Food and Drug Administration (FDA) defines monoclonal antibodies as immunoglobulin molecules which are secreted from a population of identical cells. They are homogenous in structure and binding specificity. These are used as multifunctional components for the immune system. They facilitate numerous cellular and humoral reactions to a variety of antigens, which includes host and foreign substances.
The market is projected to reach US$ 243.05 billion by 2028 from US$ 111.01 billion in 2021; it is expected to grow at a CAGR of 11.8% from 2021 to 2028.
COVID-19 has a positive impact on the adoption and growth of global monoclonal antibodies market. For example, the NCBI report states that, the Food and Drug Administration (FDA) announced emergency use authorization (EUA) for three monoclonal antibodies intended for COVID-19 patients with allocation of nearly 1 million antibody treatments. Also, monoclonal antibodies remain the only approved outpatient therapies intended for COVID-19 patients. Also, various regulatory agencies have favorable policies related to monoclonal antibodies effective for COVID-19 situations. For example, The Crown report states that, in August 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) announced granting approval for the first monoclonal antibody treatment intended for the prevention of COVID-19 in UK. Such aforementioned factors have a positive impact on the market growth during the analysis period from 2021 to 2028.
Based on indication, the monoclonal antibody market is segmented into cancer, autoimmune diseases, infectious diseases, inflammatory diseases, microbial diseases, and others. The cancer segment held the largest share of the market in 2021 and is projected to register the highest CAGR during the forecast period. On the other hand, the autoimmune diseases segment is estimated to register the second-highest CAGR in the market during the forecast period. Cancer metastasis causes a majority of mortalities and morbidities among cancer patients. A traditional cancer therapy focuses on the removal or destruction of tumor cells through surgery, radiation, and rather non-selective types of chemotherapy. Therefore, there is a high demand for antitumor monoclonal antibodies (mABs). For example, the Food and Drug Administration (FDA)has approved several specially engineered humanized or chimeric mABs; these include Alemtuzumab, Bevacizumab, and Cetuximab. Apart from the direct use of mAbs for treating various cancer types, mABs are also used for delivering radioisotopes selectively to cancer cells. For example, mAB-tagged radioisotopes are used for treating patients suffering from non-Hodgkin's lymphoma and are often used in combination with Rituximab.
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