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In Vitro Diagnostics Industry

  • July 2012
  • -
  • Freedonia
  • -
  • 365 pages

IVD demand in US to reach nearly $25 billion in 2016

US demand for in vitro diagnostic (IVD) products will rise more than six percent annually to nearly $25 billion in 2016. Aging demographic patterns, expanding levels of health insurance coverages, and new product introductions will underlie gains. Growth in the middle aged and elderly population segments will boost overall health care needs, leading to a rising volume of IVD tests. The extension of health insurance coverage attributable to the Affordable Health Care Act of 2010 will make basic and specialized IVD procedures available to a greater number of individuals. Advances in cellular analysis, molecular diagnostic and other advanced technologies will expand applications for IVD products in disease detection, forensic medical, and identity testing.

Clinical chemistry, immunoassay to remain top products

Clinical chemistry and immunoassay will remain the top two IVD methodologies, the former based on sales of personal blood glucose monitors and test strips and the latter due to the penetration of high value-added chemiluminescent products into infectious disease and drug testing markets. Molecular diagnostic products will post the fastest growth in demand among all IVD products based on throughput, accuracy, and speed advantages, especially in the detection of infectious diseases and cancer markers. Diabetes testing will remain the largest IVD application through 2016 and beyond due to increasing blood glucose monitoring among afflicted patients.

Hemostasis tests for cardiac conditions offer best growth

Based on their ability to quantify heart attack and embolism risk prior to occurrence, hemostasis tests for D-dimer and other cardiac parameters will command the best growth among IVD blood testing products. Demand for molecular diagnostic products will expand at a strong pace as next-generation PCR (polymerase chain reaction) and FISH (fluorescence in situ hybridization) penetrate applications involving the analysis, characterization, and therapeutic monitoring of complex infections and tumors. DNA-based forensic, genetic, and identity testing will comprise one of the fastest growing IVD applications through 2016 as the vast potential of law enforcement and genetic screening markets begins to translate into significant revenues. Among other IVD products, cellular analysis and anatomical pathology reagents and instruments will post the best sales gains. 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 and infectious disease detection.

Diabetes testing to benefit clinical chemistry reagents & instruments

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 an increasing number of diabetic patients engaging in self-blood glucose monitoring and 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 therapeutic drug monitoring, drugs of abuse detection, and infectious disease testing.

Study coverage

Details on these and other findings are contained in the upcoming Freedonia industry study, In Vitro Diagnostics, presents historical demand data for 2001, 2006 and 2011, as well as forecasts for 2016 and 2021 by product, application, and market. This study also considers key market environment factors, evaluates company market share, and profiles 27 competitors in the US IVD industry.

Table Of Contents

In Vitro Diagnostics Industry
TABLE OF CONTENTS

INTRODUCTION xii

I. EXECUTIVE SUMMARY 1

II. MARKET ENVIRONMENT 4
General 4
Macroeconomic Outlook 5
Population and Age Distribution 8
Trends in Health Care 11
Medical Conditions 12
Acute Conditions 12
Chronic Conditions 13
Health Insurance Coverage 16
National Health Expenditures 19
Spending Categories 20
Funding Sources 22
Medical Providers 24
Hospitals 25
Outpatient Facilities 26
Physicians and Physicians' Offices 29
Home Health Care Providers 30
Other Medical Providers 31
Patient Activity 33
Hospital Activity 33
Surgical Procedures 34
Outpatient Activity 35
IVD Market Composition 37
Regulation 38
510(k) Pre-Market Notification 38
Pre-Market Approval (PMA) 39
Current Good Manufacturing Practices (cGMPs) 39
Packaging 39
Post-Marketing Surveillance 40
Laboratory Regulations 40
Medicare and Medicaid 41
Technology 41
Trends in IVD Testing 42
IVD Tests by Technology 43
IVD Testing Sites 45
Historical Market Trends 46
US Trade 48
World IVD Demand 50

