Global Insulin Biosimilars Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

• In September 2023, Meitheal Pharmaceuticals formed an exclusive licensing agreement with Tonghua Dongbao Pharmaceutical, a prominent pharmaceutical company based in China. Under this partnership, Meitheal Pharmaceuticals has secured the exclusive rights to market three insulin biosimilars in the United States. This agreement marks a significant step in expanding access to affordable insulin alternatives, as Meitheal aims to meet the growing demand for biosimilar insulin treatments. With this move, the companies are poised to strengthen their position in the competitive U.S. insulin market, providing patients with more cost-effective options for managing diabetes.

• In November 2021, Viatris Inc. and Biocon Biologics Ltd. introduced SEMGLEE, an interchangeable biosimilar insulin injection designed to help manage blood sugar levels in patients with diabetes. This innovative product offers a cost-effective alternative to branded insulin therapies, contributing to the growing demand for affordable diabetes management options. By launching SEMGLEE, the companies aim to provide patients with a reliable and accessible treatment option while enhancing their presence in the competitive biosimilars market.

In this report, the Global Insulin Biosimilars Market has been segmented by Type, Indication, End User, and Geography.

Global Insulin Biosimilars Market, Segmentation by Type

The Global Insulin Biosimilars Market has been segmented by Type into Rapid-Acting Biosimilars, Long-Acting Biosimilars, and Premixed Biosimilars.

Rapid-Acting Biosimilars
Rapid-acting insulin biosimilars hold the largest share in the global insulin biosimilars market, accounting for around 42% of total usage. These formulations are designed for quick blood sugar management after meals, closely mimicking the body's natural insulin release. They are widely prescribed for both type 1 and type 2 diabetes and are especially valued for their fast onset and high efficacy. Growing adoption is driven by their cost efficiency, increasing approvals, and accessibility in both developed and developing regions.

Long-Acting Biosimilars
With a share of nearly 38%, long-acting biosimilars are a critical component in diabetes management for maintaining steady glucose levels throughout the day and night. They typically require once-daily dosing, making them ideal for improving treatment adherence. These biosimilars are increasingly favored for their predictable pharmacokinetics, broader insurance coverage, and growing availability. Their role continues to expand, particularly in chronic diabetes management strategies.

Premixed Biosimilars
Premixed biosimilars make up approximately 20% of the market. They offer a combination of short-acting and intermediate-acting insulin, delivering dual-phase glucose control in fewer daily injections. These biosimilars are popular among patients seeking convenient dosing schedules, especially those with regular meal patterns. Adoption is rising in low-resource settings, where ease of use and minimal medical supervision are significant factors.

Global Insulin Biosimilars Market, Segmentation by Indication

The Global Insulin Biosimilars Market has been segmented by Indication into Type I Diabetes and Type II Diabetes.

Type I Diabetes
Type I diabetes currently contributes to around 45% of the global insulin biosimilars market, with patients requiring daily insulin therapy due to complete insulin deficiency. This condition is typically diagnosed at a younger age and demands long-term reliance on insulin, making the availability of affordable biosimilar options especially important. The steady rise in pediatric diagnoses and ongoing healthcare efforts to improve access to essential diabetes medications are supporting sustained market demand in this segment.

Type II Diabetes
Making up approximately 55% of the market, Type II diabetes is the dominant indication for insulin biosimilars. Though initially managed with oral antidiabetic agents, many Type II patients eventually require insulin supplementation, especially in later stages. The rising prevalence of this condition, fueled by obesity, aging populations, and sedentary lifestyles, is driving increased adoption of biosimilar insulin therapies, particularly in cost-sensitive healthcare systems across Asia, Latin America, and Africa.

Global Insulin Biosimilars Market, Segmentation by End User

In this report, the Global Insulin Biosimilars Market has been segmented by End User into Hospitals, Ambulatory Surgical Centers, and Others.

