Clinical Nutrition November 2012

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CHAPTER ONE: EXECUTIVE SUMMARY ..........................................................1

Introduction ......................................................................................................................... 1
Infant Nutrition.................................................................................................................. 1
Enteral Nutrition................................................................................................................ 2
Parenteral Nutrition ........................................................................................................... 2
Scope and Methodology ...................................................................................................... 3
Size and Growth of the Market .......................................................................................... 4
Issues and Trends Affecting the Market ........................................................................... 7
Leading Competitors ........................................................................................................... 8

CHAPTER TWO: INTRODUCTION TO THE CLINICAL NUTRITION

INDUSTRY ...................................................................................................................9
Introduction and History of Nutrition in the Clinical Setting ......................................... 9
Defining Clinical Nutrition ............................................................................................... 10
Infant Nutrition................................................................................................................ 10
Enteral Nutrition.............................................................................................................. 10
Parenteral Nutrition ......................................................................................................... 11
Regulatory Environment .................................................................................................. 12
Environments for Clinical Nutrition................................................................................ 15
Hospital Settings ............................................................................................................. 15
United States ........................................................................................................ 15
International ......................................................................................................... 18
Skilled Nursing Settings .................................................................................................. 19
United States ........................................................................................................ 19
International ......................................................................................................... 21
Home Care Settings......................................................................................................... 21
Hospice ................................................................................................................. 23
Essential Nutrients............................................................................................................. 26
Carbohydrates ................................................................................................................. 27
Proteins............................................................................................................................ 27
Fats .................................................................................................................................. 28
Vitamins .......................................................................................................................... 28
Minerals........................................................................................................................... 28
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Demographics and Statistics ............................................................................................ 31

Worldwide Demographics .............................................................................................. 31
Global Aging Population ..................................................................................... 34
U.S. Demographics ......................................................................................................... 39
U.S. Aging Population ......................................................................................... 40
Cancer and Nutrition....................................................................................................... 43
Cardiovascular Disease and Nutrition ................................................................. 50
Diabetes and Nutrition ......................................................................................... 52
HIV/AIDS and Nutrition ..................................................................................... 54
Obesity and Nutrition........................................................................................... 56
Summary of Diseases ..................................................................................................... 62

CHAPTER THREE: INFANT NUTRITION .........................................................69

Overview ............................................................................................................................ 69
Product Categories............................................................................................................ 78
Milk-based Formulas ...................................................................................................... 79
Soy-based Formulas........................................................................................................ 80
Elemental Formulas ........................................................................................................ 80
Follow-Up Formulas ....................................................................................................... 81
Organic Infant Formula .................................................................................................. 81
Probiotic/Prebiotic Infant Formula ................................................................................. 82
Premature Infant Formulas ............................................................................................. 83
Newborn Formulas ......................................................................................................... 84
Other Specialized Formulas ............................................................................................ 84
Research & Development Trends .................................................................................... 86
Market Size and Growth .................................................................................................. 86
Global Market Introduction ............................................................................................ 86
Sales by Product Type .................................................................................................... 89
Global Markets ............................................................................................................... 91
Competitive Analysis ........................................................................................................ 96

CHAPTER FOUR: ENTERAL NUTRITION ......................................................102

Overview .......................................................................................................................... 102
Product Categories.......................................................................................................... 109
Industry Developments ................................................................................................... 114
Current Developments .................................................................................................. 114
Recent Business Activities ........................................................................................... 115
New Product Launches ................................................................................................. 115
Market Size and Growth ................................................................................................ 116
Global Market Introduction .......................................................................................... 116
Sales by Product Type .................................................................................................. 120
Global Markets ............................................................................................................. 122
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Competitive Analysis ....................................................................................................... 126

