It is estimated that, in 2017, nearly 415 million adults had diabetes (both Type 1 and Type 2), and this number is expected to increase to 630 million by 2045. Diabetes patients on insulin therapy have traditionally relied on multiple daily injections (MDI) or insulin pump therapy with continuous glucose monitoring (CGM).
Type 1 diabetics, who are not capable of producing insulin, are required to check blood glucose levels, alter their insulin doses, and adjust their therapy based on carbohydrate intake on a daily basis; type 2 diabetics, who can produce insulin but either produce too little or are resistant to it, also face similar challenges but do not necessarily require treatment with insulin, and can manage the condition with medication and self-care regimes, such as regular exercise and healthy diets. Perhaps the most difficult (and dangerous) aspect of managing diabetes is dealing with unexpected variations in blood glucose levels, which can lead to serious complications if not managed in a timely manner.
The development of a closed-loop system—a so-called “artificial pancreas”—has therefore become the holy grail of diabetes treatments, representing both a highly anticipated solution for the millions of diabetics worldwide and the crowning technological achievement of the many companies vying for the top spot in this space. Read on to learn more about the current state of this technology and how companies are attempting to make sure they are at the vanguard of technological development.
The Artificial Pancreas: Innovation and Quality of Life
Several innovations have been produced in this field in order to make it easier for diabetics to manage their condition. For example, subcutaneous insulin infusion pumps and subcutaneous CGMs allow patients to sidestep the need for multiple finger sticks, measuring insulin doses, and administering the injections on a daily basis; instead, patients can view glucose readings on their monitors (which take measurements directly from the body) and can spur the pumps to infuse insulin directly.
To further improve quality of life for diabetes patients, researchers and medtech companies have finally managed to combine the aforementioned components into a single “artificial pancreas” device (also known as a hybrid closed-loop system), which also utilizes an algorithm that allows the device to continuously monitor glucose levels and administer insulin as needed, with barely any input required from the patient! This allows the device to emulate the functions of a healthy pancreas, mitigating the need for burdensome insulin management. Not only that, but this technology will also enable the control of drastic and unexpected variations in blood glucose levels, especially those that may occur without alerting the patient, such as during sports activities or during sleep.
Current Therapeutic Landscape:
The global insulin pump market is limited by restricted reimbursement guidelines
The global MDI market is currently quite saturated, with 10-year forecasts projecting either very slow growth or a steady decline in revenues across the geographies shown above; this is a reflection of the commoditized nature of the MDI market and is an indication that most diabetics who require MDI therapy are already receiving it.
The insulin pump market, on the other hand, is growing steadily in Europe and the Asia Pacific region; however, in the US, the uptake of insulin pumps is limited because reimbursement for these devices is provided for Type 1 patients only, and these devices are generally quite costly, which limits uptake among Type 2 diabetics, who represent the vast majority of the overall diabetic population. Similarly, in Europe and the Asia Pacific region, the reimbursement of insulin pumps is fairly restricted; however, these markets are not yet saturated, and awareness and device availability continue to increase, supporting market growth.
With that said, it is expected that insulin pump reimbursement will ultimately be expanded to Type 2 diabetics, which will support substantial growth in the insulin pump market and will likely also support the uptake of artificial pancreas systems going forward.
Until then, however, some organizations are attempting to improve access to insulin by subsidizing these treatments for certain individuals; for instance, the Australian government and JDRF provide insulin subsidies to limited-income families who have children with type 1 diabetes and do not have access to reimbursement; some clinics are also attempting to improve access to insulin by renting out insulin pumps instead of selling them, reducing the burden of initial cost. Nevertheless, the potential of a true artificial pancreas remains the most promising and exciting development in this market in recent years.
The Mnimed 670G, Diabeloop’s DBLG1, and numerous ongoing clinical trials
Though fully closed-loop systems—that is, systems that need absolutely no patient input—have not yet been developed, a number of hybrid closed-loop systems, which minimize the need for input, have received regulatory approval in recent years.
Perhaps most notable among them is Medtronic’s Minimed 670G, which became the world’s first approved artificial pancreas when it was approved by the FDA in 2016 for type 1 diabetics aged 14 years and older, and in 2018 received expanded approval for use in children who are between 7 and 13 years old. This device also received CE mark in June 2018, making it available to European type 1 diabetics over 7 years of age.
