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Report

China Immunoassay Reagents and Devices Market

Market Report I 2025-08-01 I 350 Pages I Data Bridge Market Research

China immunoassay reagents and devices market is expected to reach USD 3.04 billion by 2032 from USD 1.88 billion in 2024, growing with a CAGR of 6.2% in the forecast period of 2025 to 2032.
Market Segmentation:
China Immunoassay Reagents and Devices Market, By Product Type (Immunoassay Reagents & Kits, Immunoassay Devices), By Platform (Chemiluminescence Immunoassays (CLIA), Enzyme Immunoassay (EIA/ELISA), Fluorescence Immunoassays (FIA), Chromatographic Immunoassays, Immunohistochemistry, Radioimmunoassays (RIA), Turbidimetric Immunoassays, Microarray Immunoassays, Counting Immunoassays, Others), By Type (Laboratory Based, Point Of Care), By Specimen Type (Blood, Urine, Saliva, Others), By Application (Infectious Diseases, Cancer Biomarkers, Endocrinology, Bone and Mineral Disorders, Cardiology, Hematology and Blood Screening, Autoimmune Disorders, Toxicology, Neonatal Screening, Allergy Diagnostics, Gastrology, Others), By End User (Hospitals, Clinical Laboratories, Pharmaceutical And Biotechnology Companies, Blood Banks, Research And Academic Laboratories, Ambulatory Care Centers, Nursing Homes, Home Healthcare Agencies, Others) -Industry Trends & Forecast To 2032

Overview of the Global Immunoassay reagents and devices are:

Driver

- Increasing prevalence of chronic diseases boosting demand.
Restrain

- High cost of immunoassay reagents and devices

Opportunity

- Expansion of healthcare infrastructure in emerging markets

Market Players:

The key market players for China Immunoassay reagents and devices are listed below:

- F. Hoffmann-La Roche Ltd (Switzerland)
- Siemens (Germany)
- Abbott Laboratories (U.S.)
- Thermo Fisher Scientific Inc. (U.S.)
- QuidelOrtho Corporation (U.S.)
- Bio-Techne (U.S.)
- BIOM?RIEUX (France)
- DIASORIN S.P.A (Italy)
- Danaher (U.S.)
- Tosoh Bioscience LLC (Japan)
- Hipro Biotechnology Co., Ltd. (China)
- Agilent Technologies, Inc. (U.S.)
- Bio-Rad Laboratories, Inc. (U.S.)
- Sysmex (Japan)
- BD (U.S.)
- QIAGEN (Germany)
- Revvity (U.S.)
- SD Biosensor, INC (South Korea)

