1. Introduction and Market Definition .......................................................................................... 16
1.1 Introduction ................................................................................................................................... 17
1.2 Market Definition .......................................................................................................................... 19
1.2.1 Volumes.................................................................................................................................. 19
1.2.2 Prices ...................................................................................................................................... 19
1.2.3 Revenue Market Size............................................................................................................... 20
1.3 Methodology ................................................................................................................................. 20
1.3.1 Authors ................................................................................................................................... 20
1.3.2 Sources ................................................................................................................................... 21
1.4 U.S. Medical Market and Clinical Laboratory Testing - Perspective ............................................ 22
1.3.1 U.S. Medicare Expenditures for Clinical Testing ................................................................... 22
2. Market Overview ...................................................................................................................... 24
2.1 Market Participants ........................................................................................................................ 25
2.1.1 Supplier/pharmaceutical .......................................................................................................... 25
2.1.2 Independent lab specialized/esoteric ....................................................................................... 26
2.1.3 Independent lab national/regional ........................................................................................... 26
2.1.4 Independent lab analytical ....................................................................................................... 26
2.1.5 Public National/regional lab .................................................................................................... 27
2.1.6 Hospital lab............................................................................................................................. 27
2.1.7 Physician lab............................................................................................................................ 27
2.1.8 Audit body ............................................................................................................................... 27
2.2 Market Segments ........................................................................................................................... 29
2.2.1 Traditional Market Segmentation ............................................................................................ 29
2.2.2 Laboratory Focus and Segmentation ....................................................................................... 29
2.3 Industry Structure .......................................................................................................................... 31
2.3.1 Hospital Testing Share ............................................................................................................ 31
2.3.2 Economies of Scale ................................................................................................................. 31
2.3.3 Physician Office Lab’s ............................................................................................................ 32
2.3.4 Physician’s and POCT............................................................................................................. 33
2.4 Profiles of Key Companies ............................................................................................................ 34
2.4.1 Quest Diagnostics .................................................................................................................... 34
2.4.2 Laboratory Corporation of America ........................................................................................ 36
2.4.3 Lifelabs Medical Laboratory Services .................................................................................... 39
2.4.4 ACM Medical Laboratory ....................................................................................................... 40
2.4.5 Spectra Spectra Laboratories, Inc. ........................................................................................... 42
2.4.6 Bio-Reference Laboratories, Inc. ............................................................................................ 43
2.4.7 Signal Genetics LLC ............................................................................................................... 45
2.4.8 CompuNet Clinical Laboratories, LLC ................................................................................... 46
2.4.9 Genzyme Corporation ............................................................................................................. 47
2.4.10 Sonic Healthcare Limited ...................................................................................................... 50
2.4.11 Exagen Diagnostics, Inc. ....................................................................................................... 51
2.4.12 Clongen Laboratories LLC .................................................................................................... 53
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2.4.13 Clinical Reference Laboratory, Inc. ...................................................................................... 54
2.4.14 Rosetta Genomics Inc. ........................................................................................................... 56
2.4.15 Mid America Clinical Laboratories, LLC ............................................................................. 57
