Biobanking: Technologies and Global Markets

Biobanking: Technologies and Global Markets


Use this report to:
- Analyze the role biobanks play in the development of new drugs for specific disease treatments.
- Learn about the prevailing market size for certain biobank services available in the general, ever-growing pharmaceutical/biomedical technology market.
- Identify factors influencing the ever-increasing demand for biobanks and significant biobank technologies, repositories and geographies.



Highlights
- The global market for biobanking technologies was valued at $186.3 billion in 2015. This market is expected to increase from $198.2 billion in 2016 to $240.2 billion in 2021 at a compound annual growth rate (CAGR) of 3.9% for 2016-2021.
- The private sector of biobanking is expected to grow from $78.5 billion in 2016 to $93.7 billion in 2021 at a CAGR of 3.6% from 2016 through 2021.
- Population biobanking is expected to grow from $57.8 billion in 2016 to $76.7 billion at a CAGR of 5.8% from 2016 through 2021.



STUDY GOALS AND OBJECTIVES
This is a comprehensive analysis report of the global biobanks market. It reviews various products in the global biobank markets together with projected sales and trends in the industry through 2021. The document offers a range of information, spanning general trends in the industry to detailed analyses of the role biobanks play in the development of new drugs for specific disease treatments.

The information offered in this report is valuable to the reader in quantifying and evaluating the prevailing market size for certain biobank services available in the general, ever-growing pharmaceutical/biomedical technology market. Various data sources, including but not limited to company publications, industry sources and benchmarks, and other sources, have been used to develop trends and forecasts in the biobank industry. Other elements discussed in the paper include: factors influencing the ever-increasing demand for biobanks and significant biobank technologies, repositories and geographies. Evaluation of biotech/pharmaceutical industry markets vs. the government is given a major consideration in the report.



REASONS FOR DOING THE STUDY
Great opportunities in the biobank industry await companies that have deployed effective strategies to invest in this ripe market. As much as this is true, however, the availability of opportunities marks a company’s ability to develop an effective strategy and ends with the effective execution of the strategy to capture profit from it.

In the field of developing new drugs and treatments for particular diseases, the largest opportunities are found in the biobanks market. Introduction of a resource into the biobank market for investigating various combined disease therapies is a critical driver in the pharma/biotech area; this is an element looked into thoroughly by this research. During the forecast period, 2016 to 2021, this element is expected to make a substantial contribution to the growth of the industry. Emerging biobank markets based on particular applications and disease segments are also analyzed in this report.

Emerging geographies are expected to continually drive growth in the global markets. This is attributed to the ever-growing middle-class in emerging countries like Brazil, India, Russia and China. The critical topics required for evaluating emerging technologies and players, changing market dynamics and strategies for accessing particular geographies, disease segments and emerging markets to enable resource allocation and effective decision-making are also addressed in this study.



SCOPE OF REPORT
This report entails forecasted and prevailing biobank products within the 2016 to 2021 period. Biobanks play a critical role in the development of new drugs. The document also features new FDA-approved products in 2015 and 2016, as well as those awaiting approval within the forecast period. The 2016 figures in this report are approximated except in cases where reports of exact results have been released; this is attributed to the timing of this report’s release.

Emerging companies and the leading competitors in the prevailing global Biobanks industry are analyzed extensively in this report. The specific product strategies and products of leading drug manufacturers in the market are analyzed and profiled in the report. Biotechnology companies that utilize biobanks to develop new, novel products are also included in the analysis. New products expected to be introduced in the market within the forecast period and their manufacturers, in addition to their impact on the competitive biobank market are discussed in this report.

The competitive market environment is evaluated with a unique emphasis on the effect of the new technologies and products on the prevailing patient care standard. Emerging companies and current leaders in the market are profiled and discussed in detail. Market figures are founded on the revenue level of the manufacturers and forecast done in the 2016-dollar value. Forecast figures exclude inflation. Parameters like the introduction of new products, forecast sales for prevailing products, expanded indications for prevailing products and forecasted changes in the rates of diagnosis, prevalence and scripting for specific diseases are considered when assessing trends.

Forecasts featured in this report for the period between 2016 and 2021 are based on disease category, product and company. The study is organized for an overview of the biobanks market by geography, company and product. The projections are based on country or geographic region. For every disease sub-segment, the global market is evaluated and data provided.