TABLE OF CONTENTS
1 INTRODUCTION 17
1.1 OBJECTIVES OF THE STUDY 17
1.2 MARKET DEFINITION 17
1.3 OVERVIEW OF CHINA IMMUNOASSAY REAGENTS AND DEVICE MARKET 17
1.4 MARKETS COVERED 19
2 MARKET SEGMENTATION 22
2.1 MARKETS COVERED 22
2.2 GEOGRAPHICAL SCOPE 23
2.3 YEARS CONSIDERED FOR THE STUDY 23
2.4 CURRENCY AND PRICING 23
2.5 DBMR TRIPOD DATA VALIDATION MODEL 24
2.6 MULTIVARIATE MODELLING 27
2.7 PRIMARY INTERVIEWS WITH KEY OPINION LEADERS 28
2.8 DBMR MARKET POSITION GRID 29
2.9 VENDOR SHARE ANALYSIS 30
2.10 MARKET END USER COVERAGE GRID 31
2.11 SECONDARY SOURCES 32
2.12 ASSUMPTIONS 32
3 EXECUTIVE SUMMARY 33
4 PREMIUM INSIGHTS 40
5 PREMIUM INSIGHTS 41
5.1 PESTAL ANALYSIS 41
5.2 PORTER'S FIVE FORCES ANALYSIS 42
5.3 TECHNOLOGICAL ADVANCEMENTS IN THE TECHNOLOGICAL ADVANCEMENTS IN THE GLOBAL NATURAL TERPENE MARKET 43
5.4 MICRO AND MACRO ECONOMIC FACTORS 49
5.5 PENETRATION AND GROWTH PROSPECT MAPPING 50
5.6 KEY PRICING STRATEGIES 50
5.7 INTELLECTUAL PROPERTY (IP) PORTFOLIO ANALYSIS 51
5.7.1 PATENT QUALITY AND STRENGTH 51
5.7.2 AND COLLABORATIONS 51
5.8 COST STRUCTURE BREAKDOWN 52
5.8.1 IMMUNOASSAY REAGENTS 52
5.8.2 IMMUNOASSAY DEVICES (ANALYZERS): 53
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5.9 REGULATORY COMPLIANCE 54
5.9.1 REGULATORY AUTHORITIES 54
5.9.2 REGULATORY CLASSIFICATIONS 54
5.9.2.1 CLASS I (LOW RISK) 54
5.9.2.2 CLASS II (MODERATE RISK) 54
5.9.2.3 CLASS III (HIGH RISK) 54
5.9.3 REGULATORY SUBMISSIONS 54
5.9.4 INTERNATIONAL HARMONIZATION 55
5.9.5 COMPLIANCE AND QUALITY MANAGEMENT SYSTEMS 55
5.9.6 REGULATORY CHALLENGES AND STRATEGIES 55
5.10 OPPORTUNITY MAP ANALYSIS 56
5.11 VALUE CHAIN ANALYSIS 57
6 MARKET OVERVIEW 58
6.1 DRIVERS 60
6.1.1 INCREASING PREVALENCE OF CHRONIC DISEASES 60
6.1.2 RISING HEALTHCARE INVESTMENTS IN DIAGNOSTIC TECHNOLOGIES 61
6.1.3 GROWING DEMAND FOR PERSONALIZED MEDICINE AND TREATMENTS 61
6.1.4 TECHNOLOGICAL ADVANCEMENTS IN IMMUNOASSAY REAGENTS AND DEVICES 62
6.2 RESTRAINTS 64
6.2.1 FRAGMENTED MARKET WITH INTENSE LOW-COST COMPETITION CAUSING PRICING PRESSURE 64
6.2.2 STRINGENT REGULATORY APPROVAL PROCESSES FOR NEW PRODUCTS 64
6.3 OPPORTUNITIES 65
6.3.1 GROWTH IN RESEARCH AND DEVELOPMENT OF IMMUNOASSAYS 65
6.3.2 EXPANSION OF POINT-OF-CARE IMMUNOASSAY TESTING 66
6.3.3 INDUSTRY COLLABORATIONS ADVANCING IMMUNOASSAY CAPABILITIES 66
6.4 CHALLENGES 68
6.4.1 HIGH COST OF ADVANCED IMMUNOASSAY SYSTEMS AND IMPLEMENTATION 68
6.4.2 SHORTAGE OF SKILLED WORKFORCE AND TECHNICAL EXPERTISE 69
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7 CHINA IMMUNOASSAY REAGENTS AND DEVICES MARKET, BY PRODUCT TYPE 70
