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Biobanking for Medicine Technology, Industry and Market 2014-2024


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For an Executive Summary of this report please contact (+44 (0)20 7549 9976) or refer to our website …

For an Executive Summary of this report please contact (+44 (0)20 7549 9976) or refer to our website

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  • 1. ©notice This material is copyright by visiongain. It is against the law to reproduce any of this material without the prior written agreement of vision- gain. You cannot photocopy, fax, download to database or duplicate in any other way any of the material contained in this report. Each pur- chase and single copy is for personal use only. Biobanking for Medicine: Technology, Industry and Market 2014-2024
  • 2. Contents 1.1 What Does This Report Cover? 1.1.1 The Human Tissue Banking Market – Our Definition 1.1.2 The Stem Cell Banking Market – Our Breakdown 1.2 Biobanking for Medicine: Technology, Industry and Market 2014-2024 Overview 1.3 Chapter Outlines 1.4 Speculative Aspects of Assessing the Biobanking Market 1.5 Research and Analysis Methods 1.6 Glossary of Terms in this Report 2.1 What is Biobanking? 2.2 Main Features of Biobanks 2.3 What Processes are Involved in Biobanking? 2.4 Classification of Biobanks: Tissue Type, Volunteer Group and Ownership Classification Models 2.4.1 Volunteer Group: Population- vs. Disease-Based 2.4.2 Ownership Structure: Public vs. Private 2.5 The Guidelines and Standards for Biobanking 2.6 Laws and Regulations for Biobank-Based Research 2.6.1 HIPAA Amendments 2.7 Biobanking and the Pharmaceutical Industry 2.7.1 Biobanking in Research, Drug Discovery and Development 2. Introduction to Biobanking and its Applications 1. Executive Summary
  • 3. Contents Understanding Disease Pathways Drug Discovery Biomarker Discovery in Drug Development 2.7.2 Biobanking for Therapeutics 2.7.3 Biobanking in Clinical Trials 3.1 The World Biobanking for Medicine Market in 2013 3.2 Biobanking for Medicine: Research vs. Therapeutics in 2018 and 2024 3.3 World Biobanking for Medicine Market: Overarching Revenue Forecast 2014-2024 3.4 Biobanks Stored Almost 1.3 Billion Specimens in 2013, and That Figure Increases 3.5 The Biobanking for Medicine Market by Sector: Grouped Revenue Forecasts 2014-2024 3.6 Biobanking for Research: A $10bn Industry 3.6.1 Biobanking for Research: Revenue Forecast 2014-2024 3.6.2 Driving Forces Outweigh Restraints on the Biobanking Industry for Research 3.7 Biobanking for Future Therapeutic Use: A Worthwhile Endeavour or a Waste of Money? 3.7.1 Arguments Against Commercial Stem Cell Banking for Therapeutic Purposes 3.7.2 Biobanking for Future Therapeutic Use: Revenue Forecast 2014-2024 3.7.3 Driving and Restraining Forces Influencing the Biobanking Market for Therapeutic Use, 2014-2024 4.1 Breakdown of the Biobanking for Research Market by Tissue Type, 2013 4. Biobanking for Research Purposes 3. Biobanking for Medicine: World Market 2014-2024
  • 4. Contents 4.2 Biobanking for Research in 2018 and 2024: Comparison by Tissue Type 4.3 Biobanking for Research by Tissue Type: Grouped Revenue Forecasts 2014-2024 4.4 How Many Specimens are Biobanked for Research? 4.5 The Human Tissue Banking Market for Research in 2013 4.6 The Human Tissue Banking Market for Research: Revenue Forecast 2014-2024 4.7 The Human Tissue Banking Market: Commercial vs. Public Sector 4.7.1 Commercial Human Tissue Banks: Revenue Forecast 2014-2024 4.7.2 Public Sector Human Tissue Banks: Revenue Forecast 2014-2024 4.8 The Stem Cell Banking Market for Research in 2013 4.9 The Stem Cell Banking Market for Research: Revenue Forecast 2014-2024 4.9.1 A Shift in R&D Towards Stem Cells 4.10 Banking of Other Biologic Specimens for Research in 2013 4.11 Banking of Other Biologic Specimens for Research: Revenue Forecast 2014-2024 5.1 Stem Cell Banking for Therapeutic Use in 2013: A Breakdown by Stem Cell Type 5.2 Stem Cell Banking for Therapeutic Use by Stem Cell Type: Comparison of Revenue and Market Share, 2018 and 2024 5.3 Stem Cell Banking for Therapeutic Use by Stem Cell Type: A Grouped Revenue Forecast 5.4 How Many Stem Cell Samples Are Biobanked Each Year? 5.5 The Umbilical Cord Blood Banking Market in 2013 5.5.1 Private vs. Public Cord Blood Banking 5.5.2 Umbilical Cord Blood Banking: The Controversies 5.6 The Umbilical Cord Blood Banking Market: Revenue Forecast 2014-2024 5. Stem Cell Banking for Future Therapeutic Use
  • 5. Contents 5.7 The Adult Stem Cell Banking Market in 2013 5.8 The Adult Stem Cell Banking Market: Revenue Forecast 2014-2024 6.1 The Geographical Footprint of Biobanking 6.1.1 Biobanking in Europe: Leading the World with Biobanking Networks and Infrastructure 6.1.2 Biobanks in the US: A Fragmented Picture 6.1.3 Biobanking in Asia: A Region Rapidly Gaining Prominence 6.2 Biobanking for Medicine: The US Led the Way in 2013 6.3 The Leading National Markets: A Grouped Revenue Forecast 2014-2024 6.4 How Will Regional Market Shares Change to 2024? 6.5 The US Biobanking Market 2014-2024: Diversifying and Expanding 6.6 The Leading European Biobanking Markets 2014-2024: Leading the Way in Biobanking Infrastructure 6.6.1 Germany: An Advanced Industry with 74 Biobanks Associated with the BBMRI 6.6.2 France: Restrictions on Private Stem Cell Banking Limit the Market 6.6.3 Italy: Is the Limited Private Stem Cell Banking Market Off-Set by Strong Biobanking Networks for Research? 6.6.4 UK: 215 Biobanks Were Licensed Under the HTA in 2013 6.6.5 Spain: Controversy Between Private and Public Umbilical Cord Blood Banks 6.6.6 The Netherlands is Characterised by Comprehensive Biobanking Networks 6.7 The Japanese Biobanking Market 2014-2024: A High Level of Government Investment Drives Growth 6. Leading National Markets 2014-2024
  • 6. Contents 6.8 The Biobanking Industry in the BRIC Countries: High Growth and Increasing Market Share Between 2014 and 2024 6.8.1 The Chinese Biobanking Market 2014-2024: The High Rate of Growth Will Continue 6.8.2 The Indian Biobanking Market 2014-2024: Set to Become the Leading Market for Private Stem Cell Banking? 6.8.3 The Brazilian Biobanking Market 2014-2024: Will New Regulations Drive or Restrain the Market? 6.8.4 Russia: Ban on the Import and Export of Human Tissue and Genetic Information Restricts the Market, But Can This Be Overcome from 2014-2024? 7.1 The Biobanking-Associated Market: Overview 7.2 Systems Technology: Fully Automated Handling 7.2.1 Automated Liquid Handling Systems 7.2.2 Frozen Aliquotting: Patented Technology From CryoXtract 7.2.3 Automated DNA Isolation 7.3 Storage Technology: The Most Important Component of Biobanking? 7.3.1 Dry State, Room Temperature Storage Eliminates the Need for Expensive, Energy- Consuming Freezers 7.3.2 Ultra-Low Temperature Freezers: Is Their Use Declining? 7.3.3 Cryopreservation: Mechanical vs. Liquid/ Vapour Phase Nitrogen 7.3.4 Automated Storage and Retrieval Systems: Essential Technology 7.3.5 RFID and Tagging Technology: Advantages over Barcodes 7. Technology for Biobanking: Systems, Software, Consumables and Services Associated With Biobanking
  • 7. Contents 7.4 Software for Biobanks 7.4.1 Laboratory Information Management System (LIMS): Unmet Needs in the Market Remain, Despite Recent Advances 7.4.2 LIMS Functions 7.5 Consumables: High Quality Required for Effective Sample Management 7.5.1 Addressing Sample Storage and Tracking Issues 7.6 Biobanking Services: Storage, Management and Transport of Biologic Samples for a Fee 8.1 The Differing Business Models of Biobanking Companies: Sourcing vs. Storing 8.2 Commercial Biobanks for Research Purposes in 2013 8.2.1 Tissue Solutions: A Virtual Biobank with a Global Presence An Overview of the Products and Services Offered by Tissue Solutions Banked Samples Occur in Many Formats Prospective Tissue Collection for Hard-to-Find Samples Fresh Samples from Surgical Resections are in High Demand Freshly Isolated Human Cells are a Valuable Research Tool FDA/ EMA Panel of Normal Tissues Strengths, Capabilities and the Future Outlook for Tissue Solutions 8.2.2 Asterand is now Part of Stemgent Asterand’s Products and Services: XpressBANK, ProCURE and PhaseZERO 8.2.3 Biopta Provides Fresh Human Tissues, for Which Demand is Growing Services From Biopta: Fresh Tissue Sample Procurement and a Variety of Lab Services 8. Leading Companies in the Biobanking Market
  • 8. Contents The First Catalogue of Assays Based on Human Functional Tissues The Future Outlook for Biopta 8.2.4 BioServe: One of the World’s Largest Commercial Biorepositories BioServe Offers a Comprehensive List of Services: Biobanking, Sourcing and Preclinical Molecular Services The Future Outlook for BioServe 8.2.5 Coriell Institute for Medical Research: Reportedly the Largest Biobank in the World Features of Coriell Biobank Future Outlook for the Coriell Biobank 8.3 Prominent Biobanks for Therapeutic Use in 2014 8.3.1 Cord Blood America: Expansion into the Emerging Markets Apparently Stalled 8.3.2 Cryo-Cell International: The First Private Cord Blood Bank in the Market 8.3.3 Cryo-Save’s Educational Programme Benefits Company’s Growth 8.3.4 China Cord Blood Corp: The Only Cord Blood Bank in China with Multiple Licences 8.3.5 LifebankUSA: Placental and Cord Blood Banking Means a Significant Survival Advantage in Transplant Patients 8.3.6 ViaCord: More Blood Units Released for Therapy than Any Other Family Bank 8.3.7 Cord Blood Registry: The World’s Largest Newborn Stem Cell Company, Accounting for 3% of the Private Stem Cell Banking Industry 8.3.8 Biogenea Pharmaceuticals: A Comprehensive Offering of Stem Cell Banking Services across the Balkan Peninsula 8.3.9 StemLife is Facing Challenges due to Government Regulations in Malaysia 8.3.10 Future Health Biobank: A Strong Market Presence Owing to International Operations 8.3.11 NeoStem Operates a Multi-Faceted Business Strategy 8.3.12 Precious Cells is Well Positioned to Take Advantage of the Growing Demand in India
  • 9. Contents 9.1 Industry Trends 9.1.1 The Growing Demand for Biobank Resources for Research 9.1.2 The Establishment of Biobanking Networks BBMRI: The Most Extensive Biobank Network 9.1.3 Virtual Biobanks: Connecting a Fragmented Industry 9.1.4 Commercial Biobanks as Intermediaries: New Resources for Research 9.1.5 Automated Biobanking Has Become Imperative 9.1.6 Increasing Uptake of LIMS 9.1.7 Green Banking – Becoming More Energy Efficient 9.2 The Strengths and Weaknesses of the Biobanking Market in 2014 9.2.1 HBS are Valuable Resources for R&D 9.2.2 Governmental Support for Biobanking Forms a Strength of that Industry 9.2.3 Development of Potential Novel Stem Cell Therapies has Increased Public Awareness of Stem Cell Banking 9.2.4 Insufficient Accessible Numbers of High Quality Biospecimens 9.2.5 Biobanks are Fragmented and Uncoordinated 9.2.6 Lack of Standardisation is a Weakness of the Industry 9.2.7 Lack of Public Awareness Limits Number of Donors 9.2.8 Lack of Engagement with Public Health Services Limits the Stem Cell Banking Market 9.3 Opportunities and Threats Facing the Biobanking Market, 2014-2024 9.3.1 Increasing Use of Biobanked Specimens in Genome-Wide Association Studies (GWAS) 9.3.2 Increasing Demand for Biobanked Samples for Preclinical Research 9. Qualitative Analysis of the Biobanking Industry and Market 2014- 2024
  • 10. Contents 9.3.3 Biobanking Networks as a Basis for Personalised Medicine 9.3.4 Options for Adult Stem Cell Banking Mean an Increasing Target Population for Private Stem Cell Banks 9.3.5 Even With Governmental Funding, Biobanks Must Become Self-Sufficient to Thrive Long Term 9.3.6 Public Concerns over Confidentiality and Security Threaten Availability of Donors 9.3.7 Limitations Surrounding Informed Consent 9.4 Social, Technological, Economic and Political Factors (STEP) Influencing the Biobanking Industry, 2014-2024 10.1 Interview with Dr Kirstin Goldring, Biobank and BioResource Coordinator, University College London, UK 10.1.1 On the Size of the UCL Biobank and How its Growing 10.1.2 On Users of UCL Biobank 10.1.3 On the Increasing Demand for Biobanked Samples 10.1.4 On Technology Used at UCL Biobank 10.1.5 On the Cost of Access to Samples 10.1.6 Concerns, Challenges and Restraining Factors 10.1.7 The Future of Biobanking 10.2 Interview With Dr Husein Salem, Chief Executive Officer, Precious Cells BioBank, London 10.2.1 On the Increasing Demand for Stem Cell Banking Services 10.2.2 On Novel Stem Cell Therapies in Development 10.2.3 Storage of Adult Stem Cells vs. Storage of Umbilical Cord Blood 10. Research Interviews from Our Survey
  • 11. Contents 10.2.4 On the Demand for Stem Cell Banking in Different Countries 10.2.5 On Challenges in the Industry 10.2.6 On Technology Used at Precious Cells 10.2.7 On Unmet Needs in the Stem Cell Banking Industry 10.2.8 On the Future of Stem Cell Banking 10.3 Interview with Dr David Bunton, CEO and Co-Founder, Biopta Ltd. 10.3.1 One the Use of Human Tissue Samples by Biopharmaceutical Companies 10.3.2 Human Tissue vs. Stem Cells 10.3.3 On the Technology Used in Biobanks 10.3.4 On the Future of the Biobanking Market 10.4 Interview with Dr Michael Leek, Commercial Operations Director, Pharmacells 10.4.1 On the Recent Increase in Stem Cell Banking Activity 10.4.2 On the Services of Pharmacells 10.4.3 On Adult Stem Cell Banking vs. Umbilical Cord Blood Banking 10.4.4 On Challenges Facing the Stem Cell Banking Market 10.4.5 On the Technology Used by Pharmacells 10.4.6 On the Future of the Market 10.5 Interview with Dr Tetsuro Wakatsuki, Chief Scientific Officer, InvivoSciences Inc. 10.5.1 On the Services Provided by InvivoSciences 10.5.2 On the Future of this Biobanking-Associated Market 11.1 World Biobanking Market 2014-2024: High Revenue Growth Predicted 11. Conclusions from the Research and Analysis
  • 12. Contents 11.2 Biobanking for Research 2014-2024: The Value of Biobanked Specimens is Increasingly Recognised 11.3 Biobanking for Therapeutic Use 2014-2024: Rapid Expansion in Adult Stem Cell Banking 11.4 The Leading National Markets: High Sales Growth Worldwide 11.5 Current and Future Trends in Biobanking 11.5.1 Increasing Demand for Biobanked Samples Means Increasing Revenue 11.5.2 Improving Biobanking Infrastructure Engenders Growth 11.5.3 Marked Challenges, but Opportunities for Expansion
  • 13. Page 76 Biobanking for Medicine: Technology, Industry and Market 2014-2024 4.5 The Human Tissue Banking Market for Research in 2013 According to industry estimates, between 80 and 90% of compounds in clinical trials fail, even after many years of preclinical testing in animal models. Additionally, the biopharmaceutical industry does not have suitable animal models for some somal, psychiatric and neurological disorders. The pharmaceutical industry is accepting the fact that drug response in animals is only a partial guide to responses in human beings, and is moving towards the use of human tissue samples stored in biobanks for preclinical testing. More and more people are realising the potential benefits of testing on human samples in the drug development process. The human tissue banking market is also expanding to include fresh, functional human tissues. Rather than being stored, such tissues are procured on-demand directly from hospitals, often from patients undergoing biopsy or surgery for example. We include such activity in our definition of human tissue banking. One advantage of using human tissue in comparison to cell lines or stem cells is that you can work with the disease phenotype; you can establish the efficacy of the drug in its diseased target tissue. This is more indicative of response in vivo and helps pharmaceutical companies make important stop/go decisions earlier in the drug development process, saving a lot of money if that drug were to be ineffective. Human tissue is also a popular specimen type since DNA or RNA for example can then be extracted for further analysis. In 2013, the human tissue banking market for research generated $3.37bn, accounting for 33.57% of the total biobanking market for research. 4.6 The Human Tissue Banking Market for Research: Revenue Forecast 2014-2024 Table 4.5 The Human Tissue Banking Market: Revenue ($bn) and Market Share (%) Forecast, 2013-2024 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 Market Share (%) 33.57 34.97 36.19 37.77 39.32 40.68 41.78 42.66 43.23 43.67 44.16 44.40 Revenue ($bn) 3.37 3.91 4.53 5.31 6.15 7.02 7.86 8.72 9.51 10.27 10.99 11.65 AGR (%) 16 16 17 16 14 12 11 9 8 7 6 CAGR (%) 15.80 8.81 The human tissue banking market for research will grow rapidly between 2013 and 2018, expanding at a CAGR of 15.8% (Table 4.5). This growth will be driven by the increasing use of human tissues in drug discovery and development, as well as disease biomarker discovery. The demand for more specific and fresh tissue will increase, which will be one of the main growth Source: visiongain 2014 CAGRs cover 2013-2018 and 2018-2024
  • 14. Page 77 Biobanking for Medicine: Technology, Industry and Market 2014-2024 drivers of this market. Increasingly, researchers and scientists are realising the benefits of human tissue samples. There is a high level of inter-patient variability in drug responses and most non-clinical assays used to predict efficacy do not take this into account. Using human tissues, clinical efficacy and patient variability can be predicted and the responders and non-responders identified. Tissue samples have the potential to cater to specific inclusion and exclusion criterions of clinical studies. Therefore, the use of human tissue in research is an important factor in the efforts towards personalised medicine. However, the industry is limited by the lack of standardisation among biobanks. The supporting demographic and health data behind samples varies, as does how samples are managed and stored. As a result, there is often a limit to the number of quality specimens that can be used by a researcher. This will restrict revenue generation. Figure 4.7 The Human Tissue Banking Market: Revenue Forecast ($bn), 2013-2024 Growth in the tissue banking market for research will being slow towards the end of the forecast period as the market becomes increasingly saturated, moves towards maturity and stabilizes (Figure 4.7). Improved supply will reduce the industry’s prices, contributing to a decrease in the rate of market growth. The decrease in growth rate will also be due competition with in vitro stem 0 2 4 6 8 10 12 14 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 Revenue($bn) Year Source: visiongain 2014
  • 15. Page 78 Biobanking for Medicine: Technology, Industry and Market 2014-2024 cell screening models for drug discovery. Between 2018 and 2024, this market subsector will expand at a CAGR of 8.81%. In addition to existing commercial organisations expanding their operations to meet the increasing demand for high-quality human tissue samples for research, the market will witness an increase in the number of commercial players, our analyses reveal. Many non-profit biobanks are funded by governments or regulatory authorities. With increasing restrictions on government funding in the current economic climate, many such biobanks will have to become self-sufficient in the future. In 2024, the human tissue banking market for research will generate $11.65bn, accounting for 44.4% of the total biobanking for research market. Figure 4.8 highlights the driving and restraining factors influencing the human tissue banking market for research during the forecast period 2014-2024. Figure 4.8 Human Tissue Banking for Research: Market Drivers and Restraints, 2014- 2024 Source: visiongain 2014 • Increasing demand for specific human tissues for drug discovery and development and biomarker discovery. • Establishment of biobank networks is increasing access to banked specimens. • Increasing demand for samples for epidemiological and genetic study of disease. • Human tissue is popular, since DNA and RNA can then be extracted, adding to analysis. • Increasing commercialisation of the market. Drivers Restraints • Competition with stem cell models for drug discovery and development. • Lack of standardisation of tissue banks mean researchers face difficulties finding sufficient high quality tissue samples. • A limited number of biobanks have sufficient associated donor information with samples.