Circulating Tumor Cell (CTC) Diagnostics: Technologies and Global Markets

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Circulating Tumor Cell (CTC) Diagnostics: Technologies and Global

Markets

Published on January 2014

Report Summary

STUDY GOALS AND OBJECTIVES

This report, PHM153A ' Circulating Tumor Cell (CTC) Diagnostic: Technologies and Global Markets, gives market insight on

monitoring tests used for cancer prognoses. The market is analyzed by cancer type: prostate, breast and colorectal. This report

analyzes the circulating tumor cells market, including technologies as well as commercial perspective and describes the overall

market size, industry growth rate and market trends. It gives a summary of the recent developments in the CTC market and includes

detailed profiles of key players.

The report's focus is on circulating tumor cell testing and monitoring methods. The report also includes an overview on cancer,

diagnostic strategies and treatment technologies. Important trends in the field of cancer research and development have been

reviewed in this report, and sales forecasts by treatment and screening categories are provided from 2013 through 2018. Issues and

trends addressed in this report are based on information from industry sources, regulatory and healthcare policies, demographics and

other factors that directly affect the circulating tumor cell market.

REASONS FOR DOING THIS STUDY

This study was conducted to provide detailed information regarding new developments, testing and treatment options for cancer.

There is an increasing need for new and innovative technologies. This industry is experiencing growth; the use of new diagnostic

technologies for cancer has increased in the past few years.

This BCC Research study will increase the awareness of current and emerging technologies and diagnostics for cancer, especially

prostate, breast and colorectal cancer.

INTENDED AUDIENCE

This report is an exhaustive study on the global cancer market with important incidence statistics and analysis of diagnostic

technologies, latest trends, market structure, market size, key drug segments and trends in technology. This study contributes to the

areas of market growth in circulating tumor cells and diagnostic strategies for metastatic cancer. This study will be of interest largely

to the pharmaceutical and biotechnology industries, as well as to clinics, hospitals and research institutes. Also, this report may prove

crucial for investment firms with involvement in this sector. The report shows tests currently being used for cancer diagnosis and

prognosis, new developments, spending trends and revenue prospects for these technologies. The report provides market data for

2012 to 2018 and also covers commercial prospects for cancer diagnostic assays and tests currently in use and that are forecast for

future use.

SCOPE OF THE STUDY

The scope of this study is clinical testing, prognostic and monitoring markets for CTCs in cancer. The report also includes the clinical

segment, currently approved CTC tests and their markets, the regulatory environment, current technologies, new technologies,

cancer incidence, market projections and market share along with the latest trends and new developments in this area. This report

does not include the segment's research market including reagents, or any accessories used for CTC isolation or studies. The

research segment of the market includes numerous competitors with different capabilities, developing and commercializing products

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such as CTC isolation devices and protocols, CTC characterization reagents, assay and instrumentation, and various identification

technologies based on cell imaging. These market players include specialized or research-based companies that contribute

considerably to the technological advancements in the field of CTC technologies. The data collected for the report is focused on

breast, prostate and colorectal cancers for which clinical data and tests are available currently on the market. CTCs in other cancers

are being researched and some are in clinical trials; these are not included within the scope of this report.

METHODOLOGY

Both primary and secondary research methodologies were used in preparing this report. Secondary sources include books,

newspapers, trade journals, white papers, industry portals, government agencies, trade associations, monitoring industry news and

developments, and through access to paid and free databases. The base year of the report is 2012, with forecast data provided

through 2018. Historical, base year and forecast data are provided for each market segment of this report.

The report provides a comprehensive review of cancer incidence and development of the disease, drugs currently being used and

diagnostic technologies. The report also reviews technological developments, product innovations/introductions and recent strategic

industry activity of major players across various product categories. Growth rates, global incidence and projections are determined

through a compilation of data including past trends, future trends, demographics, incidence, mortality, products in R&D, current

product growth, etc. Forecasts and projections were based on estimates such as the current trends, potential users, mergers and

acquisitions, and market trends.

A comprehensive and exhaustive search of the literature on prostate cancer assay development and currently marketed products,

global incidence and latest drug developments was conducted. These secondary sources include scientific'related journals and

articles, textbooks, press releases, marketing literature, other product/promotional literature, annual reports, security analyst reports

and other publications. A patent search and analysis was also conducted. Some informal interviews were conducted with experts and

personnel in this area at biotech and pharmaceutical companies. Other resources include academics, technology and consulting

companies.

INFORMATION SOURCES

Many companies within the industry were surveyed to obtain data for this study. Included were manufacturers and end users of

products that include pharmaceutical and biotechnical industries, research institutes, etc. Data were gathered from various industry

sources. BCC Research spoke with officials within the industry, consulted newsletters, company literature, product literature and a

host of technical articles, journals, indexes and abstracts. Exhaustive investigations of databases by key terminology were completed.

In addition, data were compiled from current financial, trade and government sources.

ABOUT THE AUTHOR

Usha Nagavarapu, PhD, is an experienced pharmaceutical professional with scientific and business development experience. She

has managed preclinical discovery programs from target identification including investigational new drug (IND)-enabling studies, and

assisted out-licensing and portfolio development activities. Her strong focus areas include oncology, dermatology and cardiovascular

diseases. Usha has extensive experience working with early start-ups to fulfill operational obligations while minimizing overall

operational cost and burden.

REPORT HIGHLIGHTS

The global market for circulating tumor cell (CTC) technology reached nearly $2.8 billion in 2012 and $3.7 billion in 2013. This market

is estimated to reach nearly $8.9 billion by 2018, demonstrating a compound annual growth rate (CAGR) of 18.9% for the five-year

period, 2013 to 2018.

This report provides:









' An overview of the global market for cancer diagnostics based on circulating tumor cells, which are used to increase understanding

of tumor cell biology and metastatic cancer as a disease.

' Analyses of global market trends, with data from 2012 and 2013, and projections of compound annual growth rates for the period of

2013 to 2018.

' Discussion of the advantages and disadvantages of CTC enrichment techniques.

' Estimations of cancer incidence, cancer deaths, new cases by type in the United States, and breast cancer statistics and facts.

' Examination of growth opportunities and drivers in the CTC market and recent breakthroughs in research, along with a patent

analysis.

