Press release
Biosimilars Market to Surpass US$ 171.79 Billion by 2033, Driven by Rapid FDA Approvals and Affordable Biologic Alternatives
Biosimilars Market
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The global market is being fueled by a surge in biosimilar approvals, falling production costs, and strong support from healthcare regulators. The increasing use of biologics in oncology, autoimmune diseases, diabetes, and hematology has created an urgent need for cost-effective alternatives, where biosimilars are bridging the affordability gap. North America remains the largest market, driven by the U.S. FDA's accelerated approval process and growing adoption by major healthcare systems, while Asia-Pacific is the fastest-growing region with expanding clinical research and local manufacturing capabilities.
Key Highlights from the Report
➤ Market value projected to rise from US$ 22.58 billion in 2024 to US$ 171.79 billion by 2033, growing at 25.5% CAGR.
➤ Over 70 biosimilars approved in the U.S. to date, strengthening North America's leadership in biosimilar development.
➤ Oncology segment dominates with increasing biosimilars for bevacizumab, rituximab, and trastuzumab.
➤ Lower pricing and expanded access to biologic therapies driving adoption across emerging markets.
➤ New FDA approvals in 2024-2025 include biosimilars like Omlyclo (omalizumab), Steqeyma (ustekinumab), and Pavblu (aflibercept).
➤ Immunogenicity and cost of large-scale manufacturing remain key market challenges.
Market Segmentation
The global biosimilars market is segmented by product type, application, and region.
Application: Oncology Dominates Global Share
The oncology segment holds the largest share in the biosimilars market, supported by a rising global cancer burden and the growing need for affordable therapeutic options. According to the World Health Organization (WHO), cancer remains one of the leading causes of death, with nearly 20 million new cases in 2022 and projected cases expected to reach 29.9 million by 2040. Biosimilars offer a cost-effective alternative for expensive cancer therapies.
Several oncology-based biosimilars-such as those for Herceptin (trastuzumab), Avastin (bevacizumab), and Rituxan (rituximab)-have received approvals from the FDA and European Medicines Agency (EMA), solidifying market confidence. The expanded use of biosimilars for biologics like Eylea, Stelara, and Prolia continues to enhance the oncology segment's revenue contribution.
Product Pipeline: Expanding Therapeutic Reach
Biosimilars are now approved across a wide range of treatments, including diabetes (insulins), autoimmune diseases (adalimumab, infliximab), and hematologic conditions (filgrastim). The FDA-approved Omlyclo as an interchangeable biosimilar to Xolair in March 2025, marking a breakthrough for asthma and allergy treatment biosimilars. New entries like Steqeyma and Yesintek for Stelara continue to diversify the market landscape.
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Regional Insights
North America: Global Market Leader
North America dominates the global biosimilars market, fueled by rapid FDA approvals, a robust legal framework under the Biologics Price Competition and Innovation Act (BPCI Act), and major pharmaceutical players. The U.S. FDA's 71 approved biosimilars demonstrate its proactive approach to regulating and accelerating market entry. Amgen, Pfizer, and Celltrion are leading the charge, with flagship products such as Amjevita (adalimumab), Inflectra (infliximab), and STEQEYMA (ustekinumab-stba) now available in the region.
Asia-Pacific: Fastest-Growing Market
Asia-Pacific is emerging as the fastest-growing market for biosimilars, aided by strategic collaborations and strong investment in R&D. Countries such as India, China, South Korea, and Japan are advancing domestic biosimilar production to reduce dependency on imports. India's Biocon Biologics and Dr. Reddy's Laboratories are at the forefront of global biosimilar innovation, supporting healthcare affordability across Asia and Africa.
Market Dynamics
Market Drivers
The broader adoption of biosimilars across oncology, immunology, and chronic diseases is driving exponential growth. Regulatory clarity from organizations like the FDA and EMA promotes industry competition, creating pathways for cost-effective and timely approvals.
Market Restraints
Immunogenicity and safety concerns remain barriers to wider adoption. Patient responses to biosimilars may vary slightly due to molecular structure differences during manufacturing, raising long-term safety considerations. Moreover, the high cost of production and stringent regulatory requirements constrain entry for smaller manufacturers.
Market Opportunities
As patents for blockbuster biologics continue to expire, emerging biopharmaceutical companies have opportunities to launch biosimilars across new therapeutic categories. Technological advances in purification, analytical testing, and recombinant DNA technologies also promise higher manufacturing efficiency and global competitiveness.
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Reasons to Buy the Report
✔ Detailed analysis of biosimilar trends, emerging therapeutic segments, and competitive dynamics.
✔ Insights into regulatory pathways driving biosimilar approvals globally.
✔ Comprehensive overview of key therapeutic categories, including oncology and autoimmune diseases.
✔ Regional insights highlighting North America's leadership and Asia-Pacific's high-growth potential.
✔ Evaluation of investment opportunities and market challenges for new entrants.
Frequently Asked Questions (FAQs)
◆ How big is the biosimilars market in 2024?
◆ What is the expected CAGR for the global biosimilars market through 2033?
◆ Which region leads the global biosimilars market?
◆ Which therapeutic segment holds the largest share in the biosimilars industry?
◆ Who are the key players operating in the global biosimilars market?
Company Insights
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
Recent Developments
March 2025: Celltrion received FDA approval for OMLYCLO (omalizumab-igec), the first interchangeable biosimilar to Xolair, broadening treatment accessibility for asthma and allergic disorders.
December 2024: Celltrion gained FDA approval for STEQEYMA (ustekinumab-stba), reinforcing its standing in the immunology biosimilars segment.
Conclusion
The Global Biosimilars Market is undergoing unprecedented expansion as pharmaceutical companies capitalize on patent expiries, technological progress, and favorable regulatory reforms. North America's well-defined approval pathways continue to set benchmarks for quality and accessibility, while Asia-Pacific's cost-efficient manufacturing capabilities are expanding the global supply network. As biosimilars become integral to healthcare systems worldwide, their growing affordability and therapeutic diversity will redefine patient access to biologic medications through 2033.
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DataM Intelligence 4Market Research is a comprehensive market intelligence platform offering syndicated and customized reports along with expert consulting across multiple industries, including chemicals, healthcare, agriculture, food & beverages, and more. With extensive experience and a strategy-focused approach, DataM provides businesses and individuals with reliable market insights, statistical forecasts, and personalized research solutions to help them make informed decisions and successfully bring innovations to market.
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