The number of pipeline In Vitro Diagnostics products in 2021 saw a 26% drop globally when compared to In Vitro Diagnostics 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 In Vitro Diagnostics market was worth $54.40bn in 2020 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 (41.93%) in 2021, followed by Oncology (16.37%) and Immuno Chemistry (12.03%).

Of the global medical devices market value, the In Vitro Diagnostics market held a 10% share worth $54bn in 2021 and is expected to reach $55.37bn by 2025.

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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 50.29% of medical devices in 2021, compared with 58.51% in 2020. The number of devices at the In Approval stage declined by 54% 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 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 (52%) during 2021, followed by Asia-Pacific (24%), and Europe (19%).

On a country level, the US had the most pipeline In Vitro Diagnostics during the year, representing the largest share (45%) of In Vitro Diagnostics pipeline products. In second place was India (8%), followed by China (8%).

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

According to GlobalData, approximately 35% of pipeline In Vitro Diagnostics 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 Infectious Diagnostics Rapid Tests & POC, at 3% 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.

All India Institute of Medical Sciences tops In Vitro Diagnostics development in 2021

According to GlobalData, top ten medical device companies accounted for 11.51% of pipeline In Vitro Diagnostics activity during 2021. The leading company for developing In Vitro Diagnostics was All India Institute of Medical Sciences with 2.02%, followed by Roche Diagnostics International Ltd at 2.02%.

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 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 84% share of the In Vitro Diagnostics medical devices market, while institute-developed pipeline products held the remaining share.

The monthly average for 2021 saw company-developed In Vitro Diagnostics pipeline products account for 84% of pipeline products and institute-developed pipeline products account for 16%.

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.