IDENTIFICATION OF OPPORTUNITIES FOR SACCHAROMYCES BOULARDII Prepared by: CPL Business Consultants CAB International Centre, Wallingford, Oxfordshire, OX10 8DE Tel: +44 1491 829 346, info@cplconsult.com, www.cplconsult.com Ms Megha Chugh Dr Robert Harwood Dr Esther Hunter Dr Steve Lisansky December 2010
Saccharomyces boulardii - contents - i TABLE OF CONTENTS OBJECTIVE... 1 METHOD... 1 PRINCIPAL FINDINGS... 2 MARKET... 2 MARKET SEGMENTATION... 3 PLAYERS & COMPETITION... 4 PRICES... 5 PRODUCTS... 5 Pharmaceutical Products... 5 Dietary Supplement Products... 6 PATENTS... 6 SCIENTIFIC SUBSTANTIATION... 8 CLINICAL TRIALS... 8 REGULATIONS... 9 United States - FDA... 9 Europe - EFSA... 9 Brazil... 10 TRADEMARKS... 10 CONCLUSIONS... 11 KEY SUCCESS FACTORS... 12 BARRIERS TO ENTRY... 13 RECOMMENDATIONS... 14 INTRODUCTION... 15 SUPPLY CHAIN... 17 MARKETS... 26 PROBIOTICS... 26 GASTROINTESTINAL DRUGS... 26 SACCHAROMYCES BOULARDII... 28 Global Market... 28 US Market... 29 European Market... 29 Indian Market... 30 Korean Market... 30 Brazil... 30 PLAYERS... 37 6 BIOTECH COMPANIES... 37 EXAMPLES OF PRODUCTS CONTAINING SACCHAROMYCES BOULARDII... 53 PRODUCTS & PRICES... 56 PRICES... 56 Asia - India... 57 Europe... 58 Latin America Chile... 59 PRODUCTS CONTAINING S. BOULARDII SOLD AS DRUGS... 60 Asia... 60 Europe... 68 Latin America... 74 Rest of the World (RoW)... 75
Saccharomyces boulardii - contents - ii SCIENTIFIC SUBSTANTIATION... 76 SUMMARY... 76 Taxonomy... 76 Mechanisms of action... 76 Clinical efficacy... 77 Effective Doses... 77 Characteristics & Disposition... 78 Scientific evidence against various disorders... 78 Safety and Contraindications... 80 Number of published papers... 81 Number of peer-reviewed papers published on S. boulardii from 1976 to 2009... 83 ABSTRACTS OF 25 RECENT SIGNIFICANT SCIENTIFIC PAPERS... 83 STUDIES FUNDED BY A KEY PLAYER... 97 CONTACTS... 101 OVERVIEW OF CONTACT VIEWS... 101 Market... 101 Regulations... 102 Players & Competition... 103 Prices... 103 Technology... 104 Applications... 104 Scientific backing... 104 CONTACT REPORTS... 104 6 YEAST PRODUCERS... 104 10 SUPPLEMENTS AND DRUGS MANUFACTURERS... 112 1 OTHER PROBIOTICS COMPANY... 118 2 INFANT FORMULA COMPANIES... 119 DISTRIBUTORS... 120 CONSULTANCIES... 120 ACADEMICIANS... 121 NEWS... 121 OVERVIEW... 121 22 articles... 122 PATENTS - IP AND TECHNOLOGICAL POSITIONS... 145 PATENT ABSTRACTS... 155 PHARMACEUTICAL PRODUCTS... 158 FDA... 203 Biologics License Applications (BLA) Process (CBER)... 204 EFSA... 206 Article 13 Submissions... 206 TRADEMARKS... 218 TABLES TABLE 1 PRODUCERS OF SACCHAROMYCES BOULARDII - GLOBAL... 4 TABLE 2 EXPLANATION OF ATC CODING FOR SACCHAROMYCES BOULARDII... 16 TABLE 3 RAW MATERIAL SALES OF US HEALTH INGREDIENTS: 1998-2008... 20 TABLE 4 VALUE OF RETAIL, WHOLESALE AND RAW MATERIAL SALES FOR SPECIALTY SUPPLEMENTS IN THE US, 1997-2008... 21 TABLE 5 SALES VALUE GROWTH FOR SPECIALTY SUPPLEMENTS IN THE US (CAGR)... 21 TABLE 6 US SPECIALTY SUPPLEMENTS VALUE CHAIN % GROWTH YEAR ON YEAR... 22 TABLE 7 US SPECIALTY SUPPLEMENTS VALUE CHAIN WHOLESALE AND RAW MATERIAL SALES VALUE AS % OF CONSUMER SALES 1997-2007... 23
