ADULT ENTERAL NUTRITION PARENTERAL NUTRITION U.S. REGULATORY ENVIRONMENT THE INFANT FORMULA ACT OF The 1986 Amendments

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1 CHAPTER ONE: INTRODUCTION... 1 STUDY GOALS AND OBJECTIVES... 1 REASONS FOR DOING THE STUDY... 1 SCOPE AND FORMAT... 1 METHODOLOGY AND INFORMATION SOURCES... 2 ANALYST CREDENTIALS... 2 RELATED BCC REPORTS... 2 BCC ONLINE SERVICES... 3 DISCLAIMER... 3 CHAPTER TWO: SUMMARY... 4 SUMMARY TABLE MARKET FORECAST FOR GLOBAL ETHICAL NUTRITION PRODUCTS BY CATEGORY, THROUGH 2015 ($ MILLIONS)... 4 SUMMARY FIGURE TOTAL REVENUES OF GLOBAL ETHICAL NUTRITION PRODUCTS BY CATEGORY AT MANUFACTURERS SALES LEVELS ($ MILLIONS)... 5 CHAPTER THREE: INDUSTRY OVERVIEW... 6 DEFINITION OF ETHICAL NUTRITION... 6 HUMAN DIGESTION... 6 STRUCTURES AND FUNCTIONS OF THE GASTROINTESTINAL SYSTEM... 6 Structures and Functions of (Continued)... 7 DIGESTION AND ABSORPTION... 8 Digestion and Absorption (Continued)... 9 Digestion and Absorption (Continued) Digestion and Absorption (Continued) EFFECTS OF AGING NUTRITION TABLE 1 ESSENTIAL NUTRIENTS REQUIRED FOR HEALTH FIGURE 1 DAILY MEAN ENERGY INTAKE FOR PERSONS AGES 2 MONTHS TO 19 YEARS (%) Nutrition (Continued) MALNUTRITION TYPES OF SUPPLEMENTAL NUTRITION Oral Feeding Tube Feeding Total Parenteral Nutrition IMPORTANCE OF THE INDUSTRY HISTORY OF THE INDUSTRY INFANT NUTRITION PEDIATRIC ENTERAL NUTRITION TABLE 2 CONTINUOUS VERSUS INTERMITTENT FEEDINGS... 21

2 ADULT ENTERAL NUTRITION PARENTERAL NUTRITION U.S. REGULATORY ENVIRONMENT THE INFANT FORMULA ACT OF The 1986 Amendments to the Infant Formula Act The 1986 Amendments to the (Continued) REALIGNMENT OF THE CENTER FOR FOOD SAFETY AND APPLIED NUTRITION SAFETY COST CONTAINMENT REIMBURSEMENT TABLE 3 SELECTED HEALTH CARE PROCEDURAL CODES, TABLE 3 (CONTINUED) TABLE 3 (CONTINUED) TABLE 3 (CONTINUED) ADVERTISING ADVERTISING (CONTINUED) WOUND HEALING AND NUTRITION PACKAGING END-USER ISSUES MELAMINE CONTAMINATION PRODUCT RECALLS TABLE 4 INFANT FORMULA PRODUCT RECALLS TABLE 4 (CONTINUED) DEMOGRAPHICS TABLE 5 TOTAL WORLDWIDE BIRTH RATES, BY SELECTED REGIONS, (MILLIONS) FIGURE 2 TOTAL WORLDWIDE BIRTH RATES BY REGION, (MILLIONS) TABLE 6 WORLD POPULATION BY SELECTED AGE GROUPS AND REGIONS, (MILLIONS) FIGURE 3 GLOBAL POPULATION 65+ AND OVER BY REGION 2010 (MILLIONS) FIGURE 4 WORLD POPULATION BY REGIONS, 2010 (MILLIONS) FORMULAS WITH DHA AND ARA ADDED DHA, ARA, AND INFANT GROWTH DHA, ARA, and Infant Growth (Continued) GENETICALLY ENGINEERED HUMAN BREAST MILK ENTERAL VS PARENTERAL NUTRITION INTERNET CAUTIONS PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FIBER-BOOSTED FORMULA FUTURE TRENDS FUTURE TRENDS (CONTINUED)... 48