2.4.16 Alere Inc ............................................................................................................................... 58
2.4.17 Caris Life Sciences, Inc. ........................................................................................................ 61
2.4.18 Psychemedics Corp. .............................................................................................................. 63
2.4.19 Aurora Diagnostics, LLC ...................................................................................................... 64
2.4.20 DL Reference Laboratory ...................................................................................................... 66
2.4.21 Myriad Genetics, Inc. ............................................................................................................ 67
2.4.22 Bioscientia Institut fuer Medizinische Diagnostik GmbH .................................................... 69
2.4.23 Acibadem Labmed Laboratory .............................................................................................. 70
2.4.24 Claymon Biomnis Laboratories Ltd. ..................................................................................... 71
2.4.25 Biomnis (France) ................................................................................................................... 73
2.4.26 The Doctor’s Laboratory (Sonic Healthcare U.K.) ............................................................... 73
2.4.27 Pathology Inc. ........................................................................................................................ 74
2.4.28 Gribbles Pathology ................................................................................................................ 76
2.4.29 BP Lab .................................................................................................................................. 77
2.4.30 Adicon Clinical Laboratories, Inc. ........................................................................................ 77
2.4.31 Diagnósticos da América (DASA) ........................................................................................ 78
2.4.32 Medicus Phillipines Inc. ........................................................................................................ 80
2.4.33 Kingmed Diagnostics ............................................................................................................ 80
2.4.34 Ascend Clinical, LLC ............................................................................................................ 81
2.4.35 Unilabs SA ............................................................................................................................ 82
2.4.36 American Pathology Partners, Inc. ........................................................................................ 84
2.4.37 Centrex Clinical Laboratories, Inc. ....................................................................................... 86
2.4.38 Integrated Regional Laboratories, Inc. .................................................................................. 87
2.4.39 Vira Cor-Ibt Laboratories ...................................................................................................... 88
2.4.40 Clarient, Inc. .......................................................................................................................... 89
2.4.41 Genomic Health, Inc. ............................................................................................................. 91
2.4.42 ARUP Laboratories, Inc. ....................................................................................................... 93
2.4.43 MEDTOX Scientific, Inc. ..................................................................................................... 96
2.4.44 Solstas Lab Partners .............................................................................................................. 98
2.4.45 Predictive Biosciences, Inc. ................................................................................................... 99
2.4.46 Enzo Biochem, Inc. ............................................................................................................. 101
2.5 National and Regional Diversity ................................................................................................. 104
3. Market Trends ......................................................................................................................... 106
3.1 Factors Driving Growth ............................................................................................................... 107
3.1.1 Impact of U.S. Health Reform (PPACA) on U.S. Market .................................................... 107
3.1.2 Understanding the Impact of Aging Population. ................................................................... 108
3.1.3 Economic growth drives health spending. ............................................................................ 108
3.1.4 Point of Care Testing can increase demand .......................................................................... 108
3.1.5 Wellness concerns create growth .......................................................................................... 108
3.1.6 Esoteric Testing Moving Mainstream ................................................................................... 109
3.1.7 Genetic Based Testing Creates New Department and New Discipline................................. 109
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3.2 Factors Limiting Growth ............................................................................................................. 110
3.2.1 Lower costs trend to continue ............................................................................................... 110
3.2.2 Economic or population contraction. .................................................................................... 110
3.2.3 Testing usage analysis curtailing growth. ............................................................................. 111
3.2.4 Wellness has a downside ....................................................................................................... 111
3.2.5 Test Displacement Impacts Important ................................................................................... 111
