2012 Coagulation Testing Market Outlook: Growth Opportunities and Strategies

• Publication date: April 2012

The growing cost-containment pressures in major industrialized nations, coupled with continued technological advances in chromagenic substrates, monoclonal antibodies, immunoassays, molecular diagnostics, computers and laboratory automation will radically change the coagulation testing practice during the next ten years. New specific and sensitive markers of hemostasis will be increasingly used on automated instrumentation. Coagulation testing wi...

The growing cost-containment pressures in major industrialized nations, coupled with continued technological advances in chromagenic substrates, monoclonal antibodies, immunoassays, molecular diagnostics, computers and laboratory automation will radically change the coagulation testing practice during the next ten years. New specific and sensitive markers of hemostasis will be increasingly used on automated instrumentation. Coagulation testing will also 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 coagulation testing closer to the patient, thus creating additional opportunities and challenges for suppliers.

This comprehensive worldwide study is designed to help current suppliers and potential market entrants identify and evaluate major business opportunities emerging in the coagulation market during the next decade. The study explores business and technological trends in major markets; provides estimates of the test volume, instrument placements and installed base; as well as sales and market shares of leading competitors; compares features of major analyzers; profiles leading market players; and identifies specific product and business opportunities facing instrument and consumable suppliers during the next ten years.

