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Biomarkers: Technologies and Global Markets

  • June 2016
  • -
  • BCC Research
  • -
  • 203 pages

This BCC Research study provides a comprehensive analysis of biomarkers on a global basis. Its aim is to provide a range of information, from detailed product analyses within disease subsegments to overall industry trends, in order to quantify and qualify the market for products and services in the biomarkers segment. Forecast provided from 2015 through 2020.

Use this report to:

Analyze products and overall industry trends for products and services
Investigate one of the most important market drivers such as the introduction of combination therapies which will contribute to market growth.
Address critically important topics for analyzing a changing market dynamic, emerging players and technologies, strategies for accessing emerging markets and specific disease segments.
Examine the biomarkers market by product, company, geography and mechanism of action by country.

Highlights

The global biomarkers market grew to $39.4 billion in 2014 from $29.3 billion in 2013.
The market is expected to grow at a five-year compound annual growth rate (CAGR) of 13.8% from 2015 to 2020, increasing from $50.6 billion in 2015 to $96.6 billion in 2020.
The genomics segment is the largest sector of the market.
The segment is expected to grow from $27.9 billion in 2015 to $54.0 billion in 2020 at a CAGR of 14.1% for the period 2015-2020.
Imaging as a segment is expected to grow from $12.1 billion in 2015 to $24.4 billion in 2020 increasing at a CAGR of 15.0% for the period 2015-2020.

STUDY GOALS AND OBJECTIVES

This study provides a comprehensive analysis of biomarkers on a global basis. Its aim is to provide a range of information, from detailed product analyses within disease subsegments to overall industry trends, in order to quantify and qualify the market for products and services in the biomarkers segment. Individual product types are forecast on a global basis, as are overall segments. Forecasts and trends are developed from a cross-reference of data points gleaned from proprietary industry sources, company publications, industry benchmarking and other divergent data sources to arrive at a cogent and coordinated forecast.

REASONS FOR DOING THE STUDY

For companies with an effective strategy, market opportunity awaits. Importantly, the ability to develop an effective strategy begins with where opportunity exists and ends with how to execute effectively in order to capture profit from opportunity. The biomarkers market presents the largest of all opportunities in representative disease subsegments. 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 emerging geographies, driven by the growing middle class in emerging countries such as India, China, Brazil and Russia. This report seeks to address the critically important topics of analyzing a changing market dynamic, emerging players and technologies, strategies for accessing emerging markets and specific disease segments and geographies in order to allocate resources and make effective decisions.