Saccharomyces boulardii - contents - iii TABLE 8 PER CENT MARK-UP FOR SPECIALTY SUPPLEMENTS RETAILERS AND WHOLESALERS IN THE US 1997-2007... 24 TABLE 9 GLOBAL PROBIOTICS MARKET, VALUE AND GROWTH 2009-2014... 26 TABLE 10 GLOBAL PROBIOTICS MARKET BY GEOGRAPHIC REGION, 2009... 26 TABLE 11 ESTIMATED GLOBAL CONSUMPTION OF S. BOULARDII BY COUNTRY OR GEOGRAPHIC REGION... 28 TABLE 12 COMPANY X S GLOBAL SALES S. BOULARDII AND TOTAL SALES (2008)... 29 TABLE 13 UNITS OF S. BOULARDII PRODUCTS MANUFACTURED AND QUANTITY OF S. BOULARDII USED IN BRAZIL, 2010.... 30 TABLE 14 VOLUME AND MARKET VALUE FOR S. BOULARDII PRODUCTS IN BRAZIL BY PRODUCT, 2006-2010... 32 TABLE 15 VALUE PER UNIT AND ESTIMATE OF TONNAGE USED IN S. BOULARDII PRODUCTS IN BRAZIL BY PRODUCT, 2006-2010... 33 TABLE 16 GROWTH IN VOLUME AND VALUE FOR S. BOULARDII PRODUCTS IN BRAZIL BY PRODUCT, 2006-2010... 34 TABLE 17 PER CENT MARKET SHARE IN TERMS OF VOLUME AND VALUE FOR S. BOULARDII P RODUCTS IN BRAZIL BY PRODUCT, 2006-2010... 35 TABLE 18 SALES VALUE AND VOLUME FOR UL-250 IN PORTUGAL, 2008... 36 TABLE 19 PRODUCERS OF SACCHAROMYCES BOULARDII - GLOBAL... 37 TABLE 20 COMPANY Y KEY FINANCIAL DATA 2003-2009... 40 TABLE 21 COMPANY Z S SACCHAROMYCES BOULARDII SPECIFICATIONS... 50 TABLE 22 SOME COMMERCIALLY AVAILABLE PROBIOTICS CONTAINING SACCHAROMYCES BOULARDII... 53 TABLE 23 PRICE POINTS AT DIFFERENT LEVELS ON THE VALUE CHAIN... 56 TABLE 24 RETAIL PRICE ( ) PER DOSE OF S. BOULARDII (AND OTHER STRAINS, IN SOME) - INDIA... 57 TABLE 25 RETAIL PRICE ( ) PER DOSE OF S. BOULARDII - EUROPE... 58 TABLE 26 RETAIL PRICE ( ) PER GRAM OF S. BOULARDII - CHILE... 59 TABLE 27 PRODUCTS FROM DRUGS DATABASES ASIA... 60 TABLE 28 PRODUCTS FROM DRUGS DATABASES - EUROPE... 68 TABLE 29 PRODUCTS FROM DRUGS DATABASES LATIN AMERICA... 74 TABLE 30 PRODUCTS FROM DRUGS DATABASES ROW... 75 TABLE 31 RECOMMENDED DOSES FOR CLINICAL USE OF S. BOULARDII IN ADULTS... 78 TABLE 32 PATENTS RELATING TO SACCHAROMYCES BOULARDII... 148 TABLE 33 KOREAN PATENTS RELATING TO S. BOULARDII... 152 TABLE 34 PRODUCTS CONTAINING S. BOULARDII FOUND IN DRUGS DATABASES, BY COUNTRY.... 160 TABLE 35 TRADEMARKS RELATED TO S. BOULARDII PRODUCTS... 218 FIGURES FIGURE 1 SUPPLEMENTS INDUSTRY SUPPLY CHAIN... 17 FIGURE 2 US NUTRITION INDUSTRY VALUE CHAIN, 2008... 18 FIGURE 3 US NUTRITION INDUSTRY SUPPLY CHAIN, 2008... 19 FIGURE 4 RAW MATERIAL SALES OF US HEALTH INGREDIENTS: 1998-2008... 20 FIGURE 5 US SPECIALTY SUPPLEMENTS SALES VALUE 1997-2008... 22 FIGURE 6 US SPECIALTY SUPPLEMENTS VALUE CHAIN % GROWTH YEAR ON YEAR... 23 FIGURE 7 US SPECIALTY SUPPLEMENTS VALUE CHAIN WHOLESALE AND RAW MATERIAL SALES VALUE AS % OF CONSUMER SALES 1997-2007... 24 FIGURE 8 PER CENT MARK-UP FOR SPECIALTY SUPPLEMENTS RETAILERS AND WHOLESALERS 1997-2007... 25 FIGURE 9 GLOBAL PRESCRIPTION AND OTC GASTROINTESTINAL DISORDER P HARMACEUTICAL MARKET 2001-2014... 27 FIGURE 10 PREVALENCE OF IBS BY COUNTRY... 27 FIGURE 11 PROBIOTICS IN ITALY PHARMACEUTICAL MARKET VOLUMES AND VALUES 2006-2008 (M UNITS / M)... 135 FIGURE 12 COMPOSITION OF THE ITALIAN PHARMACEUTICAL AND SUPPLEMENT MARKET... 136 FIGURE 13 NON-REGISTERED PROBIOTICS IN ITALY VOLUMES AND VALUES 2 006-2008 (M UNITS/ M)... 137 FIGURE 14 NON-REGISTERED PROBIOTICS IN ITALY FORMS OF ADMINISTRATION... 137 FIGURE 15 EXAMPLES OF PROBIOTIC PHARMACEUTICAL PRODUCTS IN ITALY... 138
Saccharomyces boulardii - contents - iv FIGURE 16 FIGURE 17 FIGURE 18 NUMBER OF PATENTS CONTAINING THE WORD 'BOULARDII' BY YEAR (WIPO PATENTSCOPE)... 145 NUMBER OF PATENTS CONTAINING THE WORD 'BOULARDII' BY MAIN GEOGRAPHY (WIPO PATENTSCOPE)... 146 NUMBER OF PATENTS CONTAINING THE WORD 'BOULARDII' BY MAIN APPLICANT (WIPO PATENTSCOPE)... 147