Sphingotec GmbH

What Sphingotec GmbH does

SphingoTec GmbH is a privately held German biomarker company founded in 2002 and headquartered in Hennigsdorf near Berlin. The company develops proprietary blood-based biomarkers — primarily Proenkephalin A 119-159 (penKid) for real-time kidney function assessment and bioactive Adrenomedullin 1-52 (bio-ADM) for endothelial function assessment — targeting diagnostic blind spots in critical care settings such as acute kidney injury (AKI), sepsis, septic shock, and kidney transplantation. Its technological foundation is a patented high-sensitivity chemiluminescence detection platform capable of picomolar-range biomarker quantification, with a complementary ELISA platform now offered for research use.

SphingoTec operates a hybrid commercialization model. Clinical diagnostics are monetized via out-licensing its proprietary biomarkers to global IVD platform companies, notably Boditech Med (whose AFIAS sphingotest penKid assay launched with IVDR marking in May 2025, distributed across 120+ countries) and the Nexus IB10 platform. Direct revenue is generated through sales of research-use ELISA assays via its online store and through pharma collaborations in which penKid and bio-ADM are used as enrichment and efficacy-monitoring biomarkers in critical-care drug development programs. End users span hospitals and ICUs (clinical diagnostics), pharmaceutical and biotech companies (clinical-trial enrichment), and academic and industrial research laboratories (biomarker validation studies).

The company is led by CEO Deborah Bergmann (with founder Andreas Bergmann serving in a CSO capacity per supplementary input) and is backed by investors including Think.Health Ventures, HBM Healthcare Investments, Wellington Partners, NRW.BANK, and Brandenburg Kapital, having raised approximately €5 million in Series C financing in August 2024 to support global expansion with explicit US-market focus. Multiple peer-reviewed clinical validations — including an AUROC of 0.87 versus 0.56 for serum creatinine in delayed graft function prediction and 48-hour earlier AKI detection — support SphingoTec's clinical differentiation thesis in an addressable renal biomarkers market projected to reach USD 3.16 billion by 2033.

Name

Sphingotec GmbH

Legal name

SphingoTec GmbH

Website

https://sphingotec.com

Company type

Private

Founded year

2002

Operating status

Operating

Headcount range

11–50 employees

Short description

SphingoTec GmbH is a German diagnostics company that develops and out-licenses proprietary blood-based biomarkers — penKid for kidney function and bio-ADM for endothelial function — to global IVD platform partners and pharmaceutical companies for critical care applications including AKI, sepsis, and kidney transplantation.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics (IVD)

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro industry

PRIMARYHLAGADAG

Proteomics & Biomarker Analytical Testing

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Laboratory Testing & Analytical Services

SECONDARYHLAAAMAF

Prognostic & Risk Stratification Biomarkers (disease progression, recurrence risk)

Healthcare & Life Sciences/Biotechnology & Biologics/Biomarkers and Companion Diagnostics

SECONDARYHLAGAEAB

Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Central Labs & Clinical Diagnostics Services (Trial Support)

Keywords

• Critical care biomarkers
• Acute kidney injury diagnostics
• Kidney function immunoassays
• Sepsis biomarker testing
• Endothelial function diagnostics

Headquarters

HQ city

Hohen Neuendorf

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Biomarker out-licensing: SphingoTec develops proprietary biomarkers (penKid, bio-ADM) to commercial stage and licenses them to IVD companies for global commercialization on their diagnostic platforms. Licensing partners (e.g., Boditech Med) develop, manufacture, and distribute IVDR-marked assays, paying licensing/royalty fees to SphingoTec.
2. Pharma collaborations: Biomarkers provided to pharmaceutical companies for use in clinical trials — supporting enrichment strategies, patient stratification, and efficacy monitoring in critical care drug development programs.
3. Direct biomarker assay sales (research use): SphingoTec directly sells biomarker assays (e.g., ELISA sphingotest penKid) for research use to laboratories and pharmaceutical partners, enabling broad market adoption and generating direct revenue from product sales.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Sphingotec develops and out-licenses proprietary blood-based biomarkers — penKid (Proenkephalin A 119-159) for kidney function and bio-ADM (bioactive Adrenomedullin 1-52) for endothelial function — to support the diagnosis, prediction, and monitoring of acute medical conditions such as acute kidney injury, sepsis, and acute heart failure. The company sells research-use ELISA assays directly through its online shop and licenses biomarkers to IVD platform partners (Boditech Med AFIAS, Nexus IB10) that commercialize IVDR-marked clinical diagnostic assays globally.

Product overview

SphingoTec is a biomarker company offering a portfolio of proprietary critical care biomarkers for diagnosing, predicting, and monitoring acute medical conditions. The core products include penKid (Proenkephalin A 119-159) for kidney function assessment and bio-ADM (bioactive Adrenomedullin 1-52) for endothelial function assessment. These biomarkers are commercialized through multiple channels: the company offers research-use assays (ELISA sphingotest penKid) for laboratories, while clinical IVD products are made available through out-licensing partnerships on platforms like AFIAS (Boditech Med) and Nexus IB10 (Meridian Bioscience). The company also provides service measurements and biomarker out-licensing to pharmaceutical partners for drug development applications.

Differentiator

Problem solved

Functional benefit

Brands

• sphingotest: Proprietary biomarker assay brand including sphingotest penKid and sphingotest bio-ADM assays for research and clinical diagnostics.

