Growth is being fueled by stringent regulatory requirements, a global pivot toward animal-free safety assessment, and rising demand from pharmaceutical, cosmetics, and chemical sectors. Regulatory frameworks such as the US EPA’s New Approach Methods (NAM) directive, OECD test guideline approvals, and the EU Cosmetics Regulation are compelling sponsors to adopt cell-based assays over traditional animal studies, accelerating equipment investments in high-content screening systems, 3D microtissue bioreactors, and automated liquid-handling robots.
Chicago, Feb. 03, 2026 (GLOBE NEWSWIRE) — The global in-vitro toxicology testing market was valued at 26.00 billion in 2024 and is expected to reach US$ 57.55 billion by 2033, growing at a CAGR of 9.23% from 2025 to 2033.
Today, the global in-vitro toxicology testing market is being steered by tighter regulatory timelines and a marked pivot toward animal-free safety assessment. The US Environmental Protection Agency’s New Approach Methods workplan logged 236 in-vitro submissions in 2023, double the figure recorded four years earlier, and the agency confirms that every new pesticide active-ingredient dossier filed this year must include at least one cell-based toxicity study. On the equipment front, high-content screening imagers that can analyze 200,000 wells per day are now standard in tier-one laboratories, while 3D liver microtissue bioreactors have reached a throughput of 3,600 compounds per week, eliminating more than 7,000 rodent acute toxicity studies during 2022–2023 alone. The OECD’s 2023 approval of four additional in-vitro test guidelines is accelerating this transition.
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High Demand Drives Expansion in In-Vitro Toxicology: Pharma Reports Soar, Cosmetic Assays on the Rise
Pharmaceutical developers remain the dominant consumers across the global in-vitro toxicology testing market, submitting 14,300 in-vitro toxicity reports to the US Food and Drug Administration between January 2022 and March 2024, according to the agency’s Pharmacology/Toxicology evaluation logs. However, cosmetics and personal-care companies are rapidly growing, with the sharpest rise in assay volumes; Episkin’s Lyon facility alone supplied 76,000 reconstructed human epidermis units in 2023, an expansion of 9,500 units over the prior year that was absorbed by European and South-Korean formulators. Supply capacity is expanding to fulfill this pull: Charles River Laboratories raised its organ-on-a-chip suite from 12 to 28 instruments, while Chinese CRO JOINN tripled its microfluidic plate output to 1.2 million pieces annually, ensuring shorter lead times for high-throughput hepatotoxicity screens.
Non-Animal Testing Boom: NAM and OECD Guidelines Spur Equipment Orders and Investor Funding
Strict legislative timelines introduced between 2022 and 2024 are forcing sponsors in the in-vitro toxicology testing market to front-load projects with cell-based safety studies instead of conventional animal models. The US Environmental Protection Agency’s Revised NAM Directive, effective January 2024, rejects toxicology submissions lacking at least one validated in-vitro assay for acute, developmental, or endocrine endpoints.
During the first two quarters, the agency logged 1,940 NAM dossiers, up from 980 during the same period of 2022, covering industrial chemicals, crop-protection actives, and oil-field additives. In Europe, the Chemicals Strategy for Sustainability needs every new REACH registration above ten metric tons to include data from OECD Test Guidelines 442E or 497, and ECHA reports 6,800 such filings between June 2023 and April 2024. China’s Ministry of Ecology and Environment now requests domestically produced cosmetics to deliver results from the neutral red uptake phototoxicity assay before shelf clearance; the National Institutes for Food and Drug Control received 4,200 in-vitro phototoxicity reports in 2023 and projects 5,900 for 2024.
