Table of Content



i. Clinical Laboratory Services - Strategic Situation Analysis and Impact Analysis of COVID Recession ................................................................................................................................25
ii. Guide for Executives, Marketing, Sales and Business Development Staff .....................28
iii. Guide for Management Consultants and Investment Advisors ....................................29
1. Introduction and Market Definition ...................................................................................30
1.1 The Growing Demand for Clinical Testing ............................................................................ 31
1.2 Defining the Opportunity ....................................................................................................... 33
1.2.1 Volumes............................................................................................................................. 33
1.2.2 Prices ................................................................................................................................. 34
1.2.3 Revenue Market Size........................................................................................................ 34
1.3 Methods and Sources ............................................................................................................ 35
1.3.1 Authors .............................................................................................................................. 35
1.3.2 Sources.............................................................................................................................. 35
1.4 U.S. Medical Market and laboratory Testing - Perspective ................................................. 36
1.4.1 U.S. Medicare Expenditures for Laboratory Testing ....................................................... 36
2. Overview of a Dynamic Market ........................................................................................38
2.1 Market Players – Roles & Impacts.......................................................................................... 39
2.1.1 Supplier/pharmaceutical ................................................................................................ 39
2.1.2 Independent lab specialized/esoteric ........................................................................... 40
2.1.3 Independent lab national/regional................................................................................ 40
2.1.4 Independent lab analytical ............................................................................................ 41
2.1.5 Public National/regional lab ........................................................................................... 41
2.1.6 Hospital lab ....................................................................................................................... 41
2.1.7 Physician lab..................................................................................................................... 42
2.1.8 Audit body ........................................................................................................................ 42
2.2 Segmentation – Different Approaches................................................................................. 44
2.2.1 Traditional Market Segmentation.................................................................................... 44
2.2.2 Laboratory Focus and Segmentation............................................................................. 45
2.3 Structure of Clinical Testing Industry...................................................................................... 47
2.3.1 The Hospital Lab – Share of the Pie................................................................................. 47
2.3.2 Key Role for Economies of Scale..................................................................................... 47
2.3.3 Physician Office Lab’s are Still Here ................................................................................ 49
2.3.4 Physician’s and POCT – Reviving Patient Service in China........................................... 50
2.4 Profiles of Key Companies ..................................................................................................... 51
Acibadem Labmed Laboratory .............................................................................................. 51
ACM Medical Laboratory......................................................................................................... 53
Adicon Clinical Laboratories.................................................................................................... 54
American Bio-Clinical Laboratories, Int'l.................................................................................. 55
American Pathology Partners .................................................................................................. 56
ARUP Laboratories..................................................................................................................... 57
Ascend Clinical ......................................................................................................................... 59
Aurora Diagnostics.................................................................................................................... 60
Bio-Reference Laboratories...................................................................................................... 61
Bioscientia Institut für Medizinische Diagnostik GmbH ........................................................... 62
BP Healthcare Group................................................................................................................ 63
Clinical Reference Laboratory................................................................................................. 64
Clongen Laboratories ............................................................................................................... 65
CompuNet Clinical Laboratories ............................................................................................. 66
Diagnósticos da América......................................................................................................... 67
DIAN Diagnostics Co., Ltd......................................................................................................... 68
Enzo Life Sciences, Inc. ............................................................................................................. 70
Eurofins Scientific ....................................................................................................................... 71
 Exagen Diagnostics................................................................................................................... 74
Genomic Health........................................................................................................................ 75
Genzyme Corporation.............................................................................................................. 76
Gribbles Pathology.................................................................................................................... 78
Guangzhou Kingmed Diagnostics Group Co., Ltd................................................................. 79
Integrated Regional Laboratories............................................................................................ 80
KDL Group.................................................................................................................................. 81
Laboratory Corporation of America ....................................................................................... 82
Lifelabs ....................................................................................................................................... 84
