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Complete report $24,500.  DataPack (test volumes, sales forecasts, supplier shares) $15,900.

VPGMarketResearch’s new seven-country report is a strategic analysis of major business opportunities emerging in the global clinical chemistry and immunodiagnostic markets during the next five years.

The report explores future trends in the U.S., five major European countries (France, Germany, Italy, Spain, UK) and Japan; provides estimates of the specimen, test and sales volumes, as well as major suppliers’ sales and market shares; compares features of leading analyzers; profiles key competitors; and identifies specific product and marketing opportunities emerging during the next five years.

The report provides five-year volume and sales forecasts for over 100 clinical chemistry, TDM, endocrine, cancer, immunoprotein and abused drug assays performed in hospitals, commercial laboratories, physician offices, and ambulatory care centers, including controls, calibrators and consumables.

Rationale

The clinical chemistry and immunodiagnostic markets are undergoing significant transformation, caused by convergence of new and more stringent regulations; advances in diagnostic technologies, system engineering, automation, and IT; and intensifying competition.  Some segments, like routine chemistry, are already resembling commodity markets, where product positioning and cost per test are more critical than underlying technology.  This evolving marketplace creates exciting opportunities for a variety of new instruments, reagent systems, and auxiliary products, such as specimen preparation devices, controls, and calibrators.

Geographic Coverage

France, Germany, Italy, Japan, Spain, UK, USA

Worldwide Market Overview

- Estimates of facilities performing clinical chemistry and immunodiagnostic tests by country.

- Test volume and sales projections by country.

Strategic Recommendations

- New product development opportunities with significant market appeal.

- Alternative market penetration strategies.

- Potential market entry barriers and risks.

Market Segmentation Analysis

- Comprehensive review of the market dynamics, trends, structure, size, growth, and key suppliers, by country.

- Test volume and sales forecasts for over 100 clinical chemistry, TDM, endocrine, cancer, immunoprotein and abused drug assays, by country and market segment:

     ° Hospitals
     ° Commercial/Private Laboratories
     ° Physician Offices/Group Practices
     ° Ambulatory Care Centers

Tests Analyzed in the Report

Routine Clinical Chemistry

Albumin, Alkaline Phosphatase, ALT/SGPT, Ammonia, Amylase, AST/SGOT, Bilirubin, Total, BUN (Blood Urea Nitrogen), Calcium, Cardio CRP, Carbon Dioxide/Bicarbonate, Chloride, Cholesterol, Creatine Kinase (CK), CK-MB, Creatinine, CRP, Ferritin, GGT, Glucose, HDL Cholesterol, Homocysteine, Iron, LDH, LDL Cholesterol, Magnesium, Phosphorus, Potassium, Protein, Total, Sodium, Triglycerides, Troponin, Uric Acid.

Therapeutic Drug Monitoring (TDM)

Amikacin, Carbamazepine, Cyclosporin, Digoxin, Everolimus, Gentamicin, Levetiracetam, Lithium, Methotrexate, NAPA/Procainamide, Phenobarbital, Phenytoin, Quinidine, Sirolimus, Tacrolimus, Theophylline, Tobramycin, Topirimate, Valproic Acid, Vancomycin.

Endocrine Function
Cortisol, Estradiol, FSH, HCG, Gastrin, LH, Progesterone, PTH/IO PTH, Prolactin, T3, T3 Uptake,  Free T3, T4, Free T4, TBG, Testosterone, Thyroglobulin Ab,  TPO Ab, TSH.

Tumor Markers and Special Chemistry

AFP, CA 15-3/27-29, CA 19-9, CEA, Ferritin, Follate (Folic Acid), Glycosylated Hemoglobin, HCG, 25-Hydroxy Vitamin D2 and D3, Occult Blood, PAP, PSA, Thyroglobulin, Vitamin B-12.

Immunoproteins

C3, C4, Free Light Chains, Haptoglobin, IgA, IgE Specific, IgE Total, IgG, IgM, Immunofixation, Prealbumin, Protein Electrophoresis.

Drugs of Abuse

Amphetamines, Barbiturates, Benzodiazepines, Cannabinoids/Marijuana, Cocaine, LSD, Methadone, Methaqualone, Opiates, Phencyclidine (PCP), Propoxyphene, Tricyclic Antidepressants.

Current and Emerging Products

- Analysis of current and emerging clinical chemistry and immunodiagnostic tests.

- Review of current instrumentation technologies, and feature comparison of high-, medium-, and low-volume/POC analyzers.

Technology Review

- Assessment of current and emerging technologies, and their potential  market applications.

- Comprehensive lists of companies developing or marketing new technologies and products by test.

Competitive Assessments

- Strategic assessments of major suppliers and emerging market entrants, including their sales, product portfolios, marketing tactics, collaborative arrangements and new products in R&D.

- The companies analyzed in the report include:

   - Abbott Laboratories
   - AdnaGen
   - Agilent Technologies
   - Bayer Healthcare
   - Beckman Coulter/Danaher
   - Biomedical Diagnostics
   - BioMerieux
   - Bio-Rad
   - DiaSorin
   - Eiken
   - Fujirebio
   - Grifols
   - Instrumentation Laboratory
   - Kyowa Medex
   - Matritech/Alere
   - Ortho-Clinical Diagnostics
   - Quest Diagnostics
   - Roche
   - Siemens
   - Sysmex
   - Thermo Fisher
   - Tosoh
   - Wako
   - Wallac/PE

Contains 1,115 pages and 450 tables

Table Of Contents

Clinical Chemistry and Immunodiagnostics: A Market in Transition amid Regulatory Uncertainty and Intensifying Competition--Technological Breakthroughs, Emerging Tests, Market Forecasts, Competitive Intelligence
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, Total
8. Blood Gases
9. Blood Urea Nitrogen (BUN)
10. Calcium
11. Cardio CRP
12. Cholesterol
13. Cholinesterase
14. CRP
15. Creatinine
16. Electrolytes
a. Carbon Dioxide/Bicarbonate
b. Chloride
c. Potassium
d. Sodium
17. Ferritin
18. Fructosamine
19. Gamma-Glutamyl Transpeptidase (GGT)
20. Glucose
21. High Density Lipoprotein (HDL)
22. Homocysteine
23. Iron
24. Lactate Dehydrogenase (LDH)
25. Magnesium
26. Phosphorus
27. Protein
28. Triglycerides
29. Uric Acid
30. Troponin

B. Therapeutic Drug Monitoring (TDM)
1. Overview
2. Carbamazepine
3. Cyclosporin
4. Digoxin
5. Everolimus
6. Gentamicin
7. Lamotrigine/Lamictal
8. Levetiracetam
9. Lidocaine
10. Lithium
11. NAPA/Procainamide
12. Phenytoin
13. Quinidine
14. Sirolimus
15. Tacrolimus
16. Theophylline
17. Topirimate
18. Valproic Acid
C. Endocrine Function Tests
1. Cortisol
2. Estradiol
3. Follicle-Stimulating Hormone (FSH)
4. Gastrin
5. Growth Hormone/IGF-1
6. Human Chorionic Gonadotropin (HCG)
7. LH
8. Progesterone
9. PTH/IO PTH
10. Prolactin
11. T3
12. T3 Free
13. T3 Uptake
14. T4 (Thyroxine)
15. T4 Free
16. TBG
17. Testosterone
18. Thyroglobulin Ab
19. TPO Ab
20. TSH

D. Tumor Markers And Special Chemistry Tests
1. AFP
2. CA 15-3
3. CA 19-9
4. CA 27-29
5. Carcinoembrionic Antigen (CEA)
6. Folate/Folic Acid
7. HCG
8. 25-Hydroxy Vitamin D2 and D3
9. Occult Blood
10. Prostate-Specific Antigen (PSA)
11. Thyroglobulin
12. Vitamin B-12
E. Immunoprotein Tests
1. Complement
a. C3
b. C4
2. Free Light Chains
3. Immunofixation
4. Immunoglobulins (IgA, IgE, IgG, IgM)
5. Haptoglobin
6. Prealbumin
7. 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
13. Tricyclic Antidepressants

G. Instrumentation Review: Operating characteristics
and features of high-, medium-, and low-volume/POC analyzers
H. Major In Vitro Diagnostic Technologies
And Their Potential Applications
1. Monoclonal and Polyclonal Antibodies
2. Immunoassays
a. Technological Principle
b. Chemiluminescence
c. Enzyme Immunoassays (EIA)
° Overview
° ELISA
° EMIT
° Electrochemical
d. Radioimmunoassays (RIA)
e. Immunoprecipitation
f. Affinity Chromatography
3. Tandem Mass Spec
4. IT and Automation
5. Dry Chemistry
6. Biosensors
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
C. Market Structure
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/Alere
- Agilent Technologies
- Bayer Healthcare
- Beckman Coulter/Danaher
- Biomedical Diagnostics
- BioMerieux
- Bio-Rad
- DiaSorin
- Eiken
- Fujirebio
- Grifols
- Instrumentation Laboratory
- Kyowa Medex
- Matritech/Alere
- Ortho-Clinical Diagnostics
- Quest Diagnostics
- Roche
- Siemens
- Sysmex
- Thermo Fisher
- Tosoh
- Wako
- Wallac/PE

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