MIKROGEN GmbH

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.

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

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

• In vitro diagnostics
• Infectious disease testing
• Clinical diagnostic reagents
• Automated immunoassay systems
• Molecular diagnostic kits

Headquarters

HQ city

Neuried

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. 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.
2. Automation Equipment: Sale and distribution of automation solutions including KleeYa analyzer, ampliCube, Mic, RoboBlot, DSX, Gemini, and Dynablot Plus for laboratory automation
3. OEM/Third-Party Manufacturing: MIKROGEN manufactures test kits on behalf of third parties, providing additional revenue stream
4. 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

Core 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

Named customers2 records

Segments4 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration12 records

AI capability2 records

Feature6 records

Partnerships

16 partnerships are on record, tiered core and minor.

• BioVendor GroupcoreTechnology or IntegrationStrategic partner for CLIA tests compatible with KleeYa platform. BioVendor chemiluminescence immunoassays designed to work in perfect synergy with KleeYa analyzer
• Bio Molecular SystemscoreTechnology or IntegrationPartner for Mic real-time PCR cycler integration with ampliCube test systems
• DynexcoreTechnology or IntegrationPartner for DSX automated ELISA/BEAD processing systems compatible with MIKROGEN tests
• LuminexcoreTechnology or IntegrationLicensed technology partner for BEAD technology (Luminex multiplex) used in recomBead product line
• UgenTeccoreTechnology or IntegrationSoftware partner for FastFinder PCR analysis plugins distributed through Velsera platform
• VelseracoreTechnology or IntegrationDistribution partner for FastFinder assay plugin downloads and software access
• AidiancoreChannel Partner/ Reseller/ DistributorPrimary European distribution partner covering Nordic countries (Denmark, Finland, Norway, Sweden), Belgium, Netherlands
• BiosynexcoreChannel Partner/ Reseller/ DistributorFrench distribution partner for MIKROGEN products
• Biomedica GroupcoreChannel Partner/ Reseller/ DistributorMajor European distribution partner with presence in Austria, Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Serbia, Slovakia, Slovenia
• Launch DiagnosticsminorChannel Partner/ Reseller/ DistributorUK and France distribution partner specializing in PCR products
• Mikrogen Hangzhou Medical Device Co. Ltd.coreChannel Partner/ Reseller/ DistributorOwned subsidiary and primary distribution partner for China market
• FunakoshiminorChannel Partner/ Reseller/ DistributorJapanese distribution partner for diagnostic products
• Iwai ChemicalsminorChannel Partner/ Reseller/ DistributorJapanese distribution partner for diagnostic products
• Phoenix AirMid Bio-Medical CorpminorChannel Partner/ Reseller/ DistributorCanadian distribution partner in Oakville, Ontario
• PMP Systems LLCminorChannel Partner/ Reseller/ DistributorUS distribution partner based in Texas
• Leinco Technologies Inc.minorChannel Partner/ Reseller/ DistributorUS distribution partner in Missouri

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Broad 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

• LinkedInlinkedin.com/company/mikrogen

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries1 record

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 MIKROGEN GmbH