Licensing, regulations, and use of radioisotopes in the U.S. is under agencies such as the U.S. Nuclear Regulatory Commission (NRC), the U.S. Environmental Protection Agency (EPA), the U.S. Food & Drug Administration (FDA), and respective state governments. The state governments are responsible for regulating radioactive substances that occur naturally or are produced by linear accelerators and/or cyclotrons, and EPA is responsible for among other things, setting air emission and drinking water standards for radionuclides. The U.S. Food and Drug Administration (FDA) regulates manufacturing and use of linear accelerators; granting marketing authorizations to radiopharmaceutical products for diagnostic as well as therapeutic use and other activities associated with radiopharmaceutical products.
In March 2019, NorthStar Medical Radioisotopes, LLC signed a contract with Ion Beam Applications S.A. (IBA) to purchase eight Rhodotron TT300 HE electron beam accelerators to expand the U.S. production of non-uranium based radioisotope Mo-99. In January 2019, Progenics Pharmaceuticals, Inc. and Curium Pharma entered into an agreement to develop and commercialize PyL in Europe. PyL is Progenics’ PSMA-targeted small molecule PET/CT imaging agent, designed to visualize prostate cancer currently in Phase 3 development. Moreover, in 2018, Advanced Accelerator Applications S.A. entered into an exclusive worldwide license agreement with Cancer Targeted Technology, LLC (CTT) to develop and market an investigational new drug product, F-18-labeled CTT1057. Such collaborations and partnerships are expected to support the global radiopharmaceuticals in nuclear medicine market growth over the forecast period.
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In February 2019, Progenics Pharmaceuticals, Inc. acquired the manufacturing facility in Somerset, New Jersey for AZEDRA. This Somerset site serves as a launch facility for AZEDRA and will also provide manufacturing support for the company’s development stage radiopharmaceuticals. In August 2018, Alliance Medical Group (a Division of Life Healthcare Group) acquired Piramal Imaging and renamed it as Life Molecular Imaging (LMI). LMI is now part of the Alliance Medical Molecular Imaging division, an integrated business including research and development laboratories, a network of cyclotrons, radio pharmacies, and imaging facilities. Moreover, in May 2018, Curium enhanced its position in the France PET market with the acquisition of France-based commercial and manufacturing operations of Cyclopharma, developer and manufacturer of PET diagnostics.
Technological advancements in imaging have brought many changes such as the introduction of hybrid technology — positron emission tomography/computed tomography (PET/CT) and single-photon emission computed tomography/computed tomography (SPECT/CT). Combination of the anatomic details provided, for instance, by CT, with the important and much needed functional, physiologic or metabolic information provided by molecular imaging has been facilitated with the use of hybrid imaging. More accurate diagnosis is possible with the help of hybrid imaging with increased specificity, attenuation correction, and localization. Moreover, usage of PET/CT has been established in clinical practice and has added significant value in the areas of neurology, cardiology, and oncology.
Moreover, SPECT/CT has also been established and has been used in areas such as cardiology, liver/spleen imaging, thyroid imaging, cancer diagnosis, and others. Hybrid imaging (PET/CT) along with radiopharmaceuticals such as 18F-fluorodeoxyglucose (18F-FDG), the most frequently used molecule in the PET diagnosis, 18F-fluorothymidine (18F-FLT), 18F-fluorocholine (18F-FCH), 18F-fluoro-ethyltyrosine (18F-FET), 18F-fluorodihydroxyphenylalanine (18F-FDOPA), 11C-methionine (11C-MET) or 18F-fluoromisonidazole (18F-FMISO), 68Ga-DOTA derivatives, 68Ga-PSMA, 18F-florbetaben or 18F-flutemetamol for brain amyloid beta imaging has been widely used (according to European Journal of Radiology, 2017). These factors drive growth of the market and further developments in PET cameras and other technologies is expected to boost growth of the market over the forecast period.
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Detailed Segmentation:
By Product Type:
Diagnostic Nuclear Medicine
SPECT Radiopharmaceuticals
Tc-99m
In-111
Tl-201
Ga-67
I-123/I-125/I-131
Other SPECT Isotopes
PET Radiopharmaceuticals
F-18
F-18 Florbetapir/Flutemetamol/ Florbetaben
F-18-Fluoro-Deoxy-Glucose (18F-FDG)
Fluorine-18 Fluciclovine
Other F-18 Isotopes
Ru-82
Other PET Isotopes
Therapeutic Nuclear Medicine
Ra-223
I-131
Re-186/Sm-153/Sr-90
Lu-177
Ir-192
Pd-103
Cs-131
Others
By Application:
Oncology
Cardiology
Neurology
Endocrinology
Others
By End User:
Hospitals
Specialty Clinics
Diagnostic Centers
Some major players operating in the global radiopharmaceuticals in nuclear medicine market include Progenics Pharmaceuticals, Inc., NorthStar Medical Radioisotopes LLC, Curium Pharma, Life Molecular Imaging, Lantheus Holdings, Inc., Cardinal Health, Inc., General Electric Company, Bracco S.p.A., Bayer AG, Advanced Accelerator Applications, S.A., and Eli Lilly and Company.
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