2014-2018 US Molecular Diagnostics Market: Supplier Shares, Country Forecasts, Innovative Technologies, Competitive Strategies--Infectious Diseases, Genetic Diseases, Cancer, Forensic and Paternity Testing

November 2014 | 880 pages | ID: 236578D4629EN
Venture Planning Group

Abstracts

This new 880-page report from Venture Planning Group contains 37 tables, and 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
• Genetic Disease
• Cancer
• Paternity Testing/HLA Typing
• Forensic Testing
• 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.

Contains 880 pages and 37 tables

Contents

INTRODUCTION

WORLDWIDE MARKET AND TECHNOLOGY OVERVIEW

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 Technology
  1. Basic Principles
  2. Probe Preparation
  3. The DNA Probe Test
    a. Sample Preparation
    b. Hybridization
    c. Separation
    d. Detection/Measurement
  4. Test Formats
    a. Filter Hybridization
    b. Southern Blot
    c. Northern Blot
    d. In Situ Hybridization
    e. Others
  5. Labeling Techniques
  6. Amplification Methods
    Polymerase Chain Reaction
      Temperature Cyclers
      PCR Variations
        Immuno-PCR
        QC-PCR
        DAP-PCR
    Strand Displacement Activation
    TMA
    Ligase Chain Reaction
    Branched DNA
      Hybridization Protection Assay
    Nucleic-Acid Sequence-Based Amplification
    Self-Sustained Sequence Replicase
    Others
      Ampliprobe
      CAR
      CAS
      CPT
      Dendritic Polymer Technology
      ISO-CR
      LAT
      Probe Networks
      RAMP
      Repair Chain Reaction
      Rolling Circles
      Sequence Independent Gene Amplification
      Sequence Initiation Reaction
      SISPA
      Solid Phase Amplification
C. Detection Technologies
  1. Radioactive Methods
    a. Overview
    b. Major Isotopes
    P-32
    S-35
    H-3
    I-125
  2. Non-Isotopic Methods
    a. Enzymatic Labels
    b. Chemical Labeling
    Indirect Chemical Labeling
    Direct Chemical Labeling
    c. Fluorescence
    d. Chemiluminescence
    e. Electrical Conductivity
D. Instrumentation Review
  1. Abbott LCx
  2. Beckman Coulter/Biomek FK
  3. Becton Dickinson SDA
  4. Bio-Rad GeneScope
  5. Gen-Probe Tigris
  6. Roche Cobas Amplicor
  7. Tecan LS Series
E. Biochips: Genosensors, Microarrays, and 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
    Structure and Composition
    Classification
    AIDS Origins
    Animal Lentivirus Systems
    Virus Receptors
    HIV Infections in Humans
      Pathogenesis and Pathology
    CD4T Lymphocytes and Memory Cells
    Monocytes and Macrophages
    Lymphoid Organs
    Neural Cells
    Viral Coinfections
      Clinical Findings
    Plasma Viral Load
    Pediatric AIDS
      Neurologic Disease
      Opportunistic Infections
      Cancer
    Immunity
      Virus Isolation
      Serology
      Viral Nucleic Acid/Antigen Detection
    Epidemiology
      Worldwide Spread of AIDS
      United States
      Routes of Transmission
    DNA Probes
      Overview
      Quantitative PCR
      In Situ PCR
      Needed Improvements
    Viral Load/Drug Resistance Testing
    Genotype and Phenotype Testing
    Blood Banking Considerations
    Adenovirus
      Background
      Diagnostic Tests
      Vaccines and Drugs
    Adeno-Associated Viruses (AAV)
    Anthrax/Bacillus Anthracis
      Background
      Diagnostic Tests
      Vaccines and Drugs
    Babesiosis
      Background
    BEA and Other Bartonella Diseases
      Background
      Diagnostic Tests
      Vaccines and Drugs
    Chagas Disease
      Background
    Campylobacter
      Background
      Diagnostic Tests
      Culture Identification
      Vaccines and Drugs
    Chlamydia
      Background
        Chlamydia psittaci
        Chlmaydia pneumoniae
        Chlamydia trachomatis
      Diagnostic Tests
      Vaccines and Drugs
    Creutzfeldt-Jakob’s Disease
      Background
    Blood Transmission
      Diagnostic Tests
      Major Commercial and Academic Players
        Bayer
        Disease Sciences/Bio Tec Global
        Imperial College School of Medicine
        Ortho-Clinical Diagnostics
        Pall
        ProMetic Life Sciences
