The Global Blood Industry

  • June 2013
  • -
  • BCC Research
  • -
  • 245 pages

STUDY GOAL AND OBJECTIVES

The goal of this study on the blood industry is to describe and analyze the current markets for blood products, blood tests and blood processing equipment, as well as present important new developments affecting every aspect of this industry. In addition, the report provides, an analysis of market value forecasted through 2017 in constant dollars and participating company profiles. The study covers the major aspects of blood and plasma collection/transfusion including autologous donations, apheresis, fractionation, blood salvage and stem cells. The major plasma products such as coagulation factors, human serum albumin, and immunoglobulins are analyzed as well. The scope and character of the blood-testing segment is constantly changing so the impact of new products, technologies and equipment are analyzed.

The study also covers federal regulation of the blood supply, blood system management, an analysis of the companies serving these markets, the international developments in blood banking and related areas, as well as research and patents that will affect the future of the blood industry.

REASONS FOR DOING THIS STUDY

A safe and adequate blood supply is essential to the practice of modern medicine. The U.S. blood industry is safe and blood supplies are usually adequate. New advances, particularly in the area of automation, have enhanced both safety and blood availability and it is the purpose of this study to detail these advances and their impact on the blood industry.

Since BCC first looked at this market in 2001 there have been mergers, consolidations and acquisitions among the major companies as well as advances in technology that have allowed for obtaining more red blood cells from fewer donors. Technological advances have also allowed for greater economies and increased safety in the blood supply.

CONTRIBUTION OF THE STUDY AND INTENDED AUDIENCE

With its broad scope and in-depth analyses, this study will prove to be a valuable resource to anyone involved with or interested in the blood industry. This study will provide information on these areas:
• Structure and current market size of the blood industry with forecasts through 2017.
• Blood usage patterns and trends.
• Government and regulatory controls.
• Impact of disease on the blood industry.
• Major players and their relative market share 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 and disease screening technologies.

Since the study provides business and technical information of a timely nature, it 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 AND FORMAT

This study encompasses the wide range of products and services that comprise the global blood industry marketplace. The U.S. market, the largest in the world, provides the primary market breakdown with supplemental information given for other select regions. The focus of the report is two-fold: first, blood for donation and the components and derived products from this blood and plasma, and second, products used to provide and support collection, processing and transfusion. Excluded from consideration are the clinical blood tests for diseases and conditions not involved in managing blood and plasma products.

METHODOLOGY AND INFORMATION SOURCES

Data for this study were collected using both primary and secondary data research techniques. Literature searches of various sources including scientific, medical and business publications and databases were conducted. On-line databases and government sources were consulted as well. Extensive interviews with industry personnel, scientists, professional and trade organizations, government agency personnel, observers, scientists, and industry professionals were conducted.

Data collected were analyzed to determine specific findings and forecasts. Once these forecasts were obtained they were validated with industry experts. Since some segments of this report are not routinely measured, BCC derived estimates from a variety of analogous sources. Whenever market estimates are derived they are fully noted. It should be pointed out that while many factors were considered in constructing different models, the projections are ultimately speculative. As a composite of the opinions and assessments of interviewees, the author, other analysts, and secondary sources, these projections represent something of a consensus. However, all recognize that the relative importance of selected factors could change at any time with new technologies and new products, and thus change the direction of the market projections. All forecasts use constant 2013 dollars.

ANALYST’S CREDENTIALS

Melissa Elder is an experienced healthcare market analyst, specializing in prescription and over-the-counter pharmaceuticals, medical devices and emerging healthcare technologies. Ms. Elder has over 20 years of experience in the healthcare industry, specializing in market research for the past 15 years. This experience has given her substantial insight into pharmaceutical market analysis. Her work in the medical community, including emergency room medical training and healthcare information system coordination, has enhanced her ability to provide insight into many healthcare markets.

REPORT HIGHLIGHTS

This report provides:
• An overview of the structure and current market size of the global blood industry, including coverage of such segments as blood and plasma collection, blood and plasma processing, blood therapeutic products, plasma therapeutic products, and emerging trends and products
• Analyses of global market trends, with data from 2011 and 2012, and projections of compound annual growth rates (CAGRs) through 2017
• Blood usage patterns and trends
• Government and regulatory controls
• The impact of diseases on the blood industry
• Current product lines and examination of newly emerging products and technologies
• Newly issued patents relating to blood therapeutics, processing, screening, and collection technologies
• Comprehensive company profiles of major players in the industry.

Table Of Contents

TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 2

STUDY GOAL AND OBJECTIVES 2
REASONS FOR DOING THIS STUDY 2
CONTRIBUTION OF THE STUDY AND INTENDED AUDIENCE 2
SCOPE AND FORMAT 3
METHODOLOGY AND INFORMATION SOURCES 3
ANALYST'S CREDENTIALS 3
RELATED BCC REPORTS 4
BCC ON-LINE SERVICES 4
DISCLAIMER 4

CHAPTER 2 SUMMARY 6

MAJOR FINDINGS 6
SUMMARY TABLE GLOBAL MARKET FOR BLOOD PRODUCTS, THROUGH 2017 ($
MILLIONS) 7
SUMMARY FIGURE GLOBAL MARKET FOR BLOOD PRODUCTS, 2010-2017 ($
MILLIONS) 7

