REPORT SCOPE

INTRODUCTION

STUDY GOALS AND OBJECTIVES

This BCC market research report provides a detailed overview and thorough analysis of the present and future global market for breast cancer diagnostics and drug technologies. It provides detailed analysis of the breast cancer drug and diagnostics markets, as well as the currently used personalized, predictive and companion tests and their markets. The research also includes market characterization, opportunities, the unmet needs associated with breast cancer, competitive assessment, product profiles of major marketed products and promising drugs in the pipeline, an overview on discontinued projects, implications for future market competition and the key players of the breast cancer market.

This report includes products in this market and detailed analyses of markets and competitive environments. It also analyzes current and future market prospects. It provides 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. The analysis reviews technological developments, product innovations and recent strategic industry activity of major players across different product categories. It analyzes their strengths and weaknesses, opportunities and threats facing various devices and drugs in this market space and developments already on the market. It discusses the major issues involved in the research and development (R&D) of more effective devices for drug delivery to the lungs, along with new products in development.

REASONS FOR DOING THE STUDY

According to the National Cancer Institute, more than 200,000 women in the U.S. are diagnosed with breast cancer annually. It is no longer necessary for one breast cancer treatment to fit all cases, a concept that should be welcome news for physicians and their patients alike. Personalized medicine is relatively new to the market research report format, and it provides business tools to evaluate new commercial opportunities in diagnostics and biomarker fields. The scope of this report covers global companies developing tests relevant for breast cancer prognosis and diagnosis. This study describes current products in each area, identifies current market participants, and most importantly, notes the trends that will affect further product development in this area.

Companion diagnostics is also a part of the personalized medicine revolution. The field evolved as a continuation of biomarker studies and diagnostics testing. The breast cancer predictive testing segment of the industry is still growing; it has a number of successful FDA–approved products. This study will provide knowledge of the current state of the companion diagnostics industry and the new technologies in assay development. More importantly, it will describe potential and novel commercial developments in this area. The report will also provide an overview covering major biotechnology and pharma companies involved in developing innovative, targeted breast cancer treatments that address major unmet medical needs to advance cancer care. In addition, the report also provides information regarding the less-developed sectors of this market and presents a list of current companies that have new predictive testing products and drugs in development for breast cancer.

SCOPE AND FORMAT

This report will provide an update and on overview on predictive testing in breast cancer diagnostics and drug technologies and global markets. The study’s objective is to review the tumor marker-based predictive companion tests and drugs for breast cancer, and then assess their global growth potential over a five-year period from 2011 to 2016. Review includes global markets for breast cancer incidence, current drugs, new developments, predictive diagnostic tests, market trends and new technologies, and developments and forecast trends for the use of current tests for better diagnosis and prognosis for breast cancer through 2016. Important tests, technologies and developments; market share by drug, test, current products on the market and market share by company or product; and statistical information for types of breast cancer prevalence globally, with special emphasis on the U.S. market, are discussed. The report focuses on tumor marker-based testing that 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 current issues and trends affecting the industry. The report covers products in development, new technologies, trends, alliances, 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.

INTENDED AUDIENCE

This report is an exhaustive study on the global breast cancer market, giving crucial statistics and analysis on existing drugs, diagnostic technologies, latest trends, market structure, market size, key drug segments, important trends in technology development, major opportunities and market shares of key players and drugs. This information may prove crucial for the firms or investors seeking opportunities in the concerned sector. This report shows tests currently being used for breast cancer diagnosis and prognosis, new developments, spending trends and revenue prospects for these technologies. It provides market data for 2010 to 2016, and also covers commercial prospects for breast cancer diagnostic and prognostic assays.

METHODOLOGY

Both primary and secondary research methodologies were used in preparing this report. Secondary sources include books, newspapers, trade journals, white papers, industry portals, government agencies, trade associations, industry news, and paid and free databases. The base year of the report is 2010, with forecast data provided through 2016. Historical, base year and forecast data are provided for each market segment of this report.

The report provides a comprehensive review of breast cancer incidence, development of the disease, drugs currently used and diagnostic technologies based on tumor markers for accurate diagnosis and aid in deciding treatment plans for patients. The new analysis reviews technological developments, product innovations and introductions, and recent strategic industry activity of major players across various product categories. Growth rates, global incidence and projections are determined through a compilation of data, including past trends, future trends, demographics, incidence, mortality, products in R&D and current product growth. A comprehensive and exhaustive search of the literature on breast cancer assay development and already–marketed products, breast cancer global incidence and latest drug developments was conducted. These secondary sources included scientific-related journals and articles, textbooks, press releases, marketing literature, other product or promotional literature, annual reports and security analyst reports. Patent searches and analyses were also conducted. Some informal interviews were also conducted with experts and personnel in this area at biotech and pharmaceutical companies. Other resources included academic, technology transfer offices and consulting companies.

ANALYST 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 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-start-ups to fulfill operational obligations while minimizing overall operational cost and burden.

