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Genetic Testing Markets. Global Market Analysis with Forecasts by Applications, Technologies, Products and Users with Executive and Consultant Guides 2023 to 2027

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    Report

  • 490 Pages
  • October 2024
  • Region: Global
  • Howe Sound Research
  • ID: 5459736

Explosion in Genetic Knowledge Creates New Global Market for Genetic Testing. A Complex Market With Unlimited Potential

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.

This research makes you the expert in your organization. Make investment decisions and valuations with confidence using the latest data. 

Table of Contents

1 Market Guides
1.1 Genetic Testing - Strategic Situation Analysis & Company Rankings
1.1.1 Selected Genetic Testing Companies Revenue & Growth
1.1.2 Selected Companies Growth Chart
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 Invasive 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 Creating New Diagnostic Markets
4.1.2 The Aging Effect
4.1.3 Pharmacogenomics Drives Further Growth
4.1.4 Oncology and Liquid Biopsy Enter New Era
4.1.5 Fertility Practice Growth drives market
4.1.6 Direct to Consumer begins to break out
4.2 Factors Limiting Growth
4.2.1 Increased Competition Lowers Price
4.2.2 Lower Costs
4.2.3 Testing usage analysis curtailing growth
4.2.4 Wellness has a downside
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 Novitas Rescinds Coverage for Multiple Genetic Tests
5.3 PerkinElmer (now Revvity) Becomes Dx Life Science Firm
5.4 New POC Genotyping Tests Based on Electromagnetic Detection
5.5 GenoMe Dx Launching dPCR Cancer Test
5.6 mDetect To Trial Breast Cancer Liquid Biopsy
5.7 Genomics England, Aims to Sequence 100K Newborns
5.8 Juno Diagnostics NIPT With At-Home Sample Collection
5.9 Cardio Diagnostics Launches Genetic Cario Risk Test
5.10 Universal Genetic Testing in Breast Cancer Further Supported
5.11 Aniling Gets CE-IVD Marks for Cancer Sequencing Tests
5.12 MyOme Lands Investment for WGS
5.13 Type 2 Diabetes GWAS Enables Risk Prediction
5.14 LetsGetChecked to Acquire Veritas Genetics
5.15 Guardant Health Plans New Comprehensive Assay
5.16 Tesis Labs Raises $20M
5.17 Sema4: Sema4 Elements
5.18 Clarified Precision Medicine Acquires Interpares Biomedicine
5.19 Genetic Technologies to Acquire DTC Genetic Test Provider EasyDNA
5.20 Illumina, Belgium Genetic Centers Partner on WGS-Based Dx
5.21 NIH, Genomics England Launch Sequencing Studies Using Nanopore Technology
5.22 Progenity Revenues Fall on COVID-19 Effect
5.23 Natera Launches Tumor Genomic Profiling Assay
5.24 23andMe To Go Public
5.25 Guardant Health to Offer Tumor Tissue Sequencing
5.26 Ancestry Quits Health Offering
5.27 DTC Firm MyDNA Merges With Gene by Gene
5.28 Aetna Coverage for NIPT to Include All Pregnancies
5.29 Agios Pharmaceuticals, PerkinElmer Partner on Hereditary Anemia Genetic Testing
5.30 Tumor, Germline Testing of Cancer Patients Can Give Discordant Results

