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1 Published:October2011 Thestudyreviews,analyzesandprojects theglobalmarketforcordbloodstem Cels fortheperiod alrightsreserved

2 PRODUCT SEGMENTATION Cord blood stem cells are those adult stem cells which are derived from the umbilical cord during the birth of a child. These are rich source of hematopoietic (blood-forming) stem cells. These are naive cells that are capable of developing into the three types of mature blood cells present in our blood - red blood cells, white blood cells and platelets. They may also have the potential to give rise to other cell types in the body. Key Technologies of Cord Blood Stem Cells The following are known to be the key technologies of cord blood stem cells in the market - Stem Cell Transplant, Cord Blood Banking, Blood Transfusion, Cell Based Genetics and Xenotransplant. Stem Cell Transplant Stem cell transplant is essentially the infusion of healthy stem cells into the body which is necessary in cases when the bone marrow is incapable of producing healthy stem cells. A stem cell transplant helps the body make enough platelets, RBC, WBC and reduces the risk of anemia, bleeding and other life-threatening infections. This process by which body s healthy blood forming stem cells is replenished is called stem cells transplant and depending on the source of stem cells bone marrow or umbilical cord it can be termed as bone marrow transplant or umbilical cord transplant. Stem cells from own body can be used termed autologous transplant or they can be obtained from a donor termed allogeneic stem transplant. Pros and Cons of Cord Blood Treatment Pros Effortless and collection-free risk Ready-to-use, since frozen after collection, testing and storage and matching unit can be reserved at once No requirement of a perfect match (a major +), since cord blood can be transplanted even if there is only a partial match between donor and recipient Recipient at lower complication risk since immune cells present in cord blood have lower propensity to attack tissue of patient (graft vs. host disease), as in cases of bone marrow transplant Cord blood deficient in spreading viruses, such as cytomegalovirus (CMV), a deadly infection that strikes transplant recipients Statistics reveal that about half of the American population carry CMV in a latent form, while fewer than 1% babies are inflicted with this virus Cons Derived cord blood volume relatively smaller compared to the quantity of stem cell requirement, as provided by peripheral blood or bone marrow transplant Cord blood transplantation capable of exposing patient to a rare immune system or blood genetic disorder(s). Not detectable in testing the cord blood sample, since invisible in child for several years. Probability of contracting such diseases, though 1:10,000, would gain from the assurance that donor cord blood stem cells coming from a newborn baby unavailable for extra cord blood donation would give way for a second unit that could prove detrimental The promise of cord blood banking can be said to be a literal boon for the future of children, in addition to family members, who can derive numerous benefits from the same. Despite sensitizing population about its beneficial aspects, there still remains considerable work to be done, since the target population at present is negligible, more so in a country, like India. -2-

3 APPLICATION ANALYSIS The Collection of Cord Blood Units - Global Globally, until 2010, cord blood units collected through public cord blood banks reached to about xxx thousand units. Chart 1: Global Cord Blood Units Collected ( ) by Public Cord Blood Banks in Thousands Year Units Collected (Cumulative) 2000 xx 2001 xx 2002 xxx 2003 xxx 2004 xxx 2005 xxx 2006 xxx 2007 xxx 2008 xxx 2009 xxx 2010 xxx Thousands Units Collected (Cumulative)

4 Cord Blood Transplants Recent Case Studies CASET STUDY I AUTOLOGOUS UMBILICAL CORD BLOOD TRANSFUSION IN YOUNGER CHILDREN HAVING TYPE 1 DIABETES Objective: There is a renewed interest as regards umbilical cord blood therapies potential in controlling autoimmune diseases. To this end, an open-label phase I study has been conducted, using autologous umbilical cord blood infusion for the amelioration of type 1 diabetes. Research Methodology: Overall, 15 patients diagnosed with type 1 diabetes already having autologous umbilical cord blood in storage have undergone a single intravenous infusion of autologous cells, after which they have been subjected to one year of post-infusion follow-up. An extensive range of insulin regimens has also been utilized for optimizing glycemic control, while metabolic and immunologic assessments have been performed prior to infusion and also at specified time periods thereafter. Outcome and Conclusion: Median [interquartile range (IQR)] age at infusion was 5.25 ( ) years, with a median post diagnosis time to infusion of 17.7 ( ) weeks, with no infusion related adverse events being observed. Several other statistically important observations were also determined, with the result that the conclusion stated the safety of transplanting autologous umbilical cord blood in children with type 1 diabetes, though efficacy of the same in preserving C- peptide has yet to be determined. This would require a larger bench of studies, which would also ascertain the overall efficacy of such approaches, and whether they can be conducive for the future or not, more so in connection with children affected by type 1 diabetes. CASE STUDY II WHAT CORD BLOOD TRANSFUSIONS HAVE ON OFFER (JULY 2009) Cord blood banks have been established for cryogenically freezing umbilical cord blood that has a potential usage in curing a range of life-threatening diseases, including several forms of cancer, autoimmune disorders, cardiovascular complications and diabetes. Other than these specified diseases, stem cells derived from umbilical cord blood have demonstrated their expertise in a range of conditions, of which several are underway. These would determine the final outcome of this therapeutic process, which is awaited by one and all. It would not be an overstatement to state that whatever has been professed has been a magic wand, touching one and all who are requisite of the same. -21-

5 MARKET TRENDS Collection of Stem Cells After Birth Using a New Method Research students from Johns Hopkins have evolved a new method that offers the potential to considerably increase cord blood stem cells collection post birth. This innovation, called CBx System, is undergoing testing, though the students have been successful in obtaining a provisional patent for the technology and formed a company called TheraCord LLC, with the hope that it would be of wide usage in hospital maternity wards in future. Cord blood offers great potential for treating and curing several diseases, though it is usually not collected and discarded after birth. A major reason for this is that a viable collection method does not exist and this leads to wastage of valuable cord blood. Currently, when a baby is born, parents have the option of cord blood collection and storage, which involves expense or they can donate cord blood at one of 180 hospitals that are affiliated with public cord blood banks. At present, about 40-50% of units collected can be used for transplants and the stem cells are usually only enough for a child. The newly developed method uses gravity in the collection process that combines mechanical forces and a chemical solution that can detach and flush more stem cells from the cord and placenta vessels, even up to 50% more stem cells. European Hematology Association (EHA) 2011 Congress Validates Cord Blood Stem Cell Transplantation Benefits Ever since the first human cord blood transplant was performed in 1988, the case for safety and efficacy of umbilical cord blood transplantation in children, as well as adults with a range of malignant and non-malignant diseases has been upheld. A survey conducted by Dr Annalisa Ruggeri from Eurocord, Hôpital Saint Louis in Paris, France and presented at the 16th Congress of the European Hematology Association in London has further validated claims for umbilical cord blood transplantation. The earliest recognition of umbilical cord blood (UCB) transplants was first garnered only among related donors. It was only later that Cord Blood Banks (CBB) for collection and cryopreservation (freezing/storing) of cord blood for unrelated use were established. -40-

6 JULY 2011 KEY BUSINESS TRENDS Cord Blood America in an Agreement with Regence Cord Blood America, Inc and Regence entered into an agreement for offering storage of umbilical cord blood to members of its BlueCross and BlueShield plans in Idaho, Oregon, Utah and Washington at discounted rates in line with its other BlueCross BlueShield (BCBS) licensee contracts. The collaboration enables Regence members thinking about cord blood banking to gain discounts on CorCell's Saving Baby's Cord Blood program. Cord Blood America s association with BlueCross BlueShield programs all over the country has provided several benefits to members, in addition to making the company expand. JUNE 2011 Cord Blood America Takes Over Assets of NeoCells Cord Blood America, Inc, an umbilical cord blood stem cell preservation company, took over the assets of Evanston, Illinois-based NeoCells, a subsidiary of ViviCells International, Inc for a consideration of US$320,000. This deal enables Cord Blood America to add over 2,700 customers to its client base through acquisitions that included the February takeover of all the umbilical cord blood samples from Reproductive Genetics Institute, Inc. The customers umbilical cord blood stem cells that were saved at birth have been moved to the company s Las Vegas headquarters. BioLife Solutions Leads in Supply of Cryopreservation Media for Stem Cells BioLife Solutions Inc, engaged in developing, manufacturing and marketing patented hypothermic storage, transport and cryopreservation (freezing) media for cells, tissues and organs, has gained leadership position in the supply of pre-formulated GMP cryopreservation media for umbilical cord blood stem cells. The company offers its products to research facilities, hospitals and companies that engage in cell therapy, tissue engineering, cord blood banking, toxicology testing and drug discovery. BioLife has cornered a considerable market share by enhancing relationships with direct and indirect customers such as Community Blood Services and China Cord Blood Bank via contract manufacturing customer OriGen Biomedical. The company is also being assisted by several contract banking services customers, such as ViaCord, Lifeforce Cryobanks and New England Cord Blood Bank. The past two years have enabled the company to gain leading position with its GMP grade CryoStor and BloodStor stem cell freeze media products. -88-

7 Chart 65: Glance at 2006, 2012 and 2015 European Cord Blood Stem Cells Market Share (%) by Therapeutic Area Neurology, Oncology, Cardiology, Cartilage, Blood Disorders, Diabetes, Dermatology and Other Year Neurology Oncology Cardiology Cartilage Blood Disorders Diabetes Dermatology Other Total 2006 xx.xx xx.xx xx.xx xx.xx xx.xx xx.xx xx.xx xx.xx xxx.xx 2012 xx.xx xx.xx xx.xx xx.xx xx.xx xx.xx xx.xx xx.xx xxx.xx 2015 xx.xx xx.xx xx.xx xx.xx xx.xx xx.xx xx.xx xx.xx xxx.xx Neurology Oncology Cardiology Cartilage Blood Disorders Diabetes Dermatology Other -179-

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