2008/2009 Biotechnology Research Review

Table of Contents

Chapter- 1: INTRODUCTION -- Complimentary 0

• INTRODUCTION 2
• STUDY GOALS AND OBJECTIVES 2
• REASONS FOR DOING THE STUDY 2
• INTENDED AUDIENCE 3
• SCOPE OF REPORT 3
• METHODOLOGY 4
• INFORMATION SOURCES 4
• RELATED BCC REPORTS 4
• ANALYST CREDENTIALS 5
• SUMMARY 5
• TABLE 1 GLOBAL VALUE OF SYNTHETIC BIOLOGY MARKET BY INDUSTRY, THROUGH 2013 ($ MILLIONS) 6
• FIGURE 1 GLOBAL VALUE OF SYNTHETIC BIOLOGY MARKET BY INDUSTRY, 2006-2013 ($ MILLIONS) 6
• OVERVIEW 7
• SYNTHETIC BIOLOGY TECHNOLOGIES COVERED IN THIS REPORT 7
• TABLE 2 SCOPE OF THIS REPORT 8
• WHAT IS SYNTHETIC BIOLOGY? 8
• WHAT IS SYNTHETIC BIOLOGY (CONTINUED) 8
• DEVELOPMENT STAGE OF SYNTHETIC BIOLOGY 9
• FORCES DRIVING SYNTHETIC BIOLOGY MARKET GROWTH 10
• TABLE 3 SYNTHETIC BIOLOGY GROWTH DRIVING FORCES 10
• Forces Driving Synthetic Biology ...(Continued) 11
• GLOBAL MARKET POTENTIAL FOR SYNTHETIC BIOLOGY PRODUCTS 12
• TABLE 4 GLOBAL VALUE OF SYNTHETIC BIOLOGY MARKET BY END USER, THROUGH 2013 ($ MILLIONS) 12
• TABLE 5 GLOBAL VALUE OF SYNTHETIC BIOLOGY-ENABLED ENERGY MARKET BY FUEL TYPE, THROUGH 2013 ($ MILLIONS) 13
• LIFE CYCLE STATUS OF SYNTHETIC BIOLOGY TECHNOLOGIES 13
• TABLE 6 SYNTHETIC BIOLOGY PRODUCTS AND TECHNOLOGY LIFE CYCLE STAGE 14
• THE SYNTHETIC BIOLOGY INDUSTRY 14
• TABLE 7 SYNTHETIC BIOLOGY KEY COMPETITORS BY MARKET FOCUS 15
• The Synthetic Biology Industry (Continued) 16

