DUBLIN, Sept. 2, 2020 /PRNewswire/ — The “Global Cord Blood Banking Industry Report 2020” report has been added to ResearchAndMarkets.com’s offering.
This report presents the number of cord blood units stored in inventory by the largest cord blood banks worldwide and the number of cord blood units (CBUs) released by registries across the world for hematopoietic stem cell (HSC) transplantation. Although cord blood is now used to treat more than 80 different diseases, this number could substantially expand if applications related to regenerative medicine start receiving approvals in major healthcare markets worldwide.
From the early 1900s through the mid-2000s, the global cord blood banking industry expanded rapidly, with companies opening for business in all major markets worldwide. From 2005 to 2010, the market reached saturation and stabilized.
Then, from 2010 to 2020, the market began to aggressively consolidate. This has created both serious threats and unique opportunities within the industry.
Serious threats to the industry include low rates of utilization for stored cord blood, expensive cord blood transplantation procedures, difficulty educating obstetricians about cellular therapies, and an increasing trend toward industry consolidation. There are also emerging opportunities for the industry, such as accelerated regulatory pathways for cell therapies in leading healthcare markets worldwide and expanding applications for cell-based therapies. In particular, MSCs from cord tissue (and other sources) are showing intriguing promise in the treatment and management of COVID-19.
Cord Blood Industry Trends
Within recent years, new themes have been impacting the industry, including the pairing of stem cell storage services with genetic and genomic testing services, as well as reproductive health services. Cord blood banks are diversifying into new types of stem cell storage, including umbilical cord tissue storage, placental blood and tissue, amniotic fluid and tissue, and dental pulp. Cord blood banks are also investigating means of becoming integrated therapeutic companies. With hundreds of companies offering cord blood banking services worldwide, maturation of the market means that each company is fighting harder for market share.
Growing numbers of investors are also entering the marketplace, with M&A activity accelerating in the U.S. and abroad. Holding companies are emerging as a global theme, allowing for increased operational efficiency and economy of scale. Cryoholdco has established itself as the market leader within Latin America. Created in 2015, Cryoholdco is a holding company that will control nearly 270,000 stem cell units by the end of 2020. It now owns a half dozen cord blood banks, as well as a dental stem cell storage company.
Globally, networks of cord blood banks have become commonplace, with Sanpower Group establishing its dominance in Asia. Although Sanpower has been quiet about its operations, it holds 4 licenses out of only 7 issued provincial-level cord blood bank licenses in China. It has reserved over 900,000 cord blood samples in China, and its reserves amount to over 1.2 million units when Cordlife’ reserves within Southeast Asian countries are included. This positions Sanpower Group and it’s subsidiary Nanjing Cenbest as the world’s largest cord blood banking operator not only in China and Southeast Asia but in the world.
The number of cord blood banks in Europe has dropped by more than one-third over the past ten years, from approximately 150 to under 100. The industry leaders in this market segment include FamiCord Group, who has executed a dozen M&A transactions, and Vita34, who has executed approximately a half dozen. Stemlab, the largest cord blood bank in Portugal, also executed three acquisition deals prior to being acquired by FamiCord. FamiCord is now the leading stem cell bank in Europe and one of the largest worldwide.
Cord Blood Expansion Technologies
Because cord blood utilization is largely limited to use in pediatric patients, growing investment is flowing into ex vivo cord blood expansion technologies. If successful, this technology could greatly expand the market potential for cord blood, encouraging its use within new markets, such as regenerative medicine, aging, and augmented immunity.
Key strategies being explored for this purpose include:
Currently, Gamida Cell, Nohla Therapeutics, Excellthera, and Magenta Therapeutics have ex vivo cord blood expansion products proceeding through clinical trials. Growing numbers of investors have also entered the cord blood banking marketplace, led by groups such as GI Partners, ABS Capital Partners & HLM Management, KKR & Company, Bay City Capital, GTCR, LLC, and Excalibur.
Cord Blood Banking by Region
Within the United States, most of the market share is controlled by three major players: Cord Blood Registry (CBR), Cryo-Cell, and ViaCord. CBR has been traded twice, once in 2015 to AMAG Pharmaceuticals for $700 million and again in 2018 to GI Partners for $530 million. CBR also bought Natera’s Evercord Cord Blood Banking business in September 2019. In total, CBR controls over 900,000 cord blood and tissue samples, making it one of the largest cord blood banks worldwide.
