Table of Content
Table of Contents
1 Market Guides 14
1.1 Relationship Testing - Strategic Situation 15
1.2 Guide for Executives, Marketing, Sales and Business Development Staff 17
1.3 Guide for Management Consultants and Investment Advisors 18
2 Introduction and Market Definition 19
2.1 What is Paternity & Relationship Testing? 20
2.2 The Genomics 21
2.3 Market Definition 22
2.3.1 Revenue Market Size. 22
2.3.2 Legal 23
2.3.3 Migrant 23
2.3.4 Clinical 23
2.3.5 Discretionary 23
2.3.6 Instruments 24
2.3.7 Reagents 24
2.3.8 Software and Services 24
2.4 Methodology. 25
2.4.1 Methodology 25
2.4.2 Sources 25
2.4.3 Authors 25
2.5 Perspective: Healthcare and the IVD Industry 27
2.5.1 Global Healthcare Spending 27
2.5.2 Spending on Diagnostics 28
2.5.3 Important Role of Insurance for Diagnostics 30
2.6 Chromosomes, Genes and Epigenetics 31
2.6.1 Chromosomes 31
2.6.2 Genes 33
2.6.3 Epigenetics 36
3 Market Overview 38
3.1 Players in a Dynamic 39
3.1.1 Academic Research Lab 40
3.1.2 Diagnostic Test Developer 41
3.1.3 Instrumentation Supplier 41
3.1.4 Chemical/Reagent Supplier 41
3.1.5 Pathology Supplier 42
3.1.6 Independent Clinical Laboratory 42
3.1.7 Public National/regional Laboratory 42
3.1.8 Hospital Laboratory 43
3.1.9 Physicians Office Lab (POLS) 43
3.1.10 Audit Body 44
3.1.11 Certification 44
3.2 Relationship Testing 46
3.2.1 Overview 46
3.2.2 Legal Use – a special case 47
3.2.2.1 Legal 47
3.2.2.2 Private 47
3.2.3 Rights and Responsibilities – a complex picture 48
3.2.4 Forensic 48
3.2.5 Clinical Uses 48
3.2.6 Familial and Discretionary 49
3.2.7 Role of Direct to Consumer Genetic Testing Services 49
3.2.8 Immigration Use 50
4 Market Trends 51
4.1 Instrumentation, Automation & Diagnostic 52
4.1.1 Traditional Automation and Centralization 52
4.1.2 The New Automation, Decentralization and Point Of Care 52
4.1.3 Instruments Key to Market Share 54
4.1.4 Bioinformatics Plays a Role 55
4.1.5 PCR Takes Command 55
4.1.6 Next Generation Sequencing Fuels a Revolution 56
4.1.7 NGS Impact on 57
4.1.8 Whole Genome Sequencing, A Brave New World 57
4.1.9 Companion Diagnostics Blurs Diagnosis and Treatment 58
4.2 Factors Driving Growth 60
4.2.1 Genetics Takes Center Stage 60
4.2.2 Cultural Shifts – Changing Meaning of Family 61
4.2.3 Media & Celebrity 61
4.2.4 Ancestry – Changing Attitudes 61
4.3 Factors Limiting Growth 63
4.3.1 Increased Competition Lowers Price 63
4.3.2 Lower Costs 64
4.3.3 Values 64
4.3.4 DTC Competition 64
5 Relationship Testing Recent Developments 65
5.1.1 Importance of This Section 66
5.1.2 How to Use This Section 66
5.2 New law proposes DNA testing to weed-out false declarations of paternity 66
5.3 AffinityDNA Acquisition expands direct-to-consumer business 67
5.4 EasyDNA expands markets 68
5.5 AlphaBiolabs accredited as demand for prenatal paternity testing 69
5.6 Genetic Technologies to Acquire DTC Genetic Test Provider EasyDNA 70
5.7 DNA Diagnostics Center to Join Eurofins via Acquisition 71
5.8 Bode and Gene By Gene Receive 72
5.9 Pioneers, myDNA and FamilyTreeDNA Merge 73
5.10 Researchers Urged to Adopt New Genomic Technologies for Relationship Testing 74
5.11 ‘Not the Father’: Baltimore Man Filing suit 80
5.12 Thermo Fisher Scientific Applied Biosystems SeqStudio Genetic Analyzer for Human Identification 81
6 Profiles of Key Companies 82
6.1 AlphaBiolabs 83
6.2 Bureau Veritas 85
6.3 Canadian DNA Services 86
6.4 Easy DNA 88
6.5 Eurofins Scientific 89
6.6 Gene by Gene, Ltd. 91
6.7 Genex Diagnostics 93
6.8 Intelligenetics 95
6.9 Invitae 96
6.10 Laboratory Corporation of America 98
6.11 Myriad Genetics/Myriad RBM 100
6.12 Quest Diagnostics 101
6.13 Verogen 102
7 Global Relationship Testing Market Size 104
7.1 Global Market by Country 105
7.1.1 Table – Global Market by Country 105
