BioAgilytix Labs
BioAgilytix Labs is a global bioanalytical CRO providing PK, immunogenicity, biomarker, and CMC analytical services in GxP environments to pharmaceutical and biotechnology sponsors, with 1,100+ employees and operations across the US, Europe, and Australia.
- Company typePrivate
- Founded2008
- HeadquartersDurham, United States
- Headcount1,001–5,000
- GTM typeB2B
- OfferingServices
What BioAgilytix Labs does
BioAgilytix Labs is a global bioanalytical contract research organization (CRO) providing pharmacokinetic (PK), immunogenicity, biomarker, and CMC analytical services to pharmaceutical and biotechnology sponsors. Founded in 2008 and headquartered in Durham, North Carolina, the company operates 355,000+ square feet of GxP-compliant laboratory space across the United States (Durham, Morrisville, Boston, San Diego), Europe (Hamburg), and Australia (Brisbane, Melbourne), with partner labs in Beijing, China. Its scientific teams average 15+ years of bench experience and the Quality function averages 20+ years of regulatory experience, supporting 800+ assays developed and 5,000,000+ tests reported annually for clients that include 22 of the top 25 global pharma and biotech companies.
The company's core technology platform spans liquid chromatography-mass spectrometry (LC/MS), ligand binding and immunoassays (ELISA, MSD-ECL, Luminex, Gyrolab, Biacore), cell-based assays including flow cytometry across multiple instrument platforms, molecular assays (qPCR, ddPCR), and virology with PC2/PC3 and PC4 containment access. CMC analytical services include GMP-compliant cell-based potency assays for monoclonal antibodies, ADCs, AAV and lentiviral gene therapies, and LNP-based therapeutics. In February 2026, the company received an FDA Breakthrough Device Designation for its anti-AAV antibody assay supporting a gene therapy program for Friedreich ataxia cardiomyopathy. The portfolio has expanded through the acquisitions of IPM Biotech (2016), Cambridge Biomedical (2019), MicroConstants (2021), and 360biolabs (2021).
BioAgilytix operates as a privately held LLC incorporated in Delaware and generates revenue through professional services contracts on a project-by-project basis. Pricing is quote-based and varies by study scope, assay type, regulatory framework (GLP/GMP vs non-regulated), sample volume, and turnaround time, with typical engagements structured as multi-year contracts. Go-to-market is enterprise field sales through a scientist-to-scientist consultative model, with senior scientists acting as Bioanalytical Project Managers serving as single points of contact for sponsors. Marketing is driven by scientific thought leadership, peer-reviewed publications, and participation in industry conferences including WRIB, EBF, AAPS PharmSci 360, and CASSS WCBP.
BioAgilytix Labs firmographics
Firmographics- Name
- BioAgilytix Labs
- Legal name
- BioAgilytix Labs, LLC
- Website
- http://www.bioagilytix.com
- Company type
- Private
- Founded year
- 2008
- Operating status
- Operating
- Headcount range
- 1,001–5,000 employees
- Short description
- BioAgilytix Labs is a global bioanalytical CRO providing PK, immunogenicity, biomarker, and CMC analytical services in GxP environments to pharmaceutical and biotechnology sponsors, with 1,100+ employees and operations across the US, Europe, and Australia.
- Ownership category
- akta.pro rank
BioAgilytix Labs industry classification
Industry- Product category
- Bioanalytical Contract Research Services
- NAICS
- Scientific Research and Development Services (5417), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Bioanalytical & PK/PD Sample Analysis (Trial Support) (HLAGAEAG)
- akta.pro secondary industries
- Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB), Cell-Based & Potency Assays (Bioassays) (HLAGADAH), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Clinical Research & Trial Central Laboratories (HLAFAMAL)
Keywords
Where BioAgilytix Labs is headquartered
LocationHeadquarters
- HQ city
- Durham
- HQ country
- United States
- HQ region
- North America
Offices8 records
Markets served
BioAgilytix Labs business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Infrastructure, Technology or R&D, Operations, Marketing or Sales
Revenue model
- Contract Research Services: BioAgilytix provides bioanalytical testing services to pharmaceutical and biotechnology sponsors on a project-by-project basis. Services span discovery, preclinical, clinical, and CMC phases with fees structured around assay development, validation, and sample analysis. Revenue is project-based with contracts typically scoped for specific studies or programs.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Project-based CRO services with pricing determined by study scope |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels7 records
BioAgilytix Labs product offering
Product offeringCore offering
BioAgilytix Labs is a global bioanalytical contract research organization providing pharmacokinetic (PK), immunogenicity, biomarker, pharmacodynamic, DMPK, and CMC analytical services to pharmaceutical and biotechnology sponsors across discovery, preclinical, clinical, and CMC phases. Services are delivered under GLP/GMP/GCP quality systems using LC/MS, immunoassay, cell-based, molecular, and virology platforms across 355,000 sq ft of laboratories in the US, Germany, Australia, and China partner labs.
