Analysis of the assortment of plasma-derived products on Ukraine pharmaceutical market

Keywords: biologic drugs, immunoglobulins, albumin, clotting factor concentrates, deproteinized hemoderivative

Abstract

Increasing number of patients, who suffers from diseases such as immunodeficiency, autoimmune and inflammatory diseases, various congenital blood clotting disorders stimulate an increase in the pharmaceutical market in the number of drugs for treating these diseases. Providing high-quality, effective and safe drugs, obtained from blood is an urgent issue that can save lives.

The purpose of the work was to study the range of biological drugs containing active substances obtained from human and animal blood plasma and analyze the segment of these drugs on the pharmaceutical market of Ukraine for 2020. To study this segment, was used data from the State Register of Medicinal Products of Ukraine, the information retrieval program «Morion» and the ATX classification system of the electronic resource Compendium.online. Research methods: structural, statistical, graphic, generalization and systematization.

Established, that the segment of biologic drugs, derived from human and animal blood plasma, at the Ukrainian pharmaceutical market, are represented by 100 trade names of drugs, where 23% of the studied market segment is occupied by domestic manufacturers. The leaders of importing countries are Austria (31%) and Sweden (13%). Analysis of the nomenclature found, that the most common drug dosage form are lyophilized powders for injection and infusion solution (52%) and solutions for injection and infusion (35%).

Studies have shown, that the active ingredient in the largest share of blood products is the coagulation factor of human blood VIII (36% of the total assortment). The range of drugs produced using plasma of animal origin is limited, makes up only 14% and is represented by preparations of immunoglobulins (horse, rabbit) and drugs containing deproteinization of dialysate from calf blood. The lack of domestic technologies for obtaining PDMPs from cattle plasma (RED) with a sufficient number of cattle was determined.

Obtained data show, that blood is a strategic raw material for the production of a wide range of drugs for the treatment of diseases of various etiologies, interruptions in the blood supply can lead to regional and global deficiency of the main PDMPs, therefore, the development of drugs based on blood is relevant and promising.

References

Nakaz MOZ Ukrainy vid 26. 08. 2005 r. № 426 (u redaktsii nakazu MOZ Ukrainy 23. 07. 2015 № 460) «Pro zatverdzhennia Poriadku provedennia ekspertyzy reiestratsiinykh materialiv na likarski zasoby, shcho podaiutsia na derzhavnu reiestratsiiu (perereiestratsiiu), a takozh ekspertyzy materialiv pro vnesennia zmin do reiestratsiinykh materialiv protiahom dii reiestratsiinoho posvidchennia» [Elektronnyi resurs]. – Rezhym dostupu: https://zakon.rada.gov.ua/laws/show/z1069-05#Text

Liapunov M., Bezuhla O., Takhtaulova N. ta in. Nastanova ST-N MOZU 42-4.0:2020. – Likarski zasoby. Nalezhna vyrobnycha praktyka. – Kyiv, MOZ Ukrainy, 2020. – 356 s.

Ulrich Jäger, Christine Chomienne, Jan Cools, Carin Smand. Blood disorders stepping into the limelight // Haematologica. – 2016. – V. 101, N 2. ‒ Р.101–103. https://doi.org/10.3324/haematol.2016.142018

Strengers P. F., Klein H. G. Plasma is a strategic resource // Transfusion. 2016. ‒ V. 56. ‒ P. 3133‒3137. https://doi.org/10.1111/trf.13913

Burnouf T. Blood products: unmet needs for essential medicines // The Lancet Haematology. ‒ 2019. ‒ V. 6, Iss. 12. ‒ P. e598‒e599. https://doi.org/10.1016/s2352-3026(19)30217-0

Global Plasma Fractionation Market Will Reach USD 36.8 Billion By 2025: Zion Market Research. Zion Market Research July 05, 2019 [Електронний ресурс]. – Режим доступу: https://www.globenewswire.com/newsrelease /2019/07/05/1878769/0/en/Global-Plasma-Fractionation-Market-Will-Reach-USD-36-8-Billion-By-2025-Zion-Market-Research.html

Hotchko M., Robert P. Recent market status and trends of fractionated plasma products // Annals of Blood. ‒ 2018. ‒ V. 3. ‒ P. 19. https://doi.org/10.21037/aob.2018.01.06

World Health Organization (WHO). WHO model lists of essential medicines. Geneva, Switzerland: WHO; 2013 [cited 2015 Feb 18]. Available from: http://www.who.int/medicines/publications/essentialmedicines/en/

Shima M., Hermans C., de Moerloose P. Novel products for haemostasis // Нaemophilia. ‒ 2014. ‒ V. 20, Iss. 4, Special Issue: State of the Art: WFH 2014 World Congress. – P. 29‒35. https://doi.org/10.1111/hae.12413

Guidance on plasma derived medicinal products. EMA/CHMP/BWP/706271/2010 / European Medicines Agency, July 2011. – Р. 33 [Електронний ресурс]. – Режим доступу: https://www.ema.europa.eu/en/ documents/scientific-guideline/guideline-plasma-derived-medicinal-products_en.pdf

Zubkova N. V. Byotehnolohycheskye aspekty effektyvnoi y bezopasnoi pererabotky donorskoi plazmy: problemy y perspektyvy // Byopreparaty. Profylaktyka, dyahnostyka, lechenye. – 2014. – S. 4–10 [Elektronnyi resurs]. – Rezhym dostupu: https://elibrary.ru/download/elibrary_22251159_16783730.pdf

Borshchevskyi H. I., Seredynska N. M. Mozhlyvist stvorennia orhanopreparativ na osnovi peptydnykh kompleksiv // Farmats. zhurn. – 2013. – № 5. – S. 58–67 Rezhym dostupu: https://pharmj.org.ua/index.php/journal/article/view/376

Derzhavnyi reiestr likarskykh zasobiv [Elektronnyi resurs]. – Rezhym dostupu: http://www.drlz.com.ua

Kompendium online [Elektronnyi resurs]. – Rezhym dostupu: http://compendium.com.ua

Shurko N., Voroniak M., Danysh T. Preparaty faktora zghortannia krovi VIII ta sposoby ikh otrymannia // Studia Biologica. – 2014. – T. 8, № 1. – S. 197–204.

Perekhrestenko P. M., Nazarchuk L. V., Tereshchuk T. O. Plazma krovy donorov: proyzvodstvo y yspolzovanye v Ukrayne. // Ukr. med. chasopys. – 2010. – № 3 (77). – S. 41–43.

Published
2020-07-30
How to Cite
Saliy, O., Popova, M., Palchevska, T., & Tarasenko, G. (2020). Analysis of the assortment of plasma-derived products on Ukraine pharmaceutical market . Farmatsevtychnyi Zhurnal, (4), 18-29. https://doi.org/10.32352/0367-3057.4.20.02
Section
Management of pharmacy