Biosimilar Monoclonal Antibodies Market Size, Share, Growth, Report By 2032

September 25, 2023 |

8 min read

According to Vision Research Report, the global biosimilar monoclonal antibodies market size was valued at USD 8.76 billion in 2022 and it is projected to hit around USD 65.42 billion by 2032, growing at a CAGR of 22.27% from 2023 to 2032.

According to Vision Research Report, the global biosimilar monoclonal antibodies market size was valued at USD 8.76 billion in 2022 and it is projected to hit around USD 65.42 billion by 2032, growing at a CAGR of 22.27% from 2023 to 2032.

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.

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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.

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By Type

The infliximab segment accounted for the largest biosimilar monoclonal antibody market share in terms of revenue in 2022, owing to factors such as expiration of patent for infliximab enabling the introduction of biosimilar versions, offering comparable efficacy and cost-effectiveness. In addition, the increasing number of people suffering from autoimmune diseases such as rheumatoid arthritis and Crohn’s disease fueled the demand for biosimilar infliximab as an accessible treatment option, thereby driving the segment growth.

However, adalimumab segment is expected to witness highest CAGR during the forecast period. This is attributed to adalimumab’s wide range of therapeutic applications in treating autoimmune diseases such as rheumatoid arthritis, psoriasis, and Crohn’s disease, resulting in high demand for cost-effective options, which biosimilar versions offer. In addition, rise in regulatory approvals, increase in physician confidence in prescribing biosimilar adalimumab owing to robust clinical data and rigorous comparability studies, and favorable reimbursement policies in certain regions have collectively propelled the adoption of biosimilar adalimumab, thus contributing to its substantial biosimilar monoclonal antibody market growth.

By Indication

The oncology segment accounted for the largest biosimilar monoclonal antibody market share in 2022, and is expected to register highest CAGR during forecast period. This trend is primarily attributed to the increase in the prevalence of various cancers and escalating need for economical yet potent treatments for cancer. Biosimilar monoclonal antibodies present comparable efficacy and safety profiles to their originator counterparts but at a more affordable cost. This is facilitated by factors such as patent expirations, regulatory pathways that support biosimilars, and increasing confidence in their clinical performance.

By End User

The hospital segment accounted for the largest share in 2022, and is expected to register the highest CAGR during forecast period. This is attributed to increase in adoption of biosimilar mAbs within hospital settings, driven by factors such as cost-effectiveness, expanding patient population and rise in demand for targeted therapies. In addition, hospitals offer better insurance coverage, specialized medical expertise, well equipped infrastructure for complex chronic disease treatments, and wide availability of biosimilar mAbs, thereby fueling the segment growth.

By Region

The biosimilar monoclonal antibody market size is analyzed across North America, Europe, Asia-Pacific, and LAMEA. North America accounted for the largest share in 2022 and is expected to remain dominant during the forecast period, owing to a well-established regulatory framework that facilitates the approval and entry of biosimilar monoclonal antibodies, robust healthcare infrastructure that streamlines distribution and adoption, high levels of physician acceptance and patient accessibility, advanced capabilities in R&D as well as manufacturing, and proactive endeavors to enhance awareness and education regarding biosimilar mAbs.

However, Asia-Pacific is anticipated to witness notable growth during the forecast period. This growth can be attributed to the escalating demand for economical treatment options, owing to a significant increase in prevalence of chronic disease , aging population vulnerable to chronic illnesses, increase in investments in biopharmaceutical research and manufacturing capacities, and collaborations between both, local and international pharmaceutical enterprises. Thus, collectively, these factors foster an environment conducive to the adoption and expansion of biosimilar mAbs within the Asia-Pacific market.

Presence of several major players, such as Novartis AG, Pfizer Inc., Amgen Inc., and Shanghai Henlius Biotech, Inc., and advancement in manufacturing technology for development of effective treatment options for chronic diseases in the region are expected to drive the growth of biosimilar monoclonal antibody market. In addition, various private organizations organize educating camps for awareness of chronic diseases and cost-effective treatment options available across the globe are expected to drive the growth of the market. Furthermore, the presence of well-established healthcare infrastructure and rise in adoption rate of new treatment options such as biosimilar mAbs are expected to drive the market growth.

Asia-Pacific is expected to grow at the highest rate during the forecast period. The market growth in this region is attributable to the presence of key players in the region. The Asia-Pacific region has made significant efforts in improving its healthcare infrastructure, including cancer care facilities and specialized oncology centers. The establishment of comprehensive cancer centers, advancements in diagnostic technologies, and access to modern treatment modalities have positively impacted the biosimilar monoclonal antibody industry.

Improved healthcare infrastructure enables timely diagnosis, effective treatment, and access to a wide range of biosimilar mAbs, which drive the market growth. Asia-Pacific offers profitable biosimilar monoclonal antibody market opportunity for key players operating in the market, thereby registering the fastest growth rate during the forecast period, owing to the growing infrastructure of industries, rise in spending for chronic disease research, as well as well-established presence of domestic companies in the region. In addition, rise in contract manufacturing organizations within the region provides great opportunity for new entrants in the region.

Companies Mentioned in Report