What Alderley Analytical does

Alderley Analytical Ltd. is an independent UK-based bioanalytical Contract Research Organisation founded in 2013/2014 by four scientists (Paul Holme, Claire Wildgoose, Sally Hannam, and a fourth co-founder) and headquartered at Alderley Park in Macclesfield, Cheshire. The firm provides GLP- and GCP-accredited bioanalytical services spanning pre-clinical discovery, pre-clinical regulatory safety, and clinical development, serving pharmaceutical, biotechnology, and other CRO clients globally, with a secondary vertical in agrochemicals via the Concept Life Sciences partnership. Its service portfolio is structured around two pillars — Pre-Clinical Bioanalysis (non-regulatory, GLP regulatory, toxicokinetics, formulation analysis) and Clinical Bioanalysis (GCP regulatory, immunogenicity/ADA, biomarker analysis) — supported by dedicated -80°C/-20°C/4°C/ambient sample storage. The core technology platform integrates mass spectrometry (multiple Waters and Sciex LC-MS/MS systems with UHPLC), ligand binding assays (Molecular Devices EIA/ELISA plate readers and Meso Scale Discovery ECLIA readers for singleplex/multiplex), surface plasmon resonance (SPR) for ADA binding characterisation, and ICP-MS for trace element bioanalysis, with sample data captured and managed in a validated Thermo Fisher WATSON LIMS and storage environments monitored 24/7 by a Contronics environmental monitoring system.

The business operates a fee-for-service, project-based model with bespoke quote pricing and direct consultative sales; clients include large/mid pharma, biotech firms (e.g., Medannex, Infex Therapeutics), peer CROs subcontracting specialised work, and agrochemical firms. Alderley Analytical achieved profitability in March 2017, scaled its mass spectrometry fleet to seven instruments by November 2019, relocated to a doubled 3,200 sq ft laboratory at Tytherington Business Park in June 2023, and was wholly acquired by Netherlands-based Synexa Life Sciences BV (backed by Gilde Healthcare) in October 2024 as part of Synexa's 'buy and build' growth strategy. Post-acquisition, the firm continues to operate under the Alderley Analytical brand with Paul Holme retained as CEO, while gaining access to Synexa's broader biomarker, DNA, RNA, protein, cell, and tissue analysis portfolio.

Name

Alderley Analytical

Legal name

Alderley Analytical Ltd.

Website

https://alderleyanalytical.com

Company type

Private

Founded year

2013

Operating status

Acquired

Headcount range

11–50 employees

Short description

Alderley Analytical is a UK-based, GLP/GCP-accredited bioanalytical CRO providing mass spectrometry, ligand binding, immunogenicity, and biomarker services to pharmaceutical, biotech, agrochemical and CRO clients from discovery through clinical development. Now a Synexa Life Sciences subsidiary.

Ownership category

akta.pro rank

Product category

Bioanalytical Contract Research Services

NAICS

Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Medical Laboratories (8071)

akta.pro primary industry

Bioanalytical & Biomarker CROs (PK/PD/Immunogenicity) (HLAGAAAD)

akta.pro secondary industry

Central Laboratory & Clinical Trial Testing CROs (HLAGAAAE)

Keywords

• Bioanalytical services
• Contract research organization
• Mass spectrometry analysis
• Pharmacokinetic assays
• Immunogenicity testing

Headquarters

HQ city

Macclesfield

HQ country

United Kingdom

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. CRO bioanalytical services (project-based): Fee-for-service contract research revenue from providing bespoke bioanalytical services to Pharmaceutical, Biotech and CRO clients across discovery, pre-clinical safety testing, and clinical development phases. Services include GLP and GCP regulatory bioanalysis, non-regulatory bioanalysis, biomarker analysis, immunogenicity (ADA), ligand binding assays, formulation analysis, and toxicokinetics. Revenue is generated on a project/quoted basis with retained-client continuity.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels7 records

Core offering

Alderley Analytical is an independent UK-based contract research organisation (CRO) providing specialist bioanalytical services to pharmaceutical, biotech and other CRO clients across discovery, pre-clinical safety testing and clinical development phases. Services include GLP and GCP regulatory bioanalysis, non-regulatory bioanalysis, biomarker analysis, immunogenicity (anti-drug antibody) assays, ligand binding assays, toxicokinetics, formulation analysis and secure sample storage, delivered from a GLP/GCP-accredited laboratory using LC-MS/MS, ligand binding and SPR instrumentation with a validated WATSON LIMS.