Mayo Clinic Laboratories.......................................................................................................... 85
Mid America Clinical Laboratories .......................................................................................... 86
Myriad Genetics/Myriad RBM .................................................................................................. 87
NeoGenomics ........................................................................................................................... 88
Pathology, Inc. .......................................................................................................................... 89
Psychemedics Corporation...................................................................................................... 90
Quest Diagnostics ..................................................................................................................... 91
RDL Reference Laboratory ....................................................................................................... 92
Sonic Healthcare....................................................................................................................... 93
Spectra Laboratories ................................................................................................................ 94
Synlab Group............................................................................................................................. 95 Unilabs........................................................................................................................................ 96
2.5 National and Regional Diversity ............................................................................................ 97
3. Trends Driving a Changing Market....................................................................................99
3.1 Growth Is Pushed from Many Sides ..................................................................................... 100
3.1.1 Understanding the Impact of Aging Population. ........................................................ 101
3.1.2 COVID Related Testing Growth..................................................................................... 101
3.1.3 Point of Care Testing can increase demand............................................................... 101
 3.1.4 Alternative Medicine Creates Testing Opportunity ..................................................... 101
3.1.5 Esoteric Testing Moving Mainstream............................................................................. 102
3.1.6 Genetic Based Testing Creates New Department and New Discipline .................... 103
3.2 Factors at Work To Shrink The Market.................................................................................. 104
3.2.1 COVID 19 Recession....................................................................................................... 104
3.2.2 Economic or population contraction........................................................................... 105
3.2.3 Testing usage analysis curtailing growth. ..................................................................... 105
3.2.4 Wellness has a downside ............................................................................................... 105
3.2.5 Test Displacement Impacts Important.......................................................................... 105
3.2.6 Point of Care Testing ...................................................................................................... 105
3.3 Automation ........................................................................................................................... 107
3.3.1 Stranded LIMS Investment ............................................................................................. 107
3.3.2 Software as a Service..................................................................................................... 107
3.3.3 Physician Office and Access Systems........................................................................... 108
3.4 Environment and Evolution.................................................................................................. 109
3.5 Diagnostic Technology Development................................................................................ 110
3.5.1 Next Generation Sequencing Fuels a Revolution....................................................... 111
3.5.2 Impact of NGS on pricing.............................................................................................. 112
3.5.3 POCT/Self Testing Disruptive Force................................................................................ 112
3.5.4 Pharmacogenomics Blurs Diagnosis and Treatment................................................... 113
3.5.5 CGES Testing, A Brave New World ................................................................................ 114
3.5.6 Molecular Diagnostics Technologies at The Forefront of Growth .............................. 115
3.5.7 Biochips/Giant magneto resistance based assay....................................................... 116
4. Laboratory, Molecular Diagnostics and Genomic Testing Recent Developments ....117
4.1 Recent Developments – Importance and How to Use This Section................................. 118
4.1.1 Importance of These Developments ............................................................................ 118
4.1.2 How to Use This Section.................................................................................................. 118
 Private labs say demand for coronavirus tests is down........................................................... 118
CDC Ranks Two More Microbes as ‘Urgent Threat’................................................................. 119
Applied Biology to Launch New Laboratory for Hair and Skin Disorders ............................... 122
Quest Diagnostics Acquires Outreach Operations ................................................................. 123
Quest Diagnostics Buys Assets of Boston Clinical Laboratory Services .................................. 124
CLA Urges FDA to Halt Crackdown on PGx Testing................................................................. 125
ACLA Requests $5 billion to keep private labs going.............................................................. 127
Quest Diagnostics Subsidiary Buys True Health Dx Assets........................................................ 129
BioReference Laboratories selected by IPA Association ........................................................ 129
Predictive Laboratories Announces Research Collaboration ................................................ 130
NEOMED-LABS / Pacific Biomarkers Acquires PAIRimmune Français..................................... 131
LabCorp and Envigo Complete Transactions.......................................................................... 132
PathGroup Acquires Pathologists Bio-Medical Laboratories .................................................. 133
Predictive Technology Acquires Taueret Laboratories ........................................................... 133
Quest Diagnostics Acquires Laboratory Services Business of Boyce & Bynum Pathology Laboratories ................................................................................................................................ 135
Gestalt Diagnostics Expands Market Reach with Peak Medical Acquisition ........................ 136
Amazon exploring consumer health diagnostics .................................................................... 137
Quest Diagnostics Acquires Laboratory Services Operation in Central Michigan ............... 138
NeoGenomics to acquire Genoptix, Inc.................................................................................. 138
