This report presents a comprehensive analysis of the Spanish molecular diagnostics market, including:

• Major issues pertaining to the Spanish 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 DiseasesGenetic 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.

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

Spain
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 Molecular Diagnostic Technology
Appendix II: Glossary of Terms
Appendix III: Currency Exchange Rates

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 Spain, Molecular Diagnostics Test Volume and Sales Forecast by Major Application
Spain, Laboratories Performing DNA Sequencing by Market Segment
Spain, Molecular Diagnostics Market, by Laboratory Universe by Market Segment
Spain, Molecular Diagnostics Test Volume Forecast by Major Application
Spain, Major Infectious Disease Molecular Diagnostics Test Volume Forecast
Spain, Infectious Disease Screening NAT Volume Forecast
Spain, Molecular Diagnostics Market Forecast by Major Application
Spain, Infectious Disease Screening Nat Reagent Market Forecast by Test
Spain, Molecular Diagnostics Market by Major Supplier
Spain, HIV/Hepatitis NAT Market Reagent Sales by Major Supplier