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Breast Cancer Diagnostic and Drug Technologies: Global Markets

  • Published:
  • 259 Pages
  • BCC Research

REPORT HIGHLIGHTS

The global market for breast cancer diagnostic and drug technologies was about $20.8 billion in 2012. This market reached about $22.3 billion in 2014 and is expected to reach $27 billion in 2019, registering a compound annual growth rate (CAGR) of 4% through 2014-2019.

This report provides:

  • An overview of the global market for breast cancer diagnostics and drug technologies.
  • Analyses of market trends, with data from 2012, estimates for 2014, and projections of CAGRs through 2019.
  • A comprehensive review of emerging breast cancer personalized and predictive diagnostic tests, particularly with regard to companion tests, tumor markers, and gene profiling assays relevant for breast cancer prognosis and diagnosis.
  • Information on products in the market and detailed analyses of the market's segments and competitive environments.
  • Assessments of technological developments, product innovations, and recent strategic industry activity of across different product categories.
  • Comprehensive company profiles of major players in the industry.

SCOPE AND FORMAT

This report provides an update and overview on predictive testing in breast cancer diagnostics and drug technologies and global markets as well as global incidence rates for breast cancer. The study's objective is to review tumor marker-based predictive companion tests and drugs for breast cancer, and then assess their global growth potential over a five-year period from 2014 to 2019. The comprehensive review includes global markets for current drugs, new developments, predictive diagnostic tests and new technologies, drugs and developments. The report forecasts market trends forecast trends for the use of current tests for better diagnosis and prognosis of breast cancer through 2019.

Important current diagnostic tests, technologies and developments; market share by drug, test and current products on the market; market share by company or product; and statistical information for types of breast cancer incidence and prevalence globally, with special emphasis on the U.S. market, are discussed. The report focuses on tumor marker-based testing, which provides vital information about the cancer.These tests can help determine the appropriate medicine and timing of treatment to address the disease most effectively. The report also includes information on current issues and trends affecting the industry. The report covers products in development, new technologies, trends, alliances, new developments and patents and mergers. It offers market data with respect to segments and geography. Other breast cancer detection and screening technologies and markets (e.g., mammography, ultrasound, biopsy) are not included in this report

ANALYST'S CREDENTIALS

Usha Nagavarapu is a pharmaceutical professional with experience in scientific and alliance development. This includes more than 10 years of drug and device product development and alliance management experience. She has managed preclinical discovery programs from target identification through design of Phase I testing, including Investigational New Drug (IND) enabling studies, and assisted out-licensing and portfolio development activities. Strong focus areas include oncology, dermatology and cardiovascular diseases. She has extensive experience working with early startups to fulfill operational obligations while minimizing overall operational cost and burden.

Table of Contents

CHAPTER 1 - INTRODUCTION

  • STUDY GOALS AND OBJECTIVES
  • REASONS FOR COMPLETING THE STUDY
  • SCOPE AND FORMAT
  • INTENDED AUDIENCE
  • METHODOLOGY
  • ANALYST'S CREDENTIALS
  • RELATED BCC RESEARCH REPORTS
  • BCC RESEARCH WEBSITE
  • DISCLAIMER

CHAPTER 2 - SUMMARY

  • SUMMARY TABLE: GLOBAL MARKET FOR BREAST CANCER DIAGNOSTIC AND DRUG TECHNOLOGIES, THROUGH 2019 ($ MILLIONS)
  • SUMMARY FIGURE: GLOBAL MARKET FOR BREAST CANCER DIAGNOSTIC AND DRUG TECHNOLOGIES, 2012-2019 ($ MILLIONS)

CHAPTER 3 - OVERVIEW

  • INTRODUCTION
    • TABLE 1: SEER SUMMARY STAGE SYSTEM FOR BREAST CANCER
    • CLASSIFICATION OF BREAST CANCER
      • Luminal A and Luminal B Types
      • HER2 Type
      • Basal Type
    • CAUSES, INCIDENCE AND RISK FACTORS
    • SYMPTOMS
    • BREAST CANCER EVALUATION TESTS
    • PATHOPHYSIOLOGY
    • TREATMENT
      • TABLE 2: TYPES OF HORMONE THERAPY FOR BREAST CANCER
      • Cancer Treatment: Local or Systemic
        • TABLE 3: BREAST CANCER STAGES
      • Prognosis after Treatment
      • Breast Cancer Treatment Guidelines
    • PREVENTION
      • Patients at High Risk for Breast Cancer
    • METASTATIC BREAST CANCER

CHAPTER 4 - BREAST CANCER

  • LATEST DEVELOPMENTS
  • BREAST CANCER DIAGNOSTICS AND TRENDS
    • EARLY BREAST CANCER DETECTION
      • Imaging Tests
        • Mammography
          • Diagnostic Mammograms
          • Digital Mammograms
        • Usefulness of Mammography
      • Magnetic Resonance Imaging of the Breast
      • Breast Ultrasound
      • Ductal Lavage and Nipple Aspiration
      • Biopsy
        • Fine Needle Aspiration Biopsy
        • Core Needle Biopsy
        • Vacuum-Assisted Biopsies
        • Surgical (Open) Biopsy
      • Laboratory Examination
        • Grades of Breast Cancer
          • TABLE 4: BREAST CANCER GRADES
      • Types of Breast Cancer
        • Ductal Carcinoma In Situ
        • Invasive (or Infiltrating) Ductal Carcinoma
        • Invasive (or Infiltrating) Lobular Carcinoma
  • IMAGING TESTS TO DETERMINE IF BREAST CANCER HAS SPREAD
    • TABLE 5: IMAGING TESTS THAT DETERMINE IF BREAST CANCER HAS SPREAD
  • GENE EXPRESSION PROFILING
    • TABLE 6: TESTS USED TO EVALUATE DIFFERENT GENE SETS FOR BREAST CANCER TREATMENT
  • ESTROGEN RECEPTOR AND PROGESTERONE RECEPTOR STATUS
  • HER2/NEU STATUS
    • TABLE 7: BIOPSY AND SURGICAL SAMPLE TESTING TECHNIQUES
  • USEFULNESS OF TESTS
  • FUTURE OF BREAST CANCER DETECTION
    • DIAGNOSTIC TESTS AND THEIR VALUE IN BREAST CANCER TESTING
      • HER-2 Testing
        • TABLE 8: HER2 TESTING AND VARIATIONS
      • ER Testing
      • FISH Testing
      • Genomic Assay
      • Quantitative Fluorescence Testing
      • Mammostrat
    • NEED FOR BREAST CANCER SCREENING
    • OVERDIAGNOSIS
    • DIAGNOSIS AND TREATMENT REGIMEN
    • GUIDELINES FOR BREAST CANCER DETECTION
      • TABLE 9: GUIDELINES FOR EARLY DETECTION OF BREAST CANCER IN AVERAGE RISK, ASYMPTOMATIC WOMEN
      • Changes in Breast Cancer Screening Recommendations
      • Changes to Breast Cancer Screening Guidelines
    • BREAST CANCER SCREENING GUIDELINES
      • USPSTF Guidelines
      • ACR/SBI Guidelines
      • American Cancer Society Guidelines for the Early Detection of Cancer
      • Mammogram Recommendations
    • MEDICATIONS FOR RISK REDUCTION OF PRIMARY BREAST CANCER IN WOMEN
      • Potential Harms of Medications for Breast Cancer Risk Reduction

