肿瘤生物相似药市场规模、份额和成长分析（按适应症、药物类别、给药途径、最终用户、分销管道和地区划分）—2025-2032年产业预测

全球肿瘤生物相似药市场规模预计在 2024 年达到 69 亿美元，从 2025 年的 76.5 亿美元增长到 2033 年的 173.7 亿美元，在预测期（2026-2033 年）内复合年增长率为 10.8%。

受癌症负担加重和医疗成本上涨的推动，全球肿瘤生物相似药市场正经历强劲成长。随着重磅肿瘤生物製药专利到期，生物相似药凭藉其成本效益优势，在欧洲药品管理局 (EMA) 和美国食品药物管理局(FDA) 等监管机构的快速核准流程支持下，正逐渐成为更具成本效益的替代方案。医生和医疗机构，尤其是美国、德国和印度等主要市场的医生和医疗机构，对生物相似药的接受度不断提高，进一步推动了市场渗透。政府支持和有利的报销政策也为生物相似药的发展创造了有利环境。然而，挑战依然存在，包括高昂的研发成本、消费者对原厂生物製药的品牌忠诚度、低收入地区认知度有限以及严格的药品监管规定。这些挑战可能会阻碍生物相似药的全面市场渗透和商业化进程，尤其对于中小企业而言。

推动全球肿瘤生物相似药市场发展的因素

由于多款重磅生物製药的专利即将到期或到期，全球肿瘤生物相似药市场预计将会成长。这种情况为生产商推出价格更低廉的生物相似药铺平了道路，使其成为现有生物製药的广泛替代方案。此外，这些价格较亲民的选择将加剧市场参与者之间的竞争，并最终改善患者获得有效癌症治疗的机会。因此，患者将受益于更广泛的治疗选择，从而改善癌症治疗效果，为市场成长和扩张创造更有利的环境。

全球肿瘤生物相似药市场面临的限制因素

全球肿瘤生物相似药市场面临许多限制因素，包括复杂的生产流程和高成本。生物相似药的研发需要大量的分析数据、非临床数据和临床数据来证明其与参考药物的相似性。这项要求导致研发投入巨大，并延长了核准週期。因此，这些因素共同作用，显着影响了市场的成长潜力，为有意进入或拓展该领域的企业带来了挑战。

全球肿瘤生物相似药市场趋势

全球肿瘤生物相似药市场正经历显着成长，主要驱动力是高价值肿瘤生物製药的专利到期不断增加。随着这些专利的到期，製药公司正抓住机会，开发和销售生物相似药，为复杂的治疗方法提供更具成本效益的替代方案。这一趋势不仅扩大了患者获得必要治疗的机会，还有助于应对传统生物製药疗法不断上涨的医疗成本。随着市场的发展，生物相似药之间的竞争预计将会加剧，最终透过刺激创新和进一步降低价格，使全球患者和医疗保健系统受益。

目录

介绍

• 调查目标
• 市场定义和范围

调查方法

• 调查过程
• 二手资料和一手资料方法
• 市场规模估算方法

执行摘要

• 全球市场展望
• 主要市场亮点
• 细分市场概览
• 竞赛概况

市场动态与展望

• 总体经济指标
• 驱动因素和机会
• 限制与挑战
• 供给面趋势
• 需求面趋势
• 波特的分析和影响
  • 竞争对手之间的竞争
  • 替代品的威胁
  • 买方的议价能力
  • 新进入者的威胁
  • 供应商的议价能力

关键市场考察

• 关键成功因素
• 影响市场的因素
• 关键投资机会
• 生态系测绘
• 市场吸引力指数（2025）
• PESTEL 分析
• 价值链分析
• 定价分析
• 案例研究
• 监管环境
• 技术评估