Table of Content

TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 2

STUDY GOALS AND OBJECTIVES 2

REASONS FOR DOING THIS STUDY 2

INTENDED AUDIENCE 2

SCOPE OF THE STUDY 3

METHODOLOGY 3

INFORMATION SOURCES 4

ABOUT THE AUTHOR 4

RELATED BCC RESEARCH REPORTS 4

BCC RESEARCH ONLINE SERVICES 4

DISCLAIMER 5

CHAPTER 2 SUMMARY 7

SUMMARY TABLE GLOBAL MARKET SALES AND FORECAST FOR CIRCULATING

TUMOR CELL TECHNOLOGY, THROUGH 2018 ($ MILLIONS) 8

SUMMARY FIGURE GLOBAL MARKET SALES AND FORECAST FOR CIRCULATING

TUMOR CELL TECHNOLOGY, 2012-2018 ($ MILLIONS) 8

CHAPTER 3 CIRCULATING TUMOR CELLS 10

CANCER 10

RECENT ADVANCES IN TECHNOLOGY 10

INVASIVE POWER 11

CIRCULATING TUMOR CELL 11

PHENOTYPIC CHARACTERISTICS 11

CTC CLUSTERS 12

CTC DETECTION 12

CANCER STEM CELLS (CSC) 13

TABLE 1 CATEGORIES OF STEM CELLS 14

TABLE 2 PRODUCT CATEGORIES 15

CIRCULATING TUMOR CELLS - POTENTIAL USES 15









TABLE 3 KEY FACTORS OF CTC'S 16

What Are Circulating Tumor Cells' 16

Biology and Characteristics of CTCs 17

TABLE 4 CIRCULATING TUMOR CELLS - FEATURES 18

PROLIFERATIVE ACTIVITY 18

EPITHELIAL MARKER GENES ON CIRCULATING TUMOR CELLS 19

CTCs as Biomarkers 20

Biomarker Qualification Program 21

Epithelial to Mesenchymal Transition 21

CIRCULATING TUMOR CELLS AND STEM CELL-LIKE PHENOTYPE 22

CTCS AND PRIMARY TUMOR CELLS: COMPARISON 22

METASTASIS 23

The Metastatic Process 23

FUTURE DIRECTIONS 24

TABLE 5 METASTATIC CASCADE 24

METASTATIC DEVELOPMENT IN CANCER PATIENTS 25

CIRCULATING TUMOR CELL MIGRATION 25

IMPORTANT MARKERS OF DISTANT METASTASIS 25

CIRCULATING TUMOR CELL DETECTION 25

TABLE 6 EPCAM-BASED ASSAYS 26

CHALLENGES FOR DETECTION 26

THE CLINICAL APPLICATION OF CIRCULATING TUMOR DNA 27

CIRCULATING TUMOR CELLS AS PREDICTOR OF RESPONSE TO THERAPY 27

MEASUREMENT OF CTCS - APPLICATIONS 28

CONCLUSION 28

TABLE 7 CTC DETECTION - ADVANTAGES 29

CHAPTER 4 INCIDENCE OF CANCER 31

WORLDWIDE GROWTH IN THE INCIDENCE OF CANCER 31

TABLE 8 CANCER - KEY FACTS 32

CAUSES OF CANCER 32

TABLE 9 CANCER CAUSES 33

RISK FACTORS FOR CANCERS 33

BURDEN OF CANCER 33

AVOIDING RISK FACTORS 33

TABLE 10 CANCER CAUSING FACTORS 34

Prevention Strategies 34

EARLY DETECTION 34

Early Diagnosis 34

Screening 34

TABLE 11 CANCER SCREENING METHODS 35

TREATMENT 35

Treatment of Early-Detectable Cancers 35

Treatment of Other Cancers with Potential for Cure 35

PALLIATIVE CARE 35

Palliative Care Strategies 36

WORLD HEALTH ORGANIZATION RESPONSE 36









TABLE 12 NONCOMMUNICABLE DISEASES ACTION PLAN 36

WORLD CANCER STATISTICS 36

TABLE 13 GLOBAL CANCER INCIDENCE ESTIMATES, 2008 AND 2030 (MILLIONS) 37

FIGURE 1 GLOBAL CANCER INCIDENCE ESTIMATES, 2008 AND 2030 (MILLIONS) 37

TABLE 14 ESTIMATED GLOBAL CANCER INCIDENCE, 2008 (THOUSANDS) 38

CANCER AND THE GLOBAL IMPACT 38

Prevalence 39

Global Patterns 39

THE FUTURE OF CANCER 40

TABLE 15 INCREASE IN CANCER BURDEN - FACTORS 41

Common Types of Cancer 42

TABLE 16 THE MAIN TYPES OF CANCER AND ASSOCIATED MORTALITY 43

TABLE 17 GENERAL GLOBAL CANCER INCIDENCE BY TYPE 43

TABLE 18 GLOBAL INCIDENCE OF CANCER BY TYPE, 2008 (THOUSANDS/%) 44

Global Incidence in Men 45

TABLE 19 CANCER INCIDENCE IN MEN, 2008 (THOUSANDS/%) 45

Global Incidence in Women 46

TABLE 20 CANCER INCIDENCE IN WOMEN, 2008 (THOUSANDS/%) 46

Developed Countries 47

TABLE 21 GLOBAL INCIDENCE OF CANCER IN DEVELOPED COUNTRIES

AGE-STANDARDIZED RATE PER 100,000, 2008 47

Men 48

TABLE 22 GLOBAL INCIDENCE OF CANCER IN MEN - DEVELOPED COUNTRIES

AGE-STANDARDIZED RATE PER 100,000 (WORLD), 2008 48

Incidence in Women 49

TABLE 23 GLOBAL INCIDENCE OF CANCER IN WOMEN - DEVELOPED COUNTRIES


UNITED STATES CANCER INCIDENCE 50

TABLE 24 UNITED STATES - COMMON TYPE OF CANCER ESTIMATES, 2013 50

FIGURE 2 UNITED STATES - COMMON TYPE OF CANCER ESTIMATES, 2013 50

BREAST CANCER 51

TABLE 25 GLOBAL BREAST CANCER FACTS 51

TABLE 26 BREAST CANCER IN THE UNITED STATES 52

COLORECTAL CANCER 53

TABLE 27 TOP 20 COUNTRIES WITH THE HIGHEST INCIDENCE OF COLORECTAL

CANCER IN MEN, 2008 54


CANCER IN WOMEN, 2008 55

U.S. Incidence 55

TABLE 29 UNITED STATES - COLORECTAL CANCER INCIDENCE ESTIMATES, 2013 55

FIGURE 3 UNITED STATES - COLORECTAL CANCER INCIDENCE ESTIMATES, 2013 56

PROSTATE CANCER 56

