New Radiopharmaceuticals to Enter Market as R&D Activities Intensify

Over the past few decades, immunology, biology, and genetics have progressed at a considerable pace due to which the development of cardiological, oncological, and neurological therapies has received a much-needed push. In the past 20 years, multiple radionuclide-based targeted therapies have gradually emerged as one of the most efficient techniques for inflammatory lesions and cancer treatment. At present, an array of therapeutic radionuclides, particularly β− emitters, is increasingly being used across clinics or tested in ongoing clinical trials. At present, within the radiopharmaceutical market, several studies are investigating the potential of 188Re for a broad range of therapeutic applications.

Within the medical sector, the adoption of radiopharmaceuticals is at the nascent stage compared to that of other medicinal products and drugs. However, due to significant advancements and improvements in oncological and neurological therapies, the development of targeted radiopharmaceuticals has gained noteworthy momentum and are creating new growth avenues for stakeholders in the current market landscape. During the 1990s, the healthcare space across developed regions, including North America and Europe witnessed a major overhaul as new regulations and healthcare provisions were introduced. At present, manufacturers or drug developers in the radiopharmaceuticals market are required to comply with guidelines. The demand for radiopharmaceuticals is expected to witness considerable growth during the forecast period, due to their widening applications in oncology, cardiology, neurology, etc. Thus, the global radiopharmaceutical market is expected to reach a value of ~US$ 5.4 Bn by the end of 2027.

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Technetium – 99 Set to Retain Lead Due to Growing Adoption in Diagnostic Procedures

Nuclear medicine has gained significant traction in the past couple of decades. The growing popularity of nuclear medicine can be largely attributed to the availability of 99m Tc– an isotope that is deployed in ~80% diagnostic procedures. At present, nearly 25 million diagnostic procedures are carried out using 99m Tc radiopharmaceuticals and trends suggest that the number is expected to grow at a steady pace annually. One of the major factors that are driving the adoption of Technetium 99 is the availability of short-lived 99m Tc. At present, research and development activities are in full swing to improve the overall production capacity of 99 Mo, which in turn will positively impact the production of 99m Tc.

In the current scenario, 99m Tc is extensively used in multiple diagnostic procedures, including neuroendocrine tumor imaging and pertechnetate for thyroid uptake. The past few years have witnessed a significant rise in research activities that aim to discover new and improved 99m Tc radiopharmaceuticals. 99m Tc is expected to dominate the global radiopharmaceutical market as applications of 99m Tc for dynamic and morphological imaging of liver, renal, bone, etc., are likely to grow during the assessment period. In addition, several radiopharmaceuticals are set to gain acceptance due to their wide availability and economical costs.

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Stakeholders in Current Market Landscape Focus on Complying With Global FDA Guidelines

Stakeholders operating in the current radiopharmaceutical market are required to comply with the published FDA guidelines during the drug development phase. In August 2019, the U.S. FDA published the Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations. A large chunk of companies operating in the current radiopharmaceutical market has predominantly been active participants in the diagnostic sector, wherein fulfilling the stringent regulatory guidelines is the primary area of focus. At present, participants in the radiopharmaceutical market are likely to work in conjunction with companies active in the traditional pharmaceutical space to ensure that their commercialization and drug development strategies align with the FDA guidelines. Some of the major points included by the FDA focus on the evaluation of radiation toxicities, toxicities from the ligand, and data pertaining to product labeling, among others. Stakeholders in the radiopharmaceutical market will continue their pursuit of achieving approval from the FDA to stay relevant in the current market landscape.

Over the past five to six years, the FDA has approved around three advanced radiopharmaceutical therapies– LuDOTATATE for neuroendocrine carcinomas, Radium-223, and MIBG for paraganglioma and pheochromocytoma.

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