Abstract
I. INTRODUCTION
The multiclient study, "Molecular Diagnostics Market: DNA Probes and Biochips," was prepared by VENTURE PLANNING GROUP in order to help the diagnostics and biotechnology industry executives identify and evaluate emerging opportunities, and enable both current and potential suppliers to develop effective business strategies.
This report presents the following information:
- Sales and market shares of major suppliers.
- Test volume and sales projections.
- Comparison of leading molecular diagnostic analyzers.
- Review of amplification methods.
- Analysis of test formats and detection technologies.
- New product development opportunities with significant market appeal
- during the next ten years.
- Profiles of major suppliers and recent market entrants.
- Alternative market penetration strategies.
- Potential market entry barriers and risks.
- Business planning issues and concerns.
- Listings of companies developing or marketing molecular diagnostic products.
Table of Contents
I. INTRODUCTION
II. 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
- * PCR
- Temperature Cyclers
- PCR Variations
- * Immuno-PCR
- * QC-PCR
- * DAP-PCR
- * SDA
- *TMA
- * LCR
- * bDNA
- * HPA
- * NASBA
- * 3SR
- * 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
- * PCR
- 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
- b. Chemical (Indirect, Direct)
- c. Fluorescence
- d. Chemiluminescence
- e. Electrical Conductivity
- 1. Radioactive Methods
- 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
- * Adenovirus
- * Anthrax/Bacillus Anthracis
- * Babesiosis
- * BEA/Bartonella
- * Chagas Disease
- * Campylobacter
- * Chlamydia
- * Creutzfeldt-Jakob' s Disease
- * Cytomegalovirus
- * Ebola Virus
- * EchoVirus
- * Encephalitis
- * Enteroviruses
- * Epstein-Barr Virus
- * Gonorrhea
- * Hepatitis A, B, C, D, E, F, G
- * Herpes Simplex Virus
- * Legionella
- * Lyme Disease
- * Malaria
- * Mycoplasma
- * Papillomaviruses/HPV
- * Parvovirus B19
- * Pneumonia
- * Polyomaviruses
- * Salmonellosis
- * Shigellosis
- * Streptococci
- * Toxoplasmosis
- * Tuberculosis
- *West Nile Virus
- *Yersinia
- c. Antibiotic Susceptibility
- 2. Cancer Testing
- a. Overview
- b. Major Cancer Types
- * Prostate
- * Lung
- * Colon and Rectum
- * Breast
- * Skin
- * Uterine
- * Leukemia
- * Oral
- c. Oncogenes
- 3. Genetic Diseases
- a. Overview
- b. Nucleic Acid Amplification
- c. Chromosome Imaging
- d. Genomics Technologies
- e. Proteomics Technologies
- f. Current PharmacogenomicTest
- 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
- * 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
- * USA
- * UK
- 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
- b. Cardiovascular Diseases
- c. Diabetes
- d. Alzheimer' s Disease
- e. Plasma Purification
- f. Organ Transplantation
- g. Water Contamination
- h. Others
- 1. Microbiology/Infectious Diseases
- G.COST ANALYSIS
- 1. Equipment
- 2. Consumables
- H.COMPETING/COMPLEMENTING TECHNOLOGIES
- 1. Monoclonal Antibodies/Immunoassays
- 2. RNA Probes
- 3. 2D Electrophoresis
- 4. Flow Cytometry
- I.REIMBURSEMENT ISSUES
- J.WORLDWIDE MARKET OVERVIEW
- 1. Business Environment
- 2. Market Structure
- 3. Market Size and Growth
III. FRANCE
- A. EXECUTIVE SUMMARY
- B. BUSINESS ENVIRONMENT
- C. MARKET STRUCTURE
- D. MARKET SIZE, GROWTH AND MAJOR SUPPLIERS' SALES AND MARKET SHARES
IV. GERMANY
- A. EXECUTIVE SUMMARY
- B. BUSINESS ENVIRONMENT
- C. MARKET STRUCTURE
- D. MARKET SIZE, GROWTH AND MAJOR SUPPLIERS' SALES AND MARKET SHARES
V. ITALY
- A. EXECUTIVE SUMMARY
