BIOTIME

What BIOTIME does

Xiamen Biotime Biotechnology Co., Ltd. (BIOTIME) is a privately held Chinese in vitro diagnostics (IVD) manufacturer established in April 2008 and headquartered in Haicang District, Xiamen, Fujian, with a secondary office in Hangzhou. The company specializes in point-of-care testing (POCT) diagnostic devices and reagents, organized around four technology platforms: lateral flow rapid tests (for infectious diseases including COVID-19, influenza, malaria, dengue, RSV, and adenovirus), fluorescence immunoassay (FIA) using europium-chelate markers on instruments such as the BIOT-YG-I and FLI-600 analyzers, chemiluminescence immunoassay (CLiA) built on a proprietary Light-initiated Chemiluminescence Assay (LICA) technology and served by the CLi-1600 analyzer, and molecular diagnostics based on real-time PCR (including a monkeypox detection kit). The company also offers dedicated HPLC-based HbA1c testing (HLC-100 and Affinity A1c analyzers) for diabetes monitoring. The reagent menu spans cardiac markers, tumor markers, inflammatory markers (CRP, PCT, IL-6, D-Dimer), hormones, thyroid function, diabetes/renal, gastrointestinal, TORCH (prenatal), brain injury, and autoimmune disease biomarkers.

BIOTIME operates a razor-and-blade commercial model, selling or placing analyzers that consume proprietary reagent cassettes, targeting hospitals, clinics, and diagnostic laboratories as the primary end users. The company reports a headcount of 2,000+ employees (per its own website), distribution presence in 110+ countries, and 100+ product certificates including ISO 13485 for medical device quality management. Go-to-market is executed through medical device and diagnostic reagent distributors in international markets supplemented by direct sales to healthcare facilities, supported by active participation in international medical exhibitions and a multilingual website (English, French, Russian, Spanish, Portuguese).

The company is privately held with no public ticker, no disclosed ownership structure, no listed parent or subsidiaries, and no publicly available revenue or funding history beyond a January 2018 investment from Tianjin Venture Capital. No management team, board composition, M&A activity, or partnerships are disclosed in the available source material. The combination of a multi-platform POCT portfolio, a global distributor network, and a China-based cost position represents the core commercial proposition, while the absence of disclosed financial data, leadership, and AI/digital capability investment are the principal diligence gaps.

Name

BIOTIME

Legal name

Xiamen Biotime Biotechnology Co., Ltd.

Website

https://biotime.cn

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

5,001–10,000 employees

Short description

Xiamen Biotime Biotechnology is a privately held Chinese IVD manufacturer founded in 2008 that develops and sells POCT diagnostic devices and reagents across rapid test, fluorescence immunoassay, chemiluminescence (LICA), molecular diagnostics, and HPLC platforms to hospitals, clinics, and laboratories in 110+ countries.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics (POCT)

NAICS

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

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Blood Glucose & Metabolic POCT (Glucose, Ketones, Lactate) (HLAHAOAB)

Keywords

• POCT diagnostic devices
• In vitro diagnostics
• Rapid test kits
• Immunoassay analyzers
• Molecular diagnostics reagents

Headquarters

HQ city

Haicang

HQ country

China

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. POCT Diagnostic Devices and Reagents Sales: Sale of point-of-care testing (POCT) in vitro diagnostic devices and reagents including rapid tests, fluorescence immunoassay analyzers and reagents, chemiluminescence immunoassay systems, and molecular diagnostics products. Revenue is generated through product sales to healthcare providers, diagnostic laboratories, and medical distributors globally.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Xiamen Biotime Biotechnology Co., Ltd. (BIOTIME) manufactures and sells Point-of-Care Testing (POCT) in vitro diagnostic devices and reagents. The portfolio spans rapid lateral-flow tests (COVID-19, influenza, malaria, dengue), fluorescence immunoassay analyzers and reagent panels (cardiac, tumor, inflammation, thyroid, fertility, diabetes), chemiluminescence immunoassay systems based on its proprietary LICA technology, real-time PCR molecular diagnostic kits, and HPLC-based HbA1c analyzers for diabetes monitoring. Products are sold to hospitals, clinics, diagnostic laboratories, and medical distributors in 110+ countries.

Product overview

Xiamen Biotime Biotechnology Co., Ltd. is a POCT (Point-of-Care Testing) in vitro diagnostic company established in 2008, specializing in R&D, production, and sales of diagnostic devices and reagents. The product portfolio comprises three main technology platforms: Rapid Test Series (lateral flow-based tests for COVID-19, Influenza, Malaria, Dengue, ADV, RSV), Fluorescence Immunoassay (FIA) Product Line including BIOT-YG-I and FLI-600 analyzers with reagent panels for cardiac, tumor, inflammatory, hormone, thyroid, diabetes/renal, gastrointestinal, TORCH, brain injury, and autoimmune markers, and Chemiluminescence Immunoassay (CLiA) Product Line featuring the CLi-1600 analyzer based on LICA (Light-initiated Chemiluminescence Assay) technology. Additionally, the company offers Molecular Diagnostics (real-time PCR-based detection kits) and dedicated diagnostic solutions for Monkeypox, Diabetes (HLC-100 HPLC HbA1c analyzer, Affinity A1c analyzer, HbA1c rapid tests), and COVID-19 (antigen and antibody rapid tests). The instruments analyze proprietary reagent cassettes/cards, forming a unified analyzer-reagent system for clinical diagnostic use.

