Description
The Market for Blood Testing and Typing
This Kalorama Information report, Blood Testing and Typing Post-Zika details sales estimates for each market segment represent global revenues and are expressed in current dollars. Estimates are provided for 2011 to 2016 and forecasts are provided through 2021 and 2026. Historical information was gathered from a wide variety of published sources including company reports, government documents, legal filings, trade journals, newspapers and business press, analysts’ reports and other sources. Interviews with company representatives were conducted to capture the perspectives from industry participants’ point of view and assess trends.
Excluded from this report are blood testing products used in biopharmaceutical processing/manufacturing/research, and veterinary tests. Also excluded are blood products for transfusion such as red blood cells (RBCs), immunoglobulin products, synthetic blood/albumin, etc. as well as blood testing services/laboratories.
The total global market for blood testing and typing products includes products and devices used in blood banking/donations as well as products used otherwise. This can also be thought of as testing and typing on pooled blood donations (blood bank) versus individual blood samples. In both of these segments, the following products are used:
- Pathogen screening by immunoassay;
- Pathogen screening by NAT;
- Blood typing and grouping;
The global blood industry represents a diverse assortment of companies, groups and organizations that provide for the safe collection, testing, storage and delivery of human blood and blood products for transfusion. These blood transfusions are of critical importance to those with both acute and chronic medical conditions in which blood is depleted or non-functioning, since more than 9 million Americans and Europeans would die each year without transfusions.
The following sections provide highlights of the blood industry’s ongoing technological development and a background on the physiological aspects of human blood, which will form the basis for understanding the blood testing and typing industries profiled in detail in this report’s later chapters.This Kalorama Information report, Blood Testing and Typing Post-Zika details sales estimates for each market segment represent global revenues and are expressed in current dollars. Estimates are provided for 2011 to 2016 and forecasts are provided through 2021 and 2026. Historical information was gathered from a wide variety of published sources including company reports, government documents, legal filings, trade journals, newspapers and business press, analysts’ reports and other sources. Interviews with company representatives were conducted to capture the perspectives from industry participants’ point of view and assess trends.
Excluded from this report are blood testing products used in biopharmaceutical processing/manufacturing/research, and veterinary tests. Also excluded are blood products for transfusion such as red blood cells (RBCs), immunoglobulin products, synthetic blood/albumin, etc. as well as blood testing services/laboratories.
The total global market for blood testing and typing products includes products and devices used in blood banking/donations as well as products used otherwise. This can also be thought of as testing and typing on pooled blood donations (blood bank) versus individual blood samples. In both of these segments, the following products are used:
- Pathogen screening by immunoassay;
- Pathogen screening by NAT;
- Blood typing and grouping;
The global blood industry represents a diverse assortment of companies, groups and organizations that provide for the safe collection, testing, storage and delivery of human blood and blood products for transfusion. These blood transfusions are of critical importance to those with both acute and chronic medical conditions in which blood is depleted or non-functioning, since more than 9 million Americans and Europeans would die each year without transfusions.
The following sections provide highlights of the blood industry’s ongoing technological development and a background on the physiological aspects of human blood, which will form the basis for understanding the blood testing and typing industries profiled in detail in this report’s later chapters.
Table of Contents
CHAPTER ONE: EXECUTIVE SUMMARY
THE GLOBAL BLOOD TESTING AND TYPING INDUSTRY POST ZIKA
SCOPE AND METHODOLOGY
THE TOTAL BLOOD TESTING AND TYPING PRODUCTS MARKET
OVERVIEW
The Global Blood Industry
History of the Blood Industry
Table 1-1: History of Blood Testing
United States
Europe
Asia
Africa
ZIKA VIRUS
CHAPTER TWO: CURRENT BLOOD INDUSTRY ISSUES
Effects of the Economy
Changes from Health Care Reform
Demographic Shifts
Table 2-1: U.S. Expectation of Life at Birth, by Sex and Race, 2015
BASICS – BLOOD AND ITS COMPONENTS
Red Blood Cells (Erythrocytes)
RBC Shelf Life
White Blood Cells (Leukocytes)
Platelets
