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Genetic Testing market sales are expected to reach $25 billion annually by 2021 with compound annual growth rate of 10% alone in United States. The Global genetic testing market is expected to reach approximately $60 billion by 2020..
Citation preview
GLOBALGENETIC TESTING MARKET
Growth Trends &Forecasts
2014 - 2020
mordorintelligence.com
TABLE OF CONTENTS
1 INTRODUCTION ............................................................................................................................................. 1
1.1 REPORT DESCRIPTION ......................................................................................................................... 1
1.2 RESEARCH METHODOLOGY ................................................................................................................. 3
2 GLOBAL GENETIC TESTING – MARKET FORCES ......................................................................................... 4
2.1 MARKET DRIVERS ................................................................................................................................ 4
2.1.1 Increase in the Genetic Tests’ Pipeline ............................................................................................ 4
2.1.2 Early Confirmation of Genetic Disorders .......................................................................................... 4
2.1.3 Minimal Procedure Risk ................................................................................................................... 5
2.1.4 Guide Strategies for Maintaining Health .......................................................................................... 5
2.1.5 Guide Treatment Choices for a variety of Disease Conditions ......................................................... 6
2.2 MARKET RESTRAINTS ......................................................................................................................... 7
2.2.1 False-Positive and False-Negative Results...................................................................................... 7
2.2.2 Potentially Adverse Personal or Societal Consequences ................................................................ 7
2.2.3 Non-inclusion of Reimbursement Policy ......................................................................................... 8
2.3 OPPORTUNITIES .................................................................................................................................. 9
2.3.1 Genetic Counseling .......................................................................................................................... 9
3 GLOBAL GENETIC TESTING MARKET, BY TYPES ....................................................................................... 10
3.1 OVERVIEW .......................................................................................................................................... 10
3.1.1 Global Genetic Testing Market, By Types, 2014-2020 ................................................................... 10
3.2 CARRIER TESTING ............................................................................................................................. 12
3.3 DIAGNOSTIC TESTING ........................................................................................................................ 16
3.4 NEWBORN SCREENING ...................................................................................................................... 22
3.5 PREDICTIVE AND PRESYMPTOMATIC TESTING ................................................................................ 40
3.6 PRENATAL TESTING .......................................................................................................................... 48
4 GENETIC TESTING MARKET, BY GEOGRAPHY ........................................................................................... 54
4.1 OVERVIEW .......................................................................................................................................... 54
4.1.1.1 Global Genetic Testing Market, by Geography, 2014-2020 ....................................................... 54
4.2 NORTH AMERICA ............................................................................................................................... 55
4.2.1 North America Genetic Testing Market, 2014-2020 ...................................................................... 55
4.2.1.1 United States ............................................................................................................................. 55
4.2.2 Canada ........................................................................................................................................... 56
4.2.3 Mexico ............................................................................................................................................ 57
4.3 EUROPE .............................................................................................................................................. 59
4.3.1 Europe Genetic Testing Market, 2014-2020 .................................................................................. 59
4.3.1.1 France ........................................................................................................................................ 61
4.3.1.2 Germany ..................................................................................................................................... 63
4.3.1.3 Italy ............................................................................................................................................ 64
4.3.1.4 Spain .......................................................................................................................................... 64
4.3.1.5 United Kingdom ......................................................................................................................... 65
4.3.1.6 Rest of Europe ................................................................................................................................ 66
4.4 ASIA-PACIFIC ..................................................................................................................................... 69
4.4.1 Asia-Pacific Genetic Testing Market, 2014-2020 .............................................................................. 69
4.4.1.1 China ............................................................................................................................................... 70
4.4.1.2 India ................................................................................................................................................ 72
4.4.1.3 Japan .............................................................................................................................................. 74
4.4.1.4 Rest of Asia-Pacific ........................................................................................................................ 76
4.5 REST OF THE WORLD ............................................................................................................................... 78
4.5.1 Rest of the World Genetic Testing Market, by Type, 2014-2020 ....................................................... 78
5. COMPETITIVE LANDSCAPE ........................................................................................................................ 80
6. COMPANY PROFILES .................................................................................................................................. 83
6.1 23ANDME, INC. ................................................................................................................................... 83
7.1.1 Overview ............................................................................................................................................ 83
7.1.2 Major Products and Services ............................................................................................................. 83
7.1.3 Genetic Testing Pipeline Products .................................................................................................... 83
7.1.4 Financials .......................................................................................................................................... 84
7.1.5 Developments .................................................................................................................................... 84
6.2 ABBOTT MOLECULAR ......................................................................................................................... 85
6.2.1 Overview ......................................................................................................................................... 85
6.2.2 Major Products and Services ......................................................................................................... 85
6.2.3 Genetic Testing Pipeline Products ................................................................................................. 85
6.2.4 Financials ....................................................................................................................................... 85
6.2.5 Developments ................................................................................................................................ 85
6.3 ARIOSA DIAGNOSTICS, Inc ................................................................................................................. 86
6.3.1 Overview ......................................................................................................................................... 86
6.3.2 Major Products and Services ......................................................................................................... 86
6.3.3 Genetic Testing Pipeline Products ................................................................................................. 86
