APPLICATIONS OF CELL CULTURE MODEL SYSTEM CANCER RESEARCH VIROLOGY TABLE 5 CULTURE MEDIA USED FOR THE PRODUCTION OF

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1 CHAPTER ONE: INTRODUCTION... 1 STUDY OBJECTIVES... 1 REASONS FOR DOING THIS STUDY... 1 INTENDED AUDIENCE... 2 SCOPE OF THE STUDY... 2 METHODOLOGY... 2 INFORMATION SOURCES... 2 ABOUT THE AUTHOR... 3 RELATED BCC RESEARCH REPORTS... 3 BCC ONLINE SERVICES... 3 DISCLAIMER... 4 CHAPTER TWO: EXECUTIVE SUMMARY... 5 EXECUTIVE SUMMARY... 5 SUMMARY TABLE GLOBAL REVENUES FROM MEDIA, SERA AND REAGENTS USED IN THE BIOTECHNOLOGY MARKET, THROUGH 2016 ($ MILLIONS)... 6 SUMMARY FIGURE GLOBAL REVENUES FROM MEDIA, SERA AND REAGENTS USED IN THE BIOTECHNOLOGY MARKET, ($ MILLIONS)... 6 EXECUTIVE SUMMARY (CONTINUED)... 7 CHAPTER THREE: OVERVIEW... 8 DEFINITIONS... 8 HISTORY... 8 TABLE 1 HISTORICAL EVENTS IN CELL CULTURE DEVELOPMENT... 9 TABLE 1 (CONTINUED) TYPES OF CELL CULTURES PRIMARY CULTURES TABLE 2 ADVANTAGES AND DISADVANTAGES OF PRIMARY CELL CULTURE SECONDARY CELL CULTURE CONTINUOUS CELL CULTURE TABLE 3 ADVANTAGES AND DISADVANTAGES OF CONTINUOUS CELL CULTURE MORPHOLOGY OF CELLS IN CULTURE FIBROBLASTIC CELLS EPITHELIAL-LIKE CELLS LYMPHOBLAST-LIKE CELLS BASIC SYSTEMS FOR CELL CULTURE TABLE 4 ADHERENT CULTURE VS. SUSPENSION CULTURE CELL LINE, CELL STRAIN AND TRANSFORMED CELL LINES CHARACTERISTICS OF IMMORTALIZED CELL LINES FACTORS AFFECTING CELL CULTURE... 14

2 APPLICATIONS OF CELL CULTURE MODEL SYSTEM CANCER RESEARCH VIROLOGY TABLE 5 CULTURE MEDIA USED FOR THE PRODUCTION OF VACCINES TABLE 5 (CONTINUED) GENETICALLY ENGINEERED PROTEINS TABLE 6 POTENTIAL SOURCES OF CELL CULTURE ADDITIVES Recombinant Thrombolytic Agents TABLE 7 RECOMBINANT THROMBOLYTIC AGENTS Recombinant Coagulation Factor TABLE 8 RECOMBINANT COAGULATION FACTOR Cytokines Hematopoietic Growth Factors Human Growth Hormones Monoclonal Antibodies TISSUE AND ORGAN REPLACEMENT GENETIC COUNSELING GENE THERAPY PROBLEMS DURING CELL CULTURE TOXICITY MICROBIAL CONTAMINATION Cross-Contamination BASIC REQUIREMENTS OF CELL CULTURE CELL CULTURE MEDIA Basic Constituents of Media Inorganic Salts TABLE 9 THE ROLES OF DIFFERENT INORGANIC NUTRIENTS Buffering Systems Energy Source Amino Acids Vitamins Proteins and Peptides Fatty Acids and Lipids Trace Elements Antibiotics TABLE 10 COMMONLY USED ANTIBIOTICS IN CELL CULTURES Serum Types of Cell Culture Media Serum-Containing Media TABLE 11 ADVANTAGES AND DISADVANTAGES OF SERUM- CONTAINING MEDIA Serum-free Media... 30

