Emerging nipt market in asia pacific

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Transcript of Emerging nipt market in asia pacific

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All rights reserved. This publication is protected by copyright. No part of it may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic mechanical, photocopying, recording or otherwise without the prior written permission of the publisher.

published: Nov’ 2013

Emerging NIPT Market in Asia Pacific

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Emerging NIPT Market in Asia Pacific

Table of Contents

3.1 MaterniT21 PLUS3.2 Verifi3.3 Panorama3.4 Harmony3.5 NIFTY3.6 Bambni3.7 Association of Down’s syndrome Risk to Fetus with Mother’s Age

4.1 Australia 4.1.1 Market Potential 4.1.2 Market Overview 4.1.3 Regulatory Scenario4.2 China 4.2.1 Market Potential 4.2.2 Market Overview 4.2.3 Regulatory Scenario4.3 Japan 4.3.1 Market Potential 4.3.2 Market Overview 4.3.3 Regulatory Scenario4.4 India 4.4.1 Market Potential 4.4.2 Regulatory Scenario

1. Analyst View

2. Research Methodology

3. Introduction

4. Asia-Pacific NIPT Market Outlook to 2018

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Emerging NIPT Market in Asia Pacific

List of Figures

Figure 4-1: Australia - Number of Births (‘000), 2013-2018Figure 4-2: Australia - Number of Births by Mother’s Risk of Down’s syndrome (%), 2011Figure 4-3: Australia - Potential Market in Three Different Scenarios (US$), 2013Figure 4-4: Australia - NIPT Market (Million US$), 2013-2018Figure 4-5: Australia - NIPT Market (Volume ‘000), 2013-2018Figure 4-6: China - Number of Births (Million), 2013-2018Figure 4-7: China - Potential Market in Two Different Scenarios (US$), 2012Figure 4-8: China - NIPT Market (Million US$), 2013-2018Figure 4-9: China - NIPT Market (Volume ‘000), 2013-2018Figure 4-10: Japan - Number of Births (‘000), 2013-2018Figure 4-11: Japan - Number of Births by Mother’s Risk of Down’s syndrome (%), 2010Figure 4-12: Japan - Potential Market in Two Different Scenarios (US$), 2013Figure 4-13: Japan - NIPT Market (Million US$), 2013-2018Figure 4-14: Japan - NIPT Market (Volume ‘00), 2013-2018Figure 4-15: India - Number of Births (Million), 2013-2018

Table 3-1: Comparison of Features of Key NIPT Tests in APAC NIPT MarketTable 3-2: MaterniT21 PLUS Test Validation ResultsTable 3-3: Verifi Test Validation ResultsTable 3-4: Panorma Test Validation ResultsTable 3-5: Harmony Test Validation ResultsTable 3-6: NIFTY Test - Summary of Phase I Clinical TrialTable 3-7: NIFTY Test - Summary of Phase II Clinical TrialTable 3-8: Bambni Test - Summary of Phase I Clinical TrialTable 3-9: Bambni Test - Summary of Phase II Clinical TrialTable 3-10: Risk of Down’s syndrome with Rise in Maternal AgeTable 4-1: Australia - Number of Births by Age of Mother (2011)Table 4-2: Australia NIPT Market Landscape - Players; Australian Partner; Cost per TestTable 4-3: China NIPT Market Landscape - Players; Cost per TestTable 4-4: Japan - Number of Births by Age of Mother (2010)Table 4-5: Japan NIPT Market Landscape - Player; Cost per Test

L ist of Tables

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Emerging NIPT Market in Asia Pacific

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 circulat-ing 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.

Additionally, the lab is testing for sex chromosome anoma-lies with a combined detection rate of xx% with a false

positive rate of xx%. These include: Turner syndrome, Klinefelter syndrome, Triple X syndrome and xx, XYY syn-drome.

At this time, the technology has only been validated in a high-risk population, which includes1) women over the age of xx at delivery, 2) presence of an ultrasound finding, 3) a personal or family history of chromosome abnormali-ties and 4) abnormal screening (e.g., first trimester screening)

The test is indicated for use as early as ten weeks’ gesta-tion. The blood sample is sent to Sequenom CMM labora-tory and results are reported in approximately 7-10 days from receipt of the blood sample in the laboratory.

MaterniT21 PLUS

Sample Sections from the Report

Table 3-2: MaterniT21 PLUS Test Validation Results

Source: xx

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Emerging NIPT Market in Asia Pacific

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 mal-formations are performed for every pregnant woman in developed regions as a national mandatory program that allows x% of Down syndrome identification during preg-nancy. 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.

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.

Around x% of the Chinese population lives in urban regions. Though the one-child policy is more strictly im-plemented 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.

NIPT tests in China have been priced lower than else-where 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 repre-sented 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.

In China, the first trimester prenatal screening is not avail-able and second trimester karyotyping is still the main technique to detect all the aneuploidies and large chro-mosome rearrangements, which are the most frequent abnormalities identified in prenatal diagnosis.

In a published study that observed the behavior of preg-nant advanced age women, it was observed that im-proved 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 screen-ing 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.

Market Potential

China

2013 2014 2015 2016 2017 2018

Figure 5-6: China - Number of Births (Million), 2013-2018

Source: xx

Figure 5-7: China - Potential Market in Two Different Scenarios (US$), 2012

Source: RNCOS

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Emerging NIPT Market in Asia Pacific

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, Na-tional 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 syn-drome. 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; afford-ability 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.

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Emerging NIPT Market in Asia Pacific

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Emerging NIPT Market in Asia Pacific

Established in 2002, RNCOS is a premier source of healthcare research and information provider. We bring first-hand informa-tion and prudent analysis on the healthcare industry, technologies, economic and non-economic market parameters, poten-tial markets, and key competitors, to help clients identify prospective growth areas and gain competitive edge.

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