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  5. > The Market for Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs)

Circulating tumor cells (CTCs) have tremendous utility in cancer research, aiding researchers in deciphering the complex processes leading to cancer metastasis and in developing more effective cancer therapeutics. Besides the research applications, the detection and analysis of CTCs has enormous potential in the diagnosis and management of cancer, as current tools, such as tumor tissue biopsy or imaging technologies, have numerous limitations. Although their biology and characteristics are still not entirely elucidated, CTCs are believed to detach from primary or secondary tumors, enter the bloodstream, and travel to distant organs. The majority of CTCs die in the bloodstream due to the harsh environment; very few of them are able to metastasize, and even fewer – known as cancer stem cells (CSCs) – can form distant tumors. Nevertheless, this small percentage of CTCs – about 0.01% – is sufficient to initiate and continue the blood-borne metastasis process, which leads to the progression of the disease and death.

The Market for Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) is a detailed analysis of the potential opportunities for manufacturers of CTCs-based technologies, informing readers of the scientific basis of CTCs in an understandable fashion and constructing models of revenue opportunity based on several dimensions – application area, cancer type and region – that can assist with business planning efforts.

Table Of Contents

The Market for Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs)
ONE: EXECUTIVE SUMMARY
Circulating Tumor Cells in Cancer
Current and Potential Clinical Applications of CTCs
CTCs Detection, Isolation and Analysis Technologies
Industry and Market Structure
TWO: CANCER OVERVIEW
Disease Overview
Risk Factors
Prevalence and Incidence of Cancer
THREE: CIRCULATING TUMOR CELLS OVERVIEW
Overview
CTCs Applications
Characteristics of CTCs
CTCs Isolation and Characterization Challenges
Current Markers for CTCs Identification and Analysis
Epithelial Cell Adhesion Molecule (EpCAM)
Ephrin Receptor B4 (EpB4)
Epidermal Growth Factor Receptor (EGFR)
Human Epidermal Growth Factor (HER2)
Mucin-1 (MUC-1)
Carcinoembryonic Antigen (CEA)
Cytokeratins
Other CTCs Markers Investigated for Clinical Applications
Cyclophilins
Plastin3 (PLS3)
Vimentin
Conclusions
Current and Potential Clinical Applications of CTCs
Prognostic Tool for Survival
Non-Invasive Early Diagnosis of Cancer
Predictors of Disease Evolution and Metastatic Potential
Therapy Guidance and Monitoring/ Predictor of Response to Therapy
Patient Stratification in Clinical Trials
Surrogate Endpoint in Clinical Trials
Drug Development – Selection of Drug Targets
FOUR: CTCs ISOLATION AND DETECTION TECHNOLOGIES
Overview
Enrichment Methods Based on Physical Properties
Size-based Methods
Density-based Methods
Electrophysiological-based Methods
Immuno-Mediated Capture Methods
Magnetic Platforms
Microfluidic Platforms
Conclusion
Optical Identification and Enumeration
Bioview’s Duet Cell Imaging System (Israel)
CytoTrack’s Optical Scanning Technology (Denmark)
Epic Sciences (San Diego, California, USA)
Ikonisys (New Haven, CT, USA)
Nucleic Acid-based CTC Detection Methods
RNAscope (Advanced Cell Diagnostics, USA)
Cytometric Detection and Enumeration Methods
FASTcell Cytometer (SRI Biosciences, USA)
On-chip Sort Cell Sorter (On-chip Biotechnologies, Japan)
Other CTCs Isolation and Detection Approaches
Virus Vectors Fluorescence
Selectin-Mediated Capture
Cell Adhesion Matrix
Other Combination Negative Depletion/ Positive Selection Methods
Rheology-based Methods
In Vivo Detection Methods
FIVE: INDUSTRY AND MARKET LANDSCAPE
Industry Structure
Competitive Factors
Products Analysis
CellSearch
AdnaTests
Significant Market Trends
Increasing Incorporation of CTCs Technologies in Clinical Trials to Accelerate
Market Growth
The Quest for Personalized Medicine to Spur the Use of CTCs in Research and
Development
Increasing Development of CTC-based Diagnostics Tests to Augment Market
Revenues
Increasing Global Incidence of Cancer and Life Expectancy to Increase Testing
Volumes
The Impact of Clinical Utility on Adoption of CTCs Tests in Clinical Practice
The Impact of New Technologies Approved by Regulatory Agencies on Market
Growth
The Impact of Insurance Coverage on Utilization and Market Revenues
Notable Industry Events
CTCs Enumeration by CellSearch Demonstrated Potential as Efficacy-Response
Surrogate
The Menarini Group Acquired Silicon Biosystems
Cynvenio Biosystems Launched ClearID Breast Cancer Monitoring Test
Vitatex Licenses Cell Adhesion Matrix Technology to Noble Life Sciences
SWOG S0500 Clinical Trial Results Presented in December 2013
Parsorter PS1 Launched to Market in Europe
Clearbridge Biomedics Launched the ClearCell FX System for Capturing CTCs in
Whole Blood Samples
Fluxion Biosciences Launched Next Generation Sequencing Assay Kits for IsoFlux
System
Janssen Diagnostics and Asuragen Introduce NGS technology for CellSearch
Biocept Collaborates with Rosetta Genomics to Evaluate CTCs’ microRNA
Biocept Launches Lung Cancer CTC Tests
Parsortix Collaborates with EKF Diagnostics and Undisclosed Pharmaceutical
Company to Develop “Liquid Biopsy� Applications
ThermoFisher Scientific Enters into Distribution Agreement with Cynvenio
Biosystems for LiquidBiopsy Platform
QIAGEN Acquired AdnaGen’s CTC’s Technology
Total Market Revenues and Forecast
Market Snapshot
Total Market Forecast
SIX: COMPANY PROFILES
Janssen Diagnostics
AdnaGen AG (currently QIAGEN Hannover GmbH)
Acousys Biodevices, Inc.
Advanced Cell Diagnostics, Inc.
ApoCell, Inc.
BioCEP Ltd.
Biocept, Inc.
Biofluidica
BioView Ltd.
Clearbridge Biomedics Pte Ltd
Creatv MicroTech, Inc.
Cynvenio Biosystems
CytoTrack ApS
DeNovo Sciences Inc.
Epic Sciences
Fluidigm Corporation
Fluxion Biosciences
GILUPI GmbH
iCellate Medical AB
Ikonisys, Inc.
IVDiagnostics, LLC
Miltenyi Biotec GmbH
On-chip Biotechnologies
Oncolys Biopharma Inc.
Parsortix/ANGLE plc
QIAGEN N.V.
RareCells Diagnostics
RareCyte, Inc.
ScreenCell
Silicon Biosystems
SRI Biosciences
Vitatex Inc.
Vortex Biosciences