Table Of Contents

TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 1
STUDY GOALS AND OBJECTIVES 1
REASONS FOR DOING THE STUDY 1
SCOPE AND FORMAT 2
INTENDED AUDIENCE 2
METHODOLOGY 2
RELATED BCC STUDIES 3
ANALYST CREDENTIALS 3
BCC ON-LINE SERVICES 3
DISCLAIMER 3
CHAPTER 2 SUMMARY 5
SUMMARY TABLE GLOBAL MARKET FOR PREDICTIVE BREAST CANCER DIAGNOSTIC AND
DRUG TECHNOLOGIES, THROUGH 2016 ($ MILLIONS) 6
SUMMARY FIGURE GLOBAL MARKET FOR PREDICTIVE BREAST CANCER DIAGNOSTIC AND
DRUG TECHNOLOGIES, 2010-2016 ($ MILLIONS) 6
CHAPTER 3 OVERVIEW 9
BREAST CANCER DIAGNOSTICS AND TRENDS 9
BREAST CANCER 9
EARLY BREAST CANCER DETECTION 9
TABLE 1 POSSIBLE SIGNS OF BREAST CANCER 10
IMAGING TESTS 10
MAMMOGRAPHY 10
DIAGNOSTIC MAMMOGRAMS 10
TABLE 2 DIAGNOSTIC MAMMOGRAM FOR BREAST CANCER 11
DIGITAL MAMMOGRAMS 11
USEFULNESS OF MAMMOGRAPHY 11
MAGNETIC RESONANCE IMAGING OF THE BREAST 12
BREAST ULTRASOUND 12
DUCTAL LAVAGE AND NIPPLE ASPIRATION 12
BIOPSY 13
FINE NEEDLE ASPIRATION BIOPSY 13
CORE NEEDLE BIOPSY 13
VACUUM-ASSISTED BIOPSIES 14
SURGICAL (OPEN) BIOPSY 14
LYMPH NODE DISSECTION AND SENTINEL LYMPH NODE BIOPSY 14
LABORATORY EXAMINATION 14
TYPES OF BREAST CANCER 14
TABLE 3 BREAST CANCER GRADES 15
DUCTAL CARCINOMA IN SITU 15
ESTROGEN RECEPTOR AND PROGESTERONE RECEPTOR STATUS 15
HER2/NEU STATUS 16
TABLE 4 BIOPSY OR SURGERY SAMPLE TESTING 16
GENE EXPRESSION PROFILING 17
TABLE 5 TESTS USED TO EVALUATE DIFFERENT GENE SETS 17
TEST USEFULNESS 17
IMAGING TESTS TO DETERMINE IF BREAST CANCER HAS SPREAD 17
TABLE 6 IMAGING TESTS THAT DETERMINE IF BREAST CANCER HAS SPREAD 18
THE FUTURE OF BREAST CANCER DETECTION 18
DIAGNOSTIC TESTS AND THEIR VALUE IN BREAST CANCER TESTING 18
TABLE 7 HER2 TESTING AND VARIATIONS 19
NEED FOR BREAST CANCER SCREENING 22
OVERDIAGNOSIS 23
DIAGNOSIS AND TREATMENT REGIMEN 23
GUIDELINES FOR BREAST CANCER DETECTION 24
TABLE 8 GUIDELINES FOR EARLY DETECTION OF BREAST CANCER IN AVERAGE RISK,
ASYMPTOMATIC WOMEN 25
BREAST CANCER SCREENING RECOMMENDATIONS 25
USPSTF BREAST CANCER SCREENING GUIDELINES 26
TABLE 9 BREAST CANCER SCREENING RECOMMENDATIONS BY THE USPSTF 26
CHAPTER 4 BIOMARKERS AND DEVELOPMENT OF CANCER DIAGNOSTICS 29
BIOMARKERS AND CANCER 29
BIOMARKERS AND BREAST CANCER 29
TABLE 10 BREAST CANCER PROGNOSTIC FACTORS 30
TABLE 11 BREAST CANCER PREDICTIVE FACTORS 30
TABLE 12 RECURRENCE RATES AT FIVE YEARS IN PATIENTS WITH LYMPH NODES THAT
ARE POSITIVE FOR CANCER (%) 31
TABLE 13 FIVE-YEAR SURVIVAL RATES CORRELATED WITH TUMOR STAGE (%) 31
HER2 31
COMPANION DIAGNOSTICS 32
TARGETED THERAPIES 32
PREDICTIVE DIAGNOSTICS 32
TABLE 14 PREDICTIVE DIAGNOSTIC FEATURES 32
PREDICTIVE SAFETY BIOMARKERS 33
COMMERCIALIZED BIOMARKER TESTS 33
TABLE 15 CURRENT BIOMARKER TECHNOLOGIES 34
TABLE 16 BIOMARKER USES 35
BIOMARKERS AND DRUG THERAPY 35
INCREASED USE OF BIOMARKERS IN DRUG DEVELOPMENT AND CLINICAL TRIALS 36
OBSTACLES TO BIOMARKER DEVELOPMENT 36
TABLE 17 MAJOR ISSUES AND CHALLENGES 36
BIOMARKERS TYPES 37
PREDICTIVE BIOMARKERS 37
TUMOR INTERSTITIAL FLUID BIOMARKERS 37
PHARMACOGENOMIC BIOMARKERS IN DRUG LABELS 38
BENEFITS OF PHARMACOGENOMICS 38
TABLE 18 PHARMACOGENOMICS TESTS IN USE 39
BARRIERS TO PHARMACOGENOMICS PROGRESS 39
BIOMARKERS IN DRUG LABELS 39
CLASSIFICATION OF BIOMARKERS 40
TABLE 19 BIOMARKERS FOR DRUG LABELS BASED ON SPECIFIC USE 40
TABLE 20 CANCER BIOMARKERS FOR FDA-MANDATED TESTING PRIOR TO DRUG USE 40
TABLE 21 CLINICALLY RELEVANT BIOMARKERS 40
FDA GUIDANCE 41
TABLE 22 APPROVED COMPANION DIAGNOSTICS, 2011 41
COMPANION DIAGNOSTICS AND SEVERAL REGULATORY ISSUES 43
TABLE 23 REGULATORY APPROVAL OF THE DIAGNOSTICS PATHWAY 44
FDA ROUTE 44
CLIA-BASED (LABORATORY-DEVELOPED TESTS) ROUTE 44
CHOOSING A REGULATORY PATHWAY 45
A CO-DEVELOPMENT PATH 45
ISSUES AND BARRIERS TO DEVELOPMENT 46
DRUG APPROVAL IN 2011 46
TABLE 24 APPROVED CANCER DRUGS, 2011 47
POST-LAUNCH EXPECTATIONS 47
DAKO’S EGFR IMMUNOHISTOCHEMISTRY ASSAY 47
ROLE OF REIMBURSEMENT BODIES 48
CONSIDERATIONS FOR NEW DRUG-DIAGNOSTIC PARTNERSHIPS 48
TABLE 25 FACTORS INFLUENCING THE CHOICE OF A DIAGNOSTICS PARTNER 48
HERCEPTEST AND TRASTUZUMAB (HERCEPTIN) 48
