Genetic Testing: Market Research Report

December 2018 | 316 pages | ID: G6B8B51407CEN
Global Industry Analysts, Inc

Abstracts

This report analyzes the worldwide markets for Genetic Testing in US$ Million. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, and Rest of World.

Annual estimates and forecasts are provided for the period 2016 through 2024.

Also, a five-year historic analysis is provided for these markets.

Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs.

The report profiles 85 companies including many key and niche players such as -

• 23andMe, Inc.
• Abbott Laboratories
• AutoGenomics, Inc.
• Biocartis NV
• BioRad Laboratories
• Cepheid Inc.

Contents

1. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations
Data Interpretation & Reporting Level
Quantitative Techniques & Analytics
Product Definitions and Scope of Study

2. GLOBAL MARKET OVERVIEW

A Prelude
Top Ten Genetic Disorders Worldwide
Genetic Testing Market Experiences Exponential Growth
Regional Landscape
Key Challenges
Genetic Testing Paves the Way for Personalized Medicine

Table 1. Drug Ineffectiveness for Select Therapeutic Categories - Necessitating Personalized Medicine (includes corresponding Graph/Chart)

Next-Generation Sequencing (NGS) – A Giant Leap in Genome Sequencing
Biomarker Discovery Leads to Advanced Genetic Testing
List of US-FDA Approved Biomarkers for Cancer
Ballooning Global Population Offers Increased Growth Opportunities

Table 2. Top 25 Countries Worldwide in Terms of Population: 2015 & 2016 (includes corresponding Graph/Chart)

Aging Population Drives the Genetic Testing Market

Table 3. Global Population Statistics for the 60+ Age Group by Region (in Thousands): 2017 (includes corresponding Graph/Chart)

Improving Healthcare Expenditure to Drive Demand

Table 4. Healthcare Spending as % of GDP by Region (2016) (includes corresponding Graph/Chart)

Competitive Overview

3. SEGMENTAL REVIEW

Prenatal Testing Market to Rise
List of Genetic Disorders by Event, Genetic Manifestation and Prevalence
Prenatal Testing – Changing the World of Pregnancy Care
Prenatal Testing – A Rudimentary Overview
List of Available Prenatal Screening and Diagnostic Tests by Indication
Players in the Prenatal and New Born Genetic Testing Market
Conventional Invasive Pre-Natal Diagnostic Techniques – A Risky Affair

Table 5. Price Comparison of Existing Tests and Screening Procedures for Down’s Syndrome

Other Negativities of Existing Invasive Techniques
Emergence of Non-Invasive Prenatal Diagnosis (NIPD)
US Leads in NIPD Market
Competition Intensifies in the NIPD Market
Select Commercially Available NIPD (Genetic) Tests for Aneuploidy in the US
NIPD Eliminates Risks and Uncertainty of Conventional Diagnostic Procedures
Opposition to NIPD Technique – A Significant Hurdle to Adoption
Benefits Outweigh Snags in NIPD Tests
Major Factors Influencing Penetration of NIPD Tests
Diversity in NIPD Usage on the Cards
Technological Advancements Boost Prenatal Genetic Screening Market
CMA Stakes Claim as the First-Line Test in Fetal Abnormalities; Issues Hinder Growth
Fetal Diagnostic Whole-Exome Sequencing (WES) – A Promising Advancement in Prenatal Screening
Strain on Resources Prevent Wide Adoption of Expanded Carrier Sequencing
Expanded Newborn Screening
Genetic Screening of Newborns to Rise
Predictive Diagnostics
Breast Cancer Gene Testing Market to Expand Strongly
Myriad Genetics – The Unquestioned Leader in Breast Cancer Testing
Routine Clinical Testing Vs. Predictive Genetic Testing
Increasing Incidence and Prevalence of CDDs: A Major Growth Driver
Discovery of Novel Biomarkers Crucial to Predictive Diagnostics
Unresolved Issues Hamper Widespread Implementation of Genetic Diagnosis and Testing for Monogenetic Disease
Dearth of Genetic Counselors – A Major Hurdle for the Predictive Genetic Testing
Pre-implantation Genetic Diagnosis (PGD) - A Major Driver for the Genetic Testing Market
Pharmacogenomics Development Augurs Growth of Genetic Testing Market

