North America Immunodiagnostic Analyzers and Reagents Market, 2019-2023: US, Canada, Mexico--Supplier Shares and Strategies, Volume and Sales Segment Forecasts, Technology and Instrumentation Review

This new 3-country report is available by country, market segment, section, or individual test.

This report provides a granular strategic analysis of over 100 clinical chemistry, TDM, endocrine, cancer, immunoprotein and abused drug assays performed in both centralized (hospitals, commercial laboratories), and POC/decentralized locations. The report explores future market trends; forecasts specimen, test and sales volume; estimates sales and market shares of key suppliers in major countries; compares features of leading analyzers; profiles key competitors; and identifies specific product and marketing opportunities for reagent and instrument suppliers.

Rationale

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.

Country Analyses

Canada, Mexico, USA

Global Market Overview

- Estimates of facilities performing clinical chemistry and immunodiagnostic tests in major countries.

- Test volume and sales projections.

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.

Individual Tests Analyzed in the Report

Clinical Chemistry

Albumin, Alkaline Phosphatase, ALT/SGPT, Ammonia, Amylase, AST/SGOT, Bilirubin (Direct), Bilirubin (Total), BNP, BUN (Blood Urea Nitrogen), Calcium, Carbon Dioxide/Bicarbonate, Cardio CRP, Chloride, Cholesterol, Creatine Kinase (CK), CK-MB, Creatinine, CRP, Cystatin C, Ferritin, Fructosamine, GGT, Glucose, HDL Cholesterol, Homocysteine, hs-CRP, Insulin, Iron, Iron (Total Binding Capacity), Iron (Unsaturated Binding Capacity), LDH, LDL Cholesterol, LDL Cholesterol Direct, Lipase, Lipoprotein a, Magnesium, Microalbumin, NT-proBNP, Phosphorus, Potassium, Sodium, ST2, Total Protein, 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 Free, T3 Uptake, T4, T4 Free, 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, Antidepressants, 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.

- Companies developing or marketing new technologies and products by test.

Strategic Recommendations

- New product development opportunities with significant market appeal.

- Alternative market penetration strategies.

- Potential market entry barriers and risks.

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.

- 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

Contains 635 pages and 150 tables

I. Introduction
II. Market Overview
A. Business Environment
B. Market Structure
C. 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. BNP
11. Calcium
12. Cardio CRP
13. Cholesterol
14. Cholinesterase

15. CRP
16. Creatinine
17. Electrolytes
a. Carbon Dioxide/Bicarbonate
b. Chloride
c. Potassium
d. Sodium
18. Ferritin
19. Fructosamine
20. Gamma-Glutamyl Transpeptidase (GGT)
21. Glucose
22. High Density Lipoprotein (HDL)
23. Homocysteine
24. hs-CRP
25. Iron
26. Lactate Dehydrogenase (LDH)
27. Magnesium
28. NT-proBNP
29. Phosphorus
30. Protein
31. ST2
32. Triglycerides
33. Uric Acid
34. 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 Clinical 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. Country Analyses: Volume and Sales Forecasts for over 100 Immunodiagnostic, Drug of Abuse,
Endocrine Function, Immunoprotein, Therapeutic Drug Monitoring (TDM), Tumor Marker and Special
Chemistry Tests
- Canada
- Mexico
- USA
IX. 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

List Of Tables

Canada Total Chemistry and Immunoassay
Specimen Volume Forecast by Specimen Type
Canada All Market Segments, Routine
Chemistry Test Volume Forecast by Assay
Canada All Market Segments, Endocrine
Function Test Volume Forecast by Assay
Canada All Market Segments, Tumor Markers
and Special Chemistry Test Volume
Forecast by Assay
Canada All Market Segments, Immunoprotein
Test Volume Forecast by Assay
Canada All Market Segments, TDM
Test Volume Forecast by Assay
Canada All Market Segments, Drugs
of Abuse Test Volume Forecast by Assay
Canada Clinical Chemistry and Immunoassay
Calibrator and Control Market Forecast
by Test Category
Canada All Market Segments, Routine
Chemistry Reagent Market Forecast by Assay
Canada All Market Segments, Endocrine
Function Reagent Market Forecast by Assay
Canada All Market Segments, Tumor Markers
and Special Chemistry Reagent Market
Forecast by Assay
Canada All Market Segments, Immunoprotein
Reagent Market Forecast by Assay
Canada All Market Segments, TDM
Reagent Market Forecast by Assay
Canada All Market Segments, Drugs
of Abuse Reagent Market Forecast by Assay

