HLB Biostep
HLB Biostep is South Korea's first specialized non-clinical efficacy evaluation CRO, providing animal-based efficacy and safety testing, bioanalytical services, GLP lab consulting, and veterinary drug trials to pharmaceutical, biotech, and animal health companies from its Songdo, Incheon research center.
- Company typePublic
- Founded2012
- HeadquartersIncheon, South Korea
- Headcount—
- GTM typeB2B
- OfferingServices
What HLB Biostep does
HLB bioStep Co., Ltd. (KOSDAQ: 278650) is a South Korean non-clinical contract research organization (CRO) founded in 2012 as Korea's first specialized efficacy evaluation institution, headquartered in a 11,048.69 m² Songdo Research Center in Incheon. The company runs animal-based efficacy and safety studies across rodents, rabbits, dogs, pigs, guinea pigs, and primates using a fleet of high-spec imaging equipment (GE Signa Pioneer MRI, Siemens Somatom Emotion CT, PerkinElmer Quantum GX Micro-CT, Siemens Artis Zee C-arm, IVIS Spectrum) and validated disease models spanning xenograft and syngeneic oncology, metabolic, CNS, bone, ophthalmic, and other therapeutic areas. It also operates an in-house biological sample analysis center using LC-MS/MS (TQ 6500+/5500+), flow cytometry, RT-PCR, and automated workstations, a bio-infrastructure lab consulting and construction unit covering GLP/LMO/BSL facility design and licensing, and a veterinary drug non-clinical and clinical trial service designated by the Animal and Plant Quarantine Agency.
The company generates revenue through project-based professional services contracts with pharmaceutical and biotech firms (primary segment), lab construction clients across pharma/medical-device/chemical/food industries, and animal health companies; pricing is per-project and not publicly disclosed. Go-to-market is predominantly direct enterprise sales supported by a website inquiry system, industry conference participation (e.g., BioUSA 2024), and an annual Partnering Day event. Since HLB Group became the largest shareholder in June 2022 and the company was rebranded from Knotus to HLB bioStep in March 2023, the company has pursued inorganic growth — most notably acquiring GLP toxicology specialist KroEn (renamed HLB Biocode) in April 2024 — and has built a partnership network spanning Arontier (AI drug development, Dec 2023), Gradient Bioconversion (organoid platforms, June 2024), Chiron (animal-alternative testing, Oct 2025), and several Korean hospitals and universities, while operating as a KOSDAQ-listed entity with publicly disclosed share price but no publicly reported revenue.
HLB Biostep firmographics
Firmographics- Name
- HLB Biostep
- Legal name
- HLB bioStep Co., Ltd.
- Website
- https://hlbbiostep.com
- Company type
- Public
- Founded year
- 2012
- Operating status
- Operating
- Short description
- HLB Biostep is South Korea's first specialized non-clinical efficacy evaluation CRO, providing animal-based efficacy and safety testing, bioanalytical services, GLP lab consulting, and veterinary drug trials to pharmaceutical, biotech, and animal health companies from its Songdo, Incheon research center.
- Ownership category
- akta.pro rank
HLB Biostep industry classification
Industry- Product category
- Non-Clinical Contract Research (CRO)
- NAICS
- Research and Development in Biotechnology (except Nanobiotechnology) (541714), Testing Laboratories and Services (541380)
- SIC
- Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)
- akta.pro primary industry
- Preclinical CROs (Discovery/Pharmacology/DMPK) (HLAGAAAB)
- akta.pro secondary industries
- In Vivo Pharmacology (Efficacy/PD Models) (HLAGAFAA), Toxicology & Safety Assessment CROs (GLP) (HLAGAAAC)
Keywords
Where HLB Biostep is headquartered
LocationHeadquarters
- HQ city
- Incheon
- HQ country
- South Korea
- HQ region
- Asia
Offices1 record
Markets served
HLB Biostep business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Infrastructure, Technology or R&D, Marketing or Sales
Revenue model
- Non-Clinical CRO Services (Efficacy & Safety Testing): Project-based contract research for pharmaceutical and biotech companies conducting non-clinical efficacy and safety evaluations in animal models. Revenue is generated through per-project fees based on study design complexity, species used, and number of endpoints. Core revenue driver.
- Bio-infrastructure Lab Consulting & Construction: One-stop consulting and construction services for laboratory and animal facility setup including design, GLP/BSL certification support, validation, and equipment supply. Revenue generated through project-based contracts for facility construction and consulting engagements.
- Veterinary Drug Development Services: Non-clinical and clinical trial services for veterinary drug development, designated by the Animal and Plant Quarantine Agency. Includes consulting on approval procedures and direct clinical trial performance, serving animal pharmaceutical companies.