4. MARKET TRENDS

Direct-to-Consumer Genetic Testing – A Key Trend in the Genetic Testing Market
Direct-to-Consumer Genetic Testing is Here to Stay
Creating a Platform for New Companies
Business Models for DTC Genetic Testing Firms
Growing Prominence of DTC Genetic Testing: A Boon or a Curse?
Challenges to DTC-GT Market
Considerations for Market Entry
Emphasizing Consumer Empowerment
Offer Wraparound Provision
Proactive Addressing of Privacy Concerns
Whole Genome Sequencing (WGS) – Boon or Bane to Genetic Testing?
Utility of Genetic Testing for Warfarin Study
As Technologies Grow, Need for Better Interpretation of Tests Increases
Focus on Health & Wellness and Genetic Counseling
Selling Collected Patient Genetic Information Becomes a New Business
Oncology – A Key Focus Area for Genetic Testing

Table 6. Global Cancer Incidence (2015): Number of New Cancer Cases in Thousands by Type and Gender (includes corresponding Graph/Chart)

Table 7. Global Cancer Mortality (2015): Number of Cancer Related Deaths in Thousands by Type and Gender (includes corresponding Graph/Chart)

Liquid Biopsy to Change the Face of Cancer Diagnosis and Treatment
Genetic Testing May Aid CNS Disease Therapeutics
Neurodegenerative Diseases – Another Major Focus Area for Genetic Testing
Alzheimer’s Disease
Validity of Emerging Genetic Tests for Alzheimer’s
Newly Developed Test Predicts Age of Onset of Alzheimer’s
Huntington’s Disease

Table 8. Global Prevalence of Huntington’s Disease by Geographic Region (includes corresponding Graph/Chart)

Genetic Testing – An Indispensable Tool for Cystic Fibrosis

Table 9. Most Common Mutations and Worldwide Frequency (includes corresponding Graph/Chart)

Recommendations of ACOG and ACGM Augments Demand for Cystic Fibrosis Testing
Histocompatibility Testing
Pediatric Genetic Testing for Screening Adult Onset Disorders Fast Gaining Acceptance
Point-of-Care Genetic Testing Gains Popularity
Better Regulatory Safeguards Required for Global Genetic Testing Industry
Challenges Faced
Controversial Applications Marr Genetic Testing Market
Genetic Counseling Gaining Momentum
Online Approach Gains Momentum
Ethical Issues & Need for Appropriate Regulating Policies
Issues Related to Genetic Tests for Obesity
Diagnosis and Treatment during Pregnancy - An Effective Way of Alleviating Syphilis Related Deaths and Stillbirths

5. PRODUCT OVERVIEW

Preface to Genetic Testing
Genetic Testing and its Applications
Gene Candidate and Genome Screen
‘DNA Chip’ to Chip into Genetic Field
Techniques Used to Identify Changes in Genes
Types of Genetic Testing
Prenatal Diagnosis
Cancer Testing
Carrier Identification
Newborn Screening
Predictive Testing
Pre-Symptomatic Testing
Cytogenetic Tests
Steps in Genetic Testing Process
Limitations
Risks and Other Limitations of Genetic Testing
Medical Institutions to Reap the Benefit of Genetic Testing
Pharmacogenetics/Pharmacogenomics
Review of Select Genetic Tests
Cystic Fibrosis
Breast and Ovarian Cancer (BRCA)
Alzheimer's disease
Colorectal Cancer
Haemochromatosis (HH)
Cowden Syndrome
Huntington's disease (HD)
Costs of Select Tests

Table 10. Costs of Select Genetic Tests

Genetic Testing Techniques
Signal Amplification Technologies
PCR – New Developments
Quantitative Real-Time PCR for Molecular Diagnostics
Signal Detection and Quantification
Quantitative Real-Time RT-PCR Analysis
Applications of Quantitative Real-Time PCR Analysis
Viral Detection and Viral-Load Monitoring
Sensitive Detection of Infectious Disease Agents
Predisposition Testing
Non-PCR Methods
Other Signal Amplification Technologies
DNA Probe Based Products
Direct Detection of Specific Nucleic Acid Sequences
Nucleic Acid Amplification and Detection
DNA Sequencing and Gene Detection
Arrays of Immobilized Probes (DNA Chips) in Gene Detection
RNA Diagnostics

