What Agilex Biolabs does

Agilex Biolabs is an Australian contract research organization (CRO) that provides regulated bioanalytical laboratory services to global biotechnology and pharmaceutical companies conducting preclinical and clinical drug development. The company supports pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, biomarker, and GLP toxicology studies for small molecules, biologics, vaccines, cell and gene therapies, and controlled substances including cannabinoids and psychedelics. Founded in 1996 and operating from Thebarton (Adelaide), Brisbane, and Sydney, the company is part of the Healius healthcare network and serves sponsors across the US, Europe, China, and South Korea.

Agilex's technical platform combines 17 LC-MS/MS instruments with MesoScale Discovery and Gyrolab immunoassay systems, BD FACSymphony (20-color) and Cytek Aurora (40-color spectral) flow cytometers, MSD multiplex cytokine panels, ELISpot, and a national PBMC processing network operating under a single standardized SOP. The platform is differentiated by published novel methodologies (notably a CD45 magnetic-isolation-with-serum-co-incubation protocol in Immunohorizons), proprietary PBMC viability stability data underpinning the 24-hour processing window, and the only FDA-inspected bioanalytical lab of its type in the Asia-Pacific region, with three FDA inspections and OECD GLP / ISO 17025 / ISO 27001 accreditation.

Revenue is generated through professional-services contracts on a per-study or multi-year basis, with project fees, per-sample analysis fees, and ongoing retainers. The company reports supporting 80+ clinical trials and 130+ projects annually, analyzing 60,000+ samples per year, with an 85% repeat client rate. Go-to-market is enterprise field sales executed by business development managers in Australia, the US, China, and South Korea, supplemented by active participation at conferences (BIO Korea, BIO Asia Taiwan, Bio-Europe Spring, OCT West Coast, J.P. Morgan Healthcare Conference), educational webinars (including partnerships with Endpoints News), and a scientific content blog. Pricing is quote-based and project-specific, with clients also leveraging Australia's 43.5% R&D tax cash rebate to lower effective study cost.

Name

Agilex Biolabs

Legal name

Agilex Biolabs

Website

https://agilexbiolabs.com

Company type

Private

Founded year

1996

Operating status

Operating

Headcount range

101–250 employees

Ownership category

akta.pro rank

Product category

Bioanalytical Laboratory Services

NAICS

Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Testing Laboratories and Services (54138)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Medical Laboratories (8071)

akta.pro primary industry

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

akta.pro secondary industries

Toxicology & Safety Assessment CROs (GLP) (HLAGAAAC), Central Laboratory & Clinical Trial Testing CROs (HLAGAAAE), Clinical CROs (Phase I–IV) (HLAGAAAA)

Keywords

• Bioanalytical laboratory services
• Pharmacokinetics bioanalysis
• Pharmacodynamics testing
• Clinical trial bioanalysis
• Immunogenicity testing

Headquarters

HQ city

Thebarton

HQ country

Australia

HQ region

Oceania

Offices4 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Research Services (CRO): Agilex Biolabs operates as a contract research organization providing bioanalytical laboratory services to biotech and pharma companies conducting preclinical and clinical trials. Services are contracted on a per-study or project basis, typically covering pharmacokinetics, pharmacodynamics, immunogenicity, biomarker analysis, and toxicology. Revenue is generated through project fees, per-sample analysis fees, and service retainers for ongoing client engagements. The company supports over 80 clinical trials annually and analyzes more than 60,000 samples per year.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels6 records

Core offering

Agilex Biolabs is a contract research organization (CRO) providing regulated bioanalytical laboratory services for preclinical and clinical drug development. Its core offerings include Pharmacokinetics (PK) bioanalysis via LC-MS/MS and immunoassays, Pharmacodynamics (PD) testing including immunogenicity and flow cytometry, biomarker analysis, central lab services, GLP toxicology, PBMC processing, ELISpot, and immunogenicity testing — primarily serving biotech and pharma companies conducting clinical trials in Australia and globally.

