Non-Invasive Prenatal Testing Market -Analysis and Forecast - SITE LICENSE

Non-invasive prenatal testing (NIPT) is an innovative way of screening pregnancies for fetal chromosomal aneuploidies by analyzing fetal cell-free DNA circulating in maternal blood. Amniocentesis, chorionic villus sampling (CVS), maternal serum screening, and nuchal translucency (NT) scan have been the primary diagnostic and screening methods for chromosomal abnormalities. The growth of NIPT market is attributed primarily to a rapid increase in genetic disorders/abnormalities, increase in fetal mortality, adoption of NIPT test in developed countries, and advancement of healthcare technologies.
In spite of enormous competition levels that prevails in the industry, the market growth is expected to be propelled by multiple factors such as rising demand for prenatal testing, adoption toward IVF procedures, increasing awareness among parents, and upsurge in the government spending on healthcare.
The research study has segmented the entire NIPT market into test value and volume, and geographical region including detail country analysis which enables the user gain a multi-dimensional view of the market. The research report employs an exhaustive and analytical approach to estimate and understand the market thus provides an all-inclusive insight into various forms of developments, market trends and strategies. While underlining the key driving and restraining factors for the NIPT market, the report also provides a comprehensive understanding in terms of competitive landscape, market share analysis, competitor benchmarking (matrices), and their positioning within the global NIPT market.
The following questions have been answered in this report:
• What are the major market drivers, challenges and opportunities of the global NIPT market and their use cases?
• What are the key technological developments taking place in the NIPT market?
• What is the market share of the leading segments and sub-segments of the global NIPT market during the forecast period (2017-2023)?
• How will each segment of the global NIPT market grow over the forecast period and the revenue share for each of them by the end of 2023?
• Who are the leading players in the global NIPT market (2016)?
• Which geographical region will have the highest growth rate (CAGR) during the forecast period?
• What are the key development strategies employed by the key players across various geographies?
• What are the market trends and key developments in different geographical regions?
• What is the role of various regulatory and governmental agencies in global NIPT market across various geographical locations?
• What are the major consumer preferences while purchasing or undergoing an NIPT test?

The report includes the company profiles for leading players in the NIPT market which enables the readers understand the current competitive scenario that prevails in this industry. Some of the key player include Roche, Natera, Illumina, LabCorp, LifeCodexx, BGI Diagnostics, Premaitha and Berry Genomics, among others.
