美国有源植入式医疗器械市场预计将从 2022 年的 329.177 亿美元增长至到 2031 年将达到 545.271 亿美元;预计 2022 年至 2031 年复合年增长率为 8.8%。
该报告重点介绍了市场的普遍趋势以及推动其增长的因素。市场增长归因于全球心血管疾病和神经系统疾病患病率的上升以及听力障碍发病率的上升。然而,设备中的恶意软件问题正在阻碍全球活跃的植入式医疗器械市场。
根据地理位置,有源植入式医疗器械市场分为北美、欧洲、亚太地区、中东及非洲、南美和非洲中美洲。北美在全球有源植入式医疗器械市场中占据最大份额。此外,2017年美国在北美有源植入式医疗器械市场占据主导地位,其次是加拿大和墨西哥。预计美国在预测期内也将继续占据主导地位。根据美国疾病控制与预防中心 (CDC) 的数据,心脏病是美国的首要死因,2021 年该国约有 697,000 人死于心脏病。冠状动脉疾病 (CAD) 是最常见的类型2021 年,心脏病导致约 382,820 人死亡。此外,根据美国疾病控制与预防中心 (CDC) 的数据,约 2010 万 20 岁及以上的成年人患有 CAD。 2021 年,全球 65 岁以下成年人中约有十分之二死于 CAD。 2021 年 8 月,一款名为 MicroTransponder 的产品其 Vivisstim 配对 VNS 系统获得美国 FDA 批准。这是一种无药物中风康复系统,有助于治疗中度至中度疼痛。与慢性缺血性中风相关的严重上肢运动缺陷。这些因素正在支持全球有源植入式医疗器械市场的增长,预计也将在预测期内为市场提供帮助。
有源植入式医疗器械 (AIMD) 完全或部分植入在患者体内用于诊断和治疗应用目的。 有源医疗器械根据“规则 9”进行分类规则 13,根据 EU-MDR 2017/745 附件 VIII:分类规则。在与“基于软件的医疗设备”相关的有源医疗设备下引入了新规则。这包括软件和包含该软件的医疗设备。 EN 60601系列标准被有源医疗器械所接受,遵守这些标准是该器械在欧洲市场销售的基本要求之一。因此,必须对有源医疗设备进行额外的测试,以确保其安全性和有效性。
战略洞察
< a>美敦力、雅培、波士顿科学公司、百多力、LivaNova PLC、Cochlear Ltd.、MED-EL Sonova 和 William Demant Holding A/S 是全球有源植入式医疗器械市场的领先公司。随着市场参与者开发新的创新产品,市场预计将蓬勃发展。
- 2022 年 10 月,Avive Solutions, Inc. 推出了 Avive 自动体外除颤器 (AED)——一款自动除颤器,便携式、电池供电的 AED,包括治疗突然丧失心脏功能(心脏骤停)的患者所需的一切。
- 2022 年 11 月,Ventana Medical Systems, Inc. 推出了 VENTANA FOLR1 (FOLR-2.1) RxDx Assay&mdash ;旨在检测卵巢癌、腹膜癌或输卵管癌患者体内叶酸受体 α (FOLR1) 蛋白的实验室测试。
- 2022年9月,Edwards Lifesciences LLC推出了PASCAL精密经导管瓣膜修复系统,用于修复心脏二尖瓣,无需进行心脏直视手术。该设备系统包括永久植入物和输送系统。植入物的组件主要由镍钛诺(一种镍钛合金)制成,并覆盖有聚对苯二甲酸乙二醇酯 (PET) 布。
- 2022年1月,Cochlear Americas推出了Nucleus 24 Cochlear Implant System,通过直接刺激听觉神经(听觉神经)来提供声音通路。人工耳蜗系统由内部和外部组件组成。 Nucleus 24 人工耳蜗系统此前已被批准用于 9 个月及以上、双耳患有严重至极重度感音神经性听力损失的人群。此次批准扩大了该设备的使用范围,适用于 5 岁及以上、患有重度至极重度听力损失的人群一只耳朵听力损失[单侧耳聋/单侧听力损失(SSD/UHL)],另一只耳朵听力正常或轻度听力损失。
有源植入式医疗器械市场利润丰厚的区域
产品洞察
根据产品,全球有源植入式医疗器械市场分为植入式心脏复律除颤器、植入式心脏起搏器、神经刺激器、植入式听力设备、心室辅助设备和植入式心脏监护仪/插入式循环记录器。2017 年,植入式心律转复除颤器细分市场可能会占据有源植入式医疗设备市场的最大市场份额。ICD 可有效预防患有危及生命的心律失常(一种疾病)高风险人群的猝死。与心脏相关的疾病,包括室性心动过速(VT)或心室颤动(VF)。大多数ICD,称为经静脉ICD,具有两种功能,同时也充当起搏器。2021年4月,Biotronik推出了新开发的Acticor系列植入式除颤器.新推出的设备导线更少,减少了手术时间并降低了成本。
2017 年和 2025 年最终用户活跃的植入式医疗器械市场
一些在有源植入式医疗器械市场运营的主要公司正在采用产品创新战略,以满足全球不断变化的客户需求,从而使他们能够在全球市场上保持自己的品牌声誉。
活跃的植入式医疗器械市场–细分
有源植入式医疗器械市场根据产品、最终用户和地理位置进行细分。根据产品,全球有源植入式医疗器械市场分为植入式心律转复除颤器、植入式心脏起搏器、神经刺激器、植入式听力设备、心室辅助设备和植入式心脏监护仪/插入式循环记录仪。植入式心律转复除颤器细分市场进一步细分为经静脉植入式心律转复除颤器和皮下植入式心律转复除颤器。根据最终用户,全球有源植入式医疗器械市场分为医院、门诊手术中心和专科诊所。根据地理位置,有源植入式医疗器械市场分为北美(美国、加拿大和墨西哥)、欧洲(英国、德国、法国、意大利、西班牙和欧洲其他地区)、亚太地区(中国、日本、印度、澳大利亚、韩国和亚太地区其他地区)、中东和美国非洲(阿联酋、沙特阿拉伯、南非以及中东和非洲其他地区)以及南美和非洲中美洲(巴西、阿根廷以及南美洲和中美洲其他地区)。
- Historical Analysis (2 Years), Base Year, Forecast (7 Years) with CAGR
- PEST and SWOT Analysis
- Market Size Value / Volume - Global, Regional, Country
- Industry and Competitive Landscape
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Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
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Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
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Frequently Asked Questions
The active implantable medical devices market is estimated to grow with a CAGR of 8.8% from 2023 to 2031.
Asia Pacific region is likely to witness fastest growth rate during the forecast period.
The active implantable medical devices market majorly consists of the players such as Medtronic, ABBOTT, Cochlear Ltd, Boston Scientific Corporation among others.
Biodegradable materials is likely to remain the key trend during the forecast period
The market drivers include increasing prevalence of dental diseases and advancements in dental technologies are driving the active implantable medical devices market
North America dominated the active implantable medical devices market in 2023
Trends and growth analysis reports related to Life Sciences : READ MORE..
The List of Companies - Active Implantable Medical Devices Market
- Medtronic
- ABBOTT
- Cochlear Ltd.
- Boston Scientific Corporation
- BIOTRONIK
- MED-EL
- SONOVA
- William Demant Holding A/S
- LivaNova PLC
- Nurotron Biotechnology Co. Ltd.
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published and advised several client across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organization are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.