Antidiabetic biosimilars market overview
Antidiabetic medications are prescribed to regulate blood glucose levels in individuals with diabetes. These medications can be classified into various types including biguanides, thiazolidinediones, DPP-IV inhibitors, α-glucosidase inhibitors, sulfonylureas, insulin, and GLP-1 receptor agonists such as exenatide. Biosimilar products are biological products that are approved based on their high similarity to an FDA-approved reference product. To demonstrate therapeutic equivalence to the reference product, biosimilar manufacturers must provide laboratory and clinical data.
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Patent expirations will fuel the global market for antidiabetic biosimilars.
The global market for antidiabetic biosimilars is being propelled by the increasing number of people suffering from diabetes mellitus worldwide. According to the World Health Organization (WHO), the number of people affected by diabetes reached 422 million in 2014, and the global prevalence of diabetes among adults over 18 years of age increased from 4.7% in 1980 to 8.5% in 2014. The rising incidence of lifestyle disorders such as obesity increases the risk of diabetes and drives the growth of the antidiabetic biosimilars market. The authorization of the first biosimilar of insulin Glargine, Abasaglar, by the European Medicines Agency in June 2014 for the treatment of diabetes mellitus, followed by U.S. FDA approval in 2016, is expected to boost the growth of the antidiabetic biosimilars market.
Additionally, the expiry of patents for insulin aspart and insulin lispro is projected to drive growth in the antidiabetic biosimilars market. Biosimilar insulin products have the potential to reduce the cost of diabetes treatment, improve the accessibility of insulin treatment, and expand the number of insulin brands available. Currently, there are several antidiabetic biosimilars that have been approved or are in the approval process.
Constraints for growth of the antidiabetic biosimilars market
In order to enter major markets such as the U.S., biosimilars will have to meet strict regulatory requirements, with a particular focus on their production. Although biosimilars have made a successful entry into European markets, gaining entry into the U.S. market still presents a challenge due to the stringent regulatory norms. Additionally, in order to gain market traction, biosimilars will need to secure favorable reimbursement.
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Global demand for antidiabetic biosimilars is being driven by an increase in the number of diabetes patients.
The market for antidiabetic biosimilars is expected to grow due to the rising incidence of diabetes, the complexity of alternative diabetic therapies, and government incentives for the introduction of low-cost therapies. According to the International Diabetes Federation (IDF), Europe had around 59.8 million diabetic patients in 2015. The Asia Pacific region is also expected to be a high-growth market for antidiabetic biosimilars in the near future due to increasing research activities related to antidiabetic products and supportive government funding. The North American region is projected to be a profitable market for antidiabetic biosimilars due to the increasing prevalence of diabetes in this region. According to the International Diabetes Federation, over 29.1 million people in the U.S. suffered from diabetes in 2015.
- To gain a competitive edge in the market, major companies are implementing various business strategies, including product launches. For example, GC Pharma launched Biocon’s Glargia in November 2018, which is a long-acting insulin that provides a daily dose with just one injection.
- Key players in the market are employing different business strategies, such as obtaining product approvals from regulatory authorities, to improve their market presence. In March 2018, GC Pharma received approval for Glargia Prefilled Pen from the Ministry of Food and Drug Safety in South Korea.
- Major companies are using product launches as a business strategy to stay ahead in the market. For instance, Biocon and Mylan jointly launched the biosimilar insulin Glargine in the U.K. under the brand name ‘Semglee’ in November 2018.
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