종양학 바이오시밀러 시장 규모, 점유율, 성장 분석 : 적응증별, 약제 클래스별, 투여 경로별, 최종사용자별, 유통 채널별, 지역별 - 업계 예측(2025-2032년)

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