Technology · Health & biomedicine / Therapeutics & platforms
Radiopharmaceuticals & theranostics
Radioactive compounds that pair a tumor-targeting vector with a diagnostic or therapeutic isotope — 'see what you treat, treat what you see' — now commercial at multi-hundred-million-dollar manufacturing scale.
1 · What it gives
Radiopharmaceuticals and theranostics pair a tumor-targeting vector — a monoclonal antibody, peptide or small molecule — with a radioactive isotope, using a diagnostic isotope for PET/CT tumor imaging and a therapeutic isotope on the same vector for targeted cell killing. Novartis’s Pluvicto (177Lu-PSMA-617) is the sector’s commercial proof point, and the company is backing it with a planned $23 billion five-year manufacturing investment, including a new 70,000-square-foot Indianapolis facility that is now its largest and most advanced radioligand-therapy production site. Germany’s ITM supplies non-carrier-added Lutetium-177 (n.c.a. 177Lu) under long-running arrangements — including a collaboration with the Institut Laue-Langevin dating to 2009 — and has signed a fresh supply agreement with Radiopharm Theranostics to support its clinical pipeline. On the alpha-emitter side, Bristol Myers Squibb’s RayzeBio unit is developing SSTR2-targeted radiopharmaceutical therapies for gastroenteropancreatic neuroendocrine tumors and has built a dedicated Indianapolis hub for end-to-end manufacturing and on-demand RayzeBio drug-product delivery. In imaging, Curium has launched PYLCLARI (piflufolastat [18F], also marketed as Pylarify in the US) — a PSMA-targeted PET tracer for prostate cancer — commercially in Spain and Germany.
The key directions of radiopharmaceuticals and theranostics are:
- Beta-emitter targeted therapy (Lutetium-177): using 177Lu, whose beta particles travel roughly 1-2 mm in tissue, to damage cancer-cell DNA while sparing surrounding healthy tissue — the basis of Pluvicto and Lutathera.
- Targeted alpha therapy (TAT): using alpha emitters such as Actinium-225 or Lead-212, whose high-energy, ultra-short-range (under 100 micrometers) particles cause irreparable double-strand DNA breaks even from a single hit, overcoming radioresistance.
- Precision vector targeting: using highly specific delivery vectors — chiefly PSMA on prostate-cancer cells and somatostatin receptors (SSTR) on neuroendocrine tumors — chelated via DOTA or Macropa.
- PET/CT diagnostic pairing: using a short-lived diagnostic isotope on the same vector to image the tumor before or alongside therapy, the “theranostic” logic of seeing what you treat.
Sectoral value chain#
[Isotope Production (Reactor)] ──> [Chelator & Vector Synthesis] ──> [Hot-Cell Radiolabeling]
│ │ │
(Lu-177/Ac-225, targets) (DOTA/PSMA, peptides) (Radiochemical purity)
│
[Clinical Administration (GMP)] <─── [Downstream Purification & Dosing] <─────────────────┘
Value chain levels#
| Level | Description | Key inputs/outputs |
|---|---|---|
| 1. Isotope production | Producing isotopes in nuclear reactors (neutron capture) or high-energy cyclotrons (proton irradiation). | In: Starting targets (Yb-176, Ra-226), reactors/cyclotrons. Out: Radioactive feedstock (177LuCl3, 225Ac). |
| 2. Organic synthesis (vectors) | Organic synthesis of targeting molecules (peptides, antibodies) and covalent attachment of macrocyclic chelators (DOTA). | In: Amino acids, linkers, bifunctional chelators. Out: Cold precursor vector. |
| 3. Radiolabeling | Coordination reaction binding the isotope inside the chelator, performed in shielded lead hot cells. | In: Radioisotope, precursor vector, buffers. Out: Crude labeled radiopharmaceutical. |
| 4. Purification & QC | Purifying the product on SPE cartridges, with rapid radiochemical-purity testing by radio-HPLC and radio-TLC. | In: Crude labeled product, chromatography columns. Out: High-purity sterile radiopharmaceutical solution (>95%). |
| 5. Formulation & fill (GMP) | Adding radioprotectants (ascorbic acid), sterile 0.22-micron filtration, automated aseptic filling. | In: Purified radiopharmaceutical, buffers, lead vials. Out: Finished dose in a shielded lead container. |
| 6. Nuclear logistics | Express delivery to the clinic by dedicated transport with radiation-safety controls, within hours. | In: Finished lead-shielded container. Out: Product delivered to the nuclear-medicine department. |
Cross-cutting technologies of the sector:
- Macrocyclic chelation (coordination chemistry): organic macrocycle “cages” (DOTA, Macropa, crown ethers) that tightly bind trivalent radiometal ions (177Lu3+, 225Ac3+) through nitrogen and oxygen coordination bonds, preventing dissociation of free toxic isotope in the patient’s blood.
