In Vitro Diagnostics US Market

In Vitro Diagnostics US Market

US demand to rise 5.4% annually through 2013



The US market for in vitro diagnostic (IVD) products will increase 5.4 percent annually to $23 billion in 2013. Clinical chemistry and immunoassay methods will remain the top two IVD sciences: the former based on sales of blood glucose monitors and test strips; the latter due to the penetration of high value-added chemiluminescent products into infectious disease and drug testing markets. Nucleic acid testing products will generate the fastest demand gains among IVD products based on throughput, sensitivity, accuracy and speed advantages, especially in the detection of infectious diseases and cancer markers. Because of increasing blood glucose monitoring among diabetic patients, endocrine condition testing will remain the largest IVD application in 2013 and beyond.



Evolving trends, methods to benefit most IVD products



Evolving epidemiological trends and patient care approaches will impact favorably on growth opportunities for most types of IVD products. The market for clinical chemistry reagents and instruments will benefit from more diabetic patients engaging in self-blood glucose monitoring and from the expanding use of general health screening in routine patient examinations. The widening availability of chemiluminescent tests with inherent sensitivity and selectivity advantages will broaden applications for immunoassays in monitoring therapeutic drugs, detecting drugs of abuse and testing infectious diseases. Due to their ability to quantify heart attack and embolism risk prior to occurrence, hemostasis tests for D-Dimer and other cardiac parameters will provide the best growth opportunities among IVD blood testing products. Demand for nucleic acid diagnostics will expand at a strong pace as next-generation PCR (polymerase chain reaction) and microarray technologies penetrate applications involving the analysis and characterization of complex infections and tumors. DNA-based forensic, genetic and identity testing will comprise the fastest growing IVD application through 2013 as revenues from law enforcement and genetic screening markets rise. Among other IVD products, cellular analysis and anatomical pathology reagents and instruments will post the fastest gains in demand. Cellular analysis techniques will continue to dominate cervical cancer testing and penetrate additional cancer diagnostic applications. Anatomical pathology will remain the leading IVD technique for biopsy-based cancer/disease detection.





Hospital labs to remain largest IVD product market





Hospital laboratories will continue to comprise the largest market for IVD products because of extensive inpatient, emergency and post-surgical testing activities. The upgrading of testing services will keep independent clinical laboratories the second largest overall and fastest growing professional market served by the IVD industry. Noninstitutional point of care segments, consisting of physicians’ offices and outpatient clinics, will see below average gains in IVD product demand due to the low value-added nature of tests conducted and competition from hospital and independent clinical laboratories. Home health care will comprise the fasting growing IVD market through 2013, based on the expansion of self-blood glucose monitoring by diabetic patients. However, except for diabetes testing, the home health care market will remain relatively small due to the lack of cost effective products for self-use.



Study coverage



This new industry study, In Vitro Diagnostics presents historical demand data (1998, 2003, 2008) plus forecasts for 2013 and 2018 by IVD product type, methodology, application and market. The study also considers key US market environment factors, evaluates market share data and profiles industry players.

TABLE OF CONTENTS

INTRODUCTION xiii

I. EXECUTIVE SUMMARY 1

II. MARKET ENVIRONMENT 4
General 4
Macroeconomic Environment 5
Population & Demographic Trends 10
Health Care Trends 13
Acute Conditions 14
Chronic Conditions 16
Cancer & AIDS 18
Health Insurance Trends 21
National Health Expenditures 25
Medical Providers 28
Acute Care Hospitals 28
Physicians 29
Outpatient Facilities 30
Patient Activity 32
Hospital Activity 33
Surgical Procedures 33
Outpatient & Home Health Care Activity 34
IVD Product Overview 37
Regulation 37
Technology 40
Diagnostic Testing Volume 42
Clinical Laboratory Testing Services 43
Pricing Trends 45
Product Demand Patterns, 1998-2008 46
US Trade 48
International Markets 50

