The Global Blood Industry

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The Global Blood Industry

Published on June 2013

Report Summary

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.

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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 Content

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,


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


FACTORS BY REGION, THROUGH 2017 ($ MILLIONS) 121


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


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,


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,


FIGURE 22 GLOBAL MARKETS FOR BLOOD TYPING AND SCREENING PRODUCTS,

2010-2017 ($ MILLIONS) 144




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 & JOHNSON'S SALES HISTORY, 2010-2012 ($ MILLIONS) 189

FIGURE 40 JOHNSON & 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


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


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, & 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 & 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 & 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,


TABLE 32 CURRENTLY MARKETED ALBUMIN AND PLASMA PROTEIN FRACTION (PPF)

PRODUCTS (%) 115

TABLE 33 GLOBAL MARKET FOR HUMAN SERUM ALBUMIN AND PPF BY REGION,


TABLE 34 EXAMPLES OF COMMON BLOOD CLOTTING FACTORS 118

TABLE 35 WORLDWIDE AND U.S. HEMOPHILIA STATISTICS, 2012 ESTIMATES 120


FACTORS, THROUGH 2017 (REVENUES IN $ MILLIONS) 120










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,


TABLE 52 GLOBAL MARKET FOR ANTITHROMBIN, THROUGH 2017 ($ MILLIONS) 143

TABLE 53 GLOBAL MARKET FOR ANTITHROMBIN BY REGION, THROUGH 2017 ($

MILLIONS) 143





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 & 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


FACTORS, 2010-2017 ($ MILLIONS) 121


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 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


2010-2017 ($ MILLIONS) 144


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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