The future of insulin: tailored and oral

[admin]

Insulin therapy has evolved in the last century from purified bovine or porcine insulin to biosynthetic human insulin to recombinant human insulin and eventually to recombinant insulin analogs as the 3rd generation of human insulin. The worldwide market of the major human insulin products in 2007 was US$ 10.2 bln. Insulin analogs posted double digit sales growth due to successive replacement (67.5 % of total sales) of 2nd generation human insulin. Three companies dominate the worldwide insulin market, but experience more and more competition in volume sales of insulin by local manufacturers in off-patent countries, especially in China, India and Russia. The first Indian company is conducting clinical trials in the US with its rhu insulin and even plans to develop and launch a biosimilar insulin analog in the Western countries upon patent expiry in 2014. Three companies in off-patent countries have locally produced insulin analogs either in the market or in pre-registration phases.

The next generations of insulin will be “tailored” insulin and oral insulin. Tailored insulin analogs and other long-acting insulins for injection with drug delivery solutions aim at optimized pharmacokinetic profiles in order to avoid hyper- and hypo-glycemic episodes. After the failure of inhaled insulin (only one clinical stage project left), most of the R&D efforts are now made on oral insulin products. The pipeline of oral insulin shows at least seven different oral insulin formulations in clinical development, and at least six in preclinical development. The first oral insulin product is already marketed and in advanced registration in many countries. Further six different projects with non-injectable drug delivery of insulin are in clinical development: intranasal, transdermal and rectal application.