There are vast number of radiopharmaceuticals available for diagnostic as well therapeutic purposes, each with different as well as same indications for certain diseases such as Alzheimer's (Vizamyl, Amyvid, and Neuraceq). There are around 50 U.S. FDA approved radiopharmaceuticals available for diagnostic as well as therapeutic use and Technetium alone has over 30 approved products available for diagnosis purposes.
Areas where radiopharmaceuticals have applications include oncology, neurology, hematology, cardiology, thyroid applications, and others. Oncology applications include cancer diagnosis and treatment effectivity determination (using radiolabeled therapeutics). Moreover, basic cancer physiology detection is also possible with the help of these radiopharmaceuticals. For instance, Fluorine-18 fludeoxyglucose is indicated for assessing abnormal glucose metabolism in tumors
The global radiopharmaceuticals in nuclear medicine market is estimated to be valued at US$ 6,700.5 million in 2020 and is expected to exhibit a CAGR of 8.0% over the forecast period (2020-2027).
Figure 1. Global Radiopharmaceuticals in Nuclear Medicine Market Share (%) in Terms of Value, By Region, 2020
Increasing product approvals by regulatory authorities is expected to propel the market growth over the forecast period
Key players operating in the market are focusing on obtaining approvals, which is expected to drive the market growth over the forecast period. For instance, in February 2018, NorthStar Medical Radioisotopes, LLC received the U.S. FDA approval for its RadioGenix System, an innovative, high-tech radioisotope separation platform indicated for use in producing widely-used medical radioisotope technetium-99 (Tc-99m) from NorthStar’s non-uranium based molybdenum-99 (Mo-99).
Figure 2. Global Radiopharmaceuticals in Nuclear Medicine Market Share (%) in Terms of Value, By Application, 2020
Adoption of inorganic growth strategies by key players is expected to drive the market growth over the forecast period
Market players are focused on adoption of inorganic growth strategies such as mergers and acquisitions to strengthen their position in the global radiopharmaceuticals in nuclear medicine market. For instance, in 2017, Cardinal Health, Inc. acquired North American rights of Lymphoseek, a radiopharmaceutical diagnostic imaging agent, from Navidea Biopharmaceuticals, Inc. Navidea received around US$ 83 million at closing and will have the opportunity to earn up to US$ 227 million of contingent consideration based on certain milestones through 2026, with US$ 17.1 million of that amount guaranteed over the next three years.
|Base Year:||2019||Market Size in 2019:||US$ 6,700.5 Mn|
|Historical Data for:||2016 to 2019||Forecast Period:||2020 to 2027|
|Forecast Period 2020 to 2027 CAGR:||8.0%||2027 Value Projection:||US$ 11,504.8 Mn|
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., Eli Lilly and Company, Nihon Medi-Physics. Co. Ltd., FUJIFILM Toyama Chemical Co., Ltd., Jubilant Life Sciences Ltd., Samyoung Unitech, and DuChemBio, Inc.
|Restraints & Challenges:||
Global Radiopharmaceuticals in Nuclear Medicine Market – Impact of Coronavirus (Covid-19) Pandemic
Following the outbreak of COVID-19 in December 2019, the disease has spread to over 100 countries across the globe and the World Health Organization has declared it a public health emergency. According to the World Health Organization’s report, the manifestation of coronavirus (COVID-19) has resulted in more than 27.8 million infected individuals worldwide as of September 2020.
Coronavirus pandemic has negatively impacted the development, production, and supply of nuclear medicines and also affected growth of the radiopharmaceutical businesses of various companies across the globe, as COVID-19 pandemic has led to lockdown in several countries, globally. This lockdown has resulted in closure of industrial establishments, except manufacturing of essential commodities and disruption in supply chain of the radiopharmaceuticals and kits for diagnostic and therapeutic use.
Most of the oncologists and cancer research institutes in major countries such as the U.S., Canada, and other low-and-middle income countries, which are largely dependent on radioisotope suppliers, have faced issues related to radiopharmaceutical supply and difficulty in access to therapeutic tracers such as 123I, 123I-MIBG, and 131I-MIBG. This is due to cost and transportation issues faced by suppliers and distributors. Moreover, nuclear medicine manufacturers also face issues in obtaining cold kits, which are used to simplify radiopharmaceutical production.
Radiopharmaceuticals in Nuclear Medicine Market: Restraints
Nuclear medicine field is heavily dependent on availability of Technetium-99m for diagnostic use and according to International Atomic Energy Agency (IAEA), 2014, Tc-99m is used in 20-40 million scans every year globally, which is almost 75 per cent of all procedures in nuclear medicine.
As these isotopes are supplied by reactors present across the world, repeated and prolonged closures of one or more of these nuclear reactors have led to ongoing fluctuations in isotope availability (more prominently after 2007, as the National Research Universal (NRU) in Chalk River, Ontario was shut down in May 2009). Similarly, on March 31, 2018, the National Research Universal (NRU) nuclear reactor in Chalk River, Ontario, Canada went offline for the final time and the Osiris reactor in France shut down at the end of 2015. Such events are expected to restrain growth of the market over the forecast period.
Furthermore, high cost of development of radiopharmaceuticals relative to return on investment is also expected to restrain growth of the radiopharmaceuticals in nuclear medicine market. According to the National Center for Biotechnology Information studies (2006), the cost of developing a drug for diagnostic imaging to commercialization is in the range of US$ 100 to US$ 200 million, which is still applicable today according to a study by the Society of Nuclear Medicine and Molecular Imaging, Inc. (2019).
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., Eli Lilly and Company, Nihon Medi-Physics. Co. Ltd., FUJIFILM Toyama Chemical Co., Ltd., Jubilant Life Sciences Ltd., Samyoung Unitech, and DuChemBio, Inc.
Therapeutic applications of radiopharmaceuticals include treatment of specific cancers under specific conditions. For instance, Yttrium-90 Ibritumomab Tiuxetan (Zevalin, Spectrum Pharmaceuticals) is indicated for the treatment of relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma (NHL) and treatment of previously untreated follicular NHL in patients who achieve a partial or complete response to first-line chemotherapy. Also, Radium-223 dichloride (Xofigo, Bayer HealthCare Pharmaceuticals Inc.) is indicated for the treatment of patients with castration-resistant prostate cancer, and symptomatic bone metastases and no known visceral metastatic disease. Hence, increasing prevalence of cancer is expected to drive the market growth over the forecast period. According to the Cancer Research UK, in 2014, around 357,000 new cancer cases were diagnosed in the U.K., accounting for 980 cases diagnosed per day. Breast, prostate, lung, and bowel cancers together accounted for over 53% of the total cancers in the U.K.
Market players are focusing on various inorganic growth strategies such as collaboration and partnership agreements in order to expand their market presence, which is expected to boost growth of the global radiopharmaceuticals in nuclear medicine market over the forecast period. For instance, in October 2018, Cardinal Health Inc. and Telix Pharmaceuticals Inc., a subsidiary of Telix Pharmaceuticals Limited, entered into a distribution agreement. As per the agreement, Cardinal Health will both distribute the 69Ga-PSMA Kit and prepare unit doses of 68Ga-PSMA delivered as an investigational product for use in qualified investigator-sponsored clinical trials, including Telix-sponsored clinical trials.
Similarly, 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, which is in Phase 3 development.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.