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1 MarketsandMarkets Publisher Sample Phone: (US) or or (Int'l) Hours: Monday - Thursday: 5:30am - 6:30pm EST Fridays: 5:30am - 5:30pm EST MarketResearch.com

2 NEWBORN SCREENING MARKET by Test Type (Dried Blood Spot, Hearing Screening, CCHD), Technology (Tandem Mass Spectrometry, Immunoassay, Enzyme Assays, Electrophoresis, Pulse Oximeter), Instrument, Accessories, Reagent & Assay Kit Global Forecasts to 2019 MarketsandMarkets

3 MarketsandMarkets is a global market research and consulting company based in the U.S. We publish strategically analyzed market research reports and serve as a business intelligence partner to Fortune 500 companies across the world. MarketsandMarkets also provides multi-client reports, company profiles, databases, and custom research services. MarketsandMarkets covers fourteen industry verticals, including aerospace and defence, advanced materials, automotives and transportation, banking and financial services, biotechnology, chemicals, consumer goods, energy and power, food and beverages, industrial automation, medical devices, pharmaceuticals, semiconductor and electronics, and telecommunications and IT. Copyright 2014 MarketsandMarkets All Rights Reserved. This document contains highly confidential information and is the sole property of MarketsandMarkets. No part of it may be circulated, copied, quoted, or otherwise reproduced without the approval of MarketsandMarkets. MarketsandMarkets Sample Page 2

4 1 EXECUTIVE SUMMARY TABLE 1 GLOBAL NEWBORN SCREENING MARKET SIZE, BY TEST TYPE, ($MILLION) Test Type CAGR % ( ) Dry Blood Spot Test Hearing Screen Test Critical Congenital Heart Diseases Test Total Source: Annual Reports, SEC Filings, World Health Organization, International Society for Neonatal Screening, National Institute of Child Health and Human Development, Centers for Disease Control and Prevention, Newborn Screening Task Force, American Academy of Pediatrics, National Institute of Neurological Disorders and Stroke, National Newborn Screening and Genetic Resource Center, Association of Public Health Laboratories, Expert Interviews, and MarketsandMarkets Analysis In 2013, the dried blood spot test commanded the largest share of % of the total newborn screening market, on the basis of test type. The dried blood spot test is the fundamental test for screening of the newborns. The large share of the dried blood spot test is attributed to its wide usage in the newborn screening market. This test is poised to grow at the highest CAGR of % during 2013 to The high growth is likely to be driven by technological advancements and various developing countries opting for expanded newborn screening. In 2013, the enzyme assays and immunoassays segment accounted for the largest share of % of the total newborn screening market, on the basis of technology. The large share of this market is attributed to the wide usage of immunoassay techniques for newborn screening. The tandem mass spectrometry segment is slated to witness a high CAGR of % from 2013 to The major reason for the high growth of this technology is the various advantages MarketsandMarkets Sample Page 3

5 offered by mass spectrometry over traditional immunoassay methods such as cost and time effectiveness. In 2013, the instruments segment accounted for the largest share of % of the total newborn screening market, on the basis of product. The large share of this market is attributed to the wide usage of hearing screening instruments for newborn screening. The reagents and assay kits segment is poised to grow at a high CAGR of % from 2013 to The reason for this high growth is due to the technological advancements and high demand of these reagents as they are indispensible in nature. FIGURE 1 GLOBAL NEWBORN SCREENING MARKET SIZE, BY GEOGRAPHY, ($MILLION) Total Revenue ($Million) North America Europe Asia South America RoW Total CAGR% ( ) CAGR% ( ) Source: Annual Reports, SEC Filings, World Health Organization, International Society for Neonatal Screening, National Institute of Child Health and Human Development, Centers for Disease Control and Prevention, Newborn Screening Task Force, American Academy of Pediatrics, National Institute of Neurological Disorders and Stroke, National Newborn Screening and Genetic Resource Center, Association of Public Health Laboratories, Expert Interviews, and MarketsandMarkets Analysis The global newborn screening market is dominated by North America, followed by Europe, Asia, Rest of the World (RoW), and South America. North America is expected to maintain its MarketsandMarkets Sample Page 4

6 leadership position in this market over the forecast period. The growth of the North American market is likely to be driven by factors such as the increasing government investments, reduction in healthcare costs, advantages in the screening of newborn diseases, advanced techniques available in the market for newborn screening, and various symposiums and conferences being organized for discussing new ideas related to newborn screening. Europe is the second largest market for newborn screening and more than half of the European countries have implemented newborn screening programs. The European Union and government initiatives, launch of new and advanced products, and the various conferences organized for newborn screening are the key factors that are likely to drive the European newborn screening market in the next five years. MarketsandMarkets Sample Page 5

7 2 PREMIUM INSIGHTS 2.1 PORTER S FIVE FORCES ANALYSIS The competitive environment prevalent in the global newborn screening industry can be analyzed through Porter s Five Forces analytical framework. FIGURE 2 PORTER S FIVE FORCES ANALYSIS Bargaining Power of Buyers Bargaining Power of Suppliers Low - Medium Medium Rivalry Amongst Existing Players Medium - High Threat of New Entrants Low - Medium Global Newborn Screening Market Threat of Substitutes Low - Medium Annual Reports, SEC Filings, World Health Organization, International Society for Neonatal Screening, National Institute of Child Health and Human Development, Centers for Disease Control and Prevention, Newborn Screening Task Force, American Academy of Pediatrics, National Institute of Neurological Disorders and Stroke, National Newborn Screening and Genetic Resource Center, Association of Public Health Laboratories, Expert Interviews, and MarketsandMarkets Analysis MarketsandMarkets Sample Page 6

8 2.2 TECHNOLOGY LIFE CYCLE The technologies used in newborn screening are in various phases of their life cycle. Some technologies such as pulse oximetery and hearing screening technologies [Otoacoustic Emissions (OAE) technology and the auditory brainstem response (ABR) technology] are either in their introduction stage or entering the growth phase, while tandem mass spectrometry and immunoassay technologies are in their growth phase and maturity phase, respectively. FIGURE 3 TECHNOLOGY LIFE CYCLE Immunoassays Technology Adoption Rate Pulse Oximetery Technology Hearing Screening Technology Tandem Mass Spectrometry Introduction Growth Maturity Decline Phase Source: Annual Reports, SEC Filings, World Health Organization, International Society for Neonatal Screening, National Institute of Child Health and Human Development, Centers for Disease Control and Prevention, Newborn Screening Task Force, American Academy of Pediatrics, National Institute of Neurological Disorders and Stroke, National Newborn Screening and Genetic Resource Center, Association of Public Health Laboratories, Expert Interviews, and MarketsandMarkets Analysis Use ofthe pulse oximetery technology for CCHD screening for newborns is relatively new. Various researches and conferences are being organized to raise awareness regarding newborn CCHD screening. Developed regions such as some U.S. states and some European countries have recently included CCHD screening in their newborn screening programs. However, in the developing and under developed economies, the adoption rate of CCHD is very low. Owing to this, CCHD screening through the pulse oximetery technology is still in its introduction stage MarketsandMarkets Sample Page 7

9 3 MARKET OVERVIEW 3.1 MARKET SHARE ANALYSIS GLOBAL NEWBORN SCREENING DRIED BLOOD SPOT TEST MARKET The global newborn screening dried blood spot test market is dominated by PerkinElmer, Inc. (U.S.) which accounted for more than % of the newborn screening products market in FIGURE 4 MARKET SHARE ANALYSIS, BY KEY PLAYERS, 2013 % % % % % PerkinElmer, Inc. Danaher Corporation (AB SCIEX) Waters Corporation Agilent Technologies Others Source: Annual Reports, SEC Filings, World Health Organization, International Society for Neonatal Screening, National Institute of Child Health and Human Development, Centers for Disease Control and Prevention, Newborn Screening Task Force, American Academy of Pediatrics, National Institute of Neurological Disorders and Stroke, National Newborn Screening and Genetic Resource Center, Association of Public Health Laboratories, Expert Interviews, and MarketsandMarkets Analysis PerkinElmer (U.S.) is the global leader in the newborn screening market (% share); till 2013, approximately million infants had been screened by the company s products. It is a well-known company and has an exhaustive product portfolio which includes NeoGram MS/MS AAAC in vitro diagnostic kit, NeoBase Non-derivatized MS/MS kit, GSPR Neonatal htsh, T4 MarketsandMarkets Sample Page 8

10 17μ-OHP, GALT IRT and BTD kits, and various tandem mass spectrometry products. The company believes that strong intellectual property portfolio plays an important role in enhancing its market share. The company owns numerous patented products in the U.S. and other countries across the globe. The company is innovation-centric and invests heavily in R&D for maintaining its market share. In this regard, the company invested $ million in R&D in 2013.The company has established its subsidiaries at strategic locations across North America, South America, Europe, Asia, and Australia. Moreover, the company adapts geographic expansions as its major strategy for enhancing its market share in the geographies which have greatest sales potential according to the company. In this regard, in June 2014, PerkinElmer collaborated with China's National Health and Family Planning Commission (NHFPC) for implementing a three-year newborn screening training program in rural China. In September 2011, PerkinElmer, Inc. and its partner HVD Vertriebs GMBH (Austria) announced to establish the world s largest centralized laboratory for newborn screening in Egypt. In May 2014, the company signed an agreement to serve as the exclusive global distributor for Sebia's Capillarys 2 Neonat Fast system for newborn screening laboratories. Furthermore, the company possesses a strong sales force which markets its products and services in more than countries across the globe thereby helps it to maintain its market share. MarketsandMarkets Sample Page 9

11 4 NEWBORN SCREENING MARKET, BY TECHNOLOGY 4.1 INTRODUCTION FIGURE 5 GLOBAL NEWBORN SCREENING MARKET SIZE, BY TECHNOLOGY, ($MILLION) Technology CAGR % ( ) Enzyme Assays and Immunoassays Hearing Screen Technology Tandem Mass Spectrometry Pulse Oximetry DNA-Based Assays Electrophoresis Total Annual Reports, SEC Filings, World Health Organization, International Society for Neonatal Screening, National Institute of Child Health and Human Development, Centers for Disease Control and Prevention, Newborn Screening Task Force, American Academy of Pediatrics, National Institute of Neurological Disorders and Stroke, National Newborn Screening and Genetic Resource Center, Association of Public Health Laboratories, Expert Interviews, and MarketsandMarkets Analysis The enzyme assays and immunoassays segment accounted for the largest share % of the global newborn screening technology market in This segment is expected to reach $million by 2019, growing at a CAGR of % from 2013 to The large share of this market is due to the wide usage of immunoassay techniques for newborn screening. The tandem mass spectrometry market is poised to grow at the highest CAGR of % to reach $million by 2019, from $ million in The tandem mass spectrometry technology is MarketsandMarkets Sample Page 10

12 more time effective as compared to the enzyme assays and immunoassays technology. The tandem mass spectrometer can screen over inborn disorders simultaneously. These advantages are the major reasons for the growth of this market. MarketsandMarkets Sample Page 11

13 5 NEWBORN SCREENING MARKET, BY PRODUCT TYPE 5.1 INTRODUCTION TABLE 2 GLOBAL NEWBORN SCREENING MARKET SIZE, BY PRODUCT TYPE, ($MILLION) Product Type CAGR% ( ) Instruments Reagents and Assay Kits Total Source: Annual Reports, SEC Filings, World Health Organization, International Society for Neonatal Screening, National Institute of Child Health and Human Development, Centers for Disease Control and Prevention, Newborn Screening Task Force, American Academy of Pediatrics, National Institute of Neurological Disorders and Stroke, National Newborn Screening and Genetic Resource Center, Association of Public Health Laboratories, Expert Interviews, and MarketsandMarkets Analysis The instruments segment accounted for the largest share % of the global newborn screening products market in This segment is expected to reach $ million by 2019, growing at a CAGR of % from 2013 to The large share of this segment can be attributed to the wide usage of instruments for newborn screening. However, the reagents and assay kits market is poised to grow at the highest CAGR of %, to reach $ million by 2019 from $ million in The high growth in this segment is attributed to continuous demand for reagents. MarketsandMarkets Sample Page 12