NEXT STEPS 49
CHAPTER 5 BREAST CANCER 51
SYNOPSIS 51
TABLE 26 SURVEILLANCE, EPIDEMIOLOGY AND END RESULTS SUMMARY STAGE SYSTEM
FOR BREAST CANCER 52
CLASSIFICATION OF BREAST CANCER 52
TABLE 27 MAIN TYPES OF BREAST CANCER 52
LUMINAL A AND LUMINAL B TYPES 53
HER2 TYPE 53
BASAL TYPE 53
TRIPLE-NEGATIVE BREAST CANCER TREATMENTS IN THE PIPELINE 54
CAUSES, INCIDENCE AND RISK FACTORS 54
SYMPTOMS 55
TABLE 28 BREAST CANCER EVALUATION TESTS 55
BREAST CANCER CAUSES 56
PATHOPHYSIOLOGY 56
TREATMENT 56
TABLE 29 TREATMENT PLAN 56
TABLE 30 HORMONE THERAPY 57
CANCER TREATMENT: LOCAL OR SYSTEMIC 57
TABLE 31 CANCER STAGES 57
PROGNOSIS AFTER TREATMENT 58
TABLE 32 RISK FACTORS OF RECURRENCE AFTER SUCCESSFUL TREATMENT FOR BREAST
CANCER 58
BREAST CANCER TREATMENT GUIDELINES 58
PREVENTION 59
TABLE 33 BREAST CANCER PREVENTION MEASURES 59
TABLE 34 AMERICAN CANCER SOCIETY’S DIETARY GUIDELINES FOR CANCER PREVENTION 59
CHAPTER 6 BREAST CANCER PREVALENCE AND INCIDENCE RATES 61
CANCER INCIDENCE ACROSS THE GLOBE 61
BREAST CANCER GLOBALLY 61
GLOBAL BREAST CANCER STATISTICS 62
TABLE 35 BREAST CANCER INCIDENCE AND MORTALITY GLOBALLY, 2008 (THOUSANDS) 63
FIGURE 1 GLOBAL BREAST CANCER INCIDENCE AND MORTALITY, 2008 (THOUSANDS) 63
GEOGRAPHIC VARIATION IN BREAST CANCER RATES 64
TABLE 36 ESTIMATED GLOBAL INCIDENCE OF BREAST CANCER, 2010-2016 65
FIGURE 2 ESTIMATED GLOBAL INCIDENCE OF BREAST CANCER, 2010-2016 65
TABLE 37 NEW BREAST CANCER CASES BY GEOGRAPHIC REGION, 2009 (THOUSANDS/%) 66
HIGHEST INCIDENCE RATES GLOBALLY 67
TABLE 38 EFFECTIVE EDUCATION AND SCREENING ADVANTAGES IN THE U.K. AND THE
U.S. (CASES PER DAY) 67
EUROPE 68
U.K. 68
TABLE 39 CRUDE AND EUROPEAN AGE-STANDARDIZED BREAST CANCER INCIDENCE
RATES PER 100,000 POPULATIONS IN THE U.K., 2008 68
TABLE 40 U.K. ESTIMATED INCIDENCE OF BREAST CANCER, 2010-2016 (THOUSANDS) 68
FIGURE 3 U.K. ESTIMATED INCIDENCE OF BREAST CANCER, 2010-2016 (THOUSANDS) 68
GERMANY 69
TABLE 41 GERMAN ESTIMATED INCIDENCE OF BREAST CANCER AND PROJECTIONS,
2010-2016 (THOUSANDS) 69
FIGURE 4 GERMAN ESTIMATED INCIDENCE OF BREAST CANCER, 2010-2016 (THOUSANDS) 70
ASIA 70
CHINA 70
TABLE 42 CHINESE ESTIMATED INCIDENCE OF BREAST CANCER, 2008-2016 (THOUSANDS) 71
FIGURE 5 CHINESE ESTIMATED INCIDENCE OF BREAST CANCER, 2010-2016 (THOUSANDS) 71
INDIA 71
TABLE 43 INDIA ESTIMATED INCIDENCE OF BREAST CANCER, 2008-2016 (THOUSANDS) 72
FIGURE 6 INDIA ESTIMATED INCIDENCE OF BREAST CANCER, 2010-2016 (THOUSANDS) 72
JAPAN 73
TABLE 44 JAPAN ESTIMATED INCIDENCE OF BREAST CANCER, 2010 (THOUSANDS) 73
DEVELOPING COUNTRIES 73
TABLE 45 FIVE-YEAR SURVIVAL FOR BREAST CANCER (%) 74
TABLE 46 BREAST CANCER FIVE-YEAR SURVIVAL BY CANCER STAGE (%) 75
LOW-INCOME COUNTRIES 75
MIDDLE-INCOME COUNTRIES 75
U.S. 76
U.S. BREAST CANCER INCIDENCE, 2011 77
TABLE 47 U.S. ESTIMATED INCIDENCE OF BREAST CANCER, 2010-2016 (THOUSANDS) 77
FIGURE 7 U.S. ESTIMATED INCIDENCE OF BREAST CANCER, 2010-2016 (THOUSANDS) 77
HISTORICAL DATA 78
TABLE 48 U.S. ESTIMATED NEW FEMALE BREAST CANCER CASES AND DEATHS BY AGE,
2011 (THOUSANDS) 78
2010 BREAST CANCER ESTIMATES 79
TABLE 49 U.S. ESTIMATED INCIDENCE OF BREAST CANCER, 2012 (THOUSANDS) 79
MEN 79
TABLE 50 COMPARISON OF BREAST CANCER INCIDENCE AND DEATH IN MEN AND
WOMEN, 2012 79
TABLE 51 ESTIMATED BREAST CANCER INCIDENCE, 2004-2008, AND MORTALITY,
2003-2007 (THOUSANDS) 81
TABLE 52 BREAST CANCER ESTIMATES IN ASIAN WOMEN, INCIDENCE, 2004-2008, AND
MORTALITY, 2003-2007 (PER 100,000) 81
TABLE 53 ESTIMATED BREAST CANCER INCIDENCE IN HISPANIC AND LATINA WOMEN,
2004-2008, AND MORTALITY, 2003-2007 (PER 100,000) 82
AGE AND BREAST CANCER 82
TABLE 54 BREAST CANCER RISK WITH AGE 83
BREAST CANCER AND RACE IN THE U.S. 83
TABLE 55 U.S. RATES, TRENDS AND CAUSE-SPECIFIC SURVIVAL FOR FEMALE BREAST
CANCER PATIENTS BY RACE OR ETHNICITY, 2001-2007 83
IN SITU BREAST CANCER 84
INVASIVE BREAST CANCER 84
INITIATIVE RANDOMIZED TRIAL RESULTS 85
INCIDENCE TRENDS BY RACE AND TUMOR SIZE 85
INCIDENCE AND MORTALITY TRENDS FOR MALE BREAST CANCER 85
FACTORS INFLUENCING BREAST CANCER SURVIVAL 86
TABLE 56 RELATIVE CANCER SURVIVAL IN WOMEN 86
OBESITY, PHYSICAL ACTIVITY AND DIET 86
