SuZhou Hybiome Biomedical Engineering
SuZhou Hybiome Biomedical Engineering is a Chinese IVD manufacturer specializing in acridinium ester chemiluminescence immunoassay analyzers, reagents, and laboratory automation, serving hospitals and clinical laboratories in China and international markets as a bioMérieux-controlled subsidiary.
- Company typePrivate
- Founded2009
- HeadquartersSuzhou, China
- Headcount—
- GTM typeB2B
- OfferingHardware or Manufacturing
What SuZhou Hybiome Biomedical Engineering does
SuZhou Hybiome Biomedical Engineering (苏州长光华医生物医学工程有限公司) is a privately held Chinese in-vitro diagnostics (IVD) company founded in 2009 and headquartered in Suzhou High-Tech Zone, Jiangsu Province. The company was co-founded by the Chinese Academy of Sciences' Changchun Institute of Optics, Fine Mechanics and Physics, the CAS Suzhou Institute of Biomedical Engineering and Technology, and private shareholders. Since late 2018, French diagnostics major bioMérieux has held the controlling shareholder position, providing R&D expertise, raw material quality advantages, and access to a global distribution network.
Hybiome's core technology is acridinium ester (吖啶酯) direct chemiluminescence immunoassay, making it the first domestic Chinese manufacturer to apply this platform for IVD use. Its product portfolio spans the AE series of fully automated chemiluminescence immunoassay analyzers (AE-180, AE-200, AE-240, AE-240Plus, AE-480Plus), the proprietary AF-8000 total laboratory automation solution, the SA-120 automated blood type analyzer, the Starry-300 colony counter, and a co-developed assembly line with Hitachi High-Tech. The chemiluminescence menu covers 80+ testing items across tumor markers, infectious diseases, thyroid, cardiac, inflammation, sex hormones, and liver fibrosis. The company holds 114 medical device registration certificates and 53 IVDR CE certifications, supported by 356 authorized patents (94 invention patents).
Hybiome generates revenue through a hybrid instrument-plus-consumable model: one-time hardware sales of analyzers to hospitals and clinical laboratories, paired with a recurring reagent/consumables revenue stream tied to the installed base (razor-and-blade economics). Go-to-market is direct enterprise field sales across China (regional managers in provinces including Guangxi, Zhejiang, Guangdong) supplemented by bioMérieux's global distribution network for international markets (Europe, Middle East, Africa). The customer base consists of Tier 2 and Tier 3 hospital clinical laboratories, independent medical testing centers, and blood banks. Pricing is quote-based and not publicly disclosed. In April 2024 the company completed a 72,142 m² new factory (474M RMB total investment) with 2,500-unit annual instrument capacity, and in September 2024 the bioMérieux R&D Innovation Incubator Center (Suzhou) was inaugurated at the same site.
SuZhou Hybiome Biomedical Engineering firmographics
Firmographics- Name
- SuZhou Hybiome Biomedical Engineering
- Legal name
- 苏州长光华医生物医学工程有限公司
- Website
- https://hybiome.com
- Company type
- Private
- Founded year
- 2009
- Operating status
- Operating
- Short description
- SuZhou Hybiome Biomedical Engineering is a Chinese IVD manufacturer specializing in acridinium ester chemiluminescence immunoassay analyzers, reagents, and laboratory automation, serving hospitals and clinical laboratories in China and international markets as a bioMérieux-controlled subsidiary.
- Ownership category
- akta.pro rank
SuZhou Hybiome Biomedical Engineering industry classification
Industry- 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), Surgical & Medical Instruments & Apparatus (3841), Laboratory Analytical Instruments (3826)
- akta.pro primary industry
- Clinical Chemistry & Immunoassay Systems (HLAHAAAA)
- akta.pro secondary industries
- IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM), Clinical Chemistry & Hematology Diagnostics (automated analyzers, blood testing) (HLAAALAH), Biomarker Assay & Reagent Development (LDT/IVD assay design, antibodies/standards/controls) (HLAAAMAL)
Keywords
Where SuZhou Hybiome Biomedical Engineering is headquartered
LocationHeadquarters
- HQ city
- Suzhou
- HQ country
- China
- HQ region
- Asia
Offices1 record
Markets served
SuZhou Hybiome Biomedical Engineering business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Operations, Technology or R&D, Personnel, Infrastructure, Supply Chain, Marketing or Sales
Revenue model
- IVD Instruments (Analyzers): Sale of automated chemiluminescence immunoassay analyzers (AE series) and related laboratory automation equipment. Instruments include AE-200, AE-240, AE-240Plus, AE-480Plus, AE-180, AF-8000, SA-120, Starry-300, and the Hybiome-Hitachi assembly line. One-time capital equipment sale to hospitals and clinical laboratories.
