What is the “real” market size?

What is the “real” market size?

Yesterday Diabetic Investor outlined some of the obstacles as companies’ push forward developing interconnected patient management systems. As we noted yesterday Diabetic Investor is not opposed to these systems rather we see some hurdles that will make adoption not as easy as everyone thinks it will be.  As often happens in the diabetes device world, many become overly fascinated with the technology and forget there are real people who must actually use these fancy systems each and every day.

Another common mistake made when people become overly fascinated with technology is they forget that diabetes management is also a business and if the company cannot develop a market for this fancy technology then this technology won’t survive.  This is not unlike what’s going on with the quest to develop a closed loop insulin delivery system, perhaps the fanciest technology going. The real question that needs to be asked as companies move forward is – What is the real market size for this fancy technology?

Looking at the various interconnected diabetes management systems it’s pretty clear these systems, at least at this stage, are targeted at insulin using patients. As we noted yesterday insulin using patients test their glucose levels more than non-insulin patients and glucose readings are a critical for these systems to work.  However there is another reason Diabetic Investor believes non-insulin patients will not embrace these new systems, newer drugs that don’t require patients to measure their glucose levels, drugs which are very effective at controlling the patients diabetes.

Specifically Diabetic Investor is talking about GLP-1 therapy which is quickly gaining traction in the marketplace. As Diabetic Investor has outlined on several occasions GLP-1 offers several compelling advantages over insulin therapy not the least of which being simple dosing, little risk of hypoglycemia and no need to monitor glucose levels. Currently there are two FDA GLP-1’s on the market, twice-daily Byetta and once-daily Victoza; these two will soon be joined by once-weekly Bydureon.

Does anyone seriously believe patients using a GLP-1 would have a need for an interconnected diabetes management system?

The same problem presents itself with patients taking oral medications, by far the largest percentage of patients. It’s naïve to believe that these patients, many of whom which don’t even bother to monitor their glucose now will all of sudden start monitoring just because they will have access to a diabetes coach. The reason isn’t that the patients don’t need help, they do. The problem comes in how the patient is being treated.

Assume for a moment that a patient on oral medications actually uses one of these diabetes management systems. Let’s further assume that the patient’s diabetes coach notices that the patient’s glucose levels are out of whack – what happens next? Since the diabetes coach is not a physician more than likely their advice would be to have the patient discuss this situation with their physician.  While it’s possible the physician would change the patient’s therapy regimen, it’s also very possible they would not.

Some may recall the alert Diabetic Investor published back on June 1st, where we discussed the treat to failure approach used by physicians. In that piece we stated;

“What good is it to have advanced therapy options such as Byetta, Victoza®, Lantus and soon Bydureon when they are not prescribed? Diabetic Investor asks this question based on some recent conversations with some regular patients with type 2 diabetes. One example comes from our friends at Healthy Outcomes where a user asked the following question:

“My numbers keep going up and my doctor keeps telling me im eventuly going on insulin i know this but they have been doing this for a year. Im already taking metformin,actos, and gabapentin now he wants to put me on another pill. I was wandering if he is right or should i seek other info this is my pcp that tells me this.”

Another comes from a gentleman who’s A1c has risen from 7.7 to 8.9 who is currently taking Januvia and glyburide. Concerned that his A1c has risen so dramatically, he went to see his physicians who told him to change his diet and lose 12 pounds. Then after 3 months they would recheck his A1c and if there was no improvement they would add metformin to his therapy regimen.

Unfortunately these two examples are commonplace in the real world, where nearly 80% of patients are being treated by a primary care physician (PCP). PCP’s who lack the time and infrastructure to properly educate their patients and in the face of overwhelming evidence that their patients with diabetes should be treated more aggressively, remain stuck in the death spiral known as treat to failure.”

Although the patient’s diabetes coach is giving some very good advice in the real world that good advice may fall on deaf ears when the patient actually meets with their physician to discuss their situation. Why then would the patient continue using the system when their physician does not support the advice given by their coach?

Another issue with non-insulin patient is that therapy non-compliance is not the only reason a patient would see out of whack glucose numbers. As we have noted previously there are numerous factors that go into a patient’s numbers, factors like diet, stress, etc.  In the real world you can have a patient who takes their pills as prescribed yet still has numbers outside the norm.

While there will be a minority of non-insulin using patients who would embrace an interconnected system, this group is not large enough to support an ongoing business.

This leaves insulin using patients as the most likely target for an interconnected system, more specifically patients who follow multiple daily injection (MDI) therapy. Patients using insulin plus orals will have the same issues as patients on orals alone, in that they would need a physician intervention before making any changes to therapy regimen.  MDI patients on the other hand can make immediate adjustments based on the advice of their diabetes coach. This of course assumes the patient actually follows the advice of their coach.

The reality here is that there is nothing wrong with interconnected patient management systems; the problem as always is getting the patient to embrace these systems. As we have seen before just because whiz technology is made available does not mean that patients will embrace this technology. The problem isn’t with the technology; the problem is engaging the patient.

It’s equally important to remember that diabetes is not just a chronic disease, it is also a lifestyle; a lifestyle which requires a huge amount of patient interaction to achieve better outcomes.  This is why drugs like Byetta, Victoza and soon Bydureon have such vast potential as they fit easily into the patient’s lifestyle and do not add to their burden. This is also the reason insulin companies are working so hard to develop even longer acting insulin’s, they know the less times a patient needs to take their insulin the better.

Yes it is true that interconnected systems have potential, yet is also true that these systems add to the patient’s burden. Basically these companies are asking patients to make short term sacrifices for the possibility of long term gains.  This in essence is the same problem that has plagued diabetes management for years, given the importance of patient engagement with their diabetes, how can we effectively get the patient engaged with their diabetes so they do the many things necessary to achieve better outcomes.

Technology can help, but it is not the only answer, especially if the patient does not embrace the technology.