1. Emerging NIPT Market
in Asia Pacific
published: Nov’ 2013
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2. Table of Contents
1. Analyst View
2. Research Methodology
3. Introduction
3.1 MaterniT21 PLUS
3.2 Verifi
3.3 Panorama
3.4 Harmony
3.5 NIFTY
3.6 Bambni
3.7 Association of Down’s syndrome Risk to Fetus with Mother’s Age
4. Asia-Pacific NIPT Market Outlook to 2018
4.1 Australia
4.1.1 Market Potential
4.1.2 Market Overview
4.1.3 Regulatory Scenario
4.2 China
4.2.1 Market Potential
4.2.2 Market Overview
4.2.3 Regulatory Scenario
4.3 Japan
4.3.1 Market Potential
4.3.2 Market Overview
4.3.3 Regulatory Scenario
4.4 India
4.4.1 Market Potential
4.4.2 Regulatory Scenario
Emerging NIPT Market in Asia Pacific

3. List of Figures
Figure 4-1: Australia - Number of Births (‘000), 2013-2018
Figure 4-2: Australia - Number of Births by Mother’s Risk of Down’s syndrome (%), 2011
Figure 4-3: Australia - Potential Market in Three Different Scenarios (US$), 2013
Figure 4-4: Australia - NIPT Market (Million US$), 2013-2018
Figure 4-5: Australia - NIPT Market (Volume ‘000), 2013-2018
Figure 4-6: China - Number of Births (Million), 2013-2018
Figure 4-7: China - Potential Market in Two Different Scenarios (US$), 2012
Figure 4-8: China - NIPT Market (Million US$), 2013-2018
Figure 4-9: China - NIPT Market (Volume ‘000), 2013-2018
Figure 4-10: Japan - Number of Births (‘000), 2013-2018
Figure 4-11: Japan - Number of Births by Mother’s Risk of Down’s syndrome (%), 2010
Figure 4-12: Japan - Potential Market in Two Different Scenarios (US$), 2013
Figure 4-13: Japan - NIPT Market (Million US$), 2013-2018
Figure 4-14: Japan - NIPT Market (Volume ‘00), 2013-2018
Figure 4-15: India - Number of Births (Million), 2013-2018
List of Tables
Table 3-1: Comparison of Features of Key NIPT Tests in APAC NIPT Market
Table 3-2: MaterniT21 PLUS Test Validation Results
Table 3-3: Verifi Test Validation Results
Table 3-4: Panorma Test Validation Results
Table 3-5: Harmony Test Validation Results
Table 3-6: NIFTY Test - Summary of Phase I Clinical Trial
Table 3-7: NIFTY Test - Summary of Phase II Clinical Trial
Table 3-8: Bambni Test - Summary of Phase I Clinical Trial
Table 3-9: Bambni Test - Summary of Phase II Clinical Trial
Table 3-10: Risk of Down’s syndrome with Rise in Maternal Age
Table 4-1: Australia - Number of Births by Age of Mother (2011)
Table 4-2: Australia NIPT Market Landscape - Players; Australian Partner; Cost per Test
Table 4-3: China NIPT Market Landscape - Players; Cost per Test
Table 4-4: Japan - Number of Births by Age of Mother (2010)
Table 4-5: Japan NIPT Market Landscape - Player; Cost per Test
Emerging NIPT Market in Asia Pacific

4. Sample Sections from the Report
MaterniT21 PLUS
MaterniT21™ PLUS is a laboratory-developed test (LDT)
available exclusively through Sequenom Center for
Molecular Medicine (Sequenom CMM). The test utilizes
sequencing technology to identify DNA derived from fetal
chromosomes. The technology is applied to the circulating cell-free DNA in maternal blood (i.e., fragments of
DNA present in maternal blood that is not enclosed by a
membrane). This DNA from chromosomes xx, xx, and xx
is quantified and when overrepresented, the likelihood of
these chromosome problems is significantly increased.
The detection rate for Down syndrome has been estimated
to approach xx%, with a false positive rate less than xx%.
The detection rate for trisomy xx is over xx%, with a xx%
false positive rate. The detection rate for trisomy xx, based
on a small study, is estimated to be xx%, with a xx% false
positive rate.
positive rate of xx%. These include: Turner syndrome,
Klinefelter syndrome, Triple X syndrome and xx, XYY syndrome.
At this time, the technology has only been validated in a
high-risk population, which includes
1) women over the age of xx at delivery,
2) presence of an ultrasound finding,
3) a personal or family history of chromosome abnormalities and
4) abnormal screening (e.g., first trimester screening)
The test is indicated for use as early as ten weeks’ gestation. The blood sample is sent to Sequenom CMM laboratory and results are reported in approximately 7-10 days
from receipt of the blood sample in the laboratory.
Additionally, the lab is testing for sex chromosome anomalies with a combined detection rate of xx% with a false
Table 3-2: MaterniT21 PLUS Test Validation Results
Source: xx
Emerging NIPT Market in Asia Pacific

