United States Insulin Biosimilars Market Poised for Robust Growth 2024-2031 Driven by Rising Diabetes Prevalence, Patent Expirations, Cost-Effective Alternatives, and Expanding Healthcare Access

Insulin Biosimilars Market is valued at a significant CAGR during the forecast period (2024-2031). As per DataM Intelligence Database.

The insulin biosimilars market covers the development, production, and commercialization of biosimilar insulin products that closely mirror existing reference insulins in terms of safety, efficacy, and quality. Biosimilars provide a cost-effective alternative for diabetes management, especially as patents for major insulin brands expire and competition intensifies. This sector is experiencing rapid growth driven by the global spike in diabetes prevalence and expanding healthcare access across regions. Biosimilar insulin types, including rapid-acting, long-acting, and premixed formulations, are utilized to help diabetic patients regulate blood sugar levels. The market continues to evolve with technological advances and regulatory support, presenting opportunities for new entrants and established players

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☛ Insulin Biosimilars Market Recent Developments 2025:

United States: Recent Industry Developments

✅ In July 2025, the U.S. FDA approved Kirsty (insulin aspart-xjhz) as the first interchangeable rapid-acting insulin aspart biosimilar to Novolog, enhancing access to affordable mealtime insulin.

✅ In February 2025, Merilog (insulin-aspart-szjj) was approved as the first rapid-acting insulin biosimilar to Novolog by the FDA, providing an alternative to the reference product for glycemic control.

✅ In March 2025, Biocon Biologics entered into a collaboration with Civica, Inc. to supply insulin aspart drug substance for U.S. manufacture of insulin aspart products, aiming to expand patient access.

Japan: Recent Industry Developments

✅ In January 2025, Novo Nordisk Pharma launched Awiqli (insulin icodec) in Japan, introducing the country's first once-weekly basal insulin for patients requiring insulin therapy.

✅ In July 2016, Biocon's insulin glargine pen (a long-acting basal insulin) was launched in Japan, marking the first biosimilar from India to enter the Japanese insulin biosimilar market.

✅ In 2025, insulin glargine biosimilars in Japan achieved adoption rates exceeding 60% in certain settings, reflecting a high uptake compared to many other biologic classes.

☛ Insulin Biosimilars Market Trends:

The Insulin Biosimilars Market is witnessing robust growth driven by the rising global prevalence of diabetes and the growing demand for affordable treatment options. As patents for major branded insulin products continue to expire, biosimilar manufacturers are gaining opportunities to provide cost-effective alternatives, increasing access for patients in both developed and developing economies. Favorable regulatory frameworks, government initiatives to reduce healthcare expenditure, and the growing burden of type 1 and type 2 diabetes are further fueling market adoption.

Ongoing advancements in biomanufacturing, improved delivery devices, and partnerships between biosimilar developers and pharmaceutical companies are enhancing product availability and acceptance. Increasing physician awareness and patient confidence in biosimilars are also contributing to uptake. However, factors such as stringent approval requirements, pricing pressures, and competition from established insulin brands pose challenges. Despite this, expanding healthcare access in emerging markets and the focus on reducing diabetes-related complications are expected to accelerate market growth in the coming years.

☛ Insulin Biosimilars Market Competitve Landscape:

Boehringer Ingelheim, Pfizer Inc., Biocon, Merck & Co., Eli Lilly & Co., NOVO Nordisk A/S, Sanofi S.A., Ypsomed AG, Amphastar Pharmaceuticals, Inc. and Julphar Gulf Pharmaceutical Industries.

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☛ Segment Covered in the Insulin Biosimilars Market:

By Product: Long Acting Biosimilars | Rapid Acting Biosimilars | Premixed Biosimilars

By Indication: Type 1 Diabetes | Type 2 Diabetes

By Distribution Channel: Hospital Pharmacies | Retail Pharmacies | Online Pharmacies

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☛ Regional Analysis for Insulin Biosimilars Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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