- No-carrier-added Lutetium-177 (n.c.a. 177Lu) production: irradiating a highly enriched Ytterbium-176 target with thermal neutrons in a reactor, then chemically separating the resulting Lu-177 from Yb to achieve the highest specific activity with no long-lived 177mLu contamination.
- Automated hot-cell radiosynthesis modules: sealed, negative-pressure lead enclosures with automated cartridge-based radiosynthesis systems, letting all mixing, heating, column purification and sterile filtration run remotely without manual radiation contact.
2 · What it replaces 0 · matched by industry
No graded substitution linked yet.
3 · How to implement 6 steps
- 1Receiving radioactive raw material at the GMP labFeedstock & raw materialsA lead transport container arrives from a specialized reactor (e.g., ITM in Germany) carrying a vial of ultra-pure, no-carrier-added Lutetium-177 chloride solution in 0.04M hydrochloric acid; incoming QC measures total radioactivity on an ionization chamber and confirms isotopic purity (no long-lived 177mLu) by gamma spectrometry.Who can do this step matched automaticallyindustrial scale“Recent updates highlight public communications on ethanol myths and the broader role of bio-based feedstocks in India.”Sea6 Energy Indiaindustrial scale“Sea6 Energy (founded 2010, headquartered in Bangalore, India) develops mechanized tropical seaweed farming and converts cultivated seaweed biomass into carbon-negative, sustainable …”Thai Wah Thailand10,000 tons“Biodegradable products; our tapioca-based TPS is derived from renewable feedstock with 90% bio content and better elongation suitable for flexible packaging application of mulch …”“FENC is a world leader in food-grade recycled PET (rPET) and maintains a fully integrated value chain from feedstock to apparel.”
- 2Automated hot-cell radiosynthesisSynthesis & conversionEquipment & engineeringAn operator loads a single-use sterile cartridge into a radiosynthesis module inside a lead hot cell; the module automatically doses roughly 100 micrograms of cold precursor vector (e.g., PSMA-617 peptide) in sodium-acetate buffer (pH 5.0-5.5) with a 7.4 GBq dose of Lu-177 chloride, then heats the mixture to 95°C for 15 minutes as the lutetium ions coordinate inside the peptide’s DOTA macrocycle.Who can do this step matched automaticallyCell AgriTech Malaysia5,000 L industrial scale“We design and fabricate our own stainless-steel bioreactors, automation systems, and harvesting modules, which lower CAPEX and OPEX by more than 80% compared to pharma-grade …”N.Thing South Koreaindustrial scale“Services: turnkey delivery including design, construction, and operations consulting; in-house cultivation and supply to grocery, food service, catering, and manufacturing.”industrial scale“Godavari Biorefineries Limited is an Indian integrated biorefinery producing ethanol, bio-based chemicals, sugar, and power.”