5. China
Market Potential
Figure 5-6: China - Number of Births (Million), 2013-2018
2013
2014
2015
2016
2017
2018
Source: xx
The most common chromosomal disorder in live births
in China is Down syndrome. The national incidence for
Down syndrome is xx. The incidence of Down syndrome
seems higher in urban areas than rural and mountainous
areas, and this is due to low recognition, resulting from
limited healthcare and diagnostic service in rural and
mountainous areas, especially in south-western China.
Mid-term maternal screening and ultrasound screening
for Down syndrome and other severe congenital malformations are performed for every pregnant woman in
developed regions as a national mandatory program that
allows x% of Down syndrome identification during pregnancy. Although advanced maternal age greatly increases
the incidence of Down syndrome, over half of the babies
with Down syndrome are born to mothers under xx.
NIPT tests in China have been priced lower than elsewhere in the world. This has primarily been done to keep
the tests affordable to masses. They cost around US$ x
and are not covered under any insurance scheme. If we
consider the fact that currently China lacks any regulations
that limit the customer base for NIPT tests and account
the number of pregnant women that can afford to pay for
the tests through out-of pocket expenditure, China represented a potential market of around US$ x Billion in 2012.
Considering that only pregnant women who fall under
the high risk group of x years and above and can afford to
undergo NIPT tests, the potential market for NIPT in China
stood at around US$ x Million in 2012.
Figure 5-7: China - Potential Market in Two Different
Scenarios (US$), 2012
In 2012, around x Million new births took place in China.
If we observe the trend of past ten years, the number of
new births is expected to hover around x Million between
2013-2018. This birth rate has been largely influenced by
the one-child policy in the region which enforces strict
penalties and fines on couples who conceive a second
child.
In China, the first trimester prenatal screening is not available and second trimester karyotyping is still the main
technique to detect all the aneuploidies and large chromosome rearrangements, which are the most frequent
abnormalities identified in prenatal diagnosis.
Around x% of the Chinese population lives in urban
regions. Though the one-child policy is more strictly implemented in the urban China, and the rural regions are
found to have instances of couples having more than one
child, the total number of births in the region can still be
safely approximated to around x% each in rural and urban
China. The mean age at first birth in China is around
xxyears. Again, this age is higher in urban China, where
women delay child bearing due to career obligations. Still,
it is less than their counterparts in developed regions of
EU, US and Australia due to the traditional social behavior
which favors marriage and childbearing at a younger age.
In a published study that observed the behavior of pregnant advanced age women, it was observed that improved prenatal screening tests and increased availability
of screening for advanced maternal age patients led to a
steady decline in choice of invasive testing. The women
who decline the screening wanted the assurance provided
by a diagnostic test rather than proceeding with screening that provided a refined risk assessment. This rationale
reflects immense possibilities for non invasive prenatal
tests that assure a higher detection rate for chromosomal
aneuploidies than the maternal screening tests without
posing any danger to the fetus.
Source: RNCOS
Emerging NIPT Market in Asia Pacific

6. Research Methodology
Our dedicated team of industry experts intensively monitored and analyzed all the emerging trends in global molecular
diagnostics market. According to their assessment NIPT has fast emerged as the quickest growing segment. Players,
who are actively establishing their base in the US, are also fanning out to EU and APAC region. APAC, in particular has
been extensively studied in this report due to the highly underpenetrated nature of this potentially huge market.
For the study, we gathered information from various credible sources, such as the Australian Bureau of Statistics, National Bureau of Statistics of China, Statistics Bureau of Japan, Census of India and some of our paid databases, such
as LexisNexis, EIU, Hoovers, etc. In addition, we conducted expert interviews with leading players in the industry to get
the complete 360 degree overview of the market.
Our team of experts has prudently evaluated all the collected information and presented it in a chronological order to
depict a meaningful and clear picture of the APAC NIPT sector. This is worth mentioning here that, while compiling the
data we have also cross-checked all the collected information from other multiple sources, and data warehouses, so
that we can present the most accurate and precise information on the sector.
According to our analysis, rise in maternal age has a direct relation with the rise in risk of a fetus having Down’s syndrome. Also, all the NIPT tests offered in APAC region are borne through out-of-pocket expenses. We have therefore
analyzed critical factors including the number of mothers in each region by age; the age of mother at first birth; affordability factors; number of players; costs of tests etc. to present the most transparent picture possible.
Moreover, all the forecasts have been done on the basis of co-relation and judgmental analysis, which is carried out
after carefully studying key factors including rise in penetration, expansion in distributor network, rising popularity and
awareness amongst consumers, regulatory scenario and various other drivers and challenges.
Emerging NIPT Market in Asia Pacific

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Emerging NIPT Market in Asia Pacific

8. About RNCOS
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Emerging NIPT Market in Asia Pacific

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