Table Of Contents

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 4
BCC RESEARCH WEBSITE 5
DISCLAIMER 5
CHAPTER 2 SUMMARY 7
SUMMARY TABLE GLOBAL BIOMARKERS MARKET, BY SEGMENT, THROUGH 2020 ($
MILLIONS) 7
SUMMARY FIGURE GLOBAL BIOMARKERS MARKET, BY SEGMENT, 2013-2020 ($
MILLIONS) 7
BIOMARKER MARKET SEGMENTS 8
GENOMICS 8
IMAGING 8
PROTEOMICS 9
BIOINFORMATICS 9
CHAPTER 3 OVERVIEW 11
INTRODUCTION 11
TABLE 1 GLOBAL BIOMARKERS MARKET, BY SEGMENT, THROUGH 2020 ($
MILLIONS) 12
TABLE 2 GLOBAL MARKET FOR BIOMARKERS, BY SEGMENT, THROUGH 2015 ($
MILLIONS) 13
TABLE 3 GLOBAL BIOMARKERS MARKET GROWTH IN DRUG DISCOVERY, THROUGH
2020 (%) 14
TYPES OF BIOMARKERS 14
BIOMARKERS FOR CANCER 14
TABLE 4 COMPANION DIAGNOSTICS DEVELOPED IN-HOUSE OR WITH
COLLABORATORS 14
TABLE 5 PERCENTAGE OF CANCER PATIENTS WHO WILL HAVE A PREDICTIVE
BIOMARKER, BY SEGMENT, 2010-2020 (%) 15
TABLE 6 FREQUENCY OF APPROACH IN CLAIMS REVIEW, BY PAYERS, 2013-2020 (%) 16
TABLE 7 RELATIVE IMPORTANCE FOR REIMBURSEMENT DECISIONS BASED ON
TEST FACTORS, 2009-2015 (%) 16
BIOMARKERS FOR NON-ONCOLOGY INDICATIONS 19
DISEASE-SPECIFIC BIOMARKERS AND COMPANION DIAGNOSTICS 19
COST REDUCTION OPPORTUNITIES ARISING FROM BIOMARKER APPLICATIONS 21
SURROGATE ENDPOINTS 21
General Characteristics of Biomarkers/Endpoints 22
Advantages of Biomarkers/Endpoints 22
Important Features of Biomarkers/Endpoints 23
VALUE TO VACCINE AND DRUG DEVELOPMENT 23
Elements of Cost in Drug Research and Development 24
Elements of Cost in Healthcare 25
TABLE 8 U.S. HEALTHCARE SPENDING, 2013 (% OF $2.9 TRILLION) 25
TABLE 9 YEAR-OVER-YEAR PRECENT GROWTH IN SPENDING, BY CATEGORY,
2011-2012 AND 2012-2013 (%) 26
STRATEGIC BIOMARKER APPLICATIONS 27
BREAST CANCER 27
TABLE 10 PERSONALIZED TREATMENT OPTIONS FOR BREAST CANCER 29
CSF BIOMARKERS 30
PERIPHERAL BIOMARKERS 31
Ultra-Blockbuster 33
TABLE 11 CNS BIOMARKERS BY DISEASE/CONDITION 34
TABLE 12 INFORMATION TECHNOLOGY (IT) STRATEGIES 35
BIOMARKERS ON TARGET 35
TABLE 13 INITIAL DESIGNS AND CAPABILITIES FOR CLINICAL TRIALS 36
Adapting to Data 36
TABLE 14 BENEFITS OF BIOMARKERS AS SURROGATE ENDPOINTS 36
Safety/Toxicology Biomarkers 37
Liver 37
Muscle 38
Cardiac Hypertrophy 38
Vascular Injury 38
Dose Selection and Dose Optimization 38
TABLE 15 NOVEL DOSE SELECTION BIOMARKERS USED IN CANCER, DIABETES,
METABOLIC AND LIVER DISEASE 39
NEW EFFORT AIMED AT DOSE SELECTION 45
IMPROVED MEASUREMENT OF THERAPEUTIC EFFICACY 46
Developing a New Framework for Long-Term Addiction Treatment 46
Approach #1: Standard Treatment Patient Outcome Assessment 47
Approach #2: Independent Outcome Assessment Focused on
Patient Satisfaction 47
Approach #3: Recovery-Oriented System Model and Healthcare 47
Outcome Biomarkers and Surrogate Endpoints 48
TABLE 16 PATIENT OUTCOME MEASUREMENTS BIOMARKERS 48
SUMMARY OF RECOMMENDATIONS FOR EFFECTIVE BIOMARKER EVALUATION 49
THE EVALUATION FRAMEWORK 49
SCIENTIFIC PROCESS HARMONIZATION 49
BENEFITS OF BIOMARKERS AS SURROGATE ENDPOINTS 49
