Table of Content


Table of Contents
i. Clinical Laboratory Services - Strategic Situation Analysis ..................................................................... 23
ii. Guide for Executives, Marketing, Sales and Business Development Staff ............................................ 25
iii. Guide for Management Consultants and Investment Advisors ............................................................ 26
1. Introduction and Market Definition ....................................................................................................... 27
1.1 The Growing Demand for Clinical Testing .................................................................................................... 28
1.2 Defining the Opportunity ............................................................................................................................. 30
1.2.1 Volumes ................................................................................................................................................. 30
1.2.2 Prices ..................................................................................................................................................... 31
1.2.3 Revenue Market Size ............................................................................................................................. 31
1.3 Methods and Sources .................................................................................................................................. 32
1.3.1 Authors .................................................................................................................................................. 32
1.3.2 Sources .................................................................................................................................................. 32
1.4 U.S. Medical Market and Clinical Laboratory Testing - Perspective ............................................................ 33
1.3.1 U.S. Medicare Expenditures for Clinical Testing ................................................................................... 34
2. Overview of a Dynamic Market .............................................................................................................. 36
2.1 Market Players – Roles & Impacts ............................................................................................................... 37
2.1.1 Supplier/pharmaceutical ....................................................................................................................... 37
2.1.2 Independent lab specialized/esoteric ................................................................................................... 38
2.1.3 Independent lab national/regional ....................................................................................................... 38
2.1.4 Independent lab analytical .................................................................................................................... 39
2.1.5 Public National/regional lab .................................................................................................................. 39
2.1.6 Hospital lab ............................................................................................................................................ 39
2.1.7 Physician lab .......................................................................................................................................... 40
2.1.8 Audit body ............................................................................................................................................. 40
2.2 Segmentation – Different Approaches ........................................................................................................ 41
2.2.1 Traditional Market Segmentation ......................................................................................................... 41
2.2.2 Laboratory Focus and Segmentation .................................................................................................... 42
2.3 Structure of Clinical Testing Industry ........................................................................................................... 44
2.3.1 The Hospital Lab – Share of the Pie ....................................................................................................... 44
2.3.2 Key Role for Economies of Scale ........................................................................................................... 44
2.3.3 Physician Office Lab’s are Still Here ...................................................................................................... 46
2.3.4 Physician’s and POCT – Reviving Patient Service in China .................................................................... 47
2.4 Profiles of Key Companies ........................................................................................................................... 48
2.4.1 Quest Diagnostics .................................................................................................................................. 48
2.4.2 Laboratory Corporation of America ...................................................................................................... 53
2.4.3 Lifelabs Medical Laboratory Services .................................................................................................... 57
2.4.4 ACM Medical Laboratory ...................................................................................................................... 59
2.4.5 Spectra Laboratories, Inc. ...................................................................................................................... 62
2.4.6 Bio-Reference Laboratories, Inc. ........................................................................................................... 64
2.4.7 CompuNet Clinical Laboratories, LLC .................................................................................................... 68
2.4.8 Genzyme Corporation ........................................................................................................................... 70
2.4.9 Sonic Healthcare Limited ....................................................................................................................... 74
2.4.10 Exagen Diagnostics, Inc. ...................................................................................................................... 76
2.4.11 Clongen Laboratories LLC .................................................................................................................... 80
2.4.12 Clinical Reference Laboratory, Inc. ...................................................................................................... 82
2.4.13 Mid America Clinical Laboratories, LLC ............................................................................................... 86
2.4.14 Miraca Life Sciences, Inc...................................................................................................................... 88
2.4.15 Psychemedics Corp.............................................................................................................................. 92
2.4.16 Aurora Diagnostics, LLC ....................................................................................................................... 94
2.4.17 DL Reference Laboratory ..................................................................................................................... 97
2.4.18 Myriad Genetics, Inc. ........................................................................................................................... 99
2.4.19 Bioscientia Institut fuer Medizinische Diagnostik GmbH .................................................................. 101
2.4.20 Acibadem Labmed Laboratory .......................................................................................................... 103
2.4.21 Eurofins Scientific .............................................................................................................................. 105
