TABLE OF CONTENTS
1 INTRODUCTION 59
1.1 OBJECTIVES OF THE STUDY 59
1.2 MARKET DEFINITION 59
1.3 OVERVIEW 59
1.4 CURRENCY AND PRICING 61
1.5 LIMITATIONS 61
1.6 MARKETS COVERED 61
2 MARKET SEGMENTATION 67
2.1 MARKETS COVERED 67
2.2 GEOGRAPHICAL SCOPE 68
2.3 YEARS CONSIDERED FOR THE STUDY 69
2.4 DBMR TRIPOD DATA VALIDATION MODEL 70
2.5 PRIMARY INTERVIEWS WITH KEY OPINION LEADERS 73
2.6 MULTIVARIATE MODELLING 74
2.7 PRODUCTS LIFELINE CURVE 74
2.8 DBMR MARKET POSITION GRID 75
2.9 SECONDARY SOURCES 77
2.10 ASSUMPTIONS 77
3 EXECUTIVE SUMMARY 78
4 PREMIUM INSIGHT 81
4.1 PESTEL ANALYSIS 82
4.2 PORTER'S FIVE FORCES MODEL 83
4.3 NORTH AMERICA MEDICAL FOODS FOR INBORN ERRORS OF METABOLISM MARKET ANALYSIS 84
4.4 PATENT ANALYSIS 85
5 PIPELINE ANALYSIS 87
6 EPIDEMIOLOGY 88
7 INDUSTRY INSIGHTS 89
7.1 DEMOGRAPHIC TRENDS 89
7.2 KEY PRICING STRATEGIES 91
7.3 KEY PATIENT ENROLLMENT STRATEGIES 92
8 REGULATORY SCENARIO FOR MEDICAL FOOD 94
9 MARKET OVERVIEW 97
9.1 DRIVERS 99
9.1.1 RISING INCIDENCES OF INBORN ERRORS OF METABOLISM (IEM) 99
9.1.2 RISING PREFERENCE FOR DIETARY SUPPLEMENTS OVER ENZYME REPLACEMENT THERAPY (ERT) 100
9.1.3 INCREASE IN THE NUMBER OF NEW-BORN SCREENING PROCEDURES 101
9.1.4 INCREASING SPENDING ON MEDICAL FOOD PRODUCTS 102
9.2 RESTRAINTS 103
9.2.1 HIGH COST OF MEDICAL FOODS 103
9.2.2 STRINGENT REGULATIONS FOR MEDICAL FOODS 104
9.3 OPPORTUNITIES 105
9.3.1 GOVERNMENT INITIATIVES AND PROGRAMS FOR CREATING AWARENESS ABOUT INBORN ERRORS OF METABOLISM 105
9.3.2 INCREASING COLLABORATIONS AND PARTNERSHIPS IN THE MARKET 107
9.3.3 EXPANSION OF MEDICAL FOODS IN EMERGING MARKETS 107
9.4 CHALLENGES 108
9.4.1 POOR ACCESSIBILITY OF MEDICAL FOODS 108
9.4.2 ALTERNATIVE TREATMENT APPROACHES FOR INBORN ERRORS OF METABOLISM 109
10 NORTH AMERICA MEDICAL FOODS FOR INBORN ERRORS OF METABOLISM MARKET, BY PRODUCTS 110
10.1 OVERVIEW 111
10.2 AMINO ACID 114
10.2.1 AMINO ACID MIXTURES 115
10.2.1.1 PHENYLADE 116
10.2.1.1.1 DRINK MIX 116
10.2.1.1.2 GMP MIX-IN 116
10.2.1.1.3 GMP READY 116
10.2.1.1.4 OTHERS 116
10.2.1.2 PERIFLEX 116
10.2.1.3 LOPHLEX 117
10.2.1.4 PHLEXY 117
10.2.1.5 COOLER 117
10.2.1.6 ANAMIX 117
10.2.1.7 LYSINE-FREE, LOW TRYPTOPHAN 117
10.2.1.8 GLUTARADE ESSENTIAL GA-1 117
10.2.1.9 GLUTARADE GA-1 AMINO ACID BLEND 117
10.2.1.10 GLYTACTIN WITH GMP 117
10.2.1.11 ESSENTIAL AMINO ACID MIX 117
10.2.1.12 LIQUIGEN 117
10.2.1.13 MSUD GEL 118
10.2.1.14 OTHERS 118
10.2.2 SINGLE AMINO ACID 118
10.2.2.1 L-ARGININE 118
10.2.2.2 L-ISOLEUCINE 118
10.2.2.3 L-TYROSINE 119
10.2.2.4 L-LEUCINE 119
10.2.2.5 GLYCINE 119
10.2.2.6 L-ASPARTIC ACID 119
10.2.2.7 L-CITRULLINE 119
10.2.2.8 OTHERS 119
10.3 LOW PROTEIN FOOD 119
10.3.1 LOW-PROTEIN BAKING MIXES AND FLOUR SUBSTITUTES, SUCH AS RICE FLOUR OR POTATO FLOUR 121
