Table of Contents
Chapter 1: SUMMARY 2
- SUMMARY TABLE GLOBAL MARKET FOR PROTEIN THERAPEUTICS, THROUGH 2013 ($
MILLIONS) 4
- SUMMARY TABLE (CONTINUED) 5
- SUMMARY FIGURE GLOBAL MARKET FOR PROTEIN THERAPEUTICS, 2007-2013 ($
MILLIONS)
Chapter 2: OVERVIEW 7
- DEFINING THE TERMS: PROTEINS AND PEPTIDES 6
- PROTEIN DRUGS: THEN AND NOW 7
- TABLE 1 NEW DRUGS ENTERING CLINICAL TRIALS, BY TYPE, 2007 8
- DRUG ADMINISTRATION: MILESTONES AND CHALLENGES 9
- PEGYLATION 10
- PEPTIDE-MEDIATED RECEPTOR TARGETING 11
- PATIENT COMPLIANCE 11
- Patient Compliance (Continued)
Chapter 3: MARKETS BY PRODUCTS 42
- TABLE 2 GLOBAL SIZE OF PROTEIN DRUGS MARKET BY PRODUCTS, THROUGH 2013 ($
MILLIONS) 13
- FIGURE 1 GLOBAL SIZE OF PROTEIN DRUGS MARKET BY PRODUCTS, 2008 AND 2013 ($
MILLIONS) 14
- FIGURE 2 GLOBAL SHARE OF PROTEIN DRUGS MARKET BY PRODUCT, 2008 (%) 14
- FIGURE 2 (CONTINUED) 15
- FIGURE 3 GLOBAL SHARE OF PROTEIN DRUGS MARKET BY PRODUCT, 2013 (%) 15
- ANTIBODY DRUGS 16
- PRODUCTION OF ANTIBODIES FOR THERAPY 16
- Murine Monoclonal Antibodies 17
- Chimeric and Humanized Monoclonal Antibodies 17
- Human Monoclonal Antibodies 18
- Antibody-directed Enzyme Prodrug Therapy (ADEPT) 18
- HOW ANTIBODY DRUGS WORK 18
- How Antibody Drugs Work (Continued) 19
- TABLE 3 FDA-APPROVED MONOCLONAL ANTIBODIES, 2008 20
- THE ANTIBODY DRUG MARKET 21
- TABLE 4 GLOBAL MARKET FORECAST FOR ANTIBODY DRUG PRODUCTS, THROUGH 2013 ($
MILLIONS) 21
- FIGURE 4 GLOBAL MARKET FOR ANTIBODY DRUGS, 2008 (%) 21
- FIGURE 4 (CONTINUED) 22
- FIGURE 5 GLOBAL MARKET FOR ANTIBODY DRUGS, 2013 (%) 22
- FIGURE 5 (CONTINUED) 23
- CHANGES IN A DYNAMIC MARKET 23
- Possible new indications for Campath 23
- EGF-R Antibodies: Still Investigational Therapies 24
- Side Effects Could Affect Tysabri' s Future 25
- TABLE 5 FDA-APPROVED MONOCLONAL ANTIBODIES FOR CANCER TREATMENT, 2008 26
- CYTOKINES 27
- THE CYTOKINE MARKET 28
- Granulocyte-colony Stimulating Factors 28
- Interferon 28
- Interferon 28
- Interferon 29
- Interleukins 29
- TABLE 6 GLOBAL MARKET FORECAST FOR CYTOKINE PRODUCTS, THROUGH 2013 ($
MILLIONS) 30
- FIGURE 6 GLOBAL MARKET FOR CYTOKINE DRUGS, 2008 (%) 30
- FIGURE 7 FORECAST GLOBAL MARKET FOR CYTOKINE DRUGS, 2013 (%) 31
- PEPTIDE HORMONES 32
- TABLE 7 GLOBAL MARKET FORECAST FOR PEPTIDE HORMONES, THROUGH 2013 ($
MILLIONS) 33
- FIGURE 8 GLOBAL MARKET FORECAST FOR PEPTIDE HORMONES, 2008 AND 2013 ($
MILLIONS) 33
- FIGURE 9 GLOBAL MARKET FORECAST FOR PEPTIDE HORMONES, 2008 (%) 34
- VACCINES 34
- KINDS OF VACCINES 35
- Killed Whole Organisms 36
- Attenuated Organisms 36
- Toxoids 36
- Surface Proteins 36
- Inactivated Virus 37
- Attenuated Virus 37
