BioToxTech Targets 200% Growth in U.S. and European Non-Clinical CRO Orders With Bundled Turnkey Package Model

• BioToxTech (KOSDAQ), South Korea’s largest private non-clinical CRO and the only Korean private institution with U.S. FDA GLP accreditation and Full AAALAC Accreditation, is targeting an approximately 200% year-on-year increase in U.S. and European non-clinical order volume for 2026 — driven by a strategic shift from single-test services toward bundled IND-enabling packages and mid- to long-term turnkey contracts with global pharmaceutical partners.

• The company’s bundled package model consolidates general toxicity, safety pharmacology, genotoxicity, toxicokinetics, bio-sample analysis, and FDA-compliant SEND dataset preparation into a single integrated offering — with a measurable increase in facility and quality system audits by major U.S. and European biotech clients signaling strong near-term order conversion.

BioToxTech (KOSDAQ), South Korea’s largest private non-clinical CRO and parent of the BTT Group, announced on September 30, 2026, a major strategic reorientation toward bundled package-type and comprehensive turnkey non-clinical solutions — targeting an approximately 200% year-on-year increase in U.S. and European non-clinical order volume as it advances its positioning as a global top-tier CRO. The shift moves BioToxTech away from single-test service delivery toward integrated, mid- to long-term contract structures designed to serve the full IND-enabling non-clinical requirements of global pharmaceutical and biotechnology partners in a single, coordinated outsourcing relationship.

The commercial engine of the strategy is a bundled package model that consolidates what would traditionally be separate outsourced studies — general toxicity, safety pharmacology, genotoxicity, toxicokinetics, bio-sample analysis, and FDA-compliant Standard for Exchange of Nonclinical Data dataset preparation — into one integrated offering under a single CRO contract. For U.S. and European sponsors, the practical impact is a significant reduction in vendor coordination, data fragmentation, and submission preparation burden. SEND dataset preparation is embedded directly into the package, addressing one of the most operationally demanding regulatory requirements in the FDA IND and NDA submission process and positioning BioToxTech as a one-stop non-clinical submission partner rather than a test execution provider.

A leading operational indicator of the growth trajectory is audit activity. BioToxTech has reported a measurable increase in facility and quality system audits being conducted by major U.S. and European biotech clients — a direct precursor to order conversion, as global sponsors typically complete their qualification audits before committing to large-scale or long-term non-clinical outsourcing engagements. The company views this pattern as key evidence that its non-clinical data track record — built through hundreds of regulatory submissions to the U.S. FDA, Japan PMDA, and European authorities — is gaining recognition in international markets where regulatory credibility and GLP compliance are non-negotiable prerequisites for vendor selection.

BioToxTech’s BTT Group brings complementary capabilities across its three-entity structure. BioToxTech provides the full scope of IND and NDA-enabling toxicology, including subacute, subchronic, chronic, carcinogenicity, reproductive, and developmental toxicology. Keyfronbio, its non-clinical pharmacology subsidiary, covers efficacy studies, PCR-based biodistribution studies for cell and gene therapies, and GLP-compliant bioanalysis. Keyprime Research extends the group’s capabilities into NHP-based toxicology, efficacy studies for complex biologics, and rodent and NHP inhalation toxicology. Together, the BTT Group covers the full preclinical non-clinical services spectrum from early pharmacology through full IND-enabling regulatory packages.

“BioToxTech expects its 2026 non-clinical order volume in the U.S. and Europe to increase by approximately three times, or 200%, year-on-year. The company highlights this as key track record evidence of the reliability of its non-clinical data in the global market.”

BioToxTech, the company stated