Oncology Biosimilars Market Analysis 2026-2031 by Indication, Drug Class, Route of Administration, Distribution Channel and Region
Dublin, Aug. 19, 2026 (GLOBE NEWSWIRE) — The “Oncology Biosimilars – Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2026-2031)” has been added to ResearchAndMarkets.com’s offering.
The global oncology biosimilars market was valued at USD 11.22 billion in 2025 and is projected to increase from USD 12.81 billion in 2026 to USD 24.96 billion by 2031. The market is expected to register a compound annual growth rate of 14.25% during the 2026-2031 forecast period. Growth is being supported by patent expirations for major oncology biologics, payer efforts to reduce treatment costs, rising cancer incidence and broader hospital adoption of biosimilar contracts.
Key Oncology Biosimilars Market Trends
Expiring patents for high-revenue oncology biologics are creating new opportunities for biosimilar manufacturers. Competition is expanding beyond established trastuzumab, bevacizumab and rituximab products into more complex oncology therapies. Samsung Bioepis reported positive preliminary Phase 1 and Phase 3 results in June 2026 for SB27, its proposed pembrolizumab biosimilar. The European Commission’s April 2026 approval of POHERDY, the first pertuzumab biosimilar approved in Europe, also signals continued portfolio expansion.
Payer pressure is accelerating oncology biosimilar adoption as insurers, hospitals and healthcare systems seek to control treatment costs while expanding patient access. Payer-designated products, reimbursement policies, preferred formularies and institutional purchasing agreements increasingly influence product selection. Manufacturers that secure early payer alignment and hospital access are therefore positioned to convert regulatory approvals into routine clinical utilization more rapidly.
Prescriber caution remains a market restraint, particularly when switching patients who are stable on originator biologics. Concerns regarding immunogenicity, treatment continuity and interchangeability may delay adoption despite regulatory approval and institutional availability. Continued investment in clinician education, real-world evidence and switching data will remain important for increasing confidence and supporting broader use.
Additional market factors include rising global cancer incidence, increasing treatment volumes, hospital and oncology group purchasing contracts, and the complex clinical development and manufacturing requirements associated with biosimilars.
Segment Analysis
Breast cancer represented 28.15% of the oncology biosimilars market in 2025, supported by the established use of trastuzumab biosimilars in HER2-positive treatment pathways. Competition is particularly advanced in the United States, where multiple trastuzumab biosimilars are available. Blood cancer also contributes substantial revenue through widespread institutional adoption of rituximab biosimilars, while bevacizumab biosimilars support demand in colorectal and other solid-tumor indications.
Lung cancer is forecast to be the fastest-growing indication, advancing at a CAGR of 16.75% through 2031. This outlook reflects the significant global burden of lung cancer and the prospective introduction of checkpoint inhibitor biosimilars. Gastric, ovarian, liver, prostate, pancreatic and other cancer indications provide additional opportunities through broader oncology labels and expanding treatment access.
Monoclonal antibodies accounted for 68.54% of the market in 2025, led by trastuzumab, bevacizumab and rituximab biosimilars. Granulocyte colony-stimulating factors remain an important category in chemotherapy-related neutropenia management, while hematopoietic agents provide a mature source of institutional demand. Other drug classes, including immune checkpoint inhibitors and VEGF-related therapies, are projected to grow at a CAGR of 18.16% through 2031 as newer products progress toward regulatory filing and commercialization.
Intravenous and subcutaneous products are included in the route-of-administration analysis. Distribution channels comprise hospital pharmacies, retail pharmacies, online pharmacies, specialty pharmacies and government cancer institutes.
Regional Market Outlook
North America held 36.18% of the oncology biosimilars market in 2025, making it the largest regional market. Its leadership is supported by extensive oncology infusion infrastructure, sophisticated formulary management, strong biologics familiarity and high institutional adoption. Reported U.S. hospital biosimilar utilization reached 93% for bevacizumab, 87% for trastuzumab and 84% for rituximab by 2024.
Europe remains a major oncology biosimilars market due to established regulatory pathways, competitive procurement systems and broad acceptance of biosimilar treatment. Recent regulatory developments involving pertuzumab and denosumab biosimilars demonstrate the region’s expanding product portfolio.
Asia-Pacific is projected to be the fastest-growing regional market, with a CAGR of 18.05% through 2031. Growth is being driven by rising cancer incidence, cost-sensitive healthcare systems, expanding domestic manufacturing capacity and increasing demand for affordable biologic oncology treatments. The geographic analysis also covers South America and the Middle East and Africa.
