2012 Global Factor Assays Market Outlook: Test Volume Forecasts by Country and Market Segment

The growing cost-containment pressures in major industrialized nations and continued technological advances will radically change coagulation testing practice during the next ten years. New specific and sensitive markers of hemostasis will be increasingly used on automated instrumentation. Coagulation testing in general, and Factor Assays testing specifically, will become more standardized, offering opportunities for quality control products and services. Moreover, the continuing contraction of the hospital system and technological advances will facilitate decentralization of the Factor Assays testing closer to the patient, creating additional opportunities and challenges for suppliers.

This report presents a detailed analysis of the Factor Assays testing market in the US, Europe (France, Germany, Italy, Spain, UK) and Japan, including clinical significance and current laboratory practice, as well as 5- and 10-year test volume forecasts by country and market segment.

The report examines market applications of chromogenic substrates, monoclonal antibodies, immunoassays, IT, DNA probes, biochips/microarrays, and other technologies; reviews features and operating characteristics of automated analyzers; profiles leading suppliers and recent market entrants developing innovative technologies and products; and identifies alternative market penetration strategies and entry barriers/risks.

Table of Contents

I. Introduction

II. Worldwide Market and Technology Overview

A. Introduction

B. Factor Assays: Clinical Significance
and Current Laboratory Procedures
1. Introduction
2. Factor II
3. Factor V/Factor V Leiden
4. Factor VII
5. Factor VIII
6. Factor IX
7. Factor IXa
8. Factor X (Stuart Factor)
9. Factor Xa
10. Factor XI
11. Factor XII
12. Factor XIII

C. Instrumentation Review
Introduction
Benk Hemolab
Benk TRT Thrombotimer
Bio/Data MCA 310
Bio/Data MCA 210
Bio/Data PAP-4C D/4D/4C
Cardiovascular Diagnostics COAG
Diagnostica Stago STA Compact
Diagnostica Stago STA-R
Diagnostica Stago Star 4/8
Helena Laboratories Cascade 480
Helena Laboratories Cascade M
Helena Laboratories PACKS-4
Helena THOR
Instrumentation Laboratory ACL 100 and 1000 series
Instrumentation Laboratory ACL6000
Instrumentation Laboratory ACL7000
Instrumentation Laboratory ACL9000
Instrumentation Laboratory Electra 1000C
Instrumentation Laboratory Electra 1400C
Instrumentation Laboratory Electra 1600/C
Instrumentation Laboratory Electra 1800C
Instrumentation Laboratory Futura
ITC Hemochron 8000
Roche Diagnostics CoaguChek
Siemens BCS
Siemens BCT
Siemens BF II/Fibrintimer Series
Sysmex CA-50
Sysmex CA-500
Sysmex CA-1500
Sysmex CA-5000/CA-1000
Sysmex CA-6000
Sysmex CA-7000
Teco Coatron II/Jr./AccuStasis 5000
Trinity Biotech Amax CS190
Trinity Biotech Amax CS400
Trinity Biotech Coag-A-Mate Max
Trinity Biotech KC 40, 4A, 1A Series
Trinity Biotech MDA 180
Trinity Biotech Coag-A-Mate MTX
Trinity Biotech Coag-A-Mate RA4
Trinity Biotech Coag-A-Mate XC/Plus
Trinity Biotech Coag-A-Mate XM

D. Major in Vitro Diagnostic Technologies and Their
Potential Applications
1. Chromogenic Substrates
2. Monoclonal and Polyclonal Antibodies
3. Immunoassays
a. Applications
b. Technological Principle
c. Enzyme Immunoassays (EIA)
Overview
ELISA
EMIT
Dot Immunobinding Assays
Capillary Immunoassays
Enzyme Amplification
Electrochemical Immunoassay
d. Fluorescent Immunoassays
Fluorescence Polarization
Time-Resolved Pulse Fluorescence
Fluorescence Lifetime
e. Latex Agglutination
f. Immunoprecipitation
4. Microcomputers
5. Automation
6. Robotics
7. DNA Probes
a. Overview
b. Amplification Methods
PCR
Ligase Chain Reaction
Branched DNA
Q-Beta Replicase
NASBA
SDA
3 SR
HPA
Two-Tiered System
LAT
8. Artificial Intelligence
9. Dry Chemistry
10. Biosensors