Quest Diagnostics to Acquire U.S. Laboratory Services Business of Oxford Immunotec ...... 140
Charles River Labs to acquire contract research firm for $800M ........................................... 140
GROUPE BIO7 to be Sold to CERBA HEALTHCARE.................................................................... 141
GE Healthcare and Roche Partner to Develop Digital Diagnostics Platform ....................... 142
Digipath Enters into Letter of Intent to Acquire Clinical Lab Companies .............................. 143
PSP to acquire European medical lab services company ..................................................... 144
Mars, Incorporated to Acquire VCA Inc. ................................................................................. 145
 Grifols acquires Hologic’s blood screening unit for $1.85bn................................................... 147
LabCorp to acquire clinical laboratories from Mount Sinai.................................................... 148
PerkinElmer to buy Germany's Euroimmun for about $1.3 billion ........................................... 149
LabCorp to Acquire Chiltern for Approximately $1.2 Billion in Cash ...................................... 150
Precipio Diagnostics and Transgenomic Complete Merger .................................................. 151
$550 Dock Turns a Smartphone into a Medical Lab................................................................ 153
LabCorp & Interpace Extend Deal, Boost Cancer Portfolio ................................................... 153
Quest Diagnostics to Acquire Shiel Medical Laboratory from Fresenius Medical Care ....... 154
Quest Diagnostics to Acquire MedXM ..................................................................................... 155
Overview of Clinical Diagnostic Acquisition Activity............................................................... 156
New Sysmex Device Provides Blood Test Results at Point of Care in Minutes........................ 159
FDA, Congress Return Attention to Direct-to-Consumer Genetic Testing ............................. 159
QIAGEN Enters into Agreement to Acquire STAT-Dx................................................................ 160
5. Country Market Sizes – North America 2016 to 2024.....................................................162
5.1 United States of America 2016 to 2024 ............................................................................... 163
5.1.1 Clinical Chemistry – Volumes, Prices, Revenues .......................................................... 163
5.1.2 Microbiology – Volumes, Prices, Revenues .................................................................. 163
5.1.3 Hematology – Volumes, Prices, Revenues ................................................................... 164
5.1.4 Anatomic Pathology – Volumes, Prices, Revenues ..................................................... 164
5.1.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................... 165
5.1.6 All Clinical Testing – Volumes, Prices, Revenues .......................................................... 165
5.1.7 Esoteric – Volumes, Prices, Revenues ........................................................................... 166
5.2 Canada 2016 to 2024........................................................................................................... 167
5.2.1 Clinical Chemistry – Volumes, Prices, Revenues .......................................................... 167
5.2.2 Microbiology – Volumes, Prices, Revenues .................................................................. 167
5.2.3 Hematology – Volumes, Prices, Revenues ................................................................... 168
5.2.4 Anatomic Pathology – Volumes, Prices, Revenues ..................................................... 168
 5.2.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................... 169
5.2.6 All Clinical Testing – Volumes, Prices, Revenues .......................................................... 169
5.2.7 Esoteric – Volumes, Prices, Revenues ........................................................................... 170
6. Country Markets – Europe 2016 to 2024..........................................................................171
6.1 France 2016 to 2024 ............................................................................................................. 172
6.1.1 Clinical Chemistry – Volumes, Prices, Revenues .......................................................... 172
6.1.2 Microbiology – Volumes, Prices, Revenues .................................................................. 172
6.1.3 Hematology – Volumes, Prices, Revenues ................................................................... 173
6.1.4 Anatomic Pathology – Volumes, Prices, Revenues ..................................................... 173
6.1.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................... 174
6.1.6 All Clinical Testing – Volumes, Prices, Revenues .......................................................... 174
6.1.7 Esoteric – Volumes, Prices, Revenues ........................................................................... 175
6.2 Germany 2016 to 2024 ......................................................................................................... 176
6.2.1 Clinical Chemistry – Volumes, Prices, Revenues .......................................................... 176
6.2.2 Microbiology – Volumes, Prices, Revenues .................................................................. 176
6.2.3 Hematology – Volumes, Prices, Revenues ................................................................... 177
6.2.4 Anatomic Pathology – Volumes, Prices, Revenues ..................................................... 177
6.2.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................... 178
6.2.6 All Clinical Testing – Volumes, Prices, Revenues .......................................................... 178
6.2.7 Esoteric – Volumes, Prices, Revenues ........................................................................... 179
6.3 United Kingdom 2016 to 2024.............................................................................................. 180
6.3.1 Clinical Chemistry – Volumes, Prices, Revenues .......................................................... 180
6.3.2 Microbiology – Volumes, Prices, Revenues .................................................................. 180
6.3.3 Hematology – Volumes, Prices, Revenues ................................................................... 181
6.3.4 Anatomic Pathology – Volumes, Prices, Revenues ..................................................... 181
6.3.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................... 182
6.3.6 All Clinical Testing – Volumes, Prices, Revenues .......................................................... 182
 6.3.7 Esoteric – Volumes, Prices, Revenues ........................................................................... 183
6.4 Spain 2016 to 2024................................................................................................................ 184
6.4.1 Clinical Chemistry – Volumes, Prices, Revenues .......................................................... 184
6.4.2 Microbiology – Volumes, Prices, Revenues .................................................................. 184
6.4.3 Hematology – Volumes, Prices, Revenues ................................................................... 185
6.4.4 Anatomic Pathology – Volumes, Prices, Revenues ..................................................... 185
6.4.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................... 186
6.4.6 All Clinical Testing – Volumes, Prices, Revenues .......................................................... 186
6.4.7 Esoteric – Volumes, Prices, Revenues ........................................................................... 187
