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  5. > Competing in the 2016-2020 Global Clinical Chemistry and Immunodiagnostic Markets

The new seven-country market intelligence and technology assessment study from VPGMarketResearch.com was designed to help current suppliers and potential market entrants identify and evaluate emerging opportunities and develop effective strategic responses. 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 supplier 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 clinical chemistry and immunodiagnostics 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, begin to resemble 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.

The report contains 1,200 pages, 500 tables, and presents:

  • Major issues pertaining to the global clinical chemistry and immunodiagnostic laboratory practice, as well as key economic, regulatory, demographic, social and technological trends with significant market impact during the next five years.
  • Five-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-year volume forecasts for serum, whole blood, plasma, CFS, urine and other specimens.
  • Five-year reagent and instrument sales forecasts.
  • Review of current instrumentation technologies, and a feature comparison of 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.
  • Profiles of current and emerging suppliers, including their sales, market shares, product portfolios, marketing tactics, technological know-how, new products in R&D, collaborative arrangements and business strategies.
  • Market penetration strategies, entry barriers and risks.

Table Of Contents

Competing in the 2016-2020 Global Clinical Chemistry and Immunodiagnostic Markets
I. Introduction
II. Worldwide Market Overview
1. Business Environment
2. Market Structure
3. Market Size and Growth
III. Major Product Development Opportunities
IV. Design Criteria for Decentralized Testing Products
V. Alternative Market Penetration Strategies
A. Internal Development
B. Collaborative Arrangements
C. University Contracts
D. Distribution Strategies for Decentralized Testing Markets
VI. 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
VII. 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. Clinical Chemistry and Immunodiagnostic Instrumentation Review:
operating characteristics and features of high-, medium-, and
low-volume/POC analyzers
H. Major Cliinical Chemistry and Immunodiagnostic Technologies
and Their Potential Applications
1. Monoclonal and Polyclonal Antibodies
2. Immunoassays
3. Tandem Mass Spec
4. IT and Automation
5. Dry Chemistry
6. Biosensors

VIII. France Clinical Chemistry and Immunodiagnostics Market
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Test Volume and Sales Forecasts by Market Segment,
Major Supplier Instrument, Reagent Sales and Market Shares
IX. Germany Clinical Chemistry and Immunodiagnostics Market
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Test Volume and Sales Forecasts by Market Segment,
Major Supplier Instrument, Reagent Sales and Market Shares
X. Italy Clinical Chemistry and Immunodiagnostics Market
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Test Volume and Sales Forecasts by Market Segment,
Major Supplier Instrument, Reagent Sales and Market Shares
XI. Japan Clinical Chemistry and Immunodiagnostics Market
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Test Volume and Sales Forecasts by Market Segment,
Major Supplier Instrument, Reagent Sales and Market Shares
XII. Spain Clinical Chemistry and Immunodiagnostics Market
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Test Volume and Sales Forecasts by Market Segment,
Major Supplier Instrument, Reagent Sales and Market Shares

XIII. U.K. Clinical Chemistry and Immunodiagnostics Market
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Test Volume and Sales Forecasts by Market Segment,
Major Supplier Instrument, Reagent Sales and Market Shares
XIV. U.S.A. Clinical Chemistry and Immunodiagnostics Market
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Test Volume and Sales Forecasts by Market Segment,
Major Supplier Instrument, Reagent Sales and Market Shares
XV. 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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