III. France: Test Volume Forecasts by Market Segment

IV. Germany: Test Volume Forecasts by Market Segment

V. Italy: Test Volume Forecasts by Market Segment

VI. Japan: Test Volume Forecasts by Market Segment

VII. Spain: Test Volume Forecasts by Market Segment

VIII. UK: Test Volume Forecasts by Market Segment

IX. USA: Test Volume Forecasts by Market Segment

X. Design Criteria For Decentralized Testing Products

XI. Alternative Market Penetration Strategies
A. Internal Development
B. Collaborative Arrangements
C. University Contracts
D. Distribution Strategies for Decentralized Testing Markets
1. Marketing Approaches
2. Product Complexity
3. Customer Preference
4. Established Suppliers
5. Emerging Suppliers
6. Major Types Of Distributors
7. Market Segmentation

XII. Potential Market Entry Barriers and Risks
A. Market Maturity
B. Cost Containment
C. Competition
D. Technological Edge and Limitations
E. Patent Protection
F. Regulatory Constraints
G. Decentralized Testing Market Challenges

XIII. Competitive Assessments
Abbott
American Diagnostica
Avocet Medical
Axis-Shield
Beckman Coulter
Becton Dickinson
Bio/Data Corporation
Biosite
Chrono-Log
Corgenix Medical
Diagnostica Stago
Helena Laboratories
HYPEN BioMed
Instrumentation Laboratory
ITC
Nanogen
Roche
Siemens
Sienco
Sysmex
Thermo Fischer
Trinity Biotech
ZyCare

