In the realm of modern medicine, nuclear medicine has emerged as a promising and advanced tool that can be used for the diagnosis and treatment of diseases. Nuclear medicine involves the use of radiopharmaceuticals or radiotracers in which radioisotopes are bound to biological molecules that can target specific organs, tissues, or cells within the human body. Presently, nuclear reactors and particle accelerators are used to produce a wide array of radiopharmaceuticals for diagnostic and therapeutic applications. Further, innovative chemistry and automated synthesis devices have been designed to produce a multitude of novel radiopharmaceuticals for both imaging and treatment. In addition, high-resolution and high-sensitivity instruments have been developed to assess normal psychological processes, measure the distribution of drugs and monitor treatment effectiveness in living systems. As such there are several factors which will continue to drive radiopharmaceutical production market.
Radiopharmaceutical Production Market
The production of radiopharmaceuticals typically requires a specific set of components, including a radionuclide generator and a radiopharmaceutical precursor. A radionuclide generator is a system that separates a daughter radionuclide with a short half-life from a parent radionuclide with a long half-life, which is then employed in the production of radiopharmaceuticals. On the other hand, a radiopharmaceutical precursor is a non-radioactive chemical compound or ligand used in the synthesis of radiopharmaceuticals. These precursors are obtained via chemical synthesis and are combined with a radionuclide to manufacture the radiopharmaceutical formulation prior to its administration.
The manufacturing process of radiopharmaceuticals should adhere to Good Manufacturing Practice (GMP) criteria to ensure high-quality and uncontaminated substances. In addition, radiopharmaceuticals can also be produced on a small scale using radiopharmaceutical kits. These kits contain a sterilized vial filled with non-radionuclide component (carrier molecule) to which an appropriate radionuclide is added / diluted for the purpose of diagnostics, therapeutics and theranostics.
A. Radionuclide Generator
The radioisotope generator is an ion exchange column containing resin or alumina upon which a long-lived parent nuclide has been adsorbed. It is made up of glass or plastic column encased in a lead or depleted uranium shield, and the bottom of this column is filled with adsorbent material on which parent nuclide is absorbed. After 4-5 half lives, the daughter nuclide growth is eluted in a carrier free state with appropriate solvent. This portable device is only used when a short-lived radionuclide is used for the treatment. This device is mostly used in the production of Technetium-99m.
The below figure highlights the basic components of a radionuclide generator.
B. Particle Accelerator (Cyclotron)
In a cyclotron, a beam of charged particles is produced by accelerating ions around a widening circle using magnetic field. These charged particles interact with the target in the bombardment chamber resulting in the production of radioisotopes. This method of producing radiopharmaceuticals can be used only with charged particles, such as electrons, protons, and deuterons. This can be attributed to the fact that such operations depend on the interaction of magnetic and / or electrostatic fields with the charge of particles which are undergoing acceleration. Some of the radioisotopes that are produced in cyclotrons include Fluorine-18, Gallium-67 and Thallium-201.
The below figure highlights the basic components of a particle accelerator.
C. Nuclear Reactor
Nuclear reactors are the most widely used device to produce radioactive materials for use in various industries, academic research and medicine. This device is used in the production of both diagnostic and therapeutic radiopharmaceuticals including Xenon-133, Technetium-99, Iodine-131, Iodine-125, Phosphorus-32 and Carbon-14. It is worth noting that Uranium is the most common energy source used by nuclear reactors for nuclear fission.
In this process, the uranium undergoes spontaneous fission reactions, producing a large supply of neutrons. One neutron for each uranium atom undergoing fission is used to sustain this reaction. The remaining neutrons are used to produce radioactive products by causing the neutrons to interact with specific substances, which have been inserted into the ports of the reactor. The fission activity in the reactor can be controlled with control rods that engulf the cores and are made from the material that absorbs the neutrons without undergoing fission (such as cadmium or boron) preventing further fission events. On the other hand, the moderator rods are placed in the reactor to slow down the energetic fission neutrons, as slower neutrons are more efficient at initiating additional fission events.
