CHAPTER ONE: INTRODUCTION ............ 1
STUDY GOALS AND OBJECTIVES ......... 1
REASONS FOR DOING THE STUDY .......... 1
SCOPE OF REPORT .......... 1
INTENDED AUDIENCE ............ 2
METHODOLOGY AND INFORMATION SOURCES ....... 2
ANALYST'S CREDENTIALS ............. 2
RELATED BCC REPORTS ............ 3
BCC ONLINE SERVICES .......... 3
DISCLAIMER ............. 3
CHAPTER TWO: SUMMARY .......... 4
SUMMARY .............. 4
SUMMARY TABLE GLOBAL SALES OF PROBIOTIC INGREDIENTS,
SUPPLEMENTS, AND FOODS THROUGH 2015 ($ MILLIONS) .. 5
SUMMARY FIGURE PROJECTED SHARES OF GLOBAL SALES OF
PROBIOTIC INGREDIENTS, SUPPLEMENTS, AND FOODS, 2010
AND 2015 (%) ............... 5
CHAPTER THREE: OVERVIEW ............ 6
BACKGROUND .............. 6
INDUSTRY CONCEPTS ............ 7
PROBIOTICS AND INTESTINAL HEALTH ......... 7
RESIDENT AND TRANSIENT PROBIOTICS ....... 7
PROBIOTIC CLASSIFICATION AND LABELING ....... 8
PREBIOTICS ............ 8
SYNBIOTICS ........... 9
PROBIOTIC DELIVERY SYSTEM ......... 9
IMPORTANCE OF PROBIOTICS ........... 9
FORESEEABLE DEVELOPMENTS ........ 10
CHAPTER FOUR: THE GLOBAL PROBIOTIC INGREDIENTS INDUSTRY ... 11
INTRODUCTION ............. 11
STRUCTURE OF THE GLOBAL PROBIOTIC INGREDIENTS
INDUSTRY .............. 11
GLOBAL LEADERS .......... 12
Strategic Alliances, Agreements, and Acquisitions ... 13
BioGaia Partners .......... 13
Collaboration agreement with SCA ...... 13
BioGaia and Ferring Pharmaceuticals ..... 14
BioGaia and Nestle ........ 14
BioGaia in Japan: Agreement with Nippon
Access Group ......... 14
BioGaia in Japan: Agreement with Earth
Biochemical Co., Ltd ........ 15
BioGaia in China: Agreement with Asia
United (China) ...... 15
BioGaia in Indonesia: Agreement with
Interbat ......... 15
BioGaia in South Africa ......... 15
BioGaia in South America ......... 16
BioGaia in the United States .... 16
Chr. Hansen's Strengths and Alliances ....... 16
Chr. Hansen Research Base ...... 16
Chr. Hansen and TI Food and
Nutrition ........ 17
Chr. Hansen and the University of
Aarhus ........ 17
Chr. Hansen and Urex Biotech ..... 18
Chr. Hansen and Jamieson
Laboratories....... 18
Chr. Hansen and Sagitus, Ltd. ..... 18
Chr. Hansen and Jarrow Formulas .. 19
Chr. Hansen and Genome Technology .. 19
Danisco Developments ...... 19
Danisco and DuPont ...... 19
Danisco and Université Laval ....... 20
Danisco Cultures and HOWARU Brand Name .. 20
HOWARU - Growing Global Reach .. 21
Groupe Danone Alliances ......... 21
Danone and Institut Pasteur .... 21
Danone and Yakult ........ 22
Danone's Local Adaptation for Global Growth
Strategy ......... 23
Ganeden Biotech Partners........ 23
Ganeden Biotech and Organic Milling ..... 24
Ganeden Biotech and Glanbia Nutritionals .... 24
Ganeden Biotech and National Farmers'
Organization ......... 24
Institut Rosell-Lallemand's Business Strategy .. 25
Institut Rosell-Lallemand Acquires LAFTI
Strain ......... 25
Institut Rosell-Lallemand's Research Centers ... 25
Institut Rosell-Lallemand's Research
Collaborators ......... 26
Institut Rosell-Lallemand's Global Marketing
Partners ......... 26
Nebraska Cultures and the University of Nebraska ... 26
Probi Partnerships ........ 27
Probi and Institut Rosell-Lallemand ....... 27
Probi and Alapis Group ......... 28
Probi and Camox Pharmaceuticals ...... 28
Probi and Bringwell ....... 28
Probi, Danone, and ProViva ...... 29
Probi's Scientific Advisory Board ...... 29
Government Participation ........ 29
U.S. Department of Agriculture (USDA)
Agricultural Research Service (ARS) .. 30
U.S. Department of Energy-Joint Genome
Institute......... 30
The National Center for Complementary and
Alternative Medicine (NCCAM) ...... 31
Funding Agencies for Probiotic Research in Canada .. 32
Canadian Institutes of Health Research
(CIHR) ........... 32
Canada's Institute of Infection and
Immunity (III) ....... 32
European Commission: Research and
Innovation Funds ......... 33
PROBIOTIC INGREDIENTS BY TYPE .......... 34
THE GASTROINTESTINAL TRACT ........ 34
Probiotics and Immune System Function ...... 35
Bacterial Genera .......... 35
PROBIOTICS OF THE LACTOBACILLUS GENUS ....... 36
L. acidophilus ........... 36
TABLE 1 PROPRIETARY STRAINS OF L. ACIDOPHILUS, BY
PRODUCER ............... 37
L. acidophilus DDS-1 ....... 37
L. acidophilus LA-1 (L. acidophilus LA-5) ...... 37
L. acidophilus LAFTI L10 ........ 38
L. acidophilus Rosell-52 ....... 38
L. acidophilus NCFM ........ 38
L. acidophilus SBT-2062, SBT-2071, SBT-2074 .... 38
L. bulgaricus ............ 39
L. casei ............. 39
TABLE 2 PROPRIETARY STRAINS OF L. CASEI, BY PRODUCER ... 40