Canada Clinical Chemistry and Immunoassay
Instrument Market Forecast by Analyzer Type
Mexico Total Chemistry and Immunoassay
Specimen Volume Forecast by Specimen Type
Mexico All Market Segments, Routine
Chemistry Test Volume Forecast by Assay
Mexico All Market Segments, Endocrine
Function Test Volume Forecast by Assay
Mexico All Market Segments, Tumor Markers
and Special Chemistry Test Volume
Forecast by Assay
Mexico All Market Segments, Immunoprotein
Test Volume Forecast by Assay
Mexico All Market Segments, TDM
Test Volume Forecast by Assay
Mexico All Market Segments, Drugs
of Abuse Test Volume Forecast by Assay
Mexico Clinical Chemistry and Immunoassay
Calibrator and Control Market Forecast
by Test Category
Mexico All Market Segments, Routine
Chemistry Reagent Market Forecast by Assay
Mexico All Market Segments, Endocrine
Function Reagent Market Forecast by Assay
Mexico All Market Segments, Tumor Markers
and Special Chemistry Reagent Market
Forecast by Assay
Mexico All Market Segments, Immunoprotein
Reagent Market Forecast by Assay
Mexico All Market Segments, TDM
Reagent Market Forecast by Assay

Mexico All Market Segments, Drugs
of Abuse Reagent Market Forecast by Assay
Mexico Clinical Chemistry and Immunoassay
Instrument Market Forecast by Analyzer Type
U.S.A. Executive Summary Table: Clinical Chemistry
and Immunoassay Test Volume and Diagnostics
Sales Forecast by Test Category
U.S.A., Laboratories Performing Chemistry and
Immunoassay Testing by Market Segment
U.S.A., Hospital Laboratories Performing Chemistry
and Immunoassay Tests by Bed Size
U.S.A., Commercial/Private Laboratories Performing
Chemistry and Immunoassay Tests by
Annual Test Volume
U.S.A., Total Chemistry and Immunoassay
Specimen Volume Forecast
U.S.A., All Market Segments, Specimen Volume
Forecast by Test Category
U.S.A., Total Clinical Chemistry and Immunoassay
Test Volume Forecast by Test Category
U.S.A., Routine Chemistry Test Volume
Forecast by Market Segment
U.S.A., TDM Test Volume Forecast
by Market Segment
U.S.A., Endocrine Function Test Volume
Forecast by Market Segment
U.S.A., Drugs of Abuse Test Volume
Forecast by Market Segment
U.S.A., Tumor Markers and Special Chemistry
Test Volume Forecast by Market Segment

U.S.A., Immunoprotein Test Volume
Forecast by Market Segment
U.S.A., All Market Segments, Profiles,
Panels and Individual Tests Forecast
U.S.A., Hospital Laboratories, Profiles,
Panels and Individual Tests Forecast
U.S.A., Commercial/Private Laboratories,
Profiles, Panels and Individual Tests Forecast
U.S.A., Physician Offices/Group Practices,
Profiles, Panels and Individual Tests Forecast
U.S.A., All Market Segments, Routine Chemistry
Test Volume Forecast by Assay
U.S.A., Hospital Laboratories, Routine Chemistry
Test Volume Forecast by Assay
U.S.A., Commercial/Private Laboratories,
Routine Chemistry Test Volume
Forecast by Assay
U.S.A., Physician Offices/Group Practices,
Routine Chemistry Test Volume
Forecast by Assay
U.S.A., All Market Segments, TDM Test
Volume Forecast by Assay
U.S.A., Hospital Laboratories, TDM Test
Volume Forecast by Assay
U.S.A., Commercial/Private Laboratories,
TDM Test Volume Forecast by Assay
U.S.A., Physician Offices/Group Practices,
TDM Test Volume Forecast by Assay
U.S.A., All Market Segments, Endocrine Function
Test Volume Forecast by Assay

