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According to a new series of reports on the U.S. market for diabetes monitoring, treatment and drug delivery by iData Research, growth in the U.S. diabetes market is expected to persist over the next several years. Growth will be driven by the increasing prevalence of diabetes in the U.S. and technological advancements made in certain segments, particularly insulin pumps and continuous glucose monitoring (CGM). However, lower reimbursement rates exhibit a significantly limiting effect on the market, as downward pressure is applied to pricing in the overall blood glucose monitoring market.

“The recent influx of low-price competitors in the blood glucose test strip segment has placed downward pressure on prices,” explains Dr. Kamran Zamanian, CEO of iData. “As a result, overall market value has decreased despite the increasing number of diabetics testing their blood glucose levels in the United States.”

In addition, patent expirations of flagship insulin products have resulted in the emergence of biosimilars or generic insulins, as well as next-generation insulins. Biosimilars are competitively priced to their insulin counterparts and put downward pressure on the overall price of insulin. Next-generation insulins are typically premium priced due to their increased average active durations, decreasing the amount of injections patients must perform on a daily basis.

The Clinical Chemistry and Clinical Toxicology Devices panel of the FDA recently voted in favor of a non-adjunctive label that would allow DexCom G5® Mobile users to make insulin dosing decisions based on CGM data, as opposed to traditional blood glucose meter readings. Although some CGM users have already been making insulin dosing decisions based on their CGM data, attaching such a claim to the product would reinforce confidence in CGM accuracy and have significant implications for the future of the market. A non-adjunctive claim may increase the likelihood of Medicare patients, who represent nearly 40% of the total diagnosed diabetic population, receiving reimbursement for CGM products in the future. As a result, CGM penetration would be positively influenced by the increased accessibility and number of physicians who are more likely to prescribe CGM as a therapy option.

Sanofi has the largest share of the diabetes monitoring, treatment and drug delivery market, due to their strong position in the insulin, prefilled pen and pen cartridge markets. Sanofi dominates the long-acting insulin segment with its flagship product, Lantus®, which has been available on the U.S. market since 2001. The patent for Lantus® expired in 2015 and is expected to face competition from a biosimilar product by Eli Lilly and Boehringer Ingelheim. In response, Sanofi is currently developing a biosimilar to Eli Lilly’s popular rapid-acting insulin analog Humalog®. Sanofi and Novo Nordisk recently launched next-generation insulin products: insulin glargine U-300 (Toujeo®) and insulin degludec (Tresiba®), respectively. The insulin-dependent patient population is expected to transition to next-generation insulin products and will contribute to the growth of the insulin market and associated insulin delivery markets.

For Further Information
More on the diabetes device market in the U.S. can be found in a series of reports published by iData Research entitled the US Market Report Suite for Diabetes Monitoring, Treatment and Drug Delivery.