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Global Prenatal Testing Market

Analysis and Forecast, 2015-2022

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Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

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Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

Table of Contents

Executive Summary ................................................................................. 17

1 Research Scope and Methodology ...................................................... 23


1.1 Scope of the Report .................................................................. 23
1.2 Global Prenatal Testing Market Research Methodology ............ 25
1.2.1 Primary Data Sources .................................................. 25
1.2.2 Secondary Data Sources .............................................. 26

2 Introduction to the Prenatal Testing Market ....................................... 27

3 Market Dynamics ................................................................................ 37


3.1 Market Drivers .......................................................................... 37
3.1.1 Emphasis on Early Detection and Prevention ............... 38
3.1.2 Increasing Genetic and Congenital Disorders ............... 38
3.1.3 Availability of Advanced Diagnosis and Screening
Technologies ................................................................ 39
3.1.4 Evolving Government Initiatives .................................. 40
3.1.5 Adoption by Physicians: Incorporation of Tests into
Clinical Care ................................................................. 40
3.1.6 Shifting of Reimbursement Policies Towards More
Genetics Coverage ....................................................... 40
3.2 Market Challenges .................................................................... 41
3.2.1 Risk of Ethical Issues and Social Stigma ...................... 42
3.2.2 Lack of Awareness among Consumers ......................... 42
3.2.3 High Cost of Screening and Diagnosis Along with
the Lack of Accuracy .................................................... 43
3.3 Market Opportunities ................................................................ 43
3.3.1 Availability of Direct to Consumer Tests....................... 44
3.3.2 Focus Toward Pre-Implantation Genetic Diagnosis ...... 44

4 Competitive Insights .......................................................................... 46


4.1 Key Market Developments & Strategies .................................... 46

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Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

4.1.1 New Product Launch, Development and Expansion ...... 47


4.1.2 Acquisitions, Partnerships and Collaborations ............. 50
4.1.3 Business Expansion and Others ................................... 56
4.2 Industry Attractiveness ............................................................ 60

5 Industry Analysis ............................................................................... 65


5.1 Patent Analysis ......................................................................... 65
5.2 Consortiums, Alliances and Regulatory Bodies ......................... 69
5.3 Value Chain Analysis ............................................................... 72

6 Global Prenatal Testing Market, Analysis & Forecast .......................... 74


6.1 Assumptions & Limitations for Analysis and Forecast of the
Global Prenatal Testing Market ................................................. 74
6.2 Market Overview ...................................................................... 75
6.3 Global Prenatal Testing Market by Screening Methods ............. 77
6.3.1 Non-Invasive Prenatal Tests (NIPT) ............................ 79
6.3.1.1 NIPT Market by Geography ....................................... 80
6.3.1.2 North America NIPT Market....................................... 82
6.3.1.2.1 Market Share Analysis by Countries ................... 83
6.3.1.2.1.1 The U.S. ............................................. 83
6.3.1.2.1.2 Canada ............................................... 84
6.3.1.2.1.3 Mexico ................................................ 85
6.3.1.3 Europe NIPT Market ................................................. 86
6.3.1.3.1 Market Share Analysis by Countries ................... 87
6.3.1.3.1.1 Germany............................................. 87
6.3.1.3.1.2 France ................................................ 87
6.3.1.3.1.3 Italy ................................................... 88
6.3.1.3.1.4 U.K..................................................... 89
6.3.1.3.1.5 Spain .................................................. 89
6.3.1.3.1.6 Other European Countries ..................... 90
6.3.1.4 APAC NIPT Market: .................................................. 91
6.3.1.4.1 Market Share Analysis by Countries ................... 92

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Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

6.3.1.4.1.1 China.................................................. 92
6.3.1.4.1.2 India .................................................. 92
6.3.1.4.1.3 Japan ................................................. 93
6.3.1.4.1.4 Other APAC Countries ........................... 94
6.3.1.5 Rest of the World NIPT Market .................................. 95
6.3.2 Other Prenatal Screening Tests .................................... 96
6.3.2.1 Cell-Free Fetal DNA Test ........................................... 96
6.3.2.2 Maternal Serum Screening (MSS) .............................. 98
6.3.2.3 Nuchal Scan (NT Procedure) ..................................... 98
6.3.2.4 Triple Test .............................................................. 98
6.3.2.5 Quadruple Test........................................................ 98
6.4 Global Prenatal Testing Market by Diagnosis Methods ............ 100
6.4.1 Global Prenatal Diagnosis Market by Test Type .......... 102
6.4.1.1 Non-Invasive Prenatal Diagnosis Market ....................103
6.4.1.1.1 Ultrasonography ............................................103
6.4.1.1.2 Fetal Cells in Maternal Blood (FCMB).................104
6.4.1.1.3 Pre-Implantation Genetic Diagnosis ..................104
6.4.1.2 Invasive Prenatal Diagnosis Market ...........................104
6.4.1.2.1 Invasive Test Market by Test Types ..................104
6.4.1.2.1.1 Amniocentesis ................................... 105
6.4.1.2.1.2 Chorionic Villus Sampling (CVS) ........... 107
6.4.1.2.1.3 Other Invasive Tests .......................... 110
6.4.1.2.1.3.1 Fetal Blood Sampling (FBS) ................. 110
6.4.1.2.1.3.2 Transcervical Retrieval of Trophoblast Cells110
6.4.1.2.1.3.3 Embryoscopy and Fetoscopy................ 111
6.4.1.2.2 Invasive Test Market by Geography ..................112
6.4.1.2.2.1 North America Invasive Test Market ..... 113
6.4.1.2.2.1.1 Market Share Analysis by Countries...... 114
6.4.1.2.2.1.1.1 The U.S. ........................................... 114
6.4.1.2.2.1.1.2 Canada ............................................. 114
6.4.1.2.2.1.1.3 Mexico .............................................. 115

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Analysis and Forecast, 2015-2022

6.4.1.2.2.2 Europe Invasive Test Market ............... 116


6.4.1.2.2.2.1 Market Share Analysis by Countries...... 117
6.4.1.2.2.2.1.1 Germany........................................... 117
6.4.1.2.2.2.1.2 France .............................................. 117
6.4.1.2.2.2.1.3 Italy ................................................. 118
6.4.1.2.2.2.1.4 U.K................................................... 119
6.4.1.2.2.2.1.5 Spain ................................................ 119
6.4.1.2.2.2.1.6 Other European Countries ................... 120
6.4.1.2.2.3 APAC Invasive Test Market .................. 121
6.4.1.2.2.3.1 Market Share Analysis by Countries...... 121
6.4.1.2.2.3.1.1 China................................................ 122
6.4.1.2.2.3.1.2 India ................................................ 122
6.4.1.2.2.3.1.3 Japan ............................................... 123
6.4.1.2.2.3.1.4 Other APAC Countries ......................... 124
6.4.1.2.2.4 Rest of the World Invasive Test Market . 125
6.4.2 Global Prenatal Diagnosis Market by Geography ........ 126
6.4.2.1 North America ........................................................127
6.4.2.1.1 Market Analysis by Country .............................128
6.4.2.2 Europe ..................................................................130
6.4.2.2.1 Market Analysis by Country .............................131
6.4.2.3 APAC ....................................................................132
6.4.2.3.1 Market Analysis by Country .............................134
6.4.2.4 Rest of the World (RoW) ..........................................136

7 Company Profiles .............................................................................. 138


7.1 Agilent Technologies .............................................................. 138
7.1.1 Overview .................................................................... 138
7.1.2 Financials ................................................................... 139
7.1.2.1 Financial Summary .................................................141
7.1.3 SWOT Analysis ........................................................... 141
7.2 CombiMatrix ........................................................................... 142
7.2.1 Overview .................................................................... 142

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Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

7.2.2 Financials ................................................................... 143


7.2.2.1 Financial Summary .................................................143
7.2.3 SWOT Analysis ........................................................... 144
7.3 Illumina Inc. ........................................................................... 145
7.3.1 Overview .................................................................... 145
7.3.2 Financials ................................................................... 145
7.3.2.1 Financial Summary .................................................148
7.3.3 SWOT Analysis ........................................................... 148
7.4 LabCorp Of America ................................................................ 149
7.4.1 Overview .................................................................... 149
7.4.2 Financials ................................................................... 150
7.4.2.1 Financial Summary .................................................151
7.4.3 SWOT Analysis ........................................................... 152
7.5 Natera Inc. ............................................................................. 153
7.5.1 Overview .................................................................... 153
7.5.2 Financials ................................................................... 154
7.5.2.1 Financial Summary .................................................155
7.5.3 SWOT Analysis ........................................................... 156
7.6 Quest Diagnostics ................................................................... 157
7.6.1 Overview .................................................................... 157
7.6.2 Financials ................................................................... 157
7.6.2.1 Financial Summary .................................................159
7.6.3 SWOT Analysis ........................................................... 159
7.7 Roche Holding ........................................................................ 161
7.7.1 Overview .................................................................... 161
7.7.2 Ariosa Diagnostics ..................................................... 162
7.7.2.1 Overview ...............................................................162
7.7.3 Financials ................................................................... 162
7.7.3.1 Financial Summary .................................................164
7.7.4 SWOT Analysis ........................................................... 165
7.8 Sequenom Inc. ....................................................................... 166

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Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

7.8.1 Overview .................................................................... 166


7.8.2 Financials ................................................................... 167
7.8.2.1 Financial Summary .................................................168
7.8.3 SWOT Analysis ........................................................... 169
7.9 Snapshot of Some Players ...................................................... 170
7.9.1 Affymetrix, Inc. .......................................................... 170
7.9.2 Annoroad Diagnostics ................................................ 171
7.9.3 Berry Genomics .......................................................... 171
7.9.4 BGI Diagnostics ......................................................... 172
7.9.5 Progenity ................................................................... 172
7.10 List of Other Prominent Players .............................................. 176

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Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