3.2.6 Point of Care Testing ............................................................................................................. 111
3.3 Automation ................................................................................................................................. 112
3.3.1 Stranded LIMS Investment ................................................................................................... 112
3.3.2 Software as a Service ............................................................................................................ 112
3.3.3 Physician Office and Access Systems ................................................................................... 112
3.4 Environment and Evolution ......................................................................................................... 114
3.5 Diagnostic Technology Development ......................................................................................... 115
3.5.1 Next Generation Sequencing Fuels a Revolution................................................................. 116
3.5.2 Impact of NGS on pricing ..................................................................................................... 117
3.5.3 POCT/Self Testing Disruptive Force .................................................................................... 117
3.5.4 Pharmacogenomics Blurs Diagnosis and Treatment ............................................................. 118
3.5.5 CGES Testing, A Brave New World..................................................................................... 118
3.5.6 Molecular Diagnostics Technologies At The Forefront of Growth ...................................... 119
3.5.7 Biochips/Giant magneto resistance based assay ................................................................... 120
4. Laboratory, Molecular Diagnostics and Genomic Testing Recent Developments ................. 121
4.1 Recent Developments – Importance and How to Use This Section ............................................ 122
4.1.1 Importance of These Developments ...................................................................................... 122
4.1.2 How to Use This Section ....................................................................................................... 122
4.2 Quest Diagnostics to Acquire Clinical Laboratory Partners ........................................................ 122
4.3 Illumina, Almac to Collaborate on NGS CDx Assays ................................................................ 124
4.4 Rite Aid First U.S. Drugstore Chain to Offer Harmonyx Genetic Testing to Customers ........... 124
4.5 US Patent Awarded to Singulex for Expanded Use of Biomarkers ............................................ 125
4.6 Feds to scrutinize med tech Medicare reimbursement in fiscal 2016 .......................................... 126
4.7 Trovagene's Urine-Based Liquid Biopsy Platform Shows Clinical Sensitivity of 93 Percent in
Lung Cancer Study ............................................................................................................................ 127
4.8 Roche Rapid Flu MDx Test Shown to Impact Patient Care in ER .............................................. 127
4.9 CareDx Mobilizing Response Team After CMS Initial AlloMap Pricing Threatens Business .. 129
4.10 PTS Diagnostics' Patent Enforcement Against Jant Pharmacal Gains Momentum .................. 133
4.11 SeraCare Life Sciences Announces Early Access Programs for ctDNA and RNA Fusion
Reference Materials ........................................................................................................................... 134
4.12 Eurofins Acquires Diatherix to Strengthen Specialty Clinical Diagnostics Focus .................... 135
4.13 Abbott Laboratories to buy St. Jude Medical for $25 billion .................................................... 136
4.14 CombiMatrix Gets Serious About Potential M&A Options in Wake of $8M Offering ............ 137
4.15 Abbott to Acquire Alere, Becoming Leader in Point of Care Testing ...................................... 139
4.16 Achieving Dx Ambitions Key to Avant-Amarantus-Theranostics Merger ............................... 140
4.17 LabCorp Agrees to Acquire Assets of Pathology Inc. ............................................................... 143
4.18 NeoGenomics Completes Acquisition of Clarient, Inc. ............................................................ 144
4.19 FDA Gets Pushback on Move to Regulate Lab Developed Tests ............................................. 145
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4.20 Cancer Genetics, Inc. Announces Partnership with BARC Global Central Laboratory to Offer
Comprehensive Clinical Trial and Companion Diagnostic Solutions for the Oncology Industry .... 146
4.21 Theranos plans to close all its clinical labs and lay off about 340 workers............................... 148
4.22 Forte Capital Lowers stake in Laboratory Corp. of America Holdings .................................... 149
4.23 The US Oncology Network Selects Myriad Genetics As Preferred Provider For Hereditary
Cancer Testing .................................................................................................................................. 151
4.24 Pyxant Labs Commences Clinical Laboratory Testing Services ............................................... 151
4.25 Viewics Launches Diabetes Management (vCAT), A Free Solution For Laboratories Providing
Powerful Diabetes Population Management Analytics To Healthcare Organizations ...................... 152
4.26 Alpha Genomix And Rx30 Partner To Provide Personalized Medication Therapy .................. 154
4.27 LabCorp Doubles The Testing Capacity Of Covance Central Laboratory In Geneva .............. 155
4.47 OpGen Files for IPO for up to $37M......................................................................................... 156
4.48 Transgenomic Closes Public Offering of Stock, Warrants ........................................................ 157
4.49 Qiagen Discloses $114.2M Price Tag for Enyzmatics Acquisition .......................................... 157
4.50 Laboratory Corporation of America Holdings Full Year Results ............................................. 157
