Over the past few years, the adaptability of biosimilars is increasing continuously in US and recent trends are indicating towards the rapid shift of patients from branded biologics to the biosimilar products, which are comparatively cheaper that the parent products. The similar trends are believed to be followed in insulin segment and arrival of first insulin biosimilar in the US market is anticipated to transform the current scenario and this segment will probably overtake a major share of the branded insulin market in near future.
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At present, various branded insulins are available in the market of US, and this region is the current leader of global insulin market. The huge diabetic load of this region is indicating towards the high acceptance of this segment during upcoming years. Recently, Semglee becomes the first FDA approved insulin biosimilar, which is interchangeable to the insulin glargin products including Lantus, Basaglar and Toujeo. During the clinical studies, Semglee demonstrated non-inferior efficacy to the reference product in the treatment of hyperglycemia in patients with type 2 diabetes mellitus and hence it is expected to overtake the major share of its parent products in US.
Semglee is a product of Mylan pharmaceuticals, which is a well-known organisation in the generics and biosimilar market. Lower price of Semglee is believed to act as major factor responsible for shifting of insulin users towards this segment as the price of this interchangeable insulin glargine biosimilar is about 60% less than the branded products. Further, Approval of Semglee is believed to initiate a revolution in the US insulin biosimilar market, which simplifies the path of approval for other investigational biosimilars. During the next 4-5 years, new insulin biosimilars are expected to get approval in US, which will take this market segment to the next level.
With an aim of reducing the dependence over the branded insulin preparation, US diabetes healthcare is focusing to develop more biosimilar insulins and the clinical pipeline of insulin biosimilars are currently involving few advanced biosimilars, which are believed to get approval in the next few years. The radical increase in the number of clinical studies, identification and development, and some other advancement will probably extend the market by a CAGR of more than 100% by the end of 2026 to reach US$ 1 Billion. An important factor that is driving the revenue generation for the market is the balance that has been created by the FDA regarding the availability of the biosimilars in USA market.
The leading pharmaceutical and biotechnological companies including Biocon, HEC pharma, Harvest Moon Pharma, Eli Lily, Boehringer Ingelheim, Sanofi, Wockhardt etc. are currently working for the development of novel biosimilars of insulin and the major focus of these companies is on the development of interchangeable biosimilars, which can entirely replace the branded version. Along with this, the undergoing collaboration and mergers in this segment is also indicating towards the future potential of this market.
The analysis of the market with respect to growing market shifts and increase in the revenue within a short period is estimated to be the result of the increase in the total number of enterprises that believe in developing biosimilars without spending billions of dollars in the research and development process of the cancer drugs as done by the parent company of a respective branded products. In the next few years, the market is estimated to expand in terms of insulin biosimilar availability in the pipeline as well as the entrants interested in the market. Semglee is expected to hold major share in US insulin Biosimilar market during the forecasted period.