Biosimilar Monoclonal Antibodies Market Report 2025

This Biosimilar Monoclonal Antibodies market report provides a comprehensive analysis of the market’s characteristics, size, and growth, including segmentation, regional and country-level breakdowns, competitive landscape, market shares, trends, and strategies. It also tracks historical and forecasted market growth across various geographies.

The biosimilar monoclonal antibodies market size has grown rapidly in recent years. It will grow from $8.04 billion in 2024 to $9.25 billion in 2025 at a compound annual growth rate (CAGR) of 15.1%. The growth in the historic period can be attributed to patent expirations, growing awareness of biosimilars, government initiatives, increasing investment from pharmaceutical companies, and growing acceptance of biosimilars by clinicians and patients.

The biosimilar monoclonal antibodies market size is expected to see strong growth in the next few years. It will grow to $12.79 billion in 2029 at a compound annual growth rate (CAGR) of 8.5%. The growth in the forecast period can be attributed to rising biologic expenditure, biosimilar portfolio expansion, personalization of biosimilar therapy, and increasing public interest in biosimilars. Major trends in the forecast period include therapeutic expansion, personalized biosimilars, collaborations and partnerships, biosimilar autoinjectors and devices, biobetters.

The rising prevalence of chronic diseases is anticipated to boost the biosimilar monoclonal antibodies market. These biosimilar monoclonal antibodies are utilized in the treatment of chronic conditions such as cancer, autoimmune diseases, and rheumatoid arthritis. In cancer therapy, biosimilars for monoclonal antibodies, including trastuzumab, bevacizumab, and rituximab, are commonly employed. Additionally, the incidence of cancer continues to rise each year. For instance, in February 2024, reports from the Centers for Disease Control and Prevention (CDC), a U.S.-based public health agency, indicated that an increasing number of Americans are managing multiple chronic conditions, with 42% experiencing two or more conditions and 12% dealing with five or more. Consequently, the growing prevalence of chronic diseases is expected to drive the expansion of the biosimilar monoclonal antibodies market.

The growing geriatric population is also set to drive the biosimilar monoclonal antibodies market. These antibodies offer cost-effective access to vital therapies, enhancing treatment affordability and quality of life for older adults combating chronic diseases. The World Health Organization's estimates indicate a substantial rise in the elderly population, with projections of 2.1 billion elderly individuals globally by 2050, illustrating the significance of biosimilar monoclonal antibodies in catering to the healthcare needs of this demographic.

Major companies in the biosimilar monoclonal antibodies market are concentrating on the development of cost-effective biosimilar therapies to secure a competitive edge. These therapies are biologic medical products that are highly similar to already approved reference monoclonal antibodies, aimed at providing affordable treatment options for various conditions, including cancer and autoimmune diseases. For example, in 2022, Pfizer, a U.S.-based pharmaceutical company, launched Abrilada, a biosimilar of AbbVie's Humira (adalimumab). Abrilada offers a comparable efficacy and safety profile to the original product while delivering significant cost savings for both patients and healthcare systems. Furthermore, it benefits from a streamlined approval process and robust manufacturing capabilities, which improve patient access to essential treatments. This trend reflects a broader industry movement towards tackling rising healthcare costs while ensuring high-quality therapeutic options are available for patients.

Leading companies in the biosimilar monoclonal antibody market are creating biosimilar versions of monoclonal antibodies to provide cost-effective alternatives to original therapies, thereby enhancing access and affordability in healthcare. An intravenous formulation is specifically designed to be administered directly into the bloodstream via a vein for a rapid therapeutic effect. For example, in May 2024, Bio-Thera Solutions, a biopharmaceutical company based in China, in collaboration with Biogen Inc., a U.S.-based biopharmaceutical company, launched TOFIDENCE (tocilizumab-bavi) in an intravenous formulation in the United States. The U.S. Food and Drug Administration approved TOFIDENCE in September 2023 for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. Upon launch, TOFIDENCE is available in three vial sizes - 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL - designed for intravenous infusion, with plans for subcutaneous formulations to be released in the future.

In November 2022, Biocon Biologics Ltd., an India-based biopharmaceutical company, successfully acquired Viatris Inc.'s biosimilars business, marking a significant strategic move. The acquisition, though the financial details were undisclosed, positions Biocon Biologics closer to patients, customers, and payors, enhancing their direct commercial capabilities and bolstering infrastructure in both advanced markets and several emerging regions.

Biosimilar monoclonal antibodies belong to a subset of biosimilars known for their role in treating conditions like cancer or rheumatoid arthritis. These intricate proteins are integral in the immune system's function, identifying and eliminating foreign substances such as bacteria and viruses.

Within the category of biosimilar monoclonal antibodies, key types include synthetic chemicals, biopharmaceuticals, and others. Biopharmaceuticals, often referred to as biologic medical products, are pharmaceutical drugs derived from biological sources or semi-synthesized compounds. Notable compounds in this category include infliximab, rituximab, abciximab, trastuzumab, adalimumab, and bevacizumab. They find applications across various medical domains including chronic and autoimmune diseases, oncology, and other therapeutic areas. These biosimilar monoclonal antibodies play a crucial role in addressing a wide spectrum of health conditions.

The biosimilar monoclonal antibodies market research report is one of a series of new reports that provides biosimilar monoclonal antibodies market statistics, including industry global market size, regional shares, competitors with a biosimilar monoclonal antibodies market share, detailed biosimilar monoclonal antibodies market segments, market trends and opportunities, and any further data you may need to thrive in the biosimilar monoclonal antibodies industry. This biosimilar monoclonal antibody market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

Major companies operating in the biosimilar monoclonal antibodies market include Pfizer Inc., Novartis AG, AbbVie Inc., Coherus BioSciences, Biocon Limited, Amgen Inc., Boehringer Ingelheim International GmbH, Celltrion Inc., BioXpress Therapeutics SA, Intas Pharmaceuticals Limited, Genor BioPharma Co. Ltd., BIOCAD, Dr. Reddy's Laboratories Ltd., 3SBio Inc., Reliance Life Sciences, Hisun Pharmaceuticals, Celgen Biopharmaceuticals, Torrent Pharmaceuticals Ltd., Cadila Healthcare Ltd., Shanghai Henlius Biotech Inc., Teva Pharmaceutical Industries Ltd., Alvotech, Xentria Inc., Lazuline Biotech Private Limited, Epygen Biotech Pvt Ltd., Mabpharm Limited, Qilu Pharmaceutical Co. Ltd., Chiatai Tianqing Pharmaceutical Group Co. Ltd., YL Biologics Ltd., Aprogen Biologics, UNDBIO Co Ltd., Samsung Bioepis Co. Ltd., ISU Abxis Corp., Bio-Rad Laboratories Inc.

North America was the largest region in the biosimilar monoclonal antibodies market in 2024. The regions covered in the biosimilar monoclonal antibodies market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa. The countries covered in the biosimilar monoclonal antibodies market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Italy, Spain, Canada.

The biosimilar monoclonal antibodies market consists of sales of Blitzima, Ritemvia, Rituzena, and Truxima. Values in this market are 'factory gate values,' that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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