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Nucleic Acid Testing in Europe 2014: Market Segment Forecasts and Supplier Shares

January 2014 | 970 pages | ID: 27746B5581AEN
Venture Planning Group

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This comprehensive five-country report is designed to help current suppliers and potential market entrants identify and evaluate major business opportunities emerging in the molecular diagnostics market during the next five years. The report explores business and technological trends in major European countries (France, Germany, Italy, Spain, UK); provides 5-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 five years.



The $4.5 billion molecular diagnostics market is unquestionably the most rapidly growing segment of the in vitro diagnostics industry. The next five 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 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 five 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
    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

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

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

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 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 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


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