The number of General Surgery pipeline products in 2020 saw a 15% drop globally when compared to General Surgery 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 General Surgery market was worth $49.78bn in 2019 and is expected to reach $63.76bn by 2025, according to GlobalData’s analysis.


General Surgery pipeline products by categories: Image Guided Surgery has the most devices

Looking at the device categories of pipeline products, Image Guided Surgery accounted for the largest proportion (15.33%) in 2020, followed by Robotic Surgery (15.33%) and Endoscopy Devices (14.67%).

Of the global medical devices market value, the General Surgery market held a 10% share worth $49bn in 2020 and is expected to reach $63.76bn by 2025.

General Surgery 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 49.68% of medical devices in 2020, compared with 51.63% in 2019. The number of devices at the In Approval stage inclined 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 General Surgery products activity

Comparing the number of pipeline General Surgery products activity in different regions of the globe, North America held the top position (54%) during 2020, followed by Europe (20%), and Asia-Pacific (18%).

On a country level, the US had the most pipeline General Surgery during the year, representing the largest share (50%) of General Surgery pipeline products. In second place was China (13%), followed by Israel (6%).


New pipeline General Surgery medical devices: Expected to be approved by 2025


According to GlobalData, approximately 67% of pipeline General Surgery 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 Robotic Surgical Systems, at 9% 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.


Fillmed Laboratoires tops General Surgery development in 2020

According to GlobalData, top ten medical device companies accounted for 26% of pipeline General Surgery activity during 2020. The leading company for developing General Surgery was Fillmed Laboratoires with 4.67%, followed by Ambu A/S at 4%.

Companies launching new medical devices are more likely to disrupt existing market share or are better able to defend existing share.

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By GlobalData

Company-developed pipeline products lead General Surgery in development

Looking at the share of activity in terms of General Surgery pipeline products developers, company-developed pipeline products accounted for an 82% share of the General Surgery medical devices market, while institute-developed pipeline products held the remaining share.

The monthly average for 2020 saw company-developed General Surgery pipeline products account for 82% of pipeline products and institute-developed pipeline products account for 18%.


Methodology
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.