2020 | Ruei-Min Lu, Yu-Chyi Hwang, I-Ju Liu, Chi-Chiu Lee, Han-Zen Tsai, Hsin-Jung Li and Han-Chung Wu
The development of therapeutic antibodies has evolved significantly since the first monoclonal antibody (mAb) was approved by the US FDA in 1986. Over the past three decades, antibody engineering has advanced, leading to the creation of highly specific therapeutic antibodies with fewer adverse effects. These antibodies are now the most commonly used class of new drugs, with over 79 mAbs approved by the US FDA as of December 2019. The global therapeutic mAb market was valued at approximately $115.2 billion in 2018 and is expected to reach $300 billion by 2025. The market has experienced explosive growth due to the approval of new drugs for various diseases, including cancers, autoimmune, metabolic, and infectious diseases.
Key technologies in therapeutic antibody development include humanization of mAbs, phage display, human antibody mice, single B cell antibody technology, and affinity maturation. Humanized mAbs, which retain only the CDRs of the original mAb, have been approved by the US FDA, allowing for clinical application with reduced immunogenicity. Phage display technology has enabled the generation of fully human mAbs by selecting and expressing antibody fragments from a library of phage-displayed genes. Transgenic mice have also been used to produce fully human antibodies, as they can synthesize human antibodies upon immunization.
Bispecific antibodies, which can bind to two different antigens, have also been developed and approved for various therapeutic applications. These antibodies have shown promise in treating cancers and other diseases. The market for therapeutic antibodies is dominated by a few major companies, with Genentech, AbbVie, and Johnson & Johnson leading the way. The top-selling mAbs in 2018 included adalimumab (Humira), nivolumab (Opdivo), and pembrolizumab (Keytruda), with adalimumab being the best-selling drug of the year.
Therapeutic antibodies are used to treat a wide range of diseases, including cancer, autoimmune disorders, and infectious diseases. The development of these antibodies has been driven by advances in antibody engineering, which have improved their safety and efficacy. The use of phage display and transgenic mice has enabled the generation of fully human antibodies, which are more effective and less immunogenic than traditional mAbs. The future of therapeutic antibodies is promising, with ongoing research into new applications and technologies to further enhance their therapeutic potential.The development of therapeutic antibodies has evolved significantly since the first monoclonal antibody (mAb) was approved by the US FDA in 1986. Over the past three decades, antibody engineering has advanced, leading to the creation of highly specific therapeutic antibodies with fewer adverse effects. These antibodies are now the most commonly used class of new drugs, with over 79 mAbs approved by the US FDA as of December 2019. The global therapeutic mAb market was valued at approximately $115.2 billion in 2018 and is expected to reach $300 billion by 2025. The market has experienced explosive growth due to the approval of new drugs for various diseases, including cancers, autoimmune, metabolic, and infectious diseases.
Key technologies in therapeutic antibody development include humanization of mAbs, phage display, human antibody mice, single B cell antibody technology, and affinity maturation. Humanized mAbs, which retain only the CDRs of the original mAb, have been approved by the US FDA, allowing for clinical application with reduced immunogenicity. Phage display technology has enabled the generation of fully human mAbs by selecting and expressing antibody fragments from a library of phage-displayed genes. Transgenic mice have also been used to produce fully human antibodies, as they can synthesize human antibodies upon immunization.
Bispecific antibodies, which can bind to two different antigens, have also been developed and approved for various therapeutic applications. These antibodies have shown promise in treating cancers and other diseases. The market for therapeutic antibodies is dominated by a few major companies, with Genentech, AbbVie, and Johnson & Johnson leading the way. The top-selling mAbs in 2018 included adalimumab (Humira), nivolumab (Opdivo), and pembrolizumab (Keytruda), with adalimumab being the best-selling drug of the year.
Therapeutic antibodies are used to treat a wide range of diseases, including cancer, autoimmune disorders, and infectious diseases. The development of these antibodies has been driven by advances in antibody engineering, which have improved their safety and efficacy. The use of phage display and transgenic mice has enabled the generation of fully human antibodies, which are more effective and less immunogenic than traditional mAbs. The future of therapeutic antibodies is promising, with ongoing research into new applications and technologies to further enhance their therapeutic potential.