7.1 OVERVIEW 71
7.2 IMMUNOASSAY REAGENTS & KITS 74
7.2.1 CHEMILUMINESCENCE IMMUNOASSAYS KITS AND REAGENTS 77
7.2.2 ELISA KITS AND REAGENTS 77
7.2.3 RAPID TEST KITS AND REAGENTS 77
7.2.4 IMMUNOHISTOCHEMISTRY ASSAYS KITS AND REAGENTS 77
7.2.5 BEAD-BASED IMMUNOASSAYS KITS AND REAGENTS 77
7.2.6 WESTERN BLOT KITS AND REAGENTS 77
7.2.7 ELISPOT KITS AND REAGENTS 77
7.2.8 RADIOIMMUNOASSAY KITS AND REAGENTS 77
7.2.9 MICROARRAY IMMUNOASSAYS KITS AND REAGENTS 77
7.2.10 MULTIPLEX MICROARRAY ASSAYS KITS AND REAGENTS 77
7.2.11 OTHER IMMUNOASSAY KITS AND REAGENTS 77
7.3 IMMUNOASSAY DEVICES 78
7.3.1 ANALYZERS 78
7.3.1.1 AUTOMATIC ANALYZERS 79
7.3.1.1.1 CLOSED-ENDED SYSTEMS 79
7.3.1.1.1.1 MODULAR 80
7.3.1.1.1.2 FLOOR-STANDING 80
7.3.1.1.1.3 BENCH-TOP 80
7.3.1.1.1.4 OTHERS 80
7.3.1.1.2 OPEN-ENDED SYSTEMS 80
7.3.1.1.2.1 BENCH-TOP 81
7.3.1.1.2.2 FLOOR-STANDING 81
7.3.1.1.2.3 MODULAR 81
7.3.1.1.2.4 OTHERS 81
7.3.1.2 SEMI-AUTOMATIC ANALYZERS 82
7.3.1.2.1 BENCH-TOP 83
7.3.1.2.2 FLOOR-STANDING 83
7.3.1.2.3 MODULAR 83
7.3.1.2.4 OTHERS 83
7.3.1.1 RENTAL PURCHASE 83
7.3.1.2 OUTRIGHT PURCHASE 83
7.3.1.1 BENCH-TOP 83
7.3.1.2 FLOOR-STANDING 83
7.3.1.3 MODULAR 83
7.3.1.4 OTHERS 84
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7.3.2 ACCESSORIES AND CONSUMABLES 84
7.3.2.1 THERMAL PRINTER 84
7.3.2.2 BARCODE SCANNER 84
7.3.2.3 OTHERS 84
7.3.3 POCT DEVICES 84
7.3.3.1 BENCH-TOP 84
7.3.3.2 HANDHELD 84
8 CHINA IMMUNOASSAY REAGENTS AND DEVICES MARKET, BY PLATFORM 85
8.1 OVERVIEW 86
8.2 CHEMILUMINESCENCE IMMUNOASSAYS (CLIA) 90
8.3 ENZYME IMMUNOASSAY (EIA/ELISA) 91
8.3.1 ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) 92
8.3.1.1 THIRD-GENERATION ELISA 92
8.3.1.2 FOURTH-GENERATION ELISA 92
8.3.1.3 SECOND-GENERATION ELISA 92
8.3.1.4 FIRST-GENERATION ELISA 92
8.3.2 ENZYME LINKED FLUORESCENT IMMUNOASSAY (ELFA) 92
8.4 FLUORESCENCE IMMUNOASSAYS (FIA) 92
8.5 CHROMATOGRAPHIC IMMUNOASSAYS 92
8.6 IMMUNOHISTOCHEMISTRY 92
8.7 RADIOIMMUNOASSAYS (RIA) 92
8.8 TURBIDIMETRIC IMMUNOASSAYS 93
8.9 MICROARRAY IMMUNOASSAYS 93
8.10 COUNTING IMMUNOASSAYS 93
8.11 OTHERS 93
9 CHINA IMMUNOASSAY REAGENTS AND DEVICES MARKET, BY TYPE 94
9.1 OVERVIEW 95
9.2 LABORATORY BASED 98
9.3 POINT OF CARE 98
10 CHINA IMMUNOASSAY REAGENTS AND DEVICES MARKET, BY SPECIMEN TYPE 99
10.1 OVERVIEW 100
10.2 BLOOD 103
10.3 URINE 103
10.4 SALIVA 103
10.5 OTHERS 103
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11 CHINA IMMUNOASSAY REAGENTS AND DEVICES MARKET, BY APPLICATION 104
11.1 OVERVIEW 105
11.2 INFECTIOUS DISEASES 110
