Insilica
Insilica builds AI-driven toxicology software (BioBricks, ToxIndex, Sysrev) that automates regulatory-grade chemical safety assessments for regulatory agencies and chemical manufacturers, reducing evaluation timelines from months to hours.
- Company typePrivate
- Founded2015
- HeadquartersBethesda, United States
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What Insilica does
Insilica is a bioinformatics and regulatory-technology company that has built an integrated three-product platform (BioBricks, ToxIndex, Sysrev) to automate regulatory-grade chemical safety assessment. The company addresses a documented toxicology capacity crisis — over 88% of EPA chemical reviews are overdue, only ~9,000 toxicologists serve North America, and ~86,000 chemicals sit in the EPA inventory. Its ToxIndex platform, commercially launched in March 2026, is an agentic AI system that uses nine specialized agents to coordinate literature retrieval, database lookups, and predictive models for metabolism, QSAR, and ADME, generating OEL/HBEL reports and REACH dossiers in hours rather than months. BioBricks provides the underlying FAIR-compliant data infrastructure with 135+ curated toxicology datasets, while Sysrev delivers human-in-the-loop expert validation producing auditable provenance chains required for regulatory submissions.
Insilica firmographics
Firmographics- Name
- Insilica
- Legal name
- Insilica, LLC
- Website
- https://insilica.co
- Company type
- Private
- Founded year
- 2015
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Insilica builds AI-driven toxicology software (BioBricks, ToxIndex, Sysrev) that automates regulatory-grade chemical safety assessments for regulatory agencies and chemical manufacturers, reducing evaluation timelines from months to hours.
- Ownership category
- akta.pro rank
Insilica industry classification
Industry- Product category
- Computational Toxicology Software
- NAICS
- Testing Laboratories and Services (541380), Testing Laboratories and Services (54138)
- 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
- Chemical Hazard Risk Assessment (Residues, Toxins, Adulterants) (AFALAOAB), Method Development & Validation (ICH/USP) (HLAGADAB)
Keywords
Where Insilica is headquartered
LocationHeadquarters
- HQ city
- Bethesda
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Insilica business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure
Revenue model
- ToxIndex Platform Subscription: Regulatory-grade chemical safety report generation platform. Generates OEL/HBEL reports and REACH dossiers. Assessment time reduced from months to hours.
- Data Infrastructure (BioBricks): Curated toxicology datasets provided as FAIR-compliant data infrastructure, powering analysis and eliminating data wrangling.
- Expert Validation Services (Sysrev): Human-in-the-loop validation services where toxicologists review and validate AI outputs for regulatory submissions.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Quote-based enterprise pricing for regulatory-grade risk assessments |
Go-to-market motion2 records
Distribution channels3 records
Marketing channels4 records
Insilica product offering
Product offeringCore offering
Insilica sells an integrated three-product platform for regulatory-grade chemical safety assessment. ToxIndex uses agentic AI to transform a single query into complete risk assessments, OEL/HBEL reports, REACH dossiers, and Data Evaluation Records in hours rather than months. BioBricks provides the underlying FAIR-compliant data infrastructure (135+ curated toxicology datasets), and Sysrev delivers human-in-the-loop expert validation producing the auditable trails that regulatory submissions require.
Product overview
Insilica offers an integrated three-product platform for automated chemical safety assessment: BioBricks provides curated data infrastructure with 135+ toxicology datasets; ToxIndex delivers automated risk assessments using specialized AI agents that coordinate literature retrieval, database lookups, and QSAR/ADME models; Sysrev provides expert validation through human-in-the-loop review. Together these products form end-to-end automation from evidence synthesis through regulatory submission.
Differentiator
Problem solved
Functional benefit
Brands
- BioBricks: Data infrastructure for chemical safety. Curated toxicology datasets (135+ and growing) aggregated into a single FAIR-compliant, queryable schema.
- ToxIndex
- Sysrev
Products and services
- ToxIndex Agentic AI platform for chemical safety assessment that turns a single query into a regulatory-grade risk assessment, OEL/HBEL report, REACH dossier, or Data Evaluation Record. Uses nine specialized AI agents to coordinate literature retrieval, database lookups, and QSAR/ADME/metabolism models. Built for toxicologists at regulatory agencies, chemical manufacturers, pharmaceutical companies, and research consortia.
- BioBricks FAIR-compliant data infrastructure providing 135+ curated toxicology datasets in queryable format, eliminating months of data wrangling and powering Insilica's AI models and ToxIndex platform.
- Sysrev Human-in-the-loop expert validation platform where toxicologists review and validate AI-generated outputs, catching errors and producing the defensible audit trails required for regulatory submissions.
Quantifiable outcome
- Assessment time reduced from months to hours
- +3 more outcomes
Companies that use Insilica
Customer profileNamed customers4 records
Segments4 records
Ideal customer profiles4 records
Insilica technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability5 records
Feature5 records
Insilica partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered core.
- Johns Hopkins Bloomberg School of Public HealthcoreDr. Thomas Hartung, Professor at Johns Hopkins Bloomberg School of Public Health, co-authored the Evidence-based AI framework paper with Insilica CEO Dr. Thomas Luechtefeld. Dr. Hartung described ToxIndex as 'the most credible answer I have seen to the hallucination problem in high-stakes science.'
- NICEATM (National Toxicology Program's Interagency Center for Evaluation of Alternative Toxicological Methods)coreNICEATM is helping guide technology development for the BioBricks-OKG knowledge graph. They are addressing needs in toxicology space for a data ecosystem to integrate new approach methodology (NAM) technologies spanning in vitro, in silico, and in chemico methods.
