The 2011 Molecular Diagnostics Market: DNA Probes and Biochips -- New Product Development Opportunities and Business Expansion Strategies for Instrument and Reagent Suppliers

Venture Planning Group (VPG), February 2010, Pages: 1050

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

This report contains information not available from any other source, such as:
1) sales and market shares of major suppliers;
2) volume and sales forecasts by procedure, market segment, and country; and
3) specific new product development and business expansion opportunities for suppliers; and much more

Market Segments: Hospitals, Commercial Labs, Physician Offices, Blood Banks, Public Health Labs

According to the 7-country study from Venture Planning Group, the global molecular diagnostics market is growing at the rate of 18% a year, and is expected to reach $10 billion in 5 years. The most rapid growth is projected for genetic and cancer tests.

The report was prepared by VPG in order to assist diagnostics industry executives in evaluating emerging opportunities and developing effective business, R&D and marketing strategies for this dynamic and rapidly evolving market segment.

Report Content

This two-volume, 1050-page report contains 96 tables and presents the following information:

Worldwide Market Overview
- Laboratories performing DNA sequencing and molecular diagnostic testing, by country and market segment.
- Ten-year test volume and sales projections, by country.

Market Segmentation Analysis
- Sales and market shares for Roche, Gen-Probe and other major suppliers of molecular diagnostc tests and kit components, by country.
- Ten-year test volume and sales forecasts for major DNA probes and NAT applications, including:
-- Infectious Diseases
-- Forensic Testing
-- Cancer
-- Paternity Testing/HLA Typing
-- Genetic Diseases
-- Others
- Ten-year test volume and sales projections for 30 molecular diagnostic assays.
- A comprehensive analysis of the DNA sequencing market, by country and laboratory segment, including:
-- Industrial
-- Academic
-- Government
-- Commercial
- A detailed market segmentation analysis, including review of the market dynamics, trends, structure, size, growth and major suppliers, by country.

Product/Technology Review
- A comparison of leading molecular diagnostic analyzers from Abbott, Beckman Coulter, BD, Bio-Rad, Gen-Probe, Roche, Tecan and others.
- An extensive review of the molecular diagnostic technologies, test formats, detection methodologies, trends in testing automation and over 30 target/signal amplification methods, including:
-- PCR
-- bDNA
-- SDA
-- NASBA
-- TMA
-- LCR
-- SSSR, and others
- Worldwide listings of companies, universities and research centers developing new molecular diagnostic technologies and products.

Competitive Assessments
- Extensive (up to 7 pages each) strategic assessments of 45 major suppliers and emerging market entrants, including their sales, product portfolios, marketing tactics, collaborative arrangements and new projects in R&D.
- Comprehensive listings of companies developing and marketing molecular diagnostic products, by test and application.

Opportunities and Strategic Recommendations
- 63 specific new product development opportunities with potentially significant market appeal during the next ten years.
- Design criteria for new products.
- Alternative market penetration strategies.
- Potential market entry barriers and risks.
- Business planning issues and concerns.

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
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
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
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
- Applied Biosystem
- ARCA Biopharma
- Beckman Coulter
- BD
- Biokit
- BioMerieux
- Biotest
- Caliper
- Cepheid
- Chiron
- Decode
- Diadexus
- Digene
- Eiken
- Enzo
- Exact Sciences
- Fujirebio
- Gen-Probe
- Gene Tec
- Illumina
- Innogenetics
- Kreatech
- Li-Cor
- Myriad Genetics
- Nanogen
- Orchid Biosciences
- Qiagen
- Roche
- Sangtec
- Sequenom
- Seracare Life Science
- 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

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

The study is based on discussions with clinical pathologists, laboratory directors, as well as executives from leading companies and start-up firms developing innovative tests and instrumentation in the U.S., five major European countries and Japan.

In addition to primary sources of information, a comprehensive review of the technical and business publications, manufacturer product literature, industry analyst reports, as well as Venture Planning Group's proprietary data files was conducted.

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