BUHLMANN Laboratories

What BUHLMANN Laboratories does

BÜHLMANN Laboratories AG is a privately held Swiss in vitro diagnostics company founded in 1976 and headquartered in Schönenbuch, Switzerland. The company specializes in specialty diagnostic assays, with a core franchise in fecal calprotectin (fCAL) testing for inflammatory bowel disease (IBD) diagnosis and monitoring, where its ELISA assays are positioned as the market gold standard supported by more than 100 clinical publications. Its product portfolio spans ELISA kits, automated random-access turbidimetric assays (fCAL turbo, fPELA turbo), the Quantum Blue lateral-flow rapid test platform with proprietary 2nd and 3rd generation readers, and the IB*Doc* smartphone-based home calprotectin test, complemented by therapeutic drug monitoring assays for infliximab and adalimumab biologics.

Beyond gastroenterology, BÜHLMANN offers neuroimmunology assays (GanglioCombi ganglioside antibody panels, anti-MAG ELISA), cellular allergy diagnostics (Flow CAST, CAST ELISA), autoimmunity biomarkers (serum calprotectin/MRP8/14, CIC, anti-C1q), and distributes molecular diagnostics products from Seegene, Cerca Biotech, and EntroGen, including MammaTyper for breast cancer subtyping. Technology is anchored on sample preparation (CALEX Cap device with virucide/bactericide buffer), proprietary assay chemistries, and FDA 510(k) and CE IVDR regulatory clearances for major products.

The company generates revenue through a mix of one-time diagnostic kit sales, hardware sales of Quantum Blue readers, and recurring reagent/consumable streams tied to installed platforms. Go-to-market is multi-channel: direct sales via website inquiry, a regional subsidiary (BÜHLMANN Germany GmbH), and a global network of distributors, supported by participation in clinical conferences (DDW, EAACI, ADLM/AACC) and multilingual content marketing. Customers are predominantly clinical laboratories, hospital gastroenterology and immunology departments, and specialty clinics across Europe and North America.

Name

BUHLMANN Laboratories

Legal name

BÜHLMANN Laboratories AG

Website

https://buhlmannlabs.ch

Company type

Private

Founded year

1976

Operating status

Operating

Headcount range

51–100 employees

Short description

BÜHLMANN Laboratories AG is a Swiss specialty in vitro diagnostics company that develops and markets calprotectin, therapeutic drug monitoring, neuroimmunology, cellular allergy, and molecular diagnostic assays for clinical laboratories and hospitals worldwide.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511), Analytical Laboratory Instrument Manufacturing (334516)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071), Laboratory Analytical Instruments (3826)

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), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Clinical Chemistry & Immunoassay Laboratories (HLAFAMAB)

Keywords

• In vitro diagnostics
• Fecal calprotectin testing
• Therapeutic drug monitoring
• Cellular allergy diagnostics
• Neuroimmunology assays

Headquarters

HQ city

Schönenbuch

HQ country

Switzerland

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Test Kits: Sale of diagnostic test kits including calprotectin assays, TDM assays, allergy tests, and neuroimmunology assays. Products available in multiple formats (ELISA, rapid test, turbo) to serve different laboratory needs.
2. Instrument Systems: Quantum Blue Reader instruments (2nd and 3rd generation) compatible with rapid test assays. Readers enable quantitative measurement of test results.
3. Reagents and Consumables: Ongoing sales of extraction buffers, control materials, and other consumables required for diagnostic testing on BÜHLMANN platforms.

Go-to-market motion3 records

Distribution channels3 records

Marketing channels5 records

Core offering

BÜHLMANN Laboratories AG manufactures and sells in vitro diagnostic test kits, reagents, and instruments for clinical laboratories and healthcare providers. Its portfolio centers on fecal calprotectin assays (ELISA, turbidimetric, and lateral-flow rapid formats) used to diagnose and monitor inflammatory bowel disease, alongside therapeutic drug monitoring tests for anti-TNF biologics, neuroimmunology ganglioside antibody assays, and cellular allergy diagnostics. The company also distributes molecular diagnostic products from Seegene, Cerca Biotech, and EntroGen, and offers a smartphone-based home calprotectin testing system (IB*Doc*).

