2024 US Immunodiagnostic Analyzers and Reagents Market Shares and Forecasts for Over 100 Tests: Growth Opportunities, Supplier Strategies, Emerging Technologies, Latest Instrumentation

May 2020 | 600 pages | ID: 2649169990CFEN
Venture Planning Group

Abstracts

VPGMarketResearch’s 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.

Contains 600 pages and 120 tables

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

List Of Tables

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