MIZUHO MEDY CO.,LTD.
4595・Standard Market・Pharmaceuticals
Business
Mizuho Medy Co., Ltd. is a specialized manufacturer of Point Of Care Testing (POCT) reagents for infectious diseases, operating within the In-vitro Diagnostics Business (Single Segment). Founded in 1977, the company is headquartered with its main plant in Tosu City, Saga Prefecture, and also operates a gene research institute and plant in Kurume City, Fukuoka Prefecture. Its core products are the immunochromatographic antigen test kits of the Quick Chaser Series (Antigen Test Kits) and the Fully Automated Gene Analysis System Smart Gene, part of the Smart Gene Series (Gene POCT Kits). In the hospital and clinic segment, which accounts for 96.6% of net sales, the company supplies test reagents for infectious diseases such as influenza, novel coronavirus, and mycoplasma to medical institutions nationwide, primarily small and medium-sized hospitals and private practitioners. In the OTC and other segment, the company sells pregnancy test kits and ovulation test kits (OTC Test Kits (Pregnancy & Ovulation Test Kits)) to pharmacies and drugstores.
Business Model
The company handles planning and development, manufacturing, and sales through an in-house integrated system, supplying high-quality products based on ISO13485 quality management to medical institutions via pharmaceutical wholesalers (Mediceo, Toho Pharmaceutical, Alfresa, etc.). Through the installation of the "Fully Automated Gene Analysis System Smart Gene" (cumulative 5,900 units), the company is also cultivating an installed-base type revenue model that creates continuous demand for dedicated reagents. The operating margin for FY2025 (ending December 2025) remained at a high level of 41.3%, and the company has adopted a shareholder return policy targeting a dividend payout ratio of 50%.
Company Strengths
In 1994, the company was the first in Japan to apply the immunochromatography method to infectious disease test reagents, commercializing "Quick Chaser HBsAg." It subsequently expanded into a wide range of infectious disease items including respiratory, digestive, and blood-borne viruses, and in 2018 launched "Smart Gene," the industry's first gene POCT testing system. The company also holds a high-sensitivity silver-amplification immunochromatography system developed jointly with FUJIFILM.
For FY2025 (ending December 2025), the company recorded net sales of ¥11,260 million against operating profit of ¥4,646 million (operating margin of 41.3%). Against net assets of ¥18,684 million, the company has no interest-bearing debt and maintains a solid financial foundation with an overdraft facility agreement (total amount ¥1,600 million). The average operating margin over the five fiscal years from 2021 to 2025 was approximately 47%, maintaining a structurally high-profitability business model.
The cumulative number of installations of the fully automated gene analysis system "Smart Gene" has reached 5,900 units, and continuing demand for dedicated reagents (such as H.pylori G) is expanding along with the spread of the device. In FY2025 (ending December 2025), the company obtained manufacturing and marketing approval for H.pylori S (June 2025) and filed an application for manufacturing approval of a pertussis nucleic acid test kit (October 2025), expanding its range of test items and strengthening its installed-base-driven revenue foundation.
ENVALITH's Perspective
Performance Trend
Revenue peaked at ¥17,581 million in FY2022 (ended December 2022) and has continued to shrink since, reaching ¥11,260 million in FY2025 (ended December 2025). In Q1 FY2026 (ending December 2026), revenue was ¥2,208 million (down 16.7% year on year), with the pace of decline widening. External factors included the scale of the COVID-19 outbreak in the 2025/2026 winter season falling below that of the previous year, as well as a continued shift from gene testing to antigen testing, which caused shipment volumes of gene test kits to decline sharply. The operating margin, at 34.4%, remains at a high level but fell significantly from 42.4% in the same period of the previous year. The full-year forecast (revenue of ¥11,428 million, operating profit of ¥4,414 million) has been left unchanged, premised on expectations for the infectious disease season in the latter half of the fiscal year.
Growth Strategy
Growth driven by two pillars: expanding the range of gene POCT test items and developing next-generation instruments, alongside stable supply of the antigen combination test kit
Preparations are underway for the launch of H.pylori S (manufacturing and marketing approval obtained in June 2025), while the company also aims for early approval and launch of the Pertussis nucleic acid kit. By adding new test items, the company seeks to improve the utilization rate of the cumulative 5,900 installed units and boost reagent demand.
An immunochromatographic reagent capable of rapidly detecting six representative carbapenemases that confer resistance to carbapenem antibiotics is scheduled for launch as a research-use reagent in the first half of 2026. This will expand the range of test items in the Quick Chaser Series (Antigen Test Kits).
The company is promoting further reduction of measurement time and development of a multi-gene testing system. It aims to strengthen mid- to long-term product competitiveness and acquire new customers. The commercialization timing remains undetermined, but continuous R&D investment is being carried out.
In response to the need for simultaneous epidemic response and differential diagnosis of influenza and COVID-19, the company is maintaining an increased production system for the CoV/Flu combination test kit. Shipment volume in the first quarter of FY2026 (ending December 2026) increased to approximately 1.75 million tests (versus approximately 1.67 million tests in the same period of the previous year), reinforcing its position as the mainstay product for combination test demand.
Last updated: July 17, 2026