Improvements to the technology infrastructure for researching and developing new biopharmaceuticals would be expected to save the industry hundreds of millions of dollars annually, according to a new economic study sponsored by the National Institute of Standards and Technology (NIST).
Prepared by RTI International for NIST, the study¡¯s authors found that over the last two decades emphasis in new drug development has shifted from small-molecule chemicals to large-molecule proteins and other biopharmaceuticals such as human insulin, gene therapies and specialized antibiotic treatments. The report notes that the biopharmaceutical industry currently spends about $21 billion annually on research and development and has commercialized over 400 products.
Producing and maintaining the infrastructure that supports R&D, manufacturing and postmarket surveillance, including core data, methods, and standards used to determine the quality and efficacy of biopharmaceuticals, costs the industry a total of $1.2 billion annually, according to the report. The study focused on expenditures for four major categories of technical infrastructure: bioimaging, biomarkers, bioinformatics, and gene expression, as well as expenditures for infrastructure supporting processing and quality control for commercial manufacturing and activities involved with postmarket surveilliance. (See chart.)