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MediPoint: Predictive Breast Cancer Gene Testing - US Analysis and Market Forecasts

Summary

Breast cancer is the most common form of cancer in women in both the developed and developing world. The incidence of breast cancer is increasing due to the increased life span and increasing adoption of Western lifestyle risk factors. Predictive breast cancer gene tests can be used to identify women who are at increased risk of developing hereditary breast cancer. The Predictive Breast Cancer Gene Testing market has seen exponential growth in the US, dominated by Myriad Genetics. Gene testing in Europe is mostly carried out by the state funded health sector, but increasingly private companies are offering breast cancer gene tests to physicians. Myriad Genetics' position in the market is dependent on it being the leading provider of the most common breast cancer mutations. By the end of our forecast period, the competitive landscape will experience significant change due to the erosion of Myriad Genetics' position, as a result of the expiry of key patents, and the emergence of alternative molecular technologies.

This report focuses on the predictive breast cancer gene testing markets in the US and identifies unmet needs in the market, physician attitudes towards current gene testing, and the future of gene testing in the face of rapid technological advancement.

Scope

  • An overview of Breast Cancer, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
  • Annualized US Breast Cancer Gene Testing market revenue and future forecasts from 2009 to 2011, forecast for 7 years to 2018.
  • Investigation of current and future market competition for Breast Cancer Gene Testing
  • Insightful review of the key industry drivers, restraints and challenges as well as predicted impact of key events.
  • Competitor assessment including device approval analysis and device sales forecasts.
  • Marketed and pipeline product profiles covering efficiency, safety, clinical study details, device approvals, product positioning and device sales forecast.
  • Analysis of unmet needs within the market and opportunities for future players.
  • Technology trends evaluation to assess strength of pipeline.
  • An overview of all devices in development including clinical study details, design and material selection considerations, efficacy reports, and device approval timelines.
  • Company profiles including business description, financial overview and SWOT analysis.
  • Coverage of key market players.
  • Strategic assessment of the US device sector through market impact analysis, future market scenario and company analysis.
  • Direct quotes from Key Opinion Leaders (KOL) as well as oncologists

Reasons to buy

  • Understand the trends shaping and driving the US Breast Cancer Gene Testing Market.
  • Realize device preferences of physicians who have performed the tests already.
  • Access market sizing, forecasts and quantified growth opportunities in the US Breast Cancer Gene Testing Market through 2018.
  • Quantify candidate patient populations to better design product pricing & launch plans.
  • Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape.
  • Perform benchmarking analysis of growth opportunities against currently marketed products.
  • Assess competitiveness of products in market by understanding the strengths and weaknesses of current competition.
  • Take a comprehensive look at the market's device pipeline and identify promising, paradigm-shifting products.
  • Create an effective counter-strategy to gain a competitive advantage against those currently in the market.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for growth.
  • What's the next big thing in the US Breast Cancer Gene Testing market landscape? Identify, understand and capitalize.

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Catalyst

3. Disease Overview

  • 3.1. Breast Cancer
  • 3.2. Anatomy and Physiology
  • 3.3. Pathophysiology
    • 3.3.1. Inheritable High-Penetrance Gene Mutations
    • 3.3.2. Inheritable Medium/Low-Penetrance Gene Mutations
  • 3.4. Clinical Presentation

3.4.1. Family History

    • 3.4.2. Physical Examination
    • 3.4.3. Predictive Breast Cancer Gene Testing Overview
    • 3.4.4. Clinical Guidelines
    • 3.4.5. Follow-up Gene Testing
  • 3.5. Clinical Outcomes
    • 3.5.1. Treatment Options
    • 3.5.2. Treatment Paradigm
  • 3.6. Epidemiology
    • 3.6.1. Prevalence
  • 3.7. Economic Impact
    • 3.7.1. Individual Costs
    • 3.7.2. Industry Costs

4. Competitive Assessment

  • 4.1. Overview
    • 4.1.1. BRACAnalysis
    • 4.1.2. BreastNext
    • 4.1.3. BreastCancer
    • 4.1.4. PreventionGenetics CHEK2/BARD1 Sequencing
    • 4.1.5. 23AndMe DNA Spit Kit
    • 4.1.6. DeCodeMe Complete Scan
    • 4.1.7. Health Compass

5. Unmet Needs

  • 5.1. Efficacy of the BRACAnalysis Test
  • 5.2. Interpretation of Results
  • 5.3. Test Report Formats
  • 5.4. Price
  • 5.5. Data Security
  • 5.6. Genetic Counseling
  • 5.7. Database Transparency
  • 5.8. Test Validation
  • 5.9. Undiscovered Mutations
  • 5.10. Simplification of the Testing Process

