What SD Biosensor does

SD Biosensor, Inc. is a South Korean in-vitro diagnostics company founded in 2010 (with a predecessor entity, SD, dating to 1999) and headquartered in Suwon, South Korea. The company develops, manufactures, and distributes rapid diagnostic tests and instruments across infectious diseases (HIV, syphilis, hepatitis, tuberculosis, malaria, dengue, COVID-19, arboviruses, STIs, C. difficile), metabolic and chronic conditions (G6PD deficiency, diabetes via HbA1c and blood glucose monitoring, lipid profile), and select other areas. Its products are sold into public health programs in low- and middle-income countries, hospitals and clinical laboratories, and specialty care settings in over 160 countries.

The product portfolio is built on six core technology platforms: STANDARD Q (immunochromatographic rapid tests for point-of-care use), STANDARD F (fluorescence immunoassay analyzers including the F200 and F2400), STANDARD E (ELISA, including TB-Feron for latent TB), STANDARD M (point-of-care molecular diagnostics using real-time PCR, including the M10 analyzer and a growing cartridge menu), STANDARD i (fully automated chemiluminescence immunoassay), STANDARD C (HPLC-based HbA1c analyzer), plus the BGMS line of blood glucose meters and add-on products such as the STANDARD G6PD Analyzer and STANDARD LipidoCare. Multiple products carry WHO Prequalification, WHO Emergency Use Listing, IVDR CE, Korea MFDS approval, and TGA clearance, and the company operates three Korean manufacturing facilities (Giheung, Cheongju, Pyeongtaek) and a second India plant established in February 2025.

The business model combines sale of diagnostic reagents and consumables (the majority revenue driver) with instrument sales that anchor recurring reagent pull-through, supplemented by technology licensing and sublicensing arrangements (including with WHO, Medicines Patent Pool, and Nigeria's Codix Bio). Go-to-market mixes product-led adoption at the point of care, enterprise field sales to large healthcare systems and government procurement bodies, and channel partner distribution for regional reach. Customers include ministries of health, public health agencies and global organizations (WHO, FIND, UNICEF, MedAccess, CHAI, PATH), hospitals, clinics, and diagnostic laboratories, with a MedAccess/CHAI-supported sub-$1 pricing model for the HIV/Syphilis Duo Test in LMIC public-sector deals. The company has expanded internationally through a series of acquisitions (Meridian Bioscience, Mirero Corp, Bestbion dx, Relab SRL) and operates wholly-owned distribution subsidiaries in the US, Brazil, Panama, Colombia, India, Indonesia, Germany, Italy, and Spain.

Name

SD Biosensor

Legal name

SD Biosensor, Inc.

Website

https://sdbiosensor.com

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

51–100 employees

Short description

SD Biosensor is a South Korean in-vitro diagnostics company that develops and manufactures rapid diagnostic tests and instruments across infectious disease, metabolic, and chronic conditions, distributing to public health programs, hospitals, and laboratories in over 160 countries.

Ownership category

akta.pro rank

Product category

In-Vitro Diagnostics (IVD)

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Medical Laboratories (621511)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826), Surgical & Medical Instruments & Apparatus (3841), Services-Medical Laboratories (8071)

akta.pro primary industry

IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM)

akta.pro secondary industries

Home Diagnostic & Self-Test OTC Kits (HLAIADAO), Remote Diagnostics & Home Testing Devices (Connected POC/At-Home Diagnostic Readers) (HLAHACAL), Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI)

Keywords

• In-vitro diagnostics
• Rapid diagnostic tests
• Point-of-care testing
• Molecular diagnostics
• Immunoassay reagents

