Helena Biosciences Europe

What Helena Biosciences Europe does

Helena Biosciences Europe, legally Helena Laboratories (UK) Limited, is a Gateshead-headquartered in-vitro diagnostics (IVD) manufacturer founded in 1984 that designs, manufactures, and supplies clinical electrophoresis and haemostasis products to hospital and independent clinical laboratories worldwide. The company operates two product divisions. The Clinical Electrophoresis division offers the V8 UltraCE — a next-generation fully automated 8-channel capillary zone electrophoresis analyser launched in September 2025 with up to 80 serum protein tests per hour — alongside semi-automated and manual gel systems (SAS Vitrési, SAS-MX) and the Platinum laboratory data management software that links instruments to LIMS and major track automation systems (Inpeco Flexlab, Abbott Accelerator, Siemens Aptio). The Haemostasis Solutions division manufactures British-made coagulation reagents, controls, calibrators, factor deficient plasmas, chromogenic assays, and platelet function reagents, supported by the C-Series semi-automated coagulometers and the AggRAM light transmission aggregometer. Beyond its own products, Helena is the exclusive UK distributor for Swiss-made TPP tissue culture labware and resells molecular biology instruments from Eppendorf, Grant, Scie-Plas, Jenway, Stuart, and Techne.

The company monetizes through three commercial channels: direct sales of capital equipment and consumables to UK NHS and private clinical laboratories, e-commerce retail of TPP labware, and OEM/B2B supply of customized haemostasis reagents to global diagnostic companies, pharmaceutical firms, and government health organisations. Capital equipment (V8 UltraCE, C-Series, AggRAM) is sold via personalized quotes under multi-year contract structures, while TPP labware is unit-priced on the public online store with a rewards loyalty programme. Manufacturing is conducted at facilities in Gateshead and Sunderland in North East England under ISO 13485 quality management, with CE-marking, IVDR compliance, and FDA registration (V8 E-Class) supporting sales across Europe, EMEA, and selected global markets. The company operates as a private entity with no disclosed venture or private-equity backing, employs between 251 and 500 staff, and functions as a specialty mid-tier IVD player with deep domain expertise rather than a broad-line diagnostics competitor.

Name

Helena Biosciences Europe

Legal name

Helena Laboratories (UK) Limited

Website

https://helena-biosciences.com

Company type

Private

Founded year

1984

Operating status

Operating

Headcount range

251–500 employees

Short description

Helena Biosciences Europe (Helena Laboratories UK Limited) is a Gateshead-headquartered IVD manufacturer founded in 1984 that produces clinical electrophoresis instruments (V8 UltraCE, SAS systems) and British-made haemostasis reagents and coagulometers for hospital laboratories, plus distributes TPP tissue culture labware in the UK.

Ownership category

akta.pro rank

Product category

In-Vitro Diagnostics

NAICS

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

SIC

Laboratory Analytical Instruments (3826), In Vitro & In Vivo Diagnostic Substances (2835), Wholesale-Medical, Dental & Hospital Equipment & Supplies (5047)

akta.pro primary industry

Analytical Instruments & Chromatography Systems (HLAGAIAA)

akta.pro secondary industry

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

Keywords

• Clinical electrophoresis diagnostics
• Haemostasis diagnostics reagents
• Capillary electrophoresis instruments
• Coagulation testing analyzers
• In-vitro diagnostic reagents

Headquarters

HQ city

Gateshead

HQ country

United Kingdom

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Clinical Electrophoresis Products: Sales of automated capillary electrophoresis instruments (V8 UltraCE), gel electrophoresis systems (SAS Vitrési, SAS-MX), Platinum software, and associated assay reagents and consumables.
2. Haemostasis Reagents and Instruments: Sales of UK-manufactured coagulation reagents, controls, calibrators, D-Dimer assays, platelet function reagents, and coagulation analysers (C-Series, AggRAM). Includes routine, specialist, chromogenic, and factor deficient plasma assays.
3. TPP Laboratory Plastics: E-commerce sales of Swiss-made TPP tissue culture labware including flasks, tubes, plates, dishes, centrifuge tubes, cryo tubes, and bioreactors to UK NHS and private laboratories.
4. OEM and B2B Partnerships: Customised reagent development and supply agreements with global diagnostic companies, pharmaceutical firms, and government health organisations for Haemostasis products.