Product overview

Alderley Analytical delivers a unified, end-to-end bioanalytical services portfolio organised as a platform-plus-modules architecture spanning the full drug development lifecycle from discovery through clinical development. The portfolio rests on two core service pillars — Pre-Clinical Bioanalysis and Clinical Bioanalysis — supported by a dedicated Sample Storage service. Pre-Clinical Bioanalysis comprises the modules Non-Regulatory Bioanalysis, GLP Regulatory Bioanalysis, Toxicokinetics, and Formulation Analysis, while Clinical Bioanalysis comprises the modules Immunogenicity, GCP Regulatory Bioanalysis, and Biomarker Analysis. This structure enables clients to retain a single bioanalysis provider across all stages of their programme, eliminating laboratory transfers and loss of molecule-specific bioanalytical knowledge. The services are delivered from Alderley Analytical's laboratories using LC-MS/MS (Waters and Sciex) and ligand-binding assay (Molecular Devices plate readers and MSD readers) instrumentation, with bioanalytical data captured on a validated Thermo Fisher WATSON LIMS. Since October 2024, Alderley Analytical has operated as part of Synexa Life Sciences.

Differentiator

Problem solved

Functional benefit

Products and services

• Pre-Clinical Bioanalysis Full suite of bioanalytical services supporting pre-clinical drug development, covering discovery through regulatory pre-clinical safety studies, including expert handling of microsample volumes and method development/validation in compliance with regulatory guidelines.
• Non-Regulatory Bioanalysis Rapid-turnaround bioanalysis via UPLC-MS/MS and ELISA (MSD or colorimetric) for discovery PK, efficacy and DMTA-cycle decision support, offered at two levels — Level 1 rapid low-cost screen with generic methodology, and Level 2 tailored approach with method qualification for tighter data sets — with results possible in as little as 3 working days.
• GLP Regulatory Bioanalysis Fully GLP-compliant bioanalytical service for pre-clinical regulatory safety studies, with validated assays meeting MHRA and ICH guidelines, performed under the company's GLP-certified Quality Management System.
• Toxicokinetics Generation and interpretation of pharmacokinetic data as an integral component of pre-clinical toxicity studies, describing systemic exposure and its relationship to dose level and time course using validated software.
• Formulation Analysis Pre-clinical formulation analysis quantifying achieved concentrations, homogeneity and stability of dose formulations (solutions or suspensions) for GLP toxicology studies, including method development, validation and stability testing.
• Clinical Bioanalysis Comprehensive clinical bioanalysis providing fully GCP-compliant regulatory service to support bioanalysis of drug molecules through the clinical phase of testing, using highly sensitive instrumentation capable of detecting molecules at very low clinical dose levels.
• Immunogenicity Anti-drug antibody (ADA) screening, confirmation and titre analysis using a routinely tiered approach, including bridging immunoassays, inhibition confirmation, titration assays, and SPR (surface plasmon resonance) for characterising binding events and drug interference.
• GCP Regulatory Bioanalysis Fully compliant GCP bioanalytical service to quantify molecules in clinical study biological samples, including Incurred Sample Reanalysis (ISR) where required and LIMS-captured data, supporting PK determination in clinical studies.
• Biomarker Analysis Biomarker assay development and validation using single and multiplex platforms (MSD or ELISA), applying a 'fit-for-purpose' approach based on the biomarker's context of use, ranging from exploratory to fully quantitative pivotal assays.
• Sample Storage Dedicated sample storage facility offering -80°C, -20°C, 4°C and ambient temperature storage with 24/7 Contronics environmental monitoring and partner overflow capacity via Cryoniss, including stability assessment and stabiliser development during assay validation.

Quantifiable outcome

• Non-regulatory bioanalysis results delivered in as little as 3 working days after sample receipt
• +3 more outcomes

Named customers2 records

Segments4 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

Feature7 records

Partnerships

Seven partnerships are on record, tiered flagship / parent company, core and minor.

