生物相似药市场规模、份额、成长分析（按药品类别、适应症和地区）—2025 年至 2032 年产业预测

2023 年全球生物相似药市场规模为 243 亿美元，预计将从 2024 年的 283.8 亿美元成长到 2032 年的 983.1 亿美元，预测期内（2025-2032 年）的复合年增长率为 16.8%。

全球生物相似药市场预计将加速成长，这主要归因于Humira和Remicade等成熟生物製药的专利到期，为具有成本效益的替代品铺平了道路。这些生物相似药的价格通常比参考药物低 15-30%，从而刺激了它们在先前服务不足的市场中的应用。各国政府正透过优惠的报销政策促进生物相似药的引进，进一步提高其可及性。 FDA 和 EMA 等监管机构正在简化核准流程，减少时间和成本，并增加市场竞争。此外，人工智慧的进步正在透过改善生物特性和製造效率彻底改变生物相似药的发展，从而缩短研发週期并降低成本。 Biogen 和In Silico Medicine 等合作体现了人工智慧可以对产业产生的变革性影响，最终改善患者的治疗效果和市场可行性。

目录

介绍

• 调查目的
• 研究范围
• 定义

调查方法

• 资讯采购
• 二次资料和一次资料方法
• 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
• 细分机会分析

市场动态与展望

• 市场概览
• 市场规模
• 市场动态
  • 驱动因素和机会
  • 限制与挑战
• 波特的分析

关键市场考察

• 关键成功因素
• 竞争程度
• 主要投资机会
• 市场生态系统
• 市场吸引力指数（2024年）
• PESTEL分析
• 总体经济指标
• 价值链分析
• 定价分析
• 专利分析
• 监管分析
• 案例研究

生物相似药市场规模（按药物类别和复合年增长率） (2025-2032)

• 市场概览
• 单株抗体
  • Infliximab
  • Rituximab
  • 曲妥珠单抗
  • Adalimumab
  • 其他单株抗体
• 颗粒细胞增生因子
• 胰岛素
• 促红血球生成素
• 重组人体生长荷尔蒙
• Etanercept
• 促滤泡素
• 特立帕肽
• 干扰素
• 抗凝血剂
• 其他药物类别

生物相似药市场规模（按适应症和复合年增长率） (2025-2032)

• 市场概览
• 肿瘤学
• 发炎与自体免疫疾病
• 慢性病
• 血液系统疾病
• 生长激素缺乏症
• 感染疾病
• 其他适应症

生物相似药市场规模（按地区）及复合年增长率（2025-2032）

• 北美洲
  • 美国
  • 加拿大
• 欧洲
  • 德国
  • 西班牙
  • 法国
  • 英国
  • 义大利
  • 其他欧洲国家
• 亚太地区
  • 中国
  • 印度
  • 日本
  • 韩国
  • 其他亚太地区
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲
• 中东和非洲
  • 海湾合作委员会国家
  • 南非
  • 其他中东和非洲地区

竞争资讯

• 前五大公司对比
• 主要企业市场定位（2024年）
• 主要市场参与者所采取的策略
• 近期市场趋势
• 公司市场占有率分析（2024年）
• 主要企业简介
  • 公司详情
  • 产品系列分析
  • 公司分部份额分析
  • 收益与前一年同期比较对比（2022-2024 年）

主要企业简介

• Biocon Biologics（India）
• Celltrion（South Korea）
• Sandoz（Switzerland）
• Fresenius Kabi（Germany）
• Teva Pharmaceuticals（Israel）
• Amgen（USA）
• Mylan（USA）
• Coherus BioSciences（USA）
• Alvotech（Iceland）
• Polpharma Biologics（Poland）
• Accord Healthcare（United Kingdom）
• Formycon（Germany）
• Pfizer（USA）

结论和建议

Global Biosimilars Market size was valued at USD 24.3 billion in 2023 and is poised to grow from USD 28.38 billion in 2024 to USD 98.31 billion by 2032, growing at a CAGR of 16.8% during the forecast period (2025-2032).