10.3.2 LOW-PROTEIN ENERGY BARS AND SNACKS 121
10.3.3 LOW-PROTEIN CEREALS AND BREAKFAST FOOD 121
10.3.4 LOW-PROTEIN MILK SUBSTITUTES, SUCH AS RICE MILK OR ALMOND MILK 121
10.3.5 LOW-PROTEIN BREAD, PASTA, AND OTHER GRAIN-BASED PRODUCTS 121
10.3.6 OTHERS 121
10.4 GLYTACTIN WITH GMP AMINO ACID-MODIFIED INFANT FORMULA WITH IRON 121
10.4.1 BY FLAVOUR 122
10.4.1.1 VANILLA 122
10.4.1.2 BERRY 122
10.4.1.3 ORANGE 123
10.4.1.4 PLAIN 123
10.4.1.5 OTHERS 123
10.4.2 BY USAGE 123
10.4.2.1 READY TO DRINK 123
10.4.2.2 NEED DILUTION/PREPARATION 123
10.5 LOW-CALCIUM/VITAMIN D-FREE INFANT FORMULA WITH IRON 124
10.5.1 NO CALCIUM OR VITAMIN D 125
10.5.2 LOW CALCIUM, NO VITAMIN D 125
10.5.3 OTHERS 125
10.6 OTHERS 125
11 NORTH AMERICA MEDICAL FOODS FOR INBORN ERRORS OF METABOLISM MARKET, BY DISEASES 127
11.1 OVERVIEW 128
11.2 PHENYLKETONURIA (PKU) 131
11.2.1 PHENYLADE 132
11.2.2 PERIFLEX 132
11.2.3 LOPHLEX 132
11.2.4 OTHERS 132
11.3 TYROSINEMIA TYPES I AND II 132
11.4 MAPLE SYRUP URINE DISEASE (MSUD) 133
11.4.1 ANAMIX 134
11.4.2 COOLER 134
11.4.3 MSUD GEL 134
11.4.4 AMINO ACID BLEND 134
11.4.5 MAXMUM 134
11.4.6 OTHERS 134
11.5 HOMOCYSTINURIA 135
11.6 GLUTARIC ACIDEMIA TYPE I 135
11.7 UREA CYCLE DISORDERS 136
11.7.1 ORNITHINE TRANSCARBAMYLASE DEFICIENCY (OTC) 137
11.7.2 CARBAMYL PHOSPHATE SYNTHETASE DEFICIENCY (CPS) 137
11.7.3 CITRULLINAEMIA 137
11.7.4 N-ACETYLGLUTAMATE SYNTHETASE DEFICIENCY (NAGS) 137
11.7.5 ARGINASE DEFICIENCY (AG) 138
11.7.6 ARGININOSUCCINIC ACIDURIA (ASA) 138
11.7.7 OTHERS 138
11.8 METHYLMALONIC ACIDEMIA 138
11.9 ISOVALERIC ACIDEMIA 139
11.10 ORGANIC ACIDURIAS 140
11.11 RENAL DISEASE 140
11.12 PROPIONIC ACIDEMIA 141
11.13 DISORDERS OF LEUCINE METABOLISM 142
11.14 OTHERS 143
12 NORTH AMERICA MEDICAL FOODS FOR INBORN ERRORS OF METABOLISM MARKET, BY AGE GROUP 144
12.1 OVERVIEW 145
12.2 INFANTS 148
12.3 WEANING 148
12.4 ADOLESCENT 149
12.5 ADULTS 150
13 NORTH AMERICA MEDICAL FOODS FOR INBORN ERRORS OF METABOLISM MARKET, BY FORMS 151
13.1 OVERVIEW 152
13.2 POWDER 155
13.3 LIQUID 155
13.4 TABLETS 156
13.5 GELS 157
13.6 OTHERS 158
14 NORTH AMERICA MEDICAL FOODS FOR INBORN ERRORS OF METABOLISM MARKET, BY PACKAGING 159
14.1 OVERVIEW 160
14.2 CAN 163
14.3 PACKETS 163
14.4 BOTTLE 164
14.5 JAR 165
14.6 OTHERS 165
15 NORTH AMERICA MEDICAL FOODS FOR INBORN ERRORS OF METABOLISM MARKET, BY DISTRIBUTION CHANNEL 167
15.1 OVERVIEW 168
15.2 HOSPITAL PHARMACY 171
15.3 RETAIL PHARMACY 171
15.4 DRUG STORES 172
15.5 ONLINE PHARMACY 173
15.6 OTHERS 173
16 NORTH AMERICA MEDICAL FOODS FOR INBORN ERRORS OF METABOLISM MARKET, BY REGION 175
16.1 NORTH AMERICA 176
16.1.1 U.S. 187
16.1.2 CANADA 194
16.1.3 MEXICO 201
