![]() |
市场调查报告书
商品编码
1731733
2026 年至 2032 年全球有源植入式医疗设备市场规模(按产品类型、最终用户和地区)Global Active Implanted Medical Devices Market Size By Product Type, End-user, & Region for 2026-2032 |
对先进和高品质医疗设备的需求不断增加、产品设计和工程的复杂性不断增加以及数位技术的广泛使用是推动有源植入式医疗设备市场向前发展的关键驱动力。根据 Verified Market Research 分析师预测,有源植入式医疗设备市场价值将达到 508 亿美元,到 2024 年将下降至 270 亿美元左右。
需求激增将推动市场在 2026 年至 2032 年期间以 8.22% 的复合年增长率成长。
植入式医疗设备市场定义/概述
植入式医疗设备在手术过程中透过自然孔口插入体内。手术后,装置仍留在原位并由外部电能或其他来源供电。美国食品药物管理局(FDA) 将有源植入式医疗设备归类为高风险。
此外,一些主动植入式医疗设备包括心臟再同步治疗装置、药物输注帮浦、置入式除颤器、植入式心律调节器、人工电子耳和置入式除颤器。许多疾病,包括心血管疾病、帕金森氏症、癫痫、痉挛、听力和视力障碍,都透过这些设备得到了显着的治疗。
医疗技术的进步、慢性病的增加、人口老化、向微创治疗的转变以及对预防和个人化医疗的重视正在推动有源植入式医疗设备市场的发展。这些设备,例如心律调节器、神经刺激设备和植入式药物传输系统,使用先进的感测器、电子设备和软体演算法来监测生理参数、提供治疗性介入并改善患者的治疗效果。这些设备的需求是由于慢性病和与老龄化相关的疾病的日益流行,从而需要长期治疗解决方案来管理慢性病并降低医疗成本。
此外,在高龄化社会中,需要医疗干预措施使老年人能够保持独立和正常生活。微创手术和门诊护理的转变也推动了对能够实现持续监测、早期疗育和个人化治疗方法的主动植入式医疗设备的需求。随着全球医疗保健系统优先考虑对慢性病和疾病预防的主动管理,对支持个人化护理和远端监控的主动植入式医疗设备的需求预计将增加,从而推动市场扩张。
有源植入式医疗设备市场面临多项挑战,包括严格的法规要求、高成本、安全问题和互通性问题。 FDA 和 EMA 等监管机构要求进行广泛的临床试验、上市前评估和上市后监测,以确保安全性和有效性。监管核准的延迟会延长上市时间、抑制创新并增加开发成本,从而限制市场成长。此外,有源植入式医疗设备的高成本为患者和医疗保健系统带来了经济障碍。严格测试、品质保证和法规遵循的需求推高了整体成本,限制了市场采用和患者获得创新疗法的机会。
此外,对设备安全性、可靠性和长期性能的担忧也给製造商和医疗保健提供者带来了挑战。设备故障、零件缺陷和副作用等问题可能会对患者的健康和安全构成风险。电池寿命和设备劣化等长期性能问题可能会影响患者的治疗效果并增加医疗保健成本。互通性和连接性问题也对将主动植入式设备整合到医疗保健系统和电子健康记录(EHR) 中提出了挑战。
The increasing demand for advanced and high-quality medical devices, rising complexity in product design and engineering, and wide usage of digital technology are significant drivers propelling the active implanted medical devices market forward. According to the analyst from Verified Market Research, the active implanted medical devices market has a valuation of USD 50.8 Billion over the forecast subjugating around USD 27 Billion in 2024.
This surge in demand enables the market to grow at a CAGR of 8.22% from 2026 to 2032.
Active Implanted Medical Devices Market: Definition/ Overview
Active implantable medical devices are inserted into the body through a natural opening during surgery, either fully or partially. After the process, the device remains in that place and is powered by external electrical energy or another source. Active implantable medical devices are classified as high-risk by the United States Food and Drug Administration (FDA).
Furthermore, among the active implantable medical devices are cardiac resynchronization therapy devices, drug infusion pumps, implantable defibrillators, implantable pacemakers, cochlear implants, and implantable defibrillators. Numerous ailments, including cardiovascular devices, Parkinson's disease, epilepsy, spasticity, and individuals with hearing or vision impairment, are significantly managed by these devices.