CHAPTER FIVE: PARENTERAL NUTRITION ...............................................133

Overview........................................................................................................................... 133
Product Categories .......................................................................................................... 139
Amino Acids ................................................................................................................. 139
Dextrose ........................................................................................................................ 139
Fats ................................................................................................................................ 140
Nutritional Additives ..................................................................................................... 140
Industry Developments ................................................................................................... 146
Market Size and Growth................................................................................................. 146
Global Market Introduction ........................................................................................... 146
Sales by Product Type ................................................................................................... 150
Global Markets .............................................................................................................. 152
Competitive Analysis ....................................................................................................... 156

CHAPTER SIX: TOTAL MARKET SIZE AND FORECAST ..........................163

Total Market Size and Forecast ..................................................................................... 163
Global Market Overview............................................................................................... 163
Sales by Broad Market Segment ................................................................................... 166
Markets by Geographic Region..................................................................................... 171
Competitor Analysis ........................................................................................................ 174

CHAPTER SEVEN: ISSUES AND TRENDS AFFECTING

THE NUTRITION MARKET ...............................................................................177
Introduction ..................................................................................................................... 177
Wound Care applications ............................................................................................... 178
Parenteral Nutrition Shortages ...................................................................................... 179
Infant Formulas or Breast Milk: A Controversial Topic............................................. 187
Breast Feeding Rates in the U.S. ................................................................................... 187
WHO ............................................................................................................................. 190
Manufacturer Marketing of Infant Formula .................................................................. 191
Reimbursement of Nutrition Products .......................................................................... 192
Food Programs ................................................................................................................198
WIC ............................................................................................................................... 198
WIC Contracts ............................................................................................................... 205
Other Programs for Infant Formula Reimbursement .................................................... 205
Cost Containment ............................................................................................................ 206

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Nutrition and Education................................................................................................. 206

206
The Registered Dietician .............................................................................................. 207
Dietician Statistics in the United States ........................................................................ 208
DHA and ARA Additives ............................................................................................... 209
Counterfeit Infant Formulas .......................................................................................... 210
Recalls for Infant Formulas ........................................................................................... 211
Industry Acquisitions, Mergers and Alliances ............................................................. 214
Enteral Feeding Pumps .................................................................................................. 217
Abbott Laboratories ........................................................................................... 218
Caesarea Medical Electronics ............................................................................ 218
Covidien/Kendall ............................................................................................... 219
Fresenius Kabi ................................................................................................... 219
Nestle Nutrition.................................................................................................. 219
Moog, Inc. .......................................................................................................... 220

CHAPTER EIGHT: CORPORATE PROFILES .................................................221

Introduction ..................................................................................................................... 221
Abbott............................................................................................................................... 223
Baxter ............................................................................................................................... 225
B Braun ............................................................................................................................ 227
Danone ............................................................................................................................. 229
Fresenius Kabi ................................................................................................................. 231
Hospira ............................................................................................................................. 233
Mead Johnson Nutrition................................................................................................. 235
Nestl ................................................................................................................................ 237
Perrigo .............................................................................................................................. 239
Pfizer ................................................................................................................................ 241

APPENDIX: COMPANY DIRECTORY ..............................................................243

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CHAPTER ONE: EXECUTIVE SUMMARY

Table 1-1
The Global Market for Clinical Nutrition, 2008-2016 ...................................................... 5
Figure 1-1
The Global Market for Clinical Nutrition 2008-2016 ....................................................... 6

CHAPTER TWO: INTRODUCTION TO THE CLINICAL NUTRITION

INDUSTRY
Table 2-1
Nutrient Requirements for Infant Formulas as Required by the FDA Infant Formula Act ...14
Table 2-2
U.S. Registered Hospitals by Type, 2010 ....................................................................... 16
Figure 2-1
Number of Hospitals in the US, 1975-2005, Estimated 2015 ......................................... 17
Table 2-3
Statistics for U.S. Hospitals, 2010................................................................................... 17
Table 2-4
U.S. Hospital Length of Stay, Average by Age Group ................................................... 18
Table 2-5
Registered Hospitals and Acute Care Centers by Country.............................................. 19
Figure 2-2
Number of Nursing Homes, 2000-2010 .......................................................................... 20
Table 2-6
Estimated Nursing Service Establishments and Care Centers by Country ..................... 21
Figure 2-3
Number of Home Care Agencies in the U.S., 1980-2009 ............................................... 22
Figure 2-4
Growth in Hospice Programs in the United States, 1998-2009....................................... 23
Figure 2-5
Patients Served with Hospice Programs in the United States, 1998-2009 ..................... 24
Table 2-7
Percentage of Hospice Admissions by Primary Diagnosis, 2005 -2009 ........................ 25
Table 2-8
Hospice Cases by Diagnosis, 2010 Estimates ................................................................. 26

