The Business of Insulin: A Relationship Between Innovation and Economics

Abstract

Insulin, as a commercial product, is undergoing a substantial metamorphosis from a commodity item to a potential growth vehicle for its manufacturers. This trend has accelerated during the past 5 years with the introduction of a growing number of insulin analogs and novel insulin injection devices. Although this innovation has, of course, been presented as improved medical therapy, the business aspects of the insulin market suggest that the economic rewards are important drivers of these developments. The trends in economic data prophesize that business considerations may enhance the pace of innovation and may lead to the elimination of traditional insulin products in favor of more profitable analogs. Whether the clinical benefits of these trends justify the economic costs should be analyzed. Therefore, a consideration of the trends in the insulin market is clearly in order. From the clinical discovery and widespread application of insulin in the early 1920s, insulin products did not undergo major changes until 1980. Before then, insulin was partially purified from pig or cow pancreases. Much of the commercial insulin sold in the United States had relatively large levels of impurities. Therefore, patients on insulin therapy often developed antibodies to the impurities in the product and to the animal insulin itself.1 In most instances, these antibodies functioned as “blocking antibodies,” which inactivated part of the administered doses and caused reduced glycemic control. In some cases, true allergic reactions occurred from the antigenic process. As the 1980s dawned, two related trends improved the purity and reliability of commercial insulin. The impending release of purified, genetically engineered, biosynthetic human insulin by Eli Lilly and Co. caused the introduction of highly …