The Artificial Pancreas Device System (APDS) market was valued at USD 76.5 million in 2015. The APDS consists of interlinked insulin pumps and CGM devices. The potential possibility of achieving glycemic control through this treatment device is expected to cause a rise in the overall share over the forecast period.
Increasing incidence of type 1 diabetes globally and the rising demand for insulin self-administration amongst diabetic patients, especially those above the age of 65 years, are the factors responsible for the evolution of this sector.
Type 1 diabetes patients form the target group for these devices as they are completely incapable of producing insulin on their own. According to statistics provided by the WHO, as of 2014, there were about 35 million individuals suffering with type 1 diabetes with an additional 100,000 cases each year.
Furthermore, active research efforts being conducted by the prominent vertical players, such as Medtronic and Johnson & Johnson along with various other research-based academic organizations is expected to propel the growth of this vertical over the forecast period. For instance, one of the research teams at the Boston University is currently working on the development of a computer-directed insulin pump that will function as a bionic pancreas for type 1 diabetes patients.
On the other hand, Medtronic has ongoing clinical trials for their Hybrid Closed Loop System, which would be capable of regulating the insulin dosage and enable continuous glucose monitoring. The study is being conducted on over 127 patients, the results of which are awaited by the second half of 2016. The product is expected to be available by next year.
Furthermore, the company has already established a strong hold over this sector with the previous launch of MiniMed 530G in 2013 for patients above the age of 16 years. MiniMed 530G was the first prototype of the APDS to be launched and it consequently paved the way for the company to further develop this technology.
As of 2015, there are over 20 projects undertaken by key industry players across the globe, catering to the development of artificial pancreas systems. As of January 2016, two fresh trials were announced in collaboration with the National Institutes of Health, who has extended their support in the form of funds amounting to USD 12 million for the project.
Along with the aforementioned key drivers, other factors promoting growth include the increase in the non-adherence rate among patients for routine insulin administration, rising geriatric population characterized with weak memory and motor skills, which preclude the administration of daily injections in these patients, and the augmenting episodes of hypoglycemia or hyperglycemia due to irregularities in insulin administration and glucose monitoring.
On the basis of device type, the vertical is divided into threshold suspended device systems, Control to Range (CTR) system, and Control to Target (CTT) system.
The threshold suspended device system has been incorporated by Medtronic in the MiniMed 530G and is recognized as one of the early adoptions in this sector. However, this technology finds its applications majorly in case of hypoglycemic episodes, wherein it prevents a drastic fall in the blood glucose level, and it involves routine, manual administration of insulin by patients.
On the contrary, the CTR system might be applicable in case of both, hyperglycemic and hypoglycemic events. Furthermore, the CTT systems are fully automated and require no intervention on the patient’s part for the administration of insulin or for the monitoring of glucose levels. Hence, the CTR and CTT systems are anticipated to gain higher momentum over the forecast period.
North America is anticipated to dominate the overall market in terms of revenue and is expected to grow at a CAGR of 20.7% over the forecast period, which is attributable mainly to the high incidence rates of diabetes and supportive government programs that facilitate the initiation of clinical trials within the region.
However, owing to the extremely stringent regulations and policies of the U.S. FDA, the average approval time for products that are currently under development is expected to lengthen. This is leading to a shift of preference amongst the players in this vertical toward the European region due to the relatively fast-paced nature of the regulatory approval procedures in this region.
Some of the key players for the APDS vertical include Medtronic, Tandem Diabetes Care, Inc., Johnson & Johnson (Animas Corporation), Bigfoot Biomedical, and others. Increasing R&D activity, growing collaborations amongst insulin pump manufacturers, and the introduction of various new products in this domain are certain trends that are expected to be seen over the forecast period.
For instance, Bigfoot Biomedical acquired all the assets and intellectual property of Asante, which was involved in the production of Snap insulin pumps. The company aims to retain a substantial share of the highly lucrative APDS market over the forecast period and is fiercely working towards their goal.
In case of new product launches, Medtronic has lined up the introduction of MiniMed 670Gwithin the U.S. region for the year 2017, and had filed for its approval in June 2016. Similarly, Bigfoot is working towards the completion of their automated insulin delivery system (Bionic Pancreas) by 2017 and anticipating its launch in 2018.
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