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Radiopharmaceuticals are important in the diagnosis and therapy of cancer. A diagnostic scan with 123I, 124I, or low-activity 131I-iodide is followed by therapy with high-activity 131I-iodide. Similarly, adrenergic tumors such as pheochromocytoma and neuroblastoma can be imaged with 123 I-Metaiodobenzylguanidine and treated with 131 I-Metaiodobenzylguanidine. Bone scintigraphy can be used to select patients with painful bone metastases from prostate cancer who might benefit from treatment with beta or alpha-particle-emitting bone-seeking agents, the newest and most successful of which is 223Ra radium chloride. More recently established theranostics include somatostatin receptor targeting peptides for diagnosing and treating neuroendocrine tumors with agents such as 68Ga-DOTATATE and 177Lu-DOTATATE, respectively. We have built on the radioiodine experience with recently licensing somatostatin peptides, and the rapid introduction of 68Ga and 177Lu labeled prostate-specific membrane antigen targeting agents. There is also a large expansion in the availability of widely accepted theranostic radiopharmaceuticals.
GE HealthCare Technologies Inc and Curium– are Notable Market Players in the Global Radiopharmaceutical Theranostics Market
Leading companies operating in the global radiopharmaceutical theranostics market has undertaken various organic and inorganic growth strategies. The global radiopharmaceutical theranostics market comprises Bayer AG, GE HealthCare Technologies Inc, Curium, Lantheus Medical Imaging, Inc.; Telix Pharmaceuticals Ltd.; Cardinal Health Inc, Advanced Accelerator Applications S.A.; Jubilant Radiopharma, Theragnostics, and NuView Life Sciences. The companies have been implementing various strategies that have helped their growth and, in turn, brought about several breakthroughs and transitions in the industry. The companies have utilized organic strategies such as product launches in the global radiopharmaceutical theranostics market, resulting in the market’s growth. Moreover, the market players have also deployed several inorganic strategies, including mergers & acquisitions and collaborations that helped the company to strengthen its revenue, which allows the Company to hold a strong position in the market.
Below are the major growth strategies undertaken by the players operating in the global radiopharmaceutical theranostics market:
|
Company |
Month & Year |
Category |
Description |
|
GE HealthCare Technologies Inc |
March-2023 |
Product News |
GE HealthCare announced, at the European Congress of Radiology (ECR) in Vienna, Austria, the completion of Phase I subject recruitment in its early clinical development program for a first-of-its-kind manganese-based macrocyclic magnetic resonance imaging (MRI) contrast agent. Typically, MRI agents – used to enhance visualization of abnormal structures or lesions and to aid differentiation between healthy and pathological tissue – are gadolinium-based. This manganese-based agent could broaden GE HealthCare’s portfolio of MRI contrast agents available to radiologists, providing a potential alternative in light of perceived concerns about gadolinium retention. |
|
GE HealthCare Technologies Inc |
Nov-2022 |
Product News |
GE Healthcare’s DaTscan had been approved by the U.S. Food and Drug Administration (FDA) for use in patients with suspected Dementia with Lewy Bodies (DLB). This new indication is in addition to using single photon emission computed tomography (SPECT) imaging to visualize dopamine transporters (DaT) in the brains of adult patients with suspected Parkinsonian syndromes. With the expanded indication, DaTscan has been made available to more patients in the United States, including those with suspected DLB. |
|
Curium |
Nov-2022 |
Product News |
Curium had announced that it intended to submit updated labeling to the U.S. Food and Drug Administration (FDA) for its generic DaTscan (Ioflupane I 123 Injection) version) to include a new indication and updated safety information. The additional indication assists in evaluating adult patients for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging with suspected dementia with Lewy bodies (DLB). |
|
Telix Pharmaceuticals Ltd. |
Nov-2022 |
Product News |
Telix announced that Illuccix (Ga 68 gozetotide injection) with up to 50mCi for radiolabeling was available for use on 100mCi (millicurie) gallium generators, an important development in radioisotope production. This technology increases the number of daily elutions and activity in each elution, enabling hospitals and radiopharmacies to increase the number of daily doses produced, expand their service area, and gain greater production efficiency. |
|
Telix Pharmaceuticals Ltd. |
Oct-2022 |
Product Approval |
Telix announced that Health Canada had approved Illuccix [kit for the preparation of gallium (68Ga) gozetotide injection] for use in staging and re-staging intermediate and high-risk prostate cancer and localizing tumor tissue in recurrent prostate cancer. Illuccix was Canada’s first PSMA PET imaging agent to be granted regulatory approval. Health Canada was the third regulatory body worldwide to approve Illuccix, which is commercially available in Australia and the United States. |
|
NuView Life Sciences |
Oct-2022 |
Product News |
NuView Life Sciences, Inc is a clinical-stage precision oncology company focusing on innovative approaches, such as theranostics, to diagnose and treat cancer. NuView is leveraging its clinical-stage small molecule, NV-VPAC1, to advance its unique theranostic technology for precision diagnostics and targeted therapy. NV-VPAC1 binds directly to VPAC1 receptors found in high densities in breast cancer tumors. With FDA approval being sought for NV-VPAC1, there is the potential to attain tremendous benefit. Prospective advantages include the ability to differentiate malignant from benign breast lesions regardless of the level of density (BI-RADS) and the ability to improve the quality of life in patients while they are being diagnosed. |
|
