종양학 바이오시밀러 시장 규모, 점유율, 성장, 세계 산업 분석, 지역별 인사이트 및 예측(2026-2034년)

Growth Factors of oncology biosimilars Market

The global oncology biosimilars market size was valued at USD 9.80 billion in 2025 and is projected to grow from USD 10.74 billion in 2026 to USD 32.25 billion by 2034, exhibiting a CAGR of 14.73% during the forecast period. Asia Pacific dominated the market with a 32.95% share in 2025, valued at USD 3.23 billion, supported by the rising cancer burden, growing demand for affordable biologic treatments, expanding domestic biologics manufacturing, and improving regulatory frameworks. The increasing availability of biosimilars is helping healthcare systems expand access to oncology therapies while managing treatment costs.

Oncology biosimilars are increasingly being adopted as cost-effective alternatives to reference biologic medicines, including monoclonal antibodies and immune-oncology therapies. Growing regulatory approvals, physician acceptance, hospital adoption, and commercialization across developed and emerging markets are encouraging pharmaceutical companies to expand their oncology biosimilar pipelines. In January 2026, Zydus Lifesciences launched Tishtha, a nivolumab biosimilar, in India for multiple cancers at approximately one-fourth of the reference drug's cost, supporting broader access to immune-oncology treatment.

Market Definition and Scope

The oncology biosimilars market includes biologic medicines that are developed to demonstrate high similarity to approved reference biologics used in cancer treatment. These products provide treatment alternatives across several cancer indications while supporting cost containment and broader access to biological therapies. The market encompasses biosimilars targeting HER2, VEGF, CD20, immune checkpoint pathways, and other therapeutic targets.

The market is segmented by drug class, product, application, age group, route of administration, and distribution channel. Major products include trastuzumab, bevacizumab, rituximab, pertuzumab, pembrolizumab, nivolumab, and ipilimumab.

Market Dynamics

Drivers

The rising global cancer burden is a major growth driver because increasing cancer incidence expands the population eligible for biological treatment. Breast cancer, lung cancer, colorectal cancer, lymphoma, and other malignancies are increasing demand for therapies such as trastuzumab, bevacizumab, and rituximab. The expansion of approved biosimilar portfolios is allowing healthcare systems to provide biological treatments to more patients while controlling expenditure.

Price discounts, institutional procurement frameworks, reimbursement policies, and growing physician familiarity are also supporting biosimilar adoption. The upcoming loss of exclusivity for major checkpoint inhibitors is creating additional opportunities for manufacturers to develop new oncology biosimilars.

Trends

A prominent trend is the shift toward cost-effective biosimilar-based cancer treatment. Hospitals, payers, and government procurement organizations are increasingly adopting biosimilars to manage oncology budgets. Manufacturers are also expanding into checkpoint inhibitor biosimilars, including products targeting pembrolizumab and nivolumab, creating a newer growth area within the market.

Restraints

Aggressive price erosion and margin compression represent key restraints. Competition among manufacturers can reduce average selling prices, particularly for established products such as trastuzumab, bevacizumab, and rituximab. High development, manufacturing, regulatory, and commercialization costs can further pressure manufacturer margins and create barriers for smaller companies.

Impact of COVID-19

The provided report does not give a specific quantified COVID-19 impact assessment for the oncology biosimilars market. Therefore, no additional pandemic-related market values are introduced. The current market outlook in the source is primarily based on cancer treatment demand, biosimilar adoption, regulatory developments, pricing, and pharmaceutical investment.

Segmentation Analysis

By drug class, anti-HER2 monoclonal antibodies dominated in 2025, supported by extensive use of trastuzumab and pertuzumab biosimilars in HER2-positive breast and gastric cancers. Immune checkpoint inhibitor biosimilars are projected to grow at a CAGR of 103.89%.

By product, rituximab dominated in 2025 due to its extensive use in hematological cancers and the availability of multiple approved biosimilars. The ipilimumab segment is projected to register a CAGR of 121.37%.

