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Review
. 2020 Dec;20(6):557-564.
doi: 10.1097/ACI.0000000000000696.

Global immunoglobulin supply: steaming towards the iceberg?

Johan Prevot  1 , Stephen Jolles  2
Affiliations
Review

Global immunoglobulin supply: steaming towards the iceberg?

Johan Prevot et al. Curr Opin Allergy Clin Immunol. 2020 Dec.

Abstract

Purpose of review: This review describes how plasma is sourced for fractionation into plasma-derived medicinal products (PDMPs), such as immunoglobulin (Ig) together with differences between plasma from whole blood (recovered plasma) and from plasmapheresis (source plasma) in terms of global plasma supply. Specific areas of growth in immunoglobulin use are identified alongside novel therapies, which may reduce demand for some immunoglobulin indications.

Recent findings: There has been a 6--8% annual growth in immunoglobulin use. Secondary immunodeficiency alongside improved recognition and diagnosis primary immunodeficiency disorders are drivers whereas the novel neonatal Fc receptor inhibitors (FcRni) may reduce demand for some immunomodulatory indications.

Summary: There is a significant geographical imbalance in global supply of plasma with 65% collected in the United States. This results in a dependency of other countries on United States supply and argues for both more plasma supply and greater regionally balanced plasma collection. In addition, progress towards a transparent, regulated and well tolerated framework for the coexistence of unpaid and compensated plasma donations is needed as unpaid donation will not be sufficient. These discussions should be informed by the needs of patients for this life-saving therapy, the care of donors and the safety of plasma and PDMPs.

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Conflict of interest statement

S.J. declares Advisory Board, Speaker, Conference, Clinical Trial, DSMB, or Projects with CSL Behring, Shire, Takeda, Thermofisher, Swedish Orphan Biovitrum, Biotest, Binding Site, BPL, Octapharma, Sanofi, LFB, Pharming, Biocryst, Zarodex, Weatherden and UCB Pharma.

J.P. is the Executive Director of the International Patient Organisation for Primary Immunodeficiencies (IPOPI). IPOPI regularly receives support from a broad range of companies involved in the manufacture of immunoglobulin therapies and the field of primary immunodeficiencies. For an updated list please visit www.ipopi.org.

Figures

Box 1
Box 1
no caption available
FIGURE 1
FIGURE 1
Data from the Australian National Blood Authority showing the amount of immunoglobulin dispensed by medical condition with the highest amount being for secondary antibody deficiency because of hematological malignancy or haematopoietic stem cell transplantation (HSCT) and this being more than twice that for primary immunodeficiency (PID). On the basis of data https://www.blood.gov.au/ig-usage-data-and-statistics.
FIGURE 2
FIGURE 2
The annual growth rate in global immunoglobulin use (based on data from the Marketing Research Bureau) showing the year on year rise in immunoglobulin use between 2010 and 2018 at an average of around 12% per year.
FIGURE 3
FIGURE 3
The global distribution of plasma (source and recovered) collection (based on data from the Marketing Research Bureau) showing the current world reliance on the United States-based plasma collection.
FIGURE 4
FIGURE 4
Global immunoglobulin sales (based on data from the Marketing Research Bureau 2018) showing the currently low levels of sales per head and potential for growth in areas, such as Latin America and Africa alongside European sales dependent on the United States plasma collection.
See this image and copyright information in PMC

References

    1. Bruton OC. Agammaglobulinemia. Pediatrics 1952; 9:722–728. - PubMed
    1. Jolles S. Hyaluronidase facilitated subcutaneous immunoglobulin in primary immunodeficiency. Immunotargets Ther 2013; 2:125–133. - PMC - PubMed
    1. European Medicines Agency. Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg). EMA/CHMP/BPWP/94033/2007 rev. 3. Committee for Medicinal Products for Human Use (CHMP), 28 June 2018. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-cl... (Accessed 15 June 2019)
    1. European Medicines Agency. Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg). EMA/CHMP/BPWP/410415/2011 rev 1. 23 July, 2015. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-cl... (Accessed 15 June 2020)
    1. European Medicines Agency. Guideline on plasma-derived medicinal products. EMA/CHMP/BWP/706271/2010. London. 21 July, 2011. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-pl... (Accessed 29 April 2019)

MeSH terms