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Breast Cancer Diagnostic and Drug Technologies: Global Markets

Breast Cancer Diagnostic and Drug Technologies: Global Markets

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.

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

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