Name

Kibion

Legal name

Kibion GmbH

Website

https://kibion.com

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

11–50 employees

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Equipment and Supplies Manufacturing (3391)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Microbiome Diagnostics & Biomarker Platforms (gut/skin/oral/vaginal) (HLAAAFAH)

Keywords

• Urea breath tests
• Helicobacter pylori diagnostics
• 13C isotope analyzers
• In vitro diagnostics
• Medical diagnostic devices

Headquarters

HQ city

Bremen

HQ country

Germany

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Instruments: Sale of diagnostic instruments including Kibion Dynamic analyzers and Heliprobe System analyzers. Instruments are sold to hospitals, laboratories, and doctor's offices through distributor network.
2. Consumables and Test Kits: Recurring revenue from sale of consumables including Diabact UBT tablets, BreathCards, BreathBags, and Mouthpieces used with diagnostic instruments.
3. Service and Support: Annual service contracts and support for Kibion Dynamic instruments including calibration, maintenance, and technical support.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

Kibion manufactures and supplies diagnostic instruments and consumables for non-invasive detection of Helicobacter pylori (H. pylori), the bacterium implicated in gastric ulcers and gastric cancer. Its portfolio includes the Kibion Dynamic 13C-urea breath test analyzer (ND-IR spectroscopy), the Heliprobe System (14C-urea with Geiger-Müller counter), and the Diabact UBT 50mg tablet consumable, sold to hospitals, laboratories, and physician offices in 60+ countries through a distributor network.

Product overview

Kibion is a diagnostic company and global leader in complete solutions for rapid, reliable urea breath tests to diagnose Helicobacter pylori (the stomach ulcer bacterium). The product portfolio consists of two main diagnostic platforms: (1) the Kibion Dynamic infrared isotope analyzer system (formerly IRIS Dynamic) which uses non-radioactive 13C-urea breath testing with ND-IR spectroscopy, and (2) the Heliprobe System which uses C14-urea capsules with Geiger-Müller counter technology. Both systems are used with the Diabact UBT 50mg tablet formulation. The Kibion Dynamic can be extended with the Dynamic Pro unit for higher throughput. All products are designed for use in laboratories, hospitals, and doctor offices.

Differentiator

Problem solved

Functional benefit

Brands

• Kibion Dynamic: A leading instrument for quantitative diagnosis of breath tests, employing non-radioactive 13C-labelled stable isotope based on infra-red technology. Previously known as IRIS Dynamic.
• Heliprobe System
• Diabact UBT

Products and services

• Kibion Dynamic Infrared isotope analyzer for quantitative diagnosis of breath tests. Measures 13CO2 and 12CO2 concentrations from breath samples using non-dispersive IR spectroscopy (ND-IR) technology. Designed for hospitals, laboratories, and doctor offices conducting non-invasive H. pylori testing.
• Heliprobe System Portable diagnostic system using C14-urea capsules (HeliCap) and a Geiger-Müller counter-based analyzer for rapid H. pylori detection. Provides easy, inexpensive analysis that can be operated by non-specialists, suitable for point-of-care clinical settings.
• Diabact UBT 50 mg tablet formulation for urea breath testing. Features 10-minute sampling time, 100% specificity and 98% sensitivity. No test meal required - just swallow tablet with water. Used as the consumable substrate with Kibion Dynamic and Heliprobe instruments.
• HeliCap C14-urea capsule consumable for the Heliprobe System. Contains extremely low levels of radioactivity (1 microCurie), no special shielding required for shipping.
• Heliprobe BreathCard Sample collection card used with the Heliprobe System to capture breath samples for H. pylori analysis.
• BreathBag Single or double breath sample bags for the Kibion Dynamic. Standard volume of 120 ml allows two measurements per sample.

Quantifiable outcome

• Diabact UBT achieves 98% sensitivity and 100% specificity for H. pylori detection
• +2 more outcomes

Named customers3 records

Segments1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

Feature4 records

Partnerships

Five partnerships are on record, tiered core and minor.

