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2012 US Nucleic Acid Testing Market Outlook: Growth Opportunities and Strategies

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This publication has been discontinued on July 23, 2012.

Abstract

Description

Highlights

Comprehensive 880-page market segmentation analysis of the US NAT market. Major issues pertaining to the US NAT 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 Cancer Forensic Testing Genetic Diseases Paternity Testing/HLA Typing Review of testing methodologies and instrumentation technologies. Feature comparison of automated and semiautomated analyzers. Sales and market shares of leading suppliers. Over 60 specific opportunities for NAT 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

Table of 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

I. Worldwide Market Overview

  • 1. Business Environment
  • 2. Market Structure
  • 3. Market Size and Growth

USA

  • A. Executive Summary
  • B. Business Environment
  • C. Market Structure
  • 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 NAT Technology

Appendix II: Glossary of Terms

Appendix III: Currency Exchange Rates

List of Tables

  • Major Companies Developing or Marketing AIDS NAT And Other Direct Identification Tests
  • Major Companies Developing or Marketing Adenovirus NAT And Other Direct Identification Tests
  • Major Companies Developing or Marketing Campylobacter NAT And Other Direct Identification Tests
  • Major Companies Developing or Marketing Chlamydia NAT 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 NAT And Other Direct Identification Tests
  • Major Companies Developing or Marketing Hepatitis NAT And Other Direct Identification Tests
  • Major Companies Developing or Marketing Herpes NAT And Other Direct Identification Tests
  • Major Companies Developing or Marketing Legionella NAT And Other Direct Identification Tests
  • Major Companies Developing or Marketing Lyme Disease NAT And Other Direct Identification Tests
  • Major Companies Developing or Marketing Mycoplasma NAT And Other Direct Identification Tests
  • Major Companies Developing or Marketing Papilloma Virus NAT And Other Direct Identification Tests
  • Major Companies Developing or Marketing Pneumonia NAT And Other Direct Identification Tests
  • Major Companies Developing or Marketing Salmonella NAT And Other Direct Identification Tests
  • Major Companies Developing or Marketing Shigella NAT And Other Direct Identification Tests
  • Major Companies Developing or Marketing Streptococci NAT And Other Direct Identification Tests
  • Major Companies Developing or Marketing Toxoplasmosis NAT And Other Direct Identification Tests
  • Major Companies Developing or Marketing Tuberculosis NAT And Other Direct Identification Tests
  • Oncogenes Potential Application in Cancer Diagnosis
  • Major Companies Developing or Marketing Cancer NAT Tests
  • Major Companies Developing or Marketing NAT Assays For Genetic Diseases
  • Summary Table U.S.A., NAT Test Volume And Sales Forecast by Major Application
  • U.S.A., Laboratories Performing DNA Sequencing by Market Segment
  • U.S.A., NAT Market, Potential Laboratory Universe by Market Segment
  • U.S.A., NAT Test Volume Forecast By Major Application
  • U.S.A., Major Infectious Disease NAT Test Volume Forecast
  • U.S.A., Infectious Disease Screening NAT Volume by Test Forecast
  • U.S.A., NAT Market Forecast By Major Application
  • U.S.A., Infectious Disease Screening Nat Reagent Market Forecast by Test
  • U.S.A., NAT 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
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