IRE - Institute for radioelements

What IRE - Institute for radioelements does

IRE (Institut National des Radioéléments) is a Belgian public utility foundation founded in 1971 in Fleurus, operating as a global leader in medical radioisotope production for nuclear medicine. The company produces Molybdenum-99 (Mo-99), the parent isotope of Technetium-99m used in approximately 80% of nuclear medicine diagnostic procedures globally, and Iodine-131 (I-131) for thyroid cancer therapy. IRE supplies approximately 50% of European Mo-99 demand and 25% of global production, supporting an estimated 50 million nuclear medicine examinations and 13 million patients annually across five continents.

The company operates through three integrated entities: the parent IRE (core radioisotope production), IRE ELiT (founded 2010 as an innovation subsidiary developing radiopharmaceutical generators including Galli Ad, Galli Eo, and Galli Rd Germanium-68/Gallium-68 generators for PET imaging), and IRE Lab (founded 2019, providing radiological analysis, environmental monitoring, and the RAMSES and AMES monitoring platforms). IRE ELiT is one of only two global suppliers holding both European pharmaceutical approval for its Ga-68 generator and a US FDA Drug Master File. Distribution spans approximately 40 countries through a network of 30+ regional partners including ROTOP Pharmaka, Grand Pharmaceutical, Cardinal Health, and Isologic.

IRE generates revenue through direct enterprise sales and distribution partnerships of medical radioisotopes and radiopharmaceutical generators to hospitals, radiopharmacies, and nuclear medicine departments. The business model combines product sales (Mo-99, I-131, Ga-68 generators), professional services (IRE Lab radiological analysis for nuclear regulators and industry), and hardware sales (RAMSES/AMES monitoring systems). The company reports €118 million in revenue for 2025 with approximately 300 employees, and is pursuing major capital expansion including an IBA 30 MeV cyclotron for in-house Ge-68 production (commercial production targeted 2026), a CDMO facility for radiopharmaceutical contract manufacturing (opening H2 2027), and the SMART project with ASML for uranium-free Mo-99 production targeted by 2028.

Name

IRE - Institute for radioelements

Legal name

Institut National des Radioéléments

Website

https://ire.eu

Company type

Private

Founded year

1971

Operating status

Operating

Headcount range

101–250 employees

Short description

IRE is a Belgian public utility foundation and global leader in medical radioisotope production, supplying Molybdenum-99 and Iodine-131 to hospitals and radiopharmacies worldwide, with IRE ELiT developing Gallium-68 radiopharmaceutical generators and IRE Lab providing radiological monitoring services.

Ownership category

akta.pro rank

Product category

Medical Radioisotope Production

NAICS

Irradiation Apparatus Manufacturing (334517), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Radioisotope Production (Reactor/Cyclotron/Gamma) (HLAIAGAD)

akta.pro secondary industry

Medical Radioisotope Production (Reactor/Cyclotron, Mo-99/Tc-99m, I-131, Lu-177, etc.) (EUAKAIAA)

Keywords

• Medical radioisotope production
• Radiopharmaceutical manufacturing
• Nuclear medicine supplies
• Radiological analysis services
• Radiation monitoring systems

Headquarters

HQ city

Fleurus

HQ country

Belgium

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Infrastructure, Technology or R&D, Supply Chain, Operations, Marketing or Sales

Revenue model

1. Medical Radioisotope Production: Production and sale of medical radioisotopes including Molybdène-99 (99Mo) and Iode-131 (131I) for nuclear medicine diagnostics and therapies. 99Mo enables approximately 50 million SPECT scans annually worldwide, covering about 50% of European and 25% of global demand.
2. Radiopharmaceutical Generators: Sale of 68Ge/68Ga generators (Galli Ad, Galli Eo, Galli Rd) for PET imaging and preclinical research. Generators are commercialized in approximately 40 countries through distribution network.
3. Radiological Analysis Services: Laboratory and on-site radiological analysis services provided by IRE Lab, including ISO/IEC 17025 accredited measurements of radioactivity in environmental samples, biological samples, food products, and nuclear sector materials.
4. Radiological Monitoring Systems: Sale and deployment of RAMSES and AMES monitoring systems for continuous radiological surveillance in environment and installations, including custom development solutions.
5. CDMO Services: Contract Development and Manufacturing Organisation services for radiopharmaceutical development and production, planned for launch in second half of 2027 at Fleurus site.

Go-to-market motion3 records

Distribution channels3 records

Marketing channels5 records

Core offering

IRE produces medical radioisotopes (Molybdène-99 and Iode-131) and 68Ge/68Ga radiopharmaceutical generators (Galli Ad, Galli Eo, Galli Rd) for nuclear medicine diagnostics and therapy. Through its IRE Lab subsidiary, the company provides environmental radiological analysis services and develops radiological surveillance systems (RAMSES, AMES) for nuclear safety monitoring.

