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  4. > Central Nervous System (CNS) Biomarkers: Technologies and Global Markets

The BCC Research report provides a comprehensive analysis of CNS biomarkers on a global basis. Its aim is to provide a range of information, from detailed product analyses within disease sub segments to overall industry trends, in order to quantify and qualify the market for products and services in the CNS biomarkers segment. Includes forecast through 2020.

Use this report to:

Examine leading and emerging competitors in the current worldwide CNS biomarkers market.
Investigate the introduction of combination therapies, which are expected to contribute substantially to market growth through the forecast period.
Assesses companies poised to introduce products during the forecast period and discuss how it will affect the competitive environment.
Examine the competitive environment with emphasis on how new products and technologies are influencing the current standard of care.

Highlights

The global CNS biomarker market should reach nearly $5.1 billion by 2020 from $3.1 billion in 2015, a compound annual growth rate (CAGR) of 10.4% from 2015 to 2020.
The discovery application market should reach over $3.3 billion by 2020 from over $1.9 billion in 2015, a CAGR of 11.7% from 2015 to 2020.
The drug development application market should reach $776 million by 2020 from $303 million in 2015, a CAGR of 20.7% from 2015 to 2020.

REASONS FOR DOING THE STUDY

For companies with an effective strategy, market opportunity awaits. Importantly, the ability to develop such a strategy begins where opportunity exists and ends with effective execution to capture profit from that opportunity.
The CNS biomarkers market presents the largest of all opportunities in representative disease sub segments. This study investigates one of the most important market drivers: the introduction of combination therapies, which are expected to continue to contribute substantially to market growth through the forecast period. This report analyzes emerging markets by disease segment.

Continued growth is expected in countries such as India, China, Brazil and Russia where a growing middle class is driving this growth. This report seeks to address and analyze the critically important areas of changing market dynamics, emerging players and technologies, strategies for accessing emerging markets, and specific disease segments and geographies in order to help companies allocate resources and make effective decisions.

SCOPE OF REPORT

Current and projected product forecasts during the forecast period (2014 to 2020) are discussed. New products approved in 2013 and 2014 by the U.S. Food and Drug Administration (FDA), and those products expected to be approved within the forecast period are discussed. Figures for 2015 are estimated, except where actual results have been reported.

The report includes analysis of leading and emerging competitors in the current worldwide CNS biomarkers market. Profiles of manufacturers of leading products as well as biotechnology companies with novel products in development are analyzed to define the specific product strategies employed. This report also assesses companies poised to introduce products during the forecast period and discusses how these introductions will change the face of the competitive environment. The competitive environment is examined with a special focus on how new products and technologies are influencing the current standard of care. Detailed profiles are provided for current market leaders as well as companies with innovative products poised to advance within the forecast period.

Market figures are based on revenues at the manufacturers’ level and are projected at the 2015 dollar value. Inflation is not computed into the projection figures. Trends are assessed based on projected sales for existing products, new product introductions, expanded indications for existing products, and projected changes in the prevalence, diagnosis, and scripting rates for certain diseases.

Included in this report are forecasts by product, product category and company from 2015 through 2020. The study is arranged to offer an overview of the CNS biomarkers market accompanied by product, company, geography, and mechanism of action, with forecasts broken down and covered by geographic region or country. Virtually the entire globe is covered to include prevalence data for each disease sub segment.
In general, excluded from this report are over-the-counter (OTC) medications, and other consumables that do not require a physician’s prescription.

Sales figures are reported in U.S. dollars and in each case reflect currency fluctuations within the performance of revenue change. Revenue figures do not account for variation in local currencies.
All market share data presented is on a global basis, unless specifically noted.

