2019-2023 Global Immunodiagnostic Analyzers and Reagents Market: Emerging Opportunities in Americas, EMEA, APAC--A 75-Country Survey--Supplier Shares and Strategies, Volume and Sales Segment Forecasts, Technology and Instrumentation Review

This new 75-country survey provides a granular strategic analysis of over 100 clinical chemistry, TDM, endocrine, cancer, immunoprotein and abused drug assays performed in both centralized (hospitals, commercial laboratories), and POC/decentralized locations. The report explores future market trends; forecasts specimen, test and sales volume; estimates sales and market shares of key suppliers in major countries; compares features of leading analyzers; profiles key competitors; and identifies specific product and marketing opportunities for reagent and instrument suppliers.

Rationale

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.

Geographic Regions

Africa, Asia-Pacific, Europe, Latin America, Middle East, North America

Country Analyses

Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, UK, United Arab Emirates, USA, Venezuela, Vietnam

Global Market Overview

- Estimates of facilities performing clinical chemistry and immunodiagnostic tests in major countries.

- Test volume and sales projections.

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.

Individual Tests Analyzed in the Report

Clinical Chemistry

Albumin, Alkaline Phosphatase, ALT/SGPT, Ammonia, Amylase, AST/SGOT, Bilirubin (Direct), Bilirubin (Total), BNP, BUN (Blood Urea Nitrogen), Calcium, Carbon Dioxide/Bicarbonate, Cardio CRP, Chloride, Cholesterol, Creatine Kinase (CK), CK-MB, Creatinine, CRP, 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 Free, T3 Uptake, T4, T4 Free, 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, Antidepressants, 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.

- Companies developing or marketing new technologies and products by test.

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.

   - Abbott
   - AdnaGen
   - Agilent Technologies
   - Bayer Healthcare
   - Beckman Coulter/Danaher
   - Biomedical Diagnostics
   - Biomerieux
   - Bio-Rad
   - Diasorin
   - Eiken Chemical
   - Fujirebio
   - Grifols
   - Instrumentation Laboratory
   - Kyowa Medex
   - Matritech/Alere
   - Ortho-Clinical Diagnostics
   - Quest Diagnostics
   - Roche
   - Siemens
   - Sysmex
   - Thermo Fisher/Affymetrix
   - Tosoh
   - Wako
   - Wallac/PE

I. Introduction
II. Worldwide Market Overview
A. Business Environment
B. Market Structure
C. 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. BNP
11. Calcium
12. Cardio CRP
13. Cholesterol
14. Cholinesterase

15. CRP
16. Creatinine
17. Electrolytes
a. Carbon Dioxide/Bicarbonate
b. Chloride
c. Potassium
d. Sodium
18. Ferritin
19. Fructosamine
20. Gamma-Glutamyl Transpeptidase (GGT)
21. Glucose
22. High Density Lipoprotein (HDL)
23. Homocysteine
24. hs-CRP
25. Iron
26. Lactate Dehydrogenase (LDH)
27. Magnesium
28. NT-proBNP
29. Phosphorus
30. Protein
31. ST2
32. Triglycerides
33. Uric Acid
34. 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 Clinical 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. Country Analyses: Volume and Sales Forecasts for over 100 Immunodiagnostic, Drug of Abuse,
Endocrine Function, Immunoprotein, Therapeutic Drug Monitoring (TDM), Tumor Marker and Special
Chemistry Tests
- Argentina
- Australia
- Austria

- Bahrain
- Bangladesh
- Belgium
- Brazil
- Bulgaria
- Canada
- Chile
- China
- Colombia
- Croatia
- Cyprus
- Czech Republic
- Denmark
- Egypt
- Estonia
- Finland
- France
- Germany
- Ghana
- Greece
- Hong Kong
- Hungary
- Iceland
- India
- Indonesia
- Iran
- Iraq
- Ireland
- Israel
- Italy
- Japan
- Jordan
- Kenya
- Kuwait
- Latvia
- Lebanon
- Lithuania
- Malaysia
- Malta
- Mexico
- Morocco
- Myanmar
- Netherlands
- New Zealand
- Nigeria