TUMOR CHARACTERISTICS 86
AGE AT DIAGNOSIS 87
FAMILY HISTORY OF BREAST CANCER AND GENETIC PREDISPOSITION 87
HISTORICAL FACTS 88
CANADA 89
ESTIMATED NUMBER OF NEW CASES 89
TABLE 57 CANADA ESTIMATED NUMBER OF NEW BREAST CANCER CASES IN FEMALES BY
AGE, 2010 (THOUSANDS) 89
AUSTRALIA 90
TABLE 58 AUSTRALIA PROJECTED NEW CASES OF BREAST CANCER, 2011-2021 90
CHAPTER 7 BREAST CANCER DRUGS AND MARKET TRENDS 92
CLINICAL DIAGNOSIS AND MANAGEMENT 92
TABLE 59 APPROVED ONCOLOGY DRUGS, 2012 92
TABLE 60 APPROVED ONCOLOGY DRUGS, 2011 93
TABLE 61 APPROVED ONCOLOGY DRUGS, 2010 93
CANCER DRUGS AND MARKET TRENDS 94
INNOVATIONS IN THE BREAST CANCER THERAPEUTIC MARKET 94
BREAST CANCER AND DRUGS 94
EMERGING DIAGNOSTICS FOR CANCER DRUGS 95
TRIPLE NEGATIVE BREAST CANCER 96
POLY ADP RIBOSE POLYMERASE INHIBITORS 96
DRUGS APPROVED FOR BREAST CANCER 96
TABLE 62 DRUGS APPROVED FOR BREAST CANCER 97
MEDICINES FOR TREATING BREAST CANCER 98
HORMONE THERAPY 98
TABLE 63 HORMONE THERAPY FOR BREAST CANCER 98
TABLE 64 AROMATASE INHIBITORS FOR TREATING BREAST CANCER 99
CHEMOTHERAPY 99
TABLE 65 CHEMOTHERAPY DRUGS FOR TREATING BREAST CANCER 99
TABLE 66 COMMONLY USED COMBINATIONS 99
MEDICINES TO CONTROL NAUSEA AND VOMITING 100
TABLE 67 MEDICINES TO CONTROL AND PREVENT NAUSEA AND VOMITING 100
TARGETED CANCER DRUG MARKET 100
TABLE 68 MARKET FOR TARGETED CANCER DRUGS, 2008 AND 2016 ($ MILLIONS) 100
TARGETED THERAPIES FOR BREAST CANCER 100
TRASTUZUMAB (HERCEPTIN) 101
PERTUZUMAB 101
LAPATINIB 101
TABLE 69 TARGETED THERAPUETICS FOR BREAST CANCER 102
TREATMENTS FOR BREAST CANCER WITH LOW HER2 EXPRESSION 102
GLOBAL PHARMACEUTICAL MARKET 102
TABLE 70 GLOBAL PHARMACEUTICAL SALES, THROUGH 2016 ($ MILLIONS) 103
FIGURE 8 GLOBAL PHARMACEUTICAL SALES, 2010-2016 ($ MILLIONS) 103
CURRENT BREAST CANCER MARKET TRENDS 104
BREAST CANCER MARKET 105
TABLE 71 BREAST CANCER THERAPY SALES, THROUGH 2016 ($ MILLIONS) 106
FIGURE 9 BREAST CANCER THERAPY SALES, 2010-2016 ($ MILLIONS) 106
TABLE 72 BREAST CANCER DRUG MARKET, 2010 AND 2016 ($ MILLIONS) 106
FIGURE 10 BREAST CANCER DRUG MARKET, 2010 AND 2016 ($ MILLIONS) 107
TABLE 73 AROMATASE INHIBITORS MARKET, 2010 AND 2016 ($ MILLIONS) 107
TARGETED THERAPIES 107
TABLE 74 BREAST CANCER TARGETED THERAPIES, 2010 AND 2011 ($ MILLIONS) 108
TABLE 75 ROCHE SALES COMPARED TO THE GLOBAL MARKET, 2010 ($ MILLIONS/%) 108
TABLE 76 XELODA SALES, 2010 AND 2011 ($ MILLIONS) 109
TABLE 77 ROCHE-SALES VERSUS THE GLOBAL MARKET, 2011 ($ MILLIONS/%) 110
NEW MEDICINES FOR BREAST CANCER 110
TABLE 78 EXPECTED SALES FOR PERTUZUMAB, 2016 ($ MILLIONS) 111
AUSTRALIA 111
TABLE 79 CANCER THERAPY SALES, 2008 AND 2018 ($ MILLIONS) 112
TABLE 80 AUSTRALIA TARGETED CANCER THERAPY SALES, 2008 AND 2018 ($ MILLIONS) 112
BREAST CANCER DRUGS AND INDIA 112
CHINA 113
EUROPE 113
CONCLUSIONS 113
CHAPTER 8 BREAST CANCER PREDICTIVE DIAGNOSTICS MARKET 115
CANCER COSTS PROJECTED TO REACH AT LEAST $158 BILLION IN 2020 115
CANCER DRUG MARKET 115
TABLE 81 ANTINEOPLASTIC MABS MARKET, 2008 AND 2014 ($ MILLIONS) 116
U.S. PERSONALIZED MEDICINE MARKET SIZE 116
TABLE 82 U.S. PERSONALIZED MEDICINE MARKET, THROUGH 2016 ($ MILLIONS) 117
FIGURE 11 U.S. PERSONALIZED MEDICINE MARKET, 2010-2016 ($ MILLIONS) 117
TABLE 83 U.S. PERSONALIZED MEDICINE DIAGNOSTIC TESTS AND TARGETED THERAPIES
MARKET, THROUGH 2016 ($ MILLIONS) 118
FIGURE 12 U.S. PERSONALIZED MEDICINE DIAGNOSTIC TESTS AND TARGETED THERAPIES
MARKET, 2010-2016 ($ MILLIONS) 118
PERSONALIZED MEDICINE AND ISSUES 118
FACTORS INFLUENCING THE MARKET GROWTH AND INDUSTRY SPECIFIC
CHALLENGES 119
TABLE 84 GLOBAL MOLECULAR DIAGNOSTICS MARKET, THROUGH 2016 ($MILLIONS) 119
U.S. MOLECULAR-BASED CANCER TISSUE DIAGNOSTICS 119
IN VITRO DIAGNOSTICS 120
MAJOR MARKET DRIVERS AND RESTRAINTS 121
TABLE 85 GLOBAL IVD MARKET, THROUGH 2016 ($MILLIONS) 121
BREAST CANCER DRUG MARKET 121
BREAST CANCER TESTING MARKET 121
NEXT-GENERATION CANCER DIAGNOSTICS 122
TABLE 86 NEXT-GENERATION CANCER DIAGNOSTIC PRODUCTS BY TYPE, THROUGH 2016
($ MILLIONS) 122
FIGURE 13 NEXT-GENERATION CANCER DIAGNOSTIC PRODUCTS BY TYPE, 2010-2016 ($
MILLIONS) 122
