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Global & USA Cancer Biomarker Market to 2018 (Identification, Technologies, Market Analysis, Competitor Profiles, Companion Diagnostic Co-Development, Business Strategies, Industry Trends, and Pipeline Analysis)

April 2014 | 232 pages | ID: GA294DFB476EN
Kelly Scientific Publications

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'GLOBAL & USA CANCER BIOMARKER MARKET to 2018 (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. It has enormous potential for investment and the emergence of genetic-based in vitro diagnostics.

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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

7.1 23andMe
7.2 Affymetrix
7.3 Ambry Genetics
7.4 Astex Pharmaceuticals
7.5 Atossa Genetics
7.6 CuraGen
7.7 Celera Corporation (Quest Diagnostics)
7.8 Celldex Therapeutics
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

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 Illumina
  8.11.1 Illumina New-Generation Sequencing Technology
  8.11.2 Illumina HiSeq 2500/1500
  8.11.3 Illumina HiSeq 2000/1000
  8.11.4 Genome Analyzer IIx
  8.11.5 Illumina MiSeq
  8.11.6 Illumina HiScanHQ
  8.11.7 Illumina HiScan and iScan Array
8.12 Genelex
8.13 Genomic Health
  8.13.1 Oncotype DX Breast Cancer Test
  8.13.2 Oncotype DX Colon Cancer Test
  8.13.3 Oncotype DX Prostate Cancer Assay
8.14 Myriad Genetics
  8.14.1 BRACAnalysis
  8.14.2 Comprehensive BRACAnalysis
  8.14.3 BRACAnalysis Rearrangement Test (BART)
  8.14.4 Single Site BRACAnalysis
  8.14.5 Multisite 3 BRACAnalysis
  8.14.6 COLARIS/COLARIS AP
  8.14.7 MELARIS
  8.14.8 PANEXIA
  8.14.9 OnDose
  8.14.10 PREZEON
  8.14.11 THERAGUIDE 5FU
  8.14.12 Prolaris
8.15 Nodility
8.16 OriGene
  8.16.1 TissueScan Cancer cDNA Arrays
8.17 Randox
  8.17.1 Tumor PSA Marker Array
  8.17.2 Tumor Marker Array 3
  8.17.3 KRAS/ BRAF/PIK3CA Array
8.18 Qiagen
  8.18.1 Genotyping Products
  8.18.2 QIAsymphony Platform
  8.18.3 Therascreen EGFR RGQ PCR Kit
  8.18.4 Therascreen KRAS RGQ PCR System
  8.18.5 Therascreen IDH1/2 test
8.19 Roche
  8.19.1 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

