The number of Orthopedic Devices pipeline products in 2020 saw a 52% drop globally when compared to Orthopedic Devices 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 Orthopedic Devices market was worth $43.58bn in 2019 and is expected to reach $54.91bn by 2025, according to GlobalData’s analysis.

Orthopedic Devices pipeline products by categories: Orthobiologics has the most devices

Looking at the device categories of pipeline products, Orthobiologics accounted for the largest proportion (20%) in 2020, followed by Orthopedic Prosthetics (17%) and Spinal Surgery (15%).

Of the global medical devices market value, the Orthopedic Devices market held a 9% share worth $43bn in 2020 and is expected to reach $54.91bn by 2025.

Orthopedic 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 51.46% of medical devices in 2020, compared with 45.19% in 2019. The number of devices at the In Approval stage declined by 72% 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 Orthopedic Devices products activity

Comparing the number of pipeline Orthopedic Devices products activity in different regions of the globe, North America held the top position (54%) during 2020, followed by Europe (29%), and Asia-Pacific (18%).

On a country level, the US had the most pipeline Orthopedic Devices during the year, representing the largest share (73%) of Orthopedic pipeline products. In second place was Australia (17%), followed by India (4%).

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

According to GlobalData, approximately 74% of pipeline Orthopedic 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 Upper Extremity Prosthetics, at 8% 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.

Fuse Medical Inc tops Orthopedic Devices development in 2020

According to GlobalData, top ten medical device companies accounted for 25% of pipeline Orthopedic Devices activity during 2020. The leading company for developing Orthopedic Devices was Fuse Medical Inc with 4%, followed by SwissProsthetics 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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Company-developed pipeline products lead Orthopedic Devices in development

Looking at the share of activity in terms of Orthopedic pipeline products developers, company-developed pipeline products accounted for an 87% share of the Orthopedic medical devices market, while institute-developed pipeline products held the remaining share.

The monthly average for 2020 saw company-developed Orthopedic pipeline products account for 87% of pipeline products and institute-developed pipeline products account for 13%.

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.