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Future Clinical Chemistry and Immunodiagnostics Markets: Growth Opportunities and Business Expansion Strategies Product Image

Future Clinical Chemistry and Immunodiagnostics Markets: Growth Opportunities and Business Expansion Strategies

  • Published: November 2011
  • 600 pages
  • Venture Planning Group (VPG)

This report presents a comprehensive analysis of the US clinical chemistry and immunodiagnostics markets, including:

- Major issues pertaining to the US clinical chemistry and immunodiagnostic laboratory practice, as well as key economic, regulatory, demographic, social and technological trends with significant market impact during the next ten years.
- Five- and ten-year volume and sales forecasts for over 100 clinical chemistry, TDM, endocrine, cancer, immunoprotein and abused drug assays performed in US hospitals, commercial laboratories, and physician offices, including controls, calibrators and consumables.
- Five- and ten-year volume forecasts for serum, whole blood, plasma, CFS, urine and other specimens.
- Five- and ten-year reagent and instrument sales forecasts.
- Review of current instrumentation technologies, and a feature comparison of 50 high-, medium-, and low-volume/POC analyzers.
- Sales and market shares of leading reagent and instrument suppliers.
- Review of current and emerging technologies and their potential market applications.
- Product development opportunities for clinical chemistry and immunodiagnostic instruments and consumables.
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Introduction
Worldwide Market and Technology Overview

A. Major Routine Chemistry Tests
1. Albumin
2. Alkaline Phosphatase
3. ALT/SGPT
4. Ammonia
5. Amylase
6. AST/SGOT
7. Bilirubin
8. Blood Gases
9. Blood Urea Nitrogen (BUN)
10. Calcium
11. Cholesterol
12. Cholinesterase
13. Creatinine
14. Electrolytes
a. Carbon Dioxide/Bicarbonate
b. Chloride
c. Potassium
d. Sodium
15. Fructosamine
16. Gamma-Glutamyl Transpeptidase (GGT)
17. Glucose
18. High Density Lipoprotein (HDL)
19. Iron
20. Lactate Dehydrogenase (LDH)
21. Magnesium
22. Phosphorus
23. Protein
24. Triglycerides
25. Uric Acid
26. Troponin

B. Therapeutic Drug Monitoring (TDM)
1. Overview
2. Carbamazepine
3. Digoxin
4. Gentamicin
5. Lidocaine
6. Lithium
7. Phenytoin/Dilantin
8. Procainamide
9. Quinidine
10. Theophylline
11. Valproic Acid

C. Endocrine Function Tests
1. Cortisol
2. Follicle-Stimulating Hormone (FSH)
3. Gastrin
4. Human Chorionic Gonadotropin (HCG)
5. LH
6. Prolactin
7. T3
8. T3 Uptake
9. Free T3
10. Thyroxine (T4)
11. Free T4
12. TBG
13. TSH

D. Tumor Markers And Special Chemistry Tests
1. Alpha-Fetoprotein (AFP)
2. Carcinoembrionic Antigen (CEA)
3. Ferritin
4. Follate/Folic Acid
5. Occult Blood
6. Prostatic Acid Phosphatase (PAP)
7. Prostate-Specific Antigen (PSA)
8. Vitamin B-12

E. Immunoprotein Tests
1. Complement
a. C3
b. C4
2. CRP
3. Immunoglobulins (IgA, IgE, IgG, IgM)
4. Protein Electrophoresis

F. Drugs of Abuse
1. Overview
2. Test Methodologies
3. Amphetamines
4. Barbiturates
5. Benzodiazepines
6. Cannabinoids/Marijuana
7. Cocaine
8. Lysergic Acid Diethylamide (LSD)
9. Methadone
10. Methaqualone
11. Opiates
12. Phencyclidine

G. Instrumentation Review
- Abaxis Piccolo
- Abaxis Piccolo Xpress
- Abbott AxSYM
- Abbott Architect c4000
- Abbott Architect i2000 Series
- Abbott Architect ci8200 System
- Abbott i-STAT
- Alfa Wassermann ACE Alera
- AMS Liasys
- Awareness Technologies ChemWell
- Awareness Technology STAT FAX 4500
- Beckman Coulter Unicel Series
- Beckman Coulter Access
- Binding Site ESP600
- bioMerieux Mini Vidas
- Carolina Chemistries BioLis 24i
- DiaSorin Liaison
- Grifols Triturus
- Horiba ABX Pentra 400
- Inverness DS2
- J&J DT System
- J&J Vitros ECi/ECiO
- J&J Vitros 3600
- J&J Vitros 5600
- Medica EasyRA
- Nova Biomedical Critical Care Xpress
- Olympus AU480
- Olympus AU5400
- Olympus AU53000i
- Olympus AU2700
- Polymedco Poly-Chem
- Polymedco Spotchem EZ
- Randox RX Daytona
- Randox RX Imola
- Roche Modular Analytics
- Roche Cobas Integra 400
- Roche Cobas Integra 400 Plus
- Roche Elecsys
- Roche Cobas c311
- Roche Cardiac 200
- Siemens ADVIA Centaur
- Siemens Dimension
- Siemens Dimension RxL Max
- Siemens Dimension Vista 500
- Siemens Immulite
- Siemens Stratus
- Tosoh AIA-Series
- Vital Diagnostics ATAC 8000
- Vital Diagnostics Envoy 500