2.4.22 The Doctor’s Laboratory (Sonic Healthcare U.K.).............................................................................. 108
2.4.23 Pathology Inc. .................................................................................................................................... 110
2.4.24 Gribbles Pathology ............................................................................................................................ 113
2.4.25 B.P. CLINICAL LAB .............................................................................................................................. 114
2.4.26 Diagnósticos da América (DASA) ....................................................................................................... 116
2.4.27 American Bio-Clinical Laboratories, Int'l ........................................................................................... 118
2.4.28 Adicon Clinical Laboratories .............................................................................................................. 119
2.4.29 Dian Diagnostics ................................................................................................................................ 121
2.4.30 Kingmed Diagnostics ......................................................................................................................... 123
2.4.31 Ascend Clinical, LLC ........................................................................................................................... 125
2.4.32 Unilabs SA .......................................................................................................................................... 127
2.4.33 American Pathology Partners, Inc. .................................................................................................... 130
2.4.34 Integrated Regional Laboratories, Inc. .............................................................................................. 133
2.4.35 Viracor Laboratories .......................................................................................................................... 135
2.4.36 Neogenomics ..................................................................................................................................... 137
2.4.37 Genomic Health, Inc. ......................................................................................................................... 140
2.4.38 ARUP Laboratories, Inc. ..................................................................................................................... 143
2.4.39 Enzo Biochem, Inc. ............................................................................................................................ 147
2.4.40 Mayo Medical Laboratories. ............................................................................................................. 150
2.5 National and Regional Diversity ................................................................................................................. 151
3. Trends Driving a Changing Market ....................................................................................................... 153
3.1 Growth Is Pushed from Many Sides ........................................................................................................... 154
3.1.1 Understanding the Impact of Aging Population. ................................................................................. 155
3.1.2 Economic growth a Key Driver. ........................................................................................................... 155
3.1.3 Point of Care Testing can increase demand ........................................................................................ 155
3.1.4 Alternative Medicine Creates Testing Opportunity ............................................................................ 155
3.1.5 Esoteric Testing Moving Mainstream .................................................................................................. 156
3.1.6 Genetic Based Testing Creates New Department and New Discipline ............................................... 157
3.2 Factors at Work To Shrink The Market ...................................................................................................... 158
3.2.1 Lower costs trend to continue ............................................................................................................ 158
3.2.2 Economic or population contraction. .................................................................................................. 159
3.2.3 Testing usage analysis curtailing growth. ............................................................................................ 159
3.2.4 Wellness has a downside .................................................................................................................... 159
3.2.5 Test Displacement Impacts Important ................................................................................................ 159
3.2.6 Point of Care Testing ........................................................................................................................... 159
3.3 Automation ................................................................................................................................................ 161
3.3.1 Stranded LIMS Investment .................................................................................................................. 161
3.3.2 Software as a Service .......................................................................................................................... 161
3.3.3 Physician Office and Access Systems .................................................................................................. 162
3.4 Environment and Evolution ....................................................................................................................... 163
3.5 Diagnostic Technology Development ........................................................................................................ 164
3.5.1 Next Generation Sequencing Fuels a Revolution. .............................................................................. 165
3.5.2 Impact of NGS on pricing ..................................................................................................................... 166
3.5.3 POCT/Self Testing Disruptive Force ..................................................................................................... 166
3.5.4 Pharmacogenomics Blurs Diagnosis and Treatment ........................................................................... 167
3.5.5 CGES Testing, A Brave New World ...................................................................................................... 168
3.5.6 Molecular Diagnostics Technologies at The Forefront of Growth ...................................................... 169
3.5.7 Biochips/Giant magneto resistance based assay ................................................................................ 170
4. Laboratory, Molecular Diagnostics and Genomic Testing Recent Developments ............................... 171
4.1 Recent Developments – Importance and How to Use This Section .......................................................... 172
4.1.1 Importance of These Developments ................................................................................................... 172
4.1.2 How to Use This Section ...................................................................................................................... 172
4.2 LabCorp explores acquisition of clinical trials firm PPD ............................................................................. 172
4.3 Digipath Enters into Letter of Intent to Acquire Clinical Lab Companies .................................................. 173
4.4 PSP to acquire European medical lab services company ........................................................................... 174
4.5 Mars, Incorporated to Acquire VCA Inc. .................................................................................................... 175