Product overview

IRE - Institute for Radioelements is a public utility foundation and global leader in medical radioisotope production, operating through three main divisions. IRE produces radioisotope products including Molybdenum-99 (99Mo) for Technetium-99m generators and Iodine-131 (131I) for therapy. IRE ELiT, the innovation subsidiary founded in 2010, develops radiopharmaceutical products centered on Germanium-68/Gallium-68 generators (Galli Ad, Galli Eo, Galli Rd) used in PET imaging for cancer diagnosis. IRE Lab provides radiological analysis services including the RAMSES monitoring platform and AMES evaporation system. The company also operates a 30 MeV cyclotron for in-house Ge-68 production and is developing CDMO services for radiopharmaceutical manufacturing.

Differentiator

Problem solved

Functional benefit

Brands

• Galli Ad: 68Ge/68Ga generator approved in European countries for radiopharmaceutical applications
• Galli Eo
• Galli Rd
• RAMSES
• AMES
• SMART
• RECUMO

Products and services

• Molybdene-99 (99Mo) Parent isotope of Technetium-99m metastable, used in approximately 80% of nuclear medicine diagnostics including scans for heart, bones, lungs, thyroid, brain, kidneys, and gastrointestinal system. IRE supplies 50% of European and 25% of global demand.
• Iode-131 (131I) Radioisotope used primarily for therapeutic applications including thyroid cancer treatment and hyperthyroidism. Can also be used with specific molecules for other cancer therapies.
• Galli Ad Generator 68Ge/68Ga generator approved as a medicine in 29 European countries. Inspired by 99mTc generator principles, used for in vitro radiolabelling of specific targeting molecules for PET imaging diagnostics, particularly for neuroendocrine tumors and prostate cancer.
• Galli Eo Generator 68Ge/68Ga generator providing gallium chloride solution for in vitro radiolabelling. Available in USA, Canada and countries without Marketing Authorization in Europe. Used for PET imaging in cancer diagnostics.
• Galli Rd Generator 68Ge/68Ga generator dedicated to preclinical research activities and early development stages before human trials. Offered to hospitals, university labs, research centers and health industry players.
• RAMSES Radiological Monitoring System

Quantifiable outcome

• 50 million nuclear medicine examinations performed annually worldwide using IRE-produced radioisotopes
• +4 more outcomes

Named customers5 records

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Partnerships

13 partnerships are on record, tiered strategic, core and minor.

• Lemer PaxstrategicTechnology or Integration · 13 January 2026French radiation protection specialist selected to supply shielded hot cells for new CDMO (Contract Development and Manufacturing Organisation) facility under construction at Fleurus. Equipment installation planned for early 2027, with CDMO opening expected H2 2027.
• Grand Pharmaceutical (China) Co., Ltd.coreChannel Partner/ Reseller/ Distributor · 6 June 2024Distribution agreement with Grand Pharmaceutical (and subsidiary Chengdu Purevalley Medical Technology) for Galli Eo generator in China. Grand Pharma is a major pharmaceutical conglomerate covering nuclear medicine diagnostics, cerebro-cardiovascular treatment, and biotechnology.
• SCK CEN (Lutetium-177)strategicStrategic or Co-development Partner · 25 February 2022Public-public partnership for large-scale production of Lutetium-177 (Lu-177), a promising radioisotope for prostate cancer treatment. Production facility to be built at SCK CEN Mol site (2022-2024), with potential second facility at IRE Fleurus for demand growth.
• Telix PharmaceuticalsminorChannel Partner/ Reseller/ Distributor · 9 January 2021Distribution partnership for prostate cancer imaging product TLX591-CDx (68Ga-PSMA-11) in France, complementary to Galli Ad generator for radiolabelling kits in prostate cancer diagnostics.
• EKIUM BelgiumminorImplementation/ SI/ Consulting Partner · 9 January 2021Engineering firm selected for cyclotron building construction at Fleurus site, working with SPP Architecte for architecture. This represents 100% Walloon/local investment in cyclotron infrastructure.
• ROTOP PharmakacoreChannel Partner/ Reseller/ Distributor · 7 January 2021Exclusive distribution partnership for Galli Ad (68Ge/68Ga generator) in Germany. ROTOP Pharmaka is a German radiopharmaceutical company with GMP facilities and global distribution network spanning 30+ countries.
• PI Medical Diagnostic Equipment B.V.minorChannel Partner/ Reseller/ Distributor · 1 January 2021Distribution partnership for Galli Ad generator in the Netherlands and Flanders region.
• b.e. imaging AGminorChannel Partner/ Reseller/ Distributor · 1 January 2021Distribution partnership for Galli Ad generator in Switzerland.
• IBAcoreTechnology or Integration · 15 September 2020IBA (Ion Beam Applications) installed the Cyclone IKON 30 MeV cyclotron on IRE's Fleurus site. This strategic equipment enables IRE to produce Germanium-68 in-house for its Ga-68 radiopharmaceutical generators, controlling the complete production chain. Commissioning was scheduled for 2023, with first commercial production planned for 2026.
• I-carecoreImplementation/ SI/ Consulting Partner · 15 September 2020Maintenance partnership with Walloon unicorn I-care for predictive maintenance of IRE's critical nuclear production facilities. Partnership includes deployment of CMMS (GMAO), performance indicators, long-term maintenance strategy, obsolescence management, and competency certification.
• IsologicminorChannel Partner/ Reseller/ Distributor · 1 January 2020Canadian distribution partner for Galli Eo generator. Isologic received approval for Galli Eo in Canada, enabling market access in North America.
• SCK CENcoreStrategic or Co-development Partner · 1 December 2018Public-public partnership (RECUMO) for transforming radioactive residues from medical isotope production into low-enriched uranium for reuse. SCK CEN constructing RECUMO facility at Mol site to process IRE's residues starting 2026. Also partnership for Lu-177 production at scale for cancer therapy.
• ASMLstrategicStrategic or Co-development Partner · 1 January 2018Partnership with Dutch company ASML to develop SMART project - a novel technology for producing Mo-99 without uranium fission using LightHouse high-power superconducting linear electron accelerator technology. Project represents potential 300M+ EUR investment with possible market launch by 2028.

