인슐린 바이오시밀러 시장 규모, 점유율 및 성장 분석 : 유형별, 적응증별, 유통 채널별, 지역별 - 업계 예측(2026-2033년)

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).

The global insulin biosimilars market is poised for significant growth, driven primarily by the rising prevalence of diabetes. This demand is further supported by increased investments in research and development related to diabetes and a heightened emphasis on effective diabetes management globally. Ongoing clinical trials for innovative insulin biosimilars are contributing to market expansion, while the patent expirations of original insulin products present fresh opportunities for market players. However, challenges such as stringent regulatory requirements and limited clinical acceptance of new insulin biosimilars may impede long-term market development. Overall, the interplay of these factors suggests a dynamic landscape for insulin biosimilars, with potential for substantial market evolution in response to the growing healthcare demands.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Insulin Biosimilars market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global 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.

Driver of the Global Insulin Biosimilars Market

The global market for insulin biosimilars is experiencing a significant boost as established originator insulin products reach the end of their patent protection. This situation is expected to drive increased demand for innovative and novel insulin biosimilars, providing patients with more options for diabetes management. Additionally, substantial investments in medical research and development are anticipated to open new avenues for companies specializing in insulin biosimilars, fostering an environment ripe for growth and advancement within the industry. As a result, the landscape for diabetes treatment is evolving, creating compelling opportunities for providers and ultimately benefiting patients worldwide.

Restraints in the Global Insulin Biosimilars Market

The Global Insulin Biosimilars market faces significant challenges due to the stringent regulations and mandates imposed by governments and regulatory bodies concerning the development of new insulin biosimilars. These rigorous guidelines create barriers for new companies seeking to enter the market, hindering their ability to innovate and bring forth new products. As a result, potential entrants may encounter difficulties in navigating the regulatory landscape, which can stifle competition and limit the availability of diverse treatment options for patients. The complexities associated with compliance may further deter investment, impacting the overall growth and expansion of the insulin biosimilars sector.

Market Trends of the Global Insulin Biosimilars Market

The global insulin biosimilars market is experiencing a notable trend towards the adoption of biologic and biosimilar therapies for diabetes management, driven by both patient demand and healthcare institutional preferences. This shift is opening up significant opportunities for suppliers in the insulin biosimilars sector, as healthcare providers seek cost-effective alternatives to branded biologics without compromising on efficacy. Companies are encouraged to innovate by developing novel biosimilar products that align with this growing market interest, enhancing their ability to tap into a burgeoning consumer base and maximize revenue potential in an increasingly competitive landscape.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Drivers & Opportunities
  • Restraints & Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Market Attractiveness Index, 2025
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis

Global Insulin Biosimilars Market Size by Type: & CAGR (2026-2033)

• Market Overview
• Fast-acting Insulin
  • Rapid-acting Insulin Analogs
  • Regular Human Insulin
• Intermediate-acting Insulin
  • NPH Human Insulin
  • Pre-mixed Insulin
• Long-acting Insulin

Global Insulin Biosimilars Market Size by Indication: & CAGR (2026-2033)

• Market Overview
• Diabetes Type 1
• Diabetes Type 2

Global Insulin Biosimilars Market Size by By Distribution Channel: & CAGR (2026-2033)

• Market Overview
• Hospital Pharmacies
• Retail Pharmacies
• Drug Stores
• Online Pharmacies

Global Insulin Biosimilars Market Size & CAGR (2026-2033)

• North America (Type:, Indication:, By Distribution Channel:)
  • US
  • Canada
• Europe (Type:, Indication:, By Distribution Channel:)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Type:, Indication:, By Distribution Channel:)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Type:, Indication:, By Distribution Channel:)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Type:, Indication:, By Distribution Channel:)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2025
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2025
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2023-2025)

Key Company Profiles

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

Conclusion & Recommendations