OVERVIEW:
Unlimited growth potential? Genetic Testing has crossed the chasm and is now growing in every area. What are the opportunities? What are the pitfalls?
The role of genetics in health and disease is just now being understood. This new knowledge, combined with lower pricing is driving the Genetic Testing industry to record growth. New drugs may only work for people with a certain genetic makeup, and this too is driving the Genetic Testing Industry. The traditional genetic testing market is growing in volume and growing in the breadth of tests creating new life, and new problems for the industry. The report includes detailed breakouts for 14 countries and 5 regions.
Predictive Diagnostics? Pharmacogenomic Testing? Direct to Consumer? Find out about the technology in readily understood terms that explain the jargon. What are the issues? Find the opportunities and the pitfalls. Understand growth expectations and the ultimate market forecasts for the next five years.
All report data is available in Excel format on request.
Make investment decisions and valuations with confidence using the latest data.
ABOUT THE LEAD AUTHOR:
Mr. Greg Powell, B.SC., M.B.A is the President of Howe Sound Research. He is an experienced business and clinical professional. He is co-author of the paper "The Radioimmunoassay of Angiotensinogen by Antibody Trapping." He has worked in laboratory testing and management for over 20 years. Mr. Powell's education includes:
- B.Sc. (Chemistry) University of BC
- M.B.A. (Finance and Policy) University of BC
- Market Research Seminar - Burke Institute
- Finance for Senior Executives - Harvard Business School
Table of Contents
1. Market Guides
- 1.1. Genetic Testing-Strategic Situation Analysis
- 1.2. Guide for Executives, Marketing, Sales and Business Development Staff
- 1.3. Guide for Management Consultants and Investment Advisors
2. Introduction and Market Definition
- 2.1. Genetic Testing Definition in This Report
- 2.2. The Genomics Revolution
- 2.3. Market Definition
- 2.3.1. Revenue Market Size.
- 2.3.2. Newborn Screening
- 2.3.3. Non Invasise Pregnancy Testing
- 2.3.4. Predictive
- 2.3.5. Oncology
- 2.3.6. Direct to Consumer
- 2.3.7. Other Application
- 2.3.8. PCR
- 2.3.9. NGS
- 2.3.10. Cytogenetic
- 2.3.11. Other Technology
- 2.4. Methodology
- 2.4.1. Methodology
- 2.4.2. Sources
- 2.4.3. Authors
- 2.5. Perspective: Healthcare and the IVD Industry
- 2.5.1. Global Healthcare Spending
- 2.5.2. Spending on Diagnostics
- 2.5.3. Important Role of Insurance for Diagnostics
- 2.6. Chromosomes, Genes and Epigenetics
- 2.6.1. Chromosomes
- 2.6.2. Genes
- 2.6.3. Epigenetics
3. Market Overview
- 3.1. Players in a Dynamic Market
- 3.1.1. Academic Research Lab
- 3.1.2. Diagnostic Test Developer
- 3.1.3. Instrumentation Supplier
- 3.1.4. Chemical/Reagent Supplier
- 3.1.5. Pathology Supplier
- 3.1.6. Independent Clinical Laboratory
- 3.1.7. Public National/regional Laboratory
- 3.1.8. Hospital Laboratory
- 3.1.9. Physicians Office Lab (POLS)
- 3.1.10. Audit Body
- 3.1.11. Certification Body
- 3.2. Genetic Tests -Types, Examples and Discussion
- 3.2.1. Preimplantation Genetic Diagnosis- An Emerging Market
- 3.2.2. Prenatal Diagnosis-New Technologies Create Opportunity
- 3.2.3. Newborn Screening
- 3.2.4. Diagnostic Testing
- 3.2.5. Carrier Testing
- 3.2.6. Predictive and Presymptomatic Testing
- 3.2.7. Pharmacogenomics
- 3.2.8. Forensic Testing
- 3.2.9. Parental Testing
- 3.2.10. Ancestral Testing
- 3.3. Industry Structure
- 3.3.1. Hospital's Testing Share
- 3.3.2. Economies of Scale
- 3.3.3. Hospital vs. Central Lab
- 3.3.4. Physician Office Lab's
- 3.3.5. Physician's and POCT
4. Market Trends
- 4.1. Factors Driving Growth
- 4.1.1. Genetic Discoveries Impact.