• Synexa Life Sciencesflagship / parent companyStrategic or Co-development Partner · 3 October 2024Netherlands-based Synexa Life Sciences BV acquired Alderley Analytical on 3 October 2024. The acquisition is a key step in Synexa's 'buy and build' growth strategy, with Alderley's LC-MS/MS, biomarker, and bioanalytical capabilities integrated into Synexa's biomarker and bioanalytical assays (DNA, RNA, protein, cell, tissue analysis). Synexa is backed by Gilde Healthcare. Paul Holme remains as CEO of Alderley Analytical within the group; Emile Lens is CEO of Synexa Life Sciences.
• Concept Life SciencescoreStrategic or Co-development PartnerPartnership agreement to provide high-value bioanalytical and DMPK study services. Concept gains access to Alderley Analytical's bioanalytical expertise; Alderley benefits from Concept's synthetic/organic/medicinal chemistry, biology, toxicology and analytical services. Combined offering serves biotech, pharma and agrochemical clients. Quote from Michael Fort (Executive Chairman, Concept Life Sciences) and Liz Thomas (CEO, Alderley Analytical).
• TherapeutAixminorStrategic or Co-development PartnerAlderley Analytical joined the TherapeutAix global R&D network, forming a dedicated team to solve Pharmacokinetics and Pharmacodynamics (PK/PD) challenges for clients. Partnership supports emerging projects with Alderley's bioanalytical expertise.
• Infex TherapeuticsminorStrategic or Co-development PartnerDeal for PK and ADA analysis support of Infex's RESP-X program — a humanised monoclonal antibody anti-virulence therapy targeting Pseudomonas aeruginosa infections, in-licensed from Japanese pharma Shionogi. Quotes from Dr Peter Jackson (CEO, Infex) and Liz Thomas (CEO, Alderley Analytical).
• University of Leicester, Ghent University and Waters CorporationminorStrategic or Co-development PartnerCollaboration exploring an alternative COVID-19 testing method. Alderley Analytical provided specialist bioanalytical services and produced data using LC-MS high-throughput targeted proteomics to detect SARS-CoV-2. The collaboration produced a Waters application note on LC-MS detection of MRM-based SARS-CoV-2 analysis.
• Medusa-19minorStrategic or Co-development PartnerAlderley Analytical supported the Medusa-19 team in developing their Rapid Saliva Protein Test for COVID-19 detection. No formal partnership terms described.
• MedannexcoreStrategic or Co-development PartnerMulti-year (4+ years) collaboration on challenging assay development projects. Alderley Analytical delivered high quality, robust PK assays and was described as 'an extension of our team' by Dr. Fiona Dempsey, Director of Scientific Operations at Medannex.

Scale indicators8 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Synexa Life Sciences: Netherlands-based biomarker and bioanalytical CRO and parent company of Alderley Analytical since October 2024. Directly comparable as a specialist bioanalytical/biomarker lab CRO serving pharma and biotech with similar assay-development capabilities.
• BioAgilytix Labs: Specialist bioanalytical CRO focused on large-molecule PK, immunogenicity (ADA) and biomarker assays using LC-MS/MS and ligand binding platforms. Closely comparable in services, modalities served and scientific positioning to Alderley Analytical.
• Concept Life Sciences: UK-based CRO partner of Alderley Analytical offering combined bioanalytical and DMPK services to pharma, biotech and agrochemical clients. Overlaps directly in bioanalytical assay development, PK analysis and DMPK study support.

Broad incumbents

• LGC Group (Bioanalytical Services): UK-headquartered life sciences measurement and testing group with a dedicated bioanalytical/CRO services division offering LC-MS/MS, immunoassay and biomarker support. Overlaps with Alderley on regulated bioanalysis but operates at materially larger scale.
• Eurofins Bioanalytical Services: Global CRO with extensive bioanalytical, PK and immunogenicity capabilities via Eurofins Discovery and BioPharma Product Testing. Comparable on regulated LC-MS/MS and ligand binding services but at much broader portfolio and geographic scale.
• Charles River Laboratories: Large global CRO with a dedicated bioanalytical services division offering LC-MS/MS, immunoassay, ADA and biomarker support across pre-clinical and clinical phases. Direct service overlap with Alderley, though at substantially greater scale.
• ICON plc: Global CRO with bioanalytical laboratories providing LC-MS/MS, ligand binding, immunogenicity and biomarker services for clinical trials. Comparable bioanalytical offering; senior Alderley BD leadership (Justin Wildgoose) previously worked at ICON, evidencing direct industry overlap.
• Q2 Solutions (IQVIA): IQVIA-owned central and bioanalytical lab services business providing global LC-MS/MS, immunoassay and biomarker support. Direct overlap on regulated bioanalysis; Justin Wildgoose, Alderley's Director of Business Development, joined from Q2 Solutions' bioanalysis/ADME division.
• Labcorp Drug Development (Covance): One of the largest global CROs with extensive bioanalytical capabilities across small and large molecules, biomarkers and immunogenicity. Sets the upper-bound competitive benchmark on scale and global footprint for specialist bioanalytical CROs like Alderley.
• Thermo Fisher Scientific PPD: Thermo Fisher-owned global CRO with bioanalytical laboratory services spanning LC-MS/MS, ligand binding and biomarker analysis. Comparable on the regulated bioanalysis side and represents both a partner (WATSON LIMS provider) and competitor for specialist CROs.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/alderley-analytical

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 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 Alderley Analytical