Global Insulin Biosimilars Market
Insulin Biosimilars Market

Report ID: SQMIG35B2206

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Insulin Biosimilars Market Size, Share, and Growth Analysis

Global Insulin Biosimilars Market

Insulin Biosimilars Market By Type: (Fast-acting Insulin, Intermediate-acting Insulin), By Indication: (Diabetes Type 1, Diabetes Type 2), By By Distribution Channel: (Hospital Pharmacies, Retail Pharmacies), By Region - Industry Forecast 2026-2033


Report ID: SQMIG35B2206 | Region: Global | Published Date: January, 2025
Pages: 219 |Tables: 90 |Figures: 76

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Insulin Biosimilars Market Insights

Global Insulin Biosimilars Market size was valued at USD 3.08 Billion in 2024 and is poised to grow from USD 3.27 Billion in 2025 to USD 5.29 Billion by 2033, growing at a CAGR of 6.2% during the forecast period (2026–2033). 

Insulin biosimilars are drugs or products that are like insulin but not identical and can never be termed as the exact copy of original protein. Growing incidence of diabetes is the prime aspect that is projected to boost sales of insulin biosimilars over the coming years. Increasing investments in diabetes R&D and growing need for diabetes management around the world are also slated to augment the demand for insulin biosimilars across the forecast period and beyond. New clinical trials being performed for novel insulin biosimilars are also helping market expansion. The patent expiry of original insulin products is also a key trend that is estimated to create new opportunities for insulin biosimilars market players in the future. However, stringent regulatory mandates and improper clinical acceptance of novel insulin biosimilars are estimated to be key restraints for the overall market development in the long run.

Market snapshot - 2026-2033

Global Market Size

USD 2.9 billion

Largest Segment

Diabetes Type 2

Fastest Growth

Diabetes Type 1

Growth Rate

6.2% CAGR

Global Insulin Biosimilars Market 2026-2033 ($ Bn)
Country Share for North America Region 2025 (%)

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Insulin Biosimilars Market Segments Analysis

Global Insulin Biosimilars Market is segmented by Type, Indication, Distribution Channel, and region. Based on Type, the market is segmented into Fast-acting Insulin, Intermediate-acting Insulin and Long-acting Insulin. Based on Indication, the market is segmented into Diabetes Type 1 and Diabetes Type 2. Based on Distribution Channel, the market is segmented into Hospital Pharmacies, Retail Pharmacies, Drug Stores and Online Pharmacies. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.  

Analysis by Type

Long-acting insulin is estimated to account for a dominant share of the global insulin biosimilars market in the future. Growing need for effective diabetes management over long period of time without significant expenses is a key factor allowing this segment to account for a dominant market share.

Meanwhile, the demand for fast-acting insulin is predicted to increase at a rapid pace across the forecast period and beyond. High effectiveness and low cost coupled with quick action are characteristics that are making fast-acting insulin popular among diabetic people around the world.

Analysis by Indication

Type 2 diabetes is projected to account for around 80% of the global insulin biosimilars demand outlook across the forecast period. High number of people suffering from type 2 diabetes around the world is what allows this segment to maintain its prominence. High demand for cost effective type 2 diabetes management solutions will also help this segment expand in the future.

Meanwhile, the demand for insulin biosimilars for type 1 diabetes people is slated to increase at a notable pace over the coming years. Rising incidence of type 1 diabetes among people around the world is also creating demand for insulin biosimilars for type 1 diabetes and helping this segment expand at a robust pace.

Global Insulin Biosimilars Market By Indication 2026-2033

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Insulin Biosimilars Market Regional Insights

North America is slated to hold sway over global insulin biosimilars demand outlook across the forecast period. High prevalence of diabetic demographic in this region is the key factor supporting its dominance. Poor eating habits and adoption of sedentary lifestyles are key factors that have given rise to incidence of diabetes in North American countries. High healthcare spending potential and the presence of key pharmaceutical companies will also bolster the demand for insulin biosimilars in this region with United States accounting for the largest market share and Canada the second largest in North America.

