BioToxTech to Triple U.S. and European Non-Clinical Orders... Advancing as a Global Top-Tier CRO

BioToxTech is ramping up its efforts to penetrate the global non-clinical contract research organization (CRO) market, focusing primarily on the United States and Europe. Building on its experience with U.S. Food and Drug Administration (FDA) Good Laboratory Practice (GLP) inspections, the company has established a competitive advantage in quality. It is also expanding its testing services into high value-added advanced modalities such as antibody-drug conjugates (ADC), antisense oligonucleotides (ASO), and gene therapies, thereby growing the scale of its overseas order volume.

The company expects its 2026 non-clinical order volume in the U.S. and Europe to increase by approximately three times, or 200%, year-on-year, driven by the influx of new global clients and a series of large follow-up projects.

This expansion in overseas orders stems from BioToxTech’s broadened testing portfolio, which has moved from a focus on small-molecule synthetic drugs to advanced bio-pharmaceuticals. The company has established capabilities to test a wide range of modalities, including ADCs, ASOs, peptides, next-generation vaccines, and gene therapies.

Advanced modalities require higher levels of technical expertise and involve more complex evaluation criteria compared to standard non-clinical tests. As a result, the company reports that average order prices and profit margins are also relatively higher. This creates a structure in which the increase in new orders contributes not only to top-line growth but also to improved operating margins.

The overseas customer base is also rapidly diversifying beyond Japan to include the United States, Europe, and Singapore. By expanding cooperation with overseas biotech companies, BioToxTech is broadening its global business by securing follow-up pipelines in addition to standalone tests.

Experience in meeting the quality standards set by global regulatory agencies is cited as another key advantage. Among domestic private non-clinical CROs, BioToxTech possesses a quality management infrastructure that has passed on-site GLP inspections by the U.S. FDA.

From 2023 to September 2026, a total of 25 non-clinical datasets generated by BioToxTech have been utilized in the approval procedures of global regulatory agencies. Specifically, these include 18 cases for overseas Investigational New Drug (IND) applications and seven cases for New Drug Application (NDA) and Biologics License Application (BLA) submissions. The company highlights this as key track record evidence of the reliability of its non-clinical data in the global market.

In the second half of this year, there has also been an increase in facility and quality system audits by major U.S. and European biotech clients. As facility audits of non-clinical CROs are often conducted before actual project awards, these are seen as leading indicators of potential future order growth.

BioToxTech is also strengthening its package-type business model, which provides multiple non-clinical services in one bundled offering. This includes general toxicity, safety pharmacology, genotoxicity, toxicokinetics (TK), bio-sample analysis, and preparation of SEND (Standard for Exchange of Nonclinical Data) datasets required for FDA submissions—all supported in a one-stop fashion.

Based on these strengths, the company plans to expand large-scale turnkey package and mid- to long-term project contracts with global pharmaceutical firms. By shifting from single-test services to comprehensive solutions that bundle multiple tests and data preparation, BioToxTech aims to expand its business scope and enhance both order volume and profitability.

A BioToxTech spokesperson stated, "Based on our accumulated experience and quality competitiveness gained from responding to global regulations, cooperation with overseas clients is expanding. We will further strengthen our ability to address diverse modalities, including ADCs, ASOs, and gene therapies, and continue to expand our global business, with a focus on package-type and mid- to long-term projects that go beyond individual testing."

This content was produced with the assistance of AI translation services.