The U.S. biosimilars market size is calculated at USD 22.59 billion in 2025 and is predicted to reach around USD 93.52 billion by 2034, expanding at a CAGR of 17.1% from 2025 to 2034.
The U.S. biosimilars market refers to the production, distribution, and application of biosimilars, a biological medical product that is almost identical to an original product, manufactured by a different company. Biosimilar is also called a biological medicinal product similar to a biological medicine that has already been authorized, so known as a reference medicinal product. Biosimilars are a biological drug that is very much like another biological drug that the U.S. Food and Drug Administration has already approved. Biosimilars are a type of biologic medication that are safe and effectual for treating many illnesses. The U.S. FDA approved biosimilar medications to treat kidney conditions, muscular degeneration, arthritis, chronic bowel and skin diseases, and certain cancers.
Rising incidences of chronic disorders contribute to the growth of the U.S. biosimilars market. Biosimilars are safe and effective medications for treating arthritis and cancer. As with generics, biosimilars provide patients with lower-cost medicines, making these treatments more accessible and enhancing their quality of life. Biologic drugs have revolutionized disease management for many serious and chronic conditions, including psoriasis, Crohn’s disease, rheumatoid arthritis, and cancer. Biosimilars lead to significant savings in the health system, lowering the burden of healthcare expenditure. The main advantage of using biosimilars in patients with inflammatory bowel disease is reduced drug acquisition costs.
Significant research and development expenditure in biosimilars is driving notable growth in the U.S. biosimilars market. The biosimilars stimulate market competition, contribute toward healthcare sustainability, and enable greater patient access. Biosimilar development aims to establish that the biosimilar does not confer a higher safety or immunogenicity risk than the reference product. A noninferiority design may be adequate for the evolution of immunogenicity or other safety outcomes, provided that lower immunogenic or other safety outcomes provide lower immunogenic or other safety events. Research and development enhance processes, create new products and services, and increase competitiveness and profit. It helps develop new diagnostic tests, treatments, and processes that may eventually help your children or grandchildren. By reducing costs, improving the precision of drug development, and accelerating times, these innovations can transform the U.S. biosimilars market.
Artificial intelligence (AI) plays an important role in the U.S. biosimilars market. By applying these artificial intelligence methodologies to the development of biosimilars, stakeholders can significantly accelerate the process from laboratory to market, ensuring that these critical medicines are developed safely, efficiently, and at a lower cost. AI can improve biosimilar development, enhance manufacturing efficiency, and ensure safety and quality. Newly developed AI-based bioinformatic models conduct solid evidence of 3D structures, allowing the confirmation of bio similarity without the need for in vivo studies. Additionally, newly designed proteins, such as proteins with enhanced pharmacokinetics, monoclonal antibodies (mAbs) coupled with small molecules, bispecific mAbs, and multi-specific fusion proteins, are constantly being discovered. AI can include many stages of drug discovery in many ways, including AI-based modeling for personalized drug dosing, gene editing for developing gene therapies, predicting drug toxicity, computational screening, target acquisition, and disease identification.
AI can streamline prescribing and formulary management for generics and biosimilars, enhance pharmacovigilance, and improve provider engagement. Implementing AI in efficiency, automation, better decisions, advanced data analysis, reduced human error, improved customer experience, smarter decisions, cost reduction, fraud detection, new inventions, improved human experiences, improving security with AI, easily handles big data, increased business efficiency, completing repetitive tasks, digital assistance, time-saving capabilities, and personalized recommendations for customers which help the growth of the market.
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| Stats ID: | 7827 |
| Format: | Databook |
| Published: | January 2025 |
| Price | US$ 1550 |
Immediate Delivery
| Stats ID: | 7827 |
| Format: | Databook |
| Published: | January 2025 |
| Price | US$ 1550 |
Immediate Delivery
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