NEW YORK, May 11, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
The Blood Industry
http://www.reportlinker.com/p096627/The-Blood-Industry.html?utm_source=prnewswire&utm_medium=pr&utm_campaign=Blood_Sup
REPORT HIGHLIGHTS
* The global blood market includes products used for collecting, typing, processing, and transfusing of blood and the sale of blood therapeutics. This market was worth $30 billion in 2010 and is forecast to increase at an 8.4% compound annual growth rate (CAGR) to reach $45 billion in 2015.
* Blood therapeutic products, including immunoglobulins, coagulation factors, albumin, fibrin sealants, and antithrombin products, are projected to grow at a compound annual growth rate (CAGR) of 10.8% over the 5-year forecast period. This sector was valued at nearly $16 billion in 2010 and is expected to reach $26 billion in 2015.
* Sales for blood processing, collection, and typing/testing reached $14 billion in 2010. This market is forecast to grow at a 5.5% compound annual growth rate (CAGR) to reach more than $18 billion in 2015.
REPORT SCOPE
INTRODUCTION
REASONS FOR DOING THE STUDY
A safe and adequate blood supply is essential to the practice of modern medicine. Ensuring adequate supplies of trustworthy blood and derivative products has lead nations and companies to create a multibillion-dollar business that reaches around the globe.
The global blood industry encompasses the collection, typing, testing, and processing of blood and the creation of blood derivatives to help individuals with varying blood problems. The purpose of this study is to detail advances in these areas and their impact on the blood industry.
During the past 10 years, since BCC first looked at this market, mergers and acquisitions have created an industry dominated by less than 10 major companies. This consolidation and advances in technology have allowed industry participants to obtain more red blood cells from fewer donors. Technological advances have also allowed for greater economies and increased safety in the blood supply.
STUDY GOALS AND OBJECTIVES
With its broad scope and in-depth analyses, this study will be a valuable resource to anyone involved with or interested in the blood industry. This study will provide information on:
* Structure and current market size of the blood industry, with forecasts through 2015
* Analysis and projections of various segments of the industry such as collection, typing, testing, and blood therapeutics
* Blood usage patterns and trends
* Government and regulatory controls
* Impact of diseases on the blood industry
* Major players and their relative market shares and market potential
* Current product lines and examination of newly emerging products and technologies
* State of the international markets for various blood and blood-related products
* Newly issued patents relating to blood therapeutics, processing, screening, and collection technologies.
The study will prove valuable to a variety of readers, including industry executives, managers and planners, researchers, industry analysts, and investors. The projections, forecasts, and trend analyses found in this report provide readers with the necessary data and information for careful decision- making.
SCOPE OF REPORT
This report offers global and U.S. projections, by product segment, from 2010 through 2015, including supporting analyses for projections. Product segments covered consist of blood and plasma collection, blood and plasma processing, blood therapeutic products, plasma therapeutic products, and emerging trends and products.
The arrangement of this report offers an overview of the key elements in the blood collection and processing businesses: blood typing techniques and markets, and plasma fractionation. International markets are discussed, and information is provided on industry structure and the regulatory environment outside the U.S.
Profiles of more than 30 leading companies involved with blood collection, processing, and therapeutics are included. The report provides information on company placement within the market and strategic analyses of the companies' available and emerging products.
METHODOLOGIES AND INFORMATION SOURCES
Information for this report was derived from a variety of primary and secondary research sources, including industry analysts, annual reports and SEC reports, the American Red Cross (ARC), the American Association of Blood Banks (AABB), the Plasma Protein Therapeutics Association (PPTA), the National Institutes of Health (NIH), the Centers for Disease Control (CDC), other government agencies, and journal articles. Secondary sources include literature searches, product literature, and press releases.
When precise information was not available, a consensus was made using reasonable assumptions and estimates based on historical data.
CHAPTER ONE: INTRODUCTION 1
REASONS FOR DOING THE STUDY 1
STUDY GOAL AND OBJECTIVES 1
SCOPE OF REPORT 2
METHODOLOGIES AND INFORMATION SOURCES 2
ANALYST CREDENTIALS 2
RELATED BCC REPORTS 3
BCC ONLINE SERVICES 3
DISCLAIMER 3
CHAPTER TWO: SUMMARY 4
MAJOR FINDINGS 4
SUMMARY TABLE GLOBAL BLOOD COLLECTION, PROCESSING,
AND THERAPEUTICS MARKET, THROUGH 2015 ($ MILLIONS) 5
SUMMARY FIGURE GLOBAL BLOOD MARKET, BY REGION, 2010
AND 2015 (%) 5
SUMMARY FIGURE (CONTINUED) 6
CHAPTER THREE: OVERVIEW 7
HISTORY OF THE BLOOD INDUSTRY 7
TABLE 1 TIMELINE OF THE BLOOD INDUSTRY 8
CONSOLIDATION IN THE INDUSTRY 9
TABLE 2 SELECTED ACQUISITIONS AND MERGERS IN THE
GLOBAL BLOOD INDUSTRY, 2006-2011 ($ MILLIONS) 10
DYNAMICS OF BLOOD DONATION 10
BLOOD COLLECTION AND PROCESSING MARKET STRUCTURE 11
AND SIZE 11
