Introduction
Worldwide Market and Technology Overview
A. Cancer Statistics and Etiology
1. Brest Cancer
2. Lung Cancer
3. Colon and Rectum Cancer
4. Prostate Cancer
5. Stomach Cancer
6. Leukemia
7. Lymphoma
8. Oral Cancer
9. Skin Cancer
10. Uterine Cancer
11. Ovarian Cancer
12. Bladder Cancer
B. Major Current And Emerging Cancer Diagnostic Tests
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. NSE
17. Occult Blood
18. PAP Smear/HPV
19. Prostatic Acid Phosphatase (PAP)
20. Prostate-Specific Antigen (PSA)
21. Squamous Cell Carcinoma Antigen (SCC)
22. T and B Lymphocytes
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
- BCL-2
- BRCA1
- CD44
- C-fos
- C-myb
- C-myc
- CYP-17
- Erb-B
- HPC1
- N-myc
- P40
- P51
- P53
- PIK3CA
- PTI-1
- Ras
- Reg
- 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
- Antineuronal Antibodies
- 7B2
- B72.3
- Bax
- BCD-F9
- BLCA-4
- Blood Group Antigens A,B,H
- CA 50
- CA 72-4/TAG-72
- CA 195
- CA-242
- CA-549
- CAM 26
- CAR-3

- Cathepsin-D
- Chromogranin A and B
- Cluster 1 Antigen
- Cluster-5/5A Antigen
- CTA
- CU18
- DR-70
- DU-PAN-2
- Endometrial Bleeding Associated Factor
- Endostatin
- Epithelial Membrane Antigen
- Feulgen Hydrolysis
- Fibronectin
- FSH
- (1->3)-L-fucosyltransferase
- Gastrin-Releasing Peptide (GRP)
- GDCFP-15
- Glucagon
- Glycoamines
- H23
- Her-2
- Human Carcinoma Antigen
- HPA
- HSP27
- Intermediate Filaments
- Cytokeratins/CK18/Cyfra 21-1
- Desmin
- Gliofibrillary Acid Protein
- Neurofilaments
- Vimentin
- KA 93
- 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
- OA-519
- Opiod Peptides
- P-glycoprotein
- Pancreatic Oncofetal Antigen (POA)
- Placental Lactogen
- PR92
- Proliferative Index, Ki-67
- Px
- RB Inactivation/Deletion
- Ret
- SCCL 175
- Selectin
- Sialic Acid
- Sialyl SSEA-1/SLX
- SN10
- Somatostatin
- TA-90
- TABA
- Tachykinin
- TAG 12
- TPS
- Troponin
- Tubulin
- VCAM
- VEGF
- Villen
C. Instrumentation Review
And Market Needs
1. Abbott AxSYM
2. Abbott Architect c4000
3. Abbott Architect i2000 Series
4. Abbott Architect ci8200 System

5. Beckman Coulter UniCel Series
6. Beckman Coulter Access
7. Binding Site ESP600
8. bioMerieux Mini Vidas
9. Carolina Chemistries BioLis 24i
10. DiaSorin Liaison
11. Horiba ABX Pentra 400
12. Inverness DS2
13. J&J Vitros ECi/ECiQ
14. J&J Vitros 3600
15. J&J Vitros 5600
16. Olympus AU5400
17. Olympus AU3000i
18. Olympus AU2700
19. Roche Modular Analytics
20. Roche Cobas Integra 400
21. Roche Cobas Integra 400 Plus
22. Roche Elecsys
23. Roche Cobas c311
24. Siemens ADVIA Centaur
25. Siemens Dimension
26. Siemens Dimension RxL Max
27. Siemens Dimension Vista 500
28. Siemens Immulite
29. Siemens Stratus
30. Tosoh AIA-Series
31. Vital Diagnostics ATAC 8000
32. Vital Diagnostics Envoy 500
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
f. Latex Agglutination
g. Immunoprecipitation
H. Affinity Chromatographu
e. Liposome Flow-Injection Immunoassay
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. 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
5. Artificial Intelligence
6. Flow Cytometry
7. Two Dimensional Gel Electrophoresis (2-DGE)
8. Biosensors
9. Competing/Complementing Technologies
a. CT
b. MRI

c. NMR
d. PET
e. Photonics Spectroscopy
E. Personal Testing
U.S.A.
A. Executive Summary
B. Business Environment
1. Health Care Expenditures
2. Cost Consciousness
3. Industry Consolidation
4. Managed Care
5. Hospitals
6. Admissions
7. Length of Stay
8. Industry Diversification
9. Physician Demographics
10. Population Aging
a. Chronic Illness
b. Disease Incidence
c. Susceptibility to Iatrogenesis
d. Multiple Illness Cases
11. Laboratory Regulations
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. Point-Of-Care Testing
d. 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
- Agilent Technologies
- Applied Gene Technologies

- Arca Biopharma
- Beckman Coulter/Danaher
- Becton Dickinson
- Biomedical Diagnostics
- bioMerieux
- Bio-Rad
- CellSearch
- Cepheid
- Correlogic Systems/Vermillion
- Decode Genetics
- Diadexus
- Diagnocure
- Diasorin
- Eiken Chemical
- Elitech Group
- Enterix
- Enzo Biochem
- Epigenomics
- Exact Sciences
- Fujirebio
- Guided Therapeutics
- Hologic/Gen-Probe
- Kreatech/Leica
- Kyowa Medex
- Mackay Life Sciences
- Myriad Genetics
- OncoLab
- Otho-Clinical Diagnostics
- Panacea Pharmaceuticals
- Polartechnics
- Polymedco
- PreMD
- Qiagen
- Quest Diagnostics
- Radient Pharmaceuticals
- Roche

