Markets for Blood Testing and Typing Post-Zika

Jun 9, 2017
210 Pages - Pub ID: KLI15378333
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The Market for Blood Testing and Typing

The global blood testing and typing industry has experienced strong growth in recent years and growth will remain solid though 2021 and 2026 as a result of:
  • Aging populations in the U.S., Europe and Japan;
  • Rising rates of disease diagnosis and treatment;
  • Ongoing technology advancements/new product introductions and indications;
  • Expansion of health coverage in the U.S. via health care reform; and
  • Continued strong promotion of blood donation by collection agencies.
The Zika outbreak, with more than 4,000 U.S. reported through early 2017 and outbreaks in several Latin American countries, has further underscored the importance of comprehensive blood screening and heightened industry imperatives to ensure blood supply safety.

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.
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


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