Molecular Diagnostics: Technologies and Global Markets

Report Scope:

This study examines the global market for assays used to detect specific nucleic acid sequences in medical and life sciences applications. While the goal of all DNA-based diagnostic assays is similar, several different technologies can be employed. It analyzes each technology in detail, determines major players and current market status and presents forecasts of growth over the next five years. Scientific challenges and advances including the latest trends are emphasized. We examine government regulations, major collaborations, recent patents and factors affecting the industry globally. In addition, we examine new directions for DNA diagnostic technologies and emerging applications in clinical diagnostics.

Report Includes:

- An overview of the global market for molecular diagnostics
- Analyses of global market trends, with data from 2016, estimates for 2017, and projections of compound annual growth rates (CAGRs) through 2022
- Discussion of related issues, such as government regulations, reimbursement through insurance, patient confidentiality, and other legal ramifications
- Identification of scientific challenges and advances, including the latest trends in the market
- A relevant patent analysis
- Comprehensive company profiles of major players in the field


Chapter 1: Introduction ......................................................................................... 1
Study Goals and Objectives........................................................................................................................... 1
Reasons for Doing the Study ......................................................................................................................... 1
Scope of Report ............................................................................................................................................. 1
Intended Audience ........................................................................................................................................ 1
Methodology and Information Sources ........................................................................................................ 2
Geographic Breakdown ................................................................................................................................. 2
Analysts Credentials ..................................................................................................................................... 5
Related BCC Research Reports...................................................................................................................... 5
Chapter 2: Summary and Highlights ....................................................................... 7
Forecasts ....................................................................................................................................................... 7
Chapter 3: Overview ............................................................................................ 10
Introduction to Genomic Diagnostics ......................................................................................................... 10
Expression Profiling and Disease ................................................................................................................ 12
Expression Profiling and Infectious Disease ................................................................................................ 12
DNA Sequencing for Genotyping and Diagnosis ......................................................................................... 13
Clinical Pharmacology ................................................................................................................................. 13
Mutation Detection and Genotyping for Specific Genes ............................................................................ 13
Identification of New Disease Genes .......................................................................................................... 14
Chapter 4: Regulations and Finance ..................................................................... 16
Overview ..................................................................................................................................................... 16
Insurance ..................................................................................................................................................... 16
Food and Drug Administration Guidelines .................................................................................................. 17
Internal Standards for DNA Diagnostics ..................................................................................................... 18
Minimum Information about a Microarray ................................................................................................ 19
Experiment — Miame 2.0 ....................................................................................................................... 19
Microarray Quality Control (MAQC) Project ........................................................................................... 20
Clinical Laboratory Improvement Amendments (CLIA)........................................................................... 21
Personalized Medicines and Companion Diagnostics ............................................................................. 24
FDA Guidelines for In Vitro Companion Diagnostics ................................................................................... 25
Definition and Use of an IVD Companion Diagnostic Device .................................................................. 25
Review and Approval of IVD Companion Diagnostic Devices and Therapeutic Products ...................... 26
Novel Therapeutic Products .................................................................................................................... 26
Approval of a Therapeutic Product without an Approved IVD Companion Diagnostic Device ............. 26
General Policies ....................................................................................................................................... 27
FDA Approved Companion Diagnostics ................................................................................................... 28
Nucleic Acid Based Tests ......................................................................................................................... 45
Pharmacogenomics Research Network .................................................................................................. 55
Chapter 5: Commercial Market Trends ................................................................ 57
Market Conditions ...................................................................................................................................... 57
Healthcare, Hospitals, Doctors, Greater Regulation and Need for Insurance Reimbursement ............. 57
New Requirements for Success .................................................................................................................. 57
Sales and Marketing ................................................................................................................................ 57
Medical Affairs......................................................................................................................................... 58
Regulatory Compliance ........................................................................................................................... 58
Reimbursement ....................................................................................................................................... 58
Alliances and Mergers ............................................................................................................................. 58
Chapter 6: Market for Molecular Diagnostics by Technology ............................... 65
Overview ..................................................................................................................................................... 65
Description .............................................................................................................................................. 65
Revenues and Forecasts .......................................................................................................................... 66
Manufacturers ......................................................................................................................................... 67
Microarray, Lab-on-a-Chip/Biochips ........................................................................................................... 68
Description .............................................................................................................................................. 68
Microfluidic Devices ................................................................................................................................ 70
Revenues and Forecasts .......................................................................................................................... 72
Manufacturers and Products................................................................................................................... 74