TABLE 3 US BLOOD COLLECTION AND PROCESSING PRODUCTS
MARKET, THROUGH 2015 ($ MILLIONS) 11
BLOOD AND ITS COMPONENTS 11
TABLE 4 COMPOSITION OF BLOOD 12
PLASMA 12
Uses for Plasma Proteins 13
TABLE 5 PERCENT OF PLASMA PROTEINS AND THE DISEASES
AND DISORDERS THEY TREAT 13
Immunoglobulin Products 14
CELLULAR ELEMENTS 14
Red Blood Cells 14
White Blood Cells 15
Platelets 15
TRANSFUSION-ASSOCIATED RISKS 16
DISEASES CONTRACTED FROM BLOOD TRANSFUSION
AND RELATED IDENTIFICATION TESTING 16
TABLE 6 DISEASES CONTRACTED FROM BLOOD TRANSFUSIONS 16
TABLE 6 (CONTINUED) 17
HIV/AIDS 17
TABLE 7 CBER-LICENSED HIV DONOR SCREENING TESTS 18
TABLE 7 (CONTINUED) 19
Hepatitis A 20
Worldwide Incidences of Hepatitis A 20
Hepatitis B (HBV) 20
TABLE 8 CBER-LICENSED SCREENING TEST FOR HEPATITIS B 21
Hepatitis C 22
TABLE 9 CBER-LICENSED SCREENING TESTS FOR HEPATITIS C 22
Hepatitis D 23
Hepatitis E 23
Human T-Cell Lymphotropic Virus (HTLV-I, II) 23
TABLE 10 CBER-LICENSED SCREENING TESTS FOR HTLV-I AND
HTLV-II 24
Cytomegalovirus 24
TABLE 11 CBER-LICENSED SCREENING TESTS FOR CMV 25
TABLE 12 CBER-LICENSED SCREENING TESTS FOR WEST NILE
VIRUS 26
"Mad Cow Disease"/Creutzfeldt-Jakob Disease (CJD) 26
Syphilis 27
TABLE 13 CBER-LICENSED SCREENING TESTS FOR SYPHILIS 27
Chagas Disease 27
TABLE 14 CBER-LICENSED SCREENING TESTS FOR
TRYPANOSOMA CRUZI (CHAGAS DISEASE) 28
TABLE 15 CBER-LICENSED SCREENING TEST, BY TYPE 28
TABLE 15 (CONTINUED) 29
FIGURE 1 TYPES OF BLOOD SCREENING TESTS (%) 30
CREATING A VIRUS-FREE BLOOD SUPPLY 30
CERUS CORP 31
COST OF A VIRUS-FREE BLOOD SUPPLY 31
PLASMA TREATMENTS TO INACTIVATE VIRUSES 31
Trinitrobutyl Phosphate and Sodium Cholate 31
Methylene Blue-Treated Plasma 32
Amatosalen HCL-Treated Plasma 32
NEGATIVE REACTIONS FROM BLOOD TRANSFUSIONS 33
BLOOD/PLASMA COMPONENT RISKS 34
CHAPTER FOUR: BLOOD COLLECTION, TYPING, AND PROCESSING 35
TABLE 16 PROJECTED GLOBAL MARKET FOR BLOOD/PLASMA
COLLECTION, TYPING AND TESTING, AND PROCESSING
EQUIPMENT AND SUPPLIES, THROUGH 2015 ($ MILLIONS) 35
BLOOD COLLECTION 36
METHODS FOR COLLECTING BLOOD 36
TABLE 17 PROJECTED GLOBAL MARKET FOR MANUAL AND
AUTOMATIC BLOOD COLLECTION EQUIPMENT AND SUPPLIES,
THROUGH 2015 ($ MILLIONS) 37
MANUAL COLLECTION 37
AUTOMATED COLLECTION 37
Plasmapheresis 38
Plateletpheresis 38
Leukopheresis 39
Red Blood Cell Apheresis 39
BLOOD SALVAGE EQUIPMENT 39
TABLE 18 PROJECTED GLOBAL MARKET FOR AUTOMATED
BLOOD SALVAGE EQUIPMENT, THROUGH 2015 ($ MILLIONS) 40
BLOOD BAGS 40
TABLE 19 PROJECTED GLOBAL MARKET FOR BLOOD BAGS,
THROUGH 2015 ($ MILLIONS) 41
BLOOD FILTERS 41
TABLE 20 PROJECTED GLOBAL MARKET FOR BLOOD FILTERS,
THROUGH 2015 (MILLIONS) 42
TRANSFUSION SETS, ACCESSORIES 42
OTHER EQUIPMENT 42
TABLE 21 PROJECTED GLOBAL MARKET FOR OTHER
COLLECTION EQUIPMENT INCLUDING BLOOD TRANSFUSION
SETS AND ACCESSORIES, THROUGH 2015 ($ MILLIONS) 43
MARKET DRIVERS IN BLOOD COLLECTION 43
US BLOOD COLLECTION ORGANIZATIONS 43
FOR-PROFIT BLOOD COLLECTION CONTROVERSY 44
NONPROFIT BLOOD COLLECTION IN THE US 44
American Red Cross (ARC) 44
Community Blood Banks 44
Hospitals 45
Other Blood Collection Sites 45
US BLOOD DONATION DEMOGRAPHICS 45
DONOR RECRUITMENT AND REGULATIONS 45
BLOOD SCREENING AND EVALUATION 46
BLOOD COLLECTION EFFORTS THROUGHOUT THE WORLD 46
SOUTH AMERICA/CENTRAL AMERICA 47
ASIA 47
PACIFIC REGION 47
AFRICA 48
CANADA 48
EUROPE 48
United Kingdom 48
France 48
GLOBAL NATURE OF THE PLASMA INDUSTRY 49
PLASMA DONORS 49
COMMERCIAL NATURE OF PLASMAPHERESIS 50
PLASMA COLLECTION CENTERS IN THE US 50
National Donor Referral Registry 51
PLASMA FRACTIONATORS 51
DISTRIBUTORS/BROKERS 52
BLOOD TYPING 52
METHODS OF TYPING 52
Slide/Tile Testing 53
Tube Testing 53
Microplate Testing Methods 53
AUTOMATED BLOOD TYPING AND SCREENING METHODS 54
Immucor 54
Ortho-Clinical Diagnostics 54
Abbott 55
BLOOD TRANSFUSION TESTING 55
MANUAL CROSSMATCH TECHNIQUES 55
Major Crossmatch 55
Minor Crossmatch 56
Antibody Screening 56
Coombs Test 56
BLOOD TESTING 56
TABLE 22 TESTS ROUTINELY PERFORMED ON BLOOD
DONATIONS 57
TABLE 23 BLOOD TYPE ANTIGEN/ANTIBODY REACTIONS 57
TABLE 24 PROJECTED GLOBAL MARKET FOR BLOOD TYPING AND
TESTING, BY GEOGRAPHICAL AREA, THROUGH 2015 ($
MILLIONS) 58
FIGURE 2 PROJECTED GLOBAL MARKET FOR BLOOD TYPING AND
TESTING, 2010 AND 2015 (%) 58
FIGURE 2 (CONTINUED) 59
BLOOD PROCESSING 59
PREPARATION AND USE OF THE COMPONENTS 59
Red Blood Cells 60
Platelets 60
MARKET PARTICIPANTS 60
Haemonetics 60
PCS2 61
TCD Total Containment Unit 61
MCS+ 8150 System 61
Cell Saver System 61
OrthoPAT System 61
ACP 215 System 61
Fenwal 62
Autopheresis-C 62
Alyx Component Collection System 62
CS-3000 Plus Blood Cell Separator 62
Amicus Separator 62
Gambro BCT 63
Trima Accel Collection System 63
COBE Spectra Apheresis System 63
The Elutra Cell Separation System 63
GLOBAL BLOOD MANAGEMENT ISSUES 63
AVAILABILITY 63
BLOODLESS SURGERY 64
FEWER OPEN SURGICAL PROCEDURES 65
SAFETY ISSUES/RISK MANAGEMENT 65
Improved Donor Screening 65
Better Viral Testing 66
Encouraging Repeat Donors 66
Improving Viral Inactivation Processes 66
Selective Use of Blood Derivative Products 66
CHAPTER FIVE: BLOOD THERAPEUTICS 67
TABLE 25 BLOOD PRODUCTS TRANSFUSED FOR THEIR
THERAPEUTIC USES 67
WHOLE BLOOD 67
PACKED RED BLOOD CELLS 68
PLATELETS 68
LEUKOCYTES 69
FRESH FROZEN PLASMA 69
SELECTED USES OF FFP 70
CRYOPRECIPITATE 70
WASHED CELLS 70
DEGLYCEROLIZED CELLS 71
OTHER BLOOD COMPONENTS 71
GRANULOCYTES 71
GAMMA-IRRADIATED BLOOD 71
DISTRIBUTION OF COLLECTED BLOOD 71
TABLE 26 AVERAGE COST OF TRANSFUSION TO THE PATIENT IN
THE US, BY PRODUCT TYPE, 2011 ($) 72
PLASMA AND PLASMA-DERIVED PRODUCTS 72
GLOBAL PLASMA COLLECTION 73
PLASMA MARKET SIZE 73