List of Tables

Table 2.1 Types of Genetic Diseases in Fetuses: An Overview 31


Table 2.2 Prenatal Testing: Key Technologies 34
Table 3.1 Live Birth Rate- Risk of Genetic Abnormality/Disorders by Maternal Age 39
Table 3.2 Average Cost of Non-Invasive Prenatal Test (NIPT) 43
Table 4.1 New Product Launch, Development and Expansion 48
Table 4.2 Recent Acquisitions, Partnerships and Collaborations 51
Table 4.3 Recent Business Expansion and Others 56
Table 4.4 Key Factors Considered for Threat of New Entrants: Prenatal Testing 61
Table 4.5 Key Factors Affecting Bargaining Power of Buyers: Prenatal Testing 61
Table 4.6 Key Factors Affecting the Bargaining Power of Suppliers: Prenatal Testing 62
Table 4.7 Key Factors Affecting Threat of Substitute Products: Prenatal Testing 63
Table 4.8 Key Factors Determining Rivalry among Existing Firms: Prenatal Testing 64
Table 5.1 Example of Some Recent Patents 65
Table 5.2 Example of Some Regulatory Bodies/Associations/Consortium 69
Table 6.1 Global Prenatal Screening Market Size, by Test Type, 2015-2022, 78
Table 6.2 Geographical Analysis of Players and Cost of NIPT 80
Table 6.3 Global NIPT Screening Market Size, by Geography, 2015-2022, 80
Table 6.4 NIPT: Recent Key Developments 99
Table 6.5 Amniocentesis Prenatal Testing Method Snapshot 106
Table 6.6 North America Prenatal Diagnosis Market Scope Statistics 128
Table 6.7 North America: Prenatal Diagnosis Market, by Test Type, 2015-2022 128
Table 6.8 Recent Key Developments in North America 129
Table 6.9 Europe Prenatal Diagnosis Market Scope Stats 131
Table 6.10 Europe: Prenatal Diagnosis Market, by Test Type, 2015-2022 131
Table 6.11 APAC Prenatal Diagnosis Market Scope Stats 133
Table 6.12 APAC: Prenatal Diagnosis Market, by Test Type, 2015-2022 134
Table 6.13 Recent Key Developments in APAC 135
Table 6.14 RoW: Prenatal Diagnosis Market, by Test Type, 2015-2022 136
Table 6.15 RoW Prenatal Diagnosis Market Scope Stats 137
Table 7.1 Snapshot of Other Key Players 173
Table 7.2 List of other Prominent Players 176

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Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

List of Figures

Figure 1 Global Prenatal Testing Market Size, 2015-2022 ($Billion) 19


Figure 2 Global Prenatal Testing Market Size, by Type, 2015-2022 ($billion) 20
Figure 3 Global Prenatal Diagnosis Market, by Geography, 2015 and 2022 ($Billion) 21
Figure 1.1 Global Prenatal Testing Market Scope 24
Figure 1.2 Research Methodology 25
Figure 2.1 Prenatal Testing: Key Elements Covered 28
Figure 2.2 History & Evaluation of Prenatal Testing 29
Figure 2.3 Prenatal Testing Timeline during Pregnancy (Till Second Trimester) 30
Figure 2.4 Factors Responsible for Prenatal Testing 34
Figure 3.1 Market Dynamics for Prenatal Testing 37
Figure 3.2 Prenatal Testing Market: Key Market Drivers 37
Figure 3.3 Prenatal Testing: Key Challenges 41
Figure 3.4 Prenatal Testing: Key Opportunities 44
Figure 4.1 Recent Market Development Strategy Snapshot Analysis 46
Figure 4.2 Key Market Developments & Strategies 47
Figure 4.3 Porter’s Five Forces Analysis 60
Figure 5.1 Value Chain Analysis 72
Figure 6.1 Classification of Global Prenatal Testing Market 75
Figure 6.2 Global Prenatal Testing Market: Opportunity Matrix 76
Figure 6.3 Global Prenatal Testing Market, by Technique 2015-2022 ($Billion) 76
Figure 6.4 Example of a Screening Method 77
Figure 6.5 Global Prenatal Screening Market Size, 2015-2022, ($Billion) 78
Figure 6.6 Prenatal Screening Methods 79
Figure 6.7 NIPT Pricing and Market Penetration Analysis 81
Figure 6.8 NIPT Pricing and Market Size 82
Figure 6.9 North America: NIPT Market by Countries, 2015-2022 ($Million) 83
Figure 6.10 The U.S. NIPT Market, 2015-2022 ($Million) 84
Figure 6.11 Canada NIPT Market, 2015-2022 ($Million) 85
Figure 6.12 Mexico NIPT Market, 2015-2022 ($Million) 85
Figure 6.13 Europe: NIPT Market by Countries, 2015-2022 ($Million) 86
Figure 6.14 Germany NIPT Market, 2015-2022 ($Million) 87
Figure 6.15 France NIPT Market, 2015-2022 ($Million) 88
Figure 6.16 Italy NIPT Market, 2015-2022 ($Million) 88
Figure 6.17 U.K. NIPT Market, 2015-2022 ($Million) 89

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Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

Figure 6.18 Spain NIPT Market, 2015-2022 ($Million) 90


Figure 6.19 Other European Countries NIPT Market, 2015-2022 ($Million) 90
Figure 6.20 APAC: NIPT Market by Countries, 2015-2022 ($Million) 91
Figure 6.21 China NIPT Market, 2015-2022 ($Million) 92
Figure 6.22 Indian NIPT Market, 2015-2022 ($Million) 93
Figure 6.23 Japan NIPT Market, 2015-2022 ($Million) 94
Figure 6.24 Other APAC Countries NIPT Market, 2015-2022 ($Million) 94
Figure 6.25 ROW NIPT Market, 2015-2022 ($Million) 95
Figure 6.26 Global Others Screening Test Market, 2015-2022 ($Billion) 96
Figure 6.27 Factors Responsible for Cell-Free Fatal DNA 97
Figure 6.28 Cell-Free Fatal DNA Test; Suggested Time for Testing 97
Figure 6.29 Prenatal Diagnosis Benefits 100
Figure 6.30 Global Prenatal Diagnosis Market Size, 2015-2022, ($Billion) 101
Figure 6.31 Prenatal Diagnosis Market by Test Type 102
Figure 6.32 Global Prenatal Diagnosis Market Share, by Test Type, 2015 102
Figure 6.33 Global Non-Invasive Prenatal Diagnosis Market, 2015-2022 ($Million) 103
Figure 6.34 Global Invasive Prenatal Diagnosis Test Market, by Test type, 2015-2022 ($Million) 105
Figure 6.35 Amniocentesis Schematic Diagram 106
Figure 6.36 Types of procedure for CVS 108
Figure 6.37 Types of Chorionic Villus Sampling (CVS) Procedure 108
Figure 6.38 Methods of Transcervical Cell collection 111
Figure 6.39 Global Invasive Prenatal Diagnosis Test Market, by Geography, 2015-2022 ($Million)112
Figure 6.40 North America: Invasive test Market by Countries, 2015-2022 ($Million) 113
Figure 6.41 The U.S. Invasive Test Market, 2015-2022 ($Million) 114
Figure 6.42 Canada Invasive Test Market, 2015-2022 ($Million) 115
Figure 6.43 Mexico Invasive Test Market, 2015-2022 ($Million) 115
Figure 6.44 Europe: Invasive Test Market by Countries, 2015-2022 ($Million) 116
Figure 6.45 Germany Invasive Test Market, 2015-2022 ($Million) 117
Figure 6.46 France Invasive Test Market, 2015-2022 ($Million) 118
Figure 6.47 Italy Invasive Test Market, 2015-2022 ($Million) 118
Figure 6.48 U.K. Invasive Test Market, 2015-2022 ($Million) 119
Figure 6.49 Spain Invasive Test Market, 2015-2022 ($Million) 120
Figure 6.50 Other European Countries Invasive Test Market, 2015-2022 ($Million) 120
Figure 6.51 APAC: Invasive Test Market by Countries, 2015-2022 ($Million) 121
Figure 6.52 China Invasive Test Market, 2015-2022 ($Million) 122
Figure 6.53 India Invasive Test Market, 2015-2022 ($Million) 123

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Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

Figure 6.54 Japan Invasive Test Market, 2015-2022 ($Million) 124


Figure 6.55 Other APAC Countries Invasive Test Market, 2015-2022 ($Million) 124
Figure 6.56 ROW Invasive Test Market, 2015-2022 ($Million) 125
Figure 6.57 Global Prenatal Diagnosis Market by Geography 126
Figure 6.58 Global Prenatal Diagnosis Market, by Geography, 2015-2022 ($Million) 126
Figure 6.59 North American Market Dynamics 127
Figure 6.60 Key Players in North American Prenatal Testing Market 130
Figure 6.61 Key Factors Driving the Prenatal Testing Market in Europe 130
Figure 6.62 Key Players in European Prenatal Testing Market 132
Figure 6.63 Key Factors Driving the Prenatal Testing Market in APAC 133
Figure 6.64 Challenges for Prenatal Testing in APAC 135
Figure 6.65 Key Players in APAC Prenatal Testing Market 135
Figure 6.66 Key Factors Driving the Prenatal Testing Market in Row 136
Figure 6.67 Key Players in RoW Prenatal Testing Market 137
Figure 7.1 Agilent: Overall Financials, 2013-2015 139
Figure 7.2 Agilent: Net Revenue by Business Segment, 2013-2015 140
Figure 7.3 Agilent: Revenue across Different Geographies, 2013-2015 140
Figure 7.4 Agilent: SWOT Analysis 141
Figure 7.5 CombiMatrix: Overall Financials, 2013-2015 143
Figure 7.6 CombiMatrix: SWOT Analysis 144
Figure 7.7 Illumina: Overall Financials, 2013-2015 146
Figure 7.8 Illumina: Net Revenue by Business Segment, 2013-2015 147
Figure 7.9 Illumina: Revenue across Different Geographies, 2013-2015 147
Figure 7.10 Illumina: SWOT Analysis 148
Figure 7.11 LabCorp: Overall Financials, 2013-2015 150
Figure 7.12 LabCorp: Net Revenue by Business Segment, 2013-2015 151
Figure 7.13 LABCORP: SWOT Analysis 152
Figure 7.14 Natera Inc.: Overall Financials, 2013-2015 154
Figure 7.15 Natera Inc.: Revenue across Different Geographies, 2013-2015 155
Figure 7.16 Natera Inc.: SWOT Analysis 156
Figure 7.17 Quest Diagnostics: Overall Financials, 2013-2015 158
Figure 7.18 Quest Diagnostics: Net Revenue by Business Segments, 2013-2015 158
Figure 7.19 Quest Diagnostics: SWOT Analysis 159
Figure 7.20 Roche Holding: Overall Financials, 2013-2015 163
Figure 7.21 Roche Holding: Net Revenue by Business Segments, 2013-2015 163
Figure 7.22 Roche Holding: Revenue across Different Geographies, 2013-2015 164

