TY - JOUR AU - Trusheim,Mark AU - Aitken,Murray L. AU - Berndt,Ernst R. TI - Characterizing Markets for Biopharmaceutical Innovations: Do Biologics Differ from Small Molecules? JF - National Bureau of Economic Research Working Paper Series VL - No. 16014 PY - 2010 Y2 - May 2010 UR - http://www.nber.org/papers/w16014 L1 - http://www.nber.org/papers/w16014.pdf N1 - Author contact info: Mark Trusheim Sloan School of Management MIT 50 Memorial Drive Cambridge, MA 02142 Tel: 617/253-2659 E-Mail: trusheim@mit.edu Murray L. Aitken Senior Vice President Healthcare Insight IMS Health 901 Main Avenue, Suite 612 Norwalk, CT 06851 Tel: 203-845-5201 Fax: 203-845-5314 E-Mail: maitken@imshealth.com Ernst R. Berndt MIT Sloan School of Management 100 Main Street, E62-518 Cambridge, MA 02142 Tel: 617/253-2665 Fax: 617-227-0880 E-Mail: eberndt@mit.edu AB - Much has been written about the seemingly less formal, more agile biotechnology industry and its extensive interactions with academia and startups, as well as its distinct scientific, manufacturing and regulatory profile. Employing a data base encompassing all 96 biologics and 212 small molecules newly launched in the U.S. between 1998Q1 and 2008Q4, we compare their downstream clinical and commercial characteristics -- therapeutic class concentration, launch delays following approval, Orphan Drug and priority review status, supplemental indications, black box warning and safety record, and pricing and revenue growth during the product life cycle. We conclude that the market dynamics of biologics differ substantially from those of small molecules, although therapeutic class composition plays a major role. ER -