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Manuscript ID : 707663 Visit : 355 Page: 77 - 89

Article Type: Original Research

Evolution of strategic plasma industry in Iran

Subject Areas :

Zahra Ghasemi 1 , fatemeh Babaei 2 , Fatemeh Parsa 3

1 - Pharmacoeconomics and Pharma Management, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran
2 - Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences and Health Services, Tehran, Iran.
3 - Faculty of Pharmacy, Islamic Azad University of Medical Sciences, Tehran, Iran

Received: 2023-08-27 Accepted : 2023-10-04 Published : 2023-10-23

Keywords:

Abstract :

Plasma-derived Medicinal Products (PDMPs) are categorized as the biological treatments and used to treat rare, chronic, severe and life-threatening conditions, such as primary immunodeficiency syndrome, bleeding disorders (hemophilia A and B), hemolytic diseases, severe infections, burns and liver diseases, as well as other diseases that caused by absence or lack of proper functioning of certain proteins, and lastly result in recessive patient’s quality of life.The first step in the production of PDMPs, is to collect plasma from eligible and healthy donors. This initial stage is complex and is closely monitored by global authorities with high accuracy and sensitivity to ensure the quality and safety of the finished products, as well as the donor's health.The availability and accessibility of manufactured PDMPs strongly depends on the availability of human plasma as its raw material, meaning that sufficient volume of plasma for fractionation is crucial. Therefore, Adopting a suitable national health policy regarding plasma donation, establishing collection centers, and raising public awareness of the importance of plasma donation will improve nation’s culture for adequate supply of PDMPs. in this paper, we decided to provide a brief and complete oversight of the Iranian plasma industry and highlight the significance of covering the market with toll- manufactured products with Iranian plasma. 

References:


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_||_

  1. WHO model list of essential medicines - 22nd list, 2021. Available from: https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2021.02
    2.
  2. Strengers PFW, Klein HG. Plasma is a strategic resource. Transfusion. 2016;56(12):3133–7.
    3.
  3. Hartmann J, Klein HG. Supply and demand for plasma-derived medicinal products - A critical reassessment amid the COVID-19 pandemic. Transfusion. 2020;60(11):2748–52.
    4.
  4. Schmidt PJ. The plasma wars: a history. Transfusion [Internet]. 2012 May;52:2S-4S. Available from: https://onlinelibrary.wiley.com/doi/10.1111/j.1537-2995.2012.03689.x
    5.
  5. European Medicines Agency. Guideline on plasma-derived medicinal products. Vol. 44, EMA Guideline. 2011. p. 1–33.
    6.
  6. Farrugia A, Penrod J, Bult JM. The Ethics of Paid Plasma Donation: A Plea for Patient Centeredness. HEC Forum. 2015;27(4):417–29.
    7.
  7. Farrugia A, Scaramuccia D. The dynamics of contract plasma fractionation. Biologicals [Internet]. 2017;46:159–67. Available from: http://dx.doi.org/10.1016/j.biologicals.2017.02.007
    8.
  8. Structures MB. Guidance on increasing supplies of plasma-derived medicinal products in low- and middle-income countries through fractionation of domestic plasma. 2021.
    9.
  9. Rosendaal FR, Smitt C, Varekamps I. Modern haemophilia treatment : medical improvements and quality of life. 1990;633–40.
    10.
  10. N Engl J Med 1965. Production of high-potency concentrates of antihemophilic globulin in a closed-bag system. N Engl J Med. 1965;
    11.
  11. Mercier Ythier J. The contested market of plasma. Transfus Clin Biol [Internet]. 2020;27(1):52–7. Available from: https://doi.org/10.1016/j.tracli.2019.10.003
    12.
  12. Prevot J, Jolles S. Global immunoglobulin supply: Steaming towards the iceberg? Curr Opin Allergy Clin Immunol. 2020;20(6):557–64.
    13.
  13. Guidelines on Assessing Donor Suitability for Blood Donation. World Heal Organ. 2012;1(5396):1497–1497.
    14.
  14. Kluszczynski, T; Rohr, S; Ernst R. Key Economic and Value Considerations for Plasma-Derived Medicinal Products (PDMPs) in Europe. Ppta. 2020;
    15.
  15. Burnouf T. An overview of plasma fractionation. Ann Blood. 2018;3:33–33.
    16.
  16. Farrugia A, Penrod J, Bult JM. Payment, compensation and replacement - The ethics and motivation of blood and plasma donation. Vox Sang. 2010;99(3):202–11.
    17.
  17. HealthCare ED for the Q of M&. Who Recommendations for the Production , Control and Regulation of human plasma for fractionation. Methods. 2005;(October):24–8.
    18.
  18. Burnouf T. An overview of plasma fractionation. Ann Blood. 2018;3(June):33–33.
    19.
  19. Grabowski H. Key economic and value considerations in the U.S. market for plasma protein therapies. 2018;(February).
    20.
  20. Siegel J. The product: All intravenous immunoglobulins are not equivalent. Pharmacotherapy. 2005;25(11 II).
    21.
  21. Burnouf T, Faber J, Radosevic M, Goubran H. Transfusion and Apheresis Science Plasma fractionation in countries with limited infrastructure and low- / medium income : How to move forward ? Transfus Apher Sci [Internet]. 2019;(xxxx):102715. Available from: https://doi.org/10.1016/j.transci.2019.102715
    22.
  22. Robert P. “Plasma industry challenges and opportunities differences between the plasma and the pharmaceutical industries.” In: Barcelona: International Plasma Proteins Congress (IPPC). 2016.
    23.
  23. Hotchko M. Current Market Landscape For Methodology And Immunoglobulins. In 2022.
    24.
  24. Cheraghali M. Availability of blood components and plasma derived medicines in Iran. Transfus Apher Sci. 2007;37:3–7.
    25.
  25. Biodarou Co. [Internet]. Available from: https://biodarou.com/
    26.
  26. Darmanara Co. [Internet]. Available from: https://www.darmanara.com/
    27.
  27. Afsaneh Aghaei. Plasma industry history at a glance. Sci J Iran Blood Transfus Organ. 2022;40:61–74.
    28.
  28. Mohammadi S, Aghabozorg F, Balagholi S, Ferdowsi S, Sharifi S, Eshghi P. Source Plasma Donation: The Experience of the Iranian Blood Transfusion Organization. Int J Hematol Stem Cell Res [Internet]. 2022 Jul 24;16(3). Available from: https://publish.kne-publishing.com/index.php/IJHOSCR/article/view/10137
    29.
  29. Maghsudlu M, Nasizadeh S. Iranian blood donors’ motivations and their influencing factors. Transfus Med. 2011;21(4):247–52.
    30.
  30. WHO. Improving access to safe blood products through local production and technology transfer in blood establishments. 2015;
    31.
  31. Robert PP. International Blood / Plasma News. 2002;19(11).
    32.

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