4.51 GenomeDx Biosciences Implements Clarity LIMS .................................................................. 160
4.52 Merck Serono and Sysmex Inostics Announce Testing Center ................................................. 161
4.53 Lifecode Receives CAP Accreditation, Discloses Funding ...................................................... 162
4..54 Baylor College of Medicin, Miraca Holdings finalize joint venture. ....................................... 163
4.55 23andMe Gets FDA Clearance to Market Bloom Syndrome Carrier Test ................................ 164
4.56 LabCorp to Buy Covance for $6.1 Billion to Add Drug R&D .................................................. 165
4.57 Trinity Biotech Revenues Grow by 15% .................................................................................. 167
4.58 Google’s Latest Healthcare Initiative ........................................................................................ 169
4.59 Trinity Biotech Announces US Clinical Trials .......................................................................... 170
4.60 Agena Bioscience Launches Smaller Format MassArray ......................................................... 171
4.61 QuantRx® Biomedical Provides Update on Technological Progress ....................................... 171
4.62 The Journal of Molecular Diagnostics Publishes Special Article ............................................. 172
4.63 Caprion Licenses Indi's Xpresys as Part of Larger Clinical Push ............................................. 173
4.64 MDxHealth's ConfirmMDx Genes Detect Prostate Cancer ...................................................... 174
4.65 Atossa Genetics Announces That Its Subsidiary The National Reference Laboratory for Breast
Health Has Received Accreditation ................................................................................................... 175
4.66 Nuclea Bio Plans Entry into Clinical Proteomics ...................................................................... 175
4.67 Personal Genome Diagnostics Aims for FDA Clearance .......................................................... 176
4.68 Enzo Biochem Announces New Molecular Platform ................................................................ 176
4.69 Multiplicom, Premaitha Develop CE-IVDs .............................................................................. 178
4.70 Regulating the Next Generation of Genetic Testing .................................................................. 179
4.71 BioReference Laboratories, Inc. Launches an Advanced Tumor Sequencing Program ........... 181
4.72 Cytogenetics Become First Certified Lab to Offer Microarray Testing .................................... 182
4.73 Results Support Clinical Validity of Quantose IGT(TM) Diabetes Test .................................. 183
4.74 Accelerate Diagnostics' 2014 Revenues Rise Sharply .............................................................. 184
4.75 NanoString's Q4 Revenues Jump 54 Percent............................................................................. 184
4.76 New Aussie Firm Life Letters Launches Carrier, PGx Testing for Consumers ........................ 185
4.77 HTG Molecular Reports 50 Percent Increase in 2014 Revenues .............................................. 186
4.79 LabCorp Posts 5 Percent Revenue Growth ............................................................................... 187
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4.80 Genomic Vision, Quest Extend Pact for Molecular Combing Technology .............................. 189
4.81 ACT Genomics Raises $8M in Private Funding Round ............................................................ 189
4.82 NGS-based Cancer MDx Firm Lifecode Raises $20.5M, Receives CAP Accreditation .......... 190
4.83 Invitae Goes Public with $101.6M Offering ............................................................................. 190
4.84 Quidel Q4 Revenues Grow 27 Percent on Infectious Disease Sales ......................................... 191
4.85 Rosetta Signs Deal to Promote Precipio's Cancer Diagnostics ................................................. 193
4.86 Premaitha Iona NIPT Lands CE Mark ....................................................................................... 193
4.87 Sera Increases Series B Round to $25M with $5M from Gates Foundation ............................. 194
4.88 T2 Biosystems Inks $8.5M Lyme Disease Dx Deal with Canon US Life Sciences ................. 195
4.89 Invitae Amends IPO Filing Targeting up to $92.3M ................................................................. 195
4.90 Biofortuna Closes $2.2M Funding Round ................................................................................. 196
4.91 Roche MDx Sales Help Drive 2014 Diagnostics Revenues up 3 Percent ................................. 197
4.92 AltheaDx Increases Target Amount on Proposed IPO to $74.3M ............................................ 198
4.93 BioMerieux 2014 Revenues Increase 7 Percent ........................................................................ 199
4.94 Cypher Genomics and Sequenom Announce Development Agreement ................................... 200
4.95 Abcam to Acquire Firefly BioWorks for $28M ........................................................................ 201
4.96 PerkinElmer Opens Medical Laboratory in China .................................................................... 202
4.97 Human Longevity, Genentech Ink Deal to Sequence Thousands of Genomes ......................... 203
4.98 GenMark Projects 52 Percent Growth in Q4 Revenues ............................................................ 203
4.99 Amarantus Acquires DioGenix for up to $10.9M ..................................................................... 204
4.100 Roche to Invest up to $1.2B in Foundation Medicine, Take Majority Stake .......................... 205
4.101 DiaCarta Raises $8M in Series A Round ................................................................................ 207
4.102 Epic Sciences' Cancer Dx Laboratory Receives CLIA Certification ...................................... 208
4.103 Adaptive Biotechnologies Acquires Sequenta ......................................................................... 208
