“2014 Strategies for the Japanese Clinical Chemistry and Immunodiagnostic Market” is a new strategic analysis of major business opportunities emerging in the Japanese clinical chemistry and immunodiagnostic markets during the next five years. The report explores future trends in the Japanese 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

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.

Table of Contents

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. CardiCRP
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/IPTH
10. Prolactin
11. T3
12. T3 Free
13. T3 Uptake
14. T4 (Thyroxine)
15. T4 Free
16. TBG
17. Testosterone
18. Thyroglobulin Ab
19. TPAb
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 VitrDiagnostic 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. Japan
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
- ThermFisher
- 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: Japan, Clinical Chemistry and Immunoassay Test Volume and Diagnostics Sales Forecast By Test Category
Japan, Laboratories Performing Chemistry and Immunoassay Testing By Market Segment
Japan, Hospital Laboratories Performing Chemistry and Immunoassay Tests By Bed Size
Japan, Commercial/Private Laboratories Performing Chemistry and Immunoassay Tests by Annual Test Volume
Japan, Total Chemistry and Immunoassay Specimen Volume Forecast
Japan, All Market Segments, Specimen Volume Forecast By Test Category
Japan, Total Clinical Chemistry and Immunoassay Test Volume Forecast By Test Category
Japan, Routine Chemistry Test Volume Forecast By Market Segment
Japan, Endocrine Function Test Volume Forecast By Market Segment
Japan, Tumor Markers and Special Chemistry Test Volume Forecast By Market Segment
Japan, Immunoprotein Test Volume Forecast By Market Segment
Japan, TDM Test Volume Forecast By Market Segment
Japan, Drugs of Abuse Test Volume Forecast By Market Segment
Japan, All Market Segments, Profiles, Panels and Individual Tests Forecast
Japan, Hospital Laboratories, Profiles, Panels and Individual Tests Forecast
Japan, Commercial/Private Laboratories, Profiles, Panels and Individual Tests Forecast
Japan, All Market Segments, Routine Chemistry Test Volume Forecast by Assay
Japan, Hospital Laboratories, Routine Chemistry Test Volume Forecast by Assay
Japan, Commercial/Private Laboratories, Routine Chemistry Test Volume Forecast by Assay
Japan, All Market Segments, Endocrine Function Test Volume Forecast by Assay
Japan, Hospital Laboratories, Endocrine Function Test Volume Forecast by Assay
Japan, Commercial/Private Laboratories, Endocrine Function Test Volume Forecast by Assay
Japan, All Market Segments, Tumor Markers and Special Chemistry Test Volume Forecast by Assay
Japan, Hospital Laboratories, Tumor Markers and Special Chemistry Test Volume Forecast by Assay
Japan, Commercial/Private Laboratories, Tumor Markers and Special Chemistry Test Volume Forecast by Assay
Japan, All Market Segments, Immunoprotein Test Volume Forecast by Assay
Japan, Hospital Laboratories, Immunoprotein Test Volume Forecast by Assay
Japan, Commercial/Private Laboratories, Immunoprotein Test Volume Forecast by Assay
Japan, All Market Segments, TDM Test Volume Forecast by Assay
Japan, Hospital Laboratories, TDM Test Volume Forecast by Assay
Japan, Commercial/Private Laboratories, TDM Test Volume Forecast by Assay
Japan, All Market Segments, Drugs of Abuse Test Volume Forecast by Assay
Japan, Hospital Laboratories, Drugs of Abuse Test Volume Forecast by Assay
Japan, Commercial/Private Laboratories, Drugs of Abuse Test Volume Forecast by Assay
Japan, Total Clinical Chemistry and Immunoassay Reagent Market Forecast By Test Category
Japan, Clinical Chemistry and Immunoassay Calibrator and Control Market Forecast By Test Category
Japan, Routine Chemistry Reagent Market Forecast By Market Segment
Japan, Endocrine Function Reagent Market Forecast By Market Segment
Japan, Tumor Markers and Special Chemistry Reagent Market Forecast By Market Segment
Japan, TDM Reagent Market Forecast by Market Segment
Japan, Immunoprotein Reagent Market Forecast by Market Segment
Japan, Drugs of Abuse Reagent Market Forecast by Market Segment
Japan, All Market Segments, Routine Chemistry Reagent Market Forecast by Assay
Japan, Hospital Laboratories, Routine Chemistry Reagent Market Forecast by Assay
Japan, Commercial/Private Laboratories, Routine Chemistry Reagent Market Forecast by Assay
Japan, All Market Segments, Endocrine Function Reagent Market Forecast by Assay
Japan, Hospital Laboratories, Endocrine Function Reagent Market Forecast by Assay
Japan, Commercial/Private Laboratories, Endocrine Function Reagent Market Forecast by Assay
Japan, All Market Segments, Tumor Markers and Special Chemistry Reagent Market Forecast by Assay
Japan, Hospital Laboratories, Tumor Markers and Special Chemistry Reagent Market Forecast by Assay
Japan, Commercial/Private Laboratories, Tumor Markers and Special Chemistry Reagent Market Forecast by Assay
Japan, All Market Segments, TDM Reagent Market Forecast by Assay
Japan, Hospital Laboratories, TDM Reagent Market Forecast by Assay
Japan, Commercial/Private Laboratories, TDM Reagent Market Forecast by Assay
Japan, All Market Segments, Immunoprotein Reagent Market Forecast by Assay
Japan, Hospital Laboratories, Immunoprotein Reagent Market Forecast by Assay
Japan, Commercial/Private Laboratories, Immunoprotein Reagent Market Forecast by Assay
Japan, All Market Segments, Drugs of Abuse Reagent Market Forecast by Assay
Japan, Hospital Laboratories, Drugs of Abuse Reagent Market Forecast by Assay
Japan, Commercial/Private Laboratories, Drugs of Abuse Reagent Market Forecast by Assay
Japan, Clinical Chemistry and Immunoassay Instrument Market Forecast By Analyzer Type
Japan, Major Suppliers of Clinical Chemistry Diagnostic Products, Estimated Sales and Market Shares
Japan, Major Suppliers of Immunoassay Products, Estimated Sales and Market Shares