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This report describes the specific segment of the in vitro diagnostics (IVD) market known as drugs of abuse testing. This term is used to distinguish it from testing for therapeutic drugs. In the current medical diagnostics market, drugs of abuse testing offers promise for growth and innovation. The development of this sector of the diagnostics industry has been driven by: 1) The use mass spec instrumentation for drug-screening confirmation, the development of a wide variety of MS and separation based technology platforms; the rise of drug profiling; new developments in diagnosis and treatment of drug dependence; the need for screening both therapeutic and illicit drug content; improved detection levels; and the use of computer assisted data analysis and multiplexing. Specifically, areas examined in this study include: available and developing technologies in the field, the U.S. and global market size for drugs of abuse testing products, and the profiles of companies that are focusing on the drugs of abuse testing market. Detailed charts with sales forecasts and market share data for the U.S. and global drugs of abuse testing markets are included.

TABLE OF CONTENTS

1. Overview 12
1.1 Statement of Report 12
1.2 About This Report 12
1.3 Scope of the Report 13
1.4 Objectives 14
1.5 Methodology 15
1.6 Executive Summary 16

2. Introduction to Drugs of Abuse Testing 20
2.1 Drugs of Abuse Overview 20
2.2 Initiation of Illicit Drug Use 37
2.3 Major Drugs of Abuse 45
2.3.1 Amphetamines 45
2.3.2 Tricyclic Antidepressants (TCAs) 46
2.3.3 Barbiturates 47
2.3.4 Benzodiazepines 48
2.3.5 Cannabinoids/Marijuana 51
2.3.6 Cocaine 53
2.3.7 Lysergic Acid Diethylamide (LSD) 54
2.3.8 Methadone 56
2.3.9 Methaqualone and Phencyclidine (PCP) 57
2.3.10 Opiates—Heroin and OxyContin 60
2.4 Alcohol Testing 62
2.5 Test Methodologies 63
2.6 Drug Panels by Toxidromes 66
2.7 Drugs of Abuse Home Use Test 67

3. Drugs of Abuse Testing Markets 70
3.1 IVD Global Clinical Diagnostic Testing Market 70
3.2 Drugs of Abuse Testing Market Analysis 71
3.2.1 Main Players in the Industry 71
3.2.1.1 Roche Diagnostics Market Analysis 72
3.2.1.2 Abbott Laboratories Market Analysis 75
3.2.1.3 Siemens Market Analysis 76
3.2.1.4 Thermo Fisher Market Analysis 77
3.2.1.5 Beckman Coulter Market Analysis 78
3.2.1.6 OraSure Market Analysis 79
3.2.1.7 Inverness Medical Innovations Market Analysis 80
3.3 Diagnostic Testing in the Future 81

4. Market Size and Analysis for Drugs of Abuse Testing 82
4.1 Global Drugs of Abuse Testing Analysis 82
4.2 U.S. Drugs of Abuse Testing Analysis 83
4.3 European Union Drugs of Abuse Testing Analysis 84
4.4 Rest of World Drugs of Abuse Testing Analysis 85
4.4.1 Global Drivers of Drugs of Abuse Testing 86
4.4.2 Global Outlook 86
4.4.3 U.S. Market 87
4.4.4 European Market 88
4.5 Market Drivers 89
4.6 Market Restraints 89
4.7 Market and Technology Trends 90
4.7.1 Market Trends 90
4.7.2 Technology Trends 91
4.8 Strategic Recommendations 91

5. Specific Market Sectors for Drugs of Abuse Testing 93
5.1 Workplace Drugs of Abuse Laboratory Testing Methods 93
5.1.1 Introduction 93
5.1.2 Major U.S. Companies that Drug Test Employees 93
5.1.3 Drugs of Abuse Testing—A Recovering Market 94
5.1.4 Rising Pre-Employment Testing 94
5.1.5 A Growth in Alternative Specimen and Instant Drugs of Abuse Testing 99
5.2 Prescription Drugs of Abuse Market 101
5.2.1 Prescription Drugs and the Pain Market 105
5.2.2 Economic Burden of Prescription Opioid Misuse and Abuse 106
5.2.3 U.S. Food and Drug Administration Clampdown on Prescription Drug Misuse 108
5.2.4 Narcotic Analgesic Prescription Trends 108
5.3 Human Sports Drugs of Abuse Testing Markets 109
5.3.1 Introduction to the Market 109
5.3.2 Internationally Accredited Anti-Doping Laboratories 112
5.3.3 World Anti-Doping Agency Statistics 114
5.3.4 Anti-Doping International Investment Promotes Test Market 121
5.3.5 World Anti-Doping Agency Scientific Research Program 122
5.3.6 Out-of-Competition Testing Promotes Market 122
5.3.7 Use of Drugs of Abuse International Markets 122