Hospitals
Hospitals dominate the global insulin biosimilars market by end-user type, holding a substantial 52% share. These institutions manage a high volume of diabetic patients, especially those requiring specialist care, inpatient treatment, or initial insulin regimens. Hospitals also benefit from economies of scale, as they often engage in bulk purchasing agreements with biosimilar manufacturers. Their position as trusted healthcare providers ensures widespread adoption of insulin biosimilars for both emergency and long-term care.

Ambulatory Surgical Centers (ASCs)
With about 27% of the market share, ambulatory surgical centers are gaining prominence as an alternative to traditional hospital settings. ASCs support outpatient insulin administration, routine diabetes checkups, and minor surgical interventions related to diabetes complications. Their lower overhead costs, quicker turnaround times, and growing integration with specialty diabetes care programs make them a rising force in biosimilar adoption, particularly in urban healthcare systems.

Others
The Others category, encompassing clinics, homecare providers, and retail pharmacies, accounts for nearly 21% of global biosimilar insulin use. These settings play a vital role in chronic diabetes management, offering patients flexible options for self-administration and ongoing monitoring. Technological advancements like telemedicine and remote glucose tracking are enhancing biosimilar uptake in these decentralized settings, especially in regions focused on community health expansion.

Global Insulin Biosimilars Market, Segmentation by Geography

In this report, the Global Insulin Biosimilars Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Global Insulin Biosimilars Market Share (%), by Geographical Region, 2024

North America
North America commands the largest share of the global insulin biosimilars market, accounting for nearly 36% during the 2021–2031 forecast period. The region’s leadership is supported by a high diabetes burden, a mature regulatory environment, and the widespread availability of biosimilar products. Strong healthcare infrastructure and comprehensive insurance coverage have contributed to the accelerated adoption of biosimilars, especially in the United States and Canada.

Europe
With a market share of around 30%, Europe is a significant player in the insulin biosimilars industry. The region’s commitment to cost-effective healthcare solutions and proactive biosimilar promotion policies have accelerated growth. Countries like Germany, France, and the UK are leading in terms of biosimilar usage, supported by favorable government regulations and increasing clinician and patient confidence in biosimilar safety and efficacy.

Asia Pacific
The Asia Pacific region holds approximately 22% of the global market and is projected to witness the fastest growth over the next decade. This expansion is being driven by rising diabetes prevalence, especially in China, India, and Japan, along with government efforts to expand access to affordable treatment options. Improving healthcare systems and the growing presence of regional biosimilar manufacturers are further propelling market development.

Middle East & Africa and Latin America
Together making up about 12% of the global insulin biosimilars market, Middle East & Africa and Latin America are emerging regions with strong growth potential. While still in early stages, increasing investment in healthcare infrastructure, rising awareness about biosimilar alternatives, and policy shifts to support affordable diabetes care are creating new opportunities. Countries such as Brazil, Mexico, South Africa, and the UAE are at the forefront of this regional momentum.

This report provides an in depth analysis of various factors that impact the dynamics of Global Insulin Biosimilars Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Drivers

• Cost-effectiveness of Biosimilars
• Patent Expiry of Biologic Insulins
• Growing Demand for Accessible Healthcare

• Government Initiatives to Promote Biosimilar Adoption - The growing demand for accessible healthcare is a significant driver propelling the expansion of the global insulin biosimilars market. As diabetes prevalence continues to rise worldwide, particularly in low- and middle-income countries, there is an increasing need for affordable treatment options to manage the condition effectively. Insulin biosimilars offer a more cost-effective alternative to originator biologic insulins, making them accessible to a larger population of patients who may otherwise struggle to afford treatment. This affordability factor is driving the adoption of biosimilar insulin products, especially in regions with limited healthcare resources and higher prevalence rates of diabetes.

  The push for accessible healthcare is fueled by various stakeholders, including governments, healthcare providers, and patient advocacy groups, who are advocating for policies and initiatives to improve affordability and access to essential medications like insulin. Governments are implementing measures such as price controls, reimbursement policies, and incentives to encourage the adoption of biosimilars and increase competition in the insulin market, ultimately driving down costs and improving accessibility for patients. Additionally, healthcare providers are increasingly embracing biosimilars as viable treatment options, further fueling market growth and expanding patient access to insulin therapy.