6.4 BIOCARTIS SA .................................................................................................................................... 87
6.4.1 Overview ......................................................................................................................................... 87
6.4.2 Major Products and Services ......................................................................................................... 87
6.4.3 Genetic Testing Pipeline Products ................................................................................................. 87
6.4.4 Financials ....................................................................................................................................... 87
6.4.5 Developments ................................................................................................................................ 87
6.5 BIOHELIX CORPORATION (Wholly Owned Subsidiary of Quidel) ....................................................... 89
6.5.1 Overview ......................................................................................................................................... 89
6.5.2 Major Products and Services ......................................................................................................... 89
6.5.3 Genetic Testing Pipeline Products ................................................................................................. 89
6.5.4 Financials ....................................................................................................................................... 90
6.5.5 Developments ................................................................................................................................ 90
6.6 BIOMERIEUX S.A. ............................................................................................................................... 91
6.6.1 Overview ......................................................................................................................................... 91
6.6.2 Major Products and Services ......................................................................................................... 91
6.6.3 Genetic Testing Pipeline Products ................................................................................................. 93
6.6.4 Financials ....................................................................................................................................... 93
6.6.5 Developments ................................................................................................................................ 94
6.7 CELERA CORPORATION ..................................................................................................................... 95
6.7.1 Overview ......................................................................................................................................... 95
6.7.2 Major Products and Services ......................................................................................................... 95
6.7.3 Genetic Testing Pipeline Products ................................................................................................. 95
6.7.4 Financials ....................................................................................................................................... 96
6.7.5 Developments ................................................................................................................................ 96
6.8 CEPHEID ............................................................................................................................................. 97
6.8.1 Overview ......................................................................................................................................... 97
6.8.2 Major Products and Services ......................................................................................................... 97
6.8.3 Financials ....................................................................................................................................... 98
6.8.4 Developments ................................................................................................................................ 98
6.9 DAAN DIAGNOSTICS LTD. .................................................................................................................. 99
6.9.1 Overview ......................................................................................................................................... 99
6.9.2 Major Products and Services ......................................................................................................... 99
6.9.3 Genetic Testing Pipeline Products ................................................................................................. 99
6.9.4 Financials ....................................................................................................................................... 99
6.10 EKF DIAGNOSTICS HOLDINGS PLC .................................................................................................. 100
6.10.1 Overview ................................................................................................................................... 100
6.10.2 Major Products and Services ................................................................................................... 100
6.10.3 Financials ................................................................................................................................. 101
6.10.4 Developments .......................................................................................................................... 101
6.11 GENENTECH, INC.............................................................................................................................. 102
6.11.1 Overview ................................................................................................................................... 102
6.11.2 Genetic Testing Pipeline Products ........................................................................................... 102
6.11.3 Financials ................................................................................................................................. 102
6.11.4 Developments .......................................................................................................................... 102
6.12 GENOMICTREE, INC. ......................................................................................................................... 104
6.12.1 Overview ................................................................................................................................... 104
6.12.2 Major Products and Services ................................................................................................... 104
6.12.3 Genetic Testing Pipeline Products ........................................................................................... 105
6.12.4 Financials ................................................................................................................................. 105
6.12.5 Developments .......................................................................................................................... 106
6.13 HTG MOLECULAR DIAGNOSTICS, INC. ............................................................................................. 107
6.13.1 Overview ................................................................................................................................... 107
6.13.2 Major Products and Services ................................................................................................... 107
6.13.3 Genetic Testing Pipeline Products ........................................................................................... 107
6.13.4 Financials ................................................................................................................................. 108
7.13.5 Developments ................................................................................................................................ 108
6.14 ILLUMINA, INC. ................................................................................................................................. 109
6.14.1 Overview ................................................................................................................................... 109
6.14.2 Major Products and Services ................................................................................................... 109
6.14.3 Financials ................................................................................................................................. 112
6.14.4 Developments .......................................................................................................................... 112
6.15 INTEGRAGEN S.A ............................................................................................................................. 113
7. 15.1 Overview ....................................................................................................................................... 113
7. 15.2 Major Products and Services ........................................................................................................ 113
7. 15.3 Financials ..................................................................................................................................... 113
7. 15.4 Developments ............................................................................................................................... 114
6.16 LABORATORY CORPORATION OF AMERICA HOLDINGS .................................................................. 115
6.16.1 Overview ................................................................................................................................... 115
6.16.2 Major Products and Services ................................................................................................... 115
