2019-2023 North America Molecular Diagnostic Analyzers and Reagents: USA, Canada, Mexico-Infectious and Genetic Diseases, Cancer, Forensic and Paternity Testing-Supplier Shares, Volume and Sales Segment Forecasts, Emerging Technologies, Instrumentation Review

This new 3-country report is available by country, market segment, section, or individual test.

The report is designed to help current suppliers and potential market entrants identify and evaluate major business opportunities emerging in the molecular diagnostics market during the next five years.

Highlights

- Supplier sales and market shares in major countries

- Five-year test volume and sales forecasts

- Strategic profiles of market players and start-up firms developing innovative technologies and products

- Emerging technologies

- Review of molecular diagnostic analyzers

- Specific product and business opportunities for instrument and consumable suppliers

Rationale

The molecular diagnostics market is unquestionably the most rapidly growing segment of the in vitro diagnostics industry. The next five years will witness significant developments in reagent systems and automation, as well as introduction of a wide range of new products that will require innovative marketing approaches. The rate of market penetration into routine clinical laboratories, however, will depend on the introduction of cost-effective and automated systems with amplification methods.

In order to successfully capitalize on the opportunities presented by the molecular diagnostics market, many companies are already exploiting new molecular technologies as corporate strategic assets, managed in support of business and marketing strategies. Integrating new technology planning with business and corporate strategies will be one of the most challenging tasks for diagnostic companies during the next five years.

Country Analyses

Canada, Mexico, USA

Market Segmentation Analysis

- Sales and market shares of key suppliers of molecular diagnostic reagent kits and components in major markets.

Five-year test volume and sales forecasts for major applications, including:

- Infectious Diseases        - Forensic Testing
- Cancer                                 - Paternity Testing/HLA Typing
- Genetic Diseases             - Others

- Five-year test volume and sales projections for over 30 NAT assays.

- A comprehensive analysis of the sequencing market, by country and laboratory segment,
  including:

- Industrial        - Academic
- Government  - Commercial

- Market segmentation analysis, including review of the market dynamics, trends, structure, size, growth and suppliers in major countries.

Product/Technology Review

- Comparison of leading molecular diagnostic analyzers marketed by Abbott, Beckman Coulter, BD, Bio-Rad, Gen-Probe, Roche, Tecan and other suppliers.

- Extensive review of molecular diagnostic technologies, test formats, detection methodologies, trends in testing automation and over 30 target/signal amplification methods, including:

- PCR     - bDNA
- SDA     - NASBA
- TMA    - SSSR, and others
- LCR

- Universities and research centers developing new molecular diagnostic technologies and products.

Competitive Assessments

- Extensive strategic assessments of major suppliers and emerging market entrants, including their sales, product portfolios, marketing tactics, collaborative arrangements and new technologies/products in R&D.

- Companies developing and marketing molecular diagnostics products, by test and application.

Opportunities and Strategic Recommendations

- Specific new product development opportunities with potentially significant market appeal during the next five years.

- Design criteria for new products.

- Alternative market penetration strategies.

- Potential market entry barriers and risks.

- Business planning issues and concerns.