6. Pipeline Products

  • 6.1. Predictive Breast Cancer Gene Tests in Development
    • 6.1.1. Myriad Genetics RAD51C Breast Cancer Gene Test
    • 6.1.2. 23AndMe Exome 80X
  • 6.2. Breast Cancer Gene Expression Tests
    • 6.2.1. BreastGeneDX
    • 6.2.2. Diagnostic Test - Breast Cancer (Queens University/Almac Diagnostics)
    • 6.2.3. Diagnostic Test - Breast Cancer (NanoIVD)
    • 6.2.4. EpiSwitch OBD27
    • 6.2.5. Myriad HRD Test
    • 6.2.6. PAM50 Breast Cancer Test
  • 6.3. Emerging Sequencing Technology
  • 6.4. New Gene Discovery

7. Industry Overview

  • 7.1. Breast Cancer Testing Trends
    • 7.1.1. Overview
    • 7.1.2. Gene Test Analysis
    • 7.1.3. Gene-Testing Hardware
    • 7.1.4. Laboratory-Developed Tests
  • 7.2. Testing Volumes
  • 7.3. Market Access
    • 7.3.1. Adoption of Breast Cancer Gene Testing
  • 7.4. Role of Genetic Counseling
  • 7.5. Gene Testing Laboratories
  • 7.6. Reimbursement Trends
    • 7.6.1. Regulatory Issues/Recalls
  • 7.7. Mergers & Acquisitions and Key Partnerships

8. Current and Future Players

  • 8.1. Overview
  • 8.2. Trends in Corporate Strategy
  • 8.3. Common Strengths, Weaknesses, Opportunities and Threats
    • 8.3.1. Growing Incidence of Breast Cancer
    • 8.3.2. Uncertain R&D Outcomes
    • 8.3.3. Stringent Government Regulations
  • 8.4. Company Profiles
    • 8.4.1. Myriad Genetics
    • 8.4.2. Ambry Genetics
    • 8.4.3. Complete Genomics
    • 8.4.4. Navigenics (now Life Technologies)
    • 8.4.5. PreventionGenetics
    • 8.4.6. 23AndMe
    • 8.4.7. BGI-Shenzhen
    • 8.4.8. Illumina
    • 8.4.9. Life Technologies
    • 8.4.10. Roche

9. Market Drivers, Opportunities and Barriers

  • 9.1. Market Drivers
    • 9.1.1. Reducing the Cost of Breast Cancer Care
    • 9.1.2. Growing Number of Tests for Breast Cancer Gene Tests
    • 9.1.3. Increased Awareness of Breast Cancer Gene Testing from Physicians and Patients
  • 9.2. Opportunities
    • 9.2.1. New Assays and New Sequencing Technologies
    • 9.2.2. Alternative Methods to Predict Breast Cancer Risk
    • 9.2.3. Population-Based Genomic Profiling
  • 9.3. Market Barriers
    • 9.3.1. Exhaustion of Test Candidates
    • 9.3.2. Demographics
    • 9.3.3. Reimbursement
    • 9.3.4. Lack of Standardization
    • 9.3.5. Complexity of Test Results
    • 9.3.6. Shortage of Trained Personnel
    • 9.3.7. Development of New Breast Cancer Treatments
  • 9.4. Substitutes
    • 9.4.1. Improved Risk Assessment Models
    • 9.4.2. Development of Tests Based on Gene Expression Products
    • 9.4.3. Increased Surveillance
    • 9.4.4. Development of Biomarker Assays

10. US Outlook and Forecasts

  • 10.1. Market Overview
  • 10.2. US Market Analysis

11. Appendix

  • 11.1. Bibliography
  • 11.2. Abbreviations
  • 11.3. Research Methodology
    • 11.3.1. Overview
    • 11.3.2. Coverage
    • 11.3.3. Secondary Research
    • 11.3.4. Forecast Methodology
  • 11.4. Physicians and Specialists Included in this Study
  • 11.5. Primary Research
  • 11.6. Physician Survey
  • 11.7. About the Authors
    • 11.7.1. Analysts
    • 11.7.2. Global Head of Healthcare
  • 11.8. Definitions
  • 11.9. About MediPoint
  • 11.10. About GlobalData
  • 11.11. Contact Us
  • 11.12. Disclaimer

List of Tables

  • Table 1: Main Breast Cancer Types
  • Table 2: Specific Cancer Types Associated with Inherited Disorders
  • Table 3: BRCA1/2 Mutation Occurrence by Ethnic Group
  • Table 4: BRCA1/2 Mutation Occurrence in Breast Cancer Cases by Ethnic Group
  • Table 5: Breast Cancer Risk Factors
  • Table 6: Patterns in Prescribing Relatives for Breast Cancer Gene Test (Numbers per Physician) Including Expected Uptake (n=25)
  • Table 7: Breast Cancer Chemotherapies
  • Table 8: Cancer Cell Grading
  • Table 9: Selected 2002 Breast Cancer Incidence Rates
  • Table 10: BRACAnalysis Product Profile
  • Table 11: BRACAnalysis SWOT Analysis
  • Table 12: BreastNext Product Profile
  • Table 13: BreastNext SWOT Analysis
  • Table 14: BreastCancer Product Profile
  • Table 15: BreastCancer SWOT Analysis
  • Table 16: PreventionGenetics Product Profile
  • Table 17: PreventionGenetics SWOT Analysis
  • Table 18: 23AndMe Spit Kit Product Profile
  • Table 19: 23AndMe Spit Kit SWOT Analysis
  • Table 20: Complete Scan Product Profile
  • Table 21: Complete Scan SWOT Analysis
  • Table 22: Health Compass Product Profile
  • Table 23: Health Compass SWOT Analysis
  • Table 24: Predictive Breast Cancer Gene Test Product Pipeline
  • Table 25: Myriad Genetics RAD51C Breast Cancer Gene Test SWOT Analysis
  • Table 26: 23AndMe Exome 80X SWOT Analysis
  • Table 27: Breast Cancer Gene Expression Product Pipeline
  • Table 28: BreastDX SWOT Analysis
  • Table 29: Diagnostic Test - Breast Cancer (Queens University/Almac Diagnostics) SWOT Analysis
  • Table 30: NanoIVD Diagnostic Test - Breast Cancer SWOT Analysis
  • Table 31: EpiSwitch OBD27 SWOT Analysis
  • Table 32: Myriad HRD Test SWOT Analysis
  • Table 33: NanoString PAM50 Breast Cancer Test SWOT Analysis
  • Table 34: Key Mergers and Acquisitions during 2012
  • Table 35: Myriad Genetics SWOT Analysis
  • Table 36: Myriad Genetics Product Portfolio
  • Table 37: Myriad Genetics BRACAnalysis Key Patents
  • Table 38: Ambry Genetics SWOT Analysis
  • Table 39: Complete Genomics SWOT Analysis
  • Table 40: Navigenics SWOT Analysis
  • Table 41: PreventionGenetics SWOT Analysis
  • Table 42: 23AndMe SWOT Analysis
  • Table 43: BGI-Shenzhen SWOT Analysis
  • Table 44: Illumina SWOT Analysis
  • Table 45: Life Technologies SWOT Analysis
  • Table 46: Roche SWOT Analysis
  • Table 47: Skills Required for Breast Cancer Gene Testing
  • Table 48: Major Events Affecting the US Predictive Breast Cancer Gene Test Market
  • Table 49: Sales Forecasts for Predictive Breast Cancer Gene Testing in the US, 2009-2018

List of Figures

  • Figure 1: Breast Anatomy
  • Figure 2: Incidence of Inherited Breast Cancer Mutations amongst Diagnosed Breast Cancer Patients
  • Figure 3: BRCA1 and BRCA2 Gene Arrangement
  • Figure 4: USPSTF Guidelines for Inherited Breast Cancer Gene Testing
  • Figure 5: Wellcare Treatment Guidelines
  • Figure 6: US Trends in Breast Cancer Incidence, 2009-2018
  • Figure 7: Breast Cancer Risk Factors
  • Figure 8: BRACAnalysis Product Family (2012)
  • Figure 9: BRACAnalysis, Number of Tests, 1997-2012
  • Figure 10: BreastNext Mutation Detection Frequency
  • Figure 11: Average Selling Price of Breast Cancer Gene Tests (November 2012)
  • Figure 12: Growth in 23AndMe Gene Testing, 2007-2012
  • Figure 13: US Concerns on Breast Cancer Gene Testing (n=25)
  • Figure 14: Genomic Sequencing Costs, 2001-2012
  • Figure 15: Growth in Gene Testing Capability in the US
  • Figure 16: DTP and DTC Gene Tests offered by CLIA-Accredited Laboratories, 2011
  • Figure 17: Estimated Number of BRCA Tests Conducted Annually in the US, 2000-2012
  • Figure 18: Cumulative Numbers of BRCA Gene Tests in the US, 2000-2012
  • Figure 19: Numbers of Patient Relatives Recommended for Breast Cancer Gene Testing Following a Positive Result, n=69
  • Figure 20: Reasons to Refuse a Breast Cancer Gene Test, n=25
  • Figure 21: Myriad Genetics Revenue and Profit, 2005-2012
  • Figure 22: BRCA Gene Testing by the UK Genetics Testing Network in 2010
  • Figure 23: Visual Representation of Hereditary Breast Cancer Genes (Ambry Genetics)
  • Figure 24: Estimated growth in 23AndMe Revenue, 2007-2012
  • Figure 25: Illumina Revenue and Profit, 2005-2011
  • Figure 26: Life Technologies Revenue and Profit, 2007-2011
  • Figure 27: Roche Revenue and Profit, 2005-2011
  • Figure 28: Growth in Patient-Demanded Breast Cancer Gene Tests, n=25, 2009-2015
  • Figure 29: Breast Cancer Occurrence Following a Gene Test, n=25
  • Figure 30: Breast Cancer Incidence and Mortality in England, 1971-2010
  • Figure 31: Sales Forecasts for Predictive Breast Cancer Gene Testing in the US, 2009-2018
  • Figure 32: US Segmentation for Gene Tests, by Type, 2011 and 2018
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