The number of In Vitro Diagnostics pipeline products in 2020 saw an 85% rise globally when compared to In Vitro Diagnostics 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 In Vitro Diagnostics market was worth $47.03bn in 2019 and is expected to reach $55.37bn by 2025, according to GlobalData’s analysis.

In Vitro Diagnostics pipeline products by categories: Infectious Disease has the most devices

Looking at the device categories of pipeline products, Infectious Disease accounted for the largest proportion (58.06%) in 2020, followed by Immuno Chemistry (10.13%) and Instruments (9.73%).

Of the global medical devices market value, the In Vitro Diagnostics market held a 10% share worth $47bn in 2020 and is expected to reach $55.37bn by 2025.

In Vitro Diagnostics 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 57.06% of medical devices in 2020, compared with 47.71% in 2019. The number of devices at the In Approval stage inclined by 404% 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 In Vitro Diagnostics products activity

Comparing the number of pipeline In Vitro Diagnostics products activity in different regions of the globe, North America held the top position (62%) during 2020, followed by Europe (20%), and Asia-Pacific (16%).

On a country level, the US had the most pipeline In Vitro Diagnostics during the year, representing the largest share (55%) of In Vitro Diagnostics pipeline products. In second place was Canada (13%), followed by China (6%).

New pipeline In Vitro Diagnostics medical devices: Expected to be approved by 2025

According to GlobalData, approximately 31% of pipeline In Vitro Diagnostics 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 Infectious Diagnostics Rapid Tests & POC, at 5% 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.

Boditech Med Inc tops In Vitro Diagnostics development in 2020

According to GlobalData, top ten medical device companies accounted for 9.4% of pipeline In Vitro Diagnostics activity during 2020. The leading company for developing In Vitro Diagnostics was Boditech Med Inc with 1.64%, followed by Siemens Healthcare Diagnostics Inc at 1.64%.

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 In Vitro Diagnostics in development

Looking at the share of activity in terms of In Vitro Diagnostics pipeline products developers, company-developed pipeline products accounted for an 85% share of the In Vitro Diagnostics medical devices market, while institute-developed pipeline products held the remaining share.

The monthly average for 2020 saw company-developed In Vitro Diagnostics pipeline products account for 85% of pipeline products and institute-developed pipeline products account for 15%.

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.