2021 Winning Strategies in Molecular Diagnostics: US, Europe, Japan-Integrating New Technology Planning with Business Strategies-Country Shares and Market Segment Forecasts for 100 Tests-Technological Breakthroughs, Emerging Tests, Competitive Intelligence

July 2021 | 1050 pages | ID: 244CE09669B2EN
Venture Planning Group

Abstracts

This new seven-country study from LeadingMarketResearch 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 the next five years.

The report is available by section, and can be customized to specific information needs and budget.

Highlights

• Business and technological trends in seven major markets: France, Germany, Italy, Japan, Spain, UK, and US
• Five-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 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 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 five years.

Geographic Coverage

• France
• Germany
• Italy
• Japan
• Spain
• UK
• USA

Worldwide Market Overview

• Laboratories performing DNA sequencing and molecular diagnostic testing by country and market segment.
• Five-year test volume and sales projections by country.

Market Segmentation Analysis
• Sales and market shares of major suppliers of molecular diagnostic reagent kits and components.
• Five-year test volume and sales forecasts for major applications, including:
  • Infectious Diseases;
  • Forensic Testing
  • Cancer;
  • Paternity Testing/HLA Typing
  • Genetic Diseases;
  • Others
• Five-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 molecular diagnostic analyzers from Abbott, Beckman Coulter, BD, Bio-Rad, Hologic, Roche, Texan and other suppliers.
• Extensive review of molecular diagnostic 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 molecular diagnostic 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 molecular diagnostics products, by test and application.
Opportunities and Strategic Recommendations
• Specific new product development opportunities with potentially significant market appeal during the next five 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 VPGMarketResearch's proprietary data base was conducted.

Contains 1,050 pages and 96 tables

Contents

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 Meningitis
    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. 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 Technologies
Applied Gene Technologies
Arca Biopharma
Beckman Coulter/Danaher
Becton Dickinson
Biokit
bioMerieux
Bio-Rad
Biotest
Cepheid
Decode Genetics
Diadexus
Eiken Chemical
Elitech Group
Enzo Biochem
Exact Sciences
Fujirebio
Grifols
Hologic
Illumina
LabCorp
Leica Biosystems
Li-Cor Biosciences
Myriad Genetics
Ortho-Clinical Diagnostics
PerkinElmer
Proteome Sciences
Qiagen
Roche
Scienion
Sequenom
Shimadzu
Siemens Healthineers
Sierra Molecular
Takara Bio
Tecan Group
Thermo Fisher