The number of pipeline ENT products in 2021 saw a 13% drop globally when compared to ENT 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 ENT Devices market was worth $1.50bn in 2020 and is expected to reach $1.67bn by 2025, according to GlobalData’s analysis.


ENT Devices pipeline products by categories: Diagnostic Devices has the most devices

Looking at the device categories of pipeline products, Diagnostic Devices accounted for the largest proportion (25%) in 2021, followed by Hearing Aid Devices (17.86%) and Speech Aid Devices (17.86%).

Of the global medical devices market value, the ENT Devices market held a 0% share worth $1bn in 2021 and is expected to reach $1.67bn by 2025.

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By GlobalData

ENT 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 53.57% of medical devices in 2021, compared with 40% in 2020. The number of devices at the In Approval stage inclined by 400% 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 ENT Devices products activity

Comparing the number of pipeline ENT Devices products activity in different regions of the globe, North America held the top position (52%) during 2021, followed by Europe (26%), and Asia-Pacific (19%).

On a country level, the US had the most pipeline ENT Devices during the year, representing the largest share (39%) of ENT pipeline products. In second place was Australia (9%), followed by Singapore (6%).

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

According to GlobalData, approximately 64% of pipeline ENT Devices 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 Otoscopes, at 7% 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.

fiagon GmbH tops ENT Devices development in 2021

According to GlobalData, top ten medical device companies accounted for 46.43% of pipeline ENT Devices activity during 2021. The leading company for developing ENT Devices was fiagon GmbH with 10.71%, followed by Nuheara Ltd at 7.14%.

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 ENT Devices in development

Looking at the share of activity in terms of ENT pipeline products developers, company-developed pipeline products accounted for a 65% share of the ENT medical devices market, while institute-developed pipeline products held the remaining share.

The monthly average for 2021 saw company-developed ENT pipeline products account for 65% of pipeline products and institute-developed pipeline products account for 35%.

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.