CHAPTER 5 - BIOMARKERS AND DEVELOPMENT OF CANCER DIAGNOSTICS

  • BIOMARKERS AND CANCER
  • BIOMARKERS AND BREAST CANCER
    • TABLE 10: RECURRENCE RATES AT FIVE YEARS IN PATIENTS WITH LYMPH NODES THAT ARE POSITIVE FOR CANCER (NO.%)
    • TABLE 11: FIVE-YEAR SURVIVAL RATES CORRELATED WITH TUMOR STAGE
  • PROGNOSTIC TESTS
    • HER2 Status
  • COMPANION DIAGNOSTICS
    • TABLE 12: APPROVED COMPANION DIAGNOSTICS FOR BREAST CANCER
  • PREDICTIVE DIAGNOSTICS
    • Predictive Safety Biomarkers
    • Commercialized Biomarker Tests
    • Biomarkers and Drug Therapy
  • TARGETED THERAPIES
  • INCREASED USE OF BIOMARKERS IN DRUG DEVELOPMENT AND CLINICAL TRIALS
  • OBSTACLES TO BIOMARKER DEVELOPMENT
  • MAJOR ISSUES AND CHALLENGES TO BIOMARKER DEVELOPMENT
  • BIOMARKER TYPES
    • Predictive Biomarkers
    • Tumor Interstitial Fluid Biomarkers
    • Other Biomarkers
  • PHARMACOGENOMICS
    • Pharmacogenomic Biomarkers on Drug Labels
    • Benefits of Pharmacogenomics
    • Pharmacogenomics Tests Currently in Use
    • Barriers to the Pharmacogenomics Progress
    • Biomarker Information on Drug Labels
      • TABLE 13: CANCER BIOMARKERS FOR FDA-MANDATED TESTING PRIOR TO DRUG USE
      • TABLE 14: CLINICALLY RELEVANT BIOMARKERS
  • FDA GUIDANCE
  • APPROVED BIOMARKERS FOR COMPANION DIAGNOSTICS
    • Herceptin-Based Testing
    • Co-development of Drug Diagnostics
  • COMPANION DIAGNOSTICS AND REGULATORY ISSUES
  • REGULATORY APPROVAL PATHWAY FOR DIAGNOSTICS
    • FDA Route
    • CLIA-Based (Laboratory-Developed Tests) Route
  • CHOOSING A REGULATORY PATHWAY
    • Co-development Path
    • Issues and Barriers to Development
  • NEW CANCER DRUGS APPROVED IN 2014
    • TABLE 15: FDA APPROVED CANCER DRUGS, 2014
  • POST-LAUNCH EXPECTATIONS
    • Dako's EGFR Immunohistochemistry Assay
    • Role of Reimbursement Bodies
  • CONSIDERATIONS FOR NEW DRUG-DIAGNOSTIC PARTNERSHIPS
  • FDA-APPROVED COMPANION DIAGNOSTICS
    • Roche FISH DNA Probe for HER2/Neu
    • PathVysion HER2 DNA Probe Kit
    • Pathway Anti-HER2/Neu (4B5)
    • Dako EGFR PharmDx Kit
    • Dako C-Kit PharmDx
    • InSite HER2/Neu Kit
    • SPOT-Light HER2 CISH Kit
    • Bond Oracle HER2 IHC System
    • HER2 CISH PharmDx Kit
  • INFORM HER2 Dual ISH DNA Probe Cocktail
    • Vysis ALK Break Apart FISH Probe Kit
    • cobas 4800 BRAF V600 Mutation Test
    • HercepTest
    • HER2 FISH PharmDx Kit
  • PROGNOSIS AND PHARMACOGENETICS TESTS
    • TABLE 16: ESTIMATED NUMBER OF ANNUAL BREAST CANCER TREATMENT DECISIONS IN THE U.S. BY CANCER CLASSIFICATION
    • Breast Cancer MDx Platforms
      • TABLE 17: BREAST CANCER MDX TECHNOLOGY PLATFORMS
    • Next-Generation Breast Cancer Tests
      • TABLE 18: NEXT GENERATION BREAST CANCER TESTS
    • Breast Cancer Early Detection/Screening Tests
    • Breast Cancer Risk Tests
    • Chemotherapy Response, Recurrence Probability and Subtyping Tests
  • NEXT STEPS