LIST OF EXHIBITS
TWO: CANCER OVERVIEW
Table 2-1: Top Ten Causes of Death in the World by Geographic Region, 2012
Table 2-2: Top Ten Causes of Death in the World, 2012
Table 2-3: Projected Top Ten Causes of Death in the World, 2015
Table 2-4: Projected Top Ten Causes of Death in the World in High Income Countries, 2015
Table 2-5: Projected Top Ten Causes of Death in the World in Upper Middle Income Countries, 2015
Table 2-6: Global Incidence of Cancer by Geographic Region, 2012
Table 2-7: Global Incidence of the Five Most Common Types of Cancer in Men,2012
Table 2-8: Global Incidence of the Five Most Common Types of Cancer in Women, 2012
Table 2-9: Global Incidence of Most Common Types of Cancer in Both Genders,2012
Table 2-10: Projected Growth in Global Incidence of Cancer by Geographic Region, 2012-2030
THREE: CIRCULATING TUMOR CELLS OVERVIEW
Table 3-1: Typical Human Blood Cellular Composition
Table 3-2: Challenges in the Detection and Isolation of CTCs, 2015
Table 3-3: Selected Markers for CTCs Identification and Analysis
Table 3-4: Selected EpCAM-based Methods
Table 3-5: Current and Potential Clinical Uses of CTCs, 2015
FOUR: CTCs ISOLATION AND DETECTION TECHNOLOGIES
Table 4-1: Selected Size-Based CTCs Enrichment Methods
Table 4-2: Selected Density-Based CTCs Enrichment Methods
Table 4-3: Selected CTCs Detection and Isolation Methods Based on
Electrophysiological Properties
Table 4-4: Selected CTCs Magnetic Platforms Based on Cell Surface Markers
Table 4-5: Selected CTCs Immunomagnetic Microfluidics Platforms
Table 4-6: Selected CTCs Optical Identification Methods
Table 4-7: Selected Nucleic Acid-based CTCs Detection Methods
Table 4-8: Comparison of Selected Cytometric CTCs Detection Methods
Table 4-9: Selected CTCs In Vivo Detection Platforms
FIVE: INDUSTRY AND MARKET LANDSCAPE
Table 5-1: Industry Structure – Selected Competitors and Marketed Products, 2014
Table 5-2: CellSearch System (IVD Use) Analysis, 2015
Table 5-3: AdnaTest (IVD Use) Analysis, 2015
Table 5-4: Significant Trends in the CTCs Market, 2015
Figure 5-1: Estimated Market Breakdown, 2014 (Research Segment, Diagnostics Segment)
Figure 5-2: Estimated Market Breakdown by Type of Cancer, 2014 (Breast,
Prostate, Colorectal, Lung, Others)
Figure 5-3: Estimated Market Breakdown by Geographic Region, 2014 (US, EU, ROW)
Table 5-5: Global Revenues and Forecast for the CTCs Market by Application, 2013-2015 and 2019 (Diagnostics Segment, Research Segment, Total Market)
Figure 5-4: Global Revenues and Forecast for the CTCs Market, 2013-2015 and 2019 (Diagnostics Segment, Research Segment, Total Market)
Table 5-6: Global Revenues for the CTCs Market by Geographic Region, 2013-2015 and 2019 (US Market, EU Market, ROW Market, Total Market)
Figure 5-5: Global Revenues for the CTCs Market by Geographic Region, 2013- 2015 and 2019 (US Market, EU Market, ROW Market, Total Market)


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