TABLE 27 PROJECTED GLOBAL PLASMA MARKET, THROUGH 2015
($ MILLIONS) 73
FIGURE 3 PLASMA PRODUCTS MARKET SHARE, BY COMPANY,
2010 (%) 74
COAGULATION FACTORS 74
IMMUNE SERUM GLOBULIN/INTRAMUSCULAR IMMUNE
GLOBULINS (IMIG)/INTRAVENOUS IMMUNE
GLOBULIN (IVIG) 75
Market Shortages of IVIG 75
FACTOR VIII 76
FACTOR IX AND FACTOR IX COMPLEX 76
FACTOR VIIA 76
FIBRIN/THROMBIN 76
THERAPEUTIC APHERESIS 77
CLOTTING FACTORS 77
TABLE 28 BLOOD CLOTTING FACTORS 78
Hemophilia 78
TABLE 29 GLOBAL PREVALENCE OF HEMOPHILIA, 2009
(MILLIONS) 79
CLOTTING FACTOR MARKET DEMAND AND MARKET
SIZE 79
TABLE 30 PROJECTED GLOBAL MARKET FOR PLASMA-DERIVED
AND RECOMBINANT CLOTTING FACTORS, THROUGH 2015 ($
MILLIONS) 80
Factor VIII 80
TABLE 31 FDA-APPROVED FACTOR VIII PRODUCTS 81
Advate 81
Helixate FS 82
Kogenate FS 82
Recombinate 82
ReFacto 82
GLOBAL SHARE IN FACTOR VIII MARKET 83
FIGURE 4 LEADING FACTOR VIII MANUFACTURERS, 2010 (%) 83
TABLE 32 PROJECTED US MARKET FOR FACTOR VIII, THROUGH
2015 ($ MILLIONS) 84
Factor IX 84
TABLE 33 PROJECTED GLOBAL MARKET FOR FACTOR IX,
THROUGH 2015 ($ MILLIONS) 84
TABLE 34 FDA-APPROVED FACTOR IX PRODUCTS, 2009 85
Factor VIIa 85
TABLE 35 PROJECTED GLOBAL MARKET FOR FACTOR VIIA,
THROUGH 2015 ($ MILLIONS) 86
FIGURE 5 GLOBAL SALES OF FACTOR VIIA, BY GEOGRAPHIC
REGION, 2010 (%) 86
FIGURE 5 (CONTINUED) 87
ALBUMIN 87
RECOMBINANT HUMAN ALBUMIN 88
Recombinant Human Albumin Market 88
ALBUMIN MARKET DYNAMICS 88
TABLE 36 CURRENTLY MARKETED HUMAN ALBUMIN AND PPF
PRODUCTS, 2010 89
ALBUMIN AND PPF MARKET SIZE 89
TABLE 37 PROJECTED GLOBAL MARKET FOR HUMAN SERUM
ALBUMIN AND PPF, THROUGH 2015 ($ MILLIONS) 90
PROTHROMBIN COMPLEX CONCENTRATE 90
TABLE 38 FDA-APPROVED PROTHROMBIN COMPLEX
CONCENTRATE PRODUCTS 90
FIBRIN SEALANTS AND THROMBIN 91
FIBRIN-BASED WOUND CLOSURE PRODUCT MARKET 91
Cyanoacrylate 92
TABLE 39 PROJECTED GLOBAL MARKET FOR FIBRIN-BASED
SEALANTS, THROUGH 2015 ($ MILLIONS) 92
ANTITHROMBIN TREATMENTS 93
TREATMENTS FOR HD 93
Plasma Antithrombin 93
Recombinant Human Antithrombin (rhAT) 93
Talecris Biotherapeutics 93
GTC Biotherapeutics 94
GlaxoSmithKline (Arixtra) 94
GLOBAL MARKET FOR ANTITHROMBIN 94
TABLE 40 PROJECTED GLOBAL MARKET FOR ANTITHROMBIN,
THROUGH 2015 ($ MILLIONS) 95
IMMUNOGLOBULINS 95
TABLE 41 FDA-APPROVED IMMUNOGLOBULINS 96
TABLE 42 PROJECTED GLOBAL MARKET FOR
IMMUNOGLOBULINS, THROUGH 2015 ($ MILLIONS) 97
POLYVALENT IMMUNOGLOBULINS 97
TABLE 43 SELECTED CONDITIONS TREATED WITH IVIG 98
The Projected Global IVIG Therapy Market 98
TABLE 44 PROJECTED GLOBAL MARKET FOR IVIG THERAPY,
THROUGH 2015 ($ MILLIONS) 98
HYPERIMMUNE IMMUNOGLOBULINS 99
TABLE 45 FDA-APPROVED HYPERIMMUNE IMMUNOGLOBULINS 99
TABLE 45 (CONTINUED) 100
GLOBAL MARKET FOR HYPERIMMUNOGLOBULINS 100
TABLE 46 PROJECTED GLOBAL MARKET FOR
HYPERIMMUNOGLOBULINS, THROUGH 2015 ($ MILLIONS) 101
FIGURE 6 GLOBAL MARKET FOR IMMUNOGLOBULINS, BY TYPE,
2009 AND 2015 ($ MILLIONS) 101
Respiratory Syncytial Virus (RSV) 102
TABLE 47 PROJECTED GLOBAL MARKET FOR RSV
IMMUNOGLOBULIN, THROUGH 2015 ($ MILLIONS) 102
Alpha-1-Proteinase Inhibitor 102
TABLE 48 PROJECTED GLOBAL MARKET FOR ALPHA-1-
PROTEINASE INHIBITOR, THROUGH 2015 ($ MILLIONS) 103
Rho(D) 103
TABLE 49 PROJECTED GLOBAL MARKET FOR RHO(D), THROUGH
2015 ($ MILLIONS) 104
Hepatitis B Immune Globulin 104
TABLE 50 PROJECTED GLOBAL MARKET FOR HBV
IMMUNOGLOBULINS, THROUGH 2015 ($ MILLIONS) 104
CMV Immunoglobulin 105
TABLE 51 PROJECTED GLOBAL MARKET FOR CMV
IMMUNOGLOBULIN, THROUGH 2015 ($ MILLIONS) 105
Tetanus Immunoglobulin 105
TABLE 52 PROJECTED GLOBAL MARKET FOR TETANUS
IMMUNOGLOBULIN, THROUGH 2015 ($ MILLIONS) 106
Rabies Immunoglobulin 106
TABLE 53 PROJECTED GLOBAL MARKET FOR RABIES
IMMUNOGLOBULIN, THROUGH 2015 ($ MILLIONS) 107
Varicella Immunoglobulin 107
Vaccinia Immune Globulin Intravenous (VIG) 107
CHAPTER SIX: BLOOD INDUSTRY REGULATION 108
REGULATION OF THE US BLOOD BUSINESS 108
TABLE 54 US FEDERAL ORGANIZATIONS RESPONSIBLE FOR
BLOOD SAFETY 108
TABLE 54 (CONTINUED) 109
STATUTORY AUTHORITY OF THE FDA 109
Center for Biologics Evaluation and Research 109
Office of Regulatory Affairs (ORA) 110
Office of Biologics, the Division of Blood and Blood
Products 110
TABLE 55 FDA AUTHORITY IN REGULATING BLOOD BANKING
AND BLOOD PRODUCTS 111
MAJOR REGULATIONS AND POLICIES FOR THE US BLOOD
SUPPLY 111
THE CLINICAL LABORATORY IMPROVEMENT ACT OF
1988 (CLIA) 111
THE FDA APPROACH TO BLOOD REGULATION 112
TABLE 56 MAIN BLOOD REGULATION ISSUES IDENTIFIED BY THE
FDA 113
TEAM BIOLOGICS 113
REGULATION IMPLEMENTATION 114
TABLE 57 14 MAJOR AREAS OF CONCERN FOR INSPECTING
BLOOD FACILITIES 114
TABLE 57 (CONTINUED) 115
OTHER US ORGANIZATIONS INVOLVED IN BLOOD
REGULATION 115
National Heart, Lung, and Blood Institute (NHLBI) 115
Blood Disease and Resources Program 116
Occupational Safety and Health Administration (OSHA) 116
Centers for Medicare and Medicaid Services (CMS) 116
State Regulatory Agencies 117
VOLUNTARY REGULATION BY PROFESSIONAL AND
TRADE ASSOCIATIONS 117
American Association of Blood Banks (AABB) 117
National Donor Deferral Registry (NDDR) 118
Quality Plasma Program 118
America's Blood Centers (ABC) 119
Plasma Products Therapeutics Association (PPTA 119
EUROPEAN UNION (EU) REGULATIONS 119
THE INTERNATIONAL SOCIETY FOR BLOOD TRANSFUSION
(ISBT) 128 120
REGULATION IN JAPAN 120
REGULATION IN CHINA 120
THE FUTURE OF GLOBAL BLOOD REGULATIONS 121
CHAPTER SEVEN: BLOOD PRODUCTS TECHNOLOGY 122
FRACTIONATION METHODS 122
COHN METHOD 122
ADVANCED FRACTIONATION METHODS 122
Chromatography Methods 123
AMPLIFICATION METHODS 123
POLYMERASE CHAIN REACTION 123
NUCLEI AMPLIFICATION TECHNOLOGY 123
IMMUNOASSAY METHODS 124
ENZYME IMMUNOASSAY 124
Basic EIA 124
FIGURE 7 THE BASIC ENZYME IMMUNOASSAY (EIA) PROCESS 125