4.6 Caprion Biosciences Acquires the Immune Monitoring Laboratory from ImmuneHealth ........................ 178
4.7 Takara Bio USA Holdings and Rubicon Genomics Announce Merger Agreement ..................................... 180
4.8 Instrumentation Laboratory Acquires CA Casyso AG ................................................................................ 181
4.9 Schryver Medical Completes Acquisitions of Professional Clinical Laboratory, Inc. ................................. 183
4.10 Grail, Illumina’s billion-dollar diagnostics startup ................................................................................... 184
4.11 Grifols acquires Hologic’s blood screening unit for $1.85bn ................................................................... 186
4.12 Bio-Rad Laboratories to buy US firm RainDance Technologies ............................................................... 187
4.13 Abbott Laboratories to buy St. Jude Medical for $25 billion ................................................................... 188
4.14 CombiMatrix Gets Serious About Potential M&A Options in Wake of $8M Offering ............................. 189
4.15 Abbott to Acquire Alere, Becoming Leader in Point of Care Testing ....................................................... 191
4.16 Achieving Dx Ambitions Key to Avant-Amarantus-Theranostics Merger ................................................ 192
4.17 LabCorp Agrees to Acquire Assets of Pathology Inc. .......................................................................... 196
4.18 NeoGenomics Completes Acquisition of Clarient, Inc. ............................................................................ 196
4.19 FDA Gets Pushback on Move to Regulate Lab Developed Tests ............................................................. 197
4.20 Cancer Genetics, Inc. Announces Partnership ......................................................................................... 199
4.21 Theranos plans to close all its clinical labs ............................................................................................... 201
4.22 Forte Capital Lowers stake in Laboratory Corp. ....................................................................................... 201
4.23 US Oncology Network Selects Myriad Genetics ...................................................................................... 203
4.24 Pyxant Labs Commences Clinical Laboratory Testing Services ................................................................ 204
4.25 Viewics Launches Diabetes Management ............................................................................................... 205
4.26 Alpha Genomix And Rx30 Partner ........................................................................................................... 206
4.27 LabCorp Doubles Testing Capacity Of Covance ....................................................................................... 207
4.28 LabCorp to acquire clinical laboratories from Mount Sinai ..................................................................... 208
4.29 PerkinElmer to buy Germany's Euroimmun for about $1.3 billion .......................................................... 210
4.30 LabCorp to Acquire Chiltern for Approximately $1.2 Billion in Cash ....................................................... 210
4.31 Precipio Diagnostics and Transgenomic Complete Merger ..................................................................... 212
4.32 $550 Dock Turns a Smartphone into a Medical Lab ................................................................................ 213
4.33 LabCorp & Interpace Extend Deal, Boost Cancer Portfolio ..................................................................... 214
4.34 Charles River Labs to acquire contract research firm for $800M ............................................................ 215
4.35 Quest Diagnostics to Acquire Shiel Medical Laboratory from Fresenius Medical Care .......................... 216
4.36 Quest Diagnostics to Acquire MedXM ..................................................................................................... 217
4.37 Overview of Clinical Diagnostic Acquisition Activity ................................................................................ 218
4.38 New Sysmex Device Provides Blood Test Results at Point of Care in Minutes ........................................ 220
4.39 FDA, Congress Return Attention to Direct-to-Consumer Genetic Testing .............................................. 221
4.40 QIAGEN Enters into Agreement to Acquire STAT-Dx ............................................................................... 222
4.41 GE Healthcare and Roche Partner to Develop Digital Diagnostics Platform ........................................... 223
5. Country Market Sizes – North America 2015 to 2023 ......................................................................... 225
5.1 United States of America 2015 to 2023 ..................................................................................................... 226
5.1.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................................. 226
5.1.2 Microbiology – Volumes, Prices, Revenues......................................................................................... 226
5.1.3 Hematology – Volumes, Prices, Revenues .......................................................................................... 227
5.1.4 Anatomic Pathology – Volumes, Prices, Revenues ............................................................................. 227
5.1.5 Molecular Diagnostics – Volumes, Prices, Revenues .......................................................................... 228
5.1.6 All Clinical Testing – Volumes, Prices, Revenues ................................................................................. 228
5.1.7 Esoteric – Volumes, Prices, Revenues ................................................................................................. 229
5.2 Canada 2015 to 2023 ................................................................................................................................. 230
5.2.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................................. 230
5.2.2 Microbiology – Volumes, Prices, Revenues......................................................................................... 230
5.2.3 Hematology – Volumes, Prices, Revenues .......................................................................................... 231
5.2.4 Anatomic Pathology – Volumes, Prices, Revenues ............................................................................. 231
5.2.5 Molecular Diagnostics – Volumes, Prices, Revenues .......................................................................... 232
5.2.6 All Clinical Testing – Volumes, Prices, Revenues ................................................................................. 232
5.2.7 Esoteric – Volumes, Prices, Revenues ................................................................................................. 233
6. Country Markets – Europe 2015 to 2023 ............................................................................................. 234
6.1 France 2015 to 2023 .................................................................................................................................. 235
6.1.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................................. 235
6.1.2 Microbiology – Volumes, Prices, Revenues......................................................................................... 235
6.1.3 Hematology – Volumes, Prices, Revenues .......................................................................................... 236
6.1.4 Anatomic Pathology – Volumes, Prices, Revenues ............................................................................. 236
6.1.5 Molecular Diagnostics – Volumes, Prices, Revenues .......................................................................... 237
6.1.6 All Clinical Testing – Volumes, Prices, Revenues ................................................................................. 237
