胰島素生物相似藥市場規模、佔有率和成長分析（按類型、適應症、分銷管道和地區分類）—產業預測（2026-2033 年）

預計到 2024 年，全球胰島素生物相似藥市場規模將達到 30.8 億美元，到 2025 年將達到 32.7 億美元，到 2033 年將達到 52.9 億美元，預測期（2026-2033 年）的複合年成長率為 6.2%。

全球胰島素生物相似藥市場預計將迎來顯著成長，主要驅動力是糖尿病盛行率的上升。糖尿病相關研發投入的增加以及全球對有效糖尿病管理的日益重視進一步支持了這一需求。創新型胰島素生物相似藥的持續臨床試驗正在推動市場擴張，而原廠胰島素產品的專利到期也為市場新參與企業創造了新的機會。然而，嚴格的監管要求和新型胰島素生物相似藥有限的臨床接受度等挑戰可能會阻礙市場的長期發展。總而言之，這些因素的相互作用表明，胰島素生物相似藥市場處於動態變化之中，並有可能隨著醫療保健需求的成長而發生重大變化。

推動全球胰島素生物相似藥市場發展的因素

隨著現有胰島素原廠藥專利保護的到期，全球胰島素生物相似藥市場正迎來強勁成長。預計這將推動市場對創新胰島素生物相似藥的需求成長，為糖尿病患者提供更多治療選擇。此外，醫療研發領域的巨額投資可望為胰島素生物相似藥企業開闢新的發展道路，並為產業發展創造有利環境。因此，糖尿病治療格局正在不斷演變，為醫療服務提供者帶來更多機遇，並最終造福全球患者。

全球胰島素生物相似藥市場面臨的限制因素

全球胰島素生物相似藥市場面臨嚴峻挑戰，主要歸因於各國政府和監管機構對新型胰島素生物相似藥研發的嚴格監管和強制規定。這些嚴苛的指導方針為尋求進入市場的新公司設置了障礙，阻礙了它們的創新和新產品開發能力。因此，潛在的新進者可能難以適應複雜的監管環境，這可能會抑制競爭，並限制患者獲得多樣化治療方案的機會。合規方面的複雜性也可能進一步抑制投資，進而影響胰島素生物相似藥領域的整體成長和擴張。

全球胰島素生物相似藥市場趨勢

全球胰島素生物相似藥市場正呈現出顯著的趨勢，即在糖尿病管理中，生技藥品和生物相似藥的採用率正在上升，這主要受患者需求和醫療機構偏好的雙重驅動。隨著患者尋求療效不減、價格更實惠的品牌生技藥品替代方案，這項轉變為胰島素生物相似藥領域的供應商帶來了巨大的機會。企業應積極創新，開發新型生物相似藥產品以滿足不斷成長的市場需求，從而拓展消費群，並在競爭激烈的市場環境中實現最大化收益。

目錄

介紹

• 調查目標
• 調查範圍
• 定義

調查方法

• 資訊收集
• 一手和二手資料方法
• 市場規模預測
• 市場假設與限制

執行摘要

• 全球市場展望
• 供需趨勢分析
• 細分市場機會分析

市場動態與展望

• 市場規模
• 市場動態
  • 促進因素和機遇
  • 限制與挑戰
• 波特分析

關鍵市場考察

• 關鍵成功因素
• 競爭程度
• 關鍵投資機會
• 市場生態系統
• 市場吸引力指數（2025）
• PESTEL 分析
• 總體經濟指標
• 價值鏈分析
• 定價分析

全球胰島素生物相似藥市場規模（按類型和複合年成長率分類）（2026-2033 年）

• 速效胰島素
  • 速效胰島素類似物
  • 常規人類胰島素
• 中效胰島素
  • NPH人胰島素
  • 預混合料胰島素
• 長效胰島素

全球胰島素生物相似藥市場規模（按適應症和複合年成長率分類）（2026-2033 年）

• 1型糖尿病
• 2型糖尿病

全球胰島素生物相似藥市場規模（按分銷管道分類）及複合年成長率（2026-2033 年）

• 醫院藥房
• 零售藥房
• 藥局
• 網路藥房

全球胰島素生物相似藥市場規模及複合年成長率（2026-2033）

• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 西班牙
  • 法國
  • 英國
  • 義大利
  • 其他歐洲
• 亞太地區
  • 中國
  • 印度
  • 日本
  • 韓國
  • 亞太其他地區
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲
• 中東和非洲
  • GCC
  • 南非
  • 其他中東和非洲地區

競爭資訊

• 前五大公司對比
• 主要企業的市場定位（2025 年）
• 主要市場參與者所採取的策略
• 近期市場趨勢
• 公司市佔率分析（2025 年）
• 主要企業公司簡介
  • 公司詳情
  • 產品系列分析
  • 依業務板塊進行公司股票分析
  • 2023-2025年營收年比比較

  主要企業簡介

  • Viatris公司（美國）
  • 輝瑞公司（美國）
  • 賽諾菲公司（法國）
  • 禮來公司（美國）
  • 諾華公司（瑞士）
  • 默克公司（美國）
  • 勃林格殷格翰有限公司（德國）
  • Biocon有限公司（印度）
  • 三星 Bioepis（韓國）
  • 梯瓦製藥工業股份有限公司（以色列）
  • 費森尤斯卡比股份公司（德國）
  • Coherus BioSciences, Inc.（美國）
  • 瑞迪博士實驗室有限公司（印度）
  • 安進公司（美國）
  • Celltrion公司（韓國）
  • 奧羅賓多製藥有限公司（印度）
  • Intas製藥有限公司（印度）
  • 富士軟片協和麒麟生物製劑株式會社（日本）
  • 持田製藥株式會社（日本）

結論與建議

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