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Drugs of Abuse Testing Markets

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$3,400.00
Publication Date:
November 2013; Pages: 311
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Description


Drugs of Abuse Sample

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. Drugs of abuse covered in this report include barbiturates, tricyclic antidepressants, benzodiazepines, propoxyphene, SAMHSA, phenobarbital, methamphetamine, opiates, phencyclidine and oxycontin. 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 14
1.1 Statement of Report 14
1.2 About This Report 14
1.3 Scope of the Report 15
1.4 Objectives 15
1.5 Methodology 16
1.6 Executive Summary 17
2. Introduction to Drugs of Abuse Testing 21
2.1 Drugs of Abuse Overview 21
2.2 Initiation of Illicit Drug Use 24
2.3 European Levels of Drug Abuse 32
2.4 Major Drugs of Abuse 34
2.4.1 Amphetamines 34
2.4.2 Tricyclic Antidepressants (TCAs) 35
2.4.3 Barbiturates 36
2.4.4 Benzodiazepines 37
2.4.5 Cannabinoids/Marijuana 40
2.4.5.1 Synthetic Cannabinoids 40
2.4.6 Cocaine 43
2.4.7 Lysergic Acid Diethylamide (LSD) 44
2.4.8 Methadone 46
2.4.9 Methaqualone and Phencyclidine (PCP) 47
2.4.10 Opiates—Heroin and OxyContin 50
2.5 Alcohol Testing 52
2.6 Test Methodologies 53
2.7 Substance Abuse Test Types 57
2.7.1 Urine Substance/Drug Screening 57
2.7.2 Hair Tests for Substance Abuse and Screening 58
2.7.3 Blood Tests for Substance Abuse and Screening 58
2.7.4 Saliva Tests for Substance Abuse and Screening 58
2.7.5 Sweat Tests for Substance Abuse and Screening 58
2.8 Saliva Testing 58
2.9 Drug Panels by Toxidromes 59
2.10 Drugs of Abuse Home Use Test 59
2.11 Point of Care (POC) Substance Abuse Testing 61
3. Drugs of Abuse Testing Markets 69
3.1 IVD Global Clinical Diagnostic Testing Market 69
3.1.1 Market Drivers 69
3.1.2 Market Restraints 70
3.2 Drugs of Abuse Testing Market Analysis 70
3.2.1 Main Players in the Industry 70
3.2.1.1 Roche Diagnostics Market Analysis 72
3.2.1.2 Abbott Laboratories Market Analysis 74
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 (Alere) Market Analysis 81
3.3 Diagnostic Testing in the Future 84
4. Market Size and Analysis for Drugs of Abuse Testing 85
4.1 Global Drugs of Abuse Testing Analysis 85
4.2 U.S. Drugs of Abuse Testing Analysis 86
4.3 European Union Drugs of Abuse Testing Analysis 88
4.4 Rest of World Drugs of Abuse Testing Analysis 90
4.4.1 Global Drivers of Drugs of Abuse Testing 91
4.4.2 Global Outlook 92
4.4.3 U.S. Market 93
4.4.4 European Market 93
4.5 Market Drivers 94
4.6 Market Restraints 95
4.7 Market and Technology Trends 96
4.7.1 Market Trends 96
4.7.2 Technology Trends 97
4.8 Strategic Recommendations 97
5. Specific Market Sectors for Drugs of Abuse Testing 98
5.1 Workplace Drugs of Abuse Laboratory Testing Methods 98
5.1.1 Introduction 98
5.1.2 Major U.S. Companies that Drug Test Employees 98
5.1.3 Drugs of Abuse Testing—A Recovering Market 99
5.1.4 Rising Pre-Employment Testing 99
5.1.5 A Growth in Alternative Specimen and Instant Drugs of Abuse Testing 103
5.2 Prescription Drugs of Abuse Market 105
5.2.1 Prescription Drugs and the Pain Market 109
5.2.2 Economic Burden of Prescription Opioid Misuse and Abuse 113
5.2.3 U.S. Food and Drug Administration Clampdown on Prescription Drug Misuse 115
5.2.4 Narcotic Analgesic Prescription Trends 115
5.2.5 Abuse of Non-Prescribed and Illicit Drugs—Ameritox Study 2012 116
5.3 Human Sports Drugs of Abuse Testing Markets 119
5.3.1 Introduction to the Market 119
5.3.2 Internationally Accredited Anti-Doping Laboratories 122
5.3.3 World Anti-Doping Agency Statistics 124
5.3.4 Anti-Doping International Investment Promotes Test Market 126
5.3.5 World Anti-Doping Agency Scientific Research Program 127