Product overview

Agilex Biolabs is Australia's leading bioanalytical Contract Research Organization (CRO) offering a comprehensive suite of laboratory services for preclinical and clinical trials. The company provides an integrated portfolio of services centered around Pharmacokinetics (PK), Pharmacodynamics (PD), Biomarkers, Central Lab Services, Toxicology, and Off the Shelf Assays. Their core offerings include LC-MS/MS bioanalysis, immunoassays, flow cytometry, PBMC processing, and ELISpot analysis, all supported by GLP-compliant toxicology services. The company operates almost 30 years of experience with facilities in Adelaide (headquarters), Brisbane, and Sydney, Australia, serving global biotechnology and pharmaceutical companies conducting clinical research.

Differentiator

Problem solved

Functional benefit

Products and services

• Pharmacokinetics (PK) Services Study of what the body does to a drug during a clinical study, covering absorption, bioavailability, distribution, metabolism, and excretion. Includes LC-MS/MS bioanalysis, immunoassays (ligand binding assays), and cellular and molecular analysis (Flow/PCR) for biotech and pharma sponsors.
• Pharmacodynamics (PD) Services Study of the biochemical, physiological and molecular effects of a therapeutic on the body. Includes immunogenicity ADA/Neutralising Ab assays, vaccine support, cell-based immunology assays, and flow cytometry for nonclinical and clinical programs.
• Biomarkers Biomarker analysis services providing essential efficacy, safety, and pathology data around drugs and indications being investigated in preclinical and clinical studies.
• Central Lab Services Sample lifecycle management from end to end, including kit production for multi-site programs, sample logistics, and distribution to sites of choice for clinical trial sponsors.
• Off the Shelf Assays Pre-designed and pre-validated assays, often available in kit form, ready for use without extensive development or optimization, providing time and cost savings for bioanalytical packages.
• Toxicology Services GLP-compliant toxicology services including exploratory toxicology, pharmacokinetic studies, and GLP toxicology studies to support entry to first-in-human clinical trials. Includes rodent studies (Australia) and non-rodent studies via Attentive Sciences collaboration (US), all under a single Agilex contract.
• PBMC Processing Services Isolation and cryopreservation of peripheral blood mononuclear cells (PBMCs) using density gradient centrifugation. Delivered via a network of laboratories across Australia operating under a single standardized operating procedure for multicenter clinical trials.
• Flow Cytometry Services Multiparameter flow cytometry analysis using BD FACSymphony (20 colour, 22 parameters) and three Cytek Aurora spectral flow cytometers (up to 40 colours) for detailed cell phenotyping and immune cell subset assessment in clinical trials.
• ELISpot Analysis Enzyme-Linked ImmunoSpot (ELISpot) assay for detecting cytokine-secreting cells at single-cell level, used for antigen-specific T-cell or B-cell responses in vaccine development, immuno-oncology, and autoimmune disease research.
• Immunogenicity Testing Assessment of anti-drug antibodies (ADA) and immunogenicity for biotherapeutics, including assay development, validation, and screening to ensure safety and efficacy compliance for clinical trial sponsors.
• In-House PK Data Analysis Service In-house pharmacokinetic data analysis service integrating bioanalysis and PK modeling to reduce turnaround times in single-ascending-dose (SAD) and multiple-ascending-dose (MAD) clinical studies.

Quantifiable outcome

• Phase 1 clinical trial initiation in 6-8 weeks in Australia with robust nonclinical program
• +4 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature9 records

Partnerships

Five partnerships are on record, tiered core and minor.