The global biosimilars market is poised for accelerated growth, primarily fueled by the expiration of patents on established biologic drugs such as Humira and Remicade, paving the way for cost-effective alternatives. These biosimilars provide significant affordability, typically 15-30% less than their reference counterparts, thereby boosting adoption in previously underserved markets. Governments are promoting biosimilar uptake through favorable reimbursement policies, further enhancing accessibility. Regulatory bodies like the FDA and EMA have streamlined approval processes, reducing time and costs, and encouraging market competition. Moreover, advancements in AI are revolutionizing biosimilar development by improving biologic characterization and manufacturing efficiency, leading to shorter R&D cycles and lower expenses. Collaborations, such as that between Biogen and Insilico Medicine, exemplify the transformative impact of AI on the industry, ultimately enhancing patient outcomes and market viability.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global 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 Biosimilars Market Segments Analysis

Global Biosimilars Market is segmented by Drug Class, Indication and region. Based on Drug Class, the market is segmented into Monoclonal Antibodies, Granulocyte Colony-Stimulating Factor, Insulin, Erythropoietin, Recombinant Human Growth Hormone, Etanercept, Follitropin, Teriparatide, Interferons, Anticoagulants and Other Drug Classes. Based on Indication, the market is segmented into Oncology, Inflammatory & Autoimmune Diseases, Chronic Diseases, Blood Disorders, Growth Hormone Deficiency, Infectious Diseases and Other Indications. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Biosimilars Market

The increasing incidence of chronic illnesses such as cancer, diabetes, and autoimmune disorders is driving the demand for cost-effective biologic therapies. Biosimilars offer affordable alternatives to expensive biologic drugs, thereby improving patient access to essential treatments that can sustain life. As more individuals seek long-term therapeutic options, the uptake of biosimilar medications continues to rise significantly. This trend highlights the vital role that biosimilars play in addressing the healthcare needs of patients while also alleviating financial burdens associated with traditional biologic medicines, thereby fueling the growth of the global biosimilars market.

Restraints in the Global Biosimilars Market

The global biosimilars market faces significant challenges due to stringent regulatory evaluations required to demonstrate safety, efficacy, and quality in comparison to reference biologics. Variations in approval processes across different countries create delays and increase compliance costs for manufacturers. This complex regulatory landscape poses obstacles for biosimilar companies, impacting their ability to launch products effectively and ultimately restricting their market presence. As a result, the growth potential of the biosimilars market may be hindered by these regulatory hurdles, which require substantial time and resources to navigate, thus affecting overall accessibility and competitiveness within the industry.

Market Trends of the Global Biosimilars Market

The global biosimilars market is experiencing significant growth, driven by increasing demand for affordable biologic therapies and advancements in biotechnology. As companies like Arven Pharmaceuticals, established in 2013, enhance their portfolio with complex biosimilars such as Fraven, a Filgrastim biosimilar, the market is poised for further expansion. The rising prevalence of conditions like neutropenia, especially among cancer patients undergoing chemotherapy, has accelerated the adoption of biosimilars, which offer similar efficacy at lower costs. Furthermore, regulatory advancements in regions like the EU and U.S. are facilitating market entry, making biosimilars a fundamental component of the global healthcare 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
• Patent Analysis
• Regulatory Analysis
• Case Studies

Global Biosimilars Market Size by Drug Class & CAGR (2025-2032)

• Market Overview
• Monoclonal Antibodies
  • Infliximab
  • Rituximab
  • Trastuzumab
  • Adalimumab
  • Other Monoclonal Antibodies
• Granulocyte Colony-Stimulating Factor
• Insulin
• Erythropoietin
• Recombinant Human Growth Hormone
• Etanercept
• Follitropin
• Teriparatide
• Interferons
• Anticoagulants
• Other Drug Classes

Global Biosimilars Market Size by Indication & CAGR (2025-2032)

• Market Overview
• Oncology
• Inflammatory & Autoimmune Diseases
• Chronic Diseases
• Blood Disorders
• Growth Hormone Deficiency
• Infectious Diseases
• Other Indications

Global Biosimilars Market Size & CAGR (2025-2032)

• North America (Drug Class, Indication)
  • US
  • Canada
• Europe (Drug Class, Indication)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Drug Class, Indication)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Drug Class, Indication)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Drug Class, Indication)
  • 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

• Biocon Biologics (India)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Celltrion (South Korea)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sandoz (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Fresenius Kabi (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Teva Pharmaceuticals (Israel)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Amgen (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Mylan (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Coherus BioSciences (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Alvotech (Iceland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Polpharma Biologics (Poland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Accord Healthcare (United Kingdom)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Formycon (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pfizer (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations