What Biotoxtech does

Biotoxtech is Korea's largest private nonclinical contract research organization (CRO), founded in 2000 and headquartered in Cheongju. Listed on KOSDAQ since 2007 (ticker 086040), it provides GLP-compliant preclinical safety and toxicology testing services to pharmaceutical, biotech, cosmetics, food, chemical, agrochemical, and medical device clients operating across Korea, Japan, the US, and Europe, with more than 40,000 preclinical studies completed over its operating history.

The company's service portfolio spans general toxicology, carcinogenicity, reproductive and developmental toxicology, genotoxicity, immunotoxicity, safety pharmacology, aquatic ecotoxicology, and in vitro alternatives, supported by 60 GLP test certifications across MFDS, NIER, and RDA — the broadest such footprint in Korea's private sector. It was the first private Korean CRO to receive US FDA GLP eligibility (2015) and has held AAALAC International Full Accreditation since 2008, with OECD GLP compliance enabling global data acceptance. The group is structured around Biotoxtech's parent toxicology operations, Keyfronbio (KFB) for bioanalysis and pharmacokinetics, Kiprime Research for non-human primate studies with ~1,150-primate facility capacity, SCAS-BTT (SBB), and Biomixes (acquired 2017). Recent capability additions include medical device and Pig-a assay GLP certifications (2024) and an AI-driven toxicological pathology initiative via a partnership with LACK (December 2025).

Revenue is generated through project-based professional services contracts ranging from single studies to multi-year carcinogenicity programs, with pricing driven by study type, species, duration, and regulatory pathway and an estimated average contract value of ~KRW 150M. Go-to-market combines enterprise field sales, biennial scientific symposiums and conferences, a Japanese distribution relationship, and direct engagement with global pharmaceutical sponsors. Consolidated FY2023 revenue was KRW 32.6B (~$25M USD) with a closing FY2025 order backlog of KRW 415B (~12x annual revenue), indicating strong forward visibility and supporting the company's stated KRW 80B group revenue and KRW 200B asset targets.

Name

Biotoxtech

Legal name

(주)바이오톡스텍 (Biotoxtech Co., Ltd.)

Website

https://biotoxtech.com

Company type

Public

Founded year

2000

Operating status

Operating

Headcount range

101–250 employees

Short description

Biotoxtech is Korea's largest private nonclinical CRO, providing GLP-compliant preclinical toxicology, safety, and bioanalytical services to pharmaceutical, biotech, cosmetics, food, and chemical clients across more than 40,000 completed studies since 2000, with operations spanning Korea, Japan, the US, and Europe.

Ownership category

akta.pro rank

Product category

Preclinical Contract Research / Toxicology Testing Services

NAICS

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

SIC

Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)

akta.pro primary industry

Toxicology & Safety Assessment CROs (GLP) (HLAGAAAC)

akta.pro secondary industries

In Vivo Pharmacology (Efficacy/PD Models) (HLAGAFAA), Carcinogenicity Studies (HLAGAFAG), Cell-Based & Potency Assays (Bioassays) (HLAGADAH), In Vitro Toxicology (Cell-based/Organ-on-chip) (HLAGAFAJ), Bioanalytical Testing (PK/ADA/NAb) (HLAGADAA)

Keywords

• Preclinical toxicology testing
• GLP contract research services
• Safety pharmacology studies
• Nonclinical CRO services
• Bioanalytical PK studies

Headquarters

HQ city

Cheongju

HQ country

South Korea

HQ region

Asia

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Nonclinical Contract Research (CRO) Services: Project-based fees charged for GLP-compliant preclinical toxicology and safety assessment studies. Pricing varies by study type (single dose, repeat dose, carcinogenicity, reproductive/developmental, genotoxicity, etc.), species (rodent, non-rodent, NHP), duration, and regulatory pathway. Revenue recognition occurs over the project duration as studies progress. This is the primary revenue driver, with standalone studies and integrated packages offered.
2. Bioanalysis and PK/TK/ADME Services: Bioanalysis of drug concentrations in biological samples and pharmacokinetic profiling services, provided through subsidiary Keyfronbio. Includes method development, validation, and sample analysis using HPLC and LC/MS/MS.
3. NHP Preclinical Services: Specialized repeat-dose and safety pharmacology studies using non-human primates through subsidiary Kiprime Research. These premium studies command higher fees due to the specialized infrastructure, primate facility capacity (~1,150 NHP), and GLP requirements. Contributing increasingly to group revenue, now representing over 50% of Kiprime Research's revenue from overseas customers.
4. Efficacy/Potency Evaluation Services: Contract services evaluating therapeutic efficacy of drug candidates across disease models (diabetes, obesity, oncology, Alzheimer's, etc.) and for health functional food and cosmetic efficacy claims. These services complement the core toxicology offering and are often bundled with safety studies.

