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

  • Published: Oct-2018
  • Report Code: GBI091CBR
  • Report Format: pdf


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.


  • 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.

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