6.1.7 Esoteric – Volumes, Prices, Revenues ................................................................................................. 238
6.2 Germany 2015 to 2023 .............................................................................................................................. 239
6.2.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................................. 239
6.2.2 Microbiology – Volumes, Prices, Revenues......................................................................................... 239
6.2.3 Hematology – Volumes, Prices, Revenues .......................................................................................... 240
6.2.4 Anatomic Pathology – Volumes, Prices, Revenues ............................................................................. 240
6.2.5 Molecular Diagnostics – Volumes, Prices, Revenues .......................................................................... 241
6.2.6 All Clinical Testing – Volumes, Prices, Revenues ................................................................................. 241
6.2.7 Esoteric – Volumes, Prices, Revenues ................................................................................................. 242
6.3 United Kingdom 2015 to 2023 ................................................................................................................... 243
6.3.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................................. 243
6.3.2 Microbiology – Volumes, Prices, Revenues......................................................................................... 243
6.3.3 Hematology – Volumes, Prices, Revenues .......................................................................................... 244
6.3.4 Anatomic Pathology – Volumes, Prices, Revenues ............................................................................. 244
6.3.5 Molecular Diagnostics – Volumes, Prices, Revenues .......................................................................... 245
6.3.6 All Clinical Testing – Volumes, Prices, Revenues ................................................................................. 245
6.3.7 Esoteric – Volumes, Prices, Revenues ................................................................................................. 246
6.4 Spain 2015 to 2023 .................................................................................................................................... 247
6.4.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................................. 247
6.4.2 Microbiology – Volumes, Prices, Revenues......................................................................................... 247
6.4.3 Hematology – Volumes, Prices, Revenues .......................................................................................... 248
6.4.4 Anatomic Pathology – Volumes, Prices, Revenues ............................................................................. 248
6.4.5 Molecular Diagnostics – Volumes, Prices, Revenues .......................................................................... 249
6.4.6 All Clinical Testing – Volumes, Prices, Revenues ................................................................................. 249
6.4.7 Esoteric – Volumes, Prices, Revenues ................................................................................................. 250
6.5 Italy 2015 to 2023 ...................................................................................................................................... 251
6.5.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................................. 251
6.5.2 Microbiology – Volumes, Prices, Revenues......................................................................................... 251
6.5.3 Hematology – Volumes, Prices, Revenues .......................................................................................... 252
6.5.4 Anatomic Pathology – Volumes, Prices, Revenues ............................................................................. 252
6.5.5 Molecular Diagnostics – Volumes, Prices, Revenues .......................................................................... 253
6.5.6 All Clinical Testing – Volumes, Prices, Revenues ................................................................................. 253
6.5.7 Esoteric – Volumes, Prices, Revenues ................................................................................................. 254
6.6 Russia 2015 to 2023 ................................................................................................................................... 255
6.6.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................................. 255
6.6.2 Microbiology – Volumes, Prices, Revenues......................................................................................... 255
6.6.3 Hematology – Volumes, Prices, Revenues .......................................................................................... 256
6.6.4 Anatomic Pathology – Volumes, Prices, Revenues ............................................................................. 256
6.6.5 Molecular Diagnostics – Volumes, Prices, Revenues .......................................................................... 257
6.6.6 All Clinical Testing – Volumes, Prices, Revenues ................................................................................. 257
6.6.7 Esoteric – Volumes, Prices, Revenues ................................................................................................. 258
6.7 Remainder of Europe and Former Soviet Union 2015 to 2023 ................................................................. 259
6.7.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................................. 259
6.7.2 Microbiology – Volumes, Prices, Revenues......................................................................................... 259
6.7.3 Hematology – Volumes, Prices, Revenues .......................................................................................... 260
6.7.4 Anatomic Pathology – Volumes, Prices, Revenues ............................................................................. 260
6.7.5 Molecular Diagnostics – Volumes, Prices, Revenues .......................................................................... 261
6.7.6 All Clinical Testing – Volumes, Prices, Revenues ................................................................................. 261
6.7.7 Esoteric – Volumes, Prices, Revenues ................................................................................................. 262
7. Country Markets – Asia Pacific 2015 to 2023 ....................................................................................... 263
7.1 China 2015 to 2023 .................................................................................................................................... 264
7.1.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................................. 264
7.1.2 Microbiology – Volumes, Prices, Revenues......................................................................................... 264
7.1.3 Hematology – Volumes, Prices, Revenues .......................................................................................... 265
7.1.4 Anatomic Pathology – Volumes, Prices, Revenues ............................................................................. 265
7.1.5 Molecular Diagnostics – Volumes, Prices, Revenues .......................................................................... 266
7.1.6 All Clinical Testing – Volumes, Prices, Revenues ................................................................................. 266
7.1.7 Esoteric – Volumes, Prices, Revenues ................................................................................................. 267
7.2 Japan 2015 to 2023 .................................................................................................................................... 268
7.2.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................................. 268
