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Generic DrugsDiabetesBiosimilar

PUBLISHER: TechSci Research | PRODUCT CODE: 1881497

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PUBLISHER: TechSci Research | PRODUCT CODE: 1881497

Insulin biosimilars Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type, By Disease Indication Type, By Distribution Channel, By End user, By Region and Competition, 2020-2030F

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Description

Table of Contents

The Global Insulin biosimilars Market, valued at USD 1.55 Billion in 2024, is projected to experience a CAGR of 7.3% 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.

Market Overview
Forecast Period2026-2030
Market Size 2024USD 1.55 Billion
Market Size 2030USD 2.37 Billion
CAGR 2025-20307.3%
Fastest Growing SegmentRapid Acting biosimilars
Largest MarketNorth America

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.

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.

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.

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:

  • Rapid Acting biosimilars
  • Long Acting biosimilars
  • Premixed Acting biosimilars

Insulin biosimilars Market, By Disease Indication Type:

  • Type I Diabetes
  • Type II Diabetes

Insulin biosimilars Market, By Distribution Channel:

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies

Insulin biosimilars Market, By End user:

  • Hospitals
  • Ambulatory Surgical Centers
  • Others

Insulin biosimilars Market, By Region:

  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • France
    • United Kingdom
    • Italy
    • Germany
    • Spain
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
  • South America
    • Brazil
    • Argentina
    • Colombia
  • 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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Product Code: 21057

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validation
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Insulin biosimilars Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Type (Rapid Acting biosimilars, Long Acting biosimilars, Premixed Acting biosimilars)
    • 5.2.2. By Disease Indication Type (Type I Diabetes, Type II Diabetes)
    • 5.2.3. By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies)
    • 5.2.4. By End user (Hospitals, Ambulatory Surgical Centers, Others)
    • 5.2.5. By Region
    • 5.2.6. By Company (2024)
  • 5.3. Market Map

6. North America Insulin biosimilars Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Type
    • 6.2.2. By Disease Indication Type
    • 6.2.3. By Distribution Channel
    • 6.2.4. By End user
    • 6.2.5. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Insulin biosimilars Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Type
        • 6.3.1.2.2. By Disease Indication Type
        • 6.3.1.2.3. By Distribution Channel
        • 6.3.1.2.4. By End user
    • 6.3.2. Canada Insulin biosimilars Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Type
        • 6.3.2.2.2. By Disease Indication Type
        • 6.3.2.2.3. By Distribution Channel
        • 6.3.2.2.4. By End user
    • 6.3.3. Mexico Insulin biosimilars Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Type
        • 6.3.3.2.2. By Disease Indication Type
        • 6.3.3.2.3. By Distribution Channel
        • 6.3.3.2.4. By End user

7. Europe Insulin biosimilars Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Type
    • 7.2.2. By Disease Indication Type
    • 7.2.3. By Distribution Channel
    • 7.2.4. By End user
    • 7.2.5. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. Germany Insulin biosimilars Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Type
        • 7.3.1.2.2. By Disease Indication Type
        • 7.3.1.2.3. By Distribution Channel
        • 7.3.1.2.4. By End user
    • 7.3.2. France Insulin biosimilars Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Type
        • 7.3.2.2.2. By Disease Indication Type
        • 7.3.2.2.3. By Distribution Channel
        • 7.3.2.2.4. By End user
    • 7.3.3. United Kingdom Insulin biosimilars Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecast
        • 7.3.3.2.1. By Type
        • 7.3.3.2.2. By Disease Indication Type
        • 7.3.3.2.3. By Distribution Channel
        • 7.3.3.2.4. By End user
    • 7.3.4. Italy Insulin biosimilars Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Type
        • 7.3.4.2.2. By Disease Indication Type
        • 7.3.4.2.3. By Distribution Channel
        • 7.3.4.2.4. By End user
    • 7.3.5. Spain Insulin biosimilars Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Type
        • 7.3.5.2.2. By Disease Indication Type
        • 7.3.5.2.3. By Distribution Channel
        • 7.3.5.2.4. By End user

