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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. The suite covers reports on the following markets: blood glucose meters, blood glucose test strips, lancets and lancing devices, continuous glucose monitoring (CGM), insulin, inulin pens, insulin syringes and insulin pumps.
The iData report series on diabetes devices covers the U.S. and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about diabetes device market data or procedure data, register online or email us at [email protected] for a US Market Report Suite for Diabetes Monitoring, Treatment and Drug Delivery brochure and synopsis.
About iData Research
iData Research (www.idataresearch.com) is an international market research and consulting group focused on providing market intelligence for medical device and pharmaceutical companies. iData covers research in: Dental Operatory Equipment, X-Ray Imaging, Vascular Access, Peripheral Vascular, Endoscopy, Interventional Cardiology, Cardiac Surgery, Cardiac Rhythm Management, Electrophysiology, Diagnostic Imaging, Operating Room Equipment, Surgical Microscopes, Robotics and Surgical Navigation, Oncology, Ultrasound, Laparoscopy, Urology, Gynecology, Spinal Implants and VCF, Spinal MIS, Orthopedic Soft Tissue Repair and Regeneration, Orthopedic Trauma, Large and Small Joints, Anesthesiology, Wound Management, Orthopedics, Ophthalmics and more.
About Procedure Tracker
Procedure number data is available from iData’s Procedure Tracker service, which allows subscribers to define and analyze procedure data segmented by state, region, hospital, surgery centre, and physician. A customizable dashboard sorts procedure data for further analysis and research.
About Reimbursement Tracker
iData Research’s Reimbursement Policy Tracker enables medical device, dental, pharmaceutical and healthcare professionals to receive real-time policy updates from hundreds of insurance companies and 60,000+ policies across all therapeutic areas in the United States.
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