CHALLENGES TO TBI BIOMARKER DEVELOPMENT 50
TABLE 17 BIOMARKER AND CLINICAL ENDPOINT ONE 50
TABLE 18 BIOMARKER AND CLINICAL ENDPOINT TWO 51
TABLE 19 BIOMARKER INDICATION OF SEVERITY TO IMPROVE OUTCOME 51
HOW BIOMARKERS MIGHT FACILITATE TBI THERAPY DEVELOPMENT 51
Immediate Action Items 51
EARLY-STAGE CLINICAL TRIAL APPLICATIONS 52
TABLE 20 CLINICAL TRIAL PIPELINE-PHASE OF INTERVENTION DEVELOPMENT 53
BIOMARKERS: CHALLENGES AND OPPORTUNITIES 54
SUMMARY 54
CHALLENGES 55
OPPORTUNITIES 56
Personalized Healthcare Concepts - the Role of Biomarkers 57
Definitions 58
Biomarker Versus Diagnostic 58
Value of Biomarkers 58
Personalized Medicine 58
Stages of Biomarker Development 59
PROTEIN BIOMARKER TECHNOLOGY PLATFORMS - HYPOTHESIS-DRIVEN
VERSUS HYPOTHESIS-FREE APPROACHES 59
CLINICAL VALIDITY: REQUIREMENTS 59
BIOMARKER OPPORTUNITIES 60
Environmental Exposures, Effect Modifiers or Risk Factors 60
TABLE 21 CROSS-SECTIONAL INVESTIGATIONS 61
Intermediate Biomarkers 61
Screening, Diagnostic Tests, and Prognosis 61
VARIABILITY 62
VALIDITY 63
PRODUCT SUMMARY AND MARKET 64
GENOMICS 64
TABLE 22 GLOBAL BIOMARKERS MARKET, BY SEGMENT, THROUGH 2015 ($
MILLIONS) 65
Progress in Genomic Biomarker Development 65
Early Detection Biomarkers 66
Emerging Evidence 67
Democratizing Healthcare 67
BIOMARKER ADOPTION BY THE PHARMACEUTICAL INDUSTRY 68
ADDING TRIGLYCERIDE OR TESTOSTERONE TO THE LIST OF MEDICALIZED
BIOMARKERS 71
CANCER BIOMARKERS - ADOPTION IS DRIVING GROWTH 73
TABLE 23 CLINICIAL PATIENT MONITORING BY SUBDISEASE (%) 73
CLINICAL TRIAL BENEFITS - COST AND RISK AVOIDANCE 74
Phase II Trials 74
Phase IIa Basket Discovery Trials 74
Phase III Targeted (Enrichment) Designs 76
Phase III Biomarker Stratified Design 77
Phase III Adaptive 78
BIOMARKER MARKET FORECAST 79
TABLE 24 GLOBAL BIOMARKER MARKET, BY SEGMENT, THROUGH 2020 ($
MILLIONS) 79
CHAPTER 4 REGULATORY DYNAMICS, INTELLECTUAL PROPERTY AND ETHICAL
CONSIDERATIONS 81
INTRODUCTION 81
BIOMARKER LABORATORY REGULATORY SUMMARY 81
DEFINITION OF AN IVD COMPANION DIAGNOSTIC 82
Labeling 84
TABLE 25 PHARMACOGENOMIC BIOMARKERS IN DRUG LABELING 85
BIO061D - Biomarkers: Technologies and Global Markets
Copyright © BCC Research, Wellesley MA USA, Website: www.bccresearch.com
TOPIC PAGE NO.
REGULATORY PROCESSES FOR NEW TECHNOLOGIES 102
Ensuring Safety and Effectiveness of Health Technologies 102
Safe for Widespread Use? 102
REVIEW IN THE DEVELOPING WORLD 102
ASSAY DEVELOPMENT AND VALIDATION IN DRUG DIAGNOSTIC
CODEVELOPMENT 103
IVD Companion Diagnostic Devices - Key Draft Guidance Points 104
Relevant FDA Guidance Documents for Codevelopment 105
Establishing a Training and Test Set of Samples 108
Pipeline for Biomarker Development 108
Clinical Conceptions on the Biomarkers Study Design 109
Technical Considerations Regarding the Analytical Setup for
Biomarker Development 109
Discovery of Biomarkers 110
Gel-based Proteomics Platforms for Biomarker Discovery 111
