Business Risk Mitigation in the Development Process of New Monoclonal Antibody Drug Conjugates for Cancer Treatment

Abstract

Recent developments aim to extend the cytotoxic effect and therapeutic window of mAbs by constructing antibody–drug conjugates (ADCs), in which the targeting moiety is the mAb that is linked to a highly toxic drug. According to a report from mid of last year, the global ADCs market accounted for USD 1387 million in 2016 and was worth USD 7.82 billion in 2022. It is estimated to increase in value to USD 13.15 billion by 2030. One of the critical points is the linkage of any substituent to the functional group of the mAb. Increasing the efficacy against cancer cells’ highly cytotoxic molecules (warheads) are connected biologically. The connections are completed by different types of linkers, or there are efforts to add biopolymer-based nanoparticles, including chemotherapeutic agents. Recently, a combination of ADC technology and nanomedicine opened a new pathway. To fulfill the scientific knowledge for this complex development, our aim is to write an overview article that provides a basic introduction to ADC which describes the current and future opportunities in therapeutic areas and markets. Through this approach, we show which development directions are relevant both in terms of therapeutic area and market potential. Opportunities to reduce business risks are presented as new development principles.

Antibody–Calixarene Drug Conjugate: A General Drug Delivery Platform for Tumor-Targeted Therapy

“…1−4 According to statistics, the total sales of ADCs in the market exceeded 7 billion dollars in 2022. 5 ADCs comprise a unified structure in which an antibody that targets specific receptors is conjugated with therapeutic agents of interest. 6−9 The continuously developed targeting antibodies and a vast number of therapeutic drugs provide limitless possibilities for the construction of ADCs.…”

“…Antibody–drug conjugates (ADCs), which integrate the specific targeting abilities of antibodies with the potent cytotoxic effects of small-molecule drugs, have emerged as a promising strategy in cancer therapy. − According to statistics, the total sales of ADCs in the market exceeded 7 billion dollars in 2022 . ADCs comprise a unified structure in which an antibody that targets specific receptors is conjugated with therapeutic agents of interest. − The continuously developed targeting antibodies and a vast number of therapeutic drugs provide limitless possibilities for the construction of ADCs. − However, only 15 ADCs have been approved for marketing as of March 2024, and one major reason for this is the complexity of the ADC construction process.…”