4.104 Aegis Sciences Acquires MDx Firm Diagnovus ..................................................................... 209
5. Country Market Sizes – North America ................................................................................ 211
5.1 United States of America ............................................................................................................. 212
5.1.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................. 212
5.1.2 Microbiology – Volumes, Prices, Revenues ......................................................................... 212
5.1.3 Hematology – Volumes, Prices, Revenues ........................................................................... 212
5.1.4 Anatomic Pathology – Volumes, Prices, Revenues .............................................................. 213
5.1.5 Molecular Diagnostics – Volumes, Prices, Revenues ........................................................... 213
5.1.6 All Clinical Testing – Volumes, Prices, Revenues ............................................................... 213
5.1.7 Cardiac Biomarkers – Volumes, Prices, Revenues ............................................................... 214
5.1.8 Molecular Diagnostic Oncology – Volumes, Prices, Revenues ............................................ 214
5.1.9 Molecular Diagnostic Genetics – Volumes, Prices, Revenues ............................................. 214
5.2 Canada ........................................................................................................................................ 215
5.2.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................. 215
5.2.2 Microbiology – Volumes, Prices, Revenues ......................................................................... 215
5.2.3 Hematology – Volumes, Prices, Revenues ........................................................................... 215
5.2.4 Anatomic Pathology – Volumes, Prices, Revenues .............................................................. 216
5.2.5 Molecular Diagnostics – Volumes, Prices, Revenues ........................................................... 216
5.2.6 All Clinical Testing – Volumes, Prices, Revenues ............................................................... 216
5.2.7 Cardiac Biomarkers – Volumes, Prices, Revenues ............................................................... 217
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5.2.8 Molecular Diagnostic Oncology – Volumes, Prices, Revenues ............................................ 217
5.2.9 Molecular Diagnostic Genetics – Volumes, Prices, Revenues ............................................. 217
6. Country Markets – Europe ...................................................................................................... 218
6.1 France ......................................................................................................................................... 219
6.1.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................. 219
6.1.2 Microbiology – Volumes, Prices, Revenues ......................................................................... 219
6.1.3 Hematology – Volumes, Prices, Revenues ........................................................................... 219
6.1.4 Anatomic Pathology – Volumes, Prices, Revenues .............................................................. 220
6.1.5 Molecular Diagnostics – Volumes, Prices, Revenues ........................................................... 220
6.1.6 All Clinical Testing – Volumes, Prices, Revenues ............................................................... 220
6.1.7 Cardiac Biomarkers – Volumes, Prices, Revenues ............................................................... 221
6.1.8 Molecular Diagnostic Oncology – Volumes, Prices, Revenues ............................................ 221
6.1.9 Molecular Diagnostic Genetics – Volumes, Prices, Revenues ............................................. 221
6.2 Germany ..................................................................................................................................... 222
6.2.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................. 222
6.2.2 Microbiology – Volumes, Prices, Revenues ......................................................................... 222
6.2.3 Hematology – Volumes, Prices, Revenues ........................................................................... 222
6.2.4 Anatomic Pathology – Volumes, Prices, Revenues .............................................................. 223
6.2.5 Molecular Diagnostics – Volumes, Prices, Revenues ........................................................... 223
6.2.6 All Clinical Testing – Volumes, Prices, Revenues ............................................................... 223
6.2.7 Cardiac Biomarkers – Volumes, Prices, Revenues ............................................................... 224
6.2.8 Molecular Diagnostic Oncology – Volumes, Prices, Revenues ............................................ 224
6.2.9 Molecular Diagnostic Genetics – Volumes, Prices, Revenues ............................................. 224
6.3 United Kingdom .......................................................................................................................... 225
6.3.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................. 225
6.3.2 Microbiology – Volumes, Prices, Revenues ......................................................................... 225
6.3.3 Hematology – Volumes, Prices, Revenues ........................................................................... 225
6.3.4 Anatomic Pathology – Volumes, Prices, Revenues .............................................................. 226
6.3.5 Molecular Diagnostics – Volumes, Prices, Revenues ........................................................... 226
6.3.6 All Clinical Testing – Volumes, Prices, Revenues ............................................................... 226
6.3.7 Cardiac Biomarkers – Volumes, Prices, Revenues ............................................................... 227
6.3.8 Molecular Diagnostic Oncology – Volumes, Prices, Revenues ............................................ 227
6.3.9 Molecular Diagnostic Genetics – Volumes, Prices, Revenues ............................................. 227
