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2022 US Immunodiagnostic Analyzers and Reagents--Supplier Shares and Competitive Analysis, Volume and Sales Segment Forecasts for 100 Abused Drugs, Cancer Diagnostic, Endocrine Function, Immunoproteins, TDMs, and Special Chemistry Tests--Latest Technologies and Instrumentation Pipeline, Emerging Opportunities for Suppliers

DESCRIPTION

TABLE OF CONTENTS

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DESCRIPTION

LeadingMarketResearchs new report is a study of the major business opportunities emerging in the U.S. immunodiagnostic market during the next five years.

The report is available by section, and can be customized to specific information needs and budget. The report explores future trends in the U.S. market; 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 immunodiagnostic market 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.

U.S. Market Overview

- Estimates of facilities performing clinical chemistry and immunodiagnostic tests.
- Test volume and sales projections.

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.

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

Hospitals
Commercial/Private Laboratories
Physicians Offices/ Group Practices

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
- Agilent Technologies
- Beckman Coulter/Danaher
- bioMerieux
- Bio-Rad
- DiaSorin
- Eiken Chemical
- Fujifilm Wako
- Fujirebio
- Grifols
- Instrumentation Laboratory/Werfen
- Kyowa Medex
- Ortho-Clinical Diagnostics
- PerkinElmer
- Quest Diagnostics
- Roche
- Siemens Healthineers
- Sysmex
- Thermo Fisher
- Tosoh

TABLE OF CONTENTS

I. Introduction
II. 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. 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. 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
IX. Competitive Assessments
- Abbott Laboratories
- Agilent Technologies
- Beckman Coulter/Danaher
- bioMerieux
- Bio-Rad
- DiaSorin
- Eiken Chemical
- Fujirebio
- Grifols
- Instrumentation Laboratory/Werfen
- Kyowa Medex
- Ortho-Clinical Diagnostics
- PerkinElmer
- Quest Diagnostics
- Roche
- Siemens Healthineers
- Sysmex
- Thermo Fisher
- Tosoh
- Wako

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