プロテイン薬剤市場の展望(-2007)：主要薬剤・開発中主要薬剤の分析

The management report, 'The Therapeutic Proteins Outlook to 2007: An analysis of leading products and late-stage pipeline developments' is a timely global market assessment of the ten major therapeutic protein classes. This report provides product forecasts to 2007, and defines the driving forces that will impact the therapeutic proteins market, allowing you to determine how the future competitive landscape will affect your company. The therapeutic proteins market is thriving, generating global sales of $33,340m in 2002, a 24% increase upon 2001 sales of $26,881m. Understand the key growth areas and find out whether interferons will continue to be the major driver of overall growth in the next five years. This report provides a single source of key product and sales analysis, summarizing changing competitive dynamics and developments to the market therapeutic proteins. Use this timely analysis to forecast the future with confidence within this market and benchmark your product strategies by therapeutic class against your key competitors.

TABLE OF CONTENTS

Executive Summary 10

• Overview of the global therapeutic proteins market 10
• Erythropoietins 11
• Interferons 11
• Insulins 12
• Monoclonal antibodies 13
• Blood factors 14
• Colony stimulating factors 15
• Growth hormones 15
• Interleukins 16
• Growth factors 17
• Therapeutic vaccines 17
• Other therapeutic proteins 18

Chapter 1 Overview of the global therapeutic proteins market 22

• Summary 22
• Introduction 23
• Protein classification 23
• Segmentation of the global therapeutic protein market 25
• Major influencers of therapeutic protein market growth 27
• Drug delivery challenges 28
• Injectable systems 28
• Pulmonary delivery 29
• Transdermal technologies 32
• Oral delivery 32
• Manufacturing capacity shortfall 34
• Why is there a capacity shortfall? 34
• Overcoming manufacturing issues 36
• Biogeneric competition 37
• Will gene therapy supercede therapeutic proteins? 39

Chapter 2 Erythropoietins 44

• Summary 44
• Class overview 44
• Mechanism of action 46
• Global sales 46
• Analysis of leading products 47
• Procrit/Eprex (epoetin alpha) 47
• Epogen (epoetin alpha) and Aranesp (darbepoetin alpha) 50
• NeoRecormon/Epogin (epoetin beta) 52
• Late stage R&D activity 53
• Hemolink (hemoglobin raffimer) 54

Chapter 3 Interferons 56

• Summary 56
• Class overview 57
• Mechanism of action 60
• Global sales 60
• Analysis of leading products 62
• Intron family 62
• Intron A (interferon alpha-2b) 63
• PEG Intron (peg interferon alpha-2b) 63
• Rebetol (ribavirin) 64
• Rebetron (interferon alpha-2b + ribavirin) 65
• Roferon-A (interferon alpha-2a) and Pegasys (pegylated interferon alpha-2a) 65
• Avonex (interferon beta-1a) 68
• Rebif (interferon beta) 69
• Late stage R&D activity 70

Chapter 4 Insulins 74

• Summary 74
• Class overview 75
• Mechanism of action 76
• Global sales 77
• Analysis of leading products 78
• Novolin (insulin) 78
• Humulin (insulin) 81
• Humalog (insulin lispro) 82
• Lantus (glargine insulin) 83
• Late stage R&D activity 84
• NN304 (insulin Detemir) 85
• AERx iDMS 86
• Exubera (inhaled insulin) 89

Chapter 5 Monoclonal antibodies 94

• Summary 94
• Class overview 94
• Mechanism of action 99
• Global sales 99
• Analysis of leading products 101
• Mabthera/Rituxan (rituxumab) 101
• Remicade (infliximab) 102
• Herceptin (trastuzumab) 104
• Humira (adalimumab) 106
• Late stage R&D activity 107
• Xolair (omalizumab) 107
• Bexxar (tositumomab) 109
• Raptiva (efalizumab) 111
• Erbitux/IMC-C225 (cetuximab) 113

Chapter 6 Blood factors 118

• Summary 118
• Class overview 118
• Mechanism of action 121
• Global sales 122
• Analysis of leading products 124
• Activase/TNKase (alteplase/tenecteplase) 124
• NovoSeven (rh factor VIIa) 126
• Late stage R&D activity 128