Executive Summary
1 Report Scope & Methodology
1.1 Scope of the Report
1.2 Global NIPT Market Segmentation
1.3 Key Learnings
1.4 Research Methodology
1.4.1 Data Triangulation
1.4.2 Key Data Points from Secondary Sources
1.4.3 Key Data Points from Primary Sources
1.4.4 Top-Down Approach (Segment Analysis)
1.4.5 Bottom-Up-Approach (Segment Analysis)
1.4.6 Assumptions and Limitations
1.4.7 Data and Prediction Modelling
2 Market Overview
2.1 Introduction
2.2 Benefits and Risks of NIPT
2.3 Technological Approach for NIPT
2.4.1 Fetal Cell Maternal Blood (FCMB)
2.4.2 Cell-Free NIPT Test
2.5 Patent Landscape
2.6 World Economic Outlook of Prenatal Testing Market, 2016
3. Market Dynamics
3.1 Market Drivers
3.2 Market Challenges
3.3 Market Opportunities
4 Major Chromosomal Aneuploidies
5 Competitive Landscape
5.1 Key Developments & Strategies
5.2 Market Attractiveness Analysis: Global Non-Invasive Prenatal Testing Market, by Geography
5.3 Growth Share Matrix
5.4 Porter’s Five Forces Analysis
5.5 Value Chain Analysis
6. Global NIPT Market, By Test (Volume and Value)
6.1 Market Overview
6.2 Panorama Test
6.3 Sequenom Test
6.4 Harmony Test
6.5 NIFTY Test
6.6 verifi Test
6.7 IONA Test
6.8 Prena Test
6.9 BambniTest
6.10 Other NIPT Tests
7 Global NIPT Market, By Geography(Volume and Value)
7.1 Geographical Scenario
7.2 North America
7.3 Europe
7.4 Asia Pacific
7.5 Rest of the World (RoW)
8 End User Perception
9 Company Profiles
9.1 Laboratory Corporation of America
9.2 Roche AG
9.3 Premaitha Health Plc
9.4 Illumina Inc.
9.5 Natera Inc.
9.6 Quest Diagnostics
9.7 BGI Diagnostics
9.8 LifeCodexx AG
9.9 Berry Genomics
9.10 NIPD Genetics
List of Tables
Table: 1 Global Non-Invasive Prenatal Testing (NIPT) Market (2016 & 2023)
Table: 2 Technological Approach for NIPT
Table: 3 Patent Landscape
Table: 4 Types Of Genetic Diseases In Fetuses: An Overview
Table: 5 Major Chromosomal Aneuploidies and their Incidence Rate
Table: 6 Recent Partnerships & Collaborations
Table: 7 Recent Product Launch & Developments
Table: 8 Recent Merger & Acquisitions
Table: 9 Recent Patent , Certifications, Infringements & Approvals
Table: 10 Global NIPT Market Value by Test Type, 2016-2013 (In Units)
Table: 11 North America Market Scope Statistics
Table: 12 North America NIPT Market by Test Value, 2016-2023 ($Million)
Table: 13 Europe NIPT Market by Test Value, 2016-2023 ($Million)
Table: 14 Europe NIPT Market by Test Volume, 2016-2023 (in Units)
Table: 15 Europe NIPT Market by Country, 2016-2023 (in Units)
Table: 16 Europe: Recent Developments
Table: 17 APAC NIPT Market by Test Volume, 2016-2023 ($Million)
Table: 18 APAC NIPT Market by Test Value, 2016-2023 (in Units)
Table : 19 APAC NIPT Market by Country, 2016-2023 (in Units)
Table: 20 ROW NIPT Market by Test value, 2015-2023 (in Units)
Table: 21 ROW NIPT Market by Test Volume, 2015-2023 (in Units)
List of Figures
1 Global NIPT Market by Volume, 2016-2023 (in Units)
2 Global NIPT Market Value, 2016-2023 ($Million)
3 NIPT Market Value by Test Type, 2016
4 NIPT Market Value by Test Type, 2023
5 NIPT Market Volume by Test Type, 2016
6 NIPT Market Volume by Test Type, 2023
7 Global NIPT Market Value by Geography, 2016 & 2023 ($Million)
8 Global NIPT Market Volume by Geography, 2016 & 2023 (in Units)
9 Global NIPT Market Segmentation
10 Research Methodology
11 Data Triangulation
12 Top-Down Approach (Segmental Analysis)
13 Bottom-Up Approach (Segmental Analysis)
14 Assumptions and Limitations
15 NIPT: Overall Process
16 Global Prenatal Testing Market: Opportunity Matrix
17 Ecosystem Players Of Global Prenatal Testing Market
18 Prenatal Testing Timeline During Pregnancy
19 Market Dynamics
20 Market Share Analysis, 2016
21 Market Share Analysis, 2023
22 Growth Share Matrix, 2016
23 Porter’s Five Forces Analysis
24 Value Chain Analysis
25 Panorama Test by Volume, 2016-2023 (in Units)
26 Panorama Test by Value, 2016-2023 ($Million)
27 Panorama Test Volume by Geography, 2016-2023 (in Units)
28 Sequenom Test by Volume, 2016-2023 (in Units)
29 Sequenom Test by Value, 2016-2023 ($Million)
30 Sequenom Test Volume by Geography, 2016-2023 (in Units)
31 Sequenom Test Value by Geography, 2016-2023 ($Million)
32 Harmony Test by Volume, 2016-2023 (in Units)
33 Harmony Test by Value, 2016-2023 ($Million)
34 Harmony Test Volume by Geography, 2016-2023 (in Units)
35 Harmony Test Value by Geography, 2016-2023 ($Million)
36 NIFTY Test by Volume, 2016-2023 (in Units)
37 NIFTY Test by Value, 2016-2023 ($Million)
38 NIFTY Test Volume by Geography, 2016-2023 (in Units)
39 NIFTY Test Value by Geography, 2016-2023 ($Million)
40 verifi Test by Volume, 2016-2023 (in Units)
41 verifi Test by Value, 2016-2023 ($Million)
42 verifi Test Volume by Geography, 2016-2023 (in Units)
43 verifi Test Value by Geography, 2016-2023 ($Million)
44 IONA Test by Volume, 2016-2023 (in Units)
45 IONA Test by Value, 2016-2023 ($Million)
46 IONA Test Volume by Geography, 2016-2023 (in Units)
47 IONA Test Value by Geography, 2016-2023 ($Million)
48 Prena Test by Volume, 2016-2023 (in Units)
49 Prena Test by Value, 2016-2023 ($Million)
50 Prena Test Volume by Geography, 2016-2023 (in Units)
