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Taiwanese CGM manufacturers rush to enter the global marketDec 25, 2023

The Continuous Glucose Monitoring (CGM) industry is estimated that from next year the output value will exceed that of the traditional BGM, attracting manufacturers from around the world to race for market share. Bionime, which has already obtained Taiwan's TFDA's marketing approval, is actively seeking international cooperation; ApexBio Taiwan has received an OEM order from Italy; and TaiDoc Technology has the chance of receiving market approval by the end of next year or the beginning of the following year.

The CGM market contributed US$4,896 million in 2021 and is expected to hit US$16,698 million by 2028, with a CAGR of 19.16%. Experts believe that the CGM market will overtake BGM next year.

Currently, the CGM market is dominated by three major manufacturers: Abbott, Dexcom, and Medtronic. Bionime is the first Taiwanese manufacturer to enter the international market. In addition to continuing to build its own automated CGM production facilities to increase its cost advantage, Bionime is also seeking licensing deals with multinational companies.

Bionime will initially develop self-pay in Taiwan and focus on OEM overseas. As the cost of a clinical trial with 300 participants, as required by the US authorities, will be NT$300 million, Bionime will seek funding from multinational companies or partners interested in developing CGM and will share with them the future revenues generated from CGM.

ApexBio is supporting Italian customers in the development of CGM, which is mainly used in intensive care units. In June this year, ApexBio submitted the application for EU approval, which is expected to be granted by the end of the year, with a market launch in mid-2024.

In addition, TaiDoc Technology's CGM is currently undergoing clinical trials and optimisation with the aim of completing clinical trials by the end of next year and possibly obtaining certification by the end of next year or early the following year. TaiDoc has indicated that the product will first be approved in Taiwan next year and, if all goes well, clinical trials and approval will follow in the United States and Europe.

Due to the high price of CGM products and the fact that the main user group is type 1 diabetics, which accounts for only 10% of the market, TaiDoc will adjust the progress and strategy of CGM product launches according to demand in specific markets.