世界各国のリアルタイムなデータ・インテリジェンスで皆様をお手伝い

バイオバンキングの研究開発と商業展開における主要な運用、法規制、エシカル動向

Biobanking: Key Operational, Regulatory and Ethical Trends Within the R&D and Commercial Landscape

 

出版社 出版年月電子版価格 ページ数図表数
CBR Pharma Insights
CBRファーマインサイツ
2018年10月US$2,995
シングルユーザライセンス(PDF)
72 32

サマリー

米国調査会社CBRファーマインサイツ(CBR Pharma Insights)の調査レポート「バイオバンキングの研究開発と商業展開における主要な運用、法規制、エシカル動向」は、バイオバンキング(バイオバンク)の基本的な概念について、世界レベルの特に経済性と法規制に注目して記載している。バイオバンキングの収集、プロセス、貯蔵、ヒトの生物試料配送と、商業と非商業の両方のバイオ医療研究に使用される臨床的、遺伝子的、疫学的データに関して記載している。

Description

GBI Research’s latest report: “Biobanking: Key Operational, Regulatory and Ethical Trends Within the R&D and Commercial Landscape” explores the fundamental concepts in biobanking and recent advances in the field with particular focus on the economic and regulatory landscapes on a global level. Biobanking is defined as the process of collecting, processing, storing and distributing human biospecimens and the associated clinical, genetic and epidemiological data for use in biomedical research in both commercial and non-commercial settings. Once limited to supplying tissues to academics for basic scientific research, biobanking has evolved into a lucrative and complex industry comprising various types of biobanks supplying a wide variety of samples and data to the pharmaceutical and healthcare industry for drug development and therapeutic purposes. As a result, many countries have established regulations to facilitate the use of samples and data and address the complex social and ethical challenges that biobanks present. However, this has brought heterogeneity in biobanking regulations and practices worldwide, thereby adding complexity and impeding the international transfer of samples and data. This report sets out to discuss the biobanking landscape, analyzing the business models of biobanks, identifying and assessing the economic, operational, regulatory, social and ethical challenges that biobanks face. Key challenges are profiled and assessed to illustrate how biobanks and key stakeholders can work to overcome these challenges and mitigate potential risks. Current and future applications of biobanks within the pharmaceutical, healthcare and research industries are discussed, focusing on the involvement of the private sector and highlighting key challenges and opportunities for the future within specific subsectors.

Scope

  • What role do biobanks play in the pharmaceutical, healthcare and research industries?

  • What are the differences in the operating models of public and private biobanks?

  • What are the current legal and regulatory issues related to biobanking in the major markets? What is the impact of recent changes in law and policies? How will ongoing changes shape the future of biobanking regulation?

  • What are the key ethical and social challenges to biobanking? How can they be addressed?

  • What are the main drivers and barriers of the biobanking industry?

  • What are the most important emerging trends in biobanking?

  • What opportunities do stem cell biobanking, cord blood banking and DNA biobanking present?

  • Who are the prominent players in the industry?

Reasons To Buy

  • Develop a comprehensive understanding of biobanking and its role in the pharmaceutical and healthcare sectors.

  • Gain a picture of the current regulatory and ethical landscape to develop country-specific strategies in both public and private sectors.

  • Analyze trends within the biobanking market. Additionally, a granular assessment of stem cell biobanking is provided.