3 CHAPTER FOUR: INFANT NUTRITION DEFINITION OF INFANT FORMULA INFANT FORMULA REGULATION GENERAL INGREDIENT SAFETY REQUIREMENTS U.S. REQUIREMENTS SPECIFIC TO INFANT FORMULA U.S. Requirements Specific to (Continued) BREAST MILK VS. INFANT FORMULA TABLE 7 PHASES OF BREAST MILK PRODUCTION BREAST MILK VS. INFANT FORMULA (CONTINUED) BREAST MILK VS. INFANT FORMULA (CONTINUED) TABLE 8 NUTRITIONAL COMPARISON OF BREAST MILK AND COMMERCIAL INFANT FORMULAS TABLE 8 (CONTINUED) TABLE 9 VITAMIN COMPOSITION COMPARISON OF BREAST MILK AND COMMERCIAL INFANT FORMULAS NEW GROWTH CHARTS FACTORS IMPACTING INFANT FORMULA GROWTH WIC PROGRAM WIC Program (Continued) WIC Program (Continued) WIC Contract Bidding WIC Contract Bidding (Continued) INFANT FORMULA AND LIFE-LONG OBESITY AND DIABETES MILK-BASED INFANT FORMULA Product Description Product Description (Continued) Product Description (Continued) Product Description (Continued) Product Description (Continued) SOY-BASED INFANT FORMULA Product Description Product Description (Continued) Product Description (Continued) SPECIALIZED AND DISEASE-SPECIFIC INFANT FORMULAS TABLE 10 CONDITIONS AFFECTING NUTRITION TABLE 10 (CONTINUED) Specialized and Disease-Specific (Continued) Product Description INFANT NUTRITION MARKET ANALYSIS TABLE 11 MARKET FORECAST FOR GLOBAL INFANT NUTRITION PRODUCTS BY CATEGORY, THROUGH 2015 ($ MILLIONS) FIGURE 5 MARKET FORECAST FOR GLOBAL INFANT NUTRITION PRODUCTS BY CATEGORY, ($ MILLIONS)... 81

4 TABLE 12 MARKET SHARE FOR GLOBAL INFANT NUTRITION PRODUCTS BY CATEGORY, (%) FIGURE 6 REVENUE DISTRIBUTION FOR GLOBAL INFANT NUTRITION PRODUCTS BY CATEGORY, (%) GLOBAL INFANT NUTRITION MARKET ANALYSIS BY REGION TABLE 13 GLOBAL INFANT NUTRITION MARKET SHARE BY SELECTED GEOGRAPHIC REGIONS 2010 (%) FIGURE 7 GLOBAL INFANT NUTRITION MARKET SHARE BY SELECTED GEOGRAPHIC REGIONS 2010 (%) MILK-BASED INFANT FORMULA TABLE 14 GLOBAL MILK-BASED INFANT FORMULA: MANUFACTURERS MARKET SHARE, 2010 (% FIGURE 8 GLOBAL MILK-BASED INFANT FORMULA: MANUFACTURERS MARKET SHARE, 2010 (%) SOY-BASED INFANT FORMULA TABLE 15 GLOBAL SOY-BASED INFANT FORMULA: MANUFACTURERS MARKET SHARE, 2010 (%) FIGURE 9 GLOBAL SOY-BASED INFANT FORMULA: MANUFACTURERS MARKET SHARE, 2010 (%) SPECIALIZED AND DISEASE-SPECIFIC INFANT FORMULAS TABLE 16 GLOBAL SPECIALIZED AND DISEASE-SPECIFIC INFANT FORMULA: MANUFACTURERS MARKET SHARE, 2010 (%) FIGURE 10 GLOBAL SPECIALIZED AND DISEASE-SPECIFIC INFANT FORMULA: MANUFACTURERS MARKET SHARE, 2010 (%) CHAPTER FIVE: ENTERAL NUTRITION INTRODUCTION INTRODUCTION (CONTINUED) INTRODUCTION (CONTINUED) TABLE 17 ENTERAL FEEDING ROUTES TABLE 18 ENTERAL FEEDING: ADMINISTRATION METHODS TABLE 18 (CONTINUED) INTRODUCTION (CONTINUED) INTRODUCTION (CONTINUED) FACTORS IMPACTING GROWTH INTACT ENTERAL FORMULA PRODUCT DESCRIPTION MODULAR ENTERAL FORMULA PRODUCT DESCRIPTION DISEASE-SPECIFIC ENTERAL FORMULA DISEASE-SPECIFIC ENTERAL FORMULA (CONTINUED) PRODUCT DESCRIPTION