  The demand for accessible healthcare extends beyond affordability to encompass factors such as convenience, availability, and patient empowerment. Biosimilar insulin products offer advantages such as simplified treatment regimens, patient-friendly delivery devices, and broader distribution networks, making it easier for patients to access and adhere to their insulin therapy. As healthcare systems strive to meet the evolving needs of patients with diabetes, the demand for accessible and affordable insulin options is expected to continue driving the growth of the global insulin biosimilars market, ultimately improving healthcare outcomes and quality of life for millions of individuals worldwide.

Restraints

• Complex Manufacturing Processes
• Intellectual Property Rights Issues
• Concerns Regarding Safety and Efficacy

• Market Competition from Established Brands - Concerns regarding safety and efficacy represent significant barriers to the widespread adoption of insulin biosimilars in the global market. While biosimilars are designed to be highly similar to their reference biologic counterparts, slight differences in manufacturing processes or product characteristics may raise questions about their safety and effectiveness. Healthcare professionals and patients alike may be hesitant to switch to biosimilar insulin products without sufficient evidence demonstrating comparable safety and efficacy profiles to originator biologics.

  Ensuring the safety of biosimilar insulin products requires robust clinical data demonstrating equivalence in terms of pharmacokinetics, pharmacodynamics, and immunogenicity compared to the reference biologic. However, generating this data can be challenging due to the complexity of biological molecules and the variability inherent in manufacturing processes. Additionally, concerns may arise regarding the extrapolation of clinical data from one indication to another or from one patient population to another, further complicating the assessment of safety and efficacy.

  Perceptions of biosimilar products may be influenced by factors such as brand loyalty, healthcare provider preferences, and patient trust. Some stakeholders may harbor misconceptions or skepticism about biosimilars, viewing them as inferior or less reliable than originator biologics. Addressing these concerns requires comprehensive education and communication efforts to increase awareness and understanding of biosimilar development, regulation, and clinical evidence. Building trust among healthcare professionals and patients through transparent communication and real-world evidence can help alleviate concerns regarding the safety and efficacy of insulin biosimilars, ultimately facilitating their broader acceptance and adoption in clinical practice.

Opportunities

• Strategic Collaborations and Partnerships
• Growing Acceptance of Biosimilars among Healthcare Professionals
• Development of Novel Formulations and Delivery Systems

• Patient Education and Awareness Initiatives - The development of novel formulations and delivery systems represents a key opportunity in the global insulin biosimilars market, offering the potential to overcome existing challenges and enhance patient outcomes. Traditional insulin formulations often require multiple daily injections, leading to inconvenience, discomfort, and poor adherence among patients. Novel formulations aim to address these limitations by improving the pharmacokinetic and pharmacodynamic profiles of insulin products, thereby optimizing glycemic control and reducing the risk of hypoglycemia.

  One approach to innovation in insulin formulations is the development of long-acting or ultra-long-acting insulins with prolonged duration of action and reduced injection frequency. These formulations provide more stable and sustained insulin levels throughout the day, offering patients greater flexibility in their treatment regimens and minimizing the risk of fluctuations in blood glucose levels. Additionally, novel formulations may incorporate advanced delivery technologies such as microneedle patches, inhalation devices, or implantable devices, offering alternative routes of administration and improving patient comfort and convenience.

  The development of novel formulations and delivery systems represents a promising avenue for advancing insulin therapy and addressing unmet needs in the management of diabetes. Through continued innovation and collaboration, stakeholders in the insulin biosimilars market can capitalize on these opportunities to improve patient outcomes and enhance the quality of care for individuals living with diabetes.

Key players in Global Insulin Biosimilars Market include :

• Sanofi S.A
• Boehringer Ingelheim
• Eli Lilly & Co
• NOVO Nordisk A/S
• Mylan N.V
• Pfizer Inc
• Sandoz
• Fresenius Kabi

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis