StemCell Therapy

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 globally2. Number of hematopoietic stem cell transplants (HSCTs) globally using cord blood cells3. Utilization of cord blood cells in clinical trials for developing regenerative medicines4. The decline of the utilization of cord blood cells in HSC transplantations since 20055. Emerging technologies to influence the financial sustainability of public cord blood banks6. The future scope for companion products from cord blood7. The changing landscape of cord blood cell banking market8. Extension of services by cord blood banks9. Types of cord blood banks10. The economic model of public cord blood banks11. Cost analysis for public cord blood banks12. The economic model of private cord blood banks13. Cost analysis for private cord blood banks14. Profit margins for private cord blood banks15. Pricing for processing and storage in private banks16. Rate per cord blood unit in the U.S. and Europe17. Indications for the use of cord blood-derived HSCs for transplantations18. Diseases targeted by cord blood-derived MSCs in regenerative medicine19. Cord blood processing technologies20. Number of clinical trials, number of published scientific papers and NIH funding for cord blood research21. 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 OVERVIEW1.1 Statement of the Report1.2 Executive Summary1.3 Introduction1.3.1 Cord Blood: An Alternative Source for HPSCs1.3.2 Utilization of Cord Blood Cells in Clinical Trials1.3.3 The Struggle of Cord Blood Banks1.3.4 Emerging Technologies to Influence Financial Sustainability of Banks1.3.4.1 Other Opportunities to Improve Financial Stability1.3.4.2 Scope for Companion Products1.3.5 Changing Landscape of Cord Blood Cell Banking Market1.3.6 Extension of Services by Cord Blood Banks

2. CORD BLOOD & CORD BLOOD BANKING: AN OVERVIEW2.1 Cord Blood Banking (Stem Cell Banking)2.1.1 Public Cord Blood Banks2.1.1.1 Economic Model of Public Cord Blood Banks2.1.1.2 Cost Analysis for Public Banks2.1.1.3 Relationship between Costs and Release Rates2.1.2 Private Cord Blood Banks2.1.2.1 Cost Analysis for Private Cord Blood Banks2.1.2.2 Economic Model of Private Banks2.1.3 Hybrid Cord Blood Banks2.2 Globally Known Cord Blood Banks2.2.1 Comparing Cord Blood Banks2.2.2 Cord Blood Banks in the U.S.2.2.3 Proportion of Public, Private and Hybrid Banks2.3 Percent Share of Parents of Newborns Storing Cord Blood by Country/Region2.4 Pricing for Processing and Storage in Commercial Banks2.4.1 Rate per Cord Blood Unit in the U.S. and Europe2.5 Cord Blood Revenues for Major Cord Blood Banks

3. CORD BLOOD BANK ACCREDITATIONS3.1 American Association of Blood Banks (AABB)3.2 Foundation for the Accreditation of Cellular Therapy (FACT)3.3 FDA Registration3.4 FDA Biologics License Application (BLA) License3.5 Investigational New Drug (IND) for Cord Blood3.6 Human Tissue Authority (HTA)3.7 Therapeutic Goods Act (TGA) in Australia3.8 International NetCord Foundation3.9 AABB Accredited Cord Blood Facilities3.10 FACT Accreditation for Cord Blood Banks

4. APPLICATIONS OF CORD BLOOD CELLS4.1 Hematopoietic Stem Cell Transplantations with Cord Blood Cells4.2 Cord Cells in Regenerative Medicine

