Eurofins Medigenomix

What Eurofins Medigenomix does

Eurofins Medigenomix GmbH is a German contract research organization (CRO) specializing in DNA sequencing and biological safety testing, headquartered in Martinsried, Germany. Founded in 1998 and operating as a wholly-owned subsidiary of Eurofins Scientific SE (Euronext Paris: EUFI.PA), the company delivers GLP- and GMP-certified toxicological and analytical services across pharmaceuticals, cosmetics, chemicals (REACH), agrochemicals, biocides, novel food/feed, and medical devices. Service lines include OECD-validated in vitro assays (DPRA, KeratinoSens, h-CLAT, GARD, EpiDerm/EPISKIN-SM skin models), genetic toxicology tests (HPRT, chromosome aberration), and full medical device lifecycle services spanning consulting, biocompatibility and sterility testing, and sterile packaging.

Name

Eurofins Medigenomix

Legal name

Eurofins Medigenomix GmbH

Website

https://eurofins.de

Company type

Private

Founded year

1998

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

Eurofins Medigenomix is a German CRO subsidiary of Eurofins Scientific that provides GLP/GMP-certified DNA sequencing, biological safety, and toxicology testing for pharmaceutical, cosmetics, chemical, agrochemical, and medical device clients across global regulated markets.

Ownership category

akta.pro rank

Product category

Contract Research Laboratory Services (Biological Safety Testing & Toxicology)

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417), Testing Laboratories and Services (54138)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)

akta.pro primary industry

Toxicology & Safety Assessment CROs (GLP) (HLAGAAAC)

akta.pro secondary industries

Regulatory Compliance Testing (Microbiological, Chemical, Allergen) (AFALADAA), Regulatory Consulting & Compliance Program Management (FDA/USDA/EFSA) (AFALADAC), Pesticide Residue & Agrochemical Screening Services (Soil/Plant/Water) (AFACAKAF)

Keywords

• Contract research services
• Biological safety testing
• Toxicology laboratory services
• Medical device testing
• Regulatory compliance testing

Headquarters

HQ city

Martinsried

HQ country

Germany

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Research Services: Eurofins generates revenue through providing contract research laboratory (CRO) services for biological safety testing. Services include toxicological tests for chemicals, agrochemicals, biocides, cosmetics, and food. Revenue comes from project-based contracts with pharmaceutical, chemical, cosmetics, and food companies requiring regulatory testing and compliance services.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Eurofins Medigenomix GmbH is a contract research laboratory (CRO) providing biological safety testing, toxicology, ecotoxicology, and analytical services to pharmaceutical, biotech, cosmetics, food, chemical, agrochemical, and medical device manufacturers. Services cover REACH compliance, biocidal product regulation, novel food/feed safety, in vitro skin sensitisation and irritation testing, genotoxicity assays, and full medical device testing including consulting, biocompatibility testing, and sterile packaging. Testing is performed at GLP/GMP certified laboratories under OECD, FDA, and EU regulatory guidelines.

Product overview

Eurofins is a global contract research organization (CRO) offering laboratory testing services for the pharmaceutical, food, environment, and consumer goods industries. The company provides a comprehensive portfolio of biological safety testing services including chemicals testing (REACH compliance), agrochemicals, biocides, cosmetics (alternative in vitro methods), and novel food/feed testing. Services include toxicological investigations, ecotoxicology, genetic toxicity testing (AMES, HPRT, chromosome aberration, micronucleus), skin sensitisation assays (DPRA, KeratinoSens, h-CLAT, GARD), and skin corrosion/irritation testing using reconstructed human epidermis models. Eurofins Medical Device Services offers consulting, testing, and sterile packaging solutions for medical devices. Testing is performed per international guidelines including OECD, GLP, GMP, ISO, and FDA requirements at GMP/GLP certified laboratories.

