gdme1169idb - united states in vitro diagnostics market outlook … · 11.23 life technologies...

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United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and

Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form

United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture

Reference Code: GDME1169IDB

Publication Date: November 2012

SAMPLETable of Contents




1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 24

1.2 List of Figures 30

2 Introduction 33

2.1 What is This Report About? 33

3 In Vitro Diagnostics In United States 34

3.1 In Vitro Diagnostics, Market Segmentation 34

3.2 In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, 2004-2018 35

3.3 In Vitro Diagnostics Market, United States, Revenue Mix ($m), 2011 37

3.4 In Vitro Diagnostics Market, United States, Category Contribution (%), 2011 38

3.5 In Vitro Diagnostics, United States, Company Share (2010-2011) 45

4 Clinical Chemistry In United States 47

4.1 Clinical Chemistry, Market Segmentation 47

4.2 Clinical Chemistry Market, United States, Revenue Mix ($m), 2011 48

4.3 Clinical Chemistry Market, United States, Segment Contribution (%), 2011 49

4.4 Clinical Chemistry Overall Revenue, (2004-2018) 50

4.4.1 Clinical Chemisty Analyzers, Revenue (2004-2018) 54

4.4.2 Urine Analysis, Revenue (2004-2018) 58

4.5 Clinical Chemistry Distribution Share (2010-2011) 62

4.6 Clinical Chemistry, United States, Company Share (2010-2011) 63

5 Genetic Testing In United States 64

5.1 Genetic Testing, Market Segmentation 64





5.2 Genetic Testing Market, United States, Revenue Mix ($m), 2011 65

5.3 Genetic Testing Market, United States, Segment Contribution (%), 2011 66

5.4 Genetic Testing Overall Revenue, (2004-2018) 67

5.5 Genetic Testing Distribution Share (2010-2011) 71

5.6 Genetic Testing, United States, Company Share (2010-2011) 72

6 Haematology In United States 74

6.1 Haematology Market, Market Segmentation 74

6.2 Haematology Market, United States, Revenue Mix ($m), 2011 75

6.3 Haematology Market, United States, Segment Contribution (%), 2011 76

6.4 Haematology Overall Revenue, (2004-2018) 77

6.4.1 Haematology Reagents, Revenue, (2004-2018) 81

6.4.2 Immunohaematology, Revenue (2004-2018) 85

6.4.3 Haemostasis, Revenue (2004-2018) 89

6.4.4 Haematology Rapid Tests, Revenue (2004-2018) 93

6.4.5 Haematology Cell Counters, Revenue (2004-2018) 97

6.5 Haematology Distribution Share (2010-2011) 101

6.6 Haematology, United States, Company Share (2010-2011) 102

7 Histology And Cytology In United States 104

7.1 Histology and Cytology Market, Market Segmentation 104

7.2 Histology And Cytology Market, United States, Revenue Mix ($m), 2011 105

7.3 Histology And Cytology Market, United States, Segment Contribution (%), 2011 106

7.4 Histology And Cytology Overall Revenue, (2004-2018) 107

7.5 Histology And Cytology Distribution Share (2010-2011) 111

7.6 Histology And Cytology, United States, Company Share (2010-2011) 112

8 Immuno Chemistry In United States 114





8.1 Infectious Immunology, Market Segmentation 114

8.2 Immuno Chemistry Market, United States, Revenue Mix ($m), 2011 115

8.3 Immuno Chemistry Market, United States, Segment Contribution (%), 2011 116

8.4 Immuno Chemistry Overall Revenue, (2004-2018) 117

8.4.1 Disease Specific Immunochemistry, Revenue (2004-2018) 121

8.4.2 Drugs of Abuse / Toxicology, Revenue (2004-2018) 125

8.4.3 Endocrinology Tests, Revenue (2004-2018) 129

8.4.4 Immunochemistry Rapid Tests, Revenue (2004-2018) 133

8.4.5 Therapeutic Drug Monitoring, Revenue (2004-2018) 137

8.4.6 Immunochemistry Analyzers, Revenue (2004-2018) 141

8.5 Immuno Chemistry Distribution Share (2010-2011) 145

8.6 Immuno Chemistry, United States, Company Share (2010-2011) 146

9 Infectious Immunology In United States 148

9.1 Infectious Immunology Market, United States, Revenue Mix ($m), 2011 148

9.2 Infectious Immunology Market, United States, Segment Contribution (%), 2011 149

9.3 Infectious Immunology Overall Revenue, (2004-2018) 150

9.3.1 Infectious Immunology Rapid Tests, Revenue (2004-2018) 154

9.4 Infectious Immunology Distribution Share (2010-2011) 158

9.5 Infectious Immunology, United States, Company Share (2010-2011) 159

10 Microbiology Culture In United States 161

10.1 Microbiology Culture, Market Segmentation 161

10.2 Microbiology Culture Market, United States, Revenue Mix ($m), 2011 162

10.3 Microbiology Culture Market, United States, Segment Contribution (%), 2011 163

10.4 Microbiology Culture Overall Revenue, (2004-2018) 164

10.4.1 Microbiology Analyzers, Revenue (2004-2018) 168

10.5 Microbiology Culture Distribution Share (2010-2011) 172

10.6 Microbiology Culture, United States, Company Share (2010-2011) 173





11 Overview of Key Companies in United States In Vitro Diagnostics Market 175

11.1 Siemens Healthcare 175

11.1.1 Company Overview 175

11.1.2 Share in the United States In Vitro Diagnostics Market 175

11.2 Abbott Laboratories 176



11.3 F. Hoffmann-La Roche Ltd. 177



11.4 Beckman Coulter, Inc. 178


11.4.2 Share the United States In Vitro Diagnostics Market 178

11.5 Ortho-Clinical Diagnostics Inc. 179


11.5.2 Share the United States In Vitro Diagnostics Market 179

11.6 Alere Inc. 180



11.7 Danaher Corporation 181


11.8 bioMerieux S.A. 181


11.9 Becton, Dickinson and Company 182


11.10 Bio-Rad Laboratories, Inc. 182


11.11 Sysmex Corporation 183


11.12 Qiagen N.V. 183






11.13 Gen-Probe Incorporated 184


11.14 DiaSorin S.p.A 184


11.15 Immucor, Inc. 185


11.16 Cepheid 185


11.17 Thermo Fisher Scientific Inc. 186


11.18 Hologic, Inc. 186


11.19 PerkinElmer, Inc. 187


11.20 Grifols, S.A. 187


11.21 Olympus Corporation 188


11.22 Horiba, Ltd. 188


11.23 Life Technologies Corporation 189


11.24 Diagnostica Stago, Inc. 189


11.25 ELITech Group 190


11.26 OraSure Technologies, Inc. 190


12 In Vitro Diagnostics Market Pipeline Products 191





12.1 Clinical Chemisty Market Pipeline Products 191

12.2 Immuno Chemistry Market Pipeline Products 198

12.3 Haematology Market Pipeline Products 209

12.4 Infectious Immunology Market Pipeline Products 211

12.5 Microbiology Culture Market Pipeline Products 218

12.6 Histology And Cytology Market Pipeline Products 219

12.7 Genetic Testing Market Pipeline Products 220

13 Financial Deals Landscape 225

13.1 Acquisition 225

13.1.1 ERBA Diagnostics Acquires Drew Scientific, Maker Of Analytical Instruments And Reagents, For

$6.5 Million 225

13.1.2 Measurement Specialties Acquires Cambridge Technologies And Resistance Temperature

Detector Company For $18.8 Million 227

13.1.3 Atossa Genetics Acquires Acueity Healthcare, Diagnostic Device Provider 228

13.1.4 AccelPath Acquires DigiPath Solutions For $2.4 Million 229

13.1.5 Danaher Completes Acquisition Of 91.6% Stake In Iris International, Diagnostic Test Maker, For

$324 Million 230

13.1.6 Charles River Labs Acquires Accugenix, Provider Of Microbe Identification Services, For $17

Million 232

13.1.7 Leica Biosystems Completes Acquisition Of Aperio Technologies 233

13.1.8 Metabolon Acquires Lipomics Technologies, Diagnostics Company 235

13.1.9 Waters Acquires Blue Reference, Maker Of Application Scientific Databases, For $14 Million 237

13.1.10 Life Technologies Acquires Pinpoint Genomics, Molecular Diagnostics Company 238

13.1.11 Thermo Fisher Scientific Completes Acquisition Of One Lambda, Transplant Diagnostics

Company, For $925 Million 239

13.1.12 Life Technologies Acquires Navigenics 241

13.1.13 Genova Diagnostics Acquires Metametrix, Clinical Laboratory 243

13.1.14 Luminex To Acquire GenturaDx, Molecular Diagnostics Company, For $50 Million 244

13.1.15 Systagenix Acquires O2 Insights 246

13.1.16 LabCorp Completes Acquisition Of Medtox Scientific For $241 Million 247

13.1.17 Flagship Biosciences Acquires Ihctech, Provider Of Research Immunohistochemistry And

Histology Services 249

13.1.18 Halo Healthcare Acquires NeoMatrix, Maker Of Diagnostic Equipments 250

13.1.19 Qiagen Acquires AmniSure International, Manufacturer Of Non Invasive Test Solutions 251

13.1.20 Hologic Completes Acquisition Of Gen-Probe For $3.7 Billion 252





13.1.21 Haemonetics To Acquire Hemerus Medical, Provider Of Leukoreduction Technologies, For $27

Million 254

13.1.22 IntegenX Acquires SV, Provider Of DNA Identification Consumable Products, From GE

Healthcare Bio-Sciences 255

13.2 Partnerships 256

13.2.1 DioGenix Enters Into Agreement With Fast Forward To Develop New Blood Test For Multiple

Sclerosis 256

13.2.2 GNS Healthcare Enters Into Agreement With Dana-Farber Cancer Institute and Mount Sinai

School of Medicine 257

13.2.3 Crown Bioscience Enters Into Co-Development Agreement With Horizon Discovery 259

13.2.4 CombiMatrix Enters Into Co-Marketing Agreement With Pathology For Prenatal Tests 260

13.2.5 Clinical Genomics Enters Into Licensing Agreement With Quest Diagnostics For Colon Cancer

Markers 261

13.2.6 Abaxis Enters Into Distribution Agreement With Abbott Point of Care For Piccolo Blood Chemistry

System 262

13.2.7 Malvern Instruments Enters Into Co-Marketing Agreement With Affinity Biosensors For

Archimedes Particle Metrology System 263

13.2.8 Exosome Diagnostics Enters Into Co-Development Agreement With Promega For Urine Clinical

Sample Concentrator Kit 264

13.2.9 Agenix Enters Into Licensing Agreement With Tyrian Diagnostics For DiagnostIQ 265

13.2.10 Ezose Enters Into Co-Development Agreement With Fast Forward For Multiple Sclerosis

Biomarkers 266

13.2.11 BioDot Enters Into Co-Marketing Agreement With JOT Automation 267

13.2.12 Sequella Enters Into Licensing Agreement With LabCorp For B-Smart Technology 268

13.2.13 LifeTech Scientific, DiNova Venture Partners, Themes Investment Partners And Broncus

Technologies Partner To Form Broncus Medical 269

13.2.14 Van Andel Institute Enters Into Co-Development Agreement With Emory University 270

13.2.15 Merck Serono Enters Into Co-Development Agreement With Auxogyn For Early Embryo

Viability Assessment Test 271

13.2.16 PGXL Labs Enters Into Joint Venture Agreement With Essential Molecular Testing 272

13.2.17 Broad Institute Enters Into Distribution Agreement With Appistry For Genome Analysis Toolkit