5.3.6 Out-of-Competition Testing Promotes Market 127
5.3.7 Use of Drugs of Abuse International Markets 127
6. Company Specific Instrumentation and Test Kit Review 129
6.1 Biosite Diagnostics (Inverness, now called Alere) 129
6.2 Abbott Diagnostics 130
6.3 Roche Diagnostics 131
6.4 BioScan Screening Systems, Inc. 132
6.5 American Bio Medica Corp. 133
6.6 Phamatech, Inc. 136
6.7 First Check Medical Corp. 136
6.8 OraSure 137
6.9 Avitar, Inc. 137
6.10 Concateno 138
6.11 Pathtech 138
6.12 Alfa Scientific Designs, Inc. 139
6.13 TCPI, Inc. 146
6.14 Roche 146
6.15 Biophor Diagnostics 146
6.16 Alpha Scientific Designs 146
6.17 Princeton BioMeditech, Inc. 149
6.18 American BioMedica 150
6.19 Beckman Coulter 151
6.20 Bio-Rad 151
6.21 Siemens Healthcare Diagnostics 152
6.22 Thermo Fisher Scientific 153
6.23 Agilent Technologies 153
6.24 Randox 154
6.25 Awareness Technology 158
6.26 Carolina Chemistries 158
6.27 Horiba Medical 158
6.28 Ortho Clinical Diagnostics—Johnson & Johnson 158
6.29 Medica Corporation, Inc. 159
6.30 Tecan 159
7. In Vitro Diagnostic Technologies and Potential Applications 160
7.1 Performance Characteristics Required for Implementation of FDA-Approved/Cleared Tests 160
7.2 Immunoassays 160
7.3 Technology Principle 161
7.4 Enzyme Immunoassays 161
7.4.1 Enzyme-Linked Immunosorbant Assay (ELISA) 161
7.4.2 Enzyme Multiplied Immunoassay Technique (EMIT) 162
7.4.3 Cloned Enzyme Donor Immunoassay (CEDIA) 163
7.4.4 Radio Immunoassay (RIA) 163
7.4.5 Fluorescence Polarization Immunoassay (FPIA) 163
7.4.6 Lateral Flow Immunoassays (LFI) 164
7.5 Future Trends of Immunoassays 164
7.6 Latex Agglutination 164
7.7 Immunoprecipitation (IP) 164
7.8 Flow-Injection Liposome Immunoanalysis (FIIA) 165
7.9 Clinical Immunoanalyzer Instrument Market by Sector 165
7.9.1 Market Analysis: Size, Growth, Share and Competitors 165
7.9.1.1 Large- and Mid-Volume Immunochemistry Analyzers 165
7.9.1.2 Abbott Diagnostics 165
7.9.1.3 Siemens Medical Solutions Diagnostics 167
7.9.1.4 Beckman Coulter, Inc. 172
7.9.1.5 Dade Behring (Acquired by Siemens) 174
7.9.1.6 Diagnostics Products Corporation (Acquired by Siemens Healthcare Diagnostics) 174
7.9.1.7 Olympus America, Inc. (now Beckman Coulter/Danaher) 176
7.9.1.8 Ortho-Clinical Diagnostics 177
7.9.1.9 Roche Diagnostics Corp. 179
7.9.1.10 Tosoh Bioscience, Inc. 181
7.9.1.11 Batch-Type Immunoassay Analyzers 183
7.9.1.12 Bio-Rad 183
7.9.1.13 Diamedix Corporation 183
7.9.1.14 Tosoh 186
7.9.2 Small- to Mid-Volume Immunoassay Analyzers 186
7.9.2.1 Awareness Technology, Inc. 186
7.9.2.2 Siemens Healthcare Diagnostics, Inc. 186
7.9.2.3 Beckman Coulter, Inc. 187
7.9.2.4 bioMérieux SA 188
7.9.2.5 Dade Behring (Acquired by Siemens) 188
7.9.2.6 Randox Laboratories Ltd. 192
7.9.2.7 Tosoh Corporation 193
7.9.3 Other Immunoassay Analyzers 194
7.9.3.1 Inverness Medical Professional Diagnostics 194
7.9.3.2 Hycor Biomedical (A Part of Agilent Technologies) 194
7.9.3.3 Phadia AB 195
7.9.3.4 Trinity Biotech Plc 195
7.9.3.5 DiaSorin 195
7.9.3.6 Grifols U.S.A., Inc. 195
7.9.3.7 Bio-Rad Laboratories, Inc. 196
7.9.3.8 SFRI Diagnostics 196
7.9.3.9 Qualigen, Inc. 196
7.9.3.10 PerkinElmer, Inc. 197
7.9.3.11 Innotrac Diagnostics Oy 197
7.9.3.12 Tecan Group Ltd. 197
8. Business Analysis of Drugs of Abuse Testing Market 199
8.1 Ultra-large Clinical Chemistry Analyzers 199
8.1.1 Beckman Coulter 199
8.1.2 Roche Diagnostics 202
8.1.3 Siemens Medical Solutions 203
8.1.4 Ortho Clinical Diagnostics 208
8.1.5 Abbott Diagnostics 209
8.1.6 Siemens Healthcare Diagnostics 213
8.1.7 JEOL Ltd. 217
8.1.8 Siemens Healthcare Diagnostics 218
8.2 Mid-Size Clinical Chemistry Analyzers 220
8.2.1 Abbott 220
8.2.2 Beckman Coulter, Inc. 221
8.2.3 Ortho-Clinical Diagnostics, Inc. 222
8.2.4 Roche Diagnostics Corporation 222
8.2.5 Randox Laboratories 223
8.2.6 Siemens 223