- 4.1.2. The Aging Effect
- 4.1.3. Pharmacogenomics
- 4.1.4. Oncology and Liquid Biopsy Factors
- 4.1.5. Fertility Practice
- 4.1.6. Direct to Consumer
- 4.2. Factors Limiting Growth
- 4.2.1. The Competition Effect
- 4.2.2. The Cost Situation
- 4.2.3. Testing usage analysis
- 4.2.4. Wellness Effects
- 4.3. Instrumentation, Automation and Diagnostic Trends
- 4.3.1. Traditional Automation and Centralization
- 4.3.2. The New Automation, Decentralization and Point of Care
- 4.3.3. Instruments Key to Market Share
- 4.3.4. Bioinformatics Plays a Role
- 4.3.5. PCR Takes Command
- 4.3.6. Next Generation Sequencing Fuels a Revolution
- 4.3.7. NGS Impact on Pricing
- 4.3.8. Whole Genome Sequencing, A Brave New World
- 4.3.9. Companion Diagnostics Blurs Diagnosis and Treatment
- 4.3.10. Shifting Role of Diagnostics
5. Genetic Testing Recent Developments
- 5.1. Recent Developments
- 5.1.1. Importance of This Section
- 5.1.2. How to Use This Section
- 5.2. Revvity Launches NGS Panel for Newborn Screening
- 5.3. LetsGetChecked: MyGeneticScreen
- 5.4. Sysmex, Hitachi to Develop Low-Cost Sequencers
- 5.5. Fore Genomics Offering WGS Newborn Screening to Parents
- 5.6. Clinical Validation of Long-Read WGS Assay
- 5.7. Resolution Bio Acquisition-Exact Sciences Aims at Liquid Biopsy Market
- 5.8. Novitas Rescinds Coverage for Multiple Genetic Tests
- 5.9. PerkinElmer (now Revvity) Becomes Dx Life Science Firm
- 5.10. New POC Genotyping Tests Based on Electromagnetic Detection
- 5.11. GenoMe Dx Launching dPCR Cancer Test
- 5.12. mDetect To Trial Breast Cancer Liquid Biopsy
- 5.13. Genomics England, Aims to Sequence 100K Newborns
- 5.14. Juno Diagnostics NIPT With At-Home Sample Collection
- 5.15. Cardio Diagnostics Launches Genetic Cario Risk Test
- 5.16. Universal Genetic Testing in Breast Cancer Further Supported
- 5.17. Aniling Gets CE-IVD Marks for Cancer Sequencing Tests
- 5.18. MyOme Lands Investment for WGS
- 5.19. Type 2 Diabetes GWAS Enables Risk Prediction
- 5.20. LetsGetChecked to Acquire Veritas Genetics
- 5.21. Guardant Health Plans New Comprehensive Assay
- 5.22. Tesis Labs Raises $20M
- 5.23. Sema4: Sema4 Elements
- 5.24. Clarified Precision Medicine Acquires Interpares Biomedicine
- 5.25. Genetic Technologies to Acquire DTC Genetic Test Provider EasyDNA
- 5.26. Illumina, Belgium Genetic Centers Partner on WGS-Based Dx
- 5.27. NIH, Genomics England Launch Sequencing Studies Using Nanopore Technology
- 5.28. Progenity Revenues Fall on COVID-19 Effect
- 5.29. Natera Launches Tumor Genomic Profiling Assay
- 5.30. 23andMe To Go Public
- 5.31. Guardant Health to Offer Tumor Tissue Sequencing
- 5.32. Ancestry Quits Health Offering
- 5.33. DTC Firm MyDNA Merges With Gene by Gene
6. Profiles of Key Companies
- 6.1. 10x Genomics, Inc.
- 6.2. 23andME Inc.
- 6.3. Abbott Laboratories
- 6.4. Adaptive Biotechnologies
- 6.5. Admera Health, LLC
- 6.6. Agilent
- 6.7. Akonni Biosystems
- 6.8. Amoy Diagnostics Co., Ltd.
- 6.9. Ancestry.com LLC
- 6.10. Anchor Dx
- 6.11. Arrayit Corporation
- 6.12. ARUP Laboratories
- 6.13. Aus Diagnostics
- 6.14. BaseClear
- 6.15. Baylor Miraca Genetics Laboratories
- 6.16. Beckman Coulter Diagnostics (Danaher)
- 6.17. Becton, Dickinson and Company
- 6.18. BGI Genomics Co. Ltd
- 6.19. Bioarray Genetics
- 6.20. BioBam
- 6.21. Biocept, Inc.
- 6.22. Biodesix Inc.