GLOBAL MARKET AND TRENDS 123
TABLE 87 ESTIMATED GLOBAL INCIDENCE OF BREAST CANCER, 2010-2016 ($ THOUSANDS) 123
TABLE 88 GLOBAL INCIDENCE OF ESTROGEN RECEPTOR POSITIVE BREAST CANCER CASES,
2010-2016 ($ THOUSANDS) 124
GLOBAL MAMMOGRAPHY EQUIPMENT MARKET 125
BREAST BIOPSY MARKET 126
MOLECULAR DIAGNOSTICS 127
COMPANION DIAGNOSTICS 127
PREDICTIVE TECHNOLOGY AND BREST CANCER MARKET TRENDS 127
TABLE 89 PREDICTIVE TECHNOLOGY 128
RELEVANT TESTS FOR BREAST CANCER PROGNOSIS 128
HER2 128
GENE EXPRESSION PROFILING TESTS 128
IHC4 TEST 129
TABLE 90 BREAST CANCER DIAGNOSTIC TEST COSTS 130
TABLE 91 GLOBAL MARKET FOR PREDICTIVE BREAST CANCER DIAGNOSTIC
TECHNOLOGIES, THROUGH 2016 ($ MILLIONS) 131
FIGURE 14 GLOBAL MARKET FOR PREDICTIVE BREAST CANCER DIAGNOSTIC
TECHNOLOGIES, 2010-2016 ($ MILLIONS) 131
IHC AND FISH-BASED TESTS AND MARKET 131
TABLE 92 IHC AND FISH-BASED BREAST CANCER TESTING SALES, THROUGH 2016 ($
MILLIONS) 132
FIGURE 15 IHC AND FISH-BASED BREAST CANCER TESTING SALES, 2010-2012 ($ MILLIONS) 132
TISSUE-BASED IMMUNOHISTOCHEMISTRY MARKET 133
TABLE 93 FDA-APPROVED COMMERCIAL KITS 133
HERCEP TEST KITS 134
TABLE 94 FDA-APPROVED FISH ANALYSIS TESTS 135
KEY COMPANYIES 136
ROCHE 136
TABLE 95 ROCHE SALES BY DIVISION, 2010 ($ MILLIONS) 137
TABLE 96 ROCHE COMPANION DIAGNOSTICS CURRENTLY ON THE MARKET OR IN LATE
DEVELOPMENT FOR BREAST CANCER 137
DAKO 138
GENOMIC ASSAYS 138
TABLE 97 GENOMIC MARKET LEADERS 138
TABLE 98 GENOMIC TESTING MARKET FOR BREAST CANCER, THROUGH 2016 ($ MILLIONS) 139
FIGURE 16 GENOMIC TESTING MARKET FOR BREAST CANCER, 2010-2016 ($ MILLIONS) 139
GENOMIC HEALTH BUSINESS PROGRESS 140
TABLE 99 ONCOTYPE DX SALES, THROUGH 2016 ($ MILLIONS) 140
MAMMAPRINT ASSAY 140
QUANTITATIVE FLUORESCENCE-BASED TESTS 141
TABLE 100 QUANTITATIVE FLUORESCENCE DIAGNOSTIC TESTING MARKET FOR BREAST
CANCER, THROUGH 2016 ($ MILLIONS) 142
FIGURE 17 QUANTITATIVE FLUORESCENCE DIAGNOSTIC TESTING MARKET FOR BREAST
CANCER, 2010-2016 ($ MILLIONS) 142
CONCLUSIONS 144
CHAPTER 9 COMPANY PROFILES 146
ABBOTT LABORATORIES 146
AETERNA ZENTARIS 147
AGENDIA 147
U.S. 147
ALTHEADX 148
AMBERGEN INC. 149
ASTRAZENECA PLC 149
ATOSSA GENETICS INC. 149
BIOTIME 150
CCC DIAGNOSTICS LLC 150
CLARINET 151
DAKO 152
DAKO NORTH AMERICA 152
EISAI INC. (HEADQUARTERS) 152
EUTROPICS PHARMACEUTICALS 153
FLUXION BIOSCIENCES 153
GENENTECH 153
GENOMIC HEALTH 154
GLAXOSMITHKLINE 154
LIFE TECHNOLOGIES 154
MDXHEALTH 155
MERCK AND COMPANY INC. 155
MYRIAD GENETICS 155
NANOSTRING TECHNOLOGIES 156
NEKTAR 156
PFIZER 156
PHIGENIX 157
RUBICON GENOMICS 157
SANOFI US 157
VENTANA MEDICAL SYSTEMS INC. 157
CHAPTER 10 DEVELOPMENTS AND COLLABORATIONS 160
CURRENT DEVELOPMENTS AND FUTURE 160
COMMERCIAL OPPORTUNITIES FOR CANCER BIOMARKER BASED DIAGNOSTIC
TESTS 160
TABLE 101 RESULTS OF A SURVEY BY MEDCO AND THE AMERICAN MEDICAL ASSOCIATION,
2009 160
BREAST CANCER DRUGS AND PATENT EXPIRY: ROCHE PROTECTS
BREAST-CANCER DRUG HERCEPTIN 161
RECENT BREAST CANCER TEST APPROVALS 161
FDA-APPROVED USE OF BREAST CANCER ASSAY ON BENCHMARK ULTRA 161
BREAST CANCER TESTS 162
ONCOTYPE DX 162
RECENT DEVELOPMENTS 163
BIOTIME: DEVELOPMENT OF THE NOVEL PAN-CANCER DIAGNOSTIC PRODUCT
PANC-DX 163
RUBICON GENOMICS AND AGENDIA PARTNER FOR DEVELOPMENT OF BREAST
CANCER DIAGNOSTICS 164
ABBOTT AND MERCK PARTNER TO EVALUATE USE OF FISH-BASED
COMPANION DIAGNOSTICS 164
ALTHEADX PARTNERING WITH COMPENDIA BIOSCIENCE 164
GE MAKES INVESTMENT IN NANOSTRING TECHNOLOGIES 165
AETERNA ZENTARIS TAPS VENTANA FOR COMPANION DIAGNOSTIC 165
MDXHEALTH CLOSES AGREEMENT WITH PFIZER TO IDENTIFY A PREDICTIVE
BIOMARKER FOR PARP INHIBITOR THERAPIES 166
FDA GRANTS ROCHE’S PERTUZUMAB PRIORITY REVIEW 166
ALLIANCES 167
BREAST CANCER DRUG AND DIAGNOSTIC PATENT LANDSCAPE 167
BREAST CANCER DRUGS AND PATENT EXPIRY 167
BREAST CANCER PREDICTIVE DIAGNOSTIC PATENTS 167
RECENT PATENT-RELATED ACTIVITY 168
“WHO OWNS PATIENTS’ GENES?” AND PATENT ISSUES 168
MYRIAD GENE PATENT RULING 168
NEW BREAST CANCER PATENT AWARDED TO PHIGENIX 169
GALENA BIOPHARMA STRENGTHENS NEUVAX INTELLECTUAL PROPERTY
POSITION 169
CONCLUSIONS 170
CHAPTER 11 REFERENCES 172

