Biosimilars Market to Reach US$ 171.79 Billion by 2033 at 25.5% CAGR, Driven by Patent Expiries and Cost-Effective Biologic Alternatives | DataM Intelligence

According to DataM Intelligence, the global biosimilars market size reached US$ 22.58 billion in 2024 and is expected to reach US$ 171.79 billion by 2033, growing at a CAGR of 25.5% during the forecast period 2025-2033, driven by major biologic patent expiries (e.g., monoclonal antibodies and insulin), increasing demand for affordable treatments in oncology and autoimmune diseases, strong regulatory support for biosimilar approvals, rapid adoption in North America, and fastest growth in Asia-Pacific with expanding manufacturing capacity.

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United States Key Industry Developments

☑️ January 2026: Amgen Inc. expanded U.S. biosimilar portfolio with new launches and increased patient access programs for key oncology and autoimmune indications, securing broader payer coverage.
☑️ January 2026: Pfizer Inc. reported strong uptake of its biosimilar monoclonal antibodies, launching enhanced marketing and real-world evidence initiatives to support switching from originator products.
☑️ December 2025: Sandoz Group AG advanced its biosimilar insulin and growth hormone offerings, gaining additional formulary placements and reimbursement wins across major U.S. health plans.

Japan Key Industry Developments

☑️ January 2026: Japanese biosimilar manufacturers accelerated regulatory approvals and launches of monoclonal antibody and insulin biosimilars, supported by updated PMDA guidelines favoring cost-effective alternatives.
☑️ January 2026: Local and global players showcased next-generation biosimilars at major Tokyo pharma conferences, emphasizing oncology and autoimmune applications for aging populations.
☑️ December 2025: Growing adoption of biosimilars in Japan's hospitals and clinics, driven by government initiatives to reduce healthcare expenditure and promote competition in biologic therapies.

Key Mergers and Acquisitions

✦ January 2026: Amgen Inc. acquired a biosimilar development startup to expand its pipeline of next-generation monoclonal antibody biosimilars for oncology and inflammatory diseases.
✦ December 2025: Sandoz Group AG completed a strategic acquisition of a regional biosimilar manufacturing facility to increase production capacity for key autoimmune and oncology products.
✦ November 2025: Pfizer Inc. secured a licensing agreement with a biotech innovator to advance its biosimilar portfolio in growth hormone and erythropoietin categories.

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Market Segmentation Analysis

By Product Type: Monoclonal Antibodies hold the largest share due to major patent expiries and high demand in oncology and autoimmune diseases; Recombinant Human Growth Hormone (rhGH) and Insulin follow for endocrinology applications; Erythropoietin, Granulocyte Colony Stimulating Factor, and Others grow steadily for hematology and supportive care.

By Application: Oncology dominates with significant uptake of biosimilar monoclonal antibodies; Chronic Diseases and Autoimmune Diseases follow for long-term treatment needs; Infectious Diseases, Growth Hormone Deficiency, Hematology, and Others expand with supportive and niche indications.

By End-User: (Inferred from context) Pharmaceutical & Biotechnology Companies lead for biosimilar development and commercialization; Hospitals and Clinics grow rapidly for patient access; Others include government programs and specialty pharmacies.

Regional Insights

North America dominates the biosimilars market with the highest revenue share, supported by rapid FDA approvals, strong payer acceptance of biosimilars, high biologic utilization in oncology and autoimmune diseases, significant R&D investment by leading companies, and well-established reimbursement frameworks driving switching from originator products.
Asia-Pacific is the fastest-growing region, fueled by rising chronic disease burden, increasing healthcare expenditure in China, India, and Japan, expanding biosimilar manufacturing capabilities, government initiatives for cost-effective biologics, growing clinical trial activity, and aggressive market entry by global and local players focusing on oncology and chronic therapies.

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Key Players

The market includes major global players such as Amgen Inc., Pfizer Inc., Sandoz Group AG, Teva Pharmaceuticals USA, Inc., Biogen, Biocon Biologics Inc., Boehringer Ingelheim International GmbH, Samsung Bioepis, Dr. Reddy's Laboratories Ltd., Fresenius Kabi AG, and others.

Key Highlights (Top 5 Key Players)

✦ Amgen Inc. - Leading biosimilar innovator with a strong portfolio of monoclonal antibody and supportive care biosimilars, driving significant market share through oncology and nephrology products.
✦ Pfizer Inc. - Dominant in biosimilars with extensive monoclonal antibody and growth factor offerings, focusing on global access and competitive pricing strategies.
✦ Sandoz Group AG - Renowned for early and broad biosimilar launches across multiple therapeutic areas, emphasizing high-quality manufacturing and market penetration.
✦ Samsung Bioepis - Strong player in oncology and autoimmune biosimilars, leveraging cost-effective production and partnerships for rapid global rollout.
✦ Biocon Biologics Inc. - Key innovator in insulin and monoclonal antibody biosimilars, with significant presence in emerging markets and focus on affordability.

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