Humasis

What Humasis does

Humasis Co., Ltd. is a South Korea-based in vitro diagnostics (IVD) company founded in 2000 and listed on the KOSDAQ exchange, specializing in point-of-care testing (POCT) products. The company designs, manufactures, and sells rapid immunochromatographic (lateral flow assay) test kits across infectious disease categories (COVID-19, influenza, dengue, malaria, HIV, RSV, hepatitis B), cardiac and cancer markers, fertility and hormone tests, and cotinine/nicotine detection. Its technology platform combines in-house produced recombinant antigen raw materials (COVID-19 NP, HIV-1 gp41, Dengue ED3 serotypes I-IV) with proprietary POCT analyzer instruments (HUBI-TAS, HUBI-QUAN pro, U-AQ Smart) that integrate Android-based software and AI analysis algorithms to deliver quantitative readouts. The company operates three KGMP-certified production facilities (Gunpo, Anyang, and Vietnam) and has accumulated regulatory approvals across major jurisdictions including CE Mark, US FDA Emergency Use Authorization, Korea MFDS, ANVISA Brazil, MHLW Japan, NMPA China, and Health Canada.

Humasis generates revenue through four channels: (1) direct sales of rapid diagnostic kits to healthcare providers and government health authorities, (2) export through a distributor network covering 74 countries, (3) B2B sales of recombinant antigen bio-materials to other IVD manufacturers and research institutions, and (4) consumer retail sales of pregnancy and cotinine test kits through Korean marts and convenience stores. The company holds a UNICEF Long Term Agreement for diagnostic product supply, and has secured major institutional contracts with the Peruvian CDC and the French government for COVID-19 response. Its portfolio spans 163 production SKUs and includes a consumer-facing home test line (COVID-19 Ag Home Test, HUBI BPHScreen). Strategic subsidiaries include Humasis Vina Co., Ltd. (Vietnam, established 2020) and a US subsidiary (established 2021), and the company has a joint development history with Celltrion on COVID-19 antigen tests.

The company's growth profile is shaped by a 2021 export peak of $30 million (recognized with the Korea International Trade Association $30M Export Tower Award) that has since normalized as global COVID-19 antigen test demand has contracted. Total assets stood at KRW 347,308 million (~$260M USD) in fiscal year 2023, and the company has executed three CEO transitions in its history, with Park Woo-ram assuming the CEO role in 2024. Recent corporate actions include a 2026 stock par value consolidation (reverse split), and the company continues to invest in connected diagnostics through its HUBI instrument platform and a 2023 strategic investment in healthcare partner CareforU.

Name

Humasis

Legal name

Humasis Co., Ltd.

Website

https://humasis.com

Company type

Public

Founded year

2000

Operating status

Operating

Headcount range

101–250 employees

Short description

Humasis is a South Korea-based KOSDAQ-listed IVD manufacturer founded in 2000, producing point-of-care rapid diagnostic test kits (COVID-19, dengue, malaria, HIV, influenza, cardiac, fertility markers) and proprietary POCT analyzer instruments, exporting to 74 countries via distributors and institutional buyers including UNICEF.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Equipment and Supplies Manufacturing (3391)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Infectious Disease POCT (Respiratory, STI, HIV, Sepsis) (HLAHAOAA)

akta.pro secondary industries

Home-Use & OTC Rapid Self-Tests (Consumer POCT kits) (HLAHAOAK), Remote Diagnostics & Home Testing Devices (Connected POC/At-Home Diagnostic Readers) (HLAHACAL), Raw Materials & Critical Reagents Supply Services (media, resins, single-use) (HLAAAKAI)

Keywords

• Rapid diagnostic test kits
• Point-of-care testing
• Immunodiagnostic devices
• Lateral flow assays
• In vitro diagnostics

Headquarters

HQ city

Gunpo

HQ country

South Korea

HQ region

Asia

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Immunodiagnostic Rapid Test Kits: Sale of rapid immunochromatographic test kits across categories including infectious diseases (COVID-19, Dengue, Malaria, HIV, Influenza, RSV, HBV), fertility/hormone tests, cardiac markers, and cancer markers. Products sold in various formats (cassette, strip, multi-device) with shelf life of 24 months. Revenue generated through direct sales to healthcare providers and distributor/export arrangements.
2. Bio-material Raw Materials: In-house produced recombinant antigen raw materials (COVID-19 NP, HIV gp41, Dengue virus ED3 proteins) sold to other IVD manufacturers and research institutions as key inputs for immunodiagnostic kit production.
3. Diagnostic Instruments: Sale of proprietary POCT diagnostic instruments (HUBI-TAS, HUBI-QUAN pro, U-AQ Smart urine analyzer) and associated reagents for quantitative analysis in clinical settings.
4. Health Care Consumer Products: Consumer-facing health monitoring products including Cotinine tests for nicotine detection, sold through retail and convenience store channels.

