Mini-review: The market growth of diagnostic and therapeutic monoclonal antibodies – SARS CoV-2 as an example

Abstract

BACKGROUND: The emergence of novel viruses poses severe challenges to global public health highlighting the crucial necessity for new antivirals. MAIN BODY: Monoclonal antibodies (mAbs) are immunoglobulins that bind with a single epitope. Mouse mAbs are generated by classic hybridoma technology and are mainly used for immunodiagnostics. For immunotherapy, it is critical to use monoclonal antibodies in the human form to minimize adverse reactions. They have been successfully used to treat numerous illnesses, accordingly, an increasing number of mAbs, with high potency against emerging viruses is the target of every biopharmaceutical company. The diagnostic and therapeutic mAbs market grows rapidly into a multi-billion-dollar business. Biopharmaceuticals are innovative resolutions which revolutionized the treatment of significant chronic diseases and malignancies. Currently, a variety of therapeutic options that include antiviral medications, monoclonal antibodies, and immunomodulatory agents are available in the management of COVID-19. SHORT CONCLUSION: The invasion of mAbs in new medical sectors will increase the market magnitude as it is expected to generate revenue of about 300 billion $ by 2025. In the current mini-review, the applications of monoclonal antibodies in immune-diagnosis and immunotherapy will be demonstrated, particularly for COVID-19 infection and will focus mainly on monoclonal antibodies in the market.

Monoclonal antibody therapies against SARS-CoV-2

“…1 Since then, about ten new mAbs have been approved each year (mostly IgG1), with an estimated global yearly sale of US$75 billion in 2021. 2 Most of these mAbs have been licensed for non-infectious disease indications. However, successful efforts have been made in the COVID-19 pandemic to research and develop mAbs against SARS-CoV-2.…”

Rapid Antigen Diagnostics as Frontline Testing in the COVID‐19 Pandemic

“…An alternative approach is to use bispecific monoclonal antibodies to boost up the signal and improve sensitivity. [ 87 ] Concerns have been raised whether rapid antigen tests for SARS‐CoV‐2 can result in false‐positive test results and undermine pandemic management for COVID‐19. Emerging evidence suggested that the overall rate of false‐positive results among the total rapid antigen test screens for SARS‐CoV‐2 was very low.…”

Treatment of COVID-19 by monoclonal antibodies and the traditional Chinese medicine

“…So far, many types of drugs have entered Phase II/III clinical trials, it is hopeful that monoclonal antibody drugs will be put into the treatment of COVID-19 in the near future ( Table 1 ) [ 10 ]. In 2020, the US FDA issued Emergency Use Authorization (EUA) for two monoclonal antibodies (Cascilizumab and Imdevimab) against the SARS-CoV-2 spike protein which can block viral binding and reduce the occurrence of escaping mutants [ 11 ]. Nonetheless, the FDA reported that Cascilimab and Imdevimab were not permitted for patients hospitalized or requiring oxygen therapy for COVID-19 [ 12 , 13 ].…”