Pricing tiers

Go-to-market motion1 record

Distribution channels5 records

Marketing channels6 records

Core offering

Helena Biosciences Europe manufactures clinical electrophoresis and haemostasis diagnostic instruments (V8 UltraCE, SAS Vitrési, SAS-MX, C-Series coagulometers, AggRAM platelet aggregometer) supported by Platinum laboratory data management software and an extensive portfolio of British-made haemostasis reagents, controls, and calibrators. The company supplies NHS and private clinical laboratories directly and serves as the exclusive UK distributor of TPP tissue culture labware, with global reach through OEM partnerships and international distribution.

Product overview

Helena Biosciences Europe offers a comprehensive portfolio of clinical diagnostic products across two main divisions: Clinical Electrophoresis and Haemostasis Solutions. The Clinical Electrophoresis division provides the V8 UltraCE automated capillary electrophoresis system alongside SAS Vitrési semi-automated and SAS-MX manual gel electrophoresis systems, all supported by Platinum software for unified data management. The Haemostasis Solutions division encompasses the C-Series semi-automated coagulometers and AggRAM platelet aggregometer, supported by an extensive range of routine and specialist coagulation assays, factor deficient plasmas, chromogenic assays, platelet function tests, and calibrators/quality control materials. Additionally, the company distributes TPP tissue culture labware and molecular biology products from partner brands including Eppendorf, Grant, and others.

Differentiator

Problem solved

Functional benefit

Brands

• V8 UltraCE: Next-generation automated capillary electrophoresis system for clinical diagnostics.
• SAS Vitrési
• SAS MX
• C-Series
• AggRAM
• Platinum Software
• TPP

Products and services

• V8 UltraCE High-speed, fully automated 8-channel capillary zone electrophoresis analyser for clinical protein analysis, providing up to 80 serum protein tests per hour with 112 onboard sample capacity and integrated immunofixation workflow; designed for high-throughput clinical diagnostic laboratories.
• SAS Vitrési Compact, user-friendly semi-automated benchtop gel electrophoresis and staining system that combines electrophoresis and processing in a single unit for clinical laboratories.
• SAS-MX Manual benchtop gel electrophoresis chamber designed for small laboratories running routine serum protein, urine protein, immunofixation, and haemoglobin variant screening.
• Platinum Software Complete laboratory data management software supporting work list management, instrument monitoring, gel processing, interpretation, and reporting; features networked operation, LIMS connectivity, and middleware integration for clinical electrophoresis and haemostasis workflows.
• Helena C-Series Semi-Automated Coagulometers Family of 1, 2, and 4-channel semi-automated coagulation analysers with optical detection and touchscreen control designed for clinical haemostasis testing using only 75µL sample volume.
• AggRAM Platelet Aggregometer 4 or 8 channel light transmission aggregometer (650nm wavelength) for platelet aggregation and Ristocetin cofactor testing using light transmission aggregometry on plasma with micro-volume (minimum 250µL) testing capability.
• Manual D-Dimer CE-marked semi-quantitative latex agglutination assay for fibrin D-Dimer determination in human citrated plasma, providing results in under four minutes for VTE exclusion diagnostics in clinical settings.
• TPP Tissue Culture Labware Swiss-made CE-marked disposable laboratory plastics portfolio including tissue culture flasks, tubes, dishes, cell scrapers, bioreactors, centrifuge tubes, cryo tubes, serological pipettes, and vacuum filtration products, distributed exclusively to UK NHS and private laboratories.

Quantifiable outcome

• V8 UltraCE processes 80 serum protein tests per hour and 16 immunodisplacement tests per hour with 112 onboard sample capacity
• +3 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration6 records

Feature7 records

Partnerships

Eleven partnerships are on record, tiered core and minor.