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Table 2-9
Essential Nutrients for Human Health ............................................................................ 30
Table 2-10
World Population by Selected Geographical Region, 2010 - 2050 ................................ 32
Figure 2-6
World Population by Selected Geographical Region, 20102050 ................................. 33
Table 2-11
Percent Population Over 65 by Year and Region, 2010-2050 ........................................ 35
Table 2-12
International Population Trend Age 65+ ........................................................................ 36
Figure 2-7
International Population Trend Age 65+ ........................................................................ 37
Figure 2-8
Estimated World Population by Age, 2010 and 2050..................................................... 38
Table 2-13
The U.S. Population, 1980-2050 .................................................................................... 39
Figure 2-9
The U.S. Population, 1980-2050 .................................................................................... 40
Table 2-14
United States Population Trend Age 65+ ....................................................................... 41
Figure 2-10
United States Population Trend Age 65+ ....................................................................... 42
Table 2-15
World Cancer Incidence by Selected Types of Cancer, 2010 and 2020, all races, both
sexes................................................................................................................................ 45
Figure 2-11
Estimated and Projected World Cancer Incidence by Selected Types of Cancer, 2010
and 2020 ......................................................................................................................... 46
Table 2-16
Total Cancer Incidence by Sex and Country, 2010 Estimates ........................................ 47
Figure 2-12
Total Cancer Incidence by Sex and Country, 2010 Estimates ........................................ 48
Table 2-17
Summary of Strength of Evidence on Lifestyle Factors and Risk of Developing Cancer.... 49
Table 2-18
Summary of Strength of Evidence on Lifestyle Factors and Risk of Developing
Cardiovascular Diseases ................................................................................................. 51

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Table 2-19
Summary of Strength of Evidence on Lifestyle Factors and Risk of Developing Type 2
Diabetes ........................................................................................................................... 53
Table 2-20
Total Number of People Living with HIV/AIDS, Newly Infected Population and
Deaths, 2010 by Region .................................................................................................. 54
Figure 2-13
The Role of Nutrition Education as HIV Infection Develops ......................................... 55
Table 2-21
Estimated Obesity by Country, 2009 Estimates .............................................................. 57
Figure 2-14
Estimated Obesity by Country as a Portion of Total Population 2009 Estimates ........... 58
Figure 2-15
Increases in Obesity by Country2007 and 2009 Figures ............................................. 59
Table 2-22
Summary of Strength of Evidence on Factors that Might Promote or Protect Against
Weight Gain and Obesity ................................................................................................ 61
Table 2-23
Classification of Overweight in Adults According to BMI ............................................ 62
Table 2-24
Prevalence/Incidence of Diseases by Type, 2010 Estimates ........................................... 63
Figure 2-16
Prevalence/Incidence of Disease by Type, 2010 Estimates ............................................ 64
Figure 2-17
Prevalence/Incidence of Disease by Type, 2010 Estimates ............................................ 65
Table 2-25
Disease Mortality by Type, 2010 Estimates.................................................................... 66
Figure 2-18
Disease Mortality by Type, 2010 Estimates.................................................................... 67
Figure 2-19
Disease Mortality by Type, 2010 Estimates.................................................................... 68