6. Company Specific Instrumentation and Test Kit Review 124
6.1 Biosite Diagnostics (Inverness, now called Alere) 124
6.2 Abbott Diagnostics 125
6.3 Roche Diagnostics 126
6.4 BioScan Screening Systems, Inc. 127
6.5 American Bio Medica Corp. 127
6.6 Phamatech, Inc. 131
6.7 First Check Medical Corp. 131
6.8 OraSure 132
6.9 Avitar, Inc. 132
6.10 Concateno 133
6.11 Pathtech 133
6.12 Alfa Scientific Designs, Inc. 133
6.13 TCPI, Inc. 134
6.14 Roche 134
6.15 Biophor Diagnostics 134
6.16 Alpha Scientific Designs 135
6.17 Princeton BioMeditech, Inc. 138
6.18 American BioMedica 138
6.19 Beckman Coulter 139
6.20 Bio-Rad 140
6.21 Siemens Healthcare Diagnostics 141
6.22 Thermo Fisher Scientific 142
6.23 Agilent Technologies 142
6.24 Randox 143
6.25 Awareness Technology 145
6.26 Carolina Chemistries 146
6.27 Horiba Medical 146
6.28 Ortho Clinical Diagnostics—Johnson & Johnson 146
6.29 Medica Corporation, Inc. 147
6.30 Tecan 147

7. In Vitro Diagnostic Technologies and Potential Applications 148
7.1 Performance Characteristics Required for Implementation of FDA-Approved/Cleared Tests 148
7.2 Immunoassays 148
7.3 Technology Principle 149
7.4 Enzyme Immunoassays 149
7.4.1 Enzyme-Linked Immunosorbant Assay (ELISA) 149
7.4.2 Enzyme Multiplied Immunoassay Technique (EMIT) 150
7.4.3 Cloned Enzyme Donor Immunoassay (CEDIA) 151
7.4.4 Radio Immunoassay (RIA) 151
7.4.5 Fluorescence Polarization Immunoassay (FPIA) 151
7.4.6 Lateral Flow Immunoassays 152
7.5 Future Trends of Immunoassays 152
7.6 Latex Agglutination 152
7.7 Immunoprecipitation (IP) 152
7.8 Flow-Injection Liposome Immunoanalysis (FIIA) 153
7.9 Clinical Immunoanalyzer Instrument Market by Sector 153
7.9.1 Market Analysis: Size, Growth, Share and Competitors 153
7.9.1.1 Large- and Mid-Volume Immunochemistry Analyzers 153
7.9.1.2 Abbott Diagnostics 153
7.9.1.3 Siemens Medical Solutions Diagnostics 155
7.9.1.4 Beckman Coulter, Inc. 160
7.9.1.5 Dade Behring (Acquired by Siemens) 162
7.9.1.6 Diagnostics Products Corporation (Acquired by Siemens Healthcare Diagnostics) 162
7.9.1.7 Olympus America, Inc. (now Beckman Coulter) 164
7.9.1.8 Ortho-Clinical Diagnostics 165
7.9.1.9 Roche Diagnostics Corp. 168
7.9.1.10 Tosoh Bioscience, Inc. 169
7.9.1.11 Batch-type Immunoassay Analyzers 171
7.9.1.12 Bio-Rad 171
7.9.1.13 Diamedix Corporation 171
7.9.1.14 Tosoh 174
7.9.2 Small- to Mid-Volume Immunoassay Analyzers 174
7.9.2.1 Awareness Technology, Inc. 174
7.9.2.2 Siemens Healthcare Diagnostics, Inc. 174
7.9.2.3 Beckman Coulter, Inc. 175
7.9.2.4 bioMérieux SA 176
7.9.2.5 Dade Behring (Acquired by Siemens) 176
7.9.2.6 Randox Laboratories Ltd. 180
7.9.2.7 Tosoh Corporation 181
7.9.3 Other Immunoassay Analyzers 182
7.9.3.1 Inverness Medical Professional Diagnostics 182
7.9.3.2 Hycor Biomedical (A Part of Agilent Technologies) 183
7.9.3.3 Phadia AB 183
7.9.3.4 Trinity Biotech Plc 183
7.9.3.5 DiaSorin 183
7.9.3.6 Grifols U.S.A., Inc. 183
7.9.3.7 Bio-Rad Laboratories, Inc. 184
7.9.3.8 SFRI Diagnostics 184
7.9.3.9 Qualigen, Inc. 185
7.9.3.10 PerkinElmer, Inc. 185
7.9.3.11 Innotrac Diagnostics Oy 185
7.9.3.12 Tecan Group Ltd. 185