Chapter-2: SYNTHETIC BIOLOGY: EMERGING GLOBAL MARKETS (BIO066A) 15

Chapter-3: COMMERCIAL AMINO ACIDS (BIO007H) 25

• INTRODUCTION 42
• STUDY GOALS AND OBJECTIVES 42
• REASONS FOR DOING THIS STUDY 42
• SCOPE OF REPORT 42
• INTENDED AUDIENCE 43
• METHODOLOGY 43
• INFORMATION SOURCES 43
• ABOUT THE AUTHOR 43
• RELATED BCC WORK CREDENTIALS 43
• EXECUTIVE SUMMARY 44
• TABLE 19 WORLDWIDE SALES OF MONOCLONAL THERAPEUTIC AND COMPANION DIAGNOSTICS, THROUGH 2012 ($ BILLIONS) 45
• FIGURE 5 WORLDWIDE SALES OF MONOCLONAL THERAPEUTIC AND COMPANION DIAGNOSTICS, 2005-2012 ($ BILLIONS) 45
• MAB GROWTH IN THERAPEUTICS 45
• Pharma Moves In 46
• MAB GROWTH IN DIAGNOSTICS 46
• Key Drivers and Challenges 47
• Significant Trends 48
• OVERVIEW 48
• TABLE 20 BIOPHARMACEUTICAL CATEGORIES 49
• TABLE 21 MONOCLONAL ANTIBODIES APPROVED FOR DISEASE THERAPY* 49
• TABLE 21 (CONTINUED) 50
• TABLE 21 (CONTINUED) 51
• FIGURE 6 COMPOSITION OF COMMERCIALIZED ANTIBODIES BY TYPE, 2007 AND 2012 (%) 51
• FIGURE 6 (CONTINUED) 52
• FIGURE 7 ANTIBODY ILLUSTRATED 53
• MAB TECHNOLOGY: BEGINNINGS AND MOVEMENTS 54
• TABLE 22 TIMELINE FOR MAB DEVELOPMENT 54
• Moving Towards Humanization 54
• ANTIBODY TECHNOLOGY TYPES 55
• Humanization 55
• TABLE 23 WORLDWIDE FORECAST OF THERAPEUTIC MONOCLONAL ANTIBODIES, BY TYPE, THROUGH 2012 ($ BILLIONS) 56
• Superhumanization 56
• Smart Technology 57
• TABLE 24 SMART TECHNOLOGY ROYALTIES BY LICENSEE AND PRODUCT AS A PERCENTAGE OF TOTAL ROYALTY REVENUE: EXAMPLE OF TECHNOLOGY ROYALTY POTENTIAL (%) 58
• Fully Human Technology 58
• Phage Display 58
• Phage Display (Continued) 59
• Crucell' s Per.C6 and Mabstract 60
• Transgenic Mice 61
• TABLE 25 TRANSGENIC TECHNOLOGIES 62
• TABLE 25 (CONTINUED) 63
• Emerging Antibody Technology Types 64
• Fragments 64
• Single Chain Antibodies 64
• Bispecific Antibodies 65
• Conjugation 66
• TABLE 26 LEADING CONJUGATION TECHNOLOGIES 67
• TECHNOLOGY RELATED ISSUES AND CHALLENGES 68
• Optimization 68
• Adjusting Glycosylation 68
• TABLE 27 ANTIBODY TECHNOLOGY BEHIND COMMERCIALIZED MABS 69
• MANUFACTURING 70
• LEGALITY AND INTELLECTUAL PROPERTY 71
• Legality and Intellectual Property (Continued) 72
• TABLE 28 CAT' S PHAGE AND RIBOSOME DISPLAY PATENTS 73
• PHARMACEUTICAL AND BIOTECHNOLOGY LANDSCAPE 73
• TABLE 29 PHARMA' S MAB-RELATED ACQUISITIONS 74
• FIGURE 8 THE SYNERGY OF PHARMA AND BIOTECH 75
• TABLE 30 GLOBAL SNAPSHOT: BIOTECHNOLOGY INDUSTRY, 2006 75
• Pharmaceutical and Biotechnology ... (Continued) 76

Chapter-4: MONOCLONAL THERAPEUTICS AND COMPANION DIAGNOSTIC PRODUCTS (BIO016G) 35

Chapter-5: ENVIRONMENTAL MARKETS FOR BIOTECHNOLOGY (BIO019B) 6

• INTRODUCTION 77
• STUDY GOALS AND OBJECTIVES 77
• REASONS FOR STUDY AND IMPORTANCE 77
• INTENDED AUDIENCE 77
• SCOPE OF REPORT 78
• INFORMATION SOURCES 79
• ANALYST CREDENTIALS 79
• RELATED REPORTS 79
• SUMMARY 80
• TABLE 31 U.S. VALUE OF ENVIRONMENTAL BIOTECHNOLOGY PRODUCTS FOR WASTE TREATMENT, THROUGH 2013 ($ MILLIONS) 81
• FIGURE 9 MARKET SHARE BY PRODUCT TYPE, 2008 (%) 81
• SUMMARY (CONTINUED) 82