The active implanted medical devices market is gaining momentum due to advancements in medical technology, the rise of chronic diseases, the aging population, the shift towards minimally invasive procedures, and the focus on preventive and personalized medicine. These devices, such as pacemakers, neurostimulators, and implantable drug delivery systems, use advanced sensors, electronics, and software algorithms to monitor physiological parameters, deliver therapeutic interventions, and improve patient outcomes. The demand for these devices is driven by the rising prevalence of chronic diseases and age-related conditions, which require long-term therapeutic solutions to manage chronic conditions and reduce healthcare costs.
Furthermore, the aging population also demands medical interventions that enable older adults to maintain independence and functionality. The shift towards minimally invasive procedures and outpatient care is also driving the demand for active implanted medical devices, which enable continuous monitoring, early intervention, and personalized treatment approaches. As healthcare systems worldwide prioritize proactive management of chronic conditions and disease prevention, the demand for active implanted devices that support personalized care and remote monitoring is expected to increase, driving market expansion.
The active implanted medical devices market faces several challenges, including stringent regulatory requirements, high costs, safety concerns, and interoperability issues. Regulatory agencies like the FDA and EMA require extensive clinical trials, pre-market evaluations, and post-market surveillance to ensure safety and efficacy. Delays in regulatory approval prolong the time to market, hinder innovation, and increase development costs, limiting market growth. The high cost of active implanted medical devices also poses financial barriers for patients and healthcare systems. The need for rigorous testing, quality assurance, and regulatory compliance adds to the overall cost, limiting market adoption and patient access to innovative treatments.
Furthermore, concerns about device safety, reliability, and long-term performance also pose challenges for manufacturers and healthcare providers. Issues such as device malfunction, component failure, and adverse reactions can pose risks to patient health and safety. Long-term performance issues, such as battery life and device degradation, can impact patient outcomes and increase healthcare costs. Interoperability and connectivity issues also present challenges for the integration of active implanted devices into healthcare systems and electronic health records (EHRs).
According to VMR analysis, the Cardioverter defibrillators (ICDs) segment is estimated to dominate the market during the forecast period due to their effectiveness in treating life-threatening cardiac arrhythmias and sudden cardiac arrest. These devices continuously monitor the heart's rhythm and deliver electrical shocks to restore normal heart rhythm when dangerous arrhythmias occur. The increasing prevalence of cardiovascular diseases and related risk factors worldwide is driving the growth of ICDs. Technological advancements in ICD technology, such as dual-chamber pacing, cardiac resynchronization therapy (CRT), and remote monitoring capabilities, are driving the adoption of these devices. These advancements improve patient outcomes, reduce the risk of inappropriate shocks, and enable healthcare providers to remotely monitor patients' cardiac status and device performance.
Furthermore, the growing indications for ICD therapy and awareness of sudden cardiac death risk factors are driving the demand for these devices in diverse patient populations. As clinical guidelines evolve and awareness of the benefits of ICD therapy increases among healthcare providers and patients, the market for these devices is expected to grow. Emerging markets, such as. Asia-Pacific, Latin America, and the Middle East present significant opportunities for market growth. Manufacturers are expanding their presence, investing in research and development, and collaborating with local healthcare providers to address unmet medical needs. In summary, cardioverter defibrillators are essential for the growth of the active implanted medical devices market.
The hospital segment is estimated to dominate the active implanted medical devices market influenced by several factors. Advancements in medical technology have led to the development of sophisticated devices that offer targeted and personalized treatment options for various medical conditions. These devices, such as pacemakers, implantable cardioverter defibrillators (ICDs), and neurostimulators, provide therapeutic interventions that were previously unavailable or less effective. The increasing prevalence of chronic diseases and age-related conditions, such as cardiovascular disorders, neurological disorders, and chronic pain, is fueling the demand for these devices. These devices offer long-term therapeutic solutions for managing chronic conditions, improving patient quality of life, and reducing healthcare costs associated with repeated hospitalizations and outpatient visits.
Furthermore, the shift towards minimally invasive procedures and outpatient care is driving the demand for active implanted medical devices. Advances in surgical techniques, implantable materials, and device miniaturization have made it possible to implant devices through minimally invasive procedures, reducing surgical risks, complications, and hospital stays. The growing emphasis on value-based healthcare and patient outcomes is driving the adoption of active implanted medical devices in hospitals. Healthcare providers are investing in state-of-the-art facilities, medical equipment, and electronic health record (EHR) systems to enhance patient care delivery and streamline clinical workflows. As hospitals continue to modernize and digitize their operations, the adoption of active implanted devices is likely to accelerate, further driving market growth.
