Insulin is a hormone naturally produced by the pancreas that plays a central role in regulating blood sugar levels in the body. For individuals with diabetes, particularly type 1 diabetes, the body either does not produce insulin or does not produce enough, requiring external insulin for survival. This medication transforms a potentially deadly condition into a manageable one, preventing severe complications such as kidney disease, nerve damage, and cardiovascular problems. Its availability is therefore fundamental for millions globally managing their diabetes.
The Discovery and Early Production of Insulin
The discovery of insulin occurred in 1921 at the University of Toronto by a team of researchers. Frederick Banting, Charles Best, James Collip, and John Macleod were instrumental in isolating and purifying this pancreatic extract. Their initial experiments involved extracting insulin from the pancreases of dogs, later progressing to the use of pancreases from pigs and cows. This early animal-derived insulin, though life-saving, presented challenges, including varying purity levels and the potential for allergic reactions or immune responses in patients due to its non-human origin. Despite these issues, the development was revolutionary, and Banting and Macleod were awarded the Nobel Prize in Physiology or Medicine in 1923, which they shared with Best and Collip.
How Insulin Is Made Today
Modern insulin production relies on recombinant DNA technology, a process that began to revolutionize manufacturing in the 1970s and 1980s. This method involves inserting the human insulin gene into the genetic material of microorganisms, typically non-pathogenic bacteria like Escherichia coli or yeast such as Saccharomyces cerevisiae. These genetically engineered microbes then act as “biofactories,” rapidly multiplying in large fermentation tanks and producing human insulin.
After fermentation, the insulin protein is harvested from the microbial cultures and undergoes extensive purification processes to ensure high quality and safety. This modern approach yields human-identical insulin, which significantly reduces the risk of immune reactions seen with animal-sourced insulin. The precision and scalability of recombinant DNA technology allow for the efficient mass production of insulin, meeting the growing global demand.
Leading Global Manufacturers
The global insulin market is largely dominated by three major pharmaceutical companies, often referred to as the “big three”: Eli Lilly and Company, Novo Nordisk A/S, and Sanofi S.A. These companies collectively hold a substantial majority of the global market share, estimated to be between 87% and 99%. Their long-standing involvement and extensive product portfolios have solidified their positions in the market.
Eli Lilly, an American pharmaceutical company, pioneered the first commercially available insulin in 1923 and continues to be a prominent producer with products like Humalog and Humulin. Novo Nordisk, based in Denmark, is recognized for its leadership in diabetes care, offering insulin analogs such as NovoRapid and Levemir. Sanofi, a French multinational company, also maintains a significant presence with various insulin delivery devices and products like Lantus. While these three companies are the primary suppliers, other manufacturers, including Biocon, Bioton, Wockhardt, and Julphar, also contribute to global insulin production, particularly in specific regional markets.
Access to Insulin
Ensuring worldwide access to insulin is a complex undertaking, particularly as over 463 million people globally manage diabetes. The supply chain for insulin involves intricate networks of manufacturers, distributors, pharmacies, and healthcare providers. Maintaining an adequate supply can be challenging due to factors such as fluctuations in demand, the need for strict temperature control during transportation, and diverse regulatory requirements across different countries.
The market’s concentration among a few major manufacturers influences global availability. This structure can impact pricing and the array of insulin types available in various regions, especially in low- and middle-income countries. Affordability remains a significant factor, with many patients in these countries facing high out-of-pocket costs for this life-saving medication. Efforts continue to address these complexities and promote consistent access to insulin for all who require it.