In Vitro Diagnostic Industry in Japan

Table of Contents

Introduction
Worldwide Market and Technology Overview
A. Major Routine and Special Coagulation Tests
1. Introduction
2. Activated Partial Thromboplastin Time (APTT)
3. Alpha-2 Antiplasmin
4. Antithrombin III
5. Bleeding Time
6. D-Dimer
7. Ethanol Flocculation Test
8. Euglobulin Lysis
9. Factor Assays
a. Introduction
b. Factor II
c. Factor V/Factor V Leiden
d. Factor VII
e. Factor VIII
f. Factor IX
g. Factor IXa
h. Factor X (Stuart Factor)
i. Factor Xa
j. Factor XI
k. Factor XII
l. Factor XIII
10. Fibrin Degradation Products
11. Fibrinogen
12. Heparin
13. Hirudin
14. Hypercoagulability and Thrombosis
15. Lipoprotein a
16. Plasmin
17. Plasminogen
18. Plasminogen Activator Inhibitor (PAI)
19. Platelet Function Tests
20. Platelet Aggregation
21. Proteins C and S
22. Prothrombin Fragment 1.2
23. Prothrombin Time (PT)
24. Reptilase Time
25. Thrombin Time
26. Tissue-Type Plasminogen Activator (t-PA)
27. Von Willebrand's Factor
B. 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
C. 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
D. Worldwide Market Overview
1. Business Environment
2. Market Structure
3. Market Size and Growth
4. POC Testing Market
France
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers
Germany
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers
Italy
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers
Japan
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers
Spain
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers
UK
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers
USA
A. Executive Summary
B. Business Environment
1. Health Care Expenditures
2. Cost Consciousness
3. Industry Consolidation
4. Managed Care
5. Hospitals
6. Admissions
7. Length of Stay
8. Industry Diversification
9. Physician Demographics
10. Population Aging
a. Chronic Illnesses
b. Disease Incidence
c. Susceptibility to Iatrogenesis
d. Multiple Illness Cases
11. Laboratory Regulations
C. Market Structure
1. Centralized Testing
a. Hospitals
b. Commercial laboratories
2. Decentralized Testing
a. Physician Offices/Group Practices
b. Point-of-Care Testing
c. Home/Self Testing
d. Other Decentralized Testing Locations
D. Market Size, Growth And Major Suppliers
Major Product Development Opportunities
Design Criteria For Decentralized Testing Products
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
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
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 Activated Clotting Time Tests
Major Companies Developing or Marketing APTT Tests
Major Companies Developing or Marketing Alpha-2 Antiplasmin
Tests
Major Companies Developing or Marketing Antithrombin III Tests
Major Companies Developing or Marketing Bleeding Time Tests
Major Companies Developing or Marketing D-dimer Tests
Major Companies Developing or Marketing Factor Assays
Major Companies Developing or Marketing Fibrin Degradation
Product Tests
Major Companies Developing or Marketing Fibrinogen Tests
Major Companies Developing or Marketing Heparin Tests
Major Companies Developing or Marketing Plasmin Tests
Major Companies Developing or Marketing Plasminogen Tests
Major Companies Developing or Marketing Plasminogen Activator
Inhibitor Tests
Major Companies Developing or Marketing Platelet Aggregation
Tests
Major Companies Developing or Marketing Protein C Tests
Major Companies Developing or Marketing Protein S Tests
Major Companies Developing or Marketing PT Tests
Major Companies Developing or Marketing Thrombin Time Tests
Major Companies Developing or Marketing TPA Tests
Major Companies Developing or Marketing Von Willebrand's
Factor Tests
Worldwide, All Market Segments, Laboratories Performing
Coagulation Tests By Country, 2010
Worldwide, All Market Segments, Total Coagulation Test Volume
By Country, 2010-2020
Worldwide, All Market Segments, Total Coagulation Reagent
Market By Country, 2010-2020
Worldwide, All Market Segments, Total Coagulation Instrument
Market By Country, 2010-2020
Worldwide, All Market Segments, Total Coagulation Diagnostics
Market By Country, 2010-2020
Executive Summary Table: France, Total Coagulation Diagnostics
Market By Market Segment and Product Category, 2010-2020
France, Laboratories Performing Coagulation Tests By Market
Segment, 2010
France, Hospital Laboratories Performing Coagulation Tests By
Bed Size, 2010
France, Commercial/Private Laboratories Performing Coagulation
Tests By Annual Test Volume, 2010
France, Hospital Laboratories Average Daily Test Volume, 2010
France, Commercial/Private Laboratories Average Daily Test
Volume, 2010
France, Total Coagulation Test Volume By Market Segment,
2010-2020
France, All Market Segments Coagulation Test Volume,
2010-2020
France, Hospital Laboratories Coagulation Test Volume,
2010-2020
France, Commercial/Private Laboratories Coagulation Test Volume,
2010-2020
France, Coagulation Reagent Market By Market Segment,
2010-2020
France, Major Suppliers of Coagulation Reagents Estimated Sales
and Market Shares, 2010
France, Coagulation Instrument Market By Market Segment,
2010-2020
France, Major Suppliers of Coagulation Analyzers, Estimated
Total Instrument Placements and Market Shares, 2010
