Insulin Biosimilars Market Research Report Information By Type (Rapid-acting biosimilars, Long-acting biosimilars, Premixed biosimilars) and By Indication (TYPE I DIABETES, TYPE II DIABETES) – Forecast to 2032

Insulin Biosimilars Market Summary

As per MRFR Analysis, the global insulin biosimilars market is projected to reach USD 1.68 billion by 2032, growing at a CAGR of 14.6% from 2023 to 2032. The market is driven by the expiration of patents for major branded insulin products, increasing diabetes prevalence, and the rising preference for cost-effective biosimilars. However, regulatory challenges and competition from established insulin products pose significant hurdles. The demand for insulin biosimilars is further fueled by the high economic burden of diabetes treatment, which accounted for USD 760 billion in health expenditure in 2019. Major pharmaceutical companies are investing in R&D to develop biosimilar insulin products, with strategic collaborations enhancing market entry opportunities.

Key Market Trends & Highlights

Key trends influencing the insulin biosimilars market include increasing diabetes prevalence and strategic collaborations among major players.

• Projected market size by 2032: USD 1.68 billion.
• CAGR during 2023-2032: 14.6%.
• Estimated 30.3 million people in the US have diabetes.
• Total estimated cost of diagnosed diabetes in the US in 2017: USD 327 billion.

Market Size & Forecast

Market Size: USD 1.68 billion by 2032

CAGR: 14.6% from 2023 to 2032

Major Players

Sanofi S.A., Boehringer Ingelheim, Eli Lilly & Co., Novo Nordisk A/S, Biocon, Merck & Co., Mylan N.V., Sandoz, Fresenius Kabi, Amgen

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. 

Insulin Biosimilars Market Influencer

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

As patents for main branded insulin products begin to expire within the next few years, biosimilar insulin is likely to enter the insulin market. Biosimilar insulin has the potential to reduce diabetes treatment costs, increase insulin treatment accessibility, and increase the number of insulin brands available to individuals with diabetes.

Before they can succeed on the insulin biosimilars market, they will need to surmount numerous regulatory obstacles, satisfy a variety of commercial demands, and effectively compete with both established and next-generation branded insulin products. Government authorities are progressively approving insulin biosimilars to alleviate the significant financial burden posed by diabetes treatment. In addition, the aging of the global population and the increase in adiposity contribute to the increased risk of chronic diseases.

The market for insulin biosimilars is anticipated to be propelled by a growing diabetic population and a growing preference for biosimilars to reduce treatment costs. Manufacturers emphasizing on clinical trials to introduce biosimilar insulin products to the market are anticipated to fuel the growth of the insulin biosimilars market by increasing the number of product approvals and launches. The high prevalence of conditions such as type 1, type 2, and gestational diabetes is anticipated to increase the number of market entrants driving the expansion of the insulin biosimilars market.

Significant investments are being made by major pharmaceutical and healthcare companies in research and development (R&D) initiatives to develop biosimilar versions of biologics. Research and development has become a crucial growth strategy, resulting in mergers and acquisitions, partnerships, and collaborations between biotech and pharmaceutical companies.

January 2023: Lannett Company, Inc. provided an update on the clinical progression and development of its biosimilar insulin aspart and insulin glargine products in January 2023. The HEC Group of Companies (HEC) is Lannett's strategic alliance partner in the development of both products. In a study comparing Lannett/HEC biosimilar insulin aspart to US NovoLog® (the reference biologic), the company found that the products were highly comparable when administered subcutaneously to animals in equal doses.

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. 

April 2023: The Central Drugs Standard Control Organization (CDSCO) has granted marketing approval to Sanofi (India) 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 inadequately controlled on oral or injectable therapies. Due to the price-sensitive nature of the T2D insulin market, when branded insulins become available in India, they will encounter intense competition from existing insulins and forthcoming biosimilars. 

March 2023: Rezvoglar, an interchangeable insulin glargine biosimilar, will be introduced by Eli Lilly and Company in March 2023 at a 78% discount to the originator (Lantus). In November 2022, Rezvolgar (insulin glargine-aglr) was approved as the fourth biosimilar to receive interchangeability status. It was the second insulin biosimilar to obtain the interchangeability label, following the approval of Semglee (insulin glargine-yfgn) by the FDA in December 2021. In addition to Rezvoglar, Lilly produces Humulin (recombinant human insulin), Humalog (reference insulin lispro), and an unbranded insulin lispro product.

Insulin Biosimilars Market Segment Insights

Insulin Biosimilars Type Insights

• 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

Insulin Biosimilars Indication Insights

• 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

Insulin Biosimilars Regional Insights

• 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

Report Attribute/Metric	Details
Market Size	2032 : USD 1.68 Billion
CAGR	14.6% (2023-2032)
Base Year	2021
Forecast Period	2023-2032
Historical Data	2020
Forecast Units	Value (USD Billion)
Report Coverage	Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
Segments Covered	Type and Indication
Geographies Covered	North America, Europe, Asia-Pacific, and Rest of the World (RoW)
Key Vendors	Sanofi S.A., Boehringer Ingelheim, Eli Lilly & Co., NOVO Nordisk A/S, Biocon, Merck & Co., Mylan N.V., Pfizer Inc., Sandoz, Fresenius Kabi, and others.
Key Market Opportunities	Growing Diabetic Population and Increasing Preference of Biosimilars for Reduced Treatment Costs are expected to propel the Insulin Biosimilars Market.
Key Market Drivers	Manufacturers focusing on clinical trials to introduce Insulin Biosimilar products in the market are expected to fuel the market growth through an increased number of product approvals and launches.   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.   A huge expenditure spent on diabetes is expected to fuel the growth of the Insulin Biosimilars Market.   Strategic collaborations among leading players to launch innovative products are one of the trends observed in the Insulin Biosimilars Market.