The molecular diagnostics market is unquestionably the most rapidly growing segment of the in vitro diagnostics industry. The next ten years will witness significant developments in reagent systems and automation, as well as the introduction of a wide range of new products that will require innovative marketing approaches. The rate of market penetration into routine clinical laboratories, however, will depend on the introduction of cost-effective and automated systems which will utilize amplification methods.

In order to successfully capitalize on the opportunities presented by the molecular diagnostics market, many companies are already exploiting new DNA probe and biochip technologies as corporate strategic assets, managed in support of business and marketing strategies. Integrating new technology planning with business and corporate strategies will be one of the most challenging tasks for diagnostics companies during the next ten years.

This comprehensive worldwide study is designed to help current suppliers and potential market entrants identify and evaluate the major business opportunities emerging in the molecular diagnostics market during the next decade. The study explores business and technological trends in major markets; provides 5-and 10-year test volume and sales forecasts; estimates shares of leading competitors; compares features of major analyzers; profiles leading market players; and identifies specific product and business opportunities facing instrument and consumable suppliers during the next ten years.

Contains 1,050 pages and 96 tables

Table Of Contents

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

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