III. PRODUCTS 54
General 54
Product Segments 57
Reagents and Consumables 59
Instruments and Systems 62
Clinical Chemistry Products 64
Reagents and Consumables 66
Blood Glucose 68
Lipids 68
Electrolytes and Blood Gases 69
Proteins 70
Enzymes 71
Toxicology Reagents 71
Other Reagents 72
Standards and Controls 73
Instruments and Systems 74
Clinical Chemistry Analyzers 75
Blood Glucose Monitors 76
Applications 77
Producers 78
Immunoassay Products 79
Reagents and Consumables 81
Enzyme Immunoassays 83
Chemiluminescent Immunoassays 84
Fluorescent Immunoassays 85
Radioimmunoassays 86
Instruments and Systems 87
Applications 89
Producers 90
Molecular Diagnostic Products 93
Technology Overview 94
Polymerase Chain Reaction (PCR) 95
Microarrays 96
DNA Sequencing 97
In Situ Hybridization 97
Restriction Fragment Length Polymorphisms (RFLPs) 97
Reagents and Consumables 98
Amplified DNA Probe Assays 98
Direct DNA Probes 99
Microarrays 100
Other Reagents and Consumables 101
Instruments and Systems 102
PCR Systems 103
Other Molecular Diagnostic Systems 104
Applications 105
Producers 107
Blood Testing Products 112
Hematology Products 113
Reagents and Consumables 114
Instruments and Systems 115
Applications 116
Producers 117
Blood Bank Products 119
Reagents and Consumables 120
Instruments and Systems 120
Applications 121
Producers 122
Hemostasis Products 124
Reagents and Consumables 125
Instruments and Systems 127
Applications 128
Producers 129
Cellular Analysis Products 131
Flow Cytometry Products 132
Reagents and Consumables 133
Instruments and Systems 134
Applications 135
Producers 136
Other Cellular Analysis Products 137
Reagents and Consumables 138
Instruments and Systems 139
Applications 141
Producers 142
Anatomical Pathology Products 142
Reagents and Consumables 143
Instruments and Systems 145
Applications 145
Producers 146
Microbiology Products 147
Reagents and Consumables 148
Instruments and Systems 150
Applications 151
Producers 152
Other IVD Products 153
Effusion and Visual Inspection Products 154
Reagents and Consumables 155
Instruments and Systems 157
Applications 157
Producers 158
Cytology Products 161
Reagents and Consumables 162
Instruments and Systems 162
Applications 163
Producers 164

IV. APPLICATIONS 165
General 165
Infectious Disease Testing 168
Sexually Transmitted Diseases 170
AIDS/HIV 172
Chlamydia 175
Herpes Simplex (HSV) 176
Gonorrhea 177
Other Sexually Transmitted Diseases 178
Other Infectious Diseases 178
Hepatitis 180
All Other Infectious Diseases 183
Cancer Testing 184
Cervical Cancer 187
Breast Cancer 189
Prostate Cancer 191
Colorectal Cancer 192
Other Cancers 194
Producers 195
Diabetes Testing 195
Reagents and Consumables 196
Blood Glucose Test Strips and Related Consumables 196
Other Reagents and Consumables 198
Instruments and Systems 201
Heart Disease Testing 202
Lipid Profiling 205
Cardiac Markers 206
Blood Proteins 207
Blood Grouping and Screening 208
Blood Typing and Matching 210
Blood and Bleeding Disorders 211
Drug Testing 212
Therapeutic Drug Monitoring 213
Drugs-of-Abuse Testing 215
Forensic Medicine 217
DNA Analysis 218
Identity Testing 219
Other Applications 220
Other IVD Applications 221
Disease Detection 223
General Health Screening 224
Pregnancy and Ovulation Testing 226

V. MARKETS 228
General 228
Hospitals 230
Independent Clinical Laboratories 232
Outpatient Facilities 235
Home Health Care Market 237
Physicians' Offices 239
Other Markets 241

VI. INDUSTRY STRUCTURE 243
General 243
Market Share 246
Competitive Strategies 253
Mergers and Acquisitions 255
Cooperative Agreements 258
Research and Development 269
Marketing and Distribution 271
Manufacturing 273
Company Profiles 275
Abbott Laboratories 276
Affymetrix Incorporated 281
Agilent Technologies Incorporated 283
Alere Incorporated 285
ARKRAY Incorporated 289
Axis-Shield, see Alere
Bayer AG 291
BD Diagnostics Infectious Disease, see Becton Dickinson
Beckman Coulter, see Danaher
Becton, Dickinson and Company 293
Bioline, see Meridian Bioscience
bioMerieux SA 297
Bio-Rad Laboratories Incorporated 302
Caliper Life Sciences, see PerkinElmer
Celera, see Quest Diagnostics
chemagen Biopolymer-Technologie, see PerkinElmer
CombiMatrix Corporation 304
Danaher Corporation 306
Focus Diagnostics, see Quest Diagnostics
Gen-Probe Incorporated 311
HemoCue, see Quest Diagnostics
Hologic Incorporated 315
Illumina Incorporated 317
Inverness Medical Innovations, see Alere
Johnson and Johnson 319
Leica Microsystems, see Danaher
LifeScan, see Johnson and Johnson
Life Technologies Corporation 323
Lumigen, see Danaher
Meridian Bioscience Incorporated 326
Myriad Genetics Incorporated 329
Ortho-Clinical Diagnostics, see Johnson and Johnson
PerkinElmer Incorporated 331
Phoenix Bio-Tech, see Trinity Biotech
QIAGEN NV 333
Quest Diagnostics Incorporated 338
Roche Holding Limited 341
Sequenom Incorporated 348
Siemens AG 350
Sysmex Corporation 356
Thermo Fisher Scientific Incorporated 359
Third Wave Technologies, see Hologic
Trinity Biotech plc 363
TriPath Imaging, see Becton Dickinson
Veridex, see Johnson and Johnson