- TABLE 8 VACCINE PREPARATIONS, BY DISEASE 37
- TABLE 9 VACCINE-PREVENTABLE DISEASE IN THE U.S., PRE- AND POST-
VACCINATION PROGRAMS 38
- THE GLOBAL PROTEIN VACCINE MARKET 39
- TABLE 10 GLOBAL MARKET FORECAST FOR VACCINES, THROUGH 2013 ($ MILLIONS) 39
- FIGURE 10 GLOBAL MARKET FORECAST FOR VACCINES, 2008 AND 2013 ($ MILLIONS)
40
- TABLE 11 NEW AND EMERGING VACCINE PRODUCTS 41
- BLOOD PRODUCTS 42
- WHAT DRIVES DEMAND FOR BLOOD PRODUCTS 42
- THE GLOBAL MARKET FOR BLOOD PRODUCTS 43
- TABLE 12 GLOBAL MARKET FORECAST FOR BLOOD PRODUCTS, THROUGH 2013 ($
MILLIONS) 44
- FIGURE 11 GLOBAL MARKET FORECAST FOR BLOOD PRODUCTS, 2008 AND 2013 ($
MILLIONS) 44
- FIGURE 12 GLOBAL MARKET FOR BLOOD PRODUCTS, 2008 (%) 45
- Recombinant Albumin 45
- Factor VIII 46
- TABLE 13 COMPANIES INVOLVED IN FACTOR VIII DEVELOPMENT 46
- Factor IX 46
- Hemoglobin 47
- Second Generation Hemoglobins in Development 48
- TABLE 14 COMPANIES INVOLVED IN RECOMBINANT HEMOGLOBIN MANUFACTURE 49
- Protein C 49
- PEPTIDE ANTIBIOTICS 50
- TYPES OF PEPTIDE ANTIBIOTICS 50
- TABLE 15 GLOBAL MARKET FORECAST FOR PEPTIDE ANTIBIOTICS, THROUGH 2013 51
- THE RESISTANCE PROBLEM 51
- THERAPEUTIC ENZYMES 52
- Glucocerebrosidase 52
- Tissue Plasminogen Activator 53
- Pancreatin 53
- Thrombin 53
- TABLE 16 GLOBAL MARKET FORECAST FOR THERAPEUTIC ENZYMES, THROUGH 2013
Chapter 4: MANUFACTURING TECHNOLOGY 25
- NATURAL SOURCING AND EXTRACTION 55
- HUMAN SOURCING 56
- SPECIAL FEATURES OF HUMAN-SOURCING MANUFACTURE 56
- TABLE 17 PROTEIN DRUGS MADE BY HUMAN-SOURCE EXTRACTION 56
- SPECIAL FEATURES OF ANIMAL SOURCING MANUFACTURE 57
- TABLE 18 PROTEIN DRUGS MADE BY NATURAL ANIMAL-SOURCE EXTRACTION 58
- TABLE 19 PROTEIN DRUGS MANUFACTURED BY NATURAL SOURCING AND EXTRACTION, BY
PRODUCT, THROUGH 2013 ($ MILLIONS) 58
- FIGURE 13 PROTEIN DRUGS MANUFACTURED BY NATURAL SOURCING AND EXTRACTION,
BY PRODUCT, 2008 AND 2013 ($ MILLIONS) 59
- FIGURE 14 PROTEIN DRUGS MANUFACTURED BY NATURAL SOURCING AND EXTRACTION,
BY PRODUCT 2008 (%) 59
- FIGURE 15 PROTEIN DRUGS MANUFACTURED BY NATURAL SOURCING AND EXTRACTION,
BY PRODUCT, 2013 (%) 60
- MICROBIAL FERMENTATION 60
- TABLE 20 PROTEIN DRUGS MANUFACTURED BY MICROBIAL FERMENTATION, BY PRODUCT,
THROUGH 2013 ($ MILLIONS) 61
- FIGURE 16 PROTEIN DRUGS MANUFACTURED BY MICROBIAL FERMENTATION, BY
PRODUCT, 2008 AND 2013 ($ MILLIONS) 62
- FIGURE 17 PROTEIN DRUGS MANUFACTURED BY MICROBIAL FERMENTATION, BY
PRODUCT, 2008 (%) 62
- FIGURE 18 PROTEIN DRUGS MANUFACTURED BY MICROBIAL FERMENTATION, BY
PRODUCT, 2013 (%) 63
- MAMMALIAN CELL CULTURE 63
- BIOREACTORS 64
- TABLE 21 TYPES OF BIOREACTORS 64
- Bioreactors (Continued) 65
- OTHER CELL CULTURE SYSTEMS: INSECT CELLS 66