CHAPTER 6 - BREAST CANCER PREVALENCE AND INCIDENCE RATES

  • CANCER INCIDENCE GLOBALLY
    • TABLE 19: DIAGNOSED CASES OF CANCER EXCLUDING NON-MELANOMA SKIN CANCER, 2012 (NO./%)
    • TABLE 20: MOST COMMONLY DIAGNOSED CANCERS GLOBALLY, 2012 (MILLIONS/%)
  • REGIONAL DIFFERENCES IN CANCER INCIDENCE
    • Incidence in Developed and Less Developed Countries
      • TABLE 21: AGE STANDARDIZED CANCER RATE PER 100,000 PEOPLE IN DEVELOPED AND LESS DEVELOPED COUNTRIES, 2012
  • CANCER TRENDS OVER TIME
  • CANCER PROJECTIONS TO 2030
  • BREAST CANCER GLOBALLY
    • GLOBAL BREAST CANCER STATISTICS
      • TABLE 22: BREAST CANCER INCIDENCE AND MORTALITY GLOBALLY, 2008 (THOUSANDS)
      • FIGURE 1: GLOBAL BREAST CANCER INCIDENCE AND MORTALITY, 2008 (THOUSANDS)
    • GEOGRAPHIC VARIATION IN BREAST CANCER RATES
      • TABLE 23: BREAST CANCER INCIDENCE BY COUNTRY, 2012
      • TABLE 24: ESTIMATED GLOBAL INCIDENCE OF BREAST CANCER, 2011-2019
      • FIGURE 2: ESTIMATED GLOBAL INCIDENCE OF BREAST CANCER, 2011-2019 (NO. OF CASES)
  • GLOBAL INCIDENCE OF BREAST CANCER
    • RISING BREAST CANCER RATES
      • TABLE 25: NEW BREAST CANCER CASES BY GEOGRAPHIC REGION, 2009 AND 2012
      • Factors
    • BREAST CANCER INCIDENCE IN DEVELOPED COUNTRIES
      • TABLE 26: ESTIMATED GLOBAL BREAST CANCER INCIDENCE RATES FOR ALL AGES, 2012
      • TABLE 27: POTENTIAL REDUCTION IN DEATHS DUE TO BREAST CANCER FROM EARLY DETECTION, U.K. AND U.S. (CASES PER DAY)
      • United States
        • Trends in Incidence and Mortality
        • U.S. Breast Cancer Incidence
          • TABLE 28: U.S. ESTIMATED BREAST CANCER INCIDENCE, BY GENDER, 2010-2019 (NO.)
          • FIGURE 3: U.S. ESTIMATED BREAST CANCER INCIDENCE, BY GENDER, 2010-2019 (NO.)
        • Historical Data
          • TABLE 29: U.S. NEW FEMALE BREAST CANCER CASES AND DEATHS BY AGE, 2011 (THOUSANDS)
        • 2012 Breast Cancer Estimates
          • TABLE 30: U.S. ESTIMATED BREAST CANCER INCIDENCE AND DEATHS, 2012 (THOUSANDS)
        • Breast Cancer in Men
          • TABLE 31: COMPARISON OF BREAST CANCER INCIDENCE AND DEATH IN MEN AND WOMEN IN THE U.S., 2012
      • U.S. Breast Cancer Statistics and Race
        • Breast Cancer in Caucasian Women
        • Breast Cancer in African American Women
        • Breast Cancer in Ashkenazi Jewish Women
        • Breast Cancer in Women of Other Races
          • TABLE 32: U.S. ESTIMATED BREAST CANCER INCIDENCE AND MORTALITY BY RACE, 2006-2010 (INCIDENCE PER 100,000)
        • Breast Cancer in Asian American Women
          • TABLE 33: U.S. ESTIMATED BREAST CANCER INCIDENCE (2004-2008) AND MORTALITY (2003-2007) FOR ASIAN WOMEN (PER 100,000)
        • Breast Cancer in Hispanic/Latina Women
          • TABLE 34: U.S. ESTIMATED BREAST CANCER INCIDENCE AND MORTALITY FOR HISPANIC/LATINA WOMEN, 2006-2010 (PER 100,000)
        • Breast Cancer in Native American Women
          • TABLE 35: U.S. ESTIMATED BREAST CANCER INCIDENCE AND MORTALITY IN NATIVE AMERICAN WOMEN COMPARED WITH OTHER RACES, 2006-2010 (PER 100,000)
      • Recurrence and Metastatic Breast Cancer
      • Age and Breast Cancer
        • TABLE 36: BREAST CANCER RISK BY AGE
      • In Situ Breast Cancer
      • Invasive Breast Cancer
      • Incidence Trends by Race and Tumor Size
      • Incidence and Mortality Trends for Male Breast Cancer
      • Factors Influencing Breast Cancer Survival
        • TABLE 37: RELATIVE CANCER SURVIVAL IN WOMEN IN THE U.S. (%)
        • Obesity, Physical Activity and Diet
      • Historical Facts
    • Canada
      • Breast Cancer Facts
        • TABLE 38: ESTIMATED CANADIAN BREAST CANCER STATISTICS, 2014
        • TABLE 39: CANADIAN ESTIMATED NUMBER OF NEW BREAST CANCER CASES IN FEMALES BY AGE, 2010
    • Europe
      • TABLE 40: ESTIMATED NEW BREAST CANCER CASES, DEATHS FROM CANCER AND AGE-STANDARDIZED RATES PER 100,000 IN EUROPE, 2012 (THOUSANDS)
    • United Kingdom and Ireland
      • TABLE 41: BREAST CANCER STATISTICS IN THE U.K. AND IRELAND
    • Key Breast Cancer Statistics
      • TABLE 42: U.K. AGE STANDARDIZED BREAST CANCER INCIDENCE RATES, 2011 (PER 100,000)
      • TABLE 43: U.K. AGE-STANDARDIZED BREAST CANCER INCIDENCE RATES, 2008 (PER 100,000.)
      • TABLE 44: ESTIMATED INCIDENCE OF BREAST CANCER IN THE U.K.., 2008-2019
      • FIGURE 4: ESTIMATED INCIDENCE OF BREAST CANCER IN THE U.K., 2008-2019 (THOUSANDS)
    • Germany
      • TABLE 45: GERMAN ESTIMATED BREAST CANCER INCIDENCE, 2010-2019
      • FIGURE 5: GERMAN ESTIMATED BREAST CANCER INCIDENCE, 2010-2019
    • Australia
      • TABLE 46 PROJECTED NEW CASES OF BREAST CANCER IN AUSTRALIA AND NEW ZEALAND, 2012
  • BREAST CANCER INCIDENCE IN DEVELOPING COUNTRIES
    • Asia
      • TABLE 47: ASIAN ESTIMATED BREAST CANCER INCIDENCE, 2012
    • China
      • TABLE 48: CHINESE ESTIMATED BREAST CANCER INCIDENCE, 2008-2019
      • FIGURE 6: CHINESE ESTIMATED BREAST CANCER INCIDENCE, 2008-2019
    • India
      • TABLE 49: INDIAN ESTIMATED BREAST CANCER INCIDENCE, 2008-2019 (THOUSANDS)
      • FIGURE 7: INDIAN ESTIMATED BREAST CANCER INCIDENCE, 2008-(NO. OF CASES)2019
    • Japan
      • TABLE 50: JAPANESE ESTIMATED BREAST CANCER INCIDENCE, 2010-2012 (THOUSANDS)
  • BREAST CANCER INCIDENCE IN LESS DEVELOPED COUNTRIES
    • TABLE 51: FIVE-YEAR SURVIVAL RATES FOR BREAST CANCER (%)
    • TABLE 52: SELECTED BREAST CANCER FIVE-YEAR SURVIVAL BY CANCER STAGE (%)
    • Breast Cancer in Low-Income Countries
  • BREAST CANCER INCIDENCE IN MIDDLE-INCOME COUNTRIES
    • Mexico
    • Africa
    • Arabic Region
  • OTHER FACTORS
    • Tumor Characteristics
    • Environmental Factors and Breast Cancer Risk
  • SURVIVAL BY DISEASE STAGE
    • TABLE 53: U.S. PERCENTAGE OF BREAST CANCER CASES AND FIVE-YEAR RELATIVE SURVIVAL BY STAGE AT DIAGNOSIS, 2004-2010 (%)
  • FAMILY HISTORY OF BREAST CANCER AND GENETIC PREDISPOSITION
  • CONCLUSIONS