Key Topics Covered
1 INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET LANDSCAPE
4.1 Market Overview
4.2 Market Drivers
4.2.1 Expiring Blockbuster Oncology Biologic Patents
4.2.2 Payer Pressure to Lower Oncology Treatment Costs
4.2.3 Rising Global Cancer Incidence and Treatment Volumes
4.2.4 Hospital and Oncology Group Purchasing Adoption of Biosimilar Contracts
4.2.5 Biosimilar Switching and Formulary Expansion in Supportive Care Molecules
4.2.6 Tender-Based Uptake in Public Cancer Programs
4.3 Market Restraints
4.3.1 Oncology Prescriber Caution on Interchangeability and Immunogenicity
4.3.2 Complex Clinical Development and Manufacturing Requirements
4.3.3 Patent Litigation and Reference Product Exclusivity Extensions
4.3.4 Uneven Reimbursement and Pharmacy Substitution Policies Across Countries
4.4 Supply Chain Analysis
4.5 Regulatory Landscape
4.6 Technological Outlook
4.7 Porter’s Five Forces Analysis
4.7.1 Bargaining Power of Suppliers
4.7.2 Bargaining Power of Buyers
4.7.3 Threat of New Entrants
4.7.4 Threat of Substitutes
4.7.5 Industry Rivalry
5 MARKET SIZE AND GROWTH FORECASTS 9VALUE, USD)
5.1 By Indication
5.1.1 Breast Cancer
5.1.2 Lung Cancer
5.1.3 Colorectal Cancer
5.1.4 Blood Cancer
5.1.5 Liver Cancer
5.1.6 Prostate Cancer
5.1.7 Gastric Cancer
5.1.8 Ovarian Cancer
5.1.9 Others (Pancreatic Cancer, Multiple Myeloma, etc.)
5.2 By Drug Class
5.2.1 Monoclonal Antibodies
5.2.2 Granulocyte Colony-Stimulating Factors
5.2.3 Hematopoietic Agents
5.2.4 Others (Immune Checkpoint Inhibitors, VEGF Inhibitors, etc.)
5.3 By Route of Administration
5.3.1 Intravenous
5.3.2 Subcutaneous
5.4 By Distribution Channel
5.4.1 Hospital Pharmacies
5.4.2 Retail Pharmacies
5.4.3 Online Pharmacies
5.4.4 Others (Specialty Pharmacies, Government Cancer Institutes, etc.)
5.5 By Geography
5.5.1 North America
5.5.1.1 United States
5.5.1.2 Canada
5.5.1.3 Mexico
5.5.2 Europe
5.5.2.1 Germany
5.5.2.2 United Kingdom
5.5.2.3 France
5.5.2.4 Italy
5.5.2.5 Spain
5.5.2.6 Rest of Europe
5.5.3 Asia-Pacific
5.5.3.1 China
5.5.3.2 India
5.5.3.3 Japan
5.5.3.4 South Korea
5.5.3.5 Australia
5.5.3.6 Rest of Asia-Pacific
5.5.4 Middle East and Africa
5.5.4.1 GCC
5.5.4.2 South Africa
5.5.4.3 Rest of Middle East and Africa
5.5.5 South America
5.5.5.1 Brazil
5.5.5.2 Argentina
5.5.5.3 Rest of South America
6 COMPETITIVE LANDSCAPE
6.1 Market Concentration
6.2 Market Share Analysis
6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
6.3.1 Accord Healthcare Limited
6.3.2 Amgen Inc.
6.3.3 Apotex Inc.
6.3.4 Aurobindo Pharma Limited
6.3.5 Biocon Biologics Limited
6.3.6 Celltrion, Inc.
6.3.7 Cipla Limited
6.3.8 Dr. Reddy’s Laboratories Ltd.
6.3.9 Fresenius Kabi AG
6.3.10 Gedeon Richter Plc.
6.3.11 Hetero Labs Limited
6.3.12 Hikma Pharmaceuticals PLC
6.3.13 Intas Pharmaceuticals Limited
6.3.14 Mabxience S.L.U.
6.3.15 Pfizer Inc.
6.3.16 Samsung Bioepis Co., Ltd.
6.3.17 Sandoz Group AG
6.3.18 Shanghai Henlius Biotech, Inc.
6.3.19 STADA Arzneimittel AG
6.3.20 Teva Pharmaceutical Industries Ltd.
7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK
7.1 White-Space and Unmet-Need Assessment
For more information about this report visit https://www.researchandmarkets.com/r/8qkd6c
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