L. casei DN114001 and L. casei immunitas .... 40
L. casei F19 ........... 40
L. casei 431 ........ 40
L. casei LAFTI L26 ........... 41
L. Casei Shirota ........ 41
L. helveticus ............. 41
L. johnsonii .......... 41
L. plantarum ............ 42
TABLE 3 PROPRIETARY STRAINS OF L. PLANTARUM, BY
PRODUCER ............... 42
L. reuteri .......... 42
TABLE 4 PROPRIETARY STRAINS OF L. REUTERI, BY PRODUCER .. 43
L. rhamnosus ........... 43
TABLE 5 PROPRIETARY STRAINS OF L. RHAMNOSUS, BY
PRODUCER ............... 43
L. rhamnosus GG (LGG) ....... 43
L. rhamnosus GR-1 .......... 44
L. rhamnosus HN001 ........ 44
L. rhamnosus Rosell-11 ....... 44
L. salivarius ............. 45
PROBIOTICS OF THE BIFIDOBACTERIUM GENUS....... 45
B. animalis ........... 45
TABLE 6 PROPRIETARY STRAINS OF B. ANIMALIS, BY PRODUCER .... 46
BB-12 ............ 46
B. animalis DN 173 010 (also known as Bifidum
regularis) .......... 46
B. lactis HN019 (also known as HOWARU bifido) .. 46
B. bifidum ............. 47
B. LAFTI B94 ........ 47
B. breve ............ 47
TABLE 7 PROPRIETARY STRAINS OF B. BREVE, BY PRODUCER .. 47
B. infantis ............. 48
TABLE 8 PROPRIETARY STRAINS OF B. INFANTIS, BY PRODUCER .... 48
B. longum ............. 48
TABLE 9 PROPRIETARY STRAINS OF B. LONGUM, BY PRODUCER .. 49
PROBIOTICS OF THE STREPTOCOCCUS GENUS ...... 49
S. thermophilus ........... 49
S. thermophilus TH-4 ...... 49
OTHER COMMERCIALLY SIGNIFICANT PROBIOTIC
BACTERIA ............ 50
Bacillus Coagulans (B. coagulans) ...... 50
B. coagulans GBI-30, 6086 (GanedenBC30) ... 50
Lactococcus .......... 51
Pediococcus .......... 51
L. fermentum ........... 52
L. fermentum PCC ........ 52
L. fermentum ME-3 ......... 52
Saccharomyces boulardii (S. boulardii) ...... 53
PROBIOTIC SELECTION CRITERIA ........ 53
SELECTION CRITERIA FOR PROBIOTIC STRAINS.... 54
TABLE 10 SELECTION CRITERIA FOR PROBIOTIC INGREDIENTS .. 54
SPECIES-SPECIFIC BENEFICIAL PHYSIOLOGICAL EFFECTS OF
PROBIOTICS ............... 54
SCIENCE-BASED PHYSIOLOGICAL BENEFITS ..... 54
TABLE 11 HEALTH BENEFITS ASSOCIATED WITH
LACTOBACILLUS PROBIOTICS ........ 55
TABLE 12 HEALTH BENEFITS ASSOCIATED WITH
BIFIDOBACTERIUM PROBIOTICS ........... 56
TABLE 13 HEALTH BENEFITS ASSOCIATED WITH
STREPTOCOCCUS PROBIOTICS .......... 56
MECHANISMS OF PROBIOTIC ACTIVITY ...... 56
TABLE 14 PROPOSED MECHANISMS OF PROBIOTIC ACTION .. 57
RECENT AND PROJECTED GLOBAL SALES OF PROBIOTIC
INGREDIENTS ........... 58
INDUSTRY DATA .......... 58
RECENT GLOBAL SALES OF PROBIOTIC INGREDIENTS BY TYPE .. 59
RECENT GLOBAL SALES OF LACTOBACILLUS PROBIOTIC
INGREDIENTS ............. 59
FIGURE 1 SALES OF LACTOBACILLUS PROBIOTICS AS A SHARE
OF GLOBAL PROBIOTIC INGREDIENT SALES, 2009 (%) ...... 59
RECENT GLOBAL SALES OF BIFIDOBACTERIUM
PROBIOTIC INGREDIENTS ........... 60
FIGURE 2 SALES OF BIFIDOBACTERIUM PROBIOTICS AS A SHARE
OF GLOBAL PROBIOTIC INGREDIENT SALES, 2009 (%) ...... 60
RECENT GLOBAL SALES OF STREPTOCOCCUS
PROBIOTIC INGREDIENTS ........... 60
FIGURE 3 SALES OF STREPTOCOCCUS PROBIOTICS AS A SHARE
OF GLOBAL PROBIOTIC INGREDIENT SALES, 2009 (%) ...... 61
TOTAL RECENT GLOBAL SALES OF PROBIOTIC
INGREDIENTS BY TYPE ........ 61
TABLE 15 TOTAL GLOBAL SALES OF PROBIOTIC INGREDIENT BY
TYPE, 2009 ($ MILLIONS/%) .......... 62
TOTAL RECENT GLOBAL SALES OF PROBIOTIC
INGREDIENTS BY REGION .......... 62
FIGURE 4 ESTIMATED MARKET SHARES OF TOTAL GLOBAL
SALES OF PROBIOTIC INGREDIENTS BY REGION, 2009 (%) .. 62
FIGURE 4 (CONTINUED) ............. 63
MAJOR MANUFACTURERS OF PROBIOTIC INGREDIENTS ... 63
TABLE 16 MAJOR MANUFACTURERS OF PROBIOTIC
INGREDIENTS.............. 63
MARKET DRIVERS AND DRAWBACKS ....... 64
BETTER UNDERSTANDING OF PROBIOTICS THROUGH
SUSTAINED RESEARCH........ 64
TARGETING HEALTH CONDITIONS AND POPULATION
SEGMENTS .......... 64
Allergies ........... 65
Cardiovascular Diseases (CVDs) ........ 66
Chronic Constipation ........... 67
Colorectal Cancer......... 67
Inflammatory Bowel Disease (IBD) ........ 68
Vaginal Infections (Vaginitis) ......... 68
NEW ENTRANTS TO THE INDUSTRY ...... 69
GenMont Biotech Inc. - An Emerging Regional Player ..... 69
The Regulatory Environment ......... 70
SALES AND MARKET SIZE PROJECTIONS ........ 70
PROJECTED GLOBAL SALES OF LACTOBACILLUS
PROBIOTIC INGREDIENTS ........... 71
TABLE 17 GLOBAL SALES OF LACTOBACILLUS PROBIOTICS
THROUGH 2015 ($ MILLIONS) ........... 71
FIGURE 5 SALES OF LACTOBACILLUS PROBIOTICS AS A SHARE
OF GLOBAL PROBIOTIC INGREDIENT SALES, 2010 AND 2015 (%) .... 72
PROJECTED GLOBAL SALES OF BIFIDOBACTERIUM
PROBIOTICS ............ 72