U.S.A., Hospital Laboratories, Endocrine Function
Test Volume Forecast by Assay
U.S.A., Commercial/Private Laboratories,
Endocrine Function Test Volume
Forecast by Assay
U.S.A., Physician Offices/Group Practices,
Endocrine Function Test Volume
Forecast by Assay
U.S.A., All Market Segments, Drugs of Abuse
Test Volume Forecast by Assay
U.S.A., Hospital Laboratories, Drugs of Abuse
Test Volume Forecast by Assay
U.S.A., Commercial/Private Laboratories,
Drugs of Abuse Test Volume Forecast by Assay
U.S.A., Physician Offices/Group Practices,
Drugs of Abuse Test Volume Forecast by Assay
U.S.A., All Market Segments, Tumor Markers
and Special Chemistry Test Volume
Forecast by Assay
U.S.A., Hospital Laboratories, Tumor Markers
and Special Chemistry Test Volume
Forecast by Assay
U.S.A., Commercial/Private Laboratories,
Tumor Markers and Special Chemistry
Test Volume Forecast by Assay
U.S.A., Physician Offices/Group Practices,
Tumor Markers and Special Chemistry
Test Volume Forecast by Assay
U.S.A., All Market Segments, Immunoprotein
Test Volume Forecast by Assay
U.S.A., Hospital Laboratories, Immunoprotein
Test Volume Forecast by Assay

U.S.A., Commercial/Private Laboratories,
Immunoprotein Test Volume
Forecast by Assay
U.S.A., Physician Offices/Group Practices,
Immunoprotein Test Volume
Forecast by Assay
U.S.A., Total Clinical Chemistry and Immunoassay
Reagent Market Forecast by Test Category
U.S.A., Clinical Chemistry and Immunoassay Calibrator
and Control Market Forecast by Test Category
U.S.A., Routine Chemistry Reagent Market
Forecast by Market Segment
U.S.A., TDM Reagent Market Forecast
by Market Segment
U.S.A., Drugs of Abuse Reagent Market
Forecast by Market Segment
U.S.A., Tumor Markers and Special Chemistry
Reagent Market Forecast by Market Segment
U.S.A., Endocrine Function Reagent Market
Forecast by Market Segment
U.S.A., All Market Segments, Routine Chemistry
Reagent Market Forecast by Assay
U.S.A., Hospital Laboratories, Routine Chemistry
Reagent Market Forecast by Assay
U.S.A., Commercial/Private Laboratories,
Routine Chemistry Reagent Market
Forecast by Assay
U.S.A., Physician Offices/Group Practices,
Routine Chemistry Reagent Market
Forecast by Assay
U.S.A., All Market Segments, TDM Reagent
Market Forecast by Assay

U.S.A., Hospital Laboratories, TDM Reagent
Market Forecast by Assay
U.S.A., Commercial/Private Laboratories,
TDM Reagent Market Forecast by Assay
U.S.A., Physician Office/Group Practices,
TDM Reagent Market Forecast by Assay
U.S.A., All Market Segments, Drugs of Abuse
Reagent Market Forecast by Assay
U.S.A., Hospital Laboratories, Drugs of Abuse
Reagent Market Forecast by Assay
U.S.A., Commercial/Private Laboratories,
Drugs of Abuse Reagent Market
Forecast by Assay
U.S.A., Physician Offices/Group Practices,
Drugs of Abuse Reagent Market
Forecast by Assay
U.S.A., All Market Segments, Endocrine Function
Reagent Market Forecast by Assay
U.S.A., Hospital Laboratories, Endocrine Function
Reagent Market Forecast by Assay
U.S.A., Commercial/Private Laboratories,
Endocrine Function Reagent Market
Forecast by Assay
U.S.A., Physician Offices/Group Practices,
Endocrine Function Reagent Market
Forecast by Assay
U.S.A., All Market Segments, Tumor Markers
and Special Chemistry Reagent Market
Forecast by Assay
U.S.A., Hospital Laboratories, Tumor Markers
and Special Chemistry Reagent Market
Forecast by Assay