6.5 Italy 2016 to 2024 .................................................................................................................. 188
6.5.1 Clinical Chemistry – Volumes, Prices, Revenues .......................................................... 188
6.5.2 Microbiology – Volumes, Prices, Revenues .................................................................. 188
6.5.3 Hematology – Volumes, Prices, Revenues ................................................................... 189
6.5.4 Anatomic Pathology – Volumes, Prices, Revenues ..................................................... 189
6.5.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................... 190
6.5.6 All Clinical Testing – Volumes, Prices, Revenues .......................................................... 190
6.5.7 Esoteric – Volumes, Prices, Revenues ........................................................................... 191
6.6 Russia 2016 to 2024 ............................................................................................................... 192
6.6.1 Clinical Chemistry – Volumes, Prices, Revenues .......................................................... 192
6.6.2 Microbiology – Volumes, Prices, Revenues .................................................................. 192
6.6.3 Hematology – Volumes, Prices, Revenues ................................................................... 193
6.6.4 Anatomic Pathology – Volumes, Prices, Revenues ..................................................... 193
6.6.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................... 194
6.6.6 All Clinical Testing – Volumes, Prices, Revenues .......................................................... 194
6.6.7 Esoteric – Volumes, Prices, Revenues ........................................................................... 195
6.7 Remainder of Europe and Former Soviet Union 2016 to 2024........................................... 196
6.7.1 Clinical Chemistry – Volumes, Prices, Revenues .......................................................... 196
 6.7.2 Microbiology – Volumes, Prices, Revenues .................................................................. 196
6.7.3 Hematology – Volumes, Prices, Revenues ................................................................... 197
6.7.4 Anatomic Pathology – Volumes, Prices, Revenues ..................................................... 197
6.7.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................... 198
6.7.6 All Clinical Testing – Volumes, Prices, Revenues .......................................................... 198
6.7.7 Esoteric – Volumes, Prices, Revenues ........................................................................... 199
7. Country Markets – Asia Pacific 2016 to 2024 ..................................................................200
7.1 China 2016 to 2024 ............................................................................................................... 201
7.1.1 Clinical Chemistry – Volumes, Prices, Revenues .......................................................... 201
7.1.2 Microbiology – Volumes, Prices, Revenues .................................................................. 201
7.1.3 Hematology – Volumes, Prices, Revenues ................................................................... 202
7.1.4 Anatomic Pathology – Volumes, Prices, Revenues ..................................................... 202
7.1.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................... 203
7.1.6 All Clinical Testing – Volumes, Prices, Revenues .......................................................... 203
7.1.7 Esoteric – Volumes, Prices, Revenues ........................................................................... 204
7.2 Japan 2016 to 2024 .............................................................................................................. 205
7.2.1 Clinical Chemistry – Volumes, Prices, Revenues .......................................................... 205
7.2.2 Microbiology – Volumes, Prices, Revenues .................................................................. 205
7.2.3 Hematology – Volumes, Prices, Revenues ................................................................... 206
7.2.4 Anatomic Pathology – Volumes, Prices, Revenues ..................................................... 206
7.2.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................... 207
7.2.6 All Clinical Testing – Volumes, Prices, Revenues .......................................................... 207
7.2.7 Esoteric – Volumes, Prices, Revenues ........................................................................... 208
7.3 South Korea 2016 to 2024..................................................................................................... 209
7.3.1 Clinical Chemistry – Volumes, Prices, Revenues .......................................................... 209
7.3.2 Microbiology – Volumes, Prices, Revenues .................................................................. 209
7.3.3 Hematology – Volumes, Prices, Revenues ................................................................... 210
 7.3.4 Anatomic Pathology – Volumes, Prices, Revenues ..................................................... 210
7.3.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................... 211
7.3.6 All Clinical Testing – Volumes, Prices, Revenues .......................................................... 211
7.3.7 Esoteric – Volumes, Prices, Revenues ........................................................................... 212
7.4 India 2016 to 2024................................................................................................................. 213
7.4.1 Clinical Chemistry – Volumes, Prices, Revenues .......................................................... 213
7.4.2 Microbiology – Volumes, Prices, Revenues .................................................................. 213
7.4.3 Hematology – Volumes, Prices, Revenues ................................................................... 214
7.4.4 Anatomic Pathology – Volumes, Prices, Revenues ..................................................... 214
7.4.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................... 215
7.14.6 All Clinical Testing – Volumes, Prices, Revenues ........................................................ 215
7.4.7 Esoteric – Volumes, Prices, Revenues ........................................................................... 216
7.5 Australia 2016 to 2024........................................................................................................... 217
7.5.1 Clinical Chemistry – Volumes, Prices, Revenues .......................................................... 217
7.5.2 Microbiology – Volumes, Prices, Revenues .................................................................. 217
7.5.3 Hematology – Volumes, Prices, Revenues ................................................................... 218
7.5.4 Anatomic Pathology – Volumes, Prices, Revenues ..................................................... 218
7.5.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................... 219
7.5.6 All Clinical Testing – Volumes, Prices, Revenues .......................................................... 219
7.5.7 Esoteric – Volumes, Prices, Revenues ........................................................................... 220
7.6 Rest of Asia Pacific 2016 to 2024 ......................................................................................... 221
7.6.1 Clinical Chemistry – Volumes, Prices, Revenues .......................................................... 221
7.6.2 Microbiology – Volumes, Prices, Revenues .................................................................. 221
