Radiopharmaceuticals in Nuclear Medicine Market – Insights
Radiopharmaceuticals are medicinal formulations that contain radioisotopes, which are used in major clinical areas for diagnosis and/or therapy. Radiopharmaceuticals have several applications in diagnostic as well as therapeutic areas in nuclear medicine. There are around 50 U.S. Food & Drug Administration (FDA) approved radiopharmaceuticals present in the market for diagnostic and therapeutic applications. Technetium -99m has vast number of applications in diagnostic imaging using radiopharmaceuticals. Areas where radiopharmaceuticals have applications include oncology, neurology, hematology, cardiology, thyroid applications, and others. Moreover, certain radiopharmaceuticals have diagnostic as well as therapeutic applications such as certain iodine isotopes.
Vast number of applications of radiopharmaceuticals is expected to boost global radiopharmaceuticals in nuclear medicine market growth over the forecast period
Oncology applications include cancer diagnosis and treatment effectiveness determination (using radiolabeled therapeutics). Moreover, basic cancer physiology detection is also possible with the help of radiopharmaceuticals. For instance, Fluorine-18 fludeoxyglucose is indicated for assessing abnormal glucose metabolism in tumors. Neurology applications include evaluation of Alzheimer's disease and epileptic seizures. Radiopharmaceuticals such as Vizamyl (GE Healthcare), Amyvid (Eily, Lilly, and Company), and Neuraceq (Life Molecular Imaging) are indicated to estimate β amyloid neuritic plaque density in adult patients with cognitive impairment, who are being evaluated for Alzheimer’s disease (AD) or other causes of cognitive decline. Hematology applications include determination of total blood volume, plasma volume, cardiac output, glomerular filtration, and other tests. Products used in hematology include Jeanatope, Megatope, and Glofil-125 manufactured by IsoTex Diagnostics. Cardiology applications mainly include myocardial perfusion imaging for distinguishing normal from abnormal myocardium in patients with suspected myocardial infarction and other applications.
The global radiopharmaceuticals in nuclear medicine market size was valued at US$ 4,986.4 million in 2017 and is expected to witness a robust CAGR of 8.9% over the forecast period (2018–2026).
Figure 1. Global Radiopharmaceuticals in Nuclear Medicine Market Share (%), by Region
Source: Coherent Market Insights Analysis (2017)
Use of hybrid imaging in diagnosis is expected to boost growth of the global radiopharmaceuticals in nuclear medicine market over the forecast period
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.
Figure 2. Global Radiopharmaceuticals in Nuclear Medicine Market Share (%) by Product Type
However, factors such as high costs of development of radiopharmaceuticals relative to return on investment, supply shortage of radiopharmaceuticals, and short half-life of radiopharmaceuticals is expected to restrain growth of the radiopharmaceuticals in nuclear medicine market over the forecast period.
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.
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.
Factors such as approval of products such as Lutathera, a potential blockbuster drug (Advanced Accelerator Applications, 2018) and Axumin (2016, Blue Earth Diagnostics) has propelled global radiopharmaceuticals in nuclear medicine market growth. Newer trends such as increasing therapeutic applications of radiopharmaceuticals and radiolabeling of monoclonal antibodies are expected to support growth of the market. Subsequently, as the need for early diagnosis of diseases such as cancer and accurate diagnosis of diseases such as Alzheimer's has become more necessary (certain products have come close to this such as Amyvid and Vizamyl) radiopharmaceuticals are expected to find an even strong foothold in medical care.
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