Scale indicators8 records

Recent moves9 records

Expansion highlights5 records

Direct peers

• Curium Pharma: Curium is a global nuclear medicine leader producing SPECT/PET radiopharmaceuticals and supplying medical isotopes including Mo-99-derived Tc-99m generators and I-131, directly competing with IRE in hospital and radiopharmacy supply channels across Europe and the US.
• ITM Isotope Technologies Munich: ITM is a German radiopharmaceutical company producing therapeutic and diagnostic radioisotopes including Lu-177 and radiolabeling precursors, competing with IRE in the rapidly growing therapeutic radiopharmaceutical CDMO and isotope supply market.
• Telix Pharmaceuticals: Telix is a commercial-stage radiopharmaceutical company focused on PSMA imaging and therapy, distributing Ga-68 kits (TLX591-CDx) that are radiolabeled using IRE-compatible Ga-68 generators, making it both a customer-adjacent partner and competitive radiopharma player.
• NTP Radioisotopes (NeoTherapen): South Africa's NTP Radioisotopes is one of the few large-scale global Mo-99 producers (Safari-1 reactor), directly competing with IRE in the medical isotope supply market and serving many of the same radiopharmacy customers globally.
• ANSTO (Australian Nuclear Science and Technology Organisation): ANSTO operates the OPAL reactor and produces Mo-99 for global export, directly comparable to IRE as a national-scale medical isotope producer serving Asia-Pacific and European radiopharmacy customers.

Broad incumbents

• GE HealthCare (Radiopharmaceuticals): GE HealthCare operates a large radiopharma and molecular imaging business, including SPECT tracers and PET agent supply, overlapping with IRE's Tc-99m and Ga-68 generator/cold-kit offerings as part of a broader diagnostic imaging portfolio.
• Lantheus Holdings: Lantheus is a US publicly-traded radiopharmaceutical company focused on diagnostic imaging agents (including Xe-133 and emerging PET radiotracers), directly comparable to IRE in SPECT/PET tracer supply to nuclear medicine departments.
• Eckert & Ziegler: Eckert & Ziegler is a leading radiopharmaceutical and radiation therapy products manufacturer, including radioisotope production and CDMO services, directly comparable to IRE's planned new radiopharma CDMO business and isotope supply portfolio.

Emerging players

• NorthStar Medical Radioisotopes: NorthStar is a US-based emerging producer using non-reactor (accelerator and neutron capture) methods for Mo-99 production, positioning it as a competitive alternative to IRE's legacy fission-based supply chain in the North American market.
• SHINE Technologies: SHINE Technologies is scaling fusion-based Mo-99 production in the US, offering a non-uranium alternative pathway that directly competes with IRE's current method and validates the strategic direction of IRE's own SMART project.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/ire---elit
• Xx.com/IRE_IRE_ELiT

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Subsidiaries2 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about IRE - Institute for radioelements