TABLE 30 TOP 20 COUNTRIES WITH THE HIGHEST INCIDENCE OF PROSTATE

CANCER, 2008 56

Westernization Trends 57

TABLE 31 PROSTATE CANCER INCIDENCE AND MORTALITY WORLDWIDE, 2008

(THOUSANDS) 58

FIGURE 4 PROSTATE CANCER INCIDENCE AND MORTALITY WORLDWIDE, 2008









(THOUSANDS) 58

Prostate Cancer Mortality 60

TABLE 32 GLOBAL ESTIMATED PROSTATE CANCER DEATHS AND

AGE-STANDARDIZED MORTALITY RATES PER 100,000 POPULATIONS, 2008 60

FIGURE 5 GLOBAL ESTIMATED PROSTATE CANCER DEATHS AND


Prostate Cancer a Burden Globally 61

TABLE 33 GLOBAL ESTIMATED NEW CASES OF PROSTATE CANCER, 2008'2030

(NUMBER) 62

FIGURE 6 GLOBAL ESTIMATED NEW CASES OF PROSTATE CANCER 2008-2030

(NUMBER) 62

Prostate Cancer and the U.S. 63

TABLE 34 PROSTATE CANCER CASES AND DEATHS IN THE U.S. 2008-2011

(NUMBER) 63

FIGURE 7 PROSTATE CANCER CASES AND DEATHS IN THE U.S., 2008-2011

(NUMBER) 63

TABLE 35 ESTIMATED NEW CASES OF PROSTATE CANCER IN THE U.S., 2012-2030

(NUMBER) 64

FIGURE 8 ESTIMATED NEW CASES OF PROSTATE CANCER IN THE U.S., 2012-2030

(NUMBER) 64

TABLE 36 PROSTATE CANCER INCIDENCE RATES IN THE U.S. BY RACE, 2005-2009

(PER 100,000 MEN) 65

TABLE 37 ESTIMATED PROSTATE CANCER CASES IN THE U S., 2020 AND 2030

(NUMBER) 65

FIGURE 9 ESTIMATED PROSTATE CANCER CASES IN THE U.S., 2020 AND 2030

(NUMBER) 66

Prostate Cancer Mortality Rates in the U.S. 66

TABLE 38 MORTALITY RATES BY RACE IN U.S., 2005-2009 66

Prostate Cancer in Canada 67

TABLE 39 ESTIMATED PROSTATE CANCER IN CANADA, 2012 (NUMBER) 67

Prostate Cancer in Europe 67

TABLE 40 EUROPEAN (EU27 COUNTRIES) ESTIMATED PROSTATE CANCER

MORTALITY - AGE-STANDARDIZED MORTALITY RATES PER 100,000 POPULATION,

2008

68

FIGURE 10 EUROPEAN (EU27 COUNTRIES) ESTIMATED PROSTATE CANCER

MORTALITY - AGE-STANDARDIZED MORTALITY RATES PER 100,000 POPULATIONS,

2008

68

Prostate Cancer in the United Kingdom 69

TABLE 41 PROSTATE CANCER DEATHS IN THE U.K., 2010 (RATE PER 100,000

POPULATION) 70

FIGURE 11 PROSTATE CANCER DEATHS IN THE U.K., 2010 (RATE PER 100,000

POPULATION) 71

Prostate Cancer in Asia 71

CONCLUSIONS 72

CHAPTER 5 TECHNOLOGIES 74









FINDING CIRCULATING TUMOR CELLS 74

TABLE 42 POTENTIAL APPLICATIONS OF CTC-BASED DIAGNOSTICS 74

CURRENT CTC DETECTION AND ISOLATION METHODS 75

NEW TECHNOLOGIES FOR THE DETECTION 75

CANCER PROGNOSIS 76

Carcinoma - CTC and the Metastatic Cascade 77

How many CTCs' 77

The Biological Characteristics of CTC 77

TABLE 43 CLINICAL RELEVANCE OF CTC 78

Cancer Dissemination 78

CTC DETECTION TECHNIQUES - REQUIREMENTS 78

TABLE 44 CTC ENRICHMENT METHODS 78

ENRICHMENT METHODS 79

TABLE 45 TECHNIQUES USED FOR CIRCULATING TUMOR CELL (CTC) ENRICHMENT 80

Morphology-Based Enrichment Methods 80

Cell Separation Based on Density Gradient Centrifugation 80

Size-Based Cell Enrichment by Filtration 81

Immunomagnetic Separation Techniques 81

The RosetteSep-Applied Imaging Rare Event (RARE) Method 82

MagSweeper 83

DETECTION METHODS 83

TABLE 46 TECHNIQUES USED FOR CIRCULATING TUMOR CELL (CTC) ANALYSIS 84

Immunocytochemical Approaches 84

Fiber-Optic Array Scanning Technology 85

Laser Scanning Cytometer 85

Multiphoton Intravital Flow Cytometry 85

COMBINED ENRICHMENT AND DETECTION METHODS 85

TABLE 47 ENUMERATION TECHNIQUES 86

CellSearch System 86

Microfluidic Devices 87

Microfluidic Chips 87

EPISPOT 88

AdnaTest 88

TelomeScan 89

CTC Chip 89

TABLE 48 FUNCTIONAL ASSAYS 90

NUCLEIC ACID-BASED METHODS 91

Limitations 92

Flow Cytometry 92

Image-Based Approaches 93

Reverse-Transcriptase PCR 93

CLINICAL TESTING 94

CTC Analysis in Cancer Patients 94

CTC Analysis in Patients with Metastatic Disease 95

SUMMARY 96

TABLE 49 KEY FACTS ABOUT CIRCULATING TUMOR CELLS 97

NEW EMERGING TECHNOLOGIES 97

TABLE 50 MICRO-COUNT FEATURES A NEW TECHNOLOGY 98









Herringbone-Chip (HB-Chip) 98

Future Directions 99

CHAPTER 6 CIRCULATING TUMOR CELLS AND CANCER DIAGNOSTICS 101

TABLE 51 CTC ASSAY PRE-ANALYTICAL VALIDATION CONSIDERATIONS 102

TABLE 52 CTC ASSAY ANALYTICAL VALIDATION CONSIDERATIONS 102

TABLE 53 CTC ASSAY POST-ANALYTICAL VALIDATION CONSIDERATIONS 103

USE OF CTC'S FOR DIAGNOSIS 103

TABLE 54 CURRENT ENRICHMENT ASSAYS FOR CTCS 105

TABLE 55 CTC ENUMERATION ASSAYS 108

CURRENT METHODS AND APPLICATIONS 110

CTC Chip 110

