A rise in the prevalence of prostate cancer and neuroendocrine tumors, and a surge in the use of nuclear imaging techniques propel the gallium-68 market growth. However, the short half-life of gallium-68 impede the market growth. The use of radioactive tracers in cancer diagnosis is expected to bring new trends in the gallium-68 market in the coming years.
The gallium-68 market in Asia Pacific is expected to grow at the highest CAGR during the forecast period. North America accounted for the largest share of the market in 2022. The US dominated the market in this region, in terms of share, in 2022, and it is estimated to continue its dominance during 2022–2030. Nuclear medicine in the US has grown significantly owing to advancements in technologies such as hybrid imaging, the introduction of novel radiopharmaceuticals for diagnosis and treatment, and the development of molecular imaging techniques based on the tracer principle. Access to advanced healthcare infrastructure, the rising incidence and prevalence of prostate cancer, and product innovations by key players further contribute to the expansion of the gallium-68 market in North America. According to the International Agency for Research on Cancer (IARC), the number of cancer cases in the US is expected to increase from 2.28 million cases in 2020 to 3.12 million cases by 2040. Thus, the increasing cancer cases are expected to boost demand for nuclear imaging, which favors the gallium-68 market progress.
Increasing Theranostics and Precision Medicine to Drive Gallium-68 Market Growth in Future
Gallium-68 has become integral to the field of theranostics, which combines diagnostic testing with targeted therapy. Using gallium-68 with therapeutic radiopharmaceuticals such as lutetium-177 presents a promising personalized cancer treatment and management opportunity. This dual role of gallium-68 as a diagnostic tool and a therapeutic agent aligns with the increasing emphasis on personalized and precise cancer care. Thus, progress in theranostics and precision medicine fields is expected to provide lucrative opportunities for market growth.
Short Half-Life of Gallium-68 Hampers Growth of Gallium-68 Market
The half-life of radiopharmaceuticals depends on the half-life and radiochemical stability of radioisotopes, and the radionuclide impurity content in the preparation, among other miscellaneous factors. Most radiopharmaceutical preparations contain radioisotopes with very short half-lives. Gallium-68 must be used within 68 minutes of preparation. The shelf-life of a multidose radiopharmaceutical preparation after aseptic withdrawal of the first dose depends on microbiological conditions. Diagnostic radiopharmaceuticals having short shelf lives are usually prepared in the hospital radiopharmacy departments just before the administration to patients. The half-life of gallium-68 is 68 minutes, which is considerably less than the half-life of other radiopharmaceuticals such as fluorine-18 (109.8 minutes) and technetium-99m (6 hours). Therefore, the short life of radiopharmaceuticals turns out to be a hindrance in long-term procedures, which is a major factor restraining the gallium-68 market growth.
Gallium-68 Market: Segmental Overview
By application, the market is segmented into oncology, neurology, cardiology, and others. The oncology segment held the largest market share in 2022; it is anticipated to register the highest CAGR during the forecast period. The gallium-68 market for the oncology segment is subsegmented into prostate cancer, neuroendocrine tumors, and others. The market, by end user, is categorized into hospitals, diagnostic and imaging centers, and others. The hospitals segment held the largest share of the gallium-68 market in 2022. The same segment is further anticipated to register the highest CAGR during the forecast period.
The gallium-68 market report, based on geography, is segmented into North America (US, Canada, and Mexico), Europe (Germany, France, Italy, UK, Russia, and Rest of Europe), Asia Pacific (Australia, China, Japan, India, South Korea, and Rest of Asia Pacific), the Middle East & Africa (South Africa, Saudi Arabia, UAE, and the Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and Rest of South & Central America).
Gallium-68 Market: Competitive Landscape and Key Developments
Novartis AG, Telix Pharmaceuticals (US) Inc, IRE-ELiT SA, ITM Medical Isotopes GmbH, Eckert & Ziegler Radiopharma GmbH, ARTMS Inc, IBA Radiopharma Solutions, Cardinal Health, Rosatom, and Evergreen Theragnostics Inc are among the prominent players profiled in the gallium-68 market report. These companies adopt product innovation strategies to meet evolving customer demands, which allows them to maintain their brand name in the market.
A few of the recent developments in the global market are mentioned below:
• In December 2023, Ariceum Therapeutics was granted US and Canadian patents for its Gallium-68 (Ga-68) radiopharmaceutical production kit. The IP was developed by Theragnostics Ltd, which was acquired by Ariceum in 2023. Earlier, the production of Ga-68 radiopharmaceuticals involved a multistep approach, which limited the number of patient doses that could be produced at any time. The Ga-68 technology platform of Theragnostics enables the production of multiple doses of Ga-68 HBED-PSMA-11 in a single vial in one simple step.
• In March 2023, Telix Pharmaceuticals received FDA approval for its supplementary New Drug Application (sNDA) for Illuccix (Ga-68 gozetotide injection preparation kit) for the screening of patients with metastatic prostate cancer, who were recommended Lutetium-177 PSMA-directed therapy.
• In October 2022, Telix won Health Canada’s approval for Illuccix (Ga-68 gozetotide injection preparation kit) for use in the staging and re-staging of intermediate and high-risk prostate cancer, as well as for the localization of tumor tissue in recurrent prostate cancer. Illuccix, following radiolabeling with Ga-68, is recommended for use with PET to detect PSMA-positive lesions in males with prostate cancer.
• In September 2021, Eckert & Ziegler Radiopharma GmbH submitted an amendment to their Drug Master File (DMF) for GalliaPharm to the US FDA, thereby extending its Gallium-68 Generator portfolio into the US market. The company had plans to offer its patented Ge-68/Ga-68 generator in size of up to 100 mCi, with a shelf life of 12 months or 700 elutions. Ga-68 from GalliaPharm is used to prepare diagnostic imaging medicines for PET.