종양학 바이오시밀러 시장 : 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the oncology biosimilars market size was valued at USD 11.22 billion in 2025 and is estimated to grow from USD 12.81 billion in 2026 to reach USD 24.96 billion by 2031, at a CAGR of 14.25% during the forecast period (2026-2031).

This report is Segmented by Indication (Breast Cancer, Lung Cancer, and More), by Drug Class (Monoclonal Antibodies, Granulocyte Colony-Stimulating Factors, and More), by Route of Administration (Intravenous and Subcutaneous), by Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and More), Geography (North America, Europe, and More). Forecasts are Provided in Terms of Value (USD).

Global Oncology Biosimilars Market Trends and Insights

Expiring Blockbuster Oncology Biologic Patents

Patent expiry remains one of the clearest structural supports for the oncology biosimilars market because it opens access to therapies that historically carried some of the highest oncology biologic revenues. The current opportunity is not limited to older monoclonal antibodies, because the next wave increasingly includes complex oncology assets where even a small number of entrants can materially change treatment economics. Samsung Bioepis reported positive preliminary Phase 1 and Phase 3 data in June 2026 for SB27, its proposed biosimilar to pembrolizumab, which shows that the oncology biosimilars market is already moving closer to follow-on competition in a very high-value checkpoint inhibitor category. The April 2026 European Commission approval of POHERDY as the first approved pertuzumab biosimilar in Europe adds another sign that large oncology molecules are entering the next stage of commercialization beyond first-generation biosimilar classes. As more oncology biologics move toward loss of exclusivity, the oncology biosimilars market should see faster portfolio broadening, but the companies that move first will still have an advantage in payer contracting and hospital access. This pattern matters because the oncology biosimilars market is no longer defined only by mature substitutions, but also by who can reach the next launch window with clinical, regulatory, and commercial readiness already in place.

Payer Pressure to Lower Oncology Treatment Costs

Payer pressure is reinforcing growth in the oncology biosimilars market because lower-cost substitution now aligns with both budget control and broader treatment access goals. A 2025 survey of oncology pharmacy practices also found that payer-specified biosimilar selections and reimbursement limits are shaping product choice at the practice level, which confirms that the oncology biosimilars market is increasingly being steered through reimbursement design instead of only physician preference. This pressure helps the oncology biosimilars market because cost savings become more visible to institutions when switching decisions are tied to contracting, preferred products, and portfolio standardization. It also raises the importance of launch sequencing, because companies that secure payer alignment early can convert clinical similarity into routine utilization faster than late entrants can. Over time, this dynamic should keep the oncology biosimilars market on a path where access expansion and pricing discipline continue to reinforce each other.

Oncology Prescriber Caution on Interchangeability and Immunogenicity

Prescriber caution remains a real restraint for the oncology biosimilars market because institutional contracting can move product selection faster than individual clinical confidence changes. BioDrugs also reported that 31.4% to 56.8% of Korean oncologists were reluctant to switch patients already established on originator biologics, with the hesitation centered on immunogenicity and continuity concerns rather than broad doubt about efficacy. An Indian clinician survey published in 2025 found that 69.2% believed deviations beyond the standard 80% to 125% bioequivalence margin would affect clinical use, which shows that technical interpretation still influences practical adoption. For the oncology biosimilars market, this means education, real-world evidence, and switching familiarity still matter because clinical hesitation can slow utilization even when products are approved and available. It also means that uptake may continue to be stronger in institution-led pathways than in settings where the final decision still rests mainly on individual physician comfort.

Other drivers and restraints analyzed in the detailed report include:

1. Rising Global Cancer Incidence and Treatment Volumes
2. Hospital and Oncology Group Purchasing Adoption of Biosimilar Contracts
3. Complex Clinical Development and Manufacturing Requirements

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Breast cancer accounted for 28.15% of the oncology biosimilars market share in 2025, which kept it in the lead because trastuzumab biosimilars are already deeply embedded in HER2-positive treatment pathways. This position reflects both clinical familiarity and commercial maturity, since trastuzumab biosimilars have had enough time to move beyond early adoption and into routine use across major institutional settings. In the United States, the trastuzumab biosimilar category entered 2026 with seven competing products, and Samsung Bioepis reported category shares of 31% for Kanjinti, 25% for Trazimera, and 24% for Ogivri, which shows how dense competition has already become inside this segment of the oncology biosimilars market. Blood cancer also remains a meaningful revenue base because rituximab biosimilars have moved into advanced institutional adoption, with biosimilar use reaching 84% by 2024 in the U.S. hospital sample covered by JAMA. Colorectal cancer adds another important layer because bevacizumab biosimilars already have a validated economic role in metastatic treatment settings.

A 2025 Journal of Medical Economics study found that bevacizumab-bvzr delivered the greatest cost savings and the lowest number needed to convert among biosimilar options in metastatic colorectal cancer, which reinforces why this indication remains commercially relevant to the oncology biosimilars market. Lung cancer is the fastest-growing indication at a 16.75% CAGR, and that outlook is supported by disease burden as well as the future expansion potential of checkpoint inhibitor biosimilars. IARC identified lung cancer as the most incident cancer globally in 2024, with 2.6 million new cases, and also the leading cause of cancer death, which means the patient base behind this part of the oncology biosimilars market is both large and persistent. Ovarian, gastric, and other lower-share indications remain smaller today. However, they still matter because label breadth across bevacizumab-related treatment settings allows the oncology biosimilars industry to extend value across multiple oncology departments without needing a separate commercialization model for each tumor type.

