户分类

  • 介绍
  • 医院和诊所
  • 门诊手术中心

第七章全球主动植入医疗设备市场：依地区

  • 介绍
  • 北美洲
    • 副产品
    • 按最终用户
    • 按国家/地区
  • 南美洲
    • 副产品
    • 按最终用户
    • 按国家/地区
  • 欧洲
    • 副产品
    • 按最终用户
    • 按国家/地区
  • 中东/非洲
  • 亚太地区
    • 副产品
    • 按最终用户
    • 按国家/地区

第八章竞争环境及分析

  • 主要企业及策略分析
  • 市场占有率分析
  • 合併、收购、协议和合作

第九章 公司简介

  • Sonova Holding AG
  • Medtronic
  • Abbott
  • Lifetech Scientific
  • Boston Scientific Corporation
  • Cochlear Ltd.
  • MED-EL
  • Biotronik SE & Co. KG
  • LivaNova PLC
简介目录
Product Code: KSI061611637

The global active implantable medical devices market is expected to grow at a CAGR of 7.79% from US$27.017 billion in 2021 to US$45.686 billion by 2028.

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

TABLE OF CONTENTS

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

8. COMPETITIVE ENVIRONMENT AND ANALYSIS

  • 8.1. Major Players and Strategy Analysis
  • 8.2. Market Share Analysis
  • 8.3. Mergers, Acquisitions, Agreements, and Collaborations

9. COMPANY PROFILES

  • 9.1. Sonova Holding AG
  • 9.2. Medtronic
  • 9.3. Abbott
  • 9.4. Lifetech Scientific
  • 9.5. Boston Scientific Corporation
  • 9.6. Cochlear Ltd.
  • 9.7. MED-EL
  • 9.8. Biotronik SE & Co. KG
  • 9.9. LivaNova PLC