- 6.23. BioFluidica
- 6.24. BioGenex
- 6.25. BioGX
- 6.26. Biolidics Ltd
- 6.27. bioMerieux Diagnostics
- 6.28. Bioneer Corporation
- 6.29. Bio-Rad Laboratories, Inc
- 6.30. Bio-Techne
- 6.31. Burning Rock
- 6.32. C2i Genomics
- 6.33. Cantata Bio
- 6.34. CareDx
- 6.35. Caris Molecular Diagnostics
- 6.36. Celemics
- 6.37. CellMax Life
- 6.38. Centogene
- 6.39. Cepheid (Danaher)
- 6.40. Circulogene
- 6.41. Clearbridge Biomedics
- 6.42. Clinical Genomics
- 6.43. Color Genomics
- 6.44. Complete Genomics (MGI Tech)
- 6.45. CosmosID
- 6.46. Dante Labs
- 6.47. Datar Cancer Genetics Limited
- 6.48. Diasorin S.p.A.
- 6.49. DNAe
- 6.50. Easy DNA
- 6.51. Element Biosciences
- 6.52. Epic Sciences
- 6.53. Epigenomics AG
- 6.54. Eurofins Scientific
- 6.55. Excellerate Bioscience
- 6.56. Fabric Genomics
- 6.57. Freenome
- 6.58. FUJIFILM Wako Diagnostics
- 6.59. Fujirebio
- 6.60. Fulgent Genetics
- 6.61. Gene by Gene, Ltd.
- 6.62. Genedrive
- 6.63. GeneDx Holdings
- 6.64. GeneFirst Ltd.
- 6.65. Genetic Technologies Ltd.
- 6.66. Genetron Holdings
- 6.67. Genomics England
- 6.68. Genomics Personalized Health (GPH)
- 6.69. GenomOncology
- 6.70. Genzyme Corporation
- 6.71. Grifols
- 6.72. Guardant Health
- 6.73. Guardiome
- 6.74. Helix
- 6.75. Hologic
- 6.76. HTG Molecular Diagnostics
- 6.77. Human Longevity, Inc.
- 6.78. iCellate
- 6.79. Illumina
- 6.80. Incell Dx
- 6.81. Inivata
- 6.82. Invitae Corporation
- 6.83. Invivoscribe
- 6.84. Karius
- 6.85. Letsgetchecked
- 6.86. Lunglife AI Inc
- 6.87. Macrogen
- 6.88. MDNA Life SCIENCES, Inc.
- 6.89. MDx Health
- 6.90. Medgenome
- 6.91. Menarini Silicon Biosystems
- 6.92. Meridian Bioscience
- 6.93. Mesa Laboratories, Inc.
- 6.94. Metabiomics Corp
- 6.95. miR Scientific
- 6.96. NantHealth, Inc.
- 6.97. Natera
- 6.98. Nebula Genomics
- 6.99. NeoGenomics
- 6.100. New England Biolabs, Inc.
- 6.101. NGeneBio
- 6.102. Norgen Biotek Corp.
- 6.103. Novogene
- 6.104. Omega Bioservices
- 6.105. Oncocyte
- 6.106. OncoDNA
- 6.107. OpGen
- 6.108. Origene Technologies
- 6.109. Oxford Nanopore Technologies
- 6.110. Pacific Biosciences
- 6.111. Panagene
- 6.112. PathoQuest S.A.
- 6.113. Personalis
- 6.114. PGDx (Labcorp)
- 6.115. Precipio
- 6.116. PrecisionMed
- 6.117. Predictive Oncology
- 6.118. Promega
- 6.119. Qiagen
- 6.120. QuantuMDx
- 6.121. Revvity
- 6.122. Roche Diagnostics
- 6.123. Roswell Biotechnologies
- 6.124. Seegene
- 6.125. Sequencing.com
- 6.126. Siemens Healthineers
- 6.127. simfo GmbH
- 6.128. Singlera Genomics Inc.
- 6.129. Singular Genomics
- 6.130. SkylineDx
- 6.131. Standard BioTools
- 6.132. Sysmex
- 6.133. Sysmex Inostics
- 6.134. Tempus Labs, Inc.
