NEW YORK, Aug. 29, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Antifungal Drugs: Technologies and Global Marketshttp://www.reportlinker.com/p0196570/Antifungal-Drugs-Technologies-and-Global-Markets.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_and_Medication
INTRODUCTION
STUDY GOALS AND OBJECTIVESIt should be noted that there is a strong emphasis on early research given the critical need for new and more effective medicines; hence, BCC is including a section of medicines intended for human utilization that are in the preclinical (animal) models of testing, and information on new and novel in vitro therapies. Greater than 98% of medicines at the preclinical level are terminated prior to their utilization in humans, and the research in this area is vast. We are limiting this research to therapies that depict a positive result or represent a very rare and novel approach worthy of further review from R&D groups.
Our key objective in this report is to present an in-depth analysis of the current human antifungal market and explore its future direction. In the last five years there has been a vast increase in the number of patent applications filed in this area. Between 1990 and 1999 there were six U.S. patents granted—evidence of the evolution of drug resistance and an increasing mortality rate.[1],[2]
REASONS FOR DOING THIS STUDYPreviously, BCC examined the antifungal market in its 2003 report, PHM029A ? The Market for Antifungal Drugs, in PHM029B ? Global Markets for Antifungal Agents and in PHM029C ? Antifungal Drugs: Technologies and Global Markets. Due to the rapidly changing market, BCC chose to reexamine the marketplace through another analysis and project its new growth potential. Additionally, PHM029A focused only on human fungal diseases and associated antifungals; PHM029B incorporated the marketplace for antifungals in the veterinary, agricultural and environmental industries; and PHM029C focused on human therapeutics with an intensive focus on human therapeutics in the developmental pipeline. PHM029D is an update of PHM029C.
INTENDED AUDIENCE
This report was prepared as a study of the global antifungal marketplace based on fungal infections and infestations with a focus on human therapeutics. Information is presented on the antifungal industry in general, pharmaceuticals and chemical agents, new technology within the market, new and novel drug applications and market-related issues—in many cases actual revenue is given for the period of 2010 and 2011, with projections of trends and compound annual growth rates (CAGRs) 2011 through 2016.