Product overview
BioAgilytix Labs is a global bioanalytical Contract Research Organization (CRO) providing comprehensive laboratory services across drug development phases from discovery through clinical and CMC (Chemistry, Manufacturing, and Controls) testing. The company's core offering is its Bioanalytical Laboratory Services platform encompassing pharmacokinetics (PK), immunogenicity, biomarkers, pharmacodynamics, and drug metabolism (DMPK) testing. This core platform is supported by CMC Analytical Services for quality control and product release testing. The portfolio includes specialized services such as cell-based potency assays, flow cytometry, ligand binding assays, mass spectrometry (LC/MS), molecular assays, virology services, and critical reagent management. The company operates as a unified service provider with acquired brands including 360biolabs (Australia-based virology and immunology expertise) and BioAgilytix San Diego (formerly MicroConstants, providing West Coast LC/MS capabilities). Services span therapeutic modalities including large molecules, small molecules, advanced therapies (ATMPs), vaccines, and support across therapeutic areas such as oncology, immunology, metabolic disease, and neurology.
Differentiator
Problem solved
Functional benefit
Products and services
- Bioanalytical Laboratory Services Comprehensive bioanalytical testing services including pharmacokinetics (PK), immunogenicity, biomarkers, pharmacodynamics, drug metabolism (DMPK), and diagnostic testing to support drug development across preclinical and clinical phases for pharmaceutical and biotechnology sponsors.
- CMC Analytical Services Chemistry, Manufacturing, and Controls (CMC) analytical development services including bioassay, biophysical, and QC release and stability testing for pharmaceutical product quality assurance across biologics, ADCs, gene therapies, and vaccines.
- Immunogenicity Testing Services Anti-drug antibody (ADA) and neutralizing antibody (NAb) assay services assessing the immunogenicity of biological drugs and their impact on pharmacokinetics and efficacy for biologics developers.
- Biomarker Testing Services Biomarker analysis services supporting clinical trial efficacy and safety, with over 500 biomarkers validated in singleplex and multiplex formats for pharma and biotech sponsors.
- Pharmacokinetics (PK) Assay Services PK assay development and sample analysis evaluating absorption, distribution, metabolism, and excretion characteristics of drug products for pharmaceutical and biotechnology sponsors.
- Virology Services Virological expertise including classical virology (culture and PRNT), molecular PCR, and support for vaccine and antiviral discovery and development, executed in physical containment 2, 3, and 4 laboratories for vaccine and antiviral developers.
- Mass Spectrometry (LC/MS) Services Liquid chromatography-mass spectrometry services for bioanalytical testing supporting both regulated and non-regulated bioanalysis across complex biological and chemical entities for pharmaceutical and biotechnology sponsors.
- Cell-Based Potency Assay Services Regulatory-recommended cell-based assays for product release and stability testing that evaluate efficacy, quality, and consistency of drug lots, supporting monoclonal antibodies, ADCs, gene therapies, and vaccines.
- Drug-Drug Interaction Studies In vitro evaluation services for CYP450 induction, CYP/UGT inhibition, reaction phenotyping, and transporter substrate/inhibition studies per FDA guidance for small molecule drug developers.
- Dose Formulation Analysis Services Preclinical dose formulation analysis for GLP and non-GLP studies including method validation, homogeneity, stability, and Certificate of Analysis generation for pharmaceutical and biotechnology sponsors.
- Toxicology Support Services GLP and non-GLP toxicology study support including PK/toxicokinetics, ADA/NAb, biomarkers, and multiplex cytokine panels for safety assessment in drug development programs.
- Anti-AAV Antibody Assay (FDA Breakthrough Device Designation) Proprietary anti-AAV antibody assay with FDA Breakthrough Device Designation enabling precise patient selection and monitoring for AAV-based gene therapy programs, including support for Lexeo Therapeutics' Friedreich ataxia cardiomyopathy program.
- 360biolabs (a BioAgilytix Company) Australian contract research organization brand providing expertise in virology, immunology, and bioanalytical services with facilities in Brisbane and Melbourne, now operating as a BioAgilytix Company.
- BioAgilytix San Diego (formerly MicroConstants) San Diego-based bioanalytical testing laboratory brand specializing in LC/MS, HPLC, and bioanalytical techniques for West Coast pharmaceutical support, now operating as BioAgilytix San Diego.
Quantifiable outcome
- 800+ assays developed annually
- +3 more outcomes
Companies that use BioAgilytix Labs
Customer profileNamed customers5 records
Segments3 records
Ideal customer profiles3 records
BioAgilytix Labs technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature7 records
BioAgilytix Labs partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- 360biolabscoreBioAgilytix completed acquisition of Australia's 360biolabs, a contract research organization with expertise in virology, immunology, and bioanalytical services. The acquisition expanded BioAgilytix's global presence and clinical trial support capabilities in Australia. Operates as BioAgilytix Brisbane and Melbourne locations.
