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1、Blood: The Worldwide Market 5th Copyright 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. BLOOD:THEWORLDWIDEMARKET FORBLOODPRODUCTS,BLOODTESTING, BLOODEQUIPMENT AND SYNTHET
2、IC BLOODPRODUCTS AKALORAMA INFORMATION MARKETINTELLIGENCE REPORT Blood: The Worldwide Market for Blood Products, Blood Testing, Blood Equipment and Synthetic Blood Products has been prepared by Kalorama Information. We serve business and industrial clients worldwide with a complete line of informati
3、on services and research publications. Kalorama Information Market Intelligence Reports are specifically designed to aid the action-oriented executive by providing a thorough presentation of essential data and concise analysis. Author: Alison Sahoo Publication Date: May 2013 38 East 29th Street New
4、York, New York 10016 (800) 298-5699 Outside the U.S. (212) 807-2657 FAX: (212) 807-2676 http:/www.KaloramaI E-MAIL: Copyright 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibite
5、d. TABLE OF CONTENTS TABLE OF CONTENTS I? LIST OF EXHIBITS .VII? CHAPTER ONE: EXECUTIVE SUMMARY 1? THE GLOBAL BLOOD INDUSTRY . 1? SCOPE AND METHODOLOGY 1? OVERVIEW 2? Blood Collection . 3? Blood Typing and Testing for Diseases 6? Blood Testing .6? Blood Storage And Processing . 8? Blood Transfusions
6、 9? Blood Management And Safety Issues. 11? Synthetic Blood Products 12? Blood Products Market . 13? Blood Testing And Typing Products Market 15? Plasma and Blood Collection Equipment Market 16? Synthetic Blood Products Market 17? CHAPTER TWO: OVERVIEW 21? The Global Blood Industry . 21? History of
7、the Blood Industry . 21? United States 22? Europe 25? Asia 26? Current Blood Industry Issues . 27? Effects of the Economy 28? Changes from Health Care Reform 28? Demographic Shifts .29? Blood and its Components 30? Red Blood Cells (Erythrocytes) .30? White Blood Cells (Leukocytes) 31? Platelets 32?
8、Plasma 33? Table of Contents ii Copyright 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. Table of Contents ii Copyright 2013 Kalorama Information Reproduction without prio
9、r written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. Immunoglobulin Products 35? Blood Transfusions 36? Diseases Contracted from Blood Transfusions and Related Identification Testing37? Donor Deferral and Special Populations of
10、Donors . 40? Efforts to Create a Virus-Free Blood Supply 42? Plasma Treatment .42? Red Blood Cell Treatments 45? Synthetic Blood Products 46? Blood Volume Expanders 47? Hemoglobin Based Oxygen Carriers .48? Immunologic Properties 50? Vasoactive Properties 51? Performance . 51? Perflurocarbon (PFC) B
11、ased Blood Products 52? Developmental Status 52? Commercialization Challenges 53? Factor Products for Hemophilia A .54? Synthetic Platelets 54? CHAPTER THREE: THE BLOOD MANAGEMENT SYSTEM: BLOOD COLLECTION, PROCESSING AND USE 57? Blood Collection . 57? Organizations Collecting Blood 58? Not For-Profi
12、t Blood Collection 59? Red Cross .60? Community Blood Banks .60? Hospitals 61? Other Blood Collection Sites .61? For-Profit Blood Collection .61? National Donor Deferral Registry 62? Donor Donation Demographics 62? Donor Recruitment 63? Blood Screening and Evaluation 64? Methods for Collecting Blood
13、 from Donors 66? Manual Blood Collection .67? Automated Blood Collection .67? Plateletpheresis 70? Leukopheresis 72? Red Blood Cell Apheresis 72? Table of Contents iii Copyright 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter develo
14、ped, in whole or in any part, is strictly prohibited. Table of Contents iii Copyright 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. Cord Blood Collection . 73? Plasma Col
15、lection 74? Plasma Fractionators 75? Distributors/Brokers .76? Blood Typing and Testing for Diseases 76? Blood Typing .76? Methods of Blood Typing 79? Manual Blood Typing Methods 79? Automated Blood Typing and Screening Methods . 79? Blood Testing . 80? Nucleic Acid Amplification Testing (NAT) 82? P
16、olymerase Chain Reaction (PCR) Amplification 83? CBER Licensed PCR Screening Tests .86? Immunoassay .87? Enzyme-Linked Immunosorbent Assay .90? Basic ELISA . 91? Alternate ELISA Methods 93? Sandwich Method . 93? Reverse Sandwich Method . 94? Reverse Sandwich Inhibition Method 94? Costs and Other Bar
17、riers 94? Blood Storage .96? Blood Processing 97? Cohn Fractionation .97? Newer Fractionation Methods 99? Advanced Fractionation Methods 103? Cascade Plasma Fractionation 103? Automated Fractionation . 104? Blood Transfusions 104? Testing Before Transfusion 105? Coombs Test . 105? Manual Cross-Match