In China, the government controls the industry by authorizing only one cord blood bank to operate within each province, and official government support, authorization, and permits are required. Importantly, the Chinese government announced in late 2019 that it will be issuing new licenses for the first time, expanding from the current 7 licensed regions for cord blood banking to up to 19 regions, including Beijing.
In Italy and France, it is illegal to privately store one’s cord blood, which has fully eliminated the potential for a private market to exist within the region. In Ecuador, the government created the first public cord blood bank and instituted laws such that private cord blood banks cannot approach women about private cord blood banking options during the first six months of pregnancy. This created a crisis for private banks, forcing most out of business.
Recently, India’s Central Drugs Standard Control Organization (CDSCO) restricted commercial banking of stem cells from most biological materials, including cord tissue, placenta, and dental pulp stem cells – leaving only umbilical cord blood banking as permitted and licensed within the country.
While market factors vary by geography, it is crucial to have a global understanding of the industry, because research advances, clinical trial findings, and technology advances do not know international boundaries. The cord blood market is global in nature and understanding dynamics within your region is not sufficient for making strategic, informed, and profitable decisions.
Overall, the report provides the reader with the following details and answers the following questions:
1. Number of cord blood units cryopreserved in public and private cord blood banks globally 2. Number of hematopoietic stem cell transplants (HSCTs) globally using cord blood cells 3. Utilization of cord blood cells in clinical trials for developing regenerative medicines 4. The decline of the utilization of cord blood cells in HSC transplantations since 2005 5. Emerging technologies to influence the financial sustainability of public cord blood banks 6. The future scope for companion products from cord blood 7. The changing landscape of cord blood cell banking market 8. Extension of services by cord blood banks 9. Types of cord blood banks 10. The economic model of public cord blood banks 11. Cost analysis for public cord blood banks 12. The economic model of private cord blood banks 13. Cost analysis for private cord blood banks 14. Profit margins for private cord blood banks 15. Pricing for processing and storage in private banks 16. Rate per cord blood unit in the U.S. and Europe 17. Indications for the use of cord blood-derived HSCs for transplantations 18. Diseases targeted by cord blood-derived MSCs in regenerative medicine 19. Cord blood processing technologies 20. Number of clinical trials, number of published scientific papers and NIH funding for cord blood research 21. Transplantation data from different cord blood registries
Key questions answered in this report are:
1. What are the strategies being considered for improving the financial stability of public cord blood banks? 2. What are the companion products proposed to be developed from cord blood? 3. How much is being spent on processing and storing a unit of cord blood? 4. How much does a unit of cryopreserved cord blood unit fetch on release? 5. Why do most public cord blood banks incur a loss? 6. What is the net profit margin for a private cord blood bank? 7. What are the prices for processing and storage of cord blood in private cord blood banks? 8. What are the rates per cord blood units in the U.S. and Europe? 9. What are the revenues from cord blood sales for major cord blood banks? 10. Which are the different accreditation systems for cord blood banks? 11. What are the comparative merits of the various cord blood processing technologies? 12. What is to be done to increase the rate of utilization of cord blood cells in transplantations? 13. Which TNC counts are preferred for transplantation? 14. What is the number of registered clinical trials using cord blood and cord tissue? 15. How many clinical trials are involved in studying the expansion of cord blood cells in the laboratory? 16. How many matching and mismatching transplantations using cord blood units are performed on an annual basis? 17. What is the share of cord blood cells used for transplantation from 2000 to 2020? 18. What is the likelihood of finding a matching allogeneic cord blood unit by ethnicity? 19. Which are the top ten countries for donating cord blood? 20. What are the diseases targeted by cord blood-derived MSCs within clinical trials?
