Hyglos

What Hyglos does

Hyglos GmbH is a German biotech company founded in 2000 and headquartered in Bernried, Germany, that develops bacteriophage-derived recombinant proteins for the detection and removal of harmful bacteria. Its core technology is recombinant Factor C (rFC), a recombinant protein expressed in cell culture that reproduces the initial step of the enzymatic cascade found in horseshoe crab amebocytes, providing an animal-free alternative to Limulus Amebocyte Lysate (LAL) for bacterial endotoxin testing. The technology has been developed and validated over more than 20 years of published peer-reviewed data and is referenced in European Pharmacopoeia chapter 2.6.32 (since 2020) and USP chapter <86>.

Hyglos's endotoxin detection technology is commercialized through bioMérieux's ENDONEXT platform, comprising four assay products — ENDOZYME II GO (pre-filled plate format reducing hands-on time by over 50%), ENDOZYME II GO STRIPS (flexible 1-21 sample strip format), ENDOZYME II (standard second-generation assay), and ENDOLISA (ELISA-format with endotoxin-binding phage protein for complex matrices with organic solvents). The platform is augmented by ENDONEXT Software (21 CFR Part 11 compliant data management with LDAP, audit trails, and electronic signatures), ENDONEXT Automated with Tecan (full integration on the Tecan Fluent platform), and ENDOXPERTS services for routine testing, feasibility studies, and Low Endotoxin Recovery (LER) mitigation.

Hyglos generates revenue through sales of rFC-based endotoxin detection assays and reagents to pharmaceutical manufacturers and quality control laboratories, plus specialized services for method validation and LER investigation. Pricing is quote-based and not publicly disclosed. Go-to-market is enterprise field sales with installation, operational, and performance qualification (IQ/OQ/PQ) support, complemented by an online eShop and global distribution via bioMérieux's commercial channel. The primary customer segments are pharmaceutical manufacturers (in-process control, raw material and product release testing) and biopharmaceutical companies working on cell and gene therapies with complex sample matrices.

Name

Hyglos

Website

https://hyglos.de

Company type

Private

Founded year

2000

Operating status

Operating

Headcount range

11–50 employees

Short description

Hyglos is a German biotech founded in 2000 that develops bacteriophage-derived recombinant proteins, notably recombinant Factor C, for bacterial endotoxin detection. Its rFC technology is commercialized through bioMérieux's ENDONEXT platform targeting pharmaceutical and biopharmaceutical quality control laboratories.

Ownership category

akta.pro rank

Product category

Pharmaceutical Quality Control — Endotoxin Detection Assays

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI)

akta.pro secondary industries

Biomarker Assay & Reagent Development (LDT/IVD assay design, antibodies/standards/controls) (HLAAAMAL), IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM)

Keywords

• Endotoxin detection
• Recombinant proteins
• Pharmaceutical quality control
• Bacteriophage technology
• Biotech assay kits

Headquarters

HQ city

Bernried

HQ country

Germany

HQ region

Europe

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. ENDONEXT Endotoxin Detection Products: Sale of recombinant Factor C-based endotoxin detection assays including ENDOZYME II GO, ENDOZYME II GO STRIPS, ENDOLISA, and related reagents. Revenue generated from product sales to pharmaceutical quality control laboratories.
2. ENDOXPERTS Services: Specialized services including routine testing, feasibility studies, and analytical issue resolution for low endotoxin recovery (LER). Provides validation services and expert guidance for pharmaceutical laboratories.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

Hyglos develops and sells bacteriophage-derived recombinant proteins and assay kits for the detection and removal of harmful bacteria, with its primary commercial application being endotoxin detection assays for pharmaceutical quality control based on recombinant Factor C (rFC) technology. The portfolio includes pre-filled plate assays (ENDOZYME II GO), flexible strip assays (ENDOZYME II GO STRIPS), standard assays (ENDOZYME II), ELISA-format assays (ENDOLISA), 21 CFR Part 11-compliant software, automated Tecan Fluent integration, and the ENDOXPERTS testing and consulting service line.

