What ABX GmbH does

ABX GmbH (legal name: ABX advanced biochemical compounds – Biomedizinische Forschungsreagenzien GmbH) is a Germany-based radiopharmaceutical developer and contract manufacturer headquartered in Radeberg, Saxony. Founded in 1997 with five employees and grown to approximately 400 staff, ABX produces precursor chemicals, peptides, reagent kits, cassettes, and finished diagnostic radiopharmaceuticals for PET (Positron Emission Tomography) and SPECT imaging, including the proprietary prostate-cancer imaging agent Radelumin® (18F-PSMA-1007). The company operates GMP-certified manufacturing facilities with a 10 MeV cyclotron (and a 30 MeV cyclotron under construction), multiple dispensing lines, and full in-house sterility testing, and is the only radiopharmaceutical producer with a complete independent supply chain from precursor/peptide through excipients and sterile disposables.

ABX serves three primary customer segments: (1) pharmaceutical companies developing radiopharmaceutical drugs (for whom ABX provides custom synthesis, GMP manufacturing, and regulatory documentation), (2) nuclear medicine departments and PET centers (purchasing reagent kits, cassettes, and finished products like Radelumin®), and (3) academic and research institutions (for radiotracer development and clinical translation). The company monetizes via direct B2B enterprise sales of products (one-time sale of kits, cassettes, precursors, and finished drug products) and services (custom synthesis, GMP production, regulatory support), with quote-based pricing exclusively to commercial buyers. Distribution combines direct shipping from Radeberg with regional distributors handling Radelumin® in 11 European countries.

Strategically, ABX is wholly owned by Japanese conglomerate Otsuka Holdings since 2007 and operates with operational independence under CEO Dr. Marco Müller (appointed August 2024, succeeding founder Dr. Peter Moll). The company is currently executing a major capacity expansion at its Radeberg site, including a new radiochemistry building and 30 MeV cyclotron, and is a founding member of the nukliD® radiopharmacy cluster in Dresden (established January 2025). ABX also retains economic exposure to Novartis's Pluvicto (177Lu-PSMA-617), which it developed through Phase II before sublicensing to Endocyte (now Novartis).

Name

ABX GmbH

Legal name

ABX advanced biochemical compounds – Biomedizinische Forschungsreagenzien GmbH

Website

https://abx.de

Company type

Private

Founded year

1997

Operating status

Operating

Headcount range

251–500 employees

Short description

ABX GmbH is a German GMP manufacturer of radiopharmaceuticals — precursors, reagent kits, cassettes, and finished PET/SPECT drug products — serving pharmaceutical companies, hospitals, and PET centers globally with a fully vertically integrated supply chain.

Ownership category

akta.pro rank

Product category

Radiopharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414), In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Nuclear Medicine Imaging Tracers & PET/SPECT Supply Chain (FDG, Ga-68, logistics/cold chain) (EUAKAIAE)

akta.pro secondary industry

Nuclear Medicine & Molecular Imaging (SPECT/PET) (HLAHABAE)

Keywords

• PET radiopharmaceuticals
• Reagent kits cassettes
• GMP contract manufacturing
• Radiopharmaceutical precursors
• Nuclear medicine diagnostics

Headquarters

HQ city

Radeberg

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Radiopharmaceutical Products: Sale of manufactured radiopharmaceuticals including reagent kits & cassettes, small molecules & peptides (600+ different compounds), medicinal products, and accessories (cartridges, columns, evacuated vials).
2. Custom Synthesis Services: Custom research, synthesis and manufacturing based on customer needs including lead optimization, precursor development, and radiotracer development.
3. GMP Production Services: GMP production of radiopharmaceutical drug products from development through early clinical phase to commercial manufacturing, including quality control with in-house sterility testing.
4. Regulatory Support Services: Drug Master Files, full CMC documentation, close cooperation with CROs, clinical study setup support, and complete product documentation (SHS, ASMF, DMF).
5. 18O Water: High quality GMP water with DMF (in process) for radiopharmaceutical production.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels6 records

Core offering

ABX develops, manufactures, and sells radiopharmaceutical products and services for PET and SPECT imaging, including reagent kits and cassettes, more than 600 small molecules/precursors and peptides, finished medicinal products such as Radelumin® (18F-PSMA-1007), 18O-enriched water, and accessories. It also provides custom synthesis, GMP radiochemistry production, and regulatory support services, leveraging cyclotrons and GMP-certified facilities to serve pharmaceutical companies, hospitals, and PET centers globally.