By application, breast cancer held the leading position in 2025 because of its large patient population and extensive use of HER2-targeted biological therapies. The melanoma segment is projected to grow at a CAGR of 104.09%.

By age group, adults dominated the market in 2025, reflecting the larger adult cancer treatment population. By route of administration, intravenous products held the leading position, while the subcutaneous segment is projected to grow at a CAGR of 27.26%. Hospital pharmacies dominated the distribution channel, while online pharmacies are projected to record a CAGR of 21.75%.

Regional Insights

Asia Pacific dominated the market with USD 3.23 billion in 2025 and is estimated to reach USD 3.58 billion in 2026. China, Japan, and India are important regional markets, with 2026 values of approximately USD 1.17 billion, USD 0.77 billion, and USD 0.50 billion, respectively.

North America reached USD 2.48 billion in 2025, supported by biologic cancer therapy utilization, reimbursement coverage, and increasing biosimilar approvals. The U.S. market is estimated at USD 2.55 billion in 2026.

Europe is projected to reach USD 3.50 billion in 2026, supported by physician acceptance, cost-containment policies, and an established biosimilar regulatory framework. The U.K. and Germany are estimated at USD 0.62 billion and USD 0.81 billion, respectively, in 2026.

Competitive Landscape

The oncology biosimilars market includes global and regional pharmaceutical companies competing through regulatory approvals, product launches, clinical development, licensing agreements, acquisitions, and commercialization partnerships. Key companies include Celltrion, Amgen, Pfizer, Biocon Biologics, Samsung Bioepis, Sandoz, Shanghai Henlius Biotech, Teva Pharmaceutical Industries, Organon, Accord Healthcare, Fresenius Kabi, Amneal Pharmaceuticals, and Dr. Reddy's Laboratories.

Report Coverage

The report covers the 2025 market size of USD 9.80 billion, 2026 market value of USD 10.74 billion, and 2034 forecast value of USD 32.25 billion, along with a 14.73% CAGR. It analyzes market drivers, trends, restraints, opportunities, challenges, drug classes, products, applications, age groups, administration routes, distribution channels, regional markets, competitive strategies, regulatory developments, product launches, and industry developments.

Conclusion

The global oncology biosimilars market is projected to expand from USD 9.80 billion in 2025 to USD 10.74 billion in 2026 and USD 32.25 billion by 2034. Rising cancer incidence, increasing demand for affordable biologic therapies, expanding biosimilar approvals, reimbursement support, and growing physician acceptance are supporting market development. The expansion of biosimilars for established oncology medicines and emerging checkpoint inhibitor therapies is expected to remain an important component of the market's development through 2034.

Segmentation By Drug Class, Product, Application, Age Group, Route of Administration, Distribution Channel, and Region

By Drug Class

• Anti-HER2 Monoclonal Antibodies
• Anti-VEGF Monoclonal Antibodies
• Anti-CD20 Monoclonal Antibodies
• Immune Checkpoint Inhibitor Biosimilars
• Other Therapeutic Monoclonal Antibodies
• Others

By Product

• Trastuzumab
• Bevacizumab
• Rituximab
• Pertuzumab
• Pembrolizumab
• Nivolumab
• Ipilimumab
• Others

By Application

• Breast Cancer
• Lung Cancer
• Colorectal Cancer
• Non-Hodgkin's Lymphoma
• Chronic Lymphocytic Leukemia
• Gastric & Gastroesophageal Junction Cancer
• Melanoma
• Others

By Age Group

• Pediatric
• Adults

By Route of Administration

• Intravenous
• Subcutaneous
• Others

By Distribution Channel

• Hospital Pharmacies
• Specialty Pharmacies
• Drug Stores & Retail Pharmacies
• Online Pharmacies