8.2.7 Nova Biomedical Corporation 226
8.2.8 Clinical Data, Inc. 226
8.2.9 Polymedco, Inc. 226
8.2.10 Hitachi America Ltd. 227
8.2.11 Shimadzu Corp. 227
8.2.12 Thermo Fisher Scientific, Inc. 227
8.2.13 Carolina Liquid Chemistries 228
8.3 Small Volume Chemistry Analyzers 229
8.3.1 Clinical Data, Inc. 230
8.3.2 Nova Biomedical Corporation 231
8.3.3 Ortho-Clinical Diagnostics 231
8.3.4 BPC BioSed srl 232
8.3.5 Abbott Laboratories 232
8.3.6 Roche Diagnostics 232
8.3.7 Beckman Coulter 233
8.3.8 Nova Biomedical 233
8.3.9 Alfa Wassermann 234
8.3.10 Hitachi 234
8.3.11 Randox Laboratories 234
8.3.12 Abaxis 235
8.3.13 Siemens 235
8.3.14 Awareness Technology 235
8.3.15 Adaltis 236
8.3.16 Polymedco 236
8.3.17 Thermo Scientific 236
8.4 Advance of Technology Trends 238
8.4.1 Advancement of Genomics and the Pharmacogenetics of Drug Addiction 238
8.4.2 Challenges within Genetic Research of Drug Addiction 240
8.5 Ultra-Large Clinical Chemistry Analyzer Market Analysis 243
8.6 High Volume Clinical Chemistry Market 244
8.7 Mid-Size Clinical Chemistry Analyzers 245
8.8 Small-Volume Chemical Analyzer Market 246
8.9 Competitive Analysis 247
9. SWOT Analysis 250
9.1 Main Drivers of Drugs of Abuse Testing Market 250
9.2 Potential Threats and Restraints of the Drugs of Abuse Testing Market 251
9.3 Challenges of this Market Place Going Forward 251
9.4 Summary of Market Strengths, Weaknesses, Opportunities and Threats 253
9.5 Summary of Strengths, Weaknesses, Opportunities and Threats of Drugs of Abuse Test Market 254
10. Reimbursement Systems 255
10.1 Reimbursement for Laboratory Medicine 255
10.2 Public and Private Sector Payers 255
10.3 Components of Reimbursement Systems 257
10.4 Medicare Coverage Decisions 257
10.5 Medicaid Coverage Decisions 258
10.6 Private Sector Coverage Decisions 258
10.7 Payment Methodologies 259
10.8 Medicare Payment Methodologies 259
10.9 Prospective Payment Systems for Inpatient and Hospital Outpatient Care 260
10.10 Using Fee Schedules for Laboratory Tests and Services 260
10.11 Clinical Laboratory Fee Schedule 261
10.12 Coding System Used for Qualitative Drug Tests 261
11. Government Regulation 265
11.1 U.S. Regulation 265
11.1.1 Medical Devices as Regulated by the U.S. Food and Drug Administration 265
11.1.2 Pre-Market Approval (PMA) 265
11.1.3 510(k) Clearance 266
11.1.4 Importing Medical Devices into the U.S. 266
11.1.5 Exporting Medical Devices from the U.S. 267
11.2 U.K. Regulation 267
11.3 E.U. Regulation 268
11.4 French Regulation 270
11.5 Japanese Regulation 270
11.6 Korean Regulation 271
11.7 Clinical Laboratory Improvement Amendments (CLIA) 271
11.8 Omnibus Transportation Employee Testing Act 272
11.9 Employer Drug and Alcohol Compliance 273
11.10 Regulations Governing Drug Abuse Testing 274
11.10.1 Specimen Collection and Management 274
11.10.2 Test Operations and Cut-off Values 275
11.10.3 Quality Control and Quality Assurance 276
11.10.4 Medical Review Officers and the Verification Process 277
11.10.5 Confidentiality and Release of Information 279
11.11 The U.S. Anti-Doping Agency 280
11.12 Drugs of Abuse Testing in the Criminal Justice System 281
12. Company Profiles 284
12.1 Abaxis, Inc. 284
12.2 Abbott Laboratories 285
12.3 Alere 289
12.4 Alfa Scientific Designs, Inc. 290
12.5 Analyzer Medical Systems (AMS) 290
12.6 Awareness Technology 291
12.7 Beckman Coulter, Inc. 291
12.8 Binding Site 295
12.9 bioMérieux 296
12.10 Bio-Rad Laboratories 297
12.11 Carolina Chemistries 298
12.12 Dako 298
12.13 DiaSorin 298
12.14 Eiken Chemical Co., Ltd. 299
12.15 Fujirebio, Inc. 299
12.16 Grifols 299
12.17 Horiba 300
12.18 Instrumentation Laboratory 300
12.19 Johnson & Johnson 300
12.20 Kyowa Medex 301
12.21 Medica Corporation, Inc. 302
12.22 Nova Biomedical Corporation 302
12.23 Orasure 302
12.24 Ortho Clinical Diagnostics 303
