Monoclonal Antibodies


3.3 Applications and markets for Monoclonals Abroad

Detection of tumors in vivo has been attempted by the use of radiolabel led antibodies. Immunoassays are available abroad for micro biological and chemical analysis of food, for example the salmonella screen kit, test kit for toxin contaminant of food. MAbs are increasingly being used in immuno affinity chromatography (IAC) of therapeutic proteins, although use of mAb based IAC in the preparation of pharmaceuticals for parenteral use is till in its infancy. During the last 2 years, mAbs with enzyme like catalytic properties have been successfully raised and their applications will be seen in biosensors which can be used for monitoring of body functions during intensive care, effluent monitoring and in process control in pharmaceutical and chemical industries.

Monoclonals have been produced against dioxin and tetanus toxin. In additional to potential clinical utility, monoclonals to tetanus toxin have been used in vitro to aid in the localization of cells and tissues reacting to tetanus toxin. Monoclonals have also been produced for drug targeting.

According to Business Communication Co. U.S., Polyclonal antibodies accounted for 71% of the antibody products available world wide in 1988 while monoclonals accounted for abut 29% of the antibody products in the same year when the world sales of antibody products amounted to some $1082 million. Diagnostics utilizing monoclonal antibodies and DNA probes have been the fastest growing components of new biotechnology, accounting for more than half of the current market for new biotech drugs. It is predicted that by 1992, mAbs will have replaced virtually all diagnostics now based on polyclonal antibodies. At least 220 diagnostic kits using mAbs and 8 using DNA probes were available in 1989. AIDS testing alone was valued at $75 to $100 million in 1987 and is growing rapidly. The value of output of this emerging industry now represents around 1.5% of the pharmaceutical industries present commerciali-zed output. Analytical applications account for 85% and separation applications account for 10% of the total sales of antibody products. It is expected that the total monoclonal market might reach $8 billion by 2000.A.D.

3.4 Indian Markets Scenario for Monoclonals Abroad

Many of the scientists contacted in India opine that the use of monoclonal antibodies should be mainly concentrated in the diagnostics are over the next 5-10 years. The major application areas are diagnosis of hepatitis B, filarial parasites and enteric fevers, cancer markers, blood group serology, lymphocyte sub typing, pregnancy and significant animal diseases like FMD, RP, IBR, HS, Brucellosis. The study estimates that around 10 million tests would have to be done every year over the next 10 years for the diagnosis of hepatitis B virus, filiaria parasites to screen and monitor the therapy for such carriers.

Research work pertaining to development of mAbs for diagnosis of T.B., leprosy and other parasites, cancer markers and viruses (example rotavirus) are being undertaken in some of the research laboratories in the country. This would take a few years to materialize. The current and projected potential requirement of monoclonal antibodies is presented I Tables 5.5 and 5.6.                                                                                                                                                                    Back