Monoclonal antibodies held 68.54% of the oncology biosimilars market size in 2025, which reflects the strong commercial position of trastuzumab, bevacizumab, and rituximab biosimilars across both solid tumor and hematologic oncology use. Their lead is tied to a combination of mature reference products, well-understood clinical pathways, and the fact that hospitals already know how to contract and administer these therapies at scale. G-CSFs form the second major class because they support chemotherapy-related neutropenia management, and a 2025 oncology pharmacy survey reported weighted average biosimilar utilization of 88% for filgrastim and 52% for pegfilgrastim, which suggests that supportive care still has meaningful conversion room in the oncology biosimilars market. Hematopoietic agents also remain a mature part of demand, with the user draft indicating institutional penetration near 84%, which supports their role as a steady but less dynamic component of the oncology biosimilars market. Th,e current class structure, therefore, still leans heavily toward established molecules, and that makes revenue concentration look stronger at the molecule level than at the company level.

The faster shift is happening in the other category, which is forecast to grow at an 18.16% CAGR through 2031 because it captures future checkpoint inhibitor and VEGF-related biosimilar opportunities. Samsung Bioepis announced positive preliminary Phase 1 and Phase 3 data in June 2026 for SB27, its proposed pembrolizumab biosimilar, including pharmacokinetic equivalence and an equivalent objective response rate in NSCLC at Week 24, which makes this one of the clearest signs that the oncology biosimilars industry is approaching the next commercial frontier. As these assets move closer to filing and launch, the oncology biosimilars market should become less dependent on first-generation monoclonal antibody pricing cycles alone. That shift is important because the next phase of the oncology biosimilars market may be shaped less by how many entrants exist in older classes and more by which firms arrive first in newer, more complex immuno-oncology categories.

Complete Report Scope:

• By Indication
  • Breast Cancer
  • Lung Cancer
  • Colorectal Cancer
  • Blood Cancer
  • Liver Cancer
  • Prostate Cancer
  • Gastric Cancer
  • Ovarian Cancer
  • Others (Pancreatic Cancer, Multiple Myeloma, etc.)
• By Drug Class
  • Monoclonal Antibodies
  • Granulocyte Colony-Stimulating Factors
  • Hematopoietic Agents
  • Others (Immune Checkpoint Inhibitors, VEGF Inhibitors, etc.)
• By Route of Administration
  • Intravenous
  • Subcutaneous
• By Distribution Channel
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
  • Others (Specialty Pharmacies, Government Cancer Institutes, etc.)
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • South Korea
    • Australia
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 36.18% of the oncology biosimilars market size in 2025, which kept it as the largest regional contributor because hospital adoption, biologics familiarity, and commercialization depth remain strongest there. A JAMA study showed that U.S. hospital biosimilar use had already reached 93% for bevacizumab, 87% for trastuzumab, and 84% for rituximab by 2024, which points to a mature institutional environment for the oncology biosimilars market. This region also continues to benefit from a broad installed base of oncology infusion care, large payers, and sophisticated formulary management, all of which make product switching easier to implement at scale. North America,the therefore, remains the most developed revenue base for the oncology biosimilars market, even as newer molecules begin to change the competitive mix.

Europe remains a core region for the oncology biosimilars market because regulatory acceptance and procurement discipline have historically supported earlier biosimilar normalization than in many other regions. The April 2026 European Commission approval of POHERDY as the first approved pertuzumab biosimilar in Europe marked another important portfolio expansion point for the oncology biosimilars market across the region. The European Medicines Agency also adopted a positive opinion in June 2026 for Denosumab Ascend, recommended as a biosimilar to Xgeva for prevention of bone complications in adults with advanced cancer involving bone, which adds to future oncology biosimilar breadth in European channels. These steps reinforce Europe's role as a region where the oncology biosimilars market continues to broaden through both policy familiarity and a steady expansion of available products.

Asia-Pacific is the fastest-growing region at an 18.05% CAGR through 2031, which shows that the oncology biosimilars market has its strongest future momentum in large, cost-sensitive healthcare systems. The regional growth profile reflects rising cancer burden, expanding domestic manufacturing capabilities, and a stronger need to deliver biologic therapy at lower treatment cost across wider patient populations. IARC's latest global cancer statistics support that backdrop, with cancer incidence continuing to rise worldwide and creating durable demand pressure in high-population regions that need affordable oncology treatment capacity.

1. Accord Healthcare Limited
2. Amgen
3. Apotex
4. Aurobindo Pharma
5. Biocon Biologics Limited
6. Celltrion, Inc.
7. Cipla
8. Dr. Reddy's Laboratories
9. Fresenius
10. Gedeon Richter Plc.
11. Hetero Labs Limited
12. Hikma Pharmaceuticals
13. Intas Pharmaceutical
14. Mabxience S.L.U.
15. Pfizer
16. Samsung Bioepis Co., Ltd.
17. Sandoz Group AG
18. Shanghai Henlius Biotech, Inc.
19. Stada Arzneimittel
20. Teva Pharmaceutical Industries

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

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 (VALUE, 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