hVIVO

What hVIVO does

hVIVO is a London-headquartered contract research organization founded in 1989 that specializes in human challenge trials — controlled clinical studies in which healthy volunteers are intentionally exposed to an infectious agent under quarantine to evaluate vaccines and antivirals — alongside Phase I-III clinical trial delivery, laboratory services, biobanking, and drug development consulting. The company operates purpose-built quarantine facilities in Canary Wharf and acquired German sites in Mannheim and Kiel via the January 2025 acquisition of CRS, integrating operations with Cryostore and Venn Life Sciences under a unified 'One hVIVO' brand. Its core technology platform comprises proprietary human challenge models for RSV, influenza, COVID-19, HRV, hMPV, malaria, and pertussis; a Bio-Rad Droplet Digital PCR-equipped CL3 laboratory; HTA-licensed multi-temperature cryostorage; and a volunteer database of 400,000+ individuals accessed through FluCamp (UK) and Probandeninfo (Germany).

The business earns revenue on a project-based, quote-driven professional-services model spanning clinical trial fees, human challenge study fees, laboratory and bioanalysis services, consulting, and biobank storage. Customers are global pharmaceutical companies, biotechnology sponsors, CROs, start-ups, and drug development investors, with named engagements including ILiAD Biotechnologies (Phase III BPZE1 pertussis study, 500+ participants), Traws Pharma (Phase 2a influenza antiviral study), and Decoy Therapeutics (consultancy on respiratory antiviral programs). FY2025 revenue was approximately £46.7 million with a £5.99m loss but a low single-digit positive adjusted EBITDA margin; the company reported £14.3m cash and a debt-free balance sheet, with management guiding high single-digit revenue growth for 2026.

hVIVO is a publicly traded subsidiary of Open Orphan Plc on the London Stock Exchange AIM Market under ticker HVO. Leadership comprises CEO Yamin Khan, CFO Stephen Pinkerton, CSO Andrew Catchpole, and Medical Director Mariya Kalinova, supported by a workforce in the 251-500 range. The company sells through enterprise field sales and business development, complemented by scientific publications, industry conferences (BIO, World Vaccine Congress, BIO-Europe), webinars, and workshops. Differentiation rests on world-leading human challenge trial expertise, purpose-built quarantine infrastructure, and an integrated four-line service platform that competitors cannot easily replicate at equivalent scale.

Name

hVIVO

Legal name

hVIVO Services Limited

Website

https://hvivo.com

Company type

Public

Founded year

1989

Operating status

Operating

Headcount range

251–500 employees

Short description

hVIVO is a London-headquartered contract research organization that runs controlled human challenge trials, Phase I-III clinical studies, and laboratory services for global pharmaceutical and biotechnology sponsors developing vaccines and antivirals against infectious and respiratory diseases.

Ownership category

akta.pro rank

Product category

Contract Research Organization Services

NAICS

Scientific Research and Development Services (5417), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Medical and Diagnostic Laboratories (6215)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Medical Laboratories (8071)

akta.pro industry

PRIMARYHLAGAAAA

Clinical CROs (Phase I–IV)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Research Organizations (CRO)

SECONDARYHLAGAAAE

Central Laboratory & Clinical Trial Testing CROs

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Research Organizations (CRO)

SECONDARYHLAIALAH

Regulatory Strategy & IND/NDA/BLA Submissions Support

Healthcare & Life Sciences/Pharmaceuticals/Pharmaceutical Research and Development

Keywords

• Human challenge trials
• Contract research organization
• Clinical trial services
• Infectious disease research
• Drug development consulting

