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 2028.
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
Product 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
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).