世界の新生児マススクリーニング検査市場（～2019）...市場調査レポートについてご紹介

TABLE OF CONTENTS

1 INTRODUCTION 19
1.1 OBJECTIVES OF THE STUDY 20
1.1.1 KEY INSIGHTS FROM THE REPORT 20
1.2 SCOPE OF THE REPORT 22
1.2.1 MARKETS COVERED 22
1.2.2 LIMITATIONS OF THE STUDY 23
1.3 STAKEHOLDERS 24
1.4 RESEARCH METHODOLOGY 24
1.4.1 MARKET SIZE ESTIMATION 26
1.4.2 MARKET CRACKDOWN & DATA TRIANGULATION 28
1.4.3 MARKET SHARE ESTIMATION 29
1.4.4 KEY DATA FROM PRIMARY SOURCES 30
1.4.5 KEY DATA FROM SECONDARY SOURCES 31
1.4.6 ASSUMPTIONS 31
2 EXECUTIVE SUMMARY 32
3 PREMIUM INSIGHTS 36
3.1 TECHNOLOGY TRENDS 37
3.2 WINNING IMPERATIVE 38
3.2.1 INVESTMENTS IN R&D ACTIVITIES FOR PRODUCT INNOVATION 38
3.3 PORTER’S FIVE FORCES ANALYSIS 39
3.3.1 THREAT OF NEW ENTRANTS 39
3.3.2 BARGAINING POWER OF SUPPLIERS 40
3.3.3 BARGAINING POWER OF BUYERS 40
3.3.4 RIVALRY AMONGST EXISTING PLAYERS 40
3.3.5 THREAT OF SUBSITUTES 41
3.4 REGULATORY ENVIRONMENT 42
3.5 REIMBURSEMENT SCENARIO 43
3.6 TECHNOLOGY LIFE CYCLE 44
3.7 STRATEGIC BENCHMARKING 46
4 MARKET OVERVIEW 47
4.1 INTRODUCTION 48
4.1.1 COMMON INDICATIONS IN NEWBORN SCREENING 48
4.1.1.1 Phenylketonuria (PKU) 48
4.1.1.2 Congenital hypothyroidism (CH) 49
4.1.1.3 Galactosemia 49
4.1.1.4 Biotinidase deficiency 49
4.1.1.5 Congenital adrenal hyperplasia (CAH) 50
4.1.1.6 Cystic fibrosis (CF) 50
4.1.1.7 Sickle cell disease 50
4.1.1.8 Maple syrup urine disease 51
4.1.1.9 Tryosinemia 51
4.1.1.10 Medium-chain acyl-CoA dehydrogenase (MCAD) deficiency 52
4.1.1.11 Congenital toxoplasmosis 52
4.1.1.12 Newborn hearing loss 52
4.1.1.13 Critical congenital heart diseases 52
4.1.2 NEWBORN SCREENING CONFIRMATORY TEST 53
4.2 MARKET SEGMENTATION 57
4.3 MARKET DYNAMICS 59
4.3.1 DRIVERS 60
4.3.1.1 Benefits related to newborn screening to propel the growth of the market 60
4.3.1.2 Legislations and mandates demand the implementation of newborn screening programs 60
4.3.1.3 Government support, an impetus for the newborn screening market 61
4.3.1.4 Rising awareness to trigger the growth of the market 61
4.3.1.5 Technological innovations to propel the growth of the market 62
4.3.1.6 Expanding panel of newborn diseases to bolster the growth of the market 63
4.3.1.7 Rising incidences of critical congenital heart defects (CCHD) to propel the CCHD screening market 63
4.3.2 RESTRAINTS 64
4.3.2.1 Lack of professional infrastructure may hinder the growth of the market 64
4.3.2.2 Socio-economic barriers are likely to restrain the growth of the market 64
4.3.3 OPPORTUNITIES 64
4.3.3.1 Asian region presents significant growth opportunities 64
4.3.3.2 Screening of genetic disorders 65
4.3.3.3 Next-generation sequencing(NGS), an upcoming technology in the newborn screening market 65
4.3.3.4 Digital microfluidics, a new opportunity area for the newborn screening market 66
4.3.4 CHALLENGES 66
4.3.4.1 High cost of automation 66
4.3.4.2 Survival of small players and new entrants 67
4.3.4.3 Lack of uniformity of newborn screening policies and procedures across the globe 67
4.4 MARKET SHARE ANALYSIS 68
4.4.1 GLOBAL NEWBORN SCREENING DRIED BLOOD SPOT TEST MARKET 68
4.4.1.1 North America: Newborn Screening Dried Blood Spot Test Market 72
4.4.1.2 Europe: Newborn Screening Dried Blood Spot Test Market 73
4.4.1.3 Asia: Newborn Screening Dried Blood Spot Test Market 74
4.4.1.4 RoW: Newborn Screening Dried Blood Spot Test Market 75
4.4.2 NEWBORN SCREENING MARKET FOR CRITICAL CONGENITAL HEART DISEASES 76
4.4.3 NEWBORN HEARING SCREENING MARKET 77
