Plasma Fractionation in Korea
Plasma Fractionation in Korea
Plasma Fractionation in Korea
Perspective
OVERVIEW
The plasma supply for pharmaceutical manufacturing consists of surplus plasma recovered from whole blood collection
and source plasma from plasmapheresis in Korea. Shortages
are typically covered by importation. The total plasma supply for fractionation was 608,352 liters in 2009, of which
430,267 liters were supplied domestically. The self-sufficiency rate was, therefore, about 71% in terms of domestic
demand.
The fundamental policy for supplying plasma derivatives
was established by the government in 1978 following the
recommendations of WHO and IFRC (International Federation of Red Cross), based on blood self-sufficiency and
exclusion of commercialism. Since then, the government
has been maintaining a public arrangement for plasma fractionation and authorized the delegation of supplying plasma
and plasma products to the Korean Red Cross (KRC) through
the revision of Pharmaceutical Affairs Law in 1986.
According to this policy, permission for fractionation and
importation, inspection of potentially importing blood collection centers, and regular audits of plasma importers, have
been all granted and executed by KRC. Moreover, KRC
pushed ahead with its plan to produce end-products, and
3
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Perspective
Table 1. Domestic market share of plasma products sales in recent 3 years (billion KRW).
Products
Albumin
IV immunoglobulin
Tetanus IG
HBV IG
Antithrombin
Factor VIII
Factor IX
Varicella zoster IG
Gamma globulin
Histobulin
Fibrin sealant
Fibrinogen
Total
2007
2008
2009
SK
GC
Subtotal
SK
GC
Subtotal
SK
GC
Subtotal
19.6
2.9
0.8
0.7
24.0
49.7
11.2
9.8
30.4
11.0
33.1
0.2
0.04
0.03
0.3
5.4
0.03
151.2
69.3
14.1
10.6
31.1
11.0
33.1
0.2
0.04
0.03
0.3
5.4
0.03
175.2
21.4
3.7
0
0
25.1
43.9
12.4
10.8
36.7
12.6
30.2
0.3
0.05
0.03
0.3
6.3
0.01
153.6
65.3
16.1
10.8
36.7
12.6
30.2
0.3
0.05
0.03
0.3
6.3
0.01
178.7
24.8
4.1
0
0
28.9
52.1
15.5
13.1
42.3
15.6
36.7
0.5
0.04
0.04
3.5
9.6
0.01
188.9
76.9
19.6
13.1
42.3
15.6
36.7
0.5
0.04
0.04
3.5
9.6
0.01
217.8
Fig. 1. (A) Global and (B) domestic market share of plasma products.
Domestic Imported
plasma (L) plasma (L)
317,329
419,874
300,795
334,259
430,267
309,296
210,178
350,526
266,535
178,085
Total (L)
Self-sufficiency
rate (%)
626,625
630,052
651,321
600,794
608,352
50.6
66.6
46.2
55.6
70.7
the achievement of plasma self-sufficiency. With the continuous improvement in the donor recruitment and retention, this seems to be a reasonably achievable goal.