CHAPTER 3 OVERVIEW 9

THE BLOOD INDUSTRY 9
BLOOD INDUSTRY TERMS AND ABBREVIATIONS[1] 9
HISTORY OF THE BLOOD INDUSTRY 12
TABLE 1 TIMELINE OF THE BLOOD INDUSTRY 13
BLOOD AND ITS COMPONENTS 14
PLASMA 15
TABLE 2 COMPOSITION OF BLOOD 16
CELLULAR ELEMENTS 16
Red and White Blood Cells 16
Platelets 17
IMMUNOGLOBULIN PRODUCTS 17
THE DANGERS OF TRANSFUSED BLOOD 17
TRANSFUSION ASSOCIATED RISKS 18
Diseases Contracted from Blood Transfusions and Related
Identification Testing 18
TABLE 3 MAJOR DISEASES CONTRACTED FROM BLOOD TRANSFUSIONS, U.S.
ANALYSIS 18
HIV/AIDS 20
TABLE 4 CBER LICENSED HIV DONOR SCREENING TESTS (LAST UPDATED JANUARY
17, 2013) 21
Hepatitis A 22
Hepatitis B 22
TABLE 5 CBER LICENSED SCREENING TESTS FOR HEPATITIS B (LAST UPDATED
JANUARY 17, 2013) 23
Hepatitis C 23
TABLE 6 CBER LICENSED SCREENING TESTS FOR HEPATITIS C (LAST UPDATED
JANUARY 17, 2013) 24
Hepatitis D 24
Hepatitis E 25
Human T-Cell Lymphotropic Virus-(HTLV-I, -II) 25
TABLE 7 CBER LICENSED SCREENING TESTS FOR HTLV-I AND HTLV-II (LAST
UPDATED JANUARY 17, 2013) 26
Cytomegalovirus 26
TABLE 8 CBER LICENSED SCREENING TESTS FOR CMV (LAST UPDATED JANUARY 17,
2013) 27
West Nile Virus 27
TABLE 9 CBER LICENSED SCREENING TESTS FOR WEST NILE (LAST UPDATED
JANUARY 17, 2013) 28
"Mad Cow Disease"-Creutzfeldt-Jakob Disease (CJD) 28
Syphilis 29
TABLE 10 CBER LICENSED SCREENING TESTS FOR SYPHILIS (LAST UPDATED
JANUARY 17, 2013) 29
Chagas Disease 29
Chlamydia Trachomatis 31
TABLE 11 CBER LICENSED SCREENING TESTS FOR CHLAMYDIA (LAST UPDATED
JANUARY 17, 2013) 32
Neisseria Gonorrhea 32
TABLE 12 CBER LICENSED SCREENING TESTS FOR GONORRHEA (LAST UPDATED
JANUARY 17, 2013) 33
EFFORTS TO CREATE A VIRUS-FREE BLOOD SUPPLY 33
Plasma Treatments 33
Trinitrobutyl Phosphate and Sodium Cholate 33
Methylene Blue-treated Plasma 33
Amatosalen HCL-Treated Plasma 34
Platelet Treatments 34
RBCs 35
NEGATIVE REACTIONS FROM BLOOD TRANSFUSIONS 35
BLOOD/PLASMA COMPONENT RISKS 36

CHAPTER 4 THE BLOOD MANAGEMENT SYSTEM- BLOOD COLLECTION, PROCESSING
AND USE 39

BLOOD COLLECTION 39
TYPES OF BLOOD ESTABLISHMENTS AND BLOOD FACILITIES 39
Major Facilities 39
Auxiliary Facilities 40
Transfusion Services 40
ORGANIZATIONS COLLECTING BLOOD 40
TABLE 13 FDA REGISTERED BLOOD ESTABLISHMENTS BY STATE* AND
POSSESSION 41
For-Profit Blood Collection 43
Plasma Collection Centers 43
National Donor Deferral Registry 43
Non-Profit Blood Collection 43
American Red Cross 44
Community Blood Banks 44
Hospitals 44
Other Blood Collection Sites 45
BLOOD DONATION DEMOGRAPHICS 45
Global Demographic Trends 45
TABLE 14 ESTIMATED GLOBAL POPULATION AND GROWTH RATE BY SELECTED
AGE GROUP AND SELECTED YEARS, THROUGH 2030 (MILLIONS) 46
FIGURE 1 ESTIMATED GLOBAL POPULATION BY SELECTED AGE GROUP AND
SELECTED YEARS, 2000-2030 (MILLIONS) 46
TABLE 15 GLOBAL POPULATION BY SELECTED COUNTRY, THROUGH 2015
(MILLIONS) 47
FIGURE 2 GLOBAL POPULATION BY SELECTED COUNTRY, 2010 AND 2015
(MILLIONS) 47
DONOR RECRUITMENT AND REGULATIONS 47
BLOOD SCREENING AND EVALUATION 48
METHODS FOR COLLECTING BLOOD FROM A DONOR 48
Manual Collection 48
Automated Collection 49
Plasmapheresis 49
Plateletpheresis 50
Leukopheresis 50
Red Blood Cell Apheresis 50
PLASMA COLLECTION 50
Commercial Nature of Plasmapheresis 51
Global Nature of the Plasma Industry 51
Plasma Fractionators 51
Distributors/Brokers 52
BLOOD TYPING AND TESTING FOR DISEASES 52
Blood Typing 52
TABLE 16 TESTS ROUTINELY PERFORMED ON BLOOD DONATIONS 53
TABLE 17 BLOOD TYPE ANTIGEN/ANTIBODY REACTIONS 54
Methods of Typing 54
Manual Blood Typing Methods 54
Slide/Tile Testing 54
Tube Testing 54
Microplate 55
Automated Blood Typing and Screening Methods 55
Blood Testing 55
Blood Storage 56
BLOOD PROCESSING 56
Preparation and Use of the Components 56
Red Blood Cell Components 56
Platelets 56
Plasma 57
BLOOD TRANSFUSIONS 57
Transfusion in the U.S. 57
Testing before Transfusion 57
Manual Cross-Match Techniques 57
Major Cross-Match 57
Minor Cross-Match 58
Antibody Screen 58
Coombs Test 58
TYPES OF TRANSFUSIONS 58
Whole Blood 58
Packed Red Blood Cells 59
Platelets 59
Leukocytes 60
Fresh Frozen Plasma (FFP) 60
TABLE 18 SELECTED USES OF FFP 60
Cryoprecipitate 61
Coagulation Factors 61
TABLE 19 LISTING OF BLOOD PRODUCTS FOR THERAPEUTIC USE 61
Immune Serum Globulin/IMIG/IGIV 62
Factor VIII 62
Factor IX and Factor IX Complex 62
Factor VIIa 63
Fibrin/Thrombin 63
Therapeutic Apheresis 63
BLOOD MANAGEMENT ISSUES 63
AVAILABILITY ISSUES 63
BLOODLESS SURGERY 64
Bloodless Medicine and Surgery Hospital Directory 64
SAFETY ISSUES: RISK MANAGEMENT 71
TABLE 20 FACTORS TO REDUCE RISKS OF TRANSFUSION- ASSOCIATED DISEASES 71
Better Donor Screening 72
Better Viral Screening Tests 72
Get More Repeat Donors 72
Develop Better Viral Inactivation Processes 72
Selective Use of Blood Derivative Products 72
BLOOD TRANSFUSION FATALITIES 73
TABLE 21 TRANSFUSION-RELATED FATALITIES BY COMPLICATION, FY 2008-FY 2012 73
TABLE 22 FATALITIES NOT RELATED TO TRANSFUSION OR TRANSFUSION NOT
RULED OUT, FY2008-FY2012 74
TABLE 23 POST-DONATION "NOT RULED OUT" FATALITY REPORTS BY DONATED
PRODUCT, FY2008 THROUGH FY2012 74

CHAPTER 5 REGULATION OF THE BLOOD BUSINESS 76

REGULATION OF THE U.S. BLOOD BUSINESS 76
TABLE 24 FEDERAL ORGANIZATIONS RESPONSIBLE FOR U.S. BLOOD SAFETY 76
STATUTORY AUTHORITY OF THE FDA 77
Center for Biologics Evaluation and Research 77
chapter Office of Regulatory Affairs (ORA) 77
Office of Biologics, The Division of Blood and Blood Products 78
TABLE 25 FDA AUTHORITY IN REGULATING BLOOD BANKING AND BLOOD
PRODUCTS 79
THE MAJOR REGULATIONS AND POLICY MATTERS CONCERNING THE U.S.
BLOOD SUPPLY 79
The Clinical Laboratory Improvement Act of 1988 (CLIA) 79
The FDA'S Five Layers 80
Donor Screening 80
Blood Testing 80
Donor Deferral Lists 81
Quarantine 81
Problems and Deficiencies 81
The FDA Blood Action Plan 81
Team Biologics 81
Fuel, Phone Excise Taxes 82
HOW REGULATIONS GET IMPLEMENTED 82
Inspecting Blood Banks and Plasma Collection Facilities 82
TABLE 26 MAJOR AREAS OF CONCERN FOR INSPECTING BLOOD FACILITIES 83
OTHER ORGANIZATIONS INVOLVED IN BLOOD REGULATION 83
National Heart, Lung, and Blood Institute (NHLBI) 83
Blood Diseases and Resources Program 84
Occupational Safety and Health Administration (OSHA) 85
Health Care Financing Administration (HCFA) 85
The Department of Defense 85
State Regulatory Agencies 86
VOLUNTARY REGULATION BY PROFESSIONAL AND TRADE ASSOCIATIONS 86
American Association of Blood Banks 86
PPTA: Plasma Protein Therapeutics Association 87
America's Blood Centers (ABC) 88
THE EUROPEAN UNION (EU) BLOOD DIRECTIVE 88
The International Society for Blood Transfusion - ISBT 128 88
THE FUTURE OF BLOOD REGULATION 89

CHAPTER 6 THE GLOBAL BLOOD AND BLOOD PRODUCTS MARKET OVERVIEW 91

DRIVING FORCES OF THE INDUSTRY 91
FIGURE 3 VARIABLES INFLUENCING THE DYNAMICS OF DEMAND FOR BLOOD FOR
TRANSFUSION 91
MARKET SUMMARY 92
FIGURE 4 BLOOD MARKET COST AND PRICING ANALYSIS 92
PRICING OF BLOOD 93
TABLE 27 ESTIMATED U.S. COST OF BLOOD COMPONENTS, THROUGH 2012 ($) 94
National Blood Exchange (NBE) 94
RBCs and Leuko-reduced RBCs 95
Platelets 95
Random Donor Platelets 95
Fresh Frozen Plasma (FFP) 95
Cryoprecipitate 96
Washed Cells 96
Deglycerolized Cells 96
Granulocytes 96
Gamma-Irradiated Blood 96
PATTERNS OF TRANSFUSION PROCEDURES 96
Leuko-reduction 97
Impact of Autologous Donations 97
Types of Autologous Transfusions 98
Risks of PABD 99