Headquarters

HQ city

Suwon

HQ country

South Korea

HQ region

Asia

Offices8 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Operations, Personnel, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Diagnostic Reagent and Rapid Test Sales: SD Biosensor generates the majority of its revenue from the sale of rapid diagnostic tests (RDTs) across infectious diseases (HIV, syphilis, malaria, TB, COVID-19), chronic conditions (diabetes via HbA1c), and other health conditions. These are sold to public sector procurers (governments, NGOs, WHO programs) and private healthcare providers globally.
2. Diagnostic Instrument Sales: Sale of instruments including automated and semi-automated analyzers that run fluorescence immunoassay (FIA) and ELISA tests, supporting both point-of-care and laboratory settings.
3. Technology Licensing and Transfer: Revenue generated through technology transfer license agreements (e.g., with WHO and Medicines Patent Pool) and sublicensing arrangements (e.g., with Codix Bio), enabling partners to manufacture or distribute diagnostic products under agreed terms.

Pricing tiers

Go-to-market motion3 records

Distribution channels3 records

Marketing channels4 records

Core offering

SD Biosensor designs, manufactures, and globally distributes in-vitro diagnostic products including rapid immunochromatographic tests, fluorescence and chemiluminescence immunoassay analyzers, ELISA kits, real-time PCR molecular diagnostic cartridges, HPLC-based HbA1c analyzers, and blood glucose monitoring systems. The company sells these diagnostic platforms and consumables to public health agencies, national ministries of health, hospitals, clinics, and laboratories across more than 160 countries, with multiple WHO prequalified and IVDR CE marked products.

Product overview

SD Biosensor is a global in-vitro diagnostics company providing a comprehensive portfolio of diagnostic platforms spanning from screening tests to confirmation tests. The product portfolio includes: STANDARD Q (rapid immunochromatographic tests for point-of-care diagnosis across respiratory, vector-borne, blood-borne, hepatitis, and gastrointestinal diseases); STANDARD F (fluorescence immunodiagnostic system for clinical laboratories offering qualitative and quantitative testing); STANDARD E (ELISA-based enzyme immunoassay for mass screening including TB-Feron for latent TB); STANDARD M (Point-of-Care Molecular Diagnostics platform using Real-Time PCR and LAMP for infectious disease, drug resistance, and genetic testing); STANDARD i (fully automated chemiluminescence immunoassay system with comprehensive biomarker menu); STANDARD C (HPLC-based HbA1c analyzer); and BGMS (blood glucose monitoring systems). The company also provides specialized analyzers including G6PD, LipidoCare, and MultiCare, along with consumables and pretreatment kits. SD Biosensor operates manufacturing facilities in Korea with subsidiaries and distributors across the USA, Brazil, Panama, Colombia, India, Indonesia, Germany, Italy, and Spain.

Differentiator

Problem solved

Functional benefit

Brands

• STANDARD Q: Rapid diagnostic products with high sensitivity and specificity through quality control from raw material development to production
• STANDARD F
• STANDARD E
• STANDARD M
• STANDARD i
• STANDARD C
• BGMS
• STANDARD GlucoNavii
• STANDARD LipidoCare
• STANDARD G6PD
• Pilot
• i-Q