TABLE 18 GLOBAL SALES OF BIFIDOBACTERIUM PROBIOTICS
THROUGH 2015 ($ MILLIONS) ........... 73
FIGURE 6 SALES OF BIFIDOBACTERIUM PROBIOTICS AS A SHARE
OF GLOBAL PROBIOTIC INGREDIENT SALES, 2010 AND 2015 (%) .... 73
TABLE 19 GLOBAL SALES OF STREPTOCOCCUS PROBIOTICS
THROUGH 2015 ($ MILLIONS) ........... 74
FIGURE 7 SALES OF STREPTOCOCCUS PROBIOTICS AS A SHARE
OF GLOBAL PROBIOTIC INGREDIENT SALES, 2010 AND 2015 (%) .... 75
PROJECTED TOTAL GLOBAL SALES OF PROBIOTIC
INGREDIENTS BY TYPE ........ 75
TABLE 20 GLOBAL SALES OF PROBIOTIC INGREDIENTS BY TYPE
THROUGH 2015 ($ MILLIONS) ........... 76
FIGURE 8 ESTIMATED SHARES OF GLOBAL SALES OF PROBIOTIC
INGREDIENTS BY TYPE, 2010 AND 2015 (%) ...... 76
FIGURE 8 (CONTINUED) ............. 77
REGIONAL SALES OF PROBIOTIC INGREDIENTS
THROUGH 2015 ........... 77
TABLE 21 GLOBAL SALES OF PROBIOTIC INGREDIENTS BY
REGION THROUGH 2015 ($ MILLIONS) ......... 77
FIGURE 9 ESTIMATED SHARES OF GLOBAL SALES OF PROBIOTIC
INGREDIENTS BY REGION, 2010 AND 2015 (%) ......... 78
CHAPTER FIVE: THE GLOBAL PROBIOTIC SUPPLEMENTS INDUSTRY ... 79
INTRODUCTION ............. 79
STRUCTURE OF THE GLOBAL PROBIOTIC SUPPLEMENTS
INDUSTRY .............. 80
MARKET SHARE BASED ON ACCESS TO PROPRIETARY
INGREDIENTS ............. 80
Full In-house Processing Capabilities ....... 81
Bulk Ingredient Suppliers ........... 81
Contract Manufacturing .......... 82
Product Licensing and Collaboration Agreements ..... 82
MARKET SHARE BASED ON OWNERSHIP OF PROCESSING
TECHNOLOGIES ............. 82
TABLE 22 OWNERSHIP OF SUPPLEMENT PROCESSING
TECHNOLOGIES .............. 83
BIO-tract Delivery System ......... 83
LiveBac Processing Technology ...... 84
MAKTrek Bypass Technology ......... 84
Probiocap Microencapsulation Technology ..... 84
Probio-Tec ............ 85
ProTarget Technology.......... 85
STAR Technology......... 85
Triple-shell Technology .......... 85
True Delivery Technology ........... 86
MARKET SHARES BASED ON PRODUCT
DIFFERENTIATION ........ 86
Product Differentiation Based on Brand Name ..... 86
TABLE 23 SAMPLE OF PROBIOTIC SUPPLEMENT BRANDS ...... 87
Product Differentiation Based on Formulary ..... 88
Single-species Probiotic Supplement Products ... 88
TABLE 24 COMPOSITION OF SINGLE-SPECIES PROBIOTIC
SUPPLEMENTS FOR ADULTS .......... 89
Single-species Supplement from Amerifit ... 89
Single-species Supplement for Biocodex USA .... 89
Single-species Supplement from Bio-Energy
Systems ......... 90
Single-species Supplement from Ganeden
Biotech ........... 90
Single-species Supplement from Jarrow
Formulas ........... 90
Single-species Supplement from Natren ..... 91
Single-species Supplement from Nebraska
Cultures......... 91
Single-species Supplement from NOW Foods .... 91
Single-species Supplement from Procter &
Gamble (P&G)....... 91
Single-species Supplement from Solgar .. 92
Multi-species Probiotic Supplement Products .... 92
Multi-species Probiotic Supplement Products
for Adults ........... 93
Multi-species Adult Probiotic
Supplement from American
Biologics ......... 93
TABLE 25 MULTI-SPECIES PROBIOTIC SUPPLEMENT FOR
ADULTS FROM AMERICAN BIOLOGICS ........ 94
Multi-species Adult Probiotic
Supplement from Jarrow Formulas .... 94
TABLE 26 MULTI-SPECIES PROBIOTIC SUPPLEMENT FOR
ADULTS FROM JARROW FORMULAS ........ 95
Multi-species Adult Probiotic
Supplement from Kirkman
Laboratories....... 95
TABLE 27 MULTI-SPECIES PROBIOTIC SUPPLEMENT FOR
ADULTS FROM KIRKMAN LABORATORIES ...... 95
Multispecies Adult Probiotic
Supplement from Natren ..... 96
TABLE 28 MULTI-SPECIES PROBIOTIC SUPPLEMENT FOR
ADULTS FROM NATREN ............ 96
Multi-species Adult Probiotic
Supplement from NOW Foods ..... 96
TABLE 29 MULTI-SPECIES PROBIOTIC SUPPLEMENT FOR
ADULTS FROM NOW FOODS ........ 97
Multispecies Probiotic Supplement
Lozenge from Udo's Choice....... 97
TABLE 30 MULTI-SPECIES PROBIOTIC SUPPLEMENT FOR
ADULTS FROM UDO'S CHOICE ........ 97
Multi-species Probiotic Supplement Products
for Infants and Children ...... 98
Multi-species Probiotic Supplement for
Infants and Children from
American Biologics .... 98
TABLE 31 MULTI-SPECIES PROBIOTIC SUPPLEMENTS FOR
INFANTS AND CHILDREN FROM AMERICAN BIOLOGICS .... 98
Multispecies Probiotic Supplement for
Infants and Children from Country
Life.......... 99
TABLE 32 MULTI-SPECIES PROBIOTIC SUPPLEMENT FOR
INFANTS AND CHILDREN FROM COUNTRY LIFE ....... 99
Multispecies Probiotic Supplement for
Infants and Children from Jarrow
Formulas ........ 99
TABLE 33 MULTI-SPECIES PROBIOTIC SUPPLEMENT FOR
INFANTS AND CHILDREN FROM JARROW FORMULAS ....... 100
Multispecies Probiotic Supplement for