Gel-free Proteomics - Shotgun Proteomics 112
CE-MS 113
Statistical Data Mining for Proteomic Biomarker Discovery 113
Verification of Biomarkers 114
Protein Binding Assays 114
Mass Spectrometric Quantitative Approaches 115
Pre-treatment Strategies 115
Data Mining and Statistical Analysis 116
Bioinformatics Platforms in Clinical Proteomics 116
Applications of Systems Biology - Disease Diagnosis and
Treatment 116
Validation of Biomarker Candidates 117
Application of Proteomic Approaches in BCa Biomarker Discovery 119
Analytical Validation of a Companion Diagnostic 119
Companion Diagnostic Validation 121
Reasons for Problems 121
Problems Envisioned 121
CLINICAL VALIDATION 121
Short Overview of Different Kinds of Biomarkers 123
TABLE 26 BIOMARKER CATEGORIES AND TYPES 124
Overview of Approved CDx on the Market 125
Key Points to be Addressed 125
Considerations Before Initiating the Biomarker Discovery Phase 126
The Current State of Biomarker Discovery 127
Pitfalls and Limitations 127
SELECTION OF PATIENTS AND CONTROLS 128
ROLE OF THE FOOD AND DRUG ADMINISTRATION 128
FDA GUIDELINES FOR BIOMARKER APPLICATIONS 128
TABLE 27 BIOMARKER QUALIFICATION PROGRAM 130
EUROPEAN MEDICINES AGENCY 131
REGULATORY IMPACT ON DRUG SAFETY 131
INTELLECTUAL PROPERTY AND COMPETITIVE POSITIONING 132
Approved Patent Analysis 132
TABLE 28 ANNUAL PATENTS FILED AND APPROVED WITH BIOMARKER CLAIMS IN
U.S., EUROPE, JAPAN, THROUGH 2015 (NO. OF PATENTS) 132
COMPETITIVE LANDSCAPE 132
LATE-STAGE CLINICAL TRIALS - COMPETITIVE POSITIONING 133
TABLE 29 GLOBAL MARKET FOR TOTAL CLINICAL STAGE BIOMARKERS, BY
SEGMENT, THROUGH 2020 ($ MILLIONS) 133
TABLE 30 SUMMARY OF RECENT AGREEMENTS IN BIOMARKER DELIVERY 134
TABLE 31 REPRESENTATIVE LIST OF APPROVED BIOMARKER PATENTS IN THE U.S.,
EUROPE AND JAPAN 137
CHAPTER 5 APPLICATION BY THERAPY AREA 142
OVERVIEW 142
TABLE 32 GLOBAL MARKET FOR CLINICAL STAGE BIOMARKERS, BY THERAPEUTIC
AREA, THROUGH 2020 ($ MILLIONS) 144
ONCOLOGY 145
TABLE 33 REPRESENTATIVE BIOMARKERS IN CLINICAL USE - ONCOLOGY 145
TABLE 34 ONGOING REPRESENTATIVE ACTIVE BIOMARKER TRIALS FOR BREAST
CANCER, 2005-2009 146
OTHER PREDICTIVE TESTS 146
TABLE 35 ONGOING REPRESENTATIVE ACTIVE BIOMARKER TRIALS IN ONCOLOGY,
2005-2009 148
OTHER PROGNOSTIC TESTS 148
LUNG CANCER 149
INTRODUCTION 149
PREDICTIVE TESTS 149
TABLE 36 ONGOING REPRESENTATIVE ACTIVE BIOMARKER TRIALS - LUNG CANCER,
2006-2014 149
Central Nervous System 150
TABLE 37 REPRESENTATIVE BIOMARKERS IN CLINICAL USE - CNS DISEASE,
2008-2013 151
Immunology 151
TABLE 38 REPRESENTATIVE BIOMARKERS IN CLINICAL USE - IMMUNOLOGY, 2013 151
Immunology: Benlysta/GlaxoSmithKline and Human Genome
Sciences 152
EXPEDITION AND IDENTITY 152
Alzheimer's Trials: Eli Lilly 152
CLINICAL BIOMARKERS - THERAPEUTIC DISEASE MARKET FORECAST 152
TABLE 39 GLOBAL MARKET FOR CLINICAL STAGE BIOMARKERS, BY SEGMENT,
THROUGH 2020 ($ MILLIONS) 153
TABLE 40 GLOBAL MARKET OF BIOMARKERS IN LATE-STAGE CLINICAL USE BY
THERAPEUTIC AREA, THROUGH 2020 ($ MILLIONS) 153