12.25 Polymedco 304
12.26 Randox 304
12.27 Roche Diagnostics 305
12.28 Siemens AG 307
12.29 Sysmex 308
12.30 Thermo Fisher Scientific 309
12.31 Tosoh 311
12.32 Trinity Biotech 311
12.33 Wako 312
12.34 Wallac 312


INDEX OF FIGURES

Figure 2.1: Drug Classification According to Mean Harm Rating 22
Figure 2.2: Percentage of U.S. 12th Grade Students Reporting Past Month Use of Cigarettes and Marijuana, 1975-2010 23
Figure 2.3: Percentage of U.S. 12th Grade Students Reporting Daily Marijuana Use Verses Perceived Risk of Regular Marijuana Use, 1975-2010 23
Figure 2.4: Prevalence of Drug Abuse Occurring in 12th Grade Students, 2010 24
Figure 2.5: First Specific Drug Associated with Initiation of Illicit Drug Use Among Past Year Illicit Drug Initiates Aged 12 or Older 25
Figure 2.6: Past Year Initiates of Specific Illicit Drugs Among Persons Aged 12 or Older 25
Figure 2.7: Mean Age at First Use for Specific Illicit Drugs Among Past Year Initiates Aged 12 to 49 26
Figure 2.8: 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, 2004-2011 26
Figure 2.9: Past Year Hallucinogen Initiates Among Persons Aged 12 or Older, 2004-2011 27
Figure 2.10: 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, 2004-2011 28
Figure 2.11: Substance Dependence or Abuse in the Past Year Among Persons Aged 12 or Older, 2002-2011 29
Figure 2.12: Dependence on or Abuse of Specific Illicit Drugs in the Past Year Among Persons Aged 12 or Older, 2011 29
Figure 2.13: Number of Past Month Abusers of Marijuana in the U.S., 2008-2011 30
Figure 2.14: Number of U.S. Abusers of Cocaine, 2009-2011 30
Figure 2.15: Number of U.S. Abusers of Psychotherapeutic Drugs, 2009-2011 31
Figure 2.16: Methamphetamine User Prevalence, 2008-2011 31
Figure 2.17: Number of Drug Abusers in Europe, by Drug Type 32
Figure 2.18: First Time Users of Cannabis within Europe, 2006-2011 33
Figure 2.19: Top Ten European Countries for Cocaine Abuse, 1990-2011 33
Figure 2.20: Chemical Structure of Amphetamine 34
Figure 2.21: Chemical Structure of Barbituates 36
Figure 2.22: Chemical Structure of Benzodiazepines 38
Figure 2.23: Chemical Structure of Cannabinoid/Marijuana 42
Figure 2.24: Chemical Structure of Cocaine 43
Figure 2.25: Chemical Structure of Lysergic Acid Diethylamide (LSD) 45
Figure 2.26: Chemical Structure of Methadone 47
Figure 2.27: Chemical Structure of Methaqualone 48
Figure 2.28: Chemical Structure of Phenylcyclidine 48
Figure 2.29: Chemical Structure of Heroin 50
Figure 2.30: Chemical Structure of OxyContin 51
Figure 3.1: Key Diagnostic Companies by Market Share in the DOA Market 71
Figure 3.2: Roche Diagnostics Sales Volume, 2008-2012 72
Figure 3.3: Roche Diagnostics Core Operating Profit, 2008-2012 73
Figure 3.4: Roche Diagnostics Sales by Global Region, 2012 74
Figure 3.5: Abbott Laboratories Global Annual Sales, 2007-2012 75
Figure 3.6: Abbott Laboratories Operating Cash Flow, 2007-2012 75
Figure 3.7: Abbott Laboratories Net Sales—Diagnostics Division, 2008-2012 76
Figure 3.8: Siemens Market Share by Geographic Region, 2012 77
Figure 3.9: Thermo Fisher Revenue Generated by Geographic Region, 2012 77
Figure 3.10: Beckman Coulter Revenue by Geographic Region, 2010 78
Figure 3.11: Beckman Coulter Division of Sales, 2010 79
Figure 3.12: OraSure Technologies U.S. and International Revenue, 2010-2012 80
Figure 3.13: Alere Total Revenue Generated, 2011 and 2012 82
Figure 3.14: Alere Gross Profit Generated, 2011 and 2012 82
Figure 3.15: Alere Revenue Generated by Geographic Area, U.S., Europe, 2012 83
Figure 3.16: Alere Professional Diagnostic Sales, 2011 and 2012 83
Figure 3.17: Alere Toxicology and Drugs of Abuse Testing Sales, 2011 and 2012 84
Figure 4.1: Global Revenue of Drugs of Abuse Testing Market Forecast, 2009-2017 85
Figure 4.2: Drug-Test Volume in the U.S., 2006-2016 86