8. Business Analysis of Drugs of Abuse Testing Market 187
8.1 Ultra-large Clinical Chemistry Analyzers 187
8.1.1 Beckman Coulter 187
8.1.2 Roche Diagnostics 190
8.1.3 Siemens Medical Solutions 191
8.1.4 Ortho Clinical Diagnostics 196
8.1.5 Abbott Diagnostics 197
8.1.6 Siemens Healthcare Diagnostics 201
8.1.7 JEOL Ltd. 205
8.1.8 Siemens Healthcare Diagnostics 206
8.2 Mid-Size Clinical Chemistry Analyzers 208
8.2.1 Abbott 208
8.2.2 Beckman Coulter, Inc. 209
8.2.3 Ortho-Clinical Diagnostics, Inc. 210
8.2.4 Roche Diagnostics Corporation 210
8.2.5 Randox Laboratories 211
8.2.6 Siemens 211
8.2.7 Nova Biomedical Corporation 214
8.2.8 Clinical Data, Inc. 214
8.2.9 Polymedco, Inc. 215
8.2.10 Hitachi America Ltd. 215
8.2.11 Shimadzu Corp. 215
8.2.12 Thermo Fisher Scientific Inc. 216
8.2.13 Carolina Liquid Chemistries 216
8.3 Small Volume Chemistry Analyzers 218
8.3.1 Clinical Data, Inc. 219
8.3.2 Nova Biomedical Corporation 219
8.3.3 Ortho-Clinical Diagnostics 220
8.3.4 BPC BioSed srl 221
8.3.5 Abbott Laboratories 221
8.3.6 Roche Diagnostics 221
8.3.7 Beckman Coulter 222
8.3.8 Vital Diagnostics 222
8.3.9 Nova Biomedical 222
8.3.10 Alfa Wassermann 222
8.3.11 Hitachi 223
8.3.12 Randox Laboratories 223
8.3.13 Abaxis 224
8.3.14 Siemens 224
8.3.15 Awareness Technology 224
8.3.16 Adaltis 225
8.3.17 Polymedco 225
8.3.18 Thermo Scientific 225
8.4 Advance of Technology Trends 227
8.4.1 Advancement of Genomics and the Pharmacogenetics of Drug Addiction 227
8.4.2 Challenges within Genetic Research of Drug Addiction 229
8.5 Ultra-Large Clinical Chemistry Analyzer Market Analysis 232
8.6 High Volume Clinical Chemistry Market 233
8.7 Mid-Size Clinical Chemistry Analyzers 235
8.8 Small-Volume Chemical Analyzer Market 236
8.9 Competitive Analysis 236

9. SWOT Analysis 239
9.1 Main Drivers of Drugs of Abuse Testing Market 239
9.2 Potential Threats and Restraints of the Drugs of Abuse Testing Market 240
9.3 Challenges of this Market Place Going Forward 240
9.4 Summary of Market Strengths, Weaknesses, Opportunities and Threats 242
9.5 Summary of Strengths, Weaknesses, Opportunities and Threats of Drugs of Abuse Test Market 243

10. Reimbursement Systems 244
10.1 Reimbursement for Laboratory Medicine 244
10.2 Public and Private Sector Payers 244
10.3 Components of Reimbursement Systems 246
10.4 Medicare Coverage Decisions 246
10.5 Medicaid Coverage Decisions 247
10.6 Private Sector Coverage Decisions 247
10.7 Payment Methodologies 248
10.8 Medicare Payment Methodologies 248
10.9 Prospective Payment Systems for Inpatient and Hospital Outpatient Care 249
10.10 Using Fee Schedules for Laboratory Tests and Services 249
10.11 Clinical Laboratory Fee Schedule 250
10.12 Coding System Used for Qualitative Drug Tests 250

11. Government Regulation 254
11.1 U.S. Regulation 254
11.1.1 Medical Devices as Regulated by the U.S. Food and Drug Administration 254
11.1.2 Pre-Market Approval (PMA) 254
11.1.3 510(k) Clearance 255
11.1.4 Importing Medical Devices into the U.S. 255
11.1.5 Exporting Medical Devices from the U.S. 256
11.2 U.K. Regulation 256
11.3 E.U. Regulation 258
11.4 French Regulation 259
11.5 Japanese Regulation 260
11.6 Korean Regulation 260
11.7 Clinical Laboratory Improvement Amendments (CLIA) 260
11.8 Omnibus Transportation Employee Testing Act 261
11.9 Employer Drug and Alcohol Compliance 262
11.10 Regulations Governing Drug Abuse Testing 263
11.10.1 Specimen Collection and Management 263
11.10.2 Test Operations and Cut-off Values 264
11.10.3 Quality Control and Quality Assurance 265
11.10.4 Medical Review Officers and the Verification Process 266
11.10.5 Confidentiality and Release of Information 268
11.11 The U.S. Anti-Doping Agency 268
11.12 Drugs of Abuse Testing in the Criminal Justice System 270