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/Dako
6.7 Akonni Biosystems
6.8 Amoy Diagnostics Co., Ltd.
6.9 Ancestry.com LLC
6.10 Anchor Dx
6.11 Arc Bio
6.12 Arrayit Corporation
6.13 ARUP Laboratories
6.14 Aus Diagnostics
6.15 BaseClear
6.16 Baylor Miraca Genetics Laboratories
6.17 Beckman Coulter Diagnostics
6.18 Becton, Dickinson and Company
6.19 BGI Genomics Co. Ltd
6.20 Bioarray Genetics
6.21 Biocept, Inc.
6.22 Biodesix Inc.
6.23 BioFluidica
6.24 BioGenex
6.25 Biolidics Ltd
6.26 bioMérieux Diagnostics
6.27 Bioneer Corporation
6.28 Bio-Rad Laboratories, Inc
6.29 Bio-Techne
6.30 C2i Genomics
6.31 CareDx
6.32 Caris Molecular Diagnostics
6.33 CellMax Life
6.34 Centogene
6.35 Cepheid (Danaher)
6.36 Circulogene
6.37 Clinical Genomics
6.38 Color Genomics
6.39 Complete Genomics, Inc. - A BGI Company
6.40 CosmosID
6.41 Dante Labs.
6.42 Datar Cancer Genetics Limited
6.43 Diasorin S.p.A.
6.44 Element Biosciences
6.45 Element Biosciences
6.46 Epic Sciences
6.47 Epigenomics AG.
6.48 Eurofins Scientific
6.49 Excellerate Bioscience
6.50 Fabric Genomics
6.51 Freenome
6.52 Fujirebio
6.53 Fulgent Genetics
6.54 Gene by Gene, Ltd.
6.55 Genedrive
6.56 GeneFirst Ltd.
6.57 Genetron Holdings
6.58 Genomics England
6.59 Genomics Personalized Health (GPH)
6.60 GenomOncology
6.61 Genzyme Corporation
6.62 Grifols
6.63 Guardant Health
6.64 Guardiome
6.65 HeiScreen
6.66 Helix
6.67 Helix OpCo
6.68 Helomics
6.69 Hologic
6.70 HTG Molecular Diagnostics
6.71 Human Longevity, Inc.
6.72 iCellate
6.73 Illumina
6.74 Incell Dx
6.75 Inivata
6.76 Integrated Diagnostics
6.77 Invitae Corporation
6.78 Invivoscribe
6.79 Karius
6.80 Letsgetchecked
6.81 Lunglife AI Inc
6.82 Macrogen
6.83 MDNA Life SCIENCES, Inc.
6.84 MDx Health
6.85 Medgenome
6.86 Menarini Silicon Biosystems
6.87 Meridian Bioscience
6.88 Mesa Biotech (Thermo Fisher)
6.89 Mesa Laboratories, Inc.
6.90 Metabiomics Corp
6.91 miR Scientific
6.92 MNG Labs
6.93 NantHealth, Inc.
6.94 Natera
6.95 Nebula Genomics
6.96 NeoGenomics
6.97 New England Biolabs, Inc.
6.98 NGeneBio
6.99 Novogene Bioinformatics Technology Co., Ltd.
6.100 Omega Bioservices
6.101 Oncocyte
6.102 OncoDNA
6.103 OpGen
6.104 ORIG3N, Inc.
6.105 Origene Technologies
6.106 Oxford Nanopore Technologies
6.107 Pacific Biosciences
6.108 Panagene
6.109 PathoQuest S.A.
6.110 Perkin Elmer (now Revvity)
6.111 Personal Genome Diagnostics
6.112 Personalis.
6.113 Precipio
6.114 PrecisionMed
6.115 Promega
6.116 Protagen Diagnostics
6.117 Qiagen
6.118 QuantuMDx
6.119 Roche Molecular Diagnostics
6.120 Roswell Biotechnologies
6.121 Seegene
6.122 Sema4 Holdings
6.123 Sequencing.com
6.124 Siemens Healthineers
6.125 simfo GmbH
6.126 Singlera Genomics Inc.
6.127 Singular Genomics
6.128 SkylineDx
6.129 Standard BioTools
6.130 Sure Genomics, Inc.
6.131 Sysmex
6.132 Sysmex Inostics
6.133 Tempus Labs, Inc.
6.134 Thermo Fisher Scientific Inc.
6.135 Ultima Genomics
6.136 Ultima Genomics
6.137 Variantyx
6.138 Vela Diagnostics
6.139 Volition
6.140 Vyant Bio
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 Shift
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 Yea
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 United States Medicare System: Laboratory Fees Schedule
13.2 The Most Used IVD Assays
13.3 The Highest Grossing Assays