Product overview

BUHLMANN Laboratories is a Swiss in vitro diagnostic company offering a comprehensive portfolio of diagnostic products across gastroenterology, clinical chemistry, cellular allergy, neuroimmunology, and molecular diagnostics. The portfolio centers on calprotectin testing (fCAL assays in ELISA, turbo, and Quantum Blue formats) as a gold-standard marker for IBD diagnosis and monitoring. The company provides point-of-care solutions including the Quantum Blue rapid test platform with 3rd generation reader, and the IB*Doc home testing system. Therapeutic drug monitoring is offered through Quantum Blue TDM assays for biologics monitoring. Specialized areas include neuroimmunology (GanglioCombi ganglioside antibody assays), cellular allergy (Flow CAST basophil activation testing), and molecular diagnostics (MammaTyper breast cancer subtyping via Cerca Biotech partnership). Products range from manual ELISA kits to fully automated random-access clinical chemistry assays, with FDA 510(k) and CE/IVDR clearances. Distribution includes a QuidelOrtho partnership for VITROS Systems integration.

Differentiator

Problem solved

Functional benefit

Brands

• fCAL®: Fecal calprotectin ELISA assay - considered the gold standard for IBD diagnosis and monitoring
• IBDoc®
• CALEX®
• CAST®
• Quantum Blue®
• GanglioCombi®
• MammaTyper®

Products and services

• fCAL ELISA Gold-standard ELISA assay for fecal calprotectin testing with 2-hour turnaround time, used by clinical laboratories and gastroenterology departments for IBD diagnosis and monitoring.
• fCAL turbo Flexible immuno turbidimetric fecal calprotectin assay for automated, random-access testing on clinical chemistry analyzers. FDA 510(k) cleared and CE IVDR compliant.
• fPELA turbo Flexible immuno turbidimetric fecal elastase assay applicable on major clinical chemistry platforms for diagnosis of pancreatic insufficiency.
• Quantum Blue Reader (3rd Generation) Point-of-care rapid test reader for quantitative determination of calprotectin, TDM assays, and other biomarkers using lateral flow technology, delivering results in 15 minutes.
• Quantum Blue Reader (2nd Generation) Second-generation point-of-care rapid test reader compatible with Quantum Blue calprotectin and TDM assays.
• Quantum Blue TDM Rapid tests for therapeutic drug monitoring of anti-TNF biologics including Infliximab and Adalimumab, plus anti-drug antibody detection, with 15-minute time to result for hospital clinical labs.
• IB*Doc* Smartphone-based in-vitro diagnostic home testing device for fecal calprotectin monitoring, turning a smartphone into a test cassette reader using image processing technology with secure app-to-portal connection for healthcare provider monitoring.
• CALEX Cap Collection Set Safe, hygienic and efficient stool sampling kit with buffer-filled CALEX Cap tube containing virucide and bactericide components, used to pre-process samples for BÜHLMANN fecal assays. FDA 510(k) cleared.
• GanglioCombi MAG Standardized ganglioside antibody ELISA assay for the most sensitive and efficient screening and monitoring of peripheral neuropathies, including MAG and other ganglioside markers.
• GanglioCombi Light Routine-friendly package of commonly standardized ganglioside antibody ELISA assays in a simplified format for laboratory neuropathy workflows.
• Anti-MAG ELISA Gold standard ELISA for Anti-MAG antibody detection in peripheral neuropathy diagnostics.
• Flow CAST Complete cellular allergy diagnostics package using flow cytometry for basophil activation testing, complementary to specific IgE testing for complex reactions such as drug, venom, or food allergies.
• CAST ELISA Cellular allergy diagnostic test using ELISA methodology for basophil activation, complementary to IgE testing.
• CAST Allergens Allergen panels used with CAST cellular allergy diagnostic assays for basophil activation testing of drug, venom, and food allergens.
• Serum Calprotectin (MRP8/14) Serum calprotectin measurement (MRP8/14 complex) ELISA for inflammatory disease monitoring in autoimmunity applications.
• CIC (Circulating Immune Complexes) Assay for circulating immune complexes in autoimmunity diagnostics, used for detection of CIC in autoimmune disease processes such as vasculitis and lupus.
• Anti-C1q Antibodies Anti-C1q antibody assay for autoimmune disease diagnostics, particularly for lupus nephritis and related autoimmune conditions.
• MammaTyper Molecular in vitro diagnostic test for quantitative mRNA expression detection of ERBB2 (HER2), ESR1 (ER), PGR (PR), and MKI67 (Ki-67) breast cancer biomarkers using RT-qPCR, used for molecular subtyping of breast cancer.
• Amanitin ELISA ELISA assay for detection of alpha-Amanitin and gamma-Amanitin in urine, used to confirm Amanita mushroom intoxication.
• Seegene (Allplex/Anyplex II) Automated molecular diagnostic solutions using Seegene's multiplexing PCR technologies (DPO, TOCE, MuDT) for highly reliable simultaneous multi-pathogen detection, distributed by BÜHLMANN.