The below figure highlights the basic components of a nuclear reactor.
Radiopharmaceutical Production Market Landscape – Industry And Non-Industry Players
The radiopharmaceutical production market landscape features over 95 companies, which claim to have the requisite capability to manufacture a wide range of radiopharmaceuticals, including SPECT radiopharmaceuticals, positron emission tomography radiopharmaceuticals, alpha emitters and beta emitters. Further, for the production of such radiopharmaceuticals, more than 190 manufacturing facilities have been established by these industry players, across different geographical regions. Notably, the majority (~50%) of the production facility are located in North America, followed by Europe. It is interesting to note that the US has emerged as the manufacturing hub within the radiopharmaceutical production market. Further, the radiopharmaceutical production market features the presence of small, mid-sized, large, and very large companies having the required expertise to offer contract manufacturing services across the globe.
Leading companies engaged in the radiopharmaceutical production market include Advanced Accelerator Applications, Applied Molecular Therapies, Cardinal Health, DuChemBio, Eckert & Ziegler, Evergreen Theragnostics, Isotopia Molecular Imaging, ITM Isotope Technologies Munich, Nihon Medi-Physics, Nucleus RadioPharma, Pentixapharm, PharmaLogic, RadioMedix, SOFIE and Telix Pharmaceuticals.
Additionally, it is worth noting that close to 120 non-industry players are engaged in the radiopharmaceutical production market. Notably, close to 50% of these non-industry players are engaged in contract manufacturing of radiopharmaceuticals.
It is worth mentioning that majority of the non-industry players are engaged in the manufacturing of Leutetium-177. Examples of players that are engaged in the manufacturing Leutetium-177 include (in alphabetical order, based in Europe) Department of Nuclear Medicine – Ulm University Hospital, Department of Nuclear Medicine & PET-Centre – Aarhus University Hospital, Ludwig-Maximilians-University, Nuclear Medicine and Molecular Imaging – University Medical Center Groningen and ROSATOM (State Atomic Energy Corporation).
Radiopharmaceutical Production Market – Partnerships And Collaborations
Over the past few years, players engaged in the radiopharmaceutical production market have entered into various partnership agreements, with an aim of expanding and diversifying their respective portfolios. A growing interest in this field is reflected from the increase in the partnerships focused on supply agreements for radioisotopes, representing 21% of the total partnerships, followed by mergers and acquisitions (13%) and distribution agreements (9%). Such deals are inked not only to assist companies in expanding their product portfolios, but also to gain additional capabilities in their service portfolios.
Future Perspective of Radiopharmaceutical Production Market
Technological advancements has facilitated the study of radiopharmaceuticals and its applicability in a number of cutting-edge areas, such as medical imaging and targeted drug therapy. Additionally, therapeutic potential of radioactive drug substances is being widely explored in several debilitating chronic diseases, such as Alzheimer’s, Parkinson’s disease, HIV and several oncological disorders. Further, considering the ongoing pace of research within radiopharmaceutical production market, experts believe that many remarkable innovations related to radiopharmaceuticals (in terms of improvement in disease diagnosis and treatment specificity) would be introduced in the coming years.
However, the highly hazardous nature of radiopharmaceuticals requires careful consideration to ensure safety and efficacy of these radioactive drug substances. The services offered by contract service providers (CDOs, CDMOs, CMOs and CRDMOs) related to the radiopharmaceutical manufacturing are believed to invariably support researchers and drug developers in order to navigate the complexities associated with its design, development and manufacturing. Driven by the growing research efforts, development of different radiopharmaceuticals and efforts of various stakeholders, this segment of industry is likely to witness noteworthy growth in the foreseen future.
To know more details on the market opportunity for radiopharmaceutical manufacturing, visit here >> https://www.rootsanalysis.com/reports/nuclear-medicine-and-radiopharmaceuitcals-manufacturing.html
