According to Tufts Center for the Study of Drug Development (Tufts CSDD) the number of monoclonal antibody products in development nearly tripled in the last decade. A recent Tufts CSDD study found that monoclonal antibody products, referred to as mAbs, require an average of 7.6 years to complete the clinical development cycle and gain marketing approval. Development and approval times for mAbs fared well as compared with small molecule drugs, which require an average of 7.5 years. According to the study, all biotech products require an average of 8 years.
   
“Historically the province of biotechnology companies, mAbs are now just as likely to be developed and marketed by major pharmaceutical firms as they are by biotechs,” said Janice M. Reichert, senior research fellow at Tufts CSDD and author of the study. Ms. Reichert also noted that in 2006 the global market for mAbs exceeded $17 billion, with sales expected to grow an average of 14% annually through 2012.
   
Currently, 21 mAbs are approved in the U.S. and abroad, and more than 200 are in development. Research results of the Tufts study found: the average number of mAb candidates entering clinical trials went from 12 in the mid-1990s to 34.5 in the mid-2000s; the share of human mAbs entering clinical study grew from 11% in the 1990s to more than 40% in 2000-06; overall success rate was 17% for all humanized candidates, with a slightly lower rate (15%) for anticancer candidates and a slightly higher rate (21%) for immunological candidates; and transition probabilities for humanized mAbs that entered clinical study during 1988-06 were 83%, 44%, and 81%, respectively, for the three phase transitions.