What Innogenetics does

Innogenetics is a Belgian specialty diagnostics company founded in 1985 in Gent, focused on developing diagnostic products and therapies for infectious diseases. The company built a portfolio of manual and semi-automated immunoassay and line probe test kits (branded INNO-LIA, INNO-LiPA, and INNOTEST) used in clinical laboratories for infectious disease and other diagnostic applications. Following its 2010 acquisition by Fujirebio (a wholly-owned subsidiary of Japan's H.U. Group Holdings Inc.), Innogenetics became the nucleus of Fujirebio Europe N.V., also based in Ghent, and its product lines were retained as sub-brands within the larger IVD portfolio. Today, the Gent-based operations contribute diagnostic content, biomarker expertise, and R&D capabilities to the parent's broader biomarker-to-IVD platform, including neurological disease testing (Alzheimer's, MS, Parkinson's, ALS) and the CDMO services offered by the group.

The business model of the parent group (Fujirebio) combines one-time sales of instruments and assay kits (Lumipulse G, INNO-LIA Score, CanAg, INNO-LiPA, INNOTEST, controls, antibodies/antigens), recurring revenue from CDMO and OEM partnerships with other diagnostic technology providers, and subscription-style revenue from LIRAS interpretation software. The Ghent operations are central to the European arm of this model, supplying infectious disease and neurological biomarker content, supporting clinical and regulatory services, and serving as the integration point for the 2026 ADx NeuroSciences consolidation. Innogenetics' customer base is not separately disclosed; within the broader Fujirebio group, end-customers include hospital and reference laboratories, CDMO partners (e.g., the announced Alzinova collaboration), and channel partners such as Sysmex, while broader disease segments served include autoimmune, cardiac, oncology, transplantation, and infectious diseases.

Name

Innogenetics

Legal name

Fujirebio Holdings, Inc.

Website

https://innogenetics.com

Company type

Private

Founded year

1970

Operating status

Operating

Headcount range

11–50 employees

Short description

Innogenetics is a Belgian specialty diagnostics company founded in 1985 in Gent, developing diagnostic products and therapies for infectious diseases. Since its 2010 acquisition by Fujirebio, it operates as the basis of Fujirebio Europe N.V., contributing INNO-LIA, INNO-LiPA, and INNOTEST diagnostic kits and biomarker R&D to the parent's global IVD and CDMO portfolio.

Ownership category

akta.pro rank

Product category

Infectious Disease Diagnostics

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Microbiology & Infectious Disease Diagnostics (Culture/ID/AST) (HLAHAAAC)

akta.pro secondary industries

Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD), Molecular Diagnostics & Genomics Laboratories (HLAFAMAE)

Keywords

• Infectious disease diagnostics
• Specialty diagnostics products
• Biotechnology therapies
• Diagnostic test development
• In vitro diagnostics

Headquarters

HQ city

Gent

HQ country

Belgium

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Supply Chain

Revenue model

1. IVD Products and Kits: Sale of instruments (LUMIPULSE G, TENDIGO, RoboBlot, Auto-LIA, Auto-LiPA), kits for fully automated testing (Lumipulse G and INNO-LIA Score assays), manual/semi-automated testing kits (CanAg, INNO-LIA, INNO-LiPA, INNOTEST), controls, and raw materials (antibodies and antigens)
2. CDMO/Contract Services: Revenue from Contract Development & Manufacturing Organization partnerships providing development, manufacturing, and clinical and regulatory services to other technology providers. Reinvests revenues from these partnerships into further R&D to fuel innovation engine.
3. Software Solutions: LIRAS software solutions for reading and interpretation of diagnostic tests

Go-to-market motion1 record

Distribution channels4 records

Marketing channels5 records

Core offering

Innogenetics is a specialty diagnostics company that develops therapies and diagnostic products for infectious diseases. Founded in 1985 and headquartered in Ghent, Belgium, the company operates as a biotech focused on infectious-disease diagnostics, and was acquired by Fujirebio in 2010, becoming part of the Fujirebio in vitro diagnostics organization.

Product overview

Fujirebio is an in vitro diagnostics (IVD) company offering a comprehensive biomarker innovation and CDMO services portfolio. The company operates a biomarker-to-IVD journey spanning from pioneering research and scientific innovation through clinical validation on proprietary platforms to global CDMO partnerships. The core product portfolio includes: LUMIPULSE® G automated instruments paired with fully automated assay kits for neurodegenerative disease testing (pTau 217, NfL biomarkers for Alzheimer's disease); TENDIGO™, RoboBlot™, Auto-LIA™, and Auto-LiPA™ instruments for various testing needs; manual and semi-automated testing solutions (CanAg®, INNO-LIA®, INNO-LiPA®, INNOTEST®); LIRAS® software for reading and interpretation; and raw materials including antibodies and antigens. The company also offers CDMO services for contract development and manufacturing. Product categories span autoimmune diseases, bone metabolism, cardiac, diabetes, fertility, genetic disorders, hypertension, infectious diseases, inflammation, interstitial pneumonia, neurodegeneration, transplantation, and tumor markers.

