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  5. > 2016-2020 Tumor Markers: Unlocking the Mystery of the Genetic Basis of Cancer--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

Table Of Contents

2016-2020 Tumor Markers: Unlocking the Mystery of the Genetic Basis of Cancer--Technological Breakthroughs, Emerging Tests, Market Forecasts, Competitive Intelligence
TUMOR MARKERS: US, EUROPE, JAPAN
Emerging Opportunities And Business Expansion Strategies
Table of Contents

Introduction
Worldwide Market and Technology Overview
A. Cancer Statistics and Etiology
1. Bladder
2. Breast
3. Cervical
4. Colon and Rectum
5. Endometrial
6. Esophagus
7. Head and Neck
8. Leukemia
9. Lung
10. Lymphoma
11. Oral
12. Ovarian
13. Prostate
14. Renal Cell Carcinoma
15. Skin
16. Stomach
17. Uterine
B. Major Current And Emerging Tumor Marker
1. Introduction
2. Tumor Marker Classification
3. ACTH
4. Alpha-Fetoprotein (AFP)
5. Beta-2 Microglobulin
6. CA 15-3/27.29
7. CA 19-9
8. CA-125
9. Calcitonin
10. Carcinoembrionic Antigen (CEA)
11. Estrogen and Progesterone Receptors
12. Ferritin
13. Gastrin
14. Human Chorionic Gonadotropin (HCG)
15. Insulin
16. Lymphocytes CD4/CD8

17. NSE
18. Occult Blood
19. PAP Smear/HPV
20. Prostatic Acid Phosphatase (PAP)
21. Prostate-Specific Antigen (PSA)
22. Squamous Cell Carcinoma Antigen (SCC)
23. TdT
24. Thyroglobulin
25. Tissue Polypeptide Antigen (TPA)
26. Biochemical Tumor Markers
- ADA
- B-Protein
- PNP
- 5'-Nucleotidase
27. Oncogenes
- Abl/abl-bcr
- AIB1
- APC
- BTA 26
- BCL-2
- BCR-ABL
- B-raf
- BRCA
- CD44
- CDK
- C-abl
- C-fos
- C-myb
- C-myc
- CYCD1
- CYP-17
- DPC
- E-myc
- Erb-B
- HER-2/neu
- HPC1
- HSTF
- L-myc
- MET
- MSH
- NEU
- N-myc

- N-telopeptide
- PCA3
- PIK3CA
- PTI-1
- P10
- P40
- P51
? P53
? Ras
? Reg
? RET
? sFas
? Sis
- Src
28. Polypeptide Growth Factors
? Basic Fibroblast Growth Factor
? Beta-TGF
- Cachectin (TNT)
? Calmodulin
? ECFR
? Nerve Growth Factor (NGF)
? Epidermal Growth Factor (EGF)
? Ornithine Decarboxylase
? Transferrin
? Transforming Growth Factor-Alpha
29. Ectopic Hormones
30. Colony Stimulating Factors
31. Lymphokines
? Alpha-Interferon
? B Cell Growth Factors
? B Cell Growth Factor (BCGF)
? Gamma-Interferon
? Interleukin-1 (IL-1)
? Macrophage Activating Factor
32. Immunohistochemical Stains
33. Emerging Tumor Markers
? N-Acetylglucosamine
? Actin
? Alpha-Actin
? Angiogenin
? Angiostatin
? Antineuronal Antibodies

- 7B2
? B72.3
- B-Protein
? Bax
- BCD-F9
? BLCA-4
- Blood Group Antigens A,B,H
? BTA
- CA 50
? CA 72-4/TAG-72
- CA 195
? CA-242
- CA-549
? Cadherin
- CAM 26
? CAR-3
- CD105
? Cathepsin-D
- Chromogranin A and B
? Cluster 1 Antigen
- Cluster-5/5A Antigen
? COX Antigen
- CTA
? CU18
- Cyclin
? DR-70
- DU-PAN-2
? Endometrial Bleeding Associated Factor
- Endostatin
? Epithelial Membrane Antigen
- FDP
? Feulgen Hydrolysis
- Fibronectin
? FSH
- (1->3)-L-fucosyltransferase
? Gastrin-Releasing Peptide (GRP)
- GDCFP-15
? Glucagon
- Glycoamines
? H23
- HAAH
? hk3

- HPA
? HSP27
- Human Carcinoma Antigen
? ICAM
- Intermediate Filaments
- Cytokeratins/CK18/Cyfra 21-1
- Desmin
- Gliofibrillary Acid Protein
- Neurofilaments
- Vimentin
? KA 93
- Kallikrein
- Kinases
? KP16D3
- LAI
? Leukocyte Common Antigen
- Lewis Antigens
? Lysophosphatidic Acid (LPA)
- Ma 695/Ma 552
? MABDF3
- MAG
? ME1
- Minactivin
? MN/CA9
- MSA
? Mucin Cancer Antigen (MCA)
- Multiple Tumor Suppressor 1
? Myosin
- NEA-130
? NMP22
- Nucleolar
- OA-519
? Opiod Peptides
- P-glycoprotein
? Pancreatic Oncofetal Antigen (POA)
- Parathyrcoid Hormone
? Placental Lactogen
- PR92
? Proliferative Index, Ki-67
- Px
? RB Inactivation/Deletion