LIST OF TABLES
SUMMARY TABLE GLOBAL MARKET FOR PREDICTIVE BREAST CANCER DIAGNOSTIC AND
DRUG TECHNOLOGIES, THROUGH 2016 ($ MILLIONS) 6
TABLE 1 POSSIBLE SIGNS OF BREAST CANCER 10
TABLE 2 DIAGNOSTIC MAMMOGRAM FOR BREAST CANCER 11
TABLE 3 BREAST CANCER GRADES 15
TABLE 4 BIOPSY OR SURGERY SAMPLE TESTING 16
TABLE 5 TESTS USED TO EVALUATE DIFFERENT GENE SETS 17
TABLE 6 IMAGING TESTS THAT DETERMINE IF BREAST CANCER HAS SPREAD 18
TABLE 7 HER2 TESTING AND VARIATIONS 19
TABLE 8 GUIDELINES FOR EARLY DETECTION OF BREAST CANCER IN AVERAGE RISK,
ASYMPTOMATIC WOMEN 25
TABLE 9 BREAST CANCER SCREENING RECOMMENDATIONS BY THE USPSTF 26
TABLE 10 BREAST CANCER PROGNOSTIC FACTORS 30
TABLE 11 BREAST CANCER PREDICTIVE FACTORS 30
TABLE 12 RECURRENCE RATES AT FIVE YEARS IN PATIENTS WITH LYMPH NODES THAT ARE
POSITIVE FOR CANCER (%) 31
TABLE 13 FIVE-YEAR SURVIVAL RATES CORRELATED WITH TUMOR STAGE (%) 31
TABLE 14 PREDICTIVE DIAGNOSTIC FEATURES 32
TABLE 15 CURRENT BIOMARKER TECHNOLOGIES 34
TABLE 16 BIOMARKER USES 35
TABLE 17 MAJOR ISSUES AND CHALLENGES 36
TABLE 18 PHARMACOGENOMICS TESTS IN USE 39
TABLE 19 BIOMARKERS FOR DRUG LABELS BASED ON SPECIFIC USE 40
TABLE 20 CANCER BIOMARKERS FOR FDA-MANDATED TESTING PRIOR TO DRUG USE 40
TABLE 21 CLINICALLY RELEVANT BIOMARKERS 40
TABLE 22 APPROVED COMPANION DIAGNOSTICS, 2011 41
TABLE 23 REGULATORY APPROVAL OF THE DIAGNOSTICS PATHWAY 44
TABLE 24 APPROVED CANCER DRUGS, 2011 47
TABLE 25 FACTORS INFLUENCING THE CHOICE OF A DIAGNOSTICS PARTNER 48
TABLE 26 SURVEILLANCE, EPIDEMIOLOGY AND END RESULTS SUMMARY STAGE SYSTEM
FOR BREAST CANCER 52
TABLE 27 MAIN TYPES OF BREAST CANCER 52
TABLE 28 BREAST CANCER EVALUATION TESTS 55
TABLE 29 TREATMENT PLAN 56
TABLE 30 HORMONE THERAPY 57
TABLE 31 CANCER STAGES 57
TABLE 32 RISK FACTORS OF RECURRENCE AFTER SUCCESSFUL TREATMENT FOR BREAST
CANCER 58
TABLE 33 BREAST CANCER PREVENTION MEASURES 59
TABLE 34 AMERICAN CANCER SOCIETY’S DIETARY GUIDELINES FOR CANCER PREVENTION 59
TABLE 35 BREAST CANCER INCIDENCE AND MORTALITY GLOBALLY, 2008 (THOUSANDS) 63
TABLE 36 ESTIMATED GLOBAL INCIDENCE OF BREAST CANCER, 2010-2016 65
TABLE 37 NEW BREAST CANCER CASES BY GEOGRAPHIC REGION, 2009 (THOUSANDS/%) 66
TABLE 38 EFFECTIVE EDUCATION AND SCREENING ADVANTAGES IN THE U.K. AND THE U.S.
(CASES PER DAY) 67
TABLE 39 CRUDE AND EUROPEAN AGE-STANDARDIZED BREAST CANCER INCIDENCE RATES
PER 100,000 POPULATIONS IN THE U.K., 2008 68
TABLE 40 U.K. ESTIMATED INCIDENCE OF BREAST CANCER, 2010-2016 (THOUSANDS) 68
TABLE 41 GERMAN ESTIMATED INCIDENCE OF BREAST CANCER AND PROJECTIONS,
2010-2016 (THOUSANDS) 69
TABLE 42 CHINESE ESTIMATED INCIDENCE OF BREAST CANCER, 2008-2016 (THOUSANDS) 71
TABLE 43 INDIA ESTIMATED INCIDENCE OF BREAST CANCER, 2008-2016 (THOUSANDS) 72
TABLE 44 JAPAN ESTIMATED INCIDENCE OF BREAST CANCER, 2010 (THOUSANDS) 73
TABLE 45 FIVE-YEAR SURVIVAL FOR BREAST CANCER (%) 74
TABLE 46 BREAST CANCER FIVE-YEAR SURVIVAL BY CANCER STAGE (%) 75
TABLE 47 U.S. ESTIMATED INCIDENCE OF BREAST CANCER, 2010-2016 (THOUSANDS) 77
TABLE 48 U.S. ESTIMATED NEW FEMALE BREAST CANCER CASES AND DEATHS BY AGE,
2011 (THOUSANDS) 78
TABLE 49 U.S. ESTIMATED INCIDENCE OF BREAST CANCER, 2012 (THOUSANDS) 79
TABLE 50 COMPARISON OF BREAST CANCER INCIDENCE AND DEATH IN MEN AND WOMEN,
2012 79
TABLE 51 ESTIMATED BREAST CANCER INCIDENCE, 2004-2008, AND MORTALITY, 2003-2007
(THOUSANDS) 81
TABLE 52 BREAST CANCER ESTIMATES IN ASIAN WOMEN, INCIDENCE, 2004-2008, AND
