Active Implantable Medical Devices Market Size and Forecasts (2021 - 2031), Global and Regional Share, Trends, and Growth Opportunity Analysis

Coverage: Active Implantable Medical Devices Market covers analysis By Product [Implantable Cardioverter Defibrillators (Transvenous Implantable Cardioverter Defibrillators and Subcutaneous Implantable Cardioverter Defibrillators), Implantable Cardiac Pacemakers, Neurostimulators, Implantable Hearing Devices, Ventricular Assist Devices, and Implantable Heart Monitors/ Insertable Loop Recorders] and End User (Hospitals, Ambulatory Surgical Centers, and Specialty Clinics), and Geography (North America, Europe, Asia Pacific, and South and Central America)

  • Report Code : TIPMD00002232
  • Category : Medical Device
  • Status : Upcoming
  • No. of Pages : 154
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The active implantable medical devices market is expected to grow from US$ 32,917.7 million in 2022 to US$ 54,527.1 million by 2028; it is expected to grow at a CAGR of 8.8% from 2022 to 2031. 

The report highlights trends prevailing in the market and factors driving its growth. The market growth is attributed to the rising prevalence of cardiovascular diseases and neurological disorders and rising incidences of hearing disorders across the globe. However, malware problems in devices are hindering the growth of the global active implantable medical devices market.

Based on geography, the active implantable medical device market is segmented into North America, Europe, Asia Pacific, the Middle East & Africa, and South & Central America. North America held the largest share of the global active implantable medical devices market. Further, the US dominated the North America active implantable medical devices market in 2017, followed by Canada and Mexico. The US is also expected to continue its dominance during the forecast period. According to the Centers for Disease Control and Prevention (CDC), heart disease is the leading cause of death in the US, and ~697,000 people in the country died from heart disease in 2020. Coronary artery disease (CAD) is the most common type of heart disease that killed approximately 382,820 people in 2020. Further, according to the Centers for Disease Control and Prevention (CDC),~20.1 million adults aged 20 and older have CAD. In 2020, about 2 in 10 adults aged less than 65 years old suffering from CAD died, globally.  In August 2021, a product named MicroTransponder secured approval from the US FDA for its Vivistim Paired VNS System. It is a drug-free stroke rehabilitation system that helps treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke. Such factors are supporting the global active implantable medical device market growth, and are also expected to aid the market during the forecast period.  

Active implantable medical devices (AIMD) are completely or partially implanted in patient’s body for diagnostic and therapeutic application purposes. Active medical devices are classified as per ‘Rule 9 – Rule 13,’ according to EU-MDR 2017/745 Annexure VIII: Classification Rules. New Rule has been introduced under the active medical devices which is related to ‘Software based Medical devices’. This includes the software and a medical device that incorporates the software. EN 60601 series of standards are accepted for active medical devices, and compliance with these standards is one of the essential requirements for selling the device in the Europe market. Hence, additional testing must be performed on active medical devices to address their safety and effectiveness.

Strategic Insights

Medtronic, Abbott, Boston Scientific Corporation, BIOTRONIK, LivaNova PLC, Cochlear Ltd., MED-EL Sonova, and William Demant Holding A/S are the leading companies in the global active implantable medical device market. The market is anticipated to flourish with the development of new innovative products by market players.