- B. BUSINESS ENVIRONMENT
- C. MARKET STRUCTURE
- D. MARKET SIZE, GROWTH AND MAJOR SUPPLIERS' SALES AND MARKET SHARES
VI. JAPAN
- A. EXECUTIVE SUMMARY
- B. BUSINESS ENVIRONMENT
- C. MARKET STRUCTURE
- D. MARKET SIZE, GROWTH AND MAJOR SUPPLIERS' SALES AND MARKET SHARES
VII. SPAIN
- A. EXECUTIVE SUMMARY
- B. BUSINESS ENVIRONMENT
- C. MARKET STRUCTURE
- D. MARKET SIZE, GROWTH AND MAJOR SUPPLIERS' SALES AND MARKET SHARES
VIII.UK
- A. EXECUTIVE SUMMARY
- B. BUSINESS ENVIRONMENT
- C. MARKET STRUCTURE
- D. MARKET SIZE, GROWTH AND MAJOR SUPPLIERS' SALES AND MARKET SHARES
IX.USA
- A.EXECUTIVE SUMMARY
- B.BUSINESS ENVIRONMENT
- 1. Health Care Expenditures
- 2. Cost Consciousness
- 3. Reimbursement
- 4. Industry Consolidation
- 5. Managed Care
- a. HMO
- b. PPO
- 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
X.MAJOR PRODUCT DEVELOPMENT OPPORTUNITIES
- A. INSTRUMENTATION
- B. REGEANT KITS AND TEST SYSTEMS/PANELS
- C. COMPUTERS, SOFTWARE AND AUTOMATION
- D. AUXILIARY PRODUCTS
XI. DESIGN CRITERIA FOR DECENTRALIZED TESTING PRODUCTS
XII. ALTERNATIVE MARKET PENETRATION STRATEGIES
- A. INTERNAL DEVELOPMENT
- B. COLLABORATIVE ARRANGEMENTS
- C. UNIVERSITY CONTRACTS
- D. DISTRIBUTION STRATEGIES FOR DECENTRALIZED MARKETS
- 1. Marketing Approaches
- 2. Product Complexity
- 3. Customer Preference
- 4. Established Suppliers
- 5. Emerging Suppliers
- 6. Major Types Of Distributors
- 7. Market Segmentation
XIII. 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
XIV. COMPETITIVE PROFILES
- Abbott
- Aclara
- Affymetrix
- Agilent
- Ambion
- Applera
- Applied Gene
- Technologies
- Beckman Coulter
- BD
- 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
XV. APPENDIXES
- APPENDIX A: Major Companies Developing Or Marketing Molecular Diagnostic Reagents And Test Kits
- APPENDIX B: Major Universities and Research Centers Developing Molecular Diagnostic Technology
- APPENDIX C: Glossary of Terms
- APPENDIX D: Currency Exchange Rates Abbott
List of Tables:
- Table II-1: Major Companies Developing or Marketing Thermocyclers
- Table II-2: Major Companies Developing or Marketing AIDS Molecular Diagnostic and Other Direct Identification Tests
- Table II-3: Major Companies Developing or Marketing Adenovirus Molecular Diagnostic and Other Direct Identification Tests
- Table II-4: Major Companies Developing or Marketing Campylobacter Molecular Diagnostic and Other Direct Identification Tests
- Table II-5: Major Companies Developing or Marketing Chlamydia Molecular Diagnostic and Other Direct Identification Tests
- Table II-6: Major Companies Developing or Marketing CMV Molecular Diagnostic and Other Direct Identification Tests
- Table II-7: Major Companies Developing or Marketing EBV Molecular Diagnostic and Other Direct Identification Tests
- Table II-8: Major Companies Developing or Marketing Gonorrhea Molecular Diagnostic and Other Direct Identification Tests
- Table II-9: Major Companies Developing or Marketing Hepatitis Molecular Diagnostic and Other Direct Identification Tests
- Table II-10: Major Companies Developing or Marketing Herpes Molecular Diagnostic and Other Direct Identification Tests
- Table II-11: Major Companies Developing or Marketing Legionella Molecular Diagnostic and Other Direct Identification Tests
- Table II-12: Major Companies Developing or Marketing Lyme Disease Molecular Diagnostic and Other Direct Identification Tests
- Table II-13: Major Companies Developing or Marketing Mycoplasma Molecular Diagnostic and Other Direct Identification Tests
- Table II-14: Major Companies Developing or Marketing Papilloma Molecular Diagnostic and Other Direct Identification Tests
- Table II-15: Major Companies Developing or Marketing Pneumonia Molecular Diagnostic and Other Direct Identification Tests
- Table II-16: Major Companies Developing or Marketing Salmonella Molecular Diagnostic and Other Direct Identification Tests
- Table II-17: Major Companies Developing or Marketing Shigella Molecular Diagnostic and Other Direct Identification Tests
- Table II-18: Major Companies Developing or Marketing Streptococci Molecular Diagnostic and Other Direct Identification Tests
- Table II-19: Major Companies Developing or Marketing Toxoplasmosis Molecular Diagnostic and Other Direct Identification Tests
- Table II-20: Major Companies Developing or Marketing Tuberculosis Molecular Diagnostic and Other Direct Identification Tests
- Table II-21: Major Companies Developing or Marketing Cancer Molecular Diagnostic Tests
- Table II-22: Major Companies Developing or Marketing Molecular Diagnostic Tests For Genetic Diseases
- Table II-23: Worldwide, Laboratories Performing DNA Sequencing by Country
- Table II-24: Worldwide, Molecular Diagnostics Market, Potential Laboratory Universe by Country
- Table II-25: Worldwide, Molecular Diagnostic Test Volume Forecast by Country
- Table II-26: Worldwide, Molecular Diagnostics Market Forecast by Country
- Summary Table: France, Molecular Diagnostic Test Volume and Sales Forecast by Major Application
- Table III-1: France, Laboratories Performing DNA Sequencing by Market Segment
- Table III-2: France, Molecular Diagnostics Market, Potential Laboratory Universe by Segment
- Table III-3: France, Molecular Diagnostic Test Volume Forecast by Major Application
- Table III-4: France, Major Infectious Diseases Molecular Diagnositic Test Volume Forecast by Assay
- Table III-5: France, Infectious Disease Screening NAT Volume Forecast
- Table III-6: France, Molecular Diagnostics Market Forecast by Major Application
- Table III-7: France, Infectious Disease Screening NAT Market Forecast by Test
- Table III-8: France, Molecular Diagnostics Market by Major Supplier
- Table III-9: France, HIV/Hepatitis Screening NAT Market by Major Supplier
- Summary Table: Germany, Molecular Diagnostic Test Volume and Sales Forecast by Major Application
- Table IV-1: Germany, Laboratories Performing DNA Sequencing by Market Segment
- Table IV-2: Germany, Molecular Diagnostics Market, Potential Laboratory Universe by Segment
- Table IV-3: Germany, Molecular Diagnostic Test Volume Forecast by Major Application
- Table IV-4: Germany, Major Infectious Diseases Molecular Diagnositic Test Volume Forecast by Assay
- Table IV-5: Germany, Infectious Disease Screening NAT Volume Forecast
- Table IV-6: Germany, Molecular Diagnostics Market Forecast by Major Application
- Table IV-7: Germany, Infectious Disease Screening NAT Market Forecast by Test
- Table IV-8: Germany, Molecular Diagnostics Market by Major Supplier
- Table IV-9: Germany, HIV/Hepatitis Screening NAT Market by Major Supplier
- Summary Table: Italy, Molecular Diagnostic Test Volume and Sales Forecast by Major Application
- Table V-1: Italy, Laboratories Performing DNA Sequencing by Market Segment
- Table V-2: Italy, Molecular Diagnostics Market, Potential Laboratory Universe by Segment
- Table V-3: Italy, Molecular Diagnostic Test Volume Forecast by Major Application
- Table V-4: Italy, Major Infectious Diseases Molecular Diagnostic Test Volume Forecast by Assay
- Table V-5: Italy, Infectious Disease Screening NAT Volume Forecast
