10 Bioanalytical Lab Providers Operating in the United States in 2026

Bioanalytical laboratories quantify drugs, metabolites, and biomarkers in biological samples — plasma, serum, tissue — producing the pharmacokinetic and immunogenicity data that trial Sponsors need at every stage of drug development. This kind of CRO bioanalytical laboratory work, whether run on LC-MS/MS or ligand-binding platforms, underpins IND submissions, dose-selection decisions, and the bioequivalence and biosimilar studies regulators require before a product reaches patients. Sponsors sourcing this bioanalytical testing service domestically often want a lab within easy reach of their own sites, both for sample logistics and for direct access to the scientific team running a study.

The bioanalytical lab providers below, headquartered across New Jersey, Massachusetts, North Carolina, Idaho, Florida, California, Delaware, and Pennsylvania, are listed in no particular order. Between them, these companies and providers cover LC-MS/MS, ligand-binding assays, mass spectrometry imaging, flow cytometry, and immunogenicity testing, spanning small molecules, large molecules, oligonucleotides, and cell and gene therapy products.

Accurant Biotech

Accurant Biotech runs bioanalysis services for siRNA and mRNA-based therapeutics, applying LC-MS/MS alongside stem-loop RT-qPCR and ddPCR methods to quantify these molecules in biological samples. The company, founded in 2017 and based in Princeton, New Jersey, also supports large-molecule and biologic bioanalysis — antibodies, peptides, oligonucleotides — under GLP regulations. Accurant operates laboratories in both the US and China, which it says supports multi-site clinical trials for biologics drug development. Its services extend from PK/PD analysis and exposure assessment to CMC testing and central laboratory work.

Aliri Bioanalysis

Aliri Bioanalysis, formerly known as ImaBiotech and Pyxant Labs, has offered mass spectrometry imaging (MSI) services since 2009, a technique it uses to detect, localize, and quantify drugs and biomarkers directly within tissue sections. Based in Billerica, Massachusetts, the company pairs this spatial bioanalysis work with more conventional LC-MS/MS and ligand-binding assay methods for small molecules, oligonucleotides, and biologics. Founded in 1991, Aliri has developed its imaging methodologies under more than 50 patents. Its capabilities also include Cytometry by Time-of-Flight (CyTOF) and quantitative PCR, added to its analytical lineup in 2025.

Alturas Analytics

Alturas Analytics runs a bioanalytical laboratory built specifically around LC-MS/MS and GC-MS/MS instrumentation, supporting method development, validation, and sample analysis from early discovery through late-stage clinical trials. Founded in 2000 by Shane Needham and Robin Woods, the Moscow, Idaho-based company has remained privately held and independent, expanding its facility in 2008, 2016, and 2021. Alturas is GLP-compliant and supports pharmacokinetic and toxicokinetic work for IND submissions and New Drug Applications. The lab draws on its proximity to the University of Idaho and Washington State University for its scientific staff.

BioAgilytix

BioAgilytix operates 355,000 square feet of laboratory space across its network, including 24,000 square feet dedicated to liquid chromatography-mass spectrometry (LC/MS) following a 2025 investment that also expanded its Hamburg, Germany site. The Durham, North Carolina-based company combines LC/MS with ligand-binding assay (LBA) services to support antibody-drug conjugates, peptides, oligonucleotides, and both large and small molecules. Founded in 2008, BioAgilytix provides pharmacokinetic (PK), immunogenicity, biomarker, and CMC analytical testing in a GxP environment. The company also maintains laboratories in Boston, San Diego, and Melbourne and Brisbane, Australia.

Immunologix Laboratories

Immunologix Laboratories focuses on biomarker and bioanalytical support for biologics, cell and gene therapies, and nucleic acid-based therapeutics, running PK, immunogenicity (ADA and NAb), cell-based, and biomarker assay platforms. Based in Tampa, Florida and operating since 2012, the company's laboratory work is GLP- and GCP-compliant and centers on ligand-binding, cell-based, and qPCR assay techniques. Its Translational Sciences team works alongside the bioanalytical group to help design molecule-specific bioanalytical strategies for clients. Immunologix supports all phases of therapeutic development, from early discovery through regulated clinical study sample analysis.