Rapid urbanization in Asian countries has led to increased prevalence of diabetes among people and this is why the Asia Pacific region is slated to be the fastest-expanding regional market in the world. Increasing investments in healthcare infrastructure development, growing awareness regarding diabetes management, and high adoption of insulin biosimilars are key factors promoting market development. Rapid surge in geriatric population is also an aspect that could change the global insulin biosimilars demand outlook in the future. China, India, Japan, and Indonesia are key markets in this region.

Global Insulin Biosimilars Market By Region, 2026-2033
  • Largest
  • Fastest

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Insulin Biosimilars Market Dynamics

Drivers

Patent Expiry of Originator Insulin Products

  • Originator insulin products and biosimilars that have been used for years are now facing patent expiration issues and this is projected to bolster the demand for novel and innovative new insulin biosimilars. High investments in medical R&D are projected to create new opportunities for insulin biosimilar providers.

High Incidence of Diabetes

  • The prevalence of diabetes has increased exponentially on a global level in recent years, and this is projected to be a key trend that will augment the demand for insulin biosimilars over the coming years.

Restraints

Complex Regulatory Mandates

  • Governments and regulatory authorities have implemented strict mandates regarding the development of new insulin biosimilars. These strict norms make it difficult for new companies to develop and launch new insulin biosimilars.

Issues Regarding Clinical Acceptance

  • Clinical evidence is necessary for insulin biosimilars to be accepted widely by patients as well as healthcare professionals and most novel insulin biosimilars lack this aspect, which is anticipated to impede insulin biosimilars market growth potential going forward.

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Insulin Biosimilars Market Competitive Landscape

Insulin biosimilars market players can capitalize on the increasing incidence of diabetes by marketing their products as the right choice for effective diabetes management. Insulin biosimilar companies should also utilize strategies such as collaborations, partnerships, and mergers to fast-track the development of new insulin biosimilars. Companies can also improve their commercialization times by leveraging lucrative regulatory norms.

Top Players in Insulin Biosimilars Market

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

Recent Developments

  • In September 2023, Meitheal Pharmaceuticals, a leading pharmaceutical company based in the United States, announced that it had signed an exclusive agreement with Dongbao Pharmaceutical to develop 3 new insulin biosimilars for the United States market.
  • In November 2023, USV, a renowned pharmaceutical company based in India collaborated with Biogenomics to develop a local biosimilar version of Insulin Aspart called InsuQuick.

Insulin Biosimilars Key Market Trends

Insulin Biosimilars Market SkyQuest Analysis

SkyQuest's ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Co-relates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.

As per SkyQuest analysis, growing prevalence of diabetes and increasing need for effective diabetes management around the world are estimated to bolster the demand for insulin biosimilars over the coming years. High investments in diabetes R&D are also slated to boost market development. However, the imposition of stringent regulatory mandates around the world is slated to slow down insulin biosimilars market growth in the future. Asia Pacific is slated to emerge as the fastest growing market on the back of rising incidence of diabetes and expanding geriatric population. The use of biologic and biosimilar therapies for diabetes management and treatment is slated to create new opportunities for market growth in the future.