51 Prena Test Value by Geography, 2016-2023 ($Million)
52 BambniTest by Volume, 2016-2023 (in Units)
53 BambniTest by Value, 2016-2023 ($Million)
54 BambniTest Volume by Geography, 2016-2023 (in Units)
55 BambniTest Value by Geography, 2016-2023 ($Million)
56 Other NIPT Tests by Volume, 2016-2023 (in Units)
57 Other NIPT Tests by Value, 2016-2023 ($Million)
58 Other NIPT Tests Volume by Geography, 2016-2023 (in Units)
59 Other NIPT Tests Value by Geography, 2016-2023 ($Million)
60 NIPT Market Value by Geography, 2016-2023 ($Million)
61 NIPT Market Volume by Geography, 2016-2023 (in Units)
62 Key Factors Influencing Decision about NIPT Market
63 Influence of GPs, Labs, and KOLs on Decision Making
64 Willingness to Purchase NIPT Tests
65 Technology Preferences
66 Perception about Pricing
67 Perception about Brand
68 Selection Criteria for NIPT Tests
69 Sources of Information about NIPT
70 Information Required to Purchase a new Test
71 Preferred Channel for Purchasing
72 Laboratory Corporation of America Financials
73 Roche AG Financials
74 Premaitha Health Plc Financials
75 Illumina Inc. Financials
76 Natera Inc. Financials
77 Quest Diagnostics Incorporated Financials
Prenatal testing is undertaken before birth of the child to identify chromosomal abnormalities or genetic mutations in fetuses which are prone to reveal themselves immediately after birth or during infancy. Prenatal testing comes under the purview of “Antenatal Care”. It involves various techniques and methods which can detect numerous genetic disorders present in the fetus developing inside the mother’s womb and health problems in pregnant women. These disorders, many of which are inherited, are dominant X-linked autosomal recessive disorders which are easy to be detected in both conditions: prior to pregnancy and during pregnancy.
There are many methods in prenatal testing such as amniocentesis, chronic villus sampling, maternal serum screening, and Non-invasive prenatal testing (NIPT), among others. Non-invasive prenatal testing (NIPT)is used for screening pregnant women at high risk of developing fetal chromosomal aneuploidies such as Down syndrome (trisomy 21), Edwards syndrome (trisomy 18), Patau syndrome (trisomy 13), and Turner syndrome (monosomy X),alongwith fetal sex determination. The NIPT market growth is propelling due to factors such as: increasing demand for non-invasive treatments, technological innovation and advancement, increasing genetic disorder/abnormalities, and government support & regulations.
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 non-invasive screening tests. The numbers of screening tests are increasing rapidly day by day 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.
The major NIPTs currently available in the global market are MaterniT21 PLUS, Harmony, Panorama, verifi, NIFTY, PrenaTest, IONA, and BambniTest, among others. Of these, Panorama held the largest share of 19% of the market in terms of revenue in 2016, followed by NIFTY with 16%. North America was the largest market for NIPT in 2016 in terms of revenue and volume. The region is expected to retain its leadership position throughout the forecast period as major players in the NIPT market are based in the U.S. (the largest shareholder in North America). Market growth in Rest of the World (RoW) and Asia Pacific largely depends upon market penetration by the U.S.-based players and emerging indigenous players such as BGI Diagnostics (China). Non-invasive in nature, high accuracy and early detection, and rising awareness are some of the advantages offered by NIPTs as compared to invasive tests. Moreover, factors such as increasing market penetration in a number of countries in Europe and Asia and continuous rise in average maternal age are likely to fuel the growth of the global NIPT market during the forecast period.
Large population base and high birth rates indicating the presence of a large pool of potential patients (pregnant women with high risk of fetal anomalies) are likely to trigger demand for NIPTs in Asia Pacific and RoW. The market is witnessing a wide range of alliances of NIPT developers with local diagnostic service providers. Moreover, awareness about early detection of prenatal abnormalities is gradually increasing in these regions. Therefore, the NIPT market in RoW and Asia Pacific is likely to witness the highest CAGR of 22.2% and 18.8%, respectively, in terms of volume.
NIPT tests are gaining rapid pace worldwide due to various government supportive programs and schemes. In many countries, the market growth is restrained due to their cultural and ethical attitudes towards this process. However, the government educational programs support and regulations are building a platform for the development of the NIPT market that would benefit their citizens. Countries such as Saudi Arabia, the U.A.E., Turkey, Oman and Iran among others, have economical and infrastructural support but have still not approved these tests in their countries due to the shortage of educational and government development programs.