TABLE 56 CHARACTERIZATION ASSAYS FOR CTCS 111

IVD Diagnostics 112

TABLE 57 KEY FEATURES-IVD CTC TESTS 112

TABLE 58 TUMOR TYPES: PROJECTED NEW CASES AND ESTIMATED DEATHS, 2010 112

FIGURE 12 TUMOR TYPES - PROJECTED NEW CASES AND ESTIMATED DEATHS,

2010 113

IVDiagnostics Customized Aptamer Selection Service 114

IVDiagnostics CTC Capture 114

IVDiagnostics CTC Human Genetics 114

Biocept 114

CIRCULATING TUMOR CELLS IN PROSTATE CANCER: CASE STUDIES 114

TABLE 59 PROSTATE CANCER DIAGNOSIS AND ROLE OF CTC'S 115

CTC IN COMPANION DIAGNOSTICS 115

TABLE 60 CURRENT DIAGNOSTIC METHODS 115

ApoCell 116

TABLE 61 APOSTREAM KEY FEATURES 116

ApoStream CTC Imaging 116

Clarient Launches Biocept's OncoCEE-BR Test 117

Canopus Bioscience 117

TABLE 62 CANOPUS BIOSCIENCE TECHNOLOGY - BENEFITS 118

Ikonisys 118

TABLE 63 CELLOPTICS' CANCER APPLICATION 118

Technique 119

TABLE 64 CELLOPTICS' KEY FEATURES - ENRICHMENT 119

TABLE 65 CELLOPTICS' KEY FEATURES - LABELING 119

TABLE 66 CELLOPTICS' KEY FEATURES - DETECTION 120

RAREcells Diagnostics 120

TABLE 67 ISET TEST - SPECIFICATIONS 120

NEWER TECHNOLOGIES IN DEVELOPMENT 121

OriGene Technologies 121

Protein Microarray and Its Application 121

Viator Technologies 121

Photoacoustic Detection and Capture of CTCs 121

Micro Technologies 121

Interrogate Signaling in Single Cells 121









NanoVelcro 122

Embedded Microchips 122

MOLECULAR ANALYSES OF CTC 122

The Ephesia Magnetic Arrays Technology 122

New "Biopsy in a Blood Test" 122

CONCLUSIONS 124

CHAPTER 7 CTCS IN CLINICAL TRIALS 126

CTC DIAGNOSTICS 126

CIRCULATING TUMOR CELL TECHNOLOGY 126

POTENTIAL THERAPEUTIC USES OF CIRCULATING TUMOR CELLS 127

CHALLENGES IN THE DETECTION OF CIRCULATING TUMOR CELLS 128

CTC'S AS CLINICAL BIOMARKERS 129

PCR-BASED MARKERS 130

Carcinoma Cells 130

CIRCULATING TUMOR CELLS IN CANCER - CURRENT STATUS 130

Breast Cancer 130

STIC CTC METABREAST (France) 131

SWOG 0500 (USA) 132

CirCe01 (France) 132

Treat CTC (Europe) 133

DETECT III (Germany) 134

PROGNOSTIC AND PREDICTIVE VALUE OF CIRCULATING TUMOR CELLS

(CTC'S) 135

Breast Cancer 135

Pancreatic Cancer 136

Lung Cancer 137

CTC'S IN CLINICAL CANCER MANAGEMENT 137

TABLE 68 CTC TECHNOLOGIES FOR CLINICAL MANAGEMENT 137

Clinical Impact of CTCs 138

EXISTING TECHNOLOGIES IN CLINICAL TRIALS 138

Cell Search and AdnaTest - Comparision 138

Size- and Biomechanical Properties-Based Isolation 140

CLINICAL STUDIES USING CELLSEARCH TECHNOLOGY 141


APPROVALS 142

RECENT STUDIES 143

Tumor Cell (CTC) Enumeration Using Cellsearch 143

CELLSEARCH IN CHINA 144

VERIDEX AND MASSACHUSETTS GENERAL HOSPITAL COLLABORATION 145

POSSIBLE USE OF CTC'S AND DTC'S AS NEW BIOMARKERS 146

EPISPOT 147

CLINCIAL APPLICATIONS 147

TABLE 70 EPISPOT: CLINICAL TRIALS FOR DETECTION OF CTC'S 148

Descriptions of Clinical Trials 148

NCT01402154 Trial 148

NCT01558349 Trial 148









NCT01596790 Trial 148

TABLE 71 OUTCOME MEASUREMENTS NCT01596790 TRIAL 149

ApoCell 149

ApoCell and Transgenomic Present Results of Lung Cancer

Research Study 149

ApoCell's CTC Capture Technology Detects and Recovers Deadly

Liver Cancer Cells 150

Nektar's Ongoing Phase 3 BEACON Study 150

APPLICATIONS 151

Application of iCTC Detection and Culture in Personalized Cancer

Management 151

Stony Brook University Medical Center 151

Microfluidic Sorting of Blood Cells for Cellular and Molecular Analysis 152

Cancer Sample Preparation with Micromachined Magnetic Sifter and

Nanoparticles 152

Stanford Center for Magnetic Nanotechnology 152

The Scripps Research Institute: The Fluid Phase of Solid Tumors 152

ApoCell - Utilization of Dielectrophoresis for Antigen-Independent CTC

Capture Allows for Detection of Heterogeneous Tumor Cell

Populations

152

APPLICATION OF CTC TECHNOLOGIES TO CLINICAL TESTING 153

CTC TECHNOLOGIES FOR CLINICAL DEVELOPMENT 154

Practical Application 154

TABLE 72 CTC ASSAY CLINICAL READINESS EVALUATION 155


STANDARD RECOMMENDATIONS 156

Specificity of a CTC Assay 157

Clinical Trial Design Considerations 158

TABLE 74 CTC QUALIFICATION STUDIES 158

SWOG S0500 Trial 159

Study Strategy and Process 159

CTC NUMBER AS A PROGNOSTIC BIOMARKER 161

Breast Cancer 161

Metastatic Castrate-resistant Prostate Cancer 161

Colorectal Cancer 162

Lung Cancer 162