CHAPTER 7 - BREAST CANCER DRUGS AND MARKET TRENDS

  • CLINICAL DIAGNOSIS AND MANAGEMENT
    • TABLE 54: ONCOLOGY DRUGS APPROVED BY THE FDA, 2014
    • TABLE 55: ONCOLOGY DRUGS APPROVED BY THE FDA, 2013
    • TABLE 56: ONCOLOGY DRUGS APPROVED BY THE FDA, 2012
    • TABLE 57: ONCOLOGY DRUGS APPROVED BY THE FDA, 2011
    • TABLE 58: ONCOLOGY DRUGS APPROVED BY THE FDA, 2010
  • CANCER DRUGS AND MARKET TRENDS
    • DIAGNOSTICS FOR CANCER DRUGS
      • Circulating Tumor Cells
      • Imaging Tests
        • Scintimammography or Molecular Breast Imaging
        • Tomosynthesis or 3-D Mammography
    • TYPES OF THERAPEUTIC TREATMENTS FOR BREAST CANCER
      • Local versus Systemic Therapy
      • Adjuvant and Neo-adjuvant Therapy
    • BREAST CANCER TREATMENT OPTIONS
      • FDA Approved Drugs to Treat Breast Cancer
        • TABLE 59: DRUGS APPROVED TO TREAT BREAST CANCER
      • Hormone Therapy
        • TABLE 60: HORMONE THERAPY FOR BREAST CANCER
        • TABLE 61: AROMATASE INHIBITORS FOR TREATING BREAST CANCER
      • Chemotherapy
        • TABLE 62: CHEMOTHERAPY DRUGS FOR TREATING BREAST CANCER
      • Drugs to Control Side Effects of Breast Cancer Treatment
      • Targeted Therapies for Breast Cancer
        • Herceptin (Trastuzumab)
        • Pertuzumab
        • Lapatinib
          • TABLE 63: TARGETED THERAPEUTICS FOR BREAST CANCER
        • Avastin
        • Afinitor
        • Everolimus
        • Kadcyla
        • Treatment for Breast Cancer with Low HER2 Expression
          • Trastuzumab for Women with HER2-Low Breast Cancer
          • NeuVax
          • Tamoxifen
        • Palbociclib
      • Emerging Therapies
        • Triple Negative Breast Cancer
      • Treatments for BRCA Mutation-Related Cancer
  • TARGETED CANCER DRUG MARKET
    • TABLE 64: GLOBAL MARKET FOR TARGETED CANCER DRUGS, 2008-2019 ($ MILLIONS)
  • GLOBAL PHARMACEUTICAL MARKET
    • TABLE 65: GLOBAL PHARMACEUTICAL SALES, THROUGH 2019 ($ MILLIONS)
    • FIGURE 8: GLOBAL PHARMACEUTICAL SALES, 2010-2019 ($ MILLIONS)
  • CURRENT BREAST CANCER MARKET TRENDS
    • NEW DEVELOPMENTS IN THE BREAST CANCER TREATMENT MARKET
    • MARKET DYNAMICS
  • BREAST CANCER MARKET
    • TABLE 66: BREAST CANCER THERAPY SALES, THROUGH 2019 ($ MILLIONS)
    • FIGURE 9: BREAST CANCER THERAPY SALES, 2010-2019 ($ MILLIONS)
    • TABLE 67: BREAST CANCER DRUG MARKET, 2014 AND 2019 ($ MILLIONS)
    • FIGURE 10: BREAST CANCER DRUG MARKET, 2014 AND 2019 ($ MILLIONS)
  • AROMATASE INHIBITORS
  • TARGETED THERAPIES
    • Perjeta
      • TABLE 68: PERJETA DRUG SALES, 2012-2014 ($ THOUSANDS)
    • Kadcyla
      • TABLE 69: KADCYLA DRUG SALES, 2013 AND 2014 ($ THOUSANDS)
    • Herceptin
      • TABLE 70: HERCEPTIN DRUG SALES, 2012-2014 ($ THOUSANDS)
      • TABLE 71: BREAST CANCER TARGETED THERAPIES, 2010-2014 ($ MILLIONS)
    • Tykerb
  • PATENTS ON TARGETED THERAPIES
  • SALES OF HERCEPTIN, XELODA, PERJETA AND KADCYLA
    • TABLE 72 ROCHE PHARMACEUTICALS DIVISION SALES, 2012-2013 ($ MILLIONS)
    • TABLE 73: ROCHE SALES COMPARED WITH THE GLOBAL MARKET, 2010 ($ MILLIONS/%)
    • TABLE 74: XELODA SALES, 2010 AND 2011 ($ MILLIONS)
    • TABLE 75: ROCHE SALES VERSUS THE GLOBAL MARKET, 2011 ($ MILLIONS/%)
  • OTHER MEDICINES FOR BREAST CANCER
    • TABLE 76: EXPECTED SALES FOR PERTUZUMAB, 2016
    • Perjeta/Pertuzumab
  • REGIONAL BREAST CANCER MARKETS
    • Australian Breast Cancer Treatment Market
      • TABLE 77: AUSTRALIA: CANCER THERAPY SALES, 2008 AND 2018 ($ MILLIONS)
      • TABLE 78: AUSTRALIA TARGETED CANCER THERAPY SALES, 2008 AND 2018 ($ MILLIONS)
    • Indian Breast Cancer Treatment Market
    • China
    • Europe
  • CONCLUSIONS

CHAPTER 8 - BREAST CANCER PREDICTIVE DIAGNOSTICS MARKET

  • PROJECTED CANCER COSTS
  • CANCER DRUG MARKET
  • BREAST CANCER DRUGS
    • TABLE 79: BREAST CANCER MONOCLONAL ANTIBODY MARKET, 2014 AND 2019 ($ MILLIONS)
  • U.S. PERSONALIZED MEDICINE MARKET SIZE
    • COST OF BREAST CANCER CARE
      • TABLE 80: ANNUALIZED MEAN NET COST OF BREAST CANCER CARE, 2010 ($ PER PATIENT)
      • TABLE 81: U.S. PREDICTIVE PERSONALIZED MEDICINE MARKET, 2013 AND 2019 ($ MILLIONS)
      • FIGURE 11: U.S. PERSONALIZED MEDICINE MARKET, 2013 AND 2019 ($ MILLIONS)
      • TABLE 82: U.S. PERSONALIZED MEDICINE DIAGNOSTIC TESTS AND TARGETED THERAPIES MARKET, THROUGH 2019 ($ MILLIONS)
      • FIGURE 12: U.S. PERSONALIZED MEDICINE DIAGNOSTIC TESTS AND TARGETED THERAPIES MARKET, 2011-2019 ($ MILLIONS)
  • PERSONALIZED MEDICINE AND ISSUES
  • FACTORS INFLUENCING MARKET GROWTH AND INDUSTRY SPECIFIC CHALLENGES
  • GLOBAL MOLECULAR DIAGNOSTICS MARKET
    • TABLE 83: GLOBAL MOLECULAR DIAGNOSTICS MARKET, THROUGH 2019 ($ MILLIONS)
  • U.S. MOLECULAR-BASED CANCER DIAGNOSTICS MARKET
  • GLOBAL IN VITRO DIAGNOSTICS MARKET
    • TABLE 84: GLOBAL IVD MARKET, THROUGH 2019 ($ MILLIONS)
  • BREAST CANCER TESTING MARKET
    • TABLE 85: BREAST CANCER DIAGNOSTIC TESTS
    • TABLE 86: BREAST CANCER GENETIC TESTS
  • NEXT-GENERATION CANCER DIAGNOSTICS
  • GLOBAL BREAST CANCER MARKET AND TRENDS
    • TABLE 87: ESTIMATED GLOBAL INCIDENCE OF BREAST CANCER, 2012-2019
    • TABLE 88: GLOBAL INCIDENCE OF ER-POSITIVE BREAST CANCER, 2012-2019
  • BREAST IMAGING
    • Mammography Equipment
  • BREAST BIOPSY
  • BREAST CANCER AND MOLECULAR DIAGNOSTICS
  • COMPANION DIAGNOSTICS
  • PREDICTIVE TECHNOLOGY AND BREAST CANCER MARKET TRENDS
    • Tests for Breast Cancer Prognosis
      • HER2
      • Gene Expression Profiling Tests
        • IHC4 Test
          • TABLE 89: BREAST CANCER DIAGNOSTIC TEST COSTS
          • TABLE 90: GLOBAL MARKET FOR PREDICTIVE BREAST CANCER DIAGNOSTIC TECHNOLOGIES, THROUGH 2019 ($ MILLIONS)
          • FIGURE 13: GLOBAL MARKET FOR PREDICTIVE BREAST CANCER DIAGNOSTIC TECHNOLOGIES, 2012-2019 ($ MILLIONS)
  • IHC AND FISH-BASED TESTS MARKET
    • TABLE 91: IHC AND FISH-BASED BREAST CANCER TESTING SALES, THROUGH 2019 ($ MILLIONS)
    • FIGURE 14: IHC AND FISH-BASED BREAST CANCER TESTING SALES, 2012-2019 ($ MILLIONS)
  • TISSUE-BASED IMMUNOHISTOCHEMISTRY MARKET
    • TABLE 92: FDA-APPROVED COMMERCIAL IHC KITS
    • HercepTest Kits
      • TABLE 93: FDA-APPROVED FISH ANALYSIS TESTS
  • KEY COMPANIES
    • ROCHE
      • TABLE 94: ONCOLOGY BREAST CANCER DRUG SALES BY REGION, 2013 ($ MILLIONS)
      • TABLE 95: ROCHE DIAGNOSTIC SALES, 2012 AND 2013 ($ MILLIONS)
      • TABLE 96: ROCHE SALES BY DIVISION, 2010 ($ MILLIONS)
      • TABLE 97: CURRENTLY MARKETED ROCHE COMPANION DIAGNOSTICS
    • DAKO
  • GENOMIC ASSAYS
    • TABLE 98: GENOMIC ASSAY MARKET LEADERS
    • TABLE 99: GENOMIC TESTING MARKET FOR BREAST CANCER, THROUGH 2019 ($ MILLIONS)
    • FIGURE 15: GENOMIC TESTING MARKET FOR BREAST CANCER, 2012-2019 ($ MILLIONS)
  • GENOMIC HEALTH
    • Oncotype DX
      • TABLE 100: ONCOTYPE DX SALES, THROUGH 2019 ($ MILLIONS)
  • AGENDIA
    • MammaPrint Assay
  • QUANTITATIVE FLUORESCENCE-BASED TESTS
    • CCC Diagnostics LLC
      • DirectHit Test Panel
        • TABLE 101: QUANTITATIVE FLUORESCENCE DIAGNOSTIC TESTING MARKET FOR BREAST CANCER, THROUGH 2019 ($ MILLIONS)
        • FIGURE 16: QUANTITATIVE FLUORESCENCE DIAGNOSTIC TESTING MARKET FOR BREAST CANCER, 2012-2019 ($ MILLIONS)
    • NanoString Technologies
      • Prosigna Assay
  • CONCLUSIONS