Table Of Contents

Central Nervous System (CNS) Biomarkers: Technologies and Global Markets
CHAPTER 1 INTRODUCTION 2
STUDY GOALS AND OBJECTIVES 2
REASONS FOR DOING THE STUDY 2
SCOPE OF REPORT 2
INTENDED AUDIENCE 3
METHODOLOGY AND INFORMATION SOURCES 4
ANALYST'S CREDENTIALS 4
RELATED BCC RESEARCH REPORTS 5
BCC RESEARCH WEBSITE 5
DISCLAIMER 5
CHAPTER 2 SUMMARY 7
SUMMARY TABLE GLOBAL MARKET FOR CNS BIOMARKERS BY APPLICATION,
THROUGH 2020 ($ MILLIONS) 7
SUMMARY FIGURE GLOBAL MARKET FOR CNS BIOMARKERS BY APPLICATION,
2013-2020 ($ MILLIONS) 7
CHAPTER 3 OVERVIEW 11
INTRODUCTION 11
TABLE 1 GLOBAL MARKET FORECAST FOR CNS BIOMARKERS BY AREA, THROUGH
2020 ($ MILLIONS) 12
TABLE 2 GLOBAL MARKET FOR CNS BIOMARKERS BY AREA, THROUGH 2015 ($
MILLIONS) 13
TABLE 3 BIOMARKERS IN DRUG DISCOVERY: CNS BIOMARKERS MARKET, THROUGH
2020 (%) 13
BIOMARKERS FOR CANCER 14
TABLE 4 MARKET SHARE OF CNS SUBSEGMENTS, 2015 ($ MILLIONS/ %) 14
TABLE 5 PERCENTAGE OF PREDICTIVE BIOMARKERS FOR CANCER PATIENTS BY
SEGMENT, 2010-2020 (%) 15
TABLE 6 FREQUENCY OF APPROACH IN CLAIMS REVIEW BY PAYERS, 2013-2020 (%) 16
TABLE 7 RELATIVE IMPORTANCE OF REIMBURSEMENT DECISIONS OF TEST
FACTORS, 2009-2015 (%) 16
BIOMARKERS FOR NON-ONCOLOGY INDICATIONS 18
DISEASE-SPECIFIC BIOMARKERS AND COMPANION DIAGNOSTICS 19
CSF BIOMARKERS 21
PERIPHERAL BIOMARKERS 22
ULTRA-BLOCKBUSTER 24
TABLE 8 CNS BIOMARKERS 25
TABLE 9 INFORMATION TECHNOLOGY (IT) STRATEGIES 26
BIOMARKERS ON TARGET 26
TABLE 10 INITIAL DESIGNS AND CAPABILITIES 27
ADAPTING TO DATA 27
SAFETY/TOXICOLOGY BIOMARKERS 27
LIVER 28
MUSCLE 28
CARDIAC HYPERTROPHY 28
VASCULAR INJURY 29
DOSE SELECTION AND OPTIMIZATION 29
NEW EFFORT AIMED AT DOSE SELECTION 29
IMPROVED MEASUREMENT OF THERAPEUTIC EFFICACY 30
Developing a New Framework for Long-term Addiction Treatment 30
Approach #1: Standard Treatment Patient Outcome Assessment 31
Approach #2: Independent Outcome Assessment Focused on
Patient Satisfaction 31
Approach #3: Recovery-Oriented System Model and Healthcare 31
OUTCOME BIOMARKERS AND SURROGATE END POINTS 32
TABLE 11 SUMMARY OF IOM RECOMMENDATIONS FOR A FRAMEWORK FOR
EFFECTIVE BIOMARKER EVALUATION 32
TABLE 12 SUMMARY OF IOM RECOMMENDATIONS FOR A FRAMEWORK FOR
EFFECTIVE BIOMARKER EVALUATION: SCIENTIFIC PROCESS HARMONIZATION 33
TABLE 13 BENEFITS OF BIOMARKERS AS SURROGATE END POINTS 33