Consumables that do not require prescription from a physician like over-the-counter (OTC) drugs are not covered in this report. Sales figures are in U.S. dollars, with each reflecting change in revenue performance due to currency fluctuations. Variations in local currencies, however, are not accounted for by the revenue figures. Unless pointed out, all data on market share in the report are on a global basis.



INTENDED AUDIENCE
This report is meant for acquisition specialists, product managers, business planners, investors, licensing strategists, market research analysts, investor consultants and any other persons interested in the biobanks market, industry participants, products and even its future.

The significance of identifying general product opportunities, trends in the market, M&A opportunities and insights and emerging geographies that offer defensive moves or sales growth guidance cannot be overstated in this study for various constituents, including but not limited to:
- Sales and marketing, corporate strategy, R&D and business development aspects of companies that are well-established in this industry shall benefit from this report.
- Emerging biotechnology players in the biobank market must comprehend particular opportunities for out-licensing, sourced from biomarker technology or product differentiation aspects in comparison to leading, emerging and competitive therapies. Market forecasts can also support investments as long as there is in existence detailed and thorough market forecast substantiation, as provided in this report.
- Investment companies analyzing hedged investments or venture capital candidates gain insights on the risks and opportunities present in the industry, a specific analysis of the company and a product.
- Equity analysts have access to detailed forecasts substantiated through quantitative analysis, spanning the next five years, with the ability to support further evaluation of company and product forecasts in the long- and short-term.



ANALYST’S CREDENTIALS
Jackson Highsmith is a life sciences research consultant with more than 16 years of research experience. Jackson has been consulting with specialty pharmaceuticals and large pharmaceutical industry players since 2007. Prior to that, he worked at a large research consultancy, where he focused on in-depth research; he also has worked at a large pharmaceutical company in a wide range of medical therapeutics in early- and mid-stage drug development.



METHODOLOGY AND INFORMATION SOURCES
Leading industry experts, like industry analysts, company executives and top medical practitioners, were interviewed through an in-depth and thorough interviewing process. Various independent segments experiencing fast growth make up the general biobank field. The total market opportunity in every segment makes up both the projected and prevailing markets for completeness reasons. Every relevant growth area and driving mechanism features a detailed forecast in each market segment.

Emerging and participating companies in the biobank market like the National Heart, Lung and Blood Institute and the American Heart Association were the major sources of information used to develop this report. Other sources of information include: published articles in medical journals like Circulation, the American Heart Journal, Lancet and BioBanks Pharmacology Journal, among others; Government agencies and World Health Organizations; annual reports; literature searches; and 10Ks, among others. The U.S. Census Bureau International database was the major source of estimates on population data in this report.