5 Product Description (Continued) ELEMENTAL AND REHYDRATION ENTERAL FORMULA PRODUCT DESCRIPTION TABLE 19 SELECTED PEDIATRIC NUTRITIONAL COMPOSITIONS TABLE 19 (CONTINUED) ENTERAL NUTRITION MARKET ANALYSIS TABLE 20 MARKET FORECAST FOR GLOBAL ENTERAL NUTRITION PRODUCTS BY CATEGORY, THROUGH 2015 ($ MILLIONS) FIGURE 11 MARKET FORECAST FOR GLOBAL ENTERAL NUTRITION PRODUCTS BY CATEGORY, ($ MILLIONS) TABLE 21 MARKET SHARE OF GLOBAL ENTERAL NUTRITION PRODUCTS BY CATEGORY, (%) FIGURE 12 DISTRIBUTION OF REVENUES FROM GLOBAL ENTERAL NUTRITION PRODUCTS BY CATEGORY, (%) GLOBAL ENTERAL MARKET ANALYSIS BY REGION TABLE 22 GLOBAL ENTERAL NUTRITION MARKET SHARE BY SELECTED GEOGRAPHIC REGIONS, 2010 (%) FIGURE 13 GLOBAL ENTERAL NUTRITION MARKET SHARE BY SELECTED GEOGRAPHIC REGIONS 2010 (%) INTACT ENTERAL NUTRITION TABLE 23 GLOBAL INTACT ENTERAL NUTRITION MANUFACTURERS MARKET SHARE, 2010 (%) FIGURE 14 GLOBAL INTACT ENTERAL NUTRITION: MANUFACTURERS MARKET SHARE, 2010 (%) MODULAR ADULT ENTERAL NUTRITION TABLE 24 GLOBAL MODULAR ENTERAL: FORMULA MANUFACTURERS MARKET SHARE, 2010 (%) FIGURE 15 GLOBAL MODULAR ENTERAL FORMULA: MANUFACTURERS MARKET SHARE, 2010 (%) DISEASE-SPECIFIC ADULT FORMULAS TABLE 25 GLOBAL DISEASE-SPECIFIC ADULT FORMULA: MANUFACTURERS MARKET SHARE, 2010 (%) FIGURE 16 GLOBAL DISEASE-SPECIFIC FORMULA: MANUFACTURERS MARKET SHARE, 2010 (%) ELEMENTAL AND REHYDRATION FORMULAS TABLE 26 GLOBAL ELEMENTAL AND REHYDRATION FORMULA: MANUFACTURERS MARKET SHARE, 2010 (%) FIGURE 17 GLOBAL ELEMENTAL AND REHYDRATION FORMULA: MANUFACTURERS MARKET SHARE, 2010 (%) CHAPTER SIX: PARENTERAL NUTRITION INTRODUCTION INTRODUCTION (CONTINUED) PHOTODEGRADATION/OXIDATION REACTIONS SORPTION LOSSES

6 HYDROLYSIS REACTIONS COPRECIPITATION FROM DEGRADATION PRODUCTS METABOLIC AND BIOCHEMICAL FACTORS CONTRIBUTING TO VITAMIN DEFICIENCY THIAMINE STATUS IN TPN VITAMIN C OTHER VITAMIN DEFICIENCIES TPN AND CANCER PATIENTS TPN AND CANCER PATIENTS (CONTINUED) FACTORS IMPACTING GROWTH AMINO ACID PARENTERAL FORMULA PRODUCT DESCRIPTION FATS PARENTERAL FORMULA PRODUCT DESCRIPTION DEXTROSE PARENTERAL FORMULA PRODUCT DESCRIPTION MICRONUTRIENT AND MULTIVITAMIN PARENTERAL FORMULAS PRODUCT DESCRIPTION TABLE 27 RECOMMENDATIONS FOR PARENTERAL VITAMIN INTAKE TABLE 28 RECOMMENDATIONS FOR PARENTERAL MINERAL INTAKE TABLE 29 FACTORS THAT INCREASE OR DECREASE ELECTROLYTE NEEDS GLOBAL PARENTERAL NUTRITION MARKET ANALYSIS TABLE 30 MARKET FORECAST FOR GLOBAL PARENTERAL NUTRITION PRODUCTS, THROUGH 2015 ($ MILLIONS) FIGURE 18 MARKET FORECAST FOR GLOBAL PARENTERAL NUTRITION PRODUCTS BY CATEGORY, ($ MILLIONS) TABLE 31 MARKET SHARE OF GLOBAL PARENTERAL NUTRITION PRODUCTS BY CATEGORY, (%) FIGURE 19 DISTRIBUTION OF REVENUES FROM GLOBAL PARENTERAL NUTRITION PRODUCTS BY CATEGORY, (%) GLOBAL PARENTERAL MARKET ANALYSIS BY REGION TABLE 32 GLOBAL ENTERAL NUTRITION MARKET SHARE BY SELECTED GEOGRAPHIC REGIONS, 2010 (%) FIGURE 20 GLOBAL ENTERAL NUTRITION MARKET SHARE BY SELECTED GEOGRAPHIC REGIONS 2010 (%) AMINO ACID PARENTERAL FORMULAS TABLE 33 GLOBAL AMINO ACID PARENTERAL SOLUTION: MANUFACTURERS MARKET SHARE, 2010 ($ MILLIONS)

