The number of pipeline Healthcare IT products in 2021 saw a 35% rise globally when compared to Healthcare IT pipeline products in 2020, according to GlobalData’s pipeline products database. This compares to an 15% rise for all pipeline medical devices in 2021 compared to 2020.
Healthcare IT pipeline products by categories: Clinical IT Systems has the most devices
Looking at the device categories of pipeline products, Clinical IT Systems accounted for the largest proportion (7.78%) in 2021, followed by Medical Imaging Information Systems (2.09%).
Healthcare IT development activity: Advanced stage of development leads
Devices at an advanced stage of development (in clinical trials, in the approval process, already approved in Europe or the rest of the world) accounted for 48.79% of medical devices in 2021, compared with 52.52% in 2020. The number of devices at the In Approval stage inclined by 49% in 2021, when compared with 2020.
The In Approval stage is considered to be the period where the manufacturer is waiting for final approval from regulators, following completion of the required development steps.
A decrease in products awaiting approval would indicate less new products entering the market in the coming months, while an increase indicates more devices entering the market, posing a market share threat to existing marketed devices.
North America tops pipeline Healthcare IT products activity
Comparing the number of pipeline Healthcare IT products activity in different regions of the globe, North America held the top position (51%) during 2021, followed by Europe (24%), and Asia-Pacific (20%).
On a country level, the US had the most pipeline Healthcare IT during the year, representing the largest share (55%) of Healthcare IT pipeline products. In second place was China (7%), followed by Japan (6%).
New pipeline Healthcare IT medical devices: Expected to be approved by 2025
According to GlobalData, approximately 53% of pipeline Healthcare IT in 2021 were expected to receive regulatory approval by the end of 2025. The leading categories for devices expected to receive regulatory approval by the end of 2025 was Clinical Decision Support Systems, at 1% of devices. Differences in regulatory approval timelines reflect the stage of development for a device, the device complexity or risk categorization (or device class) or if there are changes in regulatory oversight.
Oncoradiomics SA tops Healthcare IT development in 2021
According to GlobalData, top ten medical device companies accounted for 9.76% of pipeline Healthcare IT activity during 2021. The leading company for developing Healthcare IT was Oncoradiomics SA with 1.74%, followed by Keya Medical Technology Corp Ltd at 1.28%.
Companies launching new medical devices are more likely to disrupt existing market share or are better able to defend existing share.
Company-developed pipeline products lead Healthcare IT in development
Looking at the share of activity in terms of Healthcare IT pipeline products developers, company-developed pipeline products accounted for an 81% share of the Healthcare IT medical devices market, while institute-developed pipeline products held the remaining share.
The monthly average for 2021 saw company-developed Healthcare IT pipeline products account for 81% of pipeline products and institute-developed pipeline products account for 19%.
The medical devices pipeline data used in this article were extracted from Medical Pipeline Products Database of GlobalData’s Medical Intelligence Center. Pipeline Products database covers all medical devices which are in development stage and intended for diagnosis, treatment, and management of diseases/conditions/symptoms directly or indirectly. Pipeline products are covered from various authenticated sources like company websites, SEC filings, conference presentations, analyst presentations, news releases, grants etc. The information is collected by following systematic research techniques and proprietary methodology.