The Singapore radiopharmaceutical market enters the second half of 2026 with more clinical capacity, more research output and a heavier regulatory calendar than at any previous point. New imaging infrastructure came online at the end of 2025, first-in-human data from a research programme involving Singapore investigators reached publication in June, and the leading lutetium-based prostate cancer therapy won a major label expansion in the United States at the end of July, with two further regulatory decisions still outstanding. Together these developments make the next six months among the most consequential the sector has faced locally.
Two tumour types anchor clinical demand
The demand base rests on two tumour types. Cancer statistics compiled by the National Cancer Centre Singapore from the Singapore Cancer Registry Annual Report 2023, covering the period from 2019 to 2023, recorded 8,114 prostate cancer cases, or 18.0 per cent of all male cancer diagnoses. Prostate cancer is now the most frequently diagnosed cancer among men in Singapore, ahead of colorectal cancer at 7,101 cases. Novartis, which markets the leading PSMA-targeted therapy, states that prostate-specific membrane antigen is present in more than 80 per cent of prostate cancers. On that basis the addressable population for PSMA-targeted imaging and therapy is both large and growing, though the figure comes from a commercially interested source.
Neuroendocrine tumours form the second pillar. Singapore General Hospital, whose nuclear medicine department is the oldest in the country and dates back to 1967, is accredited as a Theranostics Centre of Excellence by the European Association of Nuclear Medicine. It began using lutetium-177 DOTATATE for somatostatin receptor positive tumours in 2012 and commenced PSMA radioligand therapy in 2018. Yttrium-90 selective internal radiation therapy has been in use there since 2006, and radium-223 since 2008. That accumulated clinical experience is what allows Singapore centres to absorb new agents quickly.
New imaging capacity comes online
The most visible change arrived in late 2025. National University Hospital and NUS Medicine launched a Molecular Imaging and Theranostics Centre built around Singapore’s first total-body PET/CT system, delivered in partnership with Siemens Healthineers. The three parties formalised a memorandum of understanding on 16 October 2025 covering clinical diagnostics, translational research and technological innovation. The scanner was expected to become operational in early November and to serve around 2,900 patients a year, while also supporting clinical trials and research programmes.
Professor Khong Pek Lan, Head and Senior Consultant at the Department of Diagnostic Imaging at NUH and Director of the NUS Clinical Imaging Research Centre, said at the launch that patients “benefit from faster, safer and more precise diagnoses”. That assessment came from the launch announcement rather than from independent evaluation, but the underlying technical case is well established in the imaging literature.
The capacity matters commercially as well as clinically. Total-body PET/CT captures the whole body in a single bed position, which shortens acquisition times, allows lower administered tracer activity and raises daily throughput. For the Singapore radiopharmaceutical market, higher throughput converts into higher tracer volumes and a stronger case for local production.
Research output strengthens the clinical case
In June 2026, the Journal of Nuclear Medicine published first-in-human results for a fibroblast activation protein targeted therapy co-authored by investigators at the National University of Singapore. Eighty-eight patients with heavily pretreated, end-stage disease spanning 21 distinct advanced solid tumours received 227 cycles of lutetium-177, yttrium-90 or actinium-225 labelled 3BP-3940 between March 2021 and January 2025. Objective responses were recorded in 66.7 per cent of patients and disease control in 80.4 per cent, with median overall survival of seven months from the start of therapy.
Those figures need careful reading. The work was a single-centre, non-randomised treatment series conducted principally at Curanosticum Wiesbaden-Frankfurt in Germany, with NUS collaboration, rather than a controlled trial. There is no comparator arm, patients had exhausted standard options, and the seven-month median survival sits alongside the response rate as a reminder of how advanced the disease was. The results are best read as an early signal of biological activity, not as evidence of comparative benefit.
Assistant Professor Jingjing Zhang of the Department of Diagnostic Radiology at the National University of Singapore, a co-author, said the field is “no longer limited to treating just one cancer type”.
The significance lies in the target rather than the isotope. Fibroblast activation protein is expressed in the stroma of many solid tumours, including breast, colorectal, gastric and ovarian cancers as well as sarcomas, yet it is rare in healthy adult tissue. A viable agent against it would extend radioligand therapy well beyond the prostate and neuroendocrine indications that currently define the category, though that remains some distance from demonstration.
Three agencies, three sets of rules
Regulation remains a distinctive feature of the sector locally, because three bodies share oversight. The Ministry of Health licenses nuclear medicine services under the Healthcare Services Act 2020 and the Healthcare Services (Nuclear Medicine Service) Regulations 2023, covering personnel, quality management systems, shielding and treatment protocols. The Health Sciences Authority regulates product quality, safety, efficacy and good distribution practice under the Health Products Act 2007. The National Environment Agency licenses the import, distribution, supply and disposal of radioactive material under the Radiation Protection Act 2007 and the Radiation Protection (Ionising Radiation) Regulations 2023.
Writing in DIA Global Forum, Toh Ting Fu of Novartis (Singapore) set out the practical consequence from a sponsor perspective: companies must hold licences from both HSA and NEA depending on their role, and should engage each agency early. The account is explicitly one company’s experience of bringing radioligand therapy to Singapore, and centres planning their own programmes will want to confirm current requirements directly with each agency.