Sequenom, Inc., Natera, Inc., Roche Diagnostics, Illumina, Inc., BGI Diagnostics, LabCorp, LifeCodexx AG and Berry Genomics are the leading players operating in the global NIPT market. With the advent of new market entrants and increasing adoption of NIPT across the world, the competitive landscape of the market is expected to change during the forecast period, wherein players offering cost-effective, accurate, and quicker tests are projected to record a high growth rate.
The market is driven by product launches and development strategies followed by partnerships and collaborations. Moreover, established healthcare diagnostic companies are acquiring small market players/new entrants to position themselves in the NIPT market. For example, the recent acquisition of Sequenom Inc. by LabCorp in January 2017 has again showcased the need of acquisition of elementary player of the market. Also, Roche acquired Ariosa Diagnostics in 2014 while Illumina acquired Verinata Health in 2014. Due to 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. 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 early stage of pregnancy, and is foreseen as a viable opportunity for this market.
North America
Europe
Asia Pacific
Rest of the World (RoW)
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The acquisition of Sequenom Inc, by LabCorp, in 2016, has recouped the traction toward NIPT market. In recent past, Roche entered into NIPT market in 2014 with the acquisition of Ariosa Diagnostics and Illumina, Inc. gained access to NIPT market with the Verifi test developer, Verinata Health Inc. The U.S. based Sequenom Inc. launched its first MaterniT 21 PLUS and VisibiliT test, ranking number one, best-selling NIPT products. NIPT has appeared as a blessing to expectant mothers as many of them are not comfortable with the invasive testing to screen their pregnancy for assessing the risk of fetal aneuploidy because of the physical inconvenience and the risk of miscarriage during the invasive screening process. Non-invasive prenatal testing (NIPT) is an innovative way of screening pregnancies for fetal chromosomal aneuploidies by analyzing fetal cell-free DNA circulating in maternal blood. Amniocentesis, chorionic villus sampling (CVS), maternal serum screening, and nuchal translucency (NT) scan have been the primary diagnostic and screening methods for chromosomal abnormalities.
Though this market promises existing players and potential entrants a potential to reap benefits of high profit-margins, innovation and efficiency, there are factors that pose manifold challenges in the implementation of NIPT. The challenges shall be in terms of ethical, legal, clinical and social implementation. For example, better implementation of NIPT would require improved infrastructure in Low and Middle-Income Countries as these countries lack in services such as refrigeration of samples and transportation of blood samples. Another issue is that patents on the technology limit research and development. Reduced market competition could reduce availability of cheaper options.
According to the report by BIS Research titled ‘Global NIPT Market- Analysis and Forecast, 2017-2023’, the global Non-invasive Prenatal Testing market is divided by test type, viz. MaterniT21 PLUS, Harmony, Panorama, verifi, NIFTY, PrenaTest, BambniTest, informaSeq and VisibiliT, and others. Geographically, North America was the largest market for NIPT in 2015, in terms of revenue generation and volume, and is expected to lead throughout the forecast period, expanding at a CAGR of 15.6%, as major players of the NIPT market are based in the U.S. However, the market in Asia Pacific region and Rest of the World (RoW), largely depends on the market penetration by the established players in the U.S. and new entrants in the market.
Multiple number of companies are engaged in developing the NIPT test and through their distribution channels, these sell their products across the globe. Germany based LifeCodexx sells its test within Europe, North Africa and the Middle East. BGI, a Chinese test developer, is able to offer NIFTY NIPT test in Europe, Asia, South America, and the Middle East through strategic distribution partnership. The U.S. players dominate the North America, Europe and Asia Pacific.
In order to implement NIPT in low-income countries, the government requires to include it in public health policy and subsidises it in initial years of introduction. Besides, training of clinicians and health professional, expenditure spending on promotion of its adoption has to be made. All the stakeholders should be involved in adoption of NIPT globally to ensure prenatal care and positive health outcomes.
The competitive landscape of the NIPT market is estimated to be intensely competitive in the coming years, as the market is driven by product launches and development strategies followed by mergers and acquisitions. Moreover, established companies are acquiring small market players/new entrants to position themselves in the NIPT market. For example, the recent acquisition of Sequenom Inc. by LabCorp in January 2017 has again showcased the need of acquisition of elementary player of the market. Also, Roche acquired Ariosa Diagnostics in 2014 while Illumina acquired Verinata Health in 2014. Due to 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. 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 early stage of pregnancy, and is foreseen as a viable opportunity for this market.
Roche, Natera, Illumina, LabCorp, LifeCodexx, BGI Diagnostics, Premaitha and Berry Genomics