7.6.3 Hematology – Volumes, Prices, Revenues ................................................................... 222
7.6.4 Anatomic Pathology – Volumes, Prices, Revenues ..................................................... 222
7.6.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................... 223
7.6.6 All Clinical Testing – Volumes, Prices, Revenues .......................................................... 223
 7.6.7 Esoteric – Volumes, Prices, Revenues ........................................................................... 224
8. Country Markets – Latin America, Africa & The Middle East 2016 to 2024...................225
8.1 Brazil 2016 to 2024................................................................................................................. 226
8.1.1 Clinical Chemistry – Volumes, Prices, Revenues .......................................................... 226
8.1.2 Microbiology – Volumes, Prices, Revenues .................................................................. 226
8.1.3 Hematology – Volumes, Prices, Revenues ................................................................... 227
8.1.4 Anatomic Pathology – Volumes, Prices, Revenues ..................................................... 227
8.1.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................... 228
8.1.6 All Clinical Testing – Volumes, Prices, Revenues .......................................................... 228
8.1.7 Esoteric – Volumes, Prices, Revenues ........................................................................... 229
8.2 Mexico 2016 to 2024............................................................................................................. 230
8.2.1 Clinical Chemistry – Volumes, Prices, Revenues .......................................................... 230
8.2.2 Microbiology – Volumes, Prices, Revenues .................................................................. 230
8.2.3 Hematology – Volumes, Prices, Revenues ................................................................... 231
8.2.4 Anatomic Pathology – Volumes, Prices, Revenues ..................................................... 231
8.2.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................... 232
8.2.6 All Clinical Testing – Volumes, Prices, Revenues .......................................................... 232
8.2.7 Esoteric – Volumes, Prices, Revenues ........................................................................... 233
8.3 Remainder of Latin America 2016 to 2024 ......................................................................... 234
8.3.1 Clinical Chemistry – Volumes, Prices, Revenues .......................................................... 234
8.3.2 Microbiology – Volumes, Prices, Revenues .................................................................. 234
8.3.3 Hematology – Volumes, Prices, Revenues ................................................................... 235
8.3.4 Anatomic Pathology – Volumes, Prices, Revenues ..................................................... 235
8.3.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................... 236
8.3.6 All Clinical Testing – Volumes, Prices, Revenues .......................................................... 236
8.3.7 Esoteric – Volumes, Prices, Revenues ........................................................................... 237
8.4 Africa & The Middle East 2016 to 2024................................................................................ 238
 8.4.1 Clinical Chemistry – Volumes, Prices, Revenues .......................................................... 238
8.4.2 Microbiology – Volumes, Prices, Revenues .................................................................. 238
8.4.3 Hematology – Volumes, Prices, Revenues ................................................................... 239
8.4.4 Anatomic Pathology – Volumes, Prices, Revenues ..................................................... 239
8.4.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................... 240
8.4.6 All Clinical Testing – Volumes, Prices, Revenues .......................................................... 240
8.4.7 Esoteric – Volumes, Prices, Revenues ........................................................................... 241
9. Global Market Summary 2016 to 2024............................................................................242
9.1 Global Market 2016 to 2024................................................................................................. 243
9.1.1 Clinical Chemistry – Volumes, Prices, Revenues .......................................................... 243
9.1.2 Microbiology – Volumes, Prices, Revenues .................................................................. 243
9.1.3 Hematology – Volumes, Prices, Revenues ................................................................... 244
9.1.4 Anatomic Pathology – Volumes, Prices, Revenues ..................................................... 244
9.1.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................... 245
9.1.6 All Clinical Testing – Volumes, Prices, Revenues .......................................................... 245
9.1.7 Esoteric – Volumes, Prices, Revenues ........................................................................... 246
10. The Future of the Clinical Laboratory............................................................................247
11. Additional Country Breakouts McKinsey.......................................................................248
11.1 Switzerland 2016 to 2024 .................................................................................................... 248
11.1.1 Clinical Chemistry – Volumes, Prices, Revenues ........................................................ 248
11.1.2 Microbiology – Volumes, Prices, Revenues ................................................................ 248
11.1.3 Hematology – Volumes, Prices, Revenues ................................................................. 249
11.1.4 Anatomic Pathology – Volumes, Prices, Revenues ................................................... 249
11.1.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................. 250
11.1.6 All Clinical Testing – Volumes, Prices, Revenues ........................................................ 250
11.1.7 Esoteric – Volumes, Prices, Revenues ......................................................................... 251
11.2 Portugal 2016 to 2024 ......................................................................................................... 252
 11.2.1 Clinical Chemistry – Volumes, Prices, Revenues ........................................................ 252
11.2.2 Microbiology – Volumes, Prices, Revenues ................................................................ 252
11.2.3 Hematology – Volumes, Prices, Revenues ................................................................. 253
11.2.4 Anatomic Pathology – Volumes, Prices, Revenues ................................................... 253
11.2.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................. 254
11.2.6 All Clinical Testing – Volumes, Prices, Revenues ........................................................ 254
11.2.7 Esoteric – Volumes, Prices, Revenues ......................................................................... 255
11.3 Norway 2016 to 2024 .......................................................................................................... 256
11.3.1 Clinical Chemistry – Volumes, Prices, Revenues ........................................................ 256
11.3.2 Microbiology – Volumes, Prices, Revenues ................................................................ 256
11.3.3 Hematology – Volumes, Prices, Revenues ................................................................. 257
11.3.4 Anatomic Pathology – Volumes, Prices, Revenues ................................................... 257