Plasma
Figure 2-1: Composition of Blood Plasma
Immunoglobulin Products
Blood Transfusions
Diseases Contracted from Blood Transfusions and Related Identification Testing
Donor Deferral and Special Populations of Donors
Transfusion-Associated Risks
Questions about the Necessity of Transfusion
Biovigilence
CHAPTER THREE: THE BLOOD COLLECTION SYSTEM: BLOOD DONATION, PROCESSING AND USE
BLOOD COLLECTION
ORGANIZATIONS COLLECTING BLOOD
Not-For-Profit Blood Collection
Red Cross
Community Blood Banks
Hospitals
Other Blood Collection Sites
For-Profit Blood Collection
National Donor Deferral Registry
Donor Donation Demographics
Donor Recruitment
Blood Screening and Evaluation
Improving Donor Screening
METHODS FOR COLLECTING BLOOD FROM DONORS
Manual Blood Collection
Automated Blood Collection
Table 3-1: Worldwide Annual Blood Collection by Component
Plasmapheresis
Plateletpheresis
Leukopheresis
Red Blood Cell Apheresis
Cord Blood Collection
Plasma Collection
Plasma Fractionators
Distributors/Brokers
Blood Storage
Blood Freshness
Blood Processing
Cohn Fractionation
Figure 3-1: Results of Cohn Fractionation Method
Newer Fractionation Methods
Table 3-2: Plasma Proteins of Therapeutic Interest
Advanced Fractionation Methods
Cascade Plasma Fractionation
Automated Fractionation
Types of Blood Transfusions
Whole Blood
Packed Red Blood Cells
Platelets
Leukocytes
Fresh Frozen Plasma (FFP)
Cryoprecipitate
Immune Serum Globulin/IMIG/IGIV
Factor VIII
Factor IX and Factor IX Complex
Factor VIIa
C1 Inhibitor
Fibrin/Thrombin
Therapeutic Apheresis
Blood Management Issues
Increasing Repeat Donation Rates
Increasing Voluntary Donation
Other Safety Precautions
CHAPTER FOUR: BLOOD TYPING AND TESTING SEGMENTS
Blood Typing and Testing for Diseases
Blood Typing
Table 4-1: Basic Blood Types
Table 4-2: Blood Transfusion Compatibility
Methods of Blood Typing
Manual Blood Typing Methods
Automated Blood Typing and Screening Methods
Molecular methods
Reducing Blood Typing Errors
Blood Testing
Nucleic Acid Amplification Testing (NAT)
CBER Licensed NAT Screening Tests
Infectious Disease
West Nile Virus
Oncology
Inherited Disease
Other
Polymerase Chain Reaction (PCR) Amplification
CBER Licensed PCR Screening Tests
Table 4-3: PCR-Based Screening Tests Licensed by CBER
DNA Sequencing/Genetic Testing
Immunoassay
Infectious Diseases
Chagas Disease
Cardiac Markers
Tumor Markers
Diabetes
Autoimmune Diseases
Other
Enzyme-Linked Immunosorbent Assay
Basic ELISA
Table 4-4: Comparison of Direct and Indirect ELISA Tests
Competitive ELISA
Reverse Sandwich Method
Reverse Sandwich Inhibition Method
MAC-ELISA
Zika MAC-ELISA
Plaque Reduction Neutralization Test (PRNT)
Tests for Infectious Disease
Improving Viral Screening
Costs and Other Barriers
Testing Before Transfusion
Coombs Test
Crossmatch
Major Crossmatch
Minor Crossmatch
Antibody Screen
Efforts to Create a Virus-Free Blood Supply
Plasma Treatment
Table 4-5: Risk of Contamination
Table 4-6: Viral Inactivation by Procedure
Platelet Treatments
Testing for Contamination
Pathogen Reduction
Preventing Bacterial Infections
Red Blood Cell Treatments
Table 4-7: Viral Inactivation Methods for Viruses Found in Red Blood Cells
CHAPTER FIVE: BLOOD TESTING AND TYPING PRODUCT MARKETS
THE TOTAL BLOOD TESTING AND TYPING PRODUCTS MARKET
Table 5-1: Global Blood Testing and Typing Market Forecast by Segment, 2016
Market Growth for Testing and Typing
Table 5-2: Global Blood Testing and Typing Market Growth by Segment: 2011-2026
Blood Testing and Typing Market by Type (Instrument/Consumable)
Table 5-3: Breakout of Instrument vs. Consumable Revenue, by Percent of Market
BLOOD TESTING MARKET
Blood Testing Market: Immunoassay versus Nucleic Acid Testing
Blood Testing Market by Geography
Table 5-4: Geographical Distribution for Immunoassay versus Nucleic Acid Testing Products in Blood Banks: 2016
Immunoassay Market by Disease
Table 5-5: Global Blood Banking and Plasmapheresis Testing Market for Immunoassays: 2011-2026 by Disease Tested For (HIV, HCV,
HBV, Syph, Others)
NAT Blood Testing Market by Disease
Table 5-6: Global Blood Banking and Plasmapheresis Testing Market for NAT: 2011-2026
BLOOD TYPING & GROUPING MARKET AND FORECAST
Table 5-7: Total Global Market for Blood Typing & Grouping Products in Blood Banks: 2011-2026
Blood Typing and Grouping by Geography
Table 5-8: Geographical Distribution for Blood Typing & Grouping Products in Blood Banks: 2016
COMPETITIVE ANALYSIS
Market Share – Blood Bank Testing
Table 5-9: Blood Bank Testing Market Share
Nucleic Acid Tests
Blood Typing and Grouping Competitive Analysis
Table 5-10: Blood Typing Market Share
CHAPTER SIX: BLOOD TESTING AND TYPING PRODUCT MARKETS
AABB
ABBOTT LABORATORIES
AKERS BIOSCIENCES
AMERICA’S BLOOD CENTERS
AMERICAN RED CROSS
BECKMAN COULTER
BECTON DICKINSON & CO.
BIOMERIEUX, INC.
BIO-RAD LABORATORIES
DIASORIN
GRIFOLS BIOLOGICALS, INC.
HOLOGIC
HAEMONETICS, INC
IMMUCOR
MICRONICS
ORTHO CLINICAL DIAGNOSTICS
QIAGEN DIAGNOSTICS
RELIANCE LIFE SCIENCES
ROCHE
SIEMENS
TERUMO BCT