Second Antibody Precipitation Method 125
Double Antibody Sandwich Method 126
Reverse Sandwich Method 126
Reverse Sandwich Inhibition Method 126
AGGLUTINATION 126
CHEMILUMINESCENCE (CHLIA) 127
ENDOTOXIN TESTING 127
CHAPTER EIGHT: BLOOD RESEARCH AND DEVELOPMENT 128
JEROME H HOLLAND LABORATORY (ARC) 128
NATIONAL BLOOD FOUNDATION (NBF) 128
CENTER FOR BLOOD RESEARCH (CBR) 128
STEM CELL RESEARCH AT THE CBR 129
FDA BLOOD RESEARCH PRODUCTS 130
TABLE 58 SELECTED BLOOD RESEARCH FROM FDA, 2010 130
TABLE 58 (CONTINUED) 131
STEM CELL DEVELOPMENTS OUTSIDE THE US 132
NOVEL BIOENGINEERING TECHNOLOGIES 132
RESEARCH ON ALZHEIMER'S AND CIRRHOSIS OF THE LIVER 133
CURRENT RESEARCH ON BLOOD SUBSTITUTES 133
EMERGING PLATELET TREATMENTS 134
RED BLOOD CELLS 135
THE VETERINARY BLOOD MARKET 136
TABLE 59 REGIONAL US VETERINARY BLOOD BANKS 136
CHAPTER NINE: PATENTS 137
TABLE 60 RECENTLY ISSUED PATENTS, JANUARY 2005 THROUGH
JANUARY 2011 137
TABLE 61 PATENTS BY COMPANY ASSIGNEE, JANUARY 2005
THROUGH JANUARY 2011 138
TABLE 62 PATENTS ISSUED BETWEEN 2005 AND 2011: PLASMA
DERIVATIVES 139
TABLE 63 PATENTS ISSUED BETWEEN 2005 AND 2011: BLOOD
COLLECTION, SAMPLING EQUIPMENT 140
TABLE 63 (CONTINUED) 141
TABLE 63 (CONTINUED) 142
TABLE 63 (CONTINUED) 143
TABLE 63 (CONTINUED) 144
TABLE 63 (CONTINUED) 145
TABLE 64 PATENTS ISSUED BETWEEN 2005 AND 2011: BLOOD
FILTRATION, FLUID SEPARATION EQUIPMENT 146
TABLE 64 (CONTINUED) 147
TABLE 64 (CONTINUED) 148
TABLE 64 (CONTINUED) 149
TABLE 64 (CONTINUED) 150
TABLE 64 (CONTINUED) 151
TABLE 64 (CONTINUED) 152
TABLE 65 PATENTS ISSUED BETWEEN 2005 AND 2011: BLOOD
VOLUME ENHANCERS 153
TABLE 66 PATENTS ISSUED BETWEEN 2005 AND 2011: NUCLEIC
ACID AMPLIFICATION 153
TABLE 66 (CONTINUED) 154
TABLE 67 PATENTS ISSUED BETWEEN 2005 AND 2011: BLOOD
TREATMENTS 155
TABLE 67 (CONTINUED) 156
TABLE 68 PATENTS ISSUED BETWEEN 2005 AND 2011:
ADDITIONAL POTENTIAL PRODUCTS 157
TABLE 68 (CONTINUED) 158
TABLE 68 (CONTINUED) 159
TABLE 68 (CONTINUED) 160
CHAPTER TEN: COMPANY PROFILES 161
ABBOTT LABORATORIES 161
BUSINESS OVERVIEW 161
FINANCIALS 161
PRODUCTS 161
ALPHA THERAPEUTICS CORP (SEE GRIFOLS) 162
AMERICA'S BLOOD CENTERS 162
BUSINESS OVERVIEW 162
FINANCIALS 162
PRODUCTS 163
AMERICAN ASSOCIATION OF BLOOD BANKS (AABB) 163
BUSINESS OVERVIEW 163
FINANCIALS 163
PRODUCTS 163
AMERICAN RED CROSS 164
BUSINESS OVERVIEW 164
FINANCIALS 164
PRODUCTS 164
BAXTER INTERNATIONAL, INC 165
BUSINESS OVERVIEW 165
FINANCIALS 165
PRODUCTS 165
BECKMAN COULTER 166
BUSINESS OVERVIEW 166
FINANCIALS 167
PRODUCTS 167
BECTON DICKINSON AND COMPANY 167
BUSINESS OVERVIEW 167
FINANCIALS 167
PRODUCTS 168
BIO PRODUCTS LABORATORIES 168
BUSINESS OVERVIEW 168
FINANCIALS 168
PRODUCTS 168
BIO-RAD LABORATORIES, INC 169
BUSINESS OVERVIEW 169
FINANCIALS 169
PRODUCTS 169
BIOTEST AG 169
BUSINESS OVERVIEW 170
FINANCIALS 170
PRODUCTS 170
CARIDIANBCT INC 170
BUSINESS OVERVIEW 171
FINANCIALS 171
PRODUCTS 171
CERUS CORP 172
BUSINESS OVERVIEW 172
FINANCIALS 172
PRODUCTS 172
CHIRON CORP (SEE NOVARTIS DIAGNOSTICS) 172
CSL BEHRING 172
BUSINESS OVERVIEW 173
FINANCIALS 173
PRODUCTS 173
DAXOR CORP 174
BUSINESS OVERVIEW 174
FINANCIALS 174
PRODUCTS 174
DIAGAST 175
BUSINESS OVERVIEW 175
FINANCIALS 175
PRODUCTS 175
FENWAL BLOOD TECHNOLOGIES, INC 176
BUSINESS OVERVIEW 176
FINANCIALS 176
PRODUCTS 176
FRESENIUS KABI AG 176
BUSINESS OVERVIEW 177
FINANCIALS 177
PRODUCTS 177
GEN-PROBE, INC 177
BUSINESS OVERVIEW 177
FINANCIALS 178
PRODUCTS 178
GRIFOLS BIOLOGICALS, INC 178
BUSINESS OVERVIEW 178
FINANCIALS 179
PRODUCTS 179
HAEMONETICS, INC 179
BUSINESS OVERVIEW 179
FINANCIALS 180
PRODUCTS 180
Cell Saver System 181
OrthoPAT System 181
ACP 215 System 181
HEMAGEN DIAGNOSTICS, INC 181
BUSINESS OVERVIEW 181
FINANCIALS 182
PRODUCTS 182
HEMOCUE AB 182
BUSINESS OVERVIEW 182
FINANCIALS 182
PRODUCTS 182
IMMUCOR, INC 183
BUSINESS OVERVIEW 183
FINANCIALS 183
PRODUCTS 183
KAWASUMI LABORATORIES, INC 183
BUSINESS OVERVIEW 184
FINANCIALS 184
PRODUCTS 184
LUMINEX CORPORATION 184
BUSINESS OVERVIEW 185
FINANCIALS 185
PRODUCTS 185
MACOPHARMA USA (FORMERLY UNITED PHARMA) 186
BUSINESS OVERVIEW 186
FINANCIALS 186
PRODUCTS 186
MASSACHUSETTS PUBLIC HEALTH BIOLOGIC LABS 186
BUSINESS OVERVIEW 186
FINANCIALS 187
PRODUCTS 187
NOVARTIS DIAGNOSTICS 187
BUSINESS OVERVIEW 187
FINANCIAL INFORMATION 188
PRODUCTS 188
NOVO NORDISK 189
BUSINESS OVERVIEW 189
FINANCIALS 189
PRODUCTS 189
OCTAPHARMA 189
BUSINESS OVERVIEW 190
FINANCIALS 190
PRODUCTS 190
OLYMPUS AMERICA, INC (SEE BECKMAN COULTER) 190
ONE LAMBDA, INC 190
BUSINESS OVERVIEW 190
FINANCIALS 191
PRODUCTS 191
ORTHO-CLINICAL DIAGNOSTICS 191
FINANCIALS 192
PRODUCTS 192
PALL CORP 192
BUSINESS OVERVIEW 192
FINANCIALS 192
PRODUCTS 193
PFIZER 193
BUSINESS OVERVIEW 193
FINANCIALS 193
PRODUCTS 194
TALECRIS BIOTHERAPEUTICS 194
BUSINESS OVERVIEW 194
FINANCIALS 194
PRODUCTS 195
TERUMO MEDICAL CORP 195
BUSINESS OVERVIEW 195
FINANCIALS 196
PRODUCTS 196
THERMOGENESIS CORP 196
BUSINESS OVERVIEW 196
FINANCIALS 197
PRODUCTS 197
To order this report:
Blood Supply, Tissue Banking and Transplantation Industry: The Blood Industry
Blood Supply, Tissue Banking and Transplantation Business News
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Nicolas BombourgReportlinkerEmail: [email protected]US: (805)652-2626Intl: +1 805-652-2626
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REPORT HIGHLIGHTS
* The global blood market includes products used for collecting, typing, processing, and transfusing of blood and the sale of blood therapeutics. This market was worth $30 billion in 2010 and is forecast to increase at an 8.4% compound annual growth rate (CAGR) to reach $45 billion in 2015.
