Can the Type 2 market be saved?

Can the Type 2 market be saved?

This Friday, January 27th, 2012, could well be a watershed day for patients with Type 2 diabetes, as this is when the FDA is supposed to render their decision on Bydureon, the once-weekly GLP-1 from Amylin (NASDAQ:AMLN).  While Bydureon is no wonder drug it does have the potential to forever alter how type 2 diabetes is treated and its impact will be felt well beyond the GLP-1 market. As Diabetic Investor has noted before the Bydureon launch will adversely impact insulin sales, both short and long-acting, as well as sales of glucose test strips.

It is this last market Diabetic Investor will examine today as just last week yet another study was published indicating that non-insulin using patients did not achieve better outcomes even when they regularly monitored their glucose levels. It is also well known that one of the biggest benefits of GLP-1 therapy is patients do not need to regularly monitor their glucose levels nor do they need this information to properly dose their GLP-1. Unlike insulin using patients who use their glucose levels to determine how much insulin to take, GLP-1’s come with fixed dosing.

Yet an argument can be made that non-insulin patients should actually be monitoring their glucose levels at least as frequently as insulin users, if not more frequently. In fact, one could make a very strong argument that non-insulin using patients should be using a continuous glucose monitoring system on a regular basis.  The fact that numerous studies have concluded that non-insulin using patients do not benefit from regular glucose monitoring does not mean regular monitoring has no benefits, rather Diabetic Investor believes these studies ignore the very real situation that these patients have never been educated as to what these numbers mean and more importantly; how to use them to help them more effectively manage their diabetes.

Too often physicians and patients rely solely on HbA1c readings to measure whether or not the patient’s diabetes is being properly controlled. Regular glucose readings would give the patient advanced notice whether or not their therapy regimen is working and could indicate that the patient needs to move to the next phase of diabetes management. As diabetes researchers consistently note the more aggressively they treat the disease the greater the chances the patient will avoid many of the complications associated with poorly controlled diabetes.  The simple fact is in the real world these patients are not checking even their HbA1c levels regularly and are basically clueless when it comes to knowing how they are doing. This is like a pilot flying blind through the Swiss Alps in adverse weather conditions, while it’s possible they may land the plane safely the chances for error increase dramatically when the pilot has no idea where he’s been or where he’s going.

The problem as Diabetic Investor sees it is that the major glucose monitoring companies basically destroyed the market when they failed to recognize the differences between insulin and non-insulin using patients. Today we have a host of meters that are designed to help insulin users more effectively dose their insulin yet we have no meters, not one, specifically designed for the non-insulin using patient population which just so happens is the largest segment of the diabetes market. While these patients may not use the same number of test strips per day, they out-number insulin using patients by wide margin. By most estimates there are 4.5 million insulin using patients in the US compared to 16 or 17 million non-insulin using patients. Think of what it would mean to a BGM company if they could capture 30% of the non-insulin using patient population and get them to test on average twice a day. What we’re talking about here is an additional 3.5 BILLION test strips sold each year. Now Diabetic Investor may not be the sharpest knife in the kitchen but that seems like enough strips to make this market worth chasing.

Will someone please explain to Diabetic Investor why none of the major BGM companies have bothered to think out of the box and take one of their meters and reposition it as meter for non-insulin using patients? The explanation is actually obvious as these companies have become enamored with insulin using patients, believe the non-insulin patients are a lost cause and have opened the door to any company who has a fresh approach.

One such company could be Intuity Medical and their all-in-one meter called the Pogo. While Intuity insists insulin using patients will use the Pogo, Diabetic Investor sees a great opportunity with non-insulin using patients. Like all patients with diabetes and non-insulin using are no different, one of the biggest issues patients have is all the stuff they need to carry around so they can properly manage their diabetes. Even with non-insulin using patients this task can be burdensome as they not have insulin to carry around but they must constantly worry if they have their pills with them. Basically the Pogo has made testing easy as the patient doesn’t have to worry about carrying around all the testing supplies as it’s in one nice neat little package.

TelCare is another company who could capture a share of this market as their meter has the ability to deliver messages to patients and Diabetic Investor believes constant positive reinforcement will do more for increasing testing frequency than pretty colors, fast test results or small blood sample sizes. Think of the positive impact it would have on the patient if after testing the meter said Thank You or Good Job. Or what about using a color code instead of a number, green for good, red for danger and yellow for caution, now this may not be what the physician or educator wants but Diabetic Investor is almost positive that any patient would understand that it’s better to see more green zone readings than red zone readings.

The simple fact is that it will be more difficult to reach this segment of the market but by no means does it mean this market segment is not worth pursuing. It would be a mistake to assume that the many newcomers in this space will ignore non-insulin patients and concentrate solely on insulin using patients. Several of these newcomers could use their vast capital resources and go after this market segment, a segment that frankly is anxiously waiting for any company to understand and cater to their needs. However, with everyone else chasing the insulin user going after the non-insulin user could allow them to gain some valuable share points.

So in answer to our original question; can this market be saved- the answer is yes IF companies are willing to think out of the box, invest for the long term and understand that diabetes is not a one size fits all disease state. Diabetic Investor further believes this is just one more reason the old guard doesn’t stand a chance against the many newcomers in the market. They can’t or won’t think out of the box, they aren’t in it for the long term and even after all these years in the market they still don’t understand the differences between patients. They see the BGM world as the lone domain of insulin users and like a horse with blinders they don’t see whose gaining on them.