Artificial Pancreas Device System (APDS) – Putting the Ease in Diabetes Management
Administering insulin on daily basis is cumbersome for type 1 diabetes (T1D) patients in a busy lifestyle. While devices such as insulin pumps, pens, and jet injectors have made living with diabetes less stressful by ridding users of relatively painful insulin delivering devices such as needles and syringes. Juvenile Diabetes Research Foundation (JDRF) is working in collaboration with many industry players such as Medtronic, Inc., Johnson & Johnson, and Tandem Diabetes Care, Inc. to develop innovative insulin and glucose monitoring systems/devices.

Artificial pancreas is the outcome of these collaborations which is also encouraged for use by the FDA. Artificial pancreas device system (APDS) consists of an insulin pump, sensor, transmitter, and a receiver. MiniMed 530G from Medtronic, Inc. was the first artificial pancreas device system (APDS) approved by FDA. This threshold suspend device system enables temporary suspension of insulin delivery when the glucose level is lower than the threshold level. Another system, Medtrum’s P6 Easy Touch Disposable Pump is a semi-closed loop artificial pancreas that is under clinical trials in Europe. Many such systems are under clinical trials and expected to be launched in near future in the global artificial pancreas device system (APDS) market. Developed economies in North America, Europe and Pacific region would be the potential regional opportunities for this novel system in the global artificial pancreas device system (APDS) market.

In 2016, the U.S. FDA approved a hybrid closed-loop artificial pancreas device system (APDS) MiniMed 670G which is an automated system. The continuous glucose monitor in the system automatically sends signals to the insulin pump to deliver insulin when the glucose level in body goes beyond the acceptable limit. Thus, there is no need for the user to stimulate the release of insulin every time the glucose level is abnormal. This provide the user freedom to perform his/her daily activities. Such advancement in T1D management is expected to be highly preferred by the users and medical community, leading to higher advocacy to use this device especially among the patient group using insulin pumps. Moreover, in mid-2018, a study will test a bihormonal “bionic pancreas” system at the Massachusetts General Hospital (Boston) and Boston University. This would further fuel the artificial pancreas device system (APDS) market growth and attract more investments.
Strategic collaborations fostering artificial pancreas device system (APDS) market growth
There were over 20 projects undertaken by the industry payers in 2015 with respect to development of artificial pancreas device system (APDS). Bigfoot Biomedical acquired Asante’s FDA approved Snap insulin pump technology in 2015 and at the same time signed a development agreement with Dexcom to integrate Dexcom’s CGM in its under development artificial pancreas device system (APDS). Dexcom is in collaboration with many other market players such as Insulet Corporation, Animas Corporation, and International Diabetes Closed Loop wherein, these companies would be incorporating Dexcom’s CGM in their artificial pancreas device system (APDS). Such collaborations are expected to expedite market entry for new artificial pancreas device system (APDS)s and thus drive the growth of artificial pancreas device system (APDS) market.

Lack of reimbursement to hinder artificial pancreas device system (APDS) market growth
The prevalence of T1D in the U.S. is 1.35 million which is expected to increase to 5 million by 2050 as per the estimates (2016) by JDRF. Each year 40,000 people are diagnosed with T1D in the U.S. according to the JDRF. With this huge patient base, potential opportunity for artificial pancreas device system (APDS) looks considerably high at global level. However, lack of reimbursement for glucose sensors is expected to inhibit the uptake of artificial pancreas device system (APDS). With an average cost of US$ 6000-7000, adoption of artificial pancreas device system (APDS) is estimated to be restricted among rich T1D patients. Furthermore, only a few T1D patient group prefer insulin pumps for treatment. According to the 2013 report of JDRF, about 350,000 insulin pumps were sold in the U.S. Thus, creating awareness should also be an objective of artificial pancreas device system manufacturers to increase its adoption.

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