肿瘤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）

• 市场概览
• 乳癌
• 肺癌
• 大肠直肠癌
• 子宫颈癌
• 血癌
• 其他的

肿瘤生物相似药市场规模（依药物类别划分）及复合年增长率（2026-2033 年）

• 市场概览
• 单株抗体
• 颗粒细胞增生因子
• 其他的

肿瘤生物相似药市场规模（依给药途径及复合年增长率划分）（2026-2033 年）

• 市场概览
• 静脉注射
• 皮下注射
• 其他的

肿瘤生物相似药市场规模（依最终用户划分）及复合年增长率（2026-2033 年）

• 市场概览
• 医院
• 专科诊所
• 居家医疗
• 其他的

肿瘤生物相似药市场规模（依通路划分）及复合年增长率（2026-2033 年）

• 市场概览
• 医院药房
• 零售药房
• 网路药房
• 其他的

肿瘤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
  • 其他欧洲地区
• 亚太地区
  • 中国
  • 印度
  • 日本
  • 韩国
  • 亚太其他地区
• 拉丁美洲
  • 墨西哥
  • 巴西
  • 其他拉丁美洲地区
• 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

• Amgen Inc.（United States）
• Pfizer Inc.（United States）
• Sandoz Group AG（Switzerland）
• Celltrion Inc.（South Korea）
• Samsung Bioepis Co., Ltd.（South Korea）
• Biocon Biologics Limited（India）
• Viatris Inc.（United States）
• Novartis International AG（Switzerland）
• Teva Pharmaceutical Industries Ltd.（Israel）
• Dr. Reddy's Laboratories Ltd.（India）
• STADA Arzneimittel AG（Germany）
• Coherus BioSciences, Inc.（United States）
• Organon & Co.（United States）
• Accord Healthcare（United Kingdom）
• Hospira Inc.（United States）
• BIOCAD（Russia）
• Henlius Biopharmaceuticals（China）
• Apotex Inc.（Canada）
• Formycon AG（Germany）
• Alkem Laboratories Ltd.（India）

结论与建议

Global Oncology Biosimilars Market size was valued at USD 6.9 billion in 2024 and is poised to grow from USD 7.65 billion in 2025 to USD 17.37 billion by 2033, growing at a CAGR of 10.8% during the forecast period (2026-2033).

The global oncology biosimilars market is witnessing robust expansion driven by the increasing cancer burden and rising healthcare costs. As blockbuster oncology biologics lose patent protection, biosimilars emerge as cost-effective alternatives, supported by expedited regulatory pathways from agencies like the EMA and FDA. Growing adoption among physicians and healthcare facilities, particularly in major markets such as the U.S., Germany, and India, further enhances market uptake. Government backing and favorable reimbursement scenarios contribute to an encouraging landscape for biosimilars. However, challenges remain, including high development costs, brand loyalty to originator biologics, limited awareness in low-income areas, and stringent pharmacovigilance regulations, which may hinder comprehensive market penetration and the speed of commercialization, especially for smaller players.

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

Global Oncology Biosimilars Market is segmented by Indication, Drug Class, Route of Administration, End User, Distribution Channel and region. Based on Indication, the market is segmented into Breast Cancer, Lung Cancer, Colorectal Cancer, Cervical Cancer, Blood Cancer and Others. Based on Drug Class, the market is segmented into Monoclonal Antibodies, Granulocyte Colony-Stimulating Factor and Others. Based on Route of Administration, the market is segmented into Intravenous, Subcutaneous and Others. Based on End User, the market is segmented into Hospitals, Specialty Clinics, Homecare and Others. Based on Distribution Channel, the market is segmented into Hospital Pharmacy, Retail Pharmacy, Online Pharmacy and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Oncology Biosimilars Market

The Global Oncology Biosimilars market is set to thrive due to the anticipated and recent expiration of patents for several blockbuster oncology biologic drugs. This situation paves the way for manufacturers to introduce cost-effective biosimilar alternatives to a range of established biologics. Additionally, this influx of affordable options fosters heightened competition among market players, ultimately improving patient access to effective cancer treatments. As a result, the landscape becomes more favorable for market growth and expansion, as patients benefit from a wider selection of therapies that can lead to better outcomes in cancer care.

