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

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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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