- 6.135. Thermo Fisher Scientific
- 6.136. Ultima Genomics
- 6.137. Ultima Genomics
- 6.138. Variantyx
- 6.139. Vela Diagnostics
- 6.140. VolitionRX
- 6.141. Zymo Research Corp
7. Global Market Size
- 7.1. Global Market by Country
- 7.1.1. Table-Global Market by Country
- 7.1.2. Chart-Country Market Shares
- 7.2. Global Market by Application
- 7.2.1. Table-Global Market by Application
- 7.2.2. Chart-Application Share by Year
- 7.2.3. Chart-Application Segment Growth Rates
- 7.2.4. Chart-Application Segment Share Shifts
- 7.2.5. Chart-Application Segment Share Base Year
- 7.2.6. Chart-Application Segment Share Final Year
- 7.3. Global Market by Technology
- 7.3.1. Table-Global Market by Technology
- 7.3.2. Chart-Technology Share by Year
- 7.3.3. Chart-Technology Segment Growth Rates
- 7.3.4. Chart-Technology Segment Share Shifts
- 7.3.5. Chart-Technology Segment Share Base Year
- 7.3.6. Chart-Technology Segment Share Final Year
- 7.4. Global Market by Product
- 7.4.1. Table-Global Market by Product
- 7.4.2. Chart-Product Share by Year
- 7.4.3. Chart-Product Segment Growth Rates
- 7.4.4. Chart-Product Segment Share Shifts
- 7.4.5. Chart-Product Segment Share Base Year
- 7.4.6. Chart-Product Segment Share Final Year
- 7.5. Global Market by User
- 7.5.1. Table-Global Market by User
- 7.5.2. Chart-User Share by Year
- 7.5.3. Chart-User Segment Growth Rates
- 7.5.4. Chart-User Segment Share Shifts
- 7.5.5. Chart-User Segment Share Base Year
- 7.5.6. Chart-User Segment Share Final Year
8. Market Sizes by Application
- 8.1. Newborn Testing Market
- 8.1.1. Table Newborn-by Country
- 8.1.2. Chart-Newborn Growth
- 8.2. NIPT Market
- 8.2.1. Table NIPT-by Country
- 8.2.2. Chart-NIPT Growth
- 8.3. Predictive Testing Market
- 8.3.1. Table Predictive-by Country
- 8.3.2. Chart-Predictive Growth
- 8.4. Oncology Testing Market
- 8.4.1. Table Oncology-by Country
- 8.4.2. Chart-Oncology Growth
- 8.5. DTC Testing Market
- 8.5.1. Table DTC-by Country
- 8.5.2. Chart-DTC Growth
- 8.6. Other Testing Market
- 8.6.1. Table Other-by Country
- 8.6.2. Chart-Other Growth
9. Global Genetic Testing Market by Technology
- 9.1. PCR Testing Market
- 9.1.1. Table PCR-by Country
- 9.1.2. Chart-PCR Growth
- 9.2. NGS Market
- 9.2.1. Table NGS-by Country
- 9.2.2. Chart-NGS Growth
- 9.3. Cytogenetic Testing Market
- 9.3.1. Table Cytogenetic-by Country
- 9.3.2. Cytogenetic-Predictive Growth
- 9.4. Other Testing Market
- 9.4.1. Table Other-by Country
- 9.4.2. Chart-Other Growth
10. Global Genetic Testing Market by Product
- 10.1. Instruments Market
- 10.1.1. Table Instruments-by Country
- 10.1.2. Chart-Instrument Growth
- 10.2. Reagents and Kits Market
- 10.2.1. Table Reagents and Kits-by Country
- 10.2.2. Chart-Reagents and Kits Growth
- 10.3. Software Market
- 10.3.1. Table Software-by Country
- 10.3.2. Software Growth
- 10.4. Services Market
- 10.4.1. Table Services-by Country
- 10.4.2. Chart-Services Growth
11. Global Genetic Testing Market by User
- 11.1. Academic Market
- 11.1.1. Table Academic-by Country
- 11.1.2. Chart-Academic Growth
- 11.2. Clinical Market
- 11.2.1. Table Clinical-by Country
- 11.2.2. Chart-Clinical Growth
- 11.3. Pharmaceutical Market
- 11.3.1. Table Pharmaceutical-by Country
- 11.3.2. Pharmaceutical-Predictive Growth
- 11.4. Industrial and Other Market
- 11.4.1. Table Industrial and Other-by Country
- 11.4.2. Chart-Industrial and Other Growth
12. The Future of Genetic Testing
13. Appendices
- 13.1. Growth of Approved IVD Test Menu
- 13.2. Growth of Approved Average IVD Test Fee
- 13.3. The Most Used IVD Assays
- 13.4. The Highest Grossing Assays
- 13.5. Laboratory Fees Schedule