18、 Techniques 106? Major Cross-Match 107? Minor Cross-Match 107? Antibody Screen . 107? Types of Transfusions . 108? Whole Blood 108? Packed Red Blood Cells .109? Platelets 109? Leukocytes .110? Fresh Frozen Plasma (FFP) 112? Cryoprecipitate .113? Table of Contents iv Copyright 2013 Kalorama Informati
19、on Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. Table of Contents iv Copyright 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter
20、developed, in whole or in any part, is strictly prohibited. Immune Serum Globulin/IMIG/IGIV 113? Factor IX and Factor IX Complex .117? C1 Inhibitor 119? Fibrin/Thrombin .120? Therapeutic Apheresis .121? Blood Management Issues 122? Availability 122? Safety Issues . 123? Reducing Blood Typing Errors
21、124? Improving Donor Screening 125? Improving Viral Screening 126? Increasing Repeat Donation Rates .127? Enhancing Viral Inactivation Processes .128? Increasing Voluntary Donation 130? Preventing Bacterial Infections 130? Biovigilence .132? Other Safety Precautions 133? CHAPTER FOUR: THE HUMAN BLOO
22、D AND BLOOD PRODUCTS MARKET135? Driving Forces of the Human Blood Industry 135? Variables Influencing the Demand for Blood Transfusions 138? Market Size 139? Changing Patterns of Transfusion Procedures . 141? Leukocyte Reduction .141? Impact of Autologous Donations .143? Types of Autologous Donation
23、s 143? Pricing of Blood . 146? National Blood Exchange 148? RBCs and Leukoreduced RBCs .149? Washed Red Blood Cells .149? Deglycerolized Red Blood Cells 150? Single-Donor Platelets and Random-Donor Platelets 150? Fresh Frozen Plasma and Pooled Frozen Plasma.151? Cryoprecipitate .151? Granulocytes 15
24、1? Gamma-Irradiated Blood .152? Average Cost of Transfusion 152? Plasma and Plasma Derived Products . 154? Plasma Market Size 155? Market Dynamics .157? Table of Contents v Copyright 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter d
25、eveloped, in whole or in any part, is strictly prohibited. Table of Contents v Copyright 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. Immunoglobulins .160? Immunoglobuli
26、n Market Dynamics 160? Immunoglobulin Market Size . 161? Hepatitis B Immunoglobulin 162? RhoD Immunoglobulin . 163? Tetanus Immunoglobulin . 163? Rabies Immunoglobulin . 163? Varicella Immunoglobulin . 164? Vaccinia Immunoglobulin 164? Novel Immunoglobulins . 164? Albumin .165? Albumin Market Dynami
27、cs 165? Albumin Market Size 165? Prothrombin Complex Concentrates 166? Alpha-1 Proteinase Inhibitors 168? Fibrin Sealants .168? Clotting Factors and Factor VIIa .169? CHAPTER FIVE: THE BLOOD TESTING AND TYPING MARKETS .171? Blood Testing Products for Donor Screening . 171? Market Size 172? Latin Ame
28、rica 173? China 174? Immunoassays 174? Nucleic Acid Testing 175? Market Participants 178? Immunoassays 178? Nucleic Acid Testing 180? Blood Typing Products 182? Market Size 183? Market Participants 183? Plasma and Blood Collection Equipment 184? Market Size 184? Market Participants 186? CHAPTER SIX:
29、 SYNTHETIC BLOOD PRODUCTS MARKET .189? Driving Forces of the Synthetic Blood Products Industry . 189? Variables Influencing the Supply and Demand of Donated Blood 189? Recombinant Factor Market 191? Market Size 192? Market Participants 193? Table of Contents vi Copyright 2013 Kalorama Information Re
30、production without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. Table of Contents vi Copyright 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter devel
31、oped, in whole or in any part, is strictly prohibited. Oxygen Carrier Market 194? Market Size 194? Synthetic Blood Products in Clinical Development 195? Hemopure (OPK BioTech) . 196? Oxygent (Sanguine Corp.) .199? Oxycyte (Oxygen Biotherapeutics) 201? Perftoran (Perftoran) 202? PHER-O2 (Sanguine Cor
32、p.) .203? MP4OX (Sangart) 203? Advate (Baxter) 204? Recombinant Factors .205? Stem Cell Approaches 206? Other Research Initiatives 207? Jerome H. Holland Laboratory 207? Program in Cellular and Molecular Medicine208? National Blood Foundation 208? CHAPTER SEVEN: TOTAL BLOOD PRODUCTS MARKET 211? The
33、Blood Products Industry . 211? Market Size 212? CHAPTER EIGHT: COMPANY PROFILES 215? AABB 215? Abbott Laboratories 217? Americas Blood Centers 221? American Red Cross 222? Baxter International 224? Bio-Rad Laboratories 226? BioTime Inc. . 228? Gen-Probe Inc. /Hologic 232? Fenwal/Fresenius Kabi 236?