* Blood therapeutic products, including immunoglobulins, coagulation factors, albumin, fibrin sealants, and antithrombin products, are projected to grow at a compound annual growth rate (CAGR) of 10.8% over the 5-year forecast period. This sector was valued at nearly $16 billion in 2010 and is expected to reach $26 billion in 2015.
* Sales for blood processing, collection, and typing/testing reached $14 billion in 2010. This market is forecast to grow at a 5.5% compound annual growth rate (CAGR) to reach more than $18 billion in 2015.
REPORT SCOPE
INTRODUCTION
REASONS FOR DOING THE STUDY
A safe and adequate blood supply is essential to the practice of modern medicine. Ensuring adequate supplies of trustworthy blood and derivative products has lead nations and companies to create a multibillion-dollar business that reaches around the globe.
The global blood industry encompasses the collection, typing, testing, and processing of blood and the creation of blood derivatives to help individuals with varying blood problems. The purpose of this study is to detail advances in these areas and their impact on the blood industry.
During the past 10 years, since BCC first looked at this market, mergers and acquisitions have created an industry dominated by less than 10 major companies. This consolidation and advances in technology have allowed industry participants to obtain more red blood cells from fewer donors. Technological advances have also allowed for greater economies and increased safety in the blood supply.
STUDY GOALS AND OBJECTIVES
With its broad scope and in-depth analyses, this study will be a valuable resource to anyone involved with or interested in the blood industry. This study will provide information on:
* Structure and current market size of the blood industry, with forecasts through 2015
* Analysis and projections of various segments of the industry such as collection, typing, testing, and blood therapeutics
* Blood usage patterns and trends
* Government and regulatory controls
* Impact of diseases on the blood industry
* Major players and their relative market shares and market potential
* Current product lines and examination of newly emerging products and technologies
* State of the international markets for various blood and blood-related products
* Newly issued patents relating to blood therapeutics, processing, screening, and collection technologies.
The study will prove valuable to a variety of readers, including industry executives, managers and planners, researchers, industry analysts, and investors. The projections, forecasts, and trend analyses found in this report provide readers with the necessary data and information for careful decision- making.
SCOPE OF REPORT
This report offers global and U.S. projections, by product segment, from 2010 through 2015, including supporting analyses for projections. Product segments covered consist of blood and plasma collection, blood and plasma processing, blood therapeutic products, plasma therapeutic products, and emerging trends and products.
The arrangement of this report offers an overview of the key elements in the blood collection and processing businesses: blood typing techniques and markets, and plasma fractionation. International markets are discussed, and information is provided on industry structure and the regulatory environment outside the U.S.
Profiles of more than 30 leading companies involved with blood collection, processing, and therapeutics are included. The report provides information on company placement within the market and strategic analyses of the companies' available and emerging products.
METHODOLOGIES AND INFORMATION SOURCES
Information for this report was derived from a variety of primary and secondary research sources, including industry analysts, annual reports and SEC reports, the American Red Cross (ARC), the American Association of Blood Banks (AABB), the Plasma Protein Therapeutics Association (PPTA), the National Institutes of Health (NIH), the Centers for Disease Control (CDC), other government agencies, and journal articles. Secondary sources include literature searches, product literature, and press releases.
When precise information was not available, a consensus was made using reasonable assumptions and estimates based on historical data.
CHAPTER ONE: INTRODUCTION 1
REASONS FOR DOING THE STUDY 1
STUDY GOAL AND OBJECTIVES 1
SCOPE OF REPORT 2
METHODOLOGIES AND INFORMATION SOURCES 2
ANALYST CREDENTIALS 2
RELATED BCC REPORTS 3
BCC ONLINE SERVICES 3
DISCLAIMER 3
CHAPTER TWO: SUMMARY 4
MAJOR FINDINGS 4
SUMMARY TABLE GLOBAL BLOOD COLLECTION, PROCESSING,
AND THERAPEUTICS MARKET, THROUGH 2015 ($ MILLIONS) 5
SUMMARY FIGURE GLOBAL BLOOD MARKET, BY REGION, 2010
AND 2015 (%) 5
SUMMARY FIGURE (CONTINUED) 6
CHAPTER THREE: OVERVIEW 7
HISTORY OF THE BLOOD INDUSTRY 7
TABLE 1 TIMELINE OF THE BLOOD INDUSTRY 8
CONSOLIDATION IN THE INDUSTRY 9
TABLE 2 SELECTED ACQUISITIONS AND MERGERS IN THE
GLOBAL BLOOD INDUSTRY, 2006-2011 ($ MILLIONS) 10
DYNAMICS OF BLOOD DONATION 10
BLOOD COLLECTION AND PROCESSING MARKET STRUCTURE 11
AND SIZE 11
TABLE 3 US BLOOD COLLECTION AND PROCESSING PRODUCTS
MARKET, THROUGH 2015 ($ MILLIONS) 11
BLOOD AND ITS COMPONENTS 11
TABLE 4 COMPOSITION OF BLOOD 12
PLASMA 12
Uses for Plasma Proteins 13
TABLE 5 PERCENT OF PLASMA PROTEINS AND THE DISEASES
AND DISORDERS THEY TREAT 13