11.2.1 IMMUNOASSAY REAGENTS & KITS 110
11.2.2 IMMUNOASSAY DEVICES 110
11.3 CANCER BIOMARKERS 111
11.3.1 CARCINO EMBRYONIC ANTIGEN (CEA) 111
11.3.1.1 IMMUNOASSAY REAGENTS & KITS 111
11.3.1.2 IMMUNOASSAY DEVICES 111
11.3.2 ALPHA-FETOPROTEIN (AFP) 112
11.3.2.1 IMMUNOASSAY REAGENTS & KITS 112
11.3.2.2 IMMUNOASSAY DEVICES 112
11.3.3 CARBOHYDRATE ANTIGEN 19-9 (CA 19-9) 112
11.3.3.1 IMMUNOASSAY REAGENTS & KITS 112
11.3.3.2 IMMUNOASSAY DEVICES 112
11.3.4 CARBOHYDRATE ANTIGEN 125 (CA 125) 113
11.3.4.1 IMMUNOASSAY REAGENTS & KITS 113
11.3.4.2 IMMUNOASSAY DEVICES 113
11.3.5 OTHERS 113
11.3.5.1 IMMUNOASSAY REAGENTS & KITS 113
11.3.5.2 IMMUNOASSAY DEVICES 113
11.4 ENDOCRINOLOGY 114
11.4.1 IMMUNOASSAY REAGENTS & KITS 114
11.4.2 IMMUNOASSAY DEVICES 114
11.5 BONE AND MINERAL DISORDERS 114
11.5.1 IMMUNOASSAY REAGENTS & KITS 114
11.5.2 IMMUNOASSAY DEVICES 114
11.6 CARDIOLOGY 115
11.6.1 IMMUNOASSAY REAGENTS & KITS 115
11.6.2 IMMUNOASSAY DEVICES 115
11.7 HEMATOLOGY AND BLOOD SCREENING 115
11.7.1 IMMUNOASSAY REAGENTS & KITS 115
11.7.2 IMMUNOASSAY DEVICES 115
11.8 AUTOIMMUNE DISORDERS 116
11.8.1 IMMUNOASSAY REAGENTS & KITS 116
11.8.2 IMMUNOASSAY DEVICES 116
11.9 TOXICOLOGY 116
11.9.1 IMMUNOASSAY REAGENTS & KITS 116
11.9.2 IMMUNOASSAY DEVICES 116
11.10 NEONATAL SCREENING 117
11.10.1 IMMUNOASSAY REAGENTS & KITS 117
11.10.2 IMMUNOASSAY DEVICES 117
11.11 ALLERGY DIAGNOSTICS 117
11.11.1 IMMUNOASSAY REAGENTS & KITS 117
11.11.2 IMMUNOASSAY DEVICES 117
11.12 GASTROLOGY 118
11.12.1 IMMUNOASSAY REAGENTS & KITS 118
11.12.2 IMMUNOASSAY DEVICES 118
11.13 OTHERS 118
11.13.1 IMMUNOASSAY REAGENTS & KITS 118
11.13.2 IMMUNOASSAY DEVICES 118
12 CHINA IMMUNOASSAY REAGENTS AND DEVICES MARKET, BY END USER 119
12.1 OVERVIEW 120
12.2 HOSPITALS 123
12.2.1 PUBLIC 123
12.2.2 PRIVATE 123
12.2.3 TIER 3 124
12.2.4 TIER 2 124
12.2.5 TIER 1 124
12.3 CLINICAL LABORATORIES 124
12.4 PHARMACEUTICAL AND BIOTECHNOLOGY COMPANIES 124
12.5 BLOOD BANKS 124
12.6 RESEARCH AND ACADEMIC LABORATORIES 124
12.7 AMBULATORY CARE CENTERS 124
12.8 NURSING HOMES 124
12.9 HOME HEALTHCARE AGENCIES 125
12.10 OTHERS 125
13 CHINA IMMUNOASSAY REAGENTS AND DEVICES MARKET: COMPANY LANDSCAPE 126
13.1 COMPANY SHARE ANALYSIS: CHINA 126
14 SWOT ANALYSIS 127
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15 COMPANY PROFILES 128
15.1 F. HOFFMANN-LA ROCHE LTD 128
15.1.1 COMPANY SNAPSHOT 128
15.1.2 REVENUE ANALYSIS 128
15.1.3 PRODUCT PORTFOLIO 129
15.1.4 RECENT DEVELOPMENT/NEWS 131
15.2 SIEMENS 132
15.2.1 COMPANY SNAPSHOT 132
15.2.2 REVENUE ANALYSIS 132
15.2.3 PRODUCT PORTFOLIO 133