7.1.2 Chart – Country Market Shares 106
7.2 Global Market by Application 107
7.2.1 Table – Global Market by Application 107
7.2.2 Chart – Application Share by Year 108
7.2.3 Chart – Application Segment Growth Rates 109
7.2.4 Chart – Application Segment Share 110
7.2.5 Chart – Application Segment Share Base Year 111
7.2.6 Chart – Application Segment Share Final Year 112
7.3 Global Market by Product 113
7.3.1 Table – Global Market by Product 113
7.3.2 Chart – Product Share by Year 114
7.3.3 Chart – Product Segment Growth Rates 115
7.3.4 Chart – Product Segment Share Shifts 116
7.3.5 Chart – Product Segment Share Base Year 117
7.3.6 Chart – Product Segment Share Final Year 118
8 Global Relationship Market Sizes by Application 119
8.1 Legal Market 120
8.1.1 Table Legal – by Country 120
8.1.2 Chart – Legal Growth 121
8.2 Migrant Testing Market 122
8.2.1 Table Migrant – by Country 122
8.2.2 Chart – Migrant Growth 123
8.3 Clinical Market 124
8.3.1 Table Clinical – by Country 124
8.3.2 Chart – Clinical Growth 125
8.4 Consumer Discretionary Market 126
8.4.1 Table Consumer Discretionary – by Country 126
8.4.2 Chart – Consumer Discretionary Growth 127
9 Global Relationship Testing Market by Product 128
9.1 Instruments Market 129
9.1.1 Table Instruments – by Country 129
9.1.2 Chart – Instrument Growth 130
9.2 Reagents and Kits Market 131
9.2.1 Table Reagents and Kits – by Country 131
9.2.2 Chart – Reagents and Kits Growth 132
9.3 Software Market 133
9.3.1 Table Software – by Country 133
9.3.2 Software Growth 134
9.4 Services Market 135
9.4.1 Table Services – by Country 135
9.4.2 Chart – Services Growth 136
10 Appendix 137
10.1 Methodology 137
10.1.1 Authors 137
10.1.2 Sources 137
Table of Tables
Table 1 The Base Pairs 34
Table 2 Market Players by Type 40
Table 3 The Different Types of Relationship Tests 46
Table 4 Seven Key Diagnostic Laboratory Technology Trends 52
Table 5 Factors Driving Growth 60
Table 6 Four Factors Limiting Growth 63
Table 7 Global Market by Country 105
Table 8 Global Market by Application 107
Table 9 Global Market by Product 113
Table 10 Legal Segment by Country 120
Table 11 Migrant Segment by Country 122
Table 12 Clinical Segment by Country 124
Table 13 Consumer Discretionary Segment by Country 126
Table 14 Instruments Segment by Country 129
Table 15 Reagents and Kits Segment by Country 131
Table 16 Software Segment by Country 133
Table 17 Services Segment by Country 135
Table of Figures
Figure 1 Global Healthcare Spending 28
Figure 2 The Lab Test Pie 29
Figure 3 DNA Strands and Chromosomes 31
Figure 4 Karyogram of Human Chromosomes 32
Figure 5 Size of Various Genomes 35
Figure 6 The Road to Diagnostics 39
Figure 7 Centralized vs. Decentralized Laboratory Service 53
Figure 8 A Highly Multiplexed Syndromic Testing Unit 54
Figure 9 The Real Cost to Sequence the Human Genome 56
Figure 10 The Codevelopment Process 58
Figure 11 Country Market Shares 106
Figure 12 Application Share by Year 108
Figure 13 Application Segment Growth Rates 109
Figure 14 Segment Share Shifts 110
Figure 15 Application Segment Share Base Year 111
Figure 16 Application Segment Share Final Year 112
Figure 17 Product Share by Year 114
Figure 18 Product Segment Growth Rates 115
Figure 19 Product Segment Share Shifts 116
Figure 20 Product Segment Share Base Year 117
Figure 21 Product Segment Share Final Year 118
Figure 22 Legal vs. Total Market Growth 121
Figure 23 Migrant vs. Total Market Growth 123
Figure 24 Clinical vs. Total Market Growth 125
Figure 25 Consumer Discretionary vs. Total Market Growth 127
Figure 26 Instrument vs. Total Market Growth 130
Figure 27 Reagents and Kits vs. Total Market Growth 132
Figure 28 Software vs. Total Market Growth 134
Figure 29 Services vs. Total Market Growth 136