PROGNOSTIC STUDIES 162

CTC'S AS A SURROGATE RESPONSE BIOMARKER 163

CTC'S AS A REAL-TIME BIOPSY 163

CTC CHIP TECHNOLOGY AND EGFR MUTATION ANALYSIS 164

CTC CHARACTERIZATION AFTER ENRICHMENT USING THE CELLSEARCH

PLATFORM 164

FINAL REMARKS 165

CHAPTER 8 CIRCULATING TUMOR CELL MARKET 167

THE INVASIVE CANCER! 167









TABLE 75 GLOBAL CANCER INCIDENCE - ESTIMATES, 2008-2030 (MILLIONS) 167

FIGURE 13 GLOBAL CANCER INCIDENCE - ESTIMATES, 2008-2030 (MILLIONS) 167

CANCER SURVIVAL 168

TABLE 76 GLOBAL CANCER SURVIVORS, 2008 (MILLIONS) 169

FIGURE 14 GLOBAL CANCER SURVIVORS 2008 (MILLIONS) 169

TABLE 77 UNITED STATES CANCER SURVIVORS, 2008-2022 (MILLIONS) 169

TABLE 78 MALE CANCER SURVIVORS (%) 170

TABLE 79 FEMALE CANCER SURVIVORS (%) 170

GLOBAL ANNUAL ONCOLOGY MARKET 171

CANCER THERAPY 172

TABLE 80 MAJOR PLAYERS 172

TABLE 81 GLOBAL CANCER DRUG MARKET SALES AND FORECAST, THROUGH 2018

($ MILLIONS) 173

FIGURE 15 GLOBAL CANCER DRUG MARKET SALES AND FORECAST, 2012-2018 ($

MILLIONS) 173

AGING AND CANCER 174

CANCER DRUG PIPELINE 174

TABLE 82 DRUGS APPROVED IN 2013 175

CANCER COSTS IN THE U.S. 175

TABLE 83 CANCER FORECAST IN U.S., 2020 - KEY FACTS 176

TABLE 84 CANCER CARE COST IN U.S., 2010 AND 2020 ($ BILLIONS) 177

BREAST CANCER 177

Treatment and Survival 177

Common Side Effects of Treatment 178

COLON AND RECTUM 179



PROSTATE 180



CHEMOTHERAPY MARKET 180

CANCER TESTING MARKET 181

TABLE 85 GLOBAL IN VITRO DIAGNOSTICS MARKET SALES AND FORECAST

THROUGH 2018 ($ MILLIONS) 181

FIGURE 16 GLOBAL IN VITRO DIAGNOSTICS MARKET SALES AND FORECAST

2012-2018 ($ MILLIONS) 181

TABLE 86 CANCER TESTING MARKET AND FORECAST, THROUGH 2018 ($ MILLIONS) 183

FIGURE 17 CANCER TESTING MARKET AND FORECAST, 2012-2018 ($ MILLIONS) 183

TABLE 87 KEY PLAYERS 184

IVD Market in China 185

CURRENT CANCER DIAGNOSTIC TESTS 186

Cancer Testing in Developing Nations 186

New Opportunities 186

TABLE 88 SIGNIFICANT DEVELOPMENTS IN CANCER FOLLOW-UP 187

A UNIVERSAL TUMOR TEST- IS IT POSSIBLE' 187

TABLE 89 CANCER TESTS AND LIMITATIONS - THE CASE AGAINST DEVELOPMENT

OF A UNIVERSAL TEST 188

CANCER BIOMARKER TESTING MARKET 188









TABLE 90 GLOBAL BIOMARKER MARKET AND FORECAST, THROUGH 2018 ($

MILLIONS) 188

FIGURE 18 GLOBAL BIOMARKER MARKET AND FORECAST, 2012-2018 ($ MILLIONS) 188

TABLE 91 THE KEY PLAYERS 189

TABLE 92 U.S. BIOMARKER CANCER TESTING MARKET AND FORECAST, THROUGH

2018 ($ MILLIONS) 190

FIGURE 19 U.S. BIOMARKER CANCER TESTING MARKET AND FORECAST, 2012-2018

($ MILLIONS) 190

MOLECULAR DIAGNOSTICS 191

TABLE 93 MOLECULAR DIAGNOSTICS MARKET AND FORECAST, THROUGH 2018 ($

MILLIONS) 191

FIGURE 20 MOLECULAR DIAGNOSTICS MARKET AND FORECAST, 2012-2018 ($

MILLIONS) 191

CANCER BIOMARKER TESTS 192

CANCER DISEASE MANAGEMENT 192

PERSONALIZED CANCER TESTING 192

Cancer Testing Competitors 192

CIRCULATING TUMOR CELL MARKET - A NEW APPROACH 193

TABLE 94 CTC'S - DIFFERENTIATING FEATURES 194

CTCs Advantages 194

THE CLINICAL DIAGNOSTICS MARKET 195

Market Opportunities 195

TABLE 95 STEM CELL MARKET OVERVIEW 196

TABLE 96 KEY COMPANIES SELLING STEM CELL RESEARCH PRODUCTS 196

CTC Testing 197

TABLE 97 CTC COMPANIES WITH PROMISING PRODUCTS 197

CellSearch CTC test 198

TABLE 98 CLINICAL USE OF CELLSEARCH SYSTEM 198

AdnaTest 198

CURRENT STATUS OF THE MARKET 198

TABLE 99 PRICING (DOLLARS) 199

TABLE 100 CELLSEARCH KIT 199

Updated Coding and Payment for Circulating Tumor Cell Testing 200

Global Market for Circulating Cancer Cells (CTCs) 200

TABLE 101 GLOBAL CIRCULATING TUMOR CELL TESTING MARKET SALES AND

FORECAST BY REGION, THROUGH 2018 ($ MILLIONS) 201

FIGURE 21 GLOBAL CIRCULATING TUMOR CELL TESTING MARKET SALES AND

FORECAST BY REGION, 2012-2018 ($ MILLIONS) 201

TABLE 102 GLOBAL CIRCULATING TUMOR CELL MARKET FOR PROSTATE CANCER -

SALES AND FORECAST BY REGION, THROUGH 2018 ($ MILLIONS) 202

FIGURE 22 GLOBAL CIRCULATING TUMOR CELL MARKET FOR PROSTATE CANCER -

SALES AND FORECAST BY REGION, 2012-2018 ($ MILLIONS) 203

TABLE 103 GLOBAL CIRCULATING TUMOR CELL MARKET FOR BREAST CANCER -


FIGURE 23 GLOBAL CIRCULATING TUMOR CELL MARKET FOR BREAST CANCER -


TABLE 104 GLOBAL CIRCULATING TUMOR CELL MARKET FOR COLORECTAL

CANCER - SALES AND FORECAST BY REGION, THROUGH 2018 ($ MILLIONS) 205









FIGURE 24 GLOBAL CIRCULATING TUMOR CELL MARKET FOR COLORECTAL

CANCER -SALES AND FORECAST BY REGION, 2012-2018 ($ MILLIONS) 205

United States Market for Circulating Cancer Cells (CTCs) 206

TABLE 105 U.S. CIRCULATING TUMOR CELL MARKET FOR PROSTATE CANCER -

SALES AND FORECAST, THROUGH 2018 ($ MILLIONS) 207

FIGURE 25 U.S. CIRCULATING TUMOR CELL MARKET FOR PROSTATE CANCER -

SALES AND FORECAST, 2012-2018 ($ MILLIONS) 207

TIMELINE 207

TABLE 106 U.S. CIRCULATING TUMOR CELL MARKET - BY INDICATION, SALES AND

FORECAST, THROUGH 2018 ($ MILLIONS) 208

FIGURE 26 U.S. CIRCULATING TUMOR CELL MARKET - BY INDICATION SALES AND

FORECAST, 2012-2018 ($ MILLIONS) 208

Europe - Market for Circulating Cancer Cells (CTCs) 208

TABLE 107 EUROPEAN CIRCULATING TUMOR CELL MARKET SALES AND FORECAST,


FIGURE 27 EUROPEAN CIRCULATING TUMOR CELL MARKET SALES AND FORECAST,

2012-2018 ($ MILLIONS) 209

TABLE 108 EUROPEAN CIRCULATING TUMOR CELL MARKET BY CANCER TYPE -


Rest of World Market for Circulating Cancer Cells (CTCs) 210

TABLE 109 REST OF WORLD CIRCULATING TUMOR CELL MARKET SALES AND


FIGURE 28 REST OF WORLD CIRCULATING TUMOR CELL MARKET SALES AND


Canada 211

TABLE 110 REST OF WORLD CIRCULATING TUMOR CELL MARKET BY CANCER TYPE

- SALES AND FORECAST, THROUGH 2018 ($ MILLIONS) 212

FIGURE 29 REST OF WORLD CIRCULATING TUMOR CELL MARKET BY CANCER TYPE

- SALES AND FORECAST, 2012-2018 ($ MILLIONS) 212

ASIA-PACIFIC SOLID TUMORS MARKET 212

FUTURE AND NEXT STEPS 213

CHAPTER 9 PATENTS 216

TABLE 111 CIRCULATING TUMOR CELL ASSAY CHARACTERISTICS 216

KEY PATENTS 216

TABLE 112 CTC PATENTS 217

VERIDEX 218

EpCAM Based Enrichment Using Magnetic Beads 218

MAGSWEEPER 218

EpCAM Based Magnetic Beads 218

SCRIPPS RESEARCH INSTITUTE (EPIC SCIENCES) 219

HD-CTC Technology 219

CELLPOINT DIAGNOSTICS 219

ON-Q-ITY 219

BIOFLUIDICA 219

ADNAGEN 220

Multiple Antibodies on Magnetic Beads 220









FILTINI 220

3D Parylene Membrane Filter for Isolation of CTC 220

IKONISYS 220

AVIVA BIOSCIENCES 221

Methods, Compositions, and Automated Systems for Separating Rare

Cells 221

TABLE 113 KEY PATENTS BY AVIVA BIOSCIENCES 221

HARVARD UNIVERSITY - MEHMET TONER, PHD 221

Microposts Coated with EpCAM 221

CELLECTIVE DX 222

Materal Displacement Obstacle Chip 222

JOHNS HOPKINS UNIVERSITY 222

Antibody-Coated Microfluidic Chip and Quantum Dots-Based Imaging 222

MEDICAL DISCOVERY PARTNERS 222

RBC Agglutination Followed by Filtration 222

CYNVENIO BIOSYSTEMS 222

Microfluidic Sheath Flow for Cell Isolation 222

SCREENCELL 223

BIOCEPT 223

Recovery of Rare Cells Using a Microchannel Apparatus with

Patterned Posts 223

CANOPUS BIOSCIENCE 223

Enrichment Technology Is Now Protected by Key Patents 223

ADVANCED CELL DIAGNOSTICS 224

CHAPTER 10 SELECTED COMPANY PROFILES 226

COMPANIES 226

KEY PLAYERS 226

TABLE 114 COMMERCIAL CIRCULATING TUMOR CELL TECHNOLOGY PLATFORMS 226

KEY COMPANY PROFILES 227

ADNAGEN 227

ADVANCED CELL DIAGNOSTICS 227

APOCELL 228

AVIVA BIOSCIENCES 228

BIOCEP LTD. 229

BIOCEPT INC. 229

BIOFLUIDICA MICROTECHNOLOGIES LLC 230

CANOPUS BIOSCIENCES 230

CELLTRAFIX INC. 230

CELULA 231

CLEARBRIDGE BIOMEDICS 231

CREATV MICROTECH INC 232

CYNVENIO BIOSYSTEMS, INC. 232

EPIC BIOSCIENCES 232

FILTINI INC. 233

FLUXION BIOSCIENCES 233

GREINER BIO-ONE GMBH 233









IKONISYS INC. 234

IVDIAGNOSTICS INC. 234

JANSSEN DIAGNOSTICS 234

MILTENYI BIOTECH 234

NANOSTRING TECHNOLOGIES INC. 235

NATURAL NANO INC. 235

ONCO VISTA 235

ON-Q-ITY 235

RARECELLS 236

SCREENCELL 236

SILICON BIOSYSTEMS USA 237

STEMCELL TECHNOLOGIES 237

SYNERGEX CORPORATION 237

SYSMEX CORPORATION 238

VERIDEX, LLC 238

VITATEX INC. 239

CHAPTER 11 REFERENCES 241

LIST OF TABLES

SUMMARY TABLE GLOBAL MARKET SALES AND FORECAST FOR CIRCULATING

TUMOR CELL TECHNOLOGY, THROUGH 2018 ($ MILLIONS) 8

TABLE 1 CATEGORIES OF STEM CELLS 14

TABLE 2 PRODUCT CATEGORIES 15

TABLE 3 KEY FACTORS OF CTC'S 16

TABLE 4 CIRCULATING TUMOR CELLS - FEATURES 18

TABLE 5 METASTATIC CASCADE 24

TABLE 6 EPCAM-BASED ASSAYS 26

TABLE 7 CTC DETECTION - ADVANTAGES 29

TABLE 8 CANCER - KEY FACTS 32

TABLE 9 CANCER CAUSES 33

TABLE 10 CANCER CAUSING FACTORS 34

TABLE 11 CANCER SCREENING METHODS 35

TABLE 12 NONCOMMUNICABLE DISEASES ACTION PLAN 36

