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2012 World Molecular Diagnostics Market Strategic Analysis: Supplier Shares and Sales Forecasts for 35 Tests/Applications by Country

December 2012 | 1050 pages | ID: M095065701FEN
Venture Planning Group

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This comprehensive seven-country report contains 1,050 pages, 96 tables, and is designed to help current suppliers and potential market entrants identify and evaluate major business opportunities emerging in the molecular diagnostics market during this decade. The report explores business and technological trends in the US, five major European countries, (France, Germany, Italy, Spain, UK) and Japan; provides 5- and 10-year test volume/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.

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 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 with 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.
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
    
    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 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
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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