Biosimilars Market Expansion Across Emerging Healthcare Systems

The global biosimilars market was estimated at USD 39.59 billion in 2025 and is projected to reach USD 151.58 billion by 2033, expanding at a CAGR of 18.44% from 2026 to 2033. Strong market growth is primarily driven by the cost-effectiveness of biosimilar drugs and the rising global prevalence of chronic disorders, including autoimmune diseases, cancer, and metabolic conditions.

The market continues to gain momentum as biosimilars are comparatively easier and faster to develop than novel biologics, requiring lower research and development investment while delivering comparable clinical outcomes. Shorter development timelines, optimized manufacturing processes, and scale efficiencies contribute to reduced production costs, enabling competitive pricing for healthcare systems and attractive margins for manufacturers. As healthcare providers and payers increasingly prioritize affordable biologic therapies, pharmaceutical companies are strategically expanding their biosimilar portfolios to improve access and enhance long-term profitability.

Although biosimilars may exhibit minor differences in excipients or formulation components, they undergo rigorous regulatory evaluation to confirm no clinically meaningful differences from reference biologics in terms of safety, purity, and efficacy. This regulatory assurance has strengthened physician confidence and supported the broader adoption of biosimilars across multiple therapeutic areas, including oncology, immunology, and endocrinology.

Key Market Trends & Insights

• North America dominated the global biosimilars market, accounting for 42.56% of total revenue in 2025.
• Asia Pacific is expected to grow at the fastest CAGR of 19.84% during the forecast period, supported by expanding healthcare access and strong manufacturing capabilities.
• By drug class, monoclonal antibodies (mAbs) held the largest revenue share of 44.90% in 2025.
• By indication, autoimmune disorders (including RA, IBD, psoriasis, and ankylosing spondylitis) represented 39.90% of market revenue in 2025.
• By end use, the hospital segment accounted for approximately 52.34% of total revenue in 2025.

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Market Size & Forecast

• 2025 Market Size: USD 39.59 Billion
• 2033 Projected Market Size: USD 151.58 Billion
• CAGR (2026–2033): 18.44%
• Largest Regional Market: North America (2025)
• Fastest-Growing Region: Asia Pacific

Competitive Landscape

The global biosimilars market is highly competitive and innovation-driven, with key players focusing on regulatory approvals, strategic launches, and portfolio expansion to strengthen their market positions.

• In July 2025, Celltrion USA announced the commercial availability of STOBOCLO and OSENVELT in the U.S., biosimilars referencing Prolia and Xgeva, respectively.
• In April 2025, Biocon Biologics secured U.S. FDA approval for Jobevne, a biosimilar to Avastin, strengthening its oncology portfolio and U.S. market presence.
• In February 2025, multiple ustekinumab biosimilars—including Pyzchiva, Yesintek, Selarsdi, Otulfi, Imuldosa, and Steqeyma—entered the U.S. market, intensifying competition for the Stelara reference product and expanding treatment options for autoimmune disorders.
• In January 2025, Amgen Inc. launched Wezlana, the first ustekinumab biosimilar to Stelara in the U.S., marking a major milestone in complex monoclonal antibody biosimilar commercialization.

Some of the key players operating in the global biosimilars market include:

• Amgen Inc.
• F. Hoffmann-La Roche Ltd.
• Sandoz International GmbH
• Dr. Reddy’s Laboratories Ltd.
• Teva Pharmaceutical Industries Ltd.
• Pfizer Inc.
• Samsung Bioepis
• Biocon
• Viatris Inc.
• Celltrion Healthcare Co., Ltd.
• AbbVie Inc.

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Conclusion

The global biosimilars market is set for rapid expansion through 2033, driven by rising demand for affordable biologic therapies, supportive regulatory frameworks, and a robust pipeline of monoclonal antibody biosimilars. As healthcare systems worldwide seek to reduce treatment costs without compromising clinical outcomes, biosimilars are becoming integral to chronic disease management. Companies that focus on regulatory excellence, manufacturing efficiency, and strategic market entry are well positioned to capitalize on the strong growth opportunities ahead.