        Proteome Sciences/Idexx
        Q-One Biotech
        Serono
        U.S. Agricultural Research Service
    Drugs
    Vaccines
    Cytomegalovirus
      Background
        Chorioretinitis
        Gastrointestinal
        Central Nervous System Disease
      Diagnostic Tests
      Vaccines and Drugs
    Ebola Virus
      Background
        Epidemiology
        Clinical Syndromes
      Diagnostic Tests
      Vaccines and Drugs
    EchoVirus
      Background
        Acute Aseptic Meningitisis
        Encephalitis
        Exanthems
        Respiratory Disease
        Myopericarditis
        Neonatal Infections
      Diagnostic Tests
      Vaccines and Drugs
    Encephalitis
      Background
      Diagnostic Tests
      Vaccines and Drugs
    Enteroviruses
      Background
      Diagnostic Tests
        Viral Isolation and Identification
        Antibody Tests
      Vaccines and Drugs
    Epstein-Barr Virus
      Background
      Diagnostic Tests
      Vaccines and Drugs
    Gonorrhea
      Background
      Diagnostic Tests
      Vaccines and Drugs
    Hepatitis
    Hepatitis A
    Hepatitis B
        Structure and Composition
        Replication
    Hepatitis C
    Hepatitis D (Delta)
    Hepatitis E
    Hepatitis G
    Hepatitis Infections Pathology
    Clinical Findings
    Laboratory Tests
      Hepatitis A
      Hepatitis B
      Hepatitis C
      Hepatitis D
      Hepatitis E
    Virus-Host Immune Reactions
    Epidemiology
      Hepatitis A
      Hepatitis B
      Hepatitis C
      Hepatitis D (Delta)
      Vaccines and Drugs
    Herpes Simplex Virus
      Background
      Diagnostic Tests
      Vaccines and Drugs
    Legionella
      Background
      Diagnostic Tests
      Vaccines and Drugs
    Lyme Disease
      Background
        Clinical Description
        Clinical Case Definition
        Laboratory Criteria for Diagnosis
        Case Classification
      Diagnostic Tests
      Vaccines and Drugs
    Malaria
    Mycoplasma
      Background
        Ureaplasma Urealyticum & Mycoplasma Hominis
      Diagnostic Tests
      Vaccines and Drugs
    Papillomaviruses/HPV
      Background
        HPV in Cancer
        Cervical Neoplasm
      Diagnostic Tests
      Vaccines and Drugs
        Prevention
    Parvovirus B19
      Background
        Microbiology
        Epidemiology
        Clinical Syndromes
        Erythema Infectiosum (Slapped Cheek)
        Adult Polyarthropathy
        Transient Aplastic Crisis
        Transient Pancytopenia
        Red Cell Aplasia in Immunocompromised
        Perinatal Infections
    Diagnostic Test
      Vaccines and Drugs
    Pneumonia
      Background
      Diagnostic Tests
      Vaccines and Drugs
    Polyomaviruses
      Background
      Diagnostic Tests
      Vaccines and Drugs
    Salmonellosis
      Background
      Diagnostic Tests
      Vaccines and Drugs
    Shigellosis
      Background
      Diagnostic Tests
      Vaccines and Drugs
    Streptococci
      Background
      Diagnostic Tests
      Vaccines and Drugs
        Group A Streptococci
        Group B Streptococci
    Toxoplasmosis
      Background
      Diagnostic Tests
      Vaccines and Drugs
    Tuberculosis
      Background
      Diagnostic Tests
        Microscopic Characteristics
        Cultural Characteristics
        Skin Tests
        MDRTB
      Vaccines and Drugs
    West Nile Virus
      Background
        Clinical Syndromes
      Diagnostic Tests
      Vaccines and Drugs
    Yersinia
      Background
      Diagnostic Tests
      Vaccines and Drugs
    c. Antibiotic Susceptibility
  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
      Multilocus Probes
      Single Locus Probes
      PCR and RFLP
    c. The FBI
    d. DNA Profile Data Banks
      U.S.A.
      U.K.
    e. Judicial Implementation
    f. Major Crime Categories
    g. Factors Contributing to the DNA Probe Market Expansion
      Technology Availability
      Use of Hair as Evidence
    h. 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 Technologies
  1. Monoclonal Antibodies/Immunoassays
  2. RNA Probes
  3. Two-Dimensional Electrophoresis
  4. Flow Cytometry

