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2014 Analysis of the Global Nucleic Acid Testing Market: Innovative Technologies and Emerging Business Opportunities

November 2013 | 1050 pages | ID: 2C7067D58F3EN
Venture Planning Group

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This unique seven-country report , 1,050-page report is designed to help current suppliers and potential market entrants identify and evaluate major business opportunities emerging in the NAT market during this decade.

Highlights
  • Business and technological trends in seven major markets
  • Five- and ten-year test volume and sales forecasts
  • Market shares of leading competitors
  • Feature comparison of major analyzers
  • Profiles of market players and start-up firms developing innovative technologies and products
  • Specific product and business opportunities for instrument and consumable suppliers.
Rationale

The NAT 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 NAT market, many companies are already exploiting new molecular 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 diagnostic companies during the next ten years.

Geographic Coverage
  • France
  • Germany
  • Italy
  • Japan
  • Spain
  • UK
  • USA
Worldwide Market Overview
  • Laboratories performing DNA sequencing and NAT by country and market segment.
  • Ten-year test volume and sales projections by country.
Market Segmentation Analysis
  • Sales and market shares of major suppliers of NAT reagent kits and components.
  • Ten-year test volume and sales forecasts for major applications, including:
    • Infectious Diseases
    • Forensic Testing
    • Cancer
    • Paternity Testing/HLA Typing
    • Genetic Diseases
    • Others
  • Ten-year test volume and sales projections for over 30 NAT assays.
  • A comprehensive analysis of the sequencing market, by country and laboratory segment, including:
    • Industrial - Academic
    • Government - Commercial
  • Detailed market segmentation analysis, including review of the market dynamics, trends, structure, size, growth and major suppliers, by country.
Product/Technology Review
  • Comparison of leading NAT analyzers from Abbott, Beckman Coulter, BD, Bio-Rad, Gen-Probe, Roche, Tecan and other suppliers.
  • Extensive review of NAT technologies, test formats, detection methodologies, trends in testing automation and over 30 target/signal amplification methods, including:
    • PCR
    • bDNA
    • SDA
    • NASBA
    • TMA
    • SSSR, and others
    • LCR
  • Worldwide listings of companies, universities and research centers developing new NAT technologies and products.
Competitive Assessments
  • Extensive strategic assessments of major suppliers and emerging market entrants, including their sales, product portfolios, marketing tactics, collaborative arrangements and new technologies/products in R&D.
  • Comprehensive listings of companies developing and marketing NAT products, by test and application.
Opportunities and Strategic Recommendations
  • 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.
Methodology

This report is based on a combination of primary and secondary information sources, including interviews with laboratory directors and executives of leading diagnostic companies and start-up firms developing innovative technologies and products in the U.S., five major European countries and Japan.

In addition to primary sources of information, a comprehensive review of the most recent technical and business publications, manufacturer product and financial literature, as well as Venture Planning Group’s proprietary data base was conducted.

Contains 1050 pages and 96 tables
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
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. PP
    b. HM
  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 NAT Technology
Appendix II: Glossary of Terms
Appendix III: Currency Exchange Rates