TABLE 13 GLOBAL CANCER INCIDENCE ESTIMATES, 2008 AND 2030 (MILLIONS) 37

TABLE 14 ESTIMATED GLOBAL CANCER INCIDENCE, 2008 (THOUSANDS) 38

TABLE 15 INCREASE IN CANCER BURDEN - FACTORS 41

TABLE 16 THE MAIN TYPES OF CANCER AND ASSOCIATED MORTALITY 43

TABLE 17 GENERAL GLOBAL CANCER INCIDENCE BY TYPE 43

TABLE 18 GLOBAL INCIDENCE OF CANCER BY TYPE, 2008 (THOUSANDS/%) 44

TABLE 19 CANCER INCIDENCE IN MEN, 2008 (THOUSANDS/%) 45

TABLE 20 CANCER INCIDENCE IN WOMEN, 2008 (THOUSANDS/%) 46

TABLE 21 GLOBAL INCIDENCE OF CANCER IN DEVELOPED COUNTRIES

AGE-STANDARDIZED RATE PER 100,000, 2008 47

TABLE 22 GLOBAL INCIDENCE OF CANCER IN MEN - DEVELOPED COUNTRIES










TABLE 23 GLOBAL INCIDENCE OF CANCER IN WOMEN - DEVELOPED COUNTRIES


TABLE 24 UNITED STATES - COMMON TYPE OF CANCER ESTIMATES, 2013 50

TABLE 25 GLOBAL BREAST CANCER FACTS 51

TABLE 26 BREAST CANCER IN THE UNITED STATES 52


CANCER IN MEN, 2008 54


CANCER IN WOMEN, 2008 55

TABLE 29 UNITED STATES - COLORECTAL CANCER INCIDENCE ESTIMATES, 2013 55

TABLE 30 TOP 20 COUNTRIES WITH THE HIGHEST INCIDENCE OF PROSTATE CANCER,

2008 56

TABLE 31 PROSTATE CANCER INCIDENCE AND MORTALITY WORLDWIDE, 2008

(THOUSANDS) 58

TABLE 32 GLOBAL ESTIMATED PROSTATE CANCER DEATHS AND


TABLE 33 GLOBAL ESTIMATED NEW CASES OF PROSTATE CANCER, 2008'2030

(NUMBER) 62

TABLE 34 PROSTATE CANCER CASES AND DEATHS IN THE U.S. 2008-2011 (NUMBER) 63

TABLE 35 ESTIMATED NEW CASES OF PROSTATE CANCER IN THE U.S., 2012-2030

(NUMBER) 64

TABLE 36 PROSTATE CANCER INCIDENCE RATES IN THE U.S. BY RACE, 2005-2009

(PER 100,000 MEN) 65

TABLE 37 ESTIMATED PROSTATE CANCER CASES IN THE U S., 2020 AND 2030

(NUMBER) 65

TABLE 38 MORTALITY RATES BY RACE IN U.S., 2005-2009 66

TABLE 39 ESTIMATED PROSTATE CANCER IN CANADA, 2012 (NUMBER) 67

TABLE 40 EUROPEAN (EU27 COUNTRIES) ESTIMATED PROSTATE CANCER

MORTALITY - AGE-STANDARDIZED MORTALITY RATES PER 100,000 POPULATION,

2008

68

TABLE 41 PROSTATE CANCER DEATHS IN THE U.K., 2010 (RATE PER 100,000

POPULATION) 70

TABLE 42 POTENTIAL APPLICATIONS OF CTC-BASED DIAGNOSTICS 74

TABLE 43 CLINICAL RELEVANCE OF CTC 78

TABLE 44 CTC ENRICHMENT METHODS 78

TABLE 45 TECHNIQUES USED FOR CIRCULATING TUMOR CELL (CTC) ENRICHMENT 80

TABLE 46 TECHNIQUES USED FOR CIRCULATING TUMOR CELL (CTC) ANALYSIS 84

TABLE 47 ENUMERATION TECHNIQUES 86

TABLE 48 FUNCTIONAL ASSAYS 90

TABLE 49 KEY FACTS ABOUT CIRCULATING TUMOR CELLS 97

TABLE 50 MICRO-COUNT FEATURES A NEW TECHNOLOGY 98

TABLE 51 CTC ASSAY PRE-ANALYTICAL VALIDATION CONSIDERATIONS 102


TABLE 53 CTC ASSAY POST-ANALYTICAL VALIDATION CONSIDERATIONS 103

TABLE 54 CURRENT ENRICHMENT ASSAYS FOR CTCS 105

TABLE 55 CTC ENUMERATION ASSAYS 108









TABLE 56 CHARACTERIZATION ASSAYS FOR CTCS 111

TABLE 57 KEY FEATURES-IVD CTC TESTS 112

TABLE 58 TUMOR TYPES: PROJECTED NEW CASES AND ESTIMATED DEATHS, 2010 112

TABLE 59 PROSTATE CANCER DIAGNOSIS AND ROLE OF CTC'S 115

TABLE 60 CURRENT DIAGNOSTIC METHODS 115

TABLE 61 APOSTREAM KEY FEATURES 116

TABLE 62 CANOPUS BIOSCIENCE TECHNOLOGY - BENEFITS 118

TABLE 63 CELLOPTICS' CANCER APPLICATION 118

TABLE 64 CELLOPTICS' KEY FEATURES - ENRICHMENT 119

TABLE 65 CELLOPTICS' KEY FEATURES - LABELING 119

TABLE 66 CELLOPTICS' KEY FEATURES - DETECTION 120

TABLE 67 ISET TEST - SPECIFICATIONS 120



TABLE 70 EPISPOT: CLINICAL TRIALS FOR DETECTION OF CTC'S 148

TABLE 71 OUTCOME MEASUREMENTS NCT01596790 TRIAL 149

TABLE 72 CTC ASSAY CLINICAL READINESS EVALUATION 155


TABLE 74 CTC QUALIFICATION STUDIES 158

TABLE 75 GLOBAL CANCER INCIDENCE - ESTIMATES, 2008-2030 (MILLIONS) 167

TABLE 76 GLOBAL CANCER SURVIVORS, 2008 (MILLIONS) 169

TABLE 77 UNITED STATES CANCER SURVIVORS, 2008-2022 (MILLIONS) 169

TABLE 78 MALE CANCER SURVIVORS (%) 170

TABLE 79 FEMALE CANCER SURVIVORS (%) 170

TABLE 80 MAJOR PLAYERS 172

TABLE 81 GLOBAL CANCER DRUG MARKET SALES AND FORECAST, THROUGH 2018

($ MILLIONS) 173

TABLE 82 DRUGS APPROVED IN 2013 175

TABLE 83 CANCER FORECAST IN U.S., 2020 - KEY FACTS 176

TABLE 84 CANCER CARE COST IN U.S., 2010 AND 2020 ($ BILLIONS) 177

TABLE 85 GLOBAL IN VITRO DIAGNOSTICS MARKET SALES AND FORECAST


TABLE 86 CANCER TESTING MARKET AND FORECAST, THROUGH 2018 ($ MILLIONS) 183

TABLE 87 KEY PLAYERS 184

TABLE 88 SIGNIFICANT DEVELOPMENTS IN CANCER FOLLOW-UP 187

