Since the approval of Orthoclone OKT3, a murine monoclonal antibody against T cell expressed CD3 (for the treatment of acute transplant rejection) in 1986, antibody therapeutics have evolved into a prominent class of therapeutics. These therapeutics have high target specificities and favorable safety profiles.
Currently, close to 100 monoclonal antibodies have been approved while more than 500 molecules are being evaluated in clinical trials. Some of the recently approved monoclonal antibody therapies include (in reverse chronological order) Tivdak® (September 2021), Saphnelo® (August 2021), Rybrevant® (May 2021), Ebanga (December 2020) and MARGENZA® (December 2020).
It is worth highlighting that the process of antibody development, beginning from the discovery to the commercialization of a clinically validated product, takes around 10-15 years. Moreover, antibody discovery and clinical research are capital intensive processes, which, on an average, require investments of around USD 4-10 billion.
The growing popularity of antibody based therapeutics is also reflected from the extensive research being conducted on other novel antibody formats, such as bispecific antibodies, antibody drug conjugates (ADCs) and antibody fragments in the past few years.
Further, it is a well-known fact that only a small proportion of lead molecules that are shortlisted for further investigation during the discovery phase make it into the clinical phase, and an even lesser number of product candidates enter the market. In order to optimize on internal resource utilization and save costs, pharmaceutical companies are increasingly outsourcing various aspects of their discovery-stage operations to specialty contract research organizations (CROs).