IDENTIFICATION OF OPPORTUNITIES FOR SACCHAROMYCES

Transcription

1 IDENTIFICATION OF OPPORTUNITIES FOR SACCHAROMYCES BOULARDII Prepared by: CPL Business Consultants CAB International Centre, Wallingford, Oxfordshire, OX10 8DE Tel: , Ms Megha Chugh Dr Robert Harwood Dr Esther Hunter Dr Steve Lisansky December 2010

2 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 TRADEMARKS CONCLUSIONS KEY SUCCESS FACTORS BARRIERS TO ENTRY RECOMMENDATIONS INTRODUCTION SUPPLY CHAIN MARKETS PROBIOTICS GASTROINTESTINAL DRUGS SACCHAROMYCES BOULARDII Global Market US Market European Market Indian Market Korean Market Brazil PLAYERS BIOTECH COMPANIES EXAMPLES OF PRODUCTS CONTAINING SACCHAROMYCES BOULARDII PRODUCTS & PRICES PRICES Asia - India Europe Latin America Chile PRODUCTS CONTAINING S. BOULARDII SOLD AS DRUGS Asia Europe Latin America Rest of the World (RoW)... 75

3 Saccharomyces boulardii - contents - ii SCIENTIFIC SUBSTANTIATION SUMMARY Taxonomy Mechanisms of action Clinical efficacy Effective Doses Characteristics & Disposition Scientific evidence against various disorders Safety and Contraindications Number of published papers Number of peer-reviewed papers published on S. boulardii from 1976 to ABSTRACTS OF 25 RECENT SIGNIFICANT SCIENTIFIC PAPERS STUDIES FUNDED BY A KEY PLAYER CONTACTS OVERVIEW OF CONTACT VIEWS Market Regulations Players & Competition Prices Technology Applications Scientific backing CONTACT REPORTS YEAST PRODUCERS SUPPLEMENTS AND DRUGS MANUFACTURERS OTHER PROBIOTICS COMPANY INFANT FORMULA COMPANIES DISTRIBUTORS CONSULTANCIES ACADEMICIANS NEWS OVERVIEW articles PATENTS - IP AND TECHNOLOGICAL POSITIONS PATENT ABSTRACTS PHARMACEUTICAL PRODUCTS FDA Biologics License Applications (BLA) Process (CBER) EFSA Article 13 Submissions TRADEMARKS TABLES TABLE 1 PRODUCERS OF SACCHAROMYCES BOULARDII - GLOBAL... 4 TABLE 2 EXPLANATION OF ATC CODING FOR SACCHAROMYCES BOULARDII TABLE 3 RAW MATERIAL SALES OF US HEALTH INGREDIENTS: TABLE 4 VALUE OF RETAIL, WHOLESALE AND RAW MATERIAL SALES FOR SPECIALTY SUPPLEMENTS IN THE US, TABLE 5 SALES VALUE GROWTH FOR SPECIALTY SUPPLEMENTS IN THE US (CAGR) TABLE 6 US SPECIALTY SUPPLEMENTS VALUE CHAIN % GROWTH YEAR ON YEAR TABLE 7 US SPECIALTY SUPPLEMENTS VALUE CHAIN WHOLESALE AND RAW MATERIAL SALES VALUE AS % OF CONSUMER SALES