- TABLE 22 PROTEIN DRUGS MANUFACTURED BY CELL CULTURE, BY PRODUCT, THROUGH
2013 ($ MILLIONS) 66
- FIGURE 19 PROTEIN DRUGS MANUFACTURED BY CELL CULTURE, BY PRODUCT, 2008 AND
2013 ($ MILLIONS) 67
- FIGURE 20 PROTEIN DRUGS MANUFACTURED BY CELL CULTURE, 2008 (%) 67
- FIGURE 21 PROJECTED PROTEIN DRUGS MANUFACTURED BY CELL CULTURE, 2013 (%) 68
- TRANSGENICS: PLANTS AND ANIMALS 68
- TRANSGENIC PLANTS PHARMING 68
- TABLE 23 TRANSGENIC PLANT PHARMACEUTICALS UNDER DEVELOPMENT 69
- TRANSGENIC ANIMALS 70
- Founder Animal Production 70
- History in the Making: the First Transgenic Drugs 71
- TABLE 24 PROTEIN DRUGS MANUFACTURED BY TRANSGENICS, BY PRODUCT, THROUGH
2013 ($ MILLIONS) 72
- FIGURE 22 PROTEIN DRUGS MANUFACTURED BY TRANSGENICS, BY PRODUCT, THROUGH
2013 73
- FIGURE 23 PROTEIN DRUGS MANUFACTURED BY TRANSGENICS, BY PRODUCT, 2013 (%)
73
- TABLE 25 PROTEIN DRUGS DERIVED FROM TRANSGENIC ANIMALS, 2008 74
- On the Horizon: Gene Therapy with Transgenics? 74
- CHEMICAL SYNTHESIS 75
- HOW IT WORKS 75
- COST AND SCALING- UP 76
- TABLE 26 PEPTIDE PHARMACEUTICALS MANUFACTURED BY CHEMICAL SYNTHESIS 77
- TABLE 27 PROTEIN DRUGS MANUFACTURED BY CHEMICAL SYNTHESIS, BY PRODUCT
TYPE, THROUGH 2013 ($ MILLIONS) 77
- FIGURE 24 PROTEIN DRUGS MANUFACTURED BY CHEMICAL SYNTHESIS, BY PRODUCT
TYPE, THROUGH 2013 ($ MILLIONS) 78
- FIGURE 25 PROTEIN DRUGS MANUFACTURED BY CHEMICAL SYNTHESIS, BY PRODUCT
TYPE, 2008 78
- FIGURE 26 PROTEIN DRUGS MANUFACTURED BY CHEMICAL SYNTHESIS, BY PRODUCT
TYPE, 2013
Chapter 5: TECHNOLOGY 16
- MANUFACTURING, PROCESSING AND FORMULATION 80
- FIGURE 27 MANUFACTURING PROCESS FLOW CHART 80
- PROCESSING AND DOWNSTREAM 81
- PROTEIN AGGREGATION HAS CLINICAL RAMIFICATIONS 82
- FOCUS ON FORMULATION 83
- FREEZE-THAW 83
- Challenges in the Freezing Process 84
- Thawing 85
- Freeze-Thaw Technologies 85
- FORMULATION STEP 86
- Formulation Step (Continued) 87
- FILTRATION 88
- DRUG PRODUCT FILLING 88
- LYOPHILIZATION 89
- Lyophilization (Continued) 90
- Lyophilization (Continued) 91
- INSPECTION AND PACKAGING 92
- DRUG STORAGE, TRANSPORT AND DELIVERY 92
- Protein-Silicone Oil Interactions 92
- Leachables and Extractables 93
- TRANSPORTATION 94
- PHOTOSTABILITY 95
Chapter 6: PATENT ANALYSIS 8
- PATENTS BY PRODUCT TYPE 96
- TABLE 28 PROTEIN PHARMACEUTICALS, ISSUED PATENTS BY TECHNOLOGY, AUGUST
2005 TO AUGUST 2008 96
- FIGURE 28 PROTEIN PHARMACEUTICALS, ISSUED PATENTS BY PRODUCT, AUGUST 2005
TO AUGUST 2008 97
- PATENTS BY REGION 97
- TABLE 29 PROTEIN PHARMACEUTICALS, ISSUED PATENTS BY REGION, AUGUST 2005 TO
AUGUST 2008 97
- TABLE 29 (CONTINUED) 98
- TABLE 30 PROTEIN PHARMACEUTICALS, ISSUED PATENTS BY TECHNOLOGY, AUGUST
