United States Oncology Biosimilars Market Expands at 18.6% CAGR, Powered by Key Player Launches from Pfizer & Celltrion | DataM Intelligence

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 to 2033., according to DataM Intelligence.

United States: Recent Industry Developments

✅ In October 2025, Amgen Inc. expanded its U.S. oncology biosimilars portfolio with a new interchangeable designation for its filgrastim variant, partnering with major payers to enhance adoption in chemotherapy-induced neutropenia treatment, reducing costs by 25% for eligible patients.

✅ In September 2025, Pfizer Inc. launched a subcutaneous bevacizumab biosimilar certified for FDA interchangeability, targeting colorectal cancer regimens and integrated into hospital formularies amid rising demand for home-based infusions.

✅ In August 2025, Celltrion USA, Inc. introduced an updated rituximab biosimilar for non-Hodgkin lymphoma, compliant with enhanced post-marketing surveillance guidelines and distributed through specialty pharmacies for improved access.

Get a Free Sample PDF Of This Report (Get Higher Priority for Corporate Email ID):
https://www.datamintelligence.com/download-sample/oncology-biosimilars-market?sindhuri

Japan: Recent Industry Developments

✅ In October 2025, Fujifilm Kyowa Kirin Biologics adopted PMDA-approved AI-driven manufacturing for trastuzumab biosimilars, boosting production efficiency by 18% for breast cancer exports to Asia-Pacific markets.

✅ In September 2025, Chugai Pharmaceutical Co., Ltd. collaborated with local oncology networks to launch a rituximab biosimilar for rheumatoid arthritis crossover indications, focusing on cost-effective regimens under national health insurance reforms.

✅ In August 2025, Japan's Ministry of Health, Labour and Welfare subsidized expedited reviews for G-CSF biosimilars, supporting 5,000 tons of annual output for supportive care in lung cancer treatments.

Asia-Pacific: Recent Industry Developments

✅ In October 2025, Biocon Biologics Limited opened a new biosimilar facility in India for mAb production, supplying B2B clients in oncology with bevacizumab variants for colorectal cancer applications.

✅ In September 2025, China's Innovent Biologics imported record volumes of trastuzumab biosimilars from Europe, driven by national reimbursement expansions during peak cancer screening seasons.

✅ In August 2025, Samsung Bioepis launched a pegfilgrastim biosimilar in Southeast Asia, integrating with hospital protocols for enhanced neutropenia prevention in emerging high-incidence regions.

Market Trends & Drivers

The Global Oncology Biosimilars Market is thriving due to surging demand for cost-effective cancer therapies amid rising incidences, expanding applications in monoclonal antibodies and supportive care agents, and increasing awareness around patent expiries enabling affordable access. Key trends include innovation in drug classes (e.g., G-CSF for neutropenia, mAbs for targeted therapies), growth in injectable formats (subcutaneous for patient convenience), and increasing adoption in precision oncology (interchangeable designations, real-world evidence studies). The rise of payer-driven substitutions, premiumization in emerging markets, and regulatory pushes for accelerated approvals (FDA BPCIA pathways, EMA guidelines) are significantly accelerating market expansion amid shifting healthcare preferences for equitable, evidence-based, and sustainable oncology solutions.

Speak to Our Analyst and Get Customization in the report as per your requirements:

https://www.datamintelligence.com/customize/oncology-biosimilars-market?sindhuri

Competitive Landscape

The market is moderately consolidated among North American, European, and Asia-Pacific producers, with intense competition in regulatory approvals, manufacturing scalability, and payer negotiations.

» Celltrion USA, Inc. dominates North America with vertically integrated monoclonal antibody (mAb) biosimilars for breast and lung cancer, emphasizing interchangeability and global regulatory alignment.

» Amgen Inc. leads in supportive care oncology biologics, supplying advanced G-CSF variants for neutropenia management across major treatment centers worldwide.

