In Vitro Diagnostics Industry

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In Vitro Diagnostics Industry

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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

 

INTRODUCTION xii

 

I. EXECUTIVE SUMMARY 1

 

II. MARKET ENVIRONMENT 4

General 4

Macroeconomic Outlook 5

Population & 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 & 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 & 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 & Consumables 59

Instruments & Systems 62

Clinical Chemistry Products 64

Reagents & Consumables 66

Blood Glucose 68

Lipids 68

Electrolytes & Blood Gases 69

Proteins 70

Enzymes 71

Toxicology Reagents 71

Other Reagents 72

Standards & Controls 73

Instruments & Systems 74

Clinical Chemistry Analyzers 75

Blood Glucose Monitors 76

Applications 77

Producers 78

Immunoassay Products 79

Reagents & Consumables 81

Enzyme Immunoassays 83

Chemiluminescent Immunoassays 84

Fluorescent Immunoassays 85

Radioimmunoassays 86

Instruments & 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 & Consumables 98

Amplified DNA Probe Assays 98

Direct DNA Probes 99

Microarrays 100

Other Reagents & Consumables 101

Instruments & Systems 102

PCR Systems 103

Other Molecular Diagnostic Systems 104

Applications 105

Producers 107

Blood Testing Products 112

Hematology Products 113

Reagents & Consumables 114

Instruments & Systems 115

Applications 116

Producers 117

Blood Bank Products 119

Reagents & Consumables 120

Instruments & Systems 120

Applications 121

Producers 122

Hemostasis Products 124

Reagents & Consumables 125

Instruments & Systems 127

Applications 128

Producers 129

Cellular Analysis Products 131

Flow Cytometry Products 132

Reagents & Consumables 133

Instruments & Systems 134

Applications 135

Producers 136

Other Cellular Analysis Products 137

Reagents & Consumables 138

Instruments & Systems 139

Applications 141

Producers 142

Anatomical Pathology Products 142

Reagents & Consumables 143

Instruments & Systems 145

Applications 145

Producers 146

Microbiology Products 147

Reagents & Consumables 148

Instruments & Systems 150

Applications 151

Producers 152

Other IVD Products 153

Effusion & Visual Inspection Products 154

Reagents & Consumables 155

Instruments & Systems 157

Applications 157

Producers 158

Cytology Products 161

Reagents & Consumables 162

Instruments & 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 & Consumables 196

Blood Glucose Test Strips & Related Consumables 196

Other Reagents & Consumables 198

Instruments & Systems 201

Heart Disease Testing 202

Lipid Profiling 205

Cardiac Markers 206

Blood Proteins 207

Blood Grouping & Screening 208

Blood Typing & Matching 210

Blood & 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 & 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 & Acquisitions 255

Cooperative Agreements 258

Research & Development 269

Marketing & 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 & Johnson 319

Leica Microsystems, see Danaher

LifeScan, see Johnson & Johnson

Life Technologies Corporation 323

Lumigen, see Danaher

Meridian Bioscience Incorporated 326

Myriad Genetics Incorporated 329

Ortho-Clinical Diagnostics, see Johnson & 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 & 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 & Hospital Beds 26

9 Number of Outpatient Facilities by Type 29

10 Physicians & 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 & Consumable Demand by Technology 62

4 IVD Instrument & System Demand by Technology 63

5 Clinical Chemistry Product Demand by Type 66

6 Clinical Chemistry Reagent & Consumable Demand by Type 67

7 Clinical Chemistry Instrument & System Demand by Type 75

8 Clinical Chemistry Product Demand by Application 78

9 Immunoassay Product Demand by Type 80

10 Immunoassay Reagent & Consumable Demand by Type 83

11 Immunoassay Instrument & System Demand by Type 89

12 Immunoassay Product Demand by Application 90

13 Molecular Diagnostic Product Demand by Type 94

14 Molecular Diagnostic Reagent & Consumable Demand by Type 98

15 Molecular Diagnostic Instrument & 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 & Visual Inspection Product Demand by Type 155

35 Effusion & 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, & Condition 169

3 Sexually Transmitted Disease (STD) Testing IVD Product Demand by Type, Technology, & Condition 171

4 Other Infectious Disease Testing IVD Product Demand by Type, Technology, & Condition 180

5 Cancer Testing IVD Product Demand by Type, Technology, & Condition 186

6 Diabetes Testing IVD Product Demand by Type 196

7 Heart Disease Testing IVD Product Demand by Type, Technology, & Condition 205

8 Blood Grouping & Screening IVD Product Demand by Type, Technology, & Application 210

9 Drug Testing IVD Product Demand by Type, Technology, & Function 213

10 Forensic Medicine IVD Product Demand by Type, Technology, & Function 218

11 Other Applications IVD Product Demand by Type, Technology, & Function 222

 

SECTION V -- MARKETS

1 IVD Product Demand by Market 229

2 Hospital IVD Product Demand by Type & Technology 232

3 Independent Clinical Laboratory IVD Product Demand by Type & Technology 235

4 Outpatient Facility IVD Product Demand by Type & Technology 237

5 Home Health Care IVD Product Demand by Type & Technology 239

6 Physicians' Office IVD Product Demand by Type & Technology 240

7 Other Markets IVD Product Demand by Type & Technology 242

 

SECTION VI -- INDUSTRY STRUCTURE

1 IVD Product Sales by Company, 2011 244

2 Selected Acquisitions & 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

 

 

 

To order this report:

In Vitro Diagnostic Industry: In Vitro Diagnostics Industry

 

 

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Nicolas Bombourg
Reportlinker
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