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Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

Figure 7.23 Roche Holding: SWOT Analysis 165


Figure 7.24 Sequenom Inc.: Overall Financials, 2013-2015 167
Figure 7.25 Sequenom Inc.: Net Revenue by Business Segments, 2013-2015 168
Figure 7.26 Sequenom Inc.: SWOT Analysis 169

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Analysis and Forecast, 2015-2022

Executive Summary

Prenatal testing is a series of preventive measure tests performed on expectant mothers to screen and diagnose
genetic disorder in foetuses through gene mapping and sequencing of fetal cells. Screening for Open Neural Tube
Defects (ONTDs) by Maternal Serum Alpha-Fetoprotein (MSAFP) began in the 1970s, whereas screening for foetal
chromosomal anomalies along with amniocentesis emerged in the mid-1960s. Most of these screening tests
included the understanding of the genes, i.e. the DNA structures with their different configurations. A major boost
in prenatal testing occurred in the year 2003 when the human genome project became commercialized. .

Prenatal testing became the need of the hour as numerous cases related to Down syndrome and other mental
disabilities were being reported; all of which were a consequence of the mutant genes and an abnormal
chromosomal structure in the Fetus. Therefore prenatal testing allowed the patient to be mentally prepared and
helped them to take a decision either to continue or to abort the pregnancy. This market is growing at an
impressive pace due to the above mentioned advantages as well as the increasing demand for Assisted
Reproductive Technologies (ART).

There are various factors that contribute towards the growth of the market for prenatal testing, such as:
advanced maternal age, previous child with a chromosome abnormality, family history of chromosome
abnormality, family history of single gene disorders, family history of neural tube defect and congenital structural
abnormalities, abnormalities identified during pregnancy among others. .

Factors Driving and Restraining the Prenatal Test Market Growth


With the emergence of advanced technologies such as next generation sequencing, high throughput screening,
and cell free fetal DNA, there has been a gradual rise in the overall demand of the newly developed prenatal
diagnosis and screening tests. Prenatal testing emphasizes on early detection and prevention of foetus
abnormality, which is leading to a dynamic growth of the market. The numbers of screening and diagnostic tests
are increasing rapidly day by day and have reached around 3500 tests in 2016. Most of these tests are readily
available to the common people and are used in developed countries where parents are more aware about early
detection of genetic disorders in their pre-born baby. On the other hand, in developing countries, in spite of the
availability of a large number of tests, their clinical application is slow as compared to developed countries.

Other factors which are driving the market are increasing genetic and congenital disorders, which affect the
market because of genetic mutations, inactive lifestyle, advanced maternal age and inherent abnormal genes.
Due to all these reasons the disorders are rising at a fast pace. The availability of advanced diagnosis and
screening technologies is a major factor for the growth and stability of the prenatal testing market.
New technologies such as NGS, PCR, FISH, microarray, aCGH and MSS among others are becoming popular in
the prenatal diagnosis and screening market. Evolving government initiatives, adoption by physicians,

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Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

incorporation of tests into clinical care and allocation of reimbursement policies towards more genetic testing
coverage are some of the major reasons which are driving the market.

The risk of ethical issues is acting as a limitation impacting the development of this market. Prenatal test players
in Middle Eastern countries are facing challenges due to their ethical and cultural norms and also due to their
skepticism toward these tests. Moreover, in developed countries, women are unwilling and skeptical about these
tests as they assume that unexpected test results can affect their emotional and physical health and might
interfere with their overall reproductive autonomy. Lack of awareness among consumers is also a major restraint
in developing countries of Asia, Africa, Central and South America. People are not aware about the benefits and
the appropriate use of prenatal tests.

High pricing of screening and diagnostic tests along with the risk of accuracy causes hindrances in the growth of
the market. In developing countries, most of the people do not have sufficient monetary resources for undergoing
these expensive tests. In many Middle Eastern and African countries, the prenatal test players are facing huge
challenges due to their ethical and cultural norms and also due to their skepticism toward these tests. Countries
such as Saudi Arabia, the U.A.E., Turkey, Oman and Iran among others, have economic and infrastructural
support, but have still not approved of these tests in their countries due to the shortage of educational and
government development programs. Many parents have shown interest in prenatal tests due to the benefits it
brings about in the mother and child’s health. The mindset is gradually changing in these regions and more
families are approaching hospitals and clinics for prenatal tests, breaking the social stigma and gifting their future
generation with better health.

The increasing awareness and need for early diagnosis of genetic disorders will generate a huge market for
prenatal tests in the future. The development of pre-implantation diagnosis tests are helping parents in the early
stages of pregnancy, and are foreseen as a viable opportunity for this market.

Cultural and Regulatory Impact on Prenatal Testing Market


Prenatal tests are gaining rapid pace worldwide due to various government support programs and schemes. In
many countries, the prenatal market growth is restrained due to their cultural and ethical attitude towards this
process. Moreover, the government funded education and awareness programs are encouraging the development
of prenatal market that would benefit its citizens.

Regulatory bodies have established a significant position in the industry, which helps in the adoption of prenatal
tests and their applications among the people. Sometimes, it might also restrict the development of inefficient and
inaccurate diagnostic and screening tests. As a result, regulations restrict the market with clinics and hospitals
which are providing sound systems for prenatal tests. These are filled with employees who have knowledge and

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Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

necessary skills to perform the same. As the industry evolves, the role of consortiums and regulatory bodies
becomes pivotal to shape the future trajectory.

Prenatal Market Classification, Segmentation, and Size


The global prenatal testing market is growing at a CAGR of XX% from 2016 to 2022 and is estimated to grow over
$XX billion by 2022. The following figure exhibits global prenatal testing market size ($billion):

Figure 1
Global Prenatal Testing Market Size, 2015-2022 ($Billion)

XX XX%
XX
XX% XX%
XX
XX% XX% XX%
XX XX
XX%
XX%
XX
XX% XX
XX%
XX XX%
XX
XX% XX%
XX XX
XX% XX%
XX
XX XX
XX XX%

XX XX%

- XX%
2015 2016 2017 2018 2019 2020 2021 2022

Prenatal Testing YOY

BIS Research Analysis

Prenatal tests are classified into two main categories viz. Screening and Diagnostics. Both screening and
diagnostics have witnessed an exponential growth in procuring treatments for disorders which increased in the
past two decades. Screening prenatal tests are further divided into Non-Invasive Prenatal Testing Screening
(NIPT) and other screening processes such as Cell-Free Foetal DNA (cffDNA), Maternal Serum Screening (MSS),
Nuchal Scan (NT Procedure), Triple Test, and Quadruple Test. NIPT was first discovered in Hong Kong in August
2011 and at present is offered in more than 60 countries throughout six continents. NIPT is rapidly
commercializing due to its non- invasive technologies of the foetal genome that raise issues of its implementation
and hence, reduce the cost effectiveness of NIPT.

Inconsistent insurance coverage is hindering the market growth, but in the near future, it is expected that
insurance policy makers will favour these tests due to its increasing demand. The exponential growth of the NIPT

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Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

market is supported by factors such as: the high incidence rate of babies born with Down syndrome, no risk of
miscarriage with NIPT, and shifting trends towards childbirth at an advanced maternal age (35 years or older).
The number of disorders against which a foetus can be screened and protected has been increasing constantly
since the 1980s and is estimated to reach more than 100 by the end of 2020. Screening holds a major market
size of $XX billion, which will increase to $XX billion in 2022 with a CAGR of XX%, followed by Diagnostics which
stood at $XX billion in 2015 which will reach to around $XX billion in 2022 with a CAGR of XX % (2016-2022).

Figure 2
Global Prenatal Testing Market Size, by Type, 2015-2022 ($billion)

2022

XX% Diagnostic Techniques


XX%
XX% 2015
XX% Screening Methods

BIS Research Analysis

The diagnostics market is further divided into two categories viz. Invasive and Non-Invasive. The invasive
diagnostics market stood at $XX billion in 2015 and expected to grow to $XX billion by the end of 2022 at a CAGR
of XX% (2016-2022). The non-invasive testing market which stood at $XX billion in 2015 will grow to $XX billion
in 2022 at CAGR XX% (2016-2022).Invasive testing is a conventional technology amongst prenatal techniques
because of which it is still leading the market. Due to low cost, invasive testing is preferred by people in
developing countries, whereas the non-invasive is costly as well as comparatively a more recent technology which
will take time to gain popularity. Non-invasive techniques cause no harm to the human body and thus are gaining
preference amongst patients in developed regions around the world.

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Analysis and Forecast, 2015-2022

Figure 3
Global Prenatal Diagnosis Market, by Geography, 2015 and 2022 ($Billion)

NORTH AMERICA
2015: XX EUROPE
2022: XX 2015: XX
2022: XX

ROW
2015: XX
2022: XX

APAC
2015: XX
2022: XX

North America

Europe
Asia-Pacific
Rest of the World
(ROW)

BIS Research Analysis

North America is the largest contributor in the overall revenue generated in prenatal and newborn care, followed
by the European region. North America, with a market share of XX% in 2015, currently leads the market followed
by Europe with XX% share and APAC with XX% share. In the long run, APAC will surpass Europe in terms of size
and is expected to gain a XX% share in 2022.