Headquarters

HQ city

London

HQ country

United Kingdom

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Trial Services: Contract research fees for Phase I-III clinical trial delivery, including specialized early-phase and complex study designs. Revenue is project-based and recognized as services are delivered, with major contracts expecting recognition in H1 2026 and bulk flowing through 2026-2027.
2. Human Challenge Trial Services: Fees for conducting human challenge studies including virus production, participant screening and recruitment, quarantine facility access, and clinical delivery. The company signed its largest-ever Phase III human challenge trial contract with ILiAD Biotechnologies for the BPZE1 pertussis vaccine.
3. Laboratory and Bioanalysis Services: Comprehensive laboratory services including bioanalytical testing, virology, immunology, biomarker analysis, and PBMC processing. Fully integrated with clinical operations.
4. Drug Development Consulting: Strategic and scientific consultancy including regulatory affairs, CMC consulting, non-clinical development, biostatistics, and translational modeling and simulation.
5. Biobank and Storage Solutions: Cryostorage and biobanking services licensed by the HTA, providing secure biological sample and clinical material storage.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

hVIVO is a full-service early-phase Contract Research Organization (CRO) delivering human challenge trials, Phase I–III clinical trial services, drug development consulting, laboratory/bioanalysis services, and HTA-licensed biobanking and cryostorage to global pharmaceutical and biotechnology sponsors. Its flagship capability is world-leading controlled human infection models (human challenge trials) for infectious and respiratory diseases, delivered through purpose-built quarantine facilities in London, Mannheim, and Kiel.

Product overview

hVIVO is a full-service early-phase Contract Research Organization (CRO) operating under the unified 'One hVIVO' brand following acquisitions of CRS Mannheim & Kiel (January 2025) and Cryostore. The company offers an integrated platform combining five core service lines: Human Challenge Solutions (world-leading human challenge trial models for RSV, influenza, COVID-19, HRV, hMPV, malaria, and asthma/COPD), Clinical Trial Solutions (Phase I-III delivery), Drug Development Consulting (regulatory, CMC, due diligence), Laboratory Solutions (bioanalysis, virology, immunology with CL3 facilities), and Biobank/Storage Solutions (HTA-licensed cryostorage). Additional services include recruitment platforms (FluCamp in UK, Probandeninfo in Germany), and Integrated Solutions programs (Speed to Clinic Accelerator, Investor Readiness). The company supports six therapeutic areas: Infectious Diseases, Respiratory, Cardiometabolic, Women's Health, Renal & Hepatic, and Dermatology.

Differentiator

Problem solved

Functional benefit

Products and services

• Human Challenge Solutions World-leading human challenge trial models for generating early efficacy data and accelerating decision-making in drug development. Includes challenge models for RSV, influenza, COVID-19, HRV, hMPV, malaria, and asthma/COPD. Delivered to global pharma and biotech sponsors.
• Clinical Trial Solutions

Quantifiable outcome

• 500+ participants enrolled in single Phase III pertussis human challenge trial - largest ever
• +2 more outcomes

Named customers3 records

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Five partnerships are on record, tiered core.

• Decoy TherapeuticscoreStrategic or Co-development Partner · 1 June 2026Strategic partnership to advance Decoy Therapeutics' lead Designable Multi-Antiviral (D-MAV) candidate into Phase 1 first-in-human and Phase 2a proof-of-concept studies. hVIVO provides clinical development, regulatory strategy, and human challenge trial expertise. The collaboration combines Decoy's AI-enabled IMP³ACT platform with hVIVO's translational modeling and regulatory support across EMA, MHRA, and FDA pathways. Decoy intends to use outputs to support IND/CTA filings for respiratory antiviral programs.
• ILiAD BiotechnologiescoreStrategic or Co-development Partner · 22 April 2026hVIVO signed its largest-ever human challenge trial contract with ILiAD Biotechnologies for a pivotal Phase III study of the BPZE1 whooping cough vaccine. The study involves over 500 participants and marks the first pivotal Phase III human challenge study for Bordetella pertussis. hVIVO expects to begin recognizing revenue in H1 2026 with bulk flowing through 2026 and 2027.
• Traws PharmacoreStrategic or Co-development Partner · 14 April 2026hVIVO signed a clinical trial agreement with Nasdaq-listed Traws Pharma to conduct a Phase 2a influenza human challenge study of tivoxavir marboxil (TXM), an oral antiviral candidate targeting seasonal and avian flu. The randomized, double-blind, placebo-controlled trial recruits approximately 150 healthy volunteers at hVIVO's Canary Wharf quarantine facilities. Revenue expected to be recognized in H1 2026.
• CRS (Clinical Research Services)coreStrategic or Co-development Partner · 1 January 2025Acquired German company CRS in January 2025, expanding hVIVO's capabilities. The acquisition consolidated all operations under the unified 'One hVIVO' brand alongside existing Cryostore capabilities, creating an integrated four-line service platform.
• CryostorecoreStrategic or Co-development Partner · 1 January 2025Cryostore acquisition provided HTA-licensed cryostorage and biobanking services, which were integrated into the unified 'One hVIVO' brand along with CRS and existing hVIVO and Venn Life Sciences operations.

