Nuclear medicine is a medical specialty that involves the use of radionuclides or radioactive tracers in conjunction with highly specialized imaging instrumentation to detect the emissions in the body after oral, inhalation, or intravenous administration of radionuclides. A radioactive tracer is a drug that is composed of a short-lived medical isotope tightly attached to a carrier molecule. The carrier molecule transports the radioisotope to specific organs, tissues or cells. The extent to which a radioactive substance is absorbed by a particular organ or tissue indicates the level of function of the organ or tissue being studied. This can be detected by the two most common imaging modalities used in the field of nuclear medicine, namely, Single Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET) scans.
Before being accessible for routine clinical use, the radioactive tracer must demonstrate its harmlessness in the patient’s body, along with its benefit for the treatment purpose (similar to any classical drug). This demonstration process is strictly regulated by the Food and Drug Administration (FDA) in the US and the European Medicines Agency (EMA) in Europe. Once approved, these radioactive tracers are entitled as radiopharmaceuticals.
Applications of Radiopharmaceuticals
Radiopharmaceuticals are primarily used in the field of nuclear medicine for both therapeutic and diagnostic purposes, which are briefly described below:
A. Therapeutic Use
Over the past few decades, along with diagnostic radiopharmaceuticals, the pharmaceutical sector is also extensively focusing on therapeutic nuclear medicines, which confer several advantages, such as non-invasive treatment and targeted approach. The targeted approach allows alpha and beta emitting short-range particles to deliver therapeutic doses of ionizing radiation to specific diseased sites while minimizing the radiation doses to the surrounding healthy cells. It is worth highlighting that owing to their proven efficacy radiopharmaceuticals are primarily used in the management of oncological disorders. Additionally, they are used for bone pain palliation, providing a significant improvement in the quality of life for cancer patients suffering from pain associated with bone metastasis, as well as for the treatment of joint pain, as observed in rheumatoid arthritis. Some next generation drug conjugates are using radionuclides, including peptide receptor radionuclide therapy for treatment of neuroendocrine tumors.
B. NUCLEAR IMAGING / DIAGNOSIS
In diagnostic applications, a lower concentration of radioactive molecules, which are detectable due to the emissions from their radioactive labels, are added to the biological system as a radiotracer to examine the metabolism, biokinetics, and biodistribution of these molecules. This concentration is added to the biological system in such a manner that it does not alter the configuration of the process which is under investigation. Typically, the radiation emitted by isotope used for imaging vanishes completely after one day through radioactive decay and normal body excretion.
THE COMMONLY USED RADIO-IMAGING TECHNIQUES – SPECT AND PET
The following sections provide brief information about the SPECT and PET techniques used in the industry:
A. SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY
In SPECT scans, the computers generate three-dimensional (3D) (tomographic) images of the distribution of radiopharmaceuticals that have been injected in the patient’s body. The radiotracer injected emits gamma light, having a comparatively lower wavelength than visible light. Therefore, SPECT imagers are equipped with camera detectors that detect the electromagnetic radiations emitted by the tracers and help in generating 3D images. The cameras are mounted on a rotating gantry allows the detectors to move in a tight circle around a patient who is lying motionless on a pallet. Some commonly used SPECT radionuclides used in the production of radiopharmaceuticals are Ga-67, Cu-67, Tc-99m, In-111 and Gd159.
B. POSITRON EMISSION TOMOGRAPHY
Similar to SPECT, PET scans also utilize radiopharmaceuticals to create 3D images. However, the type of radiotracers injected into the patient body are different in both the imaging techniques. The PET imaging technique uses a small amount of radiotracer which starts to decay and produces small particles known as positrons. These positrons annihilate with the electrons in patient’s body and produces a small amount of energy in the form of two photons that shoot-off in opposite directions. The detectors in the PET scanner measure the energy emitted by the photons and use this information to generate images of the internal organs. Some commonly used PET radionuclides used in the production of radiopharmaceuticals are C-11, N-13, O-15 and F-18.
