Fujirebio Diagnostics

Name

Fujirebio Diagnostics

Legal name

Fujirebio Diagnostics

Website

https://fdi.com

Company type

Private

Founded year

1970

Operating status

Operating

Headcount range

5,001–10,000 employees

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics (IVD)

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516), Medical Laboratories (621511), Medical Equipment and Supplies Manufacturing (3391)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826), Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Biomarker Assay & Reagent Development (LDT/IVD assay design, antibodies/standards/controls) (HLAAAMAL)

akta.pro secondary industries

Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB), Autoimmune & Allergy Diagnostics (HLAAALAK), Clinical Chemistry & Immunoassay Laboratories (HLAFAMAB), Clinical Chemistry & Hematology Diagnostics (automated analyzers, blood testing) (HLAAALAH)

Keywords

• In vitro diagnostics
• Clinical immunoassay platforms
• Neurological biomarker assays
• Alzheimer's blood testing
• CDMO diagnostic services

Headquarters

HQ city

Malvern

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. IVD Instruments and Kits Sales: Sale of Lumipulse G instruments and fully automated testing kits including Lumipulse G pTau217, NfL, and other assay kits for clinical diagnostics
2. CDMO/Contract Services: Contract Development and Manufacturing Organization services including antibody identification, supply, product development, clinical services, and regulatory services for partners
3. Raw Materials: Sale of diagnostic raw materials including antibodies and antigens to IVD and life science industry
4. Manual/Semi-automated Testing Kits: Classic CanAg, INNO-LIA, INNO-LiPA, INNOTEST and other testing solutions for manual or semi-automated testing

Pricing tiers

Go-to-market motion1 record

Distribution channels5 records

Marketing channels6 records

Core offering

Fujirebio Diagnostics manufactures and sells in vitro diagnostics (IVD) instruments and assay kits centered on the Lumipulse G fully automated chemiluminescence enzyme immunoassay platform, including FDA-cleared and CE-marked biomarker tests for Alzheimer's disease (pTau217, β-Amyloid 1-42 plasma ratio), neurofilament light chain (NfL), and other neurological, infectious disease, oncology, autoimmune, cardiac, and metabolic conditions. The company also supplies diagnostic raw materials (antibodies, antigens, plasma-derived biologicals) to IVD manufacturers and operates CDMO/OEM services that provide antibody identification, contract manufacturing, product development, and regulatory support to partner diagnostics companies.

Product overview

Fujirebio Diagnostics offers a comprehensive in vitro diagnostics (IVD) portfolio centered on its Lumipulse® G automated chemiluminescence platform and a broad range of diagnostic kits spanning fully automated and manual/semi-automated testing options. The company's product ecosystem includes instruments (Lumipulse® G, TENDIGO™, RoboBlot™, Auto-LIA™, Auto-LiPA™), automated kits (Lumipulse® G pTau217, NfL Blood, pTau 217 Plasma/CSF assays), classic assay kits (CanAg®, INNO-LIA®, INNO-LiPA®, INNOTEST®), software (LIRAS®), raw materials (antibodies and antigens), and CDMO services. Fujirebio is notably recognized for its FDA-approved Lumipulse® G pTau217 test—the first blood test for Alzheimer's diagnosis—and has recently expanded its neurological testing portfolio with multiple CE-marked assays and the Neuro Expert Toolbox (NExT). The company also provides specialized testing for autoimmune diseases, cardiac, diabetes, fertility, genetic disorders, infectious diseases, oncology/tumor markers, and HPV.

Differentiator

Problem solved

Functional benefit

Brands

• Lumipulse: Fully automated testing platform for various diagnostic assays including pTau217, pTau181, and NfL blood tests
• INNO-LIA
• INNOTEST
• CanAg
• Neuro Expert Toolbox (NExT)

Products and services

• Lumipulse® G instrument platform

Quantifiable outcome

• First FDA-approved blood test for Alzheimer's diagnosis in patients 55+ with early cognitive decline signs
• +3 more outcomes

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Seven partnerships are on record, tiered core and flagship.

