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This is a comprehensive account of the market size, segmentation, key players, SWOT analysis, influential technologies, and business and economic environments. The report is supported by 280 tables & figures over 232 pages.

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GLOBAL & USA CANCER BIOMARKER MARKET  (Identification, Technologies, Market Analysis, Competitor Profiles, Companion Diagnostic Co-development, Business Strategies, Industry Trends, and Pipeline Analysis)” by Kelly Scientific Publications is a comprehensive report on the cancer biomarker industry and its impact on the health system. This report tackles the growing market interest in oncogenic biomarkers, personalized medicine, companion diagnostics and the associated market environment.

Cancer biomarkers are molecular or genetic moieties (e.g., cells, proteins/peptides, genetic mutations, gene products, enzymes, or hormones) that not only are readily identifiable, but easily quantified in the lab setting. They function primarily to identify or correlate significantly with the severity or occurrence of a certain disease state. The rise in number of oncogenic biomarkers over the last number of years has massive potential in the healthcare industry and serves to propel both the personalized medicine and companion diagnostic markets.

One of the most import aspects of biomarkers is their use to diagnose and assess the progress of disease states in patients. As quantitative markers, these agents also offer the ability to monitor response to certain drug treatments and so are important in the area of personalized medicine.

Individualized, targeted or personalized medicine aims to increase the efficacy of therapeutics via genetic testing and companion diagnostics. Personalized therapeutics and associated companion diagnostics will be more specific and effective thereby giving pharma/biotech companies a significant advantage to recuperate R&D costs. Personalized medicine will reduce the frequency of adverse drug reactions and therefore have a dramatic impact on health economics. Developmental and diagnostic companies will benefit from lower discovery and commercialization costs and more specific market subtypes.

This report describes the current technologies that are propelling the cancer biomarker and companion diagnostic market. It examines the current genetic diagnostic tests and companion diagnostic assays that are in use by the medical and pharmaceutical industry today. Current developments in personalized medicine and the pharmacogenomics revolution are discussed. The emerging trends that appear in the global market and the most developed market (US) are elucidated and analysed. This study reveals market figures of the overall biomarker market and the cancer biomarker space (2013-2018). Forecast projections and future growth rates are provided to give the reader a forthcoming perspective of this growing industry.

The study also provides a comprehensive financial, business strategy and product review of key players in the cancer biomarker industry. Strategic drivers and restraints of this market are revealed and market opportunities and challenges are identified.

In summary, the cancer biomarker and associated companion diagnostic market have huge opportunities for growth. This industry will revolutionize the healthcare system and will improve therapeutic effectiveness and reduce the severity of adverse effects.

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Table of Contents

Table of Contents

1.0       Executive Summary

1.1       Objectives of Report

1.2       Data Sources and Methodology

1.3       Key Findings and Observations

1.3.1    What Makes Cancer Biomarkers so Important for the Healthcare Industry?

1.3.2    What Technologies are Used to Identify Novel Biomarkers?

1.3.3    Increase in Cancer Prevalence is Propelling the Oncogenic Biomarker Market

1.3.4    Global and US Economic Impact of Cancer

1.3.5    How Cancer Biomarkers are Revolutionizing Cancer Treatment

1.3.6    What are the most Significant and Strategic Cancer Biomarkers?

1.3.7    Global Biomarker Test Market Analysis

1.3.8    Global Cancer Biomarker Market Analysis

1.3.9    Oncology Biomarker Market Main Industry Players

1.3.10  Drivers, Restraints, Opportunities and Challenges of the Cancer Biomarker Market



2.0       Global Burden of Cancer

2.1       Global Cancer Statistics

2.2       Lung Cancer Globally

2.3       Lung Cancer Mutation Analysis

2.4       Colorectal (Bowel) Cancer Globally

2.5       Prostate Cancer Globally

2.6       Breast Cancer Globally

2.7       Global Economic Impact of Cancer

2.8       Cancer in the USA

2.9       Breast Cancer in the US

2.10     Lung Cancer in the US

2.11     Colorectal Cancer in the US

2.12     Prostate Cancer in the US

2.13     Skin Cancer in the US


3.0       Oncogenic Biomarkers – An Overview

3.1       Biomarker Discovery to Clinical Validation

3.2       Specific Technologies Used in Biomarker Discovery

3.2.1    Proteomics

3.2.2    Mass Spectrometry Based Technologies

3.2.3    Principles of Diagnostic Mass Spectrometry

3.2.4    Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

3.2.5    Nano LC-MS/MS

3.2.6    MALDI-TOF

3.3       Glycomics

3.4       Metabolomics

3.5       Peptidomics

3.5.1    Enzyme-Linked Immunosorbent Assay (ELISA)

3.6       Selected (Multiple) Reaction Monitoring

3.7       DNA Based Techniques

3.7.1    Microarrays

3.7.2    Small Molecule Real Time (SMRT) DNA Sequencing

3.7.3    Digital PCR

3.7.4    Next Generation Sequencing

3.7.5    Second-Generation Sequencing Platforms

3.7.6    Whole Genome Sequencing

3.7.7    Epigenomics

3.7.8    Bioinformatics and Next Generation Sequencing

3.7.9    Third Generation Sequencing


4.0       Biomarker Validation

4.1       Introduction

4.2       Phases of Biomarker Validation

4.3       Biomarker Validation and Clinical Trials


5.0       Current and Prospective Oncogenic Biomarkers

5.1       Catalogue of Somatic Mutations in Cancer (COSMIC)

5.2       P53 Transcription Factor Oncogenic Mutations

5.2.1    Current Clinical Trials Investigating P53 as an Oncogenic Biomarker

5.3       Epidermal Growth Factor Receptor (EGFR)

5.3.1    EGFR-Activating and Resistance Mutations

5.3.2    Clinically Validated Resistance Mechanisms to EGFR Inhibitors

5.3.3    Current Strategies to Defeat Resistance to EGFR-Mediated Cancer Therapeutics

5.4       BRCA- Mutant Cancers

5.5       PARP-Inhibitors are Making a Comeback

5.5.1    Olaparib – A Pipeline PARP-Inhibitor

5.5.2    Niraparib (MK4827) in Phase III trials

5.5.3    Rucaparib

5.5.4    Veliparib

5.5.5    Novel Biomarkers in the PARP-Inhibitor Response Pathway

5.6       PTEN – Current Leader in Pipeline Onocogenic Biomarkers

5.7       Ataxia Telangiectasia Mutated (ATM) – A Pipeline Target

5.8       TMPRSS2-ERG – A Promising Prostate Cancer Biomarker

5.9       MiR-17/92 Cluster – The Oncomir with Biomarker Potential

5.9.1    Altered MiR-17/92 Expression Correlates with Cancer Pathogenesis

5.9.2    MiR-17/92 Cluster and Colorectal Cancer

5.9.3    MiR-17/92 Cluster and Breast Cancer

5.9.4    MiR-17/92 Cluster and Ovarian Cancer

5.9.5    MiR-17/92 Cluster and Lung Cancer

5.9.6    MiR-17/92 Cluster and Renal Cancer

5.9.7    MiR-17/92 Cluster and Head and Neck Cancer

5.9.8    MiR-17/92 Cluster and Pancreatic Cancer

5.9.9    MiR-17/92 Cluster and Liver Cancer

5.9.10  MiR-17/92 Cluster and Acute Myeloid Leukaemia

5.9.11  MiR-17/92 Cluster and B-Cell Lymphoma

5.9.12  MiR-17/92 Cluster and B-Cell Chronic Lymphocytic Leukemia

5.9.13  Transcriptional Regulators of MiR-17/92 Cluster

5.9.14  Significant Molecular Targets of MiR-17/92


6.0       Cancer Biomarker Test Market Analysis 2013-2018

6.1       Economic Burden of Cancer Worldwide

6.2       Economic Burden of Cancer in the US

6.3       Global Biomarker Test Market Analysis

6.4       Oncology Biomarkers Dominate the Biomarker Market

6.5       Global Cancer Profiling Technology Market

6.6       Global Cancer Biomarker Market Analysis

6.7       Market Share of Oncology Market Within Total Biomarker Market

6.8       US Cancer Biomarker Market

6.9       Oncology Biomarker Market is Fuelled by Year-on-Year Expansion of Research Publications

6.10     Proteomic and Genomic Technologies are Preferred as Methods of Detection by End-Users


7.0       Oncology Biomarker Market Main Industry Players                                102

7.1       23andMe                                                                                                                      102

7.2       Affymetrix                                                                                                                   103

7.3       Ambry Genetics

7.4       Astex Pharmaceuticals                                                                                                  105

7.5       Atossa Genetics

7.6       CuraGen                                                                                                                      108

7.7       Celera Corporation (Quest Diagnostics)

7.8       Celldex Therapeutics                                                                                                    109

7.9       deCode Genetics (Amgen)

7.10     Foundation Medicine

7.11     Illumina

7.12     Genelex

7.13     Genomic Health

7.14     Myriad

7.15     Nodality

7.16     OriGene Technologies

7.17     Randox

7.18     Qiagen                                                                                                                         116