PCR .............................................................................................................................................................. 75
Description .............................................................................................................................................. 75
Revenues and Forecasts .......................................................................................................................... 76
Manufacturers and Products................................................................................................................... 78
In Situ Hybridization (ISH) ........................................................................................................................... 78
Description .............................................................................................................................................. 78
Labeling Techniques ................................................................................................................................ 79
Applications of In Situ Hybridization ....................................................................................................... 79
Fiber Fish ................................................................................................................................................. 80
Her2 Fish Testing ..................................................................................................................................... 81
Revenues and Forecasts .......................................................................................................................... 82
Emerging and Other Diagnostic Technologies ............................................................................................ 84
Description .............................................................................................................................................. 84
The Trend toward Single-Cell Measurements ......................................................................................... 84
Revenues and Forecasts .......................................................................................................................... 85
Chapter 7: Market for Molecular Diagnostics by Application and Products ......... 87
Overview ..................................................................................................................................................... 87
Description .............................................................................................................................................. 87
Revenues and Forecasts .......................................................................................................................... 87
Pre-/Postnatal Genetic Screening ............................................................................................................... 89
Description .............................................................................................................................................. 89
Carrier Screening ..................................................................................................................................... 90
Prenatal Diagnostic Testing ..................................................................................................................... 90
Amniocentesis ......................................................................................................................................... 90
Chorionic Villus Sampling ........................................................................................................................ 91
Genetic Counseling .................................................................................................................................. 91
Preimplantation Diagnosis ...................................................................................................................... 92
Newborn Screening ................................................................................................................................. 92
Revenues and Forecasts .......................................................................................................................... 93
Infectious Disease Diagnostics .................................................................................................................... 95
Description .............................................................................................................................................. 95
Revenues and Forecasts .......................................................................................................................... 96
Oncology Diagnostics .................................................................................................................................. 98
Description .............................................................................................................................................. 98
Leukemias ................................................................................................................................................ 98
Chronic Myeloid Leukemia ...................................................................................................................... 98
Genetic Marker of Chronic Myeloid Leukemia ....................................................................................... 98
Revenues and Forecasts .......................................................................................................................... 99
Identity Diagnostics, Forensics and Paternity ........................................................................................... 101
Description ............................................................................................................................................ 101
Paternity Testing ................................................................................................................................... 101
Technology ............................................................................................................................................ 101
Accreditation ......................................................................................................................................... 101
Legal Issues ............................................................................................................................................ 101
Veterinary Identity Testing .................................................................................................................... 102
Revenues and Forecasts ........................................................................................................................ 102
Pharmacogenomics/Other Applications ................................................................................................... 104
Description ............................................................................................................................................ 104
Revenues and Forecasts ........................................................................................................................ 106
Chapter 8: Geographic Forecasts ....................................................................... 109
PCR ............................................................................................................................................................ 109
Microarray................................................................................................................................................. 109
ISH ............................................................................................................................................................. 110
Emerging and Other Markets.................................................................................................................... 110
Chapter 9: Patent Analysis ................................................................................. 112
PCR ............................................................................................................................................................ 112
ISH ............................................................................................................................................................. 119
Microarrays ............................................................................................................................................... 121
Microfluidics and Biochips ........................................................................................................................ 123
Chapter 10: Company Profiles ........................................................................... 132
About BCC Research ......................................................................................... 183
About BCC Research.................................................................................................................................. 184
BCC Membership ...................................................................................................................................... 184
BCC Custom Research ............................................................................................................................... 184


