pLOG

2024-04-01

FDA approves first OTC continuous glucose monitoring system.

The FDA has approved Dexcom's Stelo, the first over-the-counter (OTC) integrated continuous glucose monitoring system (iCGM) available without a prescription. The approved target population is adults aged 18 and older who are not using insulin, and it can also be used by generally healthy individuals who want to monitor their own blood glucose fluctuations.

Although the price of Stelo has not been disclosed, it is expected to pose a threat to Abbott's FreeStyle Libre, priced at $80 per month. Based on historical data, DexCom's pricing has generally been higher than Abbott's products, with experts estimating a price of around $90 per month, with discounts available through US health savings accounts.

Analysts believe that the FDA's approval of OTC iCGM sets a high standard, requiring high cost and development time to achieve high accuracy in the device, making it difficult for competitors other than existing DexCom and Abbott to compete.

Market potential in the Stelo market is for non-insulin-dependent diabetes patients, totaling over 25 million people, even exceeding the insulin therapy market. With the growing obesity problem and the increasing number of type 2 diabetes patients, along with potential applications for prediabetic patients and metabolic health, the demand for continuous glucose monitoring technology is increasing.

Estimates suggest that the market potential for DexCom and Abbott will cover over 100 million potential users, and Abbott is also considering launching an OTC product called Lingo, which will further expand market influence.

Reference:

FDA Approval For DexCom's Stelo Opens Continuous Glucose Monitoring To Masses, Analyst Expects Competitive Pricing Against Abbott's | Markets Insider (businessinsider.com)