8. Asia Pacific Insulin biosimilars Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Type
    • 8.2.2. By Disease Indication Type
    • 8.2.3. By Distribution Channel
    • 8.2.4. By End user
    • 8.2.5. By Country
  • 8.3. Asia Pacific: Country Analysis
    • 8.3.1. China Insulin biosimilars Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Type
        • 8.3.1.2.2. By Disease Indication Type
        • 8.3.1.2.3. By Distribution Channel
        • 8.3.1.2.4. By End user
    • 8.3.2. India Insulin biosimilars Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Type
        • 8.3.2.2.2. By Disease Indication Type
        • 8.3.2.2.3. By Distribution Channel
        • 8.3.2.2.4. By End user
    • 8.3.3. Japan Insulin biosimilars Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Type
        • 8.3.3.2.2. By Disease Indication Type
        • 8.3.3.2.3. By Distribution Channel
        • 8.3.3.2.4. By End user
    • 8.3.4. South Korea Insulin biosimilars Market Outlook
      • 8.3.4.1. Market Size & Forecast
        • 8.3.4.1.1. By Value
      • 8.3.4.2. Market Share & Forecast
        • 8.3.4.2.1. By Type
        • 8.3.4.2.2. By Disease Indication Type
        • 8.3.4.2.3. By Distribution Channel
        • 8.3.4.2.4. By End user
    • 8.3.5. Australia Insulin biosimilars Market Outlook
      • 8.3.5.1. Market Size & Forecast
        • 8.3.5.1.1. By Value
      • 8.3.5.2. Market Share & Forecast
        • 8.3.5.2.1. By Type
        • 8.3.5.2.2. By Disease Indication Type
        • 8.3.5.2.3. By Distribution Channel
        • 8.3.5.2.4. By End user

9. Middle East & Africa Insulin biosimilars Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Type
    • 9.2.2. By Disease Indication Type
    • 9.2.3. By Distribution Channel
    • 9.2.4. By End user
    • 9.2.5. By Country
  • 9.3. Middle East & Africa: Country Analysis
    • 9.3.1. Saudi Arabia Insulin biosimilars Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Type
        • 9.3.1.2.2. By Disease Indication Type
        • 9.3.1.2.3. By Distribution Channel
        • 9.3.1.2.4. By End user
    • 9.3.2. UAE Insulin biosimilars Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Type
        • 9.3.2.2.2. By Disease Indication Type
        • 9.3.2.2.3. By Distribution Channel
        • 9.3.2.2.4. By End user
    • 9.3.3. South Africa Insulin biosimilars Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Type
        • 9.3.3.2.2. By Disease Indication Type
        • 9.3.3.2.3. By Distribution Channel
        • 9.3.3.2.4. By End user

10. South America Insulin biosimilars Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Type
    • 10.2.2. By Disease Indication Type
    • 10.2.3. By Distribution Channel
    • 10.2.4. By End user
    • 10.2.5. By Country
  • 10.3. South America: Country Analysis
    • 10.3.1. Brazil Insulin biosimilars Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Type
        • 10.3.1.2.2. By Disease Indication Type
        • 10.3.1.2.3. By Distribution Channel
        • 10.3.1.2.4. By End user
    • 10.3.2. Colombia Insulin biosimilars Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Type
        • 10.3.2.2.2. By Disease Indication Type
        • 10.3.2.2.3. By Distribution Channel
        • 10.3.2.2.4. By End user
    • 10.3.3. Argentina Insulin biosimilars Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Type
        • 10.3.3.2.2. By Disease Indication Type
        • 10.3.3.2.3. By Distribution Channel
        • 10.3.3.2.4. By End user

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Merger & Acquisition (If Any)
  • 12.2. Product Launches (If Any)
  • 12.3. Recent Developments

13. Global Insulin biosimilars Market: SWOT Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Products

15. Competitive Landscape

  • 15.1. Pfizer Inc
    • 15.1.1. Business Overview
    • 15.1.2. Products & Services
    • 15.1.3. Recent Developments
    • 15.1.4. Key Personnel
    • 15.1.5. SWOT Analysis
  • 15.2. Novartis AG
  • 15.3. Boehringer Ingelheim GmbH
  • 15.4. Merck KGaA
  • 15.5. Sanofi S.A
  • 15.6. Viatris Inc
  • 15.7. NOVO Nordisk A/S
  • 15.8. Intas Pharmaceuticals Ltd
  • 15.9. Sandoz International GmbH
  • 15.10. Fresenius Kabi AG

16. Strategic Recommendations

17. About Us & Disclaimer

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