CHALLENGES TO TRAUMATIC BRAIN INJURY (TBI) BIOMARKER
DEVELOPMENT 34
TABLE 14 HOW BIOMARKERS MIGHT FACILITATE TBI THERAPY DEVELOPMENT 34
Immediate Action Items 34
EARLY STAGE CLINICAL TRIAL APPLICATIONS 35
SUMMARY OF BIOMARKER CHALLENGES AND OPPORTUNITIES 36
CHALLENGES 38
OPPORTUNITIES 39
PROTEIN BIOMARKER TECHNOLOGY PLATFORMS: HYPOTHESIS-DRIVEN VS
HYPOTHESIS-FREE APPROACHES 41
REQUIREMENTS FOR CLINICAL VALIDITY 41
BIOMARKER PROGRESS 42
ENVIRONMENTAL EXPOSURES, EFFECT MODIFIERS, OR RISK FACTORS 42
TABLE 15 CROSS-SECTIONAL INVESTIGATIONS 43
INTERMEDIATE BIOMARKERS 43
SCREENING, DIAGNOSTIC TESTS, AND PROGNOSIS 43
VARIABILITY 44
VALIDITY 44
PRODUCT SUMMARY AND MARKET 46
GENOMICS 46
TABLE 16 GLOBAL MARKETS FOR CNS BIOMARKERS THROUGH 2015 ($ MILLIONS) 46
Progress in Genomic Biomarker Development 47
Emerging Evidence 47
Democratizing Health Care 48
BIOMARKER ADOPTION BY THE PHARMACEUTICAL INDUSTRY 48
CANCER BIOMARKERS: ADOPTION IS DRIVING GROWTH 52
TABLE 17 CLINICAL PATIENT MONITORING FOR CNS BIOMARKERS, AS COMPARED
TO OTHER DISEASES (%) 53
CLINICAL TRIAL BENEFITS: COST AND RISK AVOIDANCE 54
PHASE II TRIALS 54
PHASE IIA BASKET DISCOVERY TRIALS 55
PHASE III TARGETED (ENRICHMENT) DESIGNS 56
PHASE III BIOMARKER STRATIFIED DESIGN 57
PHASE III ADAPTIVE THRESHOLD DESIGN 58
BIOMARKER MARKET FORECAST 59
TABLE 18 GLOBAL MARKET FORECAST FOR CNS BIOMARKERS BY TECHNOLOGY,
THROUGH 2020 ($ MILLIONS) 59
CHAPTER 4 REGULATORY DYNAMICS, INTELLECTUAL PROPERTY, ETHICAL
CONSIDERATIONS 61
INTRODUCTION 61
BIOMARKER LABORATORY REGULATORY SUMMARY 61
DEFINITION OF AN IVD COMPANION DIAGNOSTIC 62
Labeling 64
TABLE 19 PHARMACOGENOMIC BIOMARKERS IN DRUG LABELING 65
REGULATORY PROCESSES FOR NEW TECHNOLOGIES 80
ENSURING SAFETY AND EFFECTIVENESS OF HEALTH TECHNOLOGIES 80
SAFE FOR WIDESPREAD USE? 80
REVIEW IN THE DEVELOPING WORLD 80
ASSAY DEVELOPMENT AND VALIDATION IN DRUG DIAGNOSTIC
CO-DEVELOPMENT 81
KEY DRAFT GUIDANCE POINTS FOR IVD COMPANION DIAGNOSTIC DEVICES: 82
SOME RELEVANT FDA GUIDANCE DOCUMENTS FOR CO-DEVELOPMENT 83
PIPELINE FOR BIOMARKER DEVELOPMENT 86
CLINICAL CONCEPTIONS ON THE BIOMARKERS STUDY DESIGN 87
TECHNICAL CONSIDERATIONS REGARDING THE ANALYTICAL SET UP FOR
BIOMARKER DEVELOPMENT 87
DISCOVERY OF BIOMARKERS 88
GEL-BASED PROTEOMICS PLATFORMS FOR BIOMARKER DISCOVERY 89
SHOTGUN PROTEOMICS 90
