Vazyme Medical

What Vazyme Medical does

Nanjing Vazyme Biotech Co., Ltd. (Vazyme Medical) is a China-headquartered biotechnology company founded in 2012 that develops functional proteins and in vitro diagnostic (IVD) solutions. The company operates four proprietary technology platforms — protein directed modification and evolution, single B cell antibody discovery, multi-system recombinant protein preparation, and quantum dot modified coupling — which together support both upstream raw material production and finished diagnostic products. Vazyme's product portfolio spans molecular diagnostics, colloidal gold rapid tests, quantum dot fluorescence immunoassays, latex-enhanced immune turbidimetric assays, and microfluidic molecular point-of-care testing (POCT), with applications in COVID-19, cardiovascular, inflammatory, renal, gastric, and infectious disease diagnostics. The company reports 600+ finished products, 200+ genetic engineering recombinases, and 1,000+ antigens and monoclonal antibodies in its catalog.

Vazyme monetizes through three primary streams: sale of finished IVD diagnostic products (antigen, antibody, neutralizing antibody kits, RT-qPCR kits), biological research reagents and NGS library prep kits sold to universities and R&D centers, and supply of raw materials (recombinases, antigens, monoclonal antibodies) to other diagnostic kit manufacturers. The company claims to have supplied raw materials for over 1.2 billion COVID-19 tests globally, operates a 64,000 m² production base with GMP workshop and a stated capacity of 1 million IVD units per day, and reached more than 38,000 customers across 60+ countries in the first three quarters of 2022. Go-to-market combines direct enterprise sales to hospitals and laboratories with regional distributor networks, supplemented by recurring presence at international trade shows including Medlab Middle East, Medica, Expomed Eurasia, and TECNOSALUD. Pricing is unit-based (e.g., 1, 5, or 20 tests per kit) and not publicly disclosed.

Vazyme went public on the Shanghai Stock Exchange STAR Market in November 2021 (ticker 688105) and reported 2022 revenue of $322M (+78% YoY) with H1 2022 net profit of $92M (+56.67% YoY). R&D spend was $36M in 2021 (12.33% of operating income) and $23M in H1 2022 (9.69% of revenue), supporting 2,000+ peer-reviewed publications including 260+ in Cell, Nature, and Science. International regulatory approvals include UK MHRA, Russia GOST, Brazil ANVISA, Indonesia FDA, UAE, Saudi Arabia, and CE marking for self-testing kits. International infrastructure comprises regional offices and warehouses in the US, EU, and Hong Kong, alongside a wholly-owned subsidiary in Indonesia (established 2021).

Name

Vazyme Medical

Legal name

Nanjing Vazyme Biotech Co.,Ltd.

Website

https://en.vazymemedical.com

Company type

Public

Founded year

2012

Operating status

Operating

Headcount range

11–50 employees

Short description

Nanjing Vazyme Biotech Co., Ltd. (Vazyme Medical) is a publicly-traded Chinese biotech developing in vitro diagnostic products and biological raw materials across four proprietary technology platforms, serving hospitals, diagnostic kit manufacturers, research institutions, and biopharma firms in 60+ countries.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826)

akta.pro primary industry

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

Keywords

• In vitro diagnostics
• Molecular diagnostics
• COVID-19 testing kits
• Immunoassay analyzers
• Nucleic acid extraction

Headquarters

HQ city

Nanjing

HQ country

China

HQ region

Asia

Offices6 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. IVD Diagnostic Products: Sale of finished in vitro diagnostic products including COVID-19 detection kits (antigen, antibody, neutralizing antibody), quantum dot fluorescence immunoassay reagents, latex-enhanced immune turbidimetric reagents, and molecular diagnostics products. The company also supplies raw materials including genetic engineering recombinases, antigens, and monoclonal antibodies to other diagnostic kit manufacturers.
2. Biological Research Reagents: Scientific research reagents and NGS Library Prep Kits sold to universities, laboratories, and R&D centers. Product lines include PCR, qPCR, and other molecular biological reagents.
3. Raw Materials and Key Components: Supply of key raw materials including recombinases, antigens, and monoclonal antibodies to other diagnostic kit manufacturers. The company has supplied materials for over 1.2 billion COVID-19 tests globally.

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels5 records

Core offering

Vazyme Medical develops, manufactures, and sells in vitro diagnostic (IVD) products spanning COVID-19 detection kits (antigen, antibody, neutralizing antibody), molecular diagnostic kits and instruments, quantum dot fluorescence immunoassay analyzers and reagents, nucleic acid extraction systems, and latex-enhanced immune turbidimetric reagents. The company also supplies proprietary raw materials including genetic engineering recombinases, antigens, and monoclonal antibodies to other diagnostic kit manufacturers, and offers biological research reagents and NGS library prep kits to academic and research customers.