2005 TO AUGUST 2008 98
- FIGURE 29 PROTEIN PHARMACEUTICALS, ISSUED PATENTS BY TECHNOLOGY, AUGUST
2005 TO AUGUST 2008 (%) 99
- IMPORTANT PATENT ISSUES FOR FOLLOW-ON BIOLOGICS 99
- PATENTS OF INTEREST IN THE PROTEIN DRUGS FIELD 100
- TREATMENTS USING TRANSGENIC GOAT PRODUCED ANTITHROMBIN III 100
- HIGHLY PHOSPHORYLATED AND SULFATED RECOMBINANT FACTOR IX 101
- HEPATITIS C RECEPTOR PROTEIN CD81 101
- PURIFICATION OF POLYPEPTIDES 102
- Purification of Polypeptides (Continued) 103
Chapter 7: INTERNATIONAL ASPECTS 3
- TABLE 31 GLOBAL PROTEIN THERAPEUTIC MARKET PRODUCTION BY REGION, 2008 ($
MILLIONS) 104
- UNITED STATES 105
- WESTERN EUROPE 105
- JAPAN 105
- CHINA 106
Chapter 8: MARKET SHARE 3
- TABLE 32 MARKET SHARE OF COMPANIES INVOLVED IN ANTIBODY DRUGS, 2008 (UNIT,
%) 107
- TABLE 33 MARKET SHARE OF COMPANIES INVOLVED IN CYTOKINES, 2008 (UNIT, %)
108
- TABLE 34 MARKET SHARE OF COMPANIES INVOLVED IN PEPTIDE HORMONES, 2008
(UNIT, %) 108
- TABLE 35 MARKET SHARE OF COMPANIES INVOLVED IN VACCINES, 2008 (UNIT, %) 108
- TABLE 36 MARKET SHARE OF COMPANIES INVOLVED IN BLOOD PRODUCTS, 2008 (UNIT,
%) 109
- TABLE 37 MARKET SHARE OF COMPANIES INVOLVED PEPTIDE ANTIBIOTICS, 2008
(UNIT, %) 109
- TABLE 38 MARKET SHARE OF COMPANIES INVOLVED ENZYMES, 2008 (UNIT, %) 109
Chapter 9: COMPANY PROFILES 28
- ABBOTT LABORATORIES 110
- TABLE 39 ABBOTT LABS PROTEIN DRUGS 111
- AEGIS THERAPEUTICS 111
- ALEXION PHARMACEUTICALS 112
- AMGEN 113
- TABLE 40 AMGEN' S PROTEIN DRUGS 114
- BAYER DIAGNOSTICS 114
- BIOGEN IDEC, INC. 115
- TABLE 41 BIOGEN IDEC' S PROTEIN DRUGS 116
- CENTOCOR 116
- ELI LILLY & CO. 117
- TABLE 42 LILLY' S PROTEIN DRUGS 118
- GENENTECH, INC. 118
- TABLE 43 GENENTECH' S PROTEIN DRUGS 119
- GENZYME CORP. 119
- TABLE 44 GENZYME CORPORATION PROTEIN DRUGS 120
- TABLE 44 (CONTINUED) 121
- JOHNSON & JOHNSON INC. 121
- MEDIMMUNE, INC. 122
- MEDAREX 122
- TABLE 45 MEDAREX' S PIPELINE PROTEIN DRUGS 123
- MERCK & CO., INC. 124
- TABLE 46 MERCK' S PROTEIN DRUGS 124
- MERCK SERONO 125
- TABLE 47 MERCK-SERONO' S PROTEIN DRUGS 126
- NOVARTIS PHARMA AG 126
- TABLE 48 NOVARTIS' PROTEIN DRUGS 127
- NOVO NORDISK A/S 127
- NOVO NORDISK A/S (CONTINUED) 128
- ROCHE HOLDINGS, LTD. 129
- TABLE 49 ROCHE' S PROTEIN DRUGS 130
- SANGART 131
- SANOFI-AVENTIS 131
- UNIGENE LABORATORIES, INC. 132
- UNIGENE LABORATORIES, INC. (CONTINUED) 133
- VACCINOGEN INC 134
- WYETH 135
- WYETH (CONTINUED) 136
- TABLE 50 WYETH' PROTEIN DRUGS 137
Chapter 10: APPENDIX: WEB RESOURCES FOR PROTEIN DRUG DESIGN
- THE NATIONAL CANCER INSTITUTE 3D STRUCTURE DATABASE 138
- KIBANK 138
- COMBINATORIAL CHEMISTRY REVIEW 138
- GDB: STRUCTURES 139
|
Related Report
|
View Cart