273

13.2.18 Thermo Fisher Enters Into Co-Development Agreement With Immundiagnostik 274

13.2.19 Sage Labs Enters Into Agreement With Ekam Imaging To Develop Imaging Assays 275

13.2.20 Bruker Enters Into An Agreement With Nextval For High-throughput Screening Technology 276

13.2.21 BD Diagnostic Systems Enters Into Agreement With Lab21 To Develop New Oncology Assays

277

13.2.22 RainDance Technologies Enters Into Co-Development Agreement With Integrated DNA

Technologies For Digital PCR 278

13.2.23 Amarantus BioSciences Enters Into Option For Licensing Agreement With Memory Dx For

LymPro Blood Test 279





13.2.24 Iverson Genetic Diagnostics Enters Into Licensing Agreement With Johns Hopkins University

School For Molecular Diagnostic Tests 280

13.2.25 Rosetta Genomics Amends Co-Marketing Agreement With Precision Therapeutics For miRview

mets2 Assays 281

13.2.26 Mitomics Enters Into Co-Marketing Agreement With LabCorp For Prostate Core Mitomic Test

282

13.2.27 Trillium Diagnostics Enters Into Licensing Agreement With Leukocare For Sepsis Dx 283

13.2.28 Foundation Medicine Enters Into Agreement With Eisai For Genomic Profiling And Diagnostic

Discovery 284

13.2.29 Vela Diagnostics Enters Into Licensing Agreement With Life Technologies 285

13.2.30 Augurex Life Sciences Enters Into Licensing Agreement With Quest Diagnostics For 14-3-3n

Biomarker 286

13.2.31 CellaVision Enters Into Distribution Agreement With Siemens Healthcare For Digital

Microscopy Hematology Solutions 287

13.2.32 Ingenuity Systems Enters Into Co-Development Agreement With Life Technologies For

Diagnostic Solutions 288

13.2.33 Med BioGene Amends Licensing Agreement With Precision Therapeutics For LungExpress Dx

Test 290

13.2.34 Genia Technologies Enters Into Co-Development Agreement With Columbia University And

Harvard University 292

13.2.35 NextBio Enters Into Agreement With Winship Cancer Institute of Emory University For

Myeloma Biomarkers 294

13.2.36 Ovizio Imaging Systems Enters Into Distribution Agreement With Applikon Biotechnology 295

13.2.37 Atossa Enters Into Co-Marketing Agreement With Diagnostics Test Group For MASCT System

296

13.2.38 Genalyte Partners Scienion To Provide Sciflexarrayer Dispensers For Maverick Detection

Platform 297

13.2.39 CML HealthCare Enters Into Agreement With MaRS Innovation 298

13.2.40 Life Technologies Enters Into Agreement With Bristol-Myers Squibb For Companion

Diagnostics Development 299

13.2.41 Agilent Technologies Enters Into Co-Marketing Agreement With Molecular Discovery 300

13.2.42 Agilent Technologies Enters Into Co-Marketing Agreement With MRM Proteomics 301

13.2.43 Castle Biosciences Enters Into Licensing Agreement With Brigham and Women's Hospital For

Mesothelioma Test 302

13.2.44 Illumina Enters Into Technology Integration Agreement With Partners HealthCare System 303

13.2.45 Scienion Enters Into Co-Marketing Agreement With Maine Manufacturing For Protein Array

Products 304

13.2.46 ImaginAb Enters Into Co-Development Agreement With MacroGenics 305

13.2.47 BellBrook Labs Enters Into Co-Development Agreement With Reaction Biology 306

13.2.48 GVK Biosciences Enters Into Licensing Agreement With National Cancer Institute For GOBIOM

Database 307

13.2.49 GeneCentric Diagnostics Enters Into Licensing Agreement With University of North Carolina 308





13.2.50 Perkinelmer Enters Into Co-Development Agreement With Massachusetts General Hospital 309

13.2.51 Affymetrix Enters Into Co-Development Agreement With Pathgen Dx 310

13.2.52 Axela Enters Into Co-Marketing Agreement With OvaGene Oncology 311

13.2.53 University of Michigan Enters Into Joint Venture Agreement With International Genomics

Consortium 312

13.2.54 Regulus Therapeutics Enters Into An Agreement With Biogen Idec For Biomarkers 313

13.2.55 Curetis Enters Into Licensing Agreement With Cempra For Unyvero 314

13.2.56 Foundation Medicine Enters Into Co-Development Agreement With Clovis Oncology 315

13.2.57 Saladax Biomedical Expands Co-Development Agreement With Bristol-Myers Squibb 316

13.2.58 Epistem Enters Into Distribution Agreement With Becton Dickinson For Mycobacterium TB Test

317

13.2.59 Waters Enters Into Co-Development Agreement With Nonlinear Dynamics 318

13.2.60 Affymetrix Expands Licensing Agreement With Siemens Healthcare For Branched DNA

Technology 319

13.2.61 Molecular Targeting Technologies Enters Into Licensing Agreement With Medical College of

Wisconsin For 99mTc-HYNIC-Duramycin 320

13.2.62 Rosetta Genomics Enters Into Co-Marketing Agreement With Precision Therapeutics For

miRview mets2 Assays 321

13.2.63 Bio-Rad Labs Enters Into Distribution Agreement With Myriad RBM For Multiplex Biomarker

Kits 322

13.2.64 Gen-Probe Enters Into Co-Marketing Agreement With Life Technologies 323

13.2.65 OriGene Technologies Enters Into Co-Development Agreement With Centre of Excellence for

Prevention of Organ Failure 324

13.2.66 Siemens Healthcare Diagnostics Enters Into Distribution Agreement With Sysmex 325

13.2.67 IRIS International Enters Into Distribution Agreement With Alifax 326

13.2.68 EKF Diagnostics Enters Into Licensing Agreement With Joslin Diabetes Center 327

13.2.69 SciFluor Life Sciences Enters Into Distribution Agreement With Sigma-Aldrich For PhenoFluor

328

13.2.70 Clovis Oncology Enters Into Co-Development Agreement With Array BioPharma 329

13.2.71 RS Medical Enters Into Distribution Agreement With Harvest Technologies 330

13.2.72 Immuno-Biological Labs Enters Into Licensing Agreement With IBL International 331

13.2.73 Sandia National Labs Plans To Enter Into Licensing Agreement For SpinDx, Medical

Diagnostic Tool 332

13.2.74 HTG Molecular Diagnostics Enters Into Licensing Agreement With Merck For Breast Cancer

Marker Patent Portfolio 333

13.2.75 Genisphere Enters Into Co-Development Agreement With Lankenau Institute for Medical

Research 334

13.2.76 WaferGen Biosystems Enters Into Agreement With Integrated DNA Technologies 335

13.2.77 BioView Enters Into Co-Development Agreement With ScreenCell For Circulating Tumor Cell

Analysis Technology 336

13.2.78 MDxHealth Enters Into Licensing Agreement With Merck For MGMT Diagnostic Test 337





13.2.79 Fluxion Biosciences Enters Into Co-Development Agreement With Stanford University School

of Medicine 338

13.2.80 Merrimack Pharma Enters Into Co-Development Agreement With Cancer Treatment Centers of

America 339

13.2.81 Phenomenome Discoveries Enters Into Licensing Agreement With Polymedco For Cancer

Diagnostic Test 340

13.2.82 PlexPress Enters Into Technology Integration Agreement With Phalanx Biotech 341

13.2.83 PrimeraDx Enters Into Co-Development Agreement With Eli Lilly 342

13.2.84 Kreatech Diagnostics Enters Into Co-Development Agreement With Oridis Biomarkers For

DNA-FISH Assays 343

13.2.85 Stratos Enters Into Co- Development Agreement With nanoMR 344

13.2.86 Guided Therapeutics Extends Licensing And Co-Development Agreement With Konica Minolta

345

13.2.87 Berg Pharma Enters Into Co-Development Agreement With Parkinson's Institute 346

14 Recent Developments 347

14.1 Strategy And Business Planning 347

14.1.1 Nov 13, 2012: BG Medicine Provides Business Update 347

14.1.2 Nov 13, 2012: Great Basin Opens New, Expanded Manufacturing Facility In Salt Lake City 348

14.1.3 Nov 07, 2012: Namsa Expands Laboratory In Lyon, France 349

14.1.4 Nov 05, 2012: Flambeau Medical Markets Group Expands New Facility 349

14.1.5 Oct 16, 2012: Alliance HealthCare Services Announces Oncology Therapy Facilities Expansion

349

14.1.6 Oct 11, 2012: Quest Diagnostics To Cut 400-600 Management Jobs; Creates Two New Business

Structures 350

14.1.7 Oct 08, 2012: DSM Pharma And Almac Sign Collaboration Agreement In Biocatalysis 351

14.1.8 Oct 02, 2012: AIBioTech Expands Bioorganic Chemistry Platform 352

14.1.9 Sep 28, 2012: Sigma-Aldrich Invests In Scotland 352

14.1.10 Sep 19, 2012: Fidelis Diagnostics Opens New Office In Denver, Colorado 352

14.1.11 Sep 18, 2012: Hycor Opens European Center Of Operations In Germany To Support European

Distributors And Customers 353

14.1.12 Sep 17, 2012: Pathway Genomics And MD Revolution Partner To Incorporate Genomic And

Mobile Health Technologies Into Chronic Disease Management And Prevention 353

14.1.13 Sep 17, 2012: Boehringer Ingelheim To ShutDown One API Plant In Petersburg, Virginia 354

14.1.14 Sep 10, 2012: Icon Expands US And UK Bioanalytical Laboratories 354

14.1.15 Sep 07, 2012: Charles River Opens New Biomedical Diagnostic Facility In Wilmington,

Massachusetts 355

14.1.16 Aug 29, 2012: Bio-Rad Opens Digital Biology Center To Develop Products For R&D Markets

Based On Its Droplet Digital Technology 355

14.1.17 Aug 14, 2012: Morphotek Opens New Manufacturing Plant In Exton, US 355





14.1.18 Aug 13, 2012: Elan Announces Plan To Spin-Off Discovery Science And Neotope Biosciences

To Shareholders 356

14.1.19 Aug 01, 2012: Baxter Breaks Ground On $1 Billion Manufacturing Plant In Georgia, US 357

14.1.20 Jul 24, 2012: Life Technologies And SATuRN Collaborate To Increase Access To HIV Testing

In Africa 358

14.1.21 Jul 20, 2012: Seegene To Make Partnership Push With New Multiplex Real-Time PCR Tech358

14.1.22 Jun 26, 2012: Roche To Shut New Jersey Site, Eliminate 1,000 Jobs 359

14.1.23 Jun 21, 2012: Gentris Partners With Shanghai Institutes of Preventative Medicine 360

14.1.24 Jun 07, 2012: PerkinElmer To Create New Personalized Health Innovation Center of

Excellence In Massachusetts, US 361

14.1.25 Jun 05, 2012: Roche Diagnostics Enters Strategic Alliance With med fusion That Recognizes

As Roche MCOE 362

14.1.26 May 31, 2012: N-of-One Signs Agreement With Foundation Medicine To Provide First Patient-

Specific Genomic Diagnostic Solution For Precision Oncology 362

14.1.27 May 23, 2012: Cold Spring Harbor Laboratory Joins Illumina Genome Network 363

14.1.28 May 22, 2012: New York Genome Center Announces Formal Commencement Of Collaborative

Relationship With Illumina 363

14.1.29 May 14, 2012: KineMed And CHDI Foundation Collaborate To Develop New Biomarkers Of

Disease Progression And To Evaluate Potential Therapeutics For Huntington’s Disease 364

14.1.30 May 07, 2012: Werfen Decides To End Beckman Coulter Hemostasis Alliance 365

14.1.31 Apr 24, 2012: Reaction Biology Opens New Protein Production Facility In US 365

14.1.32 Apr 23, 2012: Life Technologies To Build Additional $20m Cell Culture Facility In Scotland 365

14.1.33 Apr 02, 2012: CaridianBCT And Terumo Transfusion Become Terumo BCT 366

14.1.34 Mar 19, 2012: OPKO Health Expands Collaboration With Arctic Partners 366

14.1.35 Mar 12, 2012: Nelson Labs Acquires Building To Accommodate Growth 367

14.1.36 Mar 12, 2012: SAW Instruments Expands Presence In US 367

14.1.37 Mar 06, 2012: Lab21 And ITOR Launch Clinical Genomics Center In US 368

14.1.38 Mar 06, 2012: Almac Adds New Commercial Packaging Facility In Audubon, Pennsylvania 368

14.1.39 Mar 02, 2012: Rubicon Genomics Selects Velesco To Manufacture TransPLEX RNA

Amplification Kits For Clinical Diagnostic Use 369

14.1.40 Mar 01, 2012: Abbott To Build Nutrition Manufacturing Facility In Ohio 369

14.2 Research And Development 370

14.2.1 Nov 07, 2012: MJFF And NINDS Collaborate On Parkinson's Disease Biomarker Discovery

Project 370

14.2.2 Sep 19, 2012: Ten Pharmaceutical Companies Unite To Accelerate Development Of New

Medicines 371

14.2.3 Aug 15, 2012: Biogen Idec And Regulus Therapeutics Form Collaboration To Explore microRNA

Biomarkers For Disease Monitoring And Response To Therapy 372

14.2.4 Aug 15, 2012: Epic Sciences Announces Six Pharma Circulating Tumor Cell Collaborations 372

14.2.5 Apr 23, 2012: Ezose And Hirosaki University To Collaborate In Glycomics Research To Find New

Cancer Biomarkers 373





14.2.6 Apr 02, 2012: Metabolon Enters Biomarker Research Collaboration With Metabolon 373

14.2.7 Mar 20, 2012: Transgenomic And MD Anderson Collaborate On Circulating Tumor Cell Study

Using ICE COLD-PCR 374

14.2.8 Mar 14, 2012: GE Healthcare And Intel To Establish Companies’ First Joint Technology

Evaluation Laboratory In Israel 374

14.2.9 Mar 08, 2012: Covidien Opens Four Global R&D Centers To Broaden Innovation Focus And

Capabilities 375

14.2.10 Jan 12, 2012: Alere Maintains Exclusive Option To License Miraculins 375

14.2.11 Jan 09, 2012: Bayer HealthCare To Share Lab Space With Start-Up Companies 376

14.3 Legal and Regulatory 376

14.3.1 Nov 09, 2012: Novartis’s Colorado Facility Obtains Clearance From FDA Inspectors 376

14.3.2 Nov 07, 2012: Fluidigm Files Lawsuit Against NanoString For False And Misleading Advertising

Under Lanham Act 377

14.3.3 Nov 02, 2012: Enzo Awarded $49m In Trial Against Applera 377

14.3.4 Oct 22, 2012: Alere Receives FDA Warning Letter Over Weak Response To Manufacturing

Errors 377

14.3.5 Oct 18, 2012: Complete Genomics Announces Court's Favorable Ruling In Patent Litigation

Against Illumina 378

14.3.6 Oct 15, 2012: Genetic Technologies Files Patent Infringement Suits Against Multiple Alleged

Infringers In US 378

14.3.7 Oct 15, 2012: AspenBio Pharma Proposes Corporate Name Change To Venaxis 379

14.3.8 Oct 15, 2012: Fluxion Registers South San Francisco Facility As Medical Device Establishment

With FDA 379

14.3.9 Oct 11, 2012: CorMedix Announces Successful Completion Of ISO 13485 Certification Audit 379

14.3.10 Oct 04, 2012: Hologic Announces Favorable Ruling In Litigation With Becton, Dickinson 380

14.3.11 Sep 26, 2012: Abaxis Announces Settlement Of Patent Litigation With Cepheid 380

14.3.12 Sep 18, 2012: AspenBio Announces Dismissal Of Class Action And Chipman Lawsuits By US

District Court 381

14.3.13 Sep 13, 2012: Promega Announces Federal Judge Overturns Jury Verdict In Patent Rights

Case 381

14.3.14 Sep 05, 2012: RayBiotech Establishes Formal Compliance In Both Good Manufacturing And

Good Laboratory Practices 382

14.3.15 Aug 30, 2012: Genetic Technologies Files Patent Infringement Suit Against Reproductive

Genetics Institute In US 382

14.3.16 Aug 29, 2012: Illumina Announces Favorable Outcome Of Patent Litigation Against Helicos

BioSciences 383

14.3.17 Aug 23, 2012: United Drug Files Motion To Dismiss Legal Action By Catalent Pharma 383

14.3.18 Aug 20, 2012: Agendia Receives ISO Certification For Facilities In Amsterdam And Irvine 383

14.3.19 Aug 16, 2012: US Court of Appeals Upholds Myriad's Gene Patents 384

14.3.20 Aug 10, 2012: EKF Announces Settlement Agreement With HemoCue 384





14.3.21 Aug 03, 2012: Meso Scale Diagnostics Announces ISO 9001:2008 And ISO 13485:2003

Certifications 385

14.3.22 Aug 01, 2012: MDxHealth CLIA Laboratory In California Receives CAP Accreditation 385

14.3.23 Jul 30, 2012: HTG Molecular Diagnostics Achieves ISO 13485:2003 Certification 385

14.3.24 Jul 24, 2012: PerkinElmer Receives State of Connecticut Clinical Laboratory Licensure And

CLIA Certificate Of Registration For Global DNA Sequencing Services 386

14.3.25 Jul 11, 2012: FDA Issues Class I Recall On Alere Triage Diagnostic Tests 386

14.3.26 Jul 09, 2012: Siemens Receives FDA Warning Letter For Violations Of CGMP Requirements

387

14.3.27 Jul 06, 2012: Sequenom Addresses Preliminary Injunction Decision, Reaffirms Defense Of

Patent 387

14.3.28 Jun 28, 2012: Nodality Receives CLIA Certification For Clinical Laboratory 388

14.3.29 Jun 27, 2012: Excelsior Medical Retracts False Statements, Settles Case With Ivera Medical

388

14.3.30 Jun 18, 2012: Illumina Files Second Patent Infringement Suit Against Complete Genomics 389

14.3.31 Jun 12, 2012: Progenika Receives CAP Certification For Its CLIA Labs 389

14.3.32 May 18, 2012: Champions Oncology Receives CLIA Certification 389

14.3.33 May 14, 2012: Helicos Settles Its Patent Litigation Against Pacific Biosciences 390

14.3.34 May 14, 2012: Helicos Settles Patent Litigation Against Pacific Biosciences 390

14.3.35 May 10, 2012: Metabolon’s Shanghai Jiao Tong University Lab Receives Validation 390

14.3.36 Apr 30, 2012: Vermillion Resolves Non-Contingent Claims With Bio-Rad 391

14.3.37 Apr 24, 2012: FDA Notifies Class I Recall Of Roche’s Elecsys Troponin I and Elecsys Troponin

I STAT Immunoassays 391

14.3.38 Apr 23, 2012: Essential Medical Dismisses Patent Case Against Masimo And Cercacor 391

14.3.39 Mar 26, 2012: Supreme Court of the United States Remands Gene Patenting Case 391

14.3.40 Mar 15, 2012: Seahorse Bioscience’s Labware Division Achieves ISO 9001:2008 Certification

393

14.3.41 Mar 13, 2012: Roche Receives Request For Additional Information From FTC 393

14.3.42 Mar 05, 2012: Atossa Genetics' National Reference Laboratory For Breast Health Receives

CLIA Certification 393

14.3.43 Mar 01, 2012: Illumina Announces Outcome Of First Phase Of Its Patent Litigation Against

LadaTech 394

14.3.44 Mar 01, 2012: Berg Diagnostics Receives CLIA Certification And Launches New Vitamin D

Assay 394

14.3.45 Mar 01, 2012: LadaTech Announces Illumina Found To Infringe Patent 395

14.3.46 Feb 22, 2012: Sequenom Files Motion For Preliminary Injunction Against Aria Diagnostics 395

14.3.47 Feb 21, 2012: Genetic Technologies Successfully Concludes Second Patent Infringement Suit

In US 396

14.3.48 Feb 16, 2012: Illumina Announces Favorable Patent Claim Construction Ruling In Litigation

Against Complete Genomics 396

14.3.49 Feb 03, 2012: London High Court Affirms 3M Legal Victory; Awards Company Litigation Fees

And Costs 396





14.3.50 Feb 01, 2012: Foundation Medicine Receives CLIA Certification For Its Genomic Sequencing

Laboratory 397

14.4 Government and Public Interest 398

14.4.1 Nov 02, 2012: CMS Issues Final Rule On Medicare’s Payments For Physician Fees For 2013 398

14.4.2 Nov 01, 2012: Researchers Use Blood Testing To Predict Level Of Enzymes That Facilitate

Disease Progression 398

14.4.3 Oct 16, 2012: New Noninvasive Test For Colorectal Cancer Shows Promise: AACR 399

14.4.4 Oct 15, 2012: VeriStrat Predicts Response But Not Survival Benefit From Erlotinib: Study 400

14.4.5 Aug 17, 2012: LabCorp Commends CDC For Revised HCV Testing Guidelines 401

14.4.6 Aug 16, 2012: CDC Now Recommends All Baby Boomers Receive One-Time Hepatitis C Test 401

14.4.7 Aug 06, 2012: Cytomedix Announces Medicare Coverage For Autologous PRP Gel In Chronic

Wound Care 402

14.4.8 Jun 25, 2012: Loyola University Chicago Stritch School of Medicine Study Of Two Vitamin D

Tests Find Inaccurate 402

14.4.9 Jun 20, 2012: UW Research Shows New Prognosis Tool For Deadly Brain Cancer 403

14.4.10 Jun 19, 2012: Genetic Marker In Vitamin D Receptor Gene Associated With Increased

Pancreatic Cancer Survival 404

14.4.11 Jun 15, 2012: US Senator John Kerry Introduces Senate Resolution Urging Federal Support To

Improve Early Detection Of Prostate Cancer 405

14.4.12 Jun 05, 2012: Noninvasive Genetic Test For Down Syndrome And Edwards Syndrome Highly

Accurate: Study 405

14.4.13 Jun 05, 2012: Battelle Introduces Industry-First Drug Discovery CoLaborative 406

14.4.14 Jun 02, 2012: Researchers Discover DNA Marker That May Indicate Differences In Breast

Cancer 407

14.4.15 May 31, 2012: Researchers Identify Promising Biomarkers And New Therapeutic Targets For

Kidney Cancer: UC Davis 408

14.4.16 May 31, 2012: Nanotechnology Advancement Could Significantly Improve Medical Tests:

Princeton University 409

14.4.17 May 29, 2012: Researchers Discover Biomarker For Advanced Bile Duct Fibrosis And Bile Duct

Cancer: The George Washington University 410

14.4.18 May 24, 2012: New Prostate Cancer Screening Guidelines Face Tough Sell, Study Suggests

411

14.4.19 May 22, 2012: New Biomarkers Reveal Evidence Of Radiation Exposure: Medical College of

Wisconsin 412

14.4.20 May 22, 2012: Biomedical Engineers At UC Davis Develops Microfluidic Chip To Test For

Latent Tuberculosis 413

14.4.21 May 19, 2012: CDC Announces First Ever National Hepatitis Testing Day And Proposes That

All Baby Boomers Be Tested Once For Hepatitis C 414

14.4.22 May 17, 2012: Researchers From University of Florida Uses Traditional Microscope-Based

Diagnosis Method As Starting Point Against Tuberculosis 415





14.4.23 May 17, 2012: NIH-Led Study Finds Genetic Test Results Do Not Trigger Increased Use Of

Health Services 416

14.4.24 May 15, 2012: New Biomarker Test Predicts Arthritis At Much Earlier Stage: University of

Missouri-Columbia 417

14.4.25 May 15, 2012: Early Biomarker For Pancreatic Cancer Identified: University of California, San

Diego 418

14.4.26 May 15, 2012: FDA Expands Use For FilmArray Respiratory Panel 419

14.4.27 May 14, 2012: Genetic Test Identifies Eye Cancer Tumors Likely To Spread: Washington

University School of Medicine 419

14.4.28 Apr 25, 2012: New Diagnostic Tool Determines Aggressiveness Of Prostate Cancer: UCF 421

14.4.29 Apr 24, 2012: New Microdevice Enables Culture Of Rare Circulating Tumor Cells From Blood

422

14.4.30 Apr 18, 2012: Researchers Develop New Optical Imaging System For Rapid And Accurate

Diagnosis Of Malaria 423

14.4.31 Apr 17, 2012: Saliva Test Could Dramatically Increase Detection Of Oral Cancer: MSU 424

14.4.32 Apr 17, 2012: Northwestern Medicine Scientist Develops First Blood Test To Diagnose Major

Depression In Teens 425

14.4.33 Apr 16, 2012: Biosensia To Showcase Latest Diagnostic Developments At AACC Oak Ridge

Conference 426

14.4.34 Apr 09, 2012: Researchers Identify Genes That May Help In Ovarian Cancer Diagnosis And

Prognosis 426

14.4.35 Apr 06, 2012: Invasive Heart Test Being Dramatically Overused, Stanford Study Shows 427

14.4.36 Apr 05, 2012: Cleveland HeartLab’s Cardiovascular Disease Risk Testing To Be Featured At

TEDMED 2012 429

14.4.37 Apr 04, 2012: Caris Life Presents Novel Findings Regarding Biological Role Of Circulating

Microvesicles 429

14.4.38 Mar 31, 2012: Biomarker Identified In Relation To Drug Response In Refractory Urothelial

Cancer 430

14.4.39 Mar 29, 2012: Complete Genomics Accepts DNA Obtained From Saliva For Whole Human

Genome Sequencing 430

14.4.40 Mar 27, 2012: Siemens Showcases Broad Portfolio Of Infectious Disease Testing Capabilities

At ECCMID 2012 431

14.4.41 Mar 20, 2012: Study Shows Colorectal Cancer Screening Rates High In Patients With Multiple

Health Problems 432

14.4.42 Mar 16, 2012: FDA Proposes Lower Risk Classification For Certain Tuberculosis Tests 433

14.4.43 Mar 16, 2012: Inflammatory Biomarkers Improve Clinical Prediction Of Mortality In COPD 433

14.4.44 Mar 15, 2012: New Professional Guidelines Recognize Benefit Of Genotyping HPV 16 And 18

For Cervical Cancer Prevention By Assessing Individual Patient Risk: Roche 434

14.4.45 Mar 15, 2012: QIAGEN Welcomes US Guideline Changes To Recommend HPV Testing As

Part Of Cervical Cancer Screening 435

14.4.46 Mar 14, 2012: Study Suggests Link Between Helicobacter pylori Bacteria And Adult Type 2

Diabetes 436





14.4.47 Mar 14, 2012: Predictive Biosciences To Present At GTCbio Oncology Biomarkers Conference

437

14.4.48 Mar 05, 2012: Pall Life Sciences Showcases Innovative Syringe Filter At Pittcon Conference

437

14.4.49 Feb 29, 2012: Cleveland Clinic Children's Hospital Launches Study To Genetically Test For

Autism 438

14.4.50 Feb 27, 2012: New Research Study Could Lead To More Timely Diagnosis And Aid Clinical

Management During Flu Season 439

14.4.51 Feb 04, 2012: Henry Ford Hospital Researchers Identity Potential Biomarker For Osteoarthritis

440

14.4.52 Feb 02, 2012: Scripps Research Scientists Demonstrate Effective New 'Biopsy In A Blood Test'

To Detect Cancer 441

14.4.53 Feb 02, 2012: Study Shows An Investigational Urine Test Can Predict High-Risk Prostate

Cancer In Men Who Choose ‘Watchful Waiting’ 442

14.4.54 Feb 02, 2012: New Research Confirms Need For Lung Cancer Testing: UCCC 443

14.4.55 Feb 01, 2012: Blood Test Accurately Distinguishes Depressed Patients From Healthy Controls:

MGH 444

14.5 Product News 445

14.5.1 Nov 13, 2012: Nanosphere Receives FDA Clearance To Market Test For Detection Of CYP2C19

Mutations Affecting Drug Metabolism 445

14.5.2 Nov 12, 2012: CardioDx To Present Corus CAD At Lazard Capital Markets And Piper Jaffray

Investor Conferences 446

14.5.3 Nov 09, 2012: Natera’s Non-Invasive Prenatal Testing Technology Shows Unparalleled

Specificity, Sensitivity In Clinical Data Presented At American Society of Human Genetics 446

14.5.4 Nov 08, 2012: Cytomedix Receives FDA 510(K) Clearance For Angel cPRP System For

Processing Blood And Bone Marrow Aspirate 447

14.5.5 Nov 08, 2012: CardioDx Announces New Data Supporting Clinical Utility And Validity Of Corus

CAD At American Heart Association Scientific Sessions 2012 448

14.5.6 Nov 08, 2012: Diazyme Receives FDA 510(k) Clearance For Cystatin C POC Test Kit On Smart

Point of Care System 449

14.5.7 Nov 07, 2012: Life Technologies Announces Next-Gen Digital PCR Instrument Designed For

Widespread Adoption 449

14.5.8 Nov 07, 2012: Caris Life Sciences Selects Illumina’s MiSeq System To Enable Next-Generation

Sequencing As Part Of Its Molecular Profiling Service 450

14.5.9 Nov 06, 2012: IntegenX Announces Commercial Introduction Of mRNA Library Preparation Kit

For Next Generation Sequencing 451

14.5.10 Nov 06, 2012: Affymetrix Introduces Axiom miRNA Target Site Genotyping Arrays 451

14.5.11 Nov 06, 2012: Verinata Health's verifi Prenatal Test Expanded To Include Most Common Sex

Chromosome Abnormalities 452

14.5.12 Nov 05, 2012: Atherotech’s VAP Lipid Panel Helps Predict Heart Attack Risk And Improved

Outcomes In African Americans 453





14.5.13 Nov 05, 2012: Ariosa Diagnostics To Present Clinical Data On Harmony Prenatal Test At

ASHG Annual Meeting 453

14.5.14 Nov 01, 2012: Affymetrix Introduces Axiom Biobank Arrays For Genotyping Studies 454

14.5.15 Oct 29, 2012: CardioDx Announces Clinical And Scientific Presentations At American Heart

Association Scientific Sessions 2012 455

14.5.16 Oct 25, 2012: Verinata Health Files Patent Infringement Action Against Ariosa And LabCorp 456

14.5.17 Oct 24, 2012: Atherotech’s VAP Lipid Panel Is Highlighted In Scientific Presentations At 2012

American Heart Association Scientific Sessions 457

14.5.18 Oct 24, 2012: Verinata Health Announces Presentations Of Its Verifi Prenatal Test At National

Society Of Genetic Counselors Conference 457

14.5.19 Oct 23, 2012: Cytonics Receives Notice Of Allowance For Patent Related To FACT Diagnostic

For Back And Joint Pain 458

14.5.20 Oct 22, 2012: Prometheus Presents Five Abstracts Of Prometheus Anser IFX Assay At ACG

2012 Scientific Meeting 459

14.5.21 Oct 18, 2012: HTG Molecular To Unveil Edge System At AMP Conference 460

14.5.22 Oct 12, 2012: SQI Diagnostics To Launch SQiDlite Multiplexing System At AAPS 460

14.5.23 Oct 11, 2012: Akonni Biosystems To Present Results Of Its Work To Develop TruTip

Automated Solution For Extracting Cell-Free DNA From Maternal Plasma At ASHG Conference 461

14.5.24 Oct 11, 2012: BD Veritor System For Rapid Detection Of RSV Receives FDA 510(k) Clearance

For Nasopharyngeal Wash, Aspirate And Swab In Transport Media Specimens 461

14.5.25 Oct 10, 2012: Myriad's HRD Score Detects Loss Of DNA Repair Function In Ovarian Cancer

462

14.5.26 Oct 09, 2012: Focus Diagnostics And 3M Launch FDA-Cleared Simplexa Test On 3M Cycler

For Molecular Influenza And Respiratory Virus Testing By Moderate Complexity Healthcare Facilities 462

14.5.27 Oct 09, 2012: OraSure Announces Availability Of OraQuick In-Home HIV Test To Consumers

Across US 463

14.5.28 Oct 03, 2012: Roche Announces Availability Of Cobas TaqMan HIV-1 Test v2.0 In US 464

14.5.29 Oct 03, 2012: BD Diagnostics Receives 510(k) FDA Clearance For Nasopharyngeal Wash,

Aspirate And Swab In Transport Media Specimens On BD Veritor System For Rapid Detection Of RSV 464

14.5.30 Oct 01, 2012: Inform Genomics Announces Positive Top-Line Results In First Phase Of

Development For Onpart Personalized Medicine Product 465

14.5.31 Oct 01, 2012: IntegenX Announces Commercial Availability Of RapidHIT 200 System In US 466

14.5.32 Oct 01, 2012: Micronics Announces Commercial Launch Of ABORhCard 467

14.5.33 Sep 27, 2012: Life Technologies Receives FDA Clearance For OpTmizer CTS T-Cell

Expansion Tissue Culture Medium 467

14.5.34 Sep 26, 2012: PrimeraDx Receives National Cancer Institute Grant To Develop B-Cell

Lymphoma Panel On ICEPlex System 468

14.5.35 Sep 25, 2012: Gynecor Adds New Cervical Cancer LAB Technology To Help Physicians

Identify Patients At Risk For Cervical Cancer, Improve Treatment Decisions 469

14.5.36 Sep 25, 2012: Genetic Technologies Announces BREVAGen Attains Clearance For Sale Into

Florida 469





14.5.37 Sep 25, 2012: NanoString Launches Single Cell Gene Expression Solution For nCounter

Analysis System 470

14.5.38 Sep 24, 2012: Study At Columbia University Using Daxor's Blood Volume Analyzer

Demonstrates Hidden Polycythemia In Heart Failure Patients 471

14.5.39 Sep 24, 2012: BD Diagnostics Receives FDA 510(k) Clearance For Nasopharyngeal Wash,

Aspirate And Swab In Transport Media Specimens On BD Veritor System For Rapid Detection Of Flu A +

B 471

14.5.40 Sep 24, 2012: Ariosa Diagnostics Announces Publication Of Clinical Study On Non-invasive

Prenatal Testing For Fetal Trisomy 13 With Harmony Prenatal Test 472

14.5.41 Sep 18, 2012: Fyodor Biotechnologies Receives Phase II SBIR Grant To Develop Broad Urine-

Based Diagnostic Test For Malaria 472

14.5.42 Sep 17, 2012: LipoScience Announces Publication Of Results From Clinical Study In American

Journal of Cardiology 473

14.5.43 Sep 17, 2012: Roche Announces Commercial Availability Of Cobas AmpliPrep/Cobas TaqMan

CMV Test In US 474

14.5.44 Sep 12, 2012: GenMark Diagnostics Receives FDA Clearance For eSensor RVP Test 474

14.5.45 Sep 11, 2012: Cytomedix To Highlight AutoloGel System In Multiple Poster Presentations At

SAWC Fall 2012 475

14.5.46 Sep 06, 2012: PTS Signs Agreement To Provide Point-of-Care Lipid Testing To Life Line

Screening 476

14.5.47 Sep 06, 2012: Polymer Technology Signs Agreement With Life Line Screening To Supply

CardioChek PA Test System 476

14.5.48 Sep 05, 2012: BioReliance To Launch Reconstructed Skin Micronucleus Assay 477

14.5.49 Sep 05, 2012: Cytomedix To Present AutoloGel System In Two Presentations At 4th Congress

Of WUWHS 2012 In Japan 477

14.5.50 Sep 05, 2012: Ariosa Diagnostics Reports Publication Of Clinical Utility Of Harmony Prenatal

Test In General Screening Population 478

14.5.51 Sep 05, 2012: LipoScience Receives FDA Clearance For Vantera Clinical Analyzer 479

14.5.52 Sep 04, 2012: Transgenomic And NYU Collaborate On Lung Cancer Study Using Ice Cold-

PCR For Blood-Based Mutation Detection 480

14.5.53 Aug 29, 2012: Siemens Unveils New Assay For Specific And Stable Free Protein S Antigen

Testing 481

14.5.54 Aug 16, 2012: AWDT Launches ACE Axcel Clinical Chemistry System 481

14.5.55 Aug 14, 2012: Beckman Coulter Announces Publication Of Positive Study Results In Journal of

The American College of Cardiology Distinguish PAPP-A From Other New Cardiovascular Biomarkers 482

14.5.56 Aug 14, 2012: CardioDx To Present Corus CAD At Wedbush PacGrow Life Sciences

Management Access Conference 483

14.5.57 Aug 14, 2012: California Schools VEBA Implements Pathway Fit Nutrigenetic Test For Weight-

Loss 483

14.5.58 Aug 10, 2012: Miraculins To Receive $0.13m Grant For PreVu From Province of Manitoba 484

14.5.59 Aug 09, 2012: Veridex Reports Updated Coding And Payment On Horizon For Circulating

Tumor Cell Testing 485





14.5.60 Aug 08, 2012: CardioDx Announces Medicare Coverage For Corus CAD Gene Expression

Test For Diagnosis Of Obstructive Coronary Artery Disease 485

14.5.61 Aug 07, 2012: LabCorp Completes And Publishes Clinical Study For Development And

Validation Of PCR Assay For Bacterial Vaginosis 486

14.5.62 Aug 07, 2012: AspenBio Pharma Submits Pre-IDE Information Package To FDA For

AppyScore Appendicitis Test System 487

14.5.63 Aug 07, 2012: Aeterna Zentaris Granted US Patent For AEZS-130 As Diagnostic Test For

Adult Growth Hormone Deficiency 487

14.5.64 Aug 06, 2012: SWOG Selects Sequenta’s LymphoSIGHT Platform For Use In 180-Patient

Mantle Cell Lymphoma Clinical Trial 488

14.5.65 Aug 06, 2012: University of Michigan Informs Interleukin Genetics Of Study Results Using PST

Genetic Test In Determining Frequency Of Dental Cleanings 488

14.5.66 Aug 06, 2012: Cytomedix Announces Medicare Coverage For Autologous PRP Gel In Chronic

Wound Care 489

14.5.67 Aug 03, 2012: Daxor Announces Sale Of BVA-100 Blood Volume Analyzer To Hospital Located

In Arizona 490

14.5.68 Aug 02, 2012: Idaho Technology Provides FilmArray Clinical Diagnostic Pipeline Update 490

14.5.69 Aug 01, 2012: AspenBio Pharma Enhances Product Development And Manufacturing

Capabilities In Preparation For Clinical Trial And Commercialization Of AppyScore 491

14.5.70 Jul 31, 2012: CardioDx’s Corus CAD Gene Expression Test Performs Equally Well In Both

Women And Men for Assessment Of Obstructive Coronary Artery Disease: New Study 492

14.5.71 Jul 31, 2012: New York Genome Center Purchases Four Ion Proton Sequencers For Its New

Innovation Center 493

14.5.72 Jul 31, 2012: Prometheus Launches PROMETHEUS Anser IFX To Help Guide Inflammatory

Bowel Disease Management 494

14.5.73 Jul 30, 2012: MolecularMD Submits PMA Application To FDA For BCR-ABL T315I Mutation

Test 494

14.5.74 Jul 30, 2012: 23andMe Submits First Round Of FDA 510(k) Documentation To FDA 495

14.5.75 Jul 26, 2012: RainDance Technologies Launches First Access Program For RainDrop Digital

PCR System 496

14.5.76 Jul 25, 2012: Cepheid Announces Release Of Updated Xpert BCR-ABL Monitor Test 497

14.5.77 Jul 24, 2012: Genalyte Launches Maverick ENA 4 Assay Kit 497

14.5.78 Jul 24, 2012: Ariosa Diagnostics Completes Clinical Study Of Harmony Prenatal Test On

General Pregnant Patient Population 498

14.5.79 Jul 19, 2012: CBLPath Launches NRAS Gene Mutation Analysis Assay 499

14.5.80 Jul 19, 2012: T2 Biosystems Announces Data Presentation On T2Hemostasis At American

Association for Clinical Chemistry Annual Meeting 499

14.5.81 Jul 18, 2012: Daxor Announces Placement Of BVA-100 Blood Volume Analyzer At New York

Presbyterian/Weill Cornell Medical Center 500

14.5.82 Jul 17, 2012: Beckman Coulter’s New AU5800 System Featured At 2012 AACC/ASCLS Annual

Meeting And Clinical Lab Expo 500





14.5.83 Jul 17, 2012: Idaho Technology Initiates Clinical Study For FilmArray Blood Culture

Identification Panel 501

14.5.84 Jul 17, 2012: BD Receives FDA 510(k) Clearance For BD BACTEC Plus Aerobic/F Blood

Culture Plastic Bottles 501

14.5.85 Jul 16, 2012: Roche Introduces Mobile Blood Gas Analyzer For Hospital Point Of Care 502

14.5.86 Jul 16, 2012: Metabolon To Showcase Quantose Test At AACC Clinical Lab Expo 502

14.5.87 Jul 12, 2012: Daxor Announces Placement Of BVA-100 Blood Volume Analyzer At North

Alabama Radiopharmacy 503

14.5.88 Jul 11, 2012: Idaho Technology To Present At 2012 AACC Annual Meeting 503

14.5.89 Jul 11, 2012: Courtagen Releases nucSEEKPDx 504

14.5.90 Jul 09, 2012: Genomic Health Releases Results Of Oncotype DX Breast Cancer Test 504

14.5.91 Jul 09, 2012: SurModics IVD To Launch BioFX TMBX At AACC In Los Angeles 505

14.5.92 Jul 06, 2012: QIAGEN Receives FDA Approval Of Therascreen KRAS RGQ PCR Kit For

Colorectal Cancer 505

14.5.93 Jul 06, 2012: Court Denies Preliminary Injunction Motion Against Ariosa Diagnostics 506

14.5.94 Jul 03, 2012: OraSure Receives FDA Clearance For Its OraQuick In-Home HIV Test 507

14.5.95 Jul 02, 2012: Roche Receives FDA Approval For COBAS TaqMan HIV-1 Test 507

14.5.96 Jul 02, 2012: Verinata Health Expands verifi Prenatal Test To Include Turner Syndrome Option

508

14.5.97 Jul 02, 2012: Seegene To Introduce Real-Time Multiple Mutation Detection Technology For

Drug Resistant Mutations In M. tuberculosis At AACC 2012 508

14.5.98 Jun 28, 2012: Abaxis Enters Into Definitive Agreement To Deliver 300 Piccolo Xpress

Instruments For Four-Year Drug Clinical Trial 509

14.5.99 Jun 28, 2012: IBM Recommends Strategy To Help Improve Cervical Cancer Screening And

Treatment In Kenya 510

14.5.100 Jun 27, 2012: OraSure Supports Rapid HIV Testing Initiatives In Recognition Of 18th Annual

National HIV Testing Day 511

14.5.101 Jun 26, 2012: BIT Companies And DRG Diagnostics To Unveil DRG:HYBRID XL Analyzer 511

14.5.102 Jun 23, 2012: BD Biosciences Launches BD FACSJazz Cell Sorting System 512

14.5.103 Jun 23, 2012: Quantimetrix Launches Complete D 25-OH Vitamin D Control 513

14.5.104 Jun 22, 2012: Accelr8 Presents Study Results For BAC-Xtrax At ASM 2012 513

14.5.105 Jun 22, 2012: Accelr8 Presents Study Results For BACcel Rapid Diagnostic System At ASM

2012 And Receives Acceptance To Present New Blood Study 513

14.5.106 Jun 21, 2012: Siemens Launches Enzygnost Anti-HCV 4.0 Assay 513

14.5.107 Jun 21, 2012: Daxor Announces Placement Of Three BVA-100 Blood Volume Analyzers 514

14.5.108 Jun 20, 2012: BioRealm Secures SBIR Contract To Develop Smokescreen For Tobacco

Addiction 514

14.5.109 Jun 11, 2012: Metabolon’s Quantose IR Test Featured In Five Poster Presentations At 2012

American Diabetes Association Meeting 515

14.5.110 Jun 08, 2012: Cytomedix To Present Multiple Poster Presentations On AutoloGel System At

44th Annual Conference Of WOCN 515





14.5.111 Jun 07, 2012: QuantRx Biomedical Provides Corporate Update: Focused On Diagnostics And

Feminine Hygiene Segments 516

14.5.112 Jun 07, 2012: Chembio Files PMA Final Module With FDA For DPP HIV 1/2 Assay 517

14.5.113 Jun 05, 2012: Transgenomic Launches ICE COLD-PCR Kit At 2012 ASCO Annual Meeting 518

14.5.114 Jun 05, 2012: Prospective Study Shows Favorable Overall Survival In Cancer Of Unknown

Primary Patients With Therapy Directed By bioTheranostics' CancerTYPE ID 519

14.5.115 Jun 04, 2012: Quantimetrix Introduces Dropper A1c Diabetes Control 519

14.5.116 Jun 04, 2012: Ariosa Diagnostics Completes First Large Cohort Validation Study On Non-

invasive Prenatal Testing For Fetal Trisomy Detection Using Harmony Prenatal Test 520

14.5.117 Jun 01, 2012: NLA Abstracts Examine Clinical Utility Of Atherotech’s VAP Lipid Panel In Type

2 Diabetes Treatment, Heart Disease Risk Assessment 520

14.5.118 Jun 01, 2012: ScotlandsDNA Selects DNA Genotek’s Oragene•DNA Kit For Ancestry Testing

521

14.5.119 Jun 01, 2012: bioTheranostics’ CancerTYPE ID Shows High Accuracy In A Multi-Site Validation

Study And Improved Performance Compared With Standard Of Care In Metastatic Tumor Diagnosis 522

14.5.120 Jun 01, 2012: LipoScience Announces Study Results Of LDL Particle Levels Using NMR

LipoProfile Test 523

14.5.121 May 31, 2012: Pathwork Diagnostics To Present Three Studies At ASCO Annual Meeting 524

14.5.122 May 31, 2012: Illumina Introduces Nextera XT DNA Sample Preparation Kit 525

14.5.123 May 31, 2012: Verinata Health Announces Introduction Of verifi Prenatal Test 526

14.5.124 May 31, 2012: CardioDx To Present Corus CAD At Jefferies 2012 Global Healthcare

Conference 527

14.5.125 May 30, 2012: Response Genetics Announces Presentation Of Lung Cancer Study Results At

2012 ASCO Annual Meeting 527

14.5.126 May 30, 2012: Biocept To Present Clinical Findings On Circulating Tumor Cells At ASCO

Annual Meeting 528

14.5.127 May 29, 2012: Sequenom Reports Recently Released Publication On Sequenom Massarray

Research Use System 529

14.5.128 May 29, 2012: Corgenix Announces Issuance Of Additional US Patent For AspirinWorks (11-

dehydro Thromboxane B2) Test 530

14.5.129 May 29, 2012: Siemens Receives FDA Warning Letter Regarding AD VIA Centaur iPTH

Immunoassay 530

14.5.130 May 24, 2012: Cepheid Receives FDA Clearance For GeneXpert Infinity-80 System For Initial

Use With Xpert Flu Assay 530

14.5.131 May 24, 2012: True Diagnostics Receives CE Mark For TrueDX Platform And TSH Test 531

14.5.132 May 23, 2012: Lucigen Corporation Receives $2.8m SBIR Grant From NIH For Lucigen

Influenza A, B & RSV test 531

14.5.133 May 21, 2012: HistoRx Announces Application Of AQUA Technology To Assessment Of

Messenger RNA In Tissue 532

14.5.134 May 21, 2012: Transgenomic Announces CE IVD Mark For WAVE MCE System 533

14.5.135 May 18, 2012: OraSure Technologies Issues Statement On CDC Proposed Draft Guidelines

For Testing Of Baby Boomers For Hepatitis C 533





14.5.136 May 18, 2012: Siemens Receives FDA Clearance For RAPIDPoint 500 System - Lactate Assay

534

14.5.137 May 18, 2012: Siemens Receives CE Mark Approval For RAPIDPoint 500 System - Pleural

Fluid pH Testing 534

14.5.138 May 18, 2012: Sequenom Announces Publication Of Clinical Study Results Using CMM's

MaterniT21 PLUS LDT 535

14.5.139 May 16, 2012: NanoString Initiates Second Clinical Validation Study For PAM50-Based Breast

Cancer Assay 536

14.5.140 May 15, 2012: OraSure’s OraQuick In-Home HIV Test Receives Unanimous Positive

Recommendation From FDA Advisory Committee 536

14.5.141 May 15, 2012: Idaho Technology Receives FDA 510(k) Clearance For Expanded FilmArray

Respiratory Panel 537

14.5.142 May 14, 2012: EMD Millipore's Muse Cell Analyzer Wins Red Dot Design Award 2012 538

14.5.143 May 09, 2012: Sequenom Signs Agreement With Coventry Health Care National Network For

CMM MaterniT21 PLUS LDT 538

14.5.144 May 07, 2012: CardioDx To Present Results From Two Studies Evaluating Clinical Utility Of

Corus CAD Gene Expression Test For Obstructive Coronary Artery Disease 539

14.5.145 May 07, 2012: Ariosa Diagnostics Announces Nationwide Launch Of Harmony Prenatal Test

Through LabCorp 539

14.5.146 May 02, 2012: Trovagene Announces Plans To Develop New Test For High Risk HPV Carrier

Screening From Urine 540

14.5.147 May 01, 2012: Singulex Adds Erenna Interleuken -17A/F To Suite Of TH17 Pathway

Immunoassay Kits 541

15 Appendix 542

15.1 Definitions of Markets Covered in the Report 543

15.1.1 In Vitro Diagnostics 543

15.2 Research Methodology 554

15.3 Secondary Research 554

15.4 Primary Research 555

15.5 Models 555

15.6 Forecasts 556

15.7 Expert Panels 556

15.8 GlobalData Consulting 556





15.9 Disclaimer 556

1.1 List of Tables

Table 1: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, 2004-2018 ..................................... 36

Table 2: In Vitro Diagnostics Market, United States, Category Contribution (%), 2011 ....................................................... 38

Table 3: In Vitro Diagnostics Market, United States, Cross-Category Analysis, 2004-2018 ............................................... 40

Table 4: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Historic, 2004-2011 ...................... 42

Table 5: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Forecast, 2011-2018 ................... 44

Table 6: In Vitro Diagnostics, United States, Company Share by Revenue ($m), USD Constant, 2010-2011................ 46

Table 7: Clinical Chemistry Market, United States, Segment Contribution (%), 2011 .......................................................... 49

Table 8: Clinical Chemistry, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ............... 51

Table 9: Clinical Chemistry, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ............. 53

Table 10: Clinical Chemisty Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .................................................................................................................................................................................................. 55

Table 11: Clinical Chemisty Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018........................................................................................................................................................................................ 57

Table 12: Urine Analysis, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ........... 59

Table 13: Urine Analysis, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ......... 61

Table 14: Clinical Chemistry, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ............. 62

Table 15: Clinical Chemistry, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 ................ 63

Table 16: Genetic Testing Market, United States, Segment Contribution (%), 2011 ............................................................ 66

Table 17: Genetic Testing, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ................. 68

Table 18: Genetic Testing, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ............... 70

Table 19: Genetic Testing, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ................. 71

Table 20: Genetic Testing, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 .................... 73

Table 21: Haematology Market, United States, Segment Contribution (%), 2011 ................................................................ 76

Table 22: Haematology, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ...................... 78

Table 23: Haematology, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ................... 80

Table 24: Haematology Reagents, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .................................................................................................................................................................................................. 82

Table 25: Haematology Reagents, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 .................................................................................................................................................................................................. 84

Table 26: Immunohaematology, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-201186

Table 27: Immunohaematology, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ........................................................................................................................................................................................................... 88

Table 28: Haemostasis, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ............. 90

Table 29: Haemostasis, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ........... 92

Table 30: Haematology Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .................................................................................................................................................................................................. 94





Table 31: Haematology Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 .................................................................................................................................................................................................. 96

Table 32: Haematology Cell Counters, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .................................................................................................................................................................................................. 98

Table 33: Haematology Cell Counters, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018...................................................................................................................................................................................... 100

Table 34: Haematology, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ................... 101

Table 35: Haematology, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 ...................... 103

Table 36: Histology And Cytology Market, United States, Segment Contribution (%), 2011 ............................................ 106

Table 37: Histology And Cytology, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011.. 108

Table 38: Histology And Cytology, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 110

Table 39: Histology And Cytology, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 . 111

Table 40: Histology And Cytology, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 .... 113

Table 41: Immuno Chemistry Market, United States, Segment Contribution (%), 2011 .................................................... 116

Table 42: Immuno Chemistry, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ......... 118

Table 43: Immuno Chemistry, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ....... 120

Table 44: Disease Specific Immunochemistry, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ...................................................................................................................................................................... 122

Table 45: Disease Specific Immunochemistry, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................... 124

Table 46: Drugs of Abuse / Toxicology, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ................................................................................................................................................................................................ 126

Table 47: Drugs of Abuse / Toxicology, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018...................................................................................................................................................................................... 128

Table 48: Endocrinology Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ......................................................................................................................................................................................................... 130

Table 49: Endocrinology Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ......................................................................................................................................................................................................... 132

Table 50: Immunochemistry Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011...................................................................................................................................................................................... 134

Table 51: Immunochemistry Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018...................................................................................................................................................................................... 136

Table 52: Therapeutic Drug Monitoring, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011...................................................................................................................................................................................... 138

Table 53: Therapeutic Drug Monitoring, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018...................................................................................................................................................................................... 140

Table 54: Immunochemistry Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ................................................................................................................................................................................................ 142

Table 55: Immunochemistry Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018...................................................................................................................................................................................... 144

Table 56: Immuno Chemistry, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ......... 145

Table 57: Immuno Chemistry, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 ............ 147

Table 58: Infectious Immunology Market, United States, Segment Contribution (%), 2011 ............................................. 149

Table 59: Infectious Immunology, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ... 151





Table 60: Infectious Immunology, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 . 153

Table 61: Infectious Immunology Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ...................................................................................................................................................................... 155

Table 62: Infectious Immunology Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................... 157

Table 63: Infectious Immunology, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ... 158

Table 64: Infectious Immunology, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 ...... 160

Table 65: Microbiology Culture Market, United States, Segment Contribution (%), 2011 ................................................. 163

Table 66: Microbiology Culture, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011....... 165

Table 67: Microbiology Culture, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 .... 167

Table 68: Microbiology Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ......................................................................................................................................................................................................... 169

Table 69: Microbiology Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................................................ 171

Table 70: Microbiology Culture, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ...... 172

Table 71: Microbiology Culture, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 ......... 174

Table 72: Clinical Chemisty Market Pipeline Products .............................................................................................................. 191

Table 73: Immuno Chemistry Market Pipeline Products ........................................................................................................... 198

Table 74: Haematology Market Pipeline Products ..................................................................................................................... 209

Table 75: Infectious Immunology Market Pipeline Products ..................................................................................................... 211

Table 76: Microbiology Culture Market Pipeline Products ........................................................................................................ 218

Table 77: Histology And Cytology Market Pipeline Products ................................................................................................... 219

Table 78: Genetic Testing Market Pipeline Products ................................................................................................................. 220

Table 79: ERBA Diagnostics Acquires Drew Scientific, Maker Of Analytical Instruments And Reagents, For $6.5 Million ............................................................................................................................................................................................. 225

Table 80: Measurement Specialties Acquires Cambridge Technologies And Resistance Temperature Detector Company For $18.8 Million ........................................................................................................................................................ 227

Table 81: Atossa Genetics Acquires Acueity Healthcare, Diagnostic Device Provider ...................................................... 228

Table 82: AccelPath Acquires DigiPath Solutions For $2.4 Million ........................................................................................ 229

Table 83: Danaher Completes Acquisition Of 91.6% Stake In Iris International, Diagnostic Test Maker, For $324 Million ............................................................................................................................................................................................. 230

Table 84: Charles River Labs Acquires Accugenix, Provider Of Microbe Identification Services, For $17 Million ....... 232

Table 85: Leica Biosystems Completes Acquisition Of Aperio Technologies ...................................................................... 233

Table 86: Metabolon Acquires Lipomics Technologies, Diagnostics Company .................................................................. 235

Table 87: Waters Acquires Blue Reference, Maker Of Application Scientific Databases, For $14 Million .................... 237

Table 88: Life Technologies Acquires Pinpoint Genomics, Molecular Diagnostics Company .......................................... 238

Table 89: Thermo Fisher Scientific Completes Acquisition Of One Lambda, Transplant Diagnostics Company, For $925 Million ................................................................................................................................................................................... 239

Table 90: Life Technologies Acquires Navigenics ..................................................................................................................... 241

Table 91: Genova Diagnostics Acquires Metametrix, Clinical Laboratory ............................................................................ 243

Table 92: Luminex To Acquire GenturaDx, Molecular Diagnostics Company, For $50 Million ........................................ 244

Table 93: Systagenix Acquires O2 Insights ................................................................................................................................ 246





Table 94: LabCorp Completes Acquisition Of Medtox Scientific For $241 Million .............................................................. 247

Table 95: Flagship Biosciences Acquires Ihctech, Provider Of Research Immunohistochemistry And Histology Services ......................................................................................................................................................................................... 249

Table 96: Halo Healthcare Acquires NeoMatrix, Maker Of Diagnostic Equipments ........................................................... 250

Table 97: Qiagen Acquires AmniSure International, Manufacturer Of Non Invasive Test Solutions ............................... 251

Table 98: Hologic Completes Acquisition Of Gen-Probe For $3.7 Billion ............................................................................. 252

Table 99: Haemonetics To Acquire Hemerus Medical, Provider Of Leukoreduction Technologies, For $27 Million .... 254

Table 100: IntegenX Acquires SV, Provider Of DNA Identification Consumable Products, From GE Healthcare Bio-Sciences ........................................................................................................................................................................................ 255

Table 101: DioGenix Enters Into Agreement With Fast Forward To Develop New Blood Test For Multiple Sclerosis 256

Table 102: GNS Healthcare Enters Into Agreement With Dana-Farber Cancer Institute and Mount Sinai School of Medicine ......................................................................................................................................................................................... 257

Table 103: Crown Bioscience Enters Into Co-Development Agreement With Horizon Discovery ................................... 259

Table 104: CombiMatrix Enters Into Co-Marketing Agreement With Pathology For Prenatal Tests ............................... 260

Table 105: Clinical Genomics Enters Into Licensing Agreement With Quest Diagnostics For Colon Cancer Markers 261

Table 106: Abaxis Enters Into Distribution Agreement With Abbott Point of Care For Piccolo Blood Chemistry System ......................................................................................................................................................................................................... 262

Table 107: Malvern Instruments Enters Into Co-Marketing Agreement With Affinity Biosensors For Archimedes Particle Metrology System .......................................................................................................................................................... 263

Table 108: Exosome Diagnostics Enters Into Co-Development Agreement With Promega For Urine Clinical Sample Concentrator Kit ............................................................................................................................................................................ 264

Table 109: Agenix Enters Into Licensing Agreement With Tyrian Diagnostics For DiagnostIQ ....................................... 265

Table 110: Ezose Enters Into Co-Development Agreement With Fast Forward For Multiple Sclerosis Biomarkers .... 266

Table 111: BioDot Enters Into Co-Marketing Agreement With JOT Automation ................................................................. 267

Table 112: Sequella Enters Into Licensing Agreement With LabCorp For B-Smart Technology ..................................... 268

Table 113: LifeTech Scientific, DiNova Venture Partners, Themes Investment Partners And Broncus Technologies Partner To Form Broncus Medical ............................................................................................................................................ 269

Table 114: Van Andel Institute Enters Into Co-Development Agreement With Emory University .................................... 270

Table 115: Merck Serono Enters Into Co-Development Agreement With Auxogyn For Early Embryo Viability Assessment Test .......................................................................................................................................................................... 271

Table 116: PGXL Labs Enters Into Joint Venture Agreement With Essential Molecular Testing ..................................... 272

Table 117: Broad Institute Enters Into Distribution Agreement With Appistry For Genome Analysis Toolkit ................. 273

Table 118: Thermo Fisher Enters Into Co-Development Agreement With Immundiagnostik ........................................... 274

Table 119: Sage Labs Enters Into Agreement With Ekam Imaging To Develop Imaging Assays ................................... 275

Table 120: Bruker Enters Into An Agreement With Nextval For High-throughput Screening Technology ...................... 276

Table 121: BD Diagnostic Systems Enters Into Agreement With Lab21 To Develop New Oncology Assays ............... 277

Table 122: RainDance Technologies Enters Into Co-Development Agreement With Integrated DNA Technologies For Digital PCR .................................................................................................................................................................................... 278

Table 123: Amarantus BioSciences Enters Into Option For Licensing Agreement With Memory Dx For LymPro Blood Test ................................................................................................................................................................................................. 279

Table 124: Iverson Genetic Diagnostics Enters Into Licensing Agreement With Johns Hopkins University School For Molecular Diagnostic Tests ........................................................................................................................................................ 280





Table 125: Rosetta Genomics Amends Co-Marketing Agreement With Precision Therapeutics For miRview mets2 Assays ............................................................................................................................................................................................ 281

Table 126: Mitomics Enters Into Co-Marketing Agreement With LabCorp For Prostate Core Mitomic Test .................. 282

Table 127: Trillium Diagnostics Enters Into Licensing Agreement With Leukocare For Sepsis Dx ................................. 283

Table 128: Foundation Medicine Enters Into Agreement With Eisai For Genomic Profiling And Diagnostic Discovery ......................................................................................................................................................................................................... 284

Table 129: Vela Diagnostics Enters Into Licensing Agreement With Life Technologies .................................................... 285

Table 130: Augurex Life Sciences Enters Into Licensing Agreement With Quest Diagnostics For 14-3-3n Biomarker ......................................................................................................................................................................................................... 286

Table 131: CellaVision Enters Into Distribution Agreement With Siemens Healthcare For Digital Microscopy Hematology Solutions ................................................................................................................................................................. 287

Table 132: Ingenuity Systems Enters Into Co-Development Agreement With Life Technologies For Diagnostic Solutions ........................................................................................................................................................................................ 288

Table 133: Med BioGene Amends Licensing Agreement With Precision Therapeutics For LungExpress Dx Test ..... 290

Table 134: Genia Technologies Enters Into Co-Development Agreement With Columbia University And Harvard University ....................................................................................................................................................................................... 292

Table 135: NextBio Enters Into Agreement With Winship Cancer Institute of Emory University For Myeloma Biomarkers .................................................................................................................................................................................... 294

Table 136: Ovizio Imaging Systems Enters Into Distribution Agreement With Applikon Biotechnology ......................... 295

Table 137: Atossa Enters Into Co-Marketing Agreement With Diagnostics Test Group For MASCT System ............... 296

Table 138: Genalyte Partners Scienion To Provide Sciflexarrayer Dispensers For Maverick Detection Platform ........ 297

Table 139: CML HealthCare Enters Into Agreement With MaRS Innovation ....................................................................... 298

Table 140: Life Technologies Enters Into Agreement With Bristol-Myers Squibb For Companion Diagnostics Development ................................................................................................................................................................................. 299

Table 141: Agilent Technologies Enters Into Co-Marketing Agreement With Molecular Discovery ................................ 300

Table 142: Agilent Technologies Enters Into Co-Marketing Agreement With MRM Proteomics ...................................... 301

Table 143: Castle Biosciences Enters Into Licensing Agreement With Brigham and Women's Hospital For Mesothelioma Test ....................................................................................................................................................................... 302

Table 144: Illumina Enters Into Technology Integration Agreement With Partners HealthCare System ........................ 303

Table 145: Scienion Enters Into Co-Marketing Agreement With Maine Manufacturing For Protein Array Products .... 304

Table 146: ImaginAb Enters Into Co-Development Agreement With MacroGenics ........................................................... 305

Table 147: BellBrook Labs Enters Into Co-Development Agreement With Reaction Biology ........................................... 306

Table 148: GVK Biosciences Enters Into Licensing Agreement With National Cancer Institute For GOBIOM Database ......................................................................................................................................................................................................... 307

Table 149: GeneCentric Diagnostics Enters Into Licensing Agreement With University of North Carolina ................... 308

Table 150: Perkinelmer Enters Into Co-Development Agreement With Massachusetts General Hospital .................... 309

Table 151: Affymetrix Enters Into Co-Development Agreement With Pathgen Dx ............................................................. 310

Table 152: Axela Enters Into Co-Marketing Agreement With OvaGene Oncology ............................................................. 311

Table 153: University of Michigan Enters Into Joint Venture Agreement With International Genomics Consortium .... 312

Table 154: Regulus Therapeutics Enters Into An Agreement With Biogen Idec For Biomarkers .................................... 313

Table 155: Curetis Enters Into Licensing Agreement With Cempra For Unyvero ............................................................... 314

Table 156: Foundation Medicine Enters Into Co-Development Agreement With Clovis Oncology .................................. 315





Table 157: Saladax Biomedical Expands Co-Development Agreement With Bristol-Myers Squibb ............................... 316

Table 158: Epistem Enters Into Distribution Agreement With Becton Dickinson For Mycobacterium TB Test .............. 317

Table 159: Waters Enters Into Co-Development Agreement With Nonlinear Dynamics ................................................... 318

Table 160: Affymetrix Expands Licensing Agreement With Siemens Healthcare For Branched DNA Technology ...... 319

Table 161: Molecular Targeting Technologies Enters Into Licensing Agreement With Medical College of Wisconsin For 99mTc-HYNIC-Duramycin ................................................................................................................................................... 320

Table 162: Rosetta Genomics Enters Into Co-Marketing Agreement With Precision Therapeutics For miRview mets2 Assays ............................................................................................................................................................................................ 321

Table 163: Bio-Rad Labs Enters Into Distribution Agreement With Myriad RBM For Multiplex Biomarker Kits ............ 322

Table 164: Gen-Probe Enters Into Co-Marketing Agreement With Life Technologies ....................................................... 323

Table 165: OriGene Technologies Enters Into Co-Development Agreement With Centre of Excellence for Prevention of Organ Failure ............................................................................................................................................................................ 324

Table 166: Siemens Healthcare Diagnostics Enters Into Distribution Agreement With Sysmex..................................... 325

Table 167: IRIS International Enters Into Distribution Agreement With Alifax ..................................................................... 326

Table 168: EKF Diagnostics Enters Into Licensing Agreement With Joslin Diabetes Center ........................................... 327

Table 169: SciFluor Life Sciences Enters Into Distribution Agreement With Sigma-Aldrich For PhenoFluor ................ 328

Table 170: Clovis Oncology Enters Into Co-Development Agreement With Array BioPharma ........................................ 329

Table 171: RS Medical Enters Into Distribution Agreement With Harvest Technologies ................................................... 330

Table 172: Immuno-Biological Labs Enters Into Licensing Agreement With IBL International ......................................... 331

Table 173: Sandia National Labs Plans To Enter Into Licensing Agreement For SpinDx, Medical Diagnostic Tool .... 332

Table 174: HTG Molecular Diagnostics Enters Into Licensing Agreement With Merck For Breast Cancer Marker Patent Portfolio ............................................................................................................................................................................. 333

Table 175: Genisphere Enters Into Co-Development Agreement With Lankenau Institute for Medical Research ....... 334

Table 176: WaferGen Biosystems Enters Into Agreement With Integrated DNA Technologies ...................................... 335

Table 177: BioView Enters Into Co-Development Agreement With ScreenCell For Circulating Tumor Cell Analysis Technology .................................................................................................................................................................................... 336

Table 178: MDxHealth Enters Into Licensing Agreement With Merck For MGMT Diagnostic Test ................................. 337

Table 179: Fluxion Biosciences Enters Into Co-Development Agreement With Stanford University School of Medicine ......................................................................................................................................................................................................... 338

Table 180: Merrimack Pharma Enters Into Co-Development Agreement With Cancer Treatment Centers of America ......................................................................................................................................................................................................... 339

Table 181: Phenomenome Discoveries Enters Into Licensing Agreement With Polymedco For Cancer Diagnostic Test ......................................................................................................................................................................................................... 340

Table 182: PlexPress Enters Into Technology Integration Agreement With Phalanx Biotech .......................................... 341

Table 183: PrimeraDx Enters Into Co-Development Agreement With Eli Lilly ..................................................................... 342

Table 184: Kreatech Diagnostics Enters Into Co-Development Agreement With Oridis Biomarkers For DNA-FISH Assays ............................................................................................................................................................................................ 343

Table 185: Stratos Enters Into Co- Development Agreement With nanoMR ....................................................................... 344

Table 186: Guided Therapeutics Extends Licensing And Co-Development Agreement With Konica Minolta ............... 345

Table 187: Berg Pharma Enters Into Co-Development Agreement With Parkinson's Institute ........................................ 346





1.2 List of Figures

Figure 1: In Vitro Diagnostics, Market Segmentation.................................................................................................................. 34

Figure 2: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, 2004-2018 .................................... 35

Figure 3: In Vitro Diagnostics Market, United States, Revenue Mix ($m), 2011 .................................................................... 37

Figure 4: In Vitro Diagnostics Market, United States, Category Contribution (%), 2011 ...................................................... 38

Figure 5: In Vitro Diagnostics Market, United States, Cross-Category Analysis, 2004-2018 .............................................. 39

Figure 6: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Historic, 2004-2011 .................... 41

Figure 7: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Forecast, 2011-2018 .................. 43

Figure 8: In Vitro Diagnostics, United States, Company Share (%), 2011 ............................................................................. 45

Figure 9: Clinical Chemistry, Market Segmentation .................................................................................................................... 47

Figure 10: Clinical Chemistry Market, United States, Revenue Mix ($m), 2011 .................................................................... 48

Figure 11: Clinical Chemistry Market, United States, Segment Contribution (%), 2011 ...................................................... 49

Figure 12: Clinical Chemistry, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ............ 50

Figure 13: Clinical Chemistry, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ......... 52

Figure 14: Clinical Chemisty Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011........................................................................................................................................................................................ 54

Figure 15: Clinical Chemisty Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018........................................................................................................................................................................................ 56

Figure 16: Urine Analysis, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .......... 58

Figure 17: Urine Analysis, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ....... 60

Figure 18: Clinical Chemistry, United States, Company Share (%), 2011 .............................................................................. 63

Figure 19: Genetic Testing, Market Segmentation ...................................................................................................................... 64

Figure 20: Genetic Testing Market, United States, Revenue Mix ($m), 2011 ........................................................................ 65

Figure 21: Genetic Testing Market, United States, Segment Contribution (%), 2011 .......................................................... 66

Figure 22: Genetic Testing, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ................ 67

Figure 23: Genetic Testing, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ............. 69

Figure 24: Genetic Testing, United States, Company Share (%), 2011 .................................................................................. 72

Figure 25: Haematology Market, Market Segmentation ............................................................................................................. 74

Figure 26: Haematology Market, United States, Revenue Mix ($m), 2011 ............................................................................ 75

Figure 27: Haematology Market, United States, Segment Contribution (%), 2011 ............................................................... 76

Figure 28: Haematology, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 .................... 77

Figure 29: Haematology, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 .................. 79

Figure 30: Haematology Reagents, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .................................................................................................................................................................................................. 81

Figure 31: Haematology Reagents, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 .................................................................................................................................................................................................. 83

Figure 32: Immunohaematology, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ........................................................................................................................................................................................................... 85

Figure 33: Immunohaematology, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ........................................................................................................................................................................................................... 87





Figure 34: Haemostasis, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ............ 89

Figure 35: Haemostasis, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 .......... 91

Figure 36: Haematology Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .................................................................................................................................................................................................. 93

Figure 37: Haematology Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 .................................................................................................................................................................................................. 95

Figure 38: Haematology Cell Counters, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .................................................................................................................................................................................................. 97

Figure 39: Haematology Cell Counters, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018........................................................................................................................................................................................ 99

Figure 40: Haematology, United States, Company Share (%), 2011 .................................................................................... 102

Figure 41: Histology and Cytology Market, Market Segmentation ......................................................................................... 104

Figure 42: Histology And Cytology Market, United States, Revenue Mix ($m), 2011 ........................................................ 105

Figure 43: Histology And Cytology Market, United States, Segment Contribution (%), 2011 ........................................... 106

Figure 44: Histology And Cytology, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 107

Figure 45: Histology And Cytology, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ......................................................................................................................................................................................................... 109

Figure 46: Histology And Cytology, United States, Company Share (%), 2011 .................................................................. 112

Figure 47: Infectious Immunology, Market Segmentation ........................................................................................................ 114

Figure 48: Immuno Chemistry Market, United States, Revenue Mix ($m), 2011 ................................................................ 115

Figure 49: Immuno Chemistry Market, United States, Segment Contribution (%), 2011 ................................................... 116

Figure 50: Immuno Chemistry, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ........ 117

Figure 51: Immuno Chemistry, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ...... 119

Figure 52: Disease Specific Immunochemistry, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ...................................................................................................................................................................... 121

Figure 53: Disease Specific Immunochemistry, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................... 123

Figure 54: Drugs of Abuse / Toxicology, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011...................................................................................................................................................................................... 125

Figure 55: Drugs of Abuse / Toxicology, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018...................................................................................................................................................................................... 127

Figure 56: Endocrinology Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ......................................................................................................................................................................................................... 129

Figure 57: Endocrinology Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ......................................................................................................................................................................................................... 131

Figure 58: Immunochemistry Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011...................................................................................................................................................................................... 133

Figure 59: Immunochemistry Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018...................................................................................................................................................................................... 135

Figure 60: Therapeutic Drug Monitoring, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011...................................................................................................................................................................................... 137

Figure 61: Therapeutic Drug Monitoring, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018...................................................................................................................................................................................... 139

Figure 62: Immunochemistry Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011...................................................................................................................................................................................... 141





Figure 63: Immunochemistry Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018...................................................................................................................................................................................... 143

Figure 64: Immuno Chemistry, United States, Company Share (%), 2011 .......................................................................... 146

Figure 65: Infectious Immunology Market, United States, Revenue Mix ($m), 2011 .......................................................... 148

Figure 66: Infectious Immunology Market, United States, Segment Contribution (%), 2011 ............................................ 149

Figure 67: Infectious Immunology, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011.. 150

Figure 68: Infectious Immunology, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 152

Figure 69: Infectious Immunology Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ...................................................................................................................................................................... 154

Figure 70: Infectious Immunology Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................... 156

Figure 71: Infectious Immunology, United States, Company Share (%), 2011 .................................................................... 159

Figure 72: Microbiology Culture, Market Segmentation ........................................................................................................... 161

Figure 73: Microbiology Culture Market, United States, Revenue Mix ($m), 2011 ............................................................. 162

Figure 74: Microbiology Culture Market, United States, Segment Contribution (%), 2011 ................................................ 163

Figure 75: Microbiology Culture, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ..... 164

Figure 76: Microbiology Culture, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ... 166

Figure 77: Microbiology Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ................................................................................................................................................................................................ 168

Figure 78: Microbiology Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................................................ 170

Figure 79: Microbiology Culture, United States, Company Share (%), 2011 ....................................................................... 173

Figure 80: Siemens Healthcare, Company Share (%),United States In Vitro Diagnostics Market, 2011 ....................... 175

Figure 81: Abbott Laboratories, Company Share (%),United States In Vitro Diagnostics Market, 2011 ........................ 176

Figure 82: F. Hoffmann-La Roche Ltd., Company Share (%),United States In Vitro Diagnostics Market, 2011 ........... 177

Figure 83: Beckman Coulter, Inc., Company Share (%),the United States In Vitro Diagnostics Market, 2011 ............. 178

Figure 84: Ortho-Clinical Diagnostics Inc., Company Share (%),the United States In Vitro Diagnostics Market, 2011 ......................................................................................................................................................................................................... 179

Figure 85: Alere Inc., Company Share (%),United States In Vitro Diagnostics Market, 2011 ........................................... 180

SAMPLEIntroduction




2 Introduction

GlobalData’s medical equipment market reports are the ideal guide for anyone wishing to

understand the market better in terms of revenue, distribution shares and company shares.

2.1 What is This Report About?

United States in vitro diagnostics market report provides the following information:

1. Comprehensive data related to the market revenue, distribution share and company share

2. Global corporate-level profiles of key companies operating in the in vitro diagnostics

market in the United States, which includes a brief overview of the company. The selection

of the companies is based on their operational presence in the United States. It includes

key multinationals as well as key local players.

3. A list of key products under development by different companies. The selection of this list

is based on the territory in which these products are being clinically investigated.

SAMPLEIn Vitro Diagnostics in United States




In Vitro Diagnostics

Monoclonal Antibodies

Genetic Testing

Clinical Chemistry

Histology And Cytology

Microbiology Culture

HaematologyImmuno

ChemistryInfectious

Immunology

Clinical Chemisty Analyzers

Urine Analysis

Electrolyte Chemistry Reagents

Metabolite Chemistry Reagents

Enzyme Chemistry Reagents

Clinical Chemistry

Rapid Tests & POC

Haematology Reagents

Haemostasis

Haematology Analyzers

Immunohaematology

Haematology Rapid Tests

Haematology Cell Counters

Immunochemistry Analyzers

Endocrinology Tests

Organ Function Assays

Immunochemistry Rapid Tests

Anemia / Vitamin Tests

Specific Proteins

Disease Specific Immunochemistry

Microbiology Analyzers

Blood Culture

Mycobacteria Culture

Parasitology Culture

Mycology Culture

Immunological Culture

Identification

Bacterial Identification & Susceptibility

Testing

Tissue Typing

Reagents

Other Genetic Tests

Acquired Gene or

Chromosome Alterations

Inborn Gene or


Therapeutic Drug Monitoring

Drugs of Abuse / Toxicology

Flow Cytometers

Retroviruses

Hepatitis Viruses

Bacteriology

Other Virology

Infectious Immunology Rapid Tests

In Vitro Diagnostics


Genetic Testing

Clinical Chemistry



HaematologyImmuno

ChemistryInfectious

Immunology


Urine Analysis




Clinical Chemistry

Rapid Tests & POC


Haemostasis


Immunohaematology




Endocrinology Tests




Specific Proteins



Blood Culture



Mycology Culture

Immunological Culture

Identification

Bacterial Identification & Susceptibility

Testing

Tissue Typing

Reagents

Other Genetic Tests

Acquired Gene or


Inborn Gene or




Flow Cytometers

Retroviruses

Hepatitis Viruses

Bacteriology

Other Virology


Retroviruses

Hepatitis Viruses

Bacteriology

Other Virology


3 In Vitro Diagnostics In United States

3.1 In Vitro Diagnostics, Market Segmentation

Figure 1: In Vitro Diagnostics, Market Segmentation

Source: GlobalData





3.2 In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, 2004-2018

Figure 2: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, 2004-2018

Source: GlobalData





Table 1: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, 2004-2018

Category 2004 2011 2018 CAGR 04-11 CAGR 11-18 CAGR 04-18

Immuno Chemistry

Clinical Chemistry

Haematology

Infectious Immunology



Genetic Testing

Total

Source: GlobalData




© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 38

3.4 In Vitro Diagnostics Market, United States, Category Contribution (%), 2011

Figure 4: In Vitro Diagnostics Market, United States, Category Contribution (%), 2011

Source: GlobalData

Table 2: In Vitro Diagnostics Market, United States, Category Contribution (%), 2011

Category Revenue ($m) Contributon Revenue (%) Contributon

Immuno Chemistry

Clinical Chemistry

Haematology




Genetic Testing

Source: GlobalData





Figure 6: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Historic, 2004-

2011

Source: GlobalData





Table 4: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Historic, 2004-

2011

Category 2004 2005 2006 2007 2008 2009 2010 2011 CAGR

Immuno Chemistry

% Growth

Clinical Chemistry

% Growth

Haematology

% Growth


% Growth


% Growth


% Growth

Genetic Testing

% Growth

Total

% Growth

Source: GlobalData





Figure 7: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Forecast, 2011-

2018

Source: GlobalData





Table 5: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Forecast, 2011-

2018

Category 2011 2012 2013 2014 2015 2016 2017 2018 CAGR

Immuno Chemistry

% Growth

Clinical Chemistry

% Growth

Haematology

% Growth


% Growth


% Growth

Genetic Testing

% Growth


% Growth

Total

% Growth

Source: GlobalData





3.5 In Vitro Diagnostics, United States, Company Share (2010-2011)

Figure 8: In Vitro Diagnostics, United States, Company Share (%), 2011

Note: Company Share estimates are based on company reports, secondary research and primary research Source: GlobalData





Table 6: In Vitro Diagnostics, United States, Company Share by Revenue ($m), USD Constant,

2010-2011

Company Name 2010 2011

Siemens Healthcare

Abbott Laboratories

F. Hoffmann-La Roche Ltd.

Beckman Coulter, Inc.

Ortho-Clinical Diagnostics Inc.

Alere Inc.

bioMerieux S.A.

Becton, Dickinson and Company

Bio-Rad Laboratories, Inc.

Sysmex Corporation

Qiagen N.V.

Gen-Probe Incorporated

Others

Total

Source: GlobalData

SAMPLEAppendix




15 Appendix

The data and analysis within this report is driven by Medical eTrack

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15,000+ Market size data tables across 740 medical equipment segments and 39 countries with

historic data from 2004 forecast to 2018

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1,100+ Conferences on medical equipment covered

1,000+ Industry leading reports per annum covering growing sectors, market trends, investment

opportunities and competitive landscape

600+ Analysis reports covering market and pipeline product analysis reports by indication, medical

equipment trends and issue reports and investment and M&A trend reports worth over $3 Million

43,000+ Medical equipment companies profiled

1,500+ Private, emerging and technology start-up company profiles

1,500+ Medical equipment manufacturers in China and India

1,500+ Medical equipment companies in Japan

700+ Companies with revenue splits and market shares by category

1,500+ Quarterly and annual medical equipment company financials

700+ Medical equipment company SWOT’s

9,000+ Pipeline product profiles

8,000+ Marketed product profiles

14,000+ Clinical trials

15,000+ Trial investigators

13,000+ New product patents

3,300+ Companies with products in development

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40+ Key healthcare indicators by country

o For more information or to receive a free demo of the service visit

http://www.medicaletrack.com/contactus.aspx?RD=Demo=

SAMPLEAppendix




15.1 Definitions of Markets Covered in the Report

15.1.1 In Vitro Diagnostics

In Vitro Diagnostics (IVD) include reagents, instruments and systems intended for use in the

diagnosis of disease or other conditions, including the determination of the state of health, in order

to treat or prevent disease. Such reagents, instruments and systems are intended for use in the

collection, preparation and examination of specimens taken from the human body. The categories

tracked under this market are clinical chemistry, immunochemistry, haematology, histology &

cytology, infectious immunology, microbiology culture and genetic testing. In this market only

values have been tracked.

15.1.1.1 Clinical Chemistry

Clinical chemistry includes reagents, test kits and devices that determine the concentration or

activity of a protein, carbohydrate, lipid, electrolyte, enzyme or small molecules in easily-collected

bodily fluids such as blood, serum, plasma or urine. Immuno chemical reagents are not included

under this category and are tracked separately under Immuno chemistry. This category comprises

of reagents for enzyme chemistry, metabolite chemistry and electrolyte chemistry. Rapid tests for

all enzymes, metabolites and electrolyte analysis and instruments used for clinical chemistry

diagnosis are also covered in this category.

Clinical Chemistry Rapid Tests & POC

Clinical chemistry rapid tests provide the test results immediately. These tests are used in low

resource settings with the help of test strips, tablets and solutions. Clinical chemistry PoC

diagnostics are used to determine the concentration or activity of blood gas, electrolytes,

metabolites, enzymes, carbohydrates, proteins, lipids and small molecules. These tests are

performed for the analysis of body fluids such as blood, serum, sputum, urine, feces and others.

Blood glucose testing is not tracked in this segment.


Clinical chemistry analyzers are instruments used to perform tests relating to enzyme chemistry,

metabolite chemistry and electrolyte chemistry. Clinical chemistry analyzers can be fully

automated or semi automated.

Automated Clinical Chemistry Analyzers

A fully automated clinical chemistry analyzer is connected to a software program that allows the

user to feed in most test parameters. The tasks associated with performing the test like dispensing

the reagents and incubation are automated and require minimum manual work.

Semi-Automated Clinical Chemistry Analyzers

A semi-automated clinical chemistry analyzer requires an operator to perform the reagent

dispensing, incubation and other tasks manually.

SAMPLEAppendix





Reagents used to quantify or detect electrolytes to detect bodily functions and disease states.

Examples of electrolytes tracked include sodium, potassium, chloride, bicarbonate, magnesium,

calcium etc from the extra cellular fluids of the body.


Reagents and test kits used for quantification and detection of enzymes that act as a marker for

identification and determination of disease states and bodily functions. Examples of enzymes

tracked include acid phosphatase, alkaline phosphatase, creatine kinase lactate dehydrogenase

etc.


Reagents used for the quantification of metabolites for the assessment of bodily functions and

disease states. Examples of metabolites tracked are creatinine, cholesterol, triglycerides, albumin,

bilirubin etc.

Urine Analysis

Urine analysis is the analysis of urine to aid in the diagnosis of disease or to detect the presence of

a specific substance.

Urine Analyzer Reagents

Urine analyzer reagents are the reagents used in urine analyzers.

Urine Analyzers

Urine analyzers are analytical laboratory equipment used in qualitative and semi-quantitative tests

performed on a urine sample.

15.1.1.2 Genetic Testing

Genetic testing reagents are used for the identification of specific syndrome present in an

individual and can improve the accuracy of the diagnostic tests leading to a better treatment.

Reagents used to perform acquired gene or chromosome alterations, inborn gene or chromosome

alterations and other genetic tests have been tracked under this category.

Acquired Gene or Chromosome Alterations

Reagents which are used in genetic tests to detect cancer causing genes/related alterations like

p53, k-ras, BRCA 1+2 etc.

Inborn Gene or Chromosome Alterations

Genetic tests to detect monogenetic disorders (like Cystic Fibrosis, Haemochromatosis,

Prothrombin Mutation etc), polygenetic disorders (like Asthma , Atherosclerosis, Diabetes,

Hypertension, Osteoporosis, etc), chromosomal disorders (like Down's Syndrome, Edwards

Syndrome etc), polymorphisms (like HLA-Typing etc).

SAMPLEAppendix




Other Genetic Tests

Other genetic tests include pharmaco-genomics which include test related to cytochrome P450

(CYP 450). These tests can be by either individual tests or multiple tests which are conducted on

micro-arrays.

15.1.1.3 Haematology

Haematology includes reagents, rapid tests and instruments used for determination and diagnosis

of both physiological and pathological aspects of blood and its components. The category also

includes immune related reagents used for analysis of blood and its components.


Analytical laboratory equipments which are used to perform tests related to blood and its

components. These analyzers are also used to identify and determine morphology of blood and

blood-forming cells such as white blood cells, lymphocytes, monocytes, neutrophils, eosinophils

and basophils.


These are blood counters used for complete blood count determination in routine examinations.

Differential Counters

These are instruments which are used in the measurement of the percentage of each type of white

blood cell of an individual. It also detects if there are any abnormal or immature cells in an

individual.

Hemoglobinometers

These are Instruments which are used for colorimetric representation of the percentage of

haemoglobin in a blood sample.


These are spot tests that generate results immediately and can be done in low resource setting.

These tests are performed to detect the Haemoglobin, Erythrocytes and Haematocrit etc

Erythrocytes (Ery)

Rapid test kits used for detecting the concentration of Erythrocytes in human blood are covered

under Erythrocytes (Ery) rapid test kits.

Haematocrit (HCT)

Rapid test kits used for detecting the concentration of Haematocrit (HCT) in human blood are

covered under Haematocrit (HCT) rapid test kits.

Haemoglobin (Hb)

Rapid test kits used for detecting the concentration of haemoglobin in human blood are covered

under Haemoglobin (Hb) rapid test kits.

Haemostasis Rapid Tests (Home Monitoring)

SAMPLEAppendix




These are spot tests to detect haemostasis. These include prothrombin time rapid test, D-Dimer

rapid test, activated clotting time (ACT) rapid test etc


These are reagents that are provided for substantially lysing the red blood cells in a whole blood

sample prior to haematology analysis.

Haematology Analyzer Reagents

Haematology analyzer reagents are exclusively used in blood lysing techniques. These reagents

generally contain tris-HCl, EDTA, EGTA, SDS, deoxycholate, tritonX, etc.

Slide Stainers

Slide stainers are reagents used in the staining of slides and smears. Reagents like crystal violet,

safranin, etc have been tracked.

Haemostasis

These include test kits and reagents that are used to conduct blood coagulation related tests.

Coagulation analyzers and reagents used to conduct various coagulation tests have been tracked

under this segment.

Coagulation Analyzers

These are automated or semi automated laboratory equipments used in clotting assay,

chromogenic assay, haemostasis profile etc.

Coagulation Factors

Reagents used in the detection of the coagulation factors are covered here. These coagulation

factors such as Factor VII, VIII, IX, XII etc, are involved in the blood coagulation process.

General Coagulation Tests

Coagulation tests include INR/prothrombin time, activated partial thromboplastin time (APTT or

PTT), bleeding time, plasma thrombin time etc. These tests are useful to diagnose disease

condition such as Haemophilia, Uremia, Thrombocytopenia and Vitamin K deficiency.

Platelet Factors

These reagents are used to conduct tests in the determination of cytokines belonging to the

chemokine family.

Special Coagulation Tests

These are reagents which are used to conduct special coagulation tests which provide quantitative

determination of anticoagulant activities of heparin and thrombin formation.

Immunohaematology

Immuno haematology studies antigen-antibody reactions and analogous phenomena as they

relate to the pathogenesis and clinical manifestations of blood disorders.

ABO Typing

SAMPLEAppendix




These are the reagents used for detecting blood types into four categories: Type A, Type B, Type

AB and Type O.

Antibody Detection

Antibody detection is done for the differential diagnosis of many different pathological conditions.

These determinations of specific antibodies to bacterial and viral pathogens as well as to parasites

enable the correct therapeutic measures to be taken.

Rhesus Typing

These are the tests which are used to detect Rh factor (antigen) on the surface of the red blood

cells.

15.1.1.4 Histology And Cytology

These are reagent test kits and instruments used in tissue and cell typing techniques. Flow

cytometers, monoclonal antibodies and tissue typing reagents have been tracked under this

category.

Flow Cytometers

Flow cytometers are an electronic detection apparatus used in a technique for counting and

examining microscopic particles, such as cells and chromosomes, by suspending them in a stream

of fluid.


Monoclonal antibodies for cell surface antigen are antibodies from a single clone of hybridoma

cells. These are used for specific target cells which identify the tissue by the cell surface antigen.

Tissue Typing Reagents

These are the reagents which are used to determine the compatibility of tissues between a

prospective donor and a recipient prior to transplantation.

15.1.1.5 Immuno Chemistry

The immunochemistry category includes reagents, instruments and test kits used for the analysis

of antigen-antibody interactions in any of the bodily fluids. The category includes both test kits and

reagents for quantification and detection of specific proteins, hormones, drug moieties and non-

infectious diseases. Reagents and kits used in the diagnosis of infectious disease are not included

in this category.


Reagents used for estimation of anaemia and vitamin deficiency. These includes the reagents

used for quantitative measurement of iron, ferritin, folate and vitamin B 1, 2, 6, 12, Vitamin-D


Disease specific immunochemistry is an assay of specific markers of a particular disease. These

tests include assays of mostly antibodies released in response to a specific disease and also other

disease-causing proteins.

SAMPLEAppendix




Allergy Blood Tests

Allergy Blood test is allergen-specific IgE antibody test used to measure the amount of

immunoglobulin (Ig) E antibodies to a specific allergen in the blood. A blood test tells a physician

what type of antibodies your blood contains in order to provide information on what is causing your

allergies. The test kits or reagents used to perform allergy blood test are covered under this sub

segment.

Auto-Immune Diseases

This includes the reagents and kits used to perform tests for the diagnosis of immune system

disorders and other disease states to detect auto-antibodies, which are antibodies produced

against the body’s own tissues. The tests are used for the diagnosis of certain autoimmune

disease such as Addison’s disease, autoimmune pancreatitis, Celiac disease, Crohns Disease,

Diabetes mellitus type 1, etc. The kits in this sub-segment include anti-nuclear antibody (ANA) kits,

etc.