- Table V-6: Italy, Molecular Diagnostics Market Forecast by Major Application
- Table V-7: Italy, Infectious Disease Screening NAT Market Forecast by Test
- Table V-8: Italy, Molecular Diagnostics Market by Major Supplier
- Table V-9: Italy, HIV/Hepatitis Screening NAT Market by Major Supplier
- Summary Table: Japan, Molecular Diagnostic Test Volume and Sales Forecast by Major Application
- Table VI-1: Japan, Laboratories Performing DNA Sequencing by Market Segment
- Table VI-2: Japan, Molecular Diagnostics Market, Potential Laboratory Universe by Segment
- Table VI-3: Japan, Molecular Diagnostic Test Volume Forecast by Major Application
- Table VI-4: Japan, Major Infectious Diseases Molecular Diagnositic Test Volume Forecast by Assay
- Table VI-5: Japan, Infectious Disease Screening NAT Volume Forecast
- Table VI-6: Japan, Molecular Diagnostics Market Forecast by Major Application
- Table VI-7: Japan, Infectious Disease Screening NAT Market by Test
- Table VI-8: Japan, Molecular Diagnostics Market Forecast by Major Supplier
- Table VI-9: Japan, HIV/Hepatitis Screening NAT Market by Major Supplier
- Summary Table: Spain, Molecular Diagnostic Test Volume and Sales Forecast by Major Application
- Table VII-1: Spain, Laboratories Performing DNA Sequencing by Market Segment
- Table VII-2: Spain, Molecular Diagnostics Market, Potential Laboratory Universe by Segment
- Table VII-3: Spain, Molecular Diagnostic Test Volume Forecast by Major Application
- Table VII-4: Spain, Major Infectious Diseases Molecular Diagnositic Test Volume Forecast by Assay
- Table VII-5: Spain, Infectious Disease Screening NAT Volume Forecast
- Table VII-6: Spain, Molecular Diagnostics Market Forecast by Major Application
- Table VII-7: Spain, Infectious Disease Screening NAT Market by Test
- Table VII-8: Spain, Molecular Diagnostics Market by Major Supplier
- Table VII-9: Spain, HIV/Hepatitis NAT Screening Market by Major Supplier
- Summary Table: UK, Molecular Diagnostic Test Volume and Sales Forecast by Major Application
- Table VIII-1: UK, Laboratories Performing DNA Sequencing by Market Segment
- Table VIII-2: UK, Molecular Diagnostics Market, Potential Laboratory Universe by Segment
- Table VIII-3: UK, Molecular Diagnostic Test Volume Forecast by Major Application
- Table VIII-4: UK, Major Infectious Diseases Molecular Diagnositic Test Volume Forecast by Assay
- Table VIII-5: UK, Infectious Disease Screening NAT Volume Forecast
- Table VIII-6: UK, Molecular Diagnostics Market Forecast by Major Application
- Table VIII-7: UK, Infectious Disease Screening NAT Market Forecast by Test
- Table VIII-8: UK, Molecular Diagnostics Market by Major Supplier
- Summary Table: USA, Molecular Diagnostic Test Volume and Sales Forecast by Major Application
- Table IX-1: USA, Laboratories Performing DNA Sequencing by Market Segment
- Table IX-2: USA, Molecular Diagnostics Market, Potential Laboratory Universe by Segment
- Table IX-3: USA, Molecular Diagnostic Test Volume Forecast by Major Application
- Table IX-4: USA, Major Infectious Diseases Molecular Diagnositic Test Volume Forecast by Assay
- Table IX-5: USA, Infectious Disease Screening NAT Volume Forecast by Test
- Table IX-6: USA, Molecular Diagnostics Market Forecast by Major Application
- Table IX-7: USA, Infectious Disease Screening NAT Market Forecast by Test
- Table IX-8: USA, Molecular Diagnostics Market by Major Supplier
- Table IX-9: USA, HIV/Hepatitis C Screening NAT Market by Major Supplier
- Table IX-10: USA, West Nile Virus Screeing NAT Market by Major Supplier

