As inflation continues to climb, so too does the higher cost of insulin. American Diabetes Association research reveals a tripling of insulin spending over the past decade, with costs reaching over $22 billion in 2022. This cost surge is partly due to a growing number of patients, however, it’s also driven by escalating prices. From 2017 to 2022, the inflation-adjusted cost of insulin increased by 24%. [1]
Lower-cost insulin is now reaching more Americans, in part due to the implementation of the Inflation Reduction Act. This federal law capped the monthly out-of-pocket cost for insulin at $35. Although the price cap only applied to Medicare beneficiaries, it resulted in a price drop for all patients when major manufacturers such as Eli Lilly, Novo Nordisk, and Sanofi lowered their prices. [2] [3] [4]
Despite these positive developments, a vast majority of available insulin still comes from the three major manufacturers. The 2020 transition of insulin from the drug regulatory pathway to the biologics regulatory pathway set the stage for increased competition by fostering the development of biosimilar insulins. [5] However, alternatives remain limited and other companies have had little success in providing competition up to this point.
New developments in the field of biosimilar insulins are in progress though. Nonprofit drugmaker Civica Rx, for example, has announced plans to commercialize insulin at significantly lower prices. Meanwhile, rBIO, a Houston-based synthetic biology start-up, is using advanced genetic coding processes to synthesize proteins and peptide hormones. Their goal is to reduce the cost of insulin by 30%. [6] [7]
Moreover, states like Washington, Maine, and California have been exploring the possibility of manufacturing their own generic drugs, including insulin. Of these states, California is particularly noteworthy due to its initiative called CalRx. This allows the state to develop, manufacture, and distribute lower-cost generic and biosimilar products, with insulin being the primary focus. [8] [9] [10] [11]
In the near future, competition in the biosimilar insulin market looks set to increase, promising new options for patients. However, currently the options remain tightly controlled by a few key players. Continued progress in this industry will depend on successful regulatory approvals and the impact of potential competitors.