U.S.A. A. EXECUTIVE SUMMARY

B. Business Environment
  1. Health Care Expenditures
  2. Cost Consciousness
  3. Reimbursement
  4. Industry Consolidation
  5. Managed Care
    a. PP
    b. HM
  6. Hospitals
  7. Admissions
  8. Length of Stay
  9. Industry Diversification
  10. Physician Demographics
  11. Population Aging
    a. Chronic Illness
    b. Disease Incidence
    c. Susceptibility to Iatrogenesis
    d. Multiple Illness Cases
  12. Laboratory Regulations
  13. FDA Reform
C. Market Structure
  1. Hospitals
  2. Commercial/Private Laboratories
  3. Blood Banks
D. Market Size, Growth and Major Suppliers’ Sales and Market Shares

MAJOR PRODUCT DEVELOPMENT OPPORTUNITIES

A. Instrumentation
B. Reagent Kits and Test Systems/panels
C. Computers, Software and Automation
D. Auxiliary Products

DESIGN CRITERIA FOR DECENTRALIZED TESTING PRODUCTS

ALTERNATIVE MARKET PENETRATION STRATEGIES

A. Internal Development
B. Collaborative Arrangements
C. University Contracts
D. Distribution Strategies For Decentralized Testing Markets
  1. Marketing Approaches
  2. Product Complexity
  3. Customer Preference
  4. Established Suppliers
  5. Emerging Suppliers
  6. Major Types Of Distributors
  7. Market Segmentation

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

COMPETITIVE PROFILES

Abbott
Affymetrix
Agilent
Applied Gene Technologies
Arca
Beckman Coulter/Danaher
Becton Dickinson
Biokit
BioMerieux
Bio-Rad
Biotest
Caliper
Cepheid
Decode
Diadexus
Eiken
Enzo
Exact Sciences
Fujirebio
Gen-Probe
Hologic
Illumina Innogenetics/Solvay
Kreatech
Li-Cor Biosciences
Life Technologies
Monogram Biosciences
Myriad Genetics
Nanogen/Elitech
Novartis
Orchid CellMark
Ortho-Clinical Diagnostics
Proteome Sciences
Qiagen
Roche
Scienion
Sequenom
Shimadzu
Siemens
Sierra Molecular
Takara Bio
Tecan Group

APPENDIXES

Appendix I: Major Universities and Research Centers Developing Molecular Diagnostic Technology
Appendix II: Glossary of Terms
Appendix III: Currency Exchange Rates

List Of Tables

LIST OF TABLES

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 Campylobacter 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 CMV 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 Gonorrhea 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 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 Mycoplasma Molecular Diagnostic And Other Direct Identification Tests
Major Companies Developing or Marketing Papilloma Virus 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 Salmonella 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 Toxoplasmosis 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 Test For Genetic Diseases
Summary Table U.S.A., Molecular Diagnostics Test Volume And Sales Forecast by Major Application
U.S.A., Laboratories Performing DNA Sequencing by Market Segment
U.S.A., Molecular Diagnostics Market, Potential Laboratory Universe by Market Segment
U.S.A., Molecular Diagnostics Test Volume Forecast By Major Application
U.S.A., Major Infectious Disease Molecular Diagnostics Test Volume Forecast
U.S.A., Infectious Disease Screening NAT Volume by Test Forecast
U.S.A., Molecular Diagnostics Market Forecast By Major Application
U.S.A., Infectious Disease Screening Nat Reagent Market Forecast by Test
U.S.A., Molecular Diagnostics Market by Major Supplier
U.S.A., HIV/Hepatitis C NAT Market Reagent Sales By Major Supplier
U.S.A., West Nile Virus NAT Market Reagent Sales By Major Supplier