CHAPTER 6 BIOMARKERS ACTIVELY GUIDING DRUG DEVELOPMENT 155
INTRODUCTION 155
TABLE 41 RECENT CORPORATE ALLIANCES BETWEEN BIOMARKERS AND DRUG
DEVELOPMENT COMPANIES 156
ASURAGEN INC. 156
BACKGROUND 156
COLLABORATION 157
Merck and Co. 157
BG MEDICINE 157
BACKGROUND 157
COLLABORATION 157
Cordex Pharma 157
BIOMERIEUX 158
BACKGROUND 158
COLLABORATIONS 158
Ipsen 158
Merck and Co. 158
ADNA Project 158
CELERA CORPORATION 159
BACKGROUND 159
COLLABORATIONS 159
Abbott 160
Merck and Co. 160
Ipsen 160
CURIDIUM 160
COLLABORATION 160
Takeda 160
DAKO NORTH AMERICA INC. 161
BACKGROUND 161
COLLABORATIONS 161
OSI Pharmaceuticals 161
Genentech 161
Bristol-Myers Squibb 161
DXS 162
BACKGROUND 162
COLLABORATIONS 162
Amgen 162
Roche Molecular Diagnostics 163
GE HEALTHCARE 163
BACKGROUND 163
COLLABORATION 163
Eli Lilly 163
GENOMIC HEALTH 164
BACKGROUND 164
COLLABORATIONS 164
Pfizer 164
Bristol-Myers Squibb and Imclone Systems 164
HISTORX 165
BACKGROUND 165
COLLABORATION 165
Eli Lilly 165
LABORATORY CORPORATION OF AMERICA HOLDINGS/LABCORP 166
BACKGROUND 166
COLLABORATIONS 166
ARCA Biopharma 166
Vanda Pharmaceuticals 167
Medco Health Solutions 167
MDXHEALTH 167
BACKGROUND 167
COLLABORATIONS 168
Merck KGaA 168
Schering-Plough 168
GlaxoSmithKline Biologicals 168
Abbott 168
MONOGRAM BIOSCIENCES 168
BACKGROUND 168
COLLABORATIONS 169
Pfizer HIV Partnership 169
VeraTag Oncology Platform 169
XDX (CAREDX) 169
BACKGROUND 170
COLLABORATION 170
Bristol-Myers Squibb 170
CHAPTER 7 COMPANY ANALYSIS 172
ABBOTT LABORATORIES INC. 172
COMPANY OVERVIEW 172
PRODUCTS AND SERVICES 172
TABLE 42 ABBOTT: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 172
COMPANY STRATEGY 173
AFFYMETRIX INC. 173
COMPANY OVERVIEW 173
PRODUCTS AND SERVICES 173
TABLE 43 AFFYMETRIX: REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 174
COMPANY STRATEGY 174
ASTELLAS PHARMA INC. 174
COMPANY OVERVIEW 175
PRODUCTS AND SERVICES 175
TABLE 44 ASTELLAS: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 175
COMPANY STRATEGY 175
ASTRAZENECA LTD. 176
COMPANY OVERVIEW 176
PRODUCTS AND SERVICES 176
TABLE 45 ASTRAZENECA: REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 177
COMPANY STRATEGY 177
BANYAN BIOMARKERS INC. 177
COMPANY OVERVIEW 177
PRODUCTS AND SERVICES 178
TABLE 46 BANYAN BIOMARKERS REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 178
COMPANY STRATEGY 178
BAYER SCHERING PHARMA AG 178
COMPANY OVERVIEW 179
PRODUCTS AND SERVICES 179
TABLE 47 BAYER SCHERING: REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 179
COMPANY STRATEGY 179
BG MEDICINE INC. 181
COMPANY OVERVIEW 181
PRODUCTS AND SERVICES 181
COMPANY STRATEGY 182
BIOPHYSICAL CORP. 182
COMPANY OVERVIEW 182
PRODUCTS AND SERVICES 182
TABLE 48 BIOPHYSICAL: REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 183
COMPANY STRATEGY 183
BIOSYSTEMS INTERNATIONAL INC. 183
COMPANY OVERVIEW 183
PRODUCTS AND SERVICES 184
TABLE 49 BIOSYSTEMS: REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 184