CHAPTER THREE: INFANT NUTRITION

Table 3-1
Composition of Breast Milk (early and mature range) and Select Infant Formulas........ 72
Table 3-2
Live Births and Birth Rates by Country* ........................................................................ 74
Figure 3-1
Live Births by Country..................................................................................................... 75
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Figure 3-2
Births Rates by Country.................................................................................................. 76
Figure 3-3
Children Under 5 Years................................................................................................... 77
Table 3-3
Marketed Infant Formulas (Manufacturer, Product Types, and Product Lines) ............ 85
Table 3-4
The Market for Infant Nutrition 2008-2016 ................................................................... 87
Figure 3-4
The Global Market for Infant Nutrition 2008-2016........................................................ 88
Table 3-5
The Global Market for Infant Nutrition by Product Type 2012 .................................... 90
Figure 3-5
The Global Market for Infant Nutrition by Product Type 2012 .................................... 90
Table 3-6
The Global Market for Infant Nutrition Estimated Products Sales by Select Geographic
Region, 2012 ................................................................................................................... 94
Figure 3-6
The Global Market for Infant Nutrition Market Share by Select Geographic Region,
2012 ................................................................................................................................ 95
Table 3-7
The Global Market for Infant Nutrition Estimated Revenues and Market Share of
Leading Suppliers, 2012 ................................................................................................. 97
Figure 3-7
The Global Market for Infant Nutrition Estimated Market Share by Leading Suppliers
2012 ................................................................................................................................ 98
Table 3-8
The Global Market for Infant Nutrition Estimated Market Shares by Region for Leading
Suppliers 2012 ................................................................................................................ 99
Figure 3-8
Estimated Infant Formula U.S. Market Shares for Leading Suppliers 2012 ................ 100
Figure 3-9
Estimated Infant Formula Market Shares Outside the U.S. for Leading Suppliers 2012 ... 100

CHAPTER FOUR: ENTERAL NUTRITION 

Table 4-1
Aging Population, Percent of Total Population, and Annual Growth by Country, 2012 ..105
Figure 4-1
Over 65 Population by Country .................................................................................... 106

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Figure 4-2
Over 65 Population as a Percent of Total Population by Country, 2012 ...................... 107
Figure 4-3
Over 65 Annual Population Growth by Country........................................................... 108
Table 4-2
Marketed Pediatric and Adult Enteral Formulas (Manufacturer, Product Types, and
Product Lines) ............................................................................................................... 110
Table 4-3
The Market for Enteral Nutrition 2008-2016 ................................................................ 118
Figure 4-4
The Global Market for Enteral Nutrition 2008-2016 .................................................... 119
Table 4-4
The Global Market for Enteral Nutrition by Product Type, 2012 ................................. 121
Figure 4-5
The Global Market for Enteral Nutrition by Product Type, 2012 ................................. 121
Table 4-5
The Global Market for Enteral Nutrition Estimated Products Sales by Select Geographic
Region, 2012 ................................................................................................................. 124
Figure 4-6
The Global Market for Enteral Nutrition Market Share by Geographic Region, 2012 ...... 125
Table 4-6
The Global Market for Enteral Nutrition Estimated Revenues and Market Share of
Leading Suppliers, 2012................................................................................................ 127
Figure 4-7
The Global Market for Enteral Nutrition Estimated Market Share by Leading Suppliers,
2012 ............................................................................................................................... 128
Table 4-7
The Global Market for Enteral Nutrition Estimated Market Shares by Region for
Leading Suppliers, 2012................................................................................................ 129
Figure 4-8
The Global Market for Enteral Nutrition Estimated U.S. Market Shares for Leading
Suppliers, 2012 .............................................................................................................. 130
Figure 4-9
The Global Market for Enteral Nutrition Estimated Market Shares Outside the U.S. for
Leading Suppliers, 2012................................................................................................ 131

CHAPTER FIVE: PARENTERAL NUTRITION

Table 5-1
Aging Population, Percent of Total Population, and Annual Growth by Country*, 2012 .. 135