8.0        Oncology Biomarker Market Products and Kits

8.1       Oncology Companion Diagnostic Tests

8.1.1    HER2 Tests in Breast Cancer Patients

8.2        23andMe

8.3       Affymetrix

8.4       Ambry Genetics

8.4.1    BRCAPlus

8.4.2    BreastNext

8.4.3    CancerNext

8.4.4    ColoNext

8.4.5    OvaNext

8.4.6    PancNext

8.4.7    RenalNext

8.4.8    Hereditary Diffuse Gastric Cancer Test

8.5       Astex Pharmaceuticals

8.6       Atossa Genetics

8.6.1    Mammary Aspirate Specimen Cytology Test (MASCT™)

8.6.2    ForeCYTE Breast Health Test (SM)

8.6.3    ArgusCYTE Breast Health Test(SM)

8.6.4    FullCYTE Breast Health Test

8.6.5    NextCYTE Breast Health Test

8.7       BioMerieux

8.7.1    THxID™ -BRAF Kit

8.8       Celera (Quest Diagnostics)

8.9       deCode Genetics

8.9.1    deCODE Breast Cancer™

8.9.2    deCODE Prostate Cancer™

8.9.3    deCODE AF™

8.9.4    deCODE Complete™

8.9.5    deCODE Cancer™

8.9.6    deCODE Services

8.10     Foundation Medicine

8.10.1  FoundationOne

8.10.2  FoundationOne Heme

8.11     Genome Health

8.11.1  Oncotype Dx Test

8.12     Illumina

8.12.1  Illumina New-Generation Sequencing Technology

8.12.2  Illumina HiSeq 2500/1500

8.12.3  Illumina HiSeq 2000/1000

8.12.4  Genome Analyzer IIx

8.12.5  Illumina MiSeq

8.13     Genelex

8.14     Genomic Health

8.14.1  Oncotype DX Breast Cancer Test

8.14.2  Oncotype DX Colon Cancer Test

8.14.3  Oncotype DX Prostate Cancer Assay

8.15     Myriad Genetics

8.15.1  BRACAnalysis®

8.15.2  Comprehensive BRACAnalysis®

8.15.3  BRACAnalysis® Rearrangement Test (BART)

8.15.4  Single Site BRACAnalysis®

8.15.5   Multisite 3 BRACAnalysis®


8.15.7  MELARIS®

8.15.8  PANEXIA®

8.15.9  OnDose®

8.15.10 PREZEON™


8.15.12 Prolaris®

8.16     Nodility

8.17     OriGene

8.17.1  TissueScan™ Cancer cDNA Arrays

8.18     Randox

8.18.1  Tumor PSA Marker Array

8.18.2  Tumor Marker Array 3

8.18.3  KRAS/ BRAF/PIK3CA Array

8.19     Qiagen

8.19.1  QIAsymphony Platform

8.19.2  Therascreen® EGFR RGQ PCR Kit

8.19.3  Therascreen KRAS RGQ PCR System

8.19.4  Therascreen® IDH1/2 test

8.20     Roche

8.20.1  Cobas® EGFR Mutation Test




9.0       Market Participant Financial and Business Strategy Analysis

9.1       23andMe

9.2       Affymetrix

9.3       Astex Pharmaceuticals (Otuska Pharamceutical)

9.4       Atossa Genetics

9.5       BioMerieux

9.6       Celera (Quest Diagnostics)

9.7       Celldex Therapeutics

9.8       deCode Genetics (Amgen)

9.9       Foundation Medicine

9.10     Illumina

9.11     Genelex

9.12     Genomic Health

9.13     Myriad

9.14     Nodality

9.15     Qiagen


10.0     Objective Business and Strategic Analysis of the Cancer Biomarker Market

10.1     Drivers of Oncogenic Biomarker Market

10.1.1  High demand and Unmet Need Enhances the Global Biomarker Market

10.1.2  Biomarkers are Highly Specific Diagnostic and Prognostic Clinical Tools

10.1.3  Increasing Cancer Prevalence Globally

10.1.4  FDA Support Increases Biomarker Development

10.1.5  More Streamlined Clinical Trials

10.1.6  Significant Growth of High-Impact Oncogenic Biomarker Research

10.1.7  Advancements in Discovery Technologies

10.2     Challenges of the Oncogenic Biomarker Market

10.2.1  Variability of Biomarkers within Different Cancer Subtypes

10.2.2  Integration of Genomics and Biomarker Diagnostics into the Healthcare System

10.2.3  Ethical Considerations

10.3     Restraints of the Cancer Biomarker Market

10.3.1  Initial Investment into Biomarker Discovery and Development

10.3.2  Are Biomarkers Profitable for Smaller Companies?

10.4     Opportunities for the Cancer Biomarker Market

10.4.1  Personalized Medicine Market Opportunities

10.4.2  Companion Diagnostics


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