目次

1 Table of Contents 4

1.1 List of Tables 6

1.2 List of Figures 6

2 Introduction 7

2.1 What is a Biobank? 7

2.2 The Biobanking Process 7

2.2.1 Collection 7

2.2.2 Processing 8

2.2.3 Storage 8

2.2.4 Release 11

2.3 Best Practices 11

2.4 History of Biobanking 11

2.5 Types of Biobank 13

2.5.1 Population-Based Biobanks 13

2.5.2 Disease-Oriented Biobanks 15

3 Operating models of Public and Private Biobanks 17

3.1 Definitions of Public and Private Biobanks 17

3.2 Financial Arrangements 17

3.2.1 Public biobanks 17

3.2.2 Private Biobanks 18

3.3 Operational Processes 19

3.3.1 Donor Recruitment and Sample Collection 19

3.3.2 Sample Processing and Storage 20

3.3.3 Access (Release of Samples) 20

4 Legislative Framework for Biobanking 22

4.1 Regulatory Framework in Europe 22

4.1.1 United Kingdom 23

4.1.2 France 23

4.1.3 Germany 23

4.1.4 Spain 24

4.1.5 Italy 24

4.2 Regulatory Framework in North America 25

4.2.1 United States 25

4.2.2 Canada 26

4.3 Regulatory Framework in Asia-Pacific 26

4.3.1 Japan 26

4.3.2 China 26

4.3.3 South Korea 28

4.3.4 Australia 29

5 Ethical and Social Issues 32

5.1 Consent Limitation 32

5.2 Privacy and Discrimination Concerns 33

5.3 Ownership 33

5.4 Returning Research Results and Incidental Findings 34

6 Key Drivers and Barriers to Biobanking 36

6.1 Drivers 36

6.1.1 Developments in Genomic Research 36

6.1.2 Industry Focus on Drug Discovery and Development 36

6.1.3 Growing Interest in Regenerative Medicine 37

6.2 Barriers 39

6.2.1 Financial Issues 39

6.2.2 Lack of Harmonization between Countries 40

6.2.3 Social and Ethical issues 40

7 Emerging Trends in Biobanking Services 41

7.1 Stem Cell Biobanking 41

7.1.1 Adipose Tissue-Derived Stem Cells (ADSC) 41

7.1.2 Bone marrow-derived stem cells (BMSC) 45

7.1.3 Umbilical Cord Blood-Derived Stem Cells (UCBSC) 50

7.2 Cord Blood Banking 55

7.2.1 Operating model 56

7.2.2 Regulation 56

7.3 DNA/RNA Biobanking 58

7.3.1 Case Study – 23andMe 58

8 Company Profiles 60

8.1 AllCells 60

8.2 BioIVT 60

8.3 Bioserve 61

8.4 Cryo-Cell International 61

8.5 FUJIFILM Cellular Dynamics 61

8.6 PrecisionMed 62

8.7 ThermoFisher Scientific 62

8.8 Tissue Solutions 62

8.9 ViaCord 63

9 Conclusion 64

10 Appendix 65

10.1 References 65

10.2 Abbreviation List 71

10.3 GBI Research Report Methodology 72

10.4 Contact Us 72

10.5 Disclaimer 72

 

List of Figures

Figure 1: Biobanking, Typical Biobanking Workflow, 2018 7

Figure 2: Biobanking, Classification of Biobanks, 2018 13

Figure 3: Biobanking, Services Provided by Public Biobanks, 2018 18

Figure 4: Biobanking, Services Provided by Commercial Biobanks, 2018 18

Figure 5: Biobanking, Contribution of Biobanks in Drug Discovery and Development, 2018 37

Figure 6: Biobanking, NIH Funding for Regenerative Medicine ($m), 2008 – 2018 38

Figure 7: Biobanking, Global Venture Capital Investment in Regenerative Medicine, 2010–2016 38

Figure 8: Biobanking, Overview of the Cost Elements of Biobanks, 2018 39

Figure 9: Biobanking, Global Clinical Trial Activity Using Adipose Tissue-Derived Stem Cells, 2008–2017 42

Figure 10: Biobanking, Global, Completed Clinical Trials Using Adipose Tissue-Derived Stem Cells by Therapy Type, Therapy Area, Sponsor and Region, 2008– 2018 43

Figure 11: Biobanking, Global, Ongoing and Planned Clinical Trials Using Adipose Tissue-Derived Stem Cells by Therapy Type, Therapy Area, Sponsor and Region, 2012–2022 45

Figure 12: Biobanking, Global, Clinical Trial Activity Using Bone Marrow-Derived Stem Cells, 2008–2017 46

Figure 13: Biobanking, Global, Completed Clinical Trials Using Bone-Marrow Derived Stem Cells by Type, 2008–2018 47

Figure 14: Biobanking, Global, Completed Clinical Trials Using Bone-Marrow Derived Stem Cells by Therapy Area, Sponsor and Region, 2008 – 2018 48

Figure 15: Biobanking, Global, Ongoing and Planned Clinical Trials Using Bone-Marrow Derived Stem Cells by Type, 2008–2035 49

Figure 16: Biobanking, Global, Ongoing and Planned Clinical Trials Using Bone-Marrow Derived Stem Cells by Therapy Area, Sponsor and Region, 2008–2035 50

Figure 17: Biobanking, Global, Clinical Trial Activity Using Umbilical Cord Blood-Derived Stem Cells, 2008–2017 51

Figure 18: Biobanking, Global, Completed Clinical Trials Using Umbilical Cord Blood-Derived Stem Cells by Type, 2008–2018 52

Figure 19: Biobanking, Global, Completed Clinical Trials Using Umbilical Cord Blood-Derived Stem Cells by Therapy Area, Sponsor Type and Region, 2008–2018 53

Figure 20: Biobanking, Global, Ongoing and Planned Clinical Trials Using Umbilical Cord Blood-Derived Stem Cells by Type, 2008–2025 54

Figure 21: Biobanking, Global, Ongoing and Planned Clinical Trials Using Umbilical Cord Blood-Derived Stem Cells by Therapy Area, Sponsor and Region, 2008–2025 55

Figure 22: Biobanking, Front-End Business of 23andMe, 2018 59

 

List of Tables

Table 1: Biobanking, Models of Consent for Sample and Data Usage, 2018 8

Table 2: Biobanking, Tissue Preservation and Storage Methods, 2018 9

Table 3: Biobanking, Chronological Development of Biobanks, 2018 12

Table 4: Biobanking, Examples of Population-based Biobanks, 2018 14

Table 5: Biobanking, Examples of Disease-oriented Biobanks, 2018 16

Table 6: Biobanking: Minimum Requirements for Authorization in Spain, 2018 24

Table 7: Biobanking, Regulations for Biobanks in China, 2018 27

Table 8: Biobanking, Legal Regulations for Biobanks by Country, 2018 29

Table 9: Biobanking, Definition of Individual Research Results and Incidental Findings, 2018 34

Table 10: Biobanking, Key Regulations Applicable to Private Cord Blood Banks by Country, 2018 57

 

ページTOPに戻る

あなたが最近チェックしたレポート一覧

  • 最近チェックしたレポートはありません。

お問合は、お電話またはWEBから承ります。お見積もりの作成もお気軽にご相談ください。

webからのお問合せはこちらのフォームから承ります

このレポートへのお問合せ

03-3582-2531

電話お問合せもお気軽に

<無料>メルマガに登録する

 

 

ページTOPに戻る