3 TABLE 12 ADVANTAGES AND DISADVANTAGES OF SERUM-FREE MEDIA Chemically Defined Media Amino Acids Carbohydrates Inorganic Salts Vitamins Protein-Free Media Selection of Cell Culture Media Serum-Free Media: Reasons for Preference Supplements for Serum-Free Media Hormones Transferrin Lipids Hydrolysates SERUM Role of Serum in Cell Culture Serum Components Growth Factors Albumin Protease Inhibitors TABLE 13 NORMAL RANGE OF CONCENTRATION OF SERUM CONSTITUENTS TABLE 13 (CONTINUED) Sources of Serum Fetal Bovine Serum Calf Serum Calf Serum, Donor (Bovine) Calf Serum, Newborn (Bovine) Other Animal Sera Chicken Serum Dog Serum Donor Donkey Serum Donor Goat Serum Donor Rat Serum Rat Serum Feline Serum Guinea Pig Serum Monkey Serum Mouse Serum Porcine Serum Rabbit Serum Sheep Serum Horse Serum... 39

4 Potential Problems with Serum Serum Selection CELL CULTURE REAGENTS Amino Acids and Vitamins Antibiotics and Antimycotics Buffers Cell Dissociation Agents Growth Supplements REGULATORY ASPECTS APPROVALS OF BIOLOGICAL LICENSE APPLICATIONS TABLE 14 APPROVALS OF BIOLOGICAL LICENSE APPLICATIONS, 2010 TO AUG TABLE 14 (CONTINUED) ADMINISTRATIVE ACTIONS: BIOLOGICS TABLE 15 ADMINISTRATIVE ACTIONS: BIOLOGICS, 2007 TO AUG TABLE 15 (CONTINUED) TABLE 16 PRODUCT RECALLS, 2007 TO AUG TABLE 16 (CONTINUED) TABLE 16 (CONTINUED) LEADING MANUFACTURERS OF MEDIA TABLE 17 LEADING MANUFACTURERS OF MEDIA TABLE 17 (CONTINUED) TABLE 17 (CONTINUED) TABLE 17 (CONTINUED) TABLE 17 (CONTINUED) TABLE 17 (CONTINUED) TABLE 17 (CONTINUED) TABLE 18 LEADING MANUFACTURERS OF SERA TABLE 18 (CONTINUED) TABLE 18 (CONTINUED) TABLE 19 LEADING MANUFACTURERS OF BIOLOGIC RESPONSE MODIFIERS TABLE 19 (CONTINUED) TABLE 19 (CONTINUED) TABLE 19 (CONTINUED) TABLE 20 LEADING MANUFACTURERS OF CELL DISSOCIATION REAGENTS TABLE 20 (CONTINUED) TABLE 21 LEADING MANUFACTURERS OF ANTIBIOTICS AND ANTIMYCOTICS USED IN CELL CULTURE TABLE 21 (CONTINUED) TABLE 22 LEADING MANUFACTURERS OF OTHER REAGENTS TABLE 22 (CONTINUED)... 64

5 TABLE 22 (CONTINUED) NEW DEVELOPMENTS TABLE 23 NEW DEVELOPMENTS IN THE CELL CULTURE INDUSTRY SINCE TABLE 23 (CONTINUED) NEW DEVELOPMENTS IN APPLICATIONS NEW DEVELOPMENTS IN APPLICATIONS (CONTINUED) TABLE 24 NEW DEVELOPMENTS IN APPLICATION OF CELL CULTURE TABLE 24 (CONTINUED) CHAPTER FOUR: GLOBAL MARKETS GLOBAL MARKETS GLOBAL MARKETS (CONTINUED) TABLE 25 GLOBAL MARKET FOR CELL CULTURE PRODUCTS, THROUGH 2016 ($ MILLIONS) FIGURE 1 GLOBAL MARKET FOR CELL CULTURE PRODUCTS, ($ MILLIONS) MEDIA MARKET REVENUE TABLE 26 GLOBAL MARKET FOR MEDIA USED IN BIOTECHNOLOGY BY REGION, THROUGH 2016 ($ MILLIONS) FIGURE 2 GLOBAL MARKET FOR MEDIA USED IN BIOTECHNOLOGY BY REGION, ($ MILLIONS) MARKET SHARES TABLE 27 GLOBAL BIOTECHNOLOGY MEDIA MARKET SHARES BY REGION, 2010 (%) FIGURE 3 GLOBAL BIOTECHNOLOGY MEDIA MARKET SHARES BY REGION, 2010 (%) SERUM-FREE MEDIA AND SERUM-REQUIRING MEDIA Serum-Free Media Market Revenue TABLE 28 GLOBAL MARKET FOR SERUM-FREE MEDIA BY REGION, THROUGH 2016 ($ MILLIONS) FIGURE 4 GLOBAL MARKET FOR SERUM-FREE MEDIA BY REGION, ($ MILLIONS) Serum-Requiring Media Market Revenue TABLE 29 GLOBAL MARKET FOR SERUM-REQUIRING MEDIA BY REGION, THROUGH 2016 ($ MILLIONS) FIGURE 5 GLOBAL MARKET FOR SERUM-REQUIRING MEDIA BY REGION, ($ MILLIONS) POWDERED MEDIA AND LIQUID MEDIA Powdered Media Market Revenue TABLE 30 GLOBAL MARKET FOR POWDERED MEDIA, THROUGH 2016 ($ MILLIONS)... 82

