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100 Plasma KCE Reports 120 4.1.2 Worldwide demand for plasma products / Focus on IVIG (2000-2008) Percentage 60 50 40 30 20 10 0 Over the last years, global demand for polyvalent Intravenous immune-globulin has raised firmly and steadily. Whereas global demand for polyvalent IVIG amounted to ca 47 000 tons in 2000, it reached more than 82 000 tons in 2008.(ie an increase by 75% in an eight-year period of time). In 2007, the share of the European Region in the global demand amounted to 25%, whereas the one of the North American Region reached 45%. In financial terms, the demand of the European Region reached 762 million US dollars (20% of the global demand), whereas the one of the North American Region amounted to 2199 million US dollars (57% of the global demand). Figure 13: Global collection and Demand of IVIG North America European Union Source: Marketing Research Bureau Other Regions 4.1.3 Potential changes in demand structure Share in Global Collection % Share in Global Demand % North America European Union Other Regions Share in Global Demand % 45 25 30 Share in Global Collection % 56 24 20 Indications have evolved over the last years. Therefore, it is important to stress that these evolutions have had an impact (or even a major) on the demand of plasma products. It remains difficult to forecast evolution of consumption precisely, as different factors must be taken into account: research progress and new evidence-based indications, but also dissemination of premature and non evidence-based practices or expert opinions. Further information in Appendix “Emerging Countries” on the Brazilian and the Chinese market
KCE Reports 120 Plasma 101 Key points • The North American region (especially the United States) remains the “World’s plasma collector” whereas Europe remains the “World’s plasma fractionator”. • The main concern of the American stakeholders is to secure the supply for plasma products, by different means (long term supply contracts, control of fractionation capacities), whereas the fulfilling of European patients simultaneously requires large imports of American plasma. • Should US health authorities decide to restrict export of their own raw plasma, European patients would be put in a predicament. Any change of American practices (new indications or change in prescription habits) must be kept under close scrutiny as it could lead to a similar deadlock. Conversely, American patients need to rely on the EU fractionation industry to fulfil their own needs. • Emerging countries are likely to play an ever greater role on the world market, which means greater competition between purchasers. 4.2 CONCEPT OF SELF SUFFICIENCY 4.2.1 In Belgium Belgian regulations do not define the proportion of plasma derivatives that must be produced in Belgium to minimise the risk of shortages of plasma derivatives. A Royal Decree of 18 June 1998 simply states that in order to ensure self-sufficiency and the quality of the supplies of stable blood products of human origin, the price of a litre of plasma, manufactured by plasmapheresis and sold by the Red Cross to the CAF-DCF, will be subsidised and that a firm of auditors will communicate each year to the SPF the number of litres sold in order to calculate correctly the subsidy. Since the quantity guaranteeing self-sufficiency is not explicitly stated in the decree, it transpires from verbal explanations gathered that the auditor i deems that self-sufficiency is achieved if the CAF-DCF provides • “a level of production covering 60% of the average national consumption of the main plasma-derived products – i.e. Factor VIII, Albumin, and IVIG - in normal sanitary and epidemiological conditions, and considering approved indications” • “a quarantine stock covering 90 days of average national consumption for the three main products mentioned above”. In practice, this stock comprises 8000 bottles of Albumin, 1 million doses of Factor VIII, and 50kg of IVIG. This quantity is shown on the first line of the table below. PWC then deducts from this quantity the number of litres of non-subsidised plasma (RP) (line 2) and adds to it the number of litres taken from stocks (line 4) to calculate the number of litres to be subsidised (line 5). i This role is assumed by the firm PricewaterhouseCoopers. See ‘Plasma from plasmapheresis required for self-sufficiency in Belgium in 2008’ PWC
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KCE Reports 120B Plasma i PRÉFACE
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KCE Reports 120B Plasma vii RECOMMA
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KCE Reports 120 Plasma 3 GLOSSARY A
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KCE Reports 120 Plasma 29 2.2 TRANS
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KCE Reports 120 Plasma 39 2.3 LIMIT
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KCE Reports 120 Plasma 43 3.2 INDIC
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73. Financement du programme de soi
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