I. Introduction
II. Major Product Development Opportunities
A. Instrumentation
B. Reagent Kits and Test Systems/panels
C. Computers, Software and Automation
D. Auxiliary Products
III. Design Criteria for Decentralized Testing Products
IV. Alternative Market Penetration Strategies
A. Internal Development
B. Collaborative Arrangements
C. University Contracts
D. Distribution Strategies for Decentralized Testing Markets
V. 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
VI. Market and Technology Review
A. DNA Sequencing
1. Introduction
2. Sequencing Methods
3. Autoradiography
4. The Human Genome Project
5. Sequencing Automation
6. Image Scanners
7. Fluorescent Detection
8. Gene Profiling
9. Gene Expression
10. Polymorphism Screening
11. Protein Interaction Networks
Table of Contents (continued)
B. DNA and RNA Probe Technologies
1. Basic Principles
2. Probe Preparation
3. The DNA Probe Test
4. Test Formats
5. Labeling Techniques
6. Amplification Methods
C. Detection Technologies
1. Radioactive Methods
a. Overview
b. Major Isotopes
2. Non-Isotopic Methods
a. Enzymatic Labels
b. Chemical Labeling
c. Fluorescence
d. Chemiluminescence
e. Electrical Conductivity
D. Molecular Diagnostic Instrumentation Review
1. Abbott LCx
2. Beckman Coulter/Biomek FK
3. BD Viper System with XTR Technology
4. BD Innova
5. Becton Dickinson SDA
6. bioMerieux NucliSENS easyMAG
7. bioMerieux NucliSENS easyQ and MiniMAG
8. Bio-Rad GeneScope
9. Cepheid GeneXpert
10. Curetis Unyvero
11. GenMark Dx eSensor XT-8
12. Hologic/Gen-Probe Panther
13. Hologic/Gen-Probe Tigris/DTS
14. HTG Molecular Edge
15. Life Technologies QuantStudio Dx
16. Qiagen QIAsymphony RGQ
17. Roche Cobas Amplicor
18. Roche Cobas TaqMan 48
19. Roche Cobas TaqMan
20. Roche Cobas TaqMan AmpliPrep
Table of Contents (continued)
21. Roche LighCycler 480
22. Roche Cobas 4800
23. Roche Cobas s 201
24. Siemens Versant
25. Tecan LS Series
E. Biochips: Genosensors, Microarrays, Labs-on-the-Chip
- Liquid Transportation and Mixing
- Separation
- Reaction
- Detection
F. Pharmacogenomics
G. Major Applications
1. Microbiology/Infectious Diseases
a. Overview
b. Major Infectious Diseases
- AIDS/HIV
- Adenovirus
- Aeromonads
- Anthrax/Bacillus Anthracis
- Arboviruses
- Babesiosis
- Bacillary Epithelioid Angiomatosis (BEA), other Bartonella (Rochalimaea)
- Blastocystis Hominis
- Brucella
- Campylobacter
- Candida
- Chagas Disease
- Chancroid
- Chlamydia
- Clostridium Difficile
- Coronaviruses
- Coxsackieviruses
- Creutzfeldt-Jakobs Disease
- Cryptosporidium Parvum
- Cyclospora Cayetanensis
- Cytomegalovirus
- Ebola Virus
- E. Coli
Table of Contents (continued)
- EchoVirus
- Encephalitis
- Enteroviruses
- Epstein-Barr Virus
- Giardia Lamblia
- Gonorrhea
- Granuloma Inguinale
- Hantavirus
- Helicobacter Pylori
- Hepatitis
- Herpes Simplex Virus
- Human Herpes Virus-6 (HHV-6)
- Influenza Viruses
- Legionella
- Lyme Disease
- Lymphogranuloma Venereum (LGV)
- Malaria
- Measles (Rubeola)
- Meningitis
- Microsporidium
- Mononucleosis
- Mumps
- Mycoplasma
- Papillomaviruses
- Parvovirus B19
- Pneumonia
- Polyomaviruses
- Pseudomonas Aeruginosa
- Rabies
- Respiratory Syncytial Virus (RSV)
- Rhinoviruses
- Rotavirus
- Rubella
- Salmonellosis
- Septicemia
- Shigellosis
- Staphylococcus Aureus
- Streptococci
- Syphilis
- Toxoplasmosis
- Trichomonas Vaginalis
- Tuberculosis
- Vibrio
Table of Contents (continued)
- West Nile Virus
- Yersina
2. Cancer Testing
a. Overview
b. Major Cancer Types
- Prostate
- Lung
- Colon and Rectum
- Breast
- Skin
- Uterine
- Leukemia
- Oral
c. Oncogenes
- Abl/abl-bcr
- AIB1
- BCL-2
- BRCA1
- CD44
- C-fos
- C-myb
- C-myc
- CYP17
- Erb-B
- HPC1
- N-myc
- P40
- P51
- P53
- PIK3CA
- PTI-1
- Ras
- Reg
- Sis
- Src
3. Genetic Diseases
a. Overview
b. Nucleic Acid Amplification
c. Chromosome Imaging
d. Genomics Technologies
e. Proteomics Technologies
f. Current Pharmacogenomic Tests
Table of Contents (continued)
g. Future Pharmacogenomic Testing
h. Major Diseases
- Achondroplasia
- Autosomal Dominant Polycystic Kidney Disease
- Cancer
- Cosmetogenomics
- Cystic Fibrosis
- Downs Syndrome
- Duchenne and Becker Muscular Dystrophy
- Factor V (Leiden)
- Factor IX Deficiency
- Fragile X Syndrome
- Heart Disease
- Hemochomatosis
- Hemophilia
- Huntingtons Disease
- Maternal-Fetal Incompatibility
- Multiple Endocrine Neoplasia
- Phenylketonuria (PKU)
- Polycystic Kidney Disease (PKD)
- Prenatal Screening
- Retinitis Pigmentosa
- Retinoblastoma
- Sickle Cell Anemia
- Spinal Muscular Atrophy
- Vitamin B12 Metabolism
i. Social Issues and Concerns
4. Forensic Testing
a. Overview
b. Multilocus and Single Locus Probes
c. DNA Profile Data Banks
d. Judicial Implementation
e. Major Crime Categories
f. Factors Contributing to the DNA Probe Market Expansion
- Technology Availability
- Use of Hair as Evidence
g. Wildlife Forensics
5. Paternity Testing/HLA Typing
6. Other Applications
a. Disease Susceptibility Testing
b. Cardiovascular Diseases
c. Diabetes
d. Alzheimers Disease
Table of Contents (continued)
e. Periodontal Disease
f. Plasma Purification
g. Organ Transplantation
h. Water Contamination
i. Other
H. Competing/complementing
1. Monoclonal Antibodies/Immunoassays
2. RNA Probes
3. Two-Dimensional Electrophoresis
4. Flow Cytometry
VII. Country Analyses: Volume and Sales Forecasts--Infectious Diseases, Genetic Diseases, Cancer,
Forensic and Paternity Testing
- Canada
- Mexico
- USA
VIII. Competitive Assessments
- Abbott
- Affymetrix/Thermo Fisher
- Agilent Technologies
- Applied Gene Technologies
- Arca Biopharma
- Beckman Coulter/Danaher
- Becton Dickinson
- Biokit
- bioMerieux
- Bio-Rad
- Biotest
- CellMark Forensics/LabCorp
- Cepheid
- Decode Genetics
- Diadexus
- Eiken
- Elitech Group
- Enzo
- Exact Sciences
- Fujirebio
- Grifols
Table of Contents (continued)
- Hologic/Gen-Probe
- Illumina
- Kreatech/Leica
- Li-Cor Biosciences
- Monogram Biosciences/LabCorp
- Myriad Genetics
- Ortho-Clinical Diagnostics
- Perkin Elmer/Caliper
- Proteome Sciences
- Qiagen
- Roche
- Scienion
- Sequenom
- Shimadzu
- Siemens
- Sierra Molecular
- Takara Bio
- Tecan Group
IX. Appendix: Major Universities and Research Centers Developing Innovative
Molecular Diagnostic Technologies and Products

