![]() The drug was developed by combining sequences of the murine variable domain with human constant region domain (Fig. The first chimeric antibody, anti-GPIIb/IIIa antigen-binding fragment (Fab) (abciximab), was approved in 1994 by the US FDA for inhibition of platelet aggregation in cardiovascular diseases (Fig. To overcome problems of decreased immunogenic potential and efficacy, while making possible the therapeutic use of antibodies for an extended duration, researchers developed techniques to transform rodent antibodies into structures more similar to human antibodies, without loss of binding properties. The marketing end date of muromonab-CD3 is on July 30th, 2011 (Table 1). The first therapeutic mAb, muromonab-CD3 (Orthoclone OKT3), was approved by the US FDA in 1986 and comprises a murine mAb against T cell-expressed CD3 that functions as an immunosuppressant for the treatment of acute transplant rejection. Ab, antibody ALCL, systematic anaplastic large-cell lymphoma aTTP, acquired thrombotic thrombocytopenic purpura BC, breast cancer CD, cluster of differentiation CGRP, calcitonin gene-related peptide CGRPR, calcitonin gene-related peptide receptor CRC, colorectal cancer CTLA-4, cytotoxic T-lymphocyte-associated protein 4 EGFR, epidermal growth factor receptor FGF, fibroblast growth factor GC, gastric cancer GD2, disialoganglioside G D2 HER2, human epidermal growth factor receptor 2 IgE, immunoglobulin E IL, interleukin IL-17R, interleukin-17 receptor mAb, monoclonal antibody MCC, merkel-cell carcinoma NSCLC, non-small cell lung cancer PD-1, programmed cell death protein 1 PD-L1, programmed death-ligand 1 TNFα, tumor necrosis factor α RA, rheumatoid arthritis RANKL, receptor activator of nuclear factor kappa-B ligand VEGF-A, vascular endothelial growth factor A VEGFR2, vascular endothelial growth factor receptor 2 vWF, von Willebrand factor XLH, X-linked hypophosphatemia Antibodies colored in red represent the top 10 best-selling antibody drugs in 2018. The height of the line and numerical annotations represent the estimated market value of mAb therapeutics in each indicated year (shown as billions of US dollars). Many biotech companies that promised antibodies as anticancer “magic bullets” were launched from 1981 to 1986. Timeline from 1975 showing the successful development of therapeutic antibodies and their applications. ![]() Finally, future applications and perspectives are also discussed. This review summarizes the latest market trends and outlines the preeminent antibody engineering technologies used in the development of therapeutic antibody drugs, such as humanization of monoclonal antibodies, phage display, the human antibody mouse, single B cell antibody technology, and affinity maturation. As of December 2019, 79 therapeutic mAbs have been approved by the US FDA, but there is still significant growth potential. Thus, the market for therapeutic antibody drugs has experienced explosive growth as new drugs have been approved for treating various human diseases, including many cancers, autoimmune, metabolic and infectious diseases. The global therapeutic monoclonal antibody market was valued at approximately US$115.2 billion in 2018 and is expected to generate revenue of $150 billion by the end of 2019 and $300 billion by 2025. Over the past five years, antibodies have become the best-selling drugs in the pharmaceutical market, and in 2018, eight of the top ten bestselling drugs worldwide were biologics. As a result, therapeutic antibodies have become the predominant class of new drugs developed in recent years. Current antibody drugs have increasingly fewer adverse effects due to their high specificity. It has been more than three decades since the first monoclonal antibody was approved by the United States Food and Drug Administration (US FDA) in 1986, and during this time, antibody engineering has dramatically evolved.
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