6. COMPETITIVE LANDSCAPE

6.1 Focus on Select Key Players

23ANDME, INC. (USA)

Abbott Laboratories (USA)
AutoGenomics, Inc. (USA)
Biocartis NV (Belgium)
BioRad Laboratories (USA)
Cepheid Inc. (USA)
ELITech Group S. P. A. (France)
Illumina, Inc. (USA)
Laboratory Corporation of America Holdings (USA)
Sequenom, Inc. (USA)
Luminex Corporation (USA)
Natera, Inc. (USA)
PerkinElmer, Inc. (USA)
QIAGEN N. V. (The Netherlands)
Quest Diagnostics, Inc. (USA)
Roche Diagnostics AG (Switzerland)
Roche Molecular Diagnostics, Inc. (USA)
Thermo Fisher Scientific Inc. (USA)
6.2 Product Launches/Innovations

23ANDME RECEIVES FDA CLEARANCE FOR FIRST-OF-ITS-KIND GENETIC TEST

Advanced Genomic Solutions Introduces a Skin Health Genetic Test
MedGenome Introduces Genetic Test for Chronic Lymphocytic Leukemia
My Gene Counsel Introduces Digital Genetic Counseling Technology
Invitae Launches Comprehensive Genetic Carrier Screening
Cordlife Introduces Genetic Testing Services for Detecting Disease-causing Mutations
AutoGenomics Rolls Out INFINITI H. pylori Assay

23ANDME OBTAINS FDA APPROVAL FOR PERSONAL GENETIC TEST FOR SELECT DISEASES

Invitae Adds News Tests to Proactive Genetic Testing Repertoire
Thermo Fisher Scientific Launches CarrierScan Assay
MedGenome Unveils Claria Carrier Screening Test in India
Phosphorus Rolls Out Advances Tests for Inherited Conditions
Cancer Genetics Launches Genomic Panel for HBOC
Illumina, Bio‑Rad Launch Single-Cell Genomic Sequencing Solution
MyHeritage Introduces MyHeritage DNA Service
Thermo Fisher Scientific Unveils Clariom Pico Assays
IBM Watson Health, Quest Diagnostics Roll Out IBM Watson Genomics
Thermo Fisher Scientific Introduces PharmacoScan Solution
Good Start Genetics Launches EmbryVu PGS Test
Spark Therapeutics Introduces Testing for Inherited Retinal Diseases
AutoGenomics Launches INFINITI Buccal Sample Collection Kit
FutuTest Launches FERTIFY Genetic Test
Quest Diagnostics Introduces New Cancer Test Services
Good Start Genetics Launches Next-Generation Embryo Screening Solution
Invitae Introduces Pediatric Tests for Rare Disease and Pediatric Genetics
Contextual Genomics Introduces Cancer Genome Test
6.3 Recent Industry Activity
CytoDyn Plans to Complete the Development of PCaTest
ADx Healthcare in Partnership with Helix Announces the Launch of New Alzheimer’s Genetic Test
Myriad Genetics Acquires Counsyl
GSK Signs an Agreement with 23andMe
QIAGEN Partners with Natera for Developing Cutting-edge, Cell-free DNA Assay
Yale New Haven Health Integrates Genetic Tests from Natera into its Epic EMR System