List Of Tables

Canada
Molecular Diagnostics Test Volume and Sales Forecasts by Application
Canada
Molecular Diagnostics Test Volume Forecasts by Application
Canada
Major Infectious Disease Test Volume Forecasts by Assay
Canada
Molecular Diagnostics Market Forecasts by Application
Canada
Major Infectious Disease Diagnostics Market Forecasts by Assay
Mexico
Molecular Diagnostics Test Volume and Sales Forecasts by Application
Mexico
Molecular Diagnostics Test Volume Forecasts by Application
Mexico
Major Infectious Disease Test Volume Forecasts by Assay
Mexico
Molecular Diagnostics Market Forecasts by Application
Mexico
Major Infectious Disease Diagnostics Market Forecasts by Assay
U.S.A.
Molecular Diagnostics Test Volume and Sales by Major Application
U.S.A.
Laboratories Performing DNA Sequencing by Market Segment
U.S.A.
Echovirus Testing Market Estimated Sales by Major Supplier
U.S.A.
Enterovirus Testing Market Estimated Sales by Major Supplier
U.S.A.
EBV Testing Market Estimated Sales by Major Supplier
List of Tables (continued)
U.S.A.
Gonorrhea Testing Market Estimated Sales by Major Supplier
U.S.A.
Hepatitis Testing Market Estimated Sales by Major Supplier
U.S.A.
Hepatitis C Testing Market Estimated Sales by Major Supplier
U.S.A.
HIV/Hepatitis Blood Screening NAT
Market Reagent Sales by Major Supplier
U.S.A.
Herpes Testing Market Estimated Sales by Major Supplier
U.S.A.
Influenza Testing Market Estimated Sales by Major Supplier
U.S.A.
Meningitis Testing Market Estimated Sales by Major Supplier
U.S.A.
Mycoplasma Testing Market Estimated Sales by Major Supplier
U.S.A.
Pneumonia Testing Market Estimated Sales by Major Supplier
U.S.A.
Rabies Testing Market Estimated Sales by Major Supplier
U.S.A.
RSV Testing Market Estimated Sales by Major Supplier
U.S.A.
Salmonella Testing Market Estimated Sales by Major Supplier
U.S.A.
Shigella Testing Market Estimated Sales by Major Supplier
U.S.A.
West Nile Virus Nat Market Reagent Sales by Major Supplier
Major Companies Developing or Marketing AIDS Molecular
Diagnostic and Other Direct Identification Tests
List of Tables (continued)
Major Companies Developing or Marketing Adenovirus
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Bartonella
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Campylobacter
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Candida
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Chlamydia
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Clostridium
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Coronavirus
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Cryptosporidium
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing CMV Molecular
Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Echovirus Molecular
Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Enterovirus Molecular
Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing EBV Molecular
Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Giardia
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Gonorrhea
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Hantavirus
Molecular Diagnostic and Other Direct Identification Tests
List of Tables (continued)
Major Companies Developing or Marketing Helicobacter
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Hepatitis
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Herpes
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Influenza
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Legionella
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Lyme
Disease Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Measles
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Meningitis
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Mononucleosis
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Mumps
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Mycoplasma
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Pneumonia
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing RSV
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Rotavirus
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Rubella
Molecular Diagnostic and Other Direct Identification Tests
List of Tables (continued)
Major Companies Developing or Marketing Salmonella
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Septicemia
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Shigella
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Streptococci
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Syphilis
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Toxoplasmosis
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Trichomonas
Molecular Diagnostic and Other Direct Identification Tests
Major Companies Developing or Marketing Tuberculosis
Molecular Diagnostic and Other Direct Identification Tests
Oncogenes Potential Application in Cancer Diagnosis
Major Companies Developing or Marketing Cancer
Molecular Diagnostic Tests
Major Companies Developing or Marketing Molecular
Diagnostic Tests for Genetic Diseases

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