5 NEWBORN SCREENING MARKET, BY TEST TYPE 78
5.1 INTRODUCTION 79
5.2 DRY BLOOD SPOT TEST 83
5.3 HEARING SCREEN TEST 85
5.4 CRITICAL CONGENITAL HEART DISEASES (CCHD) TEST 87
6 NEWBORN SCREENING MARKET, BY TECHNOLOGY 89
6.1 INTRODUCTION 90
6.2 TANDEM MASS SPECTROMETRY (TMS) 93
6.3 ELECTROPHORESIS 95
6.4 IMMUNOASSAYS AND ENZYMATIC ASSAYS 97
6.5 DNA-BASED ASSAYS 99
6.6 HEARING SCREEN TECHNOLOGY 101
6.7 PULSE OXIMETRY SCREENING TECHNOLOGY 103
7 NEWBORN SCREENING MARKET, BY PRODUCT TYPE 105
7.1 INTRODUCTION 106
7.2 INSTRUMENTS 109
7.2.1 INTRODUCTION 109
7.2.2 NEWBORN DISORDER SCREENING INSTRUMENTS 111
7.2.3 NEWBORN HEARING SCREENING INSTRUMENTS 113
7.2.3.1 Hearing screening devices 116
7.2.3.2 Hearing screening accessories 117
7.2.4 PULSE OXIMETERS 119
7.3 REAGENTS AND ASSAY KITS 121
8 NEWBORN SCREENING MARKET, BY GEOGRAPHY 123
8.1 INTRODUCTION 124
8.2 NORTH AMERICA 128
8.2.1 NEED FOR REDUCING HEALTHCARE COSTS, A MAJOR DRIVER FOR THE U.S. NEWBORN SCREENING MARKET 128
8.2.2 GOVERNMENT SUPPORT, AN IMPETUS FOR THE MARKET 128
8.2.3 NEWBORN SCREENING PROGRAM IN CANADA 137
8.2.4 NEWBORN HEARING SCREENING PROGRAM IN CANADA 144
8.2.5 ISSUES OVER PRIVACY RIGHTS OF FAMILIES MAY HINDER THE GROWTH OF THE CANADIAN MARKET 144
8.2.6 SYMPOSIUMS AND MEETINGS TO TRIGGER THE GROWTH OF THE NEWBORN SCREENING MARKET 144
8.3 SOUTH AMERICA 150
8.3.1 GROWTH IN THE SOUTH AMERICAN MARKET TO BE HINGED AT BRAZIL 150
8.3.2 RESEARCH STUDIES TO ENHANCE THE NEWBORN SCREENING PROGRAM 151
8.3.3 LACK OF TRAINED PROFESSIONALS TO HINDER THE GROWTH OF THE NEWBORN HEARING SCREENING MARKET 151
8.4 EUROPE 157
8.4.1 EUROPEAN UNION INITIATIVES TO PROPEL THE GROWTH OF THE MARKET 157
8.4.2 NEWBORN SCREENING PROGRAM IN VARIOUS EUROPEAN COUNTRIES 158
8.4.3 CONFERENCES TO RAISE AWARENESS REGARDING CCHD SCREENING 159
8.4.4 NEWBORN HEARING SCREENING PROGRAM IN EUROPE 159
8.4.5 GOVERNMENT INITIATIVES TO BOLSTER THE GROWTH OF THE EUROPEAN MARKET 160
8.4.6 LAUNCH OF NEW & ADVANCED PRODUCTS TO PROPEL THE GROWTH OF THE EUROPEAN MARKET 160
8.4.7 CONFERENCES TO BOOST THE GROWTH OF THE NEWBORN SCREENING MARKET 160
8.5 ASIA 165
8.5.1 GOVERNMENT INITIATIVES TO DRIVE THE GROWTH OF THE ASIAN MARKET 170
8.5.1.1 Japanese government initiatives 170
8.5.1.2 Indian government initiatives 170
8.5.1.3 Philippines government initiatives 171
8.5.2 COLLABORATION AMONGST LEADING PLAYERS AND GOVERNMENT TO BOOST THE CHINESE MARKET 171
8.6 ROW 173
8.6.1 NEWBORN SCREENING PROGRAM IN AUSTRALIA AND NEW ZEALAND 173
8.6.2 NEWBORN SCREENING PROGRAM IN SOUTH AFRICA 173
8.6.3 AFRICAN & MIDDLE EASTERN COUNTRIES TAKING INITIATIVES TO LAUNCH AND IMPROVE THEIR NEWBORN SCREENING PROGRAMS 173
8.6.4 SUPPORT BY FOREIGN COUNTRIES TO BOOST THE ROW MARKET 174
9 COMPETITIVE LANDSCAPE 179
9.1 INTRODUCTION 179
9.2 PARTNERSHIPS, AGREEMENTS, COLLABORATIONS, AND CONTRACTS 180
9.3 NEW PRODUCT LAUNCHES 185
9.4 EXPANSIONS 188
9.5 ACQUISITIONS 191
9.6 APPROVALS 193
10 COMPANY PROFILES 194
(Overview, Financials, Products & Services, Strategy, & Developments)*

10.1 AB SCIEX LLC (A SUBSIDIARY OF DANAHER CORPORATION) 194
10.2 PERKINELMER, INC. 202
10.3 WATERS CORPORATION 208
10.4 NATUS MEDICAL INCORPORATED 213
10.5 MASIMO CORPORATION 217
10.6 AGILENT TECHNOLOGIES INC. 224
10.7 BIO-RAD LABORATORIES, INC. 229
10.8 COVIDIEN PLC 232
10.9 GE HEALTHCARE (A SUBSIDIARY OF GENERAL ELECTRIC COMPANY) 236
10.10 TRIVITRON HEALTHCARE 239

*Details on Products & Services, Strategy, & Developments might not be captured in case of unlisted companies.