Immunoglobulin Products 14
CELLULAR ELEMENTS 14
Red Blood Cells 14
White Blood Cells 15
Platelets 15
TRANSFUSION-ASSOCIATED RISKS 16
DISEASES CONTRACTED FROM BLOOD TRANSFUSION
AND RELATED IDENTIFICATION TESTING 16
TABLE 6 DISEASES CONTRACTED FROM BLOOD TRANSFUSIONS 16
TABLE 6 (CONTINUED) 17
HIV/AIDS 17
TABLE 7 CBER-LICENSED HIV DONOR SCREENING TESTS 18
TABLE 7 (CONTINUED) 19
Hepatitis A 20
Worldwide Incidences of Hepatitis A 20
Hepatitis B (HBV) 20
TABLE 8 CBER-LICENSED SCREENING TEST FOR HEPATITIS B 21
Hepatitis C 22
TABLE 9 CBER-LICENSED SCREENING TESTS FOR HEPATITIS C 22
Hepatitis D 23
Hepatitis E 23
Human T-Cell Lymphotropic Virus (HTLV-I, II) 23
TABLE 10 CBER-LICENSED SCREENING TESTS FOR HTLV-I AND
HTLV-II 24
Cytomegalovirus 24
TABLE 11 CBER-LICENSED SCREENING TESTS FOR CMV 25
TABLE 12 CBER-LICENSED SCREENING TESTS FOR WEST NILE
VIRUS 26
"Mad Cow Disease"/Creutzfeldt-Jakob Disease (CJD) 26
Syphilis 27
TABLE 13 CBER-LICENSED SCREENING TESTS FOR SYPHILIS 27
Chagas Disease 27
TABLE 14 CBER-LICENSED SCREENING TESTS FOR
TRYPANOSOMA CRUZI (CHAGAS DISEASE) 28
TABLE 15 CBER-LICENSED SCREENING TEST, BY TYPE 28
TABLE 15 (CONTINUED) 29
FIGURE 1 TYPES OF BLOOD SCREENING TESTS (%) 30
CREATING A VIRUS-FREE BLOOD SUPPLY 30
CERUS CORP 31
COST OF A VIRUS-FREE BLOOD SUPPLY 31
PLASMA TREATMENTS TO INACTIVATE VIRUSES 31
Trinitrobutyl Phosphate and Sodium Cholate 31
Methylene Blue-Treated Plasma 32
Amatosalen HCL-Treated Plasma 32
NEGATIVE REACTIONS FROM BLOOD TRANSFUSIONS 33
BLOOD/PLASMA COMPONENT RISKS 34
CHAPTER FOUR: BLOOD COLLECTION, TYPING, AND PROCESSING 35
TABLE 16 PROJECTED GLOBAL MARKET FOR BLOOD/PLASMA
COLLECTION, TYPING AND TESTING, AND PROCESSING
EQUIPMENT AND SUPPLIES, THROUGH 2015 ($ MILLIONS) 35
BLOOD COLLECTION 36
METHODS FOR COLLECTING BLOOD 36
TABLE 17 PROJECTED GLOBAL MARKET FOR MANUAL AND
AUTOMATIC BLOOD COLLECTION EQUIPMENT AND SUPPLIES,
THROUGH 2015 ($ MILLIONS) 37
MANUAL COLLECTION 37
AUTOMATED COLLECTION 37
Plasmapheresis 38
Plateletpheresis 38
Leukopheresis 39
Red Blood Cell Apheresis 39
BLOOD SALVAGE EQUIPMENT 39
TABLE 18 PROJECTED GLOBAL MARKET FOR AUTOMATED
BLOOD SALVAGE EQUIPMENT, THROUGH 2015 ($ MILLIONS) 40
BLOOD BAGS 40
TABLE 19 PROJECTED GLOBAL MARKET FOR BLOOD BAGS,
THROUGH 2015 ($ MILLIONS) 41
BLOOD FILTERS 41
TABLE 20 PROJECTED GLOBAL MARKET FOR BLOOD FILTERS,
THROUGH 2015 (MILLIONS) 42
TRANSFUSION SETS, ACCESSORIES 42
OTHER EQUIPMENT 42
TABLE 21 PROJECTED GLOBAL MARKET FOR OTHER
COLLECTION EQUIPMENT INCLUDING BLOOD TRANSFUSION
SETS AND ACCESSORIES, THROUGH 2015 ($ MILLIONS) 43
MARKET DRIVERS IN BLOOD COLLECTION 43
US BLOOD COLLECTION ORGANIZATIONS 43
FOR-PROFIT BLOOD COLLECTION CONTROVERSY 44
NONPROFIT BLOOD COLLECTION IN THE US 44
American Red Cross (ARC) 44
Community Blood Banks 44
Hospitals 45
Other Blood Collection Sites 45
US BLOOD DONATION DEMOGRAPHICS 45
DONOR RECRUITMENT AND REGULATIONS 45
BLOOD SCREENING AND EVALUATION 46
BLOOD COLLECTION EFFORTS THROUGHOUT THE WORLD 46
SOUTH AMERICA/CENTRAL AMERICA 47
ASIA 47
PACIFIC REGION 47
AFRICA 48
CANADA 48
EUROPE 48
United Kingdom 48
France 48
GLOBAL NATURE OF THE PLASMA INDUSTRY 49
PLASMA DONORS 49
COMMERCIAL NATURE OF PLASMAPHERESIS 50
PLASMA COLLECTION CENTERS IN THE US 50
National Donor Referral Registry 51
PLASMA FRACTIONATORS 51
DISTRIBUTORS/BROKERS 52
BLOOD TYPING 52
METHODS OF TYPING 52
Slide/Tile Testing 53
Tube Testing 53
Microplate Testing Methods 53
AUTOMATED BLOOD TYPING AND SCREENING METHODS 54
Immucor 54
Ortho-Clinical Diagnostics 54
Abbott 55
BLOOD TRANSFUSION TESTING 55
MANUAL CROSSMATCH TECHNIQUES 55
Major Crossmatch 55
Minor Crossmatch 56
Antibody Screening 56
Coombs Test 56
BLOOD TESTING 56
TABLE 22 TESTS ROUTINELY PERFORMED ON BLOOD
DONATIONS 57
TABLE 23 BLOOD TYPE ANTIGEN/ANTIBODY REACTIONS 57
TABLE 24 PROJECTED GLOBAL MARKET FOR BLOOD TYPING AND
TESTING, BY GEOGRAPHICAL AREA, THROUGH 2015 ($
MILLIONS) 58
FIGURE 2 PROJECTED GLOBAL MARKET FOR BLOOD TYPING AND
TESTING, 2010 AND 2015 (%) 58
FIGURE 2 (CONTINUED) 59
BLOOD PROCESSING 59
PREPARATION AND USE OF THE COMPONENTS 59
Red Blood Cells 60
Platelets 60
MARKET PARTICIPANTS 60
Haemonetics 60
PCS2 61
TCD Total Containment Unit 61
MCS+ 8150 System 61
Cell Saver System 61
OrthoPAT System 61
ACP 215 System 61
Fenwal 62
Autopheresis-C 62
Alyx Component Collection System 62
CS-3000 Plus Blood Cell Separator 62
Amicus Separator 62
Gambro BCT 63
Trima Accel Collection System 63
COBE Spectra Apheresis System 63
The Elutra Cell Separation System 63
GLOBAL BLOOD MANAGEMENT ISSUES 63
AVAILABILITY 63
BLOODLESS SURGERY 64
FEWER OPEN SURGICAL PROCEDURES 65
SAFETY ISSUES/RISK MANAGEMENT 65
Improved Donor Screening 65
Better Viral Testing 66
Encouraging Repeat Donors 66
Improving Viral Inactivation Processes 66
Selective Use of Blood Derivative Products 66
CHAPTER FIVE: BLOOD THERAPEUTICS 67
TABLE 25 BLOOD PRODUCTS TRANSFUSED FOR THEIR
THERAPEUTIC USES 67
WHOLE BLOOD 67
PACKED RED BLOOD CELLS 68
PLATELETS 68
LEUKOCYTES 69
FRESH FROZEN PLASMA 69
SELECTED USES OF FFP 70
CRYOPRECIPITATE 70
WASHED CELLS 70
DEGLYCEROLIZED CELLS 71
OTHER BLOOD COMPONENTS 71
GRANULOCYTES 71
GAMMA-IRRADIATED BLOOD 71
DISTRIBUTION OF COLLECTED BLOOD 71
TABLE 26 AVERAGE COST OF TRANSFUSION TO THE PATIENT IN
THE US, BY PRODUCT TYPE, 2011 ($) 72
PLASMA AND PLASMA-DERIVED PRODUCTS 72
GLOBAL PLASMA COLLECTION 73
PLASMA MARKET SIZE 73
TABLE 27 PROJECTED GLOBAL PLASMA MARKET, THROUGH 2015