Company disclosures held in the public domain or by the government acted as the major sources of historical and current individual product revenue figures.
TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 2
STUDY GOALS AND OBJECTIVES 2
REASONS FOR DOING THE STUDY 2
SCOPE OF REPORT 2
INTENDED AUDIENCE 3
ANALYST'S CREDENTIALS 4
METHODOLOGY AND INFORMATION SOURCES 4
RELATED REPORTS 5
WEBSITE 5
DISCLAIMER 5
CHAPTER 2 SUMMARY 7
SUMMARY TABLE GLOBAL MARKET FOR BIOBANKS BY SEGMENT, THROUGH 2021
($ BILLIONS) 7
SUMMARY FIGURE GLOBAL MARKET FOR BIOBANKS BY SEGMENT, 2015-2021 ($ BILLIONS) 7
CHAPTER 3 OVERVIEW 11
CURRENT STATE OF THE INDUSTRY 11
THE PROCESS OF BIOBANKING 12
HISTORICAL CONTEXT 12
SCIENTIFIC AND COMMERCIAL RELEVANCE OF BIOBANKS 13
TABLE 1 CUMULATIVE NUMBER OF DNA SAMPLES BANKED IN POPULATION-BASED STUDIES*, 1970-2015 15
TABLE 2 VALUE OF DNA SAMPLES STORED, THROUGH 2021 15
TABLE 3 NIH SPONSORED CLINICAL TRIALS CONDUCTING GENE EXPRESSION PROFILING, 2000-2014* (CUMULATIVE NUMBER OF NIH -SPONSORED CLINICAL TRIALS) 15
Modern Biobanks 16
BIOBANKING COSTS 17
DRIVERS OF BIOBANKS GROWTH 18
RESISTORS OF BIOBANKS GROWTH 19
BIOBANKING TRENDS AND FORECAST 19
THE ROLE OF BIOBANKS IN FUTURE BIOMEDICAL DISCOVERIES 21
CHAPTER 4 OVERVIEW OF BIOBANK APPLICATIONS 25
TABLE 4 GLOBAL MARKET FOR BIOBANKING BY APPLICATION, THROUGH 2021 ($ MILLIONS) 25
BIOMARKERS 25
TABLE 5 SELECTED CANCER BIOBANKS IN THE U.S. 26
TABLE 6 GLOBAL MARKET FOR BIOMARKERS IN LATE STAGE CLINICAL USE BY
THERAPEUTIC AREA, THROUGH 2021 ($ MILLIONS/%) 27
OPPORTUNITIES IN CANCER 27
TABLE 7 APPLICATION OF BIOBANKS IN CANCER TREATMENT 27
TABLE 8 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: ONCOLOGY 32
OPPORTUNITIES IN CARDIOVASCULAR DISEASE 32
TABLE 9 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: CARDIOVASCULAR 33
OPPORTUNITIES IN NEUROLOGICAL DISEASES 35
THE BRAIN AND THE CENTRAL NERVOUS SYSTEM 35
TABLE 10 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: CNS DISEASE 36
OPPORTUNITIES IN IMMUNOLOGY 39
AUTOIMMUNE DISEASES 39
TABLE 11 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: IMMUNOLOGY 40
SYSTEMIC LUPUS ERYTHEMATOSUS 40
ALZHEIMER'S DISEASE 41
OTHER OPPORTUNITIES RESULTING FROM BIOBANKS 41
TARGETED THERAPEUTICS 41
DIAGNOSTIC AND PROGNOSTIC TESTS 42
Diagnostic Tests 43
Prognostic Tests 43
DRUG DEVELOPMENT 44
DISEASE ETIOLOGY 46
CHAPTER 5 CURRENT BIOBANKS WORLDWIDE 49
OVERVIEW 49
TABLE 12 GLOBAL MAJOR BIOBANKS LOCATIONS, BY COUNTRY, 1998-2009 49
TABLE 13 TYPES OF BIOBANKS 49
U.S. BIOBANKS 50
TABLE 14 MAJOR NHLBI COHORT STUDIES 50
TABLE 15 EXAMPLES OF MAJOR DISEASE-BASED BIOBANKS 50
EUROPEAN BIOBANKS 52
THE UNITED KINGDOM 52
