Comment on Grunberger “Insulin Analogs—Are They Worth It? Yes!” Diabetes Care 2014;37:1767–1770 and Davidson “Insulin Analogs—Is There a Compelling Case to Use Them? No!” Diabetes Care 2014;37:1771–1774

We applaud the initiative of Diabetes Care to provide an in-depth discussion on the role of insulin analogs as compared with regular insulins in the treatment of diabetes. Both Grunberger (1) and Davidson (2) present valuable arguments to defend their positions; however, our feeling is that the arguments provided cannot influence, to a large extent, clinicians’ decision about their use as in many parts of the world clinicians have no role in the battle between local regulatory agencies and big pharma. So, if a clinician is convinced about the superiority of any insulin analog over the human insulin counterpart, his or her scientific conviction will remain a devout aspiration simply because that analog is not available for reimbursement. The opposite, i.e., the conviction to use regular insulins over analogs, may be frustrated because human insulins are not available.

Both discussants seem worried about the rising costs of insulin preparations. However, both said nothing about this puzzling data: The U.S. spent $8.3 billion for insulin sales in 2011, against a global insulin market of $16.7 billion (2). According to Diabetes Report Card (3), the U.S. diabetic population was about 21 million at that time, which represents less than 6% of the global diabetic population (estimated 366 million in 2011), while costing 50% of the entire insulin world sales. This should not come as a surprise, as the glargine story is even more compelling. Glargine is one of the top 10 best-selling drugs in the world, with global sales of $6.6 billion in 2012 (4), and the estimated U.S. sales in 2013 are $5.1 billion (5). So, the U.S. diabetic population absorbs 50% of total insulin market and 75% of global glargine market.

We also noted that some data are not up to date, simply because things go faster than supposed. The U.S. insulin sales are said to have been $8.3 billion in 2011 (2); however, they have surpassed $10 billion in 2012 (6), an outstanding $2 billion increase in 1 year only. It is not by chance that the U.S. insulin market is dominated by glargine (6). Again, this should not come as a further surprise. According to the IMS Institute for Healthcare Informatics, the global sales for antidiabetes drugs will be situated between $44–53 billion in 2017 (7).

Eighteen years after the approval of the first analog preparation (lispro) and 14 years after the launch of glargine, the insulin market has completely changed, with regular and NPH insulin treatment visits declining to only 2% and 3% of all treatment visits in the U.S., respectively (6). The story repeats itself with new versus old insulins. With the advent of the new basal insulin analogs (degludec, PEGylated insulin lispro, glargine U300), what is today the new will become soon the old, and we will be called to decide again (8): The perception is that we can only decide about what will become available to clinicians and reimbursable for patients.