CHAPTER 9 - COMPANY PROFILES

  • ABBOTT LABORATORIES
  • AETERNA ZENTARIS
  • AGENDIA
  • ALTHEADX
  • AMBERGEN INC.
  • ASTRAZENECA PLC
  • ATOSSA GENETICS INC.
  • BIOCON
  • BIOTIME
  • CCC DIAGNOSTICS LLC
  • CLARIENT
  • DAKO
  • EISAI INC.
  • EUTROPICS PHARMACEUTICALS
  • FLUXION BIOSCIENCES
  • GENENTECH
  • GENOMIC HEALTH
  • GLAXOSMITHKLINE
  • LIFE TECHNOLOGIES CORP.
  • MATRIX-BIO INC.
  • MDXHEALTH
  • MERCK AND CO. INC.
  • MYRIAD GENETICS
  • NANOSTRING TECHNOLOGIES
  • PFIZER
  • PHIGENIX
  • PROVISTADX LABORATORIES
  • PURDUE RESEARCH FOUNDATION
  • RUBICON GENOMICS
  • SANOFI S.A.
  • VENTANA MEDICAL SYSTEMS INC.

CHAPTER 10 - DEVELOPMENTS AND COLLABORATIONS

  • CURRENT AND FUTURE DEVELOPMENTS
    • COMMERCIAL OPPORTUNITIES FOR CANCER BIOMARKER-BASED DIAGNOSTIC TESTS
      • NanoString Technologies
      • Roche
    • DISCOVERY
    • RECENT BREAST CANCER TEST APPROVALS
      • Provista
      • Matrix-Bio
      • Eutropics Laboratory
      • Ventana Medical Systems
    • BREAST CANCER TESTS
      • Oncotype DX
    • RECENT DEVELOPMENTS AND PARTNERSHIPS
      • PanC-Dx
      • TransPLEX
      • Abbott and Merck Partnership
      • AltheaDx and Compendia Bioscience Partnership
      • GE Healthcare and Early Diagnosis
      • GE Investment in NanoString Technologies
      • Aeterna Zentaris and Ventana Partnership
      • MDxHealth and Pfizer Partnership
      • Palbociclib for Treatment of ER-Positive, HER2-Negative Advanced Stage Breast Cancer
      • FDA Priority Review of Roche's Pertuzumab
      • Two Drugs that Hit One Target Show Efficacy against Metastatic Breast Cancer
      • New Experimental Breast Cancer Drug Shows Promise
      • Bemaciclib for Treatment of Metastatic Breast Cancer
      • Perjeta Trial
      • I-SPY 2 Trial for Neratinib
    • BREAST CANCER DRUG AND DIAGNOSTIC PATENT LANDSCAPE
      • Recent Patent Expirations on Breast Cancer Drugs
      • Breast Cancer Predictive Diagnostic Patents
    • RECENT PATENT-RELATED ACTIVITY
      • Gene Ownership and Patent Issues
      • Phigenix Breast Cancer Patent
      • Galena Biopharma's NeuVax Patent
      • Hospira and Roche's Herceptin Patent
      • Other Breast Cancer Drugs
        • Ridaforolimus
        • Buparlisib
          • TABLE 102: BUPARLISIB CLINICAL TRIALS
      • Faslodex (Fulvestrant Injection)
      • Iniparib (Tivolza)
      • Xgeva (Denosumab)
      • Nexavar (Sorafenib)
      • Arimidex
      • Afinitor
        • TABLE 103: AFINITOR PATENTS AND EXPIRY
  • CONCLUSIONS