Pricing tiers

Go-to-market motion3 records

Distribution channels5 records

Marketing channels6 records

Core offering

Biotoxtech is a Korean preclinical contract research organization (CRO) providing GLP-certified toxicology and safety assessment services for the pharmaceutical, biotech, cosmetic, health functional food, chemical, agrochemical, and medical device industries. Services span general and specialized toxicology (carcinogenicity, reproductive/developmental, genotoxicity, immunotoxicity, safety pharmacology, local toxicity, aquatic ecotoxicology, juvenile animal studies), in vitro alternative methods, histopathology and clinical pathology, in vivo distribution testing for cell and gene therapies, drug metabolism/PK bioanalysis, and regulatory submission support. Testing is conducted in rodents, non-rodents, and non-human primates to generate data packages for MFDS, FDA, PMDA, EMA, and other regulatory submissions.

Product overview

Biotoxtech is a preclinical contract research organization (CRO) offering a comprehensive, full-service portfolio of GLP-certified nonclinical safety testing and bioanalytical services. The company's core platform consists of a broad menu of general and specialized toxicology testing services — covering general toxicity, carcinogenicity, local toxicity, reproductive/developmental toxicity, genetic toxicology, immunotoxicity, safety pharmacology, and aquatic ecotoxicology — supported by in-house histopathology, clinical pathology, and drug metabolism/bioanalysis capabilities. Supplementary services include alternative testing methods (animal reduction/replacement), efficacy evaluation, juvenile animal studies, and in vivo distribution testing for cell and gene therapies. Testing is conducted across rodent, non-rodent, and non-human primate species. Services are delivered through its own facilities as well as subsidiaries Keyfronbio (bioanalysis) and Keyprime Research (NHP specialized studies). The company holds the largest number of GLP certifications among private institutions in Korea, covering pharmaceuticals, chemicals, agrochemicals, and medical devices, and is the only Korean nonclinical CRO publicly listed on KOSDAQ.

Differentiator

Problem solved

Functional benefit

Products and services

• General Toxicology Testing GLP-compliant preclinical safety testing service evaluating acute and repeated-dose toxicity in rodents and non-rodents, providing fundamental safety data for drug, health food, cosmetic, chemical, and agrochemical registration.
• Carcinogenicity Testing Long-term carcinogenicity assessment using traditional 18–24 month rodent studies and accelerated 6-month studies with transgenic rasH2/p53 mice models.
• Local Toxicity Testing Evaluation of skin and mucous membrane irritation potential for substances with accidental or intentional human contact, using rabbit skin and eye irritation models.
• Reproductive/Developmental Toxicity Testing Comprehensive assessment of effects on fertility, embryo-fetal development, and postnatal outcomes through Segment I, II, and III studies in rats and rabbits, covering the full reproductive lifecycle.
• Genetic Toxicology Testing Battery of genotoxicity assays including bacterial reverse mutation (Ames), in vitro and in vivo chromosomal aberration, micronucleus, Comet, and Hprt/xprt gene mutation tests, plus Pig-a gene mutation assay per OECD 470.
• Immunotoxicity Testing Assessment of immune system effects including anaphylaxis (ASA/PCA), skin sensitization (GPMT, Buehler, LLNA), phototoxicity, and flow cytometry-based cellular immune function tests.
• Safety Pharmacology Testing GLP-certified evaluation of CNS, respiratory, and cardiovascular effects (core battery), plus hERG assay for QT prolongation risk assessment, covering ICH S7A/S7B requirements.
• Histopathology and Clinical Pathology Comprehensive necropsy, slide preparation, histopathological examination, hematology, biochemistry, urinalysis, and peer review pathology services for all safety studies.
• Juvenile Animal Testing Nonclinical safety assessment in juvenile animals for pediatric pharmaceuticals, evaluating general toxicity, growth, neurobehavioral development, and organ system maturation.
• In Vivo Distribution Testing for Cell/Gene Therapies Quantitative PCR-based biodistribution analysis of cell therapy, gene therapy, and gene-modified cell products in target organs, using custom primer/probe sets for specific detection.
• Drug Metabolism and Bioanalysis Services (PK/TK/ADME) PK/TK/ADME and toxicokinetics studies using HPLC, LC/MS, LC/MS/MS, including method development, validation, biological sample analysis, and distribution testing; operated through subsidiary Keyfronbio.
• Aquatic Ecotoxicology Testing Ecotoxicity evaluation for chemicals and agrochemicals covering algae growth inhibition, Daphnia immobilization, and acute fish toxicity per OECD/NIER/RDA guidelines.
• Alternative Testing Methods (In Vitro / Ex Vivo) In vitro and ex vivo alternative methods replacing or reducing animal use, including LLNA (BrdU-ELISA/FCM), DPRA, h-CLAT, RhCE eye irritation, and 3T3 NRU phototoxicity tests per OECD guidelines.
• Efficacy / Potency Evaluation In vitro and in vivo efficacy evaluation for pharmaceuticals, health functional foods, and cosmetics across therapeutic areas including oncology, diabetes, obesity, osteoporosis, arthritis, liver disease, neurodegeneration, and skin care.
• Regulatory Submission and Consulting Regulatory consulting and documentation services for drug approval submissions to MFDS, FDA, EPA, and other global authorities, leveraging accumulated experience with hundreds of regulatory filings.
• NHP (Non-Human Primate) Toxicology Studies Specialized repeat-dose and safety pharmacology studies using non-human primates delivered through subsidiary Kiprime Research, with GLP-certified NHP facility capacity for approximately 1,150 primates simultaneously.

