Oncology Biosimilars Market to Reach US$ 30.83 Billion by 2033 at 18.6% CAGR; Patent Expiries and Cost Pressures Drive Adoption - Key Players: Amgen, Pfizer, Celltrion

The Global Oncology Biosimilars Market reached US$ 6.76 billion in 2024, up 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. The market is expanding rapidly as healthcare systems seek cost-effective alternatives to high-priced biologic cancer therapies, helping improve patient access and reduce overall oncology treatment costs.

Market growth is primarily driven by the patent expiries of blockbuster biologics such as trastuzumab, bevacizumab, rituximab, and pegfilgrastim, which has accelerated the adoption of lower-cost biosimilars across global markets. Recent regulatory approvals, including Henlius's Hercessi (trastuzumab) and Biocon's bevacizumab biosimilar, underscore increasing competition and strong regulatory momentum. Major players such as Amgen and other leading biopharmaceutical companies are actively expanding their oncology biosimilar pipelines through strategic partnerships and investments. With strong uptake across Europe and Asia-Pacific and growing acceptance in the United States, oncology biosimilars are reshaping cancer care by enhancing affordability, accessibility, and treatment sustainability worldwide.

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The Oncology Biosimilars Market is the sector that develops and supplies biosimilar versions of cancer biologic drugs to provide cost-effective and accessible oncology treatments.

Key Developments
✅ October 2025: U.S. healthcare providers expanded adoption of oncology biosimilars to reduce cancer treatment costs and improve patient access to biologic therapies across hospital and oncology clinic settings.

✅ September 2025: European regulatory agencies approved additional oncology biosimilars, supporting wider use in breast cancer, colorectal cancer, and hematologic malignancies.

✅ August 2025: Asia-Pacific pharmaceutical companies increased production and commercialization of oncology biosimilars to meet rising cancer prevalence and demand for affordable therapies.

✅ July 2025: Global oncology drug manufacturers enhanced pharmacovigilance and real-world evidence programs to strengthen physician confidence in biosimilar efficacy and safety.

✅ May 2025: North American payers and health systems promoted biosimilar substitution policies to support cost-effective oncology care delivery.

✅ March 2025: International oncology associations issued updated clinical guidelines encouraging appropriate use of biosimilars in cancer treatment protocols.

Mergers & Acquisitions
✅ November 2025: A U.S.-based biopharmaceutical company acquired an oncology biosimilars developer to expand its oncology portfolio and market presence.

✅ August 2025: A European biosimilars manufacturer partnered with a global pharmaceutical company to commercialize oncology biosimilars across multiple regions.

✅ June 2025: An Asia-Pacific biosimilars company was acquired by a multinational pharmaceutical firm to strengthen its oncology biosimilar pipeline and global distribution capabilities.

Key Players
Amgen Inc. | Pfizer Inc. | Celltrion USA | Biocon Biologics | Teva Pharmaceuticals | Organon | Accord BioPharma | Sandoz Inc.

Key Highlights

Amgen Inc. - Holds a share of 21.8 percent: Market leader with a strong biosimilars and biologics portfolio, supported by extensive research capabilities and global commercialization strength.

Pfizer Inc. - Holds a share of 18.6 percent: Maintains a strong position through diversified biologics and biosimilars pipelines, global partnerships, and wide regulatory approvals.

Celltrion USA - Holds a share of 14.2 percent: Focuses on biosimilars for oncology and autoimmune diseases, with expanding approvals and penetration in the US and European markets.

Biocon Biologics - Holds a share of 12.5 percent: Rapidly expanding global footprint in biosimilars through cost effective manufacturing and strategic collaborations.

Teva Pharmaceuticals - Holds a share of 11.1 percent: Leverages strong generics expertise and biosimilar development to expand access to biologic therapies worldwide.

Sandoz Inc. - Holds a share of 10.4 percent: Well established biosimilars provider with a broad portfolio across immunology, oncology, and endocrinology.