CHAPTER 11 - BIBLIOGRAPHY

LIST OF TABLES

  • SUMMARY TABLE: GLOBAL MARKET FOR BREAST CANCER DIAGNOSTIC AND DRUG TECHNOLOGIES, THROUGH 2019 ($ MILLIONS)
    • TABLE 1: SEER SUMMARY STAGE SYSTEM FOR BREAST CANCER
    • TABLE 2: TYPES OF HORMONE THERAPY FOR BREAST CANCER
    • TABLE 3: BREAST CANCER STAGES
    • TABLE 4: BREAST CANCER GRADES
    • TABLE 5: IMAGING TESTS THAT DETERMINE IF BREAST CANCER HAS SPREAD
    • TABLE 6: TESTS USED TO EVALUATE DIFFERENT GENE SETS FOR BREAST CANCER TREATMENT
    • TABLE 7: BIOPSY AND SURGICAL SAMPLE TESTING TECHNIQUES
    • TABLE 8: HER2 TESTING AND VARIATIONS
    • TABLE 9: GUIDELINES FOR EARLY DETECTION OF BREAST CANCER IN AVERAGE RISK, ASYMPTOMATIC WOMEN
    • TABLE 10: RECURRENCE RATES AT FIVE YEARS IN PATIENTS WITH LYMPH NODES THAT ARE POSITIVE FOR CANCER (NO.%)
    • TABLE 11: FIVE-YEAR SURVIVAL RATES CORRELATED WITH TUMOR STAGE
    • TABLE 12: APPROVED COMPANION DIAGNOSTICS FOR BREAST CANCER
    • TABLE 13: CANCER BIOMARKERS FOR FDA-MANDATED TESTING PRIOR TO DRUG USE
    • TABLE 14: CLINICALLY RELEVANT BIOMARKERS
    • TABLE 15: FDA APPROVED CANCER DRUGS, 2014
    • TABLE 16: ESTIMATED NUMBER OF ANNUAL BREAST CANCER TREATMENT DECISIONS IN THE U.S. BY CANCER CLASSIFICATION
    • TABLE 17: BREAST CANCER MDX TECHNOLOGY PLATFORMS
    • TABLE 18: NEXT GENERATION BREAST CANCER TESTS
    • TABLE 19: DIAGNOSED CASES OF CANCER EXCLUDING NON-MELANOMA SKIN CANCER, 2012 (NO./%)
    • TABLE 20: MOST COMMONLY DIAGNOSED CANCERS GLOBALLY, 2012 (MILLIONS/%)
    • TABLE 21: AGE STANDARDIZED CANCER RATE PER 100,000 PEOPLE IN DEVELOPED AND LESS DEVELOPED COUNTRIES, 2012
    • TABLE 22: BREAST CANCER INCIDENCE AND MORTALITY GLOBALLY, 2008 (THOUSANDS)
    • TABLE 23: BREAST CANCER INCIDENCE BY COUNTRY, 2012
    • TABLE 24: ESTIMATED GLOBAL INCIDENCE OF BREAST CANCER, 2011-2019
    • TABLE 25: NEW BREAST CANCER CASES BY GEOGRAPHIC REGION, 2009 AND 2012
    • TABLE 26: ESTIMATED GLOBAL BREAST CANCER INCIDENCE RATES FOR ALL AGES, 2012
    • TABLE 27: POTENTIAL REDUCTION IN DEATHS DUE TO BREAST CANCER FROM EARLY DETECTION, U.K. AND U.S. (CASES PER DAY)
    • TABLE 28: U.S. ESTIMATED BREAST CANCER INCIDENCE, BY GENDER, 2010-2019 (NO.)
    • TABLE 29: U.S. NEW FEMALE BREAST CANCER CASES AND DEATHS BY AGE, 2011 (THOUSANDS)
    • TABLE 30: U.S. ESTIMATED BREAST CANCER INCIDENCE AND DEATHS, 2012 (THOUSANDS)
    • TABLE 31: COMPARISON OF BREAST CANCER INCIDENCE AND DEATH IN MEN AND WOMEN IN THE U.S., 2012
    • TABLE 32: U.S. ESTIMATED BREAST CANCER INCIDENCE AND MORTALITY BY RACE, 2006-2010 (INCIDENCE PER 100,000)
    • TABLE 33: U.S. ESTIMATED BREAST CANCER INCIDENCE (2004-2008) AND MORTALITY (2003-2007) FOR ASIAN WOMEN (PER 100,000)
    • TABLE 34: U.S. ESTIMATED BREAST CANCER INCIDENCE AND MORTALITY FOR HISPANIC/LATINA WOMEN, 2006-2010 (PER 100,000)
    • TABLE 35: U.S. ESTIMATED BREAST CANCER INCIDENCE AND MORTALITY IN NATIVE AMERICAN WOMEN COMPARED WITH OTHER RACES, 2006-2010 (PER 100,000)
    • TABLE 36: BREAST CANCER RISK BY AGE
    • TABLE 37: RELATIVE CANCER SURVIVAL IN WOMEN IN THE U.S. (%)
    • TABLE 38: ESTIMATED CANADIAN BREAST CANCER STATISTICS, 2014
    • TABLE 39: CANADIAN ESTIMATED NUMBER OF NEW BREAST CANCER CASES IN FEMALES BY AGE, 2010
    • TABLE 40: ESTIMATED NEW BREAST CANCER CASES, DEATHS FROM CANCER AND AGE-STANDARDIZED RATES PER 100,000 IN EUROPE, 2012 (THOUSANDS)
    • TABLE 41: BREAST CANCER STATISTICS IN THE U.K. AND IRELAND
    • TABLE 42: U.K. AGE STANDARDIZED BREAST CANCER INCIDENCE RATES, 2011 (PER 100,000)
    • TABLE 43: U.K. AGE-STANDARDIZED BREAST CANCER INCIDENCE RATES, 2008 (PER 100,000.)
    • TABLE 44: ESTIMATED INCIDENCE OF BREAST CANCER IN THE U.K.., 2008-2019
    • TABLE 45: GERMAN ESTIMATED BREAST CANCER INCIDENCE, 2010-2019
    • TABLE 46: PROJECTED NEW CASES OF BREAST CANCER IN AUSTRALIA AND NEW ZEALAND, 2012
    • TABLE 47: ASIAN ESTIMATED BREAST CANCER INCIDENCE, 2012
    • TABLE 48: CHINESE ESTIMATED BREAST CANCER INCIDENCE, 2008-2019
    • TABLE 49: INDIAN ESTIMATED BREAST CANCER INCIDENCE, 2008-2019 (THOUSANDS)
    • TABLE 50: JAPANESE ESTIMATED BREAST CANCER INCIDENCE, 2010-2012 (THOUSANDS)
    • TABLE 51: FIVE-YEAR SURVIVAL RATES FOR BREAST CANCER (%)
    • TABLE 52: SELECTED BREAST CANCER FIVE-YEAR SURVIVAL BY CANCER STAGE (%)
    • TABLE 53: U.S. PERCENTAGE OF BREAST CANCER CASES AND FIVE-YEAR RELATIVE SURVIVAL BY STAGE AT DIAGNOSIS, 2004-2010 (%)
    • TABLE 54: ONCOLOGY DRUGS APPROVED BY THE FDA, 2014
    • TABLE 55: ONCOLOGY DRUGS APPROVED BY THE FDA, 2013
    • TABLE 56: ONCOLOGY DRUGS APPROVED BY THE FDA, 2012
    • TABLE 57: ONCOLOGY DRUGS APPROVED BY THE FDA, 2011
    • TABLE 58: ONCOLOGY DRUGS APPROVED BY THE FDA, 2010
    • TABLE 59: DRUGS APPROVED TO TREAT BREAST CANCER
    • TABLE 60: HORMONE THERAPY FOR BREAST CANCER
    • TABLE 61: AROMATASE INHIBITORS FOR TREATING BREAST CANCER
    • TABLE 62: CHEMOTHERAPY DRUGS FOR TREATING BREAST CANCER
    • TABLE 63: TARGETED THERAPEUTICS FOR BREAST CANCER
    • TABLE 64: GLOBAL MARKET FOR TARGETED CANCER DRUGS, 2008-2019 ($ MILLIONS)
    • TABLE 65: GLOBAL PHARMACEUTICAL SALES, THROUGH 2019 ($ MILLIONS)
    • TABLE 66: BREAST CANCER THERAPY SALES, THROUGH 2019 ($ MILLIONS)
    • TABLE 67: BREAST CANCER DRUG MARKET, 2014 AND 2019 ($ MILLIONS)
    • TABLE 68: PERJETA DRUG SALES, 2012-2014 ($ THOUSANDS)
    • TABLE 69: KADCYLA DRUG SALES, 2013 AND 2014 ($ THOUSANDS)
    • TABLE 70: HERCEPTIN DRUG SALES, 2012-2014 ($ THOUSANDS)
    • TABLE 71: BREAST CANCER TARGETED THERAPIES, 2010-2014 ($ MILLIONS)
    • TABLE 72: ROCHE PHARMACEUTICALS DIVISION SALES, 2012-2013 ($ MILLIONS)
    • TABLE 73: ROCHE SALES COMPARED WITH THE GLOBAL MARKET, 2010 ($ MILLIONS/%)
    • TABLE 74: XELODA SALES, 2010 AND 2011 ($ MILLIONS)
    • TABLE 75: ROCHE SALES VERSUS THE GLOBAL MARKET, 2011 ($ MILLIONS/%)
    • TABLE 76: EXPECTED SALES FOR PERTUZUMAB, 2016
    • TABLE 77: AUSTRALIA: CANCER THERAPY SALES, 2008 AND 2018 ($ MILLIONS)
    • TABLE 78: AUSTRALIA TARGETED CANCER THERAPY SALES, 2008 AND 2018 ($ MILLIONS)
    • TABLE 79: BREAST CANCER MONOCLONAL ANTIBODY MARKET, 2014 AND 2019 ($ MILLIONS)
    • TABLE 80: ANNUALIZED MEAN NET COST OF BREAST CANCER CARE, 2010 ($ PER PATIENT)
    • TABLE 81: U.S. PREDICTIVE PERSONALIZED MEDICINE MARKET, 2013 AND 2019 ($ MILLIONS)
    • TABLE 82: U.S. PERSONALIZED MEDICINE DIAGNOSTIC TESTS AND TARGETED THERAPIES MARKET, THROUGH 2019 ($ MILLIONS)
    • TABLE 83: GLOBAL MOLECULAR DIAGNOSTICS MARKET, THROUGH 2019 ($ MILLIONS)
    • TABLE 84: GLOBAL IVD MARKET, THROUGH 2019 ($ MILLIONS)
    • TABLE 85: BREAST CANCER DIAGNOSTIC TESTS
    • TABLE 86: BREAST CANCER GENETIC TESTS
    • TABLE 87: ESTIMATED GLOBAL INCIDENCE OF BREAST CANCER, 2012-2019
    • TABLE 88: GLOBAL INCIDENCE OF ER-POSITIVE BREAST CANCER, 2012-2019
    • TABLE 89: BREAST CANCER DIAGNOSTIC TEST COSTS
    • TABLE 90: GLOBAL MARKET FOR PREDICTIVE BREAST CANCER DIAGNOSTIC TECHNOLOGIES, THROUGH 2019 ($ MILLIONS)
    • TABLE 91: IHC AND FISH-BASED BREAST CANCER TESTING SALES, THROUGH 2019 ($ MILLIONS)
    • TABLE 92: FDA-APPROVED COMMERCIAL IHC KITS
    • TABLE 93: FDA-APPROVED FISH ANALYSIS TESTS
    • TABLE 94: ONCOLOGY BREAST CANCER DRUG SALES BY REGION, 2013 ($ MILLIONS)
    • TABLE 95: ROCHE DIAGNOSTIC SALES, 2012 AND 2013 ($ MILLIONS)
    • TABLE 96: ROCHE SALES BY DIVISION, 2010 ($ MILLIONS)
    • TABLE 97: CURRENTLY MARKETED ROCHE COMPANION DIAGNOSTICS
    • TABLE 98: GENOMIC ASSAY MARKET LEADERS
    • TABLE 99: GENOMIC TESTING MARKET FOR BREAST CANCER, THROUGH 2019 ($ MILLIONS)
    • TABLE 100: ONCOTYPE DX SALES, THROUGH 2019 ($ MILLIONS)
    • TABLE 101: QUANTITATIVE FLUORESCENCE DIAGNOSTIC TESTING MARKET FOR BREAST CANCER, THROUGH 2019 ($ MILLIONS)
    • TABLE 102: BUPARLISIB CLINICAL TRIALS
    • TABLE 103: AFINITOR PATENTS AND EXPIRY