($ MILLIONS) 73
FIGURE 3 PLASMA PRODUCTS MARKET SHARE, BY COMPANY,
2010 (%) 74
COAGULATION FACTORS 74
IMMUNE SERUM GLOBULIN/INTRAMUSCULAR IMMUNE
GLOBULINS (IMIG)/INTRAVENOUS IMMUNE
GLOBULIN (IVIG) 75
Market Shortages of IVIG 75
FACTOR VIII 76
FACTOR IX AND FACTOR IX COMPLEX 76
FACTOR VIIA 76
FIBRIN/THROMBIN 76
THERAPEUTIC APHERESIS 77
CLOTTING FACTORS 77
TABLE 28 BLOOD CLOTTING FACTORS 78
Hemophilia 78
TABLE 29 GLOBAL PREVALENCE OF HEMOPHILIA, 2009
(MILLIONS) 79
CLOTTING FACTOR MARKET DEMAND AND MARKET
SIZE 79
TABLE 30 PROJECTED GLOBAL MARKET FOR PLASMA-DERIVED
AND RECOMBINANT CLOTTING FACTORS, THROUGH 2015 ($
MILLIONS) 80
Factor VIII 80
TABLE 31 FDA-APPROVED FACTOR VIII PRODUCTS 81
Advate 81
Helixate FS 82
Kogenate FS 82
Recombinate 82
ReFacto 82
GLOBAL SHARE IN FACTOR VIII MARKET 83
FIGURE 4 LEADING FACTOR VIII MANUFACTURERS, 2010 (%) 83
TABLE 32 PROJECTED US MARKET FOR FACTOR VIII, THROUGH
2015 ($ MILLIONS) 84
Factor IX 84
TABLE 33 PROJECTED GLOBAL MARKET FOR FACTOR IX,
THROUGH 2015 ($ MILLIONS) 84
TABLE 34 FDA-APPROVED FACTOR IX PRODUCTS, 2009 85
Factor VIIa 85
TABLE 35 PROJECTED GLOBAL MARKET FOR FACTOR VIIA,
THROUGH 2015 ($ MILLIONS) 86
FIGURE 5 GLOBAL SALES OF FACTOR VIIA, BY GEOGRAPHIC
REGION, 2010 (%) 86
FIGURE 5 (CONTINUED) 87
ALBUMIN 87
RECOMBINANT HUMAN ALBUMIN 88
Recombinant Human Albumin Market 88
ALBUMIN MARKET DYNAMICS 88
TABLE 36 CURRENTLY MARKETED HUMAN ALBUMIN AND PPF
PRODUCTS, 2010 89
ALBUMIN AND PPF MARKET SIZE 89
TABLE 37 PROJECTED GLOBAL MARKET FOR HUMAN SERUM
ALBUMIN AND PPF, THROUGH 2015 ($ MILLIONS) 90
PROTHROMBIN COMPLEX CONCENTRATE 90
TABLE 38 FDA-APPROVED PROTHROMBIN COMPLEX
CONCENTRATE PRODUCTS 90
FIBRIN SEALANTS AND THROMBIN 91
FIBRIN-BASED WOUND CLOSURE PRODUCT MARKET 91
Cyanoacrylate 92
TABLE 39 PROJECTED GLOBAL MARKET FOR FIBRIN-BASED
SEALANTS, THROUGH 2015 ($ MILLIONS) 92
ANTITHROMBIN TREATMENTS 93
TREATMENTS FOR HD 93
Plasma Antithrombin 93
Recombinant Human Antithrombin (rhAT) 93
Talecris Biotherapeutics 93
GTC Biotherapeutics 94
GlaxoSmithKline (Arixtra) 94
GLOBAL MARKET FOR ANTITHROMBIN 94
TABLE 40 PROJECTED GLOBAL MARKET FOR ANTITHROMBIN,
THROUGH 2015 ($ MILLIONS) 95
IMMUNOGLOBULINS 95
TABLE 41 FDA-APPROVED IMMUNOGLOBULINS 96
TABLE 42 PROJECTED GLOBAL MARKET FOR
IMMUNOGLOBULINS, THROUGH 2015 ($ MILLIONS) 97
POLYVALENT IMMUNOGLOBULINS 97
TABLE 43 SELECTED CONDITIONS TREATED WITH IVIG 98
The Projected Global IVIG Therapy Market 98
TABLE 44 PROJECTED GLOBAL MARKET FOR IVIG THERAPY,
THROUGH 2015 ($ MILLIONS) 98
HYPERIMMUNE IMMUNOGLOBULINS 99
TABLE 45 FDA-APPROVED HYPERIMMUNE IMMUNOGLOBULINS 99
TABLE 45 (CONTINUED) 100
GLOBAL MARKET FOR HYPERIMMUNOGLOBULINS 100
TABLE 46 PROJECTED GLOBAL MARKET FOR
HYPERIMMUNOGLOBULINS, THROUGH 2015 ($ MILLIONS) 101
FIGURE 6 GLOBAL MARKET FOR IMMUNOGLOBULINS, BY TYPE,
2009 AND 2015 ($ MILLIONS) 101
Respiratory Syncytial Virus (RSV) 102
TABLE 47 PROJECTED GLOBAL MARKET FOR RSV
IMMUNOGLOBULIN, THROUGH 2015 ($ MILLIONS) 102
Alpha-1-Proteinase Inhibitor 102
TABLE 48 PROJECTED GLOBAL MARKET FOR ALPHA-1-
PROTEINASE INHIBITOR, THROUGH 2015 ($ MILLIONS) 103
Rho(D) 103
TABLE 49 PROJECTED GLOBAL MARKET FOR RHO(D), THROUGH
2015 ($ MILLIONS) 104
Hepatitis B Immune Globulin 104
TABLE 50 PROJECTED GLOBAL MARKET FOR HBV
IMMUNOGLOBULINS, THROUGH 2015 ($ MILLIONS) 104
CMV Immunoglobulin 105
TABLE 51 PROJECTED GLOBAL MARKET FOR CMV
IMMUNOGLOBULIN, THROUGH 2015 ($ MILLIONS) 105
Tetanus Immunoglobulin 105
TABLE 52 PROJECTED GLOBAL MARKET FOR TETANUS
IMMUNOGLOBULIN, THROUGH 2015 ($ MILLIONS) 106
Rabies Immunoglobulin 106
TABLE 53 PROJECTED GLOBAL MARKET FOR RABIES
IMMUNOGLOBULIN, THROUGH 2015 ($ MILLIONS) 107
Varicella Immunoglobulin 107
Vaccinia Immune Globulin Intravenous (VIG) 107
CHAPTER SIX: BLOOD INDUSTRY REGULATION 108
REGULATION OF THE US BLOOD BUSINESS 108
TABLE 54 US FEDERAL ORGANIZATIONS RESPONSIBLE FOR
BLOOD SAFETY 108
TABLE 54 (CONTINUED) 109
STATUTORY AUTHORITY OF THE FDA 109
Center for Biologics Evaluation and Research 109
Office of Regulatory Affairs (ORA) 110
Office of Biologics, the Division of Blood and Blood
Products 110
TABLE 55 FDA AUTHORITY IN REGULATING BLOOD BANKING
AND BLOOD PRODUCTS 111
MAJOR REGULATIONS AND POLICIES FOR THE US BLOOD
SUPPLY 111
THE CLINICAL LABORATORY IMPROVEMENT ACT OF
1988 (CLIA) 111
THE FDA APPROACH TO BLOOD REGULATION 112
TABLE 56 MAIN BLOOD REGULATION ISSUES IDENTIFIED BY THE
FDA 113
TEAM BIOLOGICS 113
REGULATION IMPLEMENTATION 114
TABLE 57 14 MAJOR AREAS OF CONCERN FOR INSPECTING
BLOOD FACILITIES 114
TABLE 57 (CONTINUED) 115
OTHER US ORGANIZATIONS INVOLVED IN BLOOD
REGULATION 115
National Heart, Lung, and Blood Institute (NHLBI) 115
Blood Disease and Resources Program 116
Occupational Safety and Health Administration (OSHA) 116
Centers for Medicare and Medicaid Services (CMS) 116
State Regulatory Agencies 117
VOLUNTARY REGULATION BY PROFESSIONAL AND
TRADE ASSOCIATIONS 117
American Association of Blood Banks (AABB) 117
National Donor Deferral Registry (NDDR) 118
Quality Plasma Program 118
America's Blood Centers (ABC) 119
Plasma Products Therapeutics Association (PPTA 119
EUROPEAN UNION (EU) REGULATIONS 119
THE INTERNATIONAL SOCIETY FOR BLOOD TRANSFUSION
(ISBT) 128 120
REGULATION IN JAPAN 120
REGULATION IN CHINA 120
THE FUTURE OF GLOBAL BLOOD REGULATIONS 121
CHAPTER SEVEN: BLOOD PRODUCTS TECHNOLOGY 122
FRACTIONATION METHODS 122
COHN METHOD 122
ADVANCED FRACTIONATION METHODS 122