Infants and Children from Nature's
Plus ........... 100
TABLE 34 MULTI-SPECIES PROBIOTIC SUPPLEMENT FOR
INFANTS AND CHILDREN FROM NATURE'S PLUS .... 100
Multi-species Probiotic Supplement for
Infants and Children from Udo's
Choice ....... 100
TABLE 35 MULTI-SPECIES PROBIOTIC SUPPLEMENT FOR
CHILDREN FROM UDO'S CHOICE ........ 101
Multi-species Probiotic Supplement Products
for Specific Health Conditions ....... 101
Multi-strain Probiotic Supplement for
Female Health Needs from Jarrow
Formulas ...... 102
Multi-species Probiotic Supplement for
IBD from VSL#3 ...... 102
Multi-species Probiotic Supplement for
Yeast Imbalance from Udo's Choice .. 102
Product Differentiation Based on Probiotic Dosage ..... 103
PROBIOTIC SUPPLEMENTS FOR ANIMAL USE ....... 103
The Problem of Antibiotic Resistance in Livestock .. 104
Sample of Currently Available Probiotic Supplements for
Animal Use ........... 104
TABLE 36 SAMPLE OF PROBIOTIC SUPPLEMENTS FOR ANIMAL
USE ............... 105
Multi-species Probiotic Supplement for Horses
from Jarrow Formulas ....... 105
TABLE 37 MULTI-SPECIES PROBIOTIC SUPPLEMENT FOR
HORSES FROM JARROW FORMULAS ...... 106
DISTRIBUTION CHANNELS FOR PROBIOTIC
SUPPLEMENTS ............. 106
The Internet as a Distribution Channel ....... 106
RECENT AND PROJECTED GLOBAL SALES OF PROBIOTIC
SUPPLEMENTS ............ 107
INDUSTRY DATA ............ 107
RECENT GLOBAL SALES OF PROBIOTIC SUPPLEMENTS
BY TYPE ............. 108
Recent Global Sales of Probiotic Supplements in Capsule
Form .......... 108
FIGURE 10 SALES OF PROBIOTIC CAPSULES AS A SHARE OF
GLOBAL PROBIOTIC SUPPLEMENT SALES, 2009 (%) .... 109
Recent Global Sales of Probiotic Supplements in Tablet
Form .......... 109
FIGURE 11 SALES OF PROBIOTIC TABLETS AS A SHARE OF
GLOBAL PROBIOTIC SUPPLEMENT SALES, 2009 (%) .... 110
Recent Global Sales of Probiotic Supplements in Powder
Form .......... 110
FIGURE 12 SALES OF PROBIOTIC POWDER AS A SHARE OF
GLOBAL PROBIOTIC SUPPLEMENT SALES, 2009 (%) .... 111
Total Recent Global Sales of Probiotic Supplements by
Type .......... 111
TABLE 38 TOTAL GLOBAL SALES OF PROBIOTIC SUPPLEMENTS
BY TYPE, 2009 ($ MILLIONS/%) .......... 112
TOTAL RECENT GLOBAL SALES OF PROBIOTIC
SUPPLEMENTS BY REGION ....... 112
FIGURE 13 ESTIMATED MARKET SHARES OF TOTAL GLOBAL
SALES OF PROBIOTIC SUPPLEMENTS BY REGION, 2009 (%) .. 113
MAJOR MANUFACTURERS OF PROBIOTIC SUPPLEMENTS .... 113
TABLE 39 MAJOR MANUFACTURERS OF PROBIOTIC
SUPPLEMENTS .............. 114
MARKET DRIVERS AND DRAWBACKS ...... 114
Demographics ............ 115
Science-based Substantiation of Beneficial Claims ..... 115
Continuing Consumer Education...... 115
Continuing Improvement in Processing Technologies ..... 116
Expanding the Market Base of Probiotic Supplements ... 116
Market Potential for Probiotic Supplements for
Animal Use ........ 116
Potential Demand for Supplements in
Veterinary Care ...... 117
Potential Demand for Supplements in Pet
Care ......... 117
Push Factors for Alternative (Probiotic)
Supplementation ........ 118
Product Innovation ........ 119
BioGaia's Drops, Lozenges, and Straws ..... 119
Ganeden Biotech's Topical Applications .... 119
New Application Frontier-Cosmetics ....... 119
Natren's Probiotic Cosmetics ...... 120
Nestlé and L'Oreal .......... 120
New Entrants to the Industry ....... 120
Regulatory Changes and Industry Reform ....... 120
SALE PROJECTIONS AND MARKET SIZE ..... 121
Projected Global Sales of Probiotic Supplements in
Capsule Form ........... 121
TABLE 40 GLOBAL SALES OF PROBIOTIC SUPPLEMENTS IN
CAPSULE FORM THROUGH 2015 ($ MILLIONS) ..... 122
FIGURE 14 SALES OF PROBIOTIC CAPSULES AS A SHARE OF
GLOBAL PROBIOTIC SUPPLEMENTS SALES, 2010 AND 2015 (%) .... 122
FIGURE 14 (CONTINUED) ............. 123
Projected Global Sales of Probiotic Supplements in Tablet
Form .......... 123
TABLE 41 GLOBAL SALES OF PROBIOTIC SUPPLEMENTS IN
TABLET FORM THROUGH 2015 ($ MILLIONS) ....... 123
FIGURE 15 SALES OF PROBIOTIC TABLETS AS A SHARE OF
GLOBAL PROBIOTIC SUPPLEMENTS SALES, 2010 AND 2015 (%) .... 124
Projected Global Sales of Probiotic Supplements in
Powder Form ........ 124
TABLE 42 GLOBAL SALES OF PROBIOTIC SUPPLEMENTS IN
POWDER FORM THROUGH 2015 ($ MILLIONS) ...... 125
FIGURE 16 SALES OF PROBIOTIC POWDER AS A SHARE OF
GLOBAL PROBIOTIC SUPPLEMENTS SALES, 2010 AND 2015 (%) .... 125
Projected Total Global Sales of Probiotic Supplements by
Type .......... 126
TABLE 43 GLOBAL SALES OF PROBIOTIC SUPPLEMENTS BY TYPE
THROUGH 2015 ($ MILLIONS) ......... 126
FIGURE 17 ESTIMATED SHARES OF GLOBAL SALES OF
