Future Horizons in the US Molecular Diagnostics Market: Supplier Shares and Sales Forecasts for 35 Tests and Applications

August 2012 | 880 pages | ID: F2DC209245BEN
Venture Planning Group

Abstracts

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 ten years.
• An extensive review of DNA probe and biochip technologies, test formats, detection methodologies, trends in testing automation and amplification methods.
• Ten-year test volume and reagent sales forecasts for the following categories:
• Infectious Diseases
• Genetic Diseases
• 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. PPO
    b. HMO
  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