HSA registered lutetium (177Lu) oxodotreotide for gastroenteropancreatic neuroendocrine tumours on 1 June 2020, registration number SIN15947P, following earlier clearances by the United States Food and Drug Administration and the European Medicines Agency. It was the first radioligand therapy registered for the Singapore market. HSA widened that indication on 9 April 2026, extending it from adults to patients aged 12 years and older.
Logistics remain the defining constraint
Radioactive decay imposes a constraint no other pharmaceutical category faces. Lutetium (177Lu) oxodotreotide carries a shelf life of 72 hours from calibration, and that window narrows further because consignments reach Singapore from European manufacturing sites. A delayed flight is not an inconvenience but a lost dose, which is why contingency planning is written into distribution agreements.
Domestic production narrows the gap only partially. Singapore Radiopharmaceuticals Pte Ltd has operated since 2008 and describes itself as the only cyclotron operator in the country capable of producing carbon-11 and fluorine-18, supplying PET centres nationally. Therapeutic doses of longer-lived isotopes, however, still largely originate from overseas reactors and separation facilities, and no domestic capability currently changes that.
National radiochemistry capability is being built in parallel, though its primary purpose lies elsewhere. The Singapore Nuclear Research and Safety Institute was established as a full research institute at NUS in July 2025 with a S$66 million grant under the national Research, Innovation and Enterprise plan, and intends to grow from around 50 experts to 100 by 2030. Its remit is dominated by nuclear energy safety, reactor simulation and nuclear policy rather than medical isotopes, but radiochemistry is one of its research pillars, and the building also houses National Environment Agency radiation monitoring laboratories. The adjacency is useful to the sector without being directed at it.
Reimbursement decides access
Access rather than science is the tighter limit. Since 1 September 2022, MediShield Life and MediSave have covered outpatient cancer drug treatments only where they appear on the Ministry of Health Cancer Drug List, with Integrated Shield Plans following from 1 April 2023 on renewal or purchase. Each listed treatment carries its own claim and withdrawal limits. The Agency for Care Effectiveness assesses cost-effectiveness, and its Drug Advisory Committee reviews listing decisions. The list is updated periodically as new evidence emerges.
The design was intended to strengthen price negotiation, and by MOH’s account it has done so, with public sector cancer drug prices falling substantially since implementation. Patient experience is more mixed. A cross-sectional study at the National Cancer Centre Singapore, published in Proceedings of Singapore Healthcare in 2024, found that most patients surveyed saw no change in out-of-pocket expenses after the list took effect, but that around half of those who commented called for broader coverage through more listed drugs, more subsidised indications or higher claim limits, and roughly a third were uncertain how effective the policy was. For the Singapore radiopharmaceutical market, the practical consequence is that a newly approved radioligand therapy does not become broadly accessible on approval alone: the listing decision is the commercial event that matters most.
What H2 2026 holds for the Singapore radiopharmaceutical market
The dominant near-term variable is Pluvicto. On 31 July 2026 the United States Food and Drug Administration approved lutetium (177Lu) vipivotide tetraxetan in combination with an androgen receptor pathway inhibitor for PSMA-positive metastatic hormone-sensitive prostate cancer, described in the new labelling as metastatic androgen pathway modulation-naive or sensitive disease. The decision rests on the Phase III PSMAddition trial, which met its primary endpoint of radiographic progression-free survival with a hazard ratio of 0.72 (95% CI: 0.58, 0.90) at primary analysis, a 28 per cent reduction in the risk of radiographic progression or death against standard of care alone. An updated analysis put that reduction at 33 per cent (HR 0.67; 95% CI: 0.55, 0.82), with an overall survival trend favouring the combination (HR 0.80; 95% CI: 0.63, 1.01) ahead of the final survival analysis. Grade 3 or higher adverse events occurred in 50.7 per cent of patients receiving Pluvicto plus standard of care, compared with 43.0 per cent on standard of care alone.
Novartis filed in the United States, China and Japan. The two remaining decisions are still outstanding, and approval in those markets would widen the eligible patient population further and pull on lutetium-177 supply across Asia. Singapore is not among the filing markets, but it is exposed on both sides. Singapore General Hospital reported in 2019 that it was then the sole site in the country delivering PSMA radioligand therapy, to local patients and to overseas patients from the region, and that its peptide receptor radionuclide therapy service had drawn patients from China, Malaysia, Taiwan, Indonesia and the United States. A therapy that moves earlier in the treatment pathway raises both regional demand and the risk of supply tightening. Novartis is also enrolling two Phase III trials of actinium-225 PSMA-617, PSMAcTION and AcTFirst, an indication that alpha emitter demand will follow the same curve.
Vendor market research points the same way, projecting double-digit annual growth for the Asia-Pacific nuclear medicine market to 2031 with lutetium-177 the fastest rising isotope. Estimates of this kind rest on proprietary frameworks rather than reported revenues, and country-level figures for Singapore vary widely between providers, so the direction of travel is more reliable than the absolute numbers. The wider dealmaking backdrop is set out in this Life Science Daily News review of biopharma in the first half of 2026, which records 52 transactions and roughly $134 billion of acquisition value across six months, with oncology among the areas drawing the largest single deals.
The second half of 2026 will therefore test whether Singapore can convert infrastructure into throughput, and research into reimbursed practice. The scanners are installed and the regulatory framework is in place. What remains open is supply and subsidy.