7.2.2 Microbiology – Volumes, Prices, Revenues......................................................................................... 268
7.2.3 Hematology – Volumes, Prices, Revenues .......................................................................................... 269
7.2.4 Anatomic Pathology – Volumes, Prices, Revenues ............................................................................. 269
7.2.5 Molecular Diagnostics – Volumes, Prices, Revenues .......................................................................... 270
7.2.6 All Clinical Testing – Volumes, Prices, Revenues ................................................................................. 270
7.2.7 Esoteric – Volumes, Prices, Revenues ................................................................................................. 271
7.3 South Korea 2015 to 2023 ......................................................................................................................... 272
7.3.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................................. 272
7.3.2 Microbiology – Volumes, Prices, Revenues......................................................................................... 272
7.3.3 Hematology – Volumes, Prices, Revenues .......................................................................................... 273
7.3.4 Anatomic Pathology – Volumes, Prices, Revenues ............................................................................. 273
7.3.5 Molecular Diagnostics – Volumes, Prices, Revenues .......................................................................... 274
7.3.6 All Clinical Testing – Volumes, Prices, Revenues ................................................................................. 274
7.3.7 Esoteric – Volumes, Prices, Revenues ................................................................................................. 275
7.4 India 2015 to 2023 ..................................................................................................................................... 276
7.4.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................................. 276
7.4.2 Microbiology – Volumes, Prices, Revenues......................................................................................... 276
7.4.3 Hematology – Volumes, Prices, Revenues .......................................................................................... 277
7.4.4 Anatomic Pathology – Volumes, Prices, Revenues ............................................................................. 277
7.4.5 Molecular Diagnostics – Volumes, Prices, Revenues .......................................................................... 278
7.14.6 All Clinical Testing – Volumes, Prices, Revenues ............................................................................... 278
7.4.7 Esoteric – Volumes, Prices, Revenues ................................................................................................. 279
7.5 Australia 2015 to 2023 ............................................................................................................................... 280
7.5.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................................. 280
7.5.2 Microbiology – Volumes, Prices, Revenues......................................................................................... 280
7.5.3 Hematology – Volumes, Prices, Revenues .......................................................................................... 281
7.5.4 Anatomic Pathology – Volumes, Prices, Revenues ............................................................................. 281
7.5.5 Molecular Diagnostics – Volumes, Prices, Revenues .......................................................................... 282
7.5.6 All Clinical Testing – Volumes, Prices, Revenues ................................................................................. 282
7.5.7 Esoteric – Volumes, Prices, Revenues ................................................................................................. 283
7.6 Rest of Asia Pacific 2015 to 2023 ............................................................................................................... 284
7.6.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................................. 284
7.6.2 Microbiology – Volumes, Prices, Revenues......................................................................................... 284
7.6.3 Hematology – Volumes, Prices, Revenues .......................................................................................... 285
7.6.4 Anatomic Pathology – Volumes, Prices, Revenues ............................................................................. 285
7.6.5 Molecular Diagnostics – Volumes, Prices, Revenues .......................................................................... 286
7.6.6 All Clinical Testing – Volumes, Prices, Revenues ................................................................................. 286
7.6.7 Esoteric – Volumes, Prices, Revenues ................................................................................................. 287
8. Country Markets – Latin America, Africa & The Middle East 2015 to 2023 ......................................... 288
8.1 Brazil 2015 to 2023 .................................................................................................................................... 289
8.1.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................................. 289
8.1.2 Microbiology – Volumes, Prices, Revenues......................................................................................... 289
8.1.3 Hematology – Volumes, Prices, Revenues .......................................................................................... 290
8.1.4 Anatomic Pathology – Volumes, Prices, Revenues ............................................................................. 290
8.1.5 Molecular Diagnostics – Volumes, Prices, Revenues .......................................................................... 291
8.1.6 All Clinical Testing – Volumes, Prices, Revenues ................................................................................. 291
8.1.7 Esoteric – Volumes, Prices, Revenues ................................................................................................. 292
8.2 Mexico 2015 to 2023 ................................................................................................................................. 293
8.2.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................................. 293
8.2.2 Microbiology – Volumes, Prices, Revenues......................................................................................... 293
8.2.3 Hematology – Volumes, Prices, Revenues .......................................................................................... 294
8.2.4 Anatomic Pathology – Volumes, Prices, Revenues ............................................................................. 294
8.2.5 Molecular Diagnostics – Volumes, Prices, Revenues .......................................................................... 295
8.2.6 All Clinical Testing – Volumes, Prices, Revenues ................................................................................. 295
8.2.7 Esoteric – Volumes, Prices, Revenues ................................................................................................. 296
8.3 Remainder of Latin America 2015 to 2023 ................................................................................................ 297
8.3.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................................. 297
8.3.2 Microbiology – Volumes, Prices, Revenues......................................................................................... 297
8.3.3 Hematology – Volumes, Prices, Revenues .......................................................................................... 298
8.3.4 Anatomic Pathology – Volumes, Prices, Revenues ............................................................................. 298
8.3.5 Molecular Diagnostics – Volumes, Prices, Revenues .......................................................................... 299