Chapter-6: PROTEIN DRUGS: GLOBAL MARKETS AND MANUFACTURING TECHNOLOGIES (BIO021C) 4

• INTRODUCTION 87
• STUDY BACKGROUND 87
• STUDY GOAL AND OBJECTIVES 87
• INTENDED AUDIENCE 88
• SCOPE OF REPORT 88
• Scope of Report (Continued) 89
• METHODOLOGY AND INFORMATION SOURCES 90
• COMMERCIAL DRUGS 90
• DEVELOPMENTAL DRUGS 90
• TABLE 33 FDA APPROVAL PROCESS FOR NEW DRUGS 91
• ANALYST CREDENTIALS 91
• RELATED BCC PUBLICATIONS 92
• SUMMARY 92
• TABLE 34 GLOBAL FORECAST FOR BOTANICAL* AND PLANT-DERIVED DRUGS, THROUGH 2013 ($ BILLIONS) 93
• FIGURE 11 GLOBAL FORECAST FOR BOTANICAL* AND PLANT-DERIVED DRUGS, 2006-2013 ($ BILLIONS) 93
• SUMMARY (CONTINUED) 94
• SUMMARY (CONTINUED) 95
• OVERVIEW 95
• BRIEF HISTORY OF PLANT-DERIVED MEDICINES 96
• TABLE 35 KEY DATES IN BOTANICAL MEDICINE 97
• TABLE 36 WELL KNOWN PLANT-DERIVED DRUGS 98
• OPPORTUNITY LIES BEYOND WHAT' S KNOWN 98
• FIGURE 12 COMPOSITION OF FDA-APPROVED NATURAL-DERIVED COMPOUNDS IN U.S. (2000 - 2005)* (%) 99
• KEY DRIVERS 100
• KEY CHALLENGES 100
• SIGNS OF INDUSTRY INVESTMENT 101
• TABLE 37 SWOT ANALYSIS ON BOTANICAL DRUG DEVELOPMENT 102
• TABLE 38 KEY SIGNS OF INVESTMENT IN BOTANICAL AND OTHER PLANT-DERIVED DRUGS 103
• TABLE 38 (CONTINUED) 104
• BOTANICAL DRUGS DEFINED 104
• Botanical Drugs Defined (Continued) 105
• UNDERSTANDING THE REGULATORY PROCESS 106
• TABLE 39 DISTINCTIONS AMONG PRODUCTS THAT USE PLANTS MEDICINALLY 107
• THE FIRST APPROVED BOTANICAL 107
• The First Approved Botanical (Continued) 108
• A GROWING PIPELINE 109
• FIGURE 13 INDS IN THE FDA BY THERAPEUTIC AREA (NUMBER) 109
• OVERALL PHARMA LANDSCAPE 110
• OVERALL PHARMA LANDSCAPE (CONTINUED) 111
• TABLE 40 TOP PHARMA COMPANIES BY REVENUE, 2007 ($ BILLIONS) 112
• MAJOR CLASSES OF PLANT DRUGS 112
• Terpenes and Steroids 113
• Terpenes 113
• Steroids 114
• Alkaloids and Glycosides 114
• Alkaloids 114
• " Ergot Alkaloids 115
• " Morphine Alkaloids 115
• " Vinca Alkaloids 115
• Glycosides 115
• " Cardiac Glycosides 116
• " Anthraglycosides 116
• Phenols 116
• E. Cava Algae 116
• Flavonoids 116
• " Resveratrol 117
• Coumarin 117
• Catechins 117
• Proanthocyanidins 117
• INTELLECTUAL PROPERTY 118
• PRODUCTION 119
• PRODUCTION (CONTINUED) 120
• PRODUCTION (CONTINUED) 120
• MOVING PRODUCTION FORWARD 121
• ARTEMISININ: A CASE STUDY 122
• SUPPLY AND LEGAL ISSUES 123
• TABLE 41 MAJOR PRODUCERS OF RAW MATERIALS FOR PLANT-BASED MEDICINALS 124
• DRUG DEVELOPMENT AND MANUFACTURE 124
• Drug Development ... (Continued) 125
• TABLE 42 KEY COMPANIES WITH NATURAL PRODUCT LIBRARIES 126