11.3.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................. 258
11.3.6 All Clinical Testing – Volumes, Prices, Revenues ........................................................ 258
11.3.7 Esoteric – Volumes, Prices, Revenues ......................................................................... 259
11.4 Sweden 2016 to 2024 ......................................................................................................... 260
11.4.1 Clinical Chemistry – Volumes, Prices, Revenues ........................................................ 260
11.4.2 Microbiology – Volumes, Prices, Revenues ................................................................ 260
11.4.3 Hematology – Volumes, Prices, Revenues ................................................................. 261
11.4.4 Anatomic Pathology – Volumes, Prices, Revenues ................................................... 261
11.4.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................. 262
11.4.6 All Clinical Testing – Volumes, Prices, Revenues ........................................................ 262
11.4.7 Esoteric – Volumes, Prices, Revenues ......................................................................... 263
11.5 Benelux 2016 to 2024 .......................................................................................................... 264
11.5.1 Clinical Chemistry – Volumes, Prices, Revenues ........................................................ 264
11.5.2 Microbiology – Volumes, Prices, Revenues ................................................................ 264
11.5.3 Hematology – Volumes, Prices, Revenues ................................................................. 265
 11.5.4 Anatomic Pathology – Volumes, Prices, Revenues ................................................... 265
11.5.5 Molecular Diagnostics – Volumes, Prices, Revenues................................................. 266
11.5.6 All Clinical Testing – Volumes, Prices, Revenues ........................................................ 266
11.5.7 Esoteric – Volumes, Prices, Revenues ......................................................................... 267
Appendices ..........................................................................................................................268
I. United States Medicare System: January 2019 Clinical Laboratory Fees Schedule .......... 268
 

Table of Tables
Table 1 Lab Spending 2014 to 2024 ............................................................................................... 37 Table 2 Market Players by Type ..................................................................................................... 39 Table 3 Clinical Laboratory Departments and Segments ............................................................ 44 Table 4 Laboratory Management Focus – Different Approaches .............................................. 45 Table 5 Key Segmentation Variables Going Forward................................................................... 46 Table 6 Factors Affecting Local Clinical Testing Demand ........................................................... 97 Table 7 Seven Factors Driving Growth ......................................................................................... 100 Table 8 Alternative Medicine Creates New Clinical Testing Markets ........................................ 102 Table 9 Six Factors Limiting Growth .............................................................................................. 104 Table 10 Key Diagnostic Laboratory Technology Trends ........................................................... 110 Table 11 Next Generation Sequencing Technologies – Speed and Cost ................................ 111 Table 12 Key Point of Care Testing Uses....................................................................................... 113 Table 13 Clinical Application Areas for Molecular Diagnostics ................................................. 115 Table 14 Clinical Chemistry - Volume Price and Revenue Forecast ......................................... 163 Table 15 Microbiology - Volume Price and Revenue Forecast ................................................. 163 Table 16 Hematology - Volume Price and Revenue Forecast .................................................. 164
 Table 17 Anatomic Pathology - Volume Price and Revenue Forecast .................................... 164 Table 18 Molecular Diagnostics - Volume Price and Revenue Forecast .................................. 165 Table 19 All Clinical Testing - Volume Price and Revenue Forecast.......................................... 165 Table 20 Esoteric - Volume Price and Revenue Forecast........................................................... 166 Table 21 Clinical Chemistry - Volume Price and Revenue Forecast ......................................... 167 Table 22 Microbiology - Volume Price and Revenue Forecast ................................................. 167 Table 23 Hematology - Volume Price and Revenue Forecast .................................................. 168 Table 24 Anatomic Pathology - Volume Price and Revenue Forecast .................................... 168 Table 25 Molecular Diagnostics - Volume Price and Revenue Forecast .................................. 169 Table 26 All Clinical Testing - Volume Price and Revenue Forecast.......................................... 169 Table 27 Esoteric - Volume Price and Revenue Forecast........................................................... 170 Table 28 Clinical Chemistry - Volume Price and Revenue Forecast ......................................... 172 Table 29 Microbiology - Volume Price and Revenue Forecast ................................................. 172 Table 30 Hematology - Volume Price and Revenue Forecast .................................................. 173 Table 31 Anatomic Pathology - Volume Price and Revenue Forecast .................................... 173 Table 32 Molecular Diagnostics - Volume Price and Revenue Forecast .................................. 174 Table 33 All Clinical Testing - Volume Price and Revenue Forecast.......................................... 174 Table 34 Esoteric - Volume Price and Revenue Forecast........................................................... 175 Table 35 Clinical Chemistry - Volume Price and Revenue Forecast ......................................... 176 Table 36 Microbiology - Volume Price and Revenue Forecast ................................................. 176 Table 37 Hematology - Volume Price and Revenue Forecast .................................................. 177 Table 38 Anatomic Pathology - Volume Price and Revenue Forecast .................................... 177 Table 39 Molecular Diagnostics - Volume Price and Revenue Forecast .................................. 178 Table 40 All Clinical Testing - Volume Price and Revenue Forecast.......................................... 178 Table 41 Esoteric - Volume Price and Revenue Forecast........................................................... 179 Table 42 Clinical Chemistry - Volume Price and Revenue Forecast ......................................... 180 Table 43 Microbiology - Volume Price and Revenue Forecast ................................................. 180
