ARTICLE SUMMARY:
Insulet and Tandem Diabetes Care have FDA clearance to market their automated insulin delivery systems on-label in the US for type 2 diabetes, signaling a new era of growth and innovation in the insulin pump industry. Excerpted from our recent feature article.
With two automated insulin delivery (AID) systems—from Insulet and Tandem Diabetes Care—now FDA cleared for use on-label by people with type 2 diabetes (T2D), and more expected to follow, the US insulin pump market appears to be headed for a decisive growth spurt in the months and years ahead. The full impact is difficult to predict at this early juncture, but analysts believe the stage is set for a “multiyear tailwind” as this “new era” in insulin pump therapy takes hold.
Medtronic is next in line: the company expects to file a type 2 FDA submission for the MiniMed 780G AID system sometime in the first half of 2025, which would put it on track for clearance late this year or early next year. With its large sales force and service capabilities, Medtronic could have an advantage in the type 2 market among primary care physicians who aren’t as familiar with pump technology as endocrinologists, but the company will face strong competitive headwinds from Insulet and Tandem. And while Medtronic’s recent deal to integrate Abbott’s popular Libre continuous glucose monitor (CGM) technology into its 780G AID could help, the timing of that integration is still unclear. (See “Medtronic Takes a Turn, Inks Deal With Abbott for CGM,” MedTech Strategist, September 13, 2024.)
AID newcomers Beta Bionics and Sequel Med Tech, while currently focused on type 1 diabetes, have also expressed interest in the type 2 opportunity and could prove to be formidable competitors, given their systems’ user-friendly attributes and their early moves into the pharmacy channel.
With the recent label expansions, analysts expect AID adoption by type 2s to grow meaningfully in 2025 and beyond. Most of the early momentum is likely to benefit Insulet, but there is plenty of growth runway in this huge and vastly underpenetrated space for other competitors as well.
According to Insulet, the type 2 opportunity more than triples the total addressable pump market (TAM) to about 14 million globally. In the US, there are about 2.5 million type 2s on intensive insulin therapy (IIT), including those on multiple daily insulin injections (MDI), and more than 3 million on basal-only insulin, and both of those segments are vastly underpenetrated, with only about 5% of T2s on IIT using pumps today along with a negligible percentage of basal-only patients (see Figure 1).
It's worth noting that 21% of the participants in Insulet’s pivotal trial were on basal-only insulin, and while both AID systems are approved for use by any insulin-requiring type 2, Tandem did not enroll basal-only patients in its study and is not currently prioritizing that segment of the T2 market. Insulet executives said recently that some physicians are already putting basal-only patients on O5, although early type 2 adoption trends will probably tilt more toward MDI.
Excerpted from Type 2 Era Poised to Transform US Insulin Pump Market. Read full article here.