腫瘤生物相似藥市場規模、佔有率和成長分析（按適應症、藥物類別、給藥途徑、最終用戶、分銷管道和地區分類）—2025-2032年產業預測

全球腫瘤生物相似藥市場規模預計在 2024 年達到 69 億美元，從 2025 年的 76.5 億美元成長到 2033 年的 173.7 億美元，在預測期（2026-2033 年）內複合年成長率為 10.8%。

受癌症負擔加重和醫療成本上漲的推動，全球腫瘤生物相似藥市場正經歷強勁成長。隨著重磅腫瘤生物製藥專利到期，生物相似藥憑藉其成本效益優勢，在歐洲藥品管理局 (EMA) 和美國食品藥物管理局(FDA) 等監管機構的快速核准流程支持下，正逐漸成為更具成本效益的替代方案。醫生和醫療機構，尤其是美國、德國和印度等主要市場的醫生和醫療機構，對生物相似藥的接受度不斷提高，進一步推動了市場滲透。政府支持和有利的報銷政策也為生物相似藥的發展創造了有利環境。然而，挑戰依然存在，包括高昂的研發成本、消費者對原廠生物製藥的品牌忠誠度、低收入地區認知度有限以及嚴格的藥品監管規定。這些挑戰可能會阻礙生物相似藥的全面市場滲透和商業化進程，尤其對於中小企業而言。

推動全球腫瘤生物相似藥市場發展的因素

由於多款重磅生物製藥的專利即將到期或到期，全球腫瘤生物相似藥市場預計將會成長。這種情況為生產商推出價格更低廉的生物相似藥鋪平了道路，使其成為現有生物製藥的廣泛替代方案。此外，這些價格較親民的選擇將加劇市場參與者之間的競爭，並最終改善患者獲得有效癌症治療的機會。因此，患者將受益於更廣泛的治療選擇，從而改善癌症治療效果，為市場成長和擴張創造更有利的環境。

全球腫瘤生物相似藥市場面臨的限制因素

全球腫瘤生物相似藥市場面臨許多限制因素，包括複雜的生產流程和高成本。生物相似藥的研發需要大量的分析數據、非臨床數據和臨床數據來證明其與參考藥物的相似性。這項要求導致研發投入巨大，並延長了核准週期。因此，這些因素共同作用，顯著影響了市場的成長潛力，為有意進入或拓展該領域的企業帶來了挑戰。

全球腫瘤生物相似藥市場趨勢

全球腫瘤生物相似藥市場正經歷顯著成長，主要驅動力是高價值腫瘤生物製藥的專利到期不斷增加。隨著這些專利的到期，製藥公司正抓住機遇，開發和銷售生物相似藥，為複雜的治療方法提供更具成本效益的替代方案。這一趨勢不僅擴大了患者獲得必要治療的機會，還有助於應對傳統生物製藥療法不斷上漲的醫療成本。隨著市場的發展，生物相似藥之間的競爭預計將會加劇，最終透過刺激創新和進一步降低價格，使全球患者和醫療保健系統受益。

目錄

介紹

• 調查目標
• 市場定義和範圍

調查方法

• 調查過程
• 二手資料和一手資料方法
• 市場規模估算方法

執行摘要

• 全球市場展望
• 主要市場亮點
• 細分市場概覽
• 競賽概況

市場動態與展望

• 總體經濟指標
• 促進因素和機遇
• 限制與挑戰
• 供給面趨勢
• 需求面趨勢
• 波特的分析和影響
  • 競爭對手之間的競爭
  • 替代品的威脅
  • 買方的議價能力
  • 新進入者的威脅
  • 供應商的議價能力

關鍵市場考察

• 關鍵成功因素
• 影響市場的因素
• 關鍵投資機會
• 生態系測繪
• 市場吸引力指數（2025）
• PESTEL 分析
• 價值鏈分析
• 定價分析
• 案例研究
• 監管環境
• 技術評估

腫瘤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）

• 市場概覽
• 乳癌
• 肺癌
• 大腸直腸癌
• 子宮頸癌
• 血癌
• 其他

腫瘤生物相似藥市場規模（依藥物類別分類）及複合年成長率（2026-2033 年）

• 市場概覽
• 單株抗體
• 顆粒細胞增生因子
• 其他

腫瘤生物相似藥市場規模（依給藥途徑及複合年成長率分類）（2026-2033 年）

• 市場概覽
• 靜脈注射
• 皮下注射
• 其他

腫瘤生物相似藥市場規模（依最終用戶分類）及複合年成長率（2026-2033 年）

• 市場概覽
• 醫院
• 專科診所
• 居家醫療
• 其他

腫瘤生物相似藥市場規模（依通路分類）及複合年成長率（2026-2033 年）

• 市場概覽
• 醫院藥房
• 零售藥房
• 網路藥房
• 其他

腫瘤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
  • 其他歐洲地區
• 亞太地區
  • 中國
  • 印度
  • 日本
  • 韓國
  • 亞太其他地區
• 拉丁美洲
  • 墨西哥
  • 巴西
  • 其他拉丁美洲地區
• 中東和非洲
  • 海灣合作理事會國家
  • 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

• 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）

結論與建議

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