Figure 4.3: U.S. Revenue of Drugs of Abuse Testing Market Forecast, 2009-2017 87
Figure 4.4: U.S. Percentage Market Share of Drugs-of-Abuse Testing Market, 2010-2017 88
Figure 4.5: E.U. Revenue of Drugs of Abuse Testing Market Forecast, 2009-2017 89
Figure 4.6: European Market Share of Drugs of Abuse Market, 2010-2017 90
Figure 4.7: Rest of World Revenue of Drugs of Abuse Testing Market Forecast, 2009-2017 90
Figure 4.8: Rest of World Market Share of Drugs of Abuse Market, 2010-2017 91
Figure 4.9: Global In Vitro Diagnostic Market Revenue Forecast, 2010-2016 95
Figure 4.10: Global In Vitro Diagnostic Market Share (Percentage) by Geography, 2012 95
Figure 5.1: Percentage of U.S. Workforce Testing Positive for Drugs of Abuse, 1988-2011 101
Figure 5.2: Total U.S. Prescription Market Revenue, 2006-2012 105
Figure 5.3: Total Spending on Prescription Narcotic Analgesics in the U.S., 2006-2011 106
Figure 5.4: Total Number of Narcotic Analgesic Prescriptions in the U.S., 2006-2011 107
Figure 5.5: Number of U.S. Prescriptions for Hydrocodone/Acetaminophen, 2006-2011 107
Figure 5.6: Number of U.S. Prescriptions for Oxycodone/Acetaminophen, 2006-2011 108
Figure 5.7: Total OxyContin Sales in the U.S., 2006-2012 108
Figure 5.8: National Institute for Health Statistics Survey Common U.S. Types of Pain 109
Figure 5.9: Total Market Share of Prescription Drugs in the Global Market 110
Figure 5.10: Projected Annual Peak Sales of Selected Pain Drugs Including Opioids 111
Figure 5.11: Comparison of Total Annual Healthcare Cost of U.S. Opioid Abuser and Demographically-Matched Comparison Non-Abuser 114
Figure 5.12: Direct All-Cause U.S. Healthcare Costs Per Person Associated with Opioid Abuse 114
Figure 5.13: Ameritox National Prescription Drug Report 2012—Percentage Positive and Negative for Prescribed, Non-Prescribed and Illicit Drugs in System 117
Figure 5.14: Ameritox National Prescription Drug Report 2012—Top Ten States Indicating Noncompliance to Medical Prescription, where Prescription Medication was not Detected 117
Figure 5.15: Ameritox National Prescription Drug Report 2012—Top Ten States Indicating Noncompliance to Medical Prescription, where Non-Prescription Medication was Detected 118
Figure 5.16: Ameritox National Prescription Drug Report 2012—Top Ten States Indicating Noncompliance to Medical Prescription, where an Illicit Drug was Detected 118
Figure 5.17: Ameritox National Prescription Drug Report 2012—Breakdown (Percentage) of Illicit Drugs Type 119
Figure 5.18: International Funds Received by UNESCO for the International Convention Against Doping in Sport Voluntary Fund 126
Figure 5.19: International Funds Granted By UNESCO for the International Convention Against Doping in Sport Voluntary Fund 127
Figure 7.1: Principles of Enzyme-Linked Immunosorbant Assay (ELISA) 162
Figure 7.2: Enzyme Multiplied Immunoassay Technique (EMIT) 163
Figure 8.1: U.S. Market Share for Ultra-Large Clinical Chemistry Analyzers 243
Figure 8.2: Non-U.S. Market Share for Ultra-Large Clinical Chemistry Analyzers 244
Figure 8.3: Global Sales of Chemical Analyzers from Roche Diagnostics, 2012 247
Figure 10.1: Fiscal Year 2010 Federal Outlays 255
Figure 10.2: Rise in the Number of Medicare Beneficiaries, 1966-2010 256
Figure 10.3: Clinical Laboratory Revenue Payment Breakdown 256
Figure 10.4: Hospital Insurance Medicare Benefit Payments, 2010 259
Figure 10.5: Supplementary Medical Insurance Medicare Benefit Payments, 2010 260
Figure 10.6: Coding Strategy for Qualitative Drug Tests, 2010 262
Figure 10.7: Coding Strategy for Qualitative Drug Tests, 2011 263
Figure 10.8: Specific Coding for Qualitative Drug Tests 264
Figure 11.1: Prevalence of U.S. Adults in Prison, Jail, or on Parole or Probation, 1980-2009 282


INDEX OF TABLES