COMPANY STRATEGY 184
BOEHRINGER INGELHEIM GMBH 184
COMPANY OVERVIEW 185
PRODUCTS AND SERVICES 185
COMPANY STRATEGY 185
BRISTOL-MYERS SQUIBB CO. 185
COMPANY OVERVIEW 185
PRODUCTS AND SERVICES 186
TABLE 50 BMS: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 186
COMPANY STRATEGY 186
CAPRION PROTEOMICS INC. 187
COMPANY OVERVIEW 187
PRODUCTS AND SERVICES 187
COMPANY STRATEGY 188
Infectious Diseases 188
Diabetes and Metabolic Disease 188
Oncology 188
DAIICHI SANKYO CO. LTD. 189
COMPANY OVERVIEW 189
PRODUCTS AND SERVICES 189
TABLE 51 DAIICHI SANKYO: REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 190
COMPANY STRATEGY 190
EISAI CO. LTD. 190
COMPANY OVERVIEW 191
PRODUCTS AND SERVICES 191
TABLE 52 EISAI: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 191
COMPANY STRATEGY 191
ELI LILLY AND CO. 192
COMPANY OVERVIEW 192
PRODUCTS AND SERVICES 192
TABLE 53 ELI LILLY: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 192
COMPANY STRATEGY 193
EPIGENOMICS AG 193
COMPANY OVERVIEW 193
PRODUCTS AND SERVICES 193
TABLE 54 EPIGENOMICS: REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 194
COMPANY STRATEGY 194
GENEDATA AG 195
COMPANY OVERVIEW 195
PRODUCTS AND SERVICES 195
TABLE 55 GENEDATA AG: REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 195
COMPANY STRATEGY 195
GENENEWS LTD. 196
COMPANY OVERVIEW 196
PRODUCTS AND SERVICES 196
COMPANY STRATEGY 196
GLAXOSMITHKLINE 197
COMPANY OVERVIEW 197
PRODUCTS AND SERVICES 197
TABLE 56 GSK: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 197
COMPANY STRATEGY 198
JOHNSON and JOHNSON LTD. 198
COMPANY OVERVIEW 198
PRODUCTS AND SERVICES 199
TABLE 57 JOHNSON and JOHNSON: REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 199
COMPANY STRATEGY 199
MERCK and CO. 200
COMPANY OVERVIEW 200
PRODUCTS AND SERVICES 200
TABLE 58 MERCK: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 200
COMPANY STRATEGY 201
NOVARTIS AG 201
COMPANY OVERVIEW 201
PRODUCTS AND SERVICES 202
TABLE 59 NOVARTIS: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 202
COMPANY STRATEGY 202
PFIZER INC. 203
COMPANY OVERVIEW 203
PRODUCTS AND SERVICES 203
TABLE 60 PFIZER: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 203
COMPANY STRATEGY 204
ROCHE LTD. 204
COMPANY OVERVIEW 204
PRODUCTS AND SERVICES 204
TABLE 61 ROCHE: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 205
COMPANY STRATEGY 205
SANOFI-AVENTIS 206
COMPANY OVERVIEW 206
PRODUCTS AND SERVICES 206
TABLE 62 SANOFI-AVENTIS: REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 207
COMPANY STRATEGY 207
TAKEDA PHARMACEUTICALS LTD. 207
COMPANY OVERVIEW 208
PRODUCTS AND SERVICES 208
TABLE 63 TAKEDA PHARMACEUTICALS: REPRESENTATIVE CLINICAL TRIALS
INVOLVING BIOMARKERS 208
COMPANY STRATEGY 208
TEVA PHARMACEUTICAL INDUSTRIES LTD. 209
COMPANY OVERVIEW 209
PRODUCTS AND SERVICES 209
TABLE 64 TEVA PHARMACEUTICAL: REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 210
COMPANY STRATEGY 210