Quantifiable outcome

• Delivered over 40,000 preclinical studies since founding, making it Korea's most experienced private preclinical CRO.
• +4 more outcomes

Named customers5 records

Segments6 records

Ideal customer profiles6 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

14 partnerships are on record, tiered major, moderate, core and minor.

• Novoreks (노보렉스)majorStrategic or Co-development Partner · 23 January 2026BioToxTech Group (including Keyfronbio and Kiprime Research) signed an MOU with Novoreks for strategic cooperation to accelerate drug development for NRX-NGT009, an autoimmune disease treatment candidate. The partnership encompasses pharmacology, toxicology, and PK studies across the full preclinical cycle.
• LACK (라크)moderateTechnology or Integration · 24 December 2025BioToxTech partnered with AI startup LACK through a 2025 public-private open innovation support program to jointly develop AI-based automated toxicological pathology analysis technology. The collaboration applies AI to ovarian follicle detection and quantification in Whole Slide Images (WSI) for reproductive toxicology studies, improving analysis efficiency and consistency over manual reading.
• JT2Bio (지투지바이오)majorStrategic or Co-development Partner · 12 May 2025BioToxTech signed a preclinical study agreement with JT2Bio for long-acting injectable drug development. BioToxTech leverages its polymer analysis capabilities and Kiprime Research's NHP expertise to provide exclusive preclinical research services for JT2Bio's drug candidates targeting obesity, diabetes, dementia, prostate cancer, and hair loss.
• Darnatein (OSR Holdings subsidiary)majorStrategic or Co-development Partner · 2 May 2025BioToxTech is collaborating with Darnatein on IND-enabling preclinical studies for DA Biologics platform candidates DRT-101 (joint cartilage regeneration) and DRT-102 (spinal bone repair), with support from the University of California, San Diego. BioToxTech provides GLP-compliant toxicology and safety assessment services, while Darnatein contributes its biologics pipeline.
• GSC Anti-Aging LabmoderateStrategic or Co-development Partner · 2 June 2023BioToxTech entered a strategic business partnership (strategic MOU) with GSC Anti-Aging Lab to explore collaborative research and service development in the anti-aging/healthspan sector.
• G2GBIOmajorStrategic or Co-development Partner · 1 January 2020BioToxTech holds an exclusive preclinical research service agreement with G2GBIO covering treatments for obesity, diabetes, dementia, prostate cancer, and hair loss. BioToxTech also made a KRW 1 billion investment in G2GBIO, generating approximately KRW 13 billion in realized profit (13x return).
• US FDAmajorOthersBioToxTech is the first private Korean nonclinical CRO to receive GLP eligibility recognition from the US FDA. The company has undergone multiple FDA GLP surveillances (2015, 2017) and maintains VAI (Voluntary Action Indicated) status, enabling it to directly support clients' US regulatory submissions.
• AAALAC InternationalmajorOthersAAALAC International is a voluntary accreditation organization promoting humane treatment of animals in science. BioToxTech received Full Accreditation in 2008 and has maintained it continuously. AAALAC accreditation signals international standards compliance and is a key differentiator in attracting global pharmaceutical clients.
• Keyfronbio (키프론바이오)coreOthersKeyfronbio is a subsidiary/joint venture that provides bioanalysis, PK/TK/ADME, and efficacy evaluation services. BioToxTech refers certain studies (bioanalysis, body distribution) to Keyfronbio. The company has its own Seoul office and has achieved 400%+ revenue growth over 3 years.
• Kiprime Research (키프라임리서치)coreOthersKiprime Research is BioToxTech's NHP-specialized nonclinical CRO subsidiary, established in 2021. BioToxTech invested KRW 5.8 billion in Kiprime Research (December 2024) to expand its ownership to ~50%. Kiprime Research operates an NHP facility with ~1,150 primate capacity and achieved 100%+ annual revenue growth, with 50%+ of revenue from overseas customers. IPO preparation underway.
• KFB (SCAS-BTT Bioanalysis)minorOthersKFB (originally SCAS-BTT Bioanalysis, SBB) is a joint venture between BioToxTech and Japan's Sumika Analytics Center (スミカ分析センター), established in 2011. It provides bioanalysis services for low-molecular and macromolecular drugs using LC/MS/MS, serving as a specialized bioanalysis arm within the group.
• Korea Research Institute of Bioscience and Biotechnology (KRIBB) — National Primate CentermoderateTechnology or IntegrationTechnical cooperation agreement with KRIBB's National Primate Center and Bioevaluation Center for collaborative research leveraging Korea's national primate research infrastructure.
• Iwasaki / Iwase Cosfa (Japan)moderateChannel Partner/ Reseller/ DistributorJapanese distributor and marketing partner (Iwase Cosfa Co., Ltd.) supporting BioToxTech's market access in Japan, one of its key overseas markets. BioToxTech maintains a Japanese-language website and Japanese-version company brochures.
• Eancell (이엔셀)minorStrategic or Co-development PartnerJointly hosted a Cell & Gene Therapy symposium with Eancell (a cell and gene therapy CDMO) and Sungkyunkwan University/Samsung Seoul Hospital in March 2024. Represents a co-marketing and academic collaboration in the advanced therapy space.