III. IVD PRODUCTS 54
General 54
Product Segments 56
Reagents & Consumables 59
Instruments & Systems 61
Clinical Chemistry Products 62
Professional Products 65
Reagents & Test Kits 66
Blood Glucose 67
Lipids 67
Electrolytes & Blood Gases 69
Proteins 70
Enzymes 70
Toxicology Reagents 71
Other Clinical Chemistry Reagents 71
Standards & Controls 72
Instruments & Systems 74
Applications 85
Producers 85
Self-Testing Products 86
Blood Glucose Monitoring Products 87
Test Strips & Discs 88
Monitors 90
Other Self-Testing Products 93
Immunoassay Products 94
Technology Overview 96
Competitive Immunoassays 97
Noncompetitive Immunoassays 97
Heterogeneous & Homogeneous Immunoassays 98
Labeling Techniques 98
Manual Immunoassays 100
Reagents & Test Kits 101
Enzyme Immunoassays 101
Chemiluminescent Immunoassays 102
Fluorescent Immunoassays 102
Radioimmunoassays 103
Instruments & Systems 103
Applications 104
Drug Testing 106
Therapeutic Drugs 106
Illicit Drugs 107
Infectious Disease Testing 108
Endocrine Condition Testing 108
Cancer Testing 109
Heart Disease Testing 110
Other Applications 110
Producers 111
Blood Testing Products 115
Hematology Products 116
Reagents & Consumables 117
Instruments & Systems 118
Applications 119
Producers 120
Blood Banking Products 121
Reagents & Consumables 122
Instruments & Systems 123
Applications 124
Producers 125
Hemostasis Products 127
Reagents & Consumables 128
Instruments & Systems 129
Applications 130
Producers 133
Nucleic Acid Testing Products 135
Technology Overview 137
Polymerase Chain Reaction (PCR) 138
Microarrays 139
DNA Sequencing 139
In Situ Hybridization (ISH) 140
Restriction Fragment Length Polymorphisms (RFLPs) 140
Amplified DNA Probes 140
Direct DNA Probes 143
Instruments & Systems 145
PCR Systems 145
Microarray Systems 147
Microarray Products 149
Types of Microarrays 150
IVD Applications 151
Disease Management 153
Forensic Medicine 154
Illicit Drug Testing 154
Consumables 155
Applications 157
Producers 159
Microbiology Products 159
Culture Media 160
Reagents & Consumables 161
Instruments & Systems 162
Applications 163
Producers 164
Cellular Analysis Products 165
Flow Cytometry Products 167
Reagents & Consumables 168
Instruments & Systems 168
Applications 170
Producers 170
Other Cellular Analysis Products 172
Reagents & Consumables 173
Instruments 174
Applications 176
Producers 177
Other IVD Products 177
Anatomical Pathology Products 178
Histology Products 179
Immunohistochemistry Products 181
Effusion & Visual Inspection Products 183
Visual Inspection Tests 184
Effusion Tests 185
Applications 186
Producers 187
Cytology Products 190
Reagents, Supplies & Instruments 191
Applications 193

IV. IVD APPLICATIONS 195
General 195
Endocrine Conditions 197
Diabetes Monitoring Products 199
Blood Glucose Test Strips 199
Blood Glucose Monitors 201
Other Diabetes Monitoring Products 202
Hemoglobin A1c 203
Microalbumin 204
Ketones 206
All Other Diabetes IVD Products 207
Pregnancy, Ovulation & Fertility Tests 208
Other IVD Products for Endocrine Conditions 209
Infectious Diseases 210
Sexually Transmitted Diseases 211
IVD Demand by Methodology 211
IVD Demand by Condition 212
AIDS/HIV 213
Chlamydia 216
Herpes 218
Gonorrhea 218
Other Sexually Transmitted Diseases 219
Other Infectious Diseases 220
IVD Demand by Methodology 220
IVD Demand by Condition 221
Hepatitis 222
All Other Infectious Diseases 224
Cancer 226
IVD Demand by Methodology 227
IVD Demand by Condition 228
Cervical Cancer 229
Breast Cancer 231
Prostate Cancer 233
Colorectal Cancer 234
Other Cancers 236
Drug Testing 236
Therapeutic Drug Monitoring (TDM) 238
Illicit Drug Testing 240
Heart Disease 242
Lipid Profiling 245
Cardiac Markers 246
Blood Proteins 247
Blood Grouping & Screening 248
Blood Typing & Matching 249
Blood & Bleeding Disorders 250
Forensic Medicine & Related Testing 251
Forensic Testing 252
Genetic Testing 253
Identity Testing 254
General Health Screening & Other IVD Applications 255
General Health Screening 256
Disease Detection & Other 258