PROBIOTIC SUPPLEMENTS BY TYPE, 2010 AND 2015 (%) .... 127
Projected Regional Sales of Probiotic Supplements
Through 2015 ........... 127
TABLE 44 GLOBAL SALES OF PROBIOTIC SUPPLEMENTS BY
REGION THROUGH 2015 ($ MILLIONS) ....... 128
FIGURE 18 ESTIMATED SHARES OF GLOBAL SALES OF
PROBIOTIC SUPPLEMENTS BY REGION, 2010 AND 2015 (%) ... 128
CHAPTER SIX: THE GLOBAL PROBIOTIC FOODS INDUSTRY ....... 129
BACKGROUND .............. 129
STRUCTURE OF THE GLOBAL PROBIOTIC FOODS INDUSTRY .. 130
THE ROLE OF THE DAIRY INDUSTRY ....... 130
U.S. Dairy Farming ........... 131
Global Dairy Processing ........ 131
Fonterra's Global Reach ......... 132
Arla Foods in Europe and Beyond ...... 132
Dairy Farmers of America ...... 133
Clover Industries Limited's Growing Regional
Market ........ 133
Groupe Danone ........... 133
Land O'Lakes .......... 134
PepsiCo and Wimm-Bill-Dann Foods ....... 135
Private Labels and Contract Manufacturing ....... 135
Lifeway Foods - Growing a Niche ........ 136
The Starfruit Cafe ........... 136
Strategic Acquisitions ......... 136
The Acquisition of First Juice, Inc. ..... 136
The Acquisition of Fresh Made Dairy .... 137
The Acquisition of Helios Nutrition.... 137
Creative Product Formulations ...... 137
Growing the Distribution Network .... 137
PROBIOTIC FOODS BY TYPE .......... 138
STARTER CULTURE .......... 138
Legal Definition of Starter Cultures ......... 138
Codex Standard for Fermented Milk Products .. 139
TABLE 45 CODEX STANDARDS FOR FERMENTED MILK PRODUCTS .... 139
TABLE 46 COMMERCIAL STARTER CULTURES BY PRODUCER
AND APPLICATION ........... 140
YOGURT ............... 140
Legal Definition of a Yogurt Product ........ 141
Legal Requirements for Yogurt Products in the U.S. .. 141
Types of Yogurt Products .......... 142
TABLE 47 YOGURT CLASSIFICATION ........... 142
Natural-set Yogurt ......... 142
Stirred Yogurt ......... 142
Drinkable Yogurt ........ 143
Greek Style Yogurt ......... 143
Frozen Yogurt ......... 143
The Probiotic Content of Yogurt ....... 144
NYA Seal ......... 145
Marketing Probiotic Yogurts ......... 145
TABLE 48 PROBIOTIC COMPOSITION OF SELECT YOGURT
PRODUCTS AVAILABLE IN THE U.S. ....... 146
Dannon, the Class Action and FTC Settlement ....... 147
KEFIR ............... 148
Standards for Kefir Products ........ 148
The National Kefir Association (NKA) ...... 149
Bio-Kefir ......... 149
Currently Available Kefir Products in the U.S. ....... 149
TABLE 49 PROBIOTIC COMPOSITION OF SELECT KEFIR
PRODUCTS AVAILABLE IN THE U.S. ....... 150
TABLE 49 (CONTINUED) ............ 151
Lifeway Foods, Kefir Claims, and the FDA ...... 151
DAIRY-BASED CULTURED PROBIOTIC DRINKS .... 152
Danone's Actimel/DanActive ......... 153
Arla Foods' Cultura ........... 153
Nestlé's Svelty Gastro Protect ...... 153
Stonyfield Farm's Super Smoothie ....... 153
Yakult's Dairy Drink ......... 154
NON-DAIRY BASED CULTURED DRINKS AND JUICES ..... 154
Soy-based Probiotic Drinks ...... 154
Probiotic Juices .......... 154
ProViva - the Pioneer Probiotic Juice.... 155
HOWARU Probiotic Juices ......... 155
Oasis Probiotic Juice ....... 155
GoodBelly Juices ......... 156
Probiotic Whey Drink ......... 156
TABLE 50 SAMPLE OF AVAILABLE PROBIOTIC DRINKS AND
JUICES ............ 156
PROBIOTIC CHEESE PRODUCTS ........ 157
Overcoming the Cheese Processing Challenge ..... 157
Meeting Consumer Tastes ......... 157
Improved Scientific Support...... 158
TABLE 51 CURRENTLY AVAILABLE PROBIOTIC CHEESE
PRODUCTS .............. 158
PROBIOTIC INFANT FORMULAS ........ 158
PROBIOTIC BREAKFAST, DESSERT, AND SNACK FOODS .... 159
TABLE 52 SAMPLE OF CURRENTLY AVAILABLE PROBIOTIC
BREAKFAST, DESSERT AND SNACK FOODS ....... 160
RECENT AND PROJECTED GLOBAL SALES OF PROBIOTIC
FOODS ............... 160
INDUSTRY DATA ............ 160
RECENT GLOBAL SALES OF PROBIOTIC FOODS BY TYPE ... 161
Recent Global Sales of Probiotic Yogurt ....... 161
FIGURE 19 SALES OF PROBIOTIC YOGURT AS A SHARE OF
GLOBAL SALES OF PROBIOTIC FOODS, 2009 (%) ...... 162
Recent Global Sales of Probiotic Kefir ...... 162
FIGURE 20 SALES OF PROBIOTIC KEFIR AS A SHARE OF GLOBAL
SALES OF PROBIOTIC FOODS, 2009 (%) ....... 163
Recent Global Sales of Probiotic Cultured Drinks ... 163
FIGURE 21 SALES OF PROBIOTIC CULTURED DRINKS AS A SHARE
OF GLOBAL SALES OF PROBIOTIC FOODS, 2009 (%) ..... 164
Recent Global Sales of Probiotic Cheese ....... 164
FIGURE 22 SALES OF PROBIOTIC CHEESE PRODUCTS AS A SHARE
OF GLOBAL SALES OF PROBIOTIC FOODS, 2009 (%) ..... 165
Total Recent Global Sales of Probiotic Foods by Type ..... 165
TABLE 53 TOTAL GLOBAL SALES OF PROBIOTIC FOODS BY TYPE,