Products and services

• STANDARD Q Rapid Diagnostic Test Line Immunochromatography-based rapid diagnostic tests for point-of-care use covering respiratory disease, vector-borne disease (including Malaria P.f Ag, Dengue Duo), blood-borne disease (HIV/Syphilis Combo, HCV Ab), hepatitis, and gastrointestinal disease targets. Test time generally within 15 minutes. Multiple tests are WHO Prequalified or carry WHO Emergency Use Listing.
• STANDARD F Fluorescence Immunodiagnostic System Multi-parametric, random-access fluorescence immunoassay (FIA) analyzers (F200, F2400) and reagent kits for clinical laboratories, providing qualitative and quantitative testing across respiratory, vector-borne, gastrointestinal, cardiovascular disease, and hormone panels. The F200 supports LIS/HIS connectivity.
• STANDARD E ELISA Platform Enzyme-linked immunosorbent assay (ELISA) platform for accurate and reliable mass screening, including the Covi-FERON, TB-Feron IGRA for latent tuberculosis infection, and dengue ELISA products.
• STANDARD M Point-of-Care Molecular Diagnostics (MDx) Platform Point-of-Care Molecular Diagnostics (MDx) system using Real-Time PCR and LAMP technologies, with the M10 analyzer and a menu of assay cartridges (SARS-CoV-2, Flu/RSV/SARS-CoV-2, MTB/NTM, MDR-TB, HPV, STI Panel, DENV 1-4, MPX/OPX, Arbovirus Panel, C. difficile BT) plus pretreatment kits, designed for accurate, simple, and faster clinical decision making near the patient.
• STANDARD i Chemiluminescence Immunoassay (CLIA) System
• STANDARD C HPLC HbA1c Analyzer
• BGMS (Blood Glucose Monitoring Systems) Blood glucose meters using GOD and GDH-FAD enzyme technologies, including SD CodeFree, STANDARD GlucoNavii Pro (BT), STANDARD GlucoNavii GDH, and STANDARD Mentor (BT) product lines, with companion data management software (STANDARD DMS) and Bluetooth connectivity for wireless data transfer.
• STANDARD G6PD Analyzer Point-of-care diagnostic device for quantitative measurement of Glucose-6-Phosphate Dehydrogenase (G6PD) activity and total hemoglobin simultaneously, providing a G6PD/Hb ratio (U/g Hb) in 2 minutes, with WHO Prequalification for safe administration of primaquine and tafenoquine in malaria treatment.
• STANDARD LipidoCare Analyzer
• d-BLOCK Incubator Laboratory incubator equipment used in SD Biosensor's diagnostic testing processes.
• MultiCare Analyzer Reflectometry immunoassay instrument for the quantitative measurement of analytes in human blood, urine, and other specimens, supported by STANDARD MMS (MultiCare Management System) data software (version 1.2.3).
• Transport Medium Specimen transport medium for maintaining sample integrity during diagnostic testing workflows.
• Pilot COVID-19 At-Home Antigen Test Rapid at-home antigen test for SARS-CoV-2 nucleocapsid antigen using a nasal swab specimen, delivering results in 15-30 minutes with 94.94% sensitivity and 100% specificity.

Quantifiable outcome

• STANDARD G6PD Test with WHO prequalification enables safe administration of anti-malarial drugs (primaquine/tafenoquine) by identifying G6PD-deficient patients at point-of-care.
• +1 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration5 records

Feature5 records

Partnerships

Nine partnerships are on record, tiered core and minor.

