Insulin Biosimilars Market - Global Industry Size, Share, Trends, Opportunity, & Forecast, 2020-2030

Rapid Acting biosimilars is the fastest growing segment, North America is the largest market globally

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.

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 Profiled:

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:

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:

North America
Europe
Asia Pacific
South America
Middle East & Africa

Competitive Landscape

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

Available Customizations:

With the given market data, the publisher offers customizations according to a company's specific needs. The following customization options are available for the report:

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

This product will be delivered within 1-3 business days.

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 Recommendations17. About the Publisher & Disclaimer

Companies Mentioned

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

Table Information

Report Attribute	Details
No. of Pages	187
Published	November 2025
Forecast Period	2024 - 2030
Estimated Market Value ( USD ) in 2024	$ 1.55 Billion
Forecasted Market Value ( USD ) by 2030	$ 2.37 Billion
Compound Annual Growth Rate	7.3%
Regions Covered	Global
No. of Companies Mentioned	10

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Key Market Drivers

Key Market Challenges

Key Market Trends

Key Market Players Profiled:

Report Scope:

By Type:

By Disease Indication Type:

By Distribution Channel:

By End user:

By Region:

Competitive Landscape

Available Customizations:

Table of Contents

Companies Mentioned

Table Information

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