Insulin Biosimilars Market - Size, Share, Outlook 2026

Diabetes is a group of metabolic disease characterized by high blood sugar level due to inadequate secretion of insulin. Common symptoms of diabetes include increased hunger, tiredness, weight loss, and excessive thirst and urination. The prevalence of diabetes is increasing, in turn, boosting demand for insulin biosimilar. For instance, according the World Health Organization (WHO) report in 2014, globally around 422 million adults were living with diabetes and 1.5 million people died due to the disease in 2012. Insulin biosimilar has the ability to increase access to treatment of diabetes mellitus among the patients while reducing treatment costs.

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Biosimilar is a medicine developed on the original biological reference product. The production process of biopharmaceuticals vary from one manufacturer to another, thus every biosimilar product is unique from the other. Biosimilar manufactures use different culture conditions, master cell lines, purification techniques, and raw materials. This in turn, helps meet the rising prevalence of diabetes due to inadequate healthcare services, rising prevalence of obesity, For instance, According to 2013 American Society For Metabolic And Bariatric Surgery report, obesity was a major independent risk factor for developing the disease, and more than 90% of type 2 diabetics population are overweight or obese due to growing adoption of unhealthy lifestyle. Insulin is distributed and manufactured by small number of multinational companies in emerging economies, beyond the established biosimilar manufactures, and a handful of small players are developing insulin manufacturing capacities based on modern biotechnological methods in turn, boosting growth of the insulin biosimilars market size.

Insulin Biosimilars Market – Dynamics

Increasing number of manufacturers are developing biosimilar insulin to provide clinical aid that are similar to current insulin analogs at the more affordable price. Moreover, the patents of several insulin manufacturing companies are soon expected to lose patent protection, For instance, LEVEMIR an Insulin detemir by Novo Nordisk is going to lose its patent rights in year 2019, which is influencing numerous pharmaceutical key manufacturers to develop alternatives to patents, referred as biosimilar. The low cost of biosimilar insulin for diabetes treatment and effectiveness is helping treat patients suffering from diabetes mellitus. Companies are also focusing on developing medical devices that allows for less painful and safe delivery of the biosimilar insulin treatment, which in turn, is boosting market growth. Government agencies are focusing on the endorsement of insulin biosimilar by funding research and development. Furthermore, rising geriatric population across the globe and increasing demand for rapid-acting insulin analogues is boosting growth of the insulin biosimilar market. For instance, according to a consensus report published in 2012 American Diabetes Association, showed over 25% of the U.S. population aged ≥65 years suffered from diabetes.

However, critical regulatory requirements for approval of insulin biosimilar products besides strong opposition from branded manufactures regarding patent rights, high cost of production, manufacturing complexities, and various safety concerns associated with changes in drug formulations pose as factors hampering growth of the insulin biosimilars market.

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Insulin Biosimilars Market – Regional Insights

On the basis of region, the global insulin biosimilars market is segmented into North America, Europe, Latin America, Asia Pacific, Middle East, and Africa. North America leads the global insulin biosimilar market, owing to rising geriatric population and high prevalence of diabetes-related disorders in the region. Moreover, government support for diabetes-free states is accelerating growth of the insulin biosimilar market in North America. For instance, Centers for Disease Control and Prevention (CDC) runs a National Diabetes Prevention Program in various U.S states.

The market in Europe accounts for the second-leading share in the global market, mainly due to increasing number of primary approvals for biosimilar insulin. For example, European Commission (EC) approved Mylan and Biocon’s biosimilar insulin—Glargine—for treating diabetes on March 27, 2018. Asia Pacific market is expected to gain significant traction over the forecast period due to increasing government support, improving healthcare conditions and growing diabetes incidence in the region. For instance, 2011 World Health Organization report shows that diabetes deaths will double between 20011 and 2030.

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