Go-to-market motion2 records
Distribution channels2 records
Marketing channels5 records
HLB Biostep product offering
Product offeringCore offering
HLB Biostep is Korea's first specialized non-clinical efficacy evaluation CRO, providing veterinary science-based preclinical testing services for pharmaceutical, biotech, and veterinary drug developers. Core offerings include animal-model-based efficacy evaluation across xenograft, syngeneic, and disease models; biological sample analysis using LC-MS/MS, flow cytometry, and PCR; bio-infrastructure lab design, construction, and validation; and designated veterinary drug non-clinical and clinical trial services. Services are delivered at a 11,048.69 m² Songdo research facility equipped with MRI, CT, Micro-CT, C-arm, and IVIS imaging platforms.
Product overview
HLB Biostep operates as Korea's No.1 non-clinical CRO specializing in efficacy evaluation. The company offers an integrated service portfolio comprising: (1) Non-Clinical CRO Services providing animal-based efficacy testing across multiple therapeutic areas using established disease models; (2) Biological Sample Analysis using advanced analytical platforms (LC-MS/MS, Flow cytometry, PCR, Microplate readers); (3) Lab Consulting for bio-infrastructure construction offering one-stop facility development from planning through validation; and (4) Veterinary Drug Services for non-clinical and clinical trials designated by the Animal and Plant Quarantine Agency. The portfolio is augmented by an acquired GLP toxicity testing company (Kroen/HLB Biocode) and partnerships for next-generation organoid-based evaluation platforms.
Differentiator
Problem solved
Functional benefit
Products and services
- Non-Clinical CRO Services (비임상 CRO사업) Veterinary science-based non-clinical study services for new drug development, providing efficacy evaluation across cancer, bone, brain, metabolic, ophthalmologic, articular, and other therapeutic areas using xenograft, syngeneic, orthotopic, and disease-specific animal models in rodent, rabbit, dog, pig, and primate species. Targeted at pharmaceutical and biotechnology companies advancing drug candidates through preclinical development.
- Biological Sample Analysis (생체시료분석) Bioanalysis services using LC-MS/MS (TQ 6500+, TQ 5500+), flow cytometry (NovoCyte), real-time PCR (CFX96 Touch), microplate readers (Synergy H1), and automated workstations (Biomek i5) for pharmacokinetic, biomarker, and bioanalytical studies supporting drug development. Targeted at pharmaceutical and biotech clients requiring accurate and reliable analytical data for candidate characterization.
- Bio-infrastructure Lab Consulting & Construction (바이오인프라구축사업) One-stop service for laboratory and animal facility construction including consulting, design, construction, testing and balancing (TAB), fumigation, maintenance, equipment supply, and validation for GLP, LMO, and BSL facilities. Targeted at pharmaceutical, medical device, chemical, pesticide, and food companies building or upgrading testing facilities.
- Veterinary Drug Services (동물의약품) Non-clinical and clinical trial services for veterinary drugs, designated by the Animal and Plant Quarantine Agency, including consulting on approval procedures, data review, and direct clinical trial performance for animal pharmaceutical companies. Targeted at animal health and veterinary pharmaceutical developers seeking regulatory-grade trial support.
Quantifiable outcome
- Over 1,000 experiments conducted annually with accumulated experimental know-how and data
- +1 more outcomes
Companies that use HLB Biostep
Customer profileSegments3 records
Ideal customer profiles3 records
HLB Biostep technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
HLB Biostep partnerships and signals
Strategic signalPartnerships
Ten partnerships are on record, tiered core and minor.
- ChironcoreHLB Biostep and Chiron partnered to develop next-generation non-clinical testing platforms, focusing on animal-alternative technologies to build next-gen efficacy evaluation platforms.
- Barunseong Hospital (바른세상병원)minorBarunseong Hospital signed a preclinical trial contract with HLB Biostep and HLB Biocode, combining clinical expertise with non-clinical testing capabilities.
- Karlsruhe Institute of Technology (KIT)minorHLB Biostep and KIT (Korea Institute of Toxicology) cooperated to build a joint research system for non-human primate (primate) testing, enhancing capabilities in primate-based preclinical studies.
- Gradient BioconversioncoreHLB Biostep and Gradient Bioconversion partnered for the commercialization of patient-derived organoid-based drug evaluation platforms, enabling more personalized and physiologically relevant pre-clinical testing.
- BNH InvestmentminorHLB Biostep and BNH Investment signed an MOU and hosted a Partnering Day event to identify promising biotech ventures for investment and strategic partnership opportunities.
- ArontiercoreHLB Biostep and Arontier entered into a comprehensive business cooperation agreement to accelerate AI-driven drug development. The partnership aims to leverage AI technologies across HLB Biostep's non-clinical testing capabilities.
- Ajou University Medical Center (아주대의료원)minorHLB Biostep signed an agreement with Ajou University Medical Center for efficacy evaluation of mental and behavioral disorder diseases, combining clinical research expertise with non-clinical testing.
- Seoul Asan Hospital & Jeonbuk National University HospitalminorHLB Biostep signed efficacy evaluation agreements with Seoul Asan Hospital and Jeonbuk National University Hospital, enabling collaborative research combining clinical and non-clinical expertise.