Table of Tables
Table 1 Most Common Traditional Genetic Disorders
Table 2 The Base Pairs
Table 3 Market Players by Type
Table 4 The Different Types of Genetic Tests
Table 5 Five Factors Driving Growth
Table 6 Four Factors Limiting Growth
Table 7 Seven Key Diagnostic Laboratory Technology Trends
Table 8 Global Market by Country
Table 9 Global Market by Application
Table 10 Global Market by Technology
Table 11 Global Market by Product
Table 12 Global Market by User
Table 13 Newborn Segment by Country
Table 14 NIPT Segment by Country
Table 15 Predictive Segment by Country
Table 16 Oncology Segment by Country
Table 17 DTC Segment by Country
Table 18 Other Segment by Country
Table 19 PCR Segment by Country
Table 20 NGS Segment by Country
Table 21 Cytogenetic Segment by Country
Table 22 Other Segment by Country
Table 23 Instruments Segment by Country
Table 24 Reagents and Kits Segment by Country
Table 25 Software Segment by Country
Table 26 Services Segment by Country
Table 27 Academic Segment by Country
Table 28 Clinical Segment by Country
Table 29 Pharmaceutical Segment by Country
Table 30 Industrial and Other Segment by Country
Table 31 Clinical Lab Fee Schedule
Table 32 The Most Common Assays
Table 33 Largest Revenue Assays

Table of Figures
Figure 1 Global Health Care Spending
Figure 2 The Lab Test Pie
Figure 3 DNA Strands and Chromosomes
Figure 4 Karyogram of Human Chromosomes
Figure 5 Size of Various Genomes
Figure 6 The Road to Diagnostics
Figure 7 The Changing Age of the World Population
Figure 8 Health Care Consumption by Age
Figure 9 Cancer Incidence - Age at Diagnosis
Figure 10 Centralized vs. Decentralized Laboratory Service
Figure 11 A Highly Multiplexed Syndromic Testing Unit
Figure 12 The Real Cost to Sequence the Human Genome
Figure 13 The Co-development Process
Figure 14 Comparing MDx Diagnostic and Traditional Testing
Figure 15 Country Market Shares
Figure 16 Application Share by Year
Figure 17 Application Segment Growth Rates
Figure 18 Segment Share Shifts
Figure 19 Application Segment Share Base Year
Figure 20 Application Segment Share Final Year
Figure 21 Technology Share by Year
Figure 22 Technology Segment Growth Rates
Figure 23 Technology Segment Share Shifts
Figure 24 Technology Segment Share Base Year
Figure 25 Technology Segment Share Final Year
Figure 26 Product Share by Year
Figure 27 Product Segment Growth Rates
Figure 28 Product Segment Share Shifts
Figure 29 Product Segment Share Base Year
Figure 30 Product Segment Share Final Year
Figure 31 User Share by Year
Figure 32 User Segment Growth Rates
Figure 33 User Segment Share Shifts
Figure 34 User Segment Share Base Year
Figure 35 User Segment Share Final Year
Figure 36 Newborn vs. Total Market Growth
Figure 37 NIPT vs. Total Market Growth
Figure 38 Predictive vs. Total Market Growth
Figure 39 Oncology vs. Total Market Growth
Figure 40 DTC vs. Total Market Growth
Figure 41 Other vs. Total Market Growth
Figure 42 PCR vs. Total Market Growth
Figure 43 NGS vs. Total Market Growth
Figure 44 Cytogenetic vs. Total Market Growth
Figure 45 Other vs. Total Market Growth
Figure 46 Instrument vs. Total Market Growth
Figure 47 Reagents and Kits vs. Total Market Growth
Figure 48 Software vs. Total Market Growth
Figure 49 Services vs. Total Market Growth
Figure 50 Academic vs. Total Market Growth
Figure 51 Clinical vs. Total Market Growth
Figure 52 Pharmaceutical vs. Total Market Growth
Figure 53 Industrial and Other vs. Total Market Growth

