ReviewPost screenAnalysis of FDA-approved imaging agents

- 122 new molecular entities (NMEs) for imaging have been approved for use in the United States as of the end of 2015.
- Whereas the first products emphasized conventional x-rays, scintigraphy has dominated the past half century of approvals
- Consolidation has reduced the number of active and independent companies by almost half since 2000.

The development of imaging agents was initially driven following the discovery of X-ray technologies, but quickly evolved and expanded to include radiolabeling of cells and tissues to assist disease diagnosis and progression. The first imaging agents preceded the Great War but the field did not gain momentum until the 1950s. The approval rate for imaging NMEs continued at a high level for the remainder of the 20th century, but substantially decreased thereafter. This decline in approval rates corresponds with industry consolidation. Such losses have stabilized, but could have important implications for a field that has conveyed direct benefits to medicine and that could ensure the future of the wider biopharmaceutical industry.