- Yonsei UniversityminorBasgenBio is partnering with Yonsei University (alongside Dankook University) to mine clinical and omics datasets for drug targets. Listed here as a partner connected to BasgenBio's ecosystem which HLB bioStep is invested in.
- Dankook UniversityminorBasgenBio is partnering with Dankook University alongside Yonsei University to mine clinical and omics datasets. Listed as a partner in the broader ecosystem connected to HLB bioStep's investment in BasgenBio.
Scale indicators5 records
Recent moves6 records
Expansion highlights7 records
HLB Biostep competitors and assessment
Company assessmentDirect peers
- Pharmaron: Integrated preclinical CRO with strong in vivo efficacy, DMPK, and safety assessment capabilities. Comparable service mix and customer focus on innovative drug developers.
- WuXi AppTec: Major Asian-headquartered preclinical CRO offering in vivo pharmacology, DMPK, and toxicology. Comparable service breadth and target customer base of global pharma/biotech sponsors.
- Shanghai Medicilon: China-based preclinical CRO offering in vivo efficacy, PK/PD, and toxicology services. Comparable preclinical CRO service model targeting pharma/biotech sponsors globally.
- Crown Bioscience (JSR Life Sciences): Preclinical CRO specializing in oncology in vivo models including xenograft and syngeneic tumor models — a core capability area that directly overlaps with HLB bioStep's anti-cancer efficacy evaluation services.
- ICR (International Contract Research): UK-headquartered preclinical CRO providing in vivo efficacy and safety studies in multiple species. Directly comparable core CRO service model.
- Inotiv: U.S.-based preclinical CRO providing animal model services, toxicology, and research models. Closely comparable in vivo efficacy/safety testing business model.
- Charles River Laboratories: Global leader in preclinical CRO services including in vivo efficacy and safety studies across rodent and large-animal models. Highly comparable end-to-end preclinical offering serving pharma and biotech clients.
Broad incumbents
- Eurofins Scientific: Global testing services group with preclinical and bioanalytical capabilities alongside much broader food, environmental, and pharma testing. Comparable bioanalytical and preclinical testing services as part of a much wider portfolio.
- Labcorp (Labcorp Drug Development / Covance): Diversified CRO offering preclinical and clinical services alongside diagnostics. Comparable preclinical efficacy/safety offering as one component of a much broader portfolio.
Emerging players
- Biocytogen: China-based preclinical CRO with proprietary humanized mouse models and in vivo efficacy services. Comparable preclinical efficacy offering with a strong emerging-player focus on next-gen disease models.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat6 records
Key risks6 records
Key highlights7 records
Customer concentration
HLB Biostep financial estimates
Financial estimateRevenue estimate
Valuation estimate
HLB Biostep leadership team
Management profileNumber of profiles
Profiles2 records
HLB Biostep subsidiaries and ownership
Company hierarchySubsidiaries1 record
HLB Biostep funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
HLB Biostep M&A and investment
M&A and investmentM&A
Investments1 record
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about HLB Biostep
What does HLB Biostep do?
HLB Biostep is Korea's first specialized non-clinical efficacy evaluation CRO, providing veterinary science-based preclinical testing services for pharmaceutical, biotech, and veterinary drug developers. Core offerings include animal-model-based efficacy evaluation across xenograft, syngeneic, and disease models; biological sample analysis using LC-MS/MS, flow cytometry, and PCR; bio-infrastructure lab design, construction, and validation; and designated veterinary drug non-clinical and clinical trial services. Services are delivered at a 11,048.69 m² Songdo research facility equipped with MRI, CT, Micro-CT, C-arm, and IVIS imaging platforms.
Is HLB Biostep a public or private company?
HLB Biostep is a public company. It is classified as public and is currently operating.
When was HLB Biostep founded?
HLB Biostep was founded in 2012.
Where is HLB Biostep based?
HLB Biostep is headquartered in Incheon, South Korea, in the Asia region.
How does HLB Biostep make money?
Three revenue lines are on record. Non-Clinical CRO Services (Efficacy & Safety Testing) is the primary driver. The others are bio-infrastructure Lab Consulting & Construction and veterinary Drug Development Services.
Who are HLB Biostep's main competitors?
Direct peers on record are Pharmaron, WuXi AppTec, Shanghai Medicilon, Crown Bioscience (JSR Life Sciences), ICR (International Contract Research), Inotiv and Charles River Laboratories. Broad incumbents are Eurofins Scientific and Labcorp (Labcorp Drug Development / Covance). Biocytogen is listed as an emerging player.
Does HLB Biostep have an API?
No public API is recorded for HLB Biostep.
What industry is HLB Biostep in?
HLB Biostep's product category is Non-Clinical Contract Research (CRO). Its primary akta.pro industry code is HLAGAAAB, Preclinical CROs (Discovery/Pharmacology/DMPK), with a secondary code of HLAGAFAA, In Vivo Pharmacology (Efficacy/PD Models). Its NAICS code is 541714 and its SIC code is 8731.