CHAPTER 7 BLOOD INDUSTRY ANALYSIS 101

GLOBAL MARKETS FOR WHOLE BLOOD COLLECTIONS 101
LOCAL EFFORTS AND IMPROVEMENTS 101
Africa 102
South Africa 102
Asia 103
China 103
India 103
Japan 104
Pakistan 104
Islamic Republic of Iran 104
Sri Lanka 104
Vietnam 104
Europe 105
Britain 105
France 105
Germany 105
Russia 105
Netherlands 106
Switzerland 106
Turkey 106
North America and Caribbean 106
Canada 106
Haiti 107
Oceana Region 107
Australia 107
New Zealand 107
Cook Islands 107
South America 107
Argentina 107
Bolivia 108
Brazil 108
U.S. BLOOD COLLECTION DATA 108
TABLE 28 U.S. BLOOD COLLECTION AND TRANSFUSION DATA, THROUGH 2017
(MILLION UNITS/PINTS) 109
FIGURE 5 U.S. BLOOD COLLECTION AND TRANSFUSION DATA, 2007-2017 (MILLION
UNITS/PINTS) 109
GLOBAL MARKETS FOR SOURCE PLASMA COLLECTIONS 110
TABLE 29 PLASMA COLLECTIONS FOR THE U.S. AND OTHER MARKETS, THROUGH
2017 ($ BILLIONS, MILLIONS ML) 110
FIGURE 6 PLASMA COLLECTIONS FOR THE U.S. AND OTHER MARKETS, 2010-2017
(MILLION ML) 110
GLOBAL MARKETS FOR BLOOD THERAPEUTICS 111
TABLE 30 PLASMA PRODUCTS MARKET FOR THE U.S. AND OTHER MARKETS,*
THROUGH 2017 ($ BILLIONS) 111
FIGURE 7 PLASMA PRODUCTS MARKET FOR THE U.S. AND OTHER MARKETS,*
2010-2017 ($ BILLIONS) 111
PLASMA AND PLASMA-DERIVED PRODUCTS 112
Plasma Therapeutic Products 112
TABLE 31 GLOBAL MARKET SIZE OF PLASMA THERAPEUTIC DERIVATIVES BY TYPE,
THROUGH 2017 ($ MILLIONS) 112
FIGURE 8 GLOBAL MARKET SIZE OF PLASMA THERAPEUTIC DERIVATIVES BY TYPE,
2010-2017 (MILLIONS) 112
ALBUMIN AND PLASMA PROTEIN FRACTION (PPF) 113
FDA Notification Regarding Safety of Albumin Administration in the
Critically Ill 114
Recombinant Human Albumin 114
Albumin Market Dynamics 114
TABLE 32 CURRENTLY MARKETED ALBUMIN AND PLASMA PROTEIN FRACTION (PPF)
PRODUCTS (%) 115
Albumin and PPF Market Size 116
TABLE 33 GLOBAL MARKET FOR HUMAN SERUM ALBUMIN AND PPF BY REGION,
THROUGH 2017 ($ MILLIONS) 116
FIGURE 9 GLOBAL MARKET FOR HUMAN SERUM ALBUMIN AND PPF BY REGION,
2010-2017 (MILLIONS) 116
Albumin and PPF Market Trends 117
CLOTTING FACTORS 118
TABLE 34 EXAMPLES OF COMMON BLOOD CLOTTING FACTORS 118
Hemophilia 119
TABLE 35 WORLDWIDE AND U.S. HEMOPHILIA STATISTICS, 2012 ESTIMATES 120
Market Demand and Market Size 120
TABLE 36 GLOBAL MARKET FOR PLASMA-DERIVED AND RECOMBINANT CLOTTING
FACTORS, THROUGH 2017 (REVENUES IN $ MILLIONS) 120
FIGURE 10 GLOBAL MARKET FOR PLASMA-DERIVED AND RECOMBINANT CLOTTING
FACTORS, 2010-2017 ($ MILLIONS) 121
TABLE 37 GLOBAL MARKET FOR PLASMA-DERIVED AND RECOMBINANT CLOTTING
FACTORS BY REGION, THROUGH 2017 ($ MILLIONS) 121
FIGURE 11 GLOBAL MARKET FOR PLASMA-DERIVED AND RECOMBINANT CLOTTING
FACTORS BY REGION, 2010-2017 (MILLIONS) 121
Factor VIII 122
TABLE 38 FDA APPROVED FACTOR VIII PRODUCTS 122
TABLE 39 GLOBAL MARKET SHARE OF FACTOR VIII COMPANIES, 2012 125
FIGURE 12 GLOBAL MARKET SHARE OF FACTOR VIII COMPANIES, 2012 (%) 125
FIGURE 13 GLOBAL MARKET SHARE OF FACTOR VIII BY HUMAN AND
RECOMBINANT PRODUCTS, 2012 (%) 125
Factor IX 126
TABLE 40 FDA APPROVED FACTOR IX PRODUCTS 126
TABLE 41 GLOBAL MARKET SHARE OF FACTOR IX COMPANIES, 2012 (%/MILLIONS) 127
FIGURE 14 GLOBAL MARKET SHARE OF FACTOR IX COMPANIES, 2012 (%) 127
Factor VIIa 127
Biosimilar Factor VIIa Development 128
TABLE 42 FDA APPROVED FACTOR VII PRODUCTS 128
TABLE 43 GLOBAL MARKET SHARE OF FACTOR IX COMPANIES, 20121
(PERCENT/MILLIONS) 129
FIGURE 15 GLOBAL MARKET SHARE OF FACTOR IX COMPANIES, 2012 (%) 129
Prothrombin Complex Concentrates 129
TABLE 44 FDA APPROVED PROTHROMBIN COMPLEX CONCENTRATE PRODUCTS 130
IMMUNOGLOBULINS 130
IVIG 131
TABLE 45 SELECTED CONDITIONS TREATED BY IVIG 131
TABLE 46 FDA APPROVED IMMUNOGLOBULINS 132
Hyperimmunes 133
TABLE 47 FDA APPROVED HYPERIMMUNE IMMUNOGLOBULINS 133
Other 135
IMIG 135
Immunoglobulin Market Size 135
TABLE 48 GLOBAL MARKET FOR IMMUNOGLOBULINS, THROUGH 2017 ($ MILLIONS) 136
FIGURE 16 GLOBAL MARKET FOR IMMUNOGLOBULINS, 2010-2017 (MILLIONS) 136
TABLE 49 GLOBAL MARKET FOR IMMUNOGLOBULINS BY REGION, THROUGH 2017
($ MILLIONS) 136
FIGURE 17 GLOBAL MARKET FOR IMMUNOGLOBULINS BY REGION, THROUGH 2017
($ MILLIONS) 137
RSV 137
CMV Immunoglobulin 137
Hepatitis B Immune Globulin 138
Rho(D) Immunoglobulin 138
Tetanus Immunoglobulin (TIG) 138
Rabies Immunoglobulin 138
Varicella Immunoglobulin 139
Vaccinia Immune Globulin Intravenous (VIG) 139
Alpha-1-Proteinase Inhibitor 139
FIBRIN SEALANTS AND THROMBIN 140
TABLE 50 GLOBAL MARKET FOR FIBRIN SEALANTS AND THROMBIN, THROUGH
2017 ($ MILLIONS) 140
FIGURE 18 GLOBAL MARKET FOR FIBRIN SEALANTS AND THROMBIN, 2010-2017 ($
MILLIONS) 141
TABLE 51 GLOBAL MARKET FOR FIBRIN SEALANTS AND THROMBIN BY REGION,
THROUGH 2017 ($ MILLIONS) 141
FIGURE 19 GLOBAL MARKET FOR FIBRIN SEALANTS AND THROMBIN BY REGION,
2010-2017 ($ MILLIONS) 142
ANTITHROMBIN III 142
TABLE 52 GLOBAL MARKET FOR ANTITHROMBIN, THROUGH 2017 ($ MILLIONS) 143
FIGURE 20 GLOBAL MARKET FOR ANTITHROMBIN, 2010-2017 ($ MILLIONS) 143
TABLE 53 GLOBAL MARKET FOR ANTITHROMBIN BY REGION, THROUGH 2017 ($
MILLIONS) 143
FIGURE 21 GLOBAL MARKET FOR ANTITHROMBIN BY REGION, 2010-2017 ($
MILLIONS) 143
GLOBAL MARKETS FOR BLOOD TYPING AND SCREENING PRODUCTS 144
TABLE 54 GLOBAL MARKETS FOR BLOOD TYPING AND SCREENING PRODUCTS,
THROUGH 2017 ($ MILLIONS) 144
FIGURE 22 GLOBAL MARKETS FOR BLOOD TYPING AND SCREENING PRODUCTS,
2010-2017 ($ MILLIONS) 144
TABLE 55 GLOBAL MARKETS FOR BLOOD TYPING AND SCREENING PRODUCTS,
THROUGH 2017 ($ MILLIONS) 146
FIGURE 23 GLOBAL MARKETS FOR BLOOD TYPING AND SCREENING PRODUCTS,
2010-2017 ($ MILLIONS) 146
TYPES OF TESTING 146
POLYMERASE CHAIN REACTION (PCR) AMPLIFICATION 147
TABLE 56 SELECTED PCR DONOR SCREENING TESTS 147
NUCLEIC ACID AMPLIFICATION TEST (NAT) 147
TABLE 57 SELECTED NAT DONOR SCREENING TESTS 148
IMMUNOASSAY 148
TABLE 58 SELECTED IMMUNOASSAY DONOR SCREENING TESTS 149
MARKET SIZE BLOOD TESTING PRODUCTS FOR DONOR SCREENING 150
TABLE 59 THE GLOBAL BLOOD DONOR SCREENING TESTING MARKET BY TYPE OF
TESTS, THROUGH 2017 ($ MILLIONS) 150
FIGURE 24 GLOBAL BLOOD DONOR SCREENING TESTING MARKET BY TYPE,
2010-2017 ($ MILLIONS) 150
MARKET PARTICIPANTS DONOR SCREENING PRODUCTS 151
TABLE 60 SELECTED SUPPLIERS: MAJOR DONOR SCREENING TEST AREAS 151
BLOOD TYPING 152
MARKET SIZE 0F BLOOD TYPING 152
TABLE 61 THE GLOBAL MARKET FOR BLOOD TYPING INSTRUMENTS AND SUPPLIES
BY TYPE, THROUGH 2017 ($ MILLIONS) 153
FIGURE 25 THE GLOBAL MARKET FOR BLOOD TYPING INSTRUMENTS AND SUPPLIES
BY TYPE, 2010-2017 ($ MILLIONS) 153
MARKET STRUCTURE AND PARTICIPANTS 153
Manual Typing Methods 154
Automated Blood Typing 154
Immucor 154
Ortho 155
Olympus 155
GLOBAL MARKETS FOR BLOOD PROCESSING EQUIPMENT AND ASSOCIATED
PRODUCTS 156
TABLE 62 GLOBAL MARKET FOR BLOOD COLLECTION AND PROCESSING
EQUIPMENT AND CONSUMABLES, THROUGH 2017 ($ MILLIONS) 156
FIGURE 26 GLOBAL MARKET FOR BLOOD COLLECTION AND PROCESSING
EQUIPMENT AND CONSUMABLES, 2010-2017 ($ MILLIONS) 156
TABLE 63 GLOBAL MARKET FOR BLOOD AND PLASMA COLLECTION AND
TRANSFUSION PRODUCTS, THROUGH 2017 ($ MILLIONS) 158
FIGURE 27 GLOBAL MARKET FOR BLOOD AND PLASMA COLLECTION AND
TRANSFUSION PRODUCTS, 2010-2017 ($ MILLIONS) 158
COLLECTION PRODUCTS 158
TABLE 64 GLOBAL MARKET FOR COLLECTION PRODUCTS BY TYPE, THROUGH 2017
($ MILLIONS) 159
FIGURE 28 GLOBAL MARKET FOR COLLECTION PRODUCTS BY TYPE, 2010-2017 ($
MILLIONS) 159
BLOOD AND PLASMA COLLECTION SUPPLIES 159
Plasma Collection Sets 160
Blood Bags 160
PLASMA AND BLOOD COLLECTION EQUIPMENT 160
Blood Salvage 161
Other Collection Equipment 161
MARKET PARTICIPANTS 161
Haemonetics 161
PCS2 161
Cymbal 161
MCS+ 8150 System 161
MCS+ 9000 System 162
Cell Saver Systems 162
OrthoPAT System 162
ACP 215 System 162
Fresenius Kabi/Fenwal, Inc. 162
Apheresis Collections 163
Autopheresis-C 163
Alyx Component Collection System 163
Amicus Separator 163
Aurora 163
Terumo BCT 163
TRANSFUSION PRODUCTS 164
TABLE 65 GLOBAL MARKET FOR TRANSFUSION PRODUCTS BY TYPE, THROUGH
2017 ($ MILLIONS) 164
FIGURE 29 GLOBAL MARKET FOR TRANSFUSION PRODUCTS BY TYPE, 2010-2017 ($
MILLIONS) 164
Transfusion SetsIn 165
Blood Filter Market 165
Transfusion Equipment 165
Accessories 165