Differentiator

Problem solved

Functional benefit

Products and services

• Rapid Test Series Lateral-flow rapid diagnostic test kits for point-of-care detection of infectious diseases (COVID-19, Influenza, Malaria, Dengue, ADV, RSV) intended for healthcare providers, clinics, and laboratories.
• Fluorescence Immunoassay (FIA) Product Line Fluorescence-based immunoassay analyzers and reagent panels for quantitative detection of biomarkers including cardiac, tumor, inflammatory, hormone, thyroid, diabetes/renal, gastrointestinal, TORCH, brain injury, and autoimmune markers.
• BIOT-YG-I FIA Immunoassay Analyzer Fluorescence immunoassay analyzer instrument for quantitative determination of biomarkers in clinical samples, used with the company's reagent cassettes in clinical laboratories.
• FLI-600 FIA Immunoassay Analyzer Automated fluorescence immunoassay analyzer for high-throughput quantitative biomarker detection in clinical diagnostic settings.
• Chemiluminescence Immunoassay (CLiA) Product Line High-sensitivity chemiluminescence immunoassay platform based on BIOTIME's proprietary Light-initiated Chemiluminescence Assay (LICA) technology for high-sensitivity biomarker detection.
• CLi-1600 Analyzer Automated chemiluminescence immunoassay analyzer for high-sensitivity biomarker detection, the primary instrument of the LICA-based CLiA product line.
• Molecular Diagnostics Product Line Real-time PCR-based molecular diagnostic kits for pathogen detection, including detection kits for monkeypox virus.
• HLC-100 Fully Automated HbA1c Analyzer Fully automated high-performance liquid chromatography (HPLC) analyzer for HbA1c measurement used in diabetes monitoring at clinical laboratories.
• Affinity A1c Analyzer Affinity-methodology HbA1c analyzer for diabetes monitoring in clinical laboratory settings.
• Monkeypox Diagnostic Solution Integrated diagnostic solution for monkeypox detection combining the company's real-time PCR detection kit and supporting products for healthcare providers.
• Diabetes Monitoring Solution Integrated diabetes monitoring solution bundling the Affinity A1c analyzer, HLC-100 HPLC analyzer, and HbA1c rapid quantitative test for healthcare providers.
• COVID-19 Diagnostic Solution Comprehensive COVID-19 diagnostic solution bundling SARS-CoV-2 antigen, neutralizing antibody, IgG/IgM, and Flu A/B combo rapid tests for healthcare providers.

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Emerging players

• Response Biomedical: Response Biomedical develops rapid quantitative POCT immunoassays (RAMP platform) for cardiac markers and infectious disease, overlapping BIOTIME's FIA rapid quantitative tests in niche hospital and ED settings.
• EKF Diagnostics: EKF Diagnostics offers POC clinical chemistry and HbA1c analyzers (QuikRead, Hemo Control), directly overlapping BIOTIME's diabetes-monitoring and HbA1c HPLC product line.

Direct peers

• Hangzhou AllTest Biotech: AllTest is a Chinese POCT peer focused on rapid infectious disease and women's health lateral-flow tests, mirroring BIOTIME's rapid-test product line and the same hospital, clinic, and OTC buyer segments.
• SD Biosensor: SD Biosensor is a Korean POCT and rapid diagnostics manufacturer with global distribution, overlapping BIOTIME in lateral-flow infectious-disease tests and FIA immunoassay menus sold through similar medical channel partners.
• Wondfo Biotech: Guangzhou Wondfo is one of China's largest POCT manufacturers with overlapping rapid-test, FIA, and chemiluminescence immunoassay menus and a similarly broad international distribution footprint, making it BIOTIME's closest direct competitor in both product line and channel reach.
• Guangzhou Improve Medical Instruments: Improve Medical is a Chinese POCT and rapid diagnostics peer producing lateral-flow tests, FIA analyzers, and chemiluminescence immunoassay systems sold globally to clinical labs, directly overlapping BIOTIME's core product architecture and customer base.

Broad incumbents

• Roche Diagnostics: Roche Diagnostics operates cobas LIAISON and other POCT / immunoassay platforms serving the same hospitals, clinics, and reference laboratories that buy BIOTIME's FIA, CLiA, and rapid-test products.
• Danaher (Beckman Coulter / Radiometer): Danaher's Beckman Coulter and Radiometer businesses provide central-lab immunoassay analyzers and acute-care blood-gas/POCT platforms, competing with BIOTIME's CLiA and FIA offerings for hospital lab budgets.
• Abbott (Diagnostics / i-STAT): Abbott's Diagnostics division sells i-STAT and other POCT platforms globally alongside its established lab immunoassay franchise, setting the standard for hospital POCT that BIOTIME's analyzers and reagent menus must compete against.
• QuidelOrtho: QuidelOrtho (formed via the Quidel-Ortho merger) is a global diagnostics incumbent with leading Sofia rapid antigen tests and a broad immunoassay and clinical chemistry menu, directly competing with BIOTIME in hospital and near-patient POCT.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/biotime12
• YouTubeyoutube.com/channel/UCXmCUfpu2PjLnb4f0Zakrpw
• Facebookfacebook.com/Xiamen-Biotime-Biotechnology-Co-Ltd-100923888966485
• LinkedInlinkedin.com/company/%E5%8E%A6%E9%97%A8%E5%AE%9D%E5%A4%AA%E7%94%9F%E7%89%A9%E7%A7%91%E6%8A%80%E6%9C%89%E9%99%90%E5%85%AC%E5%8F%B8
• Instagraminstagram.com/biotime_biotechnology

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

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 BIOTIME