LIST OF FIGURES

  • SUMMARY FIGURE: GLOBAL MARKET FOR BREAST CANCER DIAGNOSTIC AND DRUG TECHNOLOGIES, 2012-2019 ($ MILLIONS)
    • FIGURE 1: GLOBAL BREAST CANCER INCIDENCE AND MORTALITY, 2008 (THOUSANDS)
    • FIGURE 2: ESTIMATED GLOBAL INCIDENCE OF BREAST CANCER, 2011-2019 (NO. OF CASES)
    • FIGURE 3: U.S. ESTIMATED BREAST CANCER INCIDENCE, BY GENDER, 2010-2019 (NO.)
    • FIGURE 4: ESTIMATED INCIDENCE OF BREAST CANCER IN THE U.K., 2008-2019 (THOUSANDS)
    • FIGURE 5: GERMAN ESTIMATED BREAST CANCER INCIDENCE, 2010-2019
    • FIGURE 6: CHINESE ESTIMATED BREAST CANCER INCIDENCE, 2008-2019
    • FIGURE 7: INDIAN ESTIMATED BREAST CANCER INCIDENCE, 2008-(NO. OF CASES)2019
    • FIGURE 8: GLOBAL PHARMACEUTICAL SALES, 2010-2019 ($ MILLIONS)
    • FIGURE 9: BREAST CANCER THERAPY SALES, 2010-2019 ($ MILLIONS)
    • FIGURE 10: BREAST CANCER DRUG MARKET, 2014 AND 2019 ($ MILLIONS)
    • FIGURE 11: U.S. PERSONALIZED MEDICINE MARKET, 2013 AND 2019 ($ MILLIONS)
    • FIGURE 12: U.S. PERSONALIZED MEDICINE DIAGNOSTIC TESTS AND TARGETED THERAPIES MARKET, 2011-2019 ($ MILLIONS)
    • FIGURE 13: GLOBAL MARKET FOR PREDICTIVE BREAST CANCER DIAGNOSTIC TECHNOLOGIES, 2012-2019 ($ MILLIONS)
    • FIGURE 14: IHC AND FISH-BASED BREAST CANCER TESTING SALES, 2012-2019 ($ MILLIONS)
    • FIGURE 15: GENOMIC TESTING MARKET FOR BREAST CANCER, 2012-2019 ($ MILLIONS)
    • FIGURE 16: QUANTITATIVE FLUORESCENCE DIAGNOSTIC TESTING MARKET FOR BREAST CANCER, 2012-2019 ($ MILLIONS)
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