- 3Purification and radiochemical QCPurification & downstreamTesting & analyticsThe cooled reaction mixture is pumped through a C18 solid-phase extraction cartridge; free unbound Lu-177 washes to waste while the labeled product elutes in a small volume of sterile ethanol, then is diluted with saline containing sodium ascorbate (a radioprotectant against self-radiolysis); an automated sampler injects a 10-microliter aliquot into a radio-HPLC system to confirm radiochemical purity above 95% and free lutetium below 2%.Who can do this step matched automatically✓ GMP 500 m3“Development of robust, scalable fermentation and downstream processing (production and recovery/yield optimization).”Esco Aster Singapore5,000 L industrial scale“Adherent cell culture and downstream processing: commercialized Tide Motion bioreactor platform (MiniTide to TideXcell) with closed automated cell harvesting and single-use …”ScaleUp Bio Singapore10,000 L pilot scale“Core capabilities span pilot-industrial fermentation and downstream unit operations (centrifugation, TFF, chromatography, solvent extraction, spray/freeze drying) with cGMP …”Tsukishima Kikai Japan“Crystallization and refining: In-house developed DP Crystallizer and Oslo Crystallizer for tailored crystallization and refining processes; integrated purification units combining …”
- 4Sterile filtration and aseptic dose fillingPurification & downstreamThe purified solution passes through an inline 0.22-micron polyethersulfone sterilizing filter, is dosed into a first-hydrolytic-class glass vial, sealed with a rubber stopper and aluminum crimp cap, bubble-point tested for filter integrity, and sampled for an LAL endotoxin test (below 175 EU/dose).Who can do this step matched automatically✓ GMP 500 m3“Development of robust, scalable fermentation and downstream processing (production and recovery/yield optimization).”Esco Aster Singapore5,000 L industrial scale“Adherent cell culture and downstream processing: commercialized Tide Motion bioreactor platform (MiniTide to TideXcell) with closed automated cell harvesting and single-use …”ScaleUp Bio Singapore10,000 L pilot scale“Core capabilities span pilot-industrial fermentation and downstream unit operations (centrifugation, TFF, chromatography, solvent extraction, spray/freeze drying) with cGMP …”Tsukishima Kikai Japan“Crystallization and refining: In-house developed DP Crystallizer and Oslo Crystallizer for tailored crystallization and refining processes; integrated purification units combining …”
- 5Packing in a shielded lead containerRegulatory & certificationA robotic manipulator places the sealed vial inside a 30mm-thick lead container that absorbs the Lu-177 beta radiation, reducing the external surface dose rate to a safe level (under 0.5 mSv/hr); the container is placed in a certified transport case, labeled with Category II-Yellow radiation hazard markings, and issued a certificate of analysis with exact activity-calibration time.Registration in Russia / EAEU: Regulation
- 6Air freight and patient administrationBecause Lu-177 has a half-life of just 6.7 days (Ac-225, 9.9 days), the product cannot be warehoused; logistics teams provide express, often air-freighted, just-in-time delivery directly to the oncology clinic’s nuclear-medicine department, where a physician measures residual activity, administers the dose intravenously over 10-20 minutes, and monitors the patient in a shielded room before discharge, with therapy response later confirmed by Gallium-68 PET/CT imaging.
4 · Who delivers
Matched suppliers (matched automatically)
| Codexis | United States | Producer | active |
| Hendrix Genetics | Netherlands | Not classified | active |
| Calysta | United States | Producer | active |
| Euglena Company (TSE Prime) | Japan | Research / RTO | active |
| HLB Genex (ex-GenoFocus) | South Korea | Producer | active |
Leading companies and institutes (from the brief)
| Company / Institute | Country | Key products / platforms | Tech features | Status 2026 |
|---|---|---|---|---|
| Novartis | 🇨🇭 Switzerland | Pluvicto, Lutathera | PSMA/SSTR-targeted DOTA-chelated Lu-177 therapy | commercial |
| ITM | 🇩🇪 Germany | EndolucinBeta (n.c.a. Lu-177) | World-leading no-carrier-added Lu-177 supply | commercial |
| RayzeBio | 🇺🇸 USA | SSTR2-targeted radiopharmaceuticals | Actinium/alpha-emitter RPT pipeline for NETs | pilot |
| Curium | 🇫🇷 France | PYLCLARI (18F-PSMA PET) | Pan-European diagnostic isotope logistics network | commercial |
| Grand Pharmaceutical | 🇨🇳 China | SIR-Spheres (Yttrium-90) | Selective internal radiation therapy for liver cancer | commercial |
| DKFZ Heidelberg | 🇩🇪 Germany | PSMA-617 discovery research | Foundational vector/chelator design science | research |
5 · Rules & route to market
United States
The US is the world’s largest theranostics market and is actively working to resolve a therapeutic-isotope supply bottleneck.
Pluvicto commercial scale-up, alpha-emitter M&A, Actinium-225 supply expansion#
- Novartis: backs Pluvicto’s commercial success with a planned $23 billion five-year manufacturing investment, including a new 70,000-square-foot Indianapolis facility that is now its largest and most advanced radioligand-therapy production site.
- RayzeBio (Bristol Myers Squibb): develops SSTR2-targeted radiopharmaceutical therapies for gastroenteropancreatic neuroendocrine tumors and operates a dedicated Indianapolis hub for end-to-end manufacturing and on-demand delivery of its clinical-stage RPT candidates.
- Actinium-225 supply: the US Department of Energy and private companies are investing in Radium-226 accelerator-irradiation routes and legacy Thorium-229 reprocessing to scale global Actinium-225 production for targeted alpha therapy.