Lantheus Medical Imaging, Inc. |
June-2022 |
Product News |
Lantheus presented study results providing independent validation of PYLARIFY AI, the Company’s artificial intelligence (AI) platform developed to assist in standardized PSMA PET/CT scan quantification. PYLARIFY AI is an FDA-cleared medical device software commercially available in the United States. The results were presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting and demonstrated the higher efficiency and consistency of the PYLARIFY AI platform while maintaining the diagnostic accuracy of PSMA imaging in prostate cancer. |
|
Lantheus Medical Imaging, Inc. |
May-2022 |
Product News |
Lantheus announced the first patient had been dosed in a Phase 2 trial evaluating NM-01, its proprietary technetium 99m SPECT imaging agent used to assess PD-L1 expression in Non-Small Cell Lung Cancer (NSCLC) cells and for its potential to identify patients who would respond to checkpoint inhibitor therapies. |
|
Curium |
Apr-2022 |
Product Approval |
Curium announced that the U.S. Food and Drug Administration (FDA) approved its generic version of DaTscan (Ioflupane I 123 Injection) on March 30, 2022. Ioflupane I 123 Injection is a single-photon emission computed tomography (SPECT) brain imaging agent used to evaluate adult patients with suspected Parkinsonian Syndromes. However, the company began accepting customer orders for fulfillment beginning in April. |
|
Advanced Accelerator Applications SA |
Mar-2022 |
Product Approval |
Novartis announced that the US Food and Drug Administration (FDA) had approved PluvictoTM (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617) for the treatment of adult patients with a certain type of advanced cancer called prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) that has spread to other parts of the body (metastatic). |
|
Theragnostics |
Feb-2022 |
Product Approval |
Theragnostics announced that NephroScan, its radiodiagnostic imaging drug used to evaluate renal parenchymal disorders in adult and pediatric patients, including term neonates, has received Marketing Approval from the US Food and Drug Administration (“FDA”). GE Healthcare to commence distribution in the US and is manufactured by ROTOP Pharmaka in Germany |
|
Telix Pharmaceuticals Ltd. |
Dec-2021 |
Product Approval |
Telix was pleased to announce that the U.S. Food and Drug Administration (FDA) had approved Illuccix (TLX591-CDx), Telix’s lead prostate cancer imaging product. Illuccix is a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection, a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in patients with prostate cancer. |
|
Lantheus Medical Imaging, Inc. |
Nov-2021 |
Product News |
Lantheus announced that PYLARIFY AI, an FDA-cleared medical device software, was commercially available in the United States. PYLARIFY AI employs a deep learning algorithm that has been trained and validated across more than 3,000 images to allow healthcare professionals and researchers to perform standardized quantitative assessments of PSMA PET/CT images in prostate cancer. |
|
Curium |
Oct-2021 |
Product News |
Curium announced that the Company had received a Study May Proceed letter from the U.S. Food and Drug Administration (FDA) to begin its Phase 3 trial with its investigational product lutetium Lu 177 PSMA I&T, a therapeutic radiopharmaceutical that binds to the Prostate-Specific Membrane Antigen (PSMA) protein. |
|
Advanced Accelerator Applications SA |
Sep-2021 |
Product News |
Novartis announced that the US Food and Drug Administration (FDA) had accepted and granted Priority Review to the company’s New Drug Application (NDA) for 177Lu-PSMA-617, an investigational targeted radioligand therapy for metastatic castration-resistant prostate cancer (mCRPC) in the post-androgen receptor pathway inhibition, post-taxane-based chemotherapy setting. |
|
Lantheus Medical Imaging, Inc. |
May-2021 |
Product Approval |
Lantheus announced that the U.S. Food and Drug Administration (FDA) had approved PYLARIFY, an F 18-labeled prostate-specific membrane antigen (PSMA) targeted positron emission tomography (PET) imaging agent to identify suspected metastasis or recurrence of prostate cancer. PYLARIFY was the first and only commercially available approved PSMA PET imaging agent for prostate cancer. |
|
Advanced Accelerator Applications SA |
Mar-2021 |
Product News |
Novartis reported that the first interpretable results of the Phase III VISION study evaluating the efficacy and safety of 177Lu-PSMA-617, a targeted radioligand therapy in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), compared to the best standard of care alone. The trial met both primary endpoints of overall survival and radiographic progression-free survival, helping to move closer to the ambition of becoming the targeted treatment for >80% of patients with advanced prostate cancer. |
|
NuView Life Sciences |
Nov-2020 |
Product News |
NuView Life Sciences developed a unique and proprietary binary test to diagnose cancer more accurately by targeting only cancer cells. As a first-of-its-kind technology, NuView Life Sciences combined their proprietary NV-VPAC1 peptide construct with the radionucleotide Copper-64 [(64)Cu] for diagnostics and Cu for treatment. Research shows that malignant cells accumulate (64)Cu in much greater quantities than normal, healthy cells. As a result, the NV-VPAC1 peptide construct targets cancer cells, binding to specific receptors, called VPAC1 receptors, which are overexpressed on the surface of cancer cells. NV-VPAC1 also identifies cancerous cells shed from the body in biofluids like urine, thus offering diagnosis without radiation. |
|
Jubilant Radiopharma |
Jan-2020 |
Product Approval |
Jubilant Radiopharma, a business unit of Jubilant Pharma Limited, announced today that they received approval from Health Canada for Drax Exametazime (Kit for the Preparation of Tc99m Exametazime for leukocyte labeling). Leukocyte labeling scintigraphy is a nuclear medicine imaging procedure that helps physicians localize the intra-abdominal infection and inflammatory bowel disease. |
