Umbilical cord blood (UCB) has been an accepted source of hematopoietic stem cells (HSC) for transplantation for more than 30 years. Umbilical cord-derived stem cells are the youngest cells available for transfusion and yet their uptake lags behind bone marrow and peripheral blood-derived HSCs. Decreased engraftment rates and the low cell dose available for transplantation are limitations that are preventing umbilical cord blood-derived cells from reaching their full potential. While a handful of companies are now developing cord blood and tissue-derived cell therapeutics, it will likely take several years for these products to reach commercialization.
According to the data available from the World Marrow Donor Association (WMDA), presently, about 40,108,470 donors have stored 806,250 cord blood units in different registries across the world. The same source reveals that 61,606 CBUs were shipped from various registries for transplantation between 1997 and today.
Cord blood cells are also used for research and therapy development because of their naïve state. Researchers use umbilical cord blood units for developing NK cells, NK-CAR cells, and other types of T cells. Researchers in some companies are also developing induced pluripotent stem cells (iPSCs) derived from UCB for the creation of desired cell lineages and off-the-shelf allogeneic cell therapy products.
Every year, between 35,000 and 50,000 hematopoietic stem cell transplantations (HSCTs) are performed to treat patients with blood and immune system disorders. Traditionally, hematopoietic stem cells for these transplantations come from bone marrow donations from relatives or unrelated donors. However, about 10,000 to 15,000 patients cannot find a close enough match from among the millions of bone marrow donors listed in the global database. Some patients do not have enough time to find an unrelated adult donor due to the rapid progression of the disease. For these patients, the only other alternative is the cord blood cells stored in cord blood banks.
However, since 2010, the release of UCB units for treatment purposes has leveled off and started decreasing since 2013. Several factors have contributed to these changes. Important drivers influencing the UCB industry comprise the emergence of haploidentical HSCT and the increased use of UCB units for developing regenerative medicines. Some of the factors limiting the growth of the UCB industry include the high cost associated with UCB transplantation, the economic impact of sustaining public bank operations and an active private UCB banking sector. We predict that these factors will go on in a tug-of-war mode to shape and ultimately determine the fate of the UCB industry.
Future Trajectory of the Cord Blood & Tissue Market
At present, two important trends in the global cord blood banking industry are that public banks are struggling to stay in business and private cord blood banks are consolidating. In Western markets, the number of cord blood units released from public banks for allogeneic transplants is less than half of what it was some fifteen years ago. Thus, struggling public cord blood banks are exploring possible new applications for their inventory, such as the development of cell therapeutics derived from umbilical cord blood and tissue.
Due to severe competition, private cord blood banks in the U.S., Brazil, Hong Kong, and parts of Europe are reducing their prices. In another development, the pace of multinational cord blood banks acquiring smaller private banks is on the rise. Although research studies have confirmed that CBUs can be used to treat approximately 80 FDA-approved therapies, that number has, unfortunately, remained static for several decades.
To date, there have been promising clinical trials conducted worldwide for a range of brain-related and neurological conditions. These trials have involved cord blood-derived cells for the treatment of hypoxic ischemic encephalopathy, cerebral palsy, autism, multiple sclerosis, and stroke. While results from clinical trials for neurological indications using CBUs look highly promising, no cord blood or tissue-derived cellular product has yet to receive regulatory approval. Nonetheless, a product approval for any of these conditions could have a major impact on the global market opening up new avenues for commercialization.