V. IVD MARKETS 261
General 261
Hospitals 264
Independent Clinical Laboratories 266
Home Health Care 269
Outpatient Facilities 270
Other Markets 272

VI. INDUSTRY STRUCTURE 274
General 274
Market Share 277
Johnson & Johnson 278
Roche Holding 279
Siemens Healthcare Diagnostics 281
Abbott Laboratories 281
Beckman Coulter 282
Becton Dickinson 283
Competitive Strategies 284
Mergers & Acquisitions 285
Cooperative Agreements 290
Research & Development 294
Marketing & Distribution 296
Manufacturing 298
Company Profiles 300
454 Life Sciences, see Roche
Abbott Laboratories 301
Applied Biosystems Incorporated, see Life Technologies
Bayer AG 306
BD GeneOhm, see Becton Dickinson
Beckman Coulter Incorporated 308
Becton, Dickinson and Company 313
Bio-Rad Laboratories Incorporated 317
bioMerieux SA 319
Biosite Incorporated, see Inverness Medical Innovations
BioVeris Corporation, see Roche
Celera Corporation 322
Cholestech Corporation, see Inverness Medical Innovations
Cytopeia Incorporated, see Becton Dickinson
Cytyc Corporation, see Hologic
Dade Behring Incorporated, see Siemens
Danaher Corporation 324
Digene Corporation, see QIAGEN
First Check Diagnostics, see Inverness Medical Innovations
Gen-Probe Incorporated 325
Hologic Incorporated 327
Inverness Medical Innovations Incorporated 329
Invitrogen Corporation, see Life Technologies
Johnson & Johnson 335
Life Technologies Corporation 339
LifeScan Incorporated, see Johnson & Johnson
Lumigen Incorporated, see Beckman Coulter
Meridian Bioscience Incorporated 341
NimbleGen Systems Incorporated, see Roche
Olympus Corporation 343
Oncogene Science Incorporated, see Siemens
Ortho-Clinical Diagnostics, see Johnson & Johnson
QIAGEN NV 345
Quidel Corporation 347
Redwood Toxicology Laboratory Incorporated,
see Inverness Medical Innovations
Roche Holding Limited 348
Siemens AG 355
Swiss Precision Diagnostics, see Inverness Medical
Innovations
Sysmex Corporation 360
Thermo Fisher Scientific Incorporated 363
Third Wave Technologies Incorporated, see Hologic
Trinity Biotech plc 365
TriPath, see Becton Dickinson
Ventana Medical Systems Incorporated, see Roche
Veridex LLC, see Johnson & Johnson
Other Companies Mentioned in the Study 368

LIST OF TABLES

SECTION I -- EXECUTIVE SUMMARY
Summary Table 3

SECTION II -- MARKET ENVIRONMENT
1 Macroeconomic Indicators 10
2 Population & Demographics 13
3 Acute Conditions by Type 16
4 Chronic Conditions by Type 18
5 Cancer & AIDS Indicators 21
6 Health Insurance Coverage of the US Population, 1998-2008 24
7 National Health Expenditures by Type & Source 27
8 Acute Care Hospitals 29
9 Physicians & Physicians’ Offices 30
10 Outpatient Facilities 32
11 Hospital Activity 33
12 Surgical Procedures 34
13 Outpatient & Home Health Care Activity 36
14 Diagnostic Testing Volume 43
15 Clinical Laboratory Testing Sites & Revenues 45
16 IVD Product Demand, 1998-2008 48
17 US Trade in IVD Products 50
18 World IVD Product Demand by Region 53

SECTION III -- IVD PRODUCTS
1 IVD Demand by Product Group 56
2 IVD Product Demand by Methodology 58
3 IVD Reagent & Consumable Demand by Methodology 61
4 IVD Instrument & System Demand by Methodology 62
5 Clinical Chemistry Product Demand by Segment 65
6 Professional Clinical Chemistry Product Demand by Type 66
7 Common Clinical Chemistry Tests 76
8 Professional Clinical Chemistry Product Demand
by Application 85
9 Self-Testing Clinical Chemistry Product Demand by Type 87
10 Self-Testing Clinical Chemistry Product Demand
by Application 94
11 Immunoassay Product Demand by Type 96
12 Immunoassay Product Demand by Application 106
13 Blood Testing Product Demand by Methodology 116
14 Hematology Product Demand by Type 117
15 Hematology Product Demand by Application 120
16 Blood Banking Product Demand by Type 122
17 Blood Banking Product Demand by Application 125
18 Hemostasis Product Demand by Type 128
19 Hemostasis Product Demand by Application 132
20 Nucleic Acid Testing Product Demand by Type 136
21 Nucleic Acid Testing Product Demand by Application 158
22 Microbiology Product Demand by Type 160
23 Microbiology Product Demand by Application 164
24 Cellular Analysis Product Demand by Methodology 166
25 Flow Cytometry Product Demand by Type 167
26 Flow Cytometry Product Demand by Application 170
27 Other Cellular Analysis Product Demand by Type 173
28 Other Cellular Analysis Product Demand by Application 176
29 Other IVD Product Demand by Methodology 178
30 Anatomical Pathology Product Demand by Type 179
31 Anatomical Pathology Product Demand by Application 183
32 Effusion & Visual Inspection Product Demand by Type 184
33 Effusion & Visual Inspection Product Demand by Application 187
34 Cytology Product Demand by Type 190
35 Cytology Product Demand by Application 194

SECTION IV -- IVD APPLICATIONS
1 IVD Product Demand by Application 196
2 Endocrine Testing -- IVD Product Demand by Methodology
& Condition 198
3 Infectious Disease Testing -- IVD Product Demand
by Condition 210
4 Sexually Transmitted Disease (STD) Testing --
IVD Product Demand by Methodology 212
5 Sexually Transmitted Disease (STD) Testing --
IVD Product Demand by Condition 213
6 Other Infectious Disease Testing -- IVD Demand
by Methodology 221
7 Cancer Testing -- IVD Product Demand by Methodology 228
8 Cancer Testing -- IVD Product Demand by Condition 229
9 Drug Testing -- IVD Product Demand by Methodology
& Type 238
10 Heart Disease Testing -- IVD Product Demand
by Methodology 245
11 Blood Grouping & Screening -- IVD Product Demand
by Methodology 249
12 Forensic & Related Testing -- IVD Product Demand
by Methodology 252
13 General Health Screening & Other Applications --
IVD Product Demand by Methodology & Procedure 256

SECTION V -- IVD MARKETS
1 IVD Product Demand by Market 263
2 Hospital Laboratory IVD Product Demand 266
3 Independent Clinical Laboratory IVD Product Demand 268
4 Home IVD Product Demand 270
5 Outpatient IVD Product Demand 272
6 Other Markets: IVD Product Demand 273

SECTION VI -- INDUSTRY STRUCTURE
1 US IVD Product Sales by Company, 2008 276
2 Selected Acquisitions & Divestitures 287
3 Selected Cooperative Agreements 292

LIST OF CHARTS

SECTION III -- IVD PRODUCTS
1 IVD Product Demand by Methodology, 2008 58

SECTION IV -- IVD APPLICATIONS
1 IVD Product Demand by Application, 2008 197

SECTION V -- IVD MARKETS
1 IVD Product Demand by Market, 2008 263

SECTION VI -- INDUSTRY STRUCTURE
1 US IVD Product Sales, Market Share by Company, 2008 277