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Biosimilar Monoclonal Antibodies Market Know the Scope and Trends
According to the latest research by InsightAce Analytic, the global Biosimilar Monoclonal Antibodies Market Size is valued at USD 7.8 Billion in 2024 and is predicted to reach USD 32.1 Billion by the year 2034 at a 15.3% CAGR during the forecast period for 2025-2034.
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The production of monoclonal antibodies (mAbs) involves the use of identical immune cell clones derived from a single parent cell. As these antibodies originate from the same cell line, they exhibit uniformity in structure and function and are thus classified as biosimilar monoclonal antibodies. These biosimilars fall under the broader category of biotherapeutic products and are developed to be comparable to their reference biologic counterparts in terms of quality, efficacy, and safety. Monoclonal antibody biosimilars are complex biological macromolecules that undergo multiple post-translational modifications during production. They are widely utilized in the treatment of various autoimmune, inflammatory, and chronic diseases, offering a cost-effective and clinically effective alternative to original biologic therapies.
The rising production of advanced monoclonal antibodies, the rising geriatric population, and the high prevalence of chronic diseases like cancer, kidney failure, rheumatoid arthritis, psoriasis, diabetes, and others are all contributing factors to the growth of the global market for biosimilar monoclonal antibodies. As more mAbs' patents expire, more chances for market expansion are anticipated over the coming years. The demand for mAbs is anticipated to grow quickly throughout the forecast period due to increased patent expirations of the most popular antibodies. However, the complexity of producing biological pharmaceuticals, the lack of clinical trial experience, the tight government rules for product approvals, and the lack of awareness and understanding among manufacturers concerning biosimilar regulation and approval are all predicted to impede the market's growth.
North America is anticipated to be the major contributor to the Biosimilar Monoclonal Antibodies market over the forecast years. The region's strong growth can be ascribed to increased product approvals, a well-established health care infrastructure, and a favorable reimbursement scenario. In addition, the Asia Pacific regional market is expected to register significant growth during the estimated period because chronic disease burden, the need for affordable therapies, and government funding for healthcare facility improvements are all on the rise.
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Major market players operating in the Biosimilar Monoclonal Antibodies market include
BioXpress Therapeutics (Switzerland), Intas Pharmaceuticals Limited (Gujarat), Genor BioPharma Co. Ltd (China), BIOCAD (Russia), Dr. Reddys Laboratories Ltd (Hyderabad), 3SBio (China), Reliance Life Sciences (India), Hisun Pharma (China), Celgen Biopharma (China), Torrent Pharmaceuticals (Ahmedabad), Cadila Healthcare (Cadila Healthcare), Mylan Inc. (US) and others.
Recent collaborations and agreements in the market:
• In July 2021, Abzena (UK), a global partner research organization for biologics and bioconjugates, and BioXpress Therapeutics (Switzerland) collaborated to support third-party biosimilar development. This collaboration resulted in an integrated solution by two prominent service providers in biosimilar development and GMP manufacturing.
• In February 2021, Mylan (US) introduced Ogivri, a trastuzumab biosimilar. Trastuzumab is a monoclonal antibody used to treat human epidermal growth factor receptor 2 (HER2)-positive breast cancer, previously sold as Herceptin by Genentech.
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Market Segments
Global Biosimilar Monoclonal Antibodies Market, by Product, 2025-2034 (Value US$ Mn)
• Infliximab
• Trastuzumab
• Rituximab
• Adalimumab
• Bevacizumab
• Cetuximab
• Ranibizumab
• Denosumab
• Eculizumab
• Other Pipeline Products
Global Biosimilar Monoclonal Antibodies Market, by Indication, 2025-2034 (Value US$ Mn)
• Oncology
• Inflammatory & Autoimmune Disorders
• Chronic Diseases
• Blood Disorders
• Other Indication
Global Biosimilar Monoclonal Antibodies Market, by Region, 2025-2034 (Value US$ Mn)
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa
North America Biosimilar Monoclonal Antibodies Market, by Country, 2025-2034 (Value US$ Mn)
• U.S.
• Canada
Europe Biosimilar Monoclonal Antibodies Market, by Country, 2025-2034 (Value US$ Mn)
• Germany
• France
• Italy
• Spain
• Russia
• Rest of Europe
Asia Pacific Biosimilar Monoclonal Antibodies Market, by Country, 2025-2034 (Value US$ Mn)
• India
• China
• Japan
• South Korea
• Australia & New Zealand
Latin America Biosimilar Monoclonal Antibodies Market, by Country, 2025-2034 (Value US$ Mn)
• Brazil
• Mexico
• Rest of Latin America
Middle East & Africa Biosimilar Monoclonal Antibodies Market, by Country, 2025-2034 (Value US$ Mn)
• GCC Countries
• South Africa
• Rest of Middle East & Africa
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InsightAce Analytic is a market research and consulting firm that enables clients to make strategic decisions. Our qualitative and quantitative market intelligence solutions inform the need for market and competitive intelligence to expand businesses. We help clients gain a competitive advantage by identifying untapped markets, exploring new and competing technologies, segmenting potential markets, and repositioning products. Our expertise is in providing syndicated and custom market intelligence reports with an in-depth analysis with key market insights in a timely and cost-effective manner.https://www.insightaceanalytic.com/images_data/148861653.JPG
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