12. Company Profiles 273
12.1 Abbott Laboratories 273
12.2 AdnaGen 273
12.3 Ambrilia Biopharma 273
12.4 Radient Pharmaceuticals (Formerly AMDL) 274
12.5 Beckman Coulter, Inc. 274
12.6 Biomedical Diagnostics (Belgium) 274
12.7 bioMérieux 274
12.8 Bio-Rad Laboratories 274
12.9 CanAg Diagnostics 275
12.10 Dako 275
12.11 DiaSorin 275
12.12 Eiken Chemical 275
12.13 Fujirebio 275
12.14 Instrumentation Laboratory 276
12.15 Johnson & Johnson 276
12.16 Kyowa Medex 277
12.17 Matritech 277
12.18 Roche 277
12.19 Siemens AG 278
12.20 Sysmex 278
12.21 Thermo Fisher Scientific 279
12.22 Tosoh 280
12.23 Trinity Biotech 280
12.24 Wako 281
12.25 Wallac 281


INDEX OF FIGURES

Figure 2.1: Drug Classification According to Mean Harm Rating 21
Figure 2.2: Percentage of U.S. 12th Grade Students Reporting Past Month Use of Cigarettes and Marijuana,
1975-2010 22
Figure 2.3: Percentage of U.S. 12th Grade Students Reporting Daily Marijuana Use Verses Perceived Risk of Regular Marijuana Use, 1975-2010 22
Figure 2.4: Prevalence of Drug Abuse Occurring in 12th Grade Students, 2010 23
Figure 2.5: Past Month Illicit Drug Use Among Persons Aged 12 or Older, 2009 29
Figure 2.6: Past Month Use of Selected Illicit Drugs Among Persons Aged 12 or Older, 2002-2009 30
Figure 2.7: Past Month Non-Medical Use of Types of Psychotherapeutic Drugs Among Persons Aged 12 or Older, 2002-2009 30
Figure 2.8: Past Month Illicit Drug Use Among Persons Aged 12 or Older, by Age, 2008 and 2009 31
Figure 2.9: Past Month Illicit Drug Use Among Persons Aged 12 or Older, by Age, 2002-2009 31
Figure 2.10: Past Month Use of Selected Illicit Drugs Among Youths Aged 12 to 17, 2002-2009 32
Figure 2.11: Past Month Use of Selected Illicit Drugs Among Young Adults Aged 18 to 25, 2002-2009 32
Figure 2.12: Past Month Illicit Drug Use Among Adults Aged 50 to 59, 2002-2009 33
Figure 2.13: Past Month Marijuana Use Among Youths Aged 12 to 17, by Gender, 2002-2009 33
Figure 2.14: Past Month Illicit Drug Use Among Persons Aged 12 or Older, by Race/Ethnicity, 2009 34
Figure 2.15: Past Month Illicit Drug Use Among Persons Aged 18 or Older, by Employment Status,
2008 and 2009 34
Figure 2.16: Past Month Illicit Drug Use Among Persons Aged 12 or Older, by County Type 35
Figure 2.17: Current, Binge, and Heavy Alcohol Use Among Persons Aged 12 or Older, by Age 36
Figure 2.18: Current, Binge, and Heavy Alcohol Use Among Persons Aged 12 or Older, by Race/Ethnicity 36
Figure 2.19: Heavy Alcohol Use Among Adults Aged 18 to 22, by College Enrollment, 2002-2009 37
Figure 2.20: First Specific Drug Associated with Initiation of Illicit Drug Use Among Past Year Illicit Drug Initiates Aged 12 or Older 37
Figure 2.21: Past Year Initiates of Specific Illicit Drugs Among Persons Aged 12 or Older 38
Figure 2.22: Mean Age at First Use for Specific Illicit Drugs Among Past Year Initiates Aged 12 to 49 38
Figure 2.23: Past Year Marijuana Initiates Among Persons Aged 12 or Older and Mean Age at First Use of Marijuana Among Past Year Marijuana Initiates Aged 12 to 49, 2002-2009 39
Figure 2.24: Past Year Hallucinogen Initiates Among Persons Aged 12 or Older, 2002-2009 40
Figure 2.25: Past Year Methamphetamine Initiates Among Persons Aged 12 or Older and Mean Age at First Use of Methamphetamine Among Past Year Methamphetamine Initiates Aged 12 to 49, 2002-2009 40
Figure 2.26: Substance Dependence or Abuse in the Past Year Among Persons Aged 12 or Older,
2002-2009 41
Figure 2.27: Dependence on or Abuse of Specific Illicit Drugs in the Past Year Among Persons
Aged 12 or Older 42
Figure 2.28: Substance Dependence or Abuse in the Past Year, by Age and Gender 42
Figure 2.29: Number of Abusers of Marijuana in the U.S., 2007-2009 43
Figure 2.30: Number of U.S. Abusers of Cocaine, 2006-2009 43
Figure 2.31: Number of U.S. Abusers of Psychotherapeutic Drugs, 2007-2009 44
Figure 2.32: Methamphetamine User Prevalence, 2006-2009 44
Figure 2.33: Chemical Structure of Amphetamine 45
Figure 2.34: Chemical Structure of Barbituates 47
Figure 2.35: Chemical Structure of Benzodiazepines 49
Figure 2.36: Chemical Structure of Cannabinoid/Marijuana 52