CHAPTER 8 BLOOD RESEARCH AND DEVELOPMENT 167

DEDICATED BLOOD RESEARCH FACILITIES 167
JEROME H. HOLLAND LABORATORY (ARC) 167
NATIONAL BLOOD FOUNDATION (NBF) 167
CENTER FOR BLOOD RESEARCH (CBR) 167
BLOOD SUBSTITUTES 169
FIBRIN SEALANT AND GLUE 170
ALBUMIN AND IVIG TREATMENT FOR ALZHEIMER’S DISEASE 170
THE VETERINARY BLOOD MARKET 170
TABLE 66 REGIONAL VETERINARY BLOOD BANKS 171

CHAPTER 9 CORPORATE PROFILES 174

ABBOTT LABORATORIES 174
TABLE 67 ABBOTT'S SALES HISTORY, 2010-2012 ($ MILLIONS) 175
FIGURE 30 ABBOTT’S SALES HISTORY, 2010-2012 ($ MILLIONS) 175
BAXTER INTERNATIONAL, INC. 175
TABLE 68 BAXTER'S SALES HISTORY, 2010-2012 ($ MILLIONS) 176
FIGURE 31 BAXTER’S SALES HISTORY, 2010-2012 ($ MILLIONS) 176
BAYER AG 177
TABLE 69 BAYER'S SALES HISTORY, 2010-2012 ($ MILLIONS) 177
FIGURE 32 BAYER’S SALES HISTORY, 2010-2012 ($ MILLIONS) 177
BIO-RAD LABORATORIES, INC. 178
TABLE 70 BIO-RAD'S SALES HISTORY, 2010-2012 ($ MILLIONS) 179
FIGURE 33 BIO-RAD’S SALES HISTORY, 2010-2012 ($ MILLIONS) 179
CSL BEHRING 179
TABLE 71 CSL LIMITED'S SALES HISTORY, 2010-2012 ($ MILLIONS) 180
FIGURE 34 CSL LIMITED’S SALES HISTORY, 2010-2012 ($ MILLIONS) 180
ENTEGRION, INC. 180
GRIFOLS INTERNATIONAL, S.A./TALECRIS 181
TABLE 72 GRIFOLS' SALES HISTORY, 2010-2012 ($ MILLIONS) 182
FIGURE 35 GRIFOLS’ SALES HISTORY, 2010-2012 ($ MILLIONS) 182
HAEMONETICS CORPORATION 183
TABLE 73 HAEMONETICS' SALES HISTORY, 2010-2012 ($ MILLIONS) 183
FIGURE 36 HAEMONETICS’ SALES HISTORY 2010-2012 ($ MILLIONS) 183
HOLOGIC GEN-PROBE, INC. 184
TABLE 74 HOLOGIC'S SALES HISTORY, 2010-2012 ($ MILLIONS) 185
FIGURE 37 HOLOGIC’S SALES HISTORY 2010-2012 ($ MILLIONS) 185
NOVO NORDISK A/S 185
TABLE 75 NOVO NORDISK'S SALES HISTORY, 2010-2012 ($ MILLIONS) 186
FIGURE 38 NOVO NORDISK’S SALES HISTORY, 2010-2012 ($ MILLIONS) 186
OCTAPHARMA AG 187
TABLE 76 OCTAPHARMA'S SALES HISTORY, 2010-2012 ($ MILLIONS) 187
FIGURE 39 OCTAPHARMA’S SALES HISTORY, 2010-2012 ($ MILLIONS) 187
OMRIX BIOPHARMACEUTICALS, LTD. 188
TABLE 77 JOHNSON and JOHNSON'S SALES HISTORY, 2010-2012 ($ MILLIONS) 189
FIGURE 40 JOHNSON and JOHNSON’S SALES HISTORY, 2010-2012 ($ MILLIONS) 189
PFIZER, INC. 189
TABLE 78 PFIZER'S SALES HISTORY, 2010-2012 ($ MILLIONS) 190
FIGURE 41 PFIZER’S SALES HISTORY, 2010-2012 ($ MILLIONS) 190
ROCHE HOLDING LTD. 191
TABLE 79 ROCHE'S SALES HISTORY, 2010-2012 ($ MILLIONS) 191
FIGURE 42 ROCHE’S SALES HISTORY, 2010-2012 ($ MILLIONS) 191

