Fujirebio Europe N.V.

What Fujirebio Europe N.V. does

Fujirebio Europe N.V. is a Belgian in vitro diagnostics company headquartered in Ghent and operating as a wholly-owned subsidiary of Japan's H.U. Group Holdings Inc. The company develops, manufactures, and commercializes a portfolio of diagnostic instruments and immunoassays built around its proprietary Lumipulse G fully automated chemiluminescent enzyme immunoassay (CLEIA) platform, which includes the LUMIPULSE G1200 and G600II instruments, the TENDIGO, RoboBlot, Auto-LIA, and Auto-LiPA systems, and a broad assay menu spanning neurodegeneration (notably Alzheimer's disease biomarkers including pTau 217, pTau 181, β-Amyloid 1-40/1-42, NfL, GFAP, ApoE4, and the FDA-cleared pTau 217/β-Amyloid 1-42 Plasma Ratio), oncology tumor markers (CanAg), infectious disease screening (INNO-LiPA HPV genotyping, INNO-LIA HCV/HIV/HTLV/Syphilis), and autoimmune conditions. Fujirebio holds the first FDA-cleared blood-based IVD for amyloid pathology assessment and the first FDA-cleared IVD for amyloid plaque detection in CSF, supported by more than 30 years of neurodegenerative domain expertise and an LIMS-managed biospecimen bank of over 50,000 samples.

The company generates revenue through three streams: direct and distributor-led IVD product sales of instruments, assay kits, controls, software (LIRAS), and raw materials; contract development and manufacturing organization (CDMO) services spanning antibody identification, product development, clinical services, regulatory affairs, and GMP manufacturing for partner diagnostics and pharmaceutical companies; and recurring supply of diagnostic raw materials such as antibodies and antigens to other technology providers. Go-to-market combines enterprise field sales to hospitals, reference laboratories, and pharmaceutical accounts, distribution through regional offices and partner networks across more than 200 countries, and event-driven engagement at major scientific conferences. Recent strategic activity has centered on three acquisitions (ADx NeuroSciences 2022, Fluxus 2022, Plasma Services Group 2025), expanding pharma co-development partnerships with Biogen, Beckman Coulter, Abbott, Eisai, and Stanford Medicine, the formal integration of ADx NeuroSciences into the Ghent headquarters effective April 2026, a new sales collaboration with Sysmex for dementia testing, and a steady cadence of FDA and CE regulatory milestones extending the neurodiagnostic menu into blood-based and CSF-based biomarkers.

Name

Fujirebio Europe N.V.

Legal name

Fujirebio Europe N.V.

Website

https://fujirebio-europe.com

Company type

Private

Founded year

1970

Operating status

Operating

Headcount range

1–10 employees

Short description

Fujirebio Europe N.V. is a Belgian in vitro diagnostics subsidiary of Japan's H.U. Group Holdings that develops the Lumipulse G automated immunoassay platform and neurodegenerative, oncology, and infectious disease assays, selling instruments, kits, CDMO services, and raw materials to hospitals, reference labs, and pharmaceutical partners globally.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826)

akta.pro primary industry

Clinical Chemistry & Hematology Diagnostics (automated analyzers, blood testing) (HLAAALAH)

akta.pro secondary industries

Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB), Antibody Discovery & Engineering Platforms (display tech, bispecifics, Fc engineering) (HLAAAIAB), Autoimmune & Allergy Diagnostics (HLAAALAK)

Keywords

• In vitro diagnostics
• Immunoassay testing
• Biomarker development
• CDMO services
• Diagnostic reagents

Headquarters

HQ city

Ghent

HQ country

Belgium

HQ region

Europe

Offices14 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. IVD Product Sales: Sale of instruments (Lumipulse G1200, TENDIGO, RoboBlot, Auto-LIA, Auto-LiPA), fully automated assay kits (Lumipulse G and INNO-LIA Score), manual testing kits (CanAg, INNO-LIA, INNOTEST), raw materials (antibodies, antigens), controls, and software (LIRAS). Products are sold directly through regional sales offices and through distributors globally.
2. CDMO Services: Contract Development and Manufacturing Organization services including antibody identification and supply, product development, clinical services, regulatory services, and contract manufacturing. Fujirebio provides services from early R&D through commercial supply for both Fujirebio products and partner products. Revenues from partnerships are reinvested into R&D to fuel the innovation engine.
3. Diagnostic Raw Materials and Reagents: Supply of diagnostic raw materials including widely used ranges of antibodies and antigens to other technology providers and diagnostic manufacturers, creating a recurring supply relationship.

Go-to-market motion3 records

Distribution channels4 records

Marketing channels7 records

Core offering

Fujirebio Europe N.V. manufactures and sells in vitro diagnostic (IVD) instruments and assay kits — most prominently the fully automated Lumipulse G chemiluminescent enzyme immunoassay platform — together with biomarker assays for neurodegenerative disease (Alzheimer's, Parkinson's, MS, ALS), oncology, and infectious diseases. It also supplies diagnostic raw materials (antibodies and antigens) and offers CDMO/OEM services covering antibody identification, product development, regulatory, clinical, and contract manufacturing for diagnostic and pharma partners.

Product overview

Fujirebio Europe N.V. is an in vitro diagnostics (IVD) company with over 50 years of experience, operating as the innovation engine powering global diagnostics. The company offers a comprehensive portfolio centered on the LUMIPULSE® G automated immunoassay platform (including G1200 and G600II instruments) along with a full range of diagnostic assays. The product portfolio includes: automated instruments (LUMIPULSE G, TENDIGO, RoboBlot, Auto-LIA, Auto-LiPA); fully automated Lumipulse G assays for biomarkers including pTau 217, pTau 181, NfL, Total Tau, β-Amyloid 1-40/1-42, GFAP, ApoE4, Pan-ApoE, and sTREM2 for neurodegeneration diagnostics; manual/semi-automated assays under CanAg, INNO-LIA, INNO-LiPA, and INNOTEST brands; LIRAS software for assay reading and interpretation; raw materials (antibodies and antigens); and CDMO services including antibody identification, regulatory, clinical, product development, and contract manufacturing. The Neuro Expert Toolbox (NExT) provides a structured pathway from biomarker concept through research use only assays to routine diagnostic solutions. Fujirebio's unique value proposition combines pioneering neurological disease biomarkers with comprehensive CDMO partnership models enabling global diagnostic access.

Differentiator

Problem solved

Functional benefit

Brands

• Lumipulse G: Fully automated immunoassay platform for quantitative measurement of biomarkers
• INNO-LIA
• INNOTEST
• CanAg
• INNO-LiPA
• Neuro Expert Toolbox (NExT)
• Lumipulse G ADxPLORER
• DiaPlexQ
• AmpFire

Products and services

• LUMIPULSE G1200

Quantifiable outcome

• First FDA-cleared blood-based IVD test for early detection of amyloid plaques associated with Alzheimer's disease
• +2 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles3 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 minor, core, strategic and major.

• Alzinova ABminorStrategic or Co-development Partner · 24 June 2026Non-binding Letter of Intent regarding potential commercialization of a blood-based Alzheimer's diagnostic test. The LoI is non-binding and explores a potential future partnership for Alzinova's test using Fujirebio's platforms and distribution network.
• SysmexcoreChannel Partner/ Reseller/ Distributor · 5 February 2026Fujirebio and Sysmex began a sales collaboration for dementia testing. Sysmex distributes Fujirebio's neurodegenerative disease diagnostic products, leveraging Sysmex's global diagnostic distribution network.
• Plasma Services GroupstrategicStrategic or Co-development Partner · 23 June 2025Acquisition of Plasma Services Group to strengthen Fujirebio's position as a provider of critical and high-quality biological raw materials to the IVD and life science industries. Based in Moorestown, NJ, USA.
• Stanford MedicinecoreStrategic or Co-development Partner · 5 June 2025Strategic collaboration with Stanford Medicine to advance infectious disease research. Fujirebio provides its expertise and assay platforms to support Stanford's research programs in infectious disease diagnostics.
• Alamar BiosciencesminorStrategic or Co-development Partner · 28 October 2024ADx NeuroSciences (now part of Fujirebio) and Alamar Biosciences partnership to provide customized blood-based biomarker assay solutions to accelerate biopharma clinical development. Expands access to high-sensitivity NULISA immunoassays.
• Biogen and Beckman CoultermajorStrategic or Co-development Partner · 30 July 2024Tripartite collaboration on blood-based biomarkers and tests for tau pathology in Alzheimer's disease. Biogen contributes therapeutic development expertise, Beckman Coulter provides its automated platform, and Fujirebio contributes its biomarker expertise and assay development capabilities.
• Beckman CoultercoreStrategic or Co-development Partner · 12 March 2024Expanded partnership between Fujirebio and Beckman Coulter to develop patient-friendly, blood-based neurodegenerative disease diagnostics. Fujirebio leverages its expertise in neurodegenerative disease assays while Beckman Coulter contributes high sensitivity, high throughput automated platform capabilities.
• AbbottcoreStrategic or Co-development Partner · 12 February 2024Partnership to develop a Research Use Only Neurofilament-light Chain (Nf-L) neurology biomarker assay for Abbott's Alinity i automated platform. Fujirebio contributes its proprietary Nf-L assay technology for adaptation to Abbott's platform.
• EisaimajorStrategic or Co-development Partner · 22 December 2023Memorandum of understanding for joint research and social implementation of blood-based biomarkers in neurodegenerative diseases. Fujirebio and Eisai collaborate on biomarker research and implementation in clinical practice.
• Beckman CoultercoreStrategic or Co-development Partner · 17 July 2023Initial collaboration to bolster access to patient-friendly, blood-based Alzheimer's disease tests. Combines Fujirebio's expertise in neurodegenerative disease assays with Beckman Coulter's high sensitivity, high throughput immunoassay platform.
• AriBio Co., Ltd.minorStrategic or Co-development Partner · 8 March 2023Strategic partnership between Fujirebio Diagnostics, Inc. and AriBio to advance biomarker development for Alzheimer's disease and neurodegeneration, supporting AriBio's therapeutic development programs.
• Fluxus, Inc.strategicTechnology or Integration · 7 November 2022Acquisition of Fluxus, Inc. to accelerate new platform development based on ultra-high sensitivity detection technology. Fluxus is based in Sunnyvale, CA.
• ADx NeuroSciences N.V.coreStrategic or Co-development Partner · 23 June 2022Acquisition of ADx NeuroSciences, a neurodegenerative disease biomarker pioneer, adding unique know-how and biomarker portfolio. ADx NeuroSciences is formally integrated into Fujirebio Europe N.V. on April 1, 2026. The company was a key partner prior to acquisition, with a commercialization agreement signed in September 2020.

Scale indicators4 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• Roche Diagnostics: Roche Diagnostics is the largest IVD player globally with the Elecsys pTau 217 blood-based Alzheimer's assay and broad CSF biomarker menu on cobas analyzers. Directly competes with Fujirebio in neurodegenerative and immunoassay testing through the Lumipulse G's primary end markets.
• Siemens Healthineers: Siemens Healthineers provides the Atellica and ADVIA Centaur immunoassay platforms serving the same clinical lab customers as Lumipulse G, with a growing menu in neurodegeneration and routine specialty testing.

Direct peers

• Sysmex Corporation: Sysmex announced a sales collaboration with Fujirebio for dementia testing in Feb 2026, leveraging Sysmex's global hematology installed base to distribute Lumipulse neurodegenerative assays - making Sysmex simultaneously partner and adjacent competitor.
• Euroimmun (PerkinElmer): Euroimmun (now part of Revvity/PerkinElmer) develops autoimmune and infectious disease immunoassays including line blot and BIOCHIP technologies that overlap with Fujirebio's INNO-LIA autoimmune and infectious disease menu.
• Beckman Coulter Diagnostics: Beckman Coulter operates the Access Family of immunoassay analyzers and is both a major OEM partner of Fujirebio (tripartite with Biogen) and a competitor in the high-throughput immunoassay platform space serving the same clinical lab customers.
• Quanterix Corporation: Quanterix offers ultra-sensitive Simoa-based blood biomarker assays for neurology, oncology and infectious disease, including blood-based pTau 217 for Alzheimer's. Directly competes with Fujirebio's Lumipulse G plasma assays on sensitivity and platform footprint in neurodegenerative diagnostics.
• Abbott Diagnostics: Abbott developed Nf-L biomarker assays on its Alinity i platform in partnership with Fujirebio and runs competing immunoassay systems (ARCHITECT, Alinity) in the same hospital and reference lab accounts as Lumipulse G.

Emerging players

• C2N Diagnostics: C2N Diagnostics developed the PrecivityAD blood-based test for amyloid pathology, a flagship competitor in the same FDA-cleared and CLIA-certified Alzheimer's IVD category where Fujirebio's pTau 217/β-Amyloid ratio is positioned.
• Bühlmann Laboratories: Bühlmann Laboratories offers fecal calprotectin and emerging blood-based neurodegenerative biomarker assays used in clinical labs and hospitals. Competes with Fujirebio in specialty biomarker niches across European hospital accounts.
• Meso Scale Diagnostics: Meso Scale Diagnostics offers high-sensitivity multiplex electrochemiluminescence platforms for biomarker research and emerging clinical use, intersecting with Fujirebio's Lumipulse G and Fluxus ultra-high-sensitivity detection roadmap.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/fujirebio-europe-n.v.

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries13 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 Fujirebio Europe N.V.