By Nathan Cohen - ncohen@frost.com

Background – Medical studies

Recent studies on the benefit of tight glycemic control (TGC) in acute care settings have unveiled a tremendous untapped growth opportunity in the glucose monitoring market.  For decades, physicians have pushed the benefits of self-glucose monitoring for diabetes management, but another opportunity for glucose management was generally overlooked.  According to a now famous medical study by a Belgian physician, Greet Van den Berghe, maintaining blood glucose between 80 and 110 mg/dl with insulin infusions for all patients admitted to the ICU can reduce ICU mortality by over 40 percent, and inpatient mortality by 34 percent.  Tremendous benefits were also shown for decreasing the rate of acute renal failure, septicemia, and polyneuropathy.  Basically, not only were patient deaths dramatically minimized, but also common complications such as sepsis and organ failure were also drastically reduced.  Similar TGC clinical studies were implemented across the globe that verified these results, and a range of protocols have now been innovated to guide a hospital’s implementation of TGC programs.

Emerging Market, Emerging Leaders

At this point, medical acceptance of tight glycemic control programs is growing rapidly, but the implementation in hospitals is just beginning.  Many hospitals have implemented some form of glycemic control, but the market expansion is only just beginning.  As such, several of the major competitors in the glucose monitoring market are gearing up to drive this movement forward while increasing their penetration of this new market space.  Among the leaders are J&J’s Lifescan and Abbott Diabetes Care, both of which are heavily marketing and launching point-of-care focused products.  Some of the new clinically focused products are able to incorporate patient identification and data uploads, which facilitates accurate and efficient care.  With an estimated 6,000 ICU’s in the U.S. managing roughly 55,000 patients per day, an hourly glucose check on all patients would create a sizeable new market opportunity.

Are Finger-pricks Enough?

With the emergence of this new market for glucose monitoring, many now wonder if finger-prick technology is sufficient to address the needs a tight glycemic control program.  There are positives and negatives related to existing products that must be considered.  On the positive side, meters and strips are cheap.  The market for glucose monitoring products is consumer- and reimbursement-focused, so prices have been minimized.  The inexpensive technology facilitates experimentation by ICUs and supports widespread adoption.  Additionally, current products have significantly reduced the amount of blood needed for accurate measurements, which minimizes pain.  Despite these advantages, meters and strips also have several vital shortcomings.  The primary challenge is workflow.  Finger-prick measurements must be administered as a multi-step process for every patient measurement, and this data must be incorporated into a protocol for adjusting the insulin infusion that controls blood glucose.  This process is time consuming for nurses, potentially error prone for non-digital protocols, and the acceptable frequency of testing based on nurse workload may be insufficient for truly ‘tight’ glycemic control.  Patients may also be at increased risk.  With a frequency of testing of one measurement every hour or even every half-hour, an increase in insulin flow could drive a patient into hypoglycemia before a follow-up glucose measurement is taken.  These limitations of finger-prick technology are currently restraining the market’s growth despite the tremendous demand, and industry leaders are looking for a solution.

What is the Solution, and Where Will it Come From? 

If current technology is unable to solve the demand for tight glycemic control, then emerging technology developments, such as continuous glucose monitors, will have to fill this gap. Among the dozens of developing technologies from startup companies and market giants, several products are already being targeted to critical care environments.  Medtronic Minimed’s Guardian RT product has a leg up on the market being the only FDA-approved real time continuous glucose monitor, though its focus is more directed at consumer care.  Ultimately, any technology that is able to monitor patients automatically and at a higher frequency then meters and strips will likely suffice, as the key determinant may be workflow optimization.  On the horizon are continuous invasive, semi-invasive, minimally-invasive, and non-invasive technologies, but all have been experiencing a series of delays and only two companies have successfully brought emerging technologies to the U.S. market, and each were of limited success.  Despite the delays and string of failed attempts, the emergence of the ICU as a budding glucose monitoring market may create an ideal opportunity for a novel monitoring technology.
 
The ICU as a Technology Incubator

For a number of reasons, Frost & Sullivan believes that the acute care environment may provide an advantageous launching point for emerging continuous and non-invasive devices.  The ICU is currently an untapped market with constrained demand, which creates an ideal condition for rapid market adoption.  With a high level of demand based on the need for improved workflow, the cost tolerance for an effective product is higher in the ICU than in consumer markets.  Certainly, cost must be kept at a minimum in order to drive the expansion of tight glycemic control programs, but a higher-priced continuous monitor may ultimately cost a hospital less after considering the saved man-hours and increased impact on patient safety.  Within an ICU, a new technology can also be bulky and unattractive, as appearance and portability are of much less importance than in ambulatory consumer care environments.  As such, a first generation product that has not been optimized to “cell-phone size” may find its market opportunity limited to an ICU-type environment.  Finally, a tremendous benefit of launching a technology in the ICU is the implication for driving clinical support of the device.  The most effective marketing tool in the glucose monitoring market is the support of a physician who guides a patient’s diabetes management.  By launching a new technology in a medical setting, a company can rapidly build a customer base of healthcare professionals, which in turn will aid in driving consumer acceptance.