CE-MS 91
STATISTICAL DATA MINING FOR PROTEOMIC BIOMARKER DISCOVERY 91
VERIFICATION OF BIOMARKERS 92
PROTEIN BINDING ASSAYS 92
MASS SPECTROMETRIC QUANTITATIVE APPROACHES 93
PRE-TREATMENT STRATEGIES 93
DATA MINING AND STATISTICAL ANALYSIS 94
BIOINFORMATICS PLATFORMS IN CLINICAL PROTEOMICS 94
APPLICATIONS OF SYSTEMS BIOLOGY---DISEASE DIAGNOSIS AND
TREATMENT 94
VALIDATION OF BIOMARKER CANDIDATES 95
APPLICATION OF PROTEOMICS APPROACHES IN BCA BIOMARKER
DISCOVERY 97
Analytical Validation of a Companion Diagnostic 97
COMPANION DIAGNOSTIC VALIDATION 98
CLINICAL VALIDATION 99
OVERVIEW OF ESSENTIAL TYPES OF BIOMARKERS 100
TABLE 20 BIOMARKER CATEGORIES AND TYPES 101
OVERVIEW OF ALREADY APPROVED CDX ON THE MARKETS 102
KEY POINTS TO BE ADDRESSED 102
CONSIDERATIONS BEFORE INITIATING THE BIOMARKER DISCOVERY PHASE 103
CONSIDERATIONS ON THE SELECTION AND RANDOMIZATION OF PATIENTS
FOR BIOMARKER STUDIES: LOOKING FOR THE 'IDEAL' PATIENTS 103
THE CURRENT STATE OF BIOMARKER DISCOVERY 104
PITFALLS AND LIMITATIONS 104
SELECTION OF PATIENTS AND CONTROLS 105
ROLE OF THE FOOD and DRUG ADMINISTRATION 105
FDA GUIDELINES FOR BIOMARKER APPLICATIONS 105
TABLE 21 BIOMARKER QUALIFICATION PROGRAM 107
EUROPEAN MEDICINES AGENCY 108
REGULATORY IMPACT ON DRUG SAFETY 108
INTELLECTUAL PROPERTY AND COMPETITIVE POSITIONING 109
Approved Patent Analysis 109
TABLE 22 ANNUAL NUMBER OF PATENTS FILED AND APPROVED WITH BIOMARKER
CLAIMS IN THE U.S., EUROPE, AND JAPAN, THROUGH 2015 (NUMBER/%) 109
COMPETITIVE LANDSCAPE 109
LATE STAGE CLINICAL TRIALS: COMPETITIVE POSITIONING 110
TABLE 23 GLOBAL MARKET FOR TOTAL CLINICAL STAGE BIOMARKERS BY
SERVICES AND PRODUCTS, THROUGH 2020 ($ MILLIONS) 110
TABLE 24 SUMMARY OF RECENT AGREEMENTS IN BIOMARKER DELIVERY,
2007-2014 111
TABLE 25 REPRESENTATIVE LIST OF APPROVED BIOMARKER PATENTS IN THE U.S.,
EUROPE, AND JAPAN 114
CHAPTER 5 APPLICATIONS OF CNS BIOMARKERS 119
OVERVIEW 119
TABLE 26 GLOBAL MARKET FOR CLINICAL STAGE BIOMARKERS BY THERAPEUTIC
AREA, THROUGH 2020 ($ MILLIONS) 121
CENTRAL NERVOUS SYSTEM 122
TABLE 27 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: CNS DISEASE 122
CLINICAL BIOMARKERS: THERAPEUTIC DISEASE MARKET FORECAST 123
TABLE 28 GLOBAL MARKET FORECAST FOR CLINICAL STAGE BIOMARKERS,
THROUGH 2020 ($ MILLIONS) 123
TABLE 29 GLOBAL MARKET FORECAST FOR CNS BIOMARKERS IN LATE STAGE