Navigate BioPharma

Navigate BioPharma Services entered a 2023 collaboration with BD (Becton, Dickinson and Company) to develop flow cytometry-based companion diagnostics and clinical trial tools. Headquartered in Carlsbad, California and founded in 2016, the specialty laboratory applies genomic, flow cytometry, digital pathology, and ligand-binding analysis methods to biomarker, pharmacodynamic, and immunogenicity testing. Its flow cytometry work includes high-dimensional and spectral platforms supporting cell and gene therapy clinical trials, including measurable residual disease assessment. Navigate BioPharma has around 111 employees supporting this specialty bioanalytical and biomarker testing work.

Primera Analytical Solutions

Primera Analytical Solutions Corporation was founded in 2002 by Dr. Bibo Xu and has since built out a Bioanalytical Division handling GLP method development and validation for small and large molecules, PK/PD studies, metabolite characterization, and anti-drug antibody (ADA) assays. The Princeton, New Jersey-based company also runs a cell and gene therapy testing group, using flow cytometry, PCR, qPCR, and ddPCR platforms alongside cell culture and cell-banking services. Its assay platforms for large molecules include ligand-binding and cell-based assays run on ELISA plate readers, MSD, and automated 96-well systems. Primera pairs this bioanalytical work with CMC testing, stability studies, and impurity analysis for pharmaceutical and biotech clients.

QPS Holdings

QPS Holdings traces its origins to 1995, when founder Dr. Benjamin Chien set up a small LC-MS/MS bioanalytical shop in Delaware; the company marked its 30th anniversary in 2025 with roughly 1,200 employees and eight locations spanning the US, EU, Asia, India, and Australia. Its Newark, Delaware headquarters houses the QPS Bioanalysis Laboratory Center of Excellence for small- and large-molecule drug development, alongside a dedicated drug metabolism and pharmacokinetics (DMPK) facility. QPS's Newark bioanalytical space spans 54,000 square feet, supporting biotherapeutics and gene therapy products alongside biosafety level 2 (BSL-2) capable labs. The company's broader service lines include preclinical toxicology, neuropharmacology, translational medicine, and clinical trial operations.

Resolian

Resolian's Malvern, Pennsylvania laboratory — its founding site, established in 2008 as Alliance Pharma — spans 3,500 square meters and is staffed by more than 170 scientists working in LC-MS/MS and ligand-binding assay (LBA) suites for large-molecule bioanalysis, including antibody-drug conjugates and oligonucleotides. The company took its current name in 2023, when Alliance Pharma merged with Drug Development Solutions to unify their bioanalytical, DMPK, and CMC analytical testing operations. Resolian's Malvern site is a Gyrolab Certified CRO Partner and shares harmonized methods with the company's UK, China, and Australia laboratories. Its services span small- and large-molecule LC-MS/MS bioanalysis, immunogenicity testing, biomarker assays, and cell-based assays.

Sannova Analytical

Sannova Analytical's Somerset, New Jersey laboratory has grown from 4,000 square feet at its 2006 founding to more than 21,000 square feet today, housing 14 mass spectrometers with room to add 12 more. The company runs bioanalytical CRO services spanning pharmacokinetic (PK) research, drug metabolism and pharmacokinetics (DMPK), immunogenicity assays, and high-resolution mass spectrometry for small molecules, biologics, and oligonucleotide-based therapeutics. Its instrumentation includes Sciex LC-MS/MS systems, Thermo Exploris Orbitrap HRMS, and Agilent ICP-MS platforms. Sannova describes itself as a boutique CRO, supporting clients across preclinical through Phase IV clinical development.

Explore the full Bioanalytical Labs landscape

The companies above represent a portion of a much larger field.

Diligent's platform includes over 325 Bioanalytical Labs Vendors, many with Vendor qualification data available on demand. Talk to our team about accessing qualification data for this category.

This article is intended as an informational overview of vendors operating in this space. Inclusion on this list does not constitute an endorsement, recommendation, or qualification by Diligent.