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The Diabetes Market
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The diabetes market, which includes both pharmaceuticals and medical devices, is large and is growing steadily for four main reasons. First, the prevalence of diabetes is increasing, particularly that of type 2 in developed countries and those with increasing prosperity. Type 1 diabetes is also increasing, though less dramatically. Second, type 2 diabetes is responsive to drug therapy, and there is a continuing search for newer, better pharmacological agents. Third, insulin, required for all cases of type 1 and some of type 2 diabetes, poses administration problems, offering opportunities for new delivery systems. Fourth, patients with diabetes must monitor their condition by frequently checking the level of glucose in their blood, and there are ongoing attempts to make this process easier, less painful and generally more user-friendly by developing more advanced devices (which are also more expensive).
A fifth driving factor in the diabetes marketplace is the search for a fundamentally better way to manage the disease. Some options are mainly surgical; one example comprises pancreatic cell transplants. Another focus of diabetes research is to combine glucose monitoring with insulin administration in a self-controlled wearable device. Further in the future are prospects for using stem cells to grow new beta cells, and for using genetic knockout techniques to block the metabolic processes that cause diabetes.
Diabetes Market Segments
The diabetes market includes both pharmaceutical and medical device elements. The pharmaceutical aspect is further divided between insulin and oral antidiabetic drugs. The device segment is comprised of instruments for diagnosis and monitoring with their attendant consumables, and a range of devices for administering insulin. Some of these devices contain prepackaged insulin, so that they may be regarded as both medical devices and pharmaceuticals. The leading segments in the market for diabetes products are: insulin, blood glucose meters and related supplies (i.e., lancets, test strips), insulin pumps, insulin delivery devices (e.g., syringes, pens), and antidiabetes drugs.
Worldwide Diabetes Products Market, 2010
Source: MedMarket Diligence, LLC; Report #D510
Toward an Artificial Pancreas
The development of stem cell or other cell-based treatment of diabetes, with its potential to restore normal glycemic control in diabetes, is the most important focus of companies with long-term vision in the field of diabetes management. However, in the short-term, the most significant area of development is toward the creation of an “artificial pancreas” — a closed-loop system that provides self-regulated control of blood glucose through continuous blood glucose monitoring and automated insulin infusion.
Although no “closed-loop” system is currently on the market, regulatory approval may feasibly occur within the next year or two. Currently, Medtronic’s Paradigm REAL-Time offers an integrated CGM/pump system, but the insulin infusion rate is patient and/or physician-controlled rather than driven by algorithms or other programming based on the CGM data.
Below are exhibits containing the major insulin pump systems and the continuous blood glucose systems suppliers and developers.
Suppliers and Developers of Insulin Pump Systems
Company Product Regulatory Status Notes
Animas/Johnson & Johnson OneTouch Ping Approved Smallest basal and bolus increments available (0.025 U/hr), includes meter-remote, two-way communication, remote bolus calculator and delivery, wireless (more than 4 feet), waterproof
Asante Solutions, Inc. (formerly M2 Medical) (Unnamed) Filed for FDA 510(k) approval in March 2010, launch planned for 2011 Disposable insulin delivery pump for type 1 diabetics
Cellnovo Cellnovo Launch planned for 2010 First wireless touchscreen handset, compact disposable pump, includes blood glucose meter, food library, activity monitor; data can be sent wirelessly to a secure server for access by patients and physicians from PCs or mobile phones
Insulet/Abbott OmniPod Approved Worlds first tubing-free insulin pump; comprises a watertight Pod worn on the body (injection site) and wireless handheld PDM (Personal Diabetes Manager) with built-in FreeStyle blood glucose meter
Medingo Ltd./Roche Solo MicroPump FDA cleared but not yet available commercially, launch possible in 2012 Tubing-free, detachable, can decrease or increase basal rate in anticipation of certain activities, bolus guide, discreet boluses using either the remote or directly on the MicroPump
Medipacs Inc. (Unnamed) In development A nonmechanical infusion pump based on an expandable polymer
Medtronic MiniMed Paradigm REAL-Time Approved Includes continuous glucose monitoring, wireless transmitter sends information from a glucose sensor to the glucose monitor for readings every 5 minutes, 24 hours a day; users specify the amount of insulin they want the pump to deliver based on the readings and their meals
NiliMEDIX Ltd. Five models in development (ADI, Disposable CSII, Patch CSII, Lighty and LightyDD) ADI was slated to be on market in 1999 ADI model is small and lightweight (82 gm), with air bubble and occlusion detection
Nipro Diabetes Systems Inc. Amigo Approved Multiple basal rate and bolus settings with reminders and alerts for low insulin levels. Also provides pump data download option.
Roche Insulin Delivery Systems, Inc. (formerly Disetronic Medical Systems Inc.) Accu-Chek Approved Small, lightweight, 480 basal doses per day, 315-unit cartridge, includes backup pump, waterproof, waterproof, child lock, bidirectional infrared port to download data to a PC and upload basal rate profiles to the pump, basal insulin delivery every 3 minutes
Smiths Medical Deltec Cozmo Discontinued, pulled from market in 2009 Smiths Medical is withdrawing from the diabetes market
SOOIL Development Co., Ltd. DANA Diabecare IIS and DANA Diabecare IISG Approved Two pump models. The IISG model includes a glucometer
Tandem Diabetes Care Multiple wearable pump types in development In development Company is deep in R&D on pump technology. Company received $52 million financing in January 2010.
Source: MedMarket Diligence, LLC; Report #D510
Suppliers and Developers of Continuous Blood Glucose Monitors
Company Product Key Features Regulatory Status
Abbott FreeStyle Navigator Advanced hypo- and hyperglycenia alarms. Has integrated FreeStyle meter for calibration Approved
AiMedics Pty Ltd. HypoMon Noninvasive, electro-physiological, chest skinbased In development
ArKal Medical (Unnamed) Improved convenience and ease In development
Biorasis Inc. (aka Bio-Orasis) Glucowizzard Implantable sensor In development
Cascade Matrix, Inc. Based on the AutoSampler automated vascular blood sampling system Noninvasive mid-infrared/microfluid Developmental
DexCom, Inc. SEVEN Can be worn up to 7 days Approved
DexCom, Inc. SEVEN PLUS Can be worn up to 7 days. Adds trends, alerts and alarms Approved
Echo Therapeutics (formerly Sontra Medical) Symphony tCGS Noninvasive (needle-free), wireless, transdermal, sonophoresis In pilot trials
GluMetrics, Inc. GluCath Single-use catheter and sensor system for real-time intravenous monitoring of patients glucose; for hospital use In development
Medtronic iPro 2 Professional Disposable glucose sensor. Small automatic data recorder. Small, lightweight, watertight. Allows 288 readings in 24 hour period, uploadable via internet for remote access CE Mark, launched outside the U.S.in June 2010, approval pending in 22 other countries
Medtronic Paradigm REAL-Time Paradigm CGM combined with Minimed pump Approved
Medtronic Guardian REAL-Time CGM only Approved
Menarini GlucoDay S For type 1 and type 2 diabetics Approved in Europe
Roche SCGM1 Glucose measurement at 5 min intervals for up to 4 days. Microdialysis-based measurement Investigational
Ultradian Diagnostics Biologue Wireless, predict and alarm user 20 minutes of a high or low glucose level, calibration-free interface to an insulin pump In development
Source: MedMarket Diligence, LLC; Report #D510
From Report #D510, “Products, Technologies, Markets and Opportunities in Diabetes Management Worldwide, 2009-2018”, July 2010. See http://www.mediligence.com/rpt/rpt-d510.htm.
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