- Ret
? S-100 Protein
- SCCL 175
? Selectin
- Serotonin
? Sialic Acid
- Sialyl SSEA-1/SLX
? SN10
- Somatostatin
? TA-90
- TABA
? Tachykinin
- TAG 12
? TPS
- Troponin
? Tubulin
- VCAM
? VEGF
- Villen
- White Blood Cell Markers
C. Instrumentation Review And
Market Needs
1. Abbott AxSYM
2. Abbott IMx
3. Anagen AN2000/AuraFlex
4. Beckman Coulter Access
5. BioChem Pharma SR1
6. bioMerieux Vidas Series
7. Biotrol Systems 7000
8. JandJ Diagnostics/Amersham Amerlite
9. JandJ Diagnostics Vitros ECI
10. Olympus PK Series
11. Roche Cobas Core
12. Roche Elecsys
13. Roche ES 22
14. Roche ES 33
15. Roche ES 300/300 AL
16. Siemens ACS: 180
17. Siemens ACS: Centaur
18. Siemens ELISA Processor II/III
19. Siemens Immuno 1
20. Siemens/Opus/Plus/Magnum

21. Siemens Stratus
22. Tosoh AIA Series
23. Wallac/Pharmacia Delfia
D. Current and Emerging Technologies
1. Monoclonal and Polyclonal Antibodies
2. Immunoassays
a. Technological Principle
b. Radioimmunoassay (RIA)
c. Enzyme Immunoassays (EIA)
- Overview
- ELISA
- Immunofiltration
- Particle-Membrane Capture Immunoassay
- Enzyme Amplification
d. Fluorescent Immunoassays
e. Luminescence
- Chemiluminescence
- Bioluminescence
3. Molecular Diagnostics
a. Technology Overview
b. Amplification Methods
- PCR
- DAP-PCR
- Immuno-PCR
- QC-PCR
- CAR
- DNA
- HPA
- LCR
- NASBA
- QBR
- SDA
- 3 SR, and others
4. Biochips/Microarrays
5. Chromosome Analysis
a. Chronic Myelogenous Leukemia (CML)
b. Acute Myeloid Leukemia (AML)
c. Acute Lymphoblastic Leukemia (ALL)
d. Malignant Lymphomas
Lymphoid Malignancies
e. Chronic Lymphocytic Leukemia (CLL)
f. Solid Cancers
g. Chromosomal Translocation and Oncogenes

6. Microcomputers and Automation
7. Artificial Intelligence
8. Flow Cytometry
9. Biosensors
E. Competing/Complementing Technologies
1. CT
2. MRI
3. NMR
4. PET
5.Photonics Spectroscopy
F. Business Environment
1. Worldwide Market Structure
2. Worldwide Market Size and Growth
G. Personal Testing
France
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers
Germany
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers
Italy
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers
Japan
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers

Spain
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers
U.K.
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers
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. HMO
b. PPO
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. Centralized Testing
a. Hospitals
b. Commercial/Private Laboratories
2. POT/Decentralized Testing
a. Physician Offices/Group Practices

b. Cancer Clinics
c. Other Decentralized Testing Locations
D. Market Size, Growth and Major Suppliers Sales,
Instrument Placements and Market Shares
Major Product Development Opportunities
A. Reagent Kits and Test Systems/Panels
B. Instrumentation
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
1. Marketing Approaches
2. Product Complexity
3. Customer Preference
4. Established Suppliers
5. Emerging Suppliers
6. Major Types of Distributors
7. Market Segmentation Factor
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
- AdnaGen
- Ambrilia Biopharma
- AMDL
- Beckman Coulter
- Becton Dickinson
- Biomedical Diagnostics
- bioMerieux
- Bio-Rad
- CanAG Diagnostics
- CeMines
- Cepheid
- Correlogic Systems
- Dako
- Decode
- Diadexus
- Diagnocure
- Diasorin
- Eiken Chemical
- Enterix
- Enzo Biochem
- Epigenomics
- Exact Sciences
- Fujirebio
- Gen-Probe
- Guided Therapeutics
- Hologic
- Ipsogen
- JandJ Diagnostics
- Kreatech
- Kyowa Medex
- Mackay Life Sciences
- Matritech
- Myriad Genetics
- OncoLab
- Panacea Pharmaceuticals
- Polartechnics
- Polymedco
- PreMD
- Qiagen

- Radient Pharmaceuticals
- Roche
- Scienion
- Sequenom
- Siemens Healthcare
- Takara Bio
- Targeted Diagnostics and Therapeutics
- Tosoh
- Veridex
- Wako Pure Chemicals
- Wallac
- Zila

Appendixes
Appendix I: Major Companies Developing or
Marketing Tumor Marker Reagents
and Instruments
Appendix II: Major Universities and Research
Centers Developing Tumor Marker
Detection
Technologies and Applications
Appendix III: Assumed Currency Exchange Rates

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