TABLE 89 CANCER TESTS AND LIMITATIONS - THE CASE AGAINST DEVELOPMENT OF

A UNIVERSAL TEST 188

TABLE 90 GLOBAL BIOMARKER MARKET AND FORECAST, THROUGH 2018 ($

MILLIONS) 188

TABLE 91 THE KEY PLAYERS 189

TABLE 92 U.S. BIOMARKER CANCER TESTING MARKET AND FORECAST, THROUGH

2018 ($ MILLIONS) 190

TABLE 93 MOLECULAR DIAGNOSTICS MARKET AND FORECAST, THROUGH 2018 ($

MILLIONS) 191

TABLE 94 CTC'S - DIFFERENTIATING FEATURES 194

TABLE 95 STEM CELL MARKET OVERVIEW 196

TABLE 96 KEY COMPANIES SELLING STEM CELL RESEARCH PRODUCTS 196

TABLE 97 CTC COMPANIES WITH PROMISING PRODUCTS 197









TABLE 98 CLINICAL USE OF CELLSEARCH SYSTEM 198

TABLE 99 PRICING (DOLLARS) 199

TABLE 100 CELLSEARCH KIT 199

TABLE 101 GLOBAL CIRCULATING TUMOR CELL TESTING MARKET SALES AND

FORECAST BY REGION, THROUGH 2018 ($ MILLIONS) 201

TABLE 102 GLOBAL CIRCULATING TUMOR CELL MARKET FOR PROSTATE CANCER -


TABLE 103 GLOBAL CIRCULATING TUMOR CELL MARKET FOR BREAST CANCER -


TABLE 104 GLOBAL CIRCULATING TUMOR CELL MARKET FOR COLORECTAL CANCER

- SALES AND FORECAST BY REGION, THROUGH 2018 ($ MILLIONS) 205

TABLE 105 U.S. CIRCULATING TUMOR CELL MARKET FOR PROSTATE CANCER -


TABLE 106 U.S. CIRCULATING TUMOR CELL MARKET - BY INDICATION, SALES AND


TABLE 107 EUROPEAN CIRCULATING TUMOR CELL MARKET SALES AND FORECAST,


TABLE 108 EUROPEAN CIRCULATING TUMOR CELL MARKET BY CANCER TYPE -


TABLE 109 REST OF WORLD CIRCULATING TUMOR CELL MARKET SALES AND


TABLE 110 REST OF WORLD CIRCULATING TUMOR CELL MARKET BY CANCER TYPE -


TABLE 111 CIRCULATING TUMOR CELL ASSAY CHARACTERISTICS 216

TABLE 112 CTC PATENTS 217

TABLE 113 KEY PATENTS BY AVIVA BIOSCIENCES 221

TABLE 114 COMMERCIAL CIRCULATING TUMOR CELL TECHNOLOGY PLATFORMS 226

LIST OF FIGURES

SUMMARY FIGURE GLOBAL MARKET SALES AND FORECAST FOR CIRCULATING

TUMOR CELL TECHNOLOGY, 2012-2018 ($ MILLIONS) 8

FIGURE 1 GLOBAL CANCER INCIDENCE ESTIMATES, 2008 AND 2030 (MILLIONS) 37

FIGURE 2 UNITED STATES - COMMON TYPE OF CANCER ESTIMATES, 2013 50

FIGURE 3 UNITED STATES - COLORECTAL CANCER INCIDENCE ESTIMATES, 2013 56

FIGURE 4 PROSTATE CANCER INCIDENCE AND MORTALITY WORLDWIDE, 2008

(THOUSANDS) 58

FIGURE 5 GLOBAL ESTIMATED PROSTATE CANCER DEATHS AND


FIGURE 6 GLOBAL ESTIMATED NEW CASES OF PROSTATE CANCER 2008-2030

(NUMBER) 62

FIGURE 7 PROSTATE CANCER CASES AND DEATHS IN THE U.S., 2008-2011 (NUMBER) 63

FIGURE 8 ESTIMATED NEW CASES OF PROSTATE CANCER IN THE U.S., 2012-2030

(NUMBER) 64

FIGURE 9 ESTIMATED PROSTATE CANCER CASES IN THE U.S., 2020 AND 2030

(NUMBER) 66









FIGURE 10 EUROPEAN (EU27 COUNTRIES) ESTIMATED PROSTATE CANCER

MORTALITY - AGE-STANDARDIZED MORTALITY RATES PER 100,000 POPULATIONS,

2008

68

FIGURE 11 PROSTATE CANCER DEATHS IN THE U.K., 2010 (RATE PER 100,000

POPULATION) 71

FIGURE 12 TUMOR TYPES - PROJECTED NEW CASES AND ESTIMATED DEATHS, 2010 113

FIGURE 13 GLOBAL CANCER INCIDENCE - ESTIMATES, 2008-2030 (MILLIONS) 167

FIGURE 14 GLOBAL CANCER SURVIVORS 2008 (MILLIONS) 169

FIGURE 15 GLOBAL CANCER DRUG MARKET SALES AND FORECAST, 2012-2018 ($

MILLIONS) 173

FIGURE 16 GLOBAL IN VITRO DIAGNOSTICS MARKET SALES AND FORECAST

2012-2018 ($ MILLIONS) 181

FIGURE 17 CANCER TESTING MARKET AND FORECAST, 2012-2018 ($ MILLIONS) 183

FIGURE 18 GLOBAL BIOMARKER MARKET AND FORECAST, 2012-2018 ($ MILLIONS) 188

FIGURE 19 U.S. BIOMARKER CANCER TESTING MARKET AND FORECAST, 2012-2018

($ MILLIONS) 190

FIGURE 20 MOLECULAR DIAGNOSTICS MARKET AND FORECAST, 2012-2018 ($

MILLIONS) 191

FIGURE 21 GLOBAL CIRCULATING TUMOR CELL TESTING MARKET SALES AND

FORECAST BY REGION, 2012-2018 ($ MILLIONS) 201

FIGURE 22 GLOBAL CIRCULATING TUMOR CELL MARKET FOR PROSTATE CANCER -


FIGURE 23 GLOBAL CIRCULATING TUMOR CELL MARKET FOR BREAST CANCER -


FIGURE 24 GLOBAL CIRCULATING TUMOR CELL MARKET FOR COLORECTAL CANCER

-SALES AND FORECAST BY REGION, 2012-2018 ($ MILLIONS) 205

FIGURE 25 U.S. CIRCULATING TUMOR CELL MARKET FOR PROSTATE CANCER -


FIGURE 26 U.S. CIRCULATING TUMOR CELL MARKET - BY INDICATION SALES AND


FIGURE 27 EUROPEAN CIRCULATING TUMOR CELL MARKET SALES AND FORECAST,

2012-2018 ($ MILLIONS) 209

FIGURE 28 REST OF WORLD CIRCULATING TUMOR CELL MARKET SALES AND


FIGURE 29 REST OF WORLD CIRCULATING TUMOR CELL MARKET BY CANCER TYPE -









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