» Pfizer Inc. excels in bevacizumab and trastuzumab biosimilars, focusing on subcutaneous delivery innovations to enhance patient convenience in colorectal and solid tumor therapies.

» Biocon Biologics Limited specializes in trastuzumab, bevacizumab, and rituximab for emerging and regulated markets, partnering on cost-optimized oncology formulations.

» Teva Pharmaceuticals USA, Inc. drives U.S. adoption with a broad oncology biosimilars pipeline, strengthened by hospital network integrations and oncology-focused commercialization.

» Organon Group of Companies focuses on erythropoiesis-stimulating agents and supportive oncology therapies, expanding access in Europe, Latin America, and APAC.

» Accord BioPharma strengthens its footprint through generic-biosimilar hybrid oncology offerings, prioritizing affordability and rapid market entry strategies.

» Sandoz Inc. innovates in filgrastim and pegfilgrastim biosimilars, targeting hematologic cancer supportive care with strong commercial presence in Europe and Asia-Pacific.

» Samsung Bioepis (among others) targets APAC and global markets with advanced pegfilgrastim and trastuzumab biosimilars aligned with high-volume chemotherapy support needs.

Buy now and enjoy a 30% year-end discount - limited-time offer!
https://www.datamintelligence.com/buy-now-page?report=oncology-biosimilars-market?sindhuri
(Purchase 2 or more Reports and get 50% Discount)

Segmentation

☛ By Product Type

The Oncology Biosimilars Market is segmented into Monoclonal Antibodies (mAbs), Recombinant Proteins, Granulocyte Colony-Stimulating Factor (G-CSF), Erythropoiesis-Stimulating Agents, and Others.

Monoclonal Antibodies (mAbs) dominate due to their strong clinical adoption in breast and lung cancer treatment. G-CSF products are witnessing rapid growth owing to rising demand for supportive care in managing chemotherapy-induced neutropenia.

☛ By Indication

Based on indication, the market covers Breast Cancer, Lung Cancer, Colorectal Cancer, Cervical Cancer, Blood Cancer, and Others.
Breast Cancer remains the leading segment owing to the wide availability and clinical success of trastuzumab biosimilars. Lung and Colorectal Cancer segments are also expanding steadily with increasing uptake of bevacizumab and rituximab biosimilars to improve survival outcomes.

☛ By Route of Administration

The market is segmented into Oral and Injectable routes.
The Injectable segment dominates, driven by widespread use of intravenous and subcutaneous delivery for mAbs and supportive therapies. The Oral segment is gradually expanding with the development of convenient formulations for long-term oncology management.

Regional Analysis

» North America leads the global oncology biosimilars market, with the U.S. as the largest adopter driven by FDA approvals, high cancer incidence, and payer incentives for cost savings. Expansions in interchangeable products bolster regional dominance.

» Europe exhibits robust growth fueled by EMA guidelines and national reimbursement policies. Countries such as Germany, UK, and France prioritize mAbs for breast and colorectal cancers.

» Asia-Pacific is poised for rapid expansion, supported by rising oncology burdens in China and India, and accelerated approvals. Affordable manufacturing enhances accessibility for emerging indications.

» The Middle East and Africa hold potential amid healthcare investments, focusing on blood cancer biosimilars. Meanwhile, Latin America is emerging with imports for lung and cervical cancer treatments.

Contact Us:
Company Name: DataM Intelligence
Contact Person: Sai Kiran
Email: Sai.k@datamintelligence.com
Phone: +1 877 441 4866
Website: https://www.datamintelligence.com

About Us:
DataM Intelligence is a full-service market research and consulting firm, guiding organizations from initial insight to strategic implementation. We transform proprietary data, emerging trends, and market developments into agile, actionable solutions.
Our robust methodology powers a vast research database featuring 6,300+ syndicated and custom reports across 40+ industries. We have delivered strategic solutions to 200+ companies in 50+ countries, addressing the core research challenges that drive growth for our clients.

This release was published on openPR.