Table 2.1: Primary Site of Action and Neurotransmitters Involved in Drugs of Abuse Mechanism of Action 21
Table 2.2: Level of Drug Abuse in Britain and Average Cost of Agent 22
Table 2.3: Short-Term Effects of Amphetamine Abuse 34
Table 2.4: Long-Term Effects of Amphetamine Abuse 35
Table 2.5: Short-Term Effects of Barbiturates 36
Table 2.6: Long-Term Effects of Barbiturates 36
Table 2.7: Barbiturates Under International Control 37
Table 2.8: Common Benzodiazepines on Prescription in the U.S. 38
Table 2.9: Sedative/Hypnotic Benzodiazepines Under International Control 39
Table 2.10: Anxiolytic Benzodiazepines Under International Control 39
Table 2.11: Short-Term Effects of Benzodiazepines 40
Table 2.12: Long-Term Effects of Benzodiazepines 40
Table 2.13: Short-Term Effects of Cannabinoid/Marijuana Use 42
Table 2.14: Long-Term Effects of Cannabinoid/Marijuana use 42
Table 2.15: Short-Term Effects of Cocaine 44
Table 2.16: Long-Term Effects of Cocaine 44
Table 2.17: Physical Short-Term Effects of LSD 45
Table 2.18: Psychedelic Short-Term Effects of LSD 46
Table 2.19: Adverse Side Effects of LSD 46
Table 2.20: Long-Term Effects of LSD 46
Table 2.21: Short-Term Effects of Methadone 47
Table 2.22: Short-Term Effects of Phenylcyclidine 49
Table 2.23: Adverse Effects of Phencyclidine 49
Table 2.24: Long-Term Effects of Phencyclidine 50
Table 2.25: Short-Term Effects of Heroin Use 51
Table 2.26: Long-Term Effects of Heroin Use 51
Table 2.27: Side Effects of OxyContin 52
Table 2.28: Device Specifications for POCT Breath Alcohol Analysis 53
Table 2.29: Reasons Why U.S. Employers Comply with SAMHSA Guidelines 54
Table 2.30: “SAMHSA-5”—Basic Drug Categories to be Tested 54
Table 2.31: Extended Drugs of Abuse Panel 54
Table 2.32: Accredited Laboratories for SAMHSA Drug Testing 55
Table 2.33: Comparison of Blood, Urine, Hair, Saliva and Sweat Patch Testing for SAMHSA-5 Test (Marijuana, Cocaine, Amphetamines, Opiates and PCP) 56
Table 2.34: Immunoassay and Gas Chromatography Cut-off levels for SAMHSA-5 Drugs of Abuse 56
Table 2.35: Detection Periods of SAMHSA-5 Drugs in Blood, Saliva, Sweat, Urine and Hair 57
Table 2.36: Drugs of Abuse Test—Kinetics of Positive Result and Duration of Result 60
Table 2.37: Commonly Used Product Codes for Drugs of Abuse Tests 61
Table 2.38: Drug Testing Needs Tier I for Rapid Serum POCT in the Emergency Department 67
Table 2.39: Stat Urine Testing Drug Recommendations 67
Table 3.1: Global Distribution of IVD Testing by Geographic Region, 2012-2018 69
Table 3.2: Global Clinical Diagnostics Testing Market: Market Drivers Ranked in Order of Impact 69
Table 3.3: Global Clinical Diagnostics Market: Market Restraints Ranked in Order of Impact 70
Table 3.4: Key Diagnostic Companies for Drugs of Abuse Testing 71
Table 4.1: Global Revenue from Drugs of Abuse Testing, 2007-2017 85
Table 4.2: Worldwide Distribution of Drug Abuse Testing, 2013 86
Table 4.3: U.S. Revenue from Drugs of Abuse Testing, 2007-2017 87
Table 4.4: E.U. Revenue from Drugs of Abuse Testing, 2007-2017 89
Table 4.5: Rest of World Revenue from Drugs of Abuse Testing, 2007-2017 91
Table 4.6: U.S. Clinical Laboratory Diagnostic Test Retail Value Market Segments 93
Table 4.7: Drugs of Abuse Testing Market: Market Drivers Ranked in Order of Impact 94
Table 4.8: Drugs of Abuse Testing Market: Market Restraints Ranked in Order of Impact 95
Table 5.1: Drugs of Abuse Tested for and Cut-off Values for Employees 98
Table 5.2: U.S. Workforce Testing Positive for Opiates using Oral Fluid Drug Tests, 2007-2010 100
Table 5.3: U.S. Workforce Annual Positivity Rates using Urine Drug Tests, 1988-2011 101
Table 5.4: U.S. Workforce Positivity Rates by Testing Category using Urine Drug Tests, 2006-2011 102
Table 5.5: U.S. DOA Positivity Rates by Testing Reason Using Urine Drug Tests for Federally Mandated, Safety-Sensitive Workforce, 2006-2011 102
