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Breast Cancer Diagnostic and Drug Technologies: Global Markets
Date:8/28/2012

NEW YORK, Aug. 28, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

 

Breast Cancer Diagnostic and Drug Technologies: Global Markets

http://www.reportlinker.com/p0919332/Breast-Cancer-Diagnostic-and-Drug-Technologies-Global-Markets.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology

 

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

 

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 THERAPEUTICS 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 COMPANIES 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 THERAPEUTICS 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

 

 

 

To order this report:

Pathology Industry: Breast Cancer Diagnostic and Drug Technologies: Global Markets

 

 

More Market Research Report

 

 

 

Check our Industry Analysis and Insights

 

 

Nicolas Bombourg
Reportlinker
Email: nicolasbombourg@reportlinker.com
US: (805)652-2626
Intl: +1 805-652-2626

 

 


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