- Norway
- Oman
- Pakistan
- Peru
- Philippines
- Poland
- Portugal
- Qatar
- Romania
- Saudi Arabia
- Serbia
- Singapore
- Slovakia
- Slovenia
- South Africa
- South Korea
- Spain
- Sweden
- Switzerland
- Taiwan
- Thailand
- UK
- United Arab Emirates
- USA
- Venezuela
- Vietnam
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

Argentina Total Chemistry and Immunoassay
Specimen Volume Forecast by Specimen Type
Argentina All Market Segments, Routine
Chemistry Test Volume Forecast by Assay
Argentina All Market Segments, Endocrine
Function Test Volume Forecast by Assay
Argentina All Market Segments, Tumor Markers
and Special Chemistry Test Volume
Forecast by Assay
Argentina All Market Segments, Immunoprotein
Test Volume Forecast by Assay
Argentina All Market Segments, TDM
Test Volume Forecast by Assay
Argentina All Market Segments, Drugs
of Abuse Test Volume Forecast by Assay
Argentina Clinical Chemistry and Immunoassay
Calibrator and Control Market Forecast
by Test Category
Argentina All Market Segments, Routine
Chemistry Reagent Market Forecast by Assay
Argentina All Market Segments, Endocrine
Function Reagent Market Forecast by Assay
Argentina All Market Segments, Tumor Markers
and Special Chemistry Reagent Market
Forecast by Assay
Argentina All Market Segments, Immunoprotein
Reagent Market Forecast by Assay
Argentina All Market Segments, TDM
Reagent Market Forecast by Assay
Argentina All Market Segments, Drugs
of Abuse Reagent Market Forecast by Assay

Argentina Clinical Chemistry and Immunoassay
Instrument Market Forecast by Analyzer Type
Australia Total Chemistry and Immunoassay
Specimen Volume Forecast by Specimen Type
Australia All Market Segments, Routine
Chemistry Test Volume Forecast by Assay
Australia All Market Segments, Endocrine
Function Test Volume Forecast by Assay
Australia All Market Segments, Tumor Markers
and Special Chemistry Test Volume
Forecast by Assay
Australia All Market Segments, Immunoprotein
Test Volume Forecast by Assay
Australia All Market Segments, TDM
Test Volume Forecast by Assay
Australia All Market Segments, Drugs
of Abuse Test Volume Forecast by Assay
Australia Clinical Chemistry and Immunoassay
Calibrator and Control Market Forecast
by Test Category
Australia All Market Segments, Routine
Chemistry Reagent Market Forecast by Assay
Australia All Market Segments, Endocrine
Function Reagent Market Forecast by Assay
Australia All Market Segments, Tumor Markers
and Special Chemistry Reagent Market
Forecast by Assay
Australia All Market Segments, Immunoprotein
Reagent Market Forecast by Assay
Australia All Market Segments, TDM
Reagent Market Forecast by Assay

Australia All Market Segments, Drugs
of Abuse Reagent Market Forecast by Assay
Australia Clinical Chemistry and Immunoassay
Instrument Market Forecast by Analyzer Type
Austria Total Chemistry and Immunoassay
Specimen Volume Forecast by Specimen Type
Austria All Market Segments, Routine
Chemistry Test Volume Forecast by Assay
Austria All Market Segments, Endocrine
Function Test Volume Forecast by Assay
Austria All Market Segments, Tumor Markers
and Special Chemistry Test Volume
Forecast by Assay
Austria All Market Segments, Immunoprotein
Test Volume Forecast by Assay
Austria All Market Segments, TDM
Test Volume Forecast by Assay
Austria All Market Segments, Drugs
of Abuse Test Volume Forecast by Assay
Austria Clinical Chemistry and Immunoassay
Calibrator and Control Market Forecast
by Test Category
Austria All Market Segments, Routine
Chemistry Reagent Market Forecast by Assay
Austria All Market Segments, Endocrine
Function Reagent Market Forecast by Assay
Austria All Market Segments, Tumor Markers
and Special Chemistry Reagent Market
Forecast by Assay