LIST OF FIGURES

Figure 2.1: Global Cancer Statistics – Key Facts
Figure 2.2: Number of Lung, Breast and Colorectal Cancer Diagnoses Globally, 2012
Figure 2.3: Percentage of Lung, Breast and Colorectal Cancer Diagnoses Globally, 2012
Figure 2.4: Number of Lung, Liver and Stomach Cancer Deaths Globally, 2012
Figure 2.5: Percentage of Lung, Liver and Stomach Cancer Deaths Globally, 2012
Figure 2.6: Global Cancer Incidence, Men 2012 (per 100,000)
Figure 2.7: Global Cancer Mortality, Men 2012 (per 100,000)
Figure 2.8: Global Cancer Incidence, Women 2012 (per 100,000)
Figure 2.9: Global Cancer Mortality, Women 2012 (per 100,000)
Figure 2.10: Number (Millions) of Smokers (Men and Women) in China, Russia, India, the UK and USA
Figure 2.11: Incidence and Mortality Rates of Global Lung Cancer (Male and Female)
Figure 2.12: Incidence and Mortality Rates of Global Colorectal Cancer (Male and Female)
Figure 2.13: Incidence and Mortality Rates of Global Prostate Cancer
Figure 2.14: Global Incidence and Mortality of All Cancer Types (excl non-melanoma skin-cancer) per 100,000, Male and Female
Figure 2.15: Combined Global Prostate, Breast, Colorectal, Lung and Bladder Cancer Incidence and Mortality by Male and Female
Figure 2.16: Cancer Deaths in Women, Globally according to Cancer Type
Figure 2.17: Estimated Age-Standardised Incidence Rate per 100,000 of Breast Cancer Globally
Figure 2.18: Top Three Cancers Leading to Global Economic Burden of Cancer ($ Billion)
Figure 2.19: Top 20 Cancers in the USA, Adults (Male and Female)
Figure 2.20: Top Adult Male Cancers, USA, Estimated Five Year Prevalence 2012-2017
Figure 2.21: Top Adult Female Cancers, USA, Estimated Five Year Prevalence 2012-2017
Figure 2.22: US Age Adjusted Cancer Death Rates Per 100,000 (Male) by Cancer Type, 1930-2009
Figure 2.23: US Age Adjusted Cancer Death Rates Per 100,000 (Female) by Cancer Type, 1930-2009
Figure 2.24: Incidence and Mortality of Lung Cancer (Male) Patients in the Americas
Figure 2.25: Incidence and Mortality of Lung Cancer (Female) Patients in the Americas
Figure 2.26: Incidence and Mortality of Colorectal Cancer (Male and Female) Patients in the Americas
Figure 2.27: Colorectal Cancer Incidence Rates (per 100,000) by Race/Ethnicity and Sex, USA
Figure 2.28: Colorectal Cancer Death Rates (per 100,000) by Race/Ethnicity and Sex, USA
Figure 2.29: Colorectal Cancer Incidence Rates (per 100,000) by State, USA
Figure 2.30: Colorectal Cancer Mortality Rates (per 100,000) by State, USA
Figure 2.31: Adults Aged 50–75 Years (%) That are Up-to-Date with Colorectal Test Screening, by State, United States
Figure 2.32: Incidence and Mortality of Prostate Cancer (Male) Patients in the Americas
Figure 2.33: Incidence and Mortality of Melanoma (Male and Female) Patients in the Americas
Figure 3.1: Integration of Oncogenic Biomarker Data to Cancer Diagnosis and Clinical Decisions
Figure 3.2: Influence of Biomarker Market on R&D, Molecular Diagnostics, Emerging Diagnostics and Independent Clinical Molecular Diagnostic Services
Figure 3.3: Biomarker Discovery to Clinical Assay Development and Validation Process
Figure 3.4: Mass Spectrometry Based Technologies in Oncogenic Biomarker Discovery
Figure 3.5: Principles of Enzyme-Linked Immunosorbant Assay (ELISA)
Figure 4.1: The Different Phases of Fit-For-Purpose Biomarker Validation
Figure 4.2: Biomarker Validation Using ELISA Technique
Figure 5.1: Frequency of Genetic Mutation by Cancer Subtype
Figure 5.2: Oncogenic Biomarker P53 Signalling Pathway: Activators, Effectors, Inhibitors and Cellular Outcomes
Figure 5.3: P53 Somatic Mutation Prevalence by Tumor Site
Figure 5.4: P53 Germline Mutation Prevalence by Tumor Site
Figure 5.5: EGFR Signalling Pathways and Potential Biomarker Proteins
Figure 5.6: Clinically Validated Resistance Mechanisms to EGFR Inhibitors
Figure 5.7: BRCA Mutation Increases the Risk of Breast and Ovarian Cancer
Figure 5.8: Proactive Cancer Management and Preventative Measures Reduces the Risks of Developing BRCA-associated Breast and Ovarian Cancer
Figure 6.1: Economic Burden of Cancer in the US, Direct and Indirect Costs ($ billion)
Figure 6.2: Economic Burden of Cancer in the US, Direct and Indirect Costs (%)
Figure 6.3: Global Biomarker Market Worth (Billions) and CAGR (%) 2011-2018
Figure 6.4: Oncogenic Biomarker Share of Total Personalized Medicine Biomarker Space
Figure 6.5: Oncogenic Biomarker Market Distribution by Cancer Type
Figure 6.6: Global Cancer Profiling Technology Market Worth (Billions) and CAGR 2013-2018
Figure 6.7: Global Cancer Biomarker Market Worth (Billions) and CAGR (%) 2009-2018
Figure 6.8: Global Oncology Biomarker Market as a Percentage of Total Biomarker Market 2013-2018
Figure 6.9: USA Cancer Biomarker Market Share Compared to Global Biomarker Market 2013-2018