This study will be of significant interest to hospitals, pharmacies, pharmaceutical companies, biopharmaceutical researchers, pharmaceutical company marketing executives, contract research organizations (CROs), chemists, physicians, nurses, physician assistants, pharmaceutical directors, product managers and representatives, all manner of institutional directors ranging from nursing homes and schools to long-term-care facilities both public and private. It will also be of interest to biologists and those interested in the field of mycology.
SCOPE OF REPORT METHODOLOGY INFORMATION SOURCES ANALYST CREDENTIALS Mary Anne Crandall TABLE OF CONTENTSSTUDY GOALS AND OBJECTIVES 1
REASONS FOR DOING THIS STUDY 1
INTENDED AUDIENCE 2
SCOPE OF REPORT 2
METHODOLOGY 2
INFORMATION SOURCES 2
ANALYST CREDENTIALS 3
RELATED BCC REPORTS 3
BCC ONLINE SERVICES 3
DISCLAIMER 3
CHAPTER 2 SUMMARY 5
SUMMARY TABLE GLOBAL MARKET FORECAST FOR HUMAN ANTIFUNGAL THERAPEUTICS
BY GEOGRAPHIC REGION, THROUGH 2016 ($ MILLIONS) 5
SUMMARY FIGURE GLOBAL SALES OF HUMAN ANTIFUNGALS, 2011 AND 2016 ($ MILLIONS) 6
CHAPTER 3 OVERVIEW 8
HISTORY AND CURRENT STATE OF ANTIFUNGALS 8
TYPES OF PATHOGENIC FUNGI 9
DEFINITION OF THE INDUSTRY 9
CONCEPTS IN THE INDUSTRY 9
IMPORTANCE OF THE INDUSTRY 10
PRODUCT LIFE CYCLES 11
TABLE 1 DRUG DEVELOPMENT LIFECYCLE FOLLOWING DISCOVERY OF NEW DRUG 12
DEVELOPMENT OF ANTIFUNGALS 12
FDA-APPROVED ANTIFUNGALS 13
AZOLE ANTIFUNGALS 13
ECHINOCANDINS 13
POLYENES 13
ALLYLAMINES 13
MISCELLANEOUS ANTIFUNGALS 14
FUTURE DEVELOPMENTS 14
HUMAN CLINICAL DEVELOPMENT, 2009 TO 2011 14
NEW DRUG ACTIVITY 15
TABLE 2 CLINICAL TRIALS OF ALL NEW DRUG THERAPIES AND COMBINATIONS BY ALL
DATE FIELDS, 2009-2011 16
TABLE 3 SELECTED GLOBAL CLINICAL TRIALS OF ALL NEW DRUG THERAPIES THAT
EITHER ARE COMPLETED OR ESTIMATED TO BE COMPLETED BETWEEN 2009 AND 2012 16
ACTIVE OR COMPLETED STUDIES POSTED OR UPDATED, 2009 TO 2011 16
TABLE 4 ACTIVE OR COMPLETED STUDIES, 2009-2011 16
CHAPTER 4 INTRODUCTION TO INDUSTRY APPLICATIONS OF ANTIFUNGAL MEDICINAL
THERAPEUTICS 20
SCOPE OF APPLICATIONS: HUMAN HEALTHCARE 20
HUMAN FUNGAL INFECTIONS 21
RISK FACTORS FOR DEVELOPING FUNGAL INFECTIONS 22
TABLE 5 RISK FACTORS ASSOCIATED WITH HUMAN FUNGAL INFECTIONS 23
FUNGAL SPECIES THAT CAUSE INFECTION IN HUMANS 24
Candidiasis 24
Cutaneous Candidiasis 26
Chronic Mucocutaneous Candidiasis 26
GI Tract Candidiasis 27
Respiratory Tract Candidiasis 27
Genitourinary Tract Candidiasis 27
Hepatosplenic Candidiasis 27
Systemic Candidiasis 27
Candidemia 28
Disseminated Candidiasis 28
Aspergillosis 29
Blastomycosis 30
Coccidioidomycosis 30
Cryptococcosis 31
Dermatophytosis 32
Histoplasmosis 33
Onychomycosis 34
Paracoccidioidomycosis 35
Pseudallescheriasis 35
Sporotrichosis 36
Zygomycosis 36
TABLE 6 INCIDENCE OF COMMON FUNGAL DISEASES 38
MORE RARE FUNGAL INFECTIONS AND DISORDERS 38
Literature Review 39
FUNGAL DRUG RESISTANCE 40
CURRENT DRUG RESISTANCE TOPICS: A GLOBAL VIEW 40
MDR SPECIES 41
