Active Implantable Medical Devices (AIMD) Market - Forecasts from 2021 to 2026

The global active implantable medical devices market is expected to grow at a CAGR of 6.43% over the forecast period to reach a market size of US$36.845 billion in 2026 from US$23.818 billion in 2019. As per The Active Implantable Medical Device (AIMD) Directive, an active implantable medical device is "any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure". An implantable pacemaker, cochlear implants, ventricular assist devices, neurostimulators are some of the active implantable medical devices. Active implantable medical devices fall into the highest risk categories of medical devices listing by the U.S. Food & Drug Administration (FDA). The growth in the market may be attributed to the rising prevalence of cardiovascular and neurological disorders across the globe. Rising investments and funds by the companies to develop technologically advanced products will also boost the market for AIMD during the given forecast period. However, strict regulatory policies regarding the AIMD and the high cost of the devices may restrain the market growth during the given time frame. Major companies have been making significant developments in the market, in the past few years. With the increasing investment in innovation, research and development, and infrastructure, the market is expected to surge at an exponential rate in the coming years.

Increasing cardiovascular diseases.

The market is expected to surge in the coming years, due to the rising prevalence of cardiovascular diseases, globally. Cardiovascular diseases are one of the leading causes of death, worldwide. According to the data given by the World Health Organisation, an estimated number of 17.9 million people had died from cardiovascular diseases in the year 2019. Around 85% of these deaths were attributed to stroke and heart attack. An estimated 1.13 billion people, globally, have been suffering from hypertension, which has become a major cause of brain, heart, kidney, and other related problems. Some of the devices, such as implantable cardioverter-defibrillator have been expected to show a significant surge in the demand, in the coming period. It is a device that is usually placed on the chest, to detect irregular heartbeats and monitor heart rhythm. Major companies have been making significant developments in the market. For instance, Medtronic, one of the major players in the market, provides implantable cardioverter defibrillators to their customers. The company's model and devices, known as Cobalt XT IDDs, are enabled with advanced BlueSync technology, which allows for app-based monitoring and tablet-based monitoring. These developments are expected to enhance the overall market growth, in the coming years.

Increasing government regulations.

The European Union had announced that it had published an updated list of regulations and standards, that would be used to showcase and demonstrate conformity with required and essential requirements of its major flagship derivate known Directive 90/385/EEC, which are related to active implantable devices. According to the directive given by the European Union, an active medical device would be a major functioning source of electrical energy or any other source of energy, but different than directly released by the gravity or human body. Moreover, increasing regulations in North America, Asia Pacific, and other regions are also expected to provide a challenge to the overall market growth.

Latest Developments.

Major companies, research institutions, and organizations have been making considerable investments, intending to develop novel, advanced, and innovative active implantable medical devices for their customers.

• In May 2021, Researchers at the Columbia University announced that they had developed a novel single-chip device that takes less than 0.1 mm3. It had been one of the smallest systems, ever developed and designed. The researchers stated that the device would be injected into humans, to monitor certain biological parameters. The major goal of this research has been to replace larger implantable sensors, that require several packaging, chips, batteries, external transducers, and wires. This development is expected to have a positive impact on the market, in the coming years.
• In June 2021, FineHeart S.A., a preclinical medical device firm, announced that they had completed a EUR15 million funding round. The company had been developed an implantable cardiac output management system, called FLOWMAKER, to address the need of patients, that are suffering from severe heart failure. The company has also stated that the novel funding would allow preparing for first in human clinical trials in the year 2022.

North America is expected to have a major share.

North American region is expected to have a major share in the market, due to the rise in the number of active implantable medical device start-ups, the presence of some of the major players in the region, and increased cardiovascular problems. Other regions are also expected to exhibit higher potential in the overall market. With the rise in the geriatric population and surging cardiovascular concerns, Europe is expected to register significant CAGR growth, during the forecast period. Countries like Germany and Italy are expected to emerge as a major potential region, in the coming years.

Market Segmentation:

• By Type
• Ventricular Assist Devices
• Neurostimulators
• Implantable Cardiac Pacemakers
• Cochlear Implants
• Others
• By End-User
• Hospitals & Clinics
• Ambulatory Surgical Centers
• By Geography
• North America
• USA
• Canada
• Mexico
• South America
• Brazil
• Argentina
• Others
• Europe
• UK
• Germany
• France
• Italy
• Others
• Middle East and Africa
• Asia Pacific
• Japan
• China
• India
• South Korea
• Thailand
• Taiwan
• Indonesia
• Others