This week, the FDA approved a non-adjunctive claim coming from Dexcom, a producer of Continuous Glucose Monitors, in which appears to be a bad time for the conventional devices that may be pushed off the market.
The persons that mostly use the tests are the insulin pump patients and those who undertake multiple daily injection therapies. Even if the number of such patients is very small, the quantity of tests they use is significant. The insulin pump patients have to measure their glucose level at least six times each day, while the second category uses tests four times per day.
The new glucose monitors will take out of the market at least 1.2 million test strips every day, if the number of patients using them would be of just 1 million patients out of which only 30% would use the new devices and will not have to provide a reading confirmation. Adding another 20% new device share in the second group of patients, the standard monitors would lose another 400,000 sales each day.
When Dexcom launches its disposable system, the use of their monitoring devices will continue to rise. Moreover, the GLP-1 therapy is also most likely to increase in popularity, and this type of treatment does not require glucose monitoring.
The new glucose monitors are attracting more and more companies who try to enter the market, so soon the prices will be driven down by the competition on the market.
Another issue would be the poor education of some of the patients who do not understand the importance of testing and do not know how to interpret glucose monitoring readings.
The manufacturers of conventional devices had been reassured for years that their profits would be on a steady trend as the number of patients with diabetes who had to control their glucose level was always on the verge of a couple of millions.
At this moment, the companies will lose a fair share of the market because of the new glucose monitors and their manufacturers, Dexcom and Medtronic.
The move must have been anticipated by the producers. However, the impact is supposed to be quite significant. Abbott and Roche, two companies which relied heavily on glucose monitoring devices, will have to deal with the change. Abbott already created FreeStyle Libre, a product that is still waiting for the FDA approval, but its fate and its financial value is still unclear.
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