The U.S., the U.K., Japan, and India show a dynamic growth in the overall market due to an increasing
prevalence of genetic disorders in these countries. Globally, the APAC region is expected to show the fastest
growth, and is expected to grow at a high CAGR of XX% from 2016 to 2022 followed by the rest of the world
which will grow with a CAGR of XX%. Europe will be the slowest growing market in the future and is expected to
reach $XX million by 2022. North America’s revenue increased from $XX million in 2015 and is expected to reach
$XX million in 2022. The APAC region is focusing more on technological development and introduction of
advanced tools in the field of prenatal and newborn care in order to develop specific tests and solutions.

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Analysis and Forecast, 2015-2022

The market is driven by product launch and development strategies followed by partnerships and collaborations.
Moreover, gigantic healthcare diagnostic companies are acquiring small/new entrants to position themselves in
the prenatal testing market. For example, Roche acquired Ariosa Diagnostics in 2014 while Illumina acquired
Verinata Health in 2013. During the nascent stage of the market, the companies should focus on the development
of technologically advanced, highly accurate and cost effective tests which can screen and diagnose numerous
disorders in the prenatal market scheme. The existing players should emphasize on the expansion of their
business in countries with huge population and high birth rate such as China, India, Brazil, Niger, and other MEA
countries.

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Analysis and Forecast, 2015-2022

1 Research Scope and Methodology

1.1 Scope of the Report

The report constitutes of an in-depth study of the global prenatal testing market, including a thorough analysis of
the different diagnosis tests across geographies. The study also presents a detailed analysis of the push and pulls
forces of the market and the estimation and forecast for market size over the forecast period, 2016 to 2022.

The scope of this report is related to a detailed study of the solutions associated with prenatal testing market. The
market has been identified and segmented into ‘prenatal screening’ and ‘prenatal diagnoses’. The overall prenatal
testing market discusses in detail, the analysis of both screening and diagnosis methods. Prenatal diagnosis has
been discussed by further test types in different geographies. In case of non-invasive prenatal testing, only high-
risk pregnancy cases and their market are being considered for the time being.

Report coverage of the prenatal testing market includes key elements considered for the detailed analysis for our
study.

 The market overview provides an in depth analysis of the market dynamics: drivers, challenges and
opportunities related to prenatal testing market

 Competitive and industry overviews provide detailed insights to understand the business environment of
the prenatal testing market

 In depth analysis of different market segments consists of valuable insights into the trend followed in the
prenatal testing market

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Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

The scope of the report is summarized below:


Figure 1.1
Global Prenatal Testing Market Scope

CURRENT MARKET Competitive Insights Industry Trends


Key Regulatory Bodies and
Patent Analysis
INFORMATION
AND DATA Market Size Market Share
Key Strategies &
Developments

INFLUENCING FACTORS Legal & Regulatory


(Market Trends and Dynamics) Market Drivers Market Restraints
Framework

Market Opportunities Industry Analysis Demand Side Perspective

Market Size & Forecast:


Market Size and Share
Analysis • By Diagnostic Test
• By Screening Compound Annual
FORECAST • By Geography Growth Rate (CAGR)%
High Growth
Segments

MARKET SEGMENTATION

By Prenatal Testing By Prenatal Diagnosis, Test Type By Geography


• Prenatal Screening • Invasive Diagnosis
• North America
• NIPT • Amniocentesis
• Europe
• Others • Chorionic Villus
Sampling (CVS) • Asia Pacific (APAC)
• Prenatal Diagnosis
• Others • Rest of the World (RoW)
• Invasive Diagnosis
• Non-Invasive Prenatal • Non-Invasive Prenatal Diagnosis
Diagnosis (NIPD) (NIPD)

BIS Research Analysis

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Analysis and Forecast, 2015-2022

1.2 Global Prenatal Testing Market Research Methodology

The following chart exhibits the snapshot of the research methodology followed for the prenatal testing market:

Figure 1.2
Research Methodology

BIS Research Analysis

The research methodology starts with the scope definition which is further followed by a research design. The
market study includes both qualitative and quantitative approaches to have a better market idea. After the
completion of market study, data is collected for the purpose of further analysis. Data collection includes both
primary and secondary sources.

1.2.1 Primary Data Sources


The primary sources involve the industry experts from the global prenatal market’s supply side, demand side,
research & development organizations, lawmakers, and distributors. In the extensive primary research process
undertaken for this study, the primary sources further include industry experts such as CEOs, vice presidents,
marketing directors, technology & innovation directors, founders and related key executives from vital
companies and organizations in the prenatal testing market. All such resources have been interviewed to obtain
and verify both qualitative and quantitative aspects of this research study.

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Analysis and Forecast, 2015-2022

The key data points taken from primary sources include:

 Validation and triangulation of all the numbers and graphs

 Validation of report segmentation and key qualitative findings

 Understanding the competitive landscape

 Current and proposed production size s of a particular product by market players

 Percentage split of individual markets for geographical analysis

1.2.2 Secondary Data Sources


This research study involves the usage of extensive secondary sources, directories, company websites, white
papers, journals, and annual reports. It also makes use of databases such as the National Institute of Health
(NIH), Bloomberg, Business-week, Factiva, Genomeweb, and Medscape to collect useful and effective information
to produce an extensively technical, market-oriented, and commercial analysis of the global market.

Secondary research was done in order to obtain crucial information about the industry’s size chain, market’s
monetary chain, the total pool of key players, and the prevalent distribution channels (in terms of revenue
generation).

The key data points taken from secondary sources include:

 Segmentation breakups, split-ups, and percentage shares

 Data for market size

 Key industry trends of the top players of the market

 Qualitative insights into various aspects of the market, key trends, and emerging areas of innovation

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Analysis and Forecast, 2015-2022

History & Evaluation of Prenatal Testing


The timeline of prenatal testing has been shown below:
Figure 2.2
History & Evaluation of Prenatal Testing

1960 2003 2009 2015


 Completion of human genome  Emergence of next gene
 Double helix structure of DNA  First non-invasive prenatal
project sequencing and pre-
discovered diagnosis test licensed
 Sequenom licenses a patent for implantation diagnosis
 Trisomy 21 screening is added to non-invasive prenatal diagnosis technology
prenatal screening

 Among 10 of the greatest


 Wisconsin was the first  International Society for Prenatal
public health achievements,
state to add SCID to their Diagnosis created guidelines for
CDC quoted newborn
mandatory screening panel prenatal testing
screening as one of them
in 2008  Testing done to identify
fetal aneuploidy for the first time in the
U.S.

1990 2006 2012

BIS Research Analysis

Since the middle ages, the detection of diseases in foetus was done by visual inspection i.e. by the color of urine.
From 1900 onwards, explorers working in prenatal came up with many theories; some were proved to be correct
and extremely useful, which are still implemented today and some failed due to lack of solid theories For
example, the differences between hCG and substances like Luteinizing Hormone (LH) are still not explainable by
experts even today. Screening for open neural tube defects (ONTDs) by MSAFP began in the 1970s and screening
for fetal chromosomal anomalies along with amniocentesis started in the mid-1960s.

In the 1990s, the major advancements in technology came up and a lot of research and development was started
taking place in this field. One of the major advancements included the understanding of the genes i.e. the DNA
structures with different configuration. In the year 2003, when the human genome project was completed,
research work conducted under this project was commercialized. The numbers of disorders against which a fetus

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Analysis and Forecast, 2015-2022

can be screened and protected has been increasing continuously since the 1980s and are estimated to reach more
than 100 by the end of 2020.

Figure 2.3
Prenatal Testing Timeline during Pregnancy (Till Second Trimester)

XX XX XX XX XX XX XX XX
XX XX XX XX XX XX XX XX
First trimester XX XX XX XX
screening test–nuchal
translucency
XX
XX

XX 20
18 19
16 17
15
13 14
12
11
9 10
8
Start of Pregnancy

7
5 6
4 XX XX XX XX
3
1 2 XX XX XX XX
XX XX XX

XX XX XX XX XX XX XX XX
XX XX XX XX XX XX XX XX XX XX XX XX
XX XX XX XX XX XX XX XX
XX XX

BIS Research Analysis

Most of the screening and diagnostic tests are done till the second trimester of the pregnancy to reduce the
chances of side effects that could harm the fetus. Some of the tests are mentioned in the above chart.

Types of Genetic Disease in Fetuses


These tests are done to identify and screen large number of chromosomal and genetic disorder in the foetus so
as to provide better treatment and care in the future to the mother and her unborn baby. Some of the commonly
occurring disorders are mentioned below:

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Analysis and Forecast, 2015-2022

Table 2.1
Types of Genetic Diseases in Fetuses: An Overview
Type Of Genetic
Sub-Types Diseases
Disorder

 Huntington Disease(HD)

 Autosomal Dominant  Familial Hypercholesterolemia (FH)

Genetic Disorders  Marfan syndrome

 Myotonic Dystrophy

 Cystic Fibrosis (CF)

 Canavan Disease

 Neutropenia

 Ellis-van Creveld Syndrome (EVC)

 Familial Mediterranean fever (FMF)

 Faconi Anemia (FA)


 Single Gene
 Gaucher Disease
Disorders
 Mucopolysaccharidosis (MPSs)
 Autosomal Recessive
 Phenylketonuria (PKU)
Genetic Disorders
 Sickle Cell Disease

 Beta-Thalassaemia

 Inheritance Pattern of Autosomal Recessive Genetic


Disorders

 Chances of Inheriting a Single Gene Disorder

 Common Recessive Disease Traits in Selected Ethnic


Groups

 Comprehensive List of Common Single Gene


Disorders

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Analysis and Forecast, 2015-2022

Figure 2.4
Factors Responsible for Prenatal Testing

BIS Research Analysis

Advanced maternal age increases the risk of Down syndrome, miscarriage, cesarean section, gestational diabetes,
and placenta previa among others. In cases of genetic abnormality in the first child, family history of any disease
or hereditary diseases, parents should undergo prenatal testing to avoid future anxieties.