Report Metric Details
Market size value in 2024 USD 3.08 Billion
Market size value in 2033 USD 5.29 Billion
Growth Rate 6.2%
Base year 2024
Forecast period 2026-2033
Forecast Unit (Value) USD Billion
Segments covered
  • Type
    • Fast-acting Insulin (Rapid-acting Insulin Analogs, Regular Human Insulin), Intermediate-acting Insulin (NPH Human Insulin, Pre-mixed Insulin), Long-acting Insulin
  • Indication
    • Diabetes Type 1, Diabetes Type 2
  • Distribution Channel
    • Hospital Pharmacies, Retail Pharmacies, Drug Stores, Online Pharmacies
Regions covered North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA)
Companies covered
  • Viatris Inc. (USA) 
  • Pfizer Inc. (USA) 
  • Sanofi S.A. (France) 
  • Eli Lilly and Company (USA) 
  • Novartis AG (Switzerland) 
  • Merck & Co., Inc. (USA) 
  • Boehringer Ingelheim GmbH (Germany) 
  • Biocon Ltd. (India) 
  • Samsung Bioepis (South Korea) 
  • Teva Pharmaceutical Industries Ltd. (Israel) 
  • Fresenius Kabi AG (Germany) 
  • Coherus BioSciences, Inc. (USA) 
  • Dr. Reddy's Laboratories Ltd. (India) 
  • Amgen Inc. (USA) 
  • Celltrion Inc. (South Korea) 
  • Aurobindo Pharma Ltd. (India) 
  • Intas Pharmaceuticals Ltd. (India) 
  • Fujifilm Kyowa Kirin Biologics Co., Ltd. (Japan) 
  • Mochida Pharmaceutical Co., Ltd. (Japan) 
Customization scope

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Table Of Content

Executive Summary

Market overview

  • Exhibit: Executive Summary – Chart on Market Overview
  • Exhibit: Executive Summary – Data Table on Market Overview
  • Exhibit: Executive Summary – Chart on Insulin Biosimilars Market Characteristics
  • Exhibit: Executive Summary – Chart on Market by Geography
  • Exhibit: Executive Summary – Chart on Market Segmentation
  • Exhibit: Executive Summary – Chart on Incremental Growth
  • Exhibit: Executive Summary – Data Table on Incremental Growth
  • Exhibit: Executive Summary – Chart on Vendor Market Positioning

Parent Market Analysis

Market overview

Market size

  • Market Dynamics
    • Exhibit: Impact analysis of DROC, 2021
      • Drivers
      • Opportunities
      • Restraints
      • Challenges
  • SWOT Analysis

KEY MARKET INSIGHTS

  • Technology Analysis
    • (Exhibit: Data Table: Name of technology and details)
  • Pricing Analysis
    • (Exhibit: Data Table: Name of technology and pricing details)
  • Supply Chain Analysis
    • (Exhibit: Detailed Supply Chain Presentation)
  • Value Chain Analysis
    • (Exhibit: Detailed Value Chain Presentation)
  • Ecosystem Of the Market
    • Exhibit: Parent Market Ecosystem Market Analysis
    • Exhibit: Market Characteristics of Parent Market
  • IP Analysis
    • (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
  • Trade Analysis
    • (Exhibit: Data Table: Import and Export data details)
  • Startup Analysis
    • (Exhibit: Data Table: Emerging startups details)
  • Raw Material Analysis
    • (Exhibit: Data Table: Mapping of key raw materials)
  • Innovation Matrix
    • (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
  • Pipeline product Analysis
    • (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
  • Macroeconomic Indicators

COVID IMPACT

  • Introduction
  • Impact On Economy—scenario Assessment
    • Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
  • Revised Market Size
    • Exhibit: Data Table on Insulin Biosimilars Market size and forecast 2021-2027 ($ million)
  • Impact Of COVID On Key Segments
    • Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
  • COVID Strategies By Company
    • Exhibit: Analysis on key strategies adopted by companies

MARKET DYNAMICS & OUTLOOK

  • Market Dynamics
    • Exhibit: Impact analysis of DROC, 2021
      • Drivers
      • Opportunities
      • Restraints
      • Challenges
  • Regulatory Landscape
    • Exhibit: Data Table on regulation from different region
  • SWOT Analysis
  • Porters Analysis
    • Competitive rivalry
      • Exhibit: Competitive rivalry Impact of key factors, 2021
    • Threat of substitute products
      • Exhibit: Threat of Substitute Products Impact of key factors, 2021
    • Bargaining power of buyers
      • Exhibit: buyers bargaining power Impact of key factors, 2021
    • Threat of new entrants
      • Exhibit: Threat of new entrants Impact of key factors, 2021
    • Bargaining power of suppliers
      • Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
  • Skyquest special insights on future disruptions
    • Political Impact
    • Economic impact
    • Social Impact
    • Technical Impact
    • Environmental Impact
    • Legal Impact