MORTALITY, 2003-2007 (PER 100,000) 81
TABLE 53 ESTIMATED BREAST CANCER INCIDENCE IN HISPANIC AND LATINA WOMEN,
2004-2008, AND MORTALITY, 2003-2007 (PER 100,000) 82
TABLE 54 BREAST CANCER RISK WITH AGE 83
TABLE 55 U.S. RATES, TRENDS AND CAUSE-SPECIFIC SURVIVAL FOR FEMALE BREAST
CANCER PATIENTS BY RACE OR ETHNICITY, 2001-2007 83
TABLE 56 RELATIVE CANCER SURVIVAL IN WOMEN 86
TABLE 57 CANADA ESTIMATED NUMBER OF NEW BREAST CANCER CASES IN FEMALES BY
AGE, 2010 (THOUSANDS) 89
TABLE 58 AUSTRALIA PROJECTED NEW CASES OF BREAST CANCER, 2011-2021 90
TABLE 59 APPROVED ONCOLOGY DRUGS, 2012 92
TABLE 60 APPROVED ONCOLOGY DRUGS, 2011 93
TABLE 61 APPROVED ONCOLOGY DRUGS, 2010 93
TABLE 62 DRUGS APPROVED FOR BREAST CANCER 97
TABLE 63 HORMONE THERAPY FOR BREAST CANCER 98
TABLE 64 AROMATASE INHIBITORS FOR TREATING BREAST CANCER 99
TABLE 65 CHEMOTHERAPY DRUGS FOR TREATING BREAST CANCER 99
TABLE 66 COMMONLY USED COMBINATIONS 99
TABLE 67 MEDICINES TO CONTROL AND PREVENT NAUSEA AND VOMITING 100
TABLE 68 MARKET FOR TARGETED CANCER DRUGS, 2008 AND 2016 ($ MILLIONS) 100
TABLE 69 TARGETED THERAPUETICS FOR BREAST CANCER 102
TABLE 70 GLOBAL PHARMACEUTICAL SALES, THROUGH 2016 ($ MILLIONS) 103
TABLE 71 BREAST CANCER THERAPY SALES, THROUGH 2016 ($ MILLIONS) 106
TABLE 72 BREAST CANCER DRUG MARKET, 2010 AND 2016 ($ MILLIONS) 106
TABLE 73 AROMATASE INHIBITORS MARKET, 2010 AND 2016 ($ MILLIONS) 107
TABLE 74 BREAST CANCER TARGETED THERAPIES, 2010 AND 2011 ($ MILLIONS) 108
TABLE 75 ROCHE SALES COMPARED TO THE GLOBAL MARKET, 2010 ($ MILLIONS/%) 108
TABLE 76 XELODA SALES, 2010 AND 2011 ($ MILLIONS) 109
TABLE 77 ROCHE-SALES VERSUS THE GLOBAL MARKET, 2011 ($ MILLIONS/%) 110
TABLE 78 EXPECTED SALES FOR PERTUZUMAB, 2016 ($ MILLIONS) 111
TABLE 79 CANCER THERAPY SALES, 2008 AND 2018 ($ MILLIONS) 112
TABLE 80 AUSTRALIA TARGETED CANCER THERAPY SALES, 2008 AND 2018 ($ MILLIONS) 112
TABLE 81 ANTINEOPLASTIC MABS MARKET, 2008 AND 2014 ($ MILLIONS) 116
TABLE 82 U.S. PERSONALIZED MEDICINE MARKET, THROUGH 2016 ($ MILLIONS) 117
TABLE 83 U.S. PERSONALIZED MEDICINE DIAGNOSTIC TESTS AND TARGETED THERAPIES
MARKET, THROUGH 2016 ($ MILLIONS) 118
TABLE 84 GLOBAL MOLECULAR DIAGNOSTICS MARKET, THROUGH 2016 ($MILLIONS) 119
TABLE 85 GLOBAL IVD MARKET, THROUGH 2016 ($MILLIONS) 121
TABLE 86 NEXT-GENERATION CANCER DIAGNOSTIC PRODUCTS BY TYPE, THROUGH 2016 ($
MILLIONS) 122
TABLE 87 ESTIMATED GLOBAL INCIDENCE OF BREAST CANCER, 2010-2016 ($ THOUSANDS) 123
TABLE 88 GLOBAL INCIDENCE OF ESTROGEN RECEPTOR POSITIVE BREAST CANCER CASES,
2010-2016 ($ THOUSANDS) 124
TABLE 89 PREDICTIVE TECHNOLOGY 128
TABLE 90 BREAST CANCER DIAGNOSTIC TEST COSTS 130
TABLE 91 GLOBAL MARKET FOR PREDICTIVE BREAST CANCER DIAGNOSTIC TECHNOLOGIES,
THROUGH 2016 ($ MILLIONS) 131
TABLE 92 IHC AND FISH-BASED BREAST CANCER TESTING SALES, THROUGH 2016 ($
MILLIONS) 132
TABLE 93 FDA-APPROVED COMMERCIAL KITS 133
TABLE 94 FDA-APPROVED FISH ANALYSIS TESTS 135
TABLE 95 ROCHE SALES BY DIVISION, 2010 ($ MILLIONS) 137
TABLE 96 ROCHE COMPANION DIAGNOSTICS CURRENTLY ON THE MARKET OR IN LATE
DEVELOPMENT FOR BREAST CANCER 137
TABLE 97 GENOMIC MARKET LEADERS 138
TABLE 98 GENOMIC TESTING MARKET FOR BREAST CANCER, THROUGH 2016 ($ MILLIONS) 139
TABLE 99 ONCOTYPE DX SALES, THROUGH 2016 ($ MILLIONS) 140
TABLE 100 QUANTITATIVE FLUORESCENCE DIAGNOSTIC TESTING MARKET FOR BREAST
CANCER, THROUGH 2016 ($ MILLIONS) 142
TABLE 101 RESULTS OF A SURVEY BY MEDCO AND THE AMERICAN MEDICAL ASSOCIATION,
2009 160