 Table 44 Hematology - Volume Price and Revenue Forecast .................................................. 181 Table 45 Anatomic Pathology - Volume Price and Revenue Forecast .................................... 181 Table 46 Molecular Diagnostics - Volume Price and Revenue Forecast .................................. 182 Table 47 All Clinical Testing - Volume Price and Revenue Forecast.......................................... 182 Table 48 Esoteric - Volume Price and Revenue Forecast........................................................... 183 Table 49 Clinical Chemistry - Volume Price and Revenue Forecast ......................................... 184 Table 50 Microbiology - Volume Price and Revenue Forecast ................................................. 184 Table 51 Hematology - Volume Price and Revenue Forecast .................................................. 185 Table 52 Anatomic Pathology - Volume Price and Revenue Forecast .................................... 185 Table 53 Molecular Diagnostics - Volume Price and Revenue Forecast .................................. 186 Table 54 All Clinical Testing - Volume Price and Revenue Forecast.......................................... 186 Table 55 Esoteric - Volume Price and Revenue Forecast........................................................... 187 Table 56 Clinical Chemistry - Volume Price and Revenue Forecast ......................................... 188 Table 57 Microbiology - Volume Price and Revenue Forecast ................................................. 188 Table 58 Hematology - Volume Price and Revenue Forecast .................................................. 189 Table 59 Anatomic Pathology - Volume Price and Revenue Forecast .................................... 189 Table 60 Molecular Diagnostics - Volume Price and Revenue Forecast .................................. 190 Table 61 All Clinical Testing - Volume Price and Revenue Forecast.......................................... 190 Table 62 Esoteric - Volume Price and Revenue Forecast........................................................... 191 Table 63 Clinical Chemistry - Volume Price and Revenue Forecast ......................................... 192 Table 64 Microbiology - Volume Price and Revenue Forecast ................................................. 192 Table 65 Hematology - Volume Price and Revenue Forecast .................................................. 193 Table 66 Anatomic Pathology - Volume Price and Revenue Forecast .................................... 193 Table 67 Molecular Diagnostics - Volume Price and Revenue Forecast .................................. 194 Table 68 All Clinical Testing - Volume Price and Revenue Forecast.......................................... 194 Table 69 Esoteric - Volume Price and Revenue Forecast........................................................... 195 Table 70 Clinical Chemistry - Volume Price and Revenue Forecast ......................................... 196
 Table 71 Microbiology - Volume Price and Revenue Forecast ................................................. 196 Table 72 Hematology - Volume Price and Revenue Forecast .................................................. 197 Table 73 Anatomic Pathology - Volume Price and Revenue Forecast .................................... 197 Table 74 Molecular Diagnostics - Volume Price and Revenue Forecast .................................. 198 Table 75 All Clinical Testing - Volume Price and Revenue Forecast.......................................... 198 Table 76 Esoteric - Volume Price and Revenue Forecast........................................................... 199 Table 77 Clinical Chemistry - Volume Price and Revenue Forecast ......................................... 201 Table 78 Microbiology - Volume Price and Revenue Forecast ................................................. 201 Table 79 Hematology - Volume Price and Revenue Forecast .................................................. 202 Table 80 Anatomic Pathology - Volume Price and Revenue Forecast .................................... 202 Table 81 Molecular Diagnostics - Volume Price and Revenue Forecast .................................. 203 Table 82 All Clinical Testing - Volume Price and Revenue Forecast.......................................... 203 Table 83 Esoteric - Volume Price and Revenue Forecast........................................................... 204 Table 84 Clinical Chemistry - Volume Price and Revenue Forecast ......................................... 205 Table 85 Microbiology - Volume Price and Revenue Forecast ................................................. 205 Table 86 Hematology - Volume Price and Revenue Forecast .................................................. 206 Table 87 Anatomic Pathology - Volume Price and Revenue Forecast .................................... 206 Table 88 Molecular Diagnostics - Volume Price and Revenue Forecast .................................. 207 Table 89 All Clinical Testing - Volume Price and Revenue Forecast.......................................... 207 Table 90 Esoteric - Volume Price and Revenue Forecast........................................................... 208 Table 91 Clinical Chemistry - Volume Price and Revenue Forecast ......................................... 209 Table 92 Microbiology - Volume Price and Revenue Forecast ................................................. 209 Table 93 Hematology - Volume Price and Revenue Forecast .................................................. 210 Table 94 Anatomic Pathology - Volume Price and Revenue Forecast .................................... 210 Table 95 Molecular Diagnostics - Volume Price and Revenue Forecast .................................. 211 Table 96 All Clinical Testing - Volume Price and Revenue Forecast.......................................... 211 Table 97 Esoteric - Volume Price and Revenue Forecast........................................................... 212
 Table 98 Clinical Chemistry - Volume Price and Revenue Forecast ......................................... 213 Table 99 Microbiology - Volume Price and Revenue Forecast ................................................. 213 Table 100 Hematology - Volume Price and Revenue Forecast ................................................ 214 Table 101 Anatomic Pathology - Volume Price and Revenue Forecast .................................. 214 Table 102 Molecular Diagnostics - Volume Price and Revenue Forecast ................................ 215 Table 103 All Clinical Testing - Volume Price and Revenue Forecast........................................ 215 Table 104 Esoteric - Volume Price and Revenue Forecast......................................................... 216 Table 105 Clinical Chemistry - Volume Price and Revenue Forecast ....................................... 217 Table 106 Microbiology - Volume Price and Revenue Forecast ............................................... 217 Table 107 Hematology - Volume Price and Revenue Forecast ................................................ 218 Table 108 Anatomic Pathology - Volume Price and Revenue Forecast .................................. 218 Table 109 Molecular Diagnostics - Volume Price and Revenue Forecast ................................ 219 Table 110 All Clinical Testing - Volume Price and Revenue Forecast........................................ 219 Table 111 Esoteric - Volume Price and Revenue Forecast......................................................... 220 Table 112 Clinical Chemistry - Volume Price and Revenue Forecast ....................................... 221 Table 113 Microbiology - Volume Price and Revenue Forecast ............................................... 221 Table 114 Hematology - Volume Price and Revenue Forecast ................................................ 222 Table 115 Anatomic Pathology - Volume Price and Revenue Forecast .................................. 222 Table 116 Molecular Diagnostics - Volume Price and Revenue Forecast ................................ 223 Table 117 All Clinical Testing - Volume Price and Revenue Forecast........................................ 223 Table 118 Esoteric - Volume Price and Revenue Forecast......................................................... 224 Table 119 Clinical Chemistry - Volume Price and Revenue Forecast ....................................... 226 Table 120 Microbiology - Volume Price and Revenue Forecast ............................................... 226 Table 121 Hematology - Volume Price and Revenue Forecast ................................................ 227 Table 122 Anatomic Pathology - Volume Price and Revenue Forecast .................................. 227 Table 123 Molecular Diagnostics - Volume Price and Revenue Forecast ................................ 228 Table 124 All Clinical Testing - Volume Price and Revenue Forecast........................................ 228
