The Factor VIII Marketplace

The Factor VIII Marketplace

HRF, INC.

The blood contains plasma that serves the role of blood clotting that helps in reducing any severe blood loss that will even affect the patient. More importantly, the Factor VIII is the essential part that helps in the creation of the blood clot as well. At times, some people might lack the Factor VIII, a scenario that results in hemophilia A. such patients need Factor VIII from donors and later processed to help them in reducing the severe blood loss. In the US, nearly 16000 people have hemophilia A, but only those with severe conditions are the ones that will need the donors to offer them the Factor VIII^[1]. A number of donors and companies have emerged that focus on helping the patients in managing the blood loss they are experiencing. Evidently, with the high number of people with hemophilia A, the donors and the companies have a market for the Recombinant factor VIII concentrates that helps in reducing the severe blood loss.

Factor VIII also known as coagulation factor VIII entails the group of proteins that mainly focuses on the formation of the blood clots in the body. Often, after someone is injured from any activity, the clot plays an important role of stopping the blood vessels from releasing more blood and protecting the body in the process^[2]. Evidently, without the coagulation factor, people can even bleed to death since it is an important part in improving how one feels. Factor VIII is created by some of the cells that are found in the liver^[3]. After it has been created it starts to circulate in the body in an active form that is in the bloodstream. The von Willebrand factor is the molecule that is housing the inactive form of Factor VIII. The moment the blood reaches an injury, the inactive from changes to the active form of Factor VIII. After a chemical reaction with other substances it creates a clot that helps in the process of reducing any further blood loss as well^[4]. However, the presence of the F8 gene is not that constant in the bodies of the victims and at times its mutation affects someone negatively. In this case, the mutation often results in the hemophilia A that is a bleeding disorder^[5]. The mutation leads to the creation of the abnormal for of factor VIII that can no longer help in the process of blood clotting. Lack of blood clots means that one will bleed excessively in the moment an injury occurs. Evidently, hemophilia A is a disorder that has severe effects on the body functioning of the victim.

The mutation of the Factor VIII and the severe blood loss it causes there is the need for the replacement of those damaged Factor VIII. Such a scenario brings the need for the donors that are willing to give Factor VIII since they have the plenty ones^[6]. In fact, their cells in the liver have the ability to replace the ones donated with the ones that are healthier as well.  The market for the Factor VIII is present based on the number of people that have the Factor VIII deficiency. In the US, nearly 20,000 people are reported to have hemophilia^[7]. Of the number, roughly 80% of them have hemophilia A that is caused by the abnormal Factor VIII. Besides, nearly 400 babies are born with hemophilia in the US every year^[8]. However, not all these people will seek the donors for the factor VIII. Instead, only the people that have the severe hemophilia A will seek the factor from the donors and the companies that are known to produce the factor VIII. In the process, the market has about 8000 to about 13000 people that might be experiencing the severe hemophilia that needs prompt measures to counter the severe bleeding they might be facing^[9]. The market, on the other hand, is apportioned into those patients that might have inhibitors as well as those that will have the von Willebrand disease. Of the number, nearly 1200 of the victims have high levels of inhibitors that make it hard for the patients to have the factors for a long time in their bodies^[10]. For instance, the inhibitors often neutralize the factors making the patient to take a huge amount of factors at a time in order to reduce any severe blood loss.

In order to qualify as a donor one should have a special coagulation disorders to help in the process of reducing the severity that the victims of the hemophilia A to suffer^[11]. In essence, people with such disorders need to meet other requirements in order to qualify as donors. The same donors also benefit from a compensation plan that all depends on the demand for the Factor VIII. All the activities involved in approaching and evaluating potential donors and helping the victims are monitored by the Food and Drug Administration, Occupational Safety and Health Administration as well as Clinical Lab Improvement Act that ensures all the guidelines are met^[12]. However, the donated Factor VIII is not placed directly into the patient but has to undergo a process where it is altered into the right form needed by the patient affected. After being obtained from donors, they have to identify the specific clotting factor using the fractionation procedures that ensure the purity level is met^[13] (Calizzani et al, 2013). Initially, the cryoprecipitation does the job of separating the plasma before it undergoes the ion-exchange chromatography and monoclonal antibodies to get the purified form that is required^[14] (Calizzani et al, 2013). After the purifying process and other chemical reactions, the final product is often the Recombinant factor VIII concentrates that serves the purpose of managing the severity of Hemophilia A. some of these factor VIII concentrates also have the von Willebran Factor (vWF) that is essential in treating the von Willebrand disorder that might be present in a patient suffering from hemophilia A. in the process, the concentrates will be managing the severity of two disorders at a time and still using the same approach.