Figure 6.10: Number of Peer-Reviewed Publications in the Area of Oncology Biomarker Research 2008-2013
Figure 6.11: Number of Peer-Reviewed Publications ion Oncogenes within Oncogenic Biomarker Research 2008-2013
Figure 6.12: Number of Peer-Reviewed Publications on MicroRNAs Within Oncology Biomarker Research 2008-2013
Figure 6.13: Number of Peer-Reviewed Publications on Epigenetic Modifications Within Oncology Biomarker Research 2008-2013
Figure 6.14: Number of Peer-Reviewed Publications by the National Cancer Institute Within Oncology Biomarker Research 2008-2013
Figure 6.15: Number of Peer-Reviewed Publications on Tumor Suppressor Genes Within Oncology Biomarker Research 2008-2013
Figure 6.16: Number of Peer-Reviewed Publications on incRNA Within Oncology Biomarker Research 2008-2013
Figure 6.17: Most Popular Proteomic and Genomic Technologies Performed by End-Users
Figure 7.1: Celldex Therapeutics Product Pipeline
Figure 7.2: Single Cell Network Profiling (SCNP) Technology by Nodality
Figure 7.3: Developed Functional Assays that Nodality has explored using new SCNP Technology
Figure 8.1: HER2 Testing Algorithm for Breast Cancer
Figure 8.2: HER2 Cellular Signalling
Figure 8.3: QUICKFACTS: Herceptin – Mechanism of Action
Figure 8.4: Illumina New Generation Sequencing Technology Workflow Station
Figure 8.5: Genomic Health Studies Used in the Development of the DCIS Score Algorithm
Figure 8.6: Genomic Health Gene Panel Used for Oncotype DX Breast Cancer Test
Figure 8.7: Genomic Health Gene Panel Used for Oncotype DX Colon Cancer Test
Figure 8.8: Genomic Health Oncotype DX Prostate Cancer Test Development Process
Figure 8.9: Genomic Health Gene Panel Used for Oncotype DX Prostate Cancer Test
Figure 8.10: OriGene’s TissueScan Cancer cDNA Array Sequence of Analysis
Figure 9.1: Private Funding Gained by 23andMe 2007-2012
Figure 9.2: Affymetrix Revenue by Business Segment (Percentage), 2013
Figure 9.3: Affymetrix Revenue by Business Segment (Percentage), 2013
Figure 9.4: Affymetrix Total Revenue 2007-2013
Figure 9.5: Affymetrix Revenue by Product Division – Consumables, Instruments 2010-2012
Figure 9.6: Affymetrix Core Product Sales – Gene Expression, Genetic Analysis & Clinical Applications and Life Science Reagents, 2011-2012
Figure 9.7: Affymetrix Revenue Derived from Outside the US, 2009-2012
Figure 9.8: Affymetrix Revenue Derived from the US, 2009-2012
Figure 9.9: Affymetrix Net Loss, 2009-2012
Figure 9.10: Affymetrix Research and Development Funding, 2009-2012
Figure 9.11: Affymetrix Revenue Generated within USA (Percentage) 2010-2012
Figure 9.12: Astex Pharmaceuticals Priority Pipeline Products SGI-110 and AT13387 by Indication, Clinical Phase and Timeline
Figure 9.13: Astex Pharmaceuticals Revenue Generated 2008-2012
Figure 9.14: Astex Pharmaceuticals Net Income 2009-2012
Figure 9.15: Atossa Genetics Total Revenue (US$) 2011, 2012
Figure 9.16: Atossa Genetics Revenue (US$) Generated by MASCT Sales and ForeCYTE & ArgusCYTE Diagnostic Testing, 2012
Figure 9.17: Atossa Genetics Percentage Revenue Generated by MASCT Sales and ForeCYTE & ArgusCYTE Diagnostic Testing, 2012
Figure 9.18: Quest Diagnostics Revenue ($ Billions) 2008-2013
Figure 9.19: Quest Diagnostics Operating Revenue ($ Billions) 2008-2013
Figure 9.20: Quest Diagnostics Net Income ($ Billions) 2008-2013
Figure 9.21: Celera (Quest Diagnostics) Historic Revenue Generated 2008-2010
Figure 9.22: Celera (Quest Diagnostics) Historic Gross Margin Generated 2008-2010
Figure 9.23: Celera (Quest Diagnostics) Historic Revenue Generated– Laboratory Services and Products 2008-2010
Figure 9.24: Celera (Quest Diagnostics) Historic Revenue (%) Generated by Distribution Agreement with Abbott 2008-2010
Figure 9.25: Celera (Quest Diagnostics) Historic Research and Development Spending 2008-2010
Figure 9.26: deCode Genetics Historic Net Loss Incurred 2004-2008
Figure 9.27: Foundation Medicine International Sales – FoundationOne 2012-2013
Figure 9.28: Foundation Medicine International Revenue 2012-2013
Figure 9.29: Foundation Medicine Geographical (USA) Revenue Percentage 2011-2013
Figure 9.30: Illumina Revenue Generated ($ Billions) 2010-2013
Figure 9.31: Illumina Net Income Generated ($ Billions) 2010-2013
Figure 9.32: Genomic Health Oncotype DX Test Revenue 2008-2013
Figure 9.33: Myriad Revenue Generated 2007-2014
Figure 9.34: Operating Income Generated by Myriad 2007-2013
Figure 9.35: Myriad Revenue Generated by Molecular Diagnostic Testing and Companion Diagnostic Services, 2012-2013
Figure 9.36: Future Molecular Diagnostic Pipeline of Myriad
Figure 9.37: Customer Profile of Qiagen – Percentage of Net Sales 2012/2013
Figure 9.38: Qiagen Global Net Sales 2007-2013
Figure 9.39: Qiagen Operating Income 2007-2013
Figure 9.40: Qiagen Global Net Income 2007-2013