6.16.3 Financials ................................................................................................................................. 115
6.16.4 Developments .......................................................................................................................... 116
6.17 LUMINEX CORPORATION ................................................................................................................. 117
6.17.1 Overview ................................................................................................................................... 117
6.17.2 Major Products and Services ................................................................................................... 117
6.17.3 Genetic Testing Pipeline Products ........................................................................................... 118
6.17.4 Financials ................................................................................................................................. 118
6.17.5 Developments .......................................................................................................................... 119
6.18 MOLECULARMD, CORP. .................................................................................................................... 120
6.18.1 Overview ................................................................................................................................... 120
6.18.2 Major Products and Services ................................................................................................... 120
6.18.3 Financials ................................................................................................................................. 120
6.18.4 Developments .......................................................................................................................... 120
6.19 MYRIAD GENETICS, INC. .................................................................................................................. 122
6.19.1 Overview ................................................................................................................................... 122
6.19.2 Major Products and Services ................................................................................................... 122
6.19.3 Genetic Testing Pipeline Products ........................................................................................... 123
6.19.4 Financials ................................................................................................................................. 123
6.19.5 Developments .......................................................................................................................... 124
6.20 NATERA, INC. ................................................................................................................................... 125
6.20.1 Overview ................................................................................................................................... 125
6.20.2 Major Products and Services ................................................................................................... 125
6.20.3 Developments .......................................................................................................................... 126
6.21 OXFORD BIODYNAMICS LIMITED ..................................................................................................... 128
6.21.1 Overview ................................................................................................................................... 128
6.21.2 Major Products and Services ................................................................................................... 128
6.21.3 Genetic Testing Pipeline Products ........................................................................................... 128
6.21.4 Financials ................................................................................................................................. 129
6.21.5 Developments .......................................................................................................................... 129
6.22 PACIFIC BIOSCIENCES OF CALIFORNIA, INC. .................................................................................. 131
6.22.1 Overview ................................................................................................................................... 131
6.22.2 Major Products and Services ................................................................................................... 131
6.22.3 Financials ................................................................................................................................. 131
6.22.4 Developments .......................................................................................................................... 131
6.23 QIAGEN N.V. ..................................................................................................................................... 133
6.23.1 Overview ................................................................................................................................... 133
6.23.2 Major Products and Services ................................................................................................... 133
6.23.3 Genetic Testing Pipeline Products ........................................................................................... 134
6.23.4 Financials ................................................................................................................................. 135
6.23.5 Developments .......................................................................................................................... 135
6.24 ROCHE DIAGNOSTICS LIMITED ........................................................................................................ 136
6.24.1 Overview ................................................................................................................................... 136
6.24.2 Major Products and Services ................................................................................................... 136
6.24.3 Financials ................................................................................................................................. 136
6.24.4 Developments .......................................................................................................................... 137
6.25 SEEGENE, INC. .................................................................................................................................. 138
6.25.1 Overview ................................................................................................................................... 138
6.25.2 Financials ................................................................................................................................. 138
6.25.3 Developments .......................................................................................................................... 138
6.26 SEQUENOM, INC. .............................................................................................................................. 139
6.26.1 Overview ................................................................................................................................... 139
6.26.2 Major Products and Services ................................................................................................... 139
6.26.3 Financials ................................................................................................................................. 139
6.26.4 Developments .......................................................................................................................... 139
6.27 SIEMENS HEALTHCARE ................................................................................................................... 140
6.27.1 Overview ................................................................................................................................... 140
6.27.2 Major Products and Services ................................................................................................... 140
6.27.3 Financials ................................................................................................................................. 141
6.27.4 Developments .......................................................................................................................... 141
6.28 TRANSGENOMIC, INC. ...................................................................................................................... 142
6.28.1 Overview ................................................................................................................................... 142
6.28.2 Major Products and Services ................................................................................................... 142
6.28.3 Genetic Testing Pipeline Products ........................................................................................... 143
6.28.4 Financials ................................................................................................................................. 143
6.28.5 Developments .......................................................................................................................... 144
7. DISCLAIMER ............................................................................................................................................. 145
|Global Genetic Testing Market Sample
RESEARCH METHODOLOGY
1) Secondary Research: Information was collected from a number of public and paid data sources. Public
sources involved Government websites, publications from the genetic testing programs of different
countries, company annual reports, white papers and research publications by recognized industry
experts. Paid data sources include authentic industry databases.
2) Primary Research: After collecting data from secondary sources, primary interviews were conducted with
stakeholders at different points of the feed value chain like manufacturers, distributors, ingredient
suppliers, companies producing enzymes and key opinion leaders of the industry. Primary research is
used both to validate the data points obtained from secondary research and to fill any gaps in data.
3) Market Analysis: The market analysis phase involves analyzing the collected data, market breakdowns
and forecasting. Macroeconomic indicators and bottom-up and top-down approaches are used to arrive
at a complete set of data points that give way to valuable qualitative and quantitative insights. Each data
point is verified by the process of data triangulation to validate the numbers and arrive at a close
estimate.
4) Expert Validation: The market analysis data is verified and validated by a number of experts, both in-
house and external.
5) Report Writing: After the data is curated through the process, our analysts begin to write the report.
Garnering insights from data and forecasts, insights are drawn to visualize the entire business
ecosystem in a single report.
|Global Genetic Testing Market Sample 4 | Mordor Intelligence
2. MARKET FORCES
2.1 MARKET DRIVERS
2.1.2 EARLY CONFIRMATION OF GENETIC DISORDERS
The United States cancer testing market size alone is estimated to be roughly $10-12 billion. The prevalence of
cancer is expected to increase as the US population ages. Approximately 75-80% of all cancers are diagnosed in
people aged 55 or older and this pattern is expected to increase by 2020. According to the United Nations
Department of Economic and Social Affairs, the number of senior citizens (aged 60 years or over) is 841 million
people in 2013 and is expected to more than 2 billion by 2050.
The global share of senior citizens (aged 60 years or over), from 11.7 percent in 2013, will continue to grow as a
proportion of the world population promising to reach 21.1 percent by 2050. This clearly projects cancer as the
fastest growing segment of genetic testing across the globe.
2.1.3 MINIMAL PROCEDURE RISK
Genetic Testing is done on a sample of blood, cheek cells, urine, amniotic fluid (the fluid that surrounds a fetus
during pregnancy) or other body tissues. For cancer, several tubes of blood are collected through a thin needle
put into a vein (usually in the arm) to get the blood.
Genetic tests help directly examine the specific genes or it may involve linkage analysis or indirect testing which
analyses the ‘markers’ or stretches of DNA located near the target gene. A DNA sample is obtained from a blood
sample although it can be acquired from several other tissues. Genetic testing makes use of molecular probes to
detect a specific sequence along the length of a person's DNA molecule that is responsible for a genetic disorder.
Several other clinical tests, biopsy and oncology devices are used for cancer treatment and diagnosis. Among all
others, genetic testing provides a minimal risk. Many of the risks associated with genetic testing involve the
emotional, social and financial consequences of the test results.
|Global Genetic Testing Market Sample 55 | Mordor Intelligence
4. SEGMENTATION – BY GEOGRAPHY
4.2 NORTH AMERICAN MARKET – OVERVIEW
4.2.1 NORTH AMERICA GENETIC TESTING MARKET, 2014-2020
The genetic testing market in North America is estimated at US$8.6 billion in 2014 and is further anticipated to
post a strong CAGR of 18% in 2014-2020, reaching a projected US $ xx billion by 2020. The United States
dominates the North American market for genetic testing in terms of share at 92.7%, as well as growth at xx %. In
terms of segment, newborn screening is slated to emerge as the fastest growing category of genetic testing in
the region over the 2014-2020 analysis periods.