Differentiator

Problem solved

Functional benefit

Brands

• Eurofins Medical Device Services: Medical device testing, consulting, and sterile packaging services operating across Europe, North America, and Asia-Pacific with over 20 laboratories
• Eurofins bioskin
• Eurofins REACH Taskforce

Products and services

• Medical Device Consulting Services Regulatory consulting services for medical device lifecycle management, covering design controls, technical documentation, QMS, usability, risk analysis, biocompatibility evaluation, clinical evaluation, QA/RA management, post-market surveillance, audits, training, validation, software as medical device, and IVD/IVDR compliance. Targeted at medical device manufacturers requiring lifecycle regulatory support.
• Medical Device Testing Services Comprehensive testing services for medical device manufacturers covering chemical/physical analysis, microbiology and sterility testing, biocompatibility testing, packaging and seal integrity, viral safety, combined products, cytotoxicity testing, human factors testing, clinical studies, materials characterization, and surgical mask testing.
• Sterile Packaging Services Sterile packaging services for medical devices including cleaning, assembly, packaging materials and design, sterilization, validations and documentation, and procurement management, delivered from EN ISO 13485-certified, FDA- and MHLW-registered facilities in Calw and Birkenfeld, Germany.
• Human Safety Testing for Chemicals / REACH Toxicological testing services for chemicals in compliance with REACH regulation, including physico-chemical properties, toxicological investigations, ecotoxicology, and formulation analysis. Targeted at chemical manufacturers and importers requiring EU REACH registration.
• Human Safety Testing for Agrochemicals Safety testing and consulting services for agrochemicals including toxicological tests, ecotoxicology, environmental behavior studies, field studies, occupational exposure studies, and formulation analysis. Targeted at agrochemical manufacturers and registrants.
• Human Safety Testing for Biocides Testing services for biocidal products including quantitative suspension and surface testing, efficacy studies, ecotoxicological studies, stability studies, chemical analyses, and toxicological studies per Biocidal Products Regulation (EU) No. 528/2012. Targeted at biocidal product manufacturers seeking EU BPR approval.
• Human Safety Testing for Cosmetics Alternative in vitro testing methods for cosmetics without animal testing, including cytotoxicity, phototoxicity, skin/eye irritation, skin sensitization, genetic toxicity, endocrine disruptor identification, and reproductive toxicity testing compliant with the EU cosmetics animal testing ban. Targeted at cosmetics manufacturers requiring EU market regulatory compliance.
• Human Safety Testing for Novel Food, Feed, and Food Additives Toxicological safety testing services for novel food, food additives, and feed including genetic toxicity, subchronic/chronic toxicity, developmental and reproductive toxicology, and metabolism/toxicokinetics studies per GLP, EFSA, and FDA guidelines. Targeted at food and feed companies seeking novel ingredient approval.
• HPRT Gene Mutation Assay In vitro mammalian cell gene mutation test using HPRT gene in Chinese Hamster V79 cells to detect base pair mutations, frameshift mutations, and small deletions, performed per OECD Guideline 476.
• In vitro Chromosome Aberration Test In vitro chromosome aberration test to identify clastogenic agents causing structural chromosome aberrations, performed per OECD Guideline 473 using Chinese Hamster V79 cells or human peripheral blood lymphocytes.
• Direct Peptide Reactivity Assay (DPRA) In chemico skin sensitisation assay addressing the first molecular key event of the adverse outcome pathway (AOP) of skin sensitisation, measuring covalent binding to cysteine and lysine peptides via HPLC with UV detection per OECD 442C.
• KeratinoSens Skin Sensitisation Assay In vitro skin sensitisation assay (ARE-Nrf2 Luciferase Test Method) addressing the second molecular key event of skin sensitisation AOP, measuring induction of cyto-protective signaling pathways per OECD 442D using HaCaT keratinocytes.
• Human Cell Line Activation Test (h-CLAT) In vitro skin sensitisation assay addressing the third molecular key event of skin sensitisation AOP by quantifying CD86 and CD54 surface marker expression in THP-1 cells via FACS analysis per OECD 442E.
• Genomic Allergen Rapid Detection (GARD) In vitro skin sensitisation assay analyzing relative expression levels of a 196-gene biomarker signature using the SenzaCell human myeloid leukemia cell line and Nanostring nCounter technology for predicting skin sensitisation potential.
• In vitro Skin Corrosion Test (Human Skin Model) In vitro skin corrosion test using EpiDerm and EPISKIN-SM reconstructed three-dimensional human epidermis models to determine skin corrosivity potential per OECD 431, validated by EURL ECVAM.
• In vitro Skin Irritation Test (Human Skin Model) In vitro skin irritation test using EpiDerm and EPISKIN-SM reconstructed human epidermis models to determine skin irritation potential per OECD 439, classifying substances as non-classified or UN GHS Category 2.

