Artificial blood is an artificially developed substitute for red blood cells. For decades, scientists have been trying to develop artificial blood from various sources and through different methods to address the shortage of blood for transfusions. Inadequate number of blood donors and the criticality of blood-type rejection have encouraged researchers to develop artificial blood, thus reducing the dependency on blood donors.
Transfusion of red blood cells (RBCs) is a standard and indispensable therapy for anemic conditions. Blood transfusion process has progressed through various developments, including development of acid-citrate-dextrose blood preservation solution, and cloning of ABO gene. However, blood transfusion come with a high risk of infections. Recombinant erythropoietin stimulating agent therapy has been the prominent therapy in cases such as chronic kidney disease, and chronic anemic conditions. Yet in thrombotic and neoplastic complications, blood transfusion is the only option. Hence, RBC production from hematopoietic stem cells has been the focus of regenerative therapy, with major players investing billions of dollars in R&D related to this technique. However, the final product is yet to receive U.S. Food & Drug Administration (FDA) approval.
Artificial Blood Market Development
There has been significant progress made in the global artificial blood market with respect to finding a suitable method to produce blood cells. Scientists have been trying to develop artificial blood from diverse molecules ranging from perfluorocarbons to hemoglobin. With the advent of research in stem cells, researchers began to develop RBCs from stem cells of cord blood. The enrollment for the first clinical trials of stem-cell based red blood cells began in 2009. This study used stem cells from cord blood and adult bone marrow. The study was conducted at the Hematological Laboratory at the University of Paris VI.
A similar research conducted by scientists at the University of Bristol and the UK’s National Health Service (NHS) using stem cells from adult and umbilical cord blood has shown successful results from initial studies. The study is scheduled to enter clinical trials with 20 subjects in 2017. The focus of these trials is to provide special treatment for specific patient groups, rather than act as complete replacement for blood.
Artificial Blood Market Potential
According to the World Health Organization (WHO), there are around 50,000 stem cell transplantations performed annually worldwide, which include 2,000 cord blood hematopoietic stem cell transplants performed each year. Use of stem cells from cord blood is increasing, as it does not require perfect human leukocyte antigen (HLA) tissue matching, can be used allogenically, and has less incidence of graft v/s host disease. According to the New York Blood Center (NYBC), which is the largest cord blood bank globally in terms of units stored, over half of all stem cell transplants in children, in the U.S., use cord blood. A similar statistic has been noted among adults in Japan.
Post the trial in 2017, production is expected to commence in the following 8 to 10 years, thus prolonging the commercialization of product in the artificial blood market.
Artificial Blood Market Future Outlook
Cord blood stem cell transplantation has proved to be a successful therapy in treatment of around 70 diseases. Developing artificial blood can be of great aid to meet the demand-supply gap in blood transfusion, more so considering the fact that finding compatible donors for sickle cell anemia and thalassemia patients is a mammoth task. Development of artificial blood could be the most viable solution to address the unmet needs among these patients. Continued investment in research and development is crucial for ensuring the commercial application of this technology, a very critical factor to contribute towards development of artificial blood market. Being a critical therapy for a severe life condition, the artificial blood market is expected to get a product in a decade or so.
Key players in the artificial blood market are focused on research and development activities to expand their product portfolio. For instance, in May 2019, Baxter International announced new research on 3-in-1 Oxiris filter Set for continuous renal replacement therapy (CRRT) and sepsis management. The filter removes cytokines and endotoxins from the blood.
Major companies are also focused on conducting clinical trials to assess the efficacy of blood systems. For instance, in June 2018, Cerus Corporation presented its European Phase 3 study that evaluated the efficacy and safety of INTERCEPT-treated red blood cells (RBCs) in thalassemia major patients, at the 23rd Congress of European Hematology Association (EHA) in Stockholm, Sweden.
Moreover, in December 2018, Cerus Corporation announced the initiation and first patient enrollment in a Phase III study to evaluate the efficacy and safety of the INTERCEPT Blood System for red blood cells in patients undergoing complex cardiac surgery procedures.