• Mayoly Spindler (Laboratory Mayoly Spindler)coreStrategic or Co-development PartnerMayoly Spindler acquired Kibion in October 2016 to become the leading manufacturer of Urea Breath Tests globally. The acquisition generates synergies in gastroenterology where Mayoly Spindler has strong product portfolio. Kibion operates as a company of Mayoly with access to their gastro field expertise and pipeline products.
• Gulf Drug EstablishmentcoreChannel Partner/ Reseller/ DistributorExclusive distributor for Kibion products in the Gulf Region. Presented Kibion Dynamic at Arab Health Exhibition and Congress. Handles sales and distribution throughout Middle East market.
• IdifarmacoreOEM/ Whitelabel/ Licensing PartnerContract manufacturing organization (CMO) in Spain that assumed production of Diabact UBT tablets in 2015 after transfer from Orexo's facilities in Sweden. Production successfully transferred with smooth transition.
• Wagner Analysen Technik GmbH (WAT)coreStrategic or Co-development PartnerGerman company acquired by Kibion in 2011, manufacturer of IRIS instruments for diagnostic breath tests. Acquisition turned Kibion into complete solutions provider of both diagnostic breath tests and instruments. WAT became Kibion GmbH in November 2014.
• Analytical Services International LtdminorOthersLaboratory located at St George's University of London designated as the analysis facility for UK patient samples from April 2013, replacing Glasgow Royal Infirmary. Provides on-line reporting services for test results.

Scale indicators7 records

Recent moves10 records

Expansion highlights5 records

Broad incumbents

• Hologic: Major diagnostics and women's health company with molecular and immunoassay capabilities applicable to GI pathogens. A broad incumbent operating in clinical diagnostics infrastructure comparable to Kibion's lab/hospital customer channels.
• DiaSorin: Italian IVD company focused on specialty diagnostics including gastro and infectious disease assays. A broader incumbent with comparable hospital/lab customer base and H. pylori-relevant diagnostic menu.
• Meridian Bioscience: US-based diagnostics company with H. pylori stool antigen tests and the BreathID UBT platform (via Exalenz). A broader IVD incumbent that overlaps with Kibion in H. pylori diagnostics across multiple modalities.
• QuidelOrtho: Specialty diagnostics company with infectious disease testing including H. pylori assays. A broad incumbent peer in IVD with overlapping customer base in hospitals and reference labs.
• Abbott Laboratories: Major diagnostics incumbent with H. pylori immunoassay and other GI diagnostic products sold to hospitals and labs globally. Broad incumbent in IVD serving similar customer base but not specialized in UBT.

Direct peers

• Otsuka Pharmaceutical: Makes and markets 13C-urea breath test devices (e.g., POCone, UBiT) for H. pylori diagnosis globally. A direct UBT instrument competitor with broader pharma scale and Asia-Pacific distribution strength overlapping Kibion's served markets.
• Biohit Oyj: Finnish diagnostics company with a UBT-based H. pylori diagnostic (PyloriTek) and broader GI diagnostic portfolio. A direct niche peer in UBT and gastro diagnostics targeting hospitals and labs similar to Kibion's customer base.
• Exalenz Bioscience (acquired by Meridian Bioscience): Exalenz developed the BreathID system, a direct competitor to Kibion Dynamic for 13C-urea breath testing for H. pylori. Acquired by Meridian Bioscience, the combined entity is the most directly comparable UBT-focused peer to Kibion.
• Mayoly Spindler Laboratories: Kibion's parent company and a French pharma with a strong gastroenterology product portfolio. Directly comparable as a GI-focused specialty pharma/diagnostics group and the most relevant strategic-owner peer.

Others

• Idifarma: Spanish contract development and manufacturing organization (CDMO) that has produced Diabact UBT tablets for Kibion since 2016. Closest enabling/supply-chain partner rather than a competitor, but materially relevant to the diagnostic consumables manufacturing ecosystem.

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

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 Kibion