Government, ‘National Radiopharmaceutical-Bio Outcome Creation Strategy’
Complete self-sufficiency of key isotope raw materials by 2030
Aim to discover more than three global new drug candidates
Operation and direct management of ‘National Isotope Program’
The government has set a goal to independently develop ‘dream cancer treatments’ based on radiopharmaceuticals, from raw materials to new drugs, by 2030. To achieve this, the goal is to reach 100% self-sufficiency in essential isotope materials and discover more than three global new drug candidates in radiopharmaceuticals.
The Ministry of Science and ICT announced the ‘Radiopharmaceutical-Bio Outcome Creation Strategy’ on the 7th, which includes four main strategies and nine policy tasks to seize the rapidly growing global radiopharmaceutical-bio market.
Following the success of Novartis’s prostate cancer treatment (Pluvicto) and other radiopharmaceuticals, global pharmaceutical companies are expanding investments in radiopharmaceutical development and mergers and acquisitions (M&A). The global radiopharmaceutical-bio market is projected to expand to 29 trillion won by 2032. In Korea, the government has been focusing on developing radioactive isotope (RI) production technology using facilities like HANARO and building infrastructure such as RI New Drug Center and export-oriented research reactors. Additionally, the private sector is conducting clinical trials for cancer treatments and constructing radiopharmaceutical production facilities, accelerating technology development and investment in radiopharmaceutical-bio.
This new strategy outlines a vision to ‘establish a radiopharmaceutical-bio industry ecosystem to dominate the future global market,’ with goals to achieve complete self-sufficiency in key isotope raw materials, identify global new drug candidates in radiopharmaceuticals, and establish a comprehensive management system for the entire supply and demand cycle of radiopharmaceutical-bio.
The government plans to raise the self-sufficiency rate of essential medical isotopes, which currently stands at just 10%, to 100% by 2030 and explore exports by 2035. The ‘National Isotope Program’ will directly manage the production, supply, and certification of radioactive isotopes, identifying isotopes that require national management and planning infrastructure-based supply. It will also support the development of radiopharmaceuticals to identify more than three global new drug candidates and establish a comprehensive management system for the entire supply and demand cycle in the radiopharmaceutical-bio field.
To enhance isotope production capability, existing infrastructures like the research reactor ‘HANARO’ and the proton accelerator will be advanced, and new infrastructures such as the export-oriented Ki-jang research reactor will be constructed. Support will also focus on developing production technologies for next-generation promising isotopes such as Lutetium (Lu)-177 and Molybdenum (Mo)-99. Due to isotopes’ short half-lives, a standardized transportation system will be essential to ensure rapid supply.
Three major technologies will be supported for the development of new radiopharmaceuticals: synthesis technology linking derivatives and high-energy isotopes, next-generation drugs that simultaneously diagnose and treat, and new drug development support facilities such as GMP (Good Manufacturing Practices) will be established, for instance, at the Southeast Radiation Oncology Center, to support all stages from preclinical to clinical and post-launch.
Cluster-based regional industry ecosystems will be formed: the capital area will focus on new drug development, the southeastern area on the isotope industry, and the southwestern area on basic convergence research. The ‘Radiopharmaceutical-Bio Industry Promotion Center’ will support private sector demand technology development and commercialization while promoting tailored training of specialized manpower.
Vice Minister Lee Chang-yoon of the Ministry of Science and ICT stated, “The strategy aims to dominate the global radiopharmaceutical market by enhancing local production capabilities for radioactive isotopes and securing infrastructure to support new drug development, providing the best efforts to improve technological competitiveness and self-reliance amid the fierce global radiopharmaceutical development race.”