- Reagents and Consumables: Sale of chemiluminescence assay reagents covering tumor, infectious disease, thyroid, cardiac, inflammation, sex hormone, liver fibrosis categories. Reagent capacity noted at 2M kits. Consumables including blood type cards, colony counting supplies, and cleaning solutions. Recurring revenue stream as reagents are consumed per test.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Instrument and reagent product line for clinical diagnostics |
Go-to-market motion2 records
Distribution channels2 records
Marketing channels5 records
SuZhou Hybiome Biomedical Engineering product offering
Product offeringCore offering
SuZhou Hybiome Biomedical Engineering researches, manufactures, and sells automated in vitro diagnostic (IVD) instruments and matching reagents, principally acridinium ester chemiluminescence immunoassay analyzers (AE-200, AE-240, AE-240Plus, AE-480Plus, AE-180) and their reagent menu covering tumor, infectious disease, thyroid, cardiac, inflammation, sex hormone, and liver fibrosis categories. The portfolio also includes the AF-8000 total laboratory automation system, a Hybiome-Hitachi biochemistry-immunoassay assembly line, the SA-120 automated blood type analyzer, the Starry-300 colony counter, and specialty reagents such as BRAHMS PCT, AMH, and Gastrin-17 assays. Customers are Tier 2/3 hospital clinical laboratories and independent medical testing centers in China and international markets.
Differentiator
Problem solved
Functional benefit
Products and services
- AE-200 Desktop Chemiluminescence Immunoassay Analyzer (全自动化学发光免疫分析仪) Compact desktop chemiluminescence immunoassay analyzer for hospitals and clinical laboratories, designed for small-footprint installations with high throughput per unit area and low sample carryover (≤0.1 PPM).
- AE-240Plus High-Speed Chemiluminescence Immunoassay Analyzer (全自动化学发光免疫分析仪) High-speed chemiluminescence immunoassay analyzer with integrated reagent cartridge and dual-reagent needle for high-volume hospital and clinical laboratory use; supports flexible cascade for higher throughput.
- AE-480Plus High-Speed Chemiluminescence Immunoassay Analyzer (全自动化学发光免疫分析仪) Flagship high-throughput chemiluminescence immunoassay analyzer for large-volume clinical laboratories and hospital core labs, offering up to 1600T/H with four-module cascade and flexible integration with biochemistry and total laboratory automation systems.
- AE-240 Chemiluminescence Immunoassay Analyzer (全自动化学发光免疫分析仪) Mid-throughput chemiluminescence immunoassay analyzer for clinical laboratories with broad reagent menu (80+ items) and high precision (system CV ≤8%, 10µL sampling CV <2%, carryover <10⁻⁵).
- AE-180 Chemiluminescence Immunoassay Analyzer (全自动化学发光免疫分析仪) Full-automatic chemiluminescence immunoassay analyzer with high reliability (MTBF >300 days) and ultra-low carryover (<10⁻⁷) for hospital and clinical laboratory diagnostic use.
- AF-8000 Total Laboratory Automation (TLA) Solution (实验室整体解决方案) Proprietary total laboratory automation system that automates centrifugation, decapping, testing, recapping, quality control, retesting, and expired sample discard to eliminate manual intervention in high-volume clinical laboratories.
- Hybiome & Hitachi Biochemistry-Immunoassay Assembly Line (长光华医&日立 流水线) Combined biochemistry and immunoassay assembly line co-developed with Hitachi High-Tech that enables parallel online connection of biochemistry and immunoassay modules with flexible modular layout for hospital and clinical laboratory core labs.
- SA-120 Automated Blood Type Analyzer (全自动血型分析仪) Automated blood typing analyzer with microcolumn gel card processing, 24-card centrifuge, barcode auto-identification, and image-recognition-based result interpretation for blood banks and hospital transfusion departments.
- Starry-300 Colony Counter (菌落计数仪) Automated microbial colony counter with AI-based one-click recognition capable of separating large/small colonies and accurately counting clumped, spreading, lateral, and dense colonies for microbiology laboratories.
- EVERESYS A1800 Series Chemiluminescence Analyzer (A1800 系列化学发光测定仪) First-generation chemiluminescence analyzer (A1800 series) for clinical diagnostics, registered in 2012 and preceding the AE-series acridinium ester platform.
