Korea’s radiopharmaceutical industry is shifting from its traditional focus on diagnostic agents to a growing emphasis on therapeutic radiopharmaceuticals.

Once centered on PET-CT scan tracers, the sector is now racing to develop cancer treatments using targeted radiation, an area dominated by global pharmaceutical giants such as Novartis. 

As competition intensifies, Korean firms are seeking a foothold in this emerging market.

Radiopharmaceutical therapy (RPT) delivers radiation directly to cancer cells while sparing healthy tissue. According to the Korea Biotechnology Industry Organization (KoreaBIO), over 60 radiopharmaceuticals have received U.S. FDA approval, including 13 cancer treatments that use alpha or beta radiation to target tumor DNA. 

While these therapies have extended patient survival, a KoreaBIO official noted that concerns remain about their systemic toxicity and side effects, driving research into next-generation treatments with improved precision and safety.

One of the most promising innovations could be SK biopharmaceuticals' Actinium-225 (Ac-225), an alpha-emitting radionuclide viewed as a potential successor to Lutetium-177 (Lu-177), which currently underpins FDA-approved therapies such as Novartis’ Pluvicto for prostate cancer. According to SK biopharmaceuticals, Ac-225 delivers high-energy radiation over short distances, enhancing targeted selectivity while minimizing damage to surrounding tissues.

While Novartis dominates the radiopharmaceutical sector, Korean firms—including DuChemBio, CellBion, SK biopharmaceuticals, and FutureChem—are vying for leadership in radioligand therapy (RLT) and contract development and manufacturing (CDMO), segments where competition remains limited.

Pluvicto, a prostate-specific membrane antigen (PSMA)-targeted radiopharmaceutical, generated $1.04 billion in sales in the first three quarters of 2024, highlighting the financial potential of this market. The rapid adoption of radiopharmaceuticals has spurred major pharmaceutical investments, with companies exploring alpha-emitting radionuclides as the next frontier in cancer treatment.

DuChemBio expands into therapeutics and CDMO services

DuChemBio is expanding into therapeutics and CDMO services. The company manufactures 90,000 doses of Alzheimer’s diagnostic radiopharmaceuticals annually, and it plans to increase production by 120,000 doses. With Eisai’s Alzheimer’s drug Leqembi (lecanemab-irmb) now available in Korea and Eli Lilly’s donanemab expected to follow, demand for PET-CT imaging agents is set to rise.

"We anticipate significant growth in demand for PET-CT tracers, and as the market leader in diagnostics, we are well-positioned to benefit," a DuChemBio official said. The company views therapeutic radiopharmaceuticals as the next major opportunity, particularly given their longer half-lives, which allow for export across Asia. 

It is also entering the radiopharmaceutical CDMO market, positioning itself as a key supplier in a sector with few established players.

SK biopharmaceuticals bets on Actinium-225 supply chain

While DuChemBio focuses on Lu-177-based therapies, SK biopharmaceuticals is investing in Ac-225, a less proven but potentially more effective isotope. 

The company secured a supply agreement with U.S.-based TerraPower Isotopes (TPI) for Ac-225 and licensed FL-091, a neurotensin receptor-targeting RPT candidate, from Full-Life Technologies.

“Ac-225 is gaining recognition as a next-generation radioisotope, but supply is a critical issue due to its link to national energy infrastructure,” an SK biopharmaceuticals official said. “TerraPower is one of the few companies capable of producing and supplying Ac-225 at a stable, high-quality level. This gives us a strong position in terms of supply chain security.”

SK biopharmaceuticals aims to advance at least two clinical-stage candidates and multiple preclinical assets by 2027, prioritizing the U.S. market while securing exclusive Ac-225 supply rights in four Asian countries. 

However, industry insiders note that while SK biopharmaceuticals is more established than CellBion and DuChemBio, it faces significant challenges in competing with global pharmaceutical leaders in the radiopharmaceutical sector.

“Unlike Lu-177-based therapies, which have already been commercialized, Actinium-based therapies are still in early-stage development,” an industry insider said. “SK biopharmaceuticals must clarify whether it plans to build a full-scale radiopharmaceutical CDMO business or focus solely on Actinium-based research. The lack of commercialized Actinium-based therapies limits potential revenue, while Lu-177 is already the foundation of most industry R&D.”

CellBion and FutureChem drive prostate cancer research

CellBion and FutureChem are also vying for a share of the radiopharmaceutical market. 

CellBion’s Lu-177-DGUL, a PSMA-targeted radiopharmaceutical for metastatic castration-resistant prostate cancer, showed an overall response rate of 47.5 percent in phase 2 trials last month, surpassing the previously reported 38.5 percent. The company expects to complete final patient dosing by March and launch the treatment by October.

"While our clinical trials are currently based in Korea, our development progress is among the fastest globally," Park Jae-min, vice president and chief financial officer of CellBion, said. 

Beyond prostate cancer treatment, CellBion’s portfolio includes therapeutics, diagnostics, and radiopharmaceuticals, though the company has temporarily put other projects on hold. "Once phase 3 trials are complete and we secure regulatory approval, we will restart development of our other pipelines," Park said.

FutureChem’s FC705 (ludotadypep), a Lutetium-177-based RLT for metastatic prostate cancer, showed promising interim results in its phase 2 trial. Sixty percent of patients experienced a prostate-specific antigen (PSA) reduction of 50 percent or more, while three patients recorded complete responses. 

High barriers to entry in radiopharmaceuticals

Despite Korea’s growing interest in therapeutic radiopharmaceuticals, industry experts warn that the sector’s high entry barriers could limit players. Manufacturing requires significant capital investment, particularly in constructing radiation shielding facilities to prevent contamination.

“Even at major hospitals, these facilities resemble bomb shelters,” the DuChemBio official said. “Many physicians are reluctant to enter due to radiation concerns. This is not a market that just anyone can enter—it has one of the highest barriers in biotech.”

Unlike diagnostic radiopharmaceuticals, therapeutic agents require the ability to produce raw radioisotopes. Currently, SK biopharmaceuticals sources Ac-225 from TerraPower, meaning it operates only as a contract manufacturer rather than a full-scale radiopharmaceutical CDMO. Without in-house isotope production, experts say the company faces significant hurdles in scaling its business.

“This is a highly exclusive industry,” the DuChemBio official added. “Entry barriers are so high that the first successful CDMO will likely become a market leader. Companies must evaluate whether they have the infrastructure and technology to succeed.”