CHAPTER 10 TECHNOLOGY 194

CLASSICAL FRACTIONATION METHODS 194
COHN FRACTIONATION 194
ADVANCED FRACTIONATION METHODS 194
AMPLIFICATION METHODS 195
POLYMERASE CHAIN REACTION (PCR) 195
NUCLEIC AMPLIFICATION TECHNOLOGY (NAT) 195
IMMUNOASSAY 195
ENZYME IMMUNOASSAY (EIA) 195
Basic EIA 196
FIGURE 43 THE BASIC ENZYME IMMUNOASSAY (EIA) PROCESS 196
Alternate EIA Methods 196
Second-Antibody Precipitation Method 196
Double-Antibody Sandwich Method 197
Reverse-Sandwich Method 197
Reverse-Sandwich Inhibition Method 197

CHAPTER 11 PATENT ANALYSIS 199

PATENT ANALYSIS 199
TABLE 80 RECENTLY ISSUED PATENTS 200
TABLE 81 PATENTS BY COUNTRY OF ORIGIN 200
TABLE 82 RECENT PATENTS BY COMPANY 201
FRESENIUS MEDICAL CARE 202
ORTHO-CLINICAL DIAGNOSTICS, INC. 202
ABBOTT LABORATORIES 202
CERNER INNOVATION, INC. 202
CHANGCHUN INSTITUTE OF APPLIED CHEMISTRY CHINESE ACADEMY OF
SCIENCES 203
GELANUS B.V. 203
MICRONICS, INC. 203
TERUMO KABUSHIKI KAISHA 204
PATENT EXAMPLES 204
RECENT PATENTS 204
Blood Transfusions : Six Patents 204
Blood Bank : Three Patents 207
Blood Donor : Two Patents 208

CHAPTER 12 APPENDIX A GUIDANCE FOR INDUSTRY RECOGNITION AND USE OF A
STANDARD FOR THE UNIFORM LABELING OF BLOOD AND BLOOD COMPONENTS 211

INTRODUCTION 211
REPORTING REQUIREMENTS FOR LICENSED ESTABLISHMENTS 211
FDA LICENSED ESTABLISHMENTS 211

CHAPTER 13 APPENDIX B MAJOR SOURCES OF INFORMATION 245

ABAXIS, INC. 245
ABBOTT LABORATORIES 245
ALBUMIN BIOSCIENCE 245
ALERE, INC. 245
ALFA SCIENTIFIC DESIGNS, INC. 245
AMERICAN RED CROSS 245
ARKRAY, INC. 246
ARYOGEN BIOPHARMA CO. 246
BAYER AG 246
BECKMAN COULTER, INC. 246
BECTON, DICKINSON, and CO. 246
BIOMERIEUX FRANCE 247
BIO-RAD LABORATORIES, INC. 247
BRISTOL-MYERS SQUIBB CO. 247
BTNX, INC. 247
CANGENE CORP. 247
CHARTER MEDICAL, LTD. 247
CHURCH and DWIGHT CO., INC. 248
CSL BEHRING 248
DANAHER CORP./RADIOMETER 248
ENTEGRION, INC. 248
FORA CARE, INC. 248
FUJIREBIO DIAGNOSTICS, INC. 248
GAMBRO INC. 249
G.E. HEALTHCARE LTD. 249
GLAXOSMITHKLINE PLC 249
GRIFOLS INTERNATIONAL, S.A. 249
GTC BIOTHERAPEUTICS/REVO BIOLOGICS 249
HAEMOTRONIC S.P.A. 250
HEMOCUE AB 250
HOLOGIC GEN-PROBE, INC. 250
IMMUCOR, INC. 250
INTERNATIONAL TECHNIDYNE CORP. 250
JANT PHARMACAL CORP. 250
JOHNSON and JOHNSON 251
KEDRION S.P.A 251
NATIONAL GENETICS INSTITUTE 251
NEXTRON MEDICAL TECHNOLOGIES 251
NIPRO DIAGNOSTICS, INC. 251
NOVA BIOMEDICAL CORP. 251
NOVARTIS AG 252
NOVO NORDISK A/S 252
NOVOZYMES BIOPHARMA, INC. 252
OCTAPHARMA AG 252
OMRIX BIOPHARMACEUTICALS, LTD. 252
OPK BIOTECH LLC 252
ORASURE TECHNOLOGIES, INC. 253
PALL CORP. 253
PFIZER, INC. 253
PHAMATECH, INC. 253
PRINCETON BIOMEDITECH CORPORATION 253
QUEST DIAGNOSTICS 253
QUIDEL CORP. 254
RESPONSE BIOMEDICAL CORP. 254
ROCHE 254
SA SCIENTIFIC, LTD. 254
SEKISUI DIAGNOSTICS 254
SIEMENS MEDICAL SOLUTIONS 255
SPECTRAL DIAGNOSTICS 255
STANBIO LABORATORY 255
TRINITY BIOTECH PLC 255
ZEUS SCIENTIFIC, INC. 255

CHAPTER 14 APPENDIX C GLOBAL BLOOD DONATION SOURCES 257

AMERICAN ASSOCIATION OF BLOOD BANKS 257
AMERICAN FRIENDS OF MAGEN DAVID ADOM 257
ARMED SERVICES BLOOD PROGRAM 257
ASSOCIATION OF VOLUNTARY ITALIAN BLOOD DONORS 257
AUSTRALIAN RED CROSS 257
CANADIAN BLOOD SERVICES 258
HEARTLAND BLOOD CENTERS 258
HONG KONG RED CROSS 258
INDIAN RED CROSS SOCIETY 258
IRISH NATIONAL BLOOD CENTRE 258
JAPANESE RED CROSS SOCIETY 258
NATIONAL BLOOD SERVICE 259
NEW ZEALAND BLOOD SERVICE 259
SOUTH AFRICAN NATIONAL BLOOD SERVICE 259
WORLD HEALTH ORGANIZATION 259



