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Abbott's Libre 3 Receives CE Mark, Boosts CGM Prospects

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Abbott Laboratories (ABT - Free Report) recently received the CE Mark for its next-generation FreeStyle Libre 3 system. The regulatory approval makes the sensory device eligible for use for the diabetics living in Europe. For investors’ note, Abbott is planning to launch the system in Europe in the coming months.

The FreeStyle Libre 3 system includes a long-lasting self-applied continuous glucose monitoring (“CGM”) sensor having a 14-day wear time. This eliminates the need for painful fingersticks to monitor glucose levels.

Notably, Abbott had launched the first disposable glucose sensor in 2014 and has been working toward making high-quality, accurate and affordable diabetes technologies available to every diabetic.

Investors should note that Abbott has secured partial or full reimbursement for the FreeStyle Libre portfolio in 37 countries, including Canada, France, Germany, Japan, the U.K. and the United States.

With the latest approval, Abbott aims to fortify grounds in the global CGM market, thereby boosting the Medical Devices segment. The FreeStyle Libre portfolio is a component of the company’s diabetes care business.

Significance of the Approval

The FreeStyle Libre 3 technology provides continuous real-time glucose readings, which are automatically delivered to smartphones every minute, and also includes optional glucose alarms. This offers unparalleled 14-day accuracy in the smallest and thinnest sensor design and is priced at the same price as previous versions of the device.

Per management, the next-generation FreeStyle Libre 3 system aims to provide a better user experience and simplify diabetes management as much as possible.

Besides the sensor, the system includes the FreeStyle Libre 3 mobile app. The app is designed to enable users to capture and view their real-time glucose levels, glucose history and trend arrows (which indicate rates of glucose change and can be described as the anticipated glucose change). This will aid the users to keep a better track of their glucose levels and prevent fluctuations, thereby reducing diabetes-related hospital admissions and work absentee rates. All these features are expected to improve the overall health of the patients and quality of life.

Further, the latest Libre 3 device is environment-friendly as its current model has a 41% and 43% reduction in plastic use and carton paper, respectively.

Industry Prospects

Per a report by Grand View Research, the global CGM device market size was valued at $3,929.7 million in 2019 and is anticipated to reach $10.4 billion by 2027, at a CAGR of 12.7%. Factors like rising incidence of diabetes and increasing adoption of CGM devices are expected to drive the market.

Given the market potential, the regulatory clearance in Europe is expected to significantly boost Abbott’s business.

Recent Developments in Diabetes Care

Of late, Abbott has been witnessing a slew of developments in its business arm.

The company launched the world's first glucose sport biosensor, Libre Sense Glucose Sport Biosensor, in September. It has been designed for athletes to continuously measure glucose to better understand the correlation between their glucose levels and their athletic performance.

Further in the month, Abbott’s next-generation FreeStyle Libre 2 integrated CGM system received Medicare coverage.

The company, in June, finalized the diabetes care deal (proposed in October 2019) with Tandem Diabetes Care, Inc. (TNDM - Free Report) . The deal enabled the companies to integrate Abbott's FreeStyle Libre CGM technology with Tandem Diabetes’s insulin delivery systems for enhanced diabetes management.

Comparison With Peers

In the diabetes care business, Abbott’s peer Tandem Diabetes is progressing well. In August, Tandem Diabetes announced the publication of favorable study outcomes from the Protocol 5 study (DCLP5) of the International Diabetes Closed Loop trial in the New England Journal of Medicine. In June, Tandem Diabetes acquired Sugarmate, which is an app popular among insulin-dependent diabetic patients.

Medtronic plc (MDT - Free Report) received the FDA’s approval for its MiniMed 770G hybrid closed-loop system in September. The company, in August, announced plans to acquire the privately-held manufacturer of InPen, Companion Medical. Notably, the smart insulin pen system, InPen, is the only FDA-cleared system paired with an integrated diabetes management app currently available in the market.

Insulet Corporation (PODD - Free Report) announced the commercial launch of its Omnipod DASH Insulin Management System (Omnipod DASH System) in additional countries, in September.

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