Dramatic change for traditional immunoassay technology as new market model creates enormous opportunity…..
Forecasts by Application, Technology, Product, User and by Country. With Executive and Consultant Guides. 2024 to 2028
Howe Sound Research Published April 2024 – 409 pages
The workhorse of the diagnostic industry is finding new legs. The pandemic has created a new demand for rapid easily available diagnostics. Immunoassay is stepping up. Advances in genetic knowledge are creating new markets for immunoassay. Multiplex is becoming table stakes. Rapid diagnostics, point of care, biomarkers and consumer markets are all areas of expansion while traditional immunoassay maintains a strong position in the growing market for clinical diagnostics. We profile over 80 companies, working in this area. Learn all about the pitfalls and opportunities in this extensive report.
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1 Market Guides …………………………………………………………………………………………. 20
1.1 Immunoassay Market – Strategic Situation Analysis …………………………………….. 21
1.2 Guide for Executives, Marketing, Sales and Business Development Staff …….. 23
1.3 Guide for Management Consultants and Investment Advisors …………………… 24
2 Introduction and Market Definition …………………………………………………………… 25
2.1 Immunoassay Markets Definition In This Report …………………………………………… 26
2.1.1 Enzyme Based ……………………………………………………………………………………….. 26
2.1.2 Immunofluorescence …………………………………………………………………………….. 27
2.1.3 Chemiluminescence ……………………………………………………………………………… 27
2.1.4 DNA/NAT ………………………………………………………………………………………………. 28
2.1.5 RIA & Other ……………………………………………………………………………………………. 28
2.1.6 Reagents/Kits, Analyzers, Software & Services ………………………………………… 28
2.1.7 Infectious Disease ………………………………………………………………………………….. 28
2.1.8 Auto Immune ………………………………………………………………………………………… 28
2.1.9 Endocrinology ……………………………………………………………………………………….. 28
2.1.10 Oncology …………………………………………………………………………………………… 29
2.1.11 Cardiology …………………………………………………………………………………………. 29
2.1.12 Other Specialty…………………………………………………………………………………… 29
2.2 Market Definition ………………………………………………………………………………………. 30
2.2.1 Market Sizes …………………………………………………………………………………………… 30
2.2.2 Currency ……………………………………………………………………………………………….. 30
2.2.3 Years …………………………………………………………………………………………………….. 31
2.3 Methodology ……………………………………………………………………………………………. 32
2.3.1 Methodology ………………………………………………………………………………………… 32
2.3.2 Sources …………………………………………………………………………………………………. 32
2.3.3 Authors ………………………………………………………………………………………………….. 32
2.4 Perspective: Healthcare and the IVD Industry ……………………………………………. 34
2.4.1 Global Healthcare Spending …………………………………………………………………. 34
2.4.2 Spending on Diagnostics ……………………………………………………………………….. 35
2.4.3 Important Role of Insurance for Diagnostics ……………………………………………. 37
3 Industry Overview …………………………………………………………………………………….. 38
3.1 Players in a Dynamic Market …………………………………………………………………….. 39
3.1.1 Academic Research Lab ……………………………………………………………………….. 40
3.1.2 Diagnostic Test Developer ……………………………………………………………………… 41
3.1.3 Instrumentation Supplier ………………………………………………………………………… 41
3.1.4 Chemical/Reagent Supplier …………………………………………………………………… 41
3.1.5 Pathology Supplier…………………………………………………………………………………. 42
3.1.6 Independent Clinical Laboratory …………………………………………………………… 42
3.1.7 Public National/regional Laboratory ………………………………………………………. 42
3.1.8 Hospital Laboratory ……………………………………………………………………………….. 43
3.1.9 Physicians Office Lab (POLS) ………………………………………………………………….. 43
3.1.10 Audit Body …………………………………………………………………………………………. 44
3.1.11 Certification Body ………………………………………………………………………………. 44
3.2 The Clinical Laboratory Market Segments ………………………………………………….. 46
3.2.1 Traditional Market Segmentation …………………………………………………………… 46