7 FIGURE 21 GLOBAL AMINO ACID PARENTERAL SOLUTION: MANUFACTURERS MARKET SHARE, 2010 (%) FATS PARENTERAL FORMULAS TABLE 34 GLOBAL FATS PARENTERAL FORMULA: MANUFACTURERS MARKET SHARE, 2010 ($ MILLIONS) FIGURE 22 GLOBAL FATS PARENTERAL FORMULA: MANUFACTURERS MARKET SHARE, 2010 (%) DEXTROSE PARENTERAL FORMULAS TABLE 35 GLOBAL DEXTROSE PARENTERAL FORMULA: MANUFACTURERS MARKET SHARE, 2010 ($ MILLIONS) FIGURE 23 GLOBAL DEXTROSE PARENTERAL FORMULA: MANUFACTURERS MARKET SHARE, 2010 (%) MICRONUTRIENT AND MULTIVITAMIN PARENTERAL FORMULAS TABLE 36 GLOBAL MICRONUTRIENT AND MULTIVITAMIN PARENTERAL FORMULA: MANUFACTURERS MARKET SHARE, 2010 (%) FIGURE 24 GLOBAL MICRONUTRIENT AND MULTIVITAMIN PARENTERAL FORMULA: MANUFACTURERS MARKET SHARE, 2010 (%) CHAPTER SEVEN: TOTAL GLOBAL ETHICAL NUTRITION MARKET SUMMARY TABLE 37 MARKET FORECAST FOR GLOBAL ETHICAL NUTRITION PRODUCTS BY CATEGORY, THROUGH 2015 ($ MILLIONS) FIGURE 25 MARKET FORECAST FOR GLOBAL ETHICAL NUTRITION PRODUCTS BY CATEGORY, ($ MILLIONS) TOTAL GLOBAL MARKET FOR ETHICAL NUTRITION BY REGION TABLE 38 GLOBAL ETHICAL NUTRITION MARKET REVENUES BY SELECTED GEOGRAPHIC REGIONS, 2010 ($ MILLIONS/%) FIGURE 26 GLOBAL ENTERAL NUTRITION MARKET SHARE BY SELECTED GEOGRAPHIC REGIONS, 2010 (%) TOTAL GLOBAL MARKET PERCENTAGE BY PRODUCT TYPE TABLE 39 TOTAL REVENUES, MARKET SHARES, AND NUMBERS OF MANUFACTURERS OF GLOBAL ETHICAL NUTRITION PRODUCTS BY MARKET SEGMENT, 2010 ($ MILLIONS) FIGURE 27 PERCENT SHARES OF GLOBAL ETHICAL NUTRITION PRODUCTS BY MARKET SEGMENT, 2010 (%) CHAPTER EIGHT: GLOBAL ETHICAL NUTRITION COMPETITOR MARKET SHARE, GLOBAL ETHICAL NUTRITION COMPETITOR TABLE 40 GLOBAL ETHICAL NUTRITION COMPETITOR ANALYSIS BY MARKET SHARE (%)

8 FIGURE 28 GLOBAL ETHICAL NUTRITION COMPETITOR ANALYSIS BY MARKET SHARE (%) INDUSTRY PARTICIPANTS BY PRODUCT TYPE TABLE 41 ETHICAL NUTRITION INDUSTRY PARTICIPANTS BY PRODUCT CATEGORY, CHAPTER NINE: COMPANY PROFILES ABBOTT NUTRITION DIVISION HISTORY REVENUE HISTORY CORPORATE MANAGEMENT BAXTER INTERNATIONAL, INC COMPANY HISTORY REVENUE HISTORY CORPORATE MANAGEMENT B. BRAUN MELSUNGEN AG COMPANY HISTORY REVENUE HISTORY CORPORATE MANAGEMENT DANONE COMPANY HISTORY REVENUE HISTORY CORPORATE MANAGEMENT FRESENIUS KABI, LTD HISTORY REVENUE HISTORY CORPORATE MANAGEMENT MEAD JOHNSON NUTRITIONAL GROUP COMPANY HISTORY REVENUE HISTORY CORPORATE MANAGEMENT NESTLÉ USA, INC NESTLÉ MEDICAL NUTRITION HISTORY REVENUE HISTORY CORPORATE MANAGEMENT PBM PRODUCTS, LLC PERRIGO HISTORY REVENUE HISTORY CORPORATE MANAGEMENT APPENDIX APPENDIX APPENDIX (CONTINUED)

9 APPENDIX (CONTINUED) APPENDIX (CONTINUED) APPENDIX (CONTINUED)

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