Product overview

ENDONEXT™ is bioMérieux's flagship endotoxin detection platform for pharmaceutical quality control, based on recombinant Factor C (rFC) technology that replaces traditional horseshoe crab-derived LAL methods. The portfolio includes four assay products — ENDOZYME® II GO (pre-filled plate format), ENDOZYME® II GO STRIPS (flexible strip-based testing), ENDOZYME® II (standard second-generation assay), and ENDOLISA® (ELISA-format assay with built-in sample preparation for complex matrices) — all delivering 100% endotoxin specificity and lot-to-lot consistency. The platform is augmented by ENDONEXT™ Software for 21 CFR Part 11-compliant data management, automation integration with Tecan Fluent, and ENDOXPERTS™ services for routine testing, feasibility studies, and LER analytical support.

Differentiator

Problem solved

Functional benefit

Products and services

• ENDONEXT™ Umbrella platform brand for endotoxin detection assays based on recombinant Factor C (rFC) technology, encompassing multiple assay products, software, and automation integration to provide reliable, sustainable, and compliant pharmaceutical quality control.

Quantifiable outcome

• Over 50% reduction in handling time compared to conventional microplate assays
• +1 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature5 records

Partnerships

One partnership is on record.

• TecancoreTechnology or IntegrationENDONEXT rFC-based endotoxin testing solutions are fully automated on the Tecan Fluent platform to optimize manufacturing processes for pharmaceutical customers. This integration provides streamlined workflows for biopharmaceutical manufacturing quality control.

Scale indicators2 records

Recent moves5 records

Expansion highlights5 records

Broad incumbents

• bioMérieux: bioMérieux is both the parent/acquirer of Hyglos and a broad IVD/microbiology incumbent; the ENDONEXT line integrates Hyglos's rFC technology into bioMérieux's wider industrial and clinical diagnostics portfolio, making it the most integrated adjacent player.
• Thermo Fisher Scientific: Thermo Fisher offers a comprehensive suite of life-science reagents and immunoassay/ELISA platforms used in pharma QC and research, broadly comparable to Hyglos's assay products across a much wider catalog.
• bio-Techne: bio-Techne provides recombinant proteins, antibodies, and ELISA-based assay kits for research and regulated markets, overlapping with Hyglos's recombinant protein and ELISA-format assay capabilities.
• Merck KGaA (MilliporeSigma Life Science): MilliporeSigma supplies broad life-science reagents, consumables, and endotoxin testing products to pharma QC labs, overlapping with Hyglos at the bench-reagent and kit level across a much larger portfolio.

Emerging players

• Eurofins Scientific: Eurofins operates a global network of pharma and microbiological testing services including endotoxin and BET-support work, competing more on the ENDOXPERTS services side adjacent to Hyglos's reagent business.

Direct peers

• Lonza Group: Lonza is the leading manufacturer of LAL-based endotoxin testing reagents and the dominant incumbent in pharmaceutical QC endotoxin detection, directly competing with Hyglos's rFC products for the same pharma QC customer workflows.
• FUJIFILM Wako Chemicals: FUJIFILM Wako produces LAL reagents and endotoxin detection assays widely used in pharmaceutical and clinical QC, making it a direct alternative to Hyglos's recombinant Factor C portfolio.
• Associates of Cape Cod: Associates of Cape Cod is a specialist LAL reagent manufacturer for endotoxin detection used in pharmaceutical and clinical labs, a focused direct competitor in endotoxin testing reagents.
• Charles River Laboratories: Charles River's Endosafe division is a major endotoxin testing franchise offering both LAL reagents and contract endotoxin testing services, directly overlapping with Hyglos's product and adjacent service offering.

Others

• Tecan: Tecan is the automation partner (Tecan Fluent) on which ENDONEXT rFC assays are integrated; while not a direct reagent competitor, it is a key ecosystem enabler shaping go-to-market for Hyglos's products in automated pharma QC labs.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/HyglosGmbH
• Facebookfacebook.com/174420869253474
• LinkedInlinkedin.com/company/hyglos-gmbh

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds1 record

Investors4 records

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 Hyglos