Insulin Biosimilars Market Research Report: By Type (Rapid-acting biosimilars, Long-acting biosimilars, Premixed biosimilars) and By Indication (TYPE I DIABETES, TYPE II DIABETES) – Forecast to 2030.

Insulin Biosimilars Market Overview

Insulin Biosimilars Market was valued at USD 2311 Million in 2019 and is expected to register a CAGR of14.80% during the forecast period of 2022 to 2030.

Biosimilar insulin is likely to enter the insulin landscape as patents for major branded insulin products start to expire in the next few years. Biosimilar insulin has the potential to reduce diabetes treatment costs, increase the accessibility of insulin treatment, and expand the number of insulin brands available for those with diabetes. However, they will have to overcome numerous regulatory hurdles, meet a variety of commercial demands, and effectively confront competition from both established and next-generation branded insulin products before they can succeed on the insulin biosimilars market.

According to the International Diabetes Foundation, Diabetes caused 4.2 million deaths and at least 760 billion dollars in health expenditure in 2019 which turns out to be 10% of total spending on adults. This creates a huge demand for insulin biosimilars to treat large diabetic population. 

Market Influencer

Growing diabetic population and increasing preference of biosimilars for reduced treatment costs are expected to propel the insulin biosimilars market.

Insulin Biosimilars Market Drivers

• Manufacturers focusing on clinical trials to introduce insulin biosimilar products in the market are expected to fuel the insulin biosimilars market growth through an increased number of product approvals and launches. For example, LMC Diabetes & Endocrinology Ltd. (Canada) is recruiting volunteers for phase 4 study, “the effects of Soliqua on glucose variability in type 2 diabetes patients among South Asian population”

• The high prevalence of conditions such as type 1, type 2, and gestational diabetes is expected to increase the number of market entrants contributing to the growth of the insulin biosimilars market. According to the National Institute of Diabetes and Digestive and Kidney Diseases, an estimated 30.3 million people in the US have diabetes. An estimated 84.1 million adults aged 18 years or older (33.9 percent of U.S. adults) have prediabetes, according to the National Diabetes Statistics Report, 2017. 23.1 million adults (48.3 percent) ages 65 or older have prediabetes. The prediabetic conditions are expected to raise the number of people at risk of getting diabetic.

• A huge expenditure spent on diabetes is expected to fuel the growth of the insulin biosimilars market. According to the American Diabetes Association’s Economic Costs of Diabetes in the US, the total estimated cost of diagnosed diabetes in 2017 was USD 327 billion, including USD 237 billion in direct medical costs and USD 90 billion in reduced productivity

• Strategic collaborations among leading players to launch innovative products are one of the trends observed in the insulin biosimilars market. For instance, Eli Lilly’s Basaglar (insulin glargine), co-developed with Boehringer Ingelheim, offered at a much lower price compared to its reference brand, Lantus (marketed by Sanofi) is a result of collaborative action

Market Restraints

• The stringent regulatory norms required to gain market authorization for marketing biosimilars is one of the limitations.

Insulin Biosimilars Market Segmentation

By Type

• Rapid-acting biosimilars: This type of insulin is mostly administered within 15 minutes of starting a meal. A rapid-acting insulin is absorbed quickly and begins lowering blood glucose quickly. The rapid-acting biosimilars segment is expected to hold a larger revenue share in the insulin biosimilars market. In the United States, in 2017, more than 30 million people were classified as having type 1 or type 2 diabetes and, of them, approximately 7 million received at least one type of insulin treatment

• Long-acting biosimilars: Long-acting insulin does not peak like rapid-acting insulin. They can control blood sugar for an entire day. The mode of action is similar to the action of insulin normally produced by the pancreas to help control blood sugar levels between meals. The rising preference of this segment can be attributed to its ability for more patients with type 1 diabetes mellitus to reach better glucose targets, with lower hypoglycemia rates and a better quality of life

• Premixed biosimilars: This is a combination of two different types of insulin; one that controls blood sugar at meals and another that controls blood sugar between meals

By Indication

• TYPE I DIABETES: It is a chronic condition in which the pancreas produces little or no insulin. According to the American Diabetes Association, in 2018, 34.2 million Americans, or 10.5% of the population, had diabetes. Nearly 1.6 million Americans have type 1 diabetes, including about 187,000 children and adolescents

• TYPE II DIABETES: People with type 2 diabetes are said to have insulin resistance. Of the 34.2 million adults with diabetes, 26.8 million were diagnosed, and 7.3 million were undiagnosed. According to the Centers for Disease Control and Prevention’s (CDC) National Diabetes Report, 2019, 90 to 95% of people with diabetes in the United States have type II. Just 5% of people have type 1

By Region

• Americas: The Americas are likely to dominate the Insulin Biosimilars Market owing to the presence of major manufacturers, raising awareness, and rising product launches by major players in the region. The increasing patient pool with prediabetic and diabetes is driving the growth of the market in this region. According to the data published in the report Accessing Diabetes Medications - A Pan-Canadian Analysis of Patient Experiences, from 2010 to 2017, the number of Canadians living with diabetes increased by 28.7%. According to Diabetes Canada’s estimates, about 2 million live with diabetes and do not know it, and more than 6 million more are living with prediabetes, placing them at high risk for developing type 2 diabetes

• Europe: The need for insulin biosimilars is high in this region due to the aging population constantly at risk from diabetes. As per Eurostat in 2016, In 2016, 114,400 people in the European Union (EU) died from diabetes, representing over 2% of all deaths

• Asia-Pacific: Asia-Pacific is the fastest-growing regional market for insulin biosimilars. It has the world’s largest population and rapidly developing the healthcare sector. The International Diabetes Federation estimated that more than 60% of the people with diabetes live in Asia, with almost one-half in China and India combined. The Western Pacific, the world’s most populous region, has more than 138.2 million people with diabetes, and the number may rise to 201.8 million by 2035

• Middle East & Africa: It is estimated to account for the least share of the global market due to the limited development of healthcare facilities coupled with a lack of awareness.

Insulin Biosimilars Market Key Players

• Sanofi S.A.


• Boehringer Ingelheim


• Eli Lilly & Co.


• Novo Nordisk A/S


• Biocon


• Merck & Co.


• Mylan N.V.


• Sandoz


• Fresenius Kabi


• Amgen


• others