WuXi AppTec, Laboratory Testing Division
WuXi AppTec's Laboratory Testing Division is a global CRO providing preclinical drug development testing services—including bioanalytical, DMPK, and safety assessment—to pharmaceutical and biotechnology companies across the US, Europe, and China.
- Company typePublic
- Founded-
- HeadquartersShanghai, China
- Headcount51–100
- GTM typeB2B
- OfferingServices
What WuXi AppTec, Laboratory Testing Division does
WuXi AppTec's Laboratory Testing Division is a global contract research organization (CRO) providing preclinical drug development testing services to pharmaceutical and biotechnology companies. The division operates million-square-foot GLP and 21 CFR Part 11-validated laboratory facilities across the United States (Cranbury, New Jersey) and China (Shanghai, Nanjing, Suzhou), with capabilities supporting regulatory submissions to the FDA, EMA, and NMPA. The division's customer base spans large pharmaceutical companies and biotechnology developers advancing small molecules, biologics, and emerging therapeutic modalities through IND and NDA pathways.
The division delivers services across three core testing pillars: Bioanalytical Services (with 70+ UPLC-MS/MS instruments globally, 500+ specialized staff, and 37+ million samples analyzed annually), DMPK Services (including radiolabeled ADME studies with 3H and 14C, metabolite profiling, and in vivo PK), and Safety Assessment Services (general toxicology, safety pharmacology, genetic toxicology, developmental and reproductive toxicology, and carcinogenicity testing). The platform is structured around modality-specific solutions covering small molecules, large molecules, and new modalities including PROTACs, oligonucleotides, ADCs, peptides, CAR-T, and mRNA therapeutics. The division has supported over 1,200 successful IND submissions, conducting 10,000+ in vitro and 5,000+ in vivo studies per year through 300+ validated bioanalytical methods.
The business operates on a fee-for-service contract testing model with quote-based pricing for integrated IND-enabling and NDA-enabling packages, as well as a la carte assay services on multi-year contracts. Distribution is enterprise-direct via field sales teams and dedicated project managers engaged with pharmaceutical and biotech sponsors. The division holds first-mover regulatory positions in China, including the first CMC platform to pass FDA inspection for new chemical entities, the first GLP preclinical laboratory double-certified with OECD and NMPA, and the first GLP/GCP bioanalytical laboratory passing FDA, OECD, and NMPA inspections. As a business unit of WuXi AppTec (publicly traded on the Shanghai Stock Exchange, ticker 603259), the Laboratory Testing Division benefits from the parent group's scale and corporate infrastructure but does not have separately disclosed revenue or financials.
WuXi AppTec, Laboratory Testing Division firmographics
Firmographics- Name
- WuXi AppTec, Laboratory Testing Division
- Legal name
- WuXi AppTec
- Website
- https://labtesting.wuxiapptec.com
- Company type
- Public
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- WuXi AppTec's Laboratory Testing Division is a global CRO providing preclinical drug development testing services—including bioanalytical, DMPK, and safety assessment—to pharmaceutical and biotechnology companies across the US, Europe, and China.
- Ownership category
- akta.pro rank
WuXi AppTec, Laboratory Testing Division industry classification
Industry- Product category
- Preclinical Drug Development Testing Services
- NAICS
- Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417), Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (541715)
- SIC
- Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)
- akta.pro primary industry
- DMPK / ADME & Bioanalysis (HLAGAFAC)
- akta.pro secondary industries
- Nonclinical Study Management & Regulatory Writing (IND-enabling) (HLAGAFAN), Bioanalytical & Biomarker Assays (Preclinical) (HLAGAFAK), In Vivo Pharmacology (Efficacy/PD Models) (HLAGAFAA), Preclinical Development (Pharmacology, PK/PD, ADME, Toxicology) (HLAIALAC)
Keywords
Where WuXi AppTec, Laboratory Testing Division is headquartered
LocationHeadquarters
- HQ city
- Shanghai
- HQ country
- China
- HQ region
- Asia
Offices4 records
Markets served
WuXi AppTec, Laboratory Testing Division 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 Preclinical Testing Services: Fee-for-service preclinical testing contracts covering DMPK, bioanalysis, safety assessment, and regulatory support for drug development programs. Services offered as integrated IND/NDA packages or individual assays
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Custom IND-Enabling and NDA-Enabling Packages |
Go-to-market motion2 records
Distribution channels3 records
Marketing channels6 records
WuXi AppTec, Laboratory Testing Division product offering
Product offeringCore offering
Contract preclinical drug development testing services for pharmaceutical and biotechnology companies, covering three integrated pillars: Bioanalytical Services (small and large molecule quantification using LC-MS/MS and immunoassays), DMPK Services (in vitro ADME, in vivo PK, metabolite profiling, radiolabeled ADME), and Safety Assessment Services (general toxicology, safety pharmacology, genetic toxicology, DART, carcinogenicity). Services span the full preclinical continuum from discovery through IND and NDA submissions to FDA, EMA, and NMPA across small molecules, biologics, and emerging therapeutic modalities including PROTACs, oligonucleotides, ADCs, peptides, CAR-T, and mRNA.
