Biosimilar Monoclonal Antibodies Market Size, Share & Trends Analysis Report By Product (Infliximab, Rituximab, Abciximab, Trastuzumab, Adalimumab), By Application, By Region, And Segment Forecasts, 2023 To 2030

The growth of the global biosimilar monoclonal antibodies (mAbs) market can be attributed to various factors which include increasing patent expiries of monoclonal antibodies, advancements in mAbs innovation, increasing demand for cost-efficient products, the rising prevalence of chronic and autoimmune diseases like rheumatoid arthritis and cancer, as well as the aging population. Moreover, the rising investments in research and development for biological drugs are expected to drive the adoption during the forecast period. Increased R&D activities lead to the development of innovative drug products, improved developmental procedures, and enhanced healthcare facilities, all such factors contribute to market growth.

The expiration of patents for prominent monoclonal antibodies (mAbs) has increased significant interest among pharmaceutical companies to develop biosimilars. Moreover, the introduction of biosimilars following the patent expiries of key monoclonal antibodies, such as Remicade from Johnson & Johnson, Herceptin from Roche, and Humira from Abbott, is a major driving factor for the market.

Furthermore, strategic collaborations and initiatives among key players in space are boosting industry growth. For instance, in July 2021, Abzena (UK), a global research organization specializing in biologics and bioconjugates, collaborated with BioXpress Therapeutics (Switzerland) to support biosimilar development for third-party customers. This collaboration created an integrated solution between two leading service providers in biosimilar development and GMP manufacturing. Similarly, in February 2020, Mylan (US) launched Ogivri, a biosimilar of trastuzumab. Trastuzumab is a mAb used to treat HER2-positive breast cancer and was previously marketed by Genentech as Herceptin.

However, stringent regulations related to product approvals and the cost structure associated with the manufacturing process may hinder space growth during the forecast period. Additionally, the lack of clarity regarding regulations for the development of biosimilar mAbs in emerging markets could act as a restraint on market growth.

The biosimilar monoclonal antibodies market segmentation is based on product, application, and region. The product segment is based on Infliximab, Rituximab, Abciximab, Trastuzumab, Adalimumab, Bevacizumab, and others. The application segment is based on oncology, chronic and autoimmune diseases, and others. The Asia Pacific region is expected to experience significant growth in the market from 2020 to 2030. Factors contributing to this growth include the increasing burden of chronic diseases, the growing need for cost-effective treatments, and rising government funding for improving healthcare facilities. For instance, in Asia Pacific countries such as China, since the launch of the first biosimilar of Rituximab injection by Henlius in 2019, there have been 142 biosimilar mAbs researched and developed, targeting 16 different treatments. Out of these, 10 products have been launched, including Herceptin (trastuzumab) x 1, Avastin (bevacizumab) x 3, MabThera (rituximab) x 2, and Humira (adalimumab) x 4. China has more than 60 pharmaceutical companies actively involved in the development of products.

Biosimilar Monoclonal Antibodies Market Segmentation

Major companies operating in the biosimilar monoclonal antibodies market include Pfizer, Novartis AG, AbbVie, Inc., Coherus BioSciences, Biocon, among others.