Active Implantable Medical Devices Market Insights
Active implantable medical devices are totally or partially introduced into the body by a surgical procedure in a natural orifice. The device remains in that position after the procedure and relies on external electrical energy or any other external power source to function. Active implantable medical devices fall into highest risk categories of medical devices listing of the U.S. Food & Drug Administration (FDA). Implantable pacemaker, cochlear implants, implantable defibrillators, drug infusion pumps, neurostimulator, and cardiac resynchronization therapy devices are some of the active implantable medical devices. These devices play a significant role in management of a number of diseases such as cardiovascular devices, Parkinson’s disease, epilepsy, spasticity, and patients with hearing or visual impairment. Pacemakers and implantable cardioverter defibrillators (ICDs) are significant components in the management of cardiovascular conditions. Strong magnetic field used in Magnetic Resonance Imaging (MRI) procedures could adversely affect the functioning of conventional pacemaker. However, MRI compatible pacemakers can facilitate safe MRI scans, which in turn is expected to increase the adoption of pacemakers. For instance, MRI compatible pacemakers, and leadless pacemakers have been introduced in the market since 2011 by Medtronic, and BIOTRONIK
Advancements in technology in the product space and new product launches is expected to boost growth of the active implantable medical devices market
Leading players in the market are focusing on development and launching of new products in order to remain competitive in the market and retain their market share. Initially, these devices were large in size, however, miniaturization of pacemakers and ICDs has simplified the implantation procedure and miniaturization of the products reflects the continuous innovation in the products. This is expected to fuel demand for such products, in turn reflecting growth of the market. For instance, Medtronic’s first leadless pacemaker Micra TPS was approved by the U.S. Food & Drug Administration in 2016 and is known to be the smallest pacemaker. Other innovations such as cardiac contractility modulation, and wireless pacing are expected to positively impact growth of the active implantable medical devices market. Implantable continuous glucose monitoring (Sensonic’s Eversense CGM with implantable sensor, which lasts up to 90 days), and implantable infusion pumps are also expected to propel market growth. Introduction of wireless technology and mobile connectivity has further led to increased functions and effectiveness of these devices. For instance, Cochlear Ltd. collaborated with Apple, Inc. to offer cochlear implants with iPhone connectivity, which was launched in July 2017.
The global active implantable medical devices market was valued at US$ 16,721.2 million in 2016 and is expected to witness a robust CAGR of 5.4% over the forecast period (2017–2025).
Figure 1. Global Active Implantable Medical Devices Market, by Region - 2016 (US$ Mn)
Rising prevalence of cardiovascular, chronic pain diseases, and hearing disorders is expected to boost growth of the active implantable medical devices market over the forecast period
Increasing global prevalence of cardiovascular system diseases, chronic pain diseases, and associated co morbidities is expected to have a positive impact on the growth of the market. According to the World Health Organization (WHO), around 17 million people die annually from cardiovascular diseases. According to the Centers for Disease Control and Prevention (CDC), 2017, 2.7 to 6.1 million people in the U.S. are suffering from atrial fibrillation, which is the most common type of heart arrhythmia. Prevalence of neurological disorders such as Parkinson’s disease, epilepsy, essential tremors, and dystopia is reported to be high in developed and emerging economies such as India. For instance, around 50,000 people are diagnosed with Parkinson’s disease, annually, in the U.S. according to National Institute of Health (NIH), 2013 data. Neurostimulation is effective in the treatment of these neurological diseases, which is expected to support growth of implantable medical devices market over the forecast period.
However, restraining factors for the market growth are risks associated with use of active implantable medical devices, which are infection at the surgical site and sensitivity to the device material. Furthermore, failure to deliver therapy when needed or receiving extra therapy when not necessary is another factor adversely affecting growth of the market. Active implantable medical devices fall into highest risk category of medical device listing of the U.S. FDA and are subjected to strict scrutiny highly focused on security and privacy which has resulted in various product recalls. For instance, recall of about 500,000 pacemakers manufactured by St. Jude Medical, Inc. in August 2017, due to hacking concerns. Such events could hamper the growth of active implantable medical devices market over the forecast period.
Some major players operating in the active implantable medical devices market are Cochlear Limited, Boston Scientific Corporation, Medtronic Plc, LivaNova Plc, Abbott Laboratories, Sonova Holding AG, William Demant holding A/S, Nurotron Biotechnology Co., Ltd., and Med-EL.
Active implantable medical devices such as cardiac pacemaker systems, cochlear implants, implantable infusion pumps, cardiac resynchronization therapy devices aid in improving patient’s health and outcome of the medical treatment. Active implantable medical devices are prosthetic devices, which provide support in functioning of organs. For instance, pacemakers and defibrillators are capable of monitoring the heart rhythm. Pacemakers replace the natural pacemaker of the heart i.e. sinoatrial node (SA node) and defibrillator, monitors the heart rhythm and can prevent cardiac arrest. These devices come under Class II and some under Class III devices in the U.S. FDA medical devices listing and are subject to stringent regulations as they pose surgical risks during placement, bruising at surgical site, pain, and high risks due to implant failure. The active implantable medical devices market is dominated by few leading players such as Medtronic Plc., Abbott Laboratories, Boston Scientific Corporation, and Cochlear Ltd. accounting for over 70% of the market share.
Advancements in technology such as magnetic resonance imaging (MRI) compatible pacemakers and growing support in favor of use of such devices in cardiovascular and chronic pain diseases is expected to boost growth of the active implantable medical devices market. For instance, in November 2017, American Heart Association (AHA), the American College of Cardiology (ACC), and the Heart Rhythm Society (HRS) approved the use of subcutaneous implantable cardioverter defibrillator, (S-ICD), for the treatment of ventricular arrhythmias and to prevent cardiac arrest. Major manufacturers in the market are focusing on collaborations and mergers and acquisitions and are increasingly investing in research and development of implantable devices. For instance, merger of Sorin Group and Cyberonics to form LivaNova Plc in 2015. Furthermore, effectiveness of these devices in improving medical outcomes of cardiovascular and chronic pain diseases, absence of effective alternatives to these devices and continuous product launches is expected to fuel growth of the market.
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“*” marked represents similar segmentation in other categories in the respective section.
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