8.3.6 All Clinical Testing – Volumes, Prices, Revenues ................................................................................. 299
8.3.7 Esoteric – Volumes, Prices, Revenues ................................................................................................. 300
8.4 Africa & The Middle East 2015 to 2023 ..................................................................................................... 301
8.4.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................................. 301
8.4.2 Microbiology – Volumes, Prices, Revenues......................................................................................... 301
8.4.3 Hematology – Volumes, Prices, Revenues .......................................................................................... 302
8.4.4 Anatomic Pathology – Volumes, Prices, Revenues ............................................................................. 302
8.4.5 Molecular Diagnostics – Volumes, Prices, Revenues .......................................................................... 303
8.4.6 All Clinical Testing – Volumes, Prices, Revenues ................................................................................. 303
8.4.7 Esoteric – Volumes, Prices, Revenues ................................................................................................. 304
9. Global Market Summary 2015 to 2023 ................................................................................................ 305
9.1 Global Market 2015 to 2023 ...................................................................................................................... 306
9.1.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................................. 306
9.1.2 Microbiology – Volumes, Prices, Revenues......................................................................................... 306
9.1.3 Hematology – Volumes, Prices, Revenues .......................................................................................... 307
9.1.4 Anatomic Pathology – Volumes, Prices, Revenues ............................................................................. 307
9.1.5 Molecular Diagnostics – Volumes, Prices, Revenues .......................................................................... 308
9.1.6 All Clinical Testing – Volumes, Prices, Revenues ................................................................................. 308
9.1.7 Esoteric – Volumes, Prices, Revenues ................................................................................................. 309
10. The Future of the Clinical Laboratory ................................................................................................. 310
Appendices ............................................................................................................................................... 311
I. United States Medicare System: January 2018 Clinical Laboratory Fees Schedule – National Limit and
Midpoint .......................................................................................................................................................... 311

Table of Tables
Table 1 Medicare Clinical Lab Expenditures Actual & Forecast 2004 to 2021 ($Billion) ....................................... 35
Table 2 Market Players by Type ............................................................................................................................ 37
Table 3 Clinical Laboratory Departments and Segments ...................................................................................... 41
Table 4 Laboratory Management Focus – Different Approaches ......................................................................... 42
Table 5 Key Segmentation Variables Going Forward ............................................................................................ 43
Table 6 Factors Affecting Local Clinical Testing Demand .................................................................................... 151
Table 7 Seven Factors Driving Growth ................................................................................................................ 154
Table 8 Alternative Medicine Creates New Clinical Testing Markets .................................................................. 156
Table 9 Six Factors Limiting Growth .................................................................................................................... 158
Table 10 Key Diagnostic Laboratory Technology Trends ..................................................................................... 164
Table 11 Next Generation Sequencing Technologies – Speed and Cost ............................................................. 165
Table 12 Key Point of Care Testing Uses ............................................................................................................. 167
Table 13 Clinical Application Areas for Molecular Diagnostics ........................................................................... 169
Table 14 Clinical Chemistry - Volume Price and Revenue Forecast .................................................................... 226
Table 15 Microbiology - Volume Price and Revenue Forecast ............................................................................ 226
Table 16 Hematology - Volume Price and Revenue Forecast ............................................................................. 227
Table 17 Anatomic Pathology - Volume Price and Revenue Forecast ................................................................ 227
Table 18 Molecular Diagnostics - Volume Price and Revenue Forecast ............................................................. 228
Table 19 All Clinical Testing - Volume Price and Revenue Forecast .................................................................... 228
Table 20 Esoteric - Volume Price and Revenue Forecast .................................................................................... 229
Table 23 Clinical Chemistry - Volume Price and Revenue Forecast .................................................................... 230
Table 24 Microbiology - Volume Price and Revenue Forecast ............................................................................ 230
Table 25 Hematology - Volume Price and Revenue Forecast ............................................................................. 231
Table 26 Anatomic Pathology - Volume Price and Revenue Forecast ................................................................ 231
Table 27 Molecular Diagnostics - Volume Price and Revenue Forecast ............................................................. 232
Table 28 All Clinical Testing - Volume Price and Revenue Forecast .................................................................... 232
Table 29 Esoteric - Volume Price and Revenue Forecast .................................................................................... 233
Table 32 Clinical Chemistry - Volume Price and Revenue Forecast .................................................................... 235
Table 33 Microbiology - Volume Price and Revenue Forecast ............................................................................ 235
Table 34 Hematology - Volume Price and Revenue Forecast ............................................................................. 236
Table 35 Anatomic Pathology - Volume Price and Revenue Forecast ................................................................ 236
Table 36 Molecular Diagnostics - Volume Price and Revenue Forecast ............................................................. 237
Table 37 All Clinical Testing - Volume Price and Revenue Forecast .................................................................... 237
Table 38 Esoteric - Volume Price and Revenue Forecast .................................................................................... 238
Table 41 Clinical Chemistry - Volume Price and Revenue Forecast .................................................................... 239
Table 42 Microbiology - Volume Price and Revenue Forecast ............................................................................ 239