By Region

• North America (By Drug Class, Product, Application, Age Group, Route of Administration, Distribution Channel, and Country)
  • U.S.
  • Canada
• Europe (By Drug Class, Product, Application, Age Group, Route of Administration, Distribution Channel, and Country/Sub-region)
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • Scandinavia
  • Rest of Europe
• Asia Pacific (By Drug Class, Product, Application, Age Group, Route of Administration, Distribution Channel, and Country/Sub-region)
  • China
  • Japan
  • India
  • Australia
  • Southeast Asia
  • Rest of Asia Pacific
• Latin America (By Drug Class, Product, Application, Age Group, Route of Administration, Distribution Channel, and Country/Sub-region)
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa (By Drug Class, Product, Application, Age Group, Route of Administration, Distribution Channel, and Country/Sub-region)
  • GCC
  • South Africa
  • Rest of the Middle East & Africa

Table of Content

1. Introduction

• 1.1. Research Scope
• 1.2. Market Segmentation
• 1.3. Research Methodology
• 1.4. Definitions and Assumptions

2. Executive Summary

3. Market Dynamics

• 3.1. Market Drivers
• 3.2. Market Restraints
• 3.3. Market Opportunities
• 3.4. Market Challenges
• 3.5. Market Trends

4. Key Insights

• 4.1. Prevalence of Key Disease Indications, By Key Regions, Countries
• 4.2. Pipeline Analysis, By Key Regions
• 4.3. Overview of Regulatory Scenario, By Key Regions/Countries
• 4.4. New Product Launches, By Key Players
• 4.5. Key Industry Developments (Mergers, Acquisitions, Partnerships, Launches, etc.)

5. Global Oncology Biosimilars Market Analysis, Insights and Forecast, 2021-2034

• 5.1. Market Analysis, Insights and Forecast - By Drug Class
  • 5.1.1. Anti-HER2 Monoclonal Antibodies
  • 5.1.2. Anti-VEGF Monoclonal Antibodies
  • 5.1.3. Anti-CD20 Monoclonal Antibodies
  • 5.1.4. Immune Checkpoint Inhibitor Biosimilars
  • 5.1.5. Other Therapeutic Monoclonal Antibodies
  • 5.1.6. Others
• 5.2. Market Analysis, Insights and Forecast - By Product
  • 5.2.1. Trastuzumab
  • 5.2.2. Bevacizumab
  • 5.2.3. Rituximab
  • 5.2.4. Pertuzumab
  • 5.2.5. Pembrolizumab
  • 5.2.6. Nivolumab
  • 5.2.7. Ipilimumab
  • 5.2.8. Others
• 5.3. Market Analysis, Insights and Forecast - By Application
  • 5.3.1. Breast Cancer
  • 5.3.2. Lung Cancer
  • 5.3.3. Colorectal Cancer
  • 5.3.4. Non-Hodgkin's Lymphoma
  • 5.3.5. Chronic Lymphocytic Leukemia
  • 5.3.6. Gastric & Gastroesophageal Junction Cancer
  • 5.3.7. Melanoma
  • 5.3.8. Others
• 5.4. Market Analysis, Insights and Forecast - By Age Group
  • 5.4.1. Pediatric
  • 5.4.2. Adults
• 5.5. Market Analysis, Insights and Forecast - By Route of Administration
  • 5.5.1. Intravenous
  • 5.5.2. Subcutaneous
  • 5.5.3. Others
• 5.6. Market Analysis, Insights and Forecast - By Distribution Channel
  • 5.6.1. Hospital Pharmacies
  • 5.6.2. Specialty Pharmacies
  • 5.6.3. Drug Stores & Retail Pharmacies
  • 5.6.4. Online Pharmacies
• 5.7. Market Analysis, Insights and Forecast - Region
  • 5.7.1. North America
  • 5.7.2. Europe
  • 5.7.3. Asia Pacific
  • 5.7.4. Latin America
  • 5.7.5. Middle East & Africa