Other notable systems include Diabeloop’s DBLG1 system, which received a CE mark in November 2018 and will likely hit the market in France (Diabeloop’s home market) in Q2 of 2019; this device’s differentiating factor is that it features smartphone connectivity, allowing patients to view readings and adjust dosage through their phones.
Furthermore, in recent years, many clinical trials—including those sponsored by both medtech companies and independent third-party organizations—have demonstrated the safety and efficacy of hybrid closed-loop systems. For example, in October 2018, a European study sponsored by JDRF showed that, compared to manual insulin delivery, hybrid closed-loop systems provide improved glucose control and reduce the risk of hypoglycaemia in Type 1 diabetics. Similarly, studies from Insulet and Tandem Diabetes Care have also reported positive results with the respective company’s closed-loop offerings.
The widespread interest in closed-loop systems has even led the US FDA to develop specific guidelines and safety standards for these products; the organization has also been engaging in consultative discussions with various diabetes groups and researchers to ensure that the development of closed-loop systems is not needlessly encumbered by regulatory barriers.
In addition to M&A, other creative solutions will help emerging companies stand out in this space
Given that the global market for closed-loop systems has only a few competitors (namely Medtronic and Diabeloop), and that this technology has not yet achieved significant penetration into the diabetic population, there remains a substantial market opportunity for companies that are currently developing and testing such systems. Because entering this space will require considerable resources to develop devices and conduct trials, many companies have made inroads into this space by entering into partnerships and collaborative initiatives with one another.
For example, in late 2016, Dexcom, Tandem Diabetes Care, and TypeZero announced that they are collaborating on a global study (funded by the NIH) that will look into an artificial pancreas system that combines Tandem’s insulin pump with Dexcom’s G5 CGM and TypeZero’s inControl, a closed-loop algorithm app. In 2017, the study’s researchers expanded on the devices used in the trial by adding Dexcom’s G6 pump and integrating it with the Tandem t:slim X2 pump.
Moreover, some competitors are utilizing flexible payment plans that ease the out-of-pocket costs associated with purchasing a new insulin pump to gain a competitive edge; for instance, Medtronic allows all of its users to spread the cost of the MiniMed 670G over the course of 48 months and also offers an additional Financial Assistance Program for users in particular situations, such as those who have become unemployed within the year prior to purchasing the system.
In addition, in November 2018, Insulet announced that it is working with Tidepool to support FDA approval for the latter’s Loop open-source, automated insulin delivery app, including by making its Omnipod the very first partnered pump.
Despite Current Limitations, Artificial Pancreas Holds Great Promise
In spite of all the excitement surrounding closed-loop systems, there are some obstacles that stand in the way of significant penetration; these include the high price of the devices (the Minimed 670G, for example, costs approximately $6500), the difficulty in obtaining reimbursement for these systems, some hesitance among patients with regards to adopting new technologies, as well as some negative press due to lawsuits or recalls caused by defective products, such as some of Medtronic’s insulin pumps.
Nevertheless, the potential benefits that these systems can provide for diabetic patients are immense and can drastically improve quality of life. As more positive clinical data emerges and these devices become more affordable (and receive reimbursement coverage approval), uptake and penetration will rise in tandem.
This will represent a substantial shift in the insulin delivery market that will favor competitors that are already engaged in developing closed-loop systems, as well as companies that manage to provide novel features and more effective products designs in the future. Moreover, the increasing popularity of these closed-loop systems, and the impending availability of a variety of similar devices, will pose a significant threat to manufacturers of other diabetes care devices, such as patch pumps.
The artificial pancreas is heading nowhere but upwards, and companies that are able to capitalize on the opportunities provided by these technological innovations—be it through specific innovative features, superior clinical data, strategic partnerships, creative solutions to improve patient access, or competitive pricing—will therefore be well-positioned for significant growth in the years to come.
For more information on DRG’s insights into diabetes care device markets, please see our Medtech Solutions. Visit PriceTrack’s homepage to learn more about our SKU-level pricing and analytics tool. For any questions, please contact us at email@example.com.
Diabetes Care Devices
- Omer Farooq Mohiuddin: Research Associate, Medtech Insights - Follow him on LinkedIn
- Immaculate Christina B: Research Associate, Medtech Insights - Follow her on LinkedIn
- Sanketh Kamath: Analyst, Medtech Insights - Follow him on Twitter & LinkedIn
- Zaid Al-Nassir: Analyst, Product Support - Follow him on LinkedIn