Cardiac Markers

Cardiac marker tests function to identify blood chemicals associated with myocardial infarction and

other acute coronary syndromes. The tests include assays for proteins and chemicals like Creatine

Kinase-MB (CK-MB), myoglobin, homocysteine, C-Reactive Protein (CRP), troponin T (cTnT) and

troponin I (cTnI), associated with heart diseases.

Rheumatoid - Inflammatory Diseases Markers

These are the reagents used to detect Rheumatoid – Inflammatory diseases markers. These

markers are antigen/antibodies that detect specific antigen/antibodies produced by bone, cartilage

or any other inflammatory disease activity.

Tumor markers

The reagents used in the tests that detect specific antibodies/antigen produced by the tumor itself

or by the body in response to the tumor. Some commonly detected tumor markers include CA19-9,

CA15-3, CA-125, AFP, etc. The tests can assay markers from samples of blood, urine or body

tissue.


Test kits used to determine the type and approximate amount of legal and illegal drugs a person

has taken are covered under Drugs of abuse/ Toxicology. Screening is most often done using a

blood or urine sample. This segment includes drugs of abuse and toxicology.

Drugs of Abuse

Test kits for measurement of drugs of abuse from blood, serum or urine. These are the systems

used for testing of depressants, narcotics, stimulants and hallucinogens.

Toxicology

SAMPLEAppendix




These are test kits for measurement of toxic substances or drugs from the blood or urine sample.

These are systems used for testing of drugs like Acetaminophene (Paracetamol), 5-

Aminolevulinate Dehydratase, Desipramine, Hippuric Acid, Phenols, Ethanol (Alcohol), etc.

Endocrinology Tests

Reagents used for quantification and detection of endocrine hormones secreted in the human

body. These include the thyroid function hormones, pregnancy hormones, individual and specified

hormones.

Fertility or Pregnancy Hormones

Pregnancy test system intended for the early detection of pregnancy by the measurement of

Human Chorionic Gonadotropin (HCG), a placental hormone, in plasma or urine.

Individual and Specified Hormones

Reagents used for a quantitative measurement of specific hormones for any purpose other than

pregnancy and thyroidal hormones are included here. They include reagents for testing of

hormones like Estrogen, Estradiol, Estriols, Adrenocorticotropic hormone, Aldosterone etc.

Thyroid Function Hormones

Reagents used for the quantification and detection of hormones secreted by the thyroid gland.

Reagents used to test TSH, T3 and T4 are included in this segment.


Immunochemistry analyzers are analytical laboratory equipments used to perform tests for specific

proteins and therapeutic drugs. These analyzers are typically offered in modular increments, which

can operate independently or simultaneously as a unit. Analyzers covered under this category

include Chemiluminescence Analyzers, Radioimmunoassay Analyzers, Immunofluorescence

Analyzers and ELISA Instruments. Analyzers used to perform chemical analysis (enzyme,

electrolyte, metabolic or urine analysis are excluded and are covered under clinical chemistry.

Chemiluminescence Analyzers

Chemiluminescence analyzers are analytical laboratory equipments used to detect glow-based

chemiluminescent reactions. These are used for the quantitative determination of bio-molecules

such as hormones, antibodies to infectious diseases and other proteins in human serum and

Plasma.

ELISA Instruments

ELISA Instruments are used in enzyme-linked immuno sorbent assays for the diagnostic analyses

of antigens or antibodies in a solution using colorimetric signals. These instruments include micro

plate readers, ELISA washers, ELISA reader, etc.

Immunofluorescence Analyzers

SAMPLEAppendix




Immunofluorescence analyzers are analytical laboratory equipments used for the visualization of

sub cellular distribution antibodies or antigens of interest. Using these analyzers the bio-molecules

of interest are labelled with specific antibodies chemically conjugated with fluorescent dye.

Radioimmunoassay Analyzers

Radioimmunoassay analyzers are analytical laboratory equipments used to measure

concentrations of antigens (for example, hormone levels in the blood) using radioactive

substances without the need to use a bioassay.


Spot test kits intended generally for rapid diagnosis with immediate results, through immuno

assays. Some of the tests carried out using immunochemistry rapid test include rabies virus test,

allergenic food proteins and enteric infection

Drugs of Abuse / Toxicology Rapid Tests

Rapid immunodiagnostic tests intended for immediate detection and measurement of illegal and

legal drugs a person has taken. These tests detects and measures Amphetamines,

Amphetamine/Methamphetamine Specific (+Ecstasy), Barbiturates, Benzodiazepines,

Cannabinoids, Cocaine, Methadone, Opiates, Phencyclidine, Tricyclic Antidepressants, etc in

blood, serum and urine samples.

Fertility / Pregnancy Rapid Tests

Rapid immunodiagnostic tests intended for immediate detection of fertility / pregnancy by

measurement of Follicle-stimulating hormone (FSH), Human placental lactogen (HPL), Human

luteinizing hormone (LH) and Human chorionic gonadotropin (HCG) hormone in plasma, serum

and urine samples.

Other Immunochemistry Rapid Tests

Immunodiagnostic tests intended for the immediate detection of Individual and Specified

Hormones/Proteins, Albumin, uAlbumin, Glycosylated/Glycated Haemoglobin, Prostate-specific

antigen (PSA), Bladder tumor antigen (BTA stat), C - Reactive protein, Rheumatoid / Inflammatory

Disease protein, Creatine Kinase, Myoglobin, Troponin, BNP / proBNP, Heart-Type Fatty Acid-

Binding Protein, etc. in plasma, serum and urine samples.


These include test systems usually carried out through blood or urine test, for evaluating the

wellness of a specific organ through an assay of the organ metabolites. These include liver

function tests, kidney function tests etc.

Specific Proteins

These are reagents and test kits which are used to quantify and detect protein molecules from

bodily fluids. Immunoglobulins (without IgE), HAMA, Immunoelectrophoresis & ImmunoFixation

Kits, Complement Components, Transport Proteins, Lipoproteins, AGP, AAT, Micro and Macro G

etc. have been tracked under this segment.

SAMPLEAppendix





Therapeutic drug monitoring include reagents and test kits intended to measure different types of

therapeutic drugs from samples ranging from serum/blood, urine, hair and sweat. Test kits for

measurement of both proteins based and chemical based therapeutic drugs are covered. This

include tests for antibiotics, anti analgesics, anti-inflammatory, antipyretic and menstrual drugs.

Antibiotic TDM / Antivirus TDM

Therapeutic drug monitoring reagents used for the measurement of antibiotics or antivirus are

covered under antibiotic/antivirus TDM. Reagents used for detection of antibiotics like Gentamicin,

Sisomycin, Streptomycin, Netilmycin etc are covered here.

Cardiovascular TDM

Therapeutic drug monitoring reagents used for the measurement of drugs specific for

cardiovascular diseases at timed intervals in order to maintain a relatively constant concentration

of the medication in the bloodstream are covered under Cardiovascular TDM. Reagents used for

detection of cardiovascular drugs like Digoxin, Procainamide, Propranolol, Quinidine, etc are

covered here.

Central Nervous Systems TDM

Therapeutic drug monitoring reagents used for the measurement of drugs specific for central

nervous system are covered under central nervous systems TDM. Reagents used for detection of

central nervous systems drugs like Carbamazepine, Ethosuximide, Free Primodine, Valproic Acid

etc are covered here.

Immunosuppressant TDM

Therapeutic drug monitoring reagents used for the detection of immunosuppressant concentration

in human body are covered under immunosuppressant TDM. This includes reagents used for

detection of Immunosuppressant like Cyclosporin, Mycophenolate, Tacrolimus, etc.

15.1.1.6 Infectious Immunology

This category includes reagents and test kits used for the detection or quantification of infectious

agents like bacteria and viruses by using antigen-antibody (Ag – Ab) and nucleic acid tests.

Bacteriology

Reagents and test kits to detect the pathogenicity of bacteria such as chlamydia, gonococci,

syphilis, helicobacter pylori, salmonella and so on.

Hepatitis Viruses

These are diagnostic test kits which are used to detect the hepatitis virus such as HAV, HBV,

HCV, HbsAg and HXV.

SAMPLEAppendix





Spot test kits intended generally for rapid diagnosis with immediate results, through immuno

assays. Tests carried out using Infectious Immunology rapid test include Hepatitis Virus,

Retrovirus and Other Virology Rapid Tests.

Hepatitis Viruses Rapid Tests

Immunodiagnostic tests intended for immediate detection of HBsAg, HCV Antibody and other

Hepatitis Viruses.

Other Infectious Immunology Rapid Tests

Immunodiagnostic tests intended for immediate detection of Chlamydia Ag, H. pylori, Strep. A,

Strep. B, Syphilis, Clost. diff. including Toxin A and B, Meningitis causitive agents, Legionella,

Strep. Pneumoniae, CMV, RSV, Mononucleosis (EBV), Influenza A and/or B, VZV, Dengue,

Plasmodium (Malaria), etc.

Retroviruses Rapid Tests

Immunodiagnostic rapid tests intended for immediate detection of HIV 1, HIV 1 / 2, HIV Ag/Ab

Combi and other Retroviruses.

Other Virology

These are diagnostic test kits which are used to confirm the antigen/antibody of rubella,

cytomegalovirus, the herpes simplex virus and the Epstein Barr Virus.

Retroviruses

These are diagnostic test kits which are used to detect the antigen/antibody of HIV1, HIV 2 and

HTLV I, HTLVII.

15.1.1.7 Microbiology Culture

This category includes reagents used for the preparation of growth medium for microbial

organisms. This category also includes dehydrated and prepared culture media for micro organism

growth.

Bacterial Identification & Susceptibility Testing

This includes the reagents and test kits (manual and automated) used to identify and test the

sensitivity of bacteria towards an antimicrobial substance.

Blood Culture

Culture media used for the preparation of medium capable of supporting the growth of bacteria

and other micro organisms. It is a culture of blood, used to identify the infection of blood stream

like bacteremia, septicaemia, etc. They are generally in solid/liquid forms or only solid and liquid

forms with constituents specific to the bacteria.

SAMPLEAppendix



© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form 3

Immunological Culture Identification

Reagents used to test the streptococci grouping, meningitis, staphylococci and serotyping.


These are analytical laboratory equipments used to perform routine and special microbiology tests.

These include fully automated or semi automated microbiology analyzers.

Automated Microbiology Analyzers

A fully automated analyzer is connected to a software program that allows the user to feed in most

test parameters. The tasks associated with performing the test like dispensing the reagents,

incubation etc are automated and require minimum manual work.

Semi-Automated Microbiology Analyzers

A semi-automated analyzer requires an operator to perform the reagent dispensing, incubation

and other tasks manually.


It includes the culture media used for the preparation of medium capable of supporting the growth

of mycobacterium.

Mycology Culture

It includes culture media and reagents for the preparation of culture medium that is capable of

supporting the growth of fungi. These cultures are used to detect infection like dermatophyte

infections, etc


Culture media used for the preparation of medium capable of supporting the growth of blood

parasites like plasmodium, pneumocystis etc.

Note: 1). Value, distribution and company shares figures reflect annual gross sales of in vitro

diagnostics in local currency converted to $ at constant rate. The annual growth (year on year

growth) and compounded annual growth rate (CAGR) in tables is rounded off to one decimal

place.

2). Company share data represents market share (in revenues and as percentage to total market)

of companies in market categories and geographies tracked. The data is rounded off to the

nearest decimal places.

SAMPLEAppendix




15.2 Research Methodology

GlobalData’s dedicated research and analysis teams consists of qualified professionals with

experience in marketing, market research, consulting background in the medical devices industry

and advanced statistical expertise.

GlobalData adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and

the Strategic and Competitive Intelligence Professionals (www.scip.org).

All GlobalData databases are continuously updated and revised. The following research

methodology is followed for all databases and reports.

15.3 Secondary Research

The research process begins with exhaustive secondary research on internal and external sources

being carried out to source qualitative and quantitative information relating to each market.

The secondary research sources that are typically referred to include, but are not limited to:

Company websites, annual reports, financial reports, broker reports, investor presentations

and SEC filings;

Industry trade journals, scientific journals and other technical literature;

Internal and external proprietary databases;

Relevant patent and regulatory databases;

National government documents, statistical databases and market reports;

Procedure registries; and

News articles, press releases and web-casts specific to the companies operating in the

market.

SAMPLEAppendix




15.4 Primary Research

GlobalData conducts thousands of interviews a year with industry participants and commentators

in order to validate its data and analysis. A typical research interview fulfills the following functions:

It provides first-hand information on market size, market trends, growth trends, competitive

landscape and future outlook;

Helps in validating and strengthening the secondary research findings; and

Further develops the analysis team’s expertise and market understanding.

Primary research involves e-mail interactions and telephonic interviews for each market, category,

segment and sub-segment across geographies.

The participants who typically take part in such a process include, but are not limited to:

Industry participants: CEOs, VPs, marketing/product managers, market intelligence managers

and national sales managers;

Hospital stores, laboratories, pharmacies, distributors and paramedics;

Outside experts: investment bankers, valuation experts, research analysts specializing in

specific medical equipment markets; and

Key opinion leaders: physicians and surgeons specializing in different therapeutic areas

corresponding to different kinds of medical equipment.

15.5 Models

Where no hard data is available, GlobalData uses modeling and estimates in order to produce

comprehensive data sets. The following rigorous methodology is adopted:

Available hard data is cross-referenced with the following data types to produce estimates:

Demographic data on population segments;

Macro-economic indicators such as GDP, inflation rate;

Healthcare indicators such as health expenditure, physician base, healthcare infrastructure

and facilities; and

Selected epidemiological and procedure statistics.

Data is then cross-checked by the expert panel. All data and assumptions related to modeling

are stored and are made available to clients on request.

SAMPLEAppendix




15.6 Forecasts

GlobalData uses proprietary forecast models. The following four factors are utilized in the forecast

models:

Historic growth rates;

Macro-indicators such as population trends and healthcare spending;

Forecast epidemiological data; and

Qualitative trend information and assumptions.

The data is then cross-checked by the expert panel.

15.7 Expert Panels

GlobalData uses a panel of experts to cross-verify its databases and forecasts.

GlobalData’s expert panel comprises marketing managers, product specialists, international sales

managers from medical device companies; academics from research universities, KOLs from

hospitals, consultants from venture capital funds and distributors/suppliers of medical equipment

and supplies etc.

Historic data and forecasts are relayed to GlobalData’s expert panel for feedback and adjusted in

accordance with their feedback.

15.8 GlobalData Consulting

We hope that the data and analysis in this brief will help you make informed and imaginative

business decisions. If you have further requirements, GlobalData’s consulting team may be able to

help you. GlobalData offers tailor-made analytical and advisory services to drive your key strategic

decisions.

15.9 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any

form by any means, electronic, mechanical, photocopying, recording or otherwise without the prior

permission of the publisher, GlobalData.

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