胰岛素生物相似药市场规模、份额和成长分析（按类型、适应症、分销管道和地区划分）—产业预测（2026-2033 年）

预计到 2024 年，全球胰岛素生物相似药市场规模将达到 30.8 亿美元，到 2025 年将达到 32.7 亿美元，到 2033 年将达到 52.9 亿美元，预测期（2026-2033 年）的复合年增长率为 6.2%。

全球胰岛素生物相似药市场预计将迎来显着成长，主要驱动力是糖尿病盛行率的上升。糖尿病相关研发投入的增加以及全球对有效糖尿病管理的日益重视进一步支持了这一需求。创新型胰岛素生物相似药的持续临床试验正在推动市场扩张，而原厂胰岛素产品的专利到期也为市场新参与企业创造了新的机会。然而，严格的监管要求和新型胰岛素生物相似药有限的临床接受度等挑战可能会阻碍市场的长期发展。总而言之，这些因素的相互作用表明，胰岛素生物相似药市场处于动态变化之中，并有可能随着医疗保健需求的增长而发生重大变化。

推动全球胰岛素生物相似药市场发展的因素

随着现有胰岛素原厂药专利保护的到期，全球胰岛素生物相似药市场正迎来强劲成长。预计这将推动市场对创新胰岛素生物相似药的需求成长，为糖尿病患者提供更多治疗选择。此外，医疗研发领域的巨额投资可望为胰岛素生物相似药企业开闢新的发展道路，并为产业发展创造有利环境。因此，糖尿病治疗格局正在不断演变，为医疗服务提供者带来更多机会，并最终造福全球患者。

全球胰岛素生物相似药市场面临的限制因素

全球胰岛素生物相似药市场面临严峻挑战，主要归因于各国政府和监管机构对新型胰岛素生物相似药研发的严格监管和强制规定。这些严苛的指导方针为寻求进入市场的新公司设置了障碍，阻碍了它们的创新和新产品开发能力。因此，潜在的新进者可能难以适应复杂的监管环境，这可能会抑制竞争，并限制患者获得多样化治疗方案的机会。合规方面的复杂性也可能进一步抑制投资，进而影响胰岛素生物相似药领域的整体成长和扩张。

全球胰岛素生物相似药市场趋势

全球胰岛素生物相似药市场正呈现出显着的趋势，即在糖尿病管理中，生技药品和生物相似药的采用率正在上升，这主要受患者需求和医疗机构偏好的双重驱动。随着患者寻求疗效不减、价格更实惠的品牌生技药品替代方案，这项转变为胰岛素生物相似药领域的供应商带来了巨大的机会。企业应积极创新，开发新型生物相似药产品以满足不断增长的市场需求，从而拓展消费群，并在竞争激烈的市场环境中实现最大化收益。

目录

介绍

• 调查目标
• 调查范围
• 定义

调查方法

• 资讯收集
• 一手和二手资料方法
• 市场规模预测
• 市场假设与限制

执行摘要

• 全球市场展望
• 供需趋势分析
• 细分市场机会分析

市场动态与展望

• 市场规模
• 市场动态
  • 驱动因素和机会
  • 限制与挑战
• 波特分析

关键市场考察

• 关键成功因素
• 竞争程度
• 关键投资机会
• 市场生态系统
• 市场吸引力指数（2025）
• PESTEL 分析
• 总体经济指标
• 价值链分析
• 定价分析

全球胰岛素生物相似药市场规模（按类型和复合年增长率划分）（2026-2033 年）

• 速效胰岛素
  • 速效胰岛素类似物
  • 常规人类胰岛素
• 中效胰岛素
  • NPH人胰岛素
  • 预混合料胰岛素
• 长效胰岛素

全球胰岛素生物相似药市场规模（按适应症和复合年增长率划分）（2026-2033 年）

• 1型糖尿病
• 2型糖尿病

全球胰岛素生物相似药市场规模（按分销管道划分）及复合年增长率（2026-2033 年）

• 医院药房
• 零售药房
• 药局
• 网路药房

全球胰岛素生物相似药市场规模及复合年增长率（2026-2033）

• 北美洲
  • 美国
  • 加拿大
• 欧洲
  • 德国
  • 西班牙
  • 法国
  • 英国
  • 义大利
  • 其他欧洲
• 亚太地区
  • 中国
  • 印度
  • 日本
  • 韩国
  • 亚太其他地区
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲
• 中东和非洲
  • GCC
  • 南非
  • 其他中东和非洲地区

竞争资讯

• 前五大公司对比
• 主要企业的市场定位（2025 年）
• 主要市场参与者所采取的策略
• 近期市场趋势
• 公司市占率分析（2025 年）
• 主要企业公司简介
  • 公司详情
  • 产品系列分析
  • 依业务板块进行公司股票分析
  • 2023-2025年营收年比比较

  主要企业简介

  • Viatris公司（美国）
  • 辉瑞公司（美国）
  • 赛诺菲公司（法国）
  • 礼来公司（美国）
  • 诺华公司（瑞士）
  • 默克公司（美国）
  • 勃林格殷格翰有限公司（德国）
  • Biocon有限公司（印度）
  • 三星 Bioepis（韩国）
  • 梯瓦製药工业股份有限公司（以色列）
  • 费森尤斯卡比股份公司（德国）
  • Coherus BioSciences, Inc.（美国）
  • 瑞迪博士实验室有限公司（印度）
  • 安进公司（美国）
  • Celltrion公司（韩国）
  • 奥罗宾多製药有限公司（印度）
  • Intas製药有限公司（印度）
  • 富士软片协和麒麟生物製剂株式会社（日本）
  • 持田製药株式会社（日本）

结论与建议

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