Find stats on top websites
Industry Landscape
The blood banking and biomedical research industry is vital, facing challenges such as maintaining adequate blood supply and evolving regulatory landscapes. It is characterized by continuous advancements in medical science and technology, particularly in diagnostics and personalized medicine, driven by ongoing research and increasing demand for specialized lab services.
Total Assets Under Management (AUM)
Number of blood donations in United States
~Approximately 13.6 million whole blood and red blood cell donations annually (AABB, 2023).
(-2% (estimated, pre-pandemic levels to 2023) CAGR)
• Decline in overall blood donations.
• Impacted by donor eligibility and retention.
• Regional variations in supply and demand.
Total Addressable Market
15 billion USD
Market Growth Stage
Pace of Market Growth
Emerging Technologies
Artificial Intelligence (AI) & Machine Learning (ML)
AI and ML can optimize blood supply chain management, predict demand, enhance donor recruitment and retention, and improve diagnostic accuracy in laboratory testing.
Genomic Sequencing & Personalized Medicine
Advances in genomics allow for more precise donor-recipient matching, personalized transfusion protocols, and targeted therapies for blood disorders, minimizing adverse reactions.
Cell and Gene Therapies (CGT)
The expanding field of CGT creates new demands for specialized blood components and processing, pushing blood banks to evolve into advanced biomanufacturing and apheresis centers.
Impactful Policy Frameworks
FDA Final Rule on Blood Donor Eligibility (2023)
The FDA issued a final guidance in 2023 revising blood donor eligibility criteria, moving from time-based deferrals for men who have sex with men (MSM) to an individualized risk-based assessment.
This policy aims to expand the eligible donor pool, potentially increasing the number of blood donations for Bloodworks Northwest and reducing deferrals for certain donor groups.
Clinical Laboratory Improvement Amendments (CLIA) Updates (Ongoing)
CLIA regulations, administered by CMS, continue to evolve, particularly regarding personnel qualifications, quality control, and proficiency testing for clinical laboratories.
Continuous updates to CLIA impact Bloodworks Northwest's specialized laboratory services by requiring adherence to the latest quality and operational standards to maintain accreditation and ensure patient safety.
HIPAA Privacy and Security Rule Enforcement (Ongoing)
Ongoing enforcement and interpretations of the Health Insurance Portability and Accountability Act (HIPAA) continue to govern the privacy and security of patient health information.
Bloodworks Northwest must strictly adhere to HIPAA regulations across all its operations, particularly in managing donor and patient data, lab results, and research information, ensuring robust cybersecurity and data privacy measures.
Transform Your Ideas into Action in Minutes with WaxWing
Sign up now and unleash the power of AI for your business growth