Quantifiable outcome

• 1,710 consulting projects per year for medical device services
• +3 more outcomes

Named customers6 records

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Three partnerships are on record, tiered core and minor.

• BSL BIOSERVICEcoreStrategic or Co-development PartnerBSL BIOSERVICE is Eurofins preferred partner for in vivo studies. The company has also been successfully accredited by AAALAC, demonstrating high standards for animal research. Eurofins collaborates with BSL BIOSERVICE for studies that require in vivo testing complementing Eurofins in vitro capabilities.
• SenzaGen ABcoreTechnology or IntegrationEurofins cooperates with SenzaGen AB in Sweden for the GARD assay. SenzaGen provides the SenzaCell human myeloid leukemia cell line and the GARD Data Analysis Application. Eurofins performs experimental steps until RNA isolation, then SenzaGen handles RNA qualification and Nanostring endpoint measurement.
• SenzaGen (External Speakers)minorStrategic or Co-development PartnerDr. Andy Forreryd from SenzaGen presented at Eurofins in vitro toxicology seminar on the GARD Platform for skin and respiratory sensitization testing.

Scale indicators11 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Bureau Veritas: Bureau Veritas is a diversified TIC incumbent with consumer-products and agri-food testing laboratories competing for similar regulatory testing mandates, though it is broader in scope than Medigenomix's toxicology-focused CRO offering.
• ICON plc: ICON is a large CRO whose laboratory services and bioanalytical offerings overlap with parts of Medigenomix's GLP-testing franchise, though it is more focused on clinical and bioanalytical work.
• Intertek Group: Intertek operates a global network of analytical and consumer-product testing labs, providing adjacent regulatory testing for chemicals, cosmetics, and food that compete with parts of Medigenomix's human safety testing portfolio.

Direct peers

• WuXi AppTec: WuXi AppTec is a global CRO with preclinical and toxicology services, particularly competitive in lab-based safety assessment for small molecules and biologics — a meaningful competitor for cost-sensitive toxicology work.
• BSL BIOSERVICE Scientific Laboratories: BSL BIOSERVICE is Eurofins Medigenomix's preferred in vivo partner and a dedicated German toxicology CRO accredited by AAALAC, offering general toxicology, reproductive toxicology, and ecotoxicology that competes for the same German/European client base.
• Eurofins Scientific SE: Eurofins Scientific SE is the publicly listed parent of Eurofins Medigenomix GmbH; comparable business model — global contract laboratory services spanning food, environment, pharma, and cosmetics testing — and directly sets the strategic and capital context for Medigenomix's German operations.
• Charles River Laboratories: Charles River is the closest direct peer — a global CRO with a dedicated Safety Assessment franchise providing general toxicology, genotoxicity, and reproductive toxicology under GLP, serving the same pharmaceutical, chemical, and consumer-products clients as Medigenomix.
• SGS SA: SGS is a global testing, inspection, and certification company with health & nutrition and crop & food safety laboratories providing analytical and toxicology services overlapping Medigenomix's chemical, food, and cosmetics REACH/biocide testing portfolio.
• Labcorp Drug Development (formerly Covance): Labcorp's early-development services compete directly with Medigenomix on preclinical safety, toxicology, and biopharma product testing, with overlapping client base of large pharma sponsors and FDA/EMA-aligned GLP operations.

Emerging players

• SenzaGen AB: SenzaGen is the technology partner behind Medigenomix's GARD skin sensitisation assay; it operates its own GARD service offering and represents both a collaboration partner and an emerging potential direct competitor in genomics-based skin sensitisation testing.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• YouTubeyoutube.com/channel/UCjJxC5xwBMAxFhfy8UTzAdg
• Facebookfacebook.com/eurofinsgenomics
• LinkedInlinkedin.com/company/eurofins-bpt-munich
• Xx.com/genomicseurope

Compliance7 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Subsidiaries3 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 Eurofins Medigenomix