Key Topics Covered
1. REPORT OVERVIEW 1.1 Statement of the Report 1.2 Executive Summary 1.3 Introduction 1.3.1 Cord Blood: An Alternative Source for HPSCs 1.3.2 Utilization of Cord Blood Cells in Clinical Trials 1.3.3 The Struggle of Cord Blood Banks 1.3.4 Emerging Technologies to Influence Financial Sustainability of Banks 184.108.40.206 Other Opportunities to Improve Financial Stability 220.127.116.11 Scope for Companion Products 1.3.5 Changing Landscape of Cord Blood Cell Banking Market 1.3.6 Extension of Services by Cord Blood Banks
2. CORD BLOOD & CORD BLOOD BANKING: AN OVERVIEW 2.1 Cord Blood Banking (Stem Cell Banking) 2.1.1 Public Cord Blood Banks 18.104.22.168 Economic Model of Public Cord Blood Banks 22.214.171.124 Cost Analysis for Public Banks 126.96.36.199 Relationship between Costs and Release Rates 2.1.2 Private Cord Blood Banks 188.8.131.52 Cost Analysis for Private Cord Blood Banks 184.108.40.206 Economic Model of Private Banks 2.1.3 Hybrid Cord Blood Banks 2.2 Globally Known Cord Blood Banks 2.2.1 Comparing Cord Blood Banks 2.2.2 Cord Blood Banks in the U.S. 2.2.3 Proportion of Public, Private and Hybrid Banks 2.3 Percent Share of Parents of Newborns Storing Cord Blood by Country/Region 2.4 Pricing for Processing and Storage in Commercial Banks 2.4.1 Rate per Cord Blood Unit in the U.S. and Europe 2.5 Cord Blood Revenues for Major Cord Blood Banks
3. CORD BLOOD BANK ACCREDITATIONS 3.1 American Association of Blood Banks (AABB) 3.2 Foundation for the Accreditation of Cellular Therapy (FACT) 3.3 FDA Registration 3.4 FDA Biologics License Application (BLA) License 3.5 Investigational New Drug (IND) for Cord Blood 3.6 Human Tissue Authority (HTA) 3.7 Therapeutic Goods Act (TGA) in Australia 3.8 International NetCord Foundation 3.9 AABB Accredited Cord Blood Facilities 3.10 FACT Accreditation for Cord Blood Banks
4. APPLICATIONS OF CORD BLOOD CELLS 4.1 Hematopoietic Stem Cell Transplantations with Cord Blood Cells 4.2 Cord Cells in Regenerative Medicine
5. CORD BLOOD PROCESSING TECHNOLOGIES 5.1 The Process of Separation 5.1.1 PrepaCyte-CB 5.1.2 Advantages of PrepaCyte-CB 5.1.3 Treatment Outcomes with PrepaCyte-CB 5.1.4 Hetastarch (HES) 5.1.5 AutoXpress (AXP) 5.1.6 SEPAX 5.1.7 Plasma Depletion Method (MaxCell Process) 5.1.8 Density Gradient Method 5.2 Comparative Merits of Different Processing Methods 5.2.1 Early Stage HSC Recovery by Technologies 5.2.2 Mid Stage HSC (CD34+/CD133+) Recovery from Cord Blood 5.2.3 Late Stage Recovery of HSCs from Cord Blood 5.3 HSC (CD45+) Recovery 5.4 Days to Neutrophil Engraftment by Technology 5.5 Anticoagulants used in Cord Blood Processing 5.5.1 Type of Anticoagulant and Cell Recovery Volume 5.5.2 Percent Cell Recovery by Sample Size 5.5.3 TNC Viability by Time Taken for Transport and Type of Anticoagulant 5.6 Cryopreservation of Cord Blood Cells 5.7 Bioprocessing of Umbilical Cord Tissue (UCT) 5.8 A Proposal to Improve the Utilization Rate of Banked Cord Blood
6. CORD BLOOD CLINICAL TRIALS, SCIENTIFIC PUBLICATIONS & NIH FUNDING 6.1 Cord Blood Cells for Research 6.2 Cord Blood Cells for Clinical Trials 6.2.1 Number of Clinical Trials involving Cord Blood Cells 6.2.2 Number of Clinical Trials using Cord Blood Cells by Geography 6.2.3 Number of Clinical Trials by Study Type 6.2.4 Number of Clinical Trials by Study Phase 6.2.5 Number of Clinical Trials by Funder Type 6.2.6 Clinical Trials Addressing Indications in Children 6.2.7 Select Three Clinical Trials Involving Children 220.127.116.11 Sensorineural Hearing Loss (NCT02038972) 18.104.22.168 Autism Spectrum (NCT02847182) 22.214.171.124 Cerebral Palsy (NCT01147653) 6.2.8 Clinical Trials for Neurological Diseases using Cord Blood and Cord Tissue 6.2.9 UCB for Diabetes 6.2.10 UCB in Cardiovascular Clinical Trials 6.2.11 Cord Blood Cells for Auto-Immune Diseases in Clinical Trials 6.2.12 Cord Tissue Cells for Orthopedic Disorders in Clinical Trials 6.2.13 Cord Blood Cells for Other Indications in Clinical Trials 6.3 Major Diseases Addressed by Cord Blood Cells in Clinical Trials 6.4 Clinical Trials using Cord Tissue-Derived MSCs 6.5 Ongoing Clinical Trials using Cord Tissue 6.5.1 Cord Tissue-Based Clinical Trials by Geography 6.5.2 Cord Tissue-Based Clinical Trials by Phase 6.5.3 Cord Tissue-Based Clinical Trials by Sponsor Types 6.5.4 Companies Sponsoring in Trials using Cord Tissue-Derived MSCs 6.6 Wharton’s Jelly-Derived MSCs in Clinical Trials 6.6.1 Wharton’s Jelly-Based Clinical Trials by Phase 6.6.2 Companies Sponsoring Wharton’s Jelly-Based Clinical Trials 6.7 Clinical Trials Involving Cord Blood Expansion Studies 6.7.1 Safe and Feasible Expansion Protocols 6.7.2 List of Clinical Trials involved in the Expansion of Cord Blood HSCs 6.7.3 Expansion Technologies 6.8 Scientific Publications on Cord Blood 6.9 Scientific Publications on Cord Tissue 6.10 Scientific Publications on Wharton’s Jelly-Derived MSCs 6.11 Published Scientific Papers on Cord Blood Cell Expansion 6.12 NIH Funding for Cord Blood Research
7. PARENT’S AWARENESS AND ATTITUDE TOWARDS CORD BLOOD BANKING 7.1 Undecided Expectant Parents 7.2 The Familiar Cord Blood Banks Known by the Expectant Parents 7.3 Factors Influencing the Choice of a Cord Blood Bank
8. CORD BLOOD: AS A TRANSPLANTATION MEDICINE 8.1 Comparisons of Cord Blood to other Allograft Sources 8.1.1 Major Indications for HCTs in the U.S. 8.1.2 Trend in Allogeneic HCT in the U.S. by Recipient Age 8.1.3 Trends in Autologous HCT in the U.S. by Recipient Age 8.2 HCTs by Cell Source in Adult Patients 8.2.1 Transplants by Cell Source in Pediatric Patients 8.3 Allogeneic HCTs by Cell Source 8.3.1 Unrelated Donor Allogeneic HCTs in Patients &lessThan;18 Years 8.4 Likelihood of Finding an Unrelated Cord Blood Unit by Ethnicity 8.4.1 Likelihood of Finding an Unrelated Cord Blood Unit for Patients &lessThan;20 Years 8.5 Odds of using a Baby’s Cord Blood 8.6 Cord Blood Utilization Trends 8.7 Number of Cord Blood Donors Worldwide 8.7.1 Number of CBUs Stored Worldwide 8.7.2 Cord Blood Donors by Geography 126.96.36.199 Cord Blood Units Stored in Different Geographies 188.8.131.52 Number of Donors by HLA Typing 8.7.3 Searches Made by Transplant Patients for Donors/CBUs 8.7.4 Types of CBU Shipments (Single/Double/Multi) 8.7.5 TNC Count of CBUs Shipped for Children and Adult Patients 8.7.6 Shipment of Multiple CBUs 8.7.7 Percent Supply of CBUs for National and International Patients 8.7.8 Decreasing Number of CBU Utilization 8.8 Top Ten Countries in Cord Blood Donation 8.8.1 HLA Typed CBUs by Continent 8.8.2 Percentage TNC of Banked CBUs 8.8.3 Total Number of CBUs, HLA-Typed Units by Country 8.9 Cord Blood Export/Import by the E.U. Member States 8.9.1 Number of Donors and CBUs in Europe 8.9.2 Number of Exports/Imports of CBUs in E.U. 8.10 Global Exchange of Cord Blood Units
