Working Paper: NBER ID: w16014
Authors: Mark Trusheim; Murray L. Aitken; Ernst R. Berndt
Abstract: 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.
Keywords: biopharmaceuticals; biologics; small molecules; market dynamics; innovation
JEL Codes: D21; I11; I18; L65
Edges that are evidenced by causal inference methods are in orange, and the rest are in light blue.
| Cause | Effect |
|---|---|
| type of therapeutic product (biologics vs. small molecules) (L65) | market dynamics (D49) |
| type of therapeutic product (biologics vs. small molecules) (L65) | pricing strategies (D49) |
| type of therapeutic product (biologics vs. small molecules) (L65) | revenue trajectories (H27) |
| type of therapeutic product (biologics vs. small molecules) (L65) | therapeutic class distribution (D39) |
| type of therapeutic product (biologics vs. small molecules) (L65) | medical innovation (O35) |
| type of therapeutic product (biologics vs. small molecules) (L65) | safety outcomes (J28) |
| biologics (L65) | higher rates of black box warnings (I12) |