In conclusion, the presence of the factor VIII in the body is essential since it aids in the blood clotting thereby reducing the impact of severe blood loss. In some rare cases, the patients might have the mutated factor VIII that cannot undergo a successful blood clotting process. In the end, it becomes hard for such people to make the blood clots, raising the need to acquire the donated factor VIII to reduce the severity of hemophilia A. With about 8000 people experiencing severe hemophilia A in the US, there is a ready market for the donors and the companies dealing with the factor VIII. The presence of regulatory bodies all help the process of accessing the factor VIII to help in the process of getting the Recombinant factor VIII concentrates. The concentrate is of the required state in helping the patients in dealing with the severe blood loss.

 

 

 

 

Bibliography

Calizzani, Gabriele, Samantha Profili, Fabio Candura, Monica Lanzoni, Stefania Vaglio, Livia Cannata, Giancarlo M. Liumbruno, Massimo Franchini, Pier Mannuccio Mannucci, and Giuliano Grazzini. “The demand for factor VIII and for factor IX and the toll fractionation product surplus management.” Blood Transfus 11, no. Suppl 4 (2013): s64-76.

Casademunt, Elisabeth, Kristina Martinelle, Mats Jernberg, Stefan Winge, Maya Tiemeyer, Lothar Biesert, Sigurd Knaub, Olaf Walter, and Carola Schröder. “The first recombinant human coagulation factor VIII of human origin: human cell line and manufacturing characteristics.” European journal of haematology 89, no. 2 (2012): 165-176.

Clement, P. New Factors Concentrates, The Future is Now! August 2013. http://www.hog.org/publications/detail/new-factor-concentrates-the-future-is-now (Accessed 20 March, 2016)

Hermans, Cedric, Hans-Hermann Brackmann, Piercarla Schinco, and Günter Auerswald. “The case for wider use of recombinant factor VIII concentrates.” Critical reviews in oncology/hematology 83, no. 1 (2012): 11-20.

HRF, INC. (n.d.). https://hrfinc.com/info-for-donors/ (Accessed 20 March, 2016)

Kruse-Jarres, Rebecca. “Current controversies in the formation and treatment of alloantibodies to factor VIII in congenital hemophilia A.” ASH Education Program Book 2011, no. 1 (2011): 407-412.

 

^[1] Clement, P. New Factors Concentrates, The Future is Now! August 2013. http://www.hog.org/publications/detail/new-factor-concentrates-the-future-is-now (Accessed 20 March, 2016)

^[2] Hermans, Cedric, Hans-Hermann Brackmann, Piercarla Schinco, and Günter Auerswald. “The case for wider use of recombinant factor VIII concentrates.” Critical reviews in oncology/hematology 83, no. 1 (2012): 11-20.

^[3] Calizzani, Gabriele, Samantha Profili, Fabio Candura, Monica Lanzoni, Stefania Vaglio, Livia Cannata, Giancarlo M. Liumbruno, Massimo Franchini, Pier Mannuccio Mannucci, and Giuliano Grazzini. “The demand for factor VIII and for factor IX and the toll fractionation product surplus management.” Blood Transfus 11, no. Suppl 4 (2013): s64-76.

 

^[4] Ibid, 2.

^[5] Ibid, 3.

^[6] Casademunt, Elisabeth, Kristina Martinelle, Mats Jernberg, Stefan Winge, Maya Tiemeyer, Lothar Biesert, Sigurd Knaub, Olaf Walter, and Carola Schröder. “The first recombinant human coagulation factor VIII of human origin: human cell line and manufacturing characteristics.” European journal of haematology 89, no. 2 (2012): 165-176.

^[7] Ibid, 1.

^[8] Ibid, 1.

^[9] Ibid, 1.

^[10] Kruse-Jarres, Rebecca. “Current controversies in the formation and treatment of alloantibodies to factor VIII in congenital hemophilia A.” ASH Education Program Book 2011, no. 1 (2011): 407-412.

^[11] HRF, INC. (n.d.). https://hrfinc.com/info-for-donors/ (Accessed 20 March, 2016)

^[12] Ibid, 11.

^[13] Ibid, 3.

^[14] Ibid, 3.