Technologies used in Prenatal Testing


The below table provides a brief introduction of some of the technologies which are being used during different
prenatal diagnosis or screening tests:
Table 2.2
Prenatal Testing: Key Technologies
Technology Technology
Application Used In Test Key Players
Name Launched

Affymetrix, Inc.,
 DNA cloning for sequencing, DNA-
Non-invasive Agilent Technologies,
Polymerase based phylogeny, or functional
and Invasive Becton Dickinson and
Chain 1983 (Kary analysis of gene
(Amniocentes Company, Bioline,
Reaction Mullis)  Diagnosis of hereditary diseases
is, PGD and and Bio-Rad
(PCR)
 Identification of genetic fingerprints others) Laboratories among
and the detection and diagnosis of others

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Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

Technology Technology
Application Used In Test Key Players
Name Launched

infectious diseases to detect


Trisomy 21, 18, 13 and sex
chromosome aneuploidies.

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Analysis and Forecast, 2015-2022

3 Market Dynamics

The chart below exhibits key segments which are covered under market dynamics. Each of them has been
considered separately in the following sections.
Figure 3.1
Market Dynamics for Prenatal Testing

BIS Research Analysis

3.1 Market Drivers

Market drivers are the underlying forces which compel markets to grow and further develop.
The chart below shows key market drivers in this market:
Figure 3.2
Prenatal Testing Market: Key Market Drivers

XX

XX XX

Market
Drivers

XX XX

XX

BIS Research Analysis

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Analysis and Forecast, 2015-2022

Table 3.1
Live Birth Rate- Risk of Genetic Abnormality/Disorders by Maternal Age

Risk of any Chromosomal


Maternity age at Delivery (Years) Risk of Down’s Syndrome
Abnormality

20 1/1667 1/526

Sample Sample Sample

Sample Sample Sample

Sample Sample Sample

Sample Sample Sample

Sample Sample Sample

BIS Research Analysis

3.1.3 Availability of Advanced Diagnosis and Screening


Technologies
With the discovery of new genetic markers, gene sequencing, hybridization technologies and non-invasive
techniques, the prenatal testing market is gaining traction in both developed and developing countries. Next Gene
Sequencing (NGS) is an innovation that permits the sequencing of an entire genome or part of a genome and
fast extraction of hereditary data from natural materials in clinical ranges such as Neonatology.

Many other technologies such as PCR, FISH, Microarray, aCGH and MSS among others are getting popular in the
prenatal diagnosis and screening market. Currently, the major constraint for the widespread adoption of NGS is
not the technology itself, but the lack of peripheral infrastructure and bioinformatics support needed to maintain
this testing technology and data interpretation. Though, NGS is considered to be the future of testing, the use of
NGS in clinical practice is very limited today, and no consensus adoption for it exists.

Moreover, the increasing adoption rate of non-invasive tests has advanced the prenatal diagnosis and screening
market. The potential of next-generation technologies and other emerging technologies are immense and require
a large level of research and development activities.

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Analysis and Forecast, 2015-2022

The costs of non-invasive tests are much higher than the traditional invasive tests and hence act as a restraining
factor in the growth of the prenatal testing market. To cope up with this problem companies are trying to cut
down the cost of medical facilities as well as healthcare insurance companies are providing reimbursement policies
to patients to facilitate the overall testing tenure.

In January 2013, the Centers for Medicare & Medicaid Service (CMS) introduced a new coding standard for
genetics that endeavored to improve coding for genetic tests, enhance the revenue cycle process, and provide
greater transparency into genetic testing practices. More sophisticated coding will allow clients to better
understand the utilization and related costs of these services.

3.2 Market Challenges

Market challenges are those types of forces which aid in slowing down the overall growth of a particular market.
The following chart exhibits key challenges of this market:

Figure 3.3
Prenatal Testing: Key Challenges

XX
XX

XX XX
XX XX

MARKET
CHALLENGES

BIS Research Analysis

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Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

The following exhibits key market opportunities for this market:


Figure 3.4
Prenatal Testing: Key Opportunities

XX

XX

BIS Research Analysis

Each of them has been discussed briefly in the following sub sections.

3.3.1 Availability of Direct to Consumer Tests


Companies like 23&ME, LabCorp of America, Counsyl, and Quest Diagnostics among others, have developed direct
to consumer genetic tests. These tests are facilitating directly to the consumer’s needs and saving their time and
travelling costs.

In some countries where pregnant women and their families are reluctant to visit the doctor for such tests, they
can opt for direct to consumer tests as another option and further consult with online healthcare consultants.
Direct to consumer tests are beneficial for2 type of patients: one with low income who cannot afford the high
consultation fees of the doctors and those who have an income but due to flawed infrastructure barrier are not
able to go for it.

3.3.2 Focus Toward Pre-Implantation Genetic Diagnosis


At present, most of the target population is opting for the invasive test due to its low cost and easy availability,
but in such tests, the termination of pregnancy is risky for the mother’s life. Pre-implantation genetic
diagnosis (PGD) is a technique in which genetic profiling of embryo is done in order to screen it against different
genetic and chromosomal disorders before implantation. PGD is similar to prenatal testing, but a prior method to
it. It helps to terminate the pregnancy in its initial phase without affecting the mother’s health if the l fetus is
found to be afflicted with some disease.

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4 Competitive Insights

Competitive analysis helps an organization understand its key business strategy in the industry, its current
competition and potential competitors that might have paved their way into the market.

Each of the competitive overview elements have been discussed in detail in the following sub sections.

4.1 Key Market Developments & Strategies

This section of the report identifies significant developments and activities that took place in the prenatal testing
market. It provides an overview of the key market developments via prominent industry players. The strategies to
gain a significant market share in this growing industry have been from varying mergers, to business
partnerships, expansions and acquisitions. Moreover, the relative inventiveness of the industry has intensified the
patent landscape resulting in a series of approvals and certifications taking place in the industry. This segment
provides insights regarding the different market development activities that the key players in the industry are
adopting to compete with one another directly and indirectly with other ecosystem players.

Figure 4.1
Recent Market Development Strategy Snapshot Analysis

XX%
XX%
New product launch,
development and expansion
Acquisition, Partnership and
Collaboration
Business expansion and Others

XX%

BIS Research Analysis

Newly formed companies are striving hard to file patents and get approval from regulatory bodies in this growing
market and launch innovative products, while established companies are busy in acquiring companies and

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Analysis and Forecast, 2015-2022

entering into partnerships with other ecosystem players. It presents a detailed analysis of the strategies and
approaches adopted by various key players in the market over the recent years.
The increasing demand of non-invasive prenatal tests due to its convenience, accuracy, and specificity have
forced various companies to focus on new product developments and innovations, and further carry out other
market developments as well. In this market, major companies are adopting partnerships and collaboration
strategies to strengthen their position among other players.

To construct a profitable business, it is necessary to build a viable strategy. The following chart exhibits key
market development strategies for prenatal testing market:

Figure 4.2
Key Market Developments & Strategies

New product
launch,
development
and expansion

Partnership,
joint venture,
Others
collaboration
and contract
MARKET
DEVELOPMENT
STRATEGIES

Business
expansion
Merger &
and financial
Acquisition
investment

BIS Research Analysis

4.1.1 New Product Launch, Development and Expansion


The primary aspect which represents the overall development of any company is its product. The aforesaid
category includes product launches, in addition to the enhancements and developments in the existing and
related products. Since the market started gaining attention, companies across the globe have been striving hard
to bring about innovation in non-invasive prenatal tests, depending upon the demand of the consumers.

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Table 4.1
New Product Launch, Development and Expansion

Company Name Date Description

October BGI launched its desktop sequencer BGISEQ-500 launched NIFTY test and
BGI
2015 NOVA Newborn genetic screening test

Sample Sample Sample

Sample Sample Sample

Sample Sample Sample

Sample Sample Sample

Sample Sample Sample

Sample Sample Sample

Sample Sample Sample

Sample Sample Sample

Sample Sample Sample

Sample Sample Sample

Sample Sample Sample

4.2 Industry Attractiveness

Industry attractiveness section incorporates Porter‘s Five Forces analysis to determine the competitive intensity of
the market. From the industry’s prospective, profitability can be expressed as a function of these five forces. This
framework helps any firm to understand the market, the competitors coming and going out of the market, and
the firm’s competitive strategy to operate in the market.

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Analysis and Forecast, 2015-2022

The essential elements of the Porter’s five forces framework are shown in the following:
Figure 4.3
Porter’s Five Forces Analysis

THREAT OF
SUBSTITUTES

XX

INTENSITY OF
BARGAINING POWER OF BARGAINING
COMPETITIVE RIVALRY
SUPPLIERS POWER OF BUYERS

XX XX XX

THREAT OF
NEW ENTRANTS

XX

BIS Research Analysis

Each of the five forces is analyzed against some of the key criteria influencing the impact of that force. Each of the
criteria is assigned a risk rating depending upon its impact on the force (high, medium and low). The detailed
analysis of each of the market forces is given in the following sections.

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Threat of New Entrants


Threat of new entrants refers to the threat that a new competitor exhibits on the existing competitors of an
industry. A profit industry attracts more competitors and if entry barriers are low, a firm can easily enter the
market. More competition without an increase in consumer demand makes the industry profit less.
Several factors, which impact the access of new entrants in the o prenatal testing field has been shown in the
following table. The threat from a new entrant is considered to have a “Medium” impact on the industry.