6. North America Oncology Biosimilars Market Analysis, Insights and Forecast, 2021-2034

• 6.1. Market Analysis, Insights and Forecast - By Drug Class
  • 6.1.1. Anti-HER2 Monoclonal Antibodies
  • 6.1.2. Anti-VEGF Monoclonal Antibodies
  • 6.1.3. Anti-CD20 Monoclonal Antibodies
  • 6.1.4. Immune Checkpoint Inhibitor Biosimilars
  • 6.1.5. Other Therapeutic Monoclonal Antibodies
  • 6.1.6. Others
• 6.2. Market Analysis, Insights and Forecast - By Product
  • 6.2.1. Trastuzumab
  • 6.2.2. Bevacizumab
  • 6.2.3. Rituximab
  • 6.2.4. Pertuzumab
  • 6.2.5. Pembrolizumab
  • 6.2.6. Nivolumab
  • 6.2.7. Ipilimumab
  • 6.2.8. Others
• 6.3. Market Analysis, Insights and Forecast - By Application
  • 6.3.1. Breast Cancer
  • 6.3.2. Lung Cancer
  • 6.3.3. Colorectal Cancer
  • 6.3.4. Non-Hodgkin's Lymphoma
  • 6.3.5. Chronic Lymphocytic Leukemia
  • 6.3.6. Gastric & Gastroesophageal Junction Cancer
  • 6.3.7. Melanoma
  • 6.3.8. Others
• 6.4. Market Analysis, Insights and Forecast - By Age Group
  • 6.4.1. Pediatric
  • 6.4.2. Adults
• 6.5. Market Analysis, Insights and Forecast - By Route of Administration
  • 6.5.1. Intravenous
  • 6.5.2. Subcutaneous
  • 6.5.3. Others
• 6.6. Market Analysis, Insights and Forecast - By Distribution Channel
  • 6.6.1. Hospital Pharmacies
  • 6.6.2. Specialty Pharmacies
  • 6.6.3. Drug Stores & Retail Pharmacies
  • 6.6.4. Online Pharmacies
• 6.7. Market Analysis, Insights and Forecast - By Country
  • 6.7.1. U.S.
  • 6.7.2. Canada

7. Europe Oncology Biosimilars Market Analysis, Insights and Forecast, 2021-2034

• 7.1. Market Analysis, Insights and Forecast - By Drug Class
  • 7.1.1. Anti-HER2 Monoclonal Antibodies
  • 7.1.2. Anti-VEGF Monoclonal Antibodies
  • 7.1.3. Anti-CD20 Monoclonal Antibodies
  • 7.1.4. Immune Checkpoint Inhibitor Biosimilars
  • 7.1.5. Other Therapeutic Monoclonal Antibodies
  • 7.1.6. Others
• 7.2. Market Analysis, Insights and Forecast - By Product
  • 7.2.1. Trastuzumab
  • 7.2.2. Bevacizumab
  • 7.2.3. Rituximab
  • 7.2.4. Pertuzumab
  • 7.2.5. Pembrolizumab
  • 7.2.6. Nivolumab
  • 7.2.7. Ipilimumab
  • 7.2.8. Others
• 7.3. Market Analysis, Insights and Forecast - By Application
  • 7.3.1. Breast Cancer
  • 7.3.2. Lung Cancer
  • 7.3.3. Colorectal Cancer
  • 7.3.4. Non-Hodgkin's Lymphoma
  • 7.3.5. Chronic Lymphocytic Leukemia
  • 7.3.6. Gastric & Gastroesophageal Junction Cancer
  • 7.3.7. Melanoma
  • 7.3.8. Others
• 7.4. Market Analysis, Insights and Forecast - By Age Group
  • 7.4.1. Pediatric
  • 7.4.2. Adults
• 7.5. Market Analysis, Insights and Forecast - By Route of Administration
  • 7.5.1. Intravenous
  • 7.5.2. Subcutaneous
  • 7.5.3. Others
• 7.6. Market Analysis, Insights and Forecast - By Distribution Channel
  • 7.6.1. Hospital Pharmacies
  • 7.6.2. Specialty Pharmacies
  • 7.6.3. Drug Stores & Retail Pharmacies
  • 7.6.4. Online Pharmacies
• 7.7. Market Analysis, Insights and Forecast - By Country/ Sub-Region
  • 7.7.1. U.K.
  • 7.7.2. Germany
  • 7.7.3. France
  • 7.7.4. Italy
  • 7.7.5. Spain
  • 7.7.6. Scandinavia
  • 7.7.7. Rest of Europe

