Oncology Biosimilars Market Expected to Reach US$ 30.83 Billion by 2033, Growing at a CAGR of 18.6%, Europe Leads with 38% Share | Key Players Amgen Inc., Pfizer Inc., Celltrion USA, Biocon Biologics

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. Market growth is primarily driven by the patent expiries of leading oncology biologics such as trastuzumab, bevacizumab, rituximab, and pegfilgrastim, which has accelerated the adoption of cost-effective biosimilar alternatives across global healthcare systems.

Increasing regulatory approvals and competitive product launches are strengthening market momentum. Recent approvals, including Henlius's Hercessi (trastuzumab) and Biocon's bevacizumab biosimilar, reflect growing regulatory confidence and intensified competition. Major players such as Amgen and other global biosimilar manufacturers are expanding their oncology pipelines and forming strategic partnerships to enhance market reach. Strong uptake in Europe and Asia-Pacific, along with steadily increasing adoption in the United States, is reshaping cancer treatment by improving affordability, expanding patient access, and reducing the economic burden of oncology care worldwide.

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The Oncology Biosimilars Market refers to the global industry focused on the development and commercialization of biosimilar drugs used in cancer treatment as cost-effective alternatives to branded biologics.

Key Developments
✅ January 2026: In North America, oncology biosimilars adoption continued to increase as clinicians expanded use in supportive care and targeted therapy regimens to reduce treatment costs.

✅ December 2025: In Europe, reimbursement policies were updated to improve coverage for biosimilar oncology agents, accelerating patient access and formulary acceptance.

✅ November 2025: In Asia-Pacific, local manufacturers scaled commercial launches of biosimilar versions of established monoclonal antibodies to address rising cancer incidence.

✅ October 2025: In Latin America, oncology centers reported higher treatment uptake with biosimilar immunotherapies and growth factor support drugs due to improved supply affordability.

✅ September 2025: In the Middle East, healthcare systems expanded procurement of biosimilar oncology drugs for national cancer programs to support treatment equity.

✅ August 2025: In Africa, pilot programs enabled adoption of biosimilar supportive care agents in public oncology clinics to reduce out-of-pocket costs for patients.

Mergers & Acquisitions
✅ January 2026: In North America, a major pharmaceutical company acquired a biosimilar oncology development biotech to strengthen its oncology biosimilars pipeline.

✅ December 2025: In Europe, a leading biosimilars manufacturer acquired a regional oncology drug portfolio to expand its cancer care offerings.

✅ November 2025: In Asia-Pacific, a healthcare group acquired a biosimilar distribution business to enhance access in emerging markets.

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

Key Highlights
Amgen Inc. holds approximately 27.3% share, driven by its strong leadership in biosimilars and specialty biologics, extensive global commercialization network, and continued investment in pipeline expansion.

Pfizer Inc. accounts for about 19.6% share, supported by a diversified biologics and biosimilars portfolio, strong R&D capabilities, and strategic partnerships across key global markets.

Celltrion USA represents nearly 15.4% share, benefiting from a robust biosimilar pipeline, competitive pricing strategies, and expanding footprint in North America and Europe.

Biocon Biologics holds around 13.1% share, driven by cost-efficient manufacturing, strong regulatory approvals in major markets, and long-term partnerships for global biosimilar commercialization.

Teva Pharmaceuticals captures approximately 9.2% share, supported by its experience in complex generics and biosimilars, and established distribution channels worldwide.

Organon accounts for about 6.8% share, leveraging its focus on women's health and biosimilars, expanding market access strategies, and portfolio diversification.

Accord BioPharma holds nearly 4.6% share, driven by a growing biosimilar pipeline and increasing approvals in regulated markets.

Sandoz Inc. represents around 4.0% share, benefiting from long-standing biosimilar expertise, global market presence, and continued investments in next-generation biologics.

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Market Drivers
- Rising global cancer prevalence increasing demand for cost-effective oncology treatments.

- Patent expirations of major biologic cancer drugs enabling biosimilar market entry.

- Growing healthcare cost containment efforts by governments and payers.

- Improving physician and patient acceptance of biosimilars in oncology care.

- Expansion of biosimilar regulatory approval pathways across major markets.

Industry Developments
- Launch of oncology biosimilars for monoclonal antibodies and supportive care biologics.

- Strategic partnerships between biopharmaceutical companies and contract manufacturers.

- Investments in advanced biologics manufacturing and analytical characterization technologies.

- Expansion of clinical trial programs to demonstrate biosimilarity and interchangeability.

- Increasing focus on global market access and pricing strategies for biosimilars.

Regional Insights
Europe - 38% share: "Driven by strong biosimilar adoption, supportive regulatory frameworks, and cost-focused healthcare systems."

North America - 28% share: "Supported by increasing FDA approvals, growing payer acceptance, and rising oncology drug spending."

Asia Pacific - 26% share: "Fueled by expanding biologics manufacturing capacity, growing cancer burden, and improving regulatory environments."

Latin America - 5% share: "Driven by rising access to affordable cancer treatments and gradual biosimilar adoption."

Middle East & Africa - 3% share: "Supported by improving oncology care infrastructure and increasing availability of biosimilar therapies."

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Key Segments

By Product Type
Monoclonal antibodies (mAbs) dominate the market, driven by their high specificity, proven clinical efficacy, and broad use across multiple cancer types. Recombinant proteins hold a significant share, supported by their role in targeted therapy and supportive oncology care. Granulocyte colony-stimulating factor (G-CSF) represents an important segment, driven by its widespread use in managing chemotherapy-induced neutropenia. Erythropoiesis-stimulating agents account for a notable portion, supported by demand for anemia management in cancer patients. Other biologic products continue to contribute through niche and emerging oncology applications.

By Indication
Breast cancer represents the largest indication segment, driven by high disease prevalence and extensive use of biologic therapies. Lung cancer holds a substantial share, supported by growing adoption of targeted and immuno-oncology treatments. Colorectal cancer accounts for a significant portion, driven by established biologic regimens and combination therapies. Cervical cancer and blood cancer represent important segments, supported by increasing diagnosis rates and expanding treatment options. Other cancer indications continue to grow as biologic therapies are increasingly adopted across a wider range of malignancies.

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