US Clinical Chemistry and Immunodiagnostic Market 2014 - Sales Forecasts, Supplier Shares, Competitive Strategies




Published: January 2014 | Pages: 600 | Format: PDF

 "US Clinical Chemistry and Immunodiagnostic Market 2014: Sales Forecasts, Supplier Shares, Competitive Strategies" is a new strategic analysis of major business opportunities emerging in the US clinical chemistry and immunodiagnostic markets during the next five years. The report explores future trends in the US 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 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. 

 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.  

 - The companies analyzed in the report include Abbott, AdnaGen, Agilent, Alere, Beckman Coulter/Danaher, Biomedical Diagnostics, bioMerieux, Bio-Rad, DiaSorin, Eiken, Fujirebio/Innogenetics, IL, Kyowa Medex, Ortho-Clinical Diagnotics, Roche, Siemens, Sysmex, Thermo Fisher, Tosoh, Wako, Wallac/PE. 

 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. 

 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 

 -Physician Offices/Group Practices 

 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. 

 Contains 600 pages and 120 tables 

 I. Introduction 

 II. 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. Instrumentation Review: Operating characteristics  

 and features of high-, medium-, and low-volume/POC analyzers 

 H. Major In Vitro Diagnostic Technologies 

 And Their Potential Applications 

 1. Monoclonal and Polyclonal Antibodies 

 2. Immunoassays 

 a. Technological Principle 

 b. Chemiluminescence  

 c. Enzyme Immunoassays (EIA) 

 ° Overview 

 ° ELISA 

 ° EMIT 

 ° Electrochemical 

 d. Radioimmunoassays (RIA) 

 e. Immunoprecipitation 

 f. Affinity Chromatography 

 3. Tandem Mass Spec 

 4. IT and Automation 

 5. Dry Chemistry 

 6. Biosensors 

 VI. U.S.A. 

 A. Executive Summary 

 B. Business Environment 

 C. Market Structure 

 D. Market Size, Growth and Major Suppliers' 

 Instrument and Reagent Sales and Market Shares 

 X. Major Product Development Opportunities 

 XI. Design Criteria for Decentralized Testing Products 

 XII. Alternative Market Penetration Strategies 

 A. Internal Development 

 B. Collaborative Arrangements 

 C. University Contracts 

 D. Distribution Strategies for Decentralized Testing Markets 

 1. Marketing Approaches 

 2. Product Complexity 

 3. Customer Preference 

 4. Established Suppliers 

 5. Emerging Suppliers 

 6. Major Types of Distributors 

 7. Market Segmentation 

 XIII. 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 

 XIV. Competitive Assessments 

  

 - Abbott Laboratories 

 - AdnaGen 

 - Agilent Technologies  

 - Beckman Coulter/Danaher 

 - Biomedical Diagnostics 

 - BioMerieux 

 - Bio-Rad  

 - DiaSorin 

 - Eiken 

 - Fujirebio/Innogenetics 

 - Instrumentation Laboratory 

 - Kyowa Medex 

 - Matritech/Alere 

 - Ortho-Clinical Diagnostics 

 - Quest Diagnostics 

 - Roche 

 - Siemens 

 - Sysmex 

 - Thermo Fisher 

 - Tosoh 

 - Wako 

 - Wallac/PE 

  

 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