Table 4.4
Key Factors Considered for Threat of New Entrants: Prenatal Testing
Factors Impact on the Industry

Product Differentiation XX

Capital Investment XX

Government Regulations XX

Access to distribution XX

Brand Equity XX

BIS Research Analysis

In this industry, threat from new entrants is moderate as the established players accommodate a significant
market share and have strong research and development units that are not affordable by new players.
These established players have strong distribution channels and a concrete brand image among the customers
that create hindrances for new and relatively inexperienced entrants in the market, the government regulation
and standards are considered as an important factor in this industry as it is directly related to the patient’s health.

Bargaining Power of Buyers


When a powerful group of buyers is present in the market, they can impact the company’s selling decisions. They
can demand better quality products or services and drive down the prices, which can impact the profit potential of
the firm.

The bargaining power of the buyer is considered to have a “low” impact on the industry. The factors affecting the
industry are discussed in below:-

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Analysis and Forecast, 2015-2022

Table 4.5
Key Factors Affecting Bargaining Power of Buyers: Prenatal Testing
Factors Impact

Industry concentration (Buyer to firm concentration ratio) XX

Buyer information about supplier product XX

Presence of substitutes XX

Dependency upon existing distribution channels XX

Switching Cost XX

BIS Research Analysis

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Global Prenatal Testing Market
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5 Industry Analysis

Industry analysis helps an organization in an attempt to understand the key elements of the surrounding business
environment of a particular industry.

5.1 Patent Analysis

Patent is defined as the right obtained by a person or a legal entity that prohibits others from launching the same
product or technology. Patents related to prenatal testing are very few as the market is in the emerging state.
Therefore, key patents related to academic and research institutes have been introduced in this segment.

The following shows the list of patents of some key players in the market:
Table 5.1
Example of Some Recent Patents
Publication
Company Name of the Patent Publication date
number

Method of mixing fluids by


Bio-Rad Laboratories, Inc. US9194861 B2 November 24, 2015
coalescence of multiple emulsions

Sample Sample Sample Sample

Sample Sample Sample Sample

Sample Sample Sample Sample

Sample Sample Sample Sample

Sample Sample Sample Sample

Sample Sample Sample Sample

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Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

5.2 Consortiums, Alliances and Regulatory Bodies

As the industry matures, the role of consortiums and regulatory bodies becomes pivotal to shape the future
trajectory. The following section highlights some of these prominent consortiums and regulatory bodies which are
impacting the evolution of the industry at a global level.

Regulatory bodies have established a significant position and the future market and its growth is heavily reliant on
a proper regulatory framework. On one hand, the regulations will help in the adoption of prenatal tests and their
applications among the people; on the other hand, it might also restrict the development of inefficient and
malfunctioning diagnostic and screening tests.
Table 5.2
Example of Some Regulatory Bodies/Associations/Consortium
Regulatory Establis
bodies/Associations/ hed Features, Regulations & Standards
Consortium Year

 Established contacts with numerous British Embassies and


Genetic Testing High Commissions to arrange collection of samples from
2003
Laboratories the U.K. overseas applicants in the most expeditious method

 Provides legal services

 Advanced, human genetics in science, health, and society


through excellence in research, education, and advocacy

 Educated consumers about a variety of other topics and


issues, including advancements in human genetics research
and technology, and their translation to clinical practice;
American College of
 •Role of genes vs. environment in determining personal
Medical Genetics and 1991
health risk and disease outcome;
Genomics (ACMG)
 •Importance of collecting family health history information,
and how health care providers can interpret and use it in
practice;

 •Direct-to-consumer genetic testing and test regulation; and

 •Genetic discrimination and related health care legislation

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Global Prenatal Testing Market
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5.3 Value Chain Analysis

The value chain gives an extensive view of the value creation in an industry. It also gives a holistic picture of the
various organizations involved in making the business ecosphere. Value chain analysis helps companies in
creating a solid strategy for a business model.
Figure 5.1
Value Chain Analysis

Investors /Funders
(Government, Financial Institutions & Private Investors) XX XX

XX XX XX

XX • XX

• XX • XX
XX
• XX • XX

XX
XX

• XX
XX • XX

XX XX

XX XX

BIS Research Analysis

The above figure depicts the value chain analysis for Prenatal Testing industry.

Research and development are two significant boosters in the pre-natal testing market. Factors such as creating
procedures, instrument outlining, improvement and building, media advancement and administrative
endorsements help in pioneering the prenatal testing market. Manufacturers and government associations are
investing heftily in this sector to ensure a better growth for the pre-birth test domain. Significant end-clients
incorporate healing facilities, fertility centers, surgical focuses, clinical examination establishments and patients.

Investors and financiers assume a noteworthy part in research and development and create a base a for the
prenatal tests market (like building up hospitals, fertility clinics, enlisting specialists and researcher for making

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6 Global Prenatal Testing Market, Analysis & Forecast

6.1 Assumptions & Limitations for Analysis and Forecast of the Global
Prenatal Testing Market

Assumptions

 Year 2015 has been considered as a base year, year 2016 holds the estimated value and years 2016
to 2022 holds the forecast value

 Historical and current market trends are analyzed to evaluate and forecast the market size

 All the numbers are adjusted off to two digits after decimal for report presentation reason. However,
the real figures have been utilized for CAGR estimation

 CAGR is calculated from 2016 and 2022

 The market has been mapped based on the key procedures used in prenatal tests

 Screening and Diagnostic techniques are only two techniques considered for this report

 Non-invasive prenatal testing forms a part of screening and Non-invasive prenatal diagnosis forms a
part of diagnostics in the prenatal market.

 North America region which includes only USA, Canada and Mexico. Central and South America are
reflected in Rest of the World region

 The base currency considered for this study is U.S. $. Monetary forms other than $ are changed over
to $ for every single factual computation considering the average transformation rate for the specific
year. The average exchange rates have been taken from Oanda website.

 Primary respondent’s verification are considered to finalize the prenatal testing market database
Limitations

 Technologies currently utilized are expected to persist through the forecast period with minor
breakthrough in technology

 The economic downturn in the future forecast period was not taken under consideration for market
estimation and forecast

 Only high risk cases are considered for calculations and research purposes. Low risk cases and
moderate risk cases are not considered

 Carrier testing/screening is not considered in this prenatal screening section of this report

 Pharmaceuticals used in Prenatal tests are not considered for this report

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Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

 Software’s used in Prenatal tests are not considered for this report

6.2 Market Overview

There are different techniques in prenatal testing market utilized by the end-users which can be further
segmented into: diagnostic techniques and screening methods. A large number of tests are available in the
market which in turn can be invasive and non-invasive in nature. The increasing maternal age and mutational
changes are some of the main causes of increase in genetic disorders/diseases.

Figure 6.1
Classification of Global Prenatal Testing Market

BIS Research Analysis

The prenatal testing market can be further classified on the basis of technique, the nature of test and geography
which are in turn further segmented and discussed in detail in the succeeding sections.

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Analysis and Forecast, 2015-2022

Opportunity Matrix
Figure 6.2
Global Prenatal Testing Market: Opportunity Matrix

High Low Competitive position High Competitive position


High Market Attractiveness High Market Attractiveness

Prenatal Screening
XX% Market Share
Prenatal Testing Market Attractiveness

Prenatal
Diagnostic Tests
XX% Market
Share

Low Competitive position High Competitive position


Low Market Attractiveness Low Market Attractiveness
Low
Low High
Prenatal Test Type: Competitive Position

BIS Research Analysis

The above figure shows the opportunity matrix for prenatal testing market. It is clear from the above figure that
prenatal screening tests have more future scope due to its first stage importance and growing adoption of NIPT
tests. While prenatal diagnostic tests holds a huge market share but due to invasive nature of majority of its
tests, its market penetration is anticipated to decline in the forecast period.

Figure 6.3
Global Prenatal Testing Market, by Technique 2015-2022 ($Billion)

XX

XX

XX

XX
Value ($Billion)

XX

XX

XX

XX

XX

-
2015 2016 2017 2018 2019 2020 2021 2022
Diagnostic Techniques XX XX XX XX XX XX XX XX
Screening Methods XX XX XX XX XX XX XX XX

BIS Research Analysis

44
Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

The following exhibits global prenatal screening market size ($ Billion):

Figure 6.5
Global Prenatal Screening Market Size, 2015-2022, ($Billion)

XX

XX

XX
Value ($Billion)

XX

XX

XX

XX

XX

XX

-
2015 2016 2017 2018 2019 2020 2021 2022
Screening Methods XX XX XX XX XX XX XX XX

BIS Research Analysis

Screening tests accounted for $XX billion in 2015 and is presumed to grow at CAGR of XX% from 2016 to 2022.
Screening tests are always followed by a diagnostic test in order to confirm the severity of the disorder.
Table 6.1
Global Prenatal Screening Market Size, by Test Type, 2015-2022,
($Billion)

Screening Methods 2015 2016 2017 2018 2019 2020 2021 2022 CAGR% (2016-2022)

NIPT XX XX XX XX XX XX XX XX XX

Others XX XX XX XX XX XX XX XX XX

Total XX XX XX XX XX XX XX XX XX

BIS Research Analysis

45
Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

6.3.1.1 NIPT Market by Geography

Table 6.2
Geographical Analysis of Players and Cost of NIPT

Region Distributors Price ($)

Sequenom, Verinata Health, Ariosa Diagnostics, Natera,


North America XX-XX
and LabCorp, Inc. among others

Iviomics, BGI Health, Radboud University Nijmegen,


Europe XX–XX
NIPD Genetics, and LifeCodexx among others

Berry Genomics, The Chinese University of Hong Kong,


APAC XX-XX
and BGI Health among others

ROW LifeCodexx, BGI Health, and Newbridge among others XX

BIS Research Analysis

North America is substantially mature in terms of NIPT testing. Around XX% women take NIPT Test in the North
American region; in the United States of America more than XX% women opted for NIPT testing. Europe also has
a high acceptance ratio for NIPT testing with more than XX% women opting for it in 2015. NIPT is still not too
popular in APAC and other regions because of lack of education, low per capita income and lack of medical
facilities and infrastructure. In APAC, roughly XX% women opted for NIPT tests in 2015; whereas in Africa, Middle
East and South America region roughly XX% of women opted for NIPT.
Table 6.3
Global NIPT Screening Market Size, by Geography, 2015-2022,
($Billion)