The main technologies that are used to discover biomarkers include bioinformatics, genomics, next generation sequencing, proteomics, nanobiology, systems biology and also the use of stem cells. This report gives a comprehensive analysis of the most important techniques used in industry and R&D today, and reveals which technologies hold the most promise within the market. The report also delves into the complicated practice of biomarker validation and assesses the different phases of validation – from identification to quality control monitoring.

Over 32 million people globally are living with cancer in 2014. According to Cancer Research UK, over 14.1 million new cancer cases were diagnosed in 2012. Of these, 7.4 million men and 6.6 million women were diagnosed. The most common cancers reported are:

  • Lung
  • Breast
  • Colorectal (bowel)
  • Prostate

These four cancer subtypes account for 40% of total. In 2012 alone, 8.2 million people died from cancer globally, with 60% of these occurring in less developed regions. Lung, liver, stomach and bowel cancers were responsible for the majority of these deaths, with lung cancer the most significant killer at 20% or 1.59 million deaths. Liver cancer killed 0.8 million in 2012, with stomach cancer killing 0.7 million.

Cancer is the second most common cause of death in the US today, killing one in every four. The National Cancer Institute estimates that 13.7 million Americans have had cancer in the past or are currently suffering from this disease. Recent statistics from the American Cancer Society (ACS) estimated over 580,000 US citizens died from cancer in 2013. Of these, 174,100 deaths could have been prevented. The World Cancer Research Fund estimated that up to 33% of US cancers in 2013 were attributed to lifestyle factors.

Breast cancer and the use of Herceptin as treatment is an important example of how biomarker detection saves lives and money. Breast cancer is the second highest frequency of cancer globally with a reported 10.9% of total cancer diagnoses. Herceptin (trastuzumab, Genentech) was FDA approved for use in breast cancer patients in 1998 at a cost of between $50,000 to $100,000 annually.

However, subsequent analysis indicated that Herceptin was only effective in 25-30% of women who’s tumour cells over synthesized the protein human epidermal growth factor-2 HER2/Neu.

By 2006 all invasive breast cancer patients were recommended to take the HER2 genetic test to identify if they would respond to Herceptin treatment. A further breakthrough in 2008 occurred when a more efficacious Herceptin formulation was approved. Since 2010, more than 420,000 women have been treated with Herceptin, globally.  

Today, over 1.7 million women are diagnosed with breast cancer annually (GLOBOCAN). This is a 20% increase in incidence since 2008 estimates, and 14% increase in mortality rates. In 2012 alone, 522,000 women died of breast cancer, compared to 458,000 deaths in 2008.

Early screening and a highly specific biomarker assay is important in detecting cancer, especially in colorectal and prostate cancers as early symptoms are negligible. The use of biomarker companion diagnostics will not only save payers money, it will also promote more targeted therapeutics – thus providing patients with personalized cancer treatment. This has the added benefit of being more effective and having lower adverse reactions and toxicity profiles. Overall, the use of oncogenic biomarker tests and targeted cancer therapies will revolutionize cancer treatment in the short and longer terms. 



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