- Hybiome Chemiluminescence Reagent Menu (80+ testing items across tumor, infectious disease, thyroid, cardiac, inflammation, sex hormones, and liver fibrosis) Recurring consumable reagents for AE-series chemiluminescence immunoassay analyzers, covering tumor markers, infectious diseases, thyroid, cardiac, inflammation, sex hormones, and liver fibrosis categories; sold per test to hospitals and clinical laboratories.
- BRAHMS PCT (Procalcitonin) Reagent First domestic PCT (procalcitonin) reagent for AE-series chemiluminescence immunoassay analyzers, used in sepsis diagnosis and antibiotic stewardship guidance in clinical laboratories and ICUs.
- Anti-Müllerian Hormone (AMH) Assay Kit (抗缪勒氏管激素测定试剂盒) AMH chemiluminescence immunoassay reagent for AE-series analyzers, used in reproductive health assessment and ovarian reserve evaluation at hospital and clinical laboratory sites.
- Gastrin-17 (G-17) Assay Kit (胃泌素-17 测定试剂盒) Gastrin-17 (G-17) chemiluminescence immunoassay reagent for AE-series analyzers, part of the gastric function three-marker panel for chronic atrophic gastritis diagnosis.
- D-Dimer II, Estradiol II, and Progesterone II Generation Reagent Kits (D-Dimer Ⅱ代、E2 Ⅱ代、P Ⅱ代) Second-generation D-Dimer, estradiol (E2), and progesterone (P) chemiluminescence immunoassay reagents for AE-series analyzers, used in coagulation and reproductive hormone testing at clinical laboratories.
Quantifiable outcome
- AE-480Plus four-module cascade system achieves 1600 tests per hour throughput
- +5 more outcomes
Companies that use SuZhou Hybiome Biomedical Engineering
Customer profileNamed customers5 records
Segments1 record
Ideal customer profiles1 record
SuZhou Hybiome Biomedical Engineering technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature10 records
SuZhou Hybiome Biomedical Engineering partnerships and signals
Strategic signalPartnerships
Five partnerships are on record, tiered core, minor and foundational.
- Hitachi High-Tech (日立高新技术)coreHybiome partnered with Hitachi to create a combined biochemistry and immunoassay assembly line solution (长光华医&日立 流水线). The solution features unique parallel online connection of biochemistry and immunoassay modules, with modular design allowing flexible I, L, U, H, E, F configurations. This represents a co-developed integration product.
- Beijing Anzhen Hospital / Multi-Center Research Partners (首都医科大学附属北京安贞医院及多中心合作医院)minorHybiome collaborates with Beijing Anzhen Hospital, Subei People's Hospital, Beijing Fangshan Liangxiang Hospital, Beijing Friendship Hospital, and Changchun Central Hospital on multi-center clinical studies for hs-cTnI diagnostic value in NSTEMI patients. Research results published in peer-reviewed journals.
- BRAHMS (part of Thermo Fisher Scientific)coreIn 2021, Hybiome became the first domestic Chinese company to launch BRAHMS PCT (procalcitonin) reagent, utilizing BRAHMS materials for sepsis biomarker detection. PCT is widely used for severe bacterial infection diagnosis and sepsis biomarker, with applications in antibiotic guidance.
- Chinese Academy of Sciences Changchun Institute of Optics, Fine Mechanics and Physics (中国科学院长春光学精密机械与物理研究所)foundationalCo-founded Hybiome together with Chinese Academy of Sciences Suzhou Institute of Biomedical Engineering and Technology and private shareholders. This institutional partnership provided the foundational scientific research capability for the company's establishment.
- Chinese Academy of Sciences Suzhou Institute of Biomedical Engineering and Technology (中国科学院苏州生物医学工程技术研究所)foundationalCo-founded Hybiome together with Chinese Academy of Sciences Changchun Institute of Optics and private shareholders. Provided biomedical engineering technology foundation for the company's IVD product development.
Scale indicators10 records
Recent moves8 records
Expansion highlights5 records
SuZhou Hybiome Biomedical Engineering competitors and assessment
Company assessmentDirect peers
- Maccura Biotechnology: Chinese IVD player offering chemiluminescence, clinical chemistry, and hematology analyzers. Comparable in scale and customer profile to Hybiome, with overlapping test menu in immunoassay.
- DiaSorin: Italian specialty immunoassay company with the LIAISON XL chemiluminescence platform. Closely comparable in technology approach and menu focus on infectious disease, cardiac, and specialty biomarkers.
- Beijing Strong Biotechnologies: Chinese IVD company with a chemiluminescence platform (Lumiray) and broad infectious disease / tumor marker menu. Direct competitor in domestic Tier 2/3 hospital segment.
