Insulin biosimilars Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Rapid Acting biosimilars, Long Acting biosimilars, Premixed Acting biosimilars), By Disease Indication Type (Type I Diabetes, Type II Diabetes), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), By End user (Hospitals, Ambulatory Surgical Centers, Others), By Region and Competition, 2020-2030F

Market Overview

The Global Insulin biosimilars Market, valued at USD 1.55 Billion in 2024, is projected to experience a CAGR of 7.30% to reach USD 2.37 Billion by 2030. Insulin biosimilars are biological medicines highly similar to an already approved reference insulin product, demonstrating comparable quality, safety, and efficacy, though not being exact copies due to their inherent biological complexity. The global insulin biosimilars market is primarily supported by the expiration of patents for major branded insulin products, facilitating market entry for biosimilar alternatives. Concurrently, the increasing global prevalence of diabetes drives consistent demand for insulin therapies, alongside a growing imperative for cost-effective treatment options to mitigate healthcare expenditure.

Market penetration by biosimilars demonstrates evolving dynamics; according to the Biosimilars Council, in Q1 2023, branded insulin retained nearly 80% of total prescription volume, while in March 2022, Semglee and unbranded Insulin Glargine together achieved 9% market share in Medicare. A significant challenge that could impede market expansion is the stringent and complex regulatory approval pathway, which necessitates extensive clinical data to confirm high similarity, adding substantial development costs and timelines.

Key Market Drivers

The increasing global burden of diabetes stands as a fundamental driver for the insulin biosimilars market. As more individuals are diagnosed with diabetes worldwide, the demand for insulin therapies inherently expands, necessitating a broader and more accessible supply of treatment options. This chronic condition requires lifelong management, ensuring a continuous and growing patient pool reliant on insulin. According to the International Diabetes Federation, December 2023, IDF Diabetes Atlas 11th Edition, approximately 589 million adults globally were living with diabetes, a number projected to reach 853 million by 2050. This significant rise in patient numbers directly translates into an escalating need for insulin, positioning biosimilars as a crucial avenue for meeting this increasing demand sustainably and cost-effectively.

The expiration of key branded insulin patents represents another pivotal catalyst for the growth of the insulin biosimilars market. Once patent protection lapses for originator insulin products, it opens the door for other manufacturers to develop and introduce biosimilar versions. This process fosters competition, which typically leads to lower prices and increased market access, especially in regions where treatment affordability is a significant concern. According to Eli Lilly and Company, February 2024, "Lilly Commits $100 Million to Increase Access to Affordable Insulin," the company announced a $100 million commitment to further increase access to affordable insulin options, reflecting the strategic response to evolving market dynamics post-patent expiries. This influx of biosimilar options is poised to expand market accessibility significantly; according to the World Health Organization, November 2023, "WHO statement on insulin use and biosimilar insulins," insulin costs are a major barrier, with biosimilars playing a critical role in increasing availability and affordability, potentially reducing treatment costs by 15-35%.

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Key Market Challenges

The stringent and complex regulatory approval pathway represents a significant impediment to the growth of the global insulin biosimilars market. This pathway demands extensive clinical data to confirm high similarity to reference products, which escalates development costs and extends timelines for market entry. The substantial investment required to navigate these rigorous processes directly deters potential manufacturers from initiating or continuing biosimilar development.

This challenge is clearly reflected in the limited pipeline for future biosimilar competition. According to the Biosimilars Council, in 2024, over 80 percent of brand biologics eligible for competition did not have biosimilars in development, illustrating a considerable gap in market readiness. Furthermore, projections from the Association for Accessible Medicines indicate that of the 118 biologics anticipated to lose patent exclusivity by 2034, only 12 currently have biosimilar development programs underway. Such high barriers to entry restrict the availability of new insulin biosimilar options, thereby limiting market competition and slowing overall segment expansion.

Key Market Trends

Advancements in interchangeability designations significantly impact insulin biosimilar adoption by streamlining pharmacy-level substitution. This regulatory status allows pharmacists to dispense an interchangeable biosimilar for its reference product without prior physician approval, subject to state laws. Such a designation builds confidence among healthcare providers and patients regarding comparable safety and efficacy, facilitating broader market acceptance. According to a study published in JAMA in April 2025, the market share for insulin glargine-yfgn, an interchangeable biosimilar, increased by 7.03 percentage points in states with less restrictive substitution laws compared to more restrictive ones after its launch. This demonstrates interchangeability's direct influence on market penetration, accelerating access to affordable insulin therapies.