6 FIGURE 6 GLOBAL MARKET FOR POWDERED MEDIA, ($ MILLIONS) Liquid Media Market Revenue TABLE 31 GLOBAL MARKET FOR LIQUID MEDIA BY REGION, THROUGH 2016 ($ MILLIONS) FIGURE 7 GLOBAL MARKET FOR LIQUID MEDIA BY REGION, ($ MILLIONS) CLASSICAL AND SPECIALTY MEDIA Classical Media Market Revenue TABLE 32 GLOBAL MARKET FOR CLASSICAL MEDIA BY REGION, THROUGH 2016 ($ MILLIONS) FIGURE 8 GLOBAL MARKET FOR CLASSICAL MEDIA BY REGION, ($ MILLIONS) Specialty Media Market Revenue TABLE 33 GLOBAL MARKET FOR SPECIALTY MEDIA BY REGION, THROUGH 2016 ($ MILLIONS) FIGURE 9 GLOBAL MARKET FOR SPECIALTY MEDIA BY REGION, ($ MILLIONS) SERA MARKET REVENUE TABLE 34 GLOBAL MARKET FOR SERA BY REGION, THROUGH 2016 ($ MILLIONS) FIGURE 10 GLOBAL MARKET FOR SERA BY REGION, ($ MILLIONS) MARKET SHARES TABLE 35 GLOBAL SERA MARKET SHARES BY REGION, 2010 (%) FIGURE 11 GLOBAL SERA MARKET SHARES BY REGION, 2010 (%) BOVINE SERA OR FETAL BOVINE SERA TABLE 36 GLOBAL MARKET FOR BOVINE SERA BY REGION, THROUGH 2016 ($ MILLIONS) FIGURE 12 GLOBAL MARKET FOR BOVINE SERA BY REGION, ($ MILLIONS) OTHER SERA TABLE 37 GLOBAL MARKET FOR OTHER SERA BY REGION, THROUGH 2016 ($ MILLIONS) FIGURE 13 GLOBAL MARKET FOR OTHER SERA BY REGION, ($ MILLIONS) REAGENTS MARKET OVERVIEW MARKET REVENUE TABLE 38 GLOBAL MARKET FOR CELL CULTURE REAGENTS BY REGION, THROUGH 2016 ($ MILLIONS) FIGURE 14 GLOBAL MARKET FOR CELL CULTURE REAGENTS BY REGION, ($ MILLIONS)... 96

7 MARKET SHARES TABLE 39 GLOBAL CELL CULTURE REAGENT MARKET SHARES BY REGION, 2010 (%) FIGURE 15 GLOBAL CELL CULTURE REAGENT MARKET SHARES BY REGION, 2010 (%) BIOLOGICAL RESPONSE MODIFIERS TABLE 40 GLOBAL MARKET FOR BIOLOGICAL RESPONSE MODIFIERS BY REGION, THROUGH 2016 ($ MILLIONS) FIGURE 16 GLOBAL MARKET FOR BIOLOGICAL RESPONSE MODIFIERS BY REGION, ($ MILLIONS) Growth Factors TABLE 41 GLOBAL MARKET FOR GROWTH FACTORS BY REGION, THROUGH 2016 ($ MILLIONS) FIGURE 17 GLOBAL MARKET FOR GROWTH FACTORS BY REGION, ($ MILLIONS) Cytokines TABLE 42 GLOBAL MARKET FOR CYTOKINES BY REGION, THROUGH 2016 ($ MILLIONS) FIGURE 18 GLOBAL MARKET FOR CYTOKINES BY REGION, ($ MILLIONS) Other Biological Response Modifiers TABLE 43 GLOBAL MARKET FOR OTHER BIOLOGICAL RESPONSE MODIFIERS BY REGION, THROUGH 2016 ($ MILLIONS) FIGURE 19 GLOBAL MARKET FOR OTHER BIOLOGICAL RESPONSE MODIFIERS BY REGION, ($ MILLIONS) CELL DISSOCIATION REAGENTS TABLE 44 GLOBAL MARKET FOR CELL DISSOCIATION REAGENTS BY REGION, THROUGH 2016 ($ MILLIONS) FIGURE 20 GLOBAL MARKET FOR CELL DISSOCIATION REAGENTS BY REGION, ($ MILLIONS) OTHERS TABLE 45 GLOBAL MARKET FOR OTHERS BY REGION, THROUGH 2016 ($ MILLIONS) FIGURE 21 GLOBAL MARKET FOR OTHERS BY REGION, ($ MILLIONS) CHAPTER FIVE: U.S. MARKET TABLE 46 U.S. MARKET FOR CELL CULTURE PRODUCTS, THROUGH 2016 ($ MILLIONS) FIGURE 22 U.S. MARKET FOR CELL CULTURE PRODUCTS, ($ MILLIONS) MEDIA MARKET OVERVIEW Market Overview (Continued) MARKET REVENUE

8 TABLE 47 U.S. MARKET FOR CELL CULTURE MEDIA, THROUGH 2016 ($ MILLIONS) FIGURE 23 U.S. MARKET FOR CELL CULTURE MEDIA, ($ MILLIONS) SERUM-REQUIRING AND SERUM-FREE MEDIA Market Revenue TABLE 48 U.S. MARKET FOR SERUM-REQUIRING AND SERUM- FREE MEDIA, THROUGH 2016 ($ MILLIONS) FIGURE 24 U.S. MARKET FOR SERUM-REQUIRING AND SERUM- FREE MEDIA, ($ MILLIONS) POWDERED AND LIQUID MEDIA Market Revenue TABLE 49 U.S. MARKET FOR POWDERED AND LIQUID MEDIA, THROUGH 2016 ($ MILLIONS) FIGURE 25 U.S. MARKET FOR POWDERED AND LIQUID MEDIA, ($ MILLIONS) CLASSICAL AND SPECIALTY MEDIA Market Revenue TABLE 50 U.S. MARKET FOR CLASSICAL AND SPECIALTY MEDIA, THROUGH 2016 ($ MILLIONS) FIGURE 26 U.S. MARKET FOR CLASSICAL AND SPECIALTY MEDIA, ($ MILLIONS) SERA MARKET OVERVIEW MARKET REVENUE TABLE 51 U.S. MARKET FOR BOVINE AND OTHER SERA, THROUGH 2016 ($ MILLIONS) FIGURE 27 U.S. MARKET FOR BOVINE AND OTHER SERA, THROUGH 2016 ($ MILLIONS) REAGENTS MARKET OVERVIEW Market Overview (Continued) MARKET REVENUE TABLE 52 U.S. MARKET FOR CELL CULTURE REAGENTS, THROUGH 2016 ($ MILLIONS) FIGURE 28 U.S. MARKET FOR CELL CULTURE REAGENTS, ($ MILLIONS) BIOLOGICAL RESPONSE MODIFIERS TABLE 53 U.S. MARKET FOR BIOLOGICAL RESPONSE MODIFIERS, THROUGH 2016 ($ MILLIONS) FIGURE 29 U.S. MARKET FOR BIOLOGICAL RESPONSE MODIFIERS, ($ MILLIONS) U.S. MARKET LEADERS MEDIA

