The Road Ahead for Biologics Manufacturing

by Peter L. Ginsberg, Sandeep Bhatia, PhD, and Rachel L. McMinn, PhD
Volume 1, Issue 1 (March 2002)

Protein-based therapeutics have led to the emergence of the biotechnology industry and should drive rapid growth in the industry over the next decade. In 2001 alone, six major biologics were approved by the FDA. According to our analysis, there are 39 biologic products (antibodies and non-antibody recombinant proteins) that are currently in Phase III clinical testing and about 60 in Phase II testing, which we estimate could lead to 34 new products on the market in the next four to six years. By our estimates, such a new product outpouring would lead to more than a doubling of the number of profitable biopharmaceutical product companies (currently 15) by mid-decade. The focus of this report is to evaluate the manufacturing aspects of biotechnology models and analyze the current and future capacity needs of the industry...

Ginsberg PL, Bhatia S, McMinn RL. The Road Ahead for Biologics Manufacturing. BioProcess J, 2002; 1(1): 19-21.