CAGR%
NIPT by Geography 2015 2016 2017 2018 2019 2020 2021 2022
(2016-2022)

North America XX XX XX XX XX XX XX XX XX

Europe XX XX XX XX XX XX XX XX XX

APAC XX XX XX XX XX XX XX XX XX

ROW XX XX XX XX XX XX XX XX XX

Total XX XX XX XX XX XX XX XX XX

BIS Research Analysis

46
Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

Figure 6.9
North America: NIPT Market by Countries, 2015-2022 ($Million)

U.S. Canada Mexico


XX
XX XX %
%
XX
XX% XX% U.S.
XX
Canada
XX Mexico
XX%
XX XX%

X
2015 2016 2017 2018 2019 2020 2021 2022

BIS Research Analysis

Market share of the U.S. is highest in the North American region because of its rules and regulations which
mandates that each and every patient with a high risk pregnancy is to take NIPT test. Roughly XX% of women opt
out of NIPT tests in the U.S. which is rare and allowed under certain circumstances. The U.S. NIPT market
accounts for XX% of the North American region in 2015, followed by Canada and Mexico, which accounts for XX%
and XX% share during the same period. Market share will see a probable shift for all the countries. Mexican
market will rise in the future because of investments which will raise its market share in the North American
region. Despite a high per capita income and infrastructure, Canada will witness a stiff market competition during
the forecast period because of low population growth.

6.3.1.2.1 Market Share Analysis by Countries


The major countries of North America contributing in the NIPT market growth are discussed below

6.3.1.2.1.1 The U.S.

The U.S. non-invasive market will witness the growth because of high acceptance rate of non-invasive testing,
because of the technique being safe and sound.

47
Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

Figure 6.10
The U.S. NIPT Market, 2015-2022 ($Million)

XX

XX

XX

XX XX
XX
XX
XX XX
XX
XX XX
XX
X
2015 2016 2017 2018 2019 2020 2021 2022

BIS Research Analysis

The U.S. market will grow with a CAGR of XX% from 2016 to 2022. It will increase from $XX million in 2015 to
$XX billion in 2022.Despite of its high price of NIPT test in the US, the non-invasive market is growing because a
large number of the population in the U.S. has medical insurance and the government provides health care
benefits to its people. Strong infrastructure, high per capita income, growing economy and high research and
development expenditure are boosting the non-invasive test market in the country. The market share of the U.S.
in North America is anticipated to decline in forecast years due to high growth rate in Mexico and Canada.

6.3.1.2.1.2 Canada

The Canadian economy boasts of developed infrastructure, high literacy rate and an advanced per capita income.
In spite of all these positive factors, Canadian NIPT market is small because of its low population growth. Around
380,000 births took place in Canada in 2015 which is just XX% of all the births in North America region. Low birth
rate per year is the one of the biggest constraints for the Canadian NIPT market which is restricting its growth.

48
Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

Recent Key Developments


The chart below depicts the recent key developments that have taken place in recent past:
Table 6.4
NIPT: Recent Key Developments
Company Date Strategy Description

Natera validated its innovative qPCR-based NIPT


December Product
Natera Inc. assay designed to determine fetal Trisomy 21 from
2015 Testing
maternal blood

Sample Sample Sample Sample

Sample Sample Sample Sample

Sample Sample Sample Sample

Sample Sample Sample Sample

Sample Sample Sample Sample

Sample Sample Sample Sample

Sample Sample Sample Sample

BIS Research Analysis

6.4.1 Global Prenatal Diagnosis Market by Test T ype


The prenatal diagnosis test can be invasive and non-invasive.
Figure 6.31
Prenatal Diagnosis Market by Test Type

BIS Research Analysis

49
Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

Each type of test has been described in the succeeding sections.


Figure 6.32
Global Prenatal Diagnosis Market Share, by Test Type, 2015

XX%
Invasive
Non-Invasive
XX%

BIS Research Analysis

Invasive Diagnosis accounted a market share of XX% in 2015 because of its presence in the past few decades. On
the other hand, Non-Invasive Diagnosis held a market share of XX% in 2015, which will increase to XX% by the
end of 2022 because of the change in a couple’s attitude towards non-invasive tests as it is not harmful to baby
and mother.
Figure 6.34
Global Invasive Prenatal Diagnosis Test Market, by Test type, 2015-2022 ($Million)

2022

2021

2020

2019 Aminocentesis
CVS
2018
Others
2017

2016

2015

- XX XX XX XX XX

BIS Research Analysis

50
Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

Amniocentesis is dominating the market and is growing at a CAGR of XX% from 2016 to 2022 followed by CVS
test which in turn is growing at a CAGR of XX from 2016 to 2022.Both the tests are very popular due to their low
costs. The patients in developing countries select these tests due to their easy availability and simple procedures.
However, the overall invasive market share is anticipated to decline in the future due to an increasing demand for
non-invasive tests. The invasive test market is estimated to grow at XX% CAGR during the forecast period.

6.4.1.2.1.1 Amniocentesis

It is an invasive diagnostic test which is performed by inserting a needle in the amniotic sac to get a sample of the
amniotic fluid. It is usually performed within 13-20 weeks of pregnancy. Amniocentesis is mainly used to diagnose
chromosome abnormalities, genetic disorders or neural tube disorders. It also provides the DNA for paternity
tests. These tests are highly accurate (up to XX%), but are not able to detect the severity of the disorder.

 In June 2015, Annoroad, partnered with Illumina to co-develop a next-generation sequencing (NGS)
diagnostic system in order to improve the patients’ reproductive health

 In June 2015, Illumina, Inc. and Annoroad entered into an agreement to jointly develop advanced
clinical applications for reproductive health based on next-generation sequencing (NGS) technology to
improve healthcare in China

 In April 2015, CombiMatrix launched a new Buccal Swab DNA collection system for the CombiSNP
Array for Pediatric Analysis microarray test

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Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

6.4.1.2.2 Invasive Test Market by Geography


The market statistics of invasive prenatal diagnosis test are discussed below in detail along with different
geographical region.
Figure 6.39
Global Invasive Prenatal Diagnosis Test Market, by Geography, 2015-2022 ($Million)

XX

XX

XX

XX

XX

-
2015 2016 2017 2018 2019 2020 2021 2022
ROW XX XX XX XX XX XX XX XX
APAC XX XX XX XX XX XX XX XX
Europe XX XX XX XX XX XX XX XX
North America XX XX XX XX XX XX XX XX

BIS Research Analysis

In the global market, North America is dominating the market followed by Europe. However, APAC region is
estimated to grow at a high CAGR of XX% from 2016 to 2022.

6.4.1.2.2.1 North America Invasive Test Market

North America is dominating the invasive test market with a market share of XX% in 2015. Despite of being the
largest market, North America will witness a CAGR of XX% from 2016 to 2022 which is much lesser than APAC
and RoW (Rest of the world). Invasive test market is almost a 30 year old technology in this region; it will show
steady growth in the next few years but as the market saturates, the yearly growth will decline. The invasive
market will rise from $XX million in 2015 to $XX billion in 2022.

52
Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

Figure 6.40
North America: Invasive test Market by Countries, 2015-2022 ($Million)

U.S. Canada Mexico

XX X%
XX%
XX
X% U.S.
X%
XX
Canada
XX
Mexico
XX%
XX XX%

0
2015 2016 2017 2018 2019 2020 2021 2022

BIS Research Analysis

Market share of the U.S. is highest in the North America region because of rules and regulations which mandates
each and every patient with high risk to take a diagnostic test. The U.S. market accounts for XX% market share
of the invasive test market in the North American region in 2015. It is closely followed by Canada and Mexico,
which account for XX% and XX% share respectively during the same period. Market share will see a pliable shift
for all the countries. The Mexican and Canadian markets will rise in the future because of high investments and
increasing adoption of these tests, which will definitely increase its market in the North American region. The
people of these countries still prefer invasive over NIPT tests due to its easy availability in most of the hospitals
and clinics.

6.4.1.2.2.1.1 Market Share Analysis by Countries

The major countries of North America contributing in the invasive market growth are discussed in below sections.

6.4.1.2.2.1.1.1 The U.S.

The U.S. invasive market will decline in near future due to increasing demand and adoption of non-invasive tests.

53
Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

Figure 6.41
The U.S. Invasive Test Market, 2015-2022 ($Million)

XX
XX.X%

XX

XX

XX

X
2015 2016 2017 2018 2019 2020 2021 2022

BIS Research Analysis

The U.S. market will grow with a CAGR of XX% from 2016 to 2022. It will increase from $XX million in 2015 to
$XX billion in 2022.Despite of its side effects on the fetus and the mother, the market is growing because after
screening tests, patients have to undergo diagnosis tests. Strong infrastructure, high per capita income, growing
economy and high research and development expenditure are boosting the non-invasive testing market in the
country.

6.4.1.2.2.1.1.2 Canada

Canada has developed infrastructure, educated population and high per capita income. Despite of all positive
factors, the Canadian invasive test market is small because of low birth rate. In 2015, Canada held XX% share of
all the births in the North America region. Low birth per year and increasing adoption of non-invasive tests are the
biggest constraints for the Canadian invasive test market which is restricting its growth.