9 Serum-Free Media TABLE 54 U.S. MARKET SHARES OF SERUM-FREE MEDIA, 2010 (%) FIGURE 30 U.S. MARKET SHARES OF SERUM-FREE MEDIA, 2010 (%) Serum-Requiring/Containing Media TABLE 55 U.S. MARKET SHARES OF SERUM-CONTAINING MEDIA, 2010 (%) FIGURE 31 U.S. MARKET SHARES OF SERUM-CONTAINING MEDIA, 2010 (%) Powdered Media TABLE 56 U.S. MARKET SHARES OF POWDERED MEDIA, 2010 (%) FIGURE 32 U.S. MARKET SHARES OF POWDERED MEDIA, 2010 (%) Liquid Media TABLE 57 U.S. MARKET SHARES OF LIQUID MEDIA, 2010 (%) FIGURE 33 U.S. MARKET SHARES OF LIQUID MEDIA, 2010 (%) Classical Media TABLE 58 U.S. MARKET SHARES OF CLASSICAL MEDIA, 2010 (%) FIGURE 34 U.S. MARKET SHARES OF CLASSICAL MEDIA, 2010 (%) Specialty Media TABLE 59 U.S. MARKET SHARES OF SPECIALTY MEDIA, 2010 (%) FIGURE 35 U.S. MARKET SHARES OF SPECIALTY MEDIA, 2010 (%) SERA Bovine Sera TABLE 60 U.S. MARKET SHARES OF BOVINE SERA, 2010 (%) FIGURE 36 U.S. MARKET SHARES OF BOVINE SERA, 2010 (%) Other Sera TABLE 61 U.S. MARKET SHARES OF OTHER SERA, 2010 (%) FIGURE 37 U.S. MARKET SHARES OF OTHER SERA, 2010 (%) REAGENTS Biological Response Modifiers TABLE 62 U.S. MARKET SHARES OF BIOLOGICAL RESPONSE MODIFIERS, 2010 (%) FIGURE 38 U.S. MARKET SHARES OF BIOLOGICAL RESPONSE MODIFIERS, 2010 (%) Cell Dissociation Reagents TABLE 63 U.S. MARKET SHARES OF CELL DISSOCIATION REAGENTS, 2010 (%) FIGURE 39 U.S. MARKET SHARES OF CELL DISSOCIATION REAGENTS, 2010 (%) Other Reagents TABLE 64 U.S. MARKET SHARES OF OTHER REAGENTS, 2010 (%) FIGURE 40 U.S. MARKET SHARES OF OTHER REAGENTS, 2010 (%) CHAPTER SIX: END USERS MARKET SHARE OF APPLICATIONS

10 TABLE 65 GLOBAL MEDIA, SERA AND REAGENT MARKET SHARES BY END USER, 2010 (%) FIGURE 41 GLOBAL MEDIA, SERA AND REAGENT MARKET SHARES BY END USER, 2010 (%) RESEARCH SEGMENT RESEARCH SEGMENT (CONTINUED) RESEARCH SEGMENT (CONTINUED) MARKET REVENUE TABLE 66 GLOBAL SALES OF MEDIA, SERA AND REAGENTS IN THE RESEARCH SEGMENT, THROUGH 2016 ($ MILLIONS) FIGURE 42 GLOBAL SALES OF MEDIA, SERA AND REAGENTS IN THE RESEARCH SEGMENT, ($ MILLIONS) PRODUCTION SEGMENT PRODUCTION SEGMENT (CONTINUED) MARKET REVENUE TABLE 67 GLOBAL SALES OF MEDIA, SERA AND REAGENTS IN THE PRODUCTION SEGMENT, THROUGH 2016 ($ MILLIONS) FIGURE 43 GLOBAL SALES OF MEDIA, SERA AND REAGENTS IN THE PRODUCTION SEGMENT, ($ MILLIONS) CONTRACT SEGMENT CONTRACT SEGMENT (CONTINUED) MARKET REVENUE TABLE 68 GLOBAL SALES OF MEDIA, SERA AND REAGENTS IN THE CONTRACT SEGMENT, THROUGH 2016 ($ MILLIONS) FIGURE 44 GLOBAL SALES OF MEDIA, SERA AND REAGENTS IN THE CONTRACT SEGMENT, ($ MILLIONS) OTHERS SEGMENT MARKET REVENUE TABLE 69 GLOBAL SALES OF MEDIA, SERA AND REAGENTS IN THE OTHERS SEGMENT, THROUGH 2016 ($ MILLIONS) FIGURE 45 GLOBAL SALES OF MEDIA, SERA AND REAGENTS IN THE OTHERS SEGMENT, ($ MILLIONS) CHAPTER SEVEN: PATENT ANALYSIS PATENTS BY YEAR TABLE 70 NUMBER OF U.S. PATENTS ISSUED BY YEAR, 2007 TO OCT FIGURE 46 U.S. PATENTS ISSUED BY YEAR, 2007 TO OCT (%) PATENTS BY TYPE TABLE 71 PATENTS BY TYPE FOR MEDIA, SERA AND REAGENTS USED IN BIOTECHNOLOGY, FIGURE 47 PATENTS BY TYPE FOR MEDIA, SERA AND REAGENTS USED IN BIOTECHNOLOGY, (NO. OF PATENTS) PATENTS BY COMPANY