Products and services

• sphingotest penKid (reference chemiluminescence assay) High-sensitivity reference assay for the proprietary penKid (Proenkephalin A 119-159) biomarker using patented chemiluminescence detection technology capable of picomolar-range measurement. Used by clinical researchers and as the reference method for licensed IVD assays.
• sphingotest bio-ADM Proprietary biomarker assay for the assessment of endothelial function via bioactive Adrenomedullin 1-52 (bio-ADM). Provides insight into endothelial dysfunction as a driver of critical illness such as sepsis. Used by clinical researchers and licensed to IVD partners for clinical diagnostic deployment.
• ELISA sphingotest penKid Research-use ELISA assay enabling widespread measurement of the penKid biomarker using standard laboratory photometers rather than dedicated chemiluminescence equipment. Developed with patented high-sensitivity technology and achieves excellent correlation with the reference chemiluminescence assay. Targeted at research laboratories and pharmaceutical partners requiring high-throughput testing.
• AFIAS sphingotest penKid (Boditech Med) IVDR-marked automated fluorescence immunoassay for quantitative determination of Proenkephalin A 119-159 (penKid) in human whole blood/plasma. Aids in the diagnosis of acute kidney injury (AKI) in adult patients with sepsis or septic shock. Commercialized via SphingoTec's licensing partner Boditech Med on its AFIAS platform, with instruments installed in over 120 countries.
• Nexus IB10 penKid Assay Clinical diagnostic assay for the penKid biomarker commercially available on the Nexus IB10 diagnostic platform for assessment of kidney function in critical diseases. Licensed to Nexus as part of SphingoTec's multi-platform out-licensing distribution strategy.

Quantifiable outcome

• penKid AUROC of 0.87 vs 0.56 for serum creatinine in predicting delayed graft function on Day 1 post-transplant
• +3 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

Feature4 records

Partnerships

Two partnerships are on record, tiered core and minor.

• Boditech Med Inc.coreOEM/ Whitelabel/ Licensing Partner · 6 May 2025Boditech Med holds a licensing agreement to develop and commercialize penKid-based assays on its diagnostic platforms. The partnership resulted in the commercial launch of the AFIAS sphingotest penKid IVDR-marked assay for kidney function diagnostics in May 2025. A market development agreement also aims to accelerate global commercialization. Boditech is based in Chuncheon, Republic of Korea, with instrument platforms installed in over 120 countries.
• Nexus (IB10 platform)minorOEM/ Whitelabel/ Licensing PartnerpenKid biomarker is commercially available on the Nexus IB10 diagnostic platform, expanding distribution to another IVD platform alongside Boditech's AFIAS system.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• BioPorto Diagnostics: Direct peer in AKI biomarker diagnostics — developer of NGAL (Neutrophil Gelatinase-Associated Lipocalin), one of the few established competitors to penKid in renal biomarker-based AKI diagnosis. Both companies target the same critical care diagnostic use case.
• Astute Medical (a BioMérieux company): Developer of NephroCheck, the leading FDA-cleared biomarker test for AKI risk assessment (TIMP-2 × IGFBP7). Closest direct competitor to SphingoTec's penKid in the renal biomarker space, now commercialized globally through BioMérieux's IVD infrastructure.
• Boditech Med Inc. South Korean IVD company and SphingoTec's primary licensing partner for the AFIAS sphingotest penKid assay. Closely comparable through the AFIAS automated immunoassay platform used to commercialize SphingoTec's penKid biomarker globally in 120+ countries.

Emerging players

• Adrenomed AG: German biotech developing Adrecizumab, an antibody therapeutic targeting adrenomedullin (the same biomarker family as SphingoTec's bio-ADM). Operates in the same endothelial dysfunction / sepsis therapeutic area, making it a thematic peer in bio-ADM's clinical landscape.
• Renalytix AI: Developer of KidneyIntelX, a kidney-focused diagnostic that uses biomarkers and AI to predict kidney disease progression. Comparable to SphingoTec in targeting renal diagnostics but with a focus on chronic kidney disease risk rather than acute critical care.

Broad incumbents

• Thermo Fisher Scientific: Major IVD incumbent explicitly identified alongside SphingoTec as a key player in the renal biomarkers market. Offers a broad portfolio of immunoassays and diagnostic platforms that could integrate or compete with SphingoTec's licensed biomarkers.
• Beckman Coulter Diagnostics: Major clinical diagnostics incumbent with extensive immunoassay platform installed base, also identified as a key renal biomarkers market player. Comparable to SphingoTec in addressing the same biomarker space but with a much broader product portfolio and global scale.
• Abbott Diagnostics: Global diagnostics leader with broad critical care biomarker menu and immunoassay platforms. Represents both a potential future licensing partner and a competitive threat given its installed base in hospital and ICU settings.
• Roche Diagnostics: One of the largest IVD companies globally with extensive immunoassay and critical care diagnostics portfolio. Could serve as a strategic licensing partner for SphingoTec's biomarkers or as a competitor with in-house alternative biomarkers.
• Siemens Healthineers: Major clinical diagnostics player with extensive critical care testing menu and global hospital footprint. Operates in overlapping biomarker/immunoassay space and could be a relevant licensing partner for SphingoTec's proprietary biomarkers.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/sphingotec
• LinkedInlinkedin.com/company/sphingotec

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds5 records

Investors6 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 Sphingotec GmbH