Product overview
WuXi AppTec Laboratory Testing Division offers a comprehensive, fully integrated preclinical drug development platform encompassing three core service pillars: Bioanalytical Services, DMPK Services, and Safety Assessment Services. These are delivered across multiple therapeutic modality categories (Small Molecule, Large Molecule, and New Modalities including Oligonucleotides, ADCs, Peptides, Protein Degraders/PROTACs, CAR-T, and mRNA). The platform provides end-to-end capabilities from discovery through IND and NDA submission, with global operations in the U.S. and China. Services are delivered through dedicated solutions for IND-Enabling and NDA-Enabling programs, supported by advanced technology platforms including LC-MS/MS, immunoassays, and high-throughput screening systems.
Differentiator
Problem solved
Functional benefit
Products and services
- Preclinical Drug Development Services Comprehensive preclinical drug development testing services encompassing bioanalytical, DMPK, and toxicology testing to support drug candidates from early discovery through IND and NDA submission for pharmaceutical and biotechnology companies.
- IND-Enabling Services Preclinical studies and regulatory submission support designed to prepare drug candidates for Investigational New Drug (IND) applications to FDA, NMPA, and EMA.
- NDA-Enabling Services GLP safety assessment and bioanalytical testing services to support New Drug Application (NDA) submissions through Phase I, II, and III clinical trials for pharmaceutical sponsors.
- Small Molecule Solutions Integrated preclinical testing platform for small molecule therapeutics covering DMPK/ADME, bioanalysis, safety assessment, pharmacology, and CMC from discovery through NDA submission.
- Large Molecule Solutions Preclinical development services for biologics and biotherapies including bioanalytical, DMPK, safety assessment, pharmacology, and CMC capabilities.
- New Modalities Solutions Preclinical testing services for emerging therapeutic modalities including PROTACs, oligonucleotides, ADCs, peptides, CAR-T, and mRNA therapeutics.
- Oligonucleotide Solutions Comprehensive testing services for oligonucleotide therapeutics covering in vitro stability, in vivo pharmacokinetics, advanced bioanalysis, and specialized safety assessments for ASOs, siRNAs, and mRNA oligonucleotides.
- Antibody-Drug Conjugate (ADC) Solutions End-to-end preclinical testing services for antibody-drug conjugates including linker stability, payload release kinetics, tissue distribution, and specialized bioanalysis for total antibody, intact ADC, and DAR analysis.
- Peptide Solutions Preclinical testing services for peptide therapeutics including stability assessment, permeability evaluation, tissue distribution, and specialized immunogenicity monitoring for peptides 500-5,000 Da.
- Protein Degrader Solutions (PROTAC) Specialized testing for targeted protein degraders including PROTACs, molecular glues, and lysosome-directed approaches with capabilities for physicochemical characterization, metabolic profiling, and off-target degradation screening.
- CAR-T Solutions Preclinical testing services for chimeric antigen receptor T-cell therapies including bioanalysis, biomarker analysis, in vitro and in vivo assays, and immunophenotyping for hematologic malignancies.
- mRNA Solutions Preclinical testing services for mRNA therapeutics and vaccines including biodistribution studies tracking mRNA and translated proteins, delivery system characterization, and tissue-specific translation assessment.
- Bioanalytical Services Comprehensive bioanalysis platform supporting small and large molecule programs through discovery, preclinical, and clinical phases with LC-MS/MS, immunoassays, and biomarker validation.
- DMPK Services Drug metabolism and pharmacokinetic services including in vitro ADME, in vivo PK studies, metabolite profiling, and radiolabeled ADME studies spanning discovery through clinical phases.
- Safety Assessment Services Comprehensive safety assessment services including general toxicology, safety pharmacology, genetic toxicology, developmental and reproductive toxicology (DART), and carcinogenicity testing across multiple species.
Quantifiable outcome
- 1,200+ successful IND submissions completed
- +3 more outcomes
Companies that use WuXi AppTec, Laboratory Testing Division
Customer profileNamed customers2 records
Segments3 records
Ideal customer profiles2 records
WuXi AppTec, Laboratory Testing Division technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
WuXi AppTec, Laboratory Testing Division partnerships and signals
Strategic signalScale indicators17 records
Recent moves6 records
Expansion highlights5 records
WuXi AppTec, Laboratory Testing Division competitors and assessment
Company assessmentDirect peers
- Eurofins Scientific: Global testing services group with significant pharma clinical and preclinical testing, bioanalytical, and DMPK offerings through Eurofins Discovery and Pharma Services; comparable on testing services model and customer overlap.
