2015-2019 Nucleic Acid Testing: Infectious Diseases, Cancer, Genetic Diseases, Forensic Testing, Paternity Testing/HLA Typing--Technological Breakthroughs, Emerging Tests, Market Forecasts, Competitive Intelligence

2015-2019 Nucleic Acid Testing: Infectious Diseases, Cancer, Genetic Diseases, Forensic Testing, Paternity Testing/HLA Typing--Technological Breakthroughs, Emerging Tests, Market Forecasts, Competitive Intelligence

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/BiTec 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 tthe 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

France
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers' Sales and Market Shares

Germany
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers' Sales and Market Shares

Italy
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers' Sales and Market Shares

Japan
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers' Sales and Market Shares

Spain
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers' Sales and Market Shares

U.K.
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers' Sales and Market Shares

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 tIatrogenesis
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
- Cepheid
- CellMark Forenciscs/LabCorp
- Decode Genetics
- Diadexus
- Eiken
- Elitech Group
- Enzo
- Exact Sciences
- Fujirebio
- Grifols
- Hologic/Gen-Probe
- Illumina
- Kreatech/Leica
- Li-Cor Biosciences
- Monogram Biosciences
- Myriad Genetics
- Ortho-Clinical Diagnostics
- Perkin Elmer/Caliper
- Proteome Sciences
- Qiagen
- Roche
- Scienion
- Sequenom
- Shimadzu
- Siemens
- Sierra Molecular
- Takara Bio
- Tecan Group
- ThermFisher

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
Worldwide, Laboratories Performing DNA Sequencing By Country
Worldwide, NAT Market Potential Laboratory Universe by Country
Worldwide, NAT Test Volume Forecast By Country
Worldwide, NAT Market Forecast by Country
Summary Table France, NAT Test Volume and Sales Forecast by Major Application
France, Laboratories Performing DNA Sequencing By Market Segment
France, NAT Market Potential Laboratory Universe by Market Segment
France, NAT Test Volume Forecast By Major Application
France, Major Infectious Disease Molecular Diagnostics Test Volume Forecast
France, Infectious Disease Screening NAT Volume Forecast
France, NAT Market Forecast By Major Application
France, Infectious Disease Screening NAT Reagent Market Forecast by Test
France, NAT Market By Major Supplier
France, HIV/Hepatitis NAT Market Reagent Sales By Major Supplier
Summary Table Germany, NAT Test Volume and Sales Forecast by Major Application
Germany, Laboratories Performing DNA Sequencing by Market Segment
Germany, NAT Market Potential Laboratory Universe By Market Segment
Germany, NAT Test Volume Forecast By Major Application
Germany, Major Infectious Disease Molecular Diagnostics Test Volume Forecast
Germany, Infectious Disease Screening NAT Volume Forecast
Germany, NAT Market Forecast By Major Application
Germany, Infectious Disease Screening NAT Reagent Market Forecast by Test
Germany, NAT Market by Major Supplier
Germany, HIV/Hepatitis NAT Market Reagent Sales by Major Supplier
Summary Table Italy, NAT Test Volume and Sales Forecast by Major Application
Italy, Laboratories Performing DNA Sequencing by Market Segment
Italy, NAT Market Potential Laboratory Universe by Market Segment
Italy, NAT Test Volume Forecast By Major Application
Italy, Major Infectious NAT Test Volume Forecast
Italy, Infectious Disease Screening NAT Volume Forecast
Italy, NAT Market Forecast By Major Application
Italy, Infectious Disease Screening NAT Reagent Market Forecast by Test
Italy, NAT Market By Major Supplier
Italy, HIV/Hepatitis NAT Market By Major Supplier
Summary Table Japan, NAT Test Volume and Sales Forecast by Major Application
Japan, Laboratories Performing DNA Sequencing by Market Segment
Japan, NAT Market Potential Laboratory Universe by Market Segment
Japan, NAT Test Volume Forecast By Major Application
Japan, Major Infectious Disease NAT Test Volume Forecast
Japan, Infectious Disease Screening NAT Volume Forecast
Japan, NAT Market Forecast By Major Application
Japan, Infectious Disease Screening Nat Reagent Market Forecast by Test
Japan, NAT Market By Major Supplier
Japan, HIV/Hepatitis NAT Market Reagent Sales by Major Supplier
Summary Table Spain, NAT Test Volume and Sales Forecast by Major Application
Spain, Laboratories Performing DNA Sequencing by Market Segment
Spain, NAT Market, Potential Laboratory Universe by Market Segment
Spain, NAT Test Volume Forecast by Major Application
Spain, Major Infectious Disease NAT Test Volume Forecast
Spain, Infectious Disease Screening NAT Volume Forecast
Spain, NAT Market Forecast By Major Application
Spain, Infectious Disease Screening Nat Reagent Market Forecast by Test
Spain, NAT Market By Major Supplier
Spain, HIV/Hepatitis NAT Market Reagent Sales by Major Supplier
Summary Table U.K., NAT Test Volume and Sales Forecast by Major Application
U.K., Laboratories Performing DNA Sequencing by Market Segment
U.K., NAT Market Potential Laboratory Universe by Market Segment
U.K., NAT Test Volume Forecast By Major Application
U.K., Major Infectious Disease Molecular Diagnostics Test Volume Forecast
U.K., Infectious Disease Screening NAT Volume Forecast
U.K., NAT Market Forecast By Major Application
U.K., Infectious Disease Screening NAT Reagent Market Forecast by Test
U.K., NAT Market by Major Supplier 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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