• InpecocoreTechnology or IntegrationV8 UltraCE includes built-in support for Inpeco Flexlab track systems, enabling seamless sample handling and automated processing in communication with centralized laboratory management software.
• AbbottcoreTechnology or IntegrationV8 UltraCE offers built-in support for Abbott Accelerator track systems, providing automated sample tube acceptance and processing integration.
• Siemens HealthineerscoreTechnology or IntegrationV8 UltraCE includes built-in support for Siemens Aptio track systems, enabling automated laboratory workflow connectivity.
• OEM PartnerscoreOEM/ Whitelabel/ Licensing PartnerHelena acts as global developer of customised haemostasis reagents and OEM supplier to diagnostic companies, providing flexible kit configurations and dedicated application support for Sysmex, IL, Behnk and other systems.
• TPP (Techno Plastic Products)coreChannel Partner/ Reseller/ DistributorExclusive UK supplier of Swiss-made TPP tissue culture labware to NHS and private laboratories. TPP products include flasks, tubes, plates, dishes, centrifuge tubes, cryo tubes, and bioreactors.
• EppendorfminorChannel Partner/ Reseller/ DistributorHelena distributes Eppendorf instruments, consumables and services as part of their molecular biology product portfolio in the UK market.
• Grant InstrumentsminorChannel Partner/ Reseller/ DistributorUK distributor for world-leading laboratory equipment from Grant Instruments.
• Scie-PlasminorChannel Partner/ Reseller/ DistributorUK distributor for high-quality laboratory products from Scie-Plas.
• JenwayminorChannel Partner/ Reseller/ DistributorUK distributor for quality scientific instruments from Jenway.
• StuartminorChannel Partner/ Reseller/ DistributorUK distributor for laboratory equipment and laboratory mixers from Stuart.
• TechneminorChannel Partner/ Reseller/ DistributorUK distributor for temperature control and life science equipment from Techne.

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Siemens Healthineers: Siemens offers the Atellica and ADVIA Centaur platforms spanning chemistry, immunoassay, haematology and haemostasis, and is a key lab automation partner (Aptio) for Helena's V8 UltraCE. It is a broad incumbent that competes for the same hospital laboratory wallet share.
• Bio-Rad Laboratories: Bio-Rad offers the Variant II HPLC system for haemoglobin analysis and a range of electrophoresis and quality control products used in clinical labs. It competes with Helena's haemoglobin and protein electrophoresis assays and serves overlapping hospital and reference laboratory customers.
• Sysmex: Sysmex is a global leader in haematology and haemostasis, with broad automation platforms (XN-Series, CS-Series coagulometers) and a comprehensive reagent menu. It competes with Helena's C-Series and AggRAM in mid-to-large hospital labs and is also a supported platform for Helena's OEM reagents.
• Roche Diagnostics: Roche offers the cobas t-series coagulation analyser line and the broader cobas integrated lab automation platform. It competes for large hospital and reference lab contracts where Helena's narrower haemostasis and electrophoresis offering may be displaced by Roche's full-menu approach.
• Abbott Diagnostics: Abbott provides the Alinity ci-series and Architect family of immunoassay/chemistry systems, plus Accelerator automation. It is both a lab automation integration partner for Helena (Abbott Accelerator) and a broad IVD competitor bidding for consolidated lab contracts.

Direct peers

• Binding Site (Thermo Fisher Scientific): Binding Site, now part of Thermo Fisher, specialises in protein diagnostics for immune system disorders, offering assays and automation for serum protein electrophoresis and immunofixation. It directly competes with Helena's clinical electrophoresis franchise in specialty protein analysis.
• Sebia: Sebia is the global market leader in clinical electrophoresis, offering capillary and gel-based systems (CAPILLARYS, MINICAP, HYDRASYS) plus reagents for protein, haemoglobin and immunotyping analysis. It is the closest direct competitor to Helena's V8 UltraCE and SAS gel electrophoresis franchises, serving the same hospital and reference lab customers.
• Stago: Stago is a global specialist in haemostasis diagnostics, offering coagulation analysers (STA Compact, STA R Max) and an extensive reagent portfolio. It directly competes with Helena's C-Series coagulometers, AggRAM aggregometer and British-made haemostasis reagents in clinical and reference laboratories worldwide.
• Instrumentation Laboratory (Werfen): IL/Werfen manufactures haemostasis instruments (ACL TOP) and reagents, including factor deficient plasmas and D-Dimer assays. It is a named compatibility partner for Helena's reagents and a direct competitor in the coagulation diagnostics market.

Regional players

• Helena Biosciences (US): Helena Biosciences US is the related North American entity that distributes clinical electrophoresis and haemostasis products in the US market. It is comparable as a sister business under the broader Helena organisation and shares the same product DNA but operates in a different geography.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

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 Helena Biosciences Europe