3.2.2 Laboratory Focus and Segmentation …………………………………………………….. 48
3.2.3 Hospital Testing Share …………………………………………………………………………….. 50
3.2.4 Economies of Scale ……………………………………………………………………………….. 50
3.2.5 Hospital vs. Central Lab …………………………………………………………………………. 51
3.2.6 Physician Office Lab’s ……………………………………………………………………………. 52
3.2.7 Physician’s and POCT…………………………………………………………………………….. 53
3.3 Immunoassay –Markets and Discussion ……………………………………………………… 54
3.3.1 Instruments – Genetics changes the picture …………………………………………… 54
3.3.1.1 RIA – A Technology Shows its Age ……………………………………………………. 55
3.3.1.2 Immunoassay vs. PCR vs. Sequencing – A See Saw Battle ………………… 55
3.3.1.3 The Smart Shrinking Instrument – Serious Implications ………………………… 56
3.3.1.4 Research Funding and Capital Expense – Instrument Pooling …………… 56
3.3.1.5 Multiplex vs. POC – A Tradeoff Analysis …………………………………………….. 58
3.3.2 Reagents and Kits – Genetics changes the picture ………………………………… 58
3.3.2.1 Bigger Test Menus a Boon for Kit Market …………………………………………… 59
3.3.2.2 Physician Office Labs – A New Frontier …………………………………………….. 59
3.3.3 Rapid and POCT to Threaten Instrument Markets ……………………………………. 60
3.3.4 OTC and DTC – Huge Market Potential …………………………………………………… 60
3.3.5 Economies of Scale. Going Away? ……………………………………………………….. 60
3.3.6 Lower Barriers to Entry for Instruments/Analyzers ……………………………………… 61
3.3.7 Miniturization and Technology Drive Acquisition……………………………………… 61
4 Market Trends …………………………………………………………………………………………… 63
4.1 Factors Driving Growth ……………………………………………………………………………… 64
4.1.1 Diagnostic Factors …………………………………………………………………………………. 64
4.1.2 Changing Technologies Spur Early Instrument Retirement ………………………. 65
4.1.3 Consumer Channels Open Wider …………………………………………………………… 65
4.1.4 Immunity Technology Comes of Age ……………………………………………………… 65
4.2 Factors Limiting Growth …………………………………………………………………………….. 66
4.2.1 Increased Competition Lowers Price ………………………………………………………. 66
4.2.2 Threat from PCR Based Instruments ………………………………………………………… 67
4.2.3 Lower Barriers to Entry ……………………………………………………………………………. 67
4.2.4 Wellness has a downside ……………………………………………………………………….. 67
4.3 Immunoassay Instrumentation …………………………………………………………………… 68
4.3.1 Instrumentation Tenacity ……………………………………………………………………….. 68
4.3.2 Declining Cost of Instruments Changes Industry Structure ……………………….. 68
4.3.3 Immunoassay – CRISPR Diagnostics ………………………………………………………… 69
5 Immunoassay Recent Developments ……………………………………………………….. 70
5.1 Recent Developments – Importance and How to Use This Section …………….. 71
5.1.1 Importance of These Developments ………………………………………………………. 71
5.1.2 How to Use This Section ………………………………………………………………………….. 71
5.2 Single-Molecule Detection Tech Shows Promise ………………………………………… 71
5.3 QuidelOrtho Vitros Fentanyl Test ………………………………………………………………… 78
5.4 Labcorp: Plasma Phosphorylated-Tau 217 …………………………………………………. 78
5.5 Renalytix Gets Immunoassay Medicare Coverage…………………………………….. 78
5.6 Roche to Acquire LumiraDx POC Tech ………………………………………………………. 80
5.7 Fujirebio, Sysmex to Collaborate on Immunoassay Development ………………. 81
5.8 EDP Biotech, New Day Diagnostics to Merge …………………………………………….. 81
5.9 Sorrento Therapeutics Nabs Contract for Dx Platform ………………………………… 82
5.10 Beckman Coulter Diagnostics DxI 9000 Access Immunoassay Analyzer………. 83
5.11 Qorvo Eyes Multiplex Immunoassay …………………………………………………………… 84
5.12 BioMérieux Launches New Products ………………………………………………………….. 90
5.13 Senzo to Commercialize Infectious Disease Lateral Flow Tests ……………………. 95
5.14 Nanomix Plans Instrument, Test Launches ………………………………………………….. 98
5.15 Startup GLX Analytix Prepares for Commercialization ………………………………. 102
5.16 Nonagen Gets CE Mark for Bladder Cancer Immunoassay ……………………… 105
5.17 Qualigen Acquires Majority Stake in NanoSynex ………………………………………. 106