Figure 2.37: Chemical Structure of Cocaine 53
Figure 2.38: Chemical Structure of Lysergic Acid Diethylamide (LSD) 55
Figure 2.39: Chemical Structure of Methadone 57
Figure 2.40: Chemical Structure of Methaqualone 58
Figure 2.41: Chemical Structure of Phenylcyclidine 58
Figure 2.42: Chemical Structure of Heroin 60
Figure 2.43: Chemical Structure of OxyContin 61
Figure 3.1: Roche Diagnostics Sales Volume, 2008-2010 73
Figure 3.2: Roche Diagnostics Core Operating Profit, 2008-2010 73
Figure 3.3: Roche Diagnostics Sales by Global Region, 2010 74
Figure 3.4: Abbott Laboratories Global Annual Sales, 2007-2010 75
Figure 3.5: Abbott Laboratories Operating Cash Flow, 2007-2010 75
Figure 3.6: Abbott Laboratories Net Sales—Diagnostics Division, 2008-2010 76
Figure 3.7: Siemens Market Share by Geographic Region, 2010 77
Figure 3.8: Thermo Fisher Revenue Generated by Geographic Region, 2010 77
Figure 3.9: Beckman Coulter Revenue by Geographic Region, 2009 78
Figure 3.10: Beckman Coulter Division of Sales, 2009 79
Figure 3.11: Revenue Generated by OraSure’s Oral Fluid Collection Devices, 2008-2010 80
Figure 4.1: Global Revenue of Drugs of Abuse Testing Market Forecast, 2007-2015 82
Figure 4.2: U.S. Revenue of Drugs of Abuse Testing Market Forecast, 2007-2015 83
Figure 4.3: E.U. Revenue of Drugs of Abuse Testing Market Forecast, 2007-2015 84
Figure 4.4: Rest of World Revenue of Drugs of Abuse Testing Market Forecast, 2007-2015 85
Figure 4.5: Global In-Vitro Diagnostic Market Revenue Forecast, 2010-2016 90
Figure 5.1: Percentage of U.S. Workforce Testing Positive for Drugs of Abuse, 1988-2010 97
Figure 5.2: Total U.S. Prescription Market Revenue, 2006-2010 101
Figure 5.3: Total Spending on Prescription Narcotic Analgesics in the U.S., 2006-2010 102
Figure 5.4: Total Number of Narcotic Analgesic Prescriptions in the U.S., 2006-2010 103
Figure 5.5: Number of U.S. Prescriptions for Hydrocodone/Acetaminophen, 2006-2010 103
Figure 5.6: Number of U.S. Prescriptions for Oxycodone/Acetaminophen, 2006-2010 104
Figure 5.7: Total OxyContin Sales in the U.S., 2006-2010 104
Figure 5.8: Total Market Share of Prescription Drugs in the Global Market, 2010 106
Figure 5.9: Projected Annual Peak Sales of Selected Pain Drugs Including Opioids 106
Figure 5.10: Comparison of Total Annual Healthcare Cost of U.S. Opioid Abuser and Demographically-matched Comparison Non-Abuser 107
Figure 5.11: Direct All-Cause U.S. Healthcare Costs Per Person Associated with Opioid Abuse 107
Figure 5.12: Anti-Doping Organization Activity Summary as Reported by Code Signatory Anti-Doping Organizations 116
Figure 5.13: World Anti-Doping Agency Positive Statistics for Urine Testing 118
Figure 5.14: World Anti-Doping Agency Positive Statistics for EPO Testing 119
Figure 5.15: World Anti-Doping Agency Positive Statistics for Blood Testing 120
Figure 5.16: International Funds Received by UNESCO for the International Convention Against Doping in Sport Voluntary Fund 121
Figure 5.17: International Funds Granted By UNESCO for the International Convention Against Doping in Sport Voluntary Fund 122
Figure 7.1: Principles of Enzyme-Linked Immunosorbant Assay (ELISA) 150
Figure 7.2: Enzyme Multiplied Immunoassay Technique (EMIT) 151
Figure 8.1: U.S. Market Share for Ultra-Large Clinical Chemistry Analyzers 233
Figure 8.2: Non-U.S. Market Share for Ultra-Large Clinical Chemistry Analyzers 233
Figure 8.3: Global Sales of Chemical Analyzers from Roche Diagnostics, 2010 237
Figure 10.1: Fiscal Year 2010 Federal Outlays 244
Figure 10.2: Rise in the Number of Medicare Beneficiaries, 1966-2010 245
Figure 10.3: Clinical Laboratory Revenue Payment Breakdown 245
Figure 10.4: Hospital Insurance Medicare Benefit Payments, 2010 248
Figure 10.5: Supplementary Medical Insurance Medicare Benefit Payments, 2010 249
Figure 10.6: Coding Strategy for Qualitative Drug Tests, 2010 251
Figure 10.7: Coding Strategy for Qualitative Drug Tests, 2011 252
Figure 10.8: Specific Coding for Qualtitative Drug Tests 253
Figure 11.1: Prevalence of U.S. Adults in Prison, Jail, or on Parole or Probation, 1980-2009 271