• Immunovirology Research Network (IVRN) / Australian Centre for HIV and Hepatitis Virology (ACH4)coreStrategic or Co-development Partner · 22 January 2025Agilex Biolabs participated in the Quality Assurance Program (QAP) coordinated by the Immunovirology Research Network (IVRN) of the Australian Centre for HIV and Hepatitis Virology (ACH4) and attained certification for the isolation and cryopreservation of PBMCs. This certification validates Agilex's PBMC processing quality and consistency for clinical trial immunology studies.
• QIMR Berghofer Medical Research InstitutecoreStrategic or Co-development Partner · 4 November 2024Agilex Biolabs expanded its flow cytometry capabilities by establishing a new Flow Cytometry Laboratory at the QIMR Berghofer Medical Research Institute Campus in Brisbane. This partnership enables Agilex to provide rapid real-time flow cytometry services and PBMC processing in Queensland, supporting immunology bioanalysis for multicenter clinical trials.
• Endpoints NewsminorGTM or Marketing Partner · 31 August 2021Agilex partnered with Endpoints News to co-host a webinar on 'Non-clinical and clinical pathways for rapid vaccine development in Australia', hosted by Endpoints News Editor Arsalan Arif. The partnership leverages Endpoints News' media reach to promote Agilex's capabilities and the Australian clinical trial advantage to a global biotech/pharma audience.
• CMAX Clinical ResearchcoreStrategic or Co-development Partner · 1 January 2020Agilex established its first satellite processing unit on the fifth floor of the CMAX Clinical Research facility in Adelaide, SA. This enables rapid PBMC processing from Phase 1 clinical trial participants with specialized technicians stationed on-site, supporting time-critical sample processing for psychedelic compounds and other sensitive therapeutics under Agilex's Schedule 9 drug license.
• Attentive SciencescoreStrategic or Co-development Partner · 1 January 2019Agilex collaborates with Attentive Sciences in the US for non-rodent toxicology studies (dogs, safety pharmacology) and specialized animal models (mice, rats, guinea pigs, ferrets, hamsters, mini pigs, canines) that are not available in Australia. Under this collaboration, clients can run rodent studies in Australia and non-rodent studies in the US under a single contract through Agilex, with a single point of contact for program management. Offshore study expenses may be eligible for the Australian R&D cash rebate.

Scale indicators12 records

Recent moves3 records

Expansion highlights6 records

Direct peers

• Celerion: Celerion is a clinical pharmacology and bioanalytical services CRO specializing in early-phase clinical research and bioanalysis (PK/PD/immunogenicity), directly comparable to Agilex's core offering for small and large molecules.
• Eurofins Bioanalytical Services: Eurofins Bioanalytical Services provides regulated LC-MS/MS and ligand-binding bioanalysis for preclinical and clinical studies, overlapping directly with Agilex's PK, biomarker, and immunogenicity service lines.
• Pharmaron: Pharmaron offers integrated drug discovery, development, and bioanalytical services including LC-MS/MS bioanalysis, in vivo PK, and immunology assays, serving as a direct competitor in bioanalytical CRO with both Western and APAC presence.

Broad incumbents

• Charles River Laboratories: Charles River is a global preclinical and bioanalytical CRO providing safety assessment, bioanalysis, and research models. Its discovery/safety division overlaps with Agilex's GLP toxicology and bioanalytical services, though it operates at much greater scale.
• WuXi AppTec: WuXi AppTec is a leading APAC-headquartered CRO/CDMO with bioanalytical, toxicology, and clinical research services, competing head-to-head with Agilex for global biotech clients seeking APAC bioanalytical capacity.
• IQVIA: IQVIA is the world's largest CRO with end-to-end clinical, bioanalytical, and real-world evidence services. While not specialized like Agilex, it competes for full-service sponsor programs that include bioanalytical work.
• ICON plc: ICON is a top-tier global CRO providing clinical development and bioanalytical services across all phases, comparable as a broad incumbent that bundles bioanalysis into integrated trial offerings.
• Fortrea (formerly LabCorp Drug Development): Fortrea is a global clinical CRO spun out of LabCorp with bioanalytical and central lab capabilities, directly overlapping with Agilex's clinical bioanalysis and central lab services for biotech and pharma sponsors.
• Intertek Pharmaceutical Services: Intertek provides pharmaceutical and bioanalytical testing services including LC-MS/MS and ligand-binding assays for regulated studies, comparable to Agilex's quality-control bioanalytical workflows.
• SGS Health Sciences: SGS Health Sciences provides clinical research, bioanalytical, and central laboratory services to pharma and biotech, overlapping with Agilex's bioanalytical and central lab offerings from a global, multi-geography footprint.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/agilex-biolabs

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Agilex Biolabs