Table 5.6: U.S. DOA Positivity Rates by Testing Reason Using Urine Drug Tests for General U.S. Workforce, 2006-2011 102
Table 5.7: Positivity Rates by Drug Category Using Urine Drug Tests for Federally Mandated, Safety-Sensitive Workforce, 2006-2011 103
Table 5.8: Positivity Rates by Drug Category Using Urine Drug Tests for General U.S. Workforce, 2006-2011 103
Table 5.9: Comparison of Saliva and Urine for Use in Drugs of Abuse Testing 103
Table 5.10: Main Devices for Saliva Collection on the Market 104
Table 5.11: Selected Mass Spectrometric Methods used to Quantify Common Drugs in Oral Fluid 104
Table 5.12: Top Ten Most-Prescribed Drugs in the U.S., 2011 105
Table 5.13: Top Ten Most-Prescribed Drugs by Sales in the U.S., 2011 106
Table 5.14: Prescription Dispensing Location by Spending in the U.S., 2006-2011 109
Table 5.15: Key Therapeutics and Manufacturers in the Narcotic Drug Pipeline, 2012 111
Table 5.16: Key Therapeutics and Manufacturers in the Non-Narcotic Pain Relief Drug Pipeline, 2012 112
Table 5.17: Key Therapeutics and Manufacturers in the Neuropathic Pain Relief Drug Pipeline, 2012 112
Table 5.18: Key Therapeutics and Manufacturers in the Anti-Migraine Drug Pipeline, 2012 112
Table 5.19: Key Therapeutics and Manufacturers in the Anti-Arthritic Pain Drug Pipeline, 2012 113
Table 5.20: Current Neuropathic Pain Therapeutics Leading the Market 113
Table 5.21: Comprehensive Steroid Panel in Drugs of Abuse Testing 120
Table 5.22: Comprehensive Diuretic Panel in Drugs of Abuse Testing 121
Table 5.23: Comprehensive Stimulant Panel in Drugs of Abuse Testing 121
Table 5.24: World Anti-Doping Agency Accredited Laboratories 122
Table 5.25: Laboratory Criteria Required for World Anti-Doping Agency Accreditation 123
Table 5.26: Relevant Provisions of International Standard for Laboratories, as Applied to the Process and Requirements for WADA Approval 124
Table 5.27: World Anti-Doping Agency Testing Statistics 125
Table 5.28: UNESCO International Convention Against Doping in Sport Voluntary Fund Guidelines 126
Table 6.1: Major Competitors in the Drugs of Abuse Oral Testing Market Segment 129
Table 6.2: Major Competitors in the Drugs of Abuse Urine Testing Market Segment 129
Table 6.3: OraSure Portfolio of Drugs of Abuse Detection Methodologies 137
Table 6.4: Avitar’s Aimstep ORALINE-4 Drugs of Abuse Cut-off Levels 138
Table 6.5: Pathtech Drug and Alcohol Saliva Testing Products 139
Table 6.6: Pathtech Drug and Alcohol Surface Testing Products 139
Table 6.7: Pathtech Drug and Alcohol Proscreen Urine Drugs of Abuse Test Cups 139
Table 6.8: Alpha Scientific Designs Drugs of Abuse Testing Cut-off Level 140
Table 6.9: Regulatory Clearance of Alpha Scientific Products for Drugs of Abuse Testing 141
Table 6.10: Available 510K Cleared Analytes for the Vision Integrated Drugs of Abuse Test Cup 142
Table 6.11: Drugs of Abuse Analytes and Cut-off Level Detected by the Oral-View Saliva Multi-Drugs of Abuse 143
Table 6.12: Alfa Scientific Drugs of Abuse Single Tests, Instant-View Brand (Urine) 143
Table 6.13: Alfa Scientific Drugs of Abuse, Multidrug Panel, Saliva—Oral-View Brand Second Generation-Two Strip Design 144
Table 6.14: Alfa Technologies Drugs of Abuse Multidrug Panel Configurations—Instant-View Brand (Urine) 145
Table 6.15: Alpha Scientific Designs Drugs of Abuse Testing Cut-off Level 147
Table 6.16: Regulatory Clearance of Alpha Scientific Products for Drugs of Abuse Testing 147
Table 6.17: Available 510K Cleared Analytes for the Vision Integrated Drugs of Abuse Test Cup 148
Table 6.18: Drugs of Abuse Analytes and Cut-off Level Detected by the Oral-View Saliva Multi-Drugs of Abuse 149
Table 6.19: Drugs of Abuse Cut-off Levels for the TOX/See Test by Bio-Rad 152