North American Genetic Testing Market for 2010-2020 by Region (In US$ Million)
Source: Mordor Intelligence Analysis
Source: Mordor Intelligence Analysis
North America Market distribution -2013
United States
Canada
Mexico
Region 2010 2011 2012 2013 2014 2020 % CAGR (2014-2020)
United States 4,969.90 xx xx xx xx xx xx
Canada xx xx xx 296.56 xx xx xx
Mexico xx xx xx xx xx xx xx
Total xx xx xx xx xx xx 18.02
|Global Genetic Testing Market Sample 56 | Mordor Intelligence
4.2.1.1 UNITED STATES
Demand for genetic testing in the United States is projected to reach in excess of US $ xx billion by 2020, from an
estimated US $ XX billion in 2014, by posting a CAGR of 18.15 % in 2014-2020. Newborn screening leads the
region’s genetic testing market, with an estimated 2014 share of 40.8%, with the prospect of witnessing the
fastest CAGR of xx % during the aforementioned analysis period.
United States Genetic Testing Market for 2010-2020 by Segment (In US$ Million)
Segment 2010 2011 2012 2013 2014 2020 % CAGR (2014-2020)
Carrier Testing 882.16 xx xx xx xx xx xx
Diagnostic Testing xx xx xx xx xx xx xx
Newborn Screening xx xx xx 2,820.33 xx xx xx
Predictive & Presymptomatic Testing xx xx xx xx xx xx xx
Prenatal Testing xx xx xx xx xx xx xx
Total 4,969.90 xx xx xx xx xx 18.15
Source: Mordor Intelligence Analysis
Source: Mordor Intelligence Analysis
0.00
1.00
2.00
3.00
4.00
5.00
6.00
7.00
8.00
9.00
10.00
2010 2011 2012 2013 2014 2020
$billi
on
Increase in Newborn Testing
DATA HIDDEN FROM VIEW
|Global Genetic Testing Market Sample 57 | Mordor Intelligence
4.2.1.2 CANADA
The Canadian market for genetic testing is poised to witness a CAGR of xx % in 2014-2020 to reach a projected
US $ xx million by 2020, from an estimated US $ 335.2 million in 2014. In addition to being the largest type of
genetic testing, with an estimated share of xx % in 2014, newborn screening is also likely to be the fastest
growing, with a forecast 2014-2020 CAGR of xx %.
Canadian Genetic Testing Market for 2010-2020 by Segment (In US$ Million)
Segment 2010 2011 2012 2013 2014 2020 % CAGR (2014-2020)
Carrier Testing 41.62 xx Xx xx Xx xx 15.74
Diagnostic Testing Xx Xx Xx Xx Xx Xx Xx
Newborn Screening Xx Xx 104.26 Xx Xx Xx Xx
Predictive & Presymptomatic Testing Xx Xx Xx Xx Xx Xx Xx
Prenatal Testing Xx Xx Xx Xx Xx Xx Xx
Total xx Xx xx Xx xx Xx Xx
Source: Mordor Intelligence Analysis
Source: Mordor Intelligence Analysis
0
50
100
150
200
250
300
350
400
2010 2011 2012 2013 2014 2020
$ m
illion
s
Comparative analysis of Newborn Screening and Prenatal Screening market
New born screening Market
Prenatal Screening Market
DATA HIDDEN FROM VIEW
|Global Genetic Testing Market Sample 59 | Mordor Intelligence
4.3 EUROPE
4.3.1 EUROPE GENETIC TESTING MARKET, 2014-2020
The European market for genetic testing is projected to reach US $ xx billion by 2020, from an estimated US$6.7
billion in 2014, by recording a CAGR of xx % in 2014-2020. While Germany accounts for the largest share of the
genetic testing market in Europe, estimated at 26.7 % in 2014, the demand for these tests is likely to be the
fastest growing in the United Kingdom, with a forecast CAGR of xx % during 2014-2020. In terms of segment,
demand for newborn screening in Europe is the largest, as well as the fastest growing and is expected to post a
CAGR of xx % over 2014-2020, to reach a projected US $ xx billion by 2020.
