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市场调查报告书
商品编码
1909086
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）—2026-2033年产业预测Oncology Biosimilars Market Size, Share, and Growth Analysis, By Indication, By Drug Class, By Route of Administration, By End User, By Distribution Channel, By Region - Industry Forecast 2026-2033 |
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预计到 2024 年，全球肿瘤生物相似药市场规模将达到 76.5 亿美元，到 2025 年将成长至 84.7 亿美元，到 2033 年将成长至 192.4 亿美元，预测期（2026-2033 年）的复合年增长率为 10.8%。
由于癌症发生率上升和医疗成本不断攀升，全球肿瘤生物相似药市场正蓬勃发展。领先的生物製药专利到期，为生物相似药作为低成本替代品提供了巨大的市场机会。监管机构正在简化核准流程，为新参与企业提供市场便利。在美国、德国和印度等地区，政府措施和优惠的报销政策推动了生物相似药的普及。然而，高昂的研发成本、消费者对现有生物製药的品牌忠诚度以及开发中国家认知度低等挑战阻碍了市场渗透。此外，严格的药物警戒要求和广泛的临床试验需求也对新型生物相似药构成障碍，儘管技术进步和监管政策的调整带来了可观的成长前景。
推动全球肿瘤生物相似药市场发展的因素
由于多种常用生物製药的专利到期，全球肿瘤生物相似药市场预计将显着扩张。这种情况为生产者提供了推出高性价比生物相似药的机会，从而刺激了市场参与企业之间的竞争。因此，患者将更容易获得必要的癌症治疗，进一步推动市场成长。价格适中的生物相似药的涌入不仅有利于产业发展，还将使更多癌症患者能够获得有效的治疗方法。总而言之，这些因素正在推动肿瘤生物相似药产业的蓬勃发展。
全球癌症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挑战，主要源自于其复杂的生产流程和高昂的研发成本。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，这需要大量的研发投入。这种复杂性不仅增加了成本，还导致核准时间延长，阻碍了肿瘤生物相似药的整体成长和应用。因此，这些因素共同限制了市场的发展。
全球肿瘤生物相似药市场趋势
随着越来越多的高价值肿瘤生物製剂专利到期，全球肿瘤生物相似药市场正经历显着的变化。这一趋势加剧了市场竞争，製药公司竞相抓住机会，开发和销售生物相似药，将其作为昂贵治疗方法的低成本替代方案。由于相关人员将获得有效癌症治疗作为首要任务，生物相似药的推出有望缓解创新生物製药带来的医疗成本上涨问题，同时减轻患者的经济负担。这一趋势有望促进创新，扩大市场参与企业，并最终改善全球患者的治疗可及性。
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
- 市场主要亮点
- 细分市场概览
- 竞争格局概述
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
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
全球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）
- 乳癌
- 肺癌
- 大肠直肠癌
- 子宫颈癌
- 血癌
- 其他的
全球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）
- 单株抗体
- 颗粒细胞增生因子
- 其他的
全球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）
- 静脉注射
- 皮下注射
- 其他的
全球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）
- 医院
- 专科诊所
- 居家医疗
- 其他的
全球肿瘤生物相似药市场规模（按分销管道和复合年增长率划分）（2026-2033 年）
- 医院药房
- 零售药房
- 网路药房
- 其他的
全球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 7.65 Billion in 2024 and is poised to grow from USD 8.47 Billion in 2025 to USD 19.24 Billion by 2033, growing at a CAGR of 10.8% during the forecast period (2026-2033).
The global oncology biosimilars market is gaining momentum, driven by the rising cancer prevalence and escalating healthcare costs. The expiration of patents for major oncology biologics provides a lucrative opportunity, with biosimilars presenting lower-cost alternatives. Regulatory bodies have streamlined approval processes, enhancing market entry for new players. The uptake is further bolstered by increased usage in regions like the U.S., Germany, and India, supported by government initiatives and favorable reimbursement policies. However, challenges such as high development costs, brand loyalty to established biologics, and limited awareness in developing nations hinder market penetration. Moreover, stringent pharmacovigilance requirements and the necessity for extensive clinical trials create barriers for new biosimilars, although technological advancements and regulatory alignment offer promising growth prospects.
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 expand significantly due to the patent expirations of several widely used oncology biologic drugs. This situation opens the door for manufacturers to introduce cost-effective biosimilars, enhancing competition among market participants. As a result, patients will gain improved access to essential cancer treatments, which is expected to stimulate further growth in the market. The influx of affordable biosimilar options not only benefits the industry's dynamics but also supports a broader availability of effective therapies for those battling cancer. Overall, these factors collectively contribute to the robust development of the oncology biosimilars sector.
Restraints in the Global Oncology Biosimilars Market
The global oncology biosimilars market faces notable challenges due to intricate manufacturing processes and substantial costs associated with the development of these sophisticated products. Creating a biosimilar requires extensive analytical, non-clinical, and clinical data to demonstrate its similarity to the reference product, which in turn necessitates considerable investments in research and development. This complexity not only drives up expenses but also leads to prolonged approval times, hindering the overall growth and accessibility of biosimilars in the oncology sector. As a result, these factors collectively act as significant restraints on the market.
Market Trends of the Global Oncology Biosimilars Market
The Global Oncology Biosimilars market is witnessing a notable shift driven by the increasing number of patent expirations for high-value oncology biologics. This trend fosters a competitive landscape where pharmaceutical companies are keen to capitalize on opportunities to develop and market biosimilars as cost-effective alternatives to expensive therapies. As stakeholders prioritize access to effective cancer treatments, the introduction of biosimilars is poised to enhance patient affordability while simultaneously addressing the rising healthcare costs associated with innovative biologic drugs. Consequently, this dynamic is expected to stimulate innovation, expand market participation, and ultimately improve treatment accessibility for patients worldwide.
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
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