Story from the Past: Import of medical devices, equipment and consumables CAGR -6.8% during 2010-2015.
Imports in 2015 – approx. 72% of the medical device market.
Global medical device technology market size: Approx. $370 billion6.
Global medical device market Projection: To reach an estimated $409.5 billion by 2023 at a CAGR of 4.5% from 2018 to 20234.
Medical Device Market Size India Projection: Market size expected to reach USD 50 bn by 2025
CAGR: Ortho/prosthetics & patient aids segments may be the 2 fastest- growing areas in Devices by 2020, and are projected to grow at a CAGR of 9.6% and 8.8%, respectively
Diagnostic imaging, dental products, & consumables are expected to grow at a CAGR of 7.1%, 7.4% & 7.1%, respectively, during the interval of 2015-20.
Indian surgical robotics market to grow at CAGR of 20%2.
*Currently, India among the top-20 markets for medical devices in the world
Total operating Manufacturers of medical devices – 800
Major Medical Device Players in India:
- Philips India
- Stryker India
- GE Healthcare
- Bolton scientific corp.
- Johnson & Johnson Medical
- Becton Dickinson India
- Opto Circuits
- Bayer Diagnostic India Ltd
Medical Device Rules (2017): Notified in 2017 & the regulations have come into effect from January 01, 2018.
FDI in Medical Devices: Upto 100%, under the automatic route is permitted for manufacturing of medical devices1.
Medical device Definition1: any instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including the software, intended by its manufacturer to be used specially for human beings or animals for one or more of the specific purposes of-
(aa) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
(ab) diagnosis, monitoring, treatment, alleviation of, or assistance for, any injury or handicap;
(ac) investigation, replacement or modification or support of the anatomy or of a physiological process;
(ad) supporting or sustaining life;
(ae) disinfection of medical devices;
(af) control of conception,
and which does not achieve its primary intended action in or on the human body or animals by any pharmacological or immunological or metabolic means, but which may be assisted in its intended function by such means;
- an accessory to such an instrument, apparatus, appliance, material or other article;
- a device which is reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system whether used alone or in combination thereof intended to be used for examination and providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body or animals.
iii. The definition of medical device at Note (ii) above would be subject to the amendment in Drugs and Cosmetics Act.
Medical Device Manufacturing Hubs in India:
Medical Device Industry is Changing its trends:
Digital Companies are putting a lot of money in R & D & may present significant changes in Medical devices usage trends in future6.
Artificail Intelligence & Big Data: Artificial Intelligence is being used in new medical devices for better decisiom making & improving treatment outcomes. Big data & cloud computing are being used to design focused& better treatment solutions.
Medical Devices are becoming household items: Be it a sugar, BP apparatus or a wearable steps counter, now can be seen as a common household item.
Robotic Surgeries: The robotic surgeries are continously on the rise. More & more surgeons are moving towards this upcoming trend. Indian surgical robotics market to grow at CAGR of 20%2.
Telemedicine: Integration of medical devices with clinical decision making solutions is gining a tremndoius boost to health care. For instance the ECG machines & Ultrasound machines are becoming smaller & more compact in size, which makes it easier to carry them to any place. Opinions can be taken by simply sharing the recordings electronically.
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