Scale indicators9 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Celerion: Celerion is an early-phase clinical CRO specializing in healthy volunteer studies, clinical pharmacology, and bioanalytical services. It directly overlaps with hVIVO's Phase I clinical trial and laboratory offerings and is one of the few CROs with comparable early-phase expertise.
• Quotient Sciences: Quotient Sciences is a UK-based early-phase CRO focused on accelerating drug development through integrated formulation, manufacturing, and clinical pharmacology services. It is comparable to hVIVO's early-phase clinical trial delivery and integrated platform strategy.
• Worldwide Clinical Trials: Worldwide Clinical Trials is a mid-sized global CRO delivering Phase I-III clinical trial services across multiple therapeutic areas. It is comparable to hVIVO's full-service Phase I-III clinical trial delivery and overlapping biotech/pharma client base.

Broad incumbents

• SGS Health Sciences (SGS Clinical Research): SGS operates a global clinical research and laboratory services business spanning Phase I-IV trials and central lab testing. As a broad incumbent with overlapping Phase I and bioanalytical offerings, it competes with hVIVO for certain early-phase and lab work, especially in Europe.
• Charles River Laboratories: Charles River is a leading early-phase CRO and preclinical services provider with global scale. It is broadly comparable to hVIVO's early-phase clinical and laboratory services, though Charles River's franchise is much larger and more diversified across preclinical, manufacturing, and discovery.
• ICON plc: ICON is one of the largest global CROs offering full-service Phase I-IV clinical research, laboratory, and consulting services. As a broad incumbent, it competes with hVIVO for pharma and biotech sponsor work and has substantially greater scale.
• IQVIA: IQVIA is the world's largest CRO with comprehensive Phase I-IV clinical, laboratory, data, and consulting capabilities. It competes with hVIVO across most service lines, though hVIVO's human challenge trial specialty is not a core IQVIA offering.
• Eurofins Scientific: Eurofins operates a global network of pharmaceutical and clinical laboratory testing services alongside its broader bioanalytical franchise. It is comparable to hVIVO's laboratory and bioanalytical offerings as a much larger incumbent in the testing services space.
• Medpace: Medpace is a mid-to-large full-service CRO with Phase I-IV capabilities and a strong biotech sponsor base. It overlaps with hVIVO's clinical trial delivery and biotech segment focus, though it does not offer HCT services.

Emerging players

• Frontage Laboratories: Frontage Laboratories provides bioanalytical, preclinical, and clinical laboratory services to pharma and biotech. It is comparable to hVIVO's laboratory services line and serves overlapping biotech sponsors, though it does not focus on human challenge trials.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/hvivo_uk
• LinkedInlinkedin.com/company/9400594

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Subsidiaries3 records

Funding overview

Funding rounds1 record

Investors1 record

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

M&A1 record

Investments2 records

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

Frequently asked questions about hVIVO