- ONTOX Project (EU Horizon)coreEU Horizon funded project for building ontologies into toxicology. Insilica's BioBricks.ai acts as the big data platform for ONTOX, providing data infrastructure for non-animal toxicology methods development.
Scale indicators7 records
Recent moves6 records
Expansion highlights6 records
Insilica competitors and assessment
Company assessmentDirect peers
- Simulations Plus (Certara): Provides AI-driven ADMET, QSAR, and physiologically-based pharmacokinetic modeling software widely used for chemical and drug safety assessment. Closely comparable to Insilica's ToxTransformer and ToxIndex products, which similarly apply computational models to predict toxicity endpoints and generate regulatory-grade reports.
- Lhasa Limited: Not-for-profit organization offering Derek Nexus and Sarah Nexus, knowledge-based expert systems for toxicity prediction and mutagenicity assessment widely used by pharmaceutical and chemical companies. Directly comparable as an established computational toxicology platform targeting the same regulatory submission workflows as Insilica's ToxIndex.
- Instem: Supplies SaaS solutions for preclinical and toxicology workflows including study management, data capture, and SEND submissions, with acquired QSAR assets (Leadscope, MultiCASE). Comparable as a software vendor serving the same toxicology customers and integrating computational safety assessment with regulatory data management, mirroring Insilica's BioBricks + ToxIndex + Sysrev stack.
Emerging players
- Toxys: Dutch biotechnology company offering in vitro and in silico toxicology services, including reporter-based assays and computational tools for developmental and reproductive toxicology. Partially comparable as a non-animal toxicology provider that combines experimental and computational methods, intersecting with Insilica's alternative methods focus.
Broad incumbents
- Charles River Laboratories: Global CRO with a large safety assessment business delivering in vivo and in vitro toxicology services to pharmaceutical, chemical, and consumer-products clients. Comparable as a broader incumbent offering the same end customer outcomes (regulatory safety assessment) via services rather than software, but at a different scale and delivery model.
- Labcorp Drug Development: Operates one of the largest CRO safety assessment and toxicology service businesses globally, serving pharmaceutical and chemical clients. Comparable as an incumbent serving the same regulatory customer workflows, with potential to add AI-driven assessment capabilities that could compete with Insilica's ToxIndex.
- Inotiv: Contract research organization providing toxicology, discovery, and research models services to pharmaceutical and chemical clients. Comparable as an incumbent toxicology services provider whose enterprise customer relationships could be leveraged to introduce in-house AI-driven assessment competing with Insilica.
- Schrödinger: Applies physics-based and AI computational chemistry platforms to drug discovery and materials science, with growing interest in predictive toxicology and ADMET. Comparable as an AI-driven scientific platform whose chemistry and biology modeling stack overlaps with Insilica's computational toxicology positioning, albeit with a much broader drug discovery focus.
- Dassault Systèmes BIOVIA: Provides scientific informatics platforms for chemistry, biology, and materials research including toxicology data management and QSAR tools. Comparable as an established scientific software suite that addresses similar chemical safety and life sciences R&D workflows, with potential to integrate AI agents comparable to Insilica's ToxIndex.
Others
- Elsevier (Reaxys): Provides one of the largest chemistry and regulatory literature databases, including Reaxys and Embase, which Insilica's ToxIndex agents query among its 2,000+ data sources. Adjacent as a critical data and content provider underpinning Insilica's evidence-gathering workflows rather than a direct competitor.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Insilica social profiles
Digital presenceInsilica financial estimates
Financial estimateRevenue estimate
Valuation estimate
Insilica leadership team
Management profileNumber of profiles
Profiles2 records
Insilica funding detail
Funding detailFunding overview
Funding rounds6 records
Investors2 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Insilica M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Insilica
What does Insilica do?
Insilica sells an integrated three-product platform for regulatory-grade chemical safety assessment. ToxIndex uses agentic AI to transform a single query into complete risk assessments, OEL/HBEL reports, REACH dossiers, and Data Evaluation Records in hours rather than months. BioBricks provides the underlying FAIR-compliant data infrastructure (135+ curated toxicology datasets), and Sysrev delivers human-in-the-loop expert validation producing the auditable trails that regulatory submissions require.
Is Insilica a public or private company?
Insilica is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Insilica founded?
Insilica was founded in 2015. It employs 11 to 50 people.
Where is Insilica based?
Insilica is headquartered in Bethesda, United States, in the North America region.
How does Insilica make money?
Three revenue lines are on record. ToxIndex Platform Subscription is the primary driver. The others are data Infrastructure (BioBricks) and expert Validation Services (Sysrev).
Who are Insilica's main competitors?
Direct peers on record are Simulations Plus (Certara), Lhasa Limited and Instem. Toxys is listed as an emerging player. Broad incumbents are Charles River Laboratories, Labcorp Drug Development, Inotiv, Schrödinger and Dassault Systèmes BIOVIA. Elsevier (Reaxys) is listed as an others.
Does Insilica have an API?
No public API is recorded for Insilica.
What industry is Insilica in?
Insilica's product category is Computational Toxicology Software. Its primary akta.pro industry code is HLAGAAAC, Toxicology & Safety Assessment CROs (GLP), with a secondary code of AFALAOAB, Chemical Hazard Risk Assessment (Residues, Toxins, Adulterants). Its NAICS code is 541380 and its SIC code is 8731.