5. CORD BLOOD PROCESSING TECHNOLOGIES5.1 The Process of Separation5.1.1 PrepaCyte-CB5.1.2 Advantages of PrepaCyte-CB5.1.3 Treatment Outcomes with PrepaCyte-CB5.1.4 Hetastarch (HES)5.1.5 AutoXpress (AXP)5.1.6 SEPAX5.1.7 Plasma Depletion Method (MaxCell Process)5.1.8 Density Gradient Method5.2 Comparative Merits of Different Processing Methods5.2.1 Early Stage HSC Recovery by Technologies5.2.2 Mid Stage HSC (CD34+/CD133+) Recovery from Cord Blood5.2.3 Late Stage Recovery of HSCs from Cord Blood5.3 HSC (CD45+) Recovery5.4 Days to Neutrophil Engraftment by Technology5.5 Anticoagulants used in Cord Blood Processing5.5.1 Type of Anticoagulant and Cell Recovery Volume5.5.2 Percent Cell Recovery by Sample Size5.5.3 TNC Viability by Time Taken for Transport and Type of Anticoagulant5.6 Cryopreservation of Cord Blood Cells5.7 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 FUNDING6.1 Cord Blood Cells for Research6.2 Cord Blood Cells for Clinical Trials6.2.1 Number of Clinical Trials involving Cord Blood Cells6.2.2 Number of Clinical Trials using Cord Blood Cells by Geography6.2.3 Number of Clinical Trials by Study Type6.2.4 Number of Clinical Trials by Study Phase6.2.5 Number of Clinical Trials by Funder Type6.2.6 Clinical Trials Addressing Indications in Children6.2.7 Select Three Clinical Trials Involving Children6.2.7.1 Sensorineural Hearing Loss (NCT02038972)6.2.7.2 Autism Spectrum (NCT02847182)6.2.7.3 Cerebral Palsy (NCT01147653)6.2.8 Clinical Trials for Neurological Diseases using Cord Blood and Cord Tissue6.2.9 UCB for Diabetes6.2.10 UCB in Cardiovascular Clinical Trials6.2.11 Cord Blood Cells for Auto-Immune Diseases in Clinical Trials6.2.12 Cord Tissue Cells for Orthopedic Disorders in Clinical Trials6.2.13 Cord Blood Cells for Other Indications in Clinical Trials6.3 Major Diseases Addressed by Cord Blood Cells in Clinical Trials6.4 Clinical Trials using Cord Tissue-Derived MSCs6.5 Ongoing Clinical Trials using Cord Tissue6.5.1 Cord Tissue-Based Clinical Trials by Geography6.5.2 Cord Tissue-Based Clinical Trials by Phase6.5.3 Cord Tissue-Based Clinical Trials by Sponsor Types6.5.4 Companies Sponsoring in Trials using Cord Tissue-Derived MSCs6.6 Wharton's Jelly-Derived MSCs in Clinical Trials6.6.1 Wharton's Jelly-Based Clinical Trials by Phase6.6.2 Companies Sponsoring Wharton's Jelly-Based Clinical Trials6.7 Clinical Trials Involving Cord Blood Expansion Studies6.7.1 Safe and Feasible Expansion Protocols6.7.2 List of Clinical Trials involved in the Expansion of Cord Blood HSCs6.7.3 Expansion Technologies6.8 Scientific Publications on Cord Blood6.9 Scientific Publications on Cord Tissue6.10 Scientific Publications on Wharton's Jelly-Derived MSCs6.11 Published Scientific Papers on Cord Blood Cell Expansion6.12 NIH Funding for Cord Blood Research

7. PARENT'S AWARENESS AND ATTITUDE TOWARDS CORD BLOOD BANKING7.1 Undecided Expectant Parents7.2 The Familiar Cord Blood Banks Known by the Expectant Parents7.3 Factors Influencing the Choice of a Cord Blood Bank

8. CORD BLOOD: AS A TRANSPLANTATION MEDICINE8.1 Comparisons of Cord Blood to other Allograft Sources8.1.1 Major Indications for HCTs in the U.S.8.1.2 Trend in Allogeneic HCT in the U.S. by Recipient Age8.1.3 Trends in Autologous HCT in the U.S. by Recipient Age8.2 HCTs by Cell Source in Adult Patients8.2.1 Transplants by Cell Source in Pediatric Patients8.3 Allogeneic HCTs by Cell Source8.3.1 Unrelated Donor Allogeneic HCTs in Patients &lessThan;18 Years8.4 Likelihood of Finding an Unrelated Cord Blood Unit by Ethnicity8.4.1 Likelihood of Finding an Unrelated Cord Blood Unit for Patients &lessThan;20 Years8.5 Odds of using a Baby's Cord Blood8.6 Cord Blood Utilization Trends8.7 Number of Cord Blood Donors Worldwide8.7.1 Number of CBUs Stored Worldwide8.7.2 Cord Blood Donors by Geography8.7.2.1 Cord Blood Units Stored in Different Geographies8.7.2.2 Number of Donors by HLA Typing8.7.3 Searches Made by Transplant Patients for Donors/CBUs8.7.4 Types of CBU Shipments (Single/Double/Multi)8.7.5 TNC Count of CBUs Shipped for Children and Adult Patients8.7.6 Shipment of Multiple CBUs8.7.7 Percent Supply of CBUs for National and International Patients8.7.8 Decreasing Number of CBU Utilization8.8 Top Ten Countries in Cord Blood Donation8.8.1 HLA Typed CBUs by Continent8.8.2 Percentage TNC of Banked CBUs8.8.3 Total Number of CBUs, HLA-Typed Units by Country8.9 Cord Blood Export/Import by the E.U. Member States8.9.1 Number of Donors and CBUs in Europe8.9.2 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 THERAPY9.1 MSCs from Cord Blood and Cord Tissue9.1.1 Potential Neurological Applications of Cord Blood-Derived Cells9.1.2 Cord Tissue-Derived MSCs for Therapeutic use9.1.2.1 Indications Targeted by UCT-MSCs in Clinical Trials9.2 Current Consumption of Cord Blood Units by Clinical Trials9.3 Select Cord Blood Stem Cell Treatments in Clinical Trials9.3.1 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 ANALYSIS10.1 Public vs. Private Cord Blood Banking Market10.2 Cord Blood Banking Market by Indication