CLINICAL USE, THROUGH 2020 ($ MILLIONS) 123
CHAPTER 6 BIOMARKERS ACTIVELY GUIDING DRUG DEVELOPMENT 125
AN OVERVIEW 125
TABLE 30 RELEVANT CORPORATE ALLIANCE BETWEEN A REFERENCE LAB AND A
DRUG DEVELOPMENT COMPANY 126
CHAPTER 7 COMPANY ANALYSIS 128
ABBOTT LABORATORIES INC. 128
COMPANY OVERVIEW 128
PRODUCTS AND SERVICES 128
TABLE 31 ABBOTT'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 128
COMPANY STRATEGY 129
AFFYMETRIX INC. 129
COMPANY OVERVIEW 129
PRODUCTS AND SERVICES 130
TABLE 32 AFFYMETRIX'S REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 130
COMPANY STRATEGY 130
ASTELLAS PHARMA INC. 131
COMPANY OVERVIEW 131
PRODUCTS AND SERVICES 131
TABLE 33 ASTELLAS' REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 132
COMPANY STRATEGY 132
ASTRAZENECA LTD. 132
COMPANY OVERVIEW 132
PRODUCTS AND SERVICES 133
TABLE 34 ASTRAZENECA'S REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 133
COMPANY STRATEGY 133
BANYAN BIOMARKERS INC. 134
COMPANY OVERVIEW 134
PRODUCTS AND SERVICES 134
TABLE 35 BANYAN'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 134
COMPANY STRATEGY 135
BAYER SCHERING PHARMA AG 135
COMPANY OVERVIEW 135
PRODUCTS AND SERVICES 135
TABLE 36 BAYER SCHERING'S REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 136
COMPANY STRATEGY 136
BG MEDICINE INC. 138
COMPANY OVERVIEW 138
PRODUCTS AND SERVICES 138
TABLE 37 BIOPHYSICAL REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 138
COMPANY STRATEGY 138
BIOPHYSICAL CORP. 139
COMPANY OVERVIEW 139
PRODUCTS AND SERVICES 139
COMPANY STRATEGY 139
BIOSYSTEMS INTERNATIONAL INC. 140
COMPANY OVERVIEW 140
PRODUCTS AND SERVICES 140
COMPANY STRATEGY 140
BOEHRINGER INGELHEIM GMBH 141
COMPANY OVERVIEW 141
PRODUCTS AND SERVICES 141
TABLE 38 BMS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 141
COMPANY STRATEGY 142
BRISTOL-MYERS SQUIBB CO. 142
COMPANY OVERVIEW 142
PRODUCTS AND SERVICES 142
TABLE 39 BMS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 143
COMPANY STRATEGY 143
CAPRION PROTEOMICS INC. 144
COMPANY OVERVIEW 144
PRODUCTS AND SERVICES 144
COMPANY STRATEGY 144
Infectious Diseases 144
Diabetes and Metabolic Disease 145
Oncology 145
DAIICHI SANKYO COMPANY LTD. 145
COMPANY OVERVIEW 145
PRODUCTS AND SERVICES 145
TABLE 40 DAIICHI SANKYO'S REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 146