INDEX OF TABLES

Table 2.1: Primary Site of Action and Neurotransmitters Involved in Drugs of Abuse Mechanism of
Action 20
Table 2.2: Level of Drug Abuse in Britain and Average Cost of Agent 21
Table 2.3: Trends in Prevalence of Various Drugs for 8th-Graders, 10th-Graders and 12th-Graders,
2007-2010 23
Table 2.4: Trends in Prevalence of Various Drugs for 8th-Graders, 10th-Graders and 12th-Graders,
2003-2006 25
Table 2.5: Trends in Prevalence of Various Drugs for 8th-Graders, 10th-Graders and 12th-Graders,
1999-2002 26
Table 2.6: Trends in Prevalence of Various Drugs for 8th-Graders, 10th-Graders and 12th-Graders,
1995-1998 28
Table 2.7: Short Term Effects of Amphetamine Abuse 45
Table 2.8: Long Term Effects of Amphetamine Abuse 46
Table 2.9: Short Term Effects of Barbiturates 47
Table 2.10: Long Term Effects of Barbiturates 47
Table 2.11: Barbiturates Under International Control 48
Table 2.12: Common Benzodiazepines on Prescription in the U.S. 49
Table 2.13: Sedative/Hypnotic Benzodiazepines Under International Control 50
Table 2.14: Anxiolytic Benzodiazepines Under International Control 50
Table 2.15: Short Term Effects of Benzodiazepines 51
Table 2.16: Long Term Effects of Benzodiazepines 51
Table 2.17: Short Term Effects of Cannabinoid/Marijuana Use 52
Table 2.18: Long Term Effects of Cannabinoid/Marijuana use 52
Table 2.19: Short Term Effects of Cocaine 54
Table 2.20: Long Term Effects of Cocaine 54
Table 2.21: Physical Short Term Effects of LSD 55
Table 2.22: Psychedelic Short Term Effects of LSD 56
Table 2.23: Adverse Side Effects of LSD 56
Table 2.24: Long Term Effects of LSD 56
Table 2.25: Short Term Effects of Methadone 57
Table 2.26: Short Term Effects of Phenylcyclidine 59
Table 2.27: Adverse Effects of Phencyclidine 59
Table 2.28: Long Term Effects of Phencyclidine 60
Table 2.29: Short Term Effects of Heroin Use 61
Table 2.30: Long Term Effects of Heroin Use 61
Table 2.31: Side Effects of OxyContin 62
Table 2.32: Device Specifications for POCT Breath Alcohol Analysis 62
Table 2.33: Reasons Why U.S. Employers Comply with SAMHSA Guidelines 63
Table 2.34: “SAMHSA -5”—Basic Drug Categories to be Tested 63
Table 2.35: Extended Drugs of Abuse Panel 63
Table 2.36: Accredited Laboratories for SAMHSA Drug Testing 64
Table 2.37: Comparison of Blood, Urine, Hair, Saliva and Sweat Patch Testing for SAMHSA-5 Test (Marijuana, Cocaine, Amphetamines, Opiates and PCP) 65
Table 2.38: Immunoassay and Gas Chromatography Cut-off levels for SAMHSA-5 Drugs of Abuse 66
Table 2.39: Detection Periods of SAMHSA-5 Drugs in Blood, Saliva, Sweat, Urine and Hair 66
Table 2.40: Drugs of Abuse Test 68
Table 2.41: Commonly Used Product Codes for Drugs of Abuse Tests 69
Table 3.1: Worldwide Geographic Distribution of IVD Testing, 2010 70
Table 3.2: Global Clinical Diagnostics Testing Market: Market Drivers Ranked in Order of Impact 70
Table 3.3: Global Clinical Diagnostics Market: Market Restraints Ranked in Order of Impact 71
Table 3.4: Key Diagnostic Companies for Drugs of Abuse Testing 72
Table 4.1: Global Revenue from Drugs of Abuse Testing, 2007-2015 82
Table 4.2: U.S. Revenue from Drugs of Abuse Testing, 2007-2015 83
Table 4.3: E.U. Revenue from Drugs of Abuse Testing, 2007-2015 84
Table 4.4: Rest of World Revenue from Drugs of Abuse Testing, 2007-2015 85
Table 4.5: Worldwide Distribution of Drug Abuse Testing, 2010 85
Table 4.6: U.S. Clinical Laboratory Diagnostic Test Retail Value Market Segments, 2008 88