European Genetic Testing Market for 2010-2020 by Region (In US$ Million)
Region 2010 2011 2012 2013 2014 2020 % CAGR (2014-2020)
France 1,017.45 xx Xx xx Xx xx 15.34
Germany xx Xx Xx Xx Xx Xx Xx
Italy xx Xx 716.78 Xx Xx Xx Xx
Spain xx Xx Xx Xx Xx Xx Xx
United Kingdom xx xx Xx Xx Xx Xx Xx
Rest of Europe xx xx Xx Xx xx Xx xx
Total 4,519.99 xx Xx xx xx xx Xx
Source: Mordor Intelligence analysis
|Global Genetic Testing Market Sample 60 | Mordor Intelligence
Source: Mordor Intelligence analysis
4.3.1.1 FRANCE
The demand for genetic testing in France is estimated at US$1.5 billion in 2014 and is likely to maintain a CAGR
of xx % in 2014-2020, to reach a projected US $ xx billion by 2020. Newborn testing is slated to emerge as the
largest, as well as the fastest growing category of genetic testing in the region, with a forecast CAGR of xx % over
2014-2020.
French Genetic Testing Market for 2010-2020 by Segment (In US$ Million)
Segment 2010 2011 2012 2013 2014 2020 % CAGR (2014-2020)
Carrier Testing 177.14 xx Xx xx Xx xx 13.91
Diagnostic Testing Xx Xx Xx Xx Xx Xx Xx
Newborn Screening Xx Xx 479.44 Xx Xx Xx Xx
Predictive & Presymptomatic Testing Xx Xx Xx Xx Xx Xx Xx
Prenatal Testing xx Xx Xx Xx Xx Xx Xx
Total 1,017.45 Xx xx Xx xx Xx Xx
Source: Mordor Intelligence analysis
Market Distribution for Europe Region 2012
France
Germany
Italy
Spain
United Kingdom
Rest of Europe
DATA HIDDEN FROM VIEW
|Global Genetic Testing Market Sample 61 | Mordor Intelligence
Source: Mordor Intelligence analysis
0
200
400
600
800
1000
1200
1400
1600
2010 2011 2012 2013 2014 2020
$ m
illion
Increase in Newborn testing Revenues ($million)
DATA HIDDEN FROM VIEW
|Global Genetic Testing Market Sample 69 | Mordor Intelligence
4.4 ASIA-PACIFIC
4.4.1 ASIA-PACIFIC GENETIC TESTING MARKET, 2014-2020
The prospect offered by the Asia-Pacific in the area of genetic testing has been diminished to a large extent due
to an imbroglio imposed on genetic testing by the largest market, viz., China. As a consequence, demand for this
category of molecular testing in Asia-Pacific is projected to reach US $ xx billion by 2020, from an estimated
US$1.5 billion in 2014, at a CAGR of xx % over 2014-2020. The Chinese market for genetic testing is slated to
sustain a sharp decline in 2014 that is likely to carry on into 2015, with prospects for recovery expected only in
2016. Underlying assumptions for the same include granting approval and clearance for the conduction of
genetic testing on a larger scale in the country, in place of limiting it for specified conditions.
Though the Asia-Pacific market for prenatal testing is the largest, the same is expected to witness a pronounced
decline of 26.4% in 2014 over 2013 because of rigorous sanctions imposed in China. Recovery for the same is
anticipated over the coming years, though not at the rate hitherto anticipated. Despite this, a CAGR of xx %
over2014-2020 still makes the market for prenatal testing in Asia-Pacific the fastest growing, with diagnostic
testing expected to maintain the slowest similar period CAGR of xx %.
Asia-Pacific Genetic Testing Market for 2010-2020 by Region (In US$ Million)
Region 2010 2011 2012 2013 2014 2020 % CAGR (2014-2020)
China Xx xx Xx xx Xx xx Xx
India 154.92 Xx Xx Xx Xx Xx Xx
Japan Xx Xx 552.36 Xx Xx Xx Xx
Rest of Asia-Pacific xx Xx Xx Xx Xx Xx Xx
Total 1,377.10 Xx xx Xx xx Xx xx
Source: Mordor Intelligence analysis
|Global Genetic Testing Market Sample 80 | Mordor Intelligence
5. COMPETITIVE LANDSCAPE
Genetic testing is a major and fast growing area of molecular diagnostics, with a slew of companies engaged in
offering a range of products and services. Since prenatal testing and newborn screening constitute the largest
applications of genetic testing, several of the players focus their attention on these critical areas. In general,
genetic testing is extremely useful in enabling the genetic diagnosis of vulnerabilities to inherited diseases, in
addition to being used for determining a child’s parentage (genetic mother and father) or an individual’s ancestry.
