GLOBAL GENETIC TESTING MARKET
2014 - 2020 Growth Trends & Forecasts
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TABLE OF CONTENTS 1
2
INTRODUCTION............................................................................................................................................. 1 1.1
REPORT DESCRIPTION......................................................................................................................... 1
1.2
RESEARCH METHODOLOGY ................................................................................................................. 3
GLOBAL GENETIC TESTING – MARKET FORCES ......................................................................................... 4 2.1 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
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
2.3.1
OPPORTUNITIES .................................................................................................................................. 9 Genetic Counseling .......................................................................................................................... 9
GLOBAL GENETIC TESTING MARKET, BY TYPES ....................................................................................... 10 3.1 3.1.1
4
MARKET RESTRAINTS ......................................................................................................................... 7
2.2.1
2.3
3
MARKET DRIVERS ................................................................................................................................ 4
OVERVIEW .......................................................................................................................................... 10 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
GENETIC TESTING MARKET, BY GEOGRAPHY ........................................................................................... 54 4.1
OVERVIEW .......................................................................................................................................... 54
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4.1.1.1 4.2
Global Genetic Testing Market, by Geography, 2014-2020 ....................................................... 54
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
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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 6.7.1
CELERA CORPORATION ..................................................................................................................... 95 Overview ......................................................................................................................................... 95
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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
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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
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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
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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
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
7.
SEEGENE, INC................................................................................................................................... 138
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
DISCLAIMER ............................................................................................................................................. 145
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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 inhouse 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
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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
4 | Mordor Intelligence
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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) 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
Source: Mordor Intelligence Analysis
North America Market distribution -2013
United States Canada Mexico
Source: Mordor Intelligence Analysis
Global Genetic Testing Market | Sample
55 | Mordor Intelligence
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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
Increase in Newborn Testing 10.00 9.00 8.00
$billion
7.00 6.00
DATA HIDDEN FROM VIEW
5.00 4.00 3.00 2.00 1.00 0.00 2010
2011
2012
2013
2014
2020
Source: Mordor Intelligence Analysis
Global Genetic Testing Market | Sample
56 | Mordor Intelligence
VIEW THIS REPORT ON OUR WEBSITE
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
400
Comparative analysis of Newborn Screening and Prenatal Screening market
350
$ millions
300
DATA HIDDEN FROM VIEW
250 200
New born screening Market
150
Prenatal Screening Market
100 50 0 2010
2011
2012
2013
2014
2020
Source: Mordor Intelligence Analysis
Global Genetic Testing Market | Sample
57 | Mordor Intelligence
VIEW THIS REPORT ON OUR WEBSITE
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
59 | Mordor Intelligence
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Market Distribution for Europe Region 2012
France Germany
DATA HIDDEN FROM VIEW
Italy Spain United Kingdom Rest of Europe
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
Global Genetic Testing Market | Sample
60 | Mordor Intelligence
VIEW THIS REPORT ON OUR WEBSITE
Increase in Newborn testing Revenues ($million) 1600 1400 1200
$ million
1000
DATA HIDDEN FROM VIEW
800 600 400 200 0 2010
2011
2012
2013
2014
2020
Source: Mordor Intelligence analysis
Global Genetic Testing Market | Sample
61 | Mordor Intelligence
VIEW THIS REPORT ON OUR WEBSITE
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
69 | Mordor Intelligence
VIEW THIS REPORT ON OUR WEBSITE
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
80 | Mordor Intelligence
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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.
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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 An automated system designed to combine NASBA technology and real-time
NucliSENSEasyQ®
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. The CMV HHV6,7,8 R-gene™ kit is designed to measure the viral load of CMV,
CMV HHV6,7,8 R-gene™
HHV-6 and the detection of HHV-7 and HHV-8 by real-time PCR after viral DNA extraction.
CMV R-gene™
Adenovirus R-gene™
The CMV R-gene™ kit is designed to measure the viral load of CMV by real-time PCR after viral DNA extraction. The ADENOVIRUS R-gene™ kit is designed to measure the viral load of Adenoviruses by real time PCR after viral DNA extraction. The EBV R-gene™ kit is designed to measure the viral load of EBV by real-time
EBV R-gene™
PCR after viral DNA extraction. User friendly and complete, the EBV R-gene™ kit is suitable for any laboratory.
HSV1 HSV2 VZV R-gene™ BK Virus R-gene™
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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. The BK Virus R-gene™ kit enables the quantification of BK virus in Real Time PCR
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after viral DNA extraction. 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
Enterovirus R-gene™
Time PCR amplification on CSF samples, stool samples, respiratory specimens or culture cells. The BORDETELLA R-gene™ kit enables the detection of bordetella bacteria containing the IS481 sequence (traditionally found in Bordetella pertussis) using
Bordetella R-gene™
real-time PCR on respiratory samples (nasopharyngeal aspiration and expectoration). Bordetellaparapertussis r-gene™ is a ready to use premix optimized for the real
Bordetellaparapertussis r-
time amplification of IS1001 region of Bordetellaparapertussis, using the 5'
gene™
nuclease technology.
HYBRIDOWELL™ Universal
Used for universal detection of amplified DNA on microwell plates
HERPES CONSENSUS
Used for CMV, HSV-1, HSV-2, VZV, EBV, HHV-6 consensus amplification
GENERIC 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
Used for Amplification and detection of Chlamydophilapneumoniae, Legionella
CONSENSUS (Norovirus)
and Mycoplasma pneumoniae.
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6.6.3
GENETIC TESTING PIPELINE PRODUCTS
Product/Services
Phase
Description The Parvovirus B19 R-gene® kit is used to detect and quantify the 3 Parvovirus
Parvovirus B19 Rgene®
II
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 rgene™ RSV/hMPV r-gene™ Rhino&EV/Cc rgene™ AdV/hBoV r-gene™ Chla/Mycopneumo r-gene™ HCoV/HPIV r-gene™ Parechovirus rgene™
6.6.4
II
II
II
II
II
II
II
Influenza A/B r-gene™ is a complete kit belonging to the Respiratory MWS rgene™ range of real-time PCR products for the detection of infectious agents 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 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™ is a complete kit belonging to the Respiratory MWS r-gene™ range of real-time PCR products for the detection of infectious agents Respiratory Multi Well System r-gene™ kit for duplex amplification and detection of Chlamydophilapneumoniae and Mycoplasma pneumoniae by real-time PCR Respiratory Multi Well System r-gene™ kit for duplex amplification and detection of Coronavirus and Parainfluenzavirus by real-time RT-PCR. Meningo Encephalitis Multi Well System r-gene™ kit for amplification and detection of Parechovirus by real-time RT-PCR.
FINANCIALS
Following were the major financial figures for the financial year 2013: Revenue: €1.588 billion Operating Income: €262 million Net Income: €165 million
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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® realtime 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
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