LIST OF TABLES

SUMMARY TABLE GLOBAL BIOMARKERS MARKET, BY SEGMENT, THROUGH 2020 ($
MILLIONS) 7
TABLE 1 GLOBAL BIOMARKERS MARKET, BY SEGMENT, THROUGH 2020 ($ MILLIONS) 12
TABLE 2 GLOBAL MARKET FOR BIOMARKERS, BY SEGMENT, THROUGH 2015 ($
MILLIONS) 13
TABLE 3 GLOBAL BIOMARKERS MARKET GROWTH IN DRUG DISCOVERY, THROUGH
2020 (%) 14
TABLE 4 COMPANION DIAGNOSTICS DEVELOPED IN-HOUSE OR WITH
COLLABORATORS 14
TABLE 5 PERCENTAGE OF CANCER PATIENTS WHO WILL HAVE A PREDICTIVE
BIOMARKER, BY SEGMENT, 2010-2020 (%) 15
TABLE 6 FREQUENCY OF APPROACH IN CLAIMS REVIEW, BY PAYERS, 2013-2020 (%) 16
TABLE 7 RELATIVE IMPORTANCE FOR REIMBURSEMENT DECISIONS BASED ON TEST
FACTORS, 2009-2015 (%) 16
TABLE 8 U.S. HEALTHCARE SPENDING, 2013 (% OF $2.9 TRILLION) 25
TABLE 9 YEAR-OVER-YEAR PRECENT GROWTH IN SPENDING, BY CATEGORY,
2011-2012 AND 2012-2013 (%) 26
TABLE 10 PERSONALIZED TREATMENT OPTIONS FOR BREAST CANCER 29
TABLE 11 CNS BIOMARKERS BY DISEASE/CONDITION 34
TABLE 12 INFORMATION TECHNOLOGY (IT) STRATEGIES 35
TABLE 13 INITIAL DESIGNS AND CAPABILITIES FOR CLINICAL TRIALS 36
TABLE 14 BENEFITS OF BIOMARKERS AS SURROGATE ENDPOINTS 36
TABLE 15 NOVEL DOSE SELECTION BIOMARKERS USED IN CANCER, DIABETES,
METABOLIC AND LIVER DISEASE 39
TABLE 16 PATIENT OUTCOME MEASUREMENTS BIOMARKERS 48
TABLE 17 BIOMARKER AND CLINICAL ENDPOINT ONE 50
TABLE 18 BIOMARKER AND CLINICAL ENDPOINT TWO 51
TABLE 19 BIOMARKER INDICATION OF SEVERITY TO IMPROVE OUTCOME 51
TABLE 20 CLINICAL TRIAL PIPELINE-PHASE OF INTERVENTION DEVELOPMENT 53
TABLE 21 CROSS-SECTIONAL INVESTIGATIONS 61
TABLE 22 GLOBAL BIOMARKERS MARKET, BY SEGMENT, THROUGH 2015 ($
MILLIONS) 65
TABLE 23 CLINICIAL PATIENT MONITORING BY SUBDISEASE (%) 73
TABLE 24 GLOBAL BIOMARKER MARKET, BY SEGMENT, THROUGH 2020 ($ MILLIONS) 79
TABLE 25 PHARMACOGENOMIC BIOMARKERS IN DRUG LABELING 85
TABLE 26 BIOMARKER CATEGORIES AND TYPES 124
TABLE 27 BIOMARKER QUALIFICATION PROGRAM 130
TABLE 28 ANNUAL PATENTS FILED AND APPROVED WITH BIOMARKER CLAIMS IN
U.S., EUROPE, JAPAN, THROUGH 2015 (NO. OF PATENTS) 132
TABLE 29 GLOBAL MARKET FOR TOTAL CLINICAL STAGE BIOMARKERS, BY SEGMENT,
THROUGH 2020 ($ MILLIONS) 133
TABLE 30 SUMMARY OF RECENT AGREEMENTS IN BIOMARKER DELIVERY 134
TABLE 31 REPRESENTATIVE LIST OF APPROVED BIOMARKER PATENTS IN THE U.S.,
EUROPE AND JAPAN 137
TABLE 32 GLOBAL MARKET FOR CLINICAL STAGE BIOMARKERS, BY THERAPEUTIC
AREA, THROUGH 2020 ($ MILLIONS) 144
TABLE 33 REPRESENTATIVE BIOMARKERS IN CLINICAL USE - ONCOLOGY 145
TABLE 34 ONGOING REPRESENTATIVE ACTIVE BIOMARKER TRIALS FOR BREAST
CANCER, 2005-2009 146
TABLE 35 ONGOING REPRESENTATIVE ACTIVE BIOMARKER TRIALS IN ONCOLOGY,
2005-2009 148
TABLE 36 ONGOING REPRESENTATIVE ACTIVE BIOMARKER TRIALS - LUNG CANCER,
2006-2014 149
TABLE 37 REPRESENTATIVE BIOMARKERS IN CLINICAL USE - CNS DISEASE,
2008-2013 151
TABLE 38 REPRESENTATIVE BIOMARKERS IN CLINICAL USE - IMMUNOLOGY, 2013 151
TABLE 39 GLOBAL MARKET FOR CLINICAL STAGE BIOMARKERS, BY SEGMENT,
THROUGH 2020 ($ MILLIONS) 153
TABLE 40 GLOBAL MARKET OF BIOMARKERS IN LATE-STAGE CLINICAL USE BY
THERAPEUTIC AREA, THROUGH 2020 ($ MILLIONS) 153
TABLE 41 RECENT CORPORATE ALLIANCES BETWEEN BIOMARKERS AND DRUG
DEVELOPMENT COMPANIES 156
TABLE 42 ABBOTT: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 172
TABLE 43 AFFYMETRIX: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 174
TABLE 44 ASTELLAS: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 175
TABLE 45 ASTRAZENECA: REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 177
TABLE 46 BANYAN BIOMARKERS REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 178
TABLE 47 BAYER SCHERING: REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 179
TABLE 48 BIOPHYSICAL: REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 183
TABLE 49 BIOSYSTEMS: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 184
TABLE 50 BMS: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 186
TABLE 51 DAIICHI SANKYO: REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 190
TABLE 52 EISAI: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 191
TABLE 53 ELI LILLY: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 192
TABLE 54 EPIGENOMICS: REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 194
TABLE 55 GENEDATA AG: REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 195
TABLE 56 GSK: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 197
TABLE 57 JOHNSON and JOHNSON: REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 199
TABLE 58 MERCK: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 200
TABLE 59 NOVARTIS: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 202
TABLE 60 PFIZER: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 203
TABLE 61 ROCHE: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 205
TABLE 62 SANOFI-AVENTIS: REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 207
TABLE 63 TAKEDA PHARMACEUTICALS: REPRESENTATIVE CLINICAL TRIALS
INVOLVING BIOMARKERS 208
TABLE 64 TEVA PHARMACEUTICAL: REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 210

