The number of Diagnostic Imaging pipeline products in 2020 saw a 17% rise globally when compared to Diagnostic Imaging pipeline products in 2019, according to GlobalData’s pipeline products database. This compares to an 34% rise for all pipeline medical devices in 2020 compared to 2019.

The global Diagnostic Imaging market was worth $27.97bn in 2019 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 (20.11%) in 2020, followed by Contrast Agents (13.41%) and MRI Systems (7.26%).

Of the global medical devices market value, the Diagnostic Imaging market held a 6% share worth $27bn in 2020 and is expected to reach $31.99bn by 2025.

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 42.54% of medical devices in 2020, compared with 43.87% in 2019. The number of devices at the In Approval stage declined by 12% in 2020, when compared with 2019.

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 (66%) during 2020, followed by Europe (20%), and Asia-Pacific (12%).

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 Japan (4%), followed by Canada (3%).

New pipeline Diagnostic Imaging medical devices: Expected to be approved by 2025

According to GlobalData, approximately 40% of pipeline Diagnostic Imaging in 2020 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 MRI Coils, 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.

GE Healthcare tops Diagnostic Imaging development in 2020

According to GlobalData, top ten medical device companies accounted for 20.11% of pipeline Diagnostic Imaging activity during 2020. The leading company for developing Diagnostic Imaging was GE Healthcare with 3.35%, followed by Philips Healthcare at 2.23%.

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 77% share of the Diagnostic Imaging medical devices market, while institute-developed pipeline products held the remaining share.

The monthly average for 2020 saw company-developed Diagnostic Imaging pipeline products account for 77% of pipeline products and institute-developed pipeline products account for 23%.

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.