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Figure 5-1
Over 65 Population by Country .................................................................................... 136
Figure 5-2
Over 65 Population as a Percent of Total Population by Country, 2012 ...................... 137
Figure 5-3
Over 65 Annual Population Growth by Country .......................................................... 138
Table 5-2
Standard Electrolyte Requirements .............................................................................. 141
Table 5-3
Standard Parenteral Multivitamin Package* Vitamin................................................... 142
Table 5-4
Standard Parenteral Trace Elements Package ............................................................... 143
Table 5-5
Single Parenteral Trace Element Formulations ............................................................ 143
Table 5-6
Major Marketed Parenteral Formulas (Manufacturer, Product Types, and Product
Lines) ............................................................................................................................ 144
Table 5-7
The Market for Parenteral Nutrition 2008-2016 ........................................................... 148
Figure 5-4
The Global Market for Parenteral Nutrition 2008-2016 ............................................... 149
Table 5-8
The Global Market for Parenteral Nutrition by Product Type* 2012 .......................... 151
Figure 5-5
The Global Market for Parenteral Nutrition by Product Type* 2012 .......................... 151
Table 5-9
The Global Market for Parenteral Nutrition Estimated Products Sales by Select
Geographic Region, 2012 ............................................................................................. 154
Figure 5-6
The Global Market for Parenteral Nutrition Market Share by Select Geographic Region,
2012 .............................................................................................................................. 155
Table 5-10
The Global Market for Parenteral Nutrition Estimated Revenues and Market Share of
Leading Suppliers 2012 ................................................................................................ 157
Figure 5-7
The Global Market for Parenteral Nutrition Estimated Market Share by Leading
Suppliers 2012 .............................................................................................................. 158
Table 5-11
The Global Market for Parenteral Nutrition Estimated Market Shares by Region for
Leading Suppliers 2012 ................................................................................................ 159
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Figure 5-8
The Global Market for Parenteral Nutrition Estimated U.S. Market Shares for Leading
Suppliers 2012 ............................................................................................................... 160
Figure 5-9
The Global Market for Parenteral Nutrition Estimated Market Shares Outside the U.S.
for Leading Suppliers 2012 ........................................................................................... 161

CHAPTER SIX: TOTAL MARKET SIZE AND FORECAST

Table 6-1
The Global Market for Clinical Nutrition 2008-2016 ................................................... 164
Figure 6-1
The Global Market for Clinical Nutrition 2008-2016 ................................................... 165
Table 6-2
The Global Market for Clinical Nutrition by Product Type 2008-2016 ...................... 167
Figure 6-2
The Global Market for Clinical Nutrition by Type 2008-2016 .................................... 168
Figure 6-3
The Global Market for Clinical Nutrition by Type 2012 ............................................. 169
Figure 6-4
The Global Market for Clinical Nutrition by Type 2016 ............................................. 170
Table 6-3
The Global Market for Clinical Nutrition by Country 2008, 2010 and 2012................ 172
Figure 6-5
The Global Market for Clinical Nutrition by Country 2008, 2010 and 2012............... 173
Table 6-4
Leading Suppliers Clinical Nutrition Revenues and Significant Segments of
Participation, 2012 ........................................................................................................ 175
Figure 6-6
Leading Suppliers Clinical Nutrition Estimated Market Shares, 2012 ......................... 176