5.18 Saladax Biomedical Using Immunoassay Dx …………………………………………….. 107
5.19 Prolight Diagnostics to Acquire Psyros Diagnostics ……………………………………. 111
5.20 Quidel to Acquire Ortho Clinical Diagnostics …………………………………………… 112
6 Profiles of Key Companies ………………………………………………………………………. 115
6.1 Abbott Laboratories ………………………………………………………………………………… 116
6.2 Abcam …………………………………………………………………………………………………… 118
6.3 Abionic …………………………………………………………………………………………………… 119
6.4 Accel Diagnostics …………………………………………………………………………………… 120
6.5 Agilent ……………………………………………………………………………………………………. 122
6.6 Akonni Biosystems …………………………………………………………………………………… 124
6.7 Applied BioCode …………………………………………………………………………………….. 125
6.8 Arlington Scientific …………………………………………………………………………………… 127
6.9 Arrayit Corporation …………………………………………………………………………………. 128
6.10 Atomo Diagnostics ………………………………………………………………………………….. 130
6.11 Aureum Diagnostics ………………………………………………………………………………… 131
6.12 Aurora Biomed ……………………………………………………………………………………….. 132
6.13 Autobio Diagnostics ………………………………………………………………………………… 134
6.14 AVIVA Systems Biology ……………………………………………………………………………. 136
6.15 Awareness Technology …………………………………………………………………………… 137
6.16 Axis-Shield Diagnostics Ltd. ………………………………………………………………………. 138
6.17 Beckman Coulter Diagnostics (Danaher) …………………………………………………. 139
6.18 Becton, Dickinson and Company ……………………………………………………………. 140
6.19 Biocartis ………………………………………………………………………………………………….. 142
6.20 Biomatik ………………………………………………………………………………………………….. 143
6.21 bioMérieux Diagnostics ……………………………………………………………………………. 144
6.22 Bioneer Corporation ……………………………………………………………………………….. 147
6.23 Bio-Rad Laboratories, Inc. ……………………………………………………………………….. 149
6.24 Bio-Synthesis ……………………………………………………………………………………………. 151
6.25 Bio-Techne ……………………………………………………………………………………………… 153
6.26 Boditech Med, Inc ………………………………………………………………………………….. 155
6.27 Boster Biological Technology …………………………………………………………………… 156
6.28 Bruker ……………………………………………………………………………………………………… 157
6.29 Cerstest Biotec ………………………………………………………………………………………… 159
6.30 Chembio ………………………………………………………………………………………………… 160
6.31 CTK Biotech …………………………………………………………………………………………….. 161
6.32 Cue Health ……………………………………………………………………………………………… 162
6.33 Cytena …………………………………………………………………………………………………… 164
6.34 Diasorin S.p.A. …………………………………………………………………………………………. 165
6.35 Dynex Technologies ………………………………………………………………………………… 166
6.36 Eiken Chemical……………………………………………………………………………………….. 167
6.37 Enzo Biochem …………………………………………………………………………………………. 168
6.38 Eurofins Scientific …………………………………………………………………………………….. 170
6.39 Fluxion Biosciences (Cell Microsystems) ……………………………………………………. 171
6.40 FUJIFILM Wako Diagnostics ………………………………………………………………………. 172
6.41 Fujirebio ………………………………………………………………………………………………….. 173
6.42 Global Access Diagnostics………………………………………………………………………. 174
6.43 Gold Standard Diagnostics ……………………………………………………………………… 175
6.44 Greiner Bio-One ………………………………………………………………………………………. 176
6.45 Grifols ……………………………………………………………………………………………………… 178
6.46 Hycor Biomedical ……………………………………………………………………………………. 180
6.47 Immunodiagnostic Systems (IDS) ……………………………………………………………… 181
6.48 Iollo ………………………………………………………………………………………………………… 182
6.49 JR Biomedical …………………………………………………………………………………………. 183
6.50 LightDeck Diagnostics …………………………………………………………………………….. 184
6.51 LumiraDx …………………………………………………………………………………………………. 185
6.52 Maxim Biomedical ………………………………………………………………………………….. 186
6.53 Meso Scale Discovery ……………………………………………………………………………… 187
6.54 Millipore Sigma ……………………………………………………………………………………….. 188
6.55 Mindray ………………………………………………………………………………………………….. 189
6.56 Molecular Devices ………………………………………………………………………………….. 190
6.57 MP Biomedical ………………………………………………………………………………………… 192
