What StageBio does

StageBio is a privately held, GLP-compliant contract research organization specializing exclusively in histopathology, toxicologic pathology, and specimen archiving services for the biopharmaceutical, medical device, and broader life sciences sectors. The company is operated by HSRL Holdings LLC, headquartered in Frederick, Maryland, with additional US operations in Maurertown, Virginia and a European facility in Freiburg, Germany acquired through TPL Path Labs in October 2020. The platform combines board-certified pathology expertise (20+ board-certified pathologists supporting toxicologic, neuro-, and ocular pathology), a 50,000+ slides-per-month histology laboratory, biorepository storage exceeding 250,000 cubic feet across -210°C to ambient conditions, whole slide imaging, and quantitative image analysis powered by Visiopharm's Biotopix AI platform. Service offerings include consulting, necropsy, histology, pathology evaluation (with SEND-ready reporting via Xybion Pristima or Instem Provantis), IHC/IF/ISH, neuropathology, medical device evaluation, ocular histopathology, and emerging spatialomics/multiplex immunofluorescence work.

StageBio operates a sales-led, consultative go-to-market organized around enterprise biopharma sponsors, medical device developers (1,000+ medical device studies per year across cardiovascular, musculoskeletal, ocular, wound healing, and biocompatibility applications), other CROs requiring pathology subcontracting, and government or academic research centers. It does not publish pricing; engagements are quote-based, scope-driven GLP study contracts. The company extends commercial reach through industry conference participation (NSH, AAIC, EuroTox), webinars, a quarterly newsletter, and an active LinkedIn presence, while thought-leadership recognition — including Lead Scientist Brian Tabb's 2026 NSH President's Award — reinforces technical credibility within the histotechnology community.

Revenue is generated from professional-services contracts covering IND, NDA, and 510(k)/PMA submission-supporting toxicologic pathology, complemented by long-tail biorepository storage and spatialomics analysis streams. The company has completed more than 5,000 studies across its roughly 27-year operating history. Two recent tuck-in acquisitions — Alizée Pathology (November 2019) and TPL Path Labs (October 2020) — expanded the US footprint and added European operations, while technology partnerships with Visiopharm (AI image analysis), LockBox (Part-11 LIMS sample tracking), Xybion Pristima, Instem Provantis, and Rees Scientific support integrated, audit-ready delivery. StageBio is privately held under HSRL Holdings LLC, does not disclose revenue, and has no public funding history.

Name

StageBio

Legal name

HSRL Holdings LLC

Website

https://stagebio.com

Company type

Private

Founded year

1998

Operating status

Operating

Headcount range

101–250 employees

Short description

StageBio is a privately held, GLP-compliant CRO specializing in histopathology, toxicologic pathology, and biorepository services for biopharmaceutical, medical device, biotech, government, and academic sponsors across the US and Europe.

Ownership category

akta.pro rank

Headquarters

HQ city

Mount Jackson

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Professional Services (CRO): StageBio generates revenue primarily through professional services contracts as a GLP-compliant CRO. Revenue is project-based and earned through fee-for-service study contracts with biopharma companies, medical device developers, and research institutions. Contracts cover histopathology studies, toxicologic pathology assessments, and custom research programs.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

StageBio is a GLP-compliant Contract Research Organization (CRO) that delivers preclinical histopathology, toxicologic pathology, and specimen archiving services to biopharmaceutical, medical device, and biotechnology sponsors. Its integrated service portfolio spans consulting, necropsy, histology, board-certified pathology evaluation, IHC/IF/ISH, neuropathology, medical device and ocular pathology, digital whole slide scanning, AI-powered image analysis, and biorepository storage from discovery through regulatory submission.

Product overview

StageBio is a GLP-compliant Contract Research Organization (CRO) specializing exclusively in histopathology and comprehensive sample management. The company operates as a unified service portfolio combining expert histopathopathology, pathology-driven insights, and secure archiving/biorepository solutions. Core services include Consulting, Necropsy, Histology, Pathology Evaluation, and Biorepository & Archiving, supported by specialty offerings in IHC/IF/ISH, Neuropathology, Medical Device Evaluation, and Ocular Histopathology. Supporting capabilities include Digital Pathology (Whole Slide Scanning) and Image Analysis using Visiopharm Biotopix™. The 2020 acquisition of TPL Path Labs (Freiburg, Germany) expanded European operations and added molecular pathology services. With 20+ board-certified pathologists and 50+ research scientists across US and Germany facilities, StageBio supports pharmaceutical, biotechnology, and medical device sponsors from discovery through regulatory submission.