CHAPTER SEVEN: ISSUES AND TRENDS AFFECTING THE NUTRITION

MARKET
Table 7-1
Nutrition Products with Specific Wound Management Benefits .................................. 179
Table 7-2
Parenteral Nutrition Shortages, updated September 2012............................................. 180
Table 7-3
U.S. National Breastfeeding Statistics .......................................................................... 188
Figure 7-1
U.S. National Breastfeeding Statistics .......................................................................... 189
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Table 7-4
Medicare Reimbursement for Home Parenteral and Enteral Nutrition; DME MAC.... 193
Table 7-5
Enteral Product Classification, 2012 ............................................................................ 195
Table 7-6
Example of DMEPOS Fee Schedule for Common Enteral Items, 2012 Fee Schedule ..... 196
Table 7-7
Example of DMEPOS Fee Schedule for Common Parenteral Items, 2012 Fee Schedule . 197
Table 7-8
WIC Participants by Participant Category in 2006, 2009, 2010 ................................... 199
Figure 7-2
Distribution of WIC Participants by Type, 2006 .......................................................... 200
Figure 7-3
Distribution of WIC Participants by Type, 2010 .......................................................... 201
Table 7-9
WIC Agencies and Distribution of Participants by State, 2010.................................... 202
Table 7-10
Dieticians and Nutritionists by Facility Type, 2011 ..................................................... 208
Table 7-11
Highest Number of Dieticians and Nutritionists by State, 2011 ................................... 209
Table 7-12
Highest Concentration of Dieticians and Nutritionists by State, 2011 ......................... 209
Table 7-13
Recalls of Infant Feeding Products, 2001-2012............................................................ 213
Table 7-14
Selected Enteral Feeding Pumps................................................................................... 220

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Two: Introduction to the Clinical Nutrition Industry

35

Table 2-11

Percent Population Over 65 by Year and Region, 2010-2050

Year

Africa

Asia

Europe

North
America

Oceania

South
America

World
7.8%
9.6%
12.1%
14.8%
16.8%

2010
2020
2030
2040
2050

Figures may not add up due to rounding.

Source: U.S. Census Bureau, World Health Organization.

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Three: Infant Nutrition

70

There are several types of malnutrition:

x

Protein-energy malnutrition

Vitamin A deficiency

Iron deficiency anemia

Iodine deficiency disorder

Overeating, obesity

After birth the infant becomes totally dependent on the outside environment
and is reliant on its parents to provide all its needs. If the infant is given an
imbalanced diet, signs of specific nutritional deficiencies will develop. Some of these
may appear almost immediately, others only after many weeks or months, depending
on the state of the body stores of the specific nutrient involved.
Breast-feeding is noted by leading organizations, physicians, and other experts
as the best choice for feeding a healthy infant. The composition of breast milk is a
perfect match for each child, containing all of the essential nutrients and antibodies a
baby needs. This results in less diarrhea, constipation and digestive upsets three
conditions which exacerbate malnutrition in infants. Antibodies in breast milk are
equally important as the nutrients as it provides the baby with the ability to fight off
disease and improve immune system function. Breast milk advantages over formula
are significantly noted in the ability for breast milk to change and adapt in
composition and providing nutrients with the babys growing needs.
There are three major components of breast milk:
x

fats

carbohydrates

proteins

Fat is required in the infants diet for optimal growth and development and
providing an energy source. Breast milk fat provides about half of the milks calories
and is its most variable component with fat ranges from 30 to 50 g/L.
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Four: Parenteral Nutrition

140

Fats
Fats are the most concentrated form of energy and are derived from animal
fats and vegetable oils. Fats supply 9 kcal of energy per gram, as compared with 4
kcal from glucose and protein. Fats are 98% triglycerides. Fats in the form of
triglycerides supply approximately two thirds of the cells total energy requirements
Fats are categorized into saturated or unsaturated. The degree of hydrogen saturation
refers to the number of double bonds between the carbon atoms in the chain. If a fatty
acid chain contains all the hydrogen molecules possible with no double bonds, it is
called a saturated fatty acid. Those fatty acids with one double bond are types a
monounsaturated, and those with several double bonds are polyunsaturated fatty
acids. All tissues in the body, with the exception of brain cells, can metabolize and
use fats as an energy source as effectively as glucose. There are several brands of fat
emulsion products available, including Intralipid by Fresenius, Lipofundin by
B/Braun and Liposyn II and III by Hospira.
Nutritional Additives
Nutritional additives replace lost electrolytes in the body. Electrolyte
imbalances are widespread in many pathophysiologic conditions. An imbalance of an
electrolyte may be a total body imbalance or it may be an imbalance in distribution of
electrolytes within compartments. Electrolyte solutions attempt to correct imbalances
that may have occurred in the body but infusing a standard or special electrolyte
solution.

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