15.2.4 RECENT DEVELOPMENT 133
15.3 ABBOTT 134
15.3.1 COMPANY SNAPSHOT 134
15.3.2 REVENUE ANALYSIS 134
15.3.3 PRODUCT PORTFOLIO 135
15.3.4 RECENT DEVELOPMENT/NEWS 136
15.4 THERMO FISHER SCIENTIFIC INC. 137
15.4.1 COMPANY SNAPSHOT 137
15.4.2 REVENUE ANALYSIS 137
15.4.3 PRODUCT PORTFOLIO 138
15.4.4 RECENT DEVELOPMENT 139
15.5 QUIDELORTHO CORPORATION 140
15.5.1 COMPANY SNAPSHOT 140
15.5.2 REVENUE ANALYSIS 140
15.5.3 PRODUCT PORTFOLIO 141
15.5.4 RECENT DEVELOPMENT/NEWS 142
15.6 AGILENT TECHNOLOGIES, INC 143
15.6.1 COMPANY SNAPSHOT 143
15.6.2 REVENUE ANALYSIS 143
15.6.3 PRODUCT PORTFOLIO 144
15.6.4 RECENT DEVELOPMENT 144
15.7 BD 145
15.7.1 COMPANY SNAPSHOT 145
15.7.2 REVENUE ANALYSIS 145
15.7.3 PRODUCT PORTFOLIO 146
15.7.4 RECENT DEVELOPMENT/NEWS 146
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15.8 BIO RAD LABORATORIES INC 147
15.8.1 COMPANY SNAPSHOT 147
15.8.2 REVENUE ANALYSIS 147
15.8.3 PRODUCT PORTFOLIO 148
15.8.4 RECENT DEVELOPMENT 149
15.9 BIO-TECHNE 150
15.9.1 COMPANY SNAPSHOT 150
15.9.2 REVENUE ANALYSIS 151
15.9.3 PRODUCT PORTFOLIO 151
15.9.4 RECENT DEVELOPMENT 152
15.10 BIOMERIEUX 153
15.10.1 COMPANY SNAPSHOT 153
15.10.2 REVENUE ANALYSIS 153
15.10.3 PRODUCT PORTFOLIO 154
15.10.4 RECENT DEVELOPMENT 154
15.11 DANAHER CORPORATION 155
15.11.1 COMPANY SNAPSHOT 155
15.11.2 REVENUE ANALYSIS 155
15.11.3 PRODUCT PORTFOLIO 156
15.11.4 RECENT DEVELOPMENT 156
15.12 DIASORIN 157
15.12.1 COMPANY SNAPSHOT 157
15.12.2 REVENUE ANALYSIS 157
15.12.3 PRODUCT PORTFOLIO 158
15.12.4 RECENT DEVELOPMENT/NEWS 158
15.13 HIPRO BIOTECHNOLOGY CO.LTD. 159
15.13.1 COMPANY SNAPSHOT 159
15.13.2 PRODUCT PORTFOLIO 159
15.13.3 RECENT DEVELOPMENT 159
15.14 QIAGEN 160
15.14.1 COMPANY SNAPSHOT 160
15.14.2 REVENUE ANALYSIS 160
15.14.3 PRODUCT PORTFOLIO 161
15.14.4 RECENT DEVELOPMENT 162
15.15 REVVITY 163
15.15.1 COMPANY SNAPSHOT 163
15.15.2 REVENUE ANALYSIS 163
15.15.3 PRODUCT PORTFOLIO 164
15.15.4 RECENT DEVELOPMENT 164
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15.16 SD BIOSENSOR, INC. 165
15.16.1 COMPANY SNAPSHOT 165
15.16.2 REVENUE ANALYSIS 165
15.16.3 PRODUCT PORTFOLIO 166
15.16.4 RECENT DEVELOPMENT 166
15.17 SYSMEX CORPORATION 167
15.17.1 COMPANY SNAPSHOT 167
15.17.2 REVENUE ANALYSIS 167
15.17.3 PRODUCT PORTFOLIO 168
15.17.4 RECENT DEVELOPMENT 168
15.18 TOSOH BIOSCIENCE, INC 169
15.18.1 COMPANY SNAPSHOT 169
15.18.2 REVENUE ANALYSIS 169
15.18.3 PRODUCT PORTFOLIO 170
15.18.4 RECENT DEVELOPMENT 170
16 QUESTIONNAIRE 171
17 RELATED REPORTS 175
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