The Future of the Insulin Market – This is getting interesting
This morning Sanofi-Aventis (NYSE:SNY) announced third quarter results, while at the same time Novo Nordisk (NYSE:NVO) was providing an analyst update. What both presentations have in common is they provided some insight into the future direction of the insulin market, a market that will be invigorated by the new treatment guidelines issued by the ADA/EASD.
As everyone knows diabetes is growing at epidemic rates worldwide. According to the most recent issue of the Diabetes Atlas the number of patients with diabetes will grow from 246 million in 2007 to 380 million by 2025. Given the increased emphasis on tighter glycemic control and the proven benefits of insulin therapy, physicians are increasingly initiating insulin therapy sooner in the treatment regimen in particular for the largest market segment patients with type 2 diabetes.
Many falsely assumed that physicians would shy away from insulin therapy for their type 2 patients fearing that patients would be non-compliant with an injectable therapy option. They further assumed that physicians would have the added burden of properly training patients on insulin usage. The major concern wasn’t that insulin therapy was ineffective rather insulin usages comes with one major drawback, hypoglycemia.
The success of Lantus, from Sanofi-Aventis, the first long acting insulin analogue which has become the world’s number one selling insulin largely disproved these false assumptions. With its long-acting profile physicians began prescribing Lantus to their type 2 patients to be used in conjunction with oral medications. Physicians quickly learned something Diabetic Investor has been stating for some time, the less frequent a therapy needs to be administered the greater patient compliance will be. Being a 24 hour insulin Lantus fit nicely into this new treatment regimen as patients only needed to inject once each day. Even more astonishing for Lantus was the fact when it was it first introduced it did not come with an easy to use delivery device, a problem that has since been corrected with the introduction of the SoloStar® insulin pen.
Already the market leader when it came to insulin delivery devices Novo Nordisk jumped into the long acting insulin market with the introduction of Levemir. Novo has long understood the value of patient friendly insulin delivery systems and a great deal of their success is due to their superior delivery systems. Novo is now developing two new insulin’s which take this concept of less frequent dosing and convenient delivery systems to another level. Currently moving into Phase 3 trials are NN5401 and NN1250. According to Novo both compounds offer a potential duration of action beyond 24 hours, meaning it’s possible instead of injecting once daily a patient could inject just three times a week.
For their part Lilly (NYSE:LLY) has reinforced this emphasis on more patient delivery systems as they have completely revamped their portfolio of insulin pens. While Lilly is also investigating newer insulin’s they are once again well behind both Novo and Sanofi-Aventis. However, Lilly is well ahead of both Novo and Sanofi when it comes to long-acting GLP-1 therapy options. Partnered with Amylin (NASDAQ:AMLN) on the long-acting once-a-week version of Byetta, Lilly sees the paradigm shifting potential of a therapy option that is injected just once weekly. Besides this convenient dosing profile Byetta LAR has proven glucose lowering capabilities, promotes patient weight loss and best of all a very low incidence of hypoglycemia. Byetta LAR also offers a hidden benefit with its fixed dosing schedule as patients do not need to monitor their glucose levels prior to injecting.
It’s well known that patients with type 2 diabetes are some of the least frequent testers of glucose levels. A potentially dangerous scenario as an over-administration of insulin leads directly to hypoglycemia. Because GLP-1’s only work in the presence of glucose there is no need for the patient to consistently monitor their levels.
This is the reason Novo along with Roche have jumped onto the GLP-1 bandwagon. When it comes to therapy compliance GLP-1 is the big winner on all fronts. Unlike patients new to insulin therapy who need a high degree of education, GLP-1 education is rather rudimentary. Granted not every type 2 patient is a candidate for GLP-1 therapy, physicians are anxiously awaiting the arrival of Byetta LAR.
The bottom line here is really quite simple to increase therapy compliance less frequent dosing combined with a patient friendly delivery device will be the big winner. It’s fair to state that going forward we can no longer analyze the insulin market without assessing the impact of GLP-1 therapies. Based on the current landscape Diabetic Investor remains convinced this battle will come down to Novo and Lilly. Sanofi will continue to be a player in the insulin market but without a GLP-1 it’s seeing them being a factor over the long term. While Lilly lacks the board insulin portfolio that Novo has, Byetta LAR is superior to Novo’s current crop of GLP-1 offerings.
All three companies are bulking up to do battle by expanding their sales forces and are gathering huge amounts of clinical data for ammunition. This is getting quite interesting.