Table 7.1: Performance Characteristics Required before Implementation of FDA-Approved/Cleared Tests 160
Table 7.2: Comparison of Monoclonal and Polyclonal Antibody Characteristics 161
Table 7.3: Samples and Sample Handling Features of Centaur CP 168
Table 7.4: Large- and Mid-Size Immunochemistry Analyzers 182
Table 7.5: Small- to Mid-Volume Immunoassay Analyzers 198
Table 8.1: Overview of the ADVIA 2400 204
Table 8.2: Sample Handling Capability of the ADVIA 2400 204
Table 8.3: Microvolume Technology Utilized by the ADVIA 2400 204
Table 8.4: Reaction Area of the ADVIA 2400 205
Table 8.5: Reagent Handling Capability of the ADVIA 2400 205
Table 8.6: Parameter Menu of the ADVIA 2400 205
Table 8.7: Open System Capability of the ADVIA 2400 207
Table 8.8: ISE Parameters of the ADVIA 2400 207
Table 8.9: Calibration Parameters of the ADVIA 2400 207
Table 8.10: Data Management Capability of the ADVIA 2400 207
Table 8.11: General Specifications of the ADVIA 2400 208
Table 8.12: Ultra-Large Clinical Chemistry Analyzers 209
Table 8.13: Overview of ADVIA 1650 213
Table 8.14: Sample Handling Capabilities of the ADVIA 1650 213
Table 8.15: Microvolume Technology Capability of the ADVIA 1650 213
Table 8.16: Reaction Area Associated with the ADVIA 1650 214
Table 8.17: Reagent Handling Capability of the ADVIA 1650 214
Table 8.18: Parameter Menu Associated with the ADVIA 1650 214
Table 8.19: Open System Capability of the ADVIA 1650 216
Table 8.20: ISE Parameters of the ADVIA 1650 216
Table 8.21: Calibration Capabilities of the ADVIA 1650 216
Table 8.22: Data Management Capabilities of the ADVIA 1650 216
Table 8.23: General Specifications of the ADVIA 1650 217
Table 8.24: JEOL Analyzer Comparison 218
Table 8.25: Large Clinical Chemistry Analyzers 219
Table 8.26: Mid-Size Clinical Chemistry Analyzers 228
Table 8.27: Small Clinical Laboratory Analyzers 237
Table 8.28: Heritability Estimates for Drugs of Abuse 238
Table 8.29: Genetic Associations Implicated in Drug Addiction Phenotypes 239
Table 8.30: FDA Recognized Pharmacogenomic Biomarkers in to Identify Responders and Non-Responders to Medications 240
Table 8.31: Common Pharmacotherapies for Drug Dependence and Genetic Variations Implicated in Treatment 242
Table 9.1: Potential Challenges of Drugs of Abuse Testing Market 251
Table 9.2: Timeline of Legislative Changes from the Health Care and Education Reconciliation Act, 2010-2013 252
Table 11.1: Clinical Laboratory Improvement Amendments (CLIA) Testing Categories 272
Table 11.2: Annual Minimum Drug and Alcohol Random Testing Rates Established within DOT Agencies and the USCG, 2011 273
Table 11.3: General Responsibilities of Employers under the Department of Transportation’s (DOT) rule, 49 Code of Federal Regulations Part 40 273
Table 11.4: Actions that Employers Must Take after an Employee Test Result is Verified Positive 274
Table 11.5: Drugs of Abuse Cut-off Values (Initial Test) as Specified under Article 15 of the Drug Abuse Urine Testing Act 276
Table 11.6: Drugs of Abuse Cut-off Values (Confirmatory Test) as Specified under Article 18 of the Drug Abuse Urine Testing Act 276
Table 11.7: Medical Review Officer Requirements in the Department of Transportation Drug Testing Program 277
Table 11.8: Medical Review Officer Responsibilities in Drug Testing Programs 278
Table 11.9: Medical Review Officer Requirements when Reporting a Drug Test Result 279
Table 11.10: International Olympic Committee, U.S. Olympic Committee and NCAA Banned Substances 280
Table 11.11: Conditions of Sentences by Adult Probationers by Severity of Offense 282
Table 11.12: Total Federal Drug Control Budget for Fiscal Years, 2002-2011 283
Table 11.13: Federal Drug Control Budget by Function for Fiscal Years, 2009-2011 283

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