The Active Implantable Medical Device (AIMD) Directive 90/385/EEC defines an active implantable medical device as "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". As one of the highest risk categories of device, they are subject to severe regulatory controls both pre- and post-market. The regulatory controls set out in the AIMD Directive also apply to any accessories that are used to enable the device to operate as intended, for examples leads, programmers, controllers, battery packs, software applications, implant kits and refill kits.
The fragmented healthcare industry and high operating margins in emerging economies make them attractive to investors when compared to developed economies. The countries such as China and India have large population base and the healthcare infrastructure in these countries is improving, thus illustrating immense healthcare market potential. Manufacturing medical devices products in the developing regions tend to decrease the overall cost of manufacturing, thus reducing the cost of the product without altering the quality. With the increasing income level and the increasing compliance for high quality implants, the demand for active implantable medical devices is expected to increase in these countries. The demand for active implantable medical devices is increasing due to increasing prevalence of cardiovascular diseases and increasing incidences of neurological disorders. Cardiovascular disease is the leading cause of premature death around the world. Implantable cardioverter defibrillators and implantable cardiac pacemakers are the key medical devices used for the treatment of different cardiovascular conditions. High prevalence of cardiovascular diseases depicts increased demand for these devices.
The Asia-Pacific market for Active Implantable Medical Devices market is segmented into Product and Region. On the basis of Product, it is segmented into Implantable Cardioverter Defibrillators (Transvenous & Subcutaneous), Cardiac Pacemaker, Ventricular Assist Device, Neurostimulator and Implantable Hearing Devices. Cardioverter defibrillators held the largest share in the active implantable medical devices market. Transvenous implantable cardioverter defibrillator is further segmented into biventricular implantable cardioverter defibrillators, dual-chamber implantable cardioverter defibrillators. Single-chamber implantable cardioverter defibrillators accounted for the largest share in this market segment followed by subcutaneous implantable cardioverter defibrillators. The neurostimulators market is projected to witness the highest growth rate in this market segment.
On the basis of geography, the market is analyzed under various regions namely India, China, Japan, Australia and South Korea. The market in the Asia-Pacific region is expected to grow at the highest CAGR, due to the rise in geriatric population, growth in the occurrence of chronic diseases, rise in healthcare spending, healthcare reforms for infrastructural development, growth in the demand for advanced technologies to develop advanced products, and less strict regulations. The disjointed healthcare industry and high operating margins in developing economies make them attractive to investors as compared to developed economies. The countries such as China and India have large geriatric population and the healthcare infrastructure in these countries is improving, thus illustrating immense healthcare market potential.
The market is dominated by companies such as Medtronic plc, Abbott Laboratories, Boston Scientific Corporation, BIOTRONIK SE & Co. KG, LivaNova PLC., Cochlear Limited, MED-EL, Sonova Holding AG, William Demant Holding A/S and Nurotron Biotechnology Co. Ltd.
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