BioToxTech’s “FDA track record” pays off as U.S. and European orders triple

[Financial News]  BioToxTech is raising both the volume and quality of its orders in the U.S. and European nonclinical testing markets. Beyond simply expanding testing volume, the company is shifting its order portfolio toward high-value advanced drug fields, including antibody-drug conjugates (ADCs), antisense oligonucleotides (ASOs) and gene therapies.
BioToxTech said on the 30th that nonclinical testing orders from the United States and Europe are expected to increase approximately threefold year on year. Its overseas customer base, previously centered on Japan, is also expanding to the United States, Europe and Singapore.
The most notable change is the transformation in the composition of its orders. Its testing portfolio, once focused on small-molecule synthetic drugs, is expanding to include ADCs, ASOs, peptides, next-generation vaccines and gene therapies. Because advanced modalities require more sophisticated testing and generally command higher average selling prices (ASPs) than standard studies, the company expects to improve profitability alongside overseas revenue.
The company has also built a track record in addressing global regulatory requirements. From 2023 through September this year, data from 25 nonclinical studies conducted by BioToxTech were used in regulatory approval processes worldwide, including 18 overseas Investigational New Drug applications (INDs) and seven product-approval applications—New Drug Applications (NDAs) and Biologics License Applications (BLAs). BioToxTech also has experience with on-site inspections under the U.S. Food and Drug Administration’s (FDA) Good Laboratory Practice (GLP) standards.
The increase in overseas client audits, which precede orders, is also drawing attention. The company explained that facility and quality-system audits by biotech firms in the United States and Europe have increased in the second half of the year, raising the prospects for additional follow-up contracts.
BioToxTech provides a comprehensive range of services, from general toxicology, safety pharmacology, genotoxicity, toxicokinetics (TK) and bioanalytical analysis to preparing Standard for Exchange of Nonclinical Data (SEND) datasets for FDA submissions. Its strategy is to increase the share of package-based projects, which involve larger contracts and longer execution periods than individual studies.
“As study designs become more complex for modalities such as ADCs and gene therapies, regulatory experience and the ability to conduct multiple studies as an integrated package become more important than price alone when selecting a contract research organization (CRO),” said a source in the biotech industry. “The key indicator of future growth will be whether audits by global clients translate into actual long-term and package contracts.”
A BioToxTech representative added, “We are strengthening our capabilities to handle various modalities, including ADCs, ASOs and gene therapies. We will expand our global business around package-based and mid- to long-term projects, moving beyond individual studies.” 


[email protected] Kim Kyung-a Reporter