Table 4.7: Drugs of Abuse Testing Market: Market Drivers Ranked in Order of Impact 89
Table 4.8: Drugs of Abuse Testing Market: Market Restraints Ranked in Order of Impact 89
Table 5.1: Drugs of Abuse Tested for and Cut-off Values for Employees 93
Table 5.2: U.S. Workforce Testing Positive for Opiates using Oral Fluid Drug Tests, 2007-2010 96
Table 5.3: U.S. Workforce Annual Positivity Rates using Urine Drug Tests, 1988-2010 96
Table 5.4: U.S. Workforce Positivity Rates by Testing Category using Urine Drug Tests, 2006-2010 97
Table 5.5: U.S. DOA Positivity Rates by Testing Reason Using Urine Drug Tests for Federally Mandated, Safety-Sensitive Workforce, 2006-2010 98
Table 5.6: U.S. DOA Positivity Rates by Testing Reason Using Urine Drug Tests for General U.S. Workforce, 2006-2010 98
Table 5.7: Positivity Rates by Drug Category Using Urine Drug Tests for Federally Mandated, Safety-Sensitive Workforce, 2006-2010 98
Table 5.8: Positivity Rates by Drug Category Using Urine Drug Tests for General U.S. Workforce,
2006-2010 99
Table 5.9: Comparison of Saliva and Urine for Use in Drugs of Abuse Testing 99
Table 5.10: Main Devices for Saliva Collection on the Market 100
Table 5.11: Selected Mass Spectrometric Methods used to Quantify Common Drugs in Oral Fluid 100
Table 5.12: Top Ten Most-Prescribed Drugs in the U.S., 2010 101
Table 5.13: Top Ten Most-Prescribed Drugs by Sales in the U.S., 2010 102
Table 5.14: Prescription Dispensing Location by Spending in the U.S., 2006-2010 105
Table 5.15: Comprehensive Steroid Panel in Drugs of Abuse Testing 110
Table 5.16: Comprehensive Diuretic Panel in Drugs of Abuse Testing 111
Table 5.17: Comprehensive Stimulant Panel in Drugs of Abuse Testing 111
Table 5.18: World Anti-Doping Agency Accredited Laboratories 113
Table 5.19: Laboratory Criteria Required for World Anti-Doping Agency Accreditation 114
Table 5.20: Relevant Provisions of International Standard for Laboratories, as Applied to the Process and Requirements for WADA Approval 114
Table 5.21: Anti-Doping Organization Activity Summary as Reported by Code Signatory Anti-Doping Organizations 115
Table 5.22: World Anti-Doping Agency Testing Statistics 117
Table 5.23: UNESCO International Convention Against Doping in Sport Voluntary Fund Guidelines 121
Table 6.1: Major Competitors in the Drugs of Abuse Oral Testing Market Segment 124
Table 6.2: Major Competitors in the Drugs of Abuse Urine Testing Market Segment 124
Table 6.3: OraSure Portfolio of Drugs of Abuse Detection Methodologies 132
Table 6.4: Avitar’s Aimstep ORALINE-4 Drugs of Abuse Cut-off Levels 133
Table 6.5: Alpha Scientific Designs Drugs of Abuse Testing Cut-off Level 135
Table 6.6: Regulatory Clearance of Alpha Scientific Products for Drugs of Abuse Testing 136
Table 6.7: Available 510K Cleared Analytes for the Vision Integrated Drugs of Abuse Test Cup 137
Table 6.8: Drugs of Abuse Analytes and Cut-off Level Detected by the Oral-View Saliva
Multi-Drugs of Abuse 138
Table 6.9: Drugs of Abuse Cut-off Levels for the TOX/See Test by Bio-Rad 141
Table 7.1: Performance Characteristics Required before Implementation of FDA-Approved/Cleared Tests 148
Table 7.2: Comparison of Monoclonal and Polyclonal Antibody Characteristics 149
Table 7.3: Samples and Sample Handling Features of Centaur CP 156
Table 7.4: Large- and Mid-Size Immunochemistry Analyzers 170
