We discussed previously the impact of high costs for preclinical systems on the global drug development research market.  We saw that there is opportunity to improve the success rate achieved using existing methodologies, and that new technologies such as PET and MRI can significantly improve efficiency, mostly thanks to a fundamental benefit: detecting unpromising compounds early in the development process.

However compelling its use might be, preclinical PET and MRI equipment both come at a very high cost, which is prohibitive for most research institutes. To worsen the situation, micro-PET systems bring another important cost component on top of equipment costs, which is the radioisotopes needed for micro-PET systems.

Costs associated with PET system radioisotopes & requirements

Radioisotopes are the biological molecules injected into an organism in order to generate radiation, which is then detected and processed by the PET system. Radioisotopes are difficult to work with, for a number of reasons. Their creation is highly complex, their transport is highly regulated (which increases costs), and you need to act fast since they decay rapidly: radiation falls to half its value in under two hours. This may seem short, but we have to keep in mind that this is to be injected into a living organism (whether human or animal). Therefore, the selected radioisotope must have a relatively short half-life so as not to expose the subject to an unnecessary radiation burden.

For situations where conventional transportation methods would exceed the two hour half-life window, you could transport your radioisotopes by helicopter (which increases costs), or buy your own cyclotron to generate them on site (which of course increases costs significantly). The Siemens Eclipse™ RD cyclotron is an example of on such onsite cyclotron.  As a side note, Nutaq is involved in the electronics within particle accelerators, which are a key component of radioisotope production.

Again for the cyclotron, costs don’t end at the equipment level. Highly qualified personnel, construction costs, packaging, and quality assurance are a few examples of additional costs to consider before purchase. Assuming a two million USD cost for the equipment itself, you can expect equivalent expenses for these additional cost factors, if not more.

For a detailed cost analysis, see the article “Activity-based costing evaluation of

[18F]-fludeoxyglucose production”[1]. This very thorough report details the production costs of fluorodeoxyglucose (18F) – a radioisotope used for PET – using an activity-based costing methodology. Not only are the micro-PET systems themselves facing high costs, but the equipment that provides the radioisotopes to make them work is faced with a similar challenge.

Reducing PET system radioisotope costs

Interestingly enough, the report concludes that reduction in equipment price and growth in demand are two key factors likely to support the financial viability of 18F-fludeoxyglucose for use in PET systems.

Another key take away from the report is that increasing throughput is vital to improving adoption. This makes sense: if daily production were improved, the price per dose would decrease and the breakeven point on the ROI would be achieved much faster. This would likely lead to an increase in the number of radioisotopes production sites, which would then reduce transportation costs and make a more compelling case for clinics to purchase their own micro-PET or multimodal PET-MRI systems.

In examining the other options for providing higher throughput, we must ask if there are other choices for radioisotopes. As an alternative to 18F-fludeoxyglucose (or fluorine-18), carbon-11 based radioisotopes have also been considered. Carbon-11 is quite compelling thanks to its production time, which is one-third the time for fluorine-18. However, an isotope’s production time is directly proportional to its half-life, so a carbon-11 based radioisotope has a half-life of just 20 minutes, which leaves little choice but to have on-site production.

Reductions in PET hardware costs also required

Micro-PET system radioisotopes are a key factor influencing growth in the small animal imaging market (and in the broad preclinical and clinical PET market in general). They are literally the raw material required for such systems to function: the fuel of the industry.

That said, addressing radioisotope costs alone won’t do it. It’s up to each player in the industry to take action and create innovations that lead to cost savings all along the food chain. A closer look at the linear accelerators required for radioisotopes manufacturing will reveal whether Nutaq can help to reduce their manufacturing costs. However, we can certainly contribute to lowering electronics costs in micro-PET and PET-MRI scans with our OEM offering, and help lower R&D costs with our development systems.

 

References:

  1. Krug, Bruno, Annie Van Zanten, Anne-Sophie Pirson, Ralph Crott, and Thierry Vander Borght. 2008 “Activity-based costing evaluation of [18F]-fludeoxyglucose production.” European Journal of Nuclear Medicine and Molecular Imaging 35(1):80–88.