9. CORD BLOOD CELLS AS THERAPEUTIC CELL PRODUCTS IN CELL THERAPY 9.1 MSCs from Cord Blood and Cord Tissue 9.1.1 Potential Neurological Applications of Cord Blood-Derived Cells 9.1.2 Cord Tissue-Derived MSCs for Therapeutic use 184.108.40.206 Indications Targeted by UCT-MSCs in Clinical Trials 9.2 Current Consumption of Cord Blood Units by Clinical Trials 9.3 Select Cord Blood Stem Cell Treatments in Clinical Trials 9.3.1 Acquired Hearing Loss (NCT02038972) 9.3.2 Autism (NCT02847182) 9.3.3 Cerebral Palsy (NCT03087110) 9.3.4 Hypoplastic Left Heart Syndrome (NCT01856049) 9.3.5 Type 1 Diabetes (NCT00989547) 9.3.6 Psoriasis (NCT03765957) 9.3.7 Parkinson’s Disease (NCT03550183) 9.3.8 Signs of Aging (NCT04174898) 9.3.9 Stroke (NCT02433509) 9.3.10 Traumatic Brain Injury (NCT01451528)
10. MARKET ANALYSIS 10.1 Public vs. Private Cord Blood Banking Market 10.2 Cord Blood Banking Market by Indication
11. PROFILES OF SELECT CORD BLOOD BANKS 11.1 AllCells 11.1.1 Whole Blood 11.1.2 Leukopak 11.1.3 Mobilized Leukopak 11.1.4 Bone Marrow 11.1.5 Cord Blood 11.2 AlphaCord LLC 11.2.1 NextGen Collection System 11.3 Americord Registry, Inc. 11.3.1 Cord Blood 2.0 11.3.2 Cord Tissue 11.3.3 Placental Tissue 2.0 11.4 Be The Match 11.4.1 Hub of Transplant Network 11.4.2 Partners of Be The Match 11.4.3 Allogeneic Cell Sources in Be The Match Registry 11.4.4 Likelihood of a Matched Donor on Be The Match by Ethnic Background 11.5 Biocell Center Corporation 11.5.1 Chorionic villi after Delivery 11.5.2 Amniotic Fluid and Chorionic Villi during Pregnancy 11.6 BioEden Group, Inc. 11.6.1 Differences between Tooth Cells and Umbilical Cord Cells 11.7 Biovault Family 11.7.1 Personalized Cord Blood Processing 11.8 Cell Care 11.9 Cells4Life Group, LLP 11.9.1 Cells4Life’s pricing 11.9.2 TotiCyte Technology 11.9.3 Cord Blood Releases 11.10 Cell-Save 11.11 Center for International Blood and Marrow Transplant Research (CIBMTR) 11.11.1 Global Collaboration 11.11.2 Scientific Working Committees 11.11.3 Medicare Clinical Trials and Studies 11.11.4 Cellular Therapy 11.12 Crio-Cell International, Inc. 11.12.1 Advanced Collection Kit 11.12.2 Prepacyte-CB 11.12.3 Crio-Cell International’s Pricing 11.12.4 Revenue for Crio-Cell International 11.13 Cord Blood Center Group 11.13.1 Cord Blood Units Released 11.14 Cordlife Group, Ltd. 11.14.1 Cordlife’s Cord Blood Release Track Record 11.15 Core23 Biobank 11.16 Cord Blood Registry (CBR) 11.17 CordVida 11.18 Crioestaminal 11.18.1 Cord Blood Transplantation in Portugal 11.19 Cryo-Cell International, Inc. 11.19.1 Processing Method 11.19.2 Financial Results of the Company 11.20 CryoHoldco 11.21 Cryoviva Biotech Pvt. Ltd 11.22 European Society for Blood and Bone Marrow Transplantation (EBMT) 11.22.1 EBMT Transplant Activity 11.23 FamiCord Group 11.24 GeneCell International 11.25 Global Cord Blood Corporation 11.25.1 The Company’s Business 11.26 HealthBaby Hong Kong 11.26.1 BioArchive System Service Plan 11.26.2 MVE Liquid Nitrogen System 11.27 HEMAFUND 11.28 Insception Lifebank 11.29 LifebankUSA 11.29.1 Placental Banking 11.30 LifeCell International Pvt. Ltd. 11.31 MiracleCord, Inc. 11.32 Maze Cord Blood Laboratories 11.33 New England Cord Blood Bank, Inc. 11.34 New York Cord Blood Center (NYBC) 11.34.1 Products 11.34.2 Laboratory Services 11.35 PacifiCord 11.35.1 FDA-Approved Sterile Collection Bags 11.35.2 AXP Processing System 11.35.3 BioArchive System 11.36 ReeLabs Pvt. Ltd. 11.37 Smart Cells International, Ltd. 11.38 Stem Cell Cryobank 11.39 StemCyte, Inc. 11.39.1 StemCyte Sponsored Clinical Trials 220.127.116.11 Spinal Cord Injury Phase II 18.104.22.168 Other Trials 11.40 Transcell Biolife 11.40.1 ScellCare 11.40.2 ToothScell 11.41 ViaCord 11.42 Vita 34 AG 11.43 World Marrow Donor Association (WMDA) 11.43.1 Search & Match Service 11.44 Worldwide Network for Blood & Marrow Transplantation (WBMT)
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