Chapter-7: BOTANICAL AND PLANT-DERIVED DRUGS: GLOBAL MARKETS (BIO022E) 40

Chapter-8: STEM CELL TECHNOLOGY: CURRENT APPLICATIONS AND FUTURE DIRECTIONS (BIO035C) 18

• INTRODUCTION 127
• STUDY GOALS AND OBJECTIVES 127
• REASONS FOR DOING THE STUDY 127
• SCOPE OF REPORT 127
• INTENDED AUDIENCE 128
• INFORMATION SOURCES 128
• ANALYST CREDENTIALS 129
• RELATED BCC REPORTS 129
• SUMMARY 129
• SUMMARY (CONTINUED) 130
• TABLE 43 U.S. MARKET FOR STEM CELLS IN REGENERATIVE MEDICINE REVENUE, THROUGH 2012 ($ MILLIONS) 131
• FIGURE 14 U.S. MARKET FOR STEM CELLS IN REGENERATIVE MEDICINE REVENUE, 2005-2012 ($ MILLIONS) 131
• INTRODUCTION TO STEM CELLS TECHNOLOGY IN REGENERATIVE MEDICINE MARKET 131
• STEM CELLS IN CELLULAR THERAPEUTICS 132
• Stem Cells in Cellular Therapeutics (Continued) 133
• Stem Cells in Cellular Therapeutics (Continued) 134
• FIGURE 15 FLOW DIAGRAM OF PROCESS USING STEM CELLS IN CELLULAR THERAPEUTICS 135
• Stem Cells in Cellular Therapeutics (Continued) 136
• TABLE 44 PROJECTED U.S. GROWTH TREND FOR STEM CELLS IN CELL-BASED THERAPEUTICS FOR HUMAN ADULT AND EMBRYONIC STEM CELLS, THROUGH 2012 ($ MILLIONS) 137
• FIGURE 16 PROJECTED U.S. GROWTH TREND FOR STEM CELLS IN CELL-BASED THERAPEUTICS FOR HUMAN ADULT AND EMBRYONIC STEM CELLS, 2005-2012 ($ MILLIONS) 138
• Stem Cells in Cellular Therapeutics towards Engineering Tissue in Vitro for Transplantation 138
• Stem Cells in Cellular Therapeutics ...(Continued) 139
• Stem Cells in Cellular Therapeutics ...(Continued) 140
• FIGURE 17 FLOW DIAGRAM OF PROCESS USING STEM CELLS IN ENGINEERING TISSUE FOR TRANSPLANTATION 141
• THERAPEUTIC STEM CELL BANKING 141
• FIGURE 18 FLOW DIAGRAM FOR PROCESS OF THERAPEUTIC BANKING OF STEM CELLS 142
• Therapeutic Stem Cell Banking (Continued) 143
• TABLE 45 PROJECTED U.S. GROWTH TREND FOR THERAPEUTIC STEM CELL BANKING, THROUGH 2012 ($ MILLIONS) 144
• FIGURE 19 PROJECTED U.S. GROWTH TREND FOR THERAPEUTIC STEM CELL BANKING, 2005-2012 ($ MILLIONS) 144

