고급 및 고품질 의료기기에 대한 수요 증가, 제품 설계 및 엔지니어링의 복잡성 증가, 디지털 기술의 광범위한 사용은 능동형 임플란트 의료기기 시장을 발전시키는 중요한 촉진요인입니다. Verified Market Research의 애널리스트에 따르면 능동 이식형 의료기기 시장의 예측 평가액은 508억 달러로, 2024년에는 약 270억 달러에 달합니다.
이러한 수요 급증으로 인해 시장은 2026-2032년 연평균 8.22%의 성장률을 보일 것으로 예측됩니다.
능동형 임플란트 의료기기 시장 정의/개요
능동형 임플란트 의료기기는 수술 중 자연 개구부를 통해 체내에 삽입됩니다. 수술 후, 기기는 그 자리에 남아 외부의 전기 에너지 또는 다른 전원으로부터 전원을 공급받습니다. 미국 식품의약국(FDA)은 능동형 이식형 의료기기를 고위험군으로 분류하고 있습니다.
또한 능동형 이식형 의료기기에는 심장 재동기화 치료 기기, 약물 주입 펌프, 이식형 제세동기, 이식형 심박조율기, 이식형 인공심장박동기, 인공와우, 이식형 제세동기 등이 있습니다. 심혈관 기기, 파킨슨병, 간질, 간질, 경련, 청각 장애 및 시각 장애를 포함한 많은 질병이 이러한 기기에 의해 현저하게 관리되고 있습니다.
의료기술의 발전, 만성질환 증가, 고령화, 최소침습적 치료로의 전환, 예방의학 및 맞춤형 의료의 중요성 등으로 인해 능동형 임플란트 의료기기 시장은 성장세를 보이고 있습니다. 심박조율기, 신경자극기, 이식형 약물전달시스템과 같은 이러한 기기들은 첨단 센서, 전자기기, 소프트웨어 알고리즘을 사용하여 생리적 매개변수를 모니터링하고 치료적 개입을 수행하여 환자의 결과를 개선합니다. 이러한 기기에 대한 수요는 만성질환 및 노화 관련 질환의 유병률 증가와 만성 증상을 관리하고 의료비용을 절감하기 위한 장기적인 치료 솔루션의 필요성이 대두되고 있는 배경에 있습니다.
또한 고령화 사회에서는 노인이 독립적으로 기능을 유지할 수 있는 의료적 개입이 요구되고 있습니다. 최소침습 수술과 외래 치료로의 전환은 지속적인 모니터링, 조기 개입, 맞춤 치료 접근을 가능하게 하는 능동형 이식형 의료기기에 대한 수요를 촉진하고 있습니다. 전 세계 의료 시스템이 만성질환의 예방적 관리와 질병 예방을 우선시함에 따라 개인 맞춤형 치료와 원격 모니터링을 지원하는 능동형 이식형 의료기기에 대한 수요가 증가하여 시장 확대의 원동력이 될 것으로 예측됩니다.
능동형 임플란트 의료기기 시장은 엄격한 규제 요건, 높은 비용, 안전성 우려, 상호운용성 문제 등 여러 가지 문제에 직면해 있으며, FDA 및 EMA와 같은 규제기관은 안전성과 유효성을 보장하기 위해 대규모 임상시험, 시판 전 평가, 시판 후 감시를 의무화하고 있습니다. 규제 당국의 승인이 늦어지면 시장 출시 기간이 길어지고, 기술 혁신을 방해하며, 개발 비용이 증가하여 시장 성장을 제한합니다. 또한 능동형 임플란트 의료기기의 높은 비용은 환자와 의료시스템에 경제적 장벽이 될 수 있습니다. 엄격한 테스트, 품질 보증 및 규제 준수에 대한 필요성이 전체 비용을 증가시켜 시장 출시와 혁신적인 치료법에 대한 환자의 접근을 제한하고 있습니다.
또한 기기의 안전성, 신뢰성, 장기적 성능에 대한 우려는 제조업체와 의료 서비스 프로바이더에게도 도전이 되고 있습니다. 기기 오작동, 부품 결함, 부작용 등의 문제는 환자의 건강과 안전에 위험을 초래할 수 있습니다. 배터리 수명 및 기기 성능 저하와 같은 장기적인 성능 문제는 환자 결과에 영향을 미치고 의료 비용을 증가시킬 수 있습니다. 상호운용성과 연결성 문제도 의료 시스템 및 전자건강기록(EHR)에 능동형 임베디드 기기를 통합하는 데 있으며, 과제가 되고 있습니다.
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