6.4 Spain ........................................................................................................................................... 228
6.4.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................. 228
6.4.2 Microbiology – Volumes, Prices, Revenues ......................................................................... 228
6.4.3 Hematology – Volumes, Prices, Revenues ........................................................................... 228
6.4.4 Anatomic Pathology – Volumes, Prices, Revenues .............................................................. 229
6.4.5 Molecular Diagnostics – Volumes, Prices, Revenues ........................................................... 229
6.4.6 All Clinical Testing – Volumes, Prices, Revenues ............................................................... 229
6.4.7 Cardiac Biomarkers – Volumes, Prices, Revenues ............................................................... 230
6.4.8 Molecular Diagnostic Oncology – Volumes, Prices, Revenues ............................................ 230
6.4.9 Molecular Diagnostic Genetics – Volumes, Prices, Revenues ............................................. 230
6.5 Italy ............................................................................................................................................. 231
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6.5.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................. 231
6.5.2 Microbiology – Volumes, Prices, Revenues ......................................................................... 231
6.5.3 Hematology – Volumes, Prices, Revenues ........................................................................... 231
6.5.4 Anatomic Pathology – Volumes, Prices, Revenues .............................................................. 232
6.5.5 Molecular Diagnostics – Volumes, Prices, Revenues ........................................................... 232
6.5.6 All Clinical Testing – Volumes, Prices, Revenues ............................................................... 232
6.5.7 Cardiac Biomarkers – Volumes, Prices, Revenues ............................................................... 233
6.5.8 Molecular Diagnostic Oncology – Volumes, Prices, Revenues ............................................ 233
6.5.9 Molecular Diagnostic Genetics – Volumes, Prices, Revenues ............................................. 233
6.6 Russia .......................................................................................................................................... 234
6.6.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................. 234
6.6.2 Microbiology – Volumes, Prices, Revenues ......................................................................... 234
6.6.3 Hematology – Volumes, Prices, Revenues ........................................................................... 234
6.6.4 Anatomic Pathology – Volumes, Prices, Revenues .............................................................. 235
6.6.5 Molecular Diagnostics – Volumes, Prices, Revenues ........................................................... 235
6.6.6 All Clinical Testing – Volumes, Prices, Revenues ............................................................... 235
6.6.7 Cardiac Biomarkers – Volumes, Prices, Revenues ............................................................... 236
6.6.8 Molecular Diagnostic Oncology – Volumes, Prices, Revenues ............................................ 236
6.6.9 Molecular Diagnostic Genetics – Volumes, Prices, Revenues ............................................. 236
6.7 Remainder of Europe and Former Soviet Union ......................................................................... 237
6.7.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................. 237
6.7.2 Microbiology – Volumes, Prices, Revenues ......................................................................... 237
6.7.3 Hematology – Volumes, Prices, Revenues ........................................................................... 237
6.7.4 Anatomic Pathology – Volumes, Prices, Revenues .............................................................. 238
6.7.5 Molecular Diagnostics – Volumes, Prices, Revenues ........................................................... 238
6.7.6 All Clinical Testing – Volumes, Prices, Revenues ............................................................... 238
6.7.7 Cardiac Biomarkers – Volumes, Prices, Revenues ............................................................... 239
6.7.8 Molecular Diagnostic Oncology – Volumes, Prices, Revenues ............................................ 239
6.7.9 Molecular Diagnostic Genetics – Volumes, Prices, Revenues ............................................. 239
7. Country Markets – Asia Pacific .............................................................................................. 240
7.1 China ........................................................................................................................................... 241
7.1.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................. 241
7.1.2 Microbiology – Volumes, Prices, Revenues ......................................................................... 241
7.1.3 Hematology – Volumes, Prices, Revenues ........................................................................... 241
7.1.4 Anatomic Pathology – Volumes, Prices, Revenues .............................................................. 242
7.1.5 Molecular Diagnostics – Volumes, Prices, Revenues ........................................................... 242
7.1.6 All Clinical Testing – Volumes, Prices, Revenues ............................................................... 242
7.1.7 Cardiac Biomarkers – Volumes, Prices, Revenues ............................................................... 243
7.1.8 Molecular Diagnostic Oncology – Volumes, Prices, Revenues ............................................ 243
7.1.9 Molecular Diagnostic Genetics – Volumes, Prices, Revenues ............................................. 243
7.2 Japan ........................................................................................................................................... 244
7.2.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................. 244