DYNAMICS OF RADIOPHARMACEUTICAL MANUFACTURING – A COMBINATION OF RADIOISOTOPES AND PHARMACEUTICALS
Radiopharmaceutical manufacturing is a highly specialized field that involves the production of radioactive drugs used in medical imaging and treatment procedures. The radiopharmaceutical manufacturing process involves several critical steps, including the production of the radioisotope, its incorporation into a pharmaceutical formulation, and the quality control testing of the final product. Radiopharmaceutical manufacturing typically involves the use of a nuclear reactor or particle accelerator and must be performed under strict regulatory guidelines to ensure safety and quality. Once the radioisotope is produced, it is combined with various chemical compounds to create a radiopharmaceutical formulation that can be administered to patients. The formulation process must be carefully controlled to ensure the stability and purity of the final product. The below figure provides a schematic representation of a radiopharmaceutical product.
NEED FOR CONTRACT AND CUSTOM MANUFACTURERS FOR RADIOPHARMACEUTICAL MANUFACTURING
The complete process of radiopharmaceutical product development is multifaceted, and selecting a suitable contract manufacturing organization (CMO) for outsourcing different operations is one of the primary challenges faced by the stakeholders in this domain. It is worth noting that most of the contract service providers in this domain have profound experience in niche and emerging areas, in terms of different types of radiopharmaceuticals manufactured. In addition, the innate expertise and availability of required capabilities, enables such service providers to offer a broader range of specialized expertise, including cutting-edge equipment and facilities, and cost-effective solutions to their clients. The below figure describes certain parameters that are commonly considered to assess the expertise and capabilities of a potential CMO partner.
FUTURE PERSPECTIVE
In recent years, there has been a growing focus on the development of novel diagnostic and therapeutic radiopharmaceuticals for the detection and treatment of various chronic diseases. As a result, medical experts are extensively focusing on developing effective, safe and versatile radiopharmaceutical / radiotracer. It is worth highlighting that more than 200 clinical trials are currently underway to investigate several radiotherapeutics for the treatment of a wide range of diseases, across different geographies. This demonstrates the extensive development efforts being undertaken by stakeholders in this domain. The anticipated success of these drugs is likely to act as an impetus to the growth of overall radiopharmaceutical manufacturing market. Furthermore, amidst the recent initiatives undertaken to develop more novel entity, theranostic radiopharmaceuticals have emerged as a promising tool for simultaneous detection and treatment of a wide range of diseases. The integration of diagnostic and therapeutic molecules in a single moiety brings forth a new era in nuclear medicine and radiopharmaceutical manufacturing wherein drug biodistribution is much better with less side-effects.
These advancements are anticipated to present significant opportunities for the stakeholders engaged in the radiopharmaceutical manufacturing domain. In recent years, demand for radiopharmaceuticals in the North America region has witnessed a tremendous increase. However, in the coming years, Asia-Pacific region is likely to grow at a much faster rate as compared to other geographies. Owing to the increasing research activity and ongoing technological advancements in the field of radiopharmaceuticals, along with the growing burden of chronic diseases, the radiopharmaceutical manufacturing market is anticipated to witness exponential market growth during the forecast period.
To know more details on the market opportunity for radiopharmaceutical manufacturing, visit here >> https://www.rootsanalysis.com/reports/nuclear-medicine-and-radiopharmaceuitcals-manufacturing.html
About Author
Jasmeet_Bhalla
With an experience of over 4 years with Roots Analysis, Jasmeet is adept at generating useful insights from unstructured / structured datasets. As a senior analyst at Roots Analysis, she has assisted several clients across multiple industry verticals within the healthcare domain. These verticals include, contract services, devices / technologies, and drugs / disease indications. Since the findings of the research are aimed at supporting the clients to make thoughtful decisions for their business, she has hands-on experience on competitive landscape assessment, benchmarking, market sizing and forecasting, as well as several quantitative / qualitative / strategic frameworks