8. Asia Pacific Oncology Biosimilars Market Analysis, Insights and Forecast, 2021-2034

• 8.1. Market Analysis, Insights and Forecast - By Drug Class
  • 8.1.1. Anti-HER2 Monoclonal Antibodies
  • 8.1.2. Anti-VEGF Monoclonal Antibodies
  • 8.1.3. Anti-CD20 Monoclonal Antibodies
  • 8.1.4. Immune Checkpoint Inhibitor Biosimilars
  • 8.1.5. Other Therapeutic Monoclonal Antibodies
  • 8.1.6. Others
• 8.2. Market Analysis, Insights and Forecast - By Product
  • 8.2.1. Trastuzumab
  • 8.2.2. Bevacizumab
  • 8.2.3. Rituximab
  • 8.2.4. Pertuzumab
  • 8.2.5. Pembrolizumab
  • 8.2.6. Nivolumab
  • 8.2.7. Ipilimumab
  • 8.2.8. Others
• 8.3. Market Analysis, Insights and Forecast - By Application
  • 8.3.1. Breast Cancer
  • 8.3.2. Lung Cancer
  • 8.3.3. Colorectal Cancer
  • 8.3.4. Non-Hodgkin's Lymphoma
  • 8.3.5. Chronic Lymphocytic Leukemia
  • 8.3.6. Gastric & Gastroesophageal Junction Cancer
  • 8.3.7. Melanoma
  • 8.3.8. Others
• 8.4. Market Analysis, Insights and Forecast - By Age Group
  • 8.4.1. Pediatric
  • 8.4.2. Adults
• 8.5. Market Analysis, Insights and Forecast - By Route of Administration
  • 8.5.1. Intravenous
  • 8.5.2. Subcutaneous
  • 8.5.3. Others
• 8.6. Market Analysis, Insights and Forecast - By Distribution Channel
  • 8.6.1. Hospital Pharmacies
  • 8.6.2. Specialty Pharmacies
  • 8.6.3. Drug Stores & Retail Pharmacies
  • 8.6.4. Online Pharmacies
• 8.7. Market Analysis, Insights and Forecast - By Country/ Sub-Region
  • 8.7.1. China
  • 8.7.2. Japan
  • 8.7.3. India
  • 8.7.4. Southeast Asia
  • 8.7.5. Australia
  • 8.7.6. Rest of Asia Pacific

9. Latin America Oncology Biosimilars Market Analysis, Insights and Forecast, 2021-2034

• 9.1. Market Analysis, Insights and Forecast - By Drug Class
  • 9.1.1. Anti-HER2 Monoclonal Antibodies
  • 9.1.2. Anti-VEGF Monoclonal Antibodies
  • 9.1.3. Anti-CD20 Monoclonal Antibodies
  • 9.1.4. Immune Checkpoint Inhibitor Biosimilars
  • 9.1.5. Other Therapeutic Monoclonal Antibodies
  • 9.1.6. Others
• 9.2. Market Analysis, Insights and Forecast - By Product
  • 9.2.1. Trastuzumab
  • 9.2.2. Bevacizumab
  • 9.2.3. Rituximab
  • 9.2.4. Pertuzumab
  • 9.2.5. Pembrolizumab
  • 9.2.6. Nivolumab
  • 9.2.7. Ipilimumab
  • 9.2.8. Others
• 9.3. Market Analysis, Insights and Forecast - By Application
  • 9.3.1. Breast Cancer
  • 9.3.2. Lung Cancer
  • 9.3.3. Colorectal Cancer
  • 9.3.4. Non-Hodgkin's Lymphoma
  • 9.3.5. Chronic Lymphocytic Leukemia
  • 9.3.6. Gastric & Gastroesophageal Junction Cancer
  • 9.3.7. Melanoma
  • 9.3.8. Others
• 9.4. Market Analysis, Insights and Forecast - By Age Group
  • 9.4.1. Pediatric
  • 9.4.2. Adults
• 9.5. Market Analysis, Insights and Forecast - By Route of Administration
  • 9.5.1. Intravenous
  • 9.5.2. Subcutaneous
  • 9.5.3. Others
• 9.6. Market Analysis, Insights and Forecast - By Distribution Channel
  • 9.6.1. Hospital Pharmacies
  • 9.6.2. Specialty Pharmacies
  • 9.6.3. Drug Stores & Retail Pharmacies
  • 9.6.4. Online Pharmacies
• 9.7. Market Analysis, Insights and Forecast - By Country/ Sub-Region
  • 9.7.1. Brazil
  • 9.7.2. Mexico
  • 9.7.3. Rest of Latin America

