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Analysis of FDA-approved imaging agents
Michael S Kinch1, Pamela K Woodard2
1Center for Research Innovation in Biotechnology, Washington University in St. Louis, St Louis, MO, USA.
Drug Discovery Today
|March 26, 2017
Summary
Imaging agents, crucial for disease diagnosis, saw high approval rates historically. However, a decline post-2000, linked to industry consolidation, impacts medical advancements and the biopharmaceutical sector.
Area of Science:
- Medical imaging
- Radiopharmaceuticals
- Biopharmaceutical industry
Background:
- Imaging agent development accelerated post-WWII, expanding from X-ray technology to radiolabeling for disease diagnosis.
- The field experienced a high approval rate for new imaging agents throughout the late 20th century.
Purpose of the Study:
- To analyze the historical trends in the development and approval of medical imaging agents.
- To investigate the impact of industry consolidation on the imaging agent pipeline.
Main Methods:
- Historical analysis of imaging agent development timelines.
- Review of new molecular entity (NME) approval rates.
- Correlation analysis between industry consolidation and NME approval trends.
Main Results:
- Imaging agent development initially surged after the discovery of X-ray technology.
- A significant decrease in the approval rate of new imaging agents occurred after the year 2000.
- This decline in approvals is associated with increased industry consolidation.
Conclusions:
- The decline in imaging agent approvals poses challenges for medical diagnostics and the broader biopharmaceutical industry.
- Stabilized losses suggest a need for strategic evaluation of the field's future.
- Continued innovation in imaging agents is vital for future medical progress and industry growth.
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