7.2.2 Microbiology – Volumes, Prices, Revenues ......................................................................... 244
7.2.3 Hematology – Volumes, Prices, Revenues ........................................................................... 244
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7.2.4 Anatomic Pathology – Volumes, Prices, Revenues .............................................................. 245
7.2.5 Molecular Diagnostics – Volumes, Prices, Revenues ........................................................... 245
7.2.6 All Clinical Testing – Volumes, Prices, Revenues ............................................................... 245
7.2.7 Cardiac Biomarkers – Volumes, Prices, Revenues ............................................................... 246
7.2.8 Molecular Diagnostic Oncology – Volumes, Prices, Revenues ............................................ 246
7.2.9 Molecular Diagnostic Genetics – Volumes, Prices, Revenues ............................................. 246
7.3 South Korea ................................................................................................................................ 247
7.3.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................. 247
7.3.2 Microbiology – Volumes, Prices, Revenues ......................................................................... 247
7.3.3 Hematology – Volumes, Prices, Revenues ........................................................................... 247
7.3.4 Anatomic Pathology – Volumes, Prices, Revenues .............................................................. 248
7.3.5 Molecular Diagnostics – Volumes, Prices, Revenues ........................................................... 248
7.3.6 All Clinical Testing – Volumes, Prices, Revenues ............................................................... 248
7.3.7 Cardiac Biomarkers – Volumes, Prices, Revenues ............................................................... 249
7.3.8 Molecular Diagnostic Oncology – Volumes, Prices, Revenues ............................................ 249
7.3.9 Molecular Diagnostic Genetics – Volumes, Prices, Revenues ............................................. 249
7.4 India ............................................................................................................................................ 250
7.4.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................. 250
7.4.2 Microbiology – Volumes, Prices, Revenues ......................................................................... 250
5.1.3 Hematology – Volumes, Prices, Revenues ........................................................................... 250
7.4.4 Anatomic Pathology – Volumes, Prices, Revenues .............................................................. 251
7.4.5 Molecular Diagnostics – Volumes, Prices, Revenues ........................................................... 251
7.4.6 All Clinical Testing – Volumes, Prices, Revenues ............................................................... 251
7.4.7 Cardiac Biomarkers – Volumes, Prices, Revenues ............................................................... 252
7.4.8 Molecular Diagnostic Oncology – Volumes, Prices, Revenues ............................................ 252
7.4.9 Molecular Diagnostic Genetics – Volumes, Prices, Revenues ............................................. 252
7.5 Australia ...................................................................................................................................... 253
7.5.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................. 253
7.5.2 Microbiology – Volumes, Prices, Revenues ......................................................................... 253
7.5.3 Hematology – Volumes, Prices, Revenues ........................................................................... 253
7.5.4 Anatomic Pathology – Volumes, Prices, Revenues .............................................................. 254
7.5.5 Molecular Diagnostics – Volumes, Prices, Revenues ........................................................... 254
7.5.6 All Clinical Testing – Volumes, Prices, Revenues ............................................................... 254
7.5.7 Cardiac Biomarkers – Volumes, Prices, Revenues ............................................................... 255
7.5.8 Molecular Diagnostic Oncology – Volumes, Prices, Revenues ............................................ 255
7.5.9 Molecular Diagnostic Genetics – Volumes, Prices, Revenues ............................................. 255
7.6 Rest of Asia Pacific ..................................................................................................................... 256
7.6.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................. 256
7.6.2 Microbiology – Volumes, Prices, Revenues ......................................................................... 256
7.6.3 Hematology – Volumes, Prices, Revenues ........................................................................... 256
7.6.4 Anatomic Pathology – Volumes, Prices, Revenues .............................................................. 257
7.6.5 Molecular Diagnostics – Volumes, Prices, Revenues ........................................................... 257
7.6.6 All Clinical Testing – Volumes, Prices, Revenues ............................................................... 257
7.6.7 Cardiac Biomarkers – Volumes, Prices, Revenues ............................................................... 258
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7.6.8 Molecular Diagnostic Oncology – Volumes, Prices, Revenues ............................................ 258
7.6.9 Molecular Diagnostic Genetics – Volumes, Prices, Revenues ............................................. 258
8. Country Markets – Latin America, Africa & The Middle East .............................................. 259
8.1 Brazil ........................................................................................................................................... 260
8.1.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................. 260
8.1.2 Microbiology – Volumes, Prices, Revenues ......................................................................... 260