• Alzinova ABcoreStrategic or Co-development Partner · 24 June 2026Non-binding Letter of Intent signed for potential commercialization of blood-based Alzheimer's diagnostic test. Alzinova AB is a Swedish biotech company developing Alzheimer's disease treatments and diagnostics.
• ADx NeuroSciences N.V.coreStrategic or Co-development Partner · 1 April 2026Full integration of ADx NeuroSciences N.V. into Fujirebio Europe N.V. organization effective April 1, 2026. This completes a process of organizational integration for the neuro biomarker specialist company.
• SysmexcoreChannel Partner/ Reseller/ Distributor · 5 February 2026Sales collaboration for dementia testing. Fujirebio Holdings, Inc. and Sysmex began sales collaboration for dementia testing products in February 2026.
• Plasma Services GroupcoreStrategic 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 Malvern, PA, USA.
• Stanford MedicinecoreStrategic or Co-development Partner · 5 June 2025Strategic collaboration to advance infectious disease research. Fujirebio announced collaboration with Stanford Medicine (Palo Alto, California) to advance infectious disease research capabilities.
• Biogen and Beckman CoultercoreStrategic or Co-development Partner · 1 July 2024Collaboration to develop blood-based biomarkers for tau pathology in Alzheimer's disease. Biogen, Beckman Coulter, and Fujirebio entered partnership in July 2024 to advance tau pathology biomarkers.
• H.U. Group Holdings Inc.flagshipOthersParent company and wholly-owned subsidiary relationship. H.U. Group Holdings Inc. is the parent company of Fujirebio Holdings, Inc. headquartered in Minato-ku, Tokyo. New leadership transition with Goki Ishikawa as President & Group CEO effective April 1, 2026.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Emerging players

• Quanterix: Quanterix is a U.S.-based developer of ultra-sensitive single-molecule array (Simoa) blood-based biomarker assays, with strong positioning in neurology (NfL, pTau) biomarkers. Direct emerging competitor to Fujirebio's Lumipulse G neurological biomarker menu, particularly in research-use-only and pharma trial-support settings.
• Meso Scale Diagnostics: Meso Scale Diagnostics (MSD) develops electrochemiluminescence-based multiplex biomarker assays with strong presence in neurodegenerative disease research (pTau, Aβ, NfL). Comparable to Fujirebio's Lumipulse G immunoassay platform in the research and pharma biomarker-services market, particularly for CNS trials.
• C2N Diagnostics: C2N Diagnostics developed the PrecivityAD blood test for Alzheimer's, an early direct competitor to Fujirebio's Lumipulse G pTau217 assay in the U.S. blood-based Alzheimer's diagnostic market. Closest head-to-head peer in the specific FDA-cleared Alzheimer's blood test category.

Broad incumbents

• Roche Diagnostics: Roche Diagnostics is the global market leader in IVD and central laboratory immunoassays (cobas platform), with an active Elecsys blood-based Alzheimer's biomarker program (pTau217). Direct competitor to Fujirebio in clinical lab immunoassays and a clear threat in the Alzheimer's blood test category.
• Siemens Healthineers: Siemens Healthineers (Atellica/ADVIA Centaur immunoassay platforms) is a major IVD incumbent with a broad neurology, cardiac, and infectious disease menu. Comparable to Fujirebio as a hospital-laboratory automated immunoassay provider and a likely competitor on blood-based Alzheimer's assays.
• Bio-Techne: Bio-Techne (ProteinSimple, R&D Systems, ExoDx) supplies biomarker assay kits, antibodies, and diagnostic raw materials overlapping with Fujirebio's raw materials portfolio. Comparable in the research-use biomarker reagent and CDMO-adjacent reagent business, and a potential competitor as blood-based neurodegenerative diagnostics expand.
• QuidelOrtho: QuidelOrtho (Vitros, Triage, Sofia platforms) is a broad IVD manufacturer spanning immunoassay, molecular diagnostics, and specialty testing including infectious disease and autoimmune. Comparable to Fujirebio's hospital-laboratory IVD business across multiple disease categories.
• Abbott Diagnostics: Abbott Diagnostics (Alinity ci-series immunoassay platforms) is one of the largest IVD players globally, with comparable neurology, infectious disease, cardiac, and oncology assay menus. Competes with Fujirebio for hospital and reference-lab contracts and is developing its own Alzheimer's blood tests.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/Fujirebio
• LinkedInlinkedin.com/company/fujirebio-us

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

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

M&A1 record

Investments

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

Frequently asked questions about Fujirebio Diagnostics