23ANDME RECEIVES FIRST FDA AUTHORIZATION FOR DIRECT- TO-CONSUMER GENETIC TEST ON CANCER RISK

Konica Minolta Completes the Acquisition of Ambry Genetics
LCM Genect Signs an Agreement with AutoGenomics
Invitae Acquires CombiMatrix
Agilent Inks Deal to Take Over Multiplicom
DNA Diagnostics Center Acquires IDENTIGENE
Genetic Analysis and Bio-Rad Ink Deal for TransferringCommercialization Rights to GA-map
Thermo Fisher Files for PMA Approval of its Oncomine Universal Dx Test
LabCorp Takes Over Sequenom
WuXi AppTec and AutoGenomics Team Up to Launch Advanced Molecular Diagnostic Technology In China
Danaher to Take Over Cepheid
Quest Diagnostics to Offer Genetic Testing Services for Ancestry
Transgenomic and LabCorp Sign Commercial License Agreement for TBIO’s DNA Susceptibility Testing IP
Next Biosciences Merges with Genesis Genetics
PerkinElmer Expands Services in India
PerkinElmer Takes Over Vanadis Diagnostics

7. GLOBAL MARKET PERSPECTIVE

Table 11. World Recent Past, Current & Future Analysis for Genetic Testing by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 12. World Historic Review for Genetic Testing by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 13. World 14-Year Perspective for Genetic Testing by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific and Rest of World Markets for Years 2011, 2018 and 2024 (includes corresponding Graph/Chart)

8. REGIONAL MARKET PERSPECTIVE

8.1 The United States
A. Market Analysis
The US: Leading Market for Genetic Testing Globally
Demographic Changes Offer Growth Opportunities

Table 14. North American Aging Population by Age Group: 1975-2050 (includes corresponding Graph/Chart)

Use of Genomic Data in Clinical Settings to Gather Pace
Predictive Screening: Another Growth Area
An important Market for Personalized Medicine
Epidemic Proportion of Cancer in the US – Driver for Cancer Genetic Testing

Table 15. New Cancer Cases in the US by State (2017E) (includes corresponding Graph/Chart)

Table 16. Number of Deaths Related to Major Types of Cancer in US by State: 2017E (includes corresponding Graph/Chart)

Table 17. New Cancer Cases by Gender and Affected Site in the US (2017E) (includes corresponding Graph/Chart)

Table 18. Cancer Related Deaths by Gender in the US (2017E) (includes corresponding Graph/Chart)

Newborn Testing Gains Ground
Success Stories
Skepticism Limits Widespread Adoption of Genetic Testing
Favorable Reimbursement Policies
Favorable Insurance Coverage for Cystic Fibrosis Genetic Testing
Popularity of Screening and ACOG Guidelines Sink Invasive Prenatal Diagnosis Numbers
Tough Market Prospects for Sex Determination Tests
Coverage of NIPT in Average Risk Pregnancies Expands Target Market
Wastage from Unnecessary Genetic Testing – A Growing Concern
Direct-to-Consumer Testing - A Growing Market
DTC Genetic Tests Provide POCT for Patients in Hospice Care
Competitive Overview
Myriad Eyes Diversification and Expansion for Growth
Natera Holds Fort in the NIPT Market

Table 19. Leading Players in the US Non-Invasive Prenatal Testing Market (2016): Percentage Breakdown of Revenue for Illumina, LabCorp/ Sequenom, Natera, Roche and Others (includes corresponding Graph/Chart)

Invitae Banks on Low Cost Solutions for Expanding Revenues
Regulatory Environment
Genetic Information Nondiscrimination Act Boosts Genetic Testing
Stricter Regulations for DTC Genetic Testing
H. R.1 313 Bill Rakes New Controversy
FDA Attempts to Put a Leash around Unapproved DTC Genetic Tests
Negotiated Prices Bring Comfort to Several Diagnostic Companies
Select Genetic Test Reimbursement Codes
B. Market Analytics

Table 20. The US Recent Past, Current & Future Analysis for Genetic Testing Market Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 21. The US Historic Review for Genetic Testing Market Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

8.2 Canada
A. Market Analysis
Current & Future Analysis
Regulatory Scenario
Rising Incidence of Chronic Diseases Spurs Genetic Testing Demand

Table 22. New Cancer Cases in Canada (2017E): Breakdown of Cancer Incidence by Gender and Affected Site (includes corresponding Graph/Chart)

Table 23. New Cancer Cases in Canada by Province: 2017E (includes corresponding Graph/Chart)

Table 24. New Cancer Cases in Canada by Age Group: 2017E (includes corresponding Graph/Chart)

