Japan Clinical Chemistry and Immunodiagnostic Analyzers and Reagents for 100 Tests: Supplier Shares and Strategies, Volume and Sales Segment Forecasts, 2019-2023

This new report is a 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 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.

Tests Analyzed in the Report:

Routine Clinical Chemistry

Albumin, Alkaline Phosphatase, ALT/SGPT, Ammonia, Amylase, AST/SGOT, Bilirubin, Bilirubin Direct, Bilirubin Total, BNP, BUN (Blood Urea Nitrogen), Calcium, Carbon Dioxide/Bicarbonate, Cardio CRP, Chloride, Cholesterol, Creatine Kinase (CK), CK-MB, Creatinine, 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 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.

I. Introduction
II. Worldwide 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. 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. 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. Japan 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
- 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

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

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