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非專利藥生技仿製藥

市場調查報告書

商品編碼

1909086

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）—2026-2033年產業預測

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

出版日期: 2026年01月02日 | 出版商:

SkyQuest | 英文 177 Pages | 商品交期: 3-5個工作天內

價格

簡介目錄

預計到 2024 年，全球腫瘤生物相似藥市場規模將達到 76.5 億美元，到 2025 年將成長至 84.7 億美元，到 2033 年將成長至 192.4 億美元，預測期（2026-2033 年）的複合年成長率為 10.8%。

由於癌症發生率上升和醫療成本不斷攀升，全球腫瘤生物相似藥市場正蓬勃發展。領先的生物製藥專利到期，為生物相似藥作為低成本替代品提供了巨大的市場機會。監管機構正在簡化核准流程，為新參與企業提供市場便利。在美國、德國和印度等地區，政府措施和優惠的報銷政策推動了生物相似藥的普及。然而，高昂的研發成本、消費者對現有生物製藥的品牌忠誠度以及開發中國家認知度低等挑戰阻礙了市場滲透。此外，嚴格的藥物警戒要求和廣泛的臨床試驗需求也對新型生物相似藥構成障礙，儘管技術進步和監管政策的調整帶來了可觀的成長前景。

推動全球腫瘤生物相似藥市場發展的因素

由於多種常用生物製藥的專利到期，全球腫瘤生物相似藥市場預計將顯著擴張。這種情況為生產者提供了推出具成本效益生物相似藥的機會，從而刺激了市場參與企業之間的競爭。因此，患者將更容易獲得必要的癌症治療，進一步推動市場成長。價格適中的生物相似藥的湧入不僅有利於產業發展，還將使更多癌症患者能夠獲得有效的治療方法。總而言之，這些因素正在推動腫瘤生物相似藥產業的蓬勃發展。

全球癌症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挑戰，主要源自於其複雜的生產流程和高昂的研發成本。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，這需要大量的研發投入。這種複雜性不僅增加了成本，還導致核准時間延長，阻礙了腫瘤生物相似藥的整體成長和應用。因此，這些因素共同限制了市場的發展。

全球腫瘤生物相似藥市場趨勢

隨著越來越多的高價值腫瘤生物製劑專利到期，全球腫瘤生物相似藥市場正經歷顯著的變化。這一趨勢加劇了市場競爭，製藥公司競相抓住機遇，開發和銷售生物相似藥，將其作為昂貴治療方法的低成本替代方案。由於相關人員將獲得有效癌症治療作為首要任務，生物相似藥的推出有望緩解創新生物製藥帶來的醫療成本上漲問題，同時減輕患者的經濟負擔。這一趨勢有望促進創新，擴大市場參與企業，並最終改善全球患者的治療可及性。

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

簡介目錄

Product Code: SQMIG35H2399

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.

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