List Of Tables


Summary Table: Global Market for Molecular Diagnostics, by Technology, Through 2022 ($ Millions) .... 7
Table 1 Minimum Information About a Microarray Experiment — MIAME 2.0 ....................................... 19
Table 2 Microarray Quality Control (MAQC) Project .................................................................................. 20
Table 3 U.S. Laboratories CLIA-Certified for Molecular Diagnostics and Number of Disease Tests .......... 22
Table 4 Genetic Testing Procedures Performed in U.S. by Type, 2015 ...................................................... 23
Table 5 FDA-approved In Vitro Companion Diagnostic Devices as of June 1, 2017 ................................... 28
Table 6 Nucleic Acid-based Tests Cleared or Approved by the Center for Devices and Radiological Health, as of June 1, 2017........................................................................................................................................ 45
Table 7 Nucleic Acid-based Tests Cleared or Approved by the Center for Devices and Radiological Health as of June 1, 2017........................................................................................................................................ 48
Table 8 Diagnostics Manufacturer Mergers and Acquisitions, 2004-2017 ................................................. 59
Table 9 Global Market for Molecular Diagnostics by Technology, Through 2022 ($ Millions) ................... 66
Table 10 Global Market Share for Molecular Diagnostics by Technology, 2017 (%) ................................. 66
Table 11 Global Market Share for Molecular Diagnostics by Manufacturer, 2017 (%) .............................. 67
Table 12 Global Microarray Market for Molecular Diagnostics, by Application, through 2022 ($ Millions) .................................................................................................................................................................... 73
Table 13 Global Microarray Market Share for Molecular Diagnostics, by Application, 2017 (%) ............. 73
Table 14 Major Suppliers of Planar DNA Microarrays ................................................................................ 74
Table 15 Major Suppliers of Bead Microarrays ........................................................................................... 75
Table 16 Global PCR Market for Molecular Diagnostics, by Application, Through 2022 ($ Millions) ........ 76
Table 17 Global PCR Market Share for Molecular Diagnostics, by Application, 2017 (%) ......................... 77
Table 18 Global PCR Market Share, by Manufacturer, 2017 (%) ................................................................ 78
Table 19 Global ISH Market for Molecular Diagnostics by Application, Through 2022 ($ Millions)........... 82
Table 20 Global ISH Market Share for Molecular Diagnostics, by Application, 2017 (%) .......................... 83
Table 21 Global Emerging/Other Molecular Diagnostics Market, by Application, Through 2022 ($ Millions) ...................................................................................................................................................... 85
Table 22 Global Emerging/Other Molecular Diagnostics Market Share, by Application, 2017 (%) ........... 85
Table 23 Global Market for Molecular Diagnostics, by Application, Through 2022 ($ Millions) ................ 88
Table 24 Global Market Share for Molecular Diagnostics, by Application, 2017 (%) ................................ 88
Table 25 Global Pre/Postnatal Screening Market for Molecular Diagnostics, by Technology, Through 2022 ($ Millions) ......................................................................................................................................... 93
Table 26 Global Pre/Postnatal Screening Market Share for Molecular Diagnostics, by Technology, 2017 .................................................................................................................................................................... 94
(%) ............................................................................................................................................................... 94
Table 27 Global Infectious Diseases Market for Molecular Diagnostics, by Technology, Through 2022 ($ Millions) ...................................................................................................................................................... 96
Table 28 Global Infectious Disease Screening Market Share for Molecular Diagnostics, by Technology, 2017 (%) ..................................................................................................................................................... 97
Table 29 Global Oncology Market for Molecular Diagnostics, by Technology, Through 2022 ($ Millions) 99
Table 30 Global Oncology Market Share for Molecular Diagnostics, by Technology, 2017 (%) .............. 100
Table 31 Global Identity Testing Market for Molecular Diagnostics, by Technology, Through 2022 ($ Millions) .................................................................................................................................................... 102
Table 32 Global Identity Testing Market Share for Molecular Diagnostics, by Technology, 2017 (%) ... 103
Table 33 Global Pharmacogenomics and Other Market Share for Molecular Diagnostics by Technology, Through 2022 ($ Millions) ......................................................................................................................... 107
Table 34 Global Pharmacogenomics and Other Market Share for Molecular Diagnostics by Technology, 2017 (%) ................................................................................................................................................... 107
Table 35 Global PCR Molecular Diagnostics Market, by Region, Through 2022 ($ Millions) ................... 109
Table 36 Global Microarray Molecular Diagnostics Market, by Region, Through 2022 ($ Millions) ........ 109
Table 37 Global ISH Molecular Diagnostics Market, by Region, Through 2022 ($ Millions) .................... 110
Table 38 Global Emerging and Other Molecular Diagnostics Markets, by Region, Through 2022 ($ Millions) .................................................................................................................................................... 110
Table 39 Selected PCR Patents Granted from January 2015 to June 2017 .............................................. 112
Table 40 Selected ISH Patents Granted from January 2015 to June 2017 ............................................... 119
Table 41 Selected Microarray Patents Granted from January 2015 to June 2017 ................................... 121
Table 42 Selected Biochip Patents Granted from January 2015 To June 2017 ........................................ 123
Table 43 Selected Microfluidics Patents Granted from January 2015 to June 2017 ................................ 124
Table 44 List of Companies Acquired, 2014-2017 .................................................................................... 182


List Of Figures


Summary Figure: Global Market for Molecular Diagnostics, 2016-2022 ($ Millions) ................................. 8
Figure 1 Growth in Clinical Laboratory Sites and Disease Testing, 2012–2015 (Number) ........................ 23
Figure 2 Global Market Share for Molecular Diagnostics by Technology, 2017 (%) .................................. 67
Figure 3 Global Market Share for Molecular Diagnostics by Manufacturer, 2017 (%) ............................... 68
Figure 4 Global Microarray Market Share for Molecular Diagnostics, by Application, 2017 (%) ............... 74
Figure 5 Global PCR Market Share for Molecular Diagnostics, by Application, 2017 (%) .......................... 77
Figure 6 Global ISH Market Share for Molecular Diagnostics, by Application, 2017 (%) ........................... 83
Figure 7 Global Market Share for Molecular Diagnostics, by Application, 2017 (%) ................................. 89
Figure 8 Global Pre/Postnatal Screening Market Share or Molecular Diagnostics, by Technology, 2017 94
(%) ............................................................................................................................................................... 94
Figure 9 Global Infectious Disease Screening Market Share for Molecular Diagnostics, by Technology, 2017 (%) ..................................................................................................................................................... 97
Figure 10 Global Oncology Market Share for Molecular Diagnostics, by Technology, 2017 (%) ............. 100
Figure 11 Global Identity Testing Market Share for Molecular Diagnostics, by Technology, 2017 (%) .. 103


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