인슐린 바이오시밀러 시장 규모, 점유율, 성장 분석 : 유형별, 적응증별, 유통 채널별, 지역별 - 산업 예측(2025-2032년)

Global Insulin Biosimilars Market size was valued at USD 2.9 billion in 2023 and is poised to grow from USD 3.08 billion in 2024 to USD 4.98 billion by 2032, growing at a CAGR of 6.2% during the forecast period (2025-2032).

The market for insulin biosimilars is poised for significant growth due to the rising prevalence of diabetes, coupled with increasing investments in diabetes research and development (R&D). The ongoing need for effective diabetes management globally is expected to drive demand for these products in the coming years. New clinical trials for innovative insulin biosimilars will further facilitate market expansion, supported by the impending patent expirations of original insulin products, which presents fresh opportunities for market players. However, challenges remain, including stringent regulatory requirements and issues surrounding the clinical acceptance of new biosimilars, which could hinder overall market development in the long term.

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 Segmental 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 Insulin Biosimilars market is significantly driven by the impending patent expirations of established originator insulin products. As these long-standing products become less protected, it is expected to increase the demand for innovative new biosimilars. Furthermore, the rising investment in medical research and development is anticipated to open up new avenues for manufacturers of insulin biosimilars, facilitating the introduction of advanced therapeutic options to the market. This combination of patent expirations and heightened R&D activities is poised to transform the competitive landscape, ultimately benefiting patients with more affordable and effective insulin alternatives.

Restraints in the Global Insulin Biosimilars Market

The global insulin biosimilars market faces significant constraints due to complex regulatory mandates imposed by governments and regulatory authorities. These stringent regulations create challenges for new companies aiming to develop and introduce insulin biosimilars to the market. The arduous approval processes and extensive requirements can hinder innovation and slow down the entry of novel products. As a result, many potential developers may find it daunting to navigate the regulatory landscape, ultimately limiting competition and variety within the market. This restrictive environment poses a substantial barrier to the growth and expansion of the insulin biosimilars sector on a global scale.

Market Trends of the Global Insulin Biosimilars Market

The Global Insulin Biosimilars market is witnessing a significant trend towards the adoption of biologic and biosimilar therapies for diabetes management. As patients and healthcare institutions increasingly prioritize cost-effective treatment options, the demand for high-quality insulin biosimilars is rising, presenting lucrative opportunities for suppliers. This shift is fueled by the need for affordable alternatives to traditional insulin therapies, alongside growing awareness of the efficacy and safety of biosimilars. Companies that innovate and develop novel biosimilar products in alignment with this market trend are poised to enhance their market presence and drive revenue growth in the competitive diabetes care 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, 2024
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis

Global Insulin Biosimilars Market Size by Type: & CAGR (2025-2032)

• 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 (2025-2032)

• Market Overview
• Diabetes Type 1
• Diabetes Type 2

Global Insulin Biosimilars Market Size by By Distribution Channel: & CAGR (2025-2032)

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

Global Insulin Biosimilars Market Size & CAGR (2025-2032)

• 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, 2024
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2024
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2022-2024)

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