34、Grifols Biologicals, Inc. . 238? Novartis Diagnostics 245? Novo Nordisk A/S 247? OPK BioTech . 249? Table of Contents vii Copyright 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly proh
35、ibited. Table of Contents vii Copyright 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. Oxygen Biotherapeutics 252? Perftoran 253? Roche 254? Sanguine Corp. 256? ? Copyrigh
36、t 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. LIST OF EXHIBITS Copyright 2013 Kalorama Information Reproduction without prior written permission, in any media now in ex
37、istence or hereafter developed, in whole or in any part, is strictly prohibited. LIST OF EXHIBITS CHAPTER ONE: EXECUTIVE SUMMARY 1? Exhibit 1-1 14? Global Blood Products Market, 2012 14? Exhibit 1-2 17? Total Global Market for Blood Collection Equipment: 2007 2017 17? Exhibit 1-3 18? Recombinant Fac
38、tor and High Blood Loss Market: 2012 - 2017 18? CHAPTER TWO: OVERVIEW 21? Exhibit 2-1 23? Timeline of Global Blood Industry Development 1922 - 2013 .23? Exhibit 2-2 34? Composition of Blood Plasma .34? Exhibit 2-3 44? Viral Inactivation Methods for Viruses Found in Platelets44? Exhibit 2-4 46? Viral
39、 Inactivation Methods for Viruses Found in Red Blood Cells .46? CHAPTER THREE: THE BLOOD MANAGEMENT SYSTEM: BLOOD COLLECTION, PROCESSING AND USE 57? Exhibit 3-1 68? Worldwide Annual Blood Collection by Component 68? Exhibit 3-2 78? Basic Blood Types .78? Exhibit 3-3 79? Blood Transfusion Compatibili
40、ty 79? Exhibit 3-4 88? PCR-Based Screening Tests Licensed by CBER .88? Exhibit 3-4 (contd.). 89? PCR-Based Screening Tests Licensed by CBER .89? Exhibit 3-5 92? Comparison of Direct and Indirect ELISA Tests .92? List of Exhibits viii Copyright 2013 Kalorama Information Reproduction without prior wri
41、tten permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. List of Exhibits viii Copyright 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any pa
42、rt, is strictly prohibited. Exhibit 3-6 99? Results of Cohn Fractionation Method 99? Exhibit 3-7 100? Plasma Proteins of Therapeutic Interest.100? Exhibit 3-8 116? Factor VIII Products in Development, 2013 116? Exhibit 3-11 129? Risk of Contamination .129? Exhibit 3-12 129? Viral Inactivation by Pro
43、cedure .129? CHAPTER FOUR: THE HUMAN BLOOD AND BLOOD PRODUCTS MARKET135? Exhibit 4-1 136? Geographical Distribution of RBC Demand by Region (United States, Europe, Japan, ROW), 2012 136? Exhibit 4-2 136? Projected World Demand for RBCs, 2012-2017 .136? Exhibit 4-3 137? Worldwide Demand for RBCs for
44、Acute and Chronic Conditions, 2012 .137? Exhibit 4-4 137? Number of High Blood Loss Surgical Procedures by Type, 2012 137? Exhibit 4-5 138? Average Blood and Component Requirements by Condition 138? Exhibit 4-6 140? Global Blood Products Market by Type, Number of Units, Average Price and Total Value
45、, 2012 .140? Exhibit 4-7 141? Global Blood Collection and Transfusion Estimates (Millions of Units), 2012-2017 141? Exhibit 4-8 141? Global Plasma Collection and Transfusion Estimates , 2012-2017 .141? Exhibit 4-9 142? Countries Conducting Routine Leukocyte Reduction, 2013 .142? Exhibit 4-10 145? Su
46、rgical Procedures Amenable to Autologous Blood Donation 145? List of Exhibits ix Copyright 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. List of Exhibits ix Copyright 201
47、3 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. Exhibit 4-11 147? CMS Blood Product Reimbursement Rates, 2013 .147? Exhibit 4-12 153? CMS Blood Transfusion Reimbursement Rates
48、, 2013 153? Exhibit 4-13 155? Selected Plasma Derived Product Approvals, 2005 - 2012 .155? Exhibit 4-14 157? The Global Market for Plasma and Plasma Derived Products, 2007 - 2017 .157? Exhibit 4-15 158? Selected Plasma Industry Shifts, 2003 - 2012 .158? Exhibit 4-16 160? Sales and Market Shares of L
49、eading Suppliers of Plasma and Plasma Derived Products, 2012 160? Exhibit 4-17 161? Global Market for Immunoglobulins by Manufacturer 2012 - 2017 .161? Exhibit 4-18 166? Global Market for Human Albumin Products by Brand, 2012 - 2017 166? Exhibit 4-20 167? Leading Factor IX Products, 2013 .167? CHAPTER FIVE: THE BLOOD TESTING AND TYPING MARKETS .171? Exhibit 5-1 173? Total Global Market for Immunoassay versus Nucleic Acid Testing Equipment: 2007 2017 173? Exhibit 5-2 175? Global Blood