Product overview

Vazyme Medical is a biotechnology company offering in vitro diagnostic solutions with a multi-platform product portfolio. The portfolio centers on four key technology platforms: the Quantum Dot Immunofluorescence Platform for cardiovascular, inflammatory, and renal diagnostics; the Latex Enhanced Immune Turbidimetric Platform for kidney, gastric cancer, and infection testing; the Molecular Diagnostics Platform for nucleic acid extraction and detection; and the Microfluidic Molecular POCT Solution Series for decentralized molecular testing. The COVID-19 Solutions suite includes antigen detection kits (Colloidal Gold-Based), IgG/IgM antibody detection kits, neutralizing antibody ELISA kits, RBD protein IgG detection kits, and triplex RT-qPCR detection kits. Supporting instrumentation includes the QD-S2000 automated immunoassay analyzer (120 tests/hour with 12 channels), QD-S600 and QD-S900 fluorescence analyzers, VNP-32YL automated nucleic acid extractor, and FMR3 real-time quantitative thermal cycler. The company also provides DNA/RNA extraction kits, virus sample stabilizers, and disposable swabs for complete sample-to-result workflows.

Differentiator

Problem solved

Functional benefit

Products and services

• SARS-CoV-2 Antigen Detection Kit (Colloidal Gold-Based) Immunoassay-based lateral flow detection kit for direct qualitative detection of SARS-CoV-2 antigen in nasal, nasopharyngeal, and saliva specimens. Provides results within 10 minutes with sensitivity of 97.57% and specificity of 99.29%. Available in 1 test, 5 tests, and 20 tests per kit configurations with 18-month shelf life at 4°C-30°C storage. Intended for healthcare professionals in clinical settings.
• SARS-CoV-2 Antigen Detection Kit (Colloidal Gold-Based) For Self-Testing Home-use version of the colloidal gold-based antigen detection kit for self-testing by consumers. Achieves 98.88% sensitivity and 100% specificity with 99.81% accuracy. CE marked for European markets. Designed for decentralized, at-home COVID-19 screening.
• 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold-Based) Rapid lateral flow screening test for simultaneous detection of IgM and IgG antibodies against 2019-nCoV. Delivers results within 10 minutes without the need for testing equipment and can be stored at room temperature. Used for screening prior COVID-19 exposure and immune response assessment.
• SARS-CoV-2 RBD Protein IgG Detection Kit (Colloidal Gold-Based) In vitro qualitative detection kit for RBD (SARS-CoV-2 Spike Receptor-Binding Domain) IgG antibody in human clinical samples including serum, plasma, and whole blood. Provides results in 15 minutes with 18-month shelf life. Used for assessing immune response to SARS-CoV-2 spike protein and vaccine-induced immunity.
• Anti-SARS-CoV-2 Neutralizing Antibody ELISA Kit ELISA-based kit for quantitative detection of neutralizing antibodies against SARS-CoV-2. Used for vaccine efficacy evaluation, high-throughput screening of immune response, and clinical trial support. Targets biopharmaceutical companies and vaccine developers.
• 2019-nCoV Triplex RT-qPCR Detection Kit Molecular diagnostic kit providing simultaneous detection of SARS-CoV-2 ORF1ab gene, N gene, and internal control (RNAse P gene) in a single tube using one-step RT-qPCR. Designed for laboratory-grade COVID-19 nucleic acid detection with high specificity. Pack size: 100 tests per kit.
• Automatic Nucleic Acids Extraction Instrument (VNP-32YL) High-throughput automated nucleic acid extractor using magnetic bead-based purification. Processes 1-32 samples per run with magnetic bead recovery rate over 95%, processing volume of 20-1000 μL, and a 9-minute extraction time. Designed for clinical and research laboratories performing high-volume sample preparation.
• Automatic Fluorescence Immunoassay Analyzer (QD-S2000) Fully automated quantum dot fluorescence immunoassay analyzer with 12 independent channels, 120 tests/hour throughput, automatic sample loading, and bidirectional LIS connectivity. Performs multi-parameter testing across cardiovascular, inflammatory, renal, and other markers. Targets high-volume clinical laboratories.
• Quantum Dot Fluorescence Immunoassay Analyzer (QD-S600) Quantum dot fluorescence immunoassay analyzer with 10.1-inch color touchscreen, manual sample entry, and bidirectional LIS data exchange. Optimized for emergency and ICU scenarios requiring real-time rapid detection with multiple cardiac, inflammatory, and infectious disease parameters.
• Fluorescence Immune Analyzer (QD-S900) Quantum dot fluorescence immunoassay analyzer with 24-channel multi-item joint detection, automatic cassette unload, and built-in barcode scanner. Designed for clinical laboratories requiring simultaneous multi-parameter detection across cardiovascular, infectious, and chronic disease markers.
• Real-Time Quantitative Thermal Cycler (FMR3) Real-time PCR instrument with 96-well capacity, 5-channel fluorescence detection (380-780nm wavelength), 6-zone independent temperature control, halogen lamp light source, heating rate of 3.5°C/s and cooling rate of 3.2°C/s. Compatible with Vazyme's triplex RT-qPCR detection kits for nucleic acid quantification and melt curve analysis.
• DNA/RNA Extraction Kit (RM301) Magnetic bead-based viral nucleic acid extraction kit for automated purification from blood, serum, plasma, and respiratory specimens. Pre-packaged reagents designed for use with the VNP-32YL automatic extraction instrument, supporting high-throughput sample preparation for downstream PCR testing.
• Virus Sample Stabilizer (R513) Sample collection and stabilization reagent containing guanidine isothiocyanate for specimen collection, virus inactivation, nuclease inhibition, and preservation of viral nucleic acid integrity. Used for sample collection in molecular diagnostic workflows prior to nucleic acid extraction.
• SARS-CoV-2 & FLU A/B Combination Tests Combination diagnostic solution including SARS-CoV-2 & FLU A/B Antigen Rapid Test and SARS-CoV-2, Influenza A/B RT-qPCR Detection Kit for simultaneous detection of COVID-19, Influenza A, and Influenza B in a single workflow. Addresses differential diagnosis of respiratory infections with overlapping clinical symptoms.

