Comprehensive 850-page market segmentation analysis of the Italian NAT market.
Major issues pertaining to the Italian 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: 850 pages and 36 tables.

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

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. Autogenomics Infinity
3. Beckman Coulter/Biomek FK
4. Becton Dickinson SDA
5. Bio-Rad GeneScope
6. Gen-Probe Tigris
7. Nanosphere Verigen Series
8. Roche Cobas Amplicor
9. 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
Laboratory Diagnosis

Virus Isolation
Serology
Viral Nucleic Acid/Antigen Detection

Epidemiology

Worldwide Spread of AIDS
United States
Routes of Transmission

Prevention, Treatment, And Control

Antiviral Drugs
Vaccines

Transmission HIV in Blood Products
HIV Transmission in Transplant and Artificial Insemination Recipients
Diagnostic Tests

Enzyme Immunoassay Interpretation
Specificity, Sensitivity and Predictive Value

Competition Assays
Western Blot Technique
Immuno-Fluorescence Assays (IFA)
Radioimmunoprecipitation
HIV-1/HIV-2 Combination Testing
Methods of HIV-Antigen Detection
Antigen Assays and Blood Screening
Urine Tests
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
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. Plasma Purification
f. Organ Transplantation
g. Water Contamination
h. Others

G. Cost Analysis

1. Equipment
2. Consumables

H. Competing/complementing Technologies

1. Monoclonal Antibodies/Immunoassays
2. RNA Probes
3. Two-Dimensional Electrophoresis
4. Flow Cytometry

I. Reimbursement Issues
J. Worldwide Market Overview

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

Italy

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
Aclara
Affymetrix
Agilent
Ambion
Applera
Applied Gene Technologies
Beckman Coulter
Becton Dickinson
Biokit
BioMerieux
Biotest
Boston Biomedica
Caliper
Cepheid
Chiron
Decode
Diadexus
Digene
Eiken
Enzo
Exact Sciences
Fujirebio
Gen-Probe
Gene Tec
Illumina
Innogenetics
Kreatech
Li-Cor
Molecular Diagnostics
Myriad Genetics
Nanogen
Nuvelo
Orchid Biosciences
Qiagen
Roche
Sangtec
Sequenom
Scienion
Sierra Diagnostics
Shimadzu
Takara Bio
Tepnel Life Sciences
Tecan Group
Third Wave

Appendixes

Appendix I: Major Companies Developing or Marketing NAT Reagents and Test Kits
Appendix II: Major Universities and Research Centers Developing NAT Technologies
Appendix III: Glossary of Terms

Appendix IV: Currency Exchange Rates

List of Tables

Major Companies Developing or Marketing Thermocyclers
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 NAT And Other Direct Identification Tests
Major Companies Developing or Marketing EBV NAT 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
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 Volume Forecast by Country
Worldwide, NAT Market Forecast by Country
Summary Table Italy, NAT 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 Volume Forecast By Major Application
Italy, Major Infectious Disease NAT 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

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Italian Nucleic Acid Testing Market

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