Organon - Holds a share of 6.1 percent: Expands its biosimilars and specialty medicines portfolio with a focus on women's health and chronic conditions.

Accord BioPharma - Holds a share of 5.3 percent: Concentrates on oncology focused biosimilars and injectables, strengthening its position through targeted launches and partnerships.

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Market Drivers
- Rising incidence and prevalence of cancer globally increasing demand for effective and affordable treatments.

- Growing healthcare expenditure and pressure to reduce oncology drug costs.

- Patent expirations of major biologic oncology therapies creating opportunities for biosimilar approvals.

- Supportive regulatory frameworks and streamlined approval pathways for biosimilars in major markets.

- Increasing adoption of biosimilars by healthcare providers and payers to improve patient access.

- Expansion of oncology treatment protocols incorporating biosimilar therapeutics.

- Advancements in bioprocessing and manufacturing technologies lowering production costs.

Industry Developments
- Launch and approval of biosimilar versions of widely used oncology biologics such as monoclonal antibodies.

- Expansion of clinical studies demonstrating equivalence, safety, and efficacy of oncology biosimilars.

- Growing partnerships between biosimilar developers, contract manufacturing organizations (CMOs), and distribution networks.

- Strategic licensing, joint ventures, and collaborations to expand global biosimilar portfolios.

- Increased investments, mergers, and acquisitions in the oncology biosimilars segment.

- Development of educational and awareness programs to promote clinician and patient confidence in biosimilars.

- Implementation of pricing and reimbursement strategies to support biosimilar uptake.

Regional Insights
North America - 45% share: "Driven by high cancer incidence, strong biosimilar regulatory pathways, expanding reimbursement support, and presence of major biotech companies."

Europe - 28% share: "Supported by favorable biosimilar policies, well-established healthcare systems, and early adoption of oncology biosimilars."

Asia Pacific - 22% share: "Fueled by increasing cancer burden, rising healthcare access, government support, and expanding biosimilar manufacturing capabilities."

Latin America - 3% share: "Boosted by improving healthcare infrastructure, growing biosimilar awareness, and cost sensitivity in oncology care."

Middle East & Africa - 2% share: "Driven by emerging healthcare investments, gradual biosimilar adoption, and efforts to improve oncology treatment accessibility."

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Key Segments
By Product Type
Monoclonal antibodies (mAbs) dominate the market owing to their high specificity, targeted mechanism of action, and widespread use across multiple cancer types. Strong clinical efficacy, expanding indications, and continuous product approvals support their leading position. Recombinant proteins hold a significant share, driven by their role in targeted cancer therapies and supportive care treatments. Granulocyte colony-stimulating factor (G-CSF) represents an important segment due to its extensive use in managing chemotherapy-induced neutropenia and improving patient outcomes. Erythropoiesis-stimulating agents contribute steadily to market growth by addressing cancer-related anemia. Other product types, including combination biologics and emerging therapies, support market expansion through innovation and pipeline development.

By Indication
Breast cancer accounts for the largest market share, supported by high global prevalence, increasing awareness, and strong adoption of biologic therapies. Lung cancer represents a key segment, driven by rising incidence rates and growing use of targeted biologics and immunotherapies. Colorectal cancer continues to witness steady growth due to advancements in biologic treatment options and improved diagnostic rates. Blood cancer holds a notable share, supported by increasing use of biologics in leukemia and lymphoma management. Cervical cancer and other indications contribute to overall market growth, particularly in emerging economies where screening and treatment access are improving.

By Route of Administration
Injectable biologics dominate the market due to higher bioavailability, rapid therapeutic action, and suitability for complex biologic formulations. The oral route represents a smaller but emerging segment, supported by ongoing research focused on improving oral bioavailability and patient convenience. Growing interest in non-invasive administration methods is expected to drive future innovation in this segment.

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