UK Biobank 52
Licensed Biobanks in The U.K. 53
TABLE 16 ESTABLISHMENTS LICENSED TO OPERATE BIOBANKS IN THE U.K., 2016 53
TABLE 17 FUNDING SOURCES FOR BIOBANKS LICENSED IN THE U.K. (%) 54
Biobank and Biomolecular Resource Research Infrastructure 54
TABLE 18 COMPOSITE FUNDING METHODS FOR BIOBANKS IN BBMRI COUNTRIES (%) 55
TABLE 19 DISTRIBUTION OF BIOBANKS IN EU COUNTRIES 56
TABLE 20 OWNERSHIP OF EUROPEAN BIOBANKS (%) 57
TABLE 21 ACCESS TO THE EUROPEAN BIOBANK (%) 57
BIOBANKS IN NORTHERN EUROPE 57
Biobanks in Denmark 59
Biobanks in the Baltic Countries 59
INTERNATIONAL BIOBANKS IN OTHER PARTS OF THE WORLD 60
Canadian Partnership for Tomorrow Project 60
Far East Biobanks 60
China Biobank 60
The Qatar Biobank 61
Middle East Biobanks 61
CHAPTER 6 DISEASE-BASED BIOBANKS 63
GROWTH IN DISEASE-BASED BIOBANKS 63
TABLE 22 GROWTH IN DISEASE-BASED BIOBANKS BY THERAPY IN THE U.S., 2007-2014 64
CANCER BIOBANKS 64
BIOBANKS FOR OTHER DISEASES 65
HEALTHY SAMPLE BIOBANKS 67
COLLABORATIVE NETWORKS 68
CORE UK 68
INTERNATIONAL GENOMICS CONSORTIUM 69
CANCER GENOME ATLAS 69
SEGMENT FORECAST 70
CHAPTER 7 POPULATION BASED BIOBANKS 72
INTRODUCTION 72
TYPES OF POPULATION BIOBANKS 72
COHORT STUDIES 73
TABLE 23 SELECTED POPULATION-BASED COHORT BIOBANKS, 1976-2009 73
FOUNDER POPULATION BIOBANKS 75
TABLE 24 FOUNDER POPULATION-BASED BIOBANKS 75
DECODE GENETICS 76
CARTAGENE 76
GENIZON BIOSCIENCES 76
JURILAB 76
NATIONAL POPULATION BIOBANKS 77
UK BIOBANK 77
LIFEGENE 78
ESTONIAN BIOBANK 79
LATVIAN BIOBANK 79
CANADIAN PARTNERSHIP FOR TOMORROW PROJECT 79
OTHER NATIONAL BIOBANKS 79
CHAPTER 8 FOR-PROFIT BIOBANK COMPANIES 82
CONTRACT BIOBANK AND SERVICE PROVIDERS 82
BIOMARKER DISCOVERY COMPANIES 83
PHARMACEUTICAL COLLECTIONS 84
RESEARCH COLLABORATIONS 85
CLINICAL TRIALS 86
CHAPTER 9 THE LIMITATIONS OF BIOBANKS 88
SAMPLE VARIABILITY 89
SAMPLE QUALITY 90
EFFORTS TO INCREASE HARMONIZATION 90
INITIATIVES TO IMPROVE BIOBANKS 92
CHAPTER 10 REGULATORY DYNAMICS, INTELLECTUAL PROPERTY, ETHICAL CONSIDERATIONS 95
INTRODUCTION 95
ROLE OF THE FOOD & DRUG ADMINISTRATION 95
CURRENT REGULATORY FRAMEWORK 96
INFORMED CONSENT 97
WITHDRAWAL AND OWNERSHIP 99
CONFIDENTIALITY 99
COMMERCIALIZATION 100
FDA GUIDELINES FOR BIOMARKER APPLICATIONS 100
TABLE 25 FDA GUIDELINES FOR BIOMARKER APPLICATIONS 101
EUROPEAN MEDICINES AGENCY 102
REGULATORY IMPACT ON DRUG SAFETY 102
INTELLECTUAL PROPERTY AND COMPETITIVE POSITIONING 103
APPROVED PATENT ANALYSIS 103
TABLE 26 GLOBAL ANNUAL PATENTS FILED AND APPROVED WITH BIOMARKER CLAIMS BY REGION, THROUGH 2016 103
COMPETITIVE LANDSCAPE 103
LATE STAGE CLINICAL TRIALS: COMPETITIVE POSITIONING 104