- Perspective Therapeutics: develops Lead-212-based peptide radiopharmaceuticals for melanoma and neuroendocrine cancers, a leading US player in the alpha-emitter space.
European Union
The EU, and Germany in particular, is the historical birthplace of theranostics, combining the world’s leading academic school with the dominant global isotope supplier.
PSMA discovery science, Lutetium-177 supply monopoly, PET tracer commercialization#
- DKFZ Heidelberg: the German Cancer Research Center is where PSMA-617 — the ligand underlying Pluvicto — was discovered, and continues total-synthesis research refining the chemistry behind PSMA-targeted radiotheranostics.
- ITM (Isotopen Technologien München): the world’s leading supplier of non-carrier-added Lutetium-177, with a Lu-177 manufacturing collaboration with the Institut Laue-Langevin dating to 2009 and a fresh 2026 supply agreement with Radiopharm Theranostics.
- Curium: has launched PYLCLARI, a PSMA-targeted 18F PET tracer for prostate cancer, commercially in Spain and Germany, extending its diagnostic-isotope logistics network across Europe.
China
China treats radiopharmaceutical self-sufficiency as a strategic health priority, building domestic reactor and cyclotron capacity while its pharmaceutical majors expand into nuclear oncology.
isotope self-sufficiency programs, domestic theranostic manufacturing, SIRT clinical expansion#
- Grand Pharmaceutical: markets SIR-Spheres Yttrium-90 microspheres (Yigantai) for selective internal radiation therapy of liver cancer, and its US DOORwaY90 clinical trial met its primary endpoint for unresectable hepatocellular carcinoma; the company is building China’s largest radiopharmaceutical production base in Wuhan.
- Isotope independence programs: China’s national medical-isotope development program is building dedicated research reactors and cyclotrons aimed at ending reliance on imported Lutetium-177 and Iodine-131.
- Domestic isotope purification research: Chinese researchers have developed an automated system for simultaneous separation and purification of the medical isotopes Actinium-225 and Radium-223, supporting future alpha-emitter production capacity.
6 · Money: tenders & grants
| Grant | Open topic: Using the Circular Cities and Regions Initiative to strengthen urban manufacturing in support of … European Commission · EU | Apr 8, 2027 174 days |
| Grant | Technical innovation to protect ecosystems and to scale up their restoration European Commission · EU | Sep 22, 2027 341 days |
| Grant | Textile circularity through advanced processing and manufacturing technologies and system approaches (IA) … European Commission · EU | Feb 2, 2027 109 days |
7 · Tech stack & innovations
Modern radiopharmaceutical production rests on the following technology stack:
- Precision bifunctional chelator synthesis (DOTA, Macropa):
- Bifunctional chelators have a dual structure: a macrocycle that tightly holds the metal ion, and a reactive group (e.g., an NHS ester) that covalently attaches to the peptide vector’s amino group; isomeric purity is critical, since even small changes in macrocycle geometry weaken isotope binding and cause bone-tissue leakage (toxicity).
- Radiosynthesis in shielded hot cells:
- Chambers built from 50-100mm lead with leaded-glass windows maintain negative pressure and Class A laminar airflow; the isotope-coordination reaction (e.g., 177Lu with PSMA-617) runs in a single-use automated cartridge module heated to roughly 95°C for 15-30 minutes.
- Radio-HPLC radiochemical purity control:
- HPLC coupled in series to a UV detector and a scintillation radio-detector separates the labeled product, free unlabeled peptide, and free unbound isotope within about 5 minutes, confirming radiochemical purity of at least 95% before release.
Where this appears 2 sources
Appears in 2 distinct sources across 1 region, 2024.
- policy documents 1
- reports 1
Regions: China
- 2021: 0
- 2022: 0
- 2023: 0
- 2024: 22
- 2025: 0
- 2026: 0
- 2027: 0
Matched themes 2
Radiopharmaceuticals 治疗性放射药物
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Sources 6 · 0 independent · 6 producer sites
Producers' own sites 6
- Novartis producer checked 2026-05-12 · link not kept
- Itm producer checked 2026-05-19 · link not kept
- Rayzebio producer checked 2026-04-23 · link not kept
- Curium producer checked 2026-03-09 · link not kept
- Grand pharmaceutical producer checked 2026-07-03 · link not kept
- Dkfz producer checked 2026-05-29 · link not kept