6.58 Operon …………………………………………………………………………………………………… 193
6.59 OraSure Technologies ……………………………………………………………………………… 194
6.60 Qiagen …………………………………………………………………………………………………… 196
6.61 QuidelOrtho ……………………………………………………………………………………………. 198
6.62 R&D Systems……………………………………………………………………………………………. 200
6.63 Randox Toxicology ………………………………………………………………………………….. 201
6.64 R-Biopharm AG ……………………………………………………………………………………….. 202
6.65 Response Biomedical ……………………………………………………………………………… 203
6.66 Revvity ……………………………………………………………………………………………………. 204
6.67 Roche Diagnostics ………………………………………………………………………………….. 206
6.68 SD Biosensor ……………………………………………………………………………………………. 208
6.69 Siemens Healthineers ………………………………………………………………………………. 210
6.70 Standard BioTools ……………………………………………………………………………………. 212
6.71 Sysmex ……………………………………………………………………………………………………. 214
6.72 Tecan ……………………………………………………………………………………………………… 216
6.73 Thermo Fisher Scientific ……………………………………………………………………………. 217
6.74 TOSOH Bioscience …………………………………………………………………………………… 219
6.75 Uniogen ………………………………………………………………………………………………….. 220
6.76 Veramarx ……………………………………………………………………………………………….. 222
6.77 Veredus Laboratories ………………………………………………………………………………. 223
6.78 Vircell ……………………………………………………………………………………………………… 224
6.79 Wantai Biopharm ……………………………………………………………………………………. 226
6.80 Werfen ……………………………………………………………………………………………………. 227
6.81 YD Diagnostics ………………………………………………………………………………………… 229
6.82 Zhejiang Orient Gene Biotech …………………………………………………………………. 231
7 The Global Market ………………………………………………………………………………….. 233
7.1 Global Market by Country ………………………………………………………………………. 234
7.1.1 Global Market by Country Table ………………………………………………………….. 234
7.1.2 Global Market by Country Chart ………………………………………………………….. 235
7.2 Global Market by Application …………………………………………………………………. 236
7.2.1 Global Market by Application Table …………………………………………………….. 236
7.2.2 Global Market by Application Segment Growth Chart …………………………. 237
7.2.3 Global Market by Application Segment Annual Chart ………………………….. 238
7.2.4 Global Market by Application Segment Base vs. Final …………………………… 239
7.2.5 Global Market by Application Base Year ……………………………………………… 240
7.2.6 Global Market by Application Final Year ………………………………………………. 241
7.3 Global Market by Technology …………………………………………………………………. 242
7.3.1 Global Market by Technology Table …………………………………………………….. 242
7.3.2 Global Market by Technology Segment Growth Chart …………………………. 243
7.3.3 Global Market by Technology Segment Annual Chart ………………………….. 244
7.3.4 Global Market by Technology Segment Base vs. Final …………………………… 245
7.3.5 Global Market by Technology Base Year ……………………………………………… 246
7.3.6 Global Market by Technology Final Year ………………………………………………. 247
7.4 Global Market by Product……………………………………………………………………….. 248
7.4.1 Global Market by Product Table…………………………………………………………… 248
7.4.2 Global Market by Product Segment Growth Chart ……………………………….. 249
7.4.3 Global Market by Product Segment Annual Chart ……………………………….. 250
7.4.4 Global Market by Product Segment Base vs. Final ………………………………… 251
7.4.5 Global Market by Product Base Year ……………………………………………………. 252
7.4.6 Global Market by Product Final Year ……………………………………………………. 253
7.5 Global Market by User …………………………………………………………………………….. 254
7.5.1 Global Market by User Table ………………………………………………………………… 254
7.5.2 Global Market by User Segment Growth Chart …………………………………….. 255
7.5.3 Global Market by User Segment Annual Chart ……………………………………… 256
7.5.4 Global Market by User Segment Base vs. Final ………………………………………. 257
7.5.5 Global Market by User Base Year …………………………………………………………. 258
7.5.6 Global Market by Application Final Year ………………………………………………. 259
8 Global Market by Application ………………………………………………………………… 260
8.1 Endocrinology Applications …………………………………………………………………….. 261