LIST OF TABLES

SUMMARY TABLE GLOBAL MARKET FOR BLOOD PRODUCTS, THROUGH 2017 ($
MILLIONS) 7
TABLE 1 TIMELINE OF THE BLOOD INDUSTRY 13
TABLE 2 COMPOSITION OF BLOOD 16
TABLE 3 MAJOR DISEASES CONTRACTED FROM BLOOD TRANSFUSIONS, U.S.
ANALYSIS 18
TABLE 4 CBER LICENSED HIV DONOR SCREENING TESTS (LAST UPDATED JANUARY
17, 2013) 21
TABLE 5 CBER LICENSED SCREENING TESTS FOR HEPATITIS B (LAST UPDATED
JANUARY 17, 2013) 23
TABLE 6 CBER LICENSED SCREENING TESTS FOR HEPATITIS C (LAST UPDATED
JANUARY 17, 2013) 24
TABLE 7 CBER LICENSED SCREENING TESTS FOR HTLV-I AND HTLV-II (LAST
UPDATED JANUARY 17, 2013) 26
TABLE 8 CBER LICENSED SCREENING TESTS FOR CMV (LAST UPDATED JANUARY 17,
2013) 27
TABLE 9 CBER LICENSED SCREENING TESTS FOR WEST NILE (LAST UPDATED
JANUARY 17, 2013) 28
TABLE 10 CBER LICENSED SCREENING TESTS FOR SYPHILIS (LAST UPDATED
JANUARY 17, 2013) 29
TABLE 11 CBER LICENSED SCREENING TESTS FOR CHLAMYDIA (LAST UPDATED
JANUARY 17, 2013) 32
TABLE 12 CBER LICENSED SCREENING TESTS FOR GONORRHEA (LAST UPDATED
JANUARY 17, 2013) 33
TABLE 13 FDA REGISTERED BLOOD ESTABLISHMENTS BY STATE* AND POSSESSION 41
TABLE 14 ESTIMATED GLOBAL POPULATION AND GROWTH RATE BY SELECTED AGE
GROUP AND SELECTED YEARS, THROUGH 2030 (MILLIONS) 46
TABLE 15 GLOBAL POPULATION BY SELECTED COUNTRY, THROUGH 2015 (MILLIONS) 47
TABLE 16 TESTS ROUTINELY PERFORMED ON BLOOD DONATIONS 53
TABLE 17 BLOOD TYPE ANTIGEN/ANTIBODY REACTIONS 54
TABLE 18 SELECTED USES OF FFP 60
TABLE 19 LISTING OF BLOOD PRODUCTS FOR THERAPEUTIC USE 61
TABLE 20 FACTORS TO REDUCE RISKS OF TRANSFUSION- ASSOCIATED DISEASES 71
TABLE 21 TRANSFUSION-RELATED FATALITIES BY COMPLICATION, FY 2008-FY 2012 73
TABLE 22 FATALITIES NOT RELATED TO TRANSFUSION OR TRANSFUSION NOT
RULED OUT, FY2008-FY2012 74
TABLE 23 POST-DONATION "NOT RULED OUT" FATALITY REPORTS BY DONATED
PRODUCT, FY2008 THROUGH FY2012 74
TABLE 24 FEDERAL ORGANIZATIONS RESPONSIBLE FOR U.S. BLOOD SAFETY 76
TABLE 25 FDA AUTHORITY IN REGULATING BLOOD BANKING AND BLOOD PRODUCTS 79
TABLE 26 MAJOR AREAS OF CONCERN FOR INSPECTING BLOOD FACILITIES 83
TABLE 27 ESTIMATED U.S. COST OF BLOOD COMPONENTS, THROUGH 2012 ($) 94
TABLE 28 U.S. BLOOD COLLECTION AND TRANSFUSION DATA, THROUGH 2017
(MILLION UNITS/PINTS) 109
TABLE 29 PLASMA COLLECTIONS FOR THE U.S. AND OTHER MARKETS, THROUGH
2017 ($ BILLIONS, MILLIONS ML) 110
TABLE 30 PLASMA PRODUCTS MARKET FOR THE U.S. AND OTHER MARKETS,*
THROUGH 2017 ($ BILLIONS) 111
TABLE 31 GLOBAL MARKET SIZE OF PLASMA THERAPEUTIC DERIVATIVES BY TYPE,
THROUGH 2017 ($ MILLIONS) 112
TABLE 32 CURRENTLY MARKETED ALBUMIN AND PLASMA PROTEIN FRACTION (PPF)
PRODUCTS (%) 115
TABLE 33 GLOBAL MARKET FOR HUMAN SERUM ALBUMIN AND PPF BY REGION,
THROUGH 2017 ($ MILLIONS) 116
TABLE 34 EXAMPLES OF COMMON BLOOD CLOTTING FACTORS 118
TABLE 35 WORLDWIDE AND U.S. HEMOPHILIA STATISTICS, 2012 ESTIMATES 120
TABLE 36 GLOBAL MARKET FOR PLASMA-DERIVED AND RECOMBINANT CLOTTING
FACTORS, THROUGH 2017 (REVENUES IN $ MILLIONS) 120
TABLE 37 GLOBAL MARKET FOR PLASMA-DERIVED AND RECOMBINANT CLOTTING
FACTORS BY REGION, THROUGH 2017 ($ MILLIONS) 121
TABLE 38 FDA APPROVED FACTOR VIII PRODUCTS 122
TABLE 39 GLOBAL MARKET SHARE OF FACTOR VIII COMPANIES, 2012 125
TABLE 40 FDA APPROVED FACTOR IX PRODUCTS 126
TABLE 41 GLOBAL MARKET SHARE OF FACTOR IX COMPANIES, 2012 (%/MILLIONS) 127
TABLE 42 FDA APPROVED FACTOR VII PRODUCTS 128
TABLE 43 GLOBAL MARKET SHARE OF FACTOR IX COMPANIES, 20121
(PERCENT/MILLIONS) 129
TABLE 44 FDA APPROVED PROTHROMBIN COMPLEX CONCENTRATE PRODUCTS 130
TABLE 45 SELECTED CONDITIONS TREATED BY IVIG 131
TABLE 46 FDA APPROVED IMMUNOGLOBULINS 132
TABLE 47 FDA APPROVED HYPERIMMUNE IMMUNOGLOBULINS 133
TABLE 48 GLOBAL MARKET FOR IMMUNOGLOBULINS, THROUGH 2017 ($ MILLIONS) 136
TABLE 49 GLOBAL MARKET FOR IMMUNOGLOBULINS BY REGION, THROUGH 2017 ($
MILLIONS) 136
TABLE 50 GLOBAL MARKET FOR FIBRIN SEALANTS AND THROMBIN, THROUGH 2017
($ MILLIONS) 140
TABLE 51 GLOBAL MARKET FOR FIBRIN SEALANTS AND THROMBIN BY REGION,
THROUGH 2017 ($ MILLIONS) 141
TABLE 52 GLOBAL MARKET FOR ANTITHROMBIN, THROUGH 2017 ($ MILLIONS) 143
TABLE 53 GLOBAL MARKET FOR ANTITHROMBIN BY REGION, THROUGH 2017 ($
MILLIONS) 143
TABLE 54 GLOBAL MARKETS FOR BLOOD TYPING AND SCREENING PRODUCTS,
THROUGH 2017 ($ MILLIONS) 144
TABLE 55 GLOBAL MARKETS FOR BLOOD TYPING AND SCREENING PRODUCTS,
THROUGH 2017 ($ MILLIONS) 146
TABLE 56 SELECTED PCR DONOR SCREENING TESTS 147
TABLE 57 SELECTED NAT DONOR SCREENING TESTS 148
TABLE 58 SELECTED IMMUNOASSAY DONOR SCREENING TESTS 149
TABLE 59 THE GLOBAL BLOOD DONOR SCREENING TESTING MARKET BY TYPE OF
TESTS, THROUGH 2017 ($ MILLIONS) 150
TABLE 60 SELECTED SUPPLIERS: MAJOR DONOR SCREENING TEST AREAS 151
TABLE 61 THE GLOBAL MARKET FOR BLOOD TYPING INSTRUMENTS AND SUPPLIES
BY TYPE, THROUGH 2017 ($ MILLIONS) 153
TABLE 62 GLOBAL MARKET FOR BLOOD COLLECTION AND PROCESSING EQUIPMENT
AND CONSUMABLES, THROUGH 2017 ($ MILLIONS) 156
TABLE 63 GLOBAL MARKET FOR BLOOD AND PLASMA COLLECTION AND
TRANSFUSION PRODUCTS, THROUGH 2017 ($ MILLIONS) 158
TABLE 64 GLOBAL MARKET FOR COLLECTION PRODUCTS BY TYPE, THROUGH 2017
($ MILLIONS) 159
TABLE 65 GLOBAL MARKET FOR TRANSFUSION PRODUCTS BY TYPE, THROUGH 2017
($ MILLIONS) 164
TABLE 66 REGIONAL VETERINARY BLOOD BANKS 171
TABLE 67 ABBOTT'S SALES HISTORY, 2010-2012 ($ MILLIONS) 175
TABLE 68 BAXTER'S SALES HISTORY, 2010-2012 ($ MILLIONS) 176
TABLE 69 BAYER'S SALES HISTORY, 2010-2012 ($ MILLIONS) 177
TABLE 70 BIO-RAD'S SALES HISTORY, 2010-2012 ($ MILLIONS) 179
TABLE 71 CSL LIMITED'S SALES HISTORY, 2010-2012 ($ MILLIONS) 180
TABLE 72 GRIFOLS' SALES HISTORY, 2010-2012 ($ MILLIONS) 182
TABLE 73 HAEMONETICS' SALES HISTORY, 2010-2012 ($ MILLIONS) 183
TABLE 74 HOLOGIC'S SALES HISTORY, 2010-2012 ($ MILLIONS) 185
TABLE 75 NOVO NORDISK'S SALES HISTORY, 2010-2012 ($ MILLIONS) 186
TABLE 76 OCTAPHARMA'S SALES HISTORY, 2010-2012 ($ MILLIONS) 187
TABLE 77 JOHNSON and JOHNSON'S SALES HISTORY, 2010-2012 ($ MILLIONS) 189
TABLE 78 PFIZER'S SALES HISTORY, 2010-2012 ($ MILLIONS) 190
TABLE 79 ROCHE'S SALES HISTORY, 2010-2012 ($ MILLIONS) 191
TABLE 80 RECENTLY ISSUED PATENTS 200
TABLE 81 PATENTS BY COUNTRY OF ORIGIN 200
TABLE 82 RECENT PATENTS BY COMPANY 201