Table 25. Cancer Related Deaths in Canada (2017E): Percentage Breakdown of Number of Deaths by Gender and Affected Site (includes corresponding Graph/Chart)

B. Market Analytics

Table 26. Canadian Recent Past, Current & Future Analysis for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 27. Canadian Historic Review for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

8.3 Japan
A. Market Analysis
Current & Future Analysis
Demographics Drive Market Growth

Table 28. Japanese Population by Age Group (2017) (includes corresponding Graph/Chart)

DTC Genetic Testing Regulatory Scenario
B. Market Analytics

Table 29. Japanese Recent Past, Current & Future Analysis for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 30. Japanese Historic Review for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

8.4 Europe
A. Market Analysis
Market Overview
Aging Population to Drive Demand for Genetic Testing

Table 31. EU-28 Country-wise Statistics of 65+ Population as % of Total Population: 2016 (includes corresponding Graph/Chart)

European Personalized Medicine Market to Exhibit Robust Growth
Legislations/Regulatory Policies in Select European Countries
Legislations Governing Genetic Testing in Select European Countries
B. Market Analytics

Table 32. European Recent Past, Current & Future Analysis for Genetic Testing by Geographic Region - France, Germany, Italy, UK and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 33. European Historic Review for Genetic Testing by Geographic Region - France, Germany, Italy, UK and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 34. European 14-Year Perspective for Genetic Testing by Geographic Region - Percentage Breakdown of Revenues for France, Germany, Italy, UK and Rest of Europe Markets for Years 2011, 2018 and 2024 (includes corresponding Graph/Chart)

  8.4.1 France
Market Analysis

Table 35. French Recent Past, Current & Future Analysis for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 36. French Historic Review for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

  8.4.2 Germany
A. Market Analysis
Current & Future Analysis
Parliamentary Regulations
B. Market Analytics

Table 37. German Recent Past, Current & Future Analysis for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 38. German Historic Review for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

  8.4.3 Italy
Market Analysis

Table 39. Italian Recent Past, Current & Future Analysis for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 40. Italian Historic Review for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

  8.4.4 The United Kingdom
A. Market Analysis
Current & Future Analysis
Increased Support for Personalized Medicine to Drive Genetic Testing
SMIP for Pharmacogenomic Testing
Increasing Need for Less Risky Prenatal Diagnostic Methods in the UK
Regulatory Scenario
Non-consensual Analysis of DNA Made Illegal
Principles for DTC Genetic Testing Laid out by HGC
B. Market Analytics

Table 41. The UK Recent Past, Current & Future Analysis for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 42. The UK Historic Review for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

  8.4.5 Rest of Europe
Market Analysis

Table 43. Rest of Europe Recent Past, Current & Future Analysis for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 44. Rest of Europe Historic Review for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes orresponding Graph/Chart)

8.5 Asia-Pacific
A. Market Analysis
Current & Future Analysis
Healthcare Spending in Asia-Pacific: On the Rise
Select Regional Markets
China
China Attracts Domestic and Foreign Players
China to Take Lead in Rapidly Growing Asian Genomics Market
Strong Focus on Genomics
Chinese Genomics Players Mark Notable Progress
New Investments by Other Countries
China Plans to Use genetic Screening to Select Athletes for Winter Olympics
Genetic Testing to Reveal Real Talent in Children – A New Popular Application
India
Diagnostics Market in India
Genomic Medicine – Nascent yet Promising
Genetic Testing in India to Rise
Australia and New Zealand
Approval of Experiments on Human Embryos in New Zealand
B. Market Analytics

Table 45. Asia-Pacific Recent Past, Current & Future Analysis for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 46. Asia-Pacific Historic Review for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

8.6 Rest of World
Market Analysis

Table 47. Rest of World Recent Past, Current & Future Analysis for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 48. Rest of World Historic Review for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

9. COMPANY PROFILES

Total Companies Profiled: 85 (including Divisions/Subsidiaries - 94)
The United States (60)
Canada (5)
Japan (1)
Europe (22)
  France (2)
  Germany (3)
  The United Kingdom (2)
  Italy (1)
  Rest of Europe (14)
Asia-Pacific (Excluding Japan) (5)
Middle East (1)