Differentiator

Problem solved

Functional benefit

Products and services

• Consulting Services Expert guidance for preclinical research including GLP training, facility audits, compliance advice, protocol review, non-clinical study monitoring, and CRO/vendor selection support. Pathology consulting available from board-certified pathologists for study protocol development through regulatory submission.
• Necropsy Services Professional prosector services with a traveling necropsy team supporting species including mouse, rat, ferret, guinea pig, pig, rabbit, dog, and non-human primate. Includes necropsy supervision by board-certified veterinary pathologists.
• Histology Services High-quality tissue processing, embedding, sectioning, and staining including bone decalcification, oversized tissue processing in paraffin and plastics, hundreds of special stains, and GLP-compliant workflows. Prepares 50,000+ slides monthly with microscopic quality control review.
• Pathology Evaluation Microscopic and digital tissue evaluation by board-certified pathologists for GLP and non-GLP regulatory and investigative projects. Services include toxicologic pathology, carcinogenicity studies, medical device evaluation, IHC/IF/ISH, peer review, and SEND-ready reporting using Xybion Pristima or Instem Provantis.
• Biorepository & Archiving Services Comprehensive sample and study material storage with ambient, cold (5°C to -20°C), ultra-low (-80°C), and liquid nitrogen (-210°C) storage solutions across more than 250,000 cubic feet of storage space. Includes 24/7 monitoring, chain-of-custody, LIMS tracking, and temperature-controlled shipping.
• IHC/IF/ISH Services Immunohistochemistry, immunofluorescence, and in-situ hybridization with 300+ validated antibody biomarkers across oncology, neuroscience, inflammation, fibrosis, and vascular biology applications. Includes multiplex IF panels (2-8+ targets), TSA-based amplification, and GLP-compliant development.
• Neuropathology Services Specialized CNS and PNS pathology with 15+ years of experience supporting 200+ GLP/non-GLP neuropathology studies annually. Includes perfusion fixation, brain/spinal cord trimming, nerve dissection, osmicated resin embedding, developmental neurotoxicity, and validated biomarker panels (NeuN, MAP2, GFAP, IBA-1, MBP).
• Medical Device Evaluation Services GLP-compliant pathology for medical devices with 1,000+ studies completed to date, including approximately 70 cardiovascular, 20 musculoskeletal, and 25 wound healing studies per year. Services include necropsy, optimized histology, IHC, Spurr/MMA embedding, digital radiography, microCT, morphometry, and pathology peer review.
• Ocular Histopathology Services Specialized ocular pathology with approximately 10 BCOP studies and ocular device/implant studies annually, supporting disease models including glaucoma, AMD, diabetic macular edema, and diabetic retinopathy, and administration routes including intravitreal, subretinal, and suprachoroidal. Services include evaluation of contact lenses, IOLs, keratoprostheses, and retinal prostheses.
• Image Analysis & Morphometry Quantitative image analysis using Visiopharm Biotopix AI software for cell counting (CD31, Ki67, BRDU), apoptosis quantification, immunophenotyping, stem cell biodistribution, GFAP/Beta-amyloid quantification, fibrosis scoring, and wound healing assessment. Data delivered in Excel or graph format with statistical analysis.
• Whole Slide Scanning Digital conversion of glass microscope slides to high-resolution images using high-capacity scanners, supporting brightfield and multiplex fluorescence (up to 6 channels) at 20X/40X magnification. Single (1x3) and double-width (2x3) slides supported, with online viewing and remote sharing via image management software.

Quantifiable outcome

• 5,000+ studies completed across 27 years
• +4 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration5 records

AI capability5 records

Feature4 records

Partnerships

Four partnerships are on record, tiered core, strategic and supporting.

