Article preview from Medtech Insight - October 28, 2013
The race to develop a fully functional artificial pancreas for patients with diabetes is entering the later stages, and the first such device could be ready for regulatory submission in the next few years. Medtronic has achieved notable success in this area to date, but positive clinical studies have put J&J in a good position as well, and the medical community is watching closely as the major developments in this groundbreaking endeavor continue to move forward.
The Artificial Pancreas: A Race To The Finish
Article preview from Medtech Insight - October 28, 2013
What originally started as a scientific hypothesis supported by a small group of believers has grown into a competitive project now involving some of the biggest names in the diabetes device space. The quest to develop a functioning artificial pancreas system (APS) is moving into the later stages, and if the current pace continues, it is possible a product could be ready for regulatory submission in the next few years. A great deal of enthusiasm and support for this milestone is coming from the business and medical communities, which have seen this technology take tremendous leaps forward in the last 10 years, moving from concept to reality. The development and refinement of insulin delivery pumps, continuous glucose monitors (CGMs), and sophisticated computer algorithms all are credited as major factors in this progress, but improvements in those elements also have been spurred along by a business environment that has supported the right balance of competition and cooperation in one of the most interesting races to see who will be first-to-market.
The demand for innovative products for patients with diabetes is one of the most attractive opportunities in the medical device field, addressing a patient population estimated at 25.8 million in the US and 347 million worldwide. The most serious form of the disease is type 1 diabetes (T1D), and people with T1D make up about 5% to 10% of the total US diabetes population; it is estimated that anywhere from 300,000 to 400,000 of these patients rely on pumps to regularly deliver insulin.
Medtronic Inc. is the clear leader in the insulin pump market, holding an estimated 74% market share in the US, and the company also is one of the two leading CGM manufacturers with its Guardian REAL-Time Continuous Glucose Monitoring System. The US CGM market, valued at $250 million according to Raymond James Financial Inc., is virtually evenly split between Medtronic and DexCom Inc., which produces the G4 Platinum CGM.
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