Samples

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Companies Mentioned

  • 10x Genomics, Inc.  
  • 23andME Inc. 
  • Abbott Laboratories  
  • Adaptive Biotechnologies  
  • Admera Health, LLC 
  • Agilent/Dako 
  • Akonni Biosystems 
  • Amoy Diagnostics Co., Ltd.  
  • Ancestry.com LLC 
  • Anchor Dx  
  • Arc Bio  
  • Arrayit Corporation  
  • ARUP Laboratories 
  • Aus Diagnostics 
  • BaseClear  
  • Baylor Miraca Genetics Laboratories  
  • Beckman Coulter Diagnostics  
  • Becton, Dickinson and Company  
  • BGI Genomics Co. Ltd  
  • Bioarray Genetics  
  • Biocept, Inc.  
  • Biodesix Inc.  
  • BioFluidica  
  • BioGenex  
  • Biolidics Ltd 
  • bioMérieux Diagnostics 
  • Bioneer Corporation 
  • Bio-Rad Laboratories, Inc 
  • Bio-Techne 
  • C2i Genomics  
  • CareDx  
  • Caris Molecular Diagnostics 
  • CellMax Life  
  • Centogene  
  • Cepheid (Danaher)  
  • Circulogene  
  • Clinical Genomics 
  • Color Genomics  
  • Complete Genomics, Inc. - A BGI Company  
  • CosmosID  
  • Dante Labs
  • Datar Cancer Genetics Limited  
  • Diasorin S.p.A.  
  • Element Biosciences 
  • Element Biosciences 
  • Epic Sciences 
  • Epigenomics AG. 
  • Eurofins Scientific  
  • Excellerate Bioscience  
  • Fabric Genomics  
  • Freenome  
  • Fujirebio  
  • Fulgent Genetics  
  • Gene by Gene, Ltd.  
  • Genedrive  
  • GeneFirst Ltd. 
  • Genetron Holdings  
  • Genomics England  
  • Genomics Personalized Health (GPH) 
  • GenomOncology  
  • Genzyme Corporation  
  • Grifols  
  • Guardant Health  
  • Guardiome  
  • HeiScreen  
  • Helix  
  • Helix OpCo 
  • Helomics 
  • Hologic  
  • HTG Molecular Diagnostics  
  • Human Longevity, Inc.  
  • iCellate  
  • Illumina  
  • Incell Dx  
  • Inivata  
  • Integrated Diagnostics 
  • Invitae Corporation  
  • Invivoscribe  
  • Karius  
  • Letsgetchecked  
  • Lunglife AI Inc  
  • Macrogen  
  • MDNA Life SCIENCES, Inc. 
  • MDx Health  
  • Medgenome 
  • Menarini Silicon Biosystems  
  • Meridian Bioscience  
  • Mesa Biotech (Thermo Fisher)  
  • Mesa Laboratories, Inc.  
  • Metabiomics Corp  
  • miR Scientific  
  • MNG Labs  
  • NantHealth, Inc.  
  • Natera  
  • Nebula Genomics 
  • NeoGenomics  
  • New England Biolabs, Inc.  
  • NGeneBio 
  • Novogene Bioinformatics Technology Co., Ltd. 
  • Omega Bioservices  
  • Oncocyte 
  • OncoDNA  
  • OpGen  
  • ORIG3N, Inc.  
  • Origene Technologies  
  • Oxford Nanopore Technologies  
  • Pacific Biosciences  
  • Panagene  
  • PathoQuest S.A.  
  • Perkin Elmer (now Revvity)  
  • Personal Genome Diagnostics 
  • Personalis. 
  • Precipio  
  • PrecisionMed 
  • Promega  
  • Protagen Diagnostics  
  • Qiagen  
  • QuantuMDx  
  • Roche Molecular Diagnostics  
  • Roswell Biotechnologies  
  • Seegene
  • Sema4 Holdings 
  • Sequencing.com  
  • Siemens Healthineers  
  • simfo GmbH  
  • Singlera Genomics Inc. 
  • Singular Genomics  
  • SkylineDx  
  • Standard BioTools  
  • Sure Genomics, Inc.  
  • Sysmex  
  • Sysmex Inostics 
  • Tempus Labs, Inc.  
  • Thermo Fisher Scientific Inc.  
  • Ultima Genomics  
  • Ultima Genomics  
  • Variantyx  
  • Vela Diagnostics  
  • Volition  
  • Vyant Bio  
  • Zymo Research Corp