Pricing tiers

Go-to-market motion1 record

Distribution channels4 records

Marketing channels5 records

Core offering

Humasis manufactures and sells point-of-care (POCT) immunodiagnostic rapid test kits for infectious diseases, fertility/hormones, cardiac markers, and cancer markers, alongside proprietary diagnostic instruments (HUBI-TAS, HUBI-QUAN pro, U-AQ Smart) and in-house produced recombinant antigen bio-materials supplied to other IVD manufacturers. The company operates 163 production SKUs and exports to 74 countries.

Product overview

Humasis is an in vitro diagnostic (IVD) company specializing in Point-of-Care Testing (POCT) products. The product portfolio includes four main categories: Immunodiagnostics (rapid test kits for COVID-19, influenza, dengue, malaria, HIV, hepatitis, RSV), Bio-materials (recombinant antigens for diagnostic kit manufacturing including COVID-19 NP, HIV gp41, Dengue ED3 proteins), Diagnostic Instruments (U-AQ Smart urine analyzer, HUBI-TAS and HUBI-QUAN Pro POCT analyzers), and Healthcare products (cotinine/nicotine tests). The company operates 163 production items exporting to 74 countries, with total exports reaching $30 million in 2021.

Differentiator

Problem solved

Functional benefit

Brands

• HUBI: POCT immunoassay devices including HUBI-QUAN pro, HUBI-TAS, HUBI DIA for quantitative analysis
• Humasis Vina

Products and services

• COVID-19/Flu Ag Combo Test One-step in vitro immunochromatographic diagnostic test for qualitative detection of SARS-CoV-2 antigens, influenza A (H1N1, H3N2) antigens, and influenza B antigens in a single nasopharyngeal swab specimen with results in 15 minutes.
• COVID-19 Ag Test Lateral flow chromatographic immunoassay for qualitative detection of SARS-CoV-2 antigen in nasopharyngeal swab specimens, validated for Omicron sub-variant detection.
• COVID-19 Ag Home Test Rapid COVID-19 antigen detection kit for home use with nasal swab specimen, results within 15 minutes, available in pack sizes of 1, 2, 5, and 25 tests per case with 24-month shelf life.
• Dengue IgG/IgM Antibody Test Immunochromatographic assay for qualitative detection of dengue virus IgG/IgM antibodies in whole blood, serum, or plasma.
• Dengue NS1 Antigen Test Rapid test for early detection of dengue virus NS1 antigen after onset of symptoms.
• Dengue Combo Test Combined NS1 and IgG/IgM test for comprehensive dengue fever diagnosis.
• Malaria P.f/Pan Antigen Test Rapid test for detection of Plasmodium falciparum (HRPII) and pLDH in human blood with 99% accuracy and minimum detection limit of 40 parasites/µL.
• Malaria P.f/P.v Antigen Test Rapid test distinguishing P. falciparum from P. vivax for targeted malaria treatment.
• Malaria P.f Antigen Test Rapid test for specific detection of Plasmodium falciparum malaria.
• Influenza Antigen Card Plus One-step immunochromatographic test for qualitative determination of influenza type A and B virus using nasopharyngeal swab specimen with 8-minute results.
• FLU/RSV Combo Test Combined rapid test for simultaneous detection of influenza A/B and RSV type A/A2/B viruses.
• RSV Antigen Test Rapid antigen detection test for respiratory syncytial virus in nasopharyngeal discharge specimens.
• HIV 1/2 Card One-step immunochromatographic test for qualitative detection of HIV-1/2 antibodies using whole blood, serum, or plasma specimens.
• HBsAg Card Rapid, qualitative detection of Hepatitis B surface antigen in serum or plasma.
• Anti-HBs Card Rapid test for detection of antibodies against Hepatitis B surface antigen in serum or plasma.
• HUBI BPHScreen (PSA Quantitative Test) Quantitative analysis of free PSA and total PSA in blood, used with HUBI-TAS or HUBI-QUAN pro devices.
• Dengue virus ED3 (I, II, III, IV) Recombinant Antigen Recombinantly produced major structural proteins of dengue virus used as raw materials or reference standards for immunodiagnostic kits, supplied in serotypes I through IV.
• COVID-19 NP (Nucleocapsid Protein) Nucleocapsid Protein (NP) for SARS-CoV-2 immunodiagnosis, produced in-house as raw material or standard material for IVD kit manufacturers.
• HIV-1 gp41 Recombinant Antigen HIV-1 surface protein produced in-house as raw material for immunodiagnostic kits, available in HIV-1 group M and group O variants.
• U-AQ Smart Urine Analyzer Urine test strips and analyzer for simplified laboratory diagnosis through ease of use and high sensitivity.
• HUBI-TAS POCT Analyzer POCT immunoassay device with Android-based analysis algorithm integrating AI for quantitative diagnostic results, supporting mobile health and remote diagnostics applications.
• HUBI-QUAN Pro POCT Analyzer
• Cotinine (Nicotine Test) Rapid test for qualitative detection of cotinine (nicotine metabolite) in urine for smoking status assessment, sold through retail and convenience store channels.

