The number of Patient Monitoring pipeline products in 2020 saw a 102% rise globally when compared to Patient Monitoring 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 Patient Monitoring market was worth $10.29bn in 2019 and is expected to reach $11.39bn by 2025, according to GlobalData’s analysis.

Patient Monitoring pipeline products by categories: Remote Patient Monitoring has the most devices

Looking at the device categories of pipeline products, Remote Patient Monitoring accounted for the largest proportion (51.69%) in 2020, followed by Multiparameter Patient Monitoring (21.35%) and Neonatal Monitors (7.87%).

Of the global medical devices market value, the Patient Monitoring market held a 2% share worth $10bn in 2020 and is expected to reach $11.39bn by 2025.

Patient Monitoring 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 57.14% of medical devices in 2020, compared with 54.55% in 2019. The number of devices at the In Approval stage inclined by 275% 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 Patient Monitoring products activity

Comparing the number of pipeline Patient Monitoring products activity in different regions of the globe, North America held the top position (68%) during 2020, followed by Asia-Pacific (16%), and Europe (12%).

On a country level, the US had the most pipeline Patient Monitoring during the year, representing the largest share (71%) of Patient Monitoring pipeline products. In second place was Japan (5%), followed by Australia (5%).

New pipeline Patient Monitoring medical devices: Expected to be approved by 2025

According to GlobalData, approximately 50% of pipeline Patient Monitoring 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 Low Acuity Monitors, at 6% 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.

Empatica Inc. tops Patient Monitoring development in 2020

According to GlobalData, top ten medical device companies accounted for 19.1% of pipeline Patient Monitoring activity during 2020. The leading company for developing Patient Monitoring was Empatica Inc. with 2.25%, followed by CardieX Ltd at 2.25%.

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 Patient Monitoring in development

Looking at the share of activity in terms of Patient Monitoring pipeline products developers, company-developed pipeline products accounted for an 83% share of the Patient Monitoring medical devices market, while institute-developed pipeline products held the remaining share.

The monthly average for 2020 saw company-developed Patient Monitoring pipeline products account for 83% of pipeline products and institute-developed pipeline products account for 17%.

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.