Austria All Market Segments, Immunoprotein
Reagent Market Forecast by Assay
Austria All Market Segments, TDM
Reagent Market Forecast by Assay
Austria All Market Segments, Drugs
of Abuse Reagent Market Forecast by Assay
Austria Clinical Chemistry and Immunoassay
Instrument Market Forecast by Analyzer Type
Bahrain Total Chemistry and Immunoassay
Specimen Volume Forecast by Specimen Type
Bahrain All Market Segments, Routine
Chemistry Test Volume Forecast by Assay
Bahrain All Market Segments, Endocrine
Function Test Volume Forecast by Assay
Bahrain All Market Segments, Tumor Markers
and Special Chemistry Test Volume
Forecast by Assay
Bahrain All Market Segments, Immunoprotein
Test Volume Forecast by Assay
Bahrain All Market Segments, TDM
Test Volume Forecast by Assay
Bahrain All Market Segments, Drugs
of Abuse Test Volume Forecast by Assay
Bahrain Clinical Chemistry and Immunoassay
Calibrator and Control Market Forecast
by Test Category
Bahrain All Market Segments, Routine
Chemistry Reagent Market Forecast by Assay
Bahrain All Market Segments, Endocrine
Function Reagent Market Forecast by Assay

Bahrain All Market Segments, Tumor Markers
and Special Chemistry Reagent Market
Forecast by Assay
Bahrain All Market Segments, Immunoprotein
Reagent Market Forecast by Assay
Bahrain All Market Segments, TDM
Reagent Market Forecast by Assay
Bahrain All Market Segments, Drugs
of Abuse Reagent Market Forecast by Assay
Bahrain Clinical Chemistry and Immunoassay
Instrument Market Forecast by Analyzer Type
Bangladesh Total Chemistry and Immunoassay
Specimen Volume Forecast by Specimen Type
Bangladesh All Market Segments, Routine
Chemistry Test Volume Forecast by Assay
Bangladesh All Market Segments, Endocrine
Function Test Volume Forecast by Assay
Bangladesh All Market Segments, Tumor Markers
and Special Chemistry Test Volume
Forecast by Assay
Bangladesh All Market Segments, Immunoprotein
Test Volume Forecast by Assay
Bangladesh All Market Segments, TDM
Test Volume Forecast by Assay
Bangladesh All Market Segments, Drugs
of Abuse Test Volume Forecast by Assay
Bangladesh Clinical Chemistry and Immunoassay
Calibrator and Control Market Forecast
by Test Category
Bangladesh All Market Segments, Routine
Chemistry Reagent Market Forecast by Assay

Bangladesh All Market Segments, Endocrine
Function Reagent Market Forecast by Assay
Bangladesh All Market Segments, Tumor Markers
and Special Chemistry Reagent Market
Forecast by Assay
Bangladesh All Market Segments, Immunoprotein
Reagent Market Forecast by Assay
Bangladesh All Market Segments, TDM
Reagent Market Forecast by Assay
Bangladesh All Market Segments, Drugs
of Abuse Reagent Market Forecast by Assay
Bangladesh Clinical Chemistry and Immunoassay
Instrument Market Forecast by Analyzer Type
Belgium Total Chemistry and Immunoassay
Specimen Volume Forecast by Specimen Type
Belgium All Market Segments, Routine
Chemistry Test Volume Forecast by Assay
Belgium All Market Segments, Endocrine
Function Test Volume Forecast by Assay
Belgium All Market Segments, Tumor Markers
and Special Chemistry Test Volume
Forecast by Assay
Belgium All Market Segments, Immunoprotein
Test Volume Forecast by Assay
Belgium All Market Segments, TDM
Test Volume Forecast by Assay
Belgium All Market Segments, Drugs
of Abuse Test Volume Forecast by Assay
Belgium Clinical Chemistry and Immunoassay
Calibrator and Control Market Forecast
by Test Category

Belgium All Market Segments, Routine
Chemistry Reagent Market Forecast by Assay
Belgium All Market Segments, Endocrine
Function Reagent Market Forecast by Assay
Belgium All Market Segments, Tumor Markers
and Special Chemistry Reagent Market
Forecast by Assay
Belgium All Market Segments, Immunoprotein
Reagent Market Forecast by Assay
Belgium All Market Segments, TDM

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