SERION Immunologics

What SERION Immunologics does

SERION Immunologics is a Würzburg, Germany-based division of Institut Virion\Serion GmbH that produces raw materials for the in vitro diagnostics (IVD) industry. The business was reorganized as a dedicated division in 2013 and serves IVD test kit manufacturers worldwide with a catalog spanning infectious disease antigens, autoimmune antigens, native plasma, polyclonal and monoclonal antibodies, magnetic beads, and customized reagent services. Its six product brands (SERION antigens, SERION autoimmune antigens, SERION plasma, SERION antibodies, SERION reagents and beads, and customized products) cover both catalog supply and bespoke OEM development, with 80+ individual antigens in routine production.

The company operates from 1,200+ m² of production space, including BSL3-certified laboratories, and holds ISO 13485 quality certification for medical device components. Technical capabilities include native and recombinant antigen production, monoclonal antibody development (notably through a partnership with Bcell Design in France), and proprietary IP including granted patent DE 10 2019 004 812 covering a Rubella Spike Ectodomain construct. The antigen production team alone exceeds 25 specialists, reflecting the labor-intensive nature of virology and protein production.

The business model is B2B supply of clinical-grade raw materials to diagnostic kit manufacturers, with revenue generated through catalog sales, custom development contracts, and OEM supply agreements. The company has reported 15%+ annual growth since the 2013 reorganization, indicating sustained expansion within a specialized niche. No external funding rounds have been disclosed, consistent with the unit operating as a division of the longer-established Institut Virion\Serion GmbH, whose origins date to 1979.

Name

SERION Immunologics

Legal name

Institut Virion\Serion GmbH

Website

https://serion-immunologics.com

Company type

Private

Founded year

2013

Operating status

Operating

Short description

SERION Immunologics is a Würzburg-based division of Institut Virion\Serion GmbH that supplies IVD manufacturers globally with antigens, antibodies, plasma, magnetic beads, and customized reagents from ISO 13485-certified and BSL3-equipped facilities.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics Raw Materials

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Biomarker Assay & Reagent Development (LDT/IVD assay design, antibodies/standards/controls) (HLAAAMAL)

akta.pro secondary industries

Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI), Antibody Discovery & Engineering Platforms (display tech, bispecifics, Fc engineering) (HLAAAIAB)

Keywords

• In vitro diagnostics raw materials
• Recombinant antigens
• Monoclonal antibodies
• IVD assay development
• Autoimmune disease diagnostics

Headquarters

HQ city

Würzburg

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. IVD Raw Material Product Sales: Sale of native and recombinant antigens, monoclonal antibodies, serum and plasma products, reagents (BSA), magnetic beads (MagSERION), and rheumatoid factor absorbent to IVD manufacturers for use in ELISA, CLIA, lateral flow and microarray diagnostics.
2. Custom Development and Manufacturing Services: Custom antigen development and production, ELISA plate coating, buffer production, and lyophilization services offered as part of SERION customized. Bcell Design partnership enables custom monoclonal antibody development.
3. Bulk Quantity Supply: Supply of bulk raw material quantities to industrial IVD manufacturers with guaranteed lot-to-lot consistency and traceability.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels6 records

Core offering

SERION Immunologics manufactures and supplies high-quality biological raw materials for in vitro diagnostic (IVD) assay development, including native and recombinant infectious disease antigens, recombinant autoimmune antigens, humanized monoclonal antibodies, human plasma and serum products, magnetic beads (MagSERION), BSA reagents, and rheumatoid factor absorbent. The company also provides custom development and manufacturing services such as antigen development, ELISA plate coating, buffer preparation, lyophilization, and monoclonal antibody development in partnership with Bcell Design. Production is carried out under EN ISO 13485-certified quality management with BSL3 biosafety certification.

Product overview

SERION Immunologics is a raw material supplier for in vitro diagnostics (IVD) manufacturers, offering a comprehensive portfolio of products organized into six main product lines: SERION antigens (native and recombinant infectious disease antigens for ELISA, LFD, and CLIA assays), SERION autoimmune (recombinant autoimmune antigens for autoimmune disease diagnostics launched in 2026), SERION plasma (human plasma and serum for calibrators and controls), SERION antibodies (humanized monoclonal antibodies as synthetic serum alternatives), SERION reagents and beads (BSA, magnetic beads, and rheumatoid factor absorbent), and SERION customized (custom development and manufacturing services including antigen development, ELISA plate coating, and lyophilization). The company operates EN ISO 13485-certified production facilities with BSL3 certification and has over 45 years of diagnostic expertise.

Differentiator

Problem solved

Functional benefit

Brands

• SERION antigens: Infectious disease antigens for ELISA, lateral flow diagnostics (LFD) and bead based assays (CLIA)
• SERION plasma
• SERION antibodies
• SERION reagents and beads
• SERION autoimmune
• SERION customized
• MagSERION beads
• Bovine Serum Albumin (BSA)
• Rheumatoid Factor Absorbent

Products and services

• SERION antigens

Quantifiable outcome

• Average annual growth rate of more than 15% per year since establishment in 2013
• +4 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature9 records

Partnerships

One partnership is on record.

• Bcell DesigncoreStrategic or Co-development PartnerBcell Design, located in Illkirch-Graffenstaden, France, is a cooperation partner for the development of custom monoclonal antibodies, especially for IgM. SERION Immunologics leverages Bcell Design's transgenic mouse platform technology where the mouse sequence of the heavy chain constant region (IgM locus) is replaced with the corresponding human sequence, enabling antibody clones that can be directly recognized by anti-human conjugates used in IVD assays.

Scale indicators5 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• LGC Group: Broad incumbent in life science tools and IVD reference materials, offering diagnostic reagents, antigens, and proficiency testing materials. Comparable to SERION in supplying OEM customers with biological raw materials for regulated diagnostic workflows.
• Bio-Rad Laboratories: Large incumbent offering a broad IVD reagents and life science research reagents portfolio, including infectious disease antigens and immunoassay components. Overlaps with SERION's OEM raw materials business as part of a much wider diagnostics and life science instrumentation portfolio.
• The Binding Site (Thermo Fisher Scientific): Acquired by Thermo Fisher, The Binding Site historically supplied specialty diagnostic antibodies and proteins for immunology diagnostics. Now part of Thermo Fisher's broader diagnostics portfolio, overlapping with SERION in autoimmune and infectious disease antibody supply.

Direct peers

• Meridian Bioscience (now Revvity): Direct peer in IVD raw materials — produces native and recombinant antigens, antibodies, and diagnostic reagents for infectious disease test development, serving the same OEM customer base with similar biological manufacturing capabilities.
• Surmodics: Direct peer in diagnostic raw materials — supplies antigens, antibodies, and assay components to IVD manufacturers, with comparable B2B go-to-market targeting IVD kit developers and clinical diagnostic companies.
• Creative Diagnostics: Specialty supplier of antigens, antibodies, and IVD reagents for infectious disease and autoimmune diagnostics. Direct competitor in the catalog antigen and antibody space, particularly for IVD assay developers sourcing recombinant and native antigens.
• Microbix Biosystems: Direct peer supplying antigens, antibodies, and quality control reagents to IVD manufacturers, including infectious disease antigens and controls. Comparable product portfolio and customer base in regulated diagnostic raw materials.
• Aalto Bio Reagents: Specialty IVD raw material supplier offering native and recombinant antigens for infectious disease diagnostics. Comparable in scale and product focus to SERION Immunologics, serving similar OEM diagnostic kit manufacturers.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 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 SERION Immunologics