LIST OF FIGURES
SUMMARY FIGURE GLOBAL MARKET FOR PREDICTIVE BREAST CANCER DIAGNOSTIC AND
DRUG TECHNOLOGIES, 2010-2016 ($ MILLIONS) 6
FIGURE 1 GLOBAL BREAST CANCER INCIDENCE AND MORTALITY, 2008 (THOUSANDS) 63
FIGURE 2 ESTIMATED GLOBAL INCIDENCE OF BREAST CANCER, 2010-2016 65
FIGURE 3 U.K. ESTIMATED INCIDENCE OF BREAST CANCER, 2010-2016 (THOUSANDS) 68
FIGURE 4 GERMAN ESTIMATED INCIDENCE OF BREAST CANCER, 2010-2016 (THOUSANDS) 70
FIGURE 5 CHINESE ESTIMATED INCIDENCE OF BREAST CANCER, 2010-2016 (THOUSANDS) 71
FIGURE 6 INDIA ESTIMATED INCIDENCE OF BREAST CANCER, 2010-2016 (THOUSANDS) 72
FIGURE 7 U.S. ESTIMATED INCIDENCE OF BREAST CANCER, 2010-2016 (THOUSANDS) 77
FIGURE 8 GLOBAL PHARMACEUTICAL SALES, 2010-2016 ($ MILLIONS) 103
FIGURE 9 BREAST CANCER THERAPY SALES, 2010-2016 ($ MILLIONS) 106
FIGURE 10 BREAST CANCER DRUG MARKET, 2010 AND 2016 ($ MILLIONS) 107
FIGURE 11 U.S. PERSONALIZED MEDICINE MARKET, 2010-2016 ($ MILLIONS) 117
FIGURE 12 U.S. PERSONALIZED MEDICINE DIAGNOSTIC TESTS AND TARGETED THERAPIES
MARKET, 2010-2016 ($ MILLIONS) 118
FIGURE 13 NEXT-GENERATION CANCER DIAGNOSTIC PRODUCTS BY TYPE, 2010-2016 ($
MILLIONS) 122
FIGURE 14 GLOBAL MARKET FOR PREDICTIVE BREAST CANCER DIAGNOSTIC
TECHNOLOGIES, 2010-2016 ($ MILLIONS) 131
FIGURE 15 IHC AND FISH-BASED BREAST CANCER TESTING SALES, 2010-2012 ($ MILLIONS) 132
FIGURE 16 GENOMIC TESTING MARKET FOR BREAST CANCER, 2010-2016 ($ MILLIONS) 139
FIGURE 17 QUANTITATIVE FLUORESCENCE DIAGNOSTIC TESTING MARKET FOR BREAST
CANCER, 2010-2016 ($ MILLIONS) 142

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