What HistoTox Labs does

HistoTox Labs is a Boulder, Colorado-based provider of histology and histopathology services, founded in 2003. The firm operates as a specialized service line within the broader Inotiv, Inc. (NASDAQ: NOTV) discovery and development contract research organization (CRO) platform, which was formed in 2021 through the merger of Covance's Research Models and Services business with Envigo. HistoTox Labs delivers tissue processing, histology, and pathology services that support drug discovery and nonclinical development, with capabilities spanning histochemistry, immunohistochemistry (IHC), immunofluorescence (IF), in situ hybridization (ISH), and stereology. Its primary buyer base includes pharmaceutical and biotechnology companies, government agencies, and academic research institutions that require GLP-compliant testing for IND-enabling studies and regulatory submissions.

The company's core technical platform centers on whole slide imaging combined with AI-driven quantitative image analysis, enabling automated and reproducible pathology assessment. Supporting infrastructure includes the proprietary Eusoft Labs laboratory information management system (LIMS) and LabTracks research model tracking software, both of which integrate laboratory data and workflow management. Adjacent capabilities include DMPK (in vitro and in vivo), safety pharmacology, genetic toxicology, developmental and reproductive toxicology, carcinogenicity studies, bioanalysis for small and large molecules, SEND-compliant reporting, predictive and computational toxicology, and medical device testing. Recent product expansions include Cell and Gene Therapy safety assessment and mass spectrometry assays covering 27 antibody-drug conjugate target proteins for oncology and other therapeutic applications.

Commercially, HistoTox Labs generates revenue through project-based service contracts as part of Inotiv's CRO portfolio, with the broader platform reporting $120.9 million in Q1 FY2026 revenue (up 0.8% year-over-year) and securing $65 million in new money financing commitments in June 2026. Distribution relies primarily on direct enterprise field sales targeting scientific decision-makers at pharmaceutical, biotech, government, and academic buyers, supported by scientific content marketing, conference presence (e.g., Society of Toxicologic Pathologists, International Conference on Environmental Mutagens), webinars, and downloadable technical resources. Pricing is quote-based rather than publicly disclosed, consistent with multi-year program contracts typical of regulated nonclinical research outsourcing.

Name

HistoTox Labs

Legal name

Inotiv, Inc.

Website

https://histotoxlabs.com

Company type

Public

Founded year

2021

Operating status

Operating

Headcount range

11–50 employees

Short description

HistoTox Labs provides histology and histopathology services, including digital pathology with AI-driven image analysis, supporting pharmaceutical, biotech, government, and academic clients in drug discovery and nonclinical development.

Ownership category

akta.pro rank

Product category

Contract Research / Preclinical Laboratory Services

NAICS

Medical Laboratories (621511)

SIC

Services-Medical Laboratories (8071)

akta.pro primary industry

Pathology & Histopathology Services (HLAGAFAI)

akta.pro secondary industries

Anatomic Pathology & Histopathology (Trial Support) (HLAGAEAC), Anatomic Pathology (Histopathology & Cytopathology) (HLAFAMAA), Cytology & Histopathology Diagnostics (IHC, ISH, tissue-based assays) (HLAAALAI)

Keywords

• Histology services
• Histopathology services
• Preclinical research
• Contract research
• Digital pathology

Headquarters

HQ city

Boulder

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Discovery and Development Services: Contract research organization providing nonclinical and analytical services including toxicology, DMPK, histology, pathology, and bioanalysis. Revenue generated through project-based service contracts with pharmaceutical and biotech companies, government agencies, and academic institutions.
2. Research Models and Services: Sale of research models (animals) and related services including genetically engineered models, contract breeding, surgical services, and genetic testing. Revenue from model sales and associated support services.
3. Teklad Laboratory Animal Products: Laboratory animal diets, bedding, and environmental enrichment products sold to research institutions and pharmaceutical companies.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

HistoTox Labs is engaged in providing histology and histopathology services. The broader portfolio evidenced includes industry-leading histology laboratories, digital pathology with whole slide imaging and AI-driven quantitative image analysis, toxicology, drug metabolism and pharmacokinetics (DMPK), safety assessment, predictive and computational toxicology, discovery bioanalysis and biomarkers, and a comprehensive range of research models, served by an integrated discovery-through-clinical-development service model.

