Frost & Sullivan estimated the total value of the diabetes care market at $80.2 million in 2016; it is expected to reach $161.69 million in 2022. Read about innovations in therapeutic approaches and research to find a cure.
Diabetes mellitus is a growing concern globally: the number of diabetics is projected to increase from 415 million in 2015 to 642 million in 2040, according to International Diabetes Foundation.
Wellness, diagnosis, monitoring and therapy encompass the diabetes management care continuum. Wellness solutions make patients and at-risk populations aware of the disease so they can make healthy choices and reduce its overall impact on their lives. Diagnosis involves identifying the risk or onset of diabetes, and the complications that may arise if diagnosis is delayed. Monitoring is the constant observation of the disease’s progress to keep it in check and alter therapy accordingly. Therapy is treatment to alleviate symptoms and any complications that arise. Frost & Sullivan estimated the total value of the diabetes care market at $80.2 million in 2016; it is expected to reach $161.69 million in 2022. Therapy held the highest market share: 72.2%. The disease’s increasing prevalence coupled with better technologies to manage it will drive market growth.
Innovations in therapeutic approaches include improvements in insulin and other drugs; oral, injectable, transdermal patch and inhalable delivery mechanisms; novel drug combinations; hospital diabetic management support products; and solutions that address obesity to control diabetes. Research to find a cure, such as by developing an artificial pancreas and cell therapies, also continues. Several innovations are discussed below.
Improvements in Drug Delivery Mechanisms
Massachusetts-based Intarcia Therapeutics’ ITCA 650 is a novel, matchstick-size device delivering exenatide continuously via a DUROS mini-pump system that can be implanted under the skin in the abdomen for treatment of type 2 diabetes. Unlike traditional type 2 diabetes therapy that involves daily medications and possibly injections, this injection-free therapy will require implants only once or twice per year. Intarcia filed for U.S. Food and Drug Administration (FDA) approval in November 2016.
PAQ, developed by Swiss-based CeQur, is an insulin delivery device worn on the abdomen that subcutaneously delivers basal insulin plus on-demand mealtime bolus in 2- unit increments for as long as 3 days. The simple, cost-effective device enables patients with type 2 diabetes to experience the benefits of continuous subcutaneous insulin infusion without the complexity of daily insulin injections. The device is CE approved in Europe and is pending FDA approval. It can be worn during exercise, sleeping, bathing and swimming.
Researchers at the University of North Carolina at Chapel Hill and North Carolina State University are developing a smart patch that is in the prototype stage. It is the first of its kind closed-loop epidermal system that can monitor and non-invasively deliver drugs. A flexible electronic patch senses excess glucose in sweat and automatically administers drugs through microneedles. It can be customized based on a user’s weight or insulin sensitivity.
A drug delivery capsule devised by researchers at MIT and Massachusetts General Hospital, also in early stages of research, holds promise to replace painful injections. It consists of a pill or capsule coated with tiny needles that can inject drugs directly into the lining of the stomach after it is swallowed. When the capsule reaches the desired location in the digestive tract, the pH-sensitive coating surrounding the capsule dissolves and allows the drug to be released through the microneedles.
Novel Drug Combinations
AstraZeneca’s XIGDUO XR reduces and removes glucose with complementary mechanisms of action—hepatic and renal glucose reduction—improving glucose tolerance in patients with type 2 diabetes and lowering both basal and postprandial plasma glucose. It is the first type 2 diabetes drug that combines two anti-hyperglycemic agents (metformin XR and dapagliflozin) in an extended release, once-daily formulation. Novo Nordisk’s Xultophy® combines insulin degludec and liraglutide to provide complementary mechanisms of action to improve glycemic control in patients with Type 2 diabetes. Both products are FDA approved and CE marked.
Hospital Diabetic Management Support Products
Glytec (Greenville, S.C.) provides FDA-cleared insulin and glucose dosing software that allows nurses to take a blood glucose reading, enter it into an e-system or mobile app and get an instant recommendation for proper insulin dosing without the need for a doctor’s intervention. New York-based Admetsys has developed the first artificial pancreas system specifically for the needs of hospital and surgical care. Connected to a patient’s IV line, the system draws blood every few minutes, measures blood glucose levels and returns the blood to the patient along with appropriate dosing of insulin or dextrose sugar. The company has conducted three FDA-approved clinical trials using fully engineered prototype devices. Pivotal trials to support market clearance will begin this year.
Diamond therapy, developed by Metacure (Hamilton, Bermuda) is positioned as an alternative to injectable therapies and is intended to treat obese type 2 diabetics who are resistant to oral medication. It includes a pacemaker-like device implanted in the abdominal skin with electrodes connected to the stomach. The device detects when eating begins and sends gentle pulse signals to stomach muscles to synchronize food intake and natural hormone secretion processes, resulting in lower post-meal glucose levels. The pulse signals also bring about an earlier satiation effect, resulting in sustained weight loss. The device is CE marked.
The artificial pancreas is a system of devices that closely mimic the glucose-regulating function of a healthy pancreas. It monitors glucose levels and automatically adjusts insulin delivery to reduce high blood glucose levels (hyperglycemia) and minimize the incidence of low blood glucose (hypoglycemia) with little or no input from the patient. Medtronic’s MiniMed 670G is the first and the only FDA-approved artificial pancreas. It is a hybrid closed-loop system that requires minimal input: users only need to enter mealtime carbohydrates, accept bolus correction recommendations, and periodically calibrate the sensor. It delivers a variable rate of insulin 24 hours a day based on personalized needs, maximizing the time glucose levels are within the target range. Other companies that are planning to enter this market include Insulet Corporation, Animas Corporation, and start-ups Beta Bionics, TypeZero, Bigfoot Biomedical and Defymed.
Cell therapy technology is touted as a potential cure by introducing functional pancreatic β-cells that sense and respond to normal biological signals into a diabetic. Clinical trials by the Florida-based Diabetes Research Institute have already provided the proof of concept for this approach. Current challenges that hinder wide-scale availability include generating a sufficient supply of insulin-producing cells, acceptance without immune rejection, and finding an optimal site in the body for normal cell functioning.
Neovacs, a French biotech company, is conducting research to determine whether a vaccine can cure diabetes. Increased levels of interferon alpha (IFNα, a cytokine) observed in type 1 diabetes is believed to be responsible for attacking pancreatic cells. The Neovacs approach is to use its IFNα–Kinoid as a vaccine to induce an immune response against IFNα, with the hope of limiting the progression of diabetes. This product is in the phase II clinical trial stage in the United States and Europe.
What’s the Future?
Even though diabetics have more treatment options than ever before, none can reliably end, reverse or cure type 1 and 2 diabetes. The research and development spend is more aligned toward alternative restorative methods. In future, the focus is expected to be mainly on permanent cures, such as improving glucose homeostasis by regeneration of β-cells and islet cell transplantation.
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