14 6 NEWBORN SCREENING MARKET, BY GEOGRAPHY 6.1 INTRODUCTION FIGURE 6 HIGH GROWTH POTENTIAL MARKET Brazil Egypt Saudi Arabia Qatar India China Source: Annual Reports, SEC Filings, World Health Organization, International Society for Neonatal Screening, National Institute of Child Health and Human Development, Centers for Disease Control and Prevention, Newborn Screening Task Force, American Academy of Pediatrics, National Institute of Neurological Disorders and Stroke, National Newborn Screening and Genetic Resource Center, Association of Public Health Laboratories, Expert Interviews, and MarketsandMarkets Analysis MarketsandMarkets Sample Page 13

15 TABLE 3 GLOBAL NEWBORN SCREENING MARKET SIZE, BY GEOGRAPHY, ($MILLION) Region CAGR% ( ) North America Europe Asia RoW South America Total Source: Annual Reports, SEC Filings, World Health Organization, International Society for Neonatal Screening, National Institute of Child Health and Human Development, Centers for Disease Control and Prevention, Newborn Screening Task Force, American Academy of Pediatrics, National Institute of Neurological Disorders and Stroke, National Newborn Screening and Genetic Resource Center, Association of Public Health Laboratories, Expert Interviews, and MarketsandMarkets Analysis The North American market commanded the largest share % of the global newborn screening market in This market is expected to reach $ million by 2019, growing at a CAGR of % from 2013 to This large size of the market is attributed to government support in terms of formation of legislation, grants and funding, need for reducing healthcare cost and rising awareness. Majority of the states in the U.S. have national newborn screening program. The Asian market is poised to grow at the highest CAGR of % to reach $ million by 2019, from $ million in This growth is likely to be driven by growing awareness regarding the benefits of newborn screening program, investment by major players, recent implementation of newborn screening programs by various Asian countries, and increasing government support. MarketsandMarkets Sample Page 14

16 Disclaimer: MarketsandMarkets strategic analysis services are limited publications containing valuable market information provided to a select group of customers in response to orders. Our customers acknowledge, when ordering, that MarketsandMarkets strategic analysis services are for our customers internal use and not for general publication or disclosure to third parties. Quantitative market information is based primarily on interviews and therefore, is subject to fluctuation. MarketsandMarkets does not endorse any vendor, product or service depicted in its research publications. MarketsandMarkets strategic analysis publications consist of the opinions of MarketsandMarkets' research and should not be construed as statements of fact. MarketsandMarkets disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose. MarketsandMarkets takes no responsibility for any incorrect information supplied to us by manufacturers or users. All trademarks, copyrights and other forms of intellectual property belong to their respective owners and may be protected by copyright. Under no circumstance may any of these be reproduced in any form without the prior written agreement of their owner. No part of this strategic analysis service may be given, lent, resold or disclosed to noncustomers without written permission. Reproduction and/or transmission in any form and by any means including photocopying, mechanical, electronic, recording or otherwise, without the permission of the publisher is prohibited. MarketsandMarkets Sample Page 15

MarketsandMarkets. Publisher Sample

MarketsandMarkets.  Publisher Sample MarketsandMarkets http://www.marketresearch.com/marketsandmarkets-v3719/ Publisher Sample Phone: 800.298.5699 (US) or +1.240.747.3093 or +1.240.747.3093 (Int'l) Hours: Monday - Thursday: 5:30am - 6:30pm

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