Chapter 7 Colony stimulating factors 132

• Summary 132
• Class overview 132
• Mechanism of action 133
• Global sales 134
• Analysis of leading products 136
• Neupogen (filgrastim) 136
• Neulasta (pegfilgrastim) 136
• Late stage R&D activity 138
• Chapter 8 Growth hormones 140
• Summary 140
• Class overview 140
• Mechanism of action 141
• Global sales 142
• Analysis of leading products 143
• Genotropin (somatropin) 143
• Nutropin/Protropin (somatropin/somatrem) 144
• Norditropin/Norditropin SimpleXx (r-Somatropin) 146
• Saizen (somatropin) 147
• Late stage R&D activity 147
• Serostim (somatropin) 148

Chapter 9 Interleukins 150

• Summary 150
• Class overview 150
• Mechanism of action 151
• Global sales 151
• Analysis of leading products 152
• Proleukin (interleukin-2) 152
• Late stage R&D activity 153

Chapter 10 Growth factors 156

• Summary 156
• Class overview 156
• Mechanism of action 158
• Global sales 159
• Analysis of leading products 160
• Regranex (beclapermin) 160
• Fiblast (trafermin) 160
• Late stage R&D activity 161
• Stemgen (ancetism) 162
• Keratinocyte growth factor 163

Chapter 11 Therapeutic vaccines 166

• Summary 166
• Class overview 166
• Mechanism of action 170
• Global sales 170
• Analysis of leading products 171
• Melacine (theraccine) 171
• M-Vax 172
• OncoVax 172
• Late stage R&D activity 173
• Cancer 173
• HIV 174
• Barriers to HIV vaccine development 176

Chapter 12 Other therapeutic proteins 182

• Summary 182
• Class overview 182
• Global sales 184
• Analysis of leading products 186
• Enbrel (etanercept) 186
• Cerezyme (imiglucerase) 188
• Xigris (drotrecogin alpha) 190
• Late stage R&D activity 193
• Index 196

List of Tables

• Table 1.1: Segmentation and growth of the global therapeutic proteins market by class, 2001-0226
• Table 2.2: Marketed and late stage development erythropoietins 45
• Table 2.3: Erythropoietin sales, 2001-02 46
• Table 2.4: Sales and forecast sales of Amgen's Epogen and Aranesp, 2000-07 51
• Table 3.5: Marketed and late stage development alpha interferons 58
• Table 3.6: Marketed and late stage development beta interferons 59
• Table 3.7: Marketed and late stage development gamma interferons 59
• Table 3.8: Major interferon sales, 2001-02 61
• Table 4.9: Marketed and late stage development insulins 76
• Table 4.10: Insulin sales, 2001-02 78
• Table 5.11: Marketed and late stage development monoclonal antibodies 96
• Table 5.12: Marketed and late stage development monoclonal antibodies (cont'd) 97
• Table 5.13: Marketed and late stage development monoclonal antibodies (cont'd) 98
• Table 5.14: Major monoclonal antibody sales, 2001-02 100
• Table 6.15: Marketed and late stage development plasminogen activators 120
• Table 6.16: Marketed and late stage development blood clotting factors 121
• Table 6.17: Major blood factor sales, 2001-02 123
• Table 7.18: Marketed and late stage development colony stimulating factors 133
• Table 7.19: Major colony stimulating factor sales, 2001-02 135
• Table 8.20: Marketed and late stage development growth hormones 141
• Table 8.21: Growth hormone sales, 2001-02 143
• Table 9.22: Marketed and late stage development interleukins 151
• Table 9.23: Interleukin sales, 2001-02 152
• Table 10.24: Marketed and late stage development growth factors 157
• Table 10.25: Growth factor classes and mechanism of action 158
• Table 10.26: Major growth factor sales, 2001-02 159
• Table 11.27: Marketed and late stage development therapeutic vaccines (cancer) 168
• Table 11.28: Marketed and late stage development therapeutic vaccines (HIV and 'others') 169
• Table 11.29: Major therapeutic vaccine sales, 2001-02 171
• Table 12.30: Marketed and late stage development of 'other' therapeutic proteins 183
• Table 12.31: Sales of major 'other' therapeutic proteins, 2001-02 185

List of Figures

• Figure 1.1: Segmentation of the global therapeutic proteins market by class, 2001-02 26
• Figure 1.2: Timeline of impact: major influencers of therapeutic protein market growth, 2002-1028