Compliance deadlines are translating directly into equipment orders in the in-vitro toxicology testing market. PerkinElmer shipped 142 Opera Phenix Plus high-content imagers to GLP facilities in North America and Western Europe in fiscal 2023, while Yokogawa augmented CellVoyager CV8000 production slots from 20 to 38 units to clear a 14-month backlog for contract research organizations. Charles River added 19,000 square feet to its Skokie toxicology hub to host 56 additional automated liquid-handling robots capable of processing 120,000 hepatocyte wells daily, enabling clients to replace 3,400 rodent acute-tox screens every twelve months. Investor interest follows the same trajectory: venture financing for non-animal safety platforms touched 1.7 billion dollars across 29 deals in 2023, according to PitchBook’s Toxicology Innovation dashboard, with Series C rounds for Emulate, MIMETAS, and TissUse collectively surpassing 410 million dollars. Market stakeholders positioned to supply reagents, imaging software, and regulatory consulting services around these mandates are capturing multi-year master-service agreements that lock in predictable assay volumes via 2027.
In-Vitro Assays Outperform Animal Tests: Faster, Cheaper, and Regulatory-Ready
Assays dominate the in-vitro toxicology testing market with more than 42.70% market share because they deliver the combination of regulatory confidence, functional speed, and economic efficiency that sponsors need to move compounds forward. The Organisation for Economic Co-operation and Development (OECD) has now validated seventy-four distinct in-vitro toxicology assays, up from forty-two only five years ago, giving regulators a well-defined menu of methods that can legally replace vertebrate studies. The U.S. Food and Drug Administration’s Pharmacology/Toxicology database logged 17,600 in-vitro assay data packages in 2023, a climb of 4,100 filings since 2021, and nearly all were tied to Investigational New Drug or 510(k) submissions.
Cost remains a pivotal driver: a standard Ames bacterial mutagenicity assay runs about 4,800 dollars per compound, whereas the corresponding rodent micronucleus test exceeds 62,000 dollars when animal housing and histopathology charges are included. Turn-around time is equally compelling; contract research organizations (CROs) such as Eurofins and Charles River quote five business days for a GLP-grade hepatotoxicity assay while delivering twenty-four-hour expedited service for screening campaigns, allowing agile portfolio decisions.
Strict Legislation and High R&D Spending Cement Europe’s Hold on Global In-Vitro Toxicology Market
Europe commands the in-vitro toxicology testing market via a nexus of strict legislation, deep R&D budgets, and a dense network of specialized labs. Market billings reached 9 919.1 million dollars in 2023 and are estimated to almost double by 2030, a trajectory propelled by mandatory non-animal data in the EU Cosmetics Regulation and the REACH chemical-safety framework. The region hosts more than thirty-three dedicated scientific facilities concentrated solely on alternative toxicology, giving sponsors immediate access to validated OECD assays and human-derived cell models.
Germany delivers the largest revenue slice, supported by Bayer, Merck KGaA, and more than 420 contract research sites that collectively processed an estimated 6 800 GLP in-vitro studies last year. Italy, France, the UK, and Spain follow closely, each anchored by at least one multinational cosmetics conglomerate that must submit thousands of dermal irritation and sensitization results annually to remain compliant with the EU animal-testing ban.
In-Vitro Toxicology Testing Market Major Players:
- Charles River
- Bio Rad Laboratories, Inc
- Abott
- Thermofisher Scientific Inc.
- Catalent Inc.
- GE Healthcare
- Eurofins Scientific
- Laboratory Corporation of America Holdings
- Evotec
- Genotronix
- BioIVT
- Merck
- Other Prominent Players
Key Market Segmentation:
By Solutions
- Equipment
- Assay
- Bacterial Toxicity Assays
- Protein Degradation
- GPCRs
- Nuclear Receptors
- Tissue Culture Assays
- Others
- Consumables
- Services
By Method
- Cellular Assay
- Biochemical Assay
- In Silicon
- Ex-Vivo
By Technology
- Cell Culture Technology
- High Throughput Technology
- OMICS Technology
By Toxicity Endpoint & Test
- ADME
- Skin Irritation, Corrosion & Sensitization
- Genotoxicity Testing
- Cytotoxicity Testing
- Ocular Toxicity
- Phototoxicity Testing
- Dermal Toxicity
- Others
By End User
- Pharmaceutical
- Cosmetics & Household
- Academic Institutes & Research Laboratories
- Diagnostics
- Chemicals Industry
- Food Industry
- Others
By Region
- North America
- Europe
- Asia Pacific
- Middle East and Africa
- South America
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