11 TABLE 72 U.S. PATENTS ISSUED FOR MEDIA, SERA AND REAGENTS IN BIOTECHNOLOGY BY COMPANY, 2007 TO OCT (NO.) PATENTS BY COUNTRY TABLE 73 U.S. PATENTS ISSUED FOR MEDIA, SERA AND REAGENTS USED IN BIOTECHNOLOGY BY COUNTRY, 2007 TO OCT (NO.) TABLE 74 SHARES OF U.S. PATENTS ISSUED FOR MEDIA, SERA AND REAGENTS USED IN BIOTECHNOLOGY BY COUNTRY, 2007 OCT (%) PATENTS BY ASSIGNEE TABLE 75 U.S. PATENTS ISSUED FOR MEDIA, SERA AND REAGENTS USED IN BIOTECHNOLOGY BY TYPE OF END USER, 2007 TO OCT (NO.) CHAPTER EIGHT: THE CURRENT SITUATION REGIONAL MARKETS UNITED STATES EUROPE ASIA EMERGING MARKETS TRENDS AND ISSUES IN THE CELL CULTURE MARKET GLOBAL ECONOMY INCREASED RESEARCH AND DEVELOPMENT BUDGET TABLE 76 R&D BUDGETS OF TOP 10 COMPANIES IN 2009 AND 2010 ($ BILLIONS) GROWING DEMAND AND RICH PIPELINE OF BIOTHERAPEUTICS RESEARCH ON THERAPEUTIC VACCINES BIOMEDICAL RESEARCH STEM CELL RESEARCH GOVERNMENT POLICIES ON RESEARCH INNOVATIONS ETHICAL AND ANIMAL WELFARE ISSUES REGULATORY ISSUES USE OF HUMAN BLOOD ALTERNATIVES MERGERS, ACQUISITIONS AND ALLIANCES SHIFT TOWARD CONTRACT MANUFACTURING CHAPTER NINE: COMPANY PROFILES ADVANCED BIOTECHNOLOGIES INC AFFYMETRIX AMRESCO LLC ATHENA ENVIRONMENTAL SCIENCES INC ATLANTA BIOLOGICALS INC

12 BD BIOSCIENCES BIORECLAMATION INC BOVOGEN BIOLOGICALS PTY. LTD CELL APPLICATIONS INC CELL CULTURE TECHNOLOGIES GMBH CLONTECH LABORATORIES INC EQUITECH-BIO INC GEMINI BIO-PRODUCTS GENEX INDIA BIOSCIENCES PVT. LTD HIMEDIA LABORATORIES INVITROGEN CORP IRVINE SCIENTIFIC J R SCIENTIFIC INC LONZA MEDIATECH INC MEDOX BIOTECH INDIA PVT. LTD MILLIPORE CORP MP BIOMEDICALS PAA LABORATORIES PEPROTECH INC PROMOCELL GMBH QUALITY BIOLOGICAL INC R&D SYSTEMS ROCHE APPLIED SCIENCES SERA LABORATORIES INTERNATIONAL LTD SERACARE LIFE SCIENCES INC SIGMA-ALDRICH STEMCELL TECHNOLOGIES STEMCELLS INC THERMO FISHER SCIENTIFIC INC TICO EUROPE VALLEY BIOMEDICAL PRODUCTS AND SERVICES INC APPENDIX: ABBREVIATIONS ABBREVIATIONS ABBREVIATIONS (CONTINUED) ABBREVIATIONS (CONTINUED)