Biomarker R&D image

A biomarker is an index of biological changes that can be used as a guide to indicate the presence or absence of a certain disease or its progress. It has become an indispensable tool for diagnosing diseases, analyzing the mechanism of action of drugs, confirming the response to therapeutic interventions, and evaluating the safety and toxicity of drugs.

The Biomarker R & D Department is conducting research and development centered on the technologies of molecular markers (substances in blood, etc.) and imaging markers (PET *, MRI ** tests, etc.). We have established highly practical new biomarkers focusing on infectious diseases, psychiatric and nervous system diseases, and new growth areas (cancer, etc.), which we are currently focusing on, and improve the accuracy and efficiency of drug development. In addition, we will develop diagnostic agents with high clinical usefulness, promote the maximization of value and proper use of pharmaceuticals and healthcare products, create healthcare services that make full use of them, and contribute to the development of a more convenient medical environment.

* Positron Emission Tomography

** Magnetic Resonance Imaging

Infectious disease Biomarker

The unprecedented pandemic that broke out in 2019 has significantly changed the diagnostic environment and social needs for infectious diseases. Under these circumstances, with the goal of thoroughly eliminating social anxiety about infectious diseases, We are promoting research on ​"establishment of evaluation indicators after vaccination (obtaining evidence regarding antibody titers)"  and "new development of diagnostic methods with an eye on the next pandemic". In addition, we are developing technology to accelerate the social penetration of the newly launched sewage epidemiology survey, and we aim to realize a society in which the infection status can be grasped through this survey.


In research and development related to diagnostic agents, the TARC (Th2 chemokine TARC * kit) test, which has been used as a test to determine the severity of patients with atopic dermatitis, was approved for expanded indication in 2021 as a new diagnostic marker that can predict patients at risk of aggravation of COVID-19.By utilizing this marker, it is expected to reduce the tightness of the medical system by identifying patients who require intensive care such as hospitalization and administration of drugs that suppress the aggravation of the disease. We are promoting efforts to meet these on-site needs.

In this way, we will contribute to fulfilling our responsibilities as a leading company of infectious diseases by providing diagnostic agents and test methods in step with vaccines and therapeutic agents.

*TARC (thymus and activation-regulated chemokine) is one of the chemokine groups that migrate Th2 cells, which are one of the lymphocytes, to the inflamed site (discovered and identified in Shionogi in 1996).

CNS disease Biomarker

CNS (Central Nervous System) diseases are areas where it is extremely difficult to develop diagnostic and therapeutic methods due to the complex and diverse pathological conditions. In addition to the development method, it is considered important to establish a robust biomarker that serves as an objective index and actively incorporate it into preclinical evaluations and clinical trials.

We focused on "imaging markers" that can visualize and quantitatively evaluate changes in brain function in CNS diseases such as PET and MRI, and "molecular markers" that quantify proteins and genes that change with the administration of therapeutic agents. We are promoting its use in medicine.

Imaging Biomarker