2009 ($ MILLIONS) ............. 166
Total Recent Global Sales of Probiotic Foods by Region .. 166
FIGURE 23 ESTIMATED MARKET SHARES OF TOTAL GLOBAL
SALES OF PROBIOTIC FOODS BY REGION, 2009 (%) .... 167
MAJOR MANUFACTURERS OF PROBIOTIC FOODS .... 167
TABLE 54 MAJOR PROBIOTIC FOOD MANUFACTURERS ..... 168
MARKET DRIVERS AND DRAWBACKS ...... 168
Untapped Market Potential ...... 168
Personalized Nutrition and Convenience ..... 169
New Entrants to the Industry ....... 169
Ganeden Biotech's enLiven Yogurt .... 169
Food Processing Challenge ........ 170
The Regulatory Crackdown ....... 170
SALE PROJECTIONS AND MARKET SIZE ..... 170
Projected Global Sales of Probiotic Yogurt ....... 171
TABLE 55 GLOBAL SALES OF PROBIOTIC YOGURT THROUGH 2015
($ MILLIONS) .............. 171
FIGURE 24 SALES OF PROBIOTIC YOGURT AS A SHARE OF
GLOBAL SALES OF PROBIOTIC FOODS, 2010 AND 2015 (%) .... 172
Projected Global Sales of Probiotic Kefir ...... 172
TABLE 56 GLOBAL SALES OF PROBIOTIC KEFIR, THROUGH 2015 ($
MILLIONS) .............. 173
FIGURE 25 SALES OF PROBIOTIC KEFIR AS A SHARE OF GLOBAL
SALES OF PROBIOTIC FOODS, 2010 AND 2015 (%) ..... 173
Projected Global Sales of Probiotic Cultured Drinks ... 174
TABLE 57 GLOBAL SALES OF PROBIOTIC CULTURED DRINKS,
THROUGH 2015 ($ MILLIONS) ......... 174
FIGURE 26 SALES OF PROBIOTIC CULTURED DRINKS AS A SHARE
OF GLOBAL SALES OF PROBIOTIC FOODS, THROUGH 2015 (%) ..... 175
Projected Global Sales of Probiotic Cheese ...... 175
TABLE 58 GLOBAL SALES OF PROBIOTIC CHEESE, THROUGH 2015
($ MILLIONS) .............. 176
FIGURE 27 SALES OF PROBIOTIC CHEESE AS A SHARE OF
GLOBAL SALES OF PROBIOTIC FOODS, 2010 AND 2015 (%) ..... 176
Projected Total Global Sales of Probiotic Foods by Type ..... 177
TABLE 59 GLOBAL SALES OF PROBIOTIC FOODS BY TYPE
THROUGH 2015 ($ MILLIONS) ......... 177
FIGURE 28 ESTIMATED SHARES OF GLOBAL SALES OF
PROBIOTIC FOODS BY TYPE, 2010 AND 2015 (%) .... 178
Projected Regional Sales of Probiotic Foods Through 2015 ..... 178
TABLE 60 GLOBAL SALES OF PROBIOTIC FOODS BY REGION,
THROUGH 2015 ($ MILLIONS) ......... 179
FIGURE 29 ESTIMATED SHARES OF GLOBAL SALES OF
PROBIOTIC FOODS BY REGION, 2010 AND 2015 (%) ....... 179
CHAPTER SEVEN: REGULATORY GUIDELINES FOR THE PROBIOTICS
INDUSTRY ............... 180
INTRODUCTION ........... 180
THE CODEX ALIMENTARIUS ......... 180
A BRIEF HISTORY OF THE CODEX: THE JOINT FAO-WHO
FOOD PROGRAM ........... 180
CODEX GUIDELINES FOR THE EVALUATION OF
PROBIOTICS .......... 181
Genus-Species-Strain ........... 181
Screening of Potential Probiotics ...... 182
Probiotic Safety Considerations ........ 182
Probiotic Health Claims ........ 183
Probiotic Product Labeling ........ 183
Codex Guidelines on Nutrition Claims ..... 183
Codex Standard for Food Additives ...... 184
CODEX STANDARD FOR GOOD MANUFACTURING
PRACTICE (GMP) .......... 185
U.S. REGULATORY PROVISIONS ........... 185
U.S. REGULATIONS RELATING TO INGREDIENTS..... 185
Legal Definition of Ingredient Products ....... 185
Definition of a Food Additive ........ 186
GRAS Provisions ........ 187
The Food Additive Petition Process ...... 187
U.S. REGULATIONS RELATING TO DIETARY
SUPPLEMENTS ............. 188
Legal Definition of a Dietary Supplement Product .. 188
Premarket Review Requirements for New Dietary
Ingredient ............. 189
Approved Product Claims for Dietary Supplements .... 190
Health Claims ......... 190
The Nutrition Labeling and Education Act
(NLEA) of 1990 ....... 190
The Food and Drug Administration
Modernization Act (FDAMA) of 1997 ... 191
Qualified Health Claims ...... 191
Product Nutrient Content Claims ...... 191
Structural-Function Claims for Supplement
Products ......... 192
RECENT AND FORESEEABLE DEVELOPMENTS IN THE
U.S. REGULATORY PROCESS ......... 192
Scientific Evaluation of Health Claims .... 192
Scientific Evaluation of ... (Continued) ..... 193
Enforcement of Current Good Manufacturing Practices ..... 194
GUIDANCE RELATING TO COMPLEMENTARY AND
ALTERNATIVE MEDICINE PRODUCTS .... 195
CANADIAN REGULATORY PROVISIONS ...... 196
HEALTH CANADA OVERSIGHT ...... 196
Regulation of Natural Health Products and Foods .. 196
CANADIAN FOOD DIRECTORATE ...... 196
The Use of the Term Probiotic ...... 197
Safety of Probiotic Microorganisms Used in Foods .. 197
Acceptable Use of Function Claims ...... 198
Labeling of Probiotic Foods ....... 198
CANADA'S NATURAL HEALTH PRODUCTS DIRECTORATE .. 199
Definition of a Natural Health Product .... 199
Clarification of Product Classification ...... 200
Regulations Relating to Natural Health Product