Quantifiable outcome

• Time to result: 15 minutes for TDM assays, enabling rapid treatment decision-making
• +1 more outcomes

Named customers3 records

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

Feature6 records

Partnerships

Two partnerships are on record, tiered core.

• QuidelOrthocoreOEM/ Whitelabel/ Licensing PartnerQuidelOrtho and BÜHLMANN announced availability of fCAL turbo and fPELA turbo assays on VITROS Systems as a MicroTip Partnership Assay (MPA), enabling rapid and non-invasive diagnosis of IBD and pancreatic insufficiency on QuidelOrtho's clinical chemistry platforms.
• SeegenecoreTechnology or IntegrationSeegene develops molecular diagnostics technology using proprietary detection technologies (DPO, TOCE, MuDT) for multiplex PCR. BÜHLMANN distributes Seegene's Allplex and Anyplex II product lines for automated molecular diagnostics.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Emerging players

• Prometheus Biosciences / Nestle Health Science: Nestle Health Science (including former Prometheus IBD diagnostics assets) operates in IBD companion diagnostics and therapeutic drug monitoring. Represents an emerging, well-capitalized competitor in the same gastroenterology/biologics-monitoring space.

Broad incumbents

• F. Hoffmann-La Roche (Diagnostics): Largest global IVD player with cobas clinical chemistry and Elecsys immunoassay platforms. Its calprotectin assays and broad gastroenterology menu represent the primary scale threat to BÜHLMANN in hospital and reference-lab channels.
• Werfen (Biokit / Instrumentation Laboratory): Specialty diagnostics group with autoimmune, hemostasis, and infectious-disease testing products. Comparable to BÜHLMANN's GanglioCombi neuroimmunology and autoimmunity franchises in serving specialty hospital laboratories.
• Thermo Fisher Scientific (Specialty Diagnostics): Diversified life-sciences and diagnostics company with ELISA kits, immunoassays, and clinical chemistry reagents. Competes with BÜHLMANN in calprotectin, autoimmunity, and specialty assay formats across global lab customers.
• DiaSorin: Italian specialty IVD company with strong immunoassay and clinical chemistry franchises. Overlaps with BÜHLMANN in clinical-chemistry-format calprotectin and in therapeutic drug monitoring for biologics.
• bioMérieux: Global IVD major with broad clinical chemistry, immunoassay, and microbiology menus. Competes at the lab-platform level with BÜHLMANN's clinical-chemistry-format calprotectin assays and is a structural threat to share in the high-throughput channel.
• QuidelOrtho: Large U.S. IVD company operating the VITROS clinical chemistry platform on which BÜHLMANN's fCAL/fPELA turbo are sold as MicroTip Partnership Assays. A critical commercial partner that is also a broader IVD incumbent in calprotectin-adjacent testing.

Direct peers

• Calpro AS: Norwegian specialty diagnostics company focused on calprotectin-based ELISA and rapid tests for IBD. The most direct head-to-head competitor to BÜHLMANN's flagship fCAL franchise in the calprotectin testing market.
• ALPCO Diagnostics: U.S.-based specialty immunoassay manufacturer offering calprotectin ELISA and other IBD/gastroenterology diagnostic kits. Competes with BÜHLMANN in the fecal calprotectin lab-testing segment, particularly in North America.
• EKF Diagnostics: UK-listed point-of-care diagnostics company with calprotectin and IBD-related testing products. Comparable in offering near-patient and lab-format calprotectin assays targeting similar gastroenterology and primary-care customers.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xlinkedin.com/company/b%C3%BChlmann-laboratories-ag
• LinkedInlinkedin.com/company/b%C3%BChlmann-laboratories-ag

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Subsidiaries1 record

Funding overview

Funding rounds1 record

Investors1 record

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 BUHLMANN Laboratories