MIKROGEN GmbH
MIKROGEN GmbH is a German biotechnology company that develops and manufactures proprietary recombinant antigen-based IVD test systems for infectious serology, autoimmune, and T-cell diagnostics, serving medical laboratories in Germany and 40+ countries through direct sales and a global distributor network.
- Company typePrivate
- Founded1989
- HeadquartersNeuried, Germany
- Headcount101–250
- GTM typeB2B
- OfferingHardware or Manufacturing
What MIKROGEN GmbH does
MIKROGEN GmbH is a privately held German biotechnology company founded in 1989 and headquartered in Neuried near Munich, specializing in in-vitro diagnostic (IVD) test systems for medical laboratories. The company develops and manufactures six core diagnostic product lines — ampliCube (real-time PCR), recomClia (chemiluminescence immunoassays on the KleeYa platform), recomWell (ELISA), recomLine (line immunoassays), recomBead (Luminex-based multiplex), and T-Track (T-cell assays) — built on proprietary recombinant antigens for which it holds patents in infectious disease areas including Borrelia burgdorferi, parvovirus B19, EBV, and HCV. The portfolio spans infectious serology, autoimmune diagnostics, T-cell immunology, and veterinary diagnostics, supported by automation instruments (KleeYa, Mic, RoboBlot, Dynex DSX, Stratec Gemini, Dynablot Plus) and analysis software (FastFinder, recomScan 5, T-Track suite).
The company's business model combines sale of proprietary test kits and reagents with hardware sales of automation platforms, supplemented by OEM/third-party manufacturing services. Commercial reach is achieved through direct sales in Germany and a distributor network covering more than 40 countries across Europe, North America, Central and South America, Asia, and Africa, with regional partners such as Aidian, Biosynex, Biomedica Group, Funakoshi, and a wholly-owned subsidiary Mikrogen Hangzhou Medical Device Co. Ltd. for China. MIKROGEN is IVDR-certified (2024), ISO 13485:2023 compliant, and positions itself as a market leader in infectious serology with 170+ employees and 30+ years of operating history.
MIKROGEN GmbH firmographics
Firmographics- Name
- MIKROGEN GmbH
- Legal name
- Mikrogen GmbH
- Website
- https://mikrogen.de
- Company type
- Private
- Founded year
- 1989
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- MIKROGEN GmbH is a German biotechnology company that develops and manufactures proprietary recombinant antigen-based IVD test systems for infectious serology, autoimmune, and T-cell diagnostics, serving medical laboratories in Germany and 40+ countries through direct sales and a global distributor network.
- Ownership category
- akta.pro rank
MIKROGEN GmbH industry classification
Industry- 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), Surgical & Medical Instruments & Apparatus (3841), Laboratory Analytical Instruments (3826)
- akta.pro primary industry
- Microbiology & Infectious Disease Diagnostics (culture, rapid antigen, syndromic panels) (HLAAALAC)
- akta.pro secondary industries
- Molecular Biology & Genomics Instruments (PCR/qPCR, Sequencing, Microarrays) (HLAGAIAF), Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI)
Keywords
Where MIKROGEN GmbH is headquartered
LocationHeadquarters
- HQ city
- Neuried
- HQ country
- Germany
- HQ region
- Europe
Offices1 record
Markets served
MIKROGEN GmbH business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Supply Chain
Revenue model
- IVD Test Systems and Reagents: Development, manufacturing and marketing of six product lines: ampliCube, recomClia, recomWell, T-Track, recomLine, and recomBead using proprietary recombinant antigens. Revenue generated from sale of diagnostic test kits for infectious diseases, autoimmune diseases, and T-cell diagnostics.