8.1.1 Endocrinology Applications by Country Table ………………………………………. 261
8.1.2 Endocrinology Applications Growth Chart ……………………………………………. 262
8.2 Immune Applications ………………………………………………………………………………. 263
8.2.1 Immune Applications by Country Table ………………………………………………… 263
8.2.2 Immune Applications Growth Chart …………………………………………………….. 264
8.3 Oncology Applications ……………………………………………………………………………. 265
8.3.1 Oncology Applications by Country Table …………………………………………….. 265
8.3.2 Oncology Applications Growth Chart ………………………………………………….. 266
8.4 Infectious Disease Applications ……………………………………………………………….. 267
8.4.1 Infectious Disease Applications by Country Table …………………………………. 267
8.4.2 Infectious Disease Applications Growth Chart ………………………………………. 268
8.5 Cardiology Applications ………………………………………………………………………….. 269
8.5.1 Cardiology Applications by Country Table …………………………………………… 269
8.5.2 Cardiology Applications Growth Chart ………………………………………………… 270
8.6 Other Applications ………………………………………………………………………………….. 271
8.6.1 Other Applications by Country Table ……………………………………………………. 271
8.6.2 Other Applications Growth Chart …………………………………………………………. 272
9 Immunoassay by Technology …………………………………………………………………. 273
9.1 Enzyme …………………………………………………………………………………………………… 274
9.1.1 Enzyme by Country Table …………………………………………………………………….. 274
9.1.2 Enzyme Growth Chart ………………………………………………………………………….. 275
9.2 Flourescence ………………………………………………………………………………………….. 276
9.2.1 Flourescence by Country Table ……………………………………………………………. 276
9.2.2 Flourescence Growth Chart …………………………………………………………………. 277
9.3 Chemiluminescence ……………………………………………………………………………….. 278
9.3.1 Chemiluminescence by Country Table…………………………………………………. 278
9.3.2 Chemiluminescence Growth Chart ……………………………………………………… 279
9.4 Nucleic Acid …………………………………………………………………………………………… 280
9.4.1 Nucleic Acid by Country Table …………………………………………………………….. 280
9.4.2 Nucleic Acid Growth Chart ………………………………………………………………….. 281
9.5 Rapid/POC …………………………………………………………………………………………….. 282
9.5.1 Rapid/POC by Country Table ………………………………………………………………. 282
9.5.2 Rapid/POC Growth Chart ……………………………………………………………………. 283
9.6 Other Technology …………………………………………………………………………………… 284
9.6.1 Other Technology by Country Table …………………………………………………….. 284
9.6.2 Other Technology Growth Chart ………………………………………………………….. 285
10 Immunoassay by Product …………………………………………………………………… 286
10.1 Instrument ………………………………………………………………………………………………. 287
10.1.1 Instrument by Country Table ……………………………………………………………… 287
10.1.2 Instrument Growth Chart …………………………………………………………………… 288
10.2 Reagents ………………………………………………………………………………………………… 289
10.2.1 Reagents by Country Table ………………………………………………………………. 289
10.2.2 Reagents Growth Chart ……………………………………………………………………. 290
10.3 Services ………………………………………………………………………………………………….. 291
10.3.1 Services by Country Table …………………………………………………………………. 291
10.3.2 Services Growth Chart ………………………………………………………………………. 292
11 Immunoassay by User …………………………………………………………………………. 293
11.1 Hospital …………………………………………………………………………………………………… 294
11.1.1 Hospital by Country Table …………………………………………………………………. 294
11.1.2 Hospital Growth Chart ………………………………………………………………………. 295
11.2 Outpatient Lab ……………………………………………………………………………………….. 296
11.2.1 Outpatient Lab by Country Table ……………………………………………………… 296
11.2.2 Outpatient Lab Growth Chart …………………………………………………………… 297
11.3 POC/Other ……………………………………………………………………………………………… 298
11.3.1 POC/Other by Country Table ……………………………………………………………. 298
11.3.2 POC/Other Growth Chart …………………………………………………………………. 299
12 Vision of the Future of Immunoassay …………………………………………………… 300
13 Appendices ……………………………………………………………………………………….. 301
13.1 Growth of Approved IVD Test Menu ………………………………………………………… 301