France, Major Suppliers of Coagulation Analyzers, Estimated
Placements and Installed Base By Supplier and Model, 2010
France, Major Suppliers of Coagulation Analyzers, Estimated
Instrument Sales and Market Shares, 2010
France, Total Coagulation Diagnostics Market By Product
Category, 2010-2020
France, Major Suppliers of Coagulation Diagnostic Products,
Estimated Sales and Market Shares, 2010
Executive Summary Table: Germany, Total Coagulation
Diagnostics Market By Market Segment and Product Category,
2010-2020
Germany, Laboratories Performing Coagulation Tests By Market
Segment, 2010
Germany, Hospital Laboratories Performing Coagulation Tests
By Bed Size, 2010
Germany, Commercial/Private Laboratories Performing
Coagulation Tests By Annual Test Volume, 2010
Germany, Hospital Laboratories Average Daily Test Volume, 2010
Germany, Commercial/Private Laboratories Average Daily Test
Volume, 2010
Germany, Physician Offices/Group Practice Average Daily Test
Volume, 2010
Germany, Total Coagulation Test Volume By Market Segment,
2010-2020
Germany, All Market Segments Coagulation Test Volume,
2010-2020
Germany, Hospital Laboratories Coagulation Test Volume,
2010-2020
Germany, Commercial/Private Laboratories Coagulation Test
Volume, 2010-2020
Germany, Physician Offices/Group Practices Coagulation Test
Volume, 2010-2020
Germany, Coagulation Reagent Market By Market Segment,
2010-2020
Germany, Major Suppliers of Coagulation Reagents, Estimated
Sales and Market Shares, 2010
Germany, Coagulation Instrument Market By Market Segment,
2010-2020
Germany, Major Suppliers of Coagulation Analyzers, Estimated
Total Instrument Placements and Market Shares, 2010
Germany, Major Suppliers of Coagulation Analyzers, Estimated
Placements and Installed Base By Supplier and Model, 2010
Germany, Major Suppliers of Coagulation Analyzers, Estimated
Instrument Sales and Market Shares, 2010
Germany, Total Coagulation Diagnostics Market By Product
Category, 2010-2020
Germany, Major Suppliers of Coagulation Diagnostic Products,
Estimated Sales and Market Shares, 2010
Executive Summary Table: Italy, Total Coagulation Diagnostics
Market By Market Segment and Product Category, 2010-2020
Italy, Laboratories Performing Coagulation Tests By Market
Segment, 2010
Italy, Hospital Laboratories Performing Coagulation Tests By
Bed Size, 2010
Italy, Commercial/Private Laboratories Performing Coagulation
Tests By Annual Test Volume, 2010
Italy, Hospital Laboratories Average Daily Test Volume, 2010
Italy, Commercial/Private Laboratories Average Daily Test
Volume, 2010
Italy, Total Coagulation Test Volum By Market Segment,
2010-2020
Italy, All Market Segments Coagulation Test Volume, 2010-2020
Italy, Hospital Laboratories Coagulation Test Volume, 2010-2020
Italy, Commercial/Private Laboratories Coagulation Test Volume,
2010-2020
Italy, Coagulation Reagent Market By Market Segment, 2010-2020
Italy, Major Suppliers of Coagulation Reagents Estimated Sales
and Market Shares, 2010
Italy, Coagulation Instrument Market By Market Segment,
2010-2020
Italy, Major Suppliers of Coagulation Analyzers, Estimated
Total Instrument Placements and Market Shares, 2010
Italy, Major Suppliers of Coagulation Analyzers, Estimated
Placements and Installed Base By Supplier and Model, 2010
Italy, Major Suppliers of Coagulation Analyzers, Estimated
Instrument Sales and Market Shares, 2010
Italy, Total Coagulation Diagnostics Market By Product Category,
2010-2020
Italy, Major Suppliers of Coagulation Diagnostic Products,
Estimated Sales and Market Shares, 2010
Executive Summary Table: Japan, Total Coagulation Diagnostics
Market By Market Segment and Product Category, 2010-2020
Japan, Laboratories Performing Coagulation Tests By Market
Segment, 2010
Japan, Hospital Laboratories Performing Coagulation Tests By
Bed Size, 2010
Japan, Commercial/Private Laboratories Performing Coagulation
Tests By Annual Test Volume, 2010
Japan, Hospital Laboratories Average Daily Test Volume, 2010
Japan, Commercial/Private Laboratories Average Daily Test
Volume, 2010
Japan, Total Coagulation Test Volume By Market Segment,
2010-2020
Japan, All Market Segments Coagulation Test Volume,
2010-2020
Japan, Hospital Laboratories Coagulation Test Volume,
2010-2020
Japan, Commercial/Private Laboratories Coagulation Test
Volume, 2010-2020
Japan, Coagulation Reagent Market By Market Segment,
2010-2020
Japan, Major Suppliers of Coagulation Reagents Estimated
Sales and Market Shares, 2010
Japan, Coagulation Instrument Market By Market Segment,
2010-2020
Japan, Major Suppliers of Coagulation Analyzers, Estimated
Total Instrument Placements and Market Shares, 2010
Japan, Major Suppliers of Coagulation Analyzers, Estimated
Placements and Installed Base By Supplier and Model, 2010
Japan, Major Suppliers of Coagulation Analyzers, Estimated
Instrument Sales and Market Shares, 2010
Japan, Total Coagulation Diagnostics Market By Product
Category, 2010-2020
Japan, Major Suppliers of Coagulation Diagnostic Products,
Estimated Sales and Market Shares, 2010
Executive Summary Table: Spain, Total Coagulation Diagnostics
Market By Market Segment and Product Category, 2010-2020
Spain, Laboratories Performing Coagulation Tests By Market