Market Size by Region

  • Chart on Market share by geography 2021-2027 (%)
  • Data Table on Market share by geography 2021-2027(%)
  • North America
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • USA
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Canada
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Europe
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • Germany
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Spain
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • France
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • UK
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of Europe
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Asia Pacific
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • China
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • India
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Japan
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • South Korea
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of Asia Pacific
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Latin America
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • Brazil
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of South America
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Middle East & Africa (MEA)
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • GCC Countries
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • South Africa
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of MEA
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)

KEY COMPANY PROFILES

  • Competitive Landscape
    • Total number of companies covered
      • Exhibit: companies covered in the report, 2021
    • Top companies market positioning
      • Exhibit: company positioning matrix, 2021
    • Top companies market Share
      • Exhibit: Pie chart analysis on company market share, 2021(%)

Methodology

For the Insulin Biosimilars Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:

1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.

2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Insulin Biosimilars Market.

3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.

4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.

Analyst Support

Customization Options

With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Insulin Biosimilars Market:

Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.

Regional Analysis: Further analysis of the Insulin Biosimilars Market for additional countries.

Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.

Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.

Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.

Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.

Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.

Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.

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FAQs

Global Insulin Biosimilars Market size was valued at USD 3.08 Billion in 2024 and is poised to grow from USD 3.27 Billion in 2025 to USD 5.29 Billion by 2033, growing at a CAGR of 6.2% during the forecast period (2026–2033). 

Insulin biosimilars market players can capitalize on the increasing incidence of diabetes by marketing their products as the right choice for effective diabetes management. Insulin biosimilar companies should also utilize strategies such as collaborations, partnerships, and mergers to fast-track the development of new insulin biosimilars. Companies can also improve their commercialization times by leveraging lucrative regulatory norms. 'Viatris Inc. (USA) ', 'Pfizer Inc. (USA) ', 'Sanofi S.A. (France) ', 'Eli Lilly and Company (USA) ', 'Novartis AG (Switzerland) ', 'Merck & Co., Inc. (USA) ', 'Boehringer Ingelheim GmbH (Germany) ', 'Biocon Ltd. (India) ', 'Samsung Bioepis (South Korea) ', 'Teva Pharmaceutical Industries Ltd. (Israel) ', 'Fresenius Kabi AG (Germany) ', 'Coherus BioSciences, Inc. (USA) ', 'Dr. Reddy's Laboratories Ltd. (India) ', 'Amgen Inc. (USA) ', 'Celltrion Inc. (South Korea) ', 'Aurobindo Pharma Ltd. (India) ', 'Intas Pharmaceuticals Ltd. (India) ', 'Fujifilm Kyowa Kirin Biologics Co., Ltd. (Japan) ', 'Mochida Pharmaceutical Co., Ltd. (Japan) '

Originator insulin products and biosimilars that have been used for years are now facing patent expiration issues and this is projected to bolster the demand for novel and innovative new insulin biosimilars. High investments in medical R&D are projected to create new opportunities for insulin biosimilar providers.

Adoption of Biologic and Biosimilar Therapies for Diabetes: Patients as well as healthcare institutions are focusing on adoption of novel biosimilar and biologic therapies for diabetes management, and this is slated to create new opportunities for suppliers of insulin biosimilars. Companies can develop novel products that are in accordance with this trend to maximize their revenue generation going forward.

North America is slated to hold sway over global insulin biosimilars demand outlook across the forecast period. High prevalence of diabetic demographic in this region is the key factor supporting its dominance. Poor eating habits and adoption of sedentary lifestyles are key factors that have given rise to incidence of diabetes in North American countries. High healthcare spending potential and the presence of key pharmaceutical companies will also bolster the demand for insulin biosimilars in this region with United States accounting for the largest market share and Canada the second largest in North America.
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