Nunn Adrian D
Ernst Felder Laboratories, Bracco Research USA Ltd., Princeton, New Jersey 08540, USA.
Invest Radiol. 2006 Mar;41(3):206-12. doi: 10.1097/01.rli.0000191370.52737.75.
The objective of this study was to estimate the financial cost of developing new imaging agents for clinical use and to discuss the effects of these costs on the future clinical imaging agent environment. Publicly available financial data from the annual reports of major companies developing and selling imaging agents were examined and the data used to develop cost estimates. These estimates were compared with the in-depth data and analyses available for the development costs of therapeutic drugs. The cost of developing a drug for diagnostic imaging to commercialization is in the 100 dollars to 200 million dollars range, whereas a blockbuster imaging drug has current sales of 200 dollars to 400 million dollars. Most of these blockbuster imaging agents have been on the market for some time. The majority provide morphologic images with general indications in a slowly changing section of the market. Future agents will most likely address smaller markets and be in the rapidly developing molecular imaging field. The costs are high and are a significant brake on the development of imaging agents for commercialization. If new imaging agents are to realize their commercial potential, ways must be found to make the financials more attractive. The prices per dose are currently low so they must either be greatly increased for new imaging agents, with a corresponding increase in the value of the information they provide, or the use of imaging agents must be widened and/or their development made less costly in time and money. Without addressing these issues, the commercialization of new imaging agents will continue to be slow and may get slower. This will impact the progress of imaging agents toward use as validated biomarkers.
本研究的目的是估计开发临床用新型成像剂的财务成本，并讨论这些成本对未来临床成像剂环境的影响。研究审查了开发和销售成像剂的主要公司年度报告中公开的财务数据，并将这些数据用于成本估算。这些估算值与治疗药物开发成本的深入数据及分析进行了比较。开发一种用于诊断成像的药物直至商业化的成本在1亿至2亿美元之间，而一种畅销成像药物目前的销售额为2亿至4亿美元。这些畅销成像剂大多已上市一段时间。大多数提供形态学图像，适用于市场中变化缓慢的一般适应症。未来的成像剂很可能针对较小的市场，并且处于快速发展的分子成像领域。成本很高，严重阻碍了成像剂商业化的发展。如果新型成像剂要实现其商业潜力，就必须找到使财务状况更具吸引力的方法。目前每剂的价格较低，因此对于新型成像剂，要么大幅提高价格，并相应提高其提供的信息价值，要么扩大成像剂的使用范围，和/或在时间和金钱上降低其开发成本。如果不解决这些问题，新型成像剂的商业化进程将继续缓慢，甚至可能更加缓慢。这将影响成像剂作为经过验证的生物标志物投入使用的进程。