Product overview

ABX GmbH is a global radiopharmaceutical company offering a comprehensive portfolio of products and services for PET (Positron Emission Tomography) and SPECT imaging. The core product portfolio consists of Reagent Kits & Cassettes for automated radiopharmaceutical synthesis, Small Molecules & Peptides (600+ compounds including PET/SPECT precursors), Medicinal Products (finished radiopharmaceuticals like Radelumin), 18O Water (target material), and Accessories (disposables and hardware). Notable products include Radelumin (18F-PSMA-1007) for prostate cancer PET diagnostics approved across Europe, and 177Lu-PSMA-617 (Pluvicto) for prostate cancer therapy. The service offering complements the product portfolio with Custom Synthesis (lead optimization, precursor development, radiotracer development), Radiochemistry Services (GMP production with cyclotron facilities, kit/cassette production), and Regulatory Support (DMF, CMC documentation, ASMF). ABX operates a complete independent supply chain from precursor/peptide through excipients and sterile disposables, positioning them as the only service provider with full vertical integration in radiopharmaceutical production.

Differentiator

Problem solved

Functional benefit

Brands

• Radelumin®: A radiotracer product ([¹⁸F]PSMA-1007) for PET imaging of prostate cancer, approved in multiple European countries.

Products and services

• Reagent Kits & Cassettes Automated synthesis reagent kits and disposable production cassettes for radiopharmaceutical manufacturing, designed for use with industry-standard synthesis modules (e.g., GE TRACERlab MX, ORA Neptis). Sold to pharmaceutical companies, hospitals, and PET centers.
• Small Molecules & Peptides Portfolio of more than 600 compounds for nuclear medicine, including PET and SPECT precursors, reference standards, and radiopharmaceutical building blocks. Available in multiple quality levels for different regulatory needs.
• Radelumin (18F-PSMA-1007) PSMA-targeting PET radiotracer for diagnostic imaging of prostate cancer (primary staging of high-risk patients and suspected recurrence). Approved in 11 European countries including Germany, France, Austria, Belgium, Italy, Luxembourg, Netherlands, Spain, Poland, Portugal, and the UK.
• 18O Water High-quality GMP water enriched with Oxygen-18, used as target material for Fluorine-18 production in PET imaging. Sold with a DMF (in process).
• Accessories Hardware and consumables for radiosyntheses, including cartridges, columns, and evacuated vials required for radiopharmaceutical production.
• Custom Synthesis Services Custom research, synthesis, and manufacturing services including lead optimization, precursor development, and radiotracer development tailored to customer needs. For pharmaceutical companies and research institutions.
• Radiochemistry Services Full-service radiochemistry capabilities including development of radiochemical labeling processes, GMP kit and cassette production, and complete radiopharmaceutical drug product manufacturing with worldwide cold-chain shipment from ABX's Radeberg site. Supports batches from 1–20 vials up to 400 filled vials.
• Regulatory Support Services Regulatory affairs support including Drug Master Files (DMF), full CMC documentation, ASMF, close cooperation with CROs, and clinical study setup support. Expert in regulatory submissions for reagent kits, cassettes, and PET/SPECT precursors.

Quantifiable outcome

• 60,000 patients/year treatment capacity with 177Lu-PSMA-617
• +3 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

Feature4 records

Partnerships

Five partnerships are on record, tiered core and minor.

• Novartis (formerly Endocyte)coreStrategic or Co-development PartnerABX developed 177Lu-PSMA-617 through Phase II clinical trials, then sublicensed to Endocyte in 2017 for Phase III. Endocyte was subsequently acquired by Novartis. Together, they led 177Lu-PSMA-617 to market readiness and approval in Europe and the US in 2022 (marketed as Pluvicto by Novartis).
• German Cancer Research Centre (DKFZ)coreStrategic or Co-development PartnerDKFZ commissioned ABX in 2014 to develop 177Lu-PSMA-617, granting worldwide exclusive license. DKFZ also licensed 18F-PSMA-1007 to ABX in 2016. ABX conducted clinical studies and obtained regulatory approvals.
• Prof. Dr. Frederik L. Giesel (University Hospital Düsseldorf)minorStrategic or Co-development PartnerDevelopment partner for Radelumin® (18F-PSMA-1007), providing clinical expertise as Director of Clinic for Nuclear Medicine at University Hospital Düsseldorf.
• Prof. Dr. Klaus Kopka (Helmholtz-Zentrum Dresden-Rossendorf)minorStrategic or Co-development PartnerDevelopment partner for Radelumin®, providing research expertise as Director of Institute of Radiopharmaceutical Cancer Research at Helmholtz-Zentrum Dresden-Rossendorf and formerly head of Radiopharmaceutical Chemistry at DKFZ.
• nukliD® (Radiopharmacy Cluster Dresden)minorStrategic or Co-development PartnerABX is a founding member of nukliD®, the Radiopharmacy Cluster Dresden, established January 2025 to strengthen the radiopharmaceutical ecosystem in the Dresden region.

Scale indicators12 records

Recent moves9 records

Expansion highlights7 records

Broad incumbents

• Curium: Curium is one of the world's largest nuclear medicine companies, supplying PET and SPECT radiopharmaceuticals globally. Highly comparable to ABX as a direct competitor in PET/SPECT tracer manufacturing and distribution to hospitals/PET centers.
• GE Healthcare (Pharmaceutical Diagnostics): GE Healthcare produces and distributes PET radiopharmaceuticals including FDG and operates the TRACERlab synthesis platform compatible with ABX cassettes. Direct competitor in PET tracer manufacturing and adjacent in synthesis hardware.
• Bracco Imaging: Bracco Imaging is a global diagnostic imaging company with significant radiopharmaceutical and contrast media operations. Comparable to ABX as a broader diagnostic imaging agent manufacturer with overlapping customer base in nuclear medicine.
• Cardinal Health (Nuclear & Precision Health Solutions): Cardinal Health operates one of the largest radiopharmacy networks in the US, distributing PET and SPECT products. Comparable to ABX as a radiopharma distribution and compounding competitor, particularly for US-market access.
• Bayer (radiopharmaceuticals): Bayer has a radiopharmaceuticals business developed from the Algeta acquisition, focused on therapeutic radioligands. Comparable to ABX in the therapeutic radiopharma space with Xofigo heritage and ongoing pipeline development.

Direct peers

• PETNET Solutions (Siemens Healthineers): PETNET Solutions operates a global network of PET radiopharmaceutical manufacturing and distribution sites. Directly comparable to ABX as a PET tracer producer serving hospitals and imaging centers with FDG and other diagnostic tracers.
• Lantheus Holdings: Lantheus is a radiopharmaceutical-focused company developing and commercializing diagnostic and therapeutic agents. Comparable to ABX in radiopharma development focus, with overlapping PSMA and theranostics interests.
• Telix Pharmaceuticals: Telix develops and commercializes radiopharmaceuticals for cancer diagnosis and therapy, including PSMA-targeting agents. Comparable to ABX in the theranostics/PSMA competitive landscape.

Others

• Novartis (Pluvicto franchise): Novartis commercializes Pluvicto (177Lu-PSMA-617), originally developed and sublicensed from ABX. Highly relevant as ABX's key downstream partner and as a customer of ABX's contract manufacturing/precursor services.

Emerging players

• IsoTherapeutics Group: IsoTherapeutics is a contract manufacturer of radiopharmaceuticals and radioisotopes for clinical and commercial use. Comparable to ABX as a smaller-scale radiopharma CDMO with overlapping custom synthesis and GMP production services.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/abx-advanced-biochemical-compounds-gmbh

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about ABX GmbH