LIST OF FIGURES

FIGURE TITLE PAGE NO.
SUMMARY FIGURE GLOBAL BIOMARKERS MARKET, BY SEGMENT, 2013-2020 ($
MILLIONS)

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Cardiac Biomarkers: Technologies and Global Markets

Cardiac Biomarkers: Technologies and Global Markets

  • $ 6 650
  • Industry report
  • June 2016
  • by BCC Research

This BCC Research report provides a comprehensive analysis of the cardiac biomarker market and its trends from 2014 through 2020. It details the history and current state of cardiovascular diseases (CVDs), ...

Cardiac Biomarkers Market By Type, By Application, By End Use, By Region And Segment Forecasts to 2024

Cardiac Biomarkers Market By Type, By Application, By End Use, By Region And Segment Forecasts to 2024

  • $ 4 950
  • Industry report
  • September 2016
  • by Grand View Research

The cardiac biomarkers market is expected to reach USD13.3 billion by 2024, according to a new report by Grand View Research, Inc. The cardiac biomarkers market is anticipated to witness a lucrative growth ...

Global Biomarkers Market Analysis & Trends - Industry Forecast to 2025

Global Biomarkers Market Analysis & Trends - Industry Forecast to 2025

  • $ 4 200
  • Industry report
  • June 2016
  • by Accuray Research LLP

The Global Biomarkers Market is poised to grow at a CAGR of around 14.4% over the next decade to reach approximately $92.5 billion by 2025. This industry report analyzes the global markets for Biomarkers ...


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The future of the Genomics Industry in Canada

  • September 2016
    9 pages
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    Genome Sequenci...  

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  • Canada  

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Related Market Segments :

Biomarker

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