The number of pipeline Diagnostic Imaging products in 2021 saw a 19% rise globally when compared to Diagnostic Imaging 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.
The global Diagnostic Imaging market was worth $30.37bn in 2020 and is expected to reach $31.99bn by 2025, according to GlobalData’s analysis.
Diagnostic Imaging pipeline products by categories: Radiopharmaceuticals has the most devices
Looking at the device categories of pipeline products, Radiopharmaceuticals accounted for the largest proportion (20.29%) in 2021, followed by Contrast Agents (15.94%) and Ultrasound Systems (14.49%).
Of the global medical devices market value, the Diagnostic Imaging market held a 6% share worth $30bn in 2021 and is expected to reach $31.99bn by 2025.
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Diagnostic Imaging 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 40.67% of medical devices in 2021, compared with 45.76% in 2020. The number of devices at the In Approval stage inclined by 62% 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 Diagnostic Imaging products activity
Comparing the number of pipeline Diagnostic Imaging products activity in different regions of the globe, North America held the top position (68%) during 2021, followed by Europe (17%), and Asia-Pacific (15%).
On a country level, the US had the most pipeline Diagnostic Imaging during the year, representing the largest share (76%) of Diagnostic Imaging pipeline products. In second place was Australia (6%), followed by India (5%).
New pipeline Diagnostic Imaging medical devices: Expected to be approved by 2025
According to GlobalData, approximately 30% of pipeline Diagnostic Imaging 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 3T MRI Systems, at 0% 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.
GE Healthcare tops Diagnostic Imaging development in 2021
According to GlobalData, top ten medical device companies accounted for 20.29% of pipeline Diagnostic Imaging activity during 2021. The leading company for developing Diagnostic Imaging was GE Healthcare with 4.35%, followed by Shenzhen Mindray Bio-Medical Electronics Co Ltd at 2.42%.
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 Diagnostic Imaging in development
Looking at the share of activity in terms of Diagnostic Imaging pipeline products developers, company-developed pipeline products accounted for a 78% share of the Diagnostic Imaging medical devices market, while institute-developed pipeline products held the remaining share.
The monthly average for 2021 saw company-developed Diagnostic Imaging pipeline products account for 78% of pipeline products and institute-developed pipeline products account for 22%.
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.