Table 43 Hematology - Volume Price and Revenue Forecast ............................................................................. 240
Table 44 Anatomic Pathology - Volume Price and Revenue Forecast ................................................................ 240
Table 45 Molecular Diagnostics - Volume Price and Revenue Forecast ............................................................. 241
Table 46 All Clinical Testing - Volume Price and Revenue Forecast .................................................................... 241
Table 47 Esoteric - Volume Price and Revenue Forecast .................................................................................... 242
Table 50 Clinical Chemistry - Volume Price and Revenue Forecast .................................................................... 243
Table 51 Microbiology - Volume Price and Revenue Forecast ............................................................................ 243
Table 52 Hematology - Volume Price and Revenue Forecast ............................................................................. 244
Table 53 Anatomic Pathology - Volume Price and Revenue Forecast ................................................................ 244
Table 54 Molecular Diagnostics - Volume Price and Revenue Forecast ............................................................. 245
Table 55 All Clinical Testing - Volume Price and Revenue Forecast .................................................................... 245
Table 56 Esoteric - Volume Price and Revenue Forecast .................................................................................... 246
Table 59 Clinical Chemistry - Volume Price and Revenue Forecast .................................................................... 247
Table 60 Microbiology - Volume Price and Revenue Forecast ............................................................................ 247
Table 61 Hematology - Volume Price and Revenue Forecast ............................................................................. 248
Table 62 Anatomic Pathology - Volume Price and Revenue Forecast ................................................................ 248
Table 63 Molecular Diagnostics - Volume Price and Revenue Forecast ............................................................. 249
Table 64 All Clinical Testing - Volume Price and Revenue Forecast .................................................................... 249
Table 65 Esoteric - Volume Price and Revenue Forecast .................................................................................... 250
Table 68 Clinical Chemistry - Volume Price and Revenue Forecast .................................................................... 251
Table 69 Microbiology - Volume Price and Revenue Forecast ............................................................................ 251
Table 70 Hematology - Volume Price and Revenue Forecast ............................................................................. 252
Table 71 Anatomic Pathology - Volume Price and Revenue Forecast ................................................................ 252
Table 72 Molecular Diagnostics - Volume Price and Revenue Forecast ............................................................. 253
Table 73 All Clinical Testing - Volume Price and Revenue Forecast .................................................................... 253
Table 74 Esoteric - Volume Price and Revenue Forecast .................................................................................... 254
Table 77 Clinical Chemistry - Volume Price and Revenue Forecast .................................................................... 255
Table 78 Microbiology - Volume Price and Revenue Forecast ............................................................................ 255
Table 79 Hematology - Volume Price and Revenue Forecast ............................................................................. 256
Table 80 Anatomic Pathology - Volume Price and Revenue Forecast ................................................................ 256
Table 81 Molecular Diagnostics - Volume Price and Revenue Forecast ............................................................. 257
Table 82 All Clinical Testing - Volume Price and Revenue Forecast .................................................................... 257
Table 83 Esoteric - Volume Price and Revenue Forecast .................................................................................... 258
Table 86 Clinical Chemistry - Volume Price and Revenue Forecast .................................................................... 259
Table 87 Microbiology - Volume Price and Revenue Forecast ............................................................................ 259
Table 88 Hematology - Volume Price and Revenue Forecast ............................................................................. 260
Table 89 Anatomic Pathology - Volume Price and Revenue Forecast ................................................................ 260
Table 90 Molecular Diagnostics - Volume Price and Revenue Forecast ............................................................. 261
Table 91 All Clinical Testing - Volume Price and Revenue Forecast .................................................................... 261
Table 92 Esoteric - Volume Price and Revenue Forecast .................................................................................... 262
Table 95 Clinical Chemistry - Volume Price and Revenue Forecast .................................................................... 264
Table 96 Microbiology - Volume Price and Revenue Forecast ............................................................................ 264
Table 97 Hematology - Volume Price and Revenue Forecast ............................................................................. 265
Table 98 Anatomic Pathology - Volume Price and Revenue Forecast ................................................................ 265
Table 99 Molecular Diagnostics - Volume Price and Revenue Forecast ............................................................. 266
Table 100 All Clinical Testing - Volume Price and Revenue Forecast .................................................................. 266
Table 101 Esoteric - Volume Price and Revenue Forecast .................................................................................. 267
Table 104 Clinical Chemistry - Volume Price and Revenue Forecast .................................................................. 268
Table 105 Microbiology - Volume Price and Revenue Forecast .......................................................................... 268
Table 106 Hematology - Volume Price and Revenue Forecast ........................................................................... 269
Table 107 Anatomic Pathology - Volume Price and Revenue Forecast .............................................................. 269
Table 108 Molecular Diagnostics - Volume Price and Revenue Forecast ........................................................... 270
Table 109 All Clinical Testing - Volume Price and Revenue Forecast .................................................................. 270
Table 110 Esoteric - Volume Price and Revenue Forecast .................................................................................. 271
Table 113 Clinical Chemistry - Volume Price and Revenue Forecast .................................................................. 272
Table 114 Microbiology - Volume Price and Revenue Forecast .......................................................................... 272
Table 115 Hematology - Volume Price and Revenue Forecast ........................................................................... 273
Table 116 Anatomic Pathology - Volume Price and Revenue Forecast .............................................................. 273
Table 117 Molecular Diagnostics - Volume Price and Revenue Forecast ........................................................... 274
