NATIONAL BUREAU OF ECONOMIC RESEARCH
NATIONAL BUREAU OF ECONOMIC RESEARCH

Characterizing Markets for Biopharmaceutical Innovations: Do Biologics Differ from Small Molecules?

Mark Trusheim, Murray L. Aitken, Ernst R. Berndt

NBER Working Paper No. 16014
Issued in May 2010
NBER Program(s):   HC   PR

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.

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Document Object Identifier (DOI): 10.3386/w16014

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