Scale indicators8 records

Recent moves9 records

Expansion highlights7 records

Direct peers

• Crown Bioscience: Preclinical and translational CRO with oncology and metabolic-disease efficacy models plus safety assessment capabilities. Already cited as a Biotoxtech technology partner, indicating direct overlap in customer base and service scope among Asia-based sponsors.
• Pharmaron: China-rooted CRO with comparable preclinical safety, bioanalysis, PK/TK, and regulatory toxicology offerings for global pharma. Closest functional peer in Asia alongside WuXi and offers similar integrated tox-plus-bionalysis packaging.
• Inotiv Inc. US-listed preclinical CRO specializing in toxicology, safety pharmacology, and disease models — the most directly comparable business model to Biotoxtech's GLP safety assessment core, including similar regulatory-driven, project-based revenue.

Emerging players

• ChemPartner: Asia-based preclinical CRO with comparative in vivo toxicology, bioanalysis, and DMPK services for early-stage discovery and IND-enabling studies. Comparable as a mid-sized alternative CRO competing for the same Korean and global biotech workload.
• Bionova Scientific: Specialty preclinical CRO with safety assessment and bioanalytical services for biologics and advanced therapies. Comparable on cell/gene therapy bioanalysis and bi-specific safety work, areas Biotoxtech targets through Keyfronbio partnerships.

Broad incumbents

• Eurofins Scientific: Diversified testing and contract research group with GLP-certified toxicology, environmental, and chemical registration services overlapping directly with BioToxTech's NIER/RDA chemical and ecotoxicology tracks, while bringing broader pharma testing reach.
• Charles River Laboratories: Global preclinical CRO offering the same general toxicology, carcinogenicity, safety pharmacology, and NHP services Biotoxtech provides, but at multibillion-dollar scale across North America, Europe, and Asia. Direct comparable on core toxicology methodology and GLP-grade regulatory deliverables.
• WuXi AppTec (and WuXi Biologics): Asia-headquartered CRO with a major toxicology, DMPK, and bioanalysis footprint across small molecules and biologics. Comparable in cross-border preclinical service delivery, though much larger and more diversified across the full drug-development stack.
• Labcorp Early Development (Covance): One of the largest preclinical CRO networks, with matching safety assessment, bioanalysis, and SEND-capable toxicology packages. Comparable on full-service preclinical delivery for FDA/EMA submissions, though significantly larger and more global.

Regional players

• Xenometrics: US-based preclinical toxicology CRO cited as a Biotoxtech partner for US-Korea service delivery, and a directly comparable specialty tox provider competing for similar North American small-molecule and biotech sponsors.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance9 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries4 records

Funding overview

Funding rounds

Investors

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

M&A

Investments1 record

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

Frequently asked questions about Biotoxtech