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36 Plasma KCE Reports 120 2.2.3.3 Produced and sold quantities Plasma fractionated by CAF-DCF in litres Albumin produced by CAF-DCF in Belgium in kg Albumin sold by CAF- DCF in Belgium in kg Number gr produced albumin for 1 litre plasma (calculated by KCE) Production of albumin if the yield equals 25,29 gr/litre Albumin produced by CAF-DCF in Belgium in kg Based on the availability of volumes of plasma fractionated by CAF-DCF, volumes of derivatives manufactured from this plasma, and yearly volume of sales, we can make the following analysis. The first finding is the bearish trend for the sale of specific derivatives. The risk of (and fear for) disease transmitted by plasma derivatives has probably contributed to the variations in the amounts of derivatives sold. For instance, the risk for Creutzfeld Jacob or other transmissible disease has contributed the increasing use of recombinant coagulation factors to treat hemophilia, and subsequent decreasing use of plasma derived factors. Indeed in 2004, the Belgian authorities have reported that Belgian hemophilic patients had received coagulation factors prepared from a European plasma pool that could have been contaminated with prions. c We will focus the following analysis on albumin and immunoglobulins. Albumin The first calculus consists in dividing the number of litres of fractionated plasma by the number of actually produced grams of albumin. This ratio is decreasing since 2001 even if the level of 2008 shows a weak increase. Table 14: Calculation of number of grams obtained from 1 litre of plasma (2000-2008) 2000 2001 2002 2003 2004 2005 2006 2007 2008 190.964 192.648 206.015 212.827 210.578 178.249 182.149 170.497 159.421 4.679 4.873 4.755 4.873 5.005 4.264 2.419 2.607 3.085 4.640 4.860 5.040 4.780 4.730 3.570 2.740 2.450 2.750 24,50 25,29 23,08 22,90 23,77 23,92 13,28 15,29 19,35 Source: CAF-DCF for the three first lines of the table As from 2003 the intermediate albumin rich fraction is sent to Sanquin ( 9 p. 12) for refining and packaging. According to Verhaegen 9 , the overall cost of this processing totals 3.1 million euros in 2003 and 4.6 million euros in 2004. We calculated the volume that could have been produced, if the albumin/plasma ratio had remained identical to the one of 2001 for the reviewed years. Table 15: Calculation of the potential production of albumins (2000-2008) 2000 2001 2002 2003 2004 2005 2006 2007 2008 4.829 4.872 5.210 5.382 5.326 4.508 4.607 4.312 4.022 4.679 4.872 4.755 4.873 5.005 4.264 2.419 2.607 3.085 Differences 150 0 455 509 321 244 2.188 1.705 1.272 Thanks to this calculus, we observe that between 0,15 and 2,18 supplementary tons of albumin per year could have been produced, technically speaking. However, line 3 of table 14 shows that no purchasers could be found for such volumes on the Belgian market. Hence, CAF-DCF had no interest to produce more albumins. The production of albumin follows the demand on the Belgian market. The real yield for fractionation of albumins ivaries between 24,6 and 25,6 gram per kilo of plasma. c Service public fédéral Santé publique. Communiqué de presse du 23 novembre 2004.
KCE Reports 120 Plasma 37 Plasma fractionated by CAF IG produced by CAF‐DCF in Belgium in gr This Belgian demand is function of the nature of the competition between firms present on the market and of an international underlying reduction of albumin demand. This is confirmed by a recent Australian Report of CSL where we can read that ‘In Australia the amount of albumin issued per annum over the period 1994-95 to 2004-5 has increased by an average annual growth rate of ca. 1.4%, as shown in, although in the last five years this value has been higher at ca. 2.3%. In contrast, the growth in plasma collections has been ca. 6% per annum over the same period and if all of this plasma had been converted into product then Australia would have accumulated a substantial excess of albumin over requirements. Recognizing this situation, CSL was instructed to limit the production of albumin from 1999-00 onward in order to balance supply with demand. As a consequence of this policy the latest data from 2004-05 indicates that Australia can meet demand for albumin by converting only about 60% of the available plasma into finished albumin product’. 16 The same phenomenon occurred in Belgium and a proportion of collected plasma is then sold to foreign firms under the form of intermediate products. The case of immunoglobulins The trend identified for IG is opposed to the trend for albumin: it shows that since 2004 the quantities of IG sold by the CAF-DCF follow a rising path despite the fall in collection. This rise in sales volume might be partly explained by the desertion of the Belgian market by one firm around 2004. Table 16: Calculation of number of grams obtained from 1 litre of plasma (2000-2008) 2000 2001 2002 2003 2004 2005 2006 2007 2008 190.964 192.648 206.015 212.827 210.578 178.249 182.149 170.497 159.421 171.000 185.000 118.000 340.000 379.000 456.000 455.000 531.000 636.000 IG sold by CAF‐DCF in Belgium in gr Number of gr of 122.000 151.000 170.000 298.000 393.000 389.000 462.000 490.000 543.000 produced IG for 1 litre plasma 0,90 0,96 0,57 1,60 1,80 2,56 2,50 3,11 3,99 Source: CAF-DCF for the tree first lines of the table The calculated ratios present a constant increase since 2000. These ratios are calculated as if all the fractionated plasma was used to produce immunoglobulins. CAF-DCF reported that the quantities of fractionated plasma used for a given derivative is always determined by the demand. The reported technical yield by the CAF-DCF is 2,7 gr/L plasma for the period 2000-2002. Since 2003, the CAF-DCF used a very performing technology to produce the Multigam. During the period 2003-2007, the yield was equal to 4,2 gr/L. In 2008, the use of the nanofiltration caused a light reduction of the yield to 3,9 gr/L. In 2008, the ratio is exactly the same as the reference mentioned in an unpublished document of PPTA (3.98 g/L). Nevertheless it seems that the world’s best fractionation operators should obtain a constant yield of 5.3 g/L (CSL reference). However, as we do not have at our disposal the right data to determine the precise content of the yields identified in other countries, this comparison must be considered with care. This evolution shows CAF-DCF’s responsiveness to demand and also its capacity to raise its production at a faster pace than the one of demand.
Page 1 and 2: Comment assurer l’autosuffisance
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Page 5 and 6: KCE Reports 120B Plasma i PRÉFACE
Page 7 and 8: KCE Reports 120B Plasma iii MÉTHOD
Page 9 and 10: KCE Reports 120B Plasma v En ce qui
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Page 15 and 16: KCE Reports 120 Plasma 3 GLOSSARY A
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KCE Reports 120 Plasma 121 APPENDIX
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