Literature Review 43
TABLE 7 COMMON REASONS FOR FUNGAL RESISTANCE 44
STRATEGIES TO IMPROVE RESPONSE AND DECREASE MORTALITY 44
Literature Review 45
CHAPTER 5 HUMAN ANTIFUNGAL AGENTS 47
TABLE 8 GLOBAL MARKET FORECAST FOR HUMAN ANTIFUNGAL CONSUMPTION BY
PRODUCT TYPE, THROUGH 2016 ($ MILLIONS) 47
CLASSES OF ANTIFUNGALS 47
ECHINOCANDINS 47
Literature Review 48
AZOLES 48
Literature Review 49
POLYENES 49
Literature Review 49
OTHER 49
TABLE 9 GLOBAL ANTIFUNGAL PHARMACEUTICAL SALES: TRIAZOLES AND
ECHINOCANDINS VERSUS OTHER ANTIFUNGALS THROUGH 2016 ($ MILLIONS) 50
TABLE 10 PHARMACEUTICAL ANTIFUNGALS BY CLASS/MECHANISM OF ACTION (%) 50
FIGURE 1 PERCENTAGE OF RECOGNIZED ANTIFUNGAL DRUGS (%) 50
TABLE 11 MAJOR ANTIFUNGAL AGENTS BY CLASS AND AVERAGE SALES PRICE PER
DOSAGE, 2009 52
TABLE 12 FUNGAL INFECTION AND TRADITIONAL PHARMACEUTICAL REMEDY 53
TABLE 13 TYPE OF CANDIDAL INFECTION AND PHARMACEUTICAL TREATMENT 54
SIDE EFFECTS 54
TABLE 14 LIFE-THREATENING SIDE EFFECTS FROM ANTIFUNGAL PHARMACEUTICALS 56
OTC ANTIFUNGAL PREPARATIONS 56
TABLE 15 COMMON FUNGAL INFECTIONS AND OTC ROUTES OF ADMINISTRATION 58
NATURAL ANTIFUNGAL REMEDIES 58
TYPES OF NATURAL ANTIFUNGAL REMEDIES 59
Herbal Remedies 59
Enzyme-based Antifungal Agents 60
TABLE 16 COMMON NATURAL ANTIFUNGALS 61
SUMMARY OF SELECTED NATURAL ANTIFUNGALS 62
Aloe 62
Literature Review 63
Curcumin 63
Literature Review 64
Mint 64
Literature Review 64
Wild Marjoram 65
Literature Review 65
Radish 65
Literature Review 66
Parnafungins 66
Literature Review 67
Ginseng 67
Literature Review 68
Walnut 68
Literature Review 68
Pau d'arco 68
Literature Review 69
Garlic 69
Literature Review 69
Grapefruit Seed 70
Literature Review 70
Olive Leaf 70
Literature Review 70
Goldenseal 71
Literature Review 71
Oregano 71
Literature Review 71
Tea Tree 72
Literature Review 72
NATURAL REMEDIES IN EARLIER DEVELOPMENT 72
Literature Review 72
LABORATORY TESTING AND HISTOPATHOLOGY FOR FUNGAL INFECTIONS IN
HUMANS 74
Specimen Examination 74
Cultures 75
Blood Serology 75
ALTERNATIVE HEALTHCARE APPROACHES TO TESTING AND DIAGNOSIS OF
FUNGAL INFECTIONS 75
CAM Testing and Specialized Laboratories 75
Questionnaire for Symptoms 76
CHAPTER 6 COMMON ENVIRONMENTAL FUNGI 78
MOLDS AND THE HUMAN ISSUES THEY PRODUCE 78
WHY ENVIRONMENTAL MOLD IS A UNIQUE PROBLEM 79
HEALTH RISKS DUE TO ENVIRONMENTAL FUNGI AND MOLD 80
TABLE 17 COMMON HEALTH SYMPTOMS BASED ON ENVIRONMENTAL FUNGI AND MOLDS 81
TABLE 18 RISK FACTORS ASSOCIATION WITH ENVIRONMENTAL MOLD REACTIONS 81
TABLE 19 COMMON SOURCE LOCATIONS FOR ENVIRONMENTAL MOLDS 82
ENVIRONMENTAL MOLDS 82
ALTERNARIA 82
Literature Review 83
ASPERGILLUS 83
Literature Review 84
CLADOSPORIUM 84
Literature Review 85
PENICILLIUM 85
Literature Review 86
EUROTIUM 87
Literature Review 87
RHIZOPUS 87
Literature Review 87
MUCOR 88
