Oncology Biosimilars Market is expected to hit US$ 30.83 Billion by 2033 | Major key players - Celltrion USA, Inc., Amgen Inc., Pfizer Inc., Biocon Biologics Limited

Market Size and Growth:

The Global Oncology Biosimilars Market size reached US$ 6.76 Billion in 2024 from US$ 5.77 Billion in 2023 and is expected to reach US$ 30.83 Billion by 2033, growing at a CAGR of 18.6% during the forecast period 2025-2033.

DataM Intelligence has published a new research report on "Oncology Biosimilars Market Size 2026". The report explores comprehensive and insightful Information about various key factors like Regional Growth, Segmentation, CAGR, Business Revenue Status of Top Key Players and Drivers. The purpose of this report is to provide a telescopic view of the current market size by value and volume, opportunities, and development status.

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The Oncology Biosimilars Market refers to the global industry focused on the development, manufacturing, approval, and commercialization of biosimilar versions of biologic drugs used in cancer treatment. These products are highly similar to reference biologics in terms of safety, efficacy, and quality, but are typically offered at lower costs. Oncology biosimilars target therapies such as monoclonal antibodies, growth factors, and immunotherapies, aiming to improve treatment accessibility, reduce healthcare expenditures, and expand patient access to advanced cancer care worldwide.

Recent Key Developments of United States:

✅ January 2026: FDA continued expanding oncology biosimilar options amid 2025's record approvals, including denosumab biosimilars for cancer-related bone loss, improving affordability in oncology supportive care.

✅ December 2025: Zydus Lifesciences and Formycon announced an exclusive partnership for FYB206, a pembrolizumab (Keytruda) biosimilar, with Zydus handling US commercialization and Formycon managing development and supply. The deal positions the product for North American oncology market entry, targeting immunotherapy access.

✅ November 2025: The FDA approved Poherdy (pertuzumab-dpzb) by Organon as the first interchangeable biosimilar to Perjeta (pertuzumab) for HER2-positive breast cancer treatments, including adjuvant therapy and metastatic cases. This approval enhances competition and access in oncology by providing a cost-effective alternative.

Recent Key Developments of Japan:

✅ February 2026: Japan's biosimilars market saw sustained oncology growth, with emphasis on monoclonal antibodies amid rising cancer incidence and partnerships enhancing penetration. No major new approvals reported this month, but prior listings drove continued adoption.

✅ January 2026: Ongoing regulatory momentum from late 2025 approvals, including oncology biosimilars, intensified competition while maintaining high safety standards in Japan's market. This builds on trastuzumab and bevacizumab uptake trends.

✅ December 2025: PMDA listed additional bevacizumab biosimilars (recombinant), expanding options for colorectal, lung, and breast cancers, as part of ongoing approvals through late 2025. These listings support broader access to oncology monoclonal antibodies.

✅ November 2025: Celltrion's Herzuma (trastuzumab biosimilar) achieved a 74% market share in Japan for breast and gastric cancer treatments, solidifying its dominance in the oncology segment. This reflects strong real-world adoption driven by cost savings and physician confidence.

List of the Key Players in the Oncology Biosimilars Market:

Celltrion USA, Inc.
Amgen Inc.
Pfizer Inc.
Biocon Biologics Limited
Teva Pharmaceuticals USA, Inc.
Organon group of companies
Accord BioPharma
Sandoz Inc.

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This Report Covers:

✔ Go-to-market Strategy.

✔ Neutral perspective on the market performance.

✔Development trends, competitive landscape analysis, supply side analysis, demand side analysis, year-on-year growth, competitive benchmarking, vendor identification, and other significant analysis, as well as development status.

✔Customized regional/country reports as per request and country level analysis.

✔ Potential & niche segments and regions exhibiting promising growth covered.

✔ Analysis of Market Size (historical and forecast), Total Addressable Market (TAM), Serviceable Available Market (SAM), Serviceable Obtainable Market (SOM), Market Growth, Technological Trends, Market Share, Market Dynamics, Competitive Landscape and Major Players (Innovators, Start-ups, Laggard, and Pioneer).

Segments Covered in the Oncology Biosimilars Market:

By Product Type: Monoclonal Antibodies (mAbs), Recombinant Proteins, Granulocyte Colony-Stimulating Factor (G-CSF), Erythropoiesis-Stimulating Agents, Others.

By Indication: Breast Cancer, Lung Cancer, Colorectal Cancer, Cervical Cancer, Blood Cancer, Others.

By Route of Administration: Oral, Injectable.

Regional Analysis:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Chapter Outline:

Chapter 1: Introduces the report scope of the report, executive summary of different market segments (by region, product type, application, etc), including the market size of each market segment, future development potential, and so on. It offers a high-level view of the current state of the market and its likely evolution in the short to mid-term, and long term.

Chapter 2: key insights, key emerging trends, etc.

Chapter 3: Manufacturers competitive analysis, detailed analysis of Oncology Biosimilars manufacturers competitive landscape, revenue market share, latest development plan, merger, and acquisition information, etc.

Chapter 4: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product revenue, gross margin, product introduction, recent development, etc.

Chapter 5 & 6: Revenue of Oncology Biosimilars in regional level and country level. It provides a quantitative analysis of the market size and development potential of each region and its main countries and introduces the market development, future development prospects, market space, and market size of each country in the world.

Chapter 7: Provides the analysis of various market segments by Type, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different market segments.

Chapter 8: Provides the analysis of various market segments by Application, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different downstream markets.

Chapter 9: Analysis of industrial chain, including the upstream and downstream of the industry.

Chapter 10: The main points and conclusions of the report.

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People Also Ask:

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