North America Molecular Diagnostic Analyzers and Reagents Market 2021: USA, Canada, Mexico--Supplier Shares by Test, Competitive Strategies, Test Volume and Sales Segment Forecasts, Technology and Instrumentation Review

June 2017 | 1170 pages | ID: N1365FD6F8BEN
Venture Planning Group

Abstracts

This new 3- country report from VPGMarketResearch.com 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, Hologic, 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.

Contains 1,170 pages and 75 tables

Contents

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
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
  19. ROCHE COBAS TAQMAN
  20. ROCHE COBAS TAQMAN AMPLIPREP
  21. ROCHE LIGHCYCLER
  22. ROCHE COBAS 4800
  23. ROCHE COBAS S
  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-Jakob’s Disease
      Cryptosporidium Parvum
      Cyclospora Cayetanensis
      Cytomegalovirus
      Ebola Virus
      E. Coli
      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
      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
    g. Future Pharmacogenomic Testing
    h. Major Diseases
      Achondroplasia
      Autosomal Dominant Polycystic Kidney Disease
      Cancer
      Cosmetogenomics
      Cystic Fibrosis
      Down's Syndrome
      Duchenne and Becker Muscular Dystrophy
      Factor V (Leiden)
      Factor IX Deficiency
      Fragile X Syndrome
      Heart Disease
      Hemochomatosis
      Hemophilia
      Huntington's 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. Alzheimer's Disease
    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
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

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
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
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
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
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