- Scienion
- Sequenom
- Siemens Healthcare
- Takara Bio
- Targeted Diagnostics & Therapeutics
- Thermo Fisher
- Tosoh
- Veridex
- Wako Pure Chemicals
- Wallac/PE
- Zila/Alere


- Arca
- Beckman Coulter/Danaher
- Becton Dickinson
- Biomedical Diagnostics
- bioMerieux
- Bio-Rad
- Cepheid
- Correlogic Systems
- Dako
- Decode
- Diadexus
- Diagnocure
- Diasorin
- Eiken Chemical
- Enterix
- Enzo Biochem
- Epigenomics
- Exact Sciences
- Fujirebio
- Gen-Probe
- Guided Therapeutics
- Hologic
- Ipsogen
- Kreatech
- Kyowa Medex
- Life Technologies
- Mackay Life Sciences
- Myriad Genetics
- Nanogen Elitech
- OncoLab
- Otho-Clinical Diagnostics
- Panacea Pharmaceuticals
- Polartechnics
- Polymedco
- PreMD
- Qiagen
- Radient Pharmaceuticals
- Roche

- Scienion
- Sequenom
- Siemens Healthcare
- Takara Bio
- Targeted Diagnostics & Therapeutics
- Tosoh
- Veridex
- Wako Pure Chemicals
- Wallac/PE
- Zila


List of Tables

Tumor Marker Classification
Major Companies Developing or Marketing
ACTH Tests
Major Companies Developing or Marketing
AFP Tests
Major Companies Developing or Marketing
Beta-2 Microglobulin Tests
Major Companies Developing or Marketing
CA 15-3/27.29 Tests
Major Companies Developing or Marketing
CA 19-9 Tests
Major Companies Developing or Marketing
CA 125 Tests
Major Companies Developing or Marketing
Calcitonin Tests
Major Companies Developing or Marketing
CEA Tests
Major Companies Developing or Marketing
Estrogen Receptor Tests
Major Companies Developing or Marketing
Progesterone Receptor Tests
Major Companies Developing or Marketing
Ferritin Tests
Major Companies Developing or Marketing
Gastrin Tests
List of Tables (continued)
Major Companies Developing or Marketing
HCG Tests

Major Companies Developing or Marketing
Insulin Tests

Major Companies Developing or Marketing
NSE Tests
Major Companies Developing or Marketing
Occult Blood Tests
Major Companies Developing or Marketing
PAP Smear/HPV Tests
Major Companies Developing or Marketing
PAP Tests
Major Companies Developing or Marketing
PSA Tests
Major Companies Developing or Marketing
Lymphocyte Subclassification Tests
Biochemical Markers Potential Applications
In Cancer Diagnosis
Oncogenes Potential Applications
In Cancer Diagnosis
Major Companies Developing or Marketing
Oncogene Tests
Growth Factors Potential Applications
In Cancer Diagnosis
Colony Stimulating Factors Potential
Applications in Cancer Diagnosis
Lymphokines Potential Applications
In Cancer Diagnosis
List of Tables (continued)
Immunohistochemical Stains Potential
Applications in Cancer Diagnosis
Executive Summary Table: U.S., Hospital
Cancer Diagnostic Test Volume and Sales Forecast
U.S., Estimated New Cancer Cases and Deaths

U.S., Estimated Cancer Death Rates
Per 100,000 Population
U.S., Laboratories Performing Cancer Diagnostic
Tests
U.S., Hospital Laboratories Performing
Cancer Diagnostics Tests by Bed Size
U.S., Hospital Laboratories Major Cancer
Diagnostic Test Volume Forecast by Test
U.S., Total Cancer Diagnostics Sales
By Major Supplier
U.S., ACTH Testing Market Diagnostics
Sales by Major Supplier
U.S., AFP Testing Market Diagnostics
Sales by Major Supplier
U.S., Beta-2 Migroblolulin Testing Market
Diagnostics Sales by Major Supplier
U.S., CA 15-3/27.29 Testing Market
Diagnostics Sales by Major Supplier
U.S., CA 19-9 Testing Market Diagnostics
Sales by Major Supplier
U.S., CA 125 Testing Market Diagnostics
Sales by Major Supplier
List of Tables (continued)
U.S., CEA Testing Market Diagnostics
Sales by Major Supplier
U.S., Ferritin Testing Market
Diagnostics Sales by Major Supplier
U.S., HCG Testing Market
Diagnostics Sales by Major Supplier
U.S., Insulin Testing Market
Diagnostics Sales by Major Supplier
U.S., Parathyroid Hormone Testing
Market Diagnostics Sales by Major Supplier
U.S., PAP Testing Market Diagnostics
Sales by Major Supplier
U.S., Progesterone Receptor Testing Market
Diagnostics Sales by Major Supplier
U.S., PSA Testing Market Diagnostics
Sales by Major Supplier