• 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 Insulin Biosimilars Market has been segmented by Type, Indication, End User, and Geography.

Insulin Biosimilars Market, Segmentation by Type

The 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 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.

Insulin Biosimilars Market, Segmentation by Indication

The 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 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.

Insulin Biosimilars Market, Segmentation by End User

The Insulin Biosimilars Market has been segmented by End User into Hospitals, Ambulatory Surgical Centers, and Others.

Hospitals
Hospitals dominate the 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.

Insulin Biosimilars Market, Segmentation by Geography

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

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

North America
North America commands the largest share of the 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 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 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 - Government-led efforts to support biosimilar adoption are significantly driving growth in the global market. To reduce the economic burden of high-cost biologics and expand patient access, health authorities are introducing measures such as accelerated regulatory pathways, financial incentives for prescribers, and inclusion of biosimilars in national reimbursement schemes. These policies are helping to build trust among clinicians while encouraging broader clinical use of biosimilar therapies.

  Governments are also backing educational campaigns and stakeholder engagement programs to increase awareness about the therapeutic equivalence and safety of biosimilars. At the same time, competitive pricing policies and support for local manufacturing are helping to create a more affordable and sustainable supply chain. As these public-sector strategies continue to evolve, they are expected to play a central role in accelerating biosimilar integration into healthcare systems worldwide.

Restraints

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

• Market Competition from Established Brands - Intense market competition from established biologic brands remains a major restraint in the biosimilars sector. Originator companies have built strong reputations through years of clinical success, provider trust, and extensive marketing, making it difficult for biosimilar products to achieve rapid acceptance. Healthcare professionals often remain cautious about switching treatments due to brand familiarity and confidence in proven therapeutic outcomes.

  Leading biologic manufacturers often employ strategic barriers such as patent protection extensions, aggressive discounting, and exclusive supply agreements to defend their market share. These practices reduce pricing flexibility and limit biosimilar accessibility, especially in regions with weak substitution policies. As a result, despite offering similar efficacy and cost advantages, biosimilars may struggle to gain widespread adoption in a highly competitive landscape.

Opportunities

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

• Patient Education and Awareness Initiatives - Increasing patient education and awareness is unlocking new opportunities for growth in the Insulin Biosimilars Market. A considerable number of patients remain unfamiliar with the safety, efficacy, and cost-effectiveness of biosimilar insulin, leading to reluctance in switching from originator products. Educating patients about the benefits and clinical reliability of insulin biosimilars can significantly enhance trust and support greater adoption.

  Evidence from educational initiatives shows improved treatment outcomes when patients are well-informed about their therapy options. Programs that explain how biosimilars work, their regulatory approval standards, and how they compare to branded insulin have helped increase acceptance, especially in regions where access to affordable insulin remains a challenge. Informed patients are more likely to adhere to prescribed treatments and engage in shared decision-making with their healthcare providers.

  Government agencies, healthcare providers, and advocacy groups are increasingly collaborating to deliver multilingual, accessible educational content on biosimilars. These efforts include workshops, digital campaigns, and community outreach to address common misconceptions and promote clarity around biosimilar insulin therapies. Such initiatives are essential for reaching diverse demographic segments and overcoming socioeconomic or cultural barriers to care.

  As insulin affordability remains a global healthcare priority, improving patient understanding through strategic education campaigns can accelerate biosimilar uptake. Greater awareness not only empowers patients but also supports market expansion by fostering confidence in cost-effective, high-quality insulin alternatives.

Key players in Insulin Biosimilars Market include :

• Viatris Inc.
• Pfizer Inc.
• Sanofi S.A.
• Eli Lilly and Company
• Novartis AG
• Merck & Co., Inc.
• Boehringer Ingelheim GmbH
• Biocon Ltd.
• Samsung Bioepis
• Teva Pharmaceutical Industries Ltd.
• Fresenius Kabi AG
• Coherus BioSciences, Inc.
• Dr. Reddy's Laboratories Ltd.
• Amgen Inc.
• Celltrion Inc.
• Aurobindo Pharma Ltd.
• Intas Pharmaceuticals Ltd.
• Fujifilm Kyowa Kirin Biologics Co., Ltd.
• Mochida Pharmaceutical Co., Ltd.

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

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