Segment, 2010
Spain, Hospital Laboratories Performing Coagulation Tests By
Bed Size, 2010
Spain, Commercial/Private Laboratories Performing Coagulation
Tests By Annual Test Volume, 2010
Spain, Hospital Laboratories Average Daily Test Volume, 2010
Spain, Ambulatory Care Centers Average Daily Test Volume, 2010
Spain, Commercial/Private Laboratories Average Daily Test
Volume, 2010
Spain, Total Coagulation Test Volume By Market Segment,
2010-2020
Spain, All Market Segments Coagulation Test Volume,
2010-2020
Spain, Hospital Laboratories Coagulation Test Volume,
2010-2020
Spain, Ambulatory Care Centers Coagulation Test Volume,
2010-2020
Spain, Commercial/Private Laboratories Coagulation Test
Volume, 2010-2020
Spain, Coagulation Reagent Market By Market Segment,
2010-2020
Spain, Major Suppliers of Coagulation Reagents, Estimated
Sales and Market Shares, 2010
Spain, Coagulation Instrument Market By Market Segment, 2010
Spain, Major Suppliers of Coagulation Analyzers, Estimated
Total Instrument Placements and Market Shares, 2010
Spain, Major Suppliers of Coagulation Analyzers, Estimated
Placements and Installed Base By Supplier and Model, 2010
Spain, Major Suppliers of Coagulation Analyzers, Estimated
Instrument Sales and Market Shares, 2010
Spain, Total Coagulation Diagnostics Market By Product
Category, 2010-2020
Spain, Major Suppliers of Coagulation Diagnostic Products,
Estimates Sales and Market Shares, 2010
Executive Summary Table: U.K., Total Coagulation Diagnostics
Market By Market Segment and Product Category, 2010-2020
U.K., Laboratories Performing Coagulation Tests By Market
Segment, 2010
U.K., Hospital Laboratories Performing Coagulation Tests By
Bed Size, 2010
U.K., Commercial/Private Laboratories Performing Coagulation
Tests By Annual Test Volume, 2010
U.K., Hospital Laboratories Average Daily Test Volume, 2010
U.K., Commercial/Private Laboratories Average Daily Test
Volume, 2010
U.K., Total Coagulation Test Volume By Market Segment,
2010-2020
U.K., All Market Segments Coagulation Test Volume, 2010-2020
U.K., Hospital Laboratories Coagulation Test Volume, 2010-2020
U.K., Commercial/Private Laboratories Coagulation Test Volume,
2010-2020
U.K., Coagulation Reagent Market By Market Segment, 2010-2020
U.K., Major Suppliers of Coagulation Reagents Estimated Sales
and Market Shares, 2010
U.K., Coagulation Instrument Market By Market Segment, 2010
U.K., Major Suppliers of Coagulation Analyzers, Estimated Total
Instrument Placements and Market Shares, 2010
U.K., Major Suppliers of Coagulation Analyzers, Estimated
Placements and Installed Base By Supplier and Model, 2010
U.K., Major Suppliers of Coagulation Analyzers, Estimated
Instrument Sales and Market Shares, 2010
U.K., Total Coagulation Diagnostics Market By Product Category,
2010-2020
U.K., Major Suppliers of Coagulation Diagnostic Products,
Estimated Sales and Market Shares, 2010
Executive Summary Table: U.S.A., Total Coagulation Diagnostics
Market By Market Segment and Product Category, 2010-2020
U.S.A., Laboratories Performing Coagulation Tests By Market
Segment, 2010
U.S.A., Hospital Laboratories Performing Coagulation Tests By
Bed Size, 2010
U.S.A., Commercial/Private Laboratories Performing Coagulation
Tests By Annual Test Volume, 2010
U.S.A., Physician Offices/Group Practices Performing Coagulation
Tests By Practice Size, 2010
U.S.A., Hospital Laboratories Average Daily Test Volume, 2010
U.S.A., Commercial/Private Laboratories Average Daily Test
Volume, 2010
U.S.A., Physician Offices/Group Practices Average Daily Test
Volume
U.S.A., Total Coagulation Test Volume By Market Segment,
2010-2020
U.S.A., All Market Segments Coagulation Test Volume, 2010-2020
U.S.A., Hospital Laboratories Coagulation Test Volume, 2010-2020
U.S.A., Physician Offices/Group Practices Coagulation Test Volume,
2010-2020
U.S.A., Commercial/Private Laboratories Coagulation Test Volume,
2010-2020
U.S.A., Coagulation Reagent Market By Market Segment,
2010-2020
U.S.A., Major Suppliers of Coagulation Reagents Estimated
Sales and Market Shares, 2010
U.S.A., Coagulation Instrument Market By Market Segment,
2010-2020
U.S.A., Major Suppliers of Coagulation Analyzers, Estimated
Total Instrument Placements and Market Shares, 2010
U.S.A., Major Suppliers of Coagulation Analyzers, Estimated
Placements and Installed Base By Supplier and Model, 2010
U.S.A., Major Suppliers of Coagulation Analyzers, Estimated
Instrument Sales and Market Shares, 2010
U.S.A., Total Coagulation Diagnostics Market By Product
Category, 2010-2020
U.S.A., Major Suppliers of Coagulation Diagnostic Products,
Estimated Sales and Market Shares, 2010

In Vitro Instrument in Japan

Japan Pharmaceutical Exports - Blood-grouping Reagents, Us$mn

• $ 250
• Industry data
• January 2013

Yearly, From 2002 To 2011
By Business Monitor International
Source: United Nations Comtrade Database DESA/UNSD, BMI

• Industries : In Vitro Diagnostic
• Countries : Japan

Japan Pharmaceutical Imports - Blood-grouping Reagents, Us$mn

• $ 250
• Industry data
• January 2013

Yearly, From 2002 To 2011
By Business Monitor International
Source: United Nations Comtrade Database DESA/UNSD, BMI

• Industries : In Vitro Diagnostic
• Countries : Japan