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How fast will the U.S. market get access to Gallium-68?

June 27, 2017
Molecular Imaging PET
From the June 2017 issue of HealthCare Business News magazine

From the final customer side there should be no major changes or investment to be required. Providers will have to guarantee a smooth supply of the new 68Ga-labeled tracers and generators or bulk 68Ga. Using gallium-68 as PET tracers instead of fluorine-18 labeled tracers will not need new equipment. Software will have to be adapted to this tracer and new indication, which is actually the case for any new tracer brought on the market. All PET imaging centers equipped for fluorine-18 will be able to use the new 68Ga tracers. This means that the installed PET customer base will remain the same.

There are an estimated 2,300 PET cameras installed in the U.S., actually largely underused equipment, that will easily cope with new tracers. This figure has to be compared with an estimated 870 PET cameras installed in the European Union countries and an estimated 5,600 PET cameras installed worldwide. The density implementation of PET cameras is very high in the U.S., with a ratio of 65 PET cameras per 10 million inhabitants, compared to a ratio of 17 PET cameras per 10 million inhabitants in the European Union.

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There is some small growth to expect in Europe in some smaller, underequipped countries, but in all countries only if new PET tracers for indications other than oncology (neurology or cardiology) become available for larger applications. The largest growth is only expected in not-yet-saturated areas such as Asian countries, including China, and South American countries as well as Russia. Availability of 68Ga on the basis of generators will favor development in those countries.

For countries with a well-developed cyclotron installed base, such as the U.S., it would make sense to use this equipment to partially supply customers with 68Ga through this channel. Almost any cyclotron able to produce 18F could, in theory, be able to produce 68Ga, providing some small investment. Like for cameras, the U.S. market has a large and underutilized installed base of cyclotrons: some 240 cyclotrons with energy below 25 MeV (mega-electron volts), able to be used for producing gallium-68, are in operation in the U.S. The density vs. cameras is even higher in the European Union with 210 installed cyclotrons. Only daily capacity production will define profitability while new local regulation hurdles may slow down the implementation.

So far, no radiopharmacy company has taken a decision to invest in one or the other technology, but such decisions need to be made soon. Both in Europe and the U.S., the structures will have to adapt. Eventually, the owners of the new proprietary 68Ga tracers will force their own way of access to market on the basis of the most cost-effective solution. The first cost of goods evaluations have shown that centralized cyclotron production could fit with both markets, but a time frame of about two years will be needed for full implementation. Let us see how this market will develop, but in any case, 68Ga tracers will become available very soon.

About the authors: Paul-Emmanuel Goethals and Dr. Richard Zimmermann are co-founders of MEDraysintell, providing first-rate strategic intelligence in nuclear medicine, proton therapy and brachytherapy. MEDraysintell offers the most comprehensive set of reports and directories, with over 1,900 pages of unrivaled intelligence covering some of the most exciting health care technologies using radiation for diagnosis and treatment.

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