  • In October 2022, Avive Solutions, Inc. launched the Avive Automated External Defibrillator (AED)—an automatic, portable, battery-operated AED that includes everything needed to treat people experiencing sudden loss of heart function (sudden cardiac arrest).
  • In November 2022, Ventana Medical Systems, Inc. launched VENTANA FOLR1 (FOLR-2.1) RxDx Assay—a laboratory test designed to detect folate receptor alpha (FOLR1) protein in patients who suffer from ovarian cancer, peritoneal cancer, or fallopian tube cancer.
  • In September 2022, Edwards Lifesciences LLC launched the PASCAL Precision Transcatheter Valve Repair System, which is used to repair the mitral valve of the heart without the need for open-heart surgery.  The device system includes a permanent implant and a delivery system. The components of the implant are primarily constructed from nitinol (a nickel-titanium alloy) and covered in polyethylene terephthalate (PET) cloth.
  • In January 2022, Cochlear Americas launched Nucleus 24 Cochlear Implant System, which provides sound access by directly stimulating the hearing nerve (auditory nerve). The cochlear implant system consists of an internal and an external component. The Nucleus 24 Cochlear Implant System was previously approved for use in people ages nine months and older, suffering from severe to profound sensorineural hearing loss in both ears. This approval expands the use of this device for people aged five years and older with severe to profound hearing loss in one ear [single-sided deafness/unilateral hearing loss (SSD/UHL)] and normal hearing or mild hearing loss in the other ear.

Lucrative Regions for Active Implantable Medical Devices Market

Lucrative Regions for Active Implantable Medical Devices MarketProduct Insights

Based on product, the global active implantable medical device market is segmented into implantable cardioverter defibrillators, implantable cardiac pacemakers, neurostimulators, implantable hearing devices, ventricular assist devices, and implantable heart monitors/insertable loop recorders. In 2017, the implantable cardioverter defibrillators segment is likely to hold the largest market share of active implantable medical device market. ICDs are useful in preventing sudden death in people who have a high risk of a life-threatening arrhythmia – a condition related to heart. These include ventricular tachycardia (VT) or ventricular fibrillation (VF). Most ICDs, called transvenous ICDs, have two functions and also serve as a pacemaker. In April 2019, Biotronik launched a newly developed implantable defibrillator of the Acticor series. The newly launched device have less leads, reduced surgical procedure time as well as reduced costs.

Active Implantable Medical Devices Market, by End User – 2017 and 2025

Active Implantable Medical Devices Market, by End User – 2017 and 2025

A few of the major companies operating in the active implantable medical device market are adopting the product innovation strategy to meet the evolving customer demands worldwide, allowing them to maintain their brand name in the market across the globe.

Active Implantable Medical Device Market – Segmentation

The active implantable medical device market is segmented on the basis of product, end user, and geography. Based on product, the global active implantable medical device market is segmented into implantable cardioverter defibrillators, implantable cardiac pacemakers, neurostimulators, implantable hearing devices, ventricular assist devices, and implantable heart monitors/insertable loop recorders. The implantable cardioverter defibrillators segment is further subdivided into transvenous implantable cardioverter defibrillators and subcutaneous implantable cardioverter defibrillators. Based on end user, the global active implantable medical device market is segmented into hospitals, ambulatory surgical centers, and specialty clinics. Based on geography, the active implantable medical device market is segmented into North America (US, Canada, and Mexico), Europe (UK, Germany, France, Italy, Spain, and Rest of Europe), Asia Pacific (China, Japan, India, Australia, South Korea, and Rest of Asia Pacific), the Middle East & Africa (UAE, Saudi Arabia, South Africa, and Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and Rest of South & Central America).


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REGIONAL FRAMEWORK
World Geography
Strategic Insights

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MARKET PLAYERS
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Research Criteria
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Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

Product, and End User

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

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The List of Companies - Active Implantable Medical Devices Market

  1. Medtronic
  2. ABBOTT
  3. Cochlear Ltd.
  4. Boston Scientific Corporation
  5. BIOTRONIK
  6. MED-EL
  7. SONOVA
  8. William Demant Holding A/S
  9. LivaNova PLC
  10. 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.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published many reports and advised several clients 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 organizations 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 the last 3 years are scrutinized and analyzed to understand the current market trends.

  1. 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/Sales 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:

Research Methodology

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.

  1. 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.

  • 3.1 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.

  • 3.2 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.

  • 3.3 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.

  • 3.4 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.

  1. 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.

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