 Table 125 Esoteric - Volume Price and Revenue Forecast......................................................... 229 Table 126 Clinical Chemistry - Volume Price and Revenue Forecast ....................................... 230 Table 127 Microbiology - Volume Price and Revenue Forecast ............................................... 230 Table 128 Hematology - Volume Price and Revenue Forecast ................................................ 231 Table 129 Anatomic Pathology - Volume Price and Revenue Forecast .................................. 231 Table 130 Molecular Diagnostics - Volume Price and Revenue Forecast ................................ 232 Table 131 All Clinical Testing - Volume Price and Revenue Forecast........................................ 232 Table 132 Esoteric - Volume Price and Revenue Forecast......................................................... 233 Table 133 Clinical Chemistry - Volume Price and Revenue Forecast ....................................... 234 Table 134 Microbiology - Volume Price and Revenue Forecast ............................................... 234 Table 135 Hematology - Volume Price and Revenue Forecast ................................................ 235 Table 136 Anatomic Pathology - Volume Price and Revenue Forecast .................................. 235 Table 137 Molecular Diagnostics - Volume Price and Revenue Forecast ................................ 236 Table 138 All Clinical Testing - Volume Price and Revenue Forecast........................................ 236 Table 139 Esoteric - Volume Price and Revenue Forecast......................................................... 237 Table 140 Clinical Chemistry - Volume Price and Revenue Forecast ....................................... 238 Table 141 Microbiology - Volume Price and Revenue Forecast ............................................... 238 Table 142 Hematology - Volume Price and Revenue Forecast ................................................ 239 Table 143 Anatomic Pathology - Volume Price and Revenue Forecast .................................. 239 Table 144 Molecular Diagnostics - Volume Price and Revenue Forecast ................................ 240 Table 145 All Clinical Testing - Volume Price and Revenue Forecast........................................ 240 Table 146 Esoteric - Volume Price and Revenue Forecast......................................................... 241 Table 147 Clinical Chemistry - Volume Price and Revenue Forecast ....................................... 243 Table 148 Microbiology - Volume Price and Revenue Forecast ............................................... 243 Table 149 Hematology - Volume Price and Revenue Forecast ................................................ 244 Table 150 Anatomic Pathology - Volume Price and Revenue Forecast .................................. 244 Table 151 Molecular Diagnostics - Volume Price and Revenue Forecast................................ 245
 Table 152 All Clinical Testing - Volume Price and Revenue Forecast........................................ 245 Table 153 Esoteric - Volume Price and Revenue Forecast......................................................... 246 TABLE 154 CLINICAL CHEMISTRY - VOLUME PRICE AND REVENUE FORECAST .............................................. 248 TABLE 155 MICROBIOLOGY - VOLUME PRICE AND REVENUE FORECAST..................................................... 248 TABLE 156 HEMATOLOGY - VOLUME PRICE AND REVENUE FORECAST........................................................ 249 TABLE 157 ANATOMIC PATHOLOGY - VOLUME PRICE AND REVENUE FORECAST ......................................... 249 TABLE 158 MOLECULAR DIAGNOSTICS - VOLUME PRICE AND REVENUE FORECAST...................................... 250 TABLE 159 ALL CLINICAL TESTING - VOLUME PRICE AND REVENUE FORECAST............................................. 250 TABLE 160 ESOTERIC - VOLUME PRICE AND REVENUE FORECAST............................................................... 251 TABLE 161 CLINICAL CHEMISTRY - VOLUME PRICE AND REVENUE FORECAST .............................................. 252 TABLE 162 MICROBIOLOGY - VOLUME PRICE AND REVENUE FORECAST..................................................... 252 TABLE 163 HEMATOLOGY - VOLUME PRICE AND REVENUE FORECAST........................................................ 253 TABLE 164 ANATOMIC PATHOLOGY - VOLUME PRICE AND REVENUE FORECAST ......................................... 253 TABLE 165 MOLECULAR DIAGNOSTICS - VOLUME PRICE AND REVENUE FORECAST...................................... 254 TABLE 166 ALL CLINICAL TESTING - VOLUME PRICE AND REVENUE FORECAST............................................. 254 TABLE 167 ESOTERIC - VOLUME PRICE AND REVENUE FORECAST............................................................... 255 TABLE 168 CLINICAL CHEMISTRY - VOLUME PRICE AND REVENUE FORECAST .............................................. 256 TABLE 169 MICROBIOLOGY - VOLUME PRICE AND REVENUE FORECAST..................................................... 256 TABLE 170 HEMATOLOGY - VOLUME PRICE AND REVENUE FORECAST........................................................ 257 TABLE 171 ANATOMIC PATHOLOGY - VOLUME PRICE AND REVENUE FORECAST ......................................... 257 TABLE 172 MOLECULAR DIAGNOSTICS - VOLUME PRICE AND REVENUE FORECAST...................................... 258 TABLE 173 ALL CLINICAL TESTING - VOLUME PRICE AND REVENUE FORECAST............................................. 258 TABLE 174 ESOTERIC - VOLUME PRICE AND REVENUE FORECAST............................................................... 259 TABLE 175 CLINICAL CHEMISTRY - VOLUME PRICE AND REVENUE FORECAST .............................................. 260 TABLE 176 MICROBIOLOGY - VOLUME PRICE AND REVENUE FORECAST..................................................... 260 TABLE 177 HEMATOLOGY - VOLUME PRICE AND REVENUE FORECAST........................................................ 261 TABLE 178 ANATOMIC PATHOLOGY - VOLUME PRICE AND REVENUE FORECAST ......................................... 261
 TABLE 179 MOLECULAR DIAGNOSTICS - VOLUME PRICE AND REVENUE FORECAST...................................... 262 TABLE 180 ALL CLINICAL TESTING - VOLUME PRICE AND REVENUE FORECAST............................................. 262 TABLE 181 ESOTERIC - VOLUME PRICE AND REVENUE FORECAST............................................................... 263 Table 182 Clinical Chemistry - Volume Price and Revenue Forecast ....................................... 264 Table 183 Microbiology - Volume Price and Revenue Forecast ............................................... 264 Table 184 Hematology - Volume Price and Revenue Forecast ................................................ 265 Table 185 Anatomic Pathology - Volume Price and Revenue Forecast .................................. 265 Table 186 Molecular Diagnostics - Volume Price and Revenue Forecast................................ 266 Table 187 All Clinical Testing - Volume Price and Revenue Forecast........................................ 266 Table 188 Esoteric - Volume Price and Revenue Forecast......................................................... 267 Table 189 2019 Clinical Lab Fee Schedule .................................................................................. 268

Table of Figures
Figure 1 Clinical Lab Spending 2014 to 2024................................................................................. 36