COMPANY STRATEGY 146
EISAI CO. LTD. 147
COMPANY OVERVIEW 147
PRODUCTS AND SERVICES 147
TABLE 41 EISAI'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 147
COMPANY STRATEGY 148
ELI LILLY AND COMPANY 148
COMPANY OVERVIEW 148
PRODUCT AND SERVICES 148
TABLE 42 ELI LILLY'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 149
COMPANY STRATEGY 149
EPIGENOMICS AG 149
COMPANY OVERVIEW 150
PRODUCTS AND SERVICES 150
TABLE 43 EPIGENOMICS' REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 150
COMPANY STRATEGY 150
GENEDATA AG 151
COMPANY OVERVIEW 151
PRODUCTS AND SERVICES 151
TABLE 44 GENEDATA'S REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 151
COMPANY STRATEGY 152
GENENEWS LTD 152
COMPANY OVERVIEW 152
PRODUCTS AND SERVICES 152
COMPANY STRATEGY 152
GLAXOSMITHKLINE 153
COMPANY OVERVIEW 153
PRODUCTS AND SERVICES 153
TABLE 45 GSK'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 153
COMPANY STRATEGY 154
JOHNSON and JOHNSON LTD. 154
COMPANY OVERVIEW 154
PRODUCTS AND SERVICES 155
TABLE 46 JOHNSON and JOHNSON'S REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 155
COMPANY STRATEGY 155
MERCK and CO. 156
COMPANY OVERVIEW 156
PRODUCTS AND SERVICES 156
TABLE 47 MERCK'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 156
COMPANY STRATEGY 157
NOVARTIS AG 157
COMPANY OVERVIEW 157
PRODUCTS AND SERVICES 158
TABLE 48 NOVARTIS' REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 158
COMPANY STRATEGY 158
PFIZER INC. 159
COMPANY OVERVIEW 159
PRODUCTS AND SERVICES 159
TABLE 49 PFIZER'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 159
COMPANY STRATEGY 160
ROCHE LTD 160
COMPANY OVERVIEW 160
PRODUCTS AND SERVICES 161
TABLE 50 ROCHE'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 161
COMPANY STRATEGY 161
SANOFI 162
COMPANY OVERVIEW 162
PRODUCTS AND SERVICES 162
TABLE 51 SANOFI'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 163
COMPANY STRATEGY 163
TAKEDA PHARMACEUTICALS LTD. 164
COMPANY OVERVIEW 164
PRODUCTS AND SERVICES 164
TABLE 52 TAKEDA'S PHARMACEUTICALS REPRESENTATIVE CLINICAL TRIALS
INVOLVING BIOMARKERS 164
COMPANY STRATEGY 165
TEVA PHARMACEUTICAL INDUSTRIES LTD. 165
COMPANY OVERVIEW 165
PRODUCTS AND SERVICES 166
TABLE 53 TEVA'S PHARMACEUTICAL REPRESNTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 166
COMPANY STRATEGY 167