8.1.3 Hematology – Volumes, Prices, Revenues ........................................................................... 260
8.1.4 Anatomic Pathology – Volumes, Prices, Revenues .............................................................. 261
8.1.5 Molecular Diagnostics – Volumes, Prices, Revenues ........................................................... 261
8.1.6 All Clinical Testing – Volumes, Prices, Revenues ............................................................... 261
8.1.7 Cardiac Biomarkers – Volumes, Prices, Revenues ............................................................... 262
8.1.8 Molecular Diagnostic Oncology – Volumes, Prices, Revenues ............................................ 262
8.1.9 Molecular Diagnostic Genetics – Volumes, Prices, Revenues ............................................. 262
8.2 Mexico ........................................................................................................................................ 263
8.2.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................. 263
8.2.2 Microbiology – Volumes, Prices, Revenues ......................................................................... 263
8.2.3 Hematology – Volumes, Prices, Revenues ........................................................................... 263
8.2.4 Anatomic Pathology – Volumes, Prices, Revenues .............................................................. 264
8.2.5 Molecular Diagnostics – Volumes, Prices, Revenues ........................................................... 264
8.2.6 All Clinical Testing – Volumes, Prices, Revenues ............................................................... 264
8.2.7 Cardiac Biomarkers – Volumes, Prices, Revenues ............................................................... 265
8.2.8 Molecular Diagnostic Oncology – Volumes, Prices, Revenues ............................................ 265
8.2.9 Molecular Diagnostic Genetics – Volumes, Prices, Revenues ............................................. 265
8.3 Remainder of Latin America ....................................................................................................... 266
8.3.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................. 266
8.3.2 Microbiology – Volumes, Prices, Revenues ......................................................................... 266
8.3.3 Hematology – Volumes, Prices, Revenues ........................................................................... 266
8.3.4 Anatomic Pathology – Volumes, Prices, Revenues .............................................................. 267
8.3.5 Molecular Diagnostics – Volumes, Prices, Revenues ........................................................... 267
8.3.6 All Clinical Testing – Volumes, Prices, Revenues ............................................................... 267
8.3.7 Cardiac Biomarkers – Volumes, Prices, Revenues ............................................................... 268
8.3.8 Molecular Diagnostic Oncology – Volumes, Prices, Revenues ............................................ 268
8.3.9 Molecular Diagnostic Genetics – Volumes, Prices, Revenues ............................................. 268
8.4 Africa & The Middle East ........................................................................................................... 269
8.4.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................. 269
8.4.2 Microbiology – Volumes, Prices, Revenues ......................................................................... 269
8.4.3 Hematology – Volumes, Prices, Revenues ........................................................................... 269
8.4.4 Anatomic Pathology – Volumes, Prices, Revenues .............................................................. 270
8.4.5 Molecular Diagnostics – Volumes, Prices, Revenues ........................................................... 270
8.4.6 All Clinical Testing – Volumes, Prices, Revenues ............................................................... 270
8.4.7 Cardiac Biomarkers – Volumes, Prices, Revenues ............................................................... 271
8.4.8 Molecular Diagnostic Oncology – Volumes, Prices, Revenues ............................................ 271
8.4.9 Molecular Diagnostic Genetics – Volumes, Prices, Revenues ............................................. 271
9. Global Market Summary ......................................................................................................... 272
Medical Laboratory Testing Services 2016 to 2019 Page | 11
HOWE SOUND RESEARCH
9.1 Global Market .............................................................................................................................. 273
9.1.1 Clinical Chemistry – Volumes, Prices, Revenues ................................................................. 273
9.1.2 Microbiology – Volumes, Prices, Revenues ......................................................................... 273
9.1.3 Hematology – Volumes, Prices, Revenues ........................................................................... 273
9.1.4 Anatomic Pathology – Volumes, Prices, Revenues .............................................................. 274
9.1.5 Molecular Diagnostics – Volumes, Prices, Revenues ........................................................... 274
9.1.6 All Clinical Testing – Volumes, Prices, Revenues ............................................................... 274
9.1.7 Cardiac Biomarkers – Volumes, Prices, Revenues ............................................................... 275
9.1.8 Molecular Diagnostic Oncology – Volumes, Prices, Revenues ............................................ 275
9.1.9 Molecular Diagnostic Genetics – Volumes, Prices, Revenues ............................................. 275
10. The Future of the Clinical Laboratory .................................................................................. 276
Appendices ................................................................................................................................. 277
I. United States Medicare System: January 2015 Clinical Laboratory Fees Schedule – National Limit
and Midpoint ..................................................................................................................................... 277