The Asia-Pacific region is poised for significant growth in the active implanted medical devices market due to its diverse population, increasing healthcare expenditure, and technological advancements. The growing prevalence of chronic diseases and age-related conditions, such as cardiovascular disorders, neurological disorders, and diabetes, is expected to drive demand for advanced medical interventions. Governments in countries like China, India, and Japan are investing in healthcare infrastructure and improving quality, creating opportunities for active implanted device manufacturers to collaborate with healthcare providers and address unmet medical needs.
Technological advancements in the region, driven by leading medical device manufacturers, research institutions, and academic centers, are also driving the development of cutting-edge active implanted devices. The growing adoption of digital health solutions and telemedicine is also driving demand for active implanted devices that support remote monitoring, data integration, and connectivity with healthcare systems. Manufacturers offering devices with remote monitoring capabilities, interoperability, and data analytics are well-positioned to capitalize on the growing demand for connected healthcare solutions in the Asia-Pacific region.
Furthermore, the region's diverse market landscape, including developed economies and emerging markets, presents significant opportunities for market expansion. As manufacturers expand their presence and product offerings, they can capitalize on these diverse market opportunities and contribute to improved healthcare outcomes for millions of patients. The Asia-Pacific market is expected to emerge as a key growth engine for the global active implanted medical devices market in the coming years.
North America is estimated to hold the largest market share during the forecast period. The region has a high level of healthcare spending, a strong regulatory environment, and a sophisticated healthcare infrastructure, all of which encourage the widespread use of active implanted devices.
Furthermore, A significant number of patients in North America suffer from age-related and chronic illnesses, which is fuelling the need for cutting-edge medical treatments like pacemakers, implanted cardioverter defibrillators (ICDs), and neurostimulators. The region's concentration of top medical device producers, research facilities, and academic institutions encourages technological innovation and product development, reinforcing North America's leadership in the market for active implanted medical devices.
The competitive landscape in the active implanted medical devices market is dynamic and evolving, driven by changing customer preferences, technological advancements, and market dynamics. Providers continue to innovate and differentiate their offerings to stay competitive and capture market share in this rapidly growing market.
Some of the prominent players operating in the active implanted medical devices market include:
NeuroPace
Axonics
NEVRO CORP
BIOTRONIK
ABIOMED
Boston Scientific Corporation
Medtronic
Abbott
Eckert & Ziegler
Sonova Holding AG
Demant A/S
Cochlear Ltd
Microson S.A.U.
Oticon Medical A/S
Nano Retina
MED-EL Medical Electronics
Masimo
Hologic
Varian Medical Systems, Inc.
In August 2022, Medtronic plc launched an investigational extravascular implantable cardioverter defibrillator (EV ICD) system, achieving a defibrillation success rate of 98.7% in a global clinical trial. With the lead positioned under the breastbone, outside the heart and veins, this innovation marks a milestone in enhancing safety and efficacy in the active medical implantable devices market
In February 2022, Abbott initiated patient implants for its dual-chamber leadless pacemaker system, marking a technological breakthrough in leadless pacing. This milestone, part of the AVEIR DR i2i pivotal clinical study, represents the first occurrence globally within the trial, highlighting Abbott's advancements in active medical implantable devices and shaping future pacing technologies
In January 2021, Boston Scientific obtained FDA approval for its Vercise Deep Brain Stimulation System, comprising an implantable pulse generator for symptom relief. This approval marks an opportunity for the company to broaden its presence in the active medical implantable devices market, offering advanced solutions for neurological disorders and expanding its business prospects
In December 2020, Health Canada approved Abbott's FreeStyle Libre 2, offering continuous glucose monitoring with customizable alarms for adults and children with diabetes. This expansion into the active medical implantable devices market allows Abbott to diversify its offerings, catering to diabetic patients' needs and fostering growth opportunities in the future.
Active Implanted Medical Devices Market, by Category
Product Type:
Implantable Cardioverter Defibrillators
Ventricular Assist Devices
Implantable Heart Monitors
Implantable Cardiac Pacemakers
Implantable Hearing Devices
Neurostimulators
Others
End-user:
Hospitals
Clinics
Ambulatory Surgical Centers
Multi-Specialty Centers
Region:
North America
Europe
Asia Pacific
Latin America
Middle East & Africa