Chromatography Methods 123
AMPLIFICATION METHODS 123
POLYMERASE CHAIN REACTION 123
NUCLEI AMPLIFICATION TECHNOLOGY 123
IMMUNOASSAY METHODS 124
ENZYME IMMUNOASSAY 124
Basic EIA 124
FIGURE 7 THE BASIC ENZYME IMMUNOASSAY (EIA) PROCESS 125
Second Antibody Precipitation Method 125
Double Antibody Sandwich Method 126
Reverse Sandwich Method 126
Reverse Sandwich Inhibition Method 126
AGGLUTINATION 126
CHEMILUMINESCENCE (CHLIA) 127
ENDOTOXIN TESTING 127
CHAPTER EIGHT: BLOOD RESEARCH AND DEVELOPMENT 128
JEROME H HOLLAND LABORATORY (ARC) 128
NATIONAL BLOOD FOUNDATION (NBF) 128
CENTER FOR BLOOD RESEARCH (CBR) 128
STEM CELL RESEARCH AT THE CBR 129
FDA BLOOD RESEARCH PRODUCTS 130
TABLE 58 SELECTED BLOOD RESEARCH FROM FDA, 2010 130
TABLE 58 (CONTINUED) 131
STEM CELL DEVELOPMENTS OUTSIDE THE US 132
NOVEL BIOENGINEERING TECHNOLOGIES 132
RESEARCH ON ALZHEIMER'S AND CIRRHOSIS OF THE LIVER 133
CURRENT RESEARCH ON BLOOD SUBSTITUTES 133
EMERGING PLATELET TREATMENTS 134
RED BLOOD CELLS 135
THE VETERINARY BLOOD MARKET 136
TABLE 59 REGIONAL US VETERINARY BLOOD BANKS 136
CHAPTER NINE: PATENTS 137
TABLE 60 RECENTLY ISSUED PATENTS, JANUARY 2005 THROUGH
JANUARY 2011 137
TABLE 61 PATENTS BY COMPANY ASSIGNEE, JANUARY 2005
THROUGH JANUARY 2011 138
TABLE 62 PATENTS ISSUED BETWEEN 2005 AND 2011: PLASMA
DERIVATIVES 139
TABLE 63 PATENTS ISSUED BETWEEN 2005 AND 2011: BLOOD
COLLECTION, SAMPLING EQUIPMENT 140
TABLE 63 (CONTINUED) 141
TABLE 63 (CONTINUED) 142
TABLE 63 (CONTINUED) 143
TABLE 63 (CONTINUED) 144
TABLE 63 (CONTINUED) 145
TABLE 64 PATENTS ISSUED BETWEEN 2005 AND 2011: BLOOD
FILTRATION, FLUID SEPARATION EQUIPMENT 146
TABLE 64 (CONTINUED) 147
TABLE 64 (CONTINUED) 148
TABLE 64 (CONTINUED) 149
TABLE 64 (CONTINUED) 150
TABLE 64 (CONTINUED) 151
TABLE 64 (CONTINUED) 152
TABLE 65 PATENTS ISSUED BETWEEN 2005 AND 2011: BLOOD
VOLUME ENHANCERS 153
TABLE 66 PATENTS ISSUED BETWEEN 2005 AND 2011: NUCLEIC
ACID AMPLIFICATION 153
TABLE 66 (CONTINUED) 154
TABLE 67 PATENTS ISSUED BETWEEN 2005 AND 2011: BLOOD
TREATMENTS 155
TABLE 67 (CONTINUED) 156
TABLE 68 PATENTS ISSUED BETWEEN 2005 AND 2011:
ADDITIONAL POTENTIAL PRODUCTS 157
TABLE 68 (CONTINUED) 158
TABLE 68 (CONTINUED) 159
TABLE 68 (CONTINUED) 160
CHAPTER TEN: COMPANY PROFILES 161
ABBOTT LABORATORIES 161
BUSINESS OVERVIEW 161
FINANCIALS 161
PRODUCTS 161
ALPHA THERAPEUTICS CORP (SEE GRIFOLS) 162
AMERICA'S BLOOD CENTERS 162
BUSINESS OVERVIEW 162
FINANCIALS 162
PRODUCTS 163
AMERICAN ASSOCIATION OF BLOOD BANKS (AABB) 163
BUSINESS OVERVIEW 163
FINANCIALS 163
PRODUCTS 163
AMERICAN RED CROSS 164
BUSINESS OVERVIEW 164
FINANCIALS 164
PRODUCTS 164
BAXTER INTERNATIONAL, INC 165
BUSINESS OVERVIEW 165
FINANCIALS 165
PRODUCTS 165
BECKMAN COULTER 166
BUSINESS OVERVIEW 166
FINANCIALS 167
PRODUCTS 167
BECTON DICKINSON AND COMPANY 167
BUSINESS OVERVIEW 167
FINANCIALS 167
PRODUCTS 168
BIO PRODUCTS LABORATORIES 168
BUSINESS OVERVIEW 168
FINANCIALS 168
PRODUCTS 168
BIO-RAD LABORATORIES, INC 169
BUSINESS OVERVIEW 169
FINANCIALS 169
PRODUCTS 169
BIOTEST AG 169
BUSINESS OVERVIEW 170
FINANCIALS 170
PRODUCTS 170
CARIDIANBCT INC 170
BUSINESS OVERVIEW 171
FINANCIALS 171
PRODUCTS 171
CERUS CORP 172
BUSINESS OVERVIEW 172
FINANCIALS 172
PRODUCTS 172
CHIRON CORP (SEE NOVARTIS DIAGNOSTICS) 172
CSL BEHRING 172
BUSINESS OVERVIEW 173
FINANCIALS 173
PRODUCTS 173
DAXOR CORP 174
BUSINESS OVERVIEW 174
FINANCIALS 174
PRODUCTS 174
DIAGAST 175
BUSINESS OVERVIEW 175
FINANCIALS 175
PRODUCTS 175
FENWAL BLOOD TECHNOLOGIES, INC 176
BUSINESS OVERVIEW 176
FINANCIALS 176
PRODUCTS 176
FRESENIUS KABI AG 176
BUSINESS OVERVIEW 177
FINANCIALS 177
PRODUCTS 177
GEN-PROBE, INC 177
BUSINESS OVERVIEW 177
FINANCIALS 178
PRODUCTS 178
GRIFOLS BIOLOGICALS, INC 178
BUSINESS OVERVIEW 178
FINANCIALS 179
PRODUCTS 179
HAEMONETICS, INC 179
BUSINESS OVERVIEW 179
FINANCIALS 180
PRODUCTS 180
Cell Saver System 181
OrthoPAT System 181
ACP 215 System 181
HEMAGEN DIAGNOSTICS, INC 181
BUSINESS OVERVIEW 181
FINANCIALS 182
PRODUCTS 182
HEMOCUE AB 182
BUSINESS OVERVIEW 182
FINANCIALS 182
PRODUCTS 182
IMMUCOR, INC 183
BUSINESS OVERVIEW 183
FINANCIALS 183
PRODUCTS 183
KAWASUMI LABORATORIES, INC 183
BUSINESS OVERVIEW 184
FINANCIALS 184
PRODUCTS 184
LUMINEX CORPORATION 184
BUSINESS OVERVIEW 185
FINANCIALS 185
PRODUCTS 185
MACOPHARMA USA (FORMERLY UNITED PHARMA) 186
BUSINESS OVERVIEW 186
FINANCIALS 186
PRODUCTS 186
MASSACHUSETTS PUBLIC HEALTH BIOLOGIC LABS 186
BUSINESS OVERVIEW 186
FINANCIALS 187
PRODUCTS 187
NOVARTIS DIAGNOSTICS 187
BUSINESS OVERVIEW 187
FINANCIAL INFORMATION 188
PRODUCTS 188
NOVO NORDISK 189
BUSINESS OVERVIEW 189
FINANCIALS 189
PRODUCTS 189
OCTAPHARMA 189
BUSINESS OVERVIEW 190
FINANCIALS 190
PRODUCTS 190
OLYMPUS AMERICA, INC (SEE BECKMAN COULTER) 190
ONE LAMBDA, INC 190
BUSINESS OVERVIEW 190
FINANCIALS 191
PRODUCTS 191
ORTHO-CLINICAL DIAGNOSTICS 191
FINANCIALS 192
PRODUCTS 192
PALL CORP 192
BUSINESS OVERVIEW 192
FINANCIALS 192
PRODUCTS 193
PFIZER 193
BUSINESS OVERVIEW 193
FINANCIALS 193
PRODUCTS 194
TALECRIS BIOTHERAPEUTICS 194
BUSINESS OVERVIEW 194
FINANCIALS 194
PRODUCTS 195
TERUMO MEDICAL CORP 195
BUSINESS OVERVIEW 195
FINANCIALS 196
PRODUCTS 196
THERMOGENESIS CORP 196
BUSINESS OVERVIEW 196
FINANCIALS 197
PRODUCTS 197
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Nicolas BombourgReportlinkerEmail: [email protected]US: (805)652-2626Intl: +1 805-652-2626
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