LIST OF TABLES

Major Companies Developing or Marketing AIDS NAT And Other Direct Identification Tests
Major Companies Developing or Marketing Adenovirus NAT And Other Direct Identification Tests
Major Companies Developing or Marketing Campylobacter NAT And Other Direct Identification Tests
Major Companies Developing or Marketing Chlamydia NAT 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 NAT And Other Direct Identification Tests
Major Companies Developing or Marketing Hepatitis NAT And Other Direct Identification Tests
Major Companies Developing or Marketing Herpes NAT And Other Direct Identification Tests
Major Companies Developing or Marketing Legionella NAT And Other Direct Identification Tests
Major Companies Developing or Marketing Lyme Disease NAT And Other Direct Identification Tests
Major Companies Developing or Marketing Mycoplasma NAT And Other Direct Identification Tests
Major Companies Developing or Marketing Papilloma Virus NAT And Other Direct Identification Tests
Major Companies Developing or Marketing Pneumonia NAt And Other Direct Identification Tests
Major Companies Developing or Marketing Salmonella NAt And Other Direct Identification Tests
Major Companies Developing or Marketing Shigella NAt And Other Direct Identification Tests
Major Companies Developing or Marketing Streptococci NAt And Other Direct Identification Tests
Major Companies Developing or Marketing Toxoplasmosis NAt And Other Direct Identification Tests
Major Companies Developing or Marketing Tuberculosis NAt And Other Direct Identification Tests
Oncogenes Potential Application in Cancer Diagnosis
Major Companies Developing or Marketing Cancer NAT Tests
Major Companies Developing or Marketing NAT Assays For Genetic Diseases
Worldwide, Laboratories Performing DNA Sequencing By Country
Worldwide, NAT Market Potential Laboratory Universe by Country
Worldwide, NAT Test Volume Forecast By Country
Worldwide, NAT Market Forecast by Country
Summary Table France, NAT Test Volume And Sales Forecast by Major Application
France, Laboratories Performing DNA Sequencing By Market Segment
France, NAT Market Potential Laboratory Universe by Market Segment
France, NAT Test Volume Forecast By Major Application
France, Major Infectious Disease Molecular Diagnostics Test Volume Forecast
France, Infectious Disease Screening NAT Volume Forecast
France, NAT Market Forecast By Major Application
France, Infectious Disease Screening NAT Reagent Market Forecast by Test
France, NAT Market By Major Supplier
France, HIV/Hepatitis NAT Market Reagent Sales By Major Supplier
Summary Table Germany, NAT Test Volume And Sales Forecast by Major Application
Germany, Laboratories Performing DNA Sequencing by Market Segment
Germany, NAT Market Potential Laboratory Universe by Market Segment
Germany, NAT Test Volume Forecast By Major Application
Germany, Major Infectious Disease Molecular Diagnostics Test Volume Forecast
Germany, Infectious Disease Screening NAT Volume Forecast
Germany, NAT Market Forecast By Major Application
Germany, Infectious Disease Screening NAT Reagent Market Forecast by Test
Germany, NAT Market by Major Supplier
Germany, HIV/Hepatitis NAT Market Reagent Sales by Major Supplier
Summary Table Italy, NAT Test Volume And Sales Forecast by Major Application
Italy, Laboratories Performing DNA Sequencing by Market Segment
Italy, NAT Market Potential Laboratory Universe by Market Segment
Italy, NAT Test Volume Forecast By Major Application
Italy, Major Infectious NAT Test Volume Forecast
Italy, Infectious Disease Screening NAT Volume Forecast
Italy, NAT Market Forecast By Major Application
Italy, Infectious Disease Screening NAT Reagent Market Forecast by Test
Italy, NAT Market By Major Supplier
Italy, HIV/Hepatitis NAT Market By Major Supplier
Summary Table Japan, NAT Test Volume And Sales Forecast by Major Application
Japan, Laboratories Performing DNA Sequencing by Market Segment
Japan, NAT Market Potential Laboratory Universe by Market Segment
Japan, NAT Test Volume Forecast By Major Application
Japan, Major Infectious Disease NAT Test Volume Forecast
Japan, Infectious Disease Screening NAT Volume Forecast
Japan, NAT Market Forecast By Major Application
Japan, Infectious Disease Screening Nat Reagent Market Forecast by Test
Japan, NAT Market By Major Supplier
Japan, HIV/Hepatitis NAT Market Reagent Sales by Major Supplier
Summary Table Spain, NAT Test Volume And Sales Forecast by Major Application
Spain, Laboratories Performing DNA Sequencing by Market Segment
Spain, NAT Market, Potential Laboratory Universe by Market Segment
Spain, NAT Test Volume Forecast by Major Application
Spain, Major Infectious Disease NAT Test Volume Forecast
Spain, Infectious Disease Screening NAT Volume Forecast
Spain, NAT Market Forecast By Major Application
Spain, Infectious Disease Screening Nat Reagent Market Forecast by Test
Spain, NAT Market By Major Supplier
Spain, HIV/Hepatitis NAT Market Reagent Sales by Major Supplier
Summary Table U.K., NAT Test Volume And Sales Forecast by Major Application
U.K., Laboratories Performing DNA Sequencing by Market Segment
U.K., NAT Market Potential Laboratory Universe by Market Segment
U.K., NAT 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., NAT Market Forecast By Major Application
U.K., Infectious Disease Screening NAT Reagent Market Forecast by Test
U.K., NAT Market by Major Supplier
Summary Table U.S.A., NAT Test Volume And Sales Forecast by Major Application
U.S.A., Laboratories Performing DNA Sequencing by Market Segment
U.S.A., NAT Market, Potential Laboratory Universe by Market Segment
U.S.A., NAT Test Volume Forecast By Major Application
U.S.A., Major Infectious Disease NAT Test Volume Forecast
U.S.A., Infectious Disease Screening NAT Volume by Test Forecast
U.S.A., NAT Market Forecast By Major Application
U.S.A., Infectious Disease Screening Nat Reagent Market Forecast by Test
U.S.A., NAT 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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