2024 US Immunoassay Analyzers and Reagents Supplier Shares 

2024 US Immunoassay Analyzers and Reagents--2023 Supplier Shares and Competitive Analysis, 2023-2028 Volume and Sales Segment Forecasts for 100 Abused Drugs, Cancer Diagnostic, Endocrine Function, Immunoproteins, TDMs, and Special Chemistry Tests Performed in Hospitals, Commercial/Private Labs and POC Locations--Latest Technologies and Instrumentation Pipeline, Emerging Opportunities for Suppliers

new report is a study of the major business opportunities emerging in the U.S. immunoassay 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 immunoassay market is 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 immunoassay 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 immunoassay 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
- PerkinElmer
- Quest Diagnostics
- QuidelOrtho
- Roche
- Siemens Healthineers
- Sysmex
- Thermo Fisher
- Tosoh

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

List Of Tables

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
Executive Summary Table: U.S.A., 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 Immunoprotein
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

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