13.2 Growth of Approved Average IVD Test Fee …………………………………………….. 302
13.3 The Most Used IVD Assays ………………………………………………………………………… 303
13.4 The Highest Grossing Assays …………………………………………………………………….. 308
13.5 Laboratory Fees Schedule ………………………………………………………………………. 313
Profiles of Key Players
6.1 Abbott Laboratories
6.2 Abcam
6.3 Abionic
6.4 Accel Diagnostics
6.5 Agilent
6.6 Akonni Biosystems
6.7 Applied BioCode
6.8 Arlington Scientific
6.9 Arrayit Corporation
6.10 Atomo Diagnostics
6.11 Aureum Diagnostics
6.12 Aurora Biomed
6.13 Autobio Diagnostics
6.14 AVIVA Systems Biology
6.15 Awareness Technology
6.16 Axis-Shield Diagnostics Ltd.
6.17 Beckman Coulter Diagnostics (Danaher)
6.18 Becton, Dickinson and Company
6.19 Biocartis
6.20 Biomatik
6.21 bioMérieux Diagnostics
6.22 Bioneer Corporation
6.23 Bio-Rad Laboratories, Inc.
6.24 Bio-Synthesis
6.25 Bio-Techne
6.26 Boditech Med, Inc
6.27 Boster Biological Technology
6.28 Bruker
6.29 Cerstest Biotec
6.30 Chembio
6.31 CTK Biotech
6.32 Cue Health
6.33 Cytena
6.34 Diasorin S.p.A.
6.35 Dynex Technologies
6.36 Eiken Chemical
6.37 Enzo Biochem
6.38 Eurofins Scientific
6.39 Fluxion Biosciences (Cell Microsystems)
6.40 FUJIFILM Wako Diagnostics
6.41 Fujirebio
6.42 Global Access Diagnostics
6.43 Gold Standard Diagnostics
6.44 Greiner Bio-One
6.45 Grifols
6.46 Hycor Biomedical
6.47 Immunodiagnostic Systems (IDS)
6.48 Iollo
6.49 JR Biomedical
6.50 LightDeck Diagnostics
6.51 LumiraDx
6.52 Maxim Biomedical
6.53 Meso Scale Discovery
6.54 Millipore Sigma
6.55 Mindray
6.56 Molecular Devices
6.57 MP Biomedical
6.58 Operon
6.59 OraSure Technologies
6.60 Qiagen
6.61 QuidelOrtho
6.62 R&D Systems
6.63 Randox Toxicology
6.64 R-Biopharm AG
6.65 Response Biomedical
6.66 Revvity
6.67 Roche Diagnostics
6.68 SD Biosensor
6.69 Siemens Healthineers
6.70 Standard BioTools
6.71 Sysmex
6.72 Tecan
6.73 Thermo Fisher Scientific
6.74 TOSOH Bioscience
6.75 Uniogen
6.76 Veramarx
6.77 Veredus Laboratories
6.78 Vircell
6.79 Wantai Biopharm
6.80 Werfen
6.81 YD Diagnostics
6.82 Zhejiang Orient Gene Biotech
Table of Tables
Table 1 Market Players by Type ……………………………………………………………………………… 40
Table 2 Clinical Laboratory Departments and Segments ………………………………………… 47
Table 3 Laboratory Management Focus – Different Approaches ……………………………. 48
Table 4 Key Segmentation Variables Going Forward ………………………………………………. 49
Table 5 The Different Markets for Immunoassay ………………………………………………………. 54
Table 6 The Factors Driving Growth ………………………………………………………………………… 64
Table 7 Factors Limiting Growth ……………………………………………………………………………… 66
Table 8 The Global Immunoassay Market by Country …………………………………………… 234
Table 9 Global Market by Application …………………………………………………………………. 236
Table 10 Global Market by Technology ……………………………………………………………….. 242
Table 11 Global Market by Product …………………………………………………………………….. 248
Table 12 Global Market by User …………………………………………………………………………… 254
Table 13 Endocrinology Immunoassay by Country ………………………………………………… 261
Table 14 Immune Immunoassay by Country …………………………………………………………. 263
Table 15 Oncology Immunoassay by Country ………………………………………………………. 265
Table 16 Infectious Disease Immunoassay by Country …………………………………………… 267
Table 17 Cardiology Immunoassay by Country …………………………………………………….. 269
Table 18 Other Immunoassay by Country……………………………………………………………… 271
Table 19 Enzyme Immunoassay by Country ………………………………………………………….. 274
Table 20 Flourescence Immunoassay by Country …………………………………………………. 276
Table 21 Chemiluminescence Immunoassay by Country ………………………………………. 278
Table 22 Nucleic Acid Immunoassay by Country ………………………………………………….. 280
Table 23 Rapid/POC Immunoassay by Country …………………………………………………….. 282
Table 24 Other Technology Immunoassay by Country ………………………………………….. 284
Table 25 Instrument by Country ……………………………………………………………………………. 287