- Automation Equipment: Sale and distribution of automation solutions including KleeYa analyzer, ampliCube, Mic, RoboBlot, DSX, Gemini, and Dynablot Plus for laboratory automation
- OEM/Third-Party Manufacturing: MIKROGEN manufactures test kits on behalf of third parties, providing additional revenue stream
- Global Distribution: Products distributed via global network of distributors across Europe, Americas, Asia and other regions
Go-to-market motion3 records
Distribution channels4 records
Marketing channels7 records
MIKROGEN GmbH product offering
Product offeringCore offering
MIKROGEN GmbH develops, manufactures, and markets system solutions for in vitro diagnostics, offering six core diagnostic product lines (ampliCube Real-Time PCR, recomClia CLIA, recomWell ELISA, recomLine Line Immunoassay, recomBead Luminex multiplex, and T-Track T-cell assays) built on proprietary recombinant antigens. The portfolio also includes laboratory automation instruments (KleeYa analyzer, Mic PCR cycler, RoboBlot, Dynex DSX, Stratec Gemini, Dynablot Plus) and supporting software such as FastFinder and recomScan 5 for medical and diagnostic laboratories.
Product overview
MIKROGEN GmbH develops, manufactures and markets system solutions for in vitro diagnostics, operating as a biotechnology company with over 30 years of experience. The product portfolio consists of six core diagnostic product lines: ampliCube (Real-Time PCR), recomClia (CLIA on KleeYa platform), recomWell (ELISA), recomLine (Line Immunoassays), recomBead (Luminex multiplex), and T-Track (T-cell assays). These are complemented by automation instruments including the KleeYa CLIA analyzer, Mic PCR cycler, RoboBlot, Dynex DSX, Stratec Gemini, and Dynablot Plus. Supporting software includes FastFinder for PCR data analysis, recomScan 5 for line immunoassay evaluation, and T-Track Software suite. The company holds ISO 13485 certification and IVDR certification, with CE marking across its product lines.
Differentiator
Problem solved
Functional benefit
Brands
- ampli*Cube: Product line for molecular diagnostics
- *recom*CLIA
- *recom*Well
- T-Track®
- *recom*Line
- *recom*Bead
- KleeYa®
- *ampli*Cube
- Mic
- RoboBlot™
- FastFinder
- *recom*Scan
Products and services
- ampliCube Real-Time PCR test system for fully automated molecular diagnostics of infectious diseases, built using proprietary recombinant antigens for medical and diagnostic laboratories.
- KleeYa Analyzer Fully automated random access chemiluminescence immunoanalyzer (CLIA) for quantitative measurement of antigens and antibodies with 72 sample capacity and up to 120 analyses per hour, with LIS connectivity.
- recomClia Chemiluminescence immunoassay (CLIA) product line for quantitative measurement of antigens and antibodies on the KleeYa automated random access analyzer.
- recomWell ELISA-based high-performance screening tests using the indirect sandwich ELISA principle with high specificity and maximum sensitivity for medical laboratories.
- recomLine Line immunoassay (LIA) product line for qualitative in vitro detection and identification of pathogen-specific antibodies with avidity determination.
- recomBead Luminex-based multiplex bead product line for quantitative in vitro assays using recombinant antigens, designed as confirmatory test for high sample throughput with automated evaluation.
- T-Track T-cell assay product line available in RT-qPCR based and ELISpot-based platforms for detecting antigen-specific T-cell reactivity and immune monitoring in seropositive patients.
- FastFinder Software Real-time PCR data analysis software providing intelligent algorithmic evaluation with over 99% reproducible and accurate results, integrating with qPCR instruments and LIS.
- recomScan 5 Basic software for evaluating recomLine strip tests with enhanced safety, efficiency, and user-friendliness, supporting LIS connection.
- Mic Magnetic Induction Cycler 4-channel magnetic induction cycler for qPCR and Real-Time PCR amplification, with included software for use with ampliCube test systems.
- RoboBlot Fully automated platform combining processing, scanning and evaluation of line immunoassays on a single instrument.
- Dynex DSX Open, fully automated analyzer for sample preparation, processing, photometer measurement, and evaluation of microplate ELISA and bead assays, processing four microtiter plates simultaneously with continuous reload and LIS integration.
- Stratec Gemini Fully automated modular microplate processor for low to medium throughput ELISA applications with integrated LIS connection and walk-away capability.
- Dynablot Plus Automated instrument for immunoblot and western blot assays, processing up to 44 strips with flexible device software and LIS connection capability.