TABLE 27 GLOBAL MARKET FOR CLINICAL STAGE BIOMARKERS BY SERVICES AND PRODUCTS, THROUGH 2021 ($ MILLIONS) 104
TABLE 28 SUMMARY OF RECENT AGREEMENTS IN BIOMARKER DELIVERY 105
TABLE 29 REPRESENTATIVE LIST OF APPROVED BIOMARKER PATENTS IN THE U.S., EUROPE AND JAPAN 106
ETHICAL CONSIDERATIONS 107
SUMMARY 107
REGULATORY IMPLICATIONS 108
CHAPTER 11 BIOBANK MARKETS FORECAST BY SEGMENT AND REGION 110
SUMMARY 110
TABLE 30 GLOBAL MARKET FOR BIOBANKS BY SEGMENT, THROUGH 2021 ($ BILLIONS) 110
GEOGRAPHIC MIX 111
TABLE 31 GLOBAL MARKET SHARE OF BIOBANKS BY REGION, 2015-2021 (%) 111
CHAPTER 12 DETAILED DESCRIPTION OF THE USE OF BIOMARKERS 113
COLORECTAL CANCER 113
CETUXIMAB 113
PANITUMUMAB 114
ELESCLOMOL 115
HERCEPTIN 116
OTHER PREDICTIVE TESTS 116
TABLE 32 CURRENT ACTIVE BIOMARKER TRIALS ONGOING: ONCOLOGY 117
BREAST CANCER 118
MAMMAPRINT 119
TABLE 33 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: BREAST CANCER, 2007-2009 119
ONCOTYPE DX 120
TEST ADOPTION 121
OTHER PROGNOSTIC TESTS 123
HORMONAL THERAPIES 124
TAXANES/ANTHRACYCLINES 125
TRIPLE NEGATIVE BREAST CANCER 126
OTHER NOVEL BIOMARKERS 126
LUNG CANCER 127
INTRODUCTION 127
PREDICTIVE TESTS 128
TABLE 34 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: LUNG CANCER,
2006-2014 128
GEFITINIB 129
ERLOTINIB 130
OTHER PREDICTIVE TESTS 131
NOVEL THERAPIES 132
PROSTATE CANCER 133
OVARIAN CANCER 135
MALIGNANT MELANOMA 136
TABLE 35 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: MALIGNANT MELANOMA, 2006-2016 137
CARDIOVASCULAR 138
TABLE 36 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: CARDIOVASCULAR, 2010-2014 140
CENTRAL NERVOUS SYSTEM 141
TABLE 37 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: CNS DISEASE, 2010-2013 142
TABLE 38 BIOMARKERS/TEST FOR OTHER NEUROLOGICAL DISEASES, 2008-2009 143
IMMUNOLOGY- AUTOIMMUNE DISEASES 143
TABLE 39 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: IMMUNOLOGY, 2009-2014 144
IMMUNOLOGY 144
BENLYSTA: HUMAN GENOME SCIENCES 144
EXPEDITION AND IDENTITY ALZHEIMER'S TRIAL: ELI LILLY 145
CHAPTER 13 COMPANY ANALYSIS 147
ABBOTT LABORATORIES INC. 147
COMPANY OVERVIEW 147
PRODUCTS AND SERVICES 147
TABLE 40 ABBOTT REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 147
COMPANY STRATEGY 148
AFFYMETRIX, INC. 148
COMPANY OVERVIEW 148
PRODUCTS AND SERVICES 148
COMPANY STRATEGY 149
ASTERAND PLC 149
COMPANY OVERVIEW 149
PRODUCTS AND SERVICES 150
TABLE 41 ASTERAND PRODUCTS OVERVIEW BY TYPE OF BIOBANK 150
COMPANY STRATEGY 150
ASTRAZENECA LTD 150
COMPANY OVERVIEW 150
PRODUCTS AND SERVICES 150
TABLE 42 ASTRAZENECA REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 151
COMPANY STRATEGY 151
BAYER SCHERING PHARMA AG 151
COMPANY OVERVIEW 152