10. Middle East & Africa Oncology Biosimilars Market Analysis, Insights and Forecast, 2021-2034

• 10.1. Market Analysis, Insights and Forecast - By Drug Class
  • 10.1.1. Anti-HER2 Monoclonal Antibodies
  • 10.1.2. Anti-VEGF Monoclonal Antibodies
  • 10.1.3. Anti-CD20 Monoclonal Antibodies
  • 10.1.4. Immune Checkpoint Inhibitor Biosimilars
  • 10.1.5. Other Therapeutic Monoclonal Antibodies
  • 10.1.6. Others
• 10.2. Market Analysis, Insights and Forecast - By Product
  • 10.2.1. Trastuzumab
  • 10.2.2. Bevacizumab
  • 10.2.3. Rituximab
  • 10.2.4. Pertuzumab
  • 10.2.5. Pembrolizumab
  • 10.2.6. Nivolumab
  • 10.2.7. Ipilimumab
  • 10.2.8. Others
• 10.3. Market Analysis, Insights and Forecast - By Application
  • 10.3.1. Breast Cancer
  • 10.3.2. Lung Cancer
  • 10.3.3. Colorectal Cancer
  • 10.3.4. Non-Hodgkin's Lymphoma
  • 10.3.5. Chronic Lymphocytic Leukemia
  • 10.3.6. Gastric & Gastroesophageal Junction Cancer
  • 10.3.7. Melanoma
  • 10.3.8. Others
• 10.4. Market Analysis, Insights and Forecast - By Age Group
  • 10.4.1. Pediatric
  • 10.4.2. Adults
• 10.5. Market Analysis, Insights and Forecast - By Route of Administration
  • 10.5.1. Intravenous
  • 10.5.2. Subcutaneous
  • 10.5.3. Others
• 10.6. Market Analysis, Insights and Forecast - By Distribution Channel
  • 10.6.1. Hospital Pharmacies
  • 10.6.2. Specialty Pharmacies
  • 10.6.3. Drug Stores & Retail Pharmacies
  • 10.6.4. Online Pharmacies
• 10.7. Market Analysis, Insights and Forecast - By Country/ Sub-Region
  • 10.7.1. GCC
  • 10.7.2. South Africa
  • 10.7.3. Rest of the Middle East & Africa

11. Competitive Analysis

• 11.1. Global Market Share Analysis (2025)
• 11.2. Company Profiles
  • 11.2.1. Celltrion, Inc.
  • 11.2.2. Amgen Inc.
  • 11.2.3. Pfizer Inc.
  • 11.2.4. Biocon Biologics Limited
  • 11.2.5. Samsung Bioepis Co., Ltd.
  • 11.2.6. Sandoz Group AG
  • 11.2.7. Shanghai Henlius Biotech, Inc.
  • 11.2.8. Teva Pharmaceutical Industries Ltd.
  • 11.2.9. Organon & Co.
  • 11.2.10. Accord Healthcare Limited
  • 11.2.11. Fresenius Kabi AG
  • 11.2.12. Amneal Pharmaceuticals, Inc.
  • 11.2.13. Dr. Reddy's Laboratories Ltd.