Literature Review 88
GEOTRICHUM 88
Literature Review 88
FUSARIUM 89
Literature Review 89
STACHYBOTRYS 90
Literature Review 90
WALLEMIA 90
Literature Review 90
TRICHOTHECIUM 91
Literature Review 91
SCOPULARIOPSIS BREVICAULIS 91
Literature Review 91
SCYTALIDIUM DIMIDIATUM 92
Literature Review 92
TRICHODERMA 92
Literature Review 93
PAECILOMYCES VARIOTII 93
Literature Review 93
CHAPTER 7 GOVERNMENT REGULATORY AGENCIES AND PROFESSIONAL ASSOCIATIONS 96
GOVERNMENT REGULATIONS 96
FDA 96
TABLE 20 ANTIFUNGAL WARNING LETTERS FOR THE HUMAN SEGMENT FROM THE FDA
TO MANUFACTURERS, 1997-2011 97
EPA 102
USDA 103
FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS 104
PROFESSIONAL ASSOCIATIONS 104
MEDICAL AND VETERINARY ASSOCIATIONS 104
AGRICULTURAL ASSOCIATIONS 104
OTHER ENVIRONMENTAL ASSOCIATIONS 104
CHAPTER 8 ANTIFUNGAL COMPANIES 107
HUMAN HEALTHCARE 107
PHARMACEUTICAL MANUFACTURERS 107
TABLE 21 MAJOR GLOBAL MANUFACTURERS OF HUMAN ANTIFUNGAL PHARMACEUTICALS 107
FIGURE 2 GLOBAL ANTIFUNGAL PHARMACEUTICAL MANUFACTURERS BY COUNTRY (%) 107
MAJOR PHARMACEUTICAL MANUFACTURER PROFILES 108
TABLE 22 COMPETITIVE MARKET SHARE BY PERCENT, 2011 (%) 109
FIGURE 3 COMPETITIVE MARKET SHARE BY PERCENT, 2011 (%) 109
Astellas Pharma, Inc. 109
Bayer HealthCare 110
Enzon Pharmaceuticals 110
Galderma Pharma SA/Galderma SA 110
Gilead Sciences, Inc. 111
Medicis Pharmaceutical Corp. 111
Novartis International AG 111
Pfizer, Inc. 112
Taro Pharmaceutical Industries, Ltd. 112
Teva Pharmaceutical Industries, Ltd. 112
OTC ANTIFUNGAL MANUFACTURERS 113
PHARMACEUTICAL OTC MARKET 113
TABLE 23 MAJOR HUMAN OTC ANTIFUNGAL MANUFACTURERS AND PRODUCTS 113
MAJOR PHARMACEUTICAL-BASED OTC MANUFACTURER PROFILES 114
Alva-Amco Pharmacal 114
Blaine Labs 114
Dartmouth Pharmaceuticals 115
Del Laboratories 115
Ganeden Biotech 115
Kramer Laboratories 115
Novartis International AG 116
Ortho McNeil 116
PEDiNOL Pharmacal, Inc. 116
Stiefel Laboratories 116
Tarmac Products 117
ALTERNATIVE OTC MANUFACTURERS 117
TABLE 24 COMMONLY AVAILABLE ALTERNATIVE ANTIFUNGALS 117
MAJOR ALTERNATIVE OTC MANUFACTURER PROFILES 118
AquaFlora 118
Crystal Star Herbal Nutrition 118
Enzymedica 118
Forest Herbs Research 119
Garden of Life 119
Michael's Naturopathic Programs 119
Nature's Plus 120
NOW Foods 120
Nutrition Now 120
PROSymbiotics 121
Pure Essence Laboratories 121
Rainbow Light 121
Renew Life 122
Solaray 122
Vitanica 122
CHAPTER 9 ANTIFUNGAL INDUSTRY 124
ANTIFUNGAL MARKET TRENDS: HUMAN HEALTHCARE 124
ACCELERATING ANTIFUNGAL DRUG DEVELOPMENT 124
TABLE 25 NEW PRESCRIPTION ANTIFUNGALS, 2005–JANUARY 2012 125
INCREASED TYPES OF TESTING 125
Need to Increase Use and Acceptance of Newer Drugs 126
EXPERIMENTAL RESEARCH: CLINICAL TRIALS PERFORMED AND SELECTED
PRECLINICAL AND IN VIVO STUDIES 126