- Inotiv: Preclinical CRO specializing in safety assessment, DMPK, bioanalysis, and research models for pharma/biotech; comparable on GLP toxicology and bioanalytical service lines.
- Frontage Laboratories: U.S./China-based CRO providing bioanalytical, DMPK, CMC, and preclinical services to pharma/biotech; directly comparable on integrated IND-enabling preclinical offerings and bilateral U.S.–China footprint.
- Labcorp Drug Development (Fortrea): Post-spin preclinical and clinical CRO offering DMPK, bioanalytical, safety assessment, and central laboratory services to pharma/biotech sponsors; directly comparable in service portfolio and customer base.
- Charles River Laboratories: Global CRO with a large preclinical Safety Assessment and DMPK/Bioanalysis business serving pharmaceutical and biotech clients across small molecules and biologics; directly comparable in core service lines (GLP toxicology, bioanalysis, DMPK) and end customers.
- Pharmaron: China-headquartered CRO/CDMO offering integrated preclinical drug discovery, DMPK, bioanalytical and safety assessment services to global pharma/biotech sponsors; directly comparable in service mix, China-based scale, and customer base.
- SGS Health Sciences: Global CRO providing preclinical and clinical bioanalytical, DMPK, and central laboratory services to pharmaceutical and biotech clients; directly comparable in GLP bioanalytical and central lab offerings.
Broad incumbents
- ICON plc: Global CRO with preclinical laboratory services (post-PRA and early-development services acquisitions) serving pharma/biotech sponsors; overlapping in bioanalytical and central lab services with broader clinical focus.
- IQVIA: Diversified life sciences services giant with preclinical and bioanalytical capabilities embedded in its broader R&D Solutions and laboratory services; comparable on bioanalysis/DMPK but broader in clinical and data offerings.
Regional players
- Hangzhou Tigermed: China-headquartered clinical CRO with growing preclinical/biologics services targeting China and global pharma; adjacent comparable as a Chinese peer serving similar pharma/biotech sponsors with expanding preclinical capabilities.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
WuXi AppTec, Laboratory Testing Division social profiles
Digital presenceWuXi AppTec, Laboratory Testing Division financial estimates
Financial estimateRevenue estimate
Valuation estimate
WuXi AppTec, Laboratory Testing Division leadership team
Management profileNumber of profiles
Profiles1 record
WuXi AppTec, Laboratory Testing Division funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
WuXi AppTec, Laboratory Testing Division M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about WuXi AppTec, Laboratory Testing Division
What does WuXi AppTec, Laboratory Testing Division do?
Contract preclinical drug development testing services for pharmaceutical and biotechnology companies, covering three integrated pillars: Bioanalytical Services (small and large molecule quantification using LC-MS/MS and immunoassays), DMPK Services (in vitro ADME, in vivo PK, metabolite profiling, radiolabeled ADME), and Safety Assessment Services (general toxicology, safety pharmacology, genetic toxicology, DART, carcinogenicity). Services span the full preclinical continuum from discovery through IND and NDA submissions to FDA, EMA, and NMPA across small molecules, biologics, and emerging therapeutic modalities including PROTACs, oligonucleotides, ADCs, peptides, CAR-T, and mRNA.
Is WuXi AppTec, Laboratory Testing Division a public or private company?
WuXi AppTec, Laboratory Testing Division is a public company. It is classified as public and is currently operating.
When was WuXi AppTec, Laboratory Testing Division founded?
WuXi AppTec, Laboratory Testing Division was founded in -1. It employs 51 to 100 people.
Where is WuXi AppTec, Laboratory Testing Division based?
WuXi AppTec, Laboratory Testing Division is headquartered in Shanghai, China, in the Asia region.
How does WuXi AppTec, Laboratory Testing Division make money?
One revenue line is on record: contract Preclinical Testing Services.
Who are WuXi AppTec, Laboratory Testing Division's main competitors?
Direct peers on record are Eurofins Scientific, Inotiv, Frontage Laboratories, Labcorp Drug Development (Fortrea), Charles River Laboratories, Pharmaron and SGS Health Sciences. Broad incumbents are ICON plc and IQVIA. Hangzhou Tigermed is listed as a regional player.
Does WuXi AppTec, Laboratory Testing Division have an API?
No public API is recorded for WuXi AppTec, Laboratory Testing Division.
What industry is WuXi AppTec, Laboratory Testing Division in?
WuXi AppTec, Laboratory Testing Division's product category is Preclinical Drug Development Testing Services. Its primary akta.pro industry code is HLAGAFAC, DMPK / ADME & Bioanalysis, with a secondary code of HLAGAFAN, Nonclinical Study Management & Regulatory Writing (IND-enabling). Its NAICS code is 541714 and its SIC code is 8731.