4 Saccharomyces boulardii - contents - iii TABLE 8 PER CENT MARK-UP FOR SPECIALTY SUPPLEMENTS RETAILERS AND WHOLESALERS IN THE US TABLE 9 GLOBAL PROBIOTICS MARKET, VALUE AND GROWTH TABLE 10 GLOBAL PROBIOTICS MARKET BY GEOGRAPHIC REGION, TABLE 11 ESTIMATED GLOBAL CONSUMPTION OF S. BOULARDII BY COUNTRY OR GEOGRAPHIC REGION TABLE 12 COMPANY X S GLOBAL SALES S. BOULARDII AND TOTAL SALES (2008) TABLE 13 UNITS OF S. BOULARDII PRODUCTS MANUFACTURED AND QUANTITY OF S. BOULARDII USED IN BRAZIL, TABLE 14 VOLUME AND MARKET VALUE FOR S. BOULARDII PRODUCTS IN BRAZIL BY PRODUCT, TABLE 15 VALUE PER UNIT AND ESTIMATE OF TONNAGE USED IN S. BOULARDII PRODUCTS IN BRAZIL BY PRODUCT, TABLE 16 GROWTH IN VOLUME AND VALUE FOR S. BOULARDII PRODUCTS IN BRAZIL BY PRODUCT, TABLE 17 PER CENT MARKET SHARE IN TERMS OF VOLUME AND VALUE FOR S. BOULARDII P RODUCTS IN BRAZIL BY PRODUCT, TABLE 18 SALES VALUE AND VOLUME FOR UL-250 IN PORTUGAL, TABLE 19 PRODUCERS OF SACCHAROMYCES BOULARDII - GLOBAL TABLE 20 COMPANY Y KEY FINANCIAL DATA TABLE 21 COMPANY Z S SACCHAROMYCES BOULARDII SPECIFICATIONS TABLE 22 SOME COMMERCIALLY AVAILABLE PROBIOTICS CONTAINING SACCHAROMYCES BOULARDII TABLE 23 PRICE POINTS AT DIFFERENT LEVELS ON THE VALUE CHAIN TABLE 24 RETAIL PRICE ( ) PER DOSE OF S. BOULARDII (AND OTHER STRAINS, IN SOME) - INDIA TABLE 25 RETAIL PRICE ( ) PER DOSE OF S. BOULARDII - EUROPE TABLE 26 RETAIL PRICE ( ) PER GRAM OF S. BOULARDII - CHILE TABLE 27 PRODUCTS FROM DRUGS DATABASES ASIA TABLE 28 PRODUCTS FROM DRUGS DATABASES - EUROPE TABLE 29 PRODUCTS FROM DRUGS DATABASES LATIN AMERICA TABLE 30 PRODUCTS FROM DRUGS DATABASES ROW TABLE 31 RECOMMENDED DOSES FOR CLINICAL USE OF S. BOULARDII IN ADULTS TABLE 32 PATENTS RELATING TO SACCHAROMYCES BOULARDII TABLE 33 KOREAN PATENTS RELATING TO S. BOULARDII TABLE 34 PRODUCTS CONTAINING S. BOULARDII FOUND IN DRUGS DATABASES, BY COUNTRY TABLE 35 TRADEMARKS RELATED TO S. BOULARDII PRODUCTS FIGURES FIGURE 1 SUPPLEMENTS INDUSTRY SUPPLY CHAIN FIGURE 2 US NUTRITION INDUSTRY VALUE CHAIN, FIGURE 3 US NUTRITION INDUSTRY SUPPLY CHAIN, FIGURE 4 RAW MATERIAL SALES OF US HEALTH INGREDIENTS: FIGURE 5 US SPECIALTY SUPPLEMENTS SALES VALUE FIGURE 6 US SPECIALTY SUPPLEMENTS VALUE CHAIN % GROWTH YEAR ON YEAR FIGURE 7 US SPECIALTY SUPPLEMENTS VALUE CHAIN WHOLESALE AND RAW MATERIAL SALES VALUE AS % OF CONSUMER SALES FIGURE 8 PER CENT MARK-UP FOR SPECIALTY SUPPLEMENTS RETAILERS AND WHOLESALERS FIGURE 9 GLOBAL PRESCRIPTION AND OTC GASTROINTESTINAL DISORDER P HARMACEUTICAL MARKET FIGURE 10 PREVALENCE OF IBS BY COUNTRY FIGURE 11 PROBIOTICS IN ITALY PHARMACEUTICAL MARKET VOLUMES AND VALUES (M UNITS / M) FIGURE 12 COMPOSITION OF THE ITALIAN PHARMACEUTICAL AND SUPPLEMENT MARKET FIGURE 13 NON-REGISTERED PROBIOTICS IN ITALY VOLUMES AND VALUES (M UNITS/ M) FIGURE 14 NON-REGISTERED PROBIOTICS IN ITALY FORMS OF ADMINISTRATION FIGURE 15 EXAMPLES OF PROBIOTIC PHARMACEUTICAL PRODUCTS IN ITALY

5 Saccharomyces boulardii - contents - iv FIGURE 16 FIGURE 17 FIGURE 18 NUMBER OF PATENTS CONTAINING THE WORD 'BOULARDII' BY YEAR (WIPO PATENTSCOPE) NUMBER OF PATENTS CONTAINING THE WORD 'BOULARDII' BY MAIN GEOGRAPHY (WIPO PATENTSCOPE) NUMBER OF PATENTS CONTAINING THE WORD 'BOULARDII' BY MAIN APPLICANT (WIPO PATENTSCOPE)