- Autobio Diagnostics: Chinese IVD company with a strong chemiluminescence immunoassay line (AutoLumo) and microbiology automation. Competes head-to-head with Hybiome for mid-tier Chinese hospital placements.
- Shenzhen New Industries Biomedical Engineering (Snibe): China's largest domestic chemiluminescence immunoassay competitor with the MAGLUMI platform. Directly comparable to Hybiome in technology (acridinium ester / ABEI chemiluminescence), menu breadth, and Tier 2/3 hospital targeting.
Broad incumbents
- Siemens Healthineers: Global IVD and imaging major with the Atellica IM chemiluminescence platform. Competes with Hybiome on high-throughput immunoassay placements and total laboratory automation integrations.
- Mindray: Largest Chinese IVD and patient monitoring player with chemiluminescence (CL-series), hematology, and microbiology offerings. Competes with Hybiome across most Chinese hospital segments but at much greater scale and broader menu.
- Roche Diagnostics: Global IVD leader with the cobas e-series chemiluminescence platform. Represents the upper-bound benchmark Hybiome is positioning against in cardiac, infectious disease, and tumor marker assays.
- Abbott Diagnostics: Global IVD major with the ARCHITECT chemiluminescence immunoassay platform. Competes globally with Hybiome on cardiac (hs-cTnI) and infectious disease menus and sets pricing benchmarks in international tenders.
Others
- Hitachi High-Tech: Japanese analytical instrument manufacturer and Hybiome's co-development partner on the combined biochemistry-immunoassay assembly line. Comparable through its clinical chemistry / immunoassay integration products serving shared hospital customers.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
SuZhou Hybiome Biomedical Engineering financial estimates
Financial estimateRevenue estimate
Valuation estimate
SuZhou Hybiome Biomedical Engineering leadership team
Management profileNumber of profiles
Profiles1 record
SuZhou Hybiome Biomedical Engineering funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
SuZhou Hybiome Biomedical Engineering M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about SuZhou Hybiome Biomedical Engineering
What does SuZhou Hybiome Biomedical Engineering do?
SuZhou Hybiome Biomedical Engineering researches, manufactures, and sells automated in vitro diagnostic (IVD) instruments and matching reagents, principally acridinium ester chemiluminescence immunoassay analyzers (AE-200, AE-240, AE-240Plus, AE-480Plus, AE-180) and their reagent menu covering tumor, infectious disease, thyroid, cardiac, inflammation, sex hormone, and liver fibrosis categories. The portfolio also includes the AF-8000 total laboratory automation system, a Hybiome-Hitachi biochemistry-immunoassay assembly line, the SA-120 automated blood type analyzer, the Starry-300 colony counter, and specialty reagents such as BRAHMS PCT, AMH, and Gastrin-17 assays. Customers are Tier 2/3 hospital clinical laboratories and independent medical testing centers in China and international markets.
Is SuZhou Hybiome Biomedical Engineering a public or private company?
SuZhou Hybiome Biomedical Engineering is a private company. It is classified as corporate owned and is currently operating.
When was SuZhou Hybiome Biomedical Engineering founded?
SuZhou Hybiome Biomedical Engineering was founded in 2009.
Where is SuZhou Hybiome Biomedical Engineering based?
SuZhou Hybiome Biomedical Engineering is headquartered in Suzhou, China, in the Asia region.
How does SuZhou Hybiome Biomedical Engineering make money?
Two revenue lines are on record. IVD Instruments (Analyzers) is the primary driver. The others are reagents and Consumables.
Who are SuZhou Hybiome Biomedical Engineering's main competitors?
Direct peers on record are Maccura Biotechnology, DiaSorin, Beijing Strong Biotechnologies, Autobio Diagnostics and Shenzhen New Industries Biomedical Engineering (Snibe). Broad incumbents are Siemens Healthineers, Mindray, Roche Diagnostics and Abbott Diagnostics. Hitachi High-Tech is listed as an others.
Does SuZhou Hybiome Biomedical Engineering have an API?
No public API is recorded for SuZhou Hybiome Biomedical Engineering.
What industry is SuZhou Hybiome Biomedical Engineering in?
SuZhou Hybiome Biomedical Engineering's product category is In Vitro Diagnostics. Its primary akta.pro industry code is HLAHAAAA, Clinical Chemistry & Immunoassay Systems, with a secondary code of HLAHAAAM, IVD Reagents, Assay Kits & Consumables (Non-instrument). Its NAICS code is 325413 and its SIC code is 2835.