- recomCLIA HEV Hepatitis E virus (HEV) IgG chemiluminescence immunoassay available exclusively on the KleeYa chemiluminescence platform for diagnostic laboratories.
- recomCLIA Borrelia Borrelia chemiluminescence immunoassay available exclusively on the KleeYa random access platform, combining test quality with automated random access workflow for diagnostic laboratories.
- OEM/Third-Party Test Kit Manufacturing Contract manufacturing service where MIKROGEN produces diagnostic test kits on behalf of third-party customers.
Quantifiable outcome
- FastFinder software achieves over 99% accuracy with 100% reproducible results
- +1 more outcomes
Companies that use MIKROGEN GmbH
Customer profileNamed customers2 records
Segments4 records
Ideal customer profiles2 records
MIKROGEN GmbH technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration12 records
AI capability2 records
Feature6 records
MIKROGEN GmbH partnerships and signals
Strategic signalPartnerships
16 partnerships are on record, tiered core and minor.
- BioVendor GroupcoreStrategic partner for CLIA tests compatible with KleeYa platform. BioVendor chemiluminescence immunoassays designed to work in perfect synergy with KleeYa analyzer
- Bio Molecular SystemscorePartner for Mic real-time PCR cycler integration with ampliCube test systems
- DynexcorePartner for DSX automated ELISA/BEAD processing systems compatible with MIKROGEN tests
- LuminexcoreLicensed technology partner for BEAD technology (Luminex multiplex) used in recomBead product line
- UgenTeccoreSoftware partner for FastFinder PCR analysis plugins distributed through Velsera platform
- VelseracoreDistribution partner for FastFinder assay plugin downloads and software access
- AidiancorePrimary European distribution partner covering Nordic countries (Denmark, Finland, Norway, Sweden), Belgium, Netherlands
- BiosynexcoreFrench distribution partner for MIKROGEN products
- Biomedica GroupcoreMajor European distribution partner with presence in Austria, Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Serbia, Slovakia, Slovenia
- Launch DiagnosticsminorUK and France distribution partner specializing in PCR products
- Mikrogen Hangzhou Medical Device Co. Ltd.coreOwned subsidiary and primary distribution partner for China market
- FunakoshiminorJapanese distribution partner for diagnostic products
- Iwai ChemicalsminorJapanese distribution partner for diagnostic products
- Phoenix AirMid Bio-Medical CorpminorCanadian distribution partner in Oakville, Ontario
- PMP Systems LLCminorUS distribution partner based in Texas
- Leinco Technologies Inc.minorUS distribution partner in Missouri
Scale indicators6 records
Recent moves6 records
Expansion highlights6 records
MIKROGEN GmbH competitors and assessment
Company assessmentBroad incumbents
- Roche Diagnostics: Global #1 IVD player with cobas and Elecsys immunoassay and PCR systems running large recombinant-antigen infectious serology menus. Sets the competitive ceiling in MIKROGEN's category.
- Qiagen: German-headquartered molecular biology and IVD player with sample-prep, PCR and syndromic infectious disease testing platforms. Comparable to MIKROGEN through overlapping PCR/qPCR infectious-disease workflow content.
- Bio-Rad Laboratories: Large US-headquartered IVD incumbent with broad infectious disease serology, molecular and quality control portfolios. Comparable to MIKROGEN through overlapping recombinant-antigen ELISA and LIA menus, though Bio-Rad operates at much greater scale.
- Hologic: Large US diagnostics and women's health company operating in molecular diagnostics, virology and infectious disease screening. Relevant as an incumbent in the broader IVD space overlapping with MIKROGEN's infectious disease focus, particularly molecular testing.
- Siemens Healthineers: Global IVD major with ADVIA Centaur, Atellica and CLIA immunoassay menus. MIKROGEN already names Siemens Healthineers as a strategic technology partner, making it both partner and competitor in clinical lab automation.
- Sekisui Diagnostics: Specialty IVD subsidiary of the Japanese Sekisui group with a portfolio spanning clinical chemistry, coagulation, infectious disease and rapid testing. Comparable as a mid-large specialty diagnostics competitor in the same infectious serology and autoimmune categories as MIKROGEN.
