The Software as a Medical Device (SaMD) market is projected to grow at a CAGR of 85.41% during the forecast period of 2019-2025. Software as a Medical Device (SaMD), according to the definition by the International Medical Device Regulators Forum (IMDRF) is a “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”. The Software as a Medical Device market is projected to witness a staggering growth during the forecast period owing to the rapid product launches and rising adoption of IoT in healthcare. Furthermore, ease in regulations for the certification of the SaMD will further boost the market. However, concerns regarding the privacy of the health data of the user might restrain the market during the given forecast period. Additionally, rising investments by the companies for SaMD will provide ample opportunities for the market players to flourish during the given forecast period.
Geographically, Americas is projected to hold the largest market share followed by Europe Middle East and Africa, while the Asia Pacific is projected to grow with the highest compound annual growth rate (CAGR) over the forecast period of 2020-2025 owing to the growing demand for SaMD keeping in view the high geriatric population of Japan, in addition to the growing health awareness among individuals where the educated individuals of emerging economies such as China and India are keenly concerend about keeping track of their own health management.
The rising adoption of IOT in the healthcare sector coupled with the recent developments in regulations in healthcare industry are expected to significantly influence the the growth of the Software as a Medical Device market over the coming years.
Some of the applications of IoT in healthcare include continuous monitoring of the blood pressure, heartbeat, body temperature, respiration rate, continuous collection of certain parameters in case of chronic illnesses and providing remote assistance among other applications. The growing adoption of IOT is expected to fuel the the SaMD market growth. Furthermore, with the growing consumer preferences for sophisticated wearables, the popularity of the connected devices in healthcare is increasing boosting the growth of the software as a medical device market as well. Although, concerns regarding data security and privacy are expected to limit to overall market growth.
PCs and Laptops dominate the device type segment owing to their advanced computing capabilites and integration with advanced sensor technologies to provide higher efficiency and better performance.
By device type, the software as a medical device (SaMD) market is segmented as PCs/laptop, smart phone/tablets and wearable device. The Rising number of product launches coupled with favoring regulatory policies is increasing the competition in the market which is anticipated to propel the market growth opportunities for manufacturers and vendors in the coming years. Currently new smart sensor laptops are changing the way users can work, in simple words the combination of sensing technology and laptops/PCs, can handle the computing capabilities of advance healthcare applications and software to monitor the daily activities. The growing adoption of smart phones for various applications in the healthcare industry is expected to drive the smart phone segment.
Cloud-based SaMD is projected to hold a significant share owing to the rising popularity and greater functionality and scope in comparison to on premise-based devices. Cloud-based SaMD is also anticipated to show multiple growth opportunities in the coming years owing to the increasing penetration of IoT in healthcare.
The global software as a medical device market is segmented as cloud and on-premise based on its deployment. Cloud-based SaMD are becoming increasingly popular around the world, owing to their ease of accessibility and growing penetration of internet in the healthcare industry. Furthermore, cloud-based software also allows for accelerated performance on lower-tier hardware which many healthcare technology giants are taking advantage of to develop high performance devices through innovations and their own research and development. For example, Singapore based Biofourmis, recently received FDA clearance for its cloud-based AI software RhythmAnalytics, a part of its digital therapeutics program.
The Americas region holds the majority market share as a number of companies are getting FDA clearances for their software coupled with the burgeoning investment in the healthcare industry by major countries such as the U.S. and Canada.
By geography, the Software as a medical device (SAMD) market has been segmented as Americas, Europe Middle East and Africa, and the Asia Pacific. Americas is estimated to hold a major share in the market owing to the burgeoning penetration of Artificial Intelligence (AI) and Machine Learning (ML) in the diagnostic segment that have the potential to adapt and optimize device performance in real-time. The European region is projected to witness good growth during the forecast period owing to the rising prevalence of diseases, mounting pressure to reduce healthcare cost and to increase the quality of healthcare services. While the Asia Pacific software as a medical device (SaMD) market, although in its niche stage, is presenting a high potential for growth. The market is expected to grow at a significant CAGR during the forecast period owing to the rising penetration of Artificial Intelligence in the medical devices and growing popularity of wearable SaMD’s among the users in the region.
The software as a medical (SaMD) market has been analyzed through the following segments:
By Device Type
· Wearable Device
· Clinical Management
· Europe Middle and Africa
· Asia Pacific
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