PRODUCTS AND SERVICES 152
COMPANY STRATEGY 152
BIOCHAIN-GENOMICS 153
COMPANY OVERVIEW 153
PRODUCTS AND SERVICES 153
TABLE 43 BIOCHAIN-GENOMICS' PRODUCTS OVERVIEW BY TYPE OF BIOBANK 153
COMPANY STRATEGY 153
BIOSTORAGE TECHNOLOGIES, INC. 154
COMPANY OVERVIEW 154
PRODUCTS AND SERVICES 154
TABLE 44 BIOSTORAGE TECHNOLOGIES' PRODUCTS OVERVIEW BY TYPE OF
BIOBANK 154
COMPANY STRATEGY 155
BOEHRINGER INGELHEIM GMBH 155
COMPANY OVERVIEW 155
PRODUCTS AND SERVICES 155
COMPANY STRATEGY 155
BRISTOL-MYERS SQUIBB CO 156
COMPANY OVERVIEW 156
PRODUCTS AND SERVICES 156
TABLE 45 BMS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 156
COMPANY STRATEGY 157
DAIICHI SANKYO COMPANY, LTD 157
COMPANY OVERVIEW 157
PRODUCTS AND SERVICES 157
COMPANY STRATEGY 158
ELI LILLY AND COMPANY 158
COMPANY OVERVIEW 159
PRODUCTS AND SERVICES 159
TABLE 46 ELI LILLY REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 159
COMPANY STRATEGY 160
EXIQON LIFE SCIENCES 160
COMPANY OVERVIEW 160
PRODUCTS AND SERVICES 160
TABLE 47 EXIQON PRODUCTS OVERVIEW BY TYPE OF BIOBANK 160
COMPANY STRATEGY 161
GLAXOSMITHKLINE 161
COMPANY OVERVIEW 161
PRODUCTS AND SERVICES 162
TABLE 48 GSK REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 162
COMPANY STRATEGY 162
JOHNSON & JOHNSON LTD 163
COMPANY OVERVIEW 163
PRODUCTS AND SERVICES 163
COMPANY STRATEGY 163
MILLENNIUM PHARMACEUTICALS 164
COMPANY OVERVIEW 164
PRODUCTS AND SERVICES 164
TABLE 49 MILLENNIUM PRODUCTS OVERVIEW BY TYPE OF BIOBANK 164
COMPANY STRATEGY 164
MERCK & CO. 165
COMPANY OVERVIEW 165
PRODUCTS AND SERVICES 165
TABLE 50 MERCK REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 166
COMPANY STRATEGY 166
NOVARTIS AG 166
COMPANY OVERVIEW 167
PRODUCTS AND SERVICES 167
TABLE 51 NOVARTIS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 167
COMPANY STRATEGY 167
PFIZER INC 168
COMPANY OVERVIEW 168
PRODUCTS AND SERVICES 168
TABLE 52 PFIZER REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 168
COMPANY STRATEGY 169
F. HOFFMAN-LA ROCHE AG 169
COMPANY OVERVIEW 169
PRODUCTS AND SERVICES 169
TABLE 53 ROCHE REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 170
COMPANY STRATEGY 170
SANOFI-AVENTIS 170
COMPANY OVERVIEW 171
PRODUCTS AND SERVICES 171
TABLE 54 SANOFI-AVENTIS REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS 172
COMPANY STRATEGY 172
SCIPAC 173
COMPANY OVERVIEW 173
PRODUCTS AND SERVICES 173
TABLE 55 SCIPAC PRODUCTS OVERVIEW BY TYPE OF BIOBANK 173
COMPANY STRATEGY 173
TAKEDA PHARMACEUTICALS LTD 174
COMPANY OVERVIEW 174
PRODUCTS AND SERVICES 174
COMPANY STRATEGY 174
TEVA PHARMACEUTICAL INDUSTRIES LTD. 175
COMPANY OVERVIEW 175
PRODUCTS AND SERVICES 175
COMPANY STRATEGY 176