Table 7.5: Small- to Mid-Volume Immunoassay Analyzers 186
Table 8.1: Overview of the ADVIA 2400 192
Table 8.2: Sample Handling Capability of the ADVIA 2400 192
Table 8.3: Microvolume Technology Utilized by the ADVIA 2400 192
Table 8.4: Reaction Area of the ADVIA 2400 193
Table 8.5: Reagent Handling Capability of the ADVIA 2400 193
Table 8.6: Parameter Menu of the ADVIA 2400 193
Table 8.7: Open System Capability of the ADVIA 2400 195
Table 8.8: ISE Parameters of the ADVIA 2400 195
Table 8.9: Calibration Parameters of the ADVIA 2400 195
Table 8.10: Data Management Capability of the ADVIA 2400 195
Table 8.11: General Specifications of the ADVIA 2400 196
Table 8.12: Ultra-Large Clinical Chemistry Analyzers 197
Table 8.13: Overview of ADVIA 1650 201
Table 8.14: Sample Handling Capabilities of the ADVIA 1650 201
Table 8.15: Microvolume Technology Capability of the ADVIA 1650 202
Table 8.16: Reaction Area Associated with the ADVIA 1650 202
Table 8.17: Reagent Handling Capability of the ADVIA 1650 202
Table 8.18: Parameter Menu Associated with the ADVIA 1650 202
Table 8.19: Open System Capability of the ADVIA 1650 204
Table 8.20: ISE Parameters of the ADVIA 1650 204
Table 8.21: Calibration Capabilities of the ADVIA 1650 204
Table 8.22: Data Management Capabilities of the ADVIA 1650 205
Table 8.23: General Specifications of the ADVIA 1650 205
Table 8.24: JEOL Analyzer Comparison 206
Table 8.25: Large Clinical Chemistry Analyzers 207
Table 8.26: Mid-Size Clinical Chemistry Analyzers 217
Table 8.27: Small Clinical Laboratory Analyzers 226
Table 8.28: Heritability Estimates for Drugs of Abuse 227
Table 8.29: Genetic Associations Implicated in Drug Addiction Phenotypes 228
Table 8.30: FDA Recognized Pharmacogenomic Biomarkers in to Identify Responders and Non-Responders to Medications 229
Table 8.31: Common Pharmacotherapies for Drug Dependence and Genetic Variations Implicated in
Treatment 232
Table 9.1: Potential Challenges of Drugs of Abuse Testing Market 240
Table 9.2: Timeline of Legislative Changes from the Health Care and Education Reconciliation Act, 2010-2013 241
Table 11.1: Clinical Laboratory Improvement Amendments (CLIA) Testing Categories 261
Table 11.2: Annual Minimum Drug and Alcohol Random Testing Rates Established within DOT Agencies and the USCG, 2011 262
Table 11.3: General Responsibilities of Employers under the Department of Transportation’s (DOT) rule, 49 Code of Federal Regulations Part 40 262
Table 11.4: Actions that Employers Must Take after an Employee Test Result is Verified Positive 262
Table 11.5: Drugs of Abuse Cut-off Values (Initial Test) as Specified under Article 15 of the Drug Abuse Urine Testing Act 264
Table 11.6: Drugs of Abuse Cut-off Values (Confirmatory Test) as Specified under Article 18 of the Drug Abuse Urine Testing Act 265
Table 11.7: Medical Review Officer Requirements in the Department of Transportation Drug
Testing Program 266
Table 11.8: Medical Review Officer Responsibilities in Drug Testing Programs 267
Table 11.9: Medical Review Officer Requirements when Reporting a Drug Test Result 268
Table 11.10: International Olympic Committee, U.S. Olympic Committee and NCAA Banned Substances 269
Table 11.11: Conditions of Sentences by Adult Probationers by Severity of Offense 271
Table 11.12: Total Federal Drug Control Budget for Fiscal Years 2002-2011 272
Table 11.13: Federal Drug Control Budget by Function for Fiscal Years 2009-2011 272