Fujirebio Diagnostics
- Company typePrivate
- Founded1970
- HeadquartersMalvern, United States
- Headcount5,001–10,000
- GTM typeB2B
- OfferingHardware or Manufacturing
Fujirebio Diagnostics firmographics
Firmographics- 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
Fujirebio Diagnostics industry classification
Industry- 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
Where Fujirebio Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Malvern
- HQ country
- United States
- HQ region
- North America
Offices4 records
Markets served
Fujirebio Diagnostics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Supply Chain, Operations, Personnel, Marketing or Sales, Infrastructure
Revenue model
- 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
- CDMO/Contract Services: Contract Development and Manufacturing Organization services including antibody identification, supply, product development, clinical services, and regulatory services for partners
- Raw Materials: Sale of diagnostic raw materials including antibodies and antigens to IVD and life science industry
- Manual/Semi-automated Testing Kits: Classic CanAg, INNO-LIA, INNO-LiPA, INNOTEST and other testing solutions for manual or semi-automated testing
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Enterprise laboratory pricing |
Go-to-market motion1 record
Distribution channels5 records
Marketing channels6 records
Fujirebio Diagnostics product offering
Product offeringCore 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
Companies that use Fujirebio Diagnostics
Customer profileSegments4 records
Ideal customer profiles3 records
Fujirebio Diagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature7 records
Fujirebio Diagnostics partnerships and signals
Strategic signalPartnerships
Seven partnerships are on record, tiered core and flagship.
- Alzinova ABcoreNon-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.coreFull 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.
- SysmexcoreSales collaboration for dementia testing. Fujirebio Holdings, Inc. and Sysmex began sales collaboration for dementia testing products in February 2026.
- Plasma Services GroupcoreAcquisition 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 collaboration to advance infectious disease research. Fujirebio announced collaboration with Stanford Medicine (Palo Alto, California) to advance infectious disease research capabilities.
- Biogen and Beckman CoultercoreCollaboration 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.flagshipParent 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
Fujirebio Diagnostics competitors and assessment
Company assessmentEmerging 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
Fujirebio Diagnostics social profiles
Digital presenceFujirebio Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Fujirebio Diagnostics leadership team
Management profileNumber of profiles
Profiles2 records
Fujirebio Diagnostics subsidiaries and ownership
Company hierarchySubsidiaries1 record
Fujirebio Diagnostics funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Fujirebio Diagnostics M&A and investment
M&A and investmentM&A1 record
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Fujirebio Diagnostics
What does Fujirebio Diagnostics do?
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.
Is Fujirebio Diagnostics a public or private company?
Fujirebio Diagnostics is a private company. It is classified as corporate owned and is currently operating.
When was Fujirebio Diagnostics founded?
Fujirebio Diagnostics was founded in 1970. It employs 5,001 to 10,000 people.
Where is Fujirebio Diagnostics based?
Fujirebio Diagnostics is headquartered in Malvern, United States, in the North America region.
How does Fujirebio Diagnostics make money?
Four revenue lines are on record. IVD Instruments and Kits Sales are the primary driver. The others are CDMO/Contract Services, raw Materials and manual/Semi-automated Testing Kits.
Who are Fujirebio Diagnostics's main competitors?
Emerging players on record are Quanterix, Meso Scale Diagnostics and C2N Diagnostics. Broad incumbents are Roche Diagnostics, Siemens Healthineers, Bio-Techne, QuidelOrtho and Abbott Diagnostics.
Does Fujirebio Diagnostics have an API?
No public API is recorded for Fujirebio Diagnostics.
What industry is Fujirebio Diagnostics in?
Fujirebio Diagnostics's product category is In Vitro Diagnostics (IVD). Its primary akta.pro industry code is HLAAAMAL, Biomarker Assay & Reagent Development (LDT/IVD assay design, antibodies/standards/controls), with a secondary code of HLAGAEAB, Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry). Its NAICS code is 325413 and its SIC code is 2835.