17 NORTH AMERICA MEDICAL FOODS FOR INBORN ERRORS OF METABOLISM MARKET, COMPANY LANDSCAPE 208
17.1 COMPANY SHARE ANALYSIS: NORTH AMERICA 208
18 SWOT ANALYSIS 209
19 COMPANY PROFILE 210
19.1 ABBOTT 210
19.1.1 COMPANY SNAPSHOT 210
19.1.2 REVENUE ANALYSIS 210
19.1.3 COMPANY SHARE ANALYSIS 211
19.1.4 PRODUCT PORTFOLIO 211
19.1.5 RECENT DEVELOPMENT 212
19.2 NESTL HEALTH SCIENCE (A SUBSIDIARY OF NESTL) 213
19.2.1 COMPANY SNAPSHOT 213
19.2.2 COMPANY SHARE ANALYSIS 213
19.2.3 PRODUCT PORTFOLIO 214
19.2.4 RECENT DEVELOPMENT 214
19.3 AJINOMOTO CAMBROOKE, INC. (A SUBSIDIARY OF AJINOMOTO CO., INC.) 215
19.3.1 COMPANY SNAPSHOT 215
19.3.2 COMPANY SHARE ANALYSIS 215
19.3.3 PRODUCT PORTFOLIO 216
19.3.4 RECENT DEVELOPMENTS 216
19.4 MEAD JOHNSON & COMPANY, LLC. (A SUBSIDIARY OF RECKITT BENCKISER GROUP PLC.) 217
19.4.1 COMPANY SNAPSHOT 217
19.4.2 COMPANY SHARE ANALYSIS 217
19.4.3 PRODUCT PORTFOLIO 218
19.4.4 RECENT DEVELOPMENT 218
19.5 NUTRICIA (A SUBSIDIARY OF DANONE) 219
19.5.1 COMPANY SNAPSHOT 219
19.5.2 COMPANY SHARE ANALYSIS 219
19.5.3 PRODUCT PORTFOLIO 220
19.5.4 RECENT DEVELOPMENT 221
19.6 APR 222
19.6.1 COMPANY SNAPSHOT 222
19.6.2 PRODUCT PORTFOLIO 222
19.6.3 RECENT DEVELOPMENT 222
19.7 B.BRAUN SE 223
19.7.1 COMPANY SNAPSHOT 223
19.7.2 PRODUCT PORTFOLIO 223
19.7.3 RECENT DEVELOPMENT 223
19.8 BAXTER 224
19.8.1 COMPANY SNAPSHOT 224
19.8.2 REVENUE ANALYSIS 224
19.8.3 PRODUCT PORTFOLIO 225
19.8.4 RECENT DEVELOPMENT 225
19.9 DR. SCHR AG / SPA 226
19.9.1 COMPANY SNAPSHOT 226
19.9.2 PRODUCT PORTFOLIO 226
19.9.3 RECENT DEVELOPMENT 227
19.10 EBM MEDICAL 228
19.10.1 COMPANY SNAPSHOT 228
19.10.2 PRODUCT PORTFOLIO 228
19.10.3 RECENT DEVELOPMENT 228
19.11 ENER-G FOODS, INC. 229
19.11.1 COMPANY SNAPSHOT 229
19.11.2 PRODUCT PORTFOLIO 229
19.11.3 RECENT DEVELOPMENT 229
19.12 FRESENIUS KABI AG (SUBSIDIARY OF FRESENIUS SE & CO. KGAA) 230
19.12.1 COMPANY SNAPSHOT 230
19.12.2 PRODUCT PORTFOLIO 230
19.12.3 RECENT DEVELOPMENT 230
19.13 GALEN LIMITED 231
19.13.1 COMPANY SNAPSHOT 231
19.13.2 PRODUCT PORTFOLIO 231
19.13.3 RECENT DEVELOPMENTS 231
19.14 HEXAGONNUTRITION LTD. 232
19.14.1 COMPANY SNAPSHOT 232
19.14.2 PRODUCT PORTFOLIO 232
19.14.3 RECENT DEVELOPMENT 232
19.15 KATE FARMS 233
19.15.1 COMPANY SNAPSHOT 233
19.15.2 PRODUCT PORTFOLIO 233
19.15.3 RECENT DEVELOPMENTS 234
19.16 MEIJI HOLDINGS CO., LTD. 235
19.16.1 COMPANY SNAPSHOT 235
19.16.2 REVENUE ANALYSIS 235
19.16.3 PRODUCT PORTFOLIO 236
19.16.4 RECENT DEVELOPMENT 236
19.17 ORPHARMA PTY LTD. 237
19.17.1 COMPANY SNAPSHOT 237
19.17.2 PRODUCT PORTFOLIO 237
19.17.3 RECENT DEVELOPMENT 237
19.18 PIAM FARMACEUTICI S.P.A 238
19.18.1 COMPANY SNAPSHOT 238
19.18.2 PRODUCT PORTFOLIO 239
19.18.3 RECENT DEVELOPMENT 239

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