A GENERAL OVERVIEW OF NON-PHARMACEUTICAL ANTIFUNGAL TECHNOLOGIES 127
Laser and Photodynamic Therapy 127
Studies 128
Literature Review 128
mAbs 128
Diagnostics and Assays 129
Literature Review 129
Computer Modeling Technology 130
Literature Review 130
R&D SECTION: AN OVERVIEW OF PRODUCTS IN DEVELOPMENT 130
TABLE 26 ANTIFUNGALS IN DEVELOPMENT 131
TRENDS IN CLASS USED AND ADMINISTRATION METHOD 132
TABLE 27 PHARMACEUTICAL ANTIFUNGALS BY ROUTE OF ADMINISTRATION, 2011 (%) 133
FIGURE 4 PHARMACEUTICAL ANTIFUNGALS BY ROUTE OF ADMINISTRATION, 2011 (%) 133
TABLE 28 GLOBAL MARKET FORECAST FOR ANTIFUNGAL PHARMACEUTICAL PRODUCTS BY
ROUTE OF ADMINISTRATION, THROUGH 2016 ($ MILLIONS) 133
UTILIZATION OF OTC AND NATURAL/ALTERNATIVE ANTIFUNGAL AGENTS 134
Shifting Market From Prescription to OTC 134
Market Demand for OTC Products 134
CHAPTER 10 PATENT ANALYSIS 136
PURPOSE OF A PATENT ANALYSIS 136
DUE CARE IN REVIEWING THE PATENT ANALYSIS 136
NEW ANTIFUNGAL PATENTS ISSUED 136
TABLE 29 U.S. ANTIFUNGAL PATENT TRENDS, 1990-2009 (NUMBER OF PATENTS ISSUED) 137
TABLE 30 NEW U.S. ANTIFUNGAL PATENTS ISSUED, 2007–2012 137
TABLE 31 ASSIGNEES OF TWO OR MORE U.S. PATENTS FOR ANTIFUNGAL PRODUCTS,
2007-2011 140
TABLE 32 U.S. PATENT TRENDS BY COUNTRY, 2007-2011 (QUANTITY/%) 140
FIGURE 5 U.S. PATENT TRENDS BY COUNTRY, 2007-2011 (%) 141
TRENDS IN PATENT APPLICATIONS 141
TABLE 33 U.S. PATENT APPLICATIONS BY ANTIFUNGAL MECHANISM OF ACTION, 2007-2011 142
FIGURE 6 U.S. PATENT APPLICATIONS BY ANTIFUNGAL MECHANISM OF ACTION, 2007
THROUGH 2011 (%) 142
TABLE 34 NEW U.S. PATENT APPLICATIONS, 2007-2011 143
TABLE 35 RECENT TRENDS IN PATENT APPLICATIONS FOR ANTIFUNGALS BY MECHANISM
OF ACTION, 2007-2011 149
TABLE 36 U.S. PATENT APPLICATION TRENDS BY COUNTRY, 2007-2011 149
FIGURE 7 U.S. ANTIFUNGAL PATENT APPLICATIONS BY COUNTRY 2007-2011 (%) 149
PATENT EXPIRATIONS 150
TABLE 37 PATENT EXPIRATIONS 2006–2018 150
CHAPTER 11 APPENDIX 153
TABLE 38 PHARMACEUTICAL COMPANIES 153
LIST OF TABLESSUMMARY TABLE GLOBAL MARKET FORECAST FOR HUMAN ANTIFUNGAL THERAPEUTICSBY GEOGRAPHIC REGION, THROUGH 2016 ($ MILLIONS) 5TABLE 1 DRUG DEVELOPMENT LIFECYCLE FOLLOWING DISCOVERY OF NEW DRUG 12TABLE 2 CLINICAL TRIALS OF ALL NEW DRUG THERAPIES AND COMBINATIONS BY ALLDATE FIELDS, 2009-2011 16TABLE 3 SELECTED GLOBAL CLINICAL TRIALS OF ALL NEW DRUG THERAPIES THAT EITHERARE COMPLETED OR ESTIMATED TO BE COMPLETED BETWEEN 2009 AND 2012 16TABLE 4 ACTIVE OR COMPLETED STUDIES, 2009-2011 16TABLE 5 RISK FACTORS ASSOCIATED WITH HUMAN FUNGAL INFECTIONS 23TABLE 6 INCIDENCE OF COMMON FUNGAL DISEASES 38TABLE 7 COMMON REASONS FOR FUNGAL RESISTANCE 44TABLE 8 GLOBAL MARKET FORECAST FOR HUMAN ANTIFUNGAL CONSUMPTION BYPRODUCT TYPE, THROUGH 2016 ($ MILLIONS) 47TABLE 9 GLOBAL ANTIFUNGAL PHARMACEUTICAL SALES: TRIAZOLES ANDECHINOCANDINS VERSUS OTHER ANTIFUNGALS