The expansion of biosimilar insulin product portfolio diversity is a pivotal trend, addressing varied patient needs beyond long-acting formulations. This involves introducing biosimilars for different insulin types, offering a wider array of therapeutic options. Historically, biosimilar availability focused primarily on long-acting insulin analogs, limiting patient choices. In a notable development illustrating this trend, Sanofi-Aventis' Merilog (insulin-aspart-szjj) was approved by the U. S. Food and Drug Administration in February 2025 as the first rapid-acting insulin biosimilar to Novolog (insulin aspart), marking the third overall insulin biosimilar product approved by the agency. This diversification supports comprehensive diabetes management by providing cost-effective alternatives across the full spectrum of insulin therapy.

Segmental Insights

The rapid-acting biosimilars segment is experiencing the most significant growth within the Global Insulin Biosimilars Market. This accelerated expansion is primarily driven by the increasing global prevalence of diabetes and the critical need for effective postprandial glucose control, which rapid-acting insulins address. Furthermore, the expiration of patents for various originator rapid-acting insulin products has opened avenues for the introduction of more affordable biosimilar versions, significantly enhancing patient access and potentially reducing overall healthcare expenditures. Supporting this growth, regulatory bodies like the European Medicines Agency and the U. S. Food and Drug Administration have established clear approval pathways for insulin biosimilars, promoting competition and facilitating the timely availability of these essential therapeutic options.

Regional Insights

North America leads the global insulin biosimilars market, driven by the substantial prevalence of diabetes throughout the region, which creates a significant demand for effective and affordable treatment options. The well-developed healthcare infrastructure, particularly in the United States, facilitates the adoption and distribution of these therapies. A crucial factor is the mature regulatory environment, where bodies such as the U. S. Food and Drug Administration (FDA) have established clear and streamlined pathways for biosimilar approval. This regulatory approach, including the transition of insulin products to a biologic pathway, actively promotes market competition and accelerates the entry of biosimilars, ultimately improving patient access and addressing rising healthcare costs.

Recent Developments

• In October 2025, positive Phase 3 clinical trial results were presented for MannKind Corporation's inhaled insulin product, Afrezza. The INHALE-1 trial demonstrated that Afrezza was a safe and effective replacement for rapid-acting mealtime insulin in children with type 1 diabetes. This research indicated comparable glycemic control to injected rapid-acting insulin, alongside less weight gain and higher patient preference scores. While Afrezza is a novel insulin, such advancements in alternative insulin delivery methods and formulations by companies influence the broader insulin market dynamics, including the competitive landscape for insulin biosimilars.

• In July 2025, Biocon Biologics received U.S. FDA approval for Kirsty™ (Insulin Aspart-xjhz), 100 units/mL. This significant regulatory milestone established Kirsty™ as the first and only interchangeable rapid-acting biosimilar to NovoLog® (Insulin Aspart). The approval expanded Biocon Biologics' biosimilar insulin portfolio and represented a breakthrough for the Global Insulin biosimilars Market. Interchangeable status allows for pharmacy-level substitution without requiring a new prescription, which is expected to further improve patient access and affordability for diabetes management.

• In March 2025, Biocon Biologics entered a strategic collaboration with Civica, Inc. The agreement focused on supplying insulin aspart drug substance, specifically for the U.S. manufacture of insulin aspart products. This collaboration is directly aimed at increasing the availability of affordable insulin in the United States, thereby impacting the Global Insulin biosimilars Market. By partnering with a nonprofit, Biocon Biologics sought to enhance patient access to essential diabetes treatments and address concerns regarding insulin affordability and supply chain stability.

• In February 2025, Sanofi announced the U.S. Food and Drug Administration (FDA) approved its biosimilar product, Merilog (insulin-aspart-szjj). This approval marked Merilog as the first rapid-acting insulin biosimilar to Novo Nordisk's NovoLog, an important development for the Global Insulin biosimilars Market. Merilog is indicated for improving glycemic control in both adult and pediatric patients with diabetes mellitus, offering a new treatment option. The product was approved for both a 3 mL single-patient-use prefilled pen and a 10 mL multiple-dose vial, expanding patient access to more affordable mealtime insulin.

Key Market Players

• Pfizer Inc
• Novartis AG
• Boehringer Ingelheim GmbH
• Merck KGaA
• Sanofi S.A
• Viatris Inc
• NOVO Nordisk A/S
• Intas Pharmaceuticals Ltd
• Sandoz International GmbH
• Fresenius Kabi AG

Report Scope:

In this report, the Global Insulin biosimilars Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Insulin biosimilars Market, By Type:

o   Rapid Acting biosimilars

o   Long Acting biosimilars

o   Premixed Acting biosimilars

• Insulin biosimilars Market, By Disease Indication Type:

o   Type I Diabetes

o   Type II Diabetes

• Insulin biosimilars Market, By Distribution Channel:

o   Hospital Pharmacies

o   Retail Pharmacies

o   Online Pharmacies

• Insulin biosimilars Market, By End user:

o   Hospitals

o   Ambulatory Surgical Centers

o   Others

• Insulin biosimilars Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Insulin biosimilars Market.

Available Customizations:

Global Insulin biosimilars Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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