Manufacturing .......... 200
Licensing Requirement ....... 200
Good Manufacturing Practices (GMPs) ..... 201
Health Canada's Compliance Policy ......... 201
EUROPEAN REGULATORY PROVISIONS ......... 201
REGULATIONS AND DIRECTIVE IN THE EU ....... 201
PRODUCT HEALTH CLAIMS ........ 202
Coverage of the Regulation ....... 203
Implementation of the Regulations ...... 203
Implementation of the ... (Continued) ....... 204
General Conditions for Health Claims ..... 205
General Principles for Scientific Substantiation of Claims ..... 205
General Principles for ... (Continued) .... 206
EFSA Industry Consultations ....... 207
EFSA Publications on Gut Health and Immunity Claims .. 207
EFSA Guidance on Gut and Immune Health .... 207
Establishing Beneficial Physiological Effect.. 208
Substantiation of Health Claims .... 208
The EFSA Technical Meeting in Amsterdam .... 208
Reaction to EFSA Activity ......... 209
REGULATORY PROVISIONS IN JAPAN ........ 210
MINISTRY OF HEALTH, LABOR, AND WELFARE
OVERSIGHT ........... 210
FOOD WITH HEALTH CLAIMS ........ 210
Foods with Nutrient Function Claims (FNFC) .... 210
Food for Specified Health Uses (FOSHU) .... 211
Requirements for FOSHU Approval ...... 211
Qualified FOSHU ......... 211
Standardized FOSHU: ......... 212
Reduction of disease risk FOSHU ...... 212
FOODS FOR SPECIAL DIETARY USES (FOSDU) ...... 212
Requirements for FOSDU Labeling ...... 212
PROHIBITION OF EXAGGERATED AND MISLEADING
CLAIMS ........... 213
THE ROLE OF EXPERT GROUPS AND PROFESSIONAL
ASSOCIATIONS ............. 213
The International Scientific Association for Probiotics and
Prebiotics (ISAPP) ........ 213
The ISAPP Industry Advisory Committee ..... 214
Recommended Industry Standards .... 214
The European Food & Feed Cultures Association
(EFFCA) ............ 215
The International Probiotics Association (IPA) ....... 216
The IPA Seal of Quality ...... 216
The U.S. Council for Responsible Nutrition (CRN) .. 217
Role of Consumer Watchdog Groups ........ 217
The Council for Agricultural Science and
Technology (CAST) ........ 218
ConsumerLab.com (CL) ...... 218
ConsumerLab.com (CL) ....... 219
CHAPTER EIGHT: TECHNOLOGY AND PATENT ANALYSIS ...... 220
BACKGROUND .............. 220
CURRENT PROBIOTIC PROCESSING TECHNOLOGIES .... 221
FERMENTATION ............ 221
Lactic Acid Bacteria ........... 221
Types of Fermentation .......... 222
Batch Fermentation Process ...... 222
Continuous Fermentation Process ..... 223
Aerobic versus Anaerobic Fermentation Process .. 223
Limitations of the Fermentation Process ..... 223
CENTRIFUGATION ............ 224
Differential Centrifugation ....... 224
Density Gradient Centrifugation ...... 225
ULTRA FILTRATION .......... 225
Nano Filtration .......... 225
LYOPHILIZATION (FREEZE-DRYING) ....... 226
ENCAPSULATION AND TABLETING ...... 227
Spray-drying Encapsulation Technologies ...... 227
Vérsale Pharma and IntelCaps ...... 227
Cell Biotech and Dual-coating ....... 228
EnCoate and Bioshield ....... 228
Riddet Institute and Pro Bio Life ....... 228
PATENT ANALYSIS .......... 229
PATENTS RELATING TO EXISTING AND NEW PROBIOTIC
STRAINS ............. 230
TABLE 61 PATENT AWARDS FOR PROBIOTIC SPECIES BY TYPE
2009 AND 2010 ............ 230
TABLE 62 PATENT AWARDS FOR PROBIOTIC SPECIES BY REGION
2009 AND 2010 ............ 231
Sample of Patents for Existing and New Probiotic Strains ..... 231
Lactic Acid Bacteria Capable of Stimulating
Mucosal Immunity ......... 231
Lactobacillus Iners for the Enhancement of
Urogenital Health ...... 232
Probiotic, Lactic acid-producing Bacteria and Uses
Thereof ........... 232
Probiotic Lactobacillus Strains for Improved
Vaginal Health ........... 233
Probiotics for Pet Food Applications ...... 234
Bifidobacteria Preventing Diarrhea Caused by
Pathogenic Bacteria ....... 234
Bacterial Composition and Its Use .... 235
Composition and Method for Inhibiting Salmonella
and Campylobacter Colonization in Poultry .... 235
Inhibition of Pathogens by Probiotic Bacteria ... 236
Composition for Promoting the Proliferation of
Lactobacillus Casei subsp. Casei ...... 237
Reinforcing Systemic Immune Responses with
Lactobacillus Casei ........ 237
PATENTS RELATING TO PROBIOTIC APPLICATIONS ... 238
TABLE 63 PATENT AWARDS FOR PROBIOTIC APPLICATIONS BY
TYPE, 2009 AND 2010 ............ 239
Sample of Patents for Probiotic Starter Culture ...... 239
Pressure Treating Food to Reduce Spoilage .. 239
Liquid Starter Cultures Having an Improved
Storage Stability and Use Thereof .... 240
Process for the Preparation of a Vegetable Yogurt ... 241