• TPL Path LabscoreOthersStageBio acquired TPL Path Labs, significantly expanding its national footprint in histopathology services. The acquisition brought additional laboratory capacity, enhanced biorepository and archiving services, and a broader geographic service reach across the United States. TPL Path Labs is now fully integrated into StageBio's service portfolio, strengthening its position as a leading GLP-compliant CRO specializing in histopathology and toxicologic pathology.
• LockBox (LIMS® Sample Tracking)coreTechnology or IntegrationLockBox is a LIMS-certified sample tracking system used by StageBio to provide chain-of-custody tracking, barcode-driven sample management, and integrated reporting for study specimens. This integration supports GLP compliance and data integrity for client studies.
• Visiopharm (Biotopix™)strategicTechnology or IntegrationStageBio has partnered with Visiopharm to integrate its Biotopix™ AI-powered image analysis solution into StageBio's digital pathology workflow. Biotopix™ enables quantitative histopathology biomarker evaluation, computer-assisted scoring, and multiplex immunofluorescence analysis, extending StageBio's capabilities in spatialomics and advanced tissue analysis.
• Spatialomics Analysis PartnerssupportingTechnology or IntegrationStageBio collaborates with specialized spatialomics analysis technology providers to deliver multiplex immunofluorescence (2–8+ targets) and spatial tissue analysis services. These partnerships enable StageBio to offer advanced biomarker profiling across 300+ validated biomarkers in 15+ species, supporting translational research programs for biopharma and biotech clients.

Scale indicators10 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• Charles River Laboratories: Large preclinical CRO offering toxicology, pathology, and safety assessment services across a global lab network. Overlaps directly with StageBio's GLP toxicologic pathology and histology offerings, but operates at significantly greater scale and broader service breadth.
• Labcorp Drug Development (formerly Covance): Global CRO with extensive preclinical and clinical laboratory services, including histopathology and anatomic pathology capabilities for regulatory submissions. Provides overlapping but broader-scope competition to StageBio's preclinical-focused service portfolio.
• WuXi AppTec: Global contract research organization providing preclinical toxicology, pathology, and bioanalysis services for biopharma sponsors. Competes with StageBio in GLP-compliant toxicologic pathology, particularly for sponsors seeking integrated preclinical-to-clinical pathways.

Direct peers

• Inotiv: Preclinical CRO and research models provider with a dedicated histopathology and pathology services practice serving biopharma and medical device sponsors. Competes head-to-head with StageBio on GLP toxicologic pathology, IHC, and medical device evaluation studies.
• Toxikon: Preclinical CRO specializing in GLP toxicology, medical device safety evaluation, and histopathology services. Direct competitor for medical device biocompatibility studies and ISO 10993 histopathology work that anchors StageBio's medical device franchise.
• HistoTox Labs: Specialized GLP-compliant histopathology and toxicologic pathology CRO serving biopharma and medical device sponsors. Closely comparable niche positioning to StageBio, with overlapping capabilities in IHC, special stains, and regulatory pathology.
• IDEXX BioAnalytics: Specialty laboratory services provider offering histology, pathology, and biomarker analysis for research and preclinical studies. Comparable in offering GLP-adjacent histopathology, IHC/IF, and image analysis services to biopharma and academic clients.
• Premier Laboratory: GLP-compliant histopathology and toxicologic pathology CRO serving biopharma and medical device sponsors. Direct niche competitor for board-certified pathology services, IHC, and regulatory-submission-ready pathology reports.
• EPL (Experimental Pathology Laboratories): Long-standing GLP histopathology and toxicologic pathology CRO with strong reputation in regulatory pathology for biopharma sponsors. Direct peer for toxicologic pathology, peer review, and SEND-compliant pathology reporting services.

Emerging players

• BRIDGE PTS (Pathology and Toxicology Solutions): Specialty CRO providing pathology and toxicology services to medical device and pharmaceutical companies. Closely comparable in service scope (GLP histopathology, medical device studies) but smaller scale than StageBio.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xtwitter.com/stagebio_cro
• LinkedInlinkedin.com/company/stagebio

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles15 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

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

M&A2 records

Investments

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

Frequently asked questions about StageBio