LIST OF TABLES


SUMMARY TABLE GLOBAL MARKET FOR BIOBANKS BY SEGMENT, THROUGH 2021 ($ BILLIONS) 7
TABLE 1 CUMULATIVE NUMBER OF DNA SAMPLES BANKED IN POPULATION-BASED STUDIES*, 1970-2015 15
TABLE 2 VALUE OF DNA SAMPLES STORED, THROUGH 2021 15
TABLE 3 NIH SPONSORED CLINICAL TRIALS CONDUCTING GENE EXPRESSION PROFILING, 2000-2014* (CUMULATIVE NUMBER OF NIH -SPONSORED CLINICAL TRIALS) 15
TABLE 4 GLOBAL MARKET FOR BIOBANKING BY APPLICATION, THROUGH 2021 ($ MILLIONS) 25
TABLE 5 SELECTED CANCER BIOBANKS IN THE U.S. 26
TABLE 6 GLOBAL MARKET FOR BIOMARKERS IN LATE STAGE CLINICAL USE BY THERAPEUTIC AREA, THROUGH 2021 ($ MILLIONS/%) 27
TABLE 7 APPLICATION OF BIOBANKS IN CANCER TREATMENT 27
TABLE 8 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: ONCOLOGY 32
TABLE 9 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: CARDIOVASCULAR 33
TABLE 10 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: CNS DISEASE 36
TABLE 11 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: IMMUNOLOGY 40
TABLE 12 GLOBAL MAJOR BIOBANKS LOCATIONS, BY COUNTRY, 1998-2009 49
TABLE 13 TYPES OF BIOBANKS 49
TABLE 14 MAJOR NHLBI COHORT STUDIES 50
TABLE 15 EXAMPLES OF MAJOR DISEASE-BASED BIOBANKS 50
TABLE 16 ESTABLISHMENTS LICENSED TO OPERATE BIOBANKS IN THE U.K., 2016 53
TABLE 17 FUNDING SOURCES FOR BIOBANKS LICENSED IN THE U.K. (%) 54
TABLE 18 COMPOSITE FUNDING METHODS FOR BIOBANKS IN BBMRI COUNTRIES (%) 55
TABLE 19 DISTRIBUTION OF BIOBANKS IN EU COUNTRIES 56
TABLE 20 OWNERSHIP OF EUROPEAN BIOBANKS (%) 57
TABLE 21 ACCESS TO THE EUROPEAN BIOBANK (%) 57
TABLE 22 GROWTH IN DISEASE-BASED BIOBANKS BY THERAPY IN THE U.S., 2007-2014 64
TABLE 23 SELECTED POPULATION-BASED COHORT BIOBANKS, 1976-2009 73
TABLE 24 FOUNDER POPULATION-BASED BIOBANKS 75
TABLE 25 FDA GUIDELINES FOR BIOMARKER APPLICATIONS 101
TABLE 26 GLOBAL ANNUAL PATENTS FILED AND APPROVED WITH BIOMARKER CLAIMS BY REGION, THROUGH 2016 103
TABLE 27 GLOBAL MARKET FOR CLINICAL STAGE BIOMARKERS BY SERVICES AND PRODUCTS, THROUGH 2021 ($ MILLIONS) 104
TABLE 28 SUMMARY OF RECENT AGREEMENTS IN BIOMARKER DELIVERY 105
TABLE 29 REPRESENTATIVE LIST OF APPROVED BIOMARKER PATENTS IN THE U.S., EUROPE AND JAPAN 106
TABLE 30 GLOBAL MARKET FOR BIOBANKS BY SEGMENT, THROUGH 2021 ($ BILLIONS) 110
TABLE 31 GLOBAL MARKET SHARE OF BIOBANKS BY REGION, 2015-2021 (%) 111
TABLE 32 CURRENT ACTIVE BIOMARKER TRIALS ONGOING: ONCOLOGY 117
TABLE 33 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: BREAST CANCER, 2007-2009 119
TABLE 34 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: LUNG CANCER, 2006-2014 128
TABLE 35 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: MALIGNANT MELANOMA, 2006-2016 137
TABLE 36 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: CARDIOVASCULAR, 2010-2014 140
TABLE 37 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: CNS DISEASE, 2010-2013 142
TABLE 38 BIOMARKERS/TEST FOR OTHER NEUROLOGICAL DISEASES, 2008-2009 143
TABLE 39 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: IMMUNOLOGY, 2009-2014 144
TABLE 40 ABBOTT REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 147
TABLE 41 ASTERAND PRODUCTS OVERVIEW BY TYPE OF BIOBANK 150
TABLE 42 ASTRAZENECA REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 151
TABLE 43 BIOCHAIN-GENOMICS' PRODUCTS OVERVIEW BY TYPE OF BIOBANK 153
TABLE 44 BIOSTORAGE TECHNOLOGIES' PRODUCTS OVERVIEW BY TYPE OF BIOBANK 154
TABLE 45 BMS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 156
TABLE 46 ELI LILLY REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 159
TABLE 47 EXIQON PRODUCTS OVERVIEW BY TYPE OF BIOBANK 160
TABLE 48 GSK REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 162
TABLE 49 MILLENNIUM PRODUCTS OVERVIEW BY TYPE OF BIOBANK 164
TABLE 50 MERCK REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 166
TABLE 51 NOVARTIS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 167
TABLE 52 PFIZER REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 168
TABLE 53 ROCHE REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 170
TABLE 54 SANOFI-AVENTIS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS 172
TABLE 55 SCIPAC PRODUCTS OVERVIEW BY TYPE OF BIOBANK 173



LIST OF FIGURES

SUMMARY FIGURE GLOBAL MARKET FOR BIOBANKS BY SEGMENT, 2015-2021 ($ BILLIONS) 7