Differentiator

Problem solved

Functional benefit

Brands

• Lumipulse: Fully automated testing platform for biomarkers including FDA-cleared neurological tests
• INNO-LIA
• INNOTEST
• CanAg
• LIRAS
• NExT (Neuro Expert Toolbox)
• Lumipulse G NfL Blood assay
• Lumipulse G pTau 217 Plasma assay
• Lumipulse G pTau 217 CSF assay

Quantifiable outcome

• Blood-based Alzheimer's disease diagnosis made a reality through FDA-cleared biomarkers
• +2 more outcomes

Named customers1 record

Segments4 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Five partnerships are on record, tiered strategic and core.

• AlzinovastrategicStrategic or Co-development Partner · 24 June 2026Non-binding Letter of Intent signed for potential commercialization of blood-based Alzheimer's disease diagnostic test. Alzinova AB (publ) announced entering into LoI with Fujirebio regarding potential commercialization of their diagnostic test.
• ADx NeuroSciencescoreStrategic or Co-development Partner · 1 April 2026Complete integration of ADx NeuroSciences N.V. into Fujirebio Europe N.V. organization (effective April 1, 2026). This completes a prior process of integration, unleashing new possibilities in neuro testing.
• SysmexcoreChannel Partner/ Reseller/ Distributor · 5 February 2026Sales collaboration for dementia testing. Fujirebio and Sysmex began sales collaboration for dementia testing products. Fujirebio Holdings, Inc. is a consolidated subsidiary of H.U. Group Holdings Inc.
• Plasma Services GroupstrategicStrategic or Co-development Partner · 23 June 2025Acquisition of Plasma Services Group to strengthen position as provider of critical and high quality biological raw materials to the IVD and life science industries. Located in Malvern, PA, USA.
• Stanford MedicinestrategicStrategic or Co-development Partner · 5 June 2025Strategic collaboration to advance infectious disease research. Fujirebio announced collaboration with Stanford Medicine (Palo Alto, CA) to advance infectious disease research.

Scale indicators2 records

Recent moves5 records

Expansion highlights5 records

Broad incumbents

• Fujirebio: Fujirebio is the parent company that acquired Innogenetics in 2010 and now commercializes Innogenetics-originated brands (INNO-LIA, INNO-LiPA, INNOTEST) alongside its own Lumipulse platform. It is the most direct corporate peer and now houses Innogenetics' product line within a global IVD portfolio.
• Roche Diagnostics: Roche Diagnostics is the global IVD market leader, with extensive infectious-disease, HPV, and now blood-based Alzheimer's (Elecsys pTau 217) assays. It competes broadly with both Innogenetics' heritage infectious-disease franchise and Fujirebio's neuro pipeline.
• Abbott Diagnostics: Abbott's diagnostics division operates ARCHITECT and Alinity platforms with broad infectious-disease and specialty testing menus. It is a broad incumbent competing with both Innogenetics' traditional assays and Fujirebio's automated Lumipulse platform.

Direct peers

• bioMérieux: bioMérieux is a global leader in in vitro diagnostics with deep specialization in microbiology and infectious disease testing (the same category Innogenetics serves). Its broad portfolio of culture, immunoassay, and molecular infectious-disease kits competes directly with Innogenetics' heritage product lines.
• Hologic: Hologic's Diagnostic Solutions division offers molecular diagnostics for infectious diseases (e.g., Panther system for HPV, CT/NG, viral load) — directly comparable to Innogenetics' specialty molecular and HPV testing franchise.
• Cepheid (Danaher): Cepheid's GeneXpert system is a leading molecular diagnostics platform for infectious disease (including HPV, MTB, MRSA). Comparable to Innogenetics' molecular infectious-disease focus and competes for the same hospital laboratory customers.
• Qiagen: Qiagen provides sample-preparation technologies and molecular diagnostic kits for infectious disease and HPV testing. It overlaps with Innogenetics' molecular diagnostics heritage and competes in similar European and global hospital-lab channels.
• DiaSorin: DiaSorin specializes in immunodiagnostics and molecular diagnostics with a strong infectious-disease and HPV testing franchise, plus a growing neurodegenerative biomarker portfolio — closely aligned with Innogenetics' specialty diagnostics focus.
• QuidelOrtho: QuidelOrtho produces rapid and specialty diagnostics for infectious disease, including Sofia and Triage product lines. Comparable to Innogenetics in specialty infectious-disease diagnostics and serves overlapping hospital and reference-lab channels.

Emerging players

• Sekisui Diagnostics: Sekisui Diagnostics offers clinical chemistry and infectious-disease diagnostics, including specialty coagulation and infectious-disease kits. It is a niche IVD player comparable in size and scope to Innogenetics as a specialty diagnostics business unit.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks5 records

Key highlights5 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries3 records

Funding overview

Funding rounds1 record

Investors1 record

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

M&A

Investments2 records

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

Frequently asked questions about Innogenetics