LIST OF TABLES

SECTION I -- EXECUTIVE SUMMARY
Summary Table 3

SECTION II -- MARKET ENVIRONMENT
1 Macroeconomic Indicators 8
2 Resident Population by Age Group 11
3 Acute Conditions by Type 13
4 Chronic Conditions by Type 16
5 Health Insurance Coverage of the US Population 19
6 National Health Expenditures by Category 21
7 National Health Expenditures by Source 24
8 Hospitals and Hospital Beds 26
9 Number of Outpatient Facilities by Type 29
10 Physicians and Physicians' Offices 30
11 Home Health Care Indicators 31
12 Number of Other Medical Providers by Type 33
13 Hospital Activity 34
14 Surgical Procedures by Site 35
15 Outpatient Episodes by Type 37
16 IVD Tests by Technology 45
17 IVD Testing Sites 46
18 IVD Product Market, 2001-2011 48
19 US Trade in IVD Products 50
20 World IVD Product Demand by Region 53

SECTION III -- PRODUCTS
1 IVD Product Demand by Type 56
2 IVD Product Demand by Technology 58
3 IVD Reagent and Consumable Demand by Technology 62
4 IVD Instrument and System Demand by Technology 63
5 Clinical Chemistry Product Demand by Type 66
6 Clinical Chemistry Reagent and Consumable Demand by Type 67
7 Clinical Chemistry Instrument and System Demand by Type 75
8 Clinical Chemistry Product Demand by Application 78
9 Immunoassay Product Demand by Type 80
10 Immunoassay Reagent and Consumable Demand by Type 83
11 Immunoassay Instrument and System Demand by Type 89
12 Immunoassay Product Demand by Application 90
13 Molecular Diagnostic Product Demand by Type 94
14 Molecular Diagnostic Reagent and Consumable Demand by Type 98
15 Molecular Diagnostic Instrument and System Demand by Type 103
16 Molecular Diagnostic Product Demand by Application 107
17 Blood Testing Product Demand by Technology 113
18 Hematology Product Demand by Type 114
19 Hematology Product Demand by Application 117
20 Blood Bank Product Demand by Type 119
21 Blood Bank Product Demand by Application 122
22 Hemostasis Product Demand by Type 125
23 Hemostasis Product Demand by Application 129
24 Cellular Analysis Product Demand by Technology 132
25 Flow Cytometry Product Demand by Type 133
26 Flow Cytometry Product Demand by Application 136
27 Other Cellular Analysis Product Demand by Type 138
28 Other Cellular Analysis Product Demand by Application 142
29 Anatomical Pathology Product Demand by Type 143
30 Anatomical Pathology Product Demand by Application 146
31 Microbiology Product Demand by Type 148
32 Microbiology Product Demand by Application 152
33 Other IVD Product Demand by Technology 154
34 Effusion and Visual Inspection Product Demand by Type 155
35 Effusion and Visual Inspection Product Demand by Application 158
36 Cytology Product Demand by Type 161
37 Cytology Product Demand by Application 164

SECTION IV -- APPLICATIONS
1 IVD Product Demand by Application 167
2 Infectious Disease Testing IVD Product Demand by Type, Technology, and Condition 169
3 Sexually Transmitted Disease (STD) Testing IVD Product Demand by Type, Technology, and Condition 171
4 Other Infectious Disease Testing IVD Product Demand by Type, Technology, and Condition 180
5 Cancer Testing IVD Product Demand by Type, Technology, and Condition 186
6 Diabetes Testing IVD Product Demand by Type 196
7 Heart Disease Testing IVD Product Demand by Type, Technology, and Condition 205
8 Blood Grouping and Screening IVD Product Demand by Type, Technology, and Application 210
9 Drug Testing IVD Product Demand by Type, Technology, and Function 213
10 Forensic Medicine IVD Product Demand by Type, Technology, and Function 218
11 Other Applications IVD Product Demand by Type, Technology, and Function 222

SECTION V -- MARKETS
1 IVD Product Demand by Market 229
2 Hospital IVD Product Demand by Type and Technology 232
3 Independent Clinical Laboratory IVD Product Demand by Type and Technology 235
4 Outpatient Facility IVD Product Demand by Type and Technology 237
5 Home Health Care IVD Product Demand by Type and Technology 239
6 Physicians' Office IVD Product Demand by Type and Technology 240
7 Other Markets IVD Product Demand by Type and Technology 242

SECTION VI -- INDUSTRY STRUCTURE
1 IVD Product Sales by Company, 2011 244
2 Selected Acquisitions and Divestitures 256
3 Selected Cooperative Agreements 260

LIST OF CHARTS

SECTION II -- MARKET ENVIRONMENT
1 National Health Expenditures by Category, 2011 22

SECTION III -- PRODUCTS
1 IVD Product Demand by Type, 2001-2021 56
2 IVD Product Demand by Technology, 2011 59

SECTION IV -- APPLICATIONS
1 IVD Product Demand by Application, 2011 168

SECTION V -- MARKETS
1 IVD Product Demand by Market, 2011 230

SECTION VI -- INDUSTRY STRUCTURE
1 IVD Product Market Share, 2011 247

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