Restraints in the Global Oncology Biosimilars Market

The Global Oncology Biosimilars market faces substantial limitations due to the complex manufacturing processes and the elevated costs associated with the development of these intricate products. Creating a biosimilar requires extensive analytical, non-clinical, and clinical data to demonstrate its similarity to the reference product. This necessity leads to considerable investments in research and development, contributing to prolonged approval timelines. As a result, the combination of these factors significantly impacts the market's growth potential and presents challenges for companies looking to enter or expand within this sector.

Market Trends of the Global Oncology Biosimilars Market

The Global Oncology Biosimilars market is witnessing significant growth, primarily fueled by the increasing number of patent expirations for high-value oncology biologics. As these patents lapse, pharmaceutical companies are seizing the opportunity to develop and market biosimilars, offering cost-effective alternatives to complex therapies. This trend not only aims to enhance patient access to essential treatments but also addresses the escalating healthcare costs associated with traditional biologic therapies. As the market evolves, the competition among biosimilars is expected to intensify, fostering innovation and further driving down prices, ultimately benefiting patients and healthcare systems globally.

Table of Contents

Introduction

• Objectives of the Study
• Market Definition & Scope

Research Methodology

• Research Process
• Secondary & Primary Data Methods
• Market Size Estimation Methods

Executive Summary

• Global Market Outlook
• Key Market Highlights
• Segmental Overview
• Competition Overview

Market Dynamics & Outlook

• Macro-Economic Indicators
• Drivers & Opportunities
• Restraints & Challenges
• Supply Side Trends
• Demand Side Trends
• Porters Analysis & Impact
  • Competitive Rivalry
  • Threat of Substitute
  • Bargaining Power of Buyers
  • Threat of New Entrants
  • Bargaining Power of Suppliers

Key Market Insights

• Key Success Factors
• Market Impacting Factors
• Top Investment Pockets
• Ecosystem Mapping
• Market Attractiveness Index, 2025
• PESTEL Analysis
• Value Chain Analysis
• Pricing Analysis
• Case Studies
• Regulatory Landscape
• Technology Assessment

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

• Market Overview
• Breast Cancer
• Lung Cancer
• Colorectal Cancer
• Cervical Cancer
• Blood Cancer
• Others

Global Oncology Biosimilars Market Size by Drug Class & CAGR (2026-2033)

• Market Overview
• Monoclonal Antibodies
• Granulocyte Colony-Stimulating Factor
• Others

Global Oncology Biosimilars Market Size by Route of Administration & CAGR (2026-2033)

• Market Overview
• Intravenous
• Subcutaneous
• Others

Global Oncology Biosimilars Market Size by End User & CAGR (2026-2033)

• Market Overview
• Hospitals
• Specialty Clinics
• Homecare
• Others

Global Oncology Biosimilars Market Size by Distribution Channel & CAGR (2026-2033)

• Market Overview
• Hospital Pharmacy
• Retail Pharmacy
• Online Pharmacy
• Others

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

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

• Amgen Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pfizer Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sandoz Group AG (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Celltrion Inc. (South Korea)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Samsung Bioepis Co., Ltd. (South Korea)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Biocon Biologics Limited (India)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Viatris Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Novartis International AG (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Teva Pharmaceutical Industries Ltd. (Israel)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Dr. Reddy's Laboratories Ltd. (India)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• STADA Arzneimittel AG (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Coherus BioSciences, Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Organon & Co. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Accord Healthcare (United Kingdom)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Hospira Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• BIOCAD (Russia)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Henlius Biopharmaceuticals (China)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Apotex Inc. (Canada)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Formycon AG (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Alkem Laboratories Ltd. (India)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations