An estimated $1bn has been invested in the biobank industry within the last ten years
Biobanks collect and store human biospecimens, playing a vital role in the development of novel drugs and diagnostics. In recent years, large population-based biobanks have been established which monitor the health status of participants over time to assess the natural occurrence and progression of common diseases. Hundreds of disease-based biobanks are located around the world, which are a valuable resource for biomarker discovery as well as for studying progression, mortality and responses to treatment.
‘The Future of Biobanks’ is a report published by Business Insights that examines major trends in the biobanking industry and identifies the key initiatives to upgrade the biobanking infrastructure. This report explores the applications of biobanks and provides examples of how large sets of high-quality biosamples are creating new ways to diagnose, prevent and treat diseases. The activities of over 180 US biobanks are assessed to illustrate how the scale and scope of biobanking is changing. This report also evaluates the limitations of biobanks, in addition to reviewing the unique legal, regulatory and ethical issues that surround this new frontier of biomolecular research.
Key Findings
• A number of new, high-quality biobanks will accelerate the development of personalized diagnostics and therapeutics over the next decade.
• Increased co-operation between biobanks can advance this progression, although many scientific and political barriers must be overcome.
• An estimated $1bn has been invested in the biobanking industry within the last ten years. The first advances are expected to result in the improved treatment of cancer, and progression for a range of other common diseases will follow.
• Recently established biobanks have reached unprecedented levels of scale, particularly the Taizhou project in China. Studies conducted on the entire population of a country may soon be possible.
• At least 179 biobanks with 345,000 donors exist in the US, most of which were established in the last 10 years.
• As biotechnology companies’ biobanking assets mature in terms of the number of samples collected their R&D productivity and the number of products available for outsourcing will increase
Use this report to...
• Assess the strengths and limitations of biobanks and understand their scientific and commercial relevance with this report’s analysis of biobank-enabled targeted therapeutics and diagnostic/prognostic tests.
• Analyze growth in disease-based biobanks by using this report’s unique review of 180 US-based biobanks by disease type and gain insights into the collaborative networks that can leverage greater sample sizes.
• Evaluate major founder/national population biobanks and gain insights into private sector biobanking with this report’s examination of contract service providers, biomarker discovery companies, pharma collections and research collaborations.
• Review developments in the regulatory framework for biobanking and understand ethical issues including informed consent, withdrawal and ownership, confidentiality and commercialization.
Explore issues including...
• Biobanking expansion. The falling cost of genomic technologies is expanding the scale and scope of biobanking research. This has already resulted in the development of several new diagnostic tests that can improve risk assessment and treatment decisions.
• Potential for personalised medicine. Very few personalized medicines exist, but the creation of large sets of high-quality biosamples should widen the clinical application of new personalized products and services.
• Legal and ethical issues. Although the legal and ethical frameworks that govern biobanking are still evolving, many major issues such as ownership and commercialization are now largely addressed during the consent process.
• Cost of national biobanks. National biobanks have been established in several countries, although their value has been questioned. Conducting large-scale population studies requires significant investment, due to the extremely large collections of biosamples and data involved (including relevant medical history, lifestyle and environmental information).
Discover...
• Why are biobanks a critical resource?
• Which types of biobank are most common?
• What are the most common disadvantages of biobanks?
• Which major drug developers have invested in biobanks?
• What are the major uncertainties surrounding the future of biobanks?
• What growing trend could boost biobanking?
• When will the benefits of biobanking be realized?
Table of Contents
The Future of Biobanks Executive summary 8
Overview 8
Biobanking trends 9
Population-based biobanks 10
Disease-based biobanks 11
Private-sector biobanks 12
Regulatory and ethical issues 13
Chapter 1 Overview 16
Summary 16
Introduction 17
Definition of biobanks 17
Historical context 18
Scientific and commercial relevance of biobanks 21
Targeted therapeutics 24
Diagnostic and prognostic tests 26
Drug development 30
Disease etiology 31
Future outlook 32
Chapter 2 Trends in biobanking 36
Introduction 36
Introduction 37
The limitations of biobanks 37
Initiatives to improve biobanks 39
Sample variability 42
Sample quality 44
Older biobanks 45
Modern biobanks 47
Biobanking costs 51
Increasing harmonization 53
Future outlook 55
Chapter 3 Population-based biobanks 60
Introduction 60
Introduction 61
Types of population biobanks 61
Cohort studies 63
Founder population biobanks 66
deCODE Genetics 66
CARTaGENE 68
Genizon Biosciences 68
Jurilab 69
National population biobanks 70
UK Biobank 70
LifeGene 73
Estonian biobank 74
Latvian biobank 75
Canadian Partnership for Tomorrow Project 75
Other national biobanks 76
Future outlook 78
Chapter 4 Disease-based biobanks 80
Introduction 80
Introduction 81
Growth in disease-based biobanks 81
Cancer biobanks 82
Other diseases 84
Healthy sample biobanks 88
Collaborative networks 89
onCORE UK 90
International Genomics Consortium 91
Cancer Genome Atlas 91
Future outlook 93
Chapter 5 Private-sector biobanks 96
Introduction 96
Introduction 97
Licensed biobanks in the UK 97
Contract service providers 99
Biomarker discovery companies 104
Pharmaceutical collections 105
Research collaborations 107
Clinical trials 108
Future outlook 110
Chapter 6 Regulatory and ethical issues 112
Summary 112
Introduction 113
Current regulatory framework 113
Informed consent 114
Withdrawal and ownership 120
Confidentiality 121
Commercialization 123
Future outlook 124
Appendix 126
Methodology 126
Index 127
List of Figures
Figure 1.1: Cumulative number of DNA samples banked in population-based studies*, 1970-2009 21
Figure 1.2: NIH sponsored clinical trials conducting gene expression profiling, 2000-08 24
Figure 2.1: Geographical distribution of biobanks 49
Figure 2.2: Drivers and resistors 51
Figure 2.3: The evolution of biobanks 56
Figure 4.1: Number of diseases-based biobanks, by therapy area, US 1995-2008 82
Figure 5.1: Establishments licensed to operate biobanks, by sector, England, Wales and Northern
Ireland, 2008 98
Figure 5.2: Examples of private-sector biobanks 104
List of Tables
Table 1.1: Applications of biobanks 27
Table 2.1: Types of biobanks 48
Table 3.1: Selected population-based cohort studies 65
Table 3.2: Population-based biobanks 75
Table 4.1: Selected cancer biobanks, US 84