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Companies use different production methods to produce their nuclides radiopharmaceutical therapy and companies progressing to clinical stage products need to have robust processes in place . This has led to hesitation from other companies investing in radiopharmaceuticals , and therefore many of the larger pharma companies have stayed away . Lantheus uses the US cyclotron network to manufacture their PSMA radioisotope which are expensive and require rapid delivery to hospitals and are therefore harder to get to clinic . Furthermore , without in-house capabilities , expanding to other geographical regions will be more difficult . As a comparison , ITM have a fully vertically integrated manufacturing and supply chain as shown in ( Figure 48 ) and have their own internal pipeline of products . Additionally , they are the supplier of 177 Lu to Telix and Novartis , and when ITM ’ s internal pipeline reaches commercial stage , they could have a dual revenue stream coming from both their products and radioisotope production . They are the only GMP manufacturer of industry scale 177 Lu globally and thus investors should be aware of companies ’ respective manufacturing capabilities and distribution plans .
Figure 48 : Manufacturing process
ITM have a fully integrated vertical manufacturing chain and supply nuclides for competitors
Source : goetzpartners Research , ITM investor presentation
Radioactive isotope selection most important While 177 Lu is the current preferred isotope for therapeutic candidates and has shown success in PSMA therapies , research is being undertaken on whether this is the best choice for radiopharmaceuticals .
177
Lu is a beta emitting radionuclide whereas actinium ( 255 Ac ), another focus of research , is an alpha emitting radionuclide . Alpha emission travels less distance and therefore damages neighbouring cells less , yielding a more targeted and potent therapy . Alpha emitters remain the end goal for these reasons , yet 255 Ac is more difficult to manufacture currently due to its synthetic nature . We believe alpha emitting radionuclides will be the main nuclide in use of future therapeutics with an ideal half-life of 10 days and supply chain processes improve . It is important that radiopharmaceutical companies have access to a range of radionuclides for diagnostic purposes through to more potent therapeutic nuclides .
Market overview
PSMA therapy for prostate cancer is the largest market so far
The success of prostate cancer PSMA imaging with radiopharmaceuticals has laid the groundwork for future radiopharmaceutical programs . Of the 19m men tested for prostate cancer using the PSA blood test in the US , 4.3m men had elevated PSA in 2013 . While around 1m men are referred for biopsy , less than 20 % are finally diagnosed with cancer and many of these have a slow growing indolent disease that should better be put under active surveillance rather than surgery or drug therapy . There is an urgent need for accurate imaged based detection and localisation of prostate cancer for primary diagnosis , as well as monitoring of treatment efficacy and recurrent disease . Although there are several other PET / CT prostate cancer imaging agents already on the market or in development , the potential convenience of onsite generation with 68 Ga and the apparent wide recognition of PSMA imaging amongst the clinical community should drive rapid adoption of the kit by both hospitals and standalone imaging facilities across the US . The use of 68 Ga radionuclide allows for onsite production as well as cyclotrons offering easier expansion . There is clear potential for the product as a CDx for selecting and monitoring treatment of men with PSMA-targeted radiopharmaceuticals .
Please see analyst certifications , important disclosure information , and information regarding the status of analysts on pages 91-94 of this research report .