Chapter-9: RNA INTERFERENCE IN THE POST-GENOMIC ERA: MARKETS AND TECHNOLOGIES 20

• INTRODUCTION 145
• STUDY GOALS AND OBJECTIVES 145
• REASONS FOR DOING THE STUDY 145
• INTENDED AUDIENCE 146
• SCOPE OF REPORT 146
• METHODOLOGY 147
• INFORMATION SOURCES 147
• RELATED BCC REPORTS 147
• ANALYST CREDENTIALS 147
• SUMMARY 148
• TABLE 46 GLOBAL VALUE OF RNA INTERFERENCE MARKET BY MARKET SEGMENT, THROUGH 2013 ($ MILLIONS) 149
• FIGURE 20 GLOBAL VALUE OF RNA INTERFERENCE MARKET BY MARKET SEGMENT, 2006-2013 ($ MILLIONS) 150
• OVERVIEW 152
• INTRODUCTION 152
• CONVERGENCE OF POST GENOME TECHNOLOGIES 152
• TABLE 47 POST GENOME ENABLING TOOLS 152
• TABLE 48 NEW PARADIGM OF RNA INTERFERENCE 153
• MARKET POTENTIAL OF RNA INTERFERENCE-BASED PRODUCTS 154
• GLOBAL RNAI MARKET FORECAST 154
• TABLE 49 GLOBAL VALUE OF RNA INTERFERENCE MARKET BY MARKET SEGMENT, THROUGH 2013 ($ MILLIONS) 154
• GLOBAL RNAI RESEARCH TOOLS MARKET 154
• TABLE 50 GLOBAL VALUE OF RNA INTERFERENCE RESEARCH TOOLS MARKET BY PRODUCT TYPE, THROUGH 2013 ($ MILLIONS) 155
• TABLE 51 GLOBAL VALUE OF RNA INTERFERENCE DRUG MARKET, BY CLASS, THROUGH 2013 ($ MILLIONS) 156
• GROWTH DRIVING FORCES IN RNA INTERFERENCE MARKETS 157
• TABLE 52 PRIMARY FORCES DRIVING RNA INTERFERENCE GROWTH 157
• RNA INTERFERENCE: BUILDING ON ANTISENSE TECHNOLOGIES 158
• TABLE 53 KEY ANTISENSE CONTRIBUTIONS TO RNA INTERFERENCE 159
• APPLICATIONS OF RNA INTERFERENCE 159
• RNA INTERFERENCE AS A GENE KNOCKDOWN TECHNOLOGY 160
• RNA INTERFERENCE AS A BIOMARKER 160
• RNA INTERFERENCE IN THERAPEUTICS 160
• RNA INTERFERENCE IN AGRICULTURE 160
• THE RNA INTERFERENCE INDUSTRY 161
• RNA INTERFERENCE TECHNOLOGIES 162
• INTRODUCTION 162
• ROLE OF MESSENGER RNA IN PROTEIN PRODUCTION 162
• FIGURE 21 ROLE OF MESSENGER RNA IN PROTEIN PRODUCTION 163
• TABLE 54 BASIC STEPS IN PROTEIN PRODUCTION 163
• Role of Messenger RNA ... (Continued) 164