Scale indicators6 records
Recent moves7 records
Expansion highlights5 records
BioAgilytix Labs competitors and assessment
Company assessmentBroad incumbents
- Labcorp Drug Development (formerly Covance): Labcorp operates one of the largest global central and bioanalytical lab networks as part of its clinical development services. Competes with BioAgilytix on bioanalytical scale, GxP compliance, and global clinical trial support for pharma/biotech sponsors.
- Charles River Laboratories: Charles River is a large, publicly traded CRO with a significant bioanalytical and safety assessment footprint serving global pharma and biotech. It competes with BioAgilytix for bioanalytical work as part of a broader CRO portfolio.
- IQVIA: IQVIA is a diversified clinical development and lab services provider with bioanalytical and central lab capabilities. Overlaps with BioAgilytix on biomarker, immunogenicity, and PK/PD testing as part of integrated clinical offerings.
- Eurofins Scientific: Eurofins operates a global network of pharma testing and bioanalytical laboratories serving drug development and clinical trials. Competes with BioAgilytix on LC/MS, immunoassay, and biomarker services as part of a broad testing portfolio.
- PPD (Thermo Fisher Scientific): PPD, now part of Thermo Fisher, is a global CRO with central lab and bioanalytical capabilities supporting clinical development. Competes with BioAgilytix for central lab and biomarker work bundled with clinical operations.
Direct peers
- Frontage Laboratories: Frontage is a contract research organization providing bioanalytical, CMC, and preclinical lab services to pharma and biotech. Directly comparable to BioAgilytix in its bioanalytical/LBA/LC-MS core, biologics CMC focus, and global expansion playbook (including acquisitions).
- Celerion: Celerion is a specialty CRO focused on early-stage clinical pharmacology, bioanalytical services, and PK/PD analysis. Closely aligned with BioAgilytix's early-phase, large-molecule bioanalytical work and sponsor base.
- Worldwide Clinical Trials: Worldwide Clinical Trials is a mid-sized CRO with bioanalytical and clinical pharmacology services for biotech and pharma. Comparable to BioAgilytix in mid-market CRO positioning, bioanalytical depth, and therapeutic-area focus.
Regional players
- WuXi AppTec / WuXi Biologics: WuXi AppTec and WuXi Biologics provide bioanalytical and biologics CMC services primarily from China-based facilities. Comparable capabilities and modality coverage to BioAgilytix, but primarily serves global sponsors via Asia-based operations.
Emerging players
- Altasciences: Altasciences is a mid-market CRO providing bioanalytical, clinical, and preclinical services with growing biologics capability. Comparable to BioAgilytix in early-phase bioanalytical focus and biotech sponsor orientation.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat6 records
Key risks6 records
Key highlights7 records
Customer concentration
BioAgilytix Labs social profiles
Digital presenceBioAgilytix Labs compliance and trust
Trust signalCompliance4 records
BioAgilytix Labs financial estimates
Financial estimateRevenue estimate
Valuation estimate
BioAgilytix Labs leadership team
Management profileNumber of profiles
Profiles6 records
BioAgilytix Labs subsidiaries and ownership
Company hierarchySubsidiaries5 records
BioAgilytix Labs funding detail
Funding detailFunding overview
Funding rounds2 records
Investors3 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
BioAgilytix Labs M&A and investment
M&A and investmentM&A4 records
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about BioAgilytix Labs
What does BioAgilytix Labs do?
BioAgilytix Labs is a global bioanalytical contract research organization providing pharmacokinetic (PK), immunogenicity, biomarker, pharmacodynamic, DMPK, and CMC analytical services to pharmaceutical and biotechnology sponsors across discovery, preclinical, clinical, and CMC phases. Services are delivered under GLP/GMP/GCP quality systems using LC/MS, immunoassay, cell-based, molecular, and virology platforms across 355,000 sq ft of laboratories in the US, Germany, Australia, and China partner labs.
Is BioAgilytix Labs a public or private company?
BioAgilytix Labs is a private company. It is classified as private equity controlled and is currently operating.
When was BioAgilytix Labs founded?
BioAgilytix Labs was founded in 2008. It employs 1,001 to 5,000 people.
Where is BioAgilytix Labs based?
BioAgilytix Labs is headquartered in Durham, United States, in the North America region.
How does BioAgilytix Labs make money?
One revenue line is on record: contract Research Services.
Who are BioAgilytix Labs's main competitors?
Broad incumbents on record are Labcorp Drug Development (formerly Covance), Charles River Laboratories, IQVIA, Eurofins Scientific and PPD (Thermo Fisher Scientific). Direct peers are Frontage Laboratories, Celerion and Worldwide Clinical Trials. WuXi AppTec / WuXi Biologics is listed as a regional player. Altasciences is listed as an emerging player.
Does BioAgilytix Labs have an API?
No public API is recorded for BioAgilytix Labs.
What industry is BioAgilytix Labs in?
BioAgilytix Labs's product category is Bioanalytical Contract Research Services. Its primary akta.pro industry code is HLAGAEAG, Bioanalytical & PK/PD Sample Analysis (Trial Support), with a secondary code of HLAGAEAB, Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry). Its NAICS code is 5417 and its SIC code is 8731.