H. Major In Vitro Diagnostic Technologies And Their Potential Applications
1. Monoclonal and Polyclonal Antibodies
2. Immunoassays
a. Technological Principle
b. Radioimmunoassays (RIA)
c. Enzyme Immunoassays (EIA)
- Overview
- ELISA
- EMIT
- Immunofiltration
- Dot Immunobinding Assays
- Capillary Immunoassays
- Particle-Membrane Capture Immunoassays
- Enzyme Amplification
- CEDIA
- Electrochemical Immunoassays
d. Fluorescent Immunoassays
- Fluorescence Polarization
- Time-Resolved Pulse Fluorescence
e. Luminescence
- Chemiluminescence
- Bioluminescence
f. Latex Agglutination
g. Immunoprecipitation
h. Affinity Chromatography Immunoassays
i. Liposome Flow-Injection Immunoassays
3. IT and Automation
4. Dry Chemistry
5. Biosensors
6. Robotics
7. Chemometrics
8. Molecular Diagnostics
a. Sample Preparation
b. Hybridization
c. Separation
d. Detection/Measurement
Test Formats
a. Filter Hybridization
b. Southern Blot
c. Northern Blot
d. In Situ Hybridization
e. Others
Labeling Techniques
Amplification Methods
- Polymerase Chain Reaction
-- Temperature Cyclers
-- PCR Variations
- Immuno-PCR
- QC-PCR.
- DAP-PCR
-- Strand Displacement Activation
-- TMA
-- Ligase Chain Reaction
-- Branched DNA
- Hybridization Protection Assay
-- Nucleic-Acid Sequence-Based Amplification
-- Self-Sustained Sequence Replicase
-- Others
- Ampliprobe
- CAR
- CAS
- CPT
- Dendritic Polymer Technology
- ISO-CR
- LAT
- Probe Networks
- RAMP
- Repair Chain Reaction
- Rolling Circles
- Sequence Independent Gene Amplification
- Sequence Initiation Reaction
- SISPA
- Solid Phase Amplification
Detection Technologies
a. Radioactive Methods
-- Overview
-- Major Isotopes
- P-32
- S-35
- H-3
- I-125
b. Non-Isotopic Methods
-- Enzymatic Labels
-- Chemical Labeling
- Indirect Chemical Labeling
- Direct Chemical Labeling
-- Fluorescence
-- Chemiluminescence
-- Electrical Conductivity
Instrumentation Review
a. Abbott LCx
b. Beckman Coulter/Biomek FK
c. Becton Dickinson SDA
d. Bio-Rad GeneScope
e. Gen-Probe Tigris
f. Roche Cobas Amplicor
g. Tecan LS Series
Biochips: Genosensors, Microarrays, and Labs-on-the-chip
- Liquid Transportation and Mixing
- Separation
- Reaction
- Detection

Worldwide Market Overview
1. Business Environment
2. Market Structure
3. Market Size and Growth

France
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers'
Instrument and Reagent Sales and Market Shares

Germany
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers'
Instrument and Reagent Sales and Market Shares

Italy
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers'
Instrument and Reagent Sales and Market Shares

Japan
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers'
Instrument and Reagent Sales and Market Shares

Spain
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers'
Instrument and Reagent Sales and Market Shares

U.K.
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers'
Instrument and Reagent Sales and Market Shares

U.S.A.
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 Illness
b. Disease Incidence
c. Susceptibility to Iatrogenesis
d. Multiple Illness Cases
11. Laboratory Regulations

C. Market Structure
1. Centralized Testing
a. Hospitals
b. Commercial/Private 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'
Instrument and Reagent Sales and Market Shares
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 Laboratories
- AdnaGen
- Ambrilia
- AMDL
- Beckman Coulter
- Biomedical Diagnostics
- BioMerieux
- Bio-Rad
- Canag Diagnostics
- Dako
- DiaSorin
- Eiken
- Fujirebio
- Instrumentation Laboratory
- J&J
- Kyowa Medex
- Matritech
- Roche
- Siemens
- Sysmex
- Thermo Fisher
- Trinity Biotech
- Tosoh
- Wako
- Wallac

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