The number of pipeline cardiovascular products in 2020 saw a 16% rise globally when compared to cardiovascular pipeline products in 2019, according to GlobalData’s pipeline products database. This compares to an 26% rise for all pipeline medical devices in 2020 compared to 2019.

The global Cardiovascular Devices market was worth $39.48bn in 2019 and is expected to reach $57.09bn by 2025, according to GlobalData’s analysis.



Cardiovascular Devices pipeline products by categories: Interventional Cardiology has the most devices

Looking at the device categories of pipeline products, Interventional Cardiology accounted for the largest proportion (15%) in 2020, followed by Peripheral Vascular Devices (13%) and Transcatheter Heart Valves (12%).

Of the global medical devices market value, the Cardiovascular Devices market held an 8% share worth $39bn in 2020 and is expected to reach $57.09bn by 2025.

Cardiovascular Devices 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 48.61% of medical devices in 2020, compared with 64.74% in 2019. The number of devices at the In Approval stage declined by 22% 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.

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North America tops pipeline Cardiovascular Devices products activity

Comparing the number of pipeline Cardiovascular Devices products activity in different regions of the globe, North America held the top position (62%) during 2020, followed by Asia-Pacific (20%), and Europe (17%).

On a country level, the US had the most pipeline Cardiovascular Devices during the year, representing the largest share (69%) of cardiovascular pipeline products. In second place was China (16%), followed by Australia (4%).



New pipeline cardiovascular medical devices: Expected to be approved by 2025

According to GlobalData, approximately 59% of pipeline cardiovascular devices 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 PTA Balloon Catheters, at 3% 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.



Shenzhen Salubris Pharmaceuticals Co Ltd tops cardiovascular device development in 2020

According to GlobalData, top ten medical device companies accounted for 23.83% of pipeline cardiovascular device activity during 2020. The leading company for developing cardiovascular devices was Shenzhen Salubris Pharmaceuticals Co Ltd with 4.21%, followed by Shockwave Medical Inc at 3.27%.

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 cardiovascular devices in development

Looking at the share of activity in terms of cardiovascular pipeline products developers, company-developed pipeline products accounted for a 91% share of the cardiovascular medical devices market, while institute-developed pipeline products held the remaining share.

The monthly average for 2020 saw company-developed cardiovascular pipeline products account for 91% of pipeline products and institute-developed pipeline products account for 9%.



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.