Product overview

HistoTox Labs operates as a discovery and development contract research organization (CRO) offering a comprehensive suite of laboratory services. The portfolio centers on histology, pathology, and toxicology services, including Digital Pathology with AI-driven image analysis, integrated with broader discovery services such as DMPK, safety assessment, and research models. Core offerings include Histology and Pathology Services, Digital Pathology, Toxicology Services, DMPK, Predictive and Computational Toxicology, Safety Assessment, Discovery Bioanalysis and Biomarkers, and Research Models, supported by add-on data management tools Eusoft Labs (LIMS) and LabTracks.

Differentiator

Problem solved

Functional benefit

Brands

• Teklad: Laboratory animal diets, bedding, and enrichment products
• Eusoft Labs
• LabTracks

Products and services

• Histology and Pathology Services Histology laboratory services supporting discovery and nonclinical development projects, covering a wide range of capabilities from tissue processing to digital analysis for pharmaceutical, biotech, government, and academic clients.
• Digital Pathology Whole slide imaging combined with precision AI-driven quantitative image analysis to support drug discovery and development projects.
• Toxicology Services General toxicology studies to evaluate the safety of drugs, medical devices, and other chemicals in accordance with international regulations (including GLP and non-GLP).
• Drug Metabolism and Pharmacokinetics (DMPK) In vitro and in vivo studies along with bioanalytical solutions spanning hit-to-lead through candidate selection.
• Pathology Services World-class anatomical, clinical, and medical device pathology team providing services from histochemistry to digital pathology, including IHC, IF, ISH, and stereology.
• Predictive and Computational Toxicology Computational approaches to predict and assess toxicological profiles of compounds.
• Safety Assessment Comprehensive safety assessment services integrating toxicology, pathology, bioanalysis, and program management.
• Discovery Bioanalysis and Biomarkers Bioanalytical services supporting discovery phases, including biomarker analysis capabilities.
• Research Models A comprehensive range of research models for pharmaceutical and biotech companies, government, academia, and life science organizations, including genetically engineered models and services (GEMS), contract breeding, surgical services, and genetic testing.

Segments4 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators4 records

Recent moves6 records

Expansion highlights4 records

Broad incumbents

• Inotiv: Inotiv is a publicly traded discovery and safety-assessment CRO with significant histopathology and digital pathology capabilities. It is comparable to HistoTox Labs as a histopathology service provider but operates at materially larger scale and across a broader service portfolio.
• Labcorp Drug Development (formerly Covance): Labcorp Drug Development operates a global nonclinical CRO business that includes histopathology and anatomic pathology support for regulated studies. It is comparable to HistoTox Labs in the same histopathology service category but at vastly greater scale.
• WuXi AppTec: WuXi AppTec is a global CRO/CDMO with preclinical pathology and toxicology services supporting drug development. It overlaps with HistoTox Labs' histopathology focus but competes primarily at much larger contract scale and across broader geographies.
• Charles River Laboratories: Charles River is a large global CRO with established histology and pathology offerings within its safety assessment and research models services. It overlaps with HistoTox Labs in tissue-based preclinical analysis but serves a much broader customer base.

Direct peers

• Histo-Scientific Research Laboratories (HSRL): HSRL is a small, specialized histopathology and toxicologic pathology laboratory serving government, academic, and biopharma clients. It is directly comparable to HistoTox Labs in scale, focus, and customer profile as a niche GLP-grade tissue analysis provider.
• Seventh Wave Laboratories: Seventh Wave is a small preclinical CRO with core capabilities in safety assessment, pharmacology, and pathology. It is comparable to HistoTox Labs as a similarly sized specialty lab serving pharmaceutical R&D clients with tissue-based endpoints.
• Tox Path Specialists: Tox Path Specialists is a veterinary and toxicologic pathology consultancy providing histopathology, peer review, and study support. It is closely comparable to HistoTox Labs as a small specialist in tissue-based toxicology analysis for regulated research.
• Experimental Pathology Laboratories (EPL): EPL provides preclinical and toxicologic pathology services, including histology, immunohistochemistry, and peer review for regulated studies. Like HistoTox Labs, it is a focused pathology lab serving pharmaceutical and chemical industry safety programs.

Market position

Strengths3 records

Weaknesses4 records

Competitive moat6 records

Key risks3 records

Key highlights4 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

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

M&A

Investments

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

Frequently asked questions about HistoTox Labs