Sanofi Soliqua to face fierce competition in Indian T2D insulin market: GlobalData

Sanofi (India) has recently received marketing approval from the Central Drugs Standard Control Organization (CDSCO) for soliqua (insulin glargine and lixisenatide recombinant fixed-dose combination) as an adjunct to diet and exercise in adults with obesity and type 2 diabetes (T2D), who are insufficiently controlled on oral or injectable therapies. As branded insulins become available in India, they will face fierce competition from the existing insulins and upcoming biosimilars, due to the price-sensitive nature of the T2D insulin market, says GlobalData.

According to GlobalData’s Pharma Intelligence Center, there were 80.1 million diagnosed prevalent cases of T2D in India in 2022. The current pipeline of T2D market in India includes only one innovator insulin, i.e., Biocon’s oral insulin tregopil, which is in Phase III and there are four biosimilar insulins in various stages of clinical development.

Notably, oral insulin is expected to increase patient compliance and reduce the cost of insulin significantly, therefore, it could change the overall market dynamics if trials are successful.

Anupama Mishra, Pharma Analyst at GlobalData, comments, “India’s T2D insulin market is dominated by multinational pharma companies such as Novo Nordisk and Sanofi. Currently, there are 15 insulin formulations marketed in India for T2D and type 1 diabetes. The recently launched Soliqua will provide stiff competition to the existing insulin brands. In addition, several biosimilar insulins are currently in the pipeline for T2D treatment in India, and they are expected to pose a significant threat to the leading branded insulins’ market share due to their lower cost. Hence, there is a need for branded insulins to differentiate themselves in terms of the ease of administration or create affordable pricing alternatives to gain market share in the price-sensitive market.”

Soliqua is administered once daily as pre-filled pens in a fixed-ratio combination (10–40 and 30–60) of insulin glargine and lixisenatide. Reportedly, soliqua was able to demonstrate weight benefit and less hypoglycaemia, when compared with twice daily premixed insulin in the global Solimix study, which included Indian patients.

Mishra concludes, “As the middle class in India experiences a surge in disposable income and T2D awareness continues to rise, it is expected that patients will prefer effective branded insulins. Nevertheless, branded insulin products are likely to encounter market access obstacles, and thus, they must be priced reasonably to penetrate deeper into this price-sensitive market.”