LIST OF FIGURES

SUMMARY FIGURE GLOBAL MARKET FOR BLOOD PRODUCTS, 2010-2017 ($
MILLIONS) 7
FIGURE 1 ESTIMATED GLOBAL POPULATION BY SELECTED AGE GROUP AND
SELECTED YEARS, 2000-2030 (MILLIONS) 46
FIGURE 2 GLOBAL POPULATION BY SELECTED COUNTRY, 2010 AND 2015 (MILLIONS) 47
FIGURE 3 VARIABLES INFLUENCING THE DYNAMICS OF DEMAND FOR BLOOD FOR
TRANSFUSION 91
FIGURE 4 BLOOD MARKET COST AND PRICING ANALYSIS 92
FIGURE 5 U.S. BLOOD COLLECTION AND TRANSFUSION DATA, 2007-2017 (MILLION
UNITS/PINTS) 109
FIGURE 6 PLASMA COLLECTIONS FOR THE U.S. AND OTHER MARKETS, 2010-2017
(MILLION ML) 110
FIGURE 7 PLASMA PRODUCTS MARKET FOR THE U.S. AND OTHER MARKETS,*
2010-2017 ($ BILLIONS) 111
FIGURE 8 GLOBAL MARKET SIZE OF PLASMA THERAPEUTIC DERIVATIVES BY TYPE,
2010-2017 (MILLIONS) 112
FIGURE 9 GLOBAL MARKET FOR HUMAN SERUM ALBUMIN AND PPF BY REGION,
2010-2017 (MILLIONS) 116
FIGURE 10 GLOBAL MARKET FOR PLASMA-DERIVED AND RECOMBINANT CLOTTING
FACTORS, 2010-2017 ($ MILLIONS) 121
FIGURE 11 GLOBAL MARKET FOR PLASMA-DERIVED AND RECOMBINANT CLOTTING
FACTORS BY REGION, 2010-2017 (MILLIONS) 121
FIGURE 12 GLOBAL MARKET SHARE OF FACTOR VIII COMPANIES, 2012 (%) 125
FIGURE 13 GLOBAL MARKET SHARE OF FACTOR VIII BY HUMAN AND RECOMBINANT
PRODUCTS, 2012 (%) 125
FIGURE 14 GLOBAL MARKET SHARE OF FACTOR IX COMPANIES, 2012 (%) 127
FIGURE 15 GLOBAL MARKET SHARE OF FACTOR IX COMPANIES, 2012 (%) 129
FIGURE 16 GLOBAL MARKET FOR IMMUNOGLOBULINS, 2010-2017 (MILLIONS) 136
FIGURE 17 GLOBAL MARKET FOR IMMUNOGLOBULINS BY REGION, THROUGH 2017
($ MILLIONS) 137
FIGURE 18 GLOBAL MARKET FOR FIBRIN SEALANTS AND THROMBIN, 2010-2017 ($
MILLIONS) 141
FIGURE 19 GLOBAL MARKET FOR FIBRIN SEALANTS AND THROMBIN BY REGION,
2010-2017 ($ MILLIONS) 142
FIGURE 20 GLOBAL MARKET FOR ANTITHROMBIN, 2010-2017 ($ MILLIONS) 143
FIGURE 21 GLOBAL MARKET FOR ANTITHROMBIN BY REGION, 2010-2017 ($
MILLIONS) 143
FIGURE 22 GLOBAL MARKETS FOR BLOOD TYPING AND SCREENING PRODUCTS,
2010-2017 ($ MILLIONS) 144
FIGURE 23 GLOBAL MARKETS FOR BLOOD TYPING AND SCREENING PRODUCTS,
2010-2017 ($ MILLIONS) 146
FIGURE 24 GLOBAL BLOOD DONOR SCREENING TESTING MARKET BY TYPE,
2010-2017 ($ MILLIONS) 150
FIGURE 25 THE GLOBAL MARKET FOR BLOOD TYPING INSTRUMENTS AND SUPPLIES
BY TYPE, 2010-2017 ($ MILLIONS) 153
FIGURE 26 GLOBAL MARKET FOR BLOOD COLLECTION AND PROCESSING
EQUIPMENT AND CONSUMABLES, 2010-2017 ($ MILLIONS) 156
FIGURE 27 GLOBAL MARKET FOR BLOOD AND PLASMA COLLECTION AND
TRANSFUSION PR

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