LIST OF TABLES

SUMMARY TABLE GLOBAL MARKET FOR CNS BIOMARKERS BY APPLICATION,
THROUGH 2020 ($ MILLIONS) 7
TABLE 1 GLOBAL MARKET FORECAST FOR CNS BIOMARKERS BY AREA, THROUGH
2020 ($ MILLIONS) 12
TABLE 2 GLOBAL MARKET FOR CNS BIOMARKERS BY AREA, THROUGH 2015 ($
MILLIONS) 13
TABLE 3 BIOMARKERS IN DRUG DISCOVERY: CNS BIOMARKERS MARKET, THROUGH
2020 (%) 13
TABLE 4 MARKET SHARE OF CNS SUBSEGMENTS, 2015 ($ MILLIONS/ %) 14
TABLE 5 PERCENTAGE OF PREDICTIVE BIOMARKERS FOR CANCER PATIENTS BY
SEGMENT, 2010-2020 (%) 15
TABLE 6 FREQUENCY OF APPROACH IN CLAIMS REVIEW BY PAYERS, 2013-2020 (%) 16
TABLE 7 RELATIVE IMPORTANCE OF REIMBURSEMENT DECISIONS OF TEST FACTORS,
2009-2015 (%) 16
TABLE 8 CNS BIOMARKERS 25
TABLE 9 INFORMATION TECHNOLOGY (IT) STRATEGIES 26
TABLE 10 INITIAL DESIGNS AND CAPABILITIES 27
TABLE 11 SUMMARY OF IOM RECOMMENDATIONS FOR A FRAMEWORK FOR
EFFECTIVE BIOMARKER EVALUATION 32
TABLE 12 SUMMARY OF IOM RECOMMENDATIONS FOR A FRAMEWORK FOR
EFFECTIVE BIOMARKER EVALUATION: SCIENTIFIC PROCESS HARMONIZATION 33
TABLE 13 BENEFITS OF BIOMARKERS AS SURROGATE END POINTS 33
TABLE 14 HOW BIOMARKERS MIGHT FACILITATE TBI THERAPY DEVELOPMENT 34
TABLE 15 CROSS-SECTIONAL INVESTIGATIONS 43
TABLE 16 GLOBAL MARKETS FOR CNS BIOMARKERS THROUGH 2015 ($ MILLIONS) 46
TABLE 17 CLINICAL PATIENT MONITORING FOR CNS BIOMARKERS, AS COMPARED TO
OTHER DISEASES (%) 53
TABLE 18 GLOBAL MARKET FORECAST FOR CNS BIOMARKERS BY TECHNOLOGY,
THROUGH 2020 ($ MILLIONS) 59
TABLE 19 PHARMACOGENOMIC BIOMARKERS IN DRUG LABELING 65
TABLE 20 BIOMARKER CATEGORIES AND TYPES 101
TABLE 21 BIOMARKER QUALIFICATION PROGRAM 107
TABLE 22 ANNUAL NUMBER OF PATENTS FILED AND APPROVED WITH BIOMARKER
CLAIMS IN THE U.S., EUROPE, AND JAPAN, THROUGH 2015 (NUMBER/%) 109
TABLE 23 GLOBAL MARKET FOR TOTAL CLINICAL STAGE BIOMARKERS BY SERVICES
AND PRODUCTS, THROUGH 2020 ($ MILLIONS) 110
TABLE 24 SUMMARY OF RECENT AGREEMENTS IN BIOMARKER DELIVERY, 2007-2014 111
TABLE 25 REPRESENTATIVE LIST OF APPROVED BIOMARKER PATENTS IN THE U.S.,
EUROPE, AND JAPAN 114
TABLE 26 GLOBAL MARKET FOR CLINICAL STAGE BIOMARKERS BY THERAPEUTIC
AREA, THROUGH 2020 ($ MILLIONS) 121
TABLE 27 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: CNS DISEASE 122
TABLE 28 GLOBAL MARKET FORECAST FOR CLINICAL STAGE BIOMARKERS,
THROUGH 2020 ($ MILLIONS) 123
TABLE 29 GLOBAL MARKET FORECAST FOR CNS BIOMARKERS IN LATE STAGE
CLINICAL USE, THROUGH 2020 ($ MILLIONS) 123
TABLE 30 RELEVANT CORPORATE ALLIANCE BETWEEN A REFERENCE LAB AND A
DRUG DEVELOPMENT COMPANY 126
TABLE 31 ABBOTT'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 128
TABLE 32 AFFYMETRIX'S REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 130
TABLE 33 ASTELLAS' REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 132
TABLE 34 ASTRAZENECA'S REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 133
TABLE 35 BANYAN'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 134
TABLE 36 BAYER SCHERING'S REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 136
TABLE 37 BIOPHYSICAL REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 138
TABLE 38 BMS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 141
TABLE 39 BMS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 143
TABLE 40 DAIICHI SANKYO'S REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 146
TABLE 41 EISAI'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 147
TABLE 42 ELI LILLY'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 149
TABLE 43 EPIGENOMICS' REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 150
TABLE 44 GENEDATA'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 151
TABLE 45 GSK'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 153
TABLE 46 JOHNSON and JOHNSON'S REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 155
TABLE 47 MERCK'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 156
TABLE 48 NOVARTIS' REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 158
TABLE 49 PFIZER'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 159
TABLE 50 ROCHE'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 161
TABLE 51 SANOFI'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 163
TABLE 52 TAKEDA'S PHARMACEUTICALS REPRESENTATIVE CLINICAL TRIALS
INVOLVING BIOMARKERS 164
TABLE 53 TEVA'S PHARMACEUTICAL REPRESNTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 166
SUMMARY FIGURE GLOBAL MARKET FOR CNS BIOMARKERS BY APPLICATION,
2013-2020 ($ MILLIONS) 7

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