Quantifiable outcome

• COVID-19 Ag Test achieved 100% clinical sensitivity for SARS-CoV-2 Omicron sub-variants BA.2.12.1, BA.4, and BA.5 in head-to-head comparison with RT-PCR using clinical samples.
• +2 more outcomes

Named customers8 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature5 records

Partnerships

Five partnerships are on record, tiered minor and core.

• CareforU (케어포유)minorStrategic or Co-development Partner · 1 June 2023Humasis made a strategic investment in CareforU, a company engaged in healthcare-related business. This investment aligns with Humasis' strategy to expand its healthcare ecosystem and develop complementary digital health solutions.
• CelltrioncoreStrategic or Co-development Partner · 1 January 2020Humasis and Celltrion signed a joint development agreement for COVID-19 Antigen Test Kit development. The partnership leveraged both companies' diagnostic expertise to rapidly develop and obtain regulatory approvals for COVID-19 rapid testing solutions during the pandemic.
• UNICEF (via Denmark office)coreChannel Partner/ Reseller/ Distributor · 1 January 2015Humasis entered into a Long Term Agreement (LTA) with UNICEF for the supply of diagnostic products. This partnership enables Humasis to supply its diagnostic products to UNICEF procurement programs globally, particularly supporting maternal and child health initiatives in developing countries.
• Korea University Medical Device Development CenterminorStrategic or Co-development PartnerMOU signed for mutual cooperation on medical device clinical trials, enabling Humasis to access clinical trial infrastructure and expertise for regulatory approvals of new diagnostic products.
• Korea University Guro HospitalminorStrategic or Co-development PartnerMOU signed for mutual cooperation on in vitro diagnostic reagent research and clinical studies. The partnership supports Humasis' R&D efforts and clinical validation of diagnostic products.

Scale indicators6 records

Recent moves11 records

Expansion highlights5 records

Broad incumbents

• Becton Dickinson (BD): Global medical technology company whose BD Veritor System and rapid antigen tests directly compete with Humasis's HUBI-TAS/QUAN and lateral-flow COVID/flu assays, while also offering broader molecular and laboratory diagnostics.
• Roche Diagnostics: World-leading diagnostics division offering rapid antigen tests (e.g., SARS-CoV-2 Rapid Antigen Test), lateral-flow assays, and molecular POCT platforms, competing with Humasis across infectious disease testing in hospital and ambulatory settings.
• QuidelOrtho: Major US-based diagnostics company offering QuickVue and Sofia rapid antigen tests across respiratory and infectious disease, overlapping with Humasis's COVID-19, flu, and RSV POCT portfolio in hospital, physician-office, and retail channels.
• Abbott Diagnostics: Global IVD leader whose rapid diagnostics arm (Binax NOW, Panbio COVID tests) competes directly with Humasis's antigen and infectious-disease POCT products across both professional and home-use channels, with vastly greater scale and brand recognition.

Direct peers

• Access Bio: US/Korean IVD manufacturer focused on rapid diagnostic tests for infectious diseases (malaria, dengue, HIV, COVID-19), with comparable product categories and emerging-market distribution overlap with Humasis's tropical-disease portfolio.
• GenBody: South Korean POCT company developing immunochromatographic rapid diagnostic kits for COVID-19, influenza, dengue, and other infectious diseases, directly competing with Humasis in both domestic Korean and export markets.
• SD Biosensor: South Korean in vitro diagnostics company specializing in rapid diagnostic test kits and POCT instruments, directly competing with Humasis across COVID-19, influenza, dengue, and other lateral-flow assays, with similar global distribution and KOSDAQ/KRX listing.

Emerging players

• Healgen Scientific: Emerging Chinese/US lateral flow assay manufacturer offering COVID-19 antigen, flu, and pregnancy tests at competitive price points, increasingly overlapping with Humasis in developing-market tenders and OEM channels.
• Biolidics: Singapore-based diagnostics company with a COVID-19 rapid antigen test and POCT portfolio, comparable to Humasis as a smaller Asian-headquartered competitor pursuing global distribution partnerships.
• Cellex: US-based rapid diagnostics company offering COVID-19 antibody/antigen tests and other lateral-flow assays, overlapping with Humasis's infectious-disease POCT offerings and US FDA-cleared product strategy.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/humasis-co-ltd-

Compliance9 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries1 record

Funding overview

Funding rounds1 record

Investors1 record

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

M&A

Investments

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

Frequently asked questions about Humasis