Report Identifies Benefits to U.S. Biopharmaceutical Industry through Investments in Technology Infrastructure

The average cost of bringing a Food and Drug Administration-approved drug to market could be cut by 25 percent to 48 percent by making targeted investments in the national biopharmaceutical R&D technology infrastructure, according to a recent report from the National Institutes of Standards and Technology. Economic Analysis of the Technological Infrastructure Needs of the U.S. Biopharmaceutical Industry cites current costs as averaging $560 million per drug, but could drop to between $289 million and $421 million. Furthermore, these improvements can reduce the time from drug identification to clinical trial completion from a current average of 11 years to sometime between 8-10 years.

 

The report describes the growing complexity of biopharmaceutical drug discovery, as a transition is underway from the standard trial-and-error research process geared towards the treatment of symptoms, to using computer modeling and knowledge of the body’s biochemistry to create drugs that target the functionality of cellular processes. To increase the efficiency and quality of new drug production, infrastructure such as new equipment, software and technology platforms, operating protocols, and manufacturing processes will need to be further developed throughout the industry. Additionally, the standardization of these developments will allow data and knowledge to be shared through all stages of drug development, from basic research to clinical trials and commercial manufacturing.

 

The report’s authors surveyed individual researchers and technical experts involved in biopharmaceutical R&D to provide quantitative estimates on how the advancement of the technical infrastructure can reduce cost and development times and improve the quality of drug development. Their analysis concentrated on the intricacies of four specific areas of technology infrastructure:

• Bioimaging – Techniques such as MRI and ultrasound that allow biological processes to be visually identified.
• Biomarkers – Measurements that allow the body’s biology to be measured, for functions such as monitoring disease progression and the response to drugs.
• Bioinformatics – The creation and interpretation of data, often based on advanced computing, modeling techniques and shared databases of information.
• Gene expression – The processes through which certain genes and proteins are involved in biological processes.

Two other components of drug production were targeted within the report: the commercial manufacturing of drugs, including the scale-up from clinical trial production, processing and quality control; and post-market analysis, including safety tracking, post-market clinical trials and determining cost-effectiveness to alternative treatments.

 

The report finds the biopharmaceutical industry invested $1.2 billion on infrastructure-related products and services in 2005 (compared to $21 billion in total R&D spending), spread throughout technology infrastructure, commercial manufacturing and post-market analysis. Of this amount, $884 million was spent on technology infrastructure alone. The largest component of investments was concentrated on gene expression analysis (30 percent of total infrastructure spending), followed by biomarkers (24 percent), bioinformatics (22 percent) and bioimaging (15 percent). In addition to the benefits on the time and cost savings in R&D from investing in this infrastructure, the report estimates the industry’s annual manufacturing costs can be reduced by $1.5 billion, or about 23 percent.

 

Economic Analysis of the Technological Infrastructure Needs of the U.S. Biopharmaceutical Industry provides in greater detail the specific emerging technologies and scientific discoveries available in the field. It can be accessed at: http://www.nist.gov/director/prog-ofc/report07-1.pdf