Quantifiable outcome

• SARS-CoV-2 Antigen Detection Kit sensitivity: 97.57%, specificity: 99.29%, accuracy: 98.99%
• +5 more outcomes

Named customers5 records

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

Feature5 records

Scale indicators22 records

Recent moves10 records

Expansion highlights6 records

Direct peers

• Autobio Diagnostics: Chinese IVD manufacturer producing immunoassay, chemiluminescence, microbiology, and clinical chemistry reagents and instruments. Directly comparable to Vazyme's immunoassay-based diagnostic reagent portfolio and instrument-reagent bundle strategy.
• SD Biosensor: Korean IVD company specializing in rapid diagnostic test kits including COVID-19 antigen and antibody tests, with strong global distribution. Comparable to Vazyme's colloidal gold-based COVID-19 detection kits and IVD reagent portfolio.
• Sansure Biotech: Chinese IVD company specializing in molecular diagnostics, nucleic acid testing kits, and clinical chemistry reagents. Closely comparable to Vazyme given overlapping molecular diagnostic and infectious disease product lines, similar Chinese listing trajectory, and parallel COVID-19 testing scale-up.
• BGI Genomics: Chinese genomics and molecular diagnostics company with global footprint, providing RT-PCR kits, sequencing services, and IVD reagents. Comparable to Vazyme in molecular diagnostics, COVID-19 testing scale, and international expansion ambitions.
• Maccura Biotechnology: Chinese IVD manufacturer offering clinical chemistry, immunoassay, chemiluminescence, and molecular diagnostic reagents and instruments. Comparable to Vazyme's IVD reagent portfolio and instrument-reagent integrated offering in China.
• Da An Gene (Hybio Pharmaceutical): Chinese molecular diagnostics and IVD company offering PCR reagents, nucleic acid testing kits, and clinical diagnostic instruments. Comparable to Vazyme's molecular diagnostics platform and COVID-19 nucleic acid detection products.
• QuidelOrtho: US-based IVD company with rapid immunoassay and molecular diagnostic products including Sofia antigen tests. Directly comparable to Vazyme's rapid antigen/antibody lateral flow and molecular diagnostic testing products.

Broad incumbents

• Roche Diagnostics: Global IVD leader offering immunoassay, clinical chemistry, molecular diagnostics, and POCT solutions (cobas, Elecsys platforms). Comparable as a broader incumbent in the same IVD reagent categories where Vazyme competes with its quantum dot and immunoassay platforms.
• Hologic: US-based women's health and molecular diagnostics leader with the Panther system and Aptima assays for infectious disease. Overlaps with Vazyme's molecular diagnostics platform and nucleic acid extraction/PCR technology direction.
• Abbott Diagnostics: Global IVD incumbent with the Architect, Alinity, and Binax product lines spanning immunoassay, molecular, and rapid diagnostics. Comparable to Vazyme across immunoassay reagents, rapid COVID-19 antigen tests, and POCT instruments.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/embed/A71pz3swBQM
• LinkedInlinkedin.com/company/vazymemedical

Compliance11 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

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 Vazyme Medical