Sample of Patents for Probiotic Fermented Foods ... 241
Bacterium of the Genus Bifidobacterium and
Fermented Foods Using the Same .... 241
Nutritional Modules ....... 242
Reducing Heart Rate in Mammals Using Milk
Derived Fermentation Products Produced Using
Lactobacillus Helveticus ....... 243
Sample of Patents for Probiotic Therapeutic Uses ... 244
Method for Preventing or Treating the
Development of Respiratory Allergies ...... 244
Methods of Inhibiting Growth of Bacteria, Yeast,
Fungus, and Virus with Pseudomonas
Lindbergii and Bacillus Coagulans Extracellular
Products ......... 244
Methods of Use of Probiotic Lactobacilli for
Companion Animals ...... 245
Method and Nutraceutical Composition for
Mammals ........... 246
Probiotic Composition Useful for Dietary
Augmentation and/or Combating Disease States
and Adverse Physiological Conditions ...... 247
Methods of Preventing Peritonitis by Administering
Lactic Acid Bacterium ....... 247
Live Bacterium Preparation Containing Lactic Acid
Bacterium as Active Ingredient and Food
Containing Lactic Acid Bacterium .... 248
Lactobacillus Paracasei-containing Product ..... 249
Compositions and Methods for Treatment of
Candidiasis ........ 249
Methods and Compositions for Preventing and
Treating Sensitive and Dry Skin ...... 250
Use of Lactobacillus Farciminis for the Prevention
or Treatment of Digestive Pathologies ..... 251
Methods of Treating Fibromyalgia Caused by Small
Intestinal Bacterial Overgrowth ....... 252
Selection and Use of Lactic Acid Bacteria for
Reducing Dental Caries and Bacteria Causing
Dental Caries ......... 252
Topical Use of Probiotic Bacillus Spores to Prevent
or Control Microbial Infections ..... 253
Bacterial Strain, Processed Plant Extracts,
Compositions Containing Same, Processes for
their Preparation and their Therapeutic and
Industrial Applications ......... 254
Hygiene Tissue with Lactic Acid Producing
Bacterial Strains ........ 254
PATENTS RELATING TO PROBIOTIC PROCESSING
TECHNOLOGIES ........... 255
TABLE 64 PATENTS FOR SELECT PROCESSING TECHNOLOGIES
BY TYPE 2009 AND 2010............ 256
Samples of Patents for Processing Technologies ...... 256
Process and Composition for the Manufacture of a
Microbial-based Product ....... 256
Method and Apparatus for the Preparation of
Capsules ......... 257
Method of Encapsulating an Active Substance ..... 257
Delivery Systems for Functional Ingredients .... 258
CHAPTER NINE: COMPANY PROFILES ......... 259
BACKGROUND .............. 259
GLOBAL MANUFACTURERS OF PROBIOTIC INGREDIENTS ... 259
BIO-ENERGY SYSTEMS, INC. ......... 259
BIOGAIA .............. 259
CHR. HANSEN A-S............. 260
Chr. Hansen, Inc. ........... 260
DANISCO CULTURES A-S ........ 261
DSM FOOD SPECIALTIES (ROYAL DSM N.V.) ....... 261
GANEDEN BIOTECH ......... 262
GROUPE DANONE ............. 262
The Dannon Company, Inc. ....... 262
INSTITUT ROSELL-LALLEMAND ....... 263
MORINAGA MILK INDUSTRY .......... 263
NEBRASKA CULTURES ........ 264
Nestlé USA Inc. ......... 264
PROBI AB ............. 265
SNOW BRAND MILK PRODUCTS (MEGMILK SNOW BRAND
CO.) .............. 265
YAKULT HONSHA COMPANY, LTD. ....... 266
Yakult U.S.A. Inc. .......... 266
MAJOR MANUFACTURERS OF PROBIOTIC SUPPLEMENTS ... 267
AMERICAN BIOLOGICS ........ 267
AMERIFIT ............ 267
BIO-K+ INTERNATIONAL INC ........ 267
CALPIS ............. 268
Calpis U.S.A., Inc........... 268
COUNTRY LIFE VITAMINS .......... 268
ENZYMATIC THERAPY ......... 269
GARDEN OF LIFE, INC. ......... 269
JARROW FORMULAS ........ 270
KIRKMAN LABORATORIES .......... 270
NATREN ............... 270
NATROL, INC. ............. 271
NATURE'S PLUS (NATURAL ORGANICS, INC.) .... 271
NATURE'S WAY .......... 272
NOW FOODS ........... 272
NUTRACEUTIX, INC. ......... 272
SOLGAR VITAMIN & HERB CO. ....... 273
UAS LABORATORIES ........ 273
MAJOR PROBIOTIC FOOD MANUFACTURERS ....... 274
ARLA FOODS AMBA .......... 274
BEL GROUP (FROMAGERIES BEL) ......... 274
BONGRAIN SA ............ 275
CASCADE FRESH ........... 275
DAIRY CREST GROUP, PLC .......... 275
FONTERRA COOPERATIVE GROUP ....... 276
FRIESLANDCAMPINA ........... 277
GENERAL MILLS ........... 277
JOHANNA FOODS, INC. ........ 277
LIFEWAY FOODS ........... 278
MEIJI DAIRIES CORPORATION ...... 278
PARMALAT S.P.A ............ 279
SAPUTO ............... 279
SODIAAL S.A. .......... 279
SPRINGFIELD CREAMERY, INC. ........ 280
STONYFIELD FARM/GROUPE DANONE ........ 280
TILLAMOOK COUNTY CREAMERY ASSOCIATION ..... 281
VALIO GROUP ............ 281
WALLABY YOGURT CO. ........ 281
WELLS' DAIRY, INC ........... 282
WIMM-BILL-DANN FOODS/PEPSICO ........ 282