THROUGH 2016 ($ MILLIONS) 50TABLE 10 PHARMACEUTICAL ANTIFUNGALS BY CLASS/MECHANISM OF ACTION (%) 50TABLE 11 MAJOR ANTIFUNGAL AGENTS BY CLASS AND AVERAGE SALES PRICE PER DOSAGE,2009 52TABLE 12 FUNGAL INFECTION AND TRADITIONAL PHARMACEUTICAL REMEDY 53TABLE 13 TYPE OF CANDIDAL INFECTION AND PHARMACEUTICAL TREATMENT 54TABLE 14 LIFE-THREATENING SIDE EFFECTS FROM ANTIFUNGAL PHARMACEUTICALS 56TABLE 15 COMMON FUNGAL INFECTIONS AND OTC ROUTES OF ADMINISTRATION 58TABLE 16 COMMON NATURAL ANTIFUNGALS 61TABLE 17 COMMON HEALTH SYMPTOMS BASED ON ENVIRONMENTAL FUNGI AND MOLDS 81TABLE 18 RISK FACTORS ASSOCIATION WITH ENVIRONMENTAL MOLD REACTIONS 81TABLE 19 COMMON SOURCE LOCATIONS FOR ENVIRONMENTAL MOLDS 82TABLE 20 ANTIFUNGAL WARNING LETTERS FOR THE HUMAN SEGMENT FROM THE FDA TOMANUFACTURERS, 1997-2011 97TABLE 21 MAJOR GLOBAL MANUFACTURERS OF HUMAN ANTIFUNGAL PHARMACEUTICALS 107TABLE 22 COMPETITIVE MARKET SHARE BY PERCENT, 2011 (%) 109TABLE 23 MAJOR HUMAN OTC ANTIFUNGAL MANUFACTURERS AND PRODUCTS 113TABLE 24 COMMONLY AVAILABLE ALTERNATIVE ANTIFUNGALS 117TABLE 25 NEW PRESCRIPTION ANTIFUNGALS, 2005–JANUARY 2012 125TABLE 26 ANTIFUNGALS IN DEVELOPMENT 131TABLE 27 PHARMACEUTICAL ANTIFUNGALS BY ROUTE OF ADMINISTRATION, 2011 (%) 133TABLE 28 GLOBAL MARKET FORECAST FOR ANTIFUNGAL PHARMACEUTICAL PRODUCTS BYROUTE OF ADMINISTRATION, THROUGH 2016 ($ MILLIONS) 133TABLE 29 U.S. ANTIFUNGAL PATENT TRENDS, 1990-2009 (NUMBER OF PATENTS ISSUED) 137TABLE 30 NEW U.S. ANTIFUNGAL PATENTS ISSUED, 2007–2012 137TABLE 31 ASSIGNEES OF TWO OR MORE U.S. PATENTS FOR ANTIFUNGAL PRODUCTS,2007-2011 140TABLE 32 U.S. PATENT TRENDS BY COUNTRY, 2007-2011 (QUANTITY/%) 140TABLE 33 U.S. PATENT APPLICATIONS BY ANTIFUNGAL MECHANISM OF ACTION, 2007-2011 142TABLE 34 NEW U.S. PATENT APPLICATIONS, 2007-2011 143TABLE 35 RECENT TRENDS IN PATENT APPLICATIONS FOR ANTIFUNGALS BY MECHANISMOF ACTION, 2007-2011 149TABLE 36 U.S. PATENT APPLICATION TRENDS BY COUNTRY, 2007-2011 149TABLE 37 PATENT EXPIRATIONS 2006–2018 150TABLE 38 PHARMACEUTICAL COMPANIES 153
LIST OF FIGURES
SUMMARY FIGURE GLOBAL SALES OF HUMAN ANTIFUNGALS, 2011 AND 2016 ($ MILLIONS) 6
FIGURE 1 PERCENTAGE OF RECOGNIZED ANTIFUNGAL DRUGS (%) 50
FIGURE 2 GLOBAL ANTIFUNGAL PHARMACEUTICAL MANUFACTURERS BY COUNTRY (%) 107
FIGURE 3 COMPETITIVE MARKET SHARE BY PERCENT, 2011 (%) 109
FIGURE 4 PHARMACEUTICAL ANTIFUNGALS BY ROUTE OF ADMINISTRATION, 2011 (%) 133
FIGURE 5 U.S. PATENT TRENDS BY COUNTRY, 2007-2011 (%) 141
FIGURE 6 U.S. PATENT APPLICATIONS BY ANTIFUNGAL MECHANISM OF ACTION, 2007
THROUGH 2011 (%) 142
FIGURE 7 U.S. ANTIFUNGAL PATENT APPLICATIONS BY COUNTRY 2007-2011 (%) 149
To order this report:Drug_and_Medication Industry: Antifungal Drugs: Technologies and Global Markets
Nicolas Bombourg
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