Following are some of the major strategies adopted by key players in the field of genetic testing:
COLLABORATIONS
BIOCARTIS SA
Lausanne, Switzerland-based Biocartis SA is a leading global developer and provider of fully integrated and
broadly applicable molecular diagnostics and immunodiagnostics solutions utilized in an extensive array of
healthcare settings to provide rapid, high-quality care to patients onsite. The company focuses on transforming
the worldwide market for diagnostics by providing instant access to o personalized medicine across the globe. To
achieve this, Biocartis aims to advance medical treatment through the broad implementation of state-of-the-art
personalized diagnostic tests performed close to the clinical decision-making point.
Forming alliances with other companies has been an inherent policy in Biocartis’ goal of expanding worldwide
presence. These are some of the latest key developments in which the company has been involved:
Formed an exclusive partnership with Abbott in June 2014 for developing multiplex companion diagnostic
tests
Entered into a collaboration agreement with Invetech in April 2014 for production of multiplex biomarker
analysis platform EVALUTION
Collaborated with VIB in December 2013 for developing an exclusive diagnostic cancer test
|Global Genetic Testing Market Sample 81 | Mordor Intelligence
MERGERS AND ACQUISITIONS
Genentech, a member of the Roche Group announced it has entered into a definitive agreement to
acquire Seragon Pharmaceuticals, Inc. (Seragon), a privately held biotechnology company based in San
Diego, California. With this acquisition, Genentech obtains rights to Seragon’s entire portfolio of
investigational next-generation oral selective estrogen receptor degraders (SERDs) for the potential
treatment of hormone receptor-positive breast cancer. The deal is estimated to be valued at close to US
$ 2 billion.
LifeLabs Medical Laboratory Services (“LifeLabs”) announced the acquisition of Centogene AG’s
(‘Centogene’) Canadian business. Based in Germany, Centogene is a world leader in genetics testing for
inherited diseases, with not only one of the world’s most extensive genetic test portfolios, but also one of
the largest databases of genetic mutations for rare diseases. Centogene performs testing for a number
of genetic centers across Canada. This acquisition places LifeLabs in a leadership role in genetic testing
in Canada.
|Global Genetic Testing Market Sample 91 | Mordor Intelligence
6. COMPANY PROFILES
6.6 BIOMERIEUX S.A.
6.6.1 OVERVIEW
A publicly traded multinational company: BioMeieux S.A. is a leader in the field of vitro diagnostics and clinical
microbiology. It provides solutions, which help in determining the source of disease and contamination to
improve patient health. It has 19 production and 17 research and development sites worldwide with more than €
1.59 billion in sales, with more than 87% of it outside France (as of Dec 2013). It employs more than 7,700
employees worldwide.
6.6.2 MAJOR PRODUCTS AND SERVICES
Products Description
NucliSENSEasyQ®
An automated system designed to combine NASBA technology and real-time
molecular detection. The system has rapid reaction time and takes a total time to
results and for amplification and detection of two hours or less for 48 samples.
CMV HHV6,7,8 R-gene™
The CMV HHV6,7,8 R-gene™ kit is designed to measure the viral load of CMV,
HHV-6 and the detection of HHV-7 and HHV-8 by real-time PCR after viral DNA
extraction.
CMV R-gene™ The CMV R-gene™ kit is designed to measure the viral load of CMV by real-time
PCR after viral DNA extraction.
Adenovirus R-gene™ The ADENOVIRUS R-gene™ kit is designed to measure the viral load of
Adenoviruses by real time PCR after viral DNA extraction.
EBV R-gene™
The EBV R-gene™ kit is designed to measure the viral load of EBV by real-time
PCR after viral DNA extraction. User friendly and complete, the EBV R-gene™ kit is
suitable for any laboratory.
HSV1 HSV2 VZV R-gene™ The HSV1 HSV2 VZV R-gene™ kit is designed to measure the viral load of HSV-1,
HSV-2 and VZV by real-time PCR after viral DNA extraction.
BK Virus R-gene™ The BK Virus R-gene™ kit enables the quantification of BK virus in Real Time PCR
|Global Genetic Testing Market Sample 92 | Mordor Intelligence
after viral DNA extraction.
Enterovirus R-gene™
The ENTEROVIRUS R-gene™ kit enables the generic detection of Enteroviruses by
amplification of the highly conserved 5' non-coding region, by means of Real
Time PCR amplification on CSF samples, stool samples, respiratory specimens or
culture cells.
