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U.S. Molecular Diagnostics Market Assessment-2021-2025 Competitive Shares and Growth Strategies, Volume and Sales Segment Forecasts for 100 Infectious, Genetic, Cancer, Forensic and Paternity Tests-Latest Technologies and Instrumentation Pipeline, Emerging Opportunities for Suppliers

November 2021 | | ID: U25BCD872F6DEN
Venture Planning Group

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This report presents a comprehensive analysis of the US molecular diagnostics market, including:

Major issues pertaining to the US molecular diagnostics laboratory practice, as well as key economic, regulatory, demographic, social and technological trends with significant market impact during the next five years.

An extensive review of DNA probe and biochip technologies, test formats, detection methodologies, trends in testing automation and amplification methods.

Five-year test volume and reagent sales forecasts for the following categories:
  • Infectious Diseases
  • Forensic Testing
  • Cancer
  • Paternity Testing/HLA Typing
  • Genetic Diseases
  • Others
Review of testing methodologies an instrumentation technologies.

Feature comparison of automated and semiautomated analyzers.

Sales and market shares of leading suppliers.

Over 60 specific opportunities for molecular diagnostic instruments, test systems, IT and auxiliary products.

Profiles of major suppliers, and emerging market entrants, including their sales, product portfolios, marketing tactics, technological know-how, new products in R&D, collaborative arrangements and business strategies.

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
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
  2. Non-Isotopic Methods
D. Instrumentation
Review of latest analyzers from Abbott, Beckm an Coulter/Danaher, Becton Dickinson, bioMerieux, Bio-Rad, Cepheid, Hologic, Qiagen, Roche, Siemens Healthineers, and others.
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 (Rubeo la)
    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
    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
The report provides review of both current and emerging oncogenes, including:
    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. MOLECULAR DIAGNOSTICS MARKET

A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Test Volume and Sales Forecasts, Major Supplier Sales and Market Shares

VIII. COMPETITIVE ASSESSMENTS

The report provides strategic assessments of over 40 leading molecular diagnostics market players and start-up companies with innovative technologies and products, including:
Abbott, Agilent Technologies, Beckman Coulter/Danaher, Becton Dickinson, bioMerieux, Bio-Rad, Cepheid, DiaSorin, Eiken Chemical, Enzo, Fujirebio, Grifols, Hologic, Illumina, LabCorp/Sequenom, Leica Biosystems, Myriad Genetics, Ortho-Clinical Diagnostics, Qiagen, Quest Diagnostics, Quidel, Roche, Shimadzu, Siemens Healthineers, Sierra Molecular, Takara Bio, Tecan Group, Thermo Fisher, Wako and others.

IX. APPENDIX: MAJOR UNIVERSITIES AND RESEARCH CENTERS DEVELOPING INNOVATIVE MOLECULAR DIAGNOSTIC TECHNOLOGIES AND PRODUCTS


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