Chapter-10: DNA DIAGNOSTICS: TECHNOLOGIES AND GLOBAL MARKETS (BIO063A) 19

• INTRODUCTION 165
• STUDY GOALS AND OBJECTIVES 165
• REASONS FOR DOING THE STUDY 165
• SCOPE OF REPORT 165
• INTENDED AUDIENCE 166
• METHODOLOGY AND INFORMATION SOURCES 166
• ANALYST CREDENTIALS 166
• RELATED BCC REPORTS 167
• SUMMARY 167
• TABLE 55 GLOBAL MARKET FOR CLINICAL DNA DIAGNOSTICS, BY SEGMENT, THROUGH 2013 ($ MILLIONS) 167
• FIGURE 22 GLOBAL MARKET FOR CLINICAL DNA DIAGNOSTICS, BY SEGMENT, 2005-2013 ($ MILLIONS) 168
• OVERVIEW 168
• INTRODUCTION TO GENOMIC DIAGNOSTICS 168
• INTRODUCTION TO GENOMIC ... (CONTINUED) 169
• INTRODUCTION TO GENOMIC ... (CONTINUED) 170
• EXPRESSION PROFILING AND DISEASE 171
• EXPRESSION PROFILING AND INFECTIOUS DISEASE 172
• DNA SEQUENCING FOR GENOTYPING AND DIAGNOSIS 172
• CLINICAL PHARMACOLOGY 173
• MUTATION DETECTION AND GENOTYPING FOR SPECIFIC GENES 173
• IDENTIFICATION OF NEW DISEASE GENES 174
• REGULATORY FACTORS 174
• SUCCESSES AND LIMITATIONS OF GENETIC TESTING 174
• REGULATORY POLICIES 175
• FOOD AND DRUG ADMINISTRATION: NEW GUIDELINES 175
• Food and Drug Administration: ...(Continued) 176
• INTERNAL STANDARDS FOR DNA DIAGNOSTICS 177
• INSURANCE 177
• Insurance (Continued) 178
• MARKETING DIRECTLY TO CONSUMERS 179
• MARKET FOR CLINICAL DNA DIAGNOSTICS, BY PRODUCT 179
• MARKET FOR CLINICAL DNA (CONTINUED) 180
• TABLE 56 GLOBAL MARKET FORECAST FOR DNA DIAGNOSTICS PRODUCTS, THROUGH 2013 ($ MILLIONS) 181
• FIGURE 23 GLOBAL MARKET FORECAST FOR DNA DIAGNOSTICS PRODUCTS, 2005-2013 ($ MILLIONS) 181
• FIGURE 24 GLOBAL DNA DIAGNOSTICS MARKET, BY PRODUCT SHARE, 2008 (%) 182
• FIGURE 25 GLOBAL DNA DIAGNOSTICS MARKET, BY PRODUCT SHARE, 2013 (%) 183

Chapter-11: BIOLOGIC IMAGING REAGENTS: TECHNOLOGIES AND GLOBAL MARKETS (BIO064A) 16

• INTRODUCTION 184
• STUDY GOALS AND OBJECTIVES 184
• REASONS FOR DOING THE STUDY 184
• INTENDED AUDIENCE 185
• SCOPE OF REPORT 186
• METHODOLOGY 186
• INFORMATION SOURCES 186
• RELATED BCC REPORTS 186
• ANALYST CREDENTIALS 187
• SUMMARY 187
• TABLE 57 GLOBAL VALUE OF BIOLOGIC IMAGING REAGENTS, BY TYPE, THROUGH 2013 ($ MILLIONS) 188
• FIGURE 26 GLOBAL VALUE OF BIOLOGIC IMAGING REAGENTS, BY TYPE, 2006-2013 ($ MILLIONS) 188
• SUMMARY (CONTINUED) 189
• OVERVIEW 190
• INTRODUCTION 190
• BIOLOGIC IMAGING TECHNOLOGIES COVERED IN THIS REPORT 191
• TABLE 58 SCOPE OF THIS REPORT 191
• MARKET POTENTIAL OF BIOLOGIC REAGENTS PRODUCTS 191
• TABLE 59 GLOBAL VALUE OF BIOLOGIC IMAGING REAGENTS, BY TECHNOLOGY, THROUGH 2013 ($ MILLIONS) 192
• TABLE 60 GLOBAL VALUE OF BIOLOGIC IMAGING REAGENTS, BY END USER MARKET, THROUGH 2013 ($ MILLIONS) 193
• FORCES DRIVING BIOLOGIC IMAGING REAGENTS INDUSTRY GROWTH 194
• TABLE 61 BIOLOGIC IMAGING REAGENTS GROWTH DRIVING FORCES 194
• FORCES DRIVING BIOLOGIC ... (CONTINUED) 195
• LIFE CYCLE STATUS OF BIOLOGIC IMAGING REAGENTS TECHNOLOGIES 196
• TABLE 62 LIFE CYCLE STAGE OF BIOLOGIC IMAGING REAGENTS 196
• THE BIOLOGIC IMAGING REAGENTS INDUSTRY 197
• TABLE 63 BIOLOGIC IMAGING REAGENTS KEY COMPETITORS 198
• THE BIOLOGIC IMAGING (CONTINUED) 199