Biobanking for Medicine, Technology, Industry and Market 2015 2025

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Biobanking for Medicine: Technology, Industry and Market 2015-2025

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Contents

1. Report Overview

1.1 Biobanking for Medicine: World Market Review 2014

1.2 Why You Should Read This Report

1.3 How This Report Delivers

1.4 Main Questions Answered by This Analysis

1.5 Who is This Study For?

1.6 Research and Analysis Methods

1.7 Frequently Asked Questions (FAQs)

1.8 Some Associated Reports

1.9 About Visiongain

2. Introduction to Biobanking and its Applications

2.1 The Human Tissue Banking Market – Our Definition

2.2 The Stem Cell Banking Market – Our Breakdown

2.3 What is Biobanking?

2.4 Main Features of Biobanks

2.5 What Processes are Involved in Biobanking?

2.6 Classification of Biobanks: Tissue Type, Volunteer Group and Ownership Classification

Models

2.6.1 Volunteer Group: General vs. Disease Population

2.6.2 Ownership Structure: Public vs. Private

2.7 The Guidelines and Standards for Biobanking

2.8 Laws and Regulations for Biobank-Based Research

2.8.1 HIPAA Amendments

2.9 Biobanking and the Pharmaceutical Industry

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Contents 2.9.1 Biobanking in Research, Drug Discovery and Development

2.9.1.1 Biobanking – Facilitates Genetic Epidemiology Studies

2.9.1.2 Novel Drug Discovery through Better Understanding of Disease Pathways

2.9.1.3 Biomarker Discovery in Drug Development

2.9.2 Biobanking for Therapeutic Purposes

2.9.3 Biobanking in Clinical Trials

3. Biobanking for Medicine: World Market 2015-2025

3.1 The World Biobanking for Medicine Market in 2014

3.2 Biobanking for Medicine: Research vs. Therapeutics in 2019 and 2025

3.3 World Biobanking for Medicine Market: Overarching Revenue Forecast 2015-2025

3.4 Biobanks Stored Around 1.3 Billion Specimens in 2014

3.5 The Biobanking for Medicine Market by Sector: Grouped Revenue Forecasts 2015-2025

3.6 Biobanking for Research: Mostly Non-Profit

3.6.1 Biobanking for Research: Revenue Forecast 2015-2025

3.6.2 Driving Forces Outweigh Restraints on the Biobanking Industry for Research

3.7 Biobanking for Future Therapeutic Use: Is It Too Commercial?

3.7.1 Arguments against Commercial Stem Cell Banking for Therapeutic Uses

3.7.2 Biobanking for Future Therapeutic Use: Revenue Forecast 2015-2025

3.7.3 Driving and Restraining Forces Influencing the Biobanking Market for Therapeutic

Applications, 2015-2025

4. Biobanking for Research Purposes

4.1 Breakdown of the Biobanking for Research Market by Tissue Type, 2014

4.2 Biobanking for Research in 2019 and 2025: Comparison by Tissue Type

4.3 Biobanking for Research by Tissue Type: Grouped Revenue Forecasts 2015-2025

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Contents

4.4 How Many Specimens are Biobanked for Research?

4.5 The Human Tissue Banking Market for Research in 2014

4.6 The Human Tissue Banking Market for Research: Revenue Forecast 2015-2025

4.7 The Human Tissue Banking Market: Commercial vs. Public Sector

4.7.1 Commercial Human Tissue Banks: Revenue Forecast 2015-2025

4.7.2 Public Sector Human Tissue Banks: Revenue Forecast 2015-2025

4.8 The Stem Cell Banking Market for Research in 2014

4.9 The Stem Cell Banking Market for Research: Revenue Forecast 2015-2025

4.9.1 R&D - Growing Interest towards iPSCs

4.10 Banking of Other Biologic Specimens for Research in 2014

4.11 Banking of Other Biologic Specimens for Research: Revenue Forecast 2015-2025

5. Stem Cell Banking for Future Therapeutic Use

5.1 Stem Cell Banking for Therapeutic Use in 2014: A Breakdown by Stem Cell Type

5.2 Stem Cell Banking for Therapeutic Use by Stem Cell Type: Comparison of Revenue and

Market Share, 2019 and 2025

5.3 Stem Cell Banking for Therapeutic Use by Stem Cell Type: Grouped Revenue Forecasts

5.4 How Many Stem Cell Samples Are Biobanked Each Year?

5.5 The Umbilical Cord Blood Banking Market in 2014

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 2015-2025

5.7 The Adult Stem Cell Banking Market in 2014

5.8 The Adult Stem Cell Banking Market: Revenue Forecast 2015-2025

6. Leading National Markets 2015-2025

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Contents

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 Fast Gaining Prominence

6.2 Biobanking for Medicine: The US Led the Way in 2014

6.3 The Leading National Markets: Grouped Revenue Forecasts 2015-2025

6.4 How Will Regional Market Shares Change to 2025?

6.5 The US Biobanking Market 2014-2024: Diversifying and Expanding

6.6 The Top European Biobanking Markets 2015-2025: 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: Limited Presence of Biobanking Networks

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 2015-2025: A High Level of Government Investment

Drives Growth

6.8 The Biobanking Industry in the BRIC Countries: High Growth and Increasing Market Share

between 2015 and 2025

6.8.1 The Chinese Biobanking Market 2015-2025: The High Rate of Growth Will Continue

6.8.2 The Indian Biobanking Market 2015-2025: Set to Become the Leading Market for

Private Stem Cell Banking?

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Contents 6.8.3 The Brazilian Biobanking Market 2015-2025: 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 2015-2025?

7. Technology for Biobanking: Systems, Software, Consumables and

Services Associated With Biobanking

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 Aliquoting : Patented Technology From CryoXtract

7.2.3 Automated DNA Isolation

7.3 Storage Technology: Sustainability and Easy Sample Tracking

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

7.4 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

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Contents

8. Leading Companies in the Biobanking Market

8.1 The Differing Business Models of Biobanking Companies: Sourcing vs. Storing

8.2 Commercial Biobanks for Research Purposes in 2014

8.2.1 Tissue Solutions: A Virtual Biobank with a Global Presence

8.2.1.1 An Overview of the Products and Services Offered by Tissue Solutions

8.2.1.2 Banked Samples Occur in Many Formats

8.2.1.3 Prospective Tissue Collection for Hard-to-Find Samples

8.2.1.4 Fresh Samples from Surgical Resections are in High Demand

8.2.1.5 Freshly Isolated Human Cells are a Valuable Research Tool

8.2.1.6 FDA/ EMA Panel of Normal Tissues

8.2.1.7 Strengths, Capabilities and the Future Outlook for Tissue Solutions

8.2.2 Asterand is now Part of Stemgent

8.2.2.1 Asterand’s Products and Services: XpressBANK, ProCURE and PhaseZERO

8.2.3 Biopta Provides Fresh Human Tissues, for Which Demand is Growing

8.2.3.1 Services From Biopta: Fresh Tissue Sample Procurement and a Variety of Lab

Services

8.2.3.2 The First Catalogue of Assays Based on Human Functional Tissues

8.2.3.3 The Future Outlook for Biopta

8.2.4 BioServe: One of the World’s Largest Commercial Biorepositories

8.2.4.1 BioServe Offers a Comprehensive List of Services: Biobanking, Sourcing and

Preclinical Molecular Services

8.2.4.2 The Future Outlook for BioServe

8.2.5 Coriell Institute for Medical Research: Reportedly the Largest Biobank in the World

8.2.5.1 Features of Coriell Biobank

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Contents

8.2.5.2 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. Qualitative Analysis of the Biobanking Industry and Market 2015-

2025

9.1 Industry Trends

9.1.1 The Growing Demand for Biobank Resources for Research

9.1.2 The Establishment of Biobanking Networks

9.1.2.1 BBMRI: The Most Extensive Biobank Network

9.1.3 Virtual Biobanks: Connecting a Fragmented Industry

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Contents 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, 2015-2025

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

9.3.3 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

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Contents

9.4 Social, Technological, Economic and Political Factors (STEP) Influencing the Biobanking

Industry, 2015-2025

10. Research Interviews from Our Survey - 2015

10.1 Dr Jeanne-Hélène di Donato, 3C-R, France

10.1.1 French Biobanks – a Network of Specialized Biobanks

10.1.2 Biobanking Management –Promoting Scientific Value of Collections

10.1.3 Harmonization – Scientific Valorisation

10.1.4 Bioethical – Diverse Views and Policies on Consent

10.1.5 Broad Consent –Is This the Best Option?

10.1.6 3C-R – Services and Solutions for Biobanks

10.2 Dr Luis Nacul and Dr Eliana Lacerda, UK ME/CFS Biobank Project

10.2.1 UK ME/CFS Biobank – Objectives and Activities

10.2.2 Biobank Resource – Available for External Researchers in August 2015

10.2.3 Main Issue - Sustainability

10.2.4 Unmet Needs – Awareness from Government and General Public

11. Conclusions from the Research and Analysis

11.1 World Biobanking Market 2015-2025: High Revenue Growth Predicted

11.2 Biobanking for Research 2015-2025: The Value of Biobanked Specimens is Increasingly

Recognised

11.3 Biobanking for Therapeutic Use 2015-2025: 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 - Increasing Revenue

11.5.2 Improving Biobanking Infrastructure – Growth Driver

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Figure 6.4 The Leading National Markets: Market Shares (%), 2019

Figure 6.5 The Leading National Markets: Market Shares (%), 2025

These national markets are discussed in more detail, below.

6.5 The US Biobanking Market 2014-2024: Diversifying and Expanding

In 2014, the US biobanking market for medicine generated $6.04bn, visiongain estimates. This

accounted for a market share of 41.8%. Over the past decade, there has been the number and

US 41%

Japan 6% Germany

5% France

4% Italy 3%

Spain 3%

UK 4%

The Netherlands

5%

China 5%

Brazil 2%

India 3%

Russia 2%

Rest of World 17%

US 41%

Japan 6% Germany

5% France

4% Italy 3%

Spain 3%

UK 4%

The Netherlands

4%

China 5%

Brazil 2%

India 3%

Russia 2%

Rest of World 18%

Source: visiongain 2015







total market. Over the course of the forecast period, Germany will gradually lose market share, on

account of higher levels of growth in the emerging markets.

Germany has a high number of biobanks, 74 of which are associated with the BBMRI. Germany is

the leading European country in terms of biobank networking. This will be an important driver of

growth during the forecast period. Additionally, there is strong demand for stem cell banking

services for therapeutic use, another major growth driver. Reportedly, Germany was one of the first

countries to regulate stem cell banking under strict principles. These principles were later

incorporated into EU regulation. The early establishment of Germany’s stem cell banking market

means public awareness is higher, driving growth in the industry. The combination of these factors

will result in strong growth in the German biobanking industry during the forecast period (Figure

6.10).

Figure 6.10 The German Biobanking Industry: Revenue Forecast ($bn), 2014-2025

KORAgen and Popgen are reportedly the largest DNA biobanks in Germany. They were developed

within the National Genome Research Network (NGFN) and funded by public fund. The objective

of KORAgen is to find the genetic markers for heart diseases and to to date has collected samples

from 18,000 donors. Popgen or population genetics project aim to analyze multiple risk factors of

diseases, such as cardiac arrest or gallstones by looking at the interplay between environmental

factors and genetic background. The project has collected up to 26,000 DNA samples. Another

biobank in large scope is the Danubian Biobank Consortium, which brings together a number of

universities along the Danube river to work together through a virtual network dedicated to

research in age-related diseases. This consortium has collected 160,000 blood samples.

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storage reagents. Also, there has been use of plates to store samples, where samples are frozen

together in a batch and to access any one of them all samples are exposed to freeze-thaw cycles.

This has been seen to be detrimental to sample integrity.

Several vendors supplying consumables such as Thermo Scientific, Micronic, and TAP have now

come up with solutions to overcome this challenge and make sample tracking easier and more

efficient. For example, both Thermo Scientific and Micronic provide sample storage tubes with

laser encrypted 2D barcodes at the bottom of the tubes, which can be read using automated

scanners or are even readable by eye. Laser encryption ensures their long-term stability and the

unique 2D coding system format ensures selection of correct samples. The use of storage tubes

instead of plates also provides a solution to preserve sample integrity at the time of retrieval.

Uniquely labelled storage tubes can allow selection of individual samples, instead of entire plates

containing the particular sample of interest and samples not required.

Another challenge in sample management, while working with large number of samples at a time,

is to prevent cross-contamination. To overcome this challenge, vendors now provide tubes with

special sealing systems. One such example is Thermo Scientific's range of septum plugs, which

are pierceable with pipetting equipment more than 200 times.

Thus, the vendors of systems and consumables to the biobanking market are continuously

evolving and developing the technology to overcome specific challenges faced with the biobanking

market.

7.6 Biobanking Services: Storage, Management and Transport of

Biologic Samples for a Fee

Several services related to storing and managing of biological samples are offered by some

companies. The services provided to the biobanks include the following:

• Sample storage/biorepository facility

• Sample collection

• Processing

• Testing

• Transportation

• Relocation.

Several biopharmaceutical companies, research laboratories, CROs, and academic institutes

make use of these services. The most commonly used of these services is the sample storage, as