11. PROFILES OF SELECT CORD BLOOD BANKS11.1 AllCells11.1.1 Whole Blood11.1.2 Leukopak11.1.3 Mobilized Leukopak11.1.4 Bone Marrow11.1.5 Cord Blood11.2 AlphaCord LLC11.2.1 NextGen Collection System11.3 Americord Registry, Inc.11.3.1 Cord Blood 2.011.3.2 Cord Tissue11.3.3 Placental Tissue 2.011.4 Be The Match11.4.1 Hub of Transplant Network11.4.2 Partners of Be The Match11.4.3 Allogeneic Cell Sources in Be The Match Registry11.4.4 Likelihood of a Matched Donor on Be The Match by Ethnic Background11.5 Biocell Center Corporation11.5.1 Chorionic villi after Delivery11.5.2 Amniotic Fluid and Chorionic Villi during Pregnancy11.6 BioEden Group, Inc.11.6.1 Differences between Tooth Cells and Umbilical Cord Cells11.7 Biovault Family11.7.1 Personalized Cord Blood Processing11.8 Cell Care11.9 Cells4Life Group, LLP11.9.1 Cells4Life's pricing11.9.2 TotiCyte Technology11.9.3 Cord Blood Releases11.10 Cell-Save11.11 Center for International Blood and Marrow Transplant Research (CIBMTR)11.11.1 Global Collaboration11.11.2 Scientific Working Committees11.11.3 Medicare Clinical Trials and Studies11.11.4 Cellular Therapy11.12 Crio-Cell International, Inc.11.12.1 Advanced Collection Kit11.12.2 Prepacyte-CB11.12.3 Crio-Cell International's Pricing11.12.4 Revenue for Crio-Cell International11.13 Cord Blood Center Group11.13.1 Cord Blood Units Released11.14 Cordlife Group, Ltd.11.14.1 Cordlife's Cord Blood Release Track Record11.15 Core23 Biobank11.16 Cord Blood Registry (CBR)11.17 CordVida11.18 Crioestaminal11.18.1 Cord Blood Transplantation in Portugal11.19 Cryo-Cell International, Inc.11.19.1 Processing Method11.19.2 Financial Results of the Company11.20 CryoHoldco11.21 Cryoviva Biotech Pvt. Ltd11.22 European Society for Blood and Bone Marrow Transplantation (EBMT)11.22.1 EBMT Transplant Activity11.23 FamiCord Group11.24 GeneCell International11.25 Global Cord Blood Corporation11.25.1 The Company's Business11.26 HealthBaby Hong Kong11.26.1 BioArchive System Service Plan11.26.2 MVE Liquid Nitrogen System11.27 HEMAFUND11.28 Insception Lifebank11.29 LifebankUSA11.29.1 Placental Banking11.30 LifeCell International Pvt. Ltd.11.31 MiracleCord, Inc.11.32 Maze Cord Blood Laboratories11.33 New England Cord Blood Bank, Inc.11.34 New York Cord Blood Center (NYBC)11.34.1 Products11.34.2 Laboratory Services11.35 PacifiCord11.35.1 FDA-Approved Sterile Collection Bags11.35.2 AXP Processing System11.35.3 BioArchive System11.36 ReeLabs Pvt. Ltd.11.37 Smart Cells International, Ltd.11.38 Stem Cell Cryobank11.39 StemCyte, Inc.11.39.1 StemCyte Sponsored Clinical Trials11.39.1.1 Spinal Cord Injury Phase II11.39.1.2 Other Trials11.40 Transcell Biolife11.40.1 ScellCare11.40.2 ToothScell11.41 ViaCord11.42 Vita 34 AG11.43 World Marrow Donor Association (WMDA)11.43.1 Search & Match Service11.44 Worldwide Network for Blood & Marrow Transplantation (WBMT)

For more information about this report visit https://www.researchandmarkets.com/r/7bm9lx

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

Research and Markets Laura Wood, Senior Manager [emailprotected]

For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets

http://www.researchandmarkets.com

Originally posted here:
Global Cord Blood Banking Market 2020 with Analysis of 44 Industry Players - PRNewswire

This entry was posted on September 3, 2020 at 5:56 pm and is filed under Regenerative Medicine. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |