US demand for in vitro (IVD) diagnostic products will rise 6.1 percent annually to $24.7 billion in 2016. Molecular diagnostic products will grow the fastest due to their advantages in the detection of infectious diseases, tumors and genetic disorders. Hospital labs will continue to comprise the largest and most diverse market.

This study analyzes the $18.4 billion US IVD products industry, with forecasts for 2016 and 2021 by product type (e.g., clinical chemistry, immunoassay, molecular diagnostic, blood testing, cellular analysis, anatomical pathology, microbiology), application (e.g., infectious disease testing, cancer testing, diabetes testing, heart disease testing, blood grouping and screening, drug testing) and market (e.g., hospitals, independent clinical laboratories).

The study also considers market environment factors, details industry structure, evaluates company market share and profiles 27 industry players, including Roche, Johnson & Johnson and Danahar).

				    TABLE OF CONTENTS

     SECTION									    PAGE

		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

    TABLE NUMBER								    PAGE


		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

    CHART NUMBER								    PAGE

		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