List of Tables

Major Companies Developing or Marketing Factor Assay Tests
France
Factor II Test Volume Forecasts by Market Segment
France
Factor V Test Volume Forecasts by Market Segment
France
Factor V Leiden Test Volume Forecasts by Market Segment
France
Factor VII Test Volume Forecasts by Market Segment
France
Factor VIII Test Volume Forecasts by Market Segment
France
Factor IX Test Volume Forecasts by Market Segment
France
Factor IXa Test Volume Forecasts by Market Segment
France
Factor X (Stuart Factor) Test Volume Forecasts by Market
Segment
France
Factor Xa Test Volume Forecasts by Market Segment
France
Factor XI Test Volume Forecasts by Market Segment
France
Factor XII Test Volume Forecasts by Market Segment
France
Factor XIII Test Volume Forecasts by Market Segment
Germany
Factor II Test Volume Forecasts by Market Segment
Germany
Factor V Test Volume Forecasts by Market Segment
Germany
Factor V Leiden Test Volume Forecasts by Market Segment
Germany
Factor VII Test Volume Forecasts by Market Segment
Germany
Factor VIII Test Volume Forecasts by Market Segment
Germany
Factor IX Test Volume Forecasts by Market Segment
Germany
Factor IXa Test Volume Forecasts by Market Segment
Germany
Factor X (Stuart Factor) Test Volume Forecasts by Market
Segment
Germany
Factor Xa Test Volume Forecasts by Market Segment
Germany
Factor XI Test Volume Forecasts by Market Segment
Germany
Factor XII Test Volume Forecasts by Market Segment
Germany
Factor XIII Test Volume Forecasts by Market Segment
Italy
Factor II Test Volume Forecasts by Market Segment
Italy
Factor V Test Volume Forecasts by Market Segment
Italy
Factor V Leiden Test Volume Forecasts by Market Segment
Italy
Factor VII Test Volume Forecasts by Market Segment
Italy
Factor VIII Test Volume Forecasts by Market Segment
Italy
Factor IX Test Volume Forecasts by Market Segment
Italy
Factor IXa Test Volume Forecasts by Market Segment
Italy
Factor X (Stuart Factor) Test Volume Forecasts by Market
Segment
Italy
Factor Xa Test Volume Forecasts by Market Segment
Italy
Factor XI Test Volume Forecasts by Market Segment
Italy
Factor XII Test Volume Forecasts by Market Segment
Italy
Factor XIII Test Volume Forecasts by Market Segment
Japan
Factor II Test Volume Forecasts by Market Segment
Japan
Factor V Test Volume Forecasts by Market Segment
Japan
Factor V Leiden Test Volume Forecasts by Market Segment
Japan
Factor VII Test Volume Forecasts by Market Segment
Japan
Factor VIII Test Volume Forecasts by Market Segment
Japan
Factor IX Test Volume Forecasts by Market Segment
Japan
Factor IXa Test Volume Forecasts by Market Segment
Japan
Factor X (Stuart Factor) Test Volume Forecasts by Market
Segment
Japan
Factor Xa Test Volume Forecasts by Market Segment
Japan
Factor XI Test Volume Forecasts by Market Segment
Japan
Factor XII Test Volume Forecasts by Market Segment
Japan
Factor XIII Test Volume Forecasts by Market Segment
Spain
Factor II Test Volume Forecasts by Market Segment
Spain
Factor V Test Volume Forecasts by Market Segment
Spain
Factor V Leiden Test Volume Forecasts by Market Segment
Spain
Factor VII Test Volume Forecasts by Market Segment
Spain
Factor VIII Test Volume Forecasts by Market Segment
Spain
Factor IX Test Volume Forecasts by Market Segment
Spain
Factor IXa Test Volume Forecasts by Market Segment
Spain
Factor X (Stuart Factor) Test Volume Forecasts by Market
Segment
Spain
Factor Xa Test Volume Forecasts by Market Segment
Spain
Factor XI Test Volume Forecasts by Market Segment
Spain
Factor XII Test Volume Forecasts by Market Segment
Spain
Factor XIII Test Volume Forecasts by Market Segment
U.K.
Factor II Test Volume Forecasts by Market Segment
U.K.
Factor V Test Volume Forecasts by Market Segment
U.K.
Factor V Leiden Test Volume Forecasts by Market Segment
U.K.
Factor VII Test Volume Forecasts by Market Segment
U.K.
Factor VIII Test Volume Forecasts by Market Segment
U.K.
Factor IX Test Volume Forecasts by Market Segment
U.K.
Factor IXa Test Volume Forecasts by Market Segment
U.K.
Factor X (Stuart Factor) Test Volume Forecasts by Market
Segment
U.K.
Factor Xa Test Volume Forecasts by Market Segment
U.K.
Factor XI Test Volume Forecasts by Market Segment
U.K.
Factor XII Test Volume Forecasts by Market Segment
U.K.
Factor XIII Test Volume Forecasts by Market Segment
U.S.A.
Factor II Test Volume Forecasts by Market Segment
U.S.A.
Factor V Test Volume Forecasts by Market Segment
U.S.A.
Factor V Leiden Test Volume Forecasts by Market Segment
U.S.A.
Factor VII Test Volume Forecasts by Market Segment
U.S.A.
Factor VIII Test Volume Forecasts by Market Segment
U.S.A.
Factor IX Test Volume Forecasts by Market Segment
U.S.A.
Factor IXa Test Volume Forecasts by Market Segment
U.S.A.
Factor X (Stuart Factor) Test Volume Forecasts by Market
Segment
U.S.A.
Factor Xa Test Volume Forecasts by Market Segment
U.S.A.
Factor XI Test Volume Forecasts by Market Segment
U.S.A.
Factor XII Test Volume Forecasts by Market Segment
U.S.A.
Factor XIII Test Volume Forecasts by Market Segment