54
Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

6.4.2 Global Prenatal Diagnosis Market by Geography


The following exhibits key regions that have been considered for the study of the market by geography:
Figure 6.57
Global Prenatal Diagnosis Market by Geography

BIS Research Analysis

Figure 6.58
Global Prenatal Diagnosis Market, by Geography, 2015-2022 ($Million)

XX
XX
XX

XX

XX

XX
XX

XX
XX

XX
XX
XX

XX
XX

XX

XX
XX

XX
XX

XX

XX
XX

XX
XX
XX

XX

XX
XX
XX

XX
XX
XX

XX
XX

XX
XX

XX
XX
XX
XX

XX

-
2015 2016 2017 2018 2019 2020 2021 2022

North America Europe APAC ROW

BIS Research Quantitative Analysis

55
Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

Table 6.6
North America Prenatal Diagnosis Market Scope Statistics
Healthcare
Population GDP Inflation Avg.
Country Expenditure Birth rate
(Million) (Trillion) rate Cost in $
as % of GDP

U.S. XX XX XX XX XX XX

Canada XX XX XX XX XX XX

Mexico XX XX XX XX XX XX

BIS Research Analysis

6.4.2.1.1 Market Analysis by Country


The invasive market in North America is still predominant. Invasive market in North America is currently of $XX
million which is expected to reach $XX million in 2022. Non-invasive market will increase from $XX million in 2015
to $XX million in 2022. In spite of harmful effects, invasive market will increase with a CAGR of XX% between
2016 and 2022, whereas non-invasive market will increase with a CAGR of XX% during the forecast period. High
growth in non-invasive market is because of its adaptation in the American market, mostly in Mexico where it is
an emerging market.
Table 6.7
North America: Prenatal Diagnosis Market, by Test Type, 2015-2022
($Million)

CAGR%
Test Type 2015 2016 2017 2018 2019 2020 2021 2022
(2016-2022)

Invasive XX XX XX XX XX XX XX XX XX

NIPD XX XX XX XX XX XX XX XX XX

Total XX XX XX XX XX XX XX XX XX

BIS Research Analysis

The non-invasive prenatal diagnosis testing market in the U.S. is extremely lucrative and a growing segment of
the diagnostics industry with market driven companies developing and offering these tests.

At present, a woman’s conception age has escalated due to a variety of factors. It's no longer unusual for women
to have a first child at age of 35 or 40. This trend has been attributed to numerous factors such as affordability
issues and gender equality in the professional domain. However, increased age of the mother also increases the
risk of her child developing chromosomal abnormalities.

56
Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

6.4.2.4 Rest of the World (RoW)

The essential reasons for the growth of prenatal testing are pointed below:

Figure 6.66
Key Factors Driving the Prenatal Testing Market in Row

Increasing cases of HIV, CH and m ental retardation in


newborn

Poor healthcare infrastructure, economic slowdown and


lack of awareness about prenatal diagnosis and screening
m ethods

Governm ent initiatives and regulations related to newborn


screening & prenatal testing

BIS Research Analysis

The prenatal testing market in the rest of the world countries will increase with a CAGR of XX% between 2016
and 2022. This invasive market has the biggest market share of XX% in 2015 in ROW which will decline to XX%
till 2022. Non-invasive market in ROW will see a growth in share from XX% in 2015 to XX% in 2022.
Table 6.14
RoW: Prenatal Diagnosis Market, by Test Type, 2015-2022
($Million)

CAGR%
TEST TYPE 2015 2016 2017 2018 2019 2020 2021 2022
(2016-2022)

Invasive XX XX XX XX XX XX XX XX XX

NIPD XX XX XX XX XX XX XXX XX XX

Total XX XX XX XX XX XX XX XXX XX

BIS Research Analysis

The invasive market in RoW will increase from $XX million in 2015 to $XX million in 2022. The non-invasive
market will increase from $XX million in 2015 to $XX million in 2022. The non-invasive market in ROW will
witness the highest CAGR of XX% between 2016 and 2022 and invasive market will grow at a CAGR of XX%
during the same period.

57
Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

Table 6.15
RoW Prenatal Diagnosis Market Scope Stats
Healthcare
Population GDP Inflation Avg. Cost in
Country Expenditure as % Birth rate
(Million) (Billion) rate $
of GDP

South Africa XX XXX XX XX XX XX

Saudi Arabia XX XX XX XX XX XX

Israel XX XX XX XX XX XX

Brazil XX XX XX XX XX XX

Australia XX XX XX XX XX XX

New Zealand XX XX XX XX XX XX

BIS Research Analysis

Key Players

The following exhibits some of the key players in the prenatal testing market in the Rest of the World:

Figure 6.67
Key Players in RoW Prenatal Testing Market

BIS Research Analysis

58
Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

7.3 Illumina Inc.

7.3.1 Overview

Particular Specifications (as of 2016)

Website www.illumina.com

San Diego, California,


Contact Details U.S
Phone : +1 858-202-4500

Year of Establishment 1998

Ownership Type Public

Company Type Diagnostic Test Developer and Technology provider

Number of Employees 4,300

Net Revenue $XX Billion (As of December 2015)

Quest Diagnostics, Berry Genomics, PerkinElmer, Inc., Laboratory Corporation of


Competitors
America, Agilent Technologies, Inc., and Sequenom Inc. among others

BlueGnome, Ltd.(the U.K.), Illumina AB(Sweden), and Illumina Trading


Subsidiaries
(Shanghai) Co., Ltd.(China) among others

Related Products & Sequencing Kits, Microarray Kits, NGS services and array-based solutions and
Services Hiscan Arrays, and Microarray reagents among others

Illumina website, Illumina annual report, BIS Research Analysis

7.3.2 Financials
The following is the overall financials, net revenue by the business segments and financial summary of the
Illumina from December (2013-2015):

59
Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

Overall Financials

The following shows the overall financials of the Illumina from the year December (2013-2015):

Figure 7.7
Illumina: Overall Financials, 2013-2015

XX XX

Net Loss/Income and Operating Income


XX
XX
($Million)

XX
Revenue

XX
XX

($Million)
Net

XX
XX

XX
XX
XX

X 0
December'13 December'14 December'15
Net Revenue XX XX XX
Net Income XX XX XX
Operating Income XX XX XX

Illumina website, Illumina annual report, BIS Research Analysis

60
Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

Net Revenue by Business Segment

The following shows Illumina’s net revenue earned by its different business segments from December (2013-
2015):
Figure 7.8
Illumina: Net Revenue by Business Segment, 2013-2015

XX
XX
XX
XX

XX
($Million)

XX
XX

2013
2014

XX
XX
XX 2015

XX
XX

XX
XX

XX
XX

XX
XX
XX
X
U.S. Europe Asia-Pacific Other markets

Illumina website, Illumina annual report, BIS Research Analysis

Revenue across Different Geographies

The following shows the revenue earned by the Illumina across different geographies from December (2013-
2015):
Figure 7.9
Illumina: Revenue across Different Geographies, 2013-2015

XX
XX

XX
XX

XX
($Million)

XX
XX

2013
2014
XX

XX
2015
XX

XX
XX

XX

XX
XX

XX
XX
XX
XX

X
U.S. Europe Asia-Pacific Other markets

Illumina website, Illumina annual report, BIS Research Analysis

61
Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

7.3.2.1 Financial Summary

The financial year (FY) starts in January and ends in December. Illumina, Inc. generated net revenue of $XX
billion which was $XX million more than the revenue generated in FY2014. The increase in the revenue accounted
to the increased sales of sequencing products which also included consumables, instruments and services. The
higher revenues also accounted for the increase in operating income by $XX million despite the increase in
research and development expenses.

The company operates in two segments namely the product and the service and other segment. The product
segment consists of consumables and instruments. The consumables showed increase in revenue of $XX million
and the reason being growth in sequencing instrument installed base. The instrument segment showed an
increase of $XX million from year 2014 primarily due to shipments of Hiseq X and NextSeq systems. Services and
other segments also showed an increase in their revenue by $XX million due to growth in volume of NIPT service
test and extended service contracts. The maximum sales were recorded in the U.S. that accounted for $XX million
followed by Europe, Asia-Pacific and other regions.

7.3.3 SWOT Analysis


Figure 7.10
Illumina: SWOT Analysis

Illumina website, BIS Research Analysis

62
Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

The chart below shows some key facts about other key players of the prenatal testing market:

Table 7.1
Snapshot of Other Key Players
Company Establishmen
Product Description Key Market Development
Name t Year

 In September 2015, Beijing


Berry and Kang Biotechnology
Co., Ltd. launched a new
"Branch pregnant Ann pre-
Non-invasive prenatal testing,
implantation genetic screening
NextSeq CN500 gene
(PGS )product series
sequencing instrument, Fetal
BERRY
2010 chromosomal aneuploidy (T13  In March 2015, the State Food
GENOMICS
/ T18 / T21) data analysis and Drug Administration

software Section pregnant (CFDA) approved the

Safety Data Analysis Software Hangzhou Conkey Berry and


Technology Co., Ltd. NextSeq
CN500 and fetal chromosomal
aneuploidy (T13 / T18 / T21)
Detection Kit

 In November 2015, Annoroad


and Sichuan University
partnered together to develop
Non-invasive prenatal DNA a new non-invasive prenatal
testing, Medical Genomics, DNA testing technology
Annoroad
2012 Bioinformatics, Genomic
Genomics  In June 2015, Annoroad,
sequencing, Personal genome
partnered with Illumina to co-
solution
develop a next-generation
sequencing (NGS) diagnostic
system in order to improve
patients’ reproductive health

63
Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

7.10 List of Other Prominent Players

The following shows list of other prominent players in the prenatal testing market:
Table 7.2
List of other Prominent Players
Onsite Neonatal Partners,
Bio-Rad Laboratories Drager Ginekaliks
Inc

Sample Sample Sample Sample

Sample Sample Sample Sample

Sample Sample Sample Sample

Sample Sample Sample Sample

Sample Sample Sample Sample

Sample Sample Sample Sample

Sample Sample Sample Sample

Sample Sample Sample Sample

Sample Sample Sample Sample

Sample Sample Sample Sample

Sample Sample Sample Sample

Sample Sample Sample Sample

Sample Sample Sample Sample

Sample Sample Sample Sample

Sample Sample Sample Sample

64
Global Prenatal Testing Market
Analysis and Forecast, 2015-2022

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