2017 Winning Strategies in Molecular Diagnostics: Integrating New Technology Planning with Business and Corporate Strategies--Technological Breakthroughs, Emerging Tests, Market Forecasts, Competitive Intelligence

This new seven-country study from VPGMarketResearch 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.

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, Gen-Probe, Roche, Tecan 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

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
O Polymerase Chain Reaction
- Temperature Cyclers
Table of Contents (continued)
- PCR Variations
* Immuno-PCR
* QC-PCR
* DAP-PCR
O Strand Displacement Activation
O TMA
O Ligase Chain Reaction
O Branched DNA
- Hybridization Protection Assay
O Nucleic-Acid Sequence-Based Amplification
O Self-Sustained Sequence Replicase
O 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
O P-32
O S-35
O H-3
O I-125
2. Non-Isotopic Methods
a. Enzymatic Labels
b. Chemical Labeling
O Indirect Chemical Labeling
O Direct Chemical Labeling
Table of Contents (continued)
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
O Structure and Composition
O Classification
O AIDS Origins
O Animal Lentivirus Systems
O Virus Receptors
O HIV Infections in Humans
- Pathogenesis and Pathology
O CD4T Lymphocytes and Memory Cells
O Monocytes and Macrophages
O Lymphoid Organs
O Neural Cells
O Viral Coinfections
- Clinical Findings
O Plasma Viral Load

Table of Contents (continued)
O Pediatric AIDS
- Neurologic Disease
- Opportunistic Infections
- Cancer
O Immunity
- Virus Isolation
- Serology
- Viral Nucleic Acid/Antigen Detection
O Epidemiology
- Worldwide Spread of AIDS
- United States
- Routes of Transmission
O DNA Probes
- Overview
- Quantitative PCR
- In Situ PCR
- Needed Improvements
O Viral Load/Drug Resistance Testing
O Genotype and Phenotype Testing
O Blood Banking Considerations
* Adenovirus
O Background
O Diagnostic Tests
O Vaccines and Drugs
O Adeno-Associated Viruses (AAV)
* Anthrax/Bacillus Anthracis
O Background
O Diagnostic Tests
O Vaccines and Drugs
* Babesiosis
O Background
* BEA and Other Bartonella Diseases
O Background
O Diagnostic Tests
O Vaccines and Drugs
* Chagas Disease
O Background
Table of Contents (continued)
* Campylobacter
O Background
O Diagnostic Tests
- Culture Identification
O Vaccines and Drugs
* Chlamydia
O Background
- Chlamydia psittaci
- Chlmaydia pneumoniae
- Chlamydia trachomatis
O Diagnostic Tests
O Vaccines and Drugs
* Creutzfeldt-Jakobs Disease
O Background
O Blood Transmission
O Diagnostic Tests
O 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
O Drugs
O Vaccines
* Cytomegalovirus
O Background
- Chorioretinitis
- Gastrointestinal
- Central Nervous System Disease
O Diagnostic Tests
O Vaccines and Drugs
* Ebola Virus
O Background
- Epidemiology
- Clinical Syndromes
Table of Contents (continued)
O Diagnostic Tests
O Vaccines and Drugs
* EchoVirus
O Background
- Acute Aseptic Meningitisis
- Encephalitis
- Exanthems
- Respiratory Disease
- Myopericarditis
- Neonatal Infections
O Diagnostic Tests
O Vaccines and Drugs
* Encephalitis
O Background
O Diagnostic Tests
O Vaccines and Drugs
* Enteroviruses
O Background
O Diagnostic Tests
- Viral Isolation and Identification
- Antibody Tests
O Vaccines and Drugs
* Epstein-Barr Virus
O Background
O Diagnostic Tests
O Vaccines and Drugs
* Gonorrhea
O Background
O Diagnostic Tests
O Vaccines and Drugs
* Hepatitis
O Hepatitis A
O Hepatitis B
- Structure and Composition
- Replication
O Hepatitis C
O Hepatitis D (Delta)
O Hepatitis E
O Hepatitis G
O Hepatitis Infections Pathology
O Clinical Findings
O Laboratory Tests
Table of Contents (continued)
- Hepatitis A
- Hepatitis B
- Hepatitis C
- Hepatitis D
- Hepatitis E
O Virus-Host Immune Reactions
O Epidemiology
- Hepatitis A
- Hepatitis B
- Hepatitis C
- Hepatitis D (Delta)
O Vaccines and Drugs
* Herpes Simplex Virus
O Background
O Diagnostic Tests
O Vaccines and Drugs
* Legionella
O Background
O Diagnostic Tests
O Vaccines and Drugs
* Lyme Disease
O Background
- Clinical Description
- Clinical Case Definition
- Laboratory Criteria for Diagnosis
- Case Classification
O Diagnostic Tests
O Vaccines and Drugs
* Malaria
* Mycoplasma
O Background
- Ureaplasma Urealyticum & Mycoplasma
Hominis
O Diagnostic Tests
O Vaccines and Drugs
* Papillomaviruses/HPV
O Background
- HPV in Cancer
- Cervical Neoplasm
O Diagnostic Tests
O Vaccines and Drugs
Table of Contents (continued)
- Prevention
* Parvovirus B19
O Background
- Microbiology
- Epidemiology
- Clinical Syndromes
- Erythema Infectiosum (Slapped Cheek)
- Adult Polyarthropathy
- Transient Aplastic Crisis
- Transient Pancytopenia
- Red Cell Aplasia in Immunocompromised
- Perinatal Infections
O Diagnostic Test
O Vaccines and Drugs
* Pneumonia
O Background
O Diagnostic Tests
O Vaccines and Drugs
* Polyomaviruses
O Background
O Diagnostic Tests
O Vaccines and Drugs
* Salmonellosis
O Background
O Diagnostic Tests
O Vaccines and Drugs
* Shigellosis
O Background
O Diagnostic Tests
O Vaccines and Drugs
* Streptococci
O Background
O Diagnostic Tests
O Vaccines and Drugs
- Group A Streptococci
- Group B Streptococci
* Toxoplasmosis
O Background
O Diagnostic Tests
O Vaccines and Drugs
Table of Contents (continued)
* Tuberculosis
O Background
O Diagnostic Tests
- Microscopic Characteristics
- Cultural Characteristics
- Skin Tests
- MDRTB
O Vaccines and Drugs
* West Nile Virus
O Background
- Clinical Syndromes
O Diagnostic Tests
O Vaccines and Drugs
* Yersinia
O Background
O Diagnostic Tests
O 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
O Abl/abl-bcr
O AIB1
O BCL-2
O BRCA1
O CD44
O C-fos
O C-myb
O C-myc
O CYP17
O Erb-B
O HPC1
Table of Contents (continued)
O N-myc
O P40
O P51
O P53
O PIK3CA
O PTI-1
O Ras
O Reg
O Sis
O 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
* Downs Syndrome
* Duchenne and Becker Muscular Dystrophy
* Factor V (Leiden)
* Factor IX Deficiency
* Fragile X Syndrome
* Heart Disease
* Hemochomatosis
* Hemophilia
* Huntingtons Disease
* Maternal-Fetal Incompatibility
* Multiple Endocrine Neoplasia
* Phenylketonuria (PKU)
* Polycystic Kidney Disease (PKD)
* Prenatal Screening
* Retinitis Pigmentosa
* Retinoblastoma
* Sickle Cell Anemia
Table of Contents (continued)
* 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. Alzheimers 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
Table of Contents (continued)
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
Table of Contents (continued)
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
Table of Contents (continued)
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
- Arca3KDUPD
- Beckman Coulter/Danaher
- Becton Dickinson
- Biokit
Table of Contents (continued)
- BioMerieux
- Bio-Rad
- Biotest
- Cepheid
- CellMark Forenciscs/LabCorp
- Decode Genetics
- Diadexus
- Eiken
- Elitech Group
- Enzo
- Exact Sciences
- Fujirebio
- Grifols
- Hologic/Gen-Probe
- Illumina
- Kreatech/Leica
- Li-Cor Biosciences
- Monogram Biosciences
- Myriad Genetics
- Ortho-Clinical Diagnostics
- Perkin Elmer/Caliper
- Proteome Sciences
- Qiagen
- Roche
- Scienion
- Sequenom
- Shimadzu
- Siemens
- Sierra Molecular
- Takara Bio
- Tecan Group
- Thermo Fisher
Table of Contents (continued)
Appendixes
Appendix I: Major Universities and Research Centers
Developing Molecular Diagnostic
Technology
Appendix II: Glossary of Terms
Appendix III: Currency Exchange Rates

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