U.S.A., Commercial/Private Laboratories,
Tumor Markers and Special Chemistry
Reagent Market Forecast by Assay
U.S.A., Physician Offices/Group Practices,
Tumor Markers and Special Chemistry
Reagent Market Forecast by Assay
U.S.A., All Market Segments, Immunoprotein
Reagent Market Forecast
U.S.A., Hospital Laboratories, Immunoprotein
Reagent Market Forecast
U.S.A., Commercial/Private Laboratories,
Immunoprotein Reagent Market Forecast
U.S.A., Physician Offices/Group Practices,
Immunoprotein Reagent Market
Forecast by Assay
U.S.A., Major Suppliers of Clinical Chemistry Reagents,
Estimated Sales and Market Shares
U.S.A., Major Suppliers of Clinical Chemistry Analyzers,
Estimated Instrument Sales and Market Shares
U.S.A., Major Suppliers of Clinical Chemistry
Diagnostics Products, Estimated Sales
and Market Shares
U.S.A., Major Suppliers of Immunoassay Reagents,
Estimated Sales and Market Shares
U.S.A., Major Suppliers of Immunoassay Analyzers,
Estimated Instrument Sales and Market Shares
U.S.A., Major Suppliers of Immunoassay
Diagnostics Products, Estimated Sales
and Market Shares
U.S.A., Clinical Chemistry and Immunoassay
Instrument Market Forecast by Analyzer Type

Major Companies Developing or Marketing
Albumin Tests
Major Companies Developing or Marketing
Alkaline Phosphatase Tests
Major Companies Developing or Marketing
ALT/SGPT Tests
Major Companies Developing or Marketing
Amylase Tests
Major Companies Developing or Marketing
AST/SGOT Tests
Major Companies Developing or Marketing
Bilirubin Tests
Major Companies Developing or Marketing
Blood Gas Analyzers
Major Companies Developing or Marketing
BUN Tests
Major Companies Developing or Marketing
Calcium Tests
Major Companies Developing or Marketing
Cholesterol Tests
Major Companies Developing or Marketing
Creatinine Tests
Major Companies Developing or Marketing
Electrolyte Tests
Major Companies Developing or Marketing
GGT Tests
Major Companies Developing or Marketing
Glucose Tests
Major Companies Developing or Marketing
HDL Tests

Major Companies Developing or Marketing
Iron Tests
Major Companies Developing or Marketing
LDH Tests
Major Companies Developing or Marketing
Magnesium Tests
Major Companies Developing or Marketing
Phosphorus Tests
Major Companies Developing or Marketing
Protein Tests
Major Companies Developing or Marketing
Triglycerides Tests
Major Companies Developing or Marketing
Uric Acid Tests
Major Companies Developing or Marketing
TDM Tests
Major Companies Developing or Marketing
Digoxin Tests
Major Companies Developing or Marketing
Lithium Tests
Major Companies Developing or Marketing
Phenytoin/Dilantin Tests
Major Companies Developing or Marketing
Theophylline Tests
Major Companies Developing or Marketing
Valproic Acid Tests
Major Companies Developing or Marketing
FSH Tests
Major Companies Developing or Marketing
HCG Tests

Major Companies Developing or Marketing
LH Tests
Major Companies Developing or Marketing
Prolactin Tests
Major Companies Developing or Marketing
T3 Tests
Major Companies Developing or Marketing
T4 Tests
Major Companies Developing or Marketing
TSH Tests
Major Companies Developing or Marketing
AFP Tests
Major Companies Developing or Marketing
CEA Tests
Major Companies Developing or Marketing
Ferritin Tests
Major Companies Developing or Marketing
Occult Blood Tests
Major Companies Developing or Marketing
Prostatic Acid Phosphatase Tests
Major Companies Developing or Marketing
PSA Tests
Major Companies Developing or Marketing
Vitamin B-12/Folate Tests
Major Companies Developing or Marketing
CRP Tests
Major Companies Developing or Marketing
Drugs of Abuse Tests
Major Companies Developing or Marketing
Biosensors for Immunological Testing

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