• World Health Organization (WHO)coreStrategic or Co-development PartnerWHO partnered with SD Biosensor on a technology transfer license agreement for diagnostic technology, and multiple SD Biosensor products (STANDARD G6PD Test, HIV/Syphilis Duo Test) have received WHO prequalification or Emergency Use Listing through this collaboration.
• Medicines Patent Pool (MPP)coreStrategic or Co-development PartnerWHO and Medicines Patent Pool partnered with SD Biosensor on a technology transfer license agreement, facilitating broader access to diagnostic technologies in LMICs.
• MedAccesscoreStrategic or Co-development PartnerMedAccess partnered with SD Biosensor and CHAI to enable procurement of the HIV/Syphilis Duo Test at under $1 per test for public sector purchasers in LMICs, supporting national dual screening programs.
• Clinton Health Access Initiative (CHAI)coreStrategic or Co-development PartnerCHAI partnered with SD Biosensor and MedAccess to facilitate affordable access to the HIV/Syphilis Duo Test at under $1 per test for public sector LMIC purchasers, enabling integration into national health programs.
• PATHcoreStrategic or Co-development PartnerPATH co-developed the STANDARD G6PD Test with SD Biosensor, which subsequently achieved WHO prequalification. This partnership enabled the development of a point-of-care test for G6PD deficiency to support safe malaria treatment.
• Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association (RIT/JATA)coreStrategic or Co-development PartnerSD Biosensor partnered with RIT/JATA for tuberculosis diagnostic technology collaboration and development, supporting global TB elimination efforts.
• Korea's International Tuberculosis Research Center (ITRC)coreStrategic or Co-development PartnerSD Biosensor entered into a tripartite MOU with ITRC for XDR-TB (extensively drug-resistant tuberculosis) diagnostics, supporting advanced TB diagnostic solutions for drug-resistant strains.
• Codix BiominorOEM/ Whitelabel/ Licensing PartnerCodix Bio, a Nigerian health technology company, entered into a sublicensing agreement with SD Biosensor for rapid diagnostic test technology in Nigeria, expanding access to diagnostic tests in the West African market.
• Korean Diabetes Education Nursing SocietyminorGTM or Marketing PartnerSD Biosensor partnered with the Korean Diabetes Education Nursing Society to support diabetes management programs, leveraging the Society's network of diabetes educators and healthcare professionals to promote diabetes diagnostic solutions.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Hologic: Panther molecular system and Aptima STI panel compete with SD Biosensor's M10 STI Panel and molecular infectious disease cartridges in clinical lab settings.
• Roche Diagnostics: Global IVD powerhouse with rapid tests, ELISA, CLIA, real-time PCR (cobas Liat for POC molecular), and HPLC HbA1c platforms that compete head-on with SD Biosensor's STANDARD Q, E, i, M, and C lines across hospital and reference-lab channels.
• Cepheid (Danaher): GeneXpert molecular PCR system is the global gold standard for point-of-care TB and infectious disease testing, directly competing with SD Biosensor's STANDARD M10 platform for decentralized molecular diagnostics in LMICs.
• Abbott (Diagnostics): Global IVD leader offering rapid antigen tests (BinaxNOW COVID, Panbio), immunoassays, molecular diagnostics, and point-of-care platforms that overlap with SD Biosensor across infectious disease, cardiac, and metabolic testing — the largest incumbent in the same end markets.
• bioMérieux: BioFire FilmArray molecular panels and VIDAS immunoassay systems overlap with SD Biosensor's M10 multiplex molecular cartridges and STANDARD F FIA analyzer across infectious disease and routine diagnostics.

Direct peers

• GenBody: Korean IVD peer offering rapid antigen and molecular diagnostic tests for COVID-19, respiratory pathogens, and tropical diseases — competing directly with SD Biosensor in price-sensitive LMIC and domestic Korean markets.
• Seegene: Korean molecular diagnostics company developing multiplex real-time PCR assays (Allplex panels) that compete with SD Biosensor's M10 STI, respiratory, and arbovirus panels in clinical laboratory markets globally.
• Access Bio: Korean-headquartered rapid diagnostic test manufacturer specializing in malaria, HIV, and other infectious disease RDTs for LMIC markets — a near-direct competitor in WHO-prequalified rapid antigen and antibody tests.
• QuidelOrtho: Sofia rapid antigen FIA platform and Triage MeterPro compete directly with SD Biosensor's STANDARD F fluorescence immunoassay system for point-of-care infectious disease and cardiac testing.

Regional players

• Mesa Labs (Meridian Bioscience competitor): While most comparable post-Meridian acquisition, the broader Mesa Labs portfolio of life sciences instrumentation overlaps with the assay and reagent categories now under SD Biosensor's Meridian business unit in the US market.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xtwitter.com/sdbiosensor_pr
• YouTubeyoutube.com/channel/UC5z_5F9oGoPG89ZOp7N9SWg
• Facebookfacebook.com/SDBIOSENSOR.pr
• Instagraminstagram.com/sdbiosensor_pr
• LinkedInlinkedin.com/company/sd-biosensor-inc-

Compliance9 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Subsidiaries9 records

Funding overview

Funding rounds1 record

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments1 record

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about SD Biosensor