Bordetella R-gene™
The BORDETELLA R-gene™ kit enables the detection of bordetella bacteria
containing the IS481 sequence (traditionally found in Bordetella pertussis) using
real-time PCR on respiratory samples (nasopharyngeal aspiration and
expectoration).
Bordetellaparapertussis r-
gene™
Bordetellaparapertussis r-gene™ is a ready to use premix optimized for the real
time amplification of IS1001 region of Bordetellaparapertussis, using the 5'
nuclease technology.
HYBRIDOWELL™ Universal Used for universal detection of amplified DNA on microwell plates
HERPES CONSENSUS
GENERIC Used for CMV, HSV-1, HSV-2, VZV, EBV, HHV-6 consensus amplification
HYBRIDOWELL™ HERPES
Identification
The HYBRIDOWELL™ HERPES Identification kit allows the identification of the
specific virus present in the positive samples obtained with HERPES CONSENSUS
GENERIC kit
ENTEROVIRUS CONSENSUS Used for Enterovirus consensus amplification
JC / BK CONSENSUS Used for Consensus amplification and differentiation of JCV and BKV
ADENOVIRUS CONSENSUS Used for Human Adenovirus consensus amplification
CALICI / ASTROVIRUS
CONSENSUS (Norovirus)
Used for Amplification and detection of Chlamydophilapneumoniae, Legionella
and Mycoplasma pneumoniae.
|Global Genetic Testing Market Sample 93 | Mordor Intelligence
6.6.3 GENETIC TESTING PIPELINE PRODUCTS
Product/Services Phase Description
Parvovirus B19 R-
gene® II
The Parvovirus B19 R-gene® kit is used to detect and quantify the 3 Parvovirus
B19 genotypes in whole blood, blood plasma and serum, and to detect the 3
Parvovirus B19 genotypes in whole bone marrow and medullary plasma, using
real-time amplification after extraction of the viral DNA.
Influenza A/B r-
gene™ II
Influenza A/B r-gene™ is a complete kit belonging to the Respiratory MWS r-
gene™ range of real-time PCR products for the detection of infectious agents
RSV/hMPV r-gene™ II RSV/hMPV r-gene™ is a complete kit belonging to the Respiratory MWS r-gene™
range of real-time PCR products for the detection of infectious agents
Rhino&EV/Cc r-
gene™ II
Respiratory Multi Well System r-gene™ kit for duplex amplification and detection
of Rhinovirus &Enterovirus and cellular control by real-time RT-PCR.
AdV/hBoV r-gene™ II AdV/hBoV r-gene™ is a complete kit belonging to the Respiratory MWS r-gene™
range of real-time PCR products for the detection of infectious agents
Chla/Mycopneumo
r-gene™ II
Respiratory Multi Well System r-gene™ kit for duplex amplification and detection
of Chlamydophilapneumoniae and Mycoplasma pneumoniae by real-time PCR
HCoV/HPIV r-gene™ II Respiratory Multi Well System r-gene™ kit for duplex amplification and detection
of Coronavirus and Parainfluenzavirus by real-time RT-PCR.
Parechovirus r-
gene™ II
Meningo Encephalitis Multi Well System r-gene™ kit for amplification and
detection of Parechovirus by real-time RT-PCR.
6.6.4 FINANCIALS
Following were the major financial figures for the financial year 2013:
Revenue: €1.588 billion
Operating Income: €262 million
Net Income: €165 million
|Global Genetic Testing Market Sample 94 | Mordor Intelligence
6.6.5 DEVELOPMENTS
05-May-214bioMérieux’sBioFire, its new molecular biology affiliate, has received U.S. Food and Drug
Administration (FDA) 510(k) clearance for the FilmArray® Gastrointestinal (GI)
26-February-2014: bioMérieuxannounced the launch of VIDAS® C. difficile GDH making it the only
company with the width to provide solutions for C.
19-February-2014: bioMérieux completes the acquisition of BioFire Diagnostics Inc., a privately held U.S.-
based company specialized in molecular biology
28-November-2013: bioMérieuxterminates its collaboration with Biocartis in molecular biology
28-October-2013: bioMérieux launches Parvovirus B19 R-gene® kit, a new CE-marked ARGENE® real-
time PCR test, used for the detection and quantification of the three Parvovirus B19 genotypes
30-September-2013: bioMérieux launches VIDAS® 25 OH Vitamin D Total for the measurement of total
vitamin D levels in human serum and plasma
|Global Genetic Testing Market Sample
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