Table 118 All Clinical Testing - Volume Price and Revenue Forecast .................................................................. 274
Table 119 Esoteric - Volume Price and Revenue Forecast .................................................................................. 275
Table 122 Clinical Chemistry - Volume Price and Revenue Forecast .................................................................. 276
Table 123 Microbiology - Volume Price and Revenue Forecast .......................................................................... 276
Table 124 Hematology - Volume Price and Revenue Forecast ........................................................................... 277
Table 125 Anatomic Pathology - Volume Price and Revenue Forecast .............................................................. 277
Table 126 Molecular Diagnostics - Volume Price and Revenue Forecast ........................................................... 278
Table 127 All Clinical Testing - Volume Price and Revenue Forecast .................................................................. 278
Table 128 Esoteric - Volume Price and Revenue Forecast .................................................................................. 279
Table 131 Clinical Chemistry - Volume Price and Revenue Forecast .................................................................. 280
Table 132 Microbiology - Volume Price and Revenue Forecast .......................................................................... 280
Table 133 Hematology - Volume Price and Revenue Forecast ........................................................................... 281
Table 134 Anatomic Pathology - Volume Price and Revenue Forecast .............................................................. 281
Table 135 Molecular Diagnostics - Volume Price and Revenue Forecast ........................................................... 282
Table 136 All Clinical Testing - Volume Price and Revenue Forecast .................................................................. 282
Table 137 Esoteric - Volume Price and Revenue Forecast .................................................................................. 283
Table 140 Clinical Chemistry - Volume Price and Revenue Forecast .................................................................. 284
Table 141 Microbiology - Volume Price and Revenue Forecast .......................................................................... 284
Table 142 Hematology - Volume Price and Revenue Forecast ........................................................................... 285
Table 143 Anatomic Pathology - Volume Price and Revenue Forecast .............................................................. 285
Table 144 Molecular Diagnostics - Volume Price and Revenue Forecast ........................................................... 286
Table 145 All Clinical Testing - Volume Price and Revenue Forecast .................................................................. 286
Table 146 Esoteric - Volume Price and Revenue Forecast .................................................................................. 287
Table 149 Clinical Chemistry - Volume Price and Revenue Forecast .................................................................. 289
Table 150 Microbiology - Volume Price and Revenue Forecast .......................................................................... 289
Table 151 Hematology - Volume Price and Revenue Forecast ........................................................................... 290
Table 152 Anatomic Pathology - Volume Price and Revenue Forecast .............................................................. 290
Table 153 Molecular Diagnostics - Volume Price and Revenue Forecast ........................................................... 291
Table 154 All Clinical Testing - Volume Price and Revenue Forecast .................................................................. 291
Table 155 Esoteric - Volume Price and Revenue Forecast .................................................................................. 292
Table 158 Clinical Chemistry - Volume Price and Revenue Forecast .................................................................. 293
Table 159 Microbiology - Volume Price and Revenue Forecast .......................................................................... 293
Table 160 Hematology - Volume Price and Revenue Forecast ........................................................................... 294
Table 161 Anatomic Pathology - Volume Price and Revenue Forecast .............................................................. 294
Table 162 Molecular Diagnostics - Volume Price and Revenue Forecast ........................................................... 295
Table 163 All Clinical Testing - Volume Price and Revenue Forecast .................................................................. 295
Table 164 Esoteric - Volume Price and Revenue Forecast .................................................................................. 296
Table 167 Clinical Chemistry - Volume Price and Revenue Forecast .................................................................. 297
Table 168 Microbiology - Volume Price and Revenue Forecast .......................................................................... 297
Table 169 Hematology - Volume Price and Revenue Forecast ........................................................................... 298
Table 170 Anatomic Pathology - Volume Price and Revenue Forecast .............................................................. 298
Table 171 Molecular Diagnostics - Volume Price and Revenue Forecast ........................................................... 299
Table 172 All Clinical Testing - Volume Price and Revenue Forecast .................................................................. 299
Table 173 Esoteric - Volume Price and Revenue Forecast .................................................................................. 300
Table 176 Clinical Chemistry - Volume Price and Revenue Forecast .................................................................. 301
Table 177 Microbiology - Volume Price and Revenue Forecast .......................................................................... 301
Table 178 Hematology - Volume Price and Revenue Forecast ........................................................................... 302
Table 179 Anatomic Pathology - Volume Price and Revenue Forecast .............................................................. 302
Table 180 Molecular Diagnostics - Volume Price and Revenue Forecast ........................................................... 303
Table 181 All Clinical Testing - Volume Price and Revenue Forecast .................................................................. 303
Table 182 Esoteric - Volume Price and Revenue Forecast .................................................................................. 304
Table 185 Clinical Chemistry - Volume Price and Revenue Forecast .................................................................. 306
Table 186 Microbiology - Volume Price and Revenue Forecast .......................................................................... 306
Table 187 Hematology - Volume Price and Revenue Forecast ........................................................................... 307
Table 188 Anatomic Pathology - Volume Price and Revenue Forecast .............................................................. 307
Table 189 Molecular Diagnostics - Volume Price and Revenue Forecast ........................................................... 308
Table 190 All Clinical Testing - Volume Price and Revenue Forecast .................................................................. 308
Table 191 Esoteric - Volume Price and Revenue Forecast .................................................................................. 309
Table 194 2018 Clinical Lab Fee Schedule ........................................................................................................... 311

Table of Figures
Figure 1 Medicare Clinical Lab Expenditures 2004 to 2021 ($Million) .................................................................. 34