Table 26 Reagents by Country ……………………………………………………………………………… 289
Table 27 Services by Country ……………………………………………………………………………….. 291
Table 28 Hospital Usrr by Country ………………………………………………………………………….. 294
Table 29 Outpatient Lab by Country …………………………………………………………………….. 296
Table 30 POC/Other by Country …………………………………………………………………………… 298
Table 31 The Most Common Assays …………………………………………………………………….. 303
Table 32 Largest Revenue Assays …………………………………………………………………………. 308
Table 33 Clinical Lab Fee Schedule ……………………………………………………………………… 313
Table of Figures
Figure 1 Global Healthcare Spending …………………………………………………………………….. 35
Figure 2 The Lab Test Pie ………………………………………………………………………………………… 36
Figure 3 The Road to Diagnostics ……………………………………………………………………………. 39
Figure 4 Immunoassay – Country Sharea ………………………………………………………………. 235
Figure 5 Chart of Growth by Application ………………………………………………………………. 237
Figure 6 Chart of Segment by Year ………………………………………………………………………. 238
Figure 7 Chart of Base vs. Final ……………………………………………………………………………… 239
Figure 8 Chart of Base Year by Application ………………………………………………………….. 240
Figure 9 Chart of Final Year by Application …………………………………………………………… 241
Figure 10 Chart of Growth by Technology …………………………………………………………….. 243
Figure 11 Chart of Technology Segment by Year ………………………………………………….. 244
Figure 12 Chart of Technology Base vs. Final …………………………………………………………. 245
Figure 13 Chart of Base Year by Technology ………………………………………………………… 246
Figure 14 Chart of Final Year by Technology …………………………………………………………. 247
Figure 15 Chart of Growth by Product ………………………………………………………………….. 249
Figure 16 Chart of Product Segment by Year ………………………………………………………… 250
Figure 17 Chart of Product Base vs. Final ………………………………………………………………. 251
Figure 18 Chart of Base Year by Product ………………………………………………………………. 252
Figure 19 Chart of Final Year by Product ………………………………………………………………. 253
Figure 20 Chart of Growth by User ………………………………………………………………………… 255
Figure 21 Chart of User Segment by Year ……………………………………………………………… 256
Figure 22 Chart of User Base vs. Final …………………………………………………………………….. 257
Figure 23 Chart of Base Year by User ……………………………………………………………………. 258
Figure 24 Chart of Final Year by User …………………………………………………………………….. 259
Figure 25 Chart – Endocrine Segment vs Total Market Growth ………………………………. 262
Figure 26 Chart – Immune Growth vs. Total ……………………………………………………………. 264
Figure 27 Chart – Oncology vs Total ……………………………………………………………………… 266
Figure 28 Chart – Infectious Disease Immunoassay vs Total ……………………………………. 268
Figure 29 Chart – Cardiology Immunoassay vs total ………………………………………………. 270
Figure 30 Chart – Other Immunoassay vs Total ………………………………………………………. 272
Figure 31 Chart – Enzyme Segment vs Total Market Growth ………………………………….. 275
Figure 32 Chart – Flourescence Growth vs. Total ……………………………………………………. 277
Figure 33 Chart – Chemiluminescence vs Total ……………………………………………………… 279
Figure 34 Chart – Nucleic Acid Immunoassay vs Total ……………………………………………. 281
Figure 35 Chart – Rapid/POC Immunoassay vs total ……………………………………………… 283
Figure 36 Chart – Other Technology Immunoassay vs Total ……………………………………. 285
Figure 37 Chart – Instrument Segment vs Total Market Growth ………………………………. 288
Figure 38 Chart – Reagents Growth vs. Total …………………………………………………………. 290
Figure 39 Chart – Services vs Total …………………………………………………………………………. 292
Figure 40 Chart – Hospital Segment vs Total Market Growth…………………………………… 295
Figure 41 Chart – Outpatient Lab Growth vs. Total ………………………………………………… 297
Figure 42 Chart – POC/Other vs Total ……………………………………………………………………. 299
Figure 43 IVD Test Menu Growth …………………………………………………………………………… 301
Figure 44 IVD Test Average Fees – A Ten Year View ………………………………………………. 302
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