Emerging players
- Oxford Immunotec (PerkinElmer/Revvity): UK-based T-cell immunology diagnostics company with the T-SPOT.TB platform, now part of Revvity. Most direct peer for MIKROGEN's T-Track T-cell diagnostic franchise, both serving transplant monitoring and cell-mediated immunity markets.
Direct peers
- EUROIMMUN (Revvity): German-headquartered autoimmune and infectious serology specialist (now part of Revvity/PerkinElmer) with deep portfolio of recombinant-antigen-based ELISA, LIA and CLIA kits. Highly comparable to MIKROGEN's infectious serology and autoimmune franchises and competes head-to-head in European tenders.
- DiaSorin: Italian specialty IVD company of comparable size (~1,800 employees globally, ~€400M revenue) developing CLIA, ELISA and molecular diagnostic kits for infectious disease and specialty testing. Closest direct peer to MIKROGEN given overlapping focus on specialty infectious serology, recombinant antigen chemiluminescence platforms, and global distribution.
- DRG Instruments: German mid-sized specialty IVD company offering ELISA and CLIA kits across endocrinology, infectious disease and autoimmune testing. Comparable to MIKROGEN in scale, product portfolio structure (reagent kits + automation) and Mittelstand positioning.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat6 records
Key risks7 records
Key highlights7 records
Customer concentration
MIKROGEN GmbH social profiles
Digital presenceMIKROGEN GmbH compliance and trust
Trust signalCompliance8 records
MIKROGEN GmbH financial estimates
Financial estimateRevenue estimate
Valuation estimate
MIKROGEN GmbH leadership team
Management profileNumber of profiles
Profiles3 records
MIKROGEN GmbH subsidiaries and ownership
Company hierarchySubsidiaries1 record
MIKROGEN GmbH funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
MIKROGEN GmbH M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about MIKROGEN GmbH
What does MIKROGEN GmbH do?
MIKROGEN GmbH develops, manufactures, and markets system solutions for in vitro diagnostics, offering six core diagnostic product lines (ampliCube Real-Time PCR, recomClia CLIA, recomWell ELISA, recomLine Line Immunoassay, recomBead Luminex multiplex, and T-Track T-cell assays) built on proprietary recombinant antigens. The portfolio also includes laboratory automation instruments (KleeYa analyzer, Mic PCR cycler, RoboBlot, Dynex DSX, Stratec Gemini, Dynablot Plus) and supporting software such as FastFinder and recomScan 5 for medical and diagnostic laboratories.
Is MIKROGEN GmbH a public or private company?
MIKROGEN GmbH is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was MIKROGEN GmbH founded?
MIKROGEN GmbH was founded in 1989. It employs 101 to 250 people.
Where is MIKROGEN GmbH based?
MIKROGEN GmbH is headquartered in Neuried, Germany, in the Europe region.
How does MIKROGEN GmbH make money?
Four revenue lines are on record. IVD Test Systems and Reagents are the primary driver. The others are automation Equipment, OEM/Third-Party Manufacturing and global Distribution.
Who are MIKROGEN GmbH's main competitors?
Broad incumbents on record are Roche Diagnostics, Qiagen, Bio-Rad Laboratories, Hologic, Siemens Healthineers and Sekisui Diagnostics. Oxford Immunotec (PerkinElmer/Revvity) is listed as an emerging player. Direct peers are EUROIMMUN (Revvity), DiaSorin and DRG Instruments.
Does MIKROGEN GmbH have an API?
No public API is recorded for MIKROGEN GmbH.
What industry is MIKROGEN GmbH in?
MIKROGEN GmbH's product category is In Vitro Diagnostics. Its primary akta.pro industry code is HLAAALAC, Microbiology & Infectious Disease Diagnostics (culture, rapid antigen, syndromic panels), with a secondary code of HLAGAIAF, Molecular Biology & Genomics Instruments (PCR/qPCR, Sequencing, Microarrays). Its NAICS code is 325413 and its SIC code is 2835.