TBPP_Economics and Trends in the Plasma Industry

donor selection --> blood/plasma collection --> testing of donations --> plasma release --> shipping to fractionator

raw material release --> manufacturing --> QC testing --> product release --> shipping to markets

most centers in USA and germany, more than 6'000 employees, more than 150 collection centers (logistics, storages, test labs etc.)

only 20% from recovered plasma (world), europe: 59%, africa: 70%, USA: 8%, great variation depending on region. Recovered plasma: 450 ml blood per donation, 220-250 ml plasma p.d., longer frequencies for donations, no donor compensation. Source Plasma (Apheresis): 600-800 ml, max. 2 donations/week, shorter frequencies for donations, donor compensation (20-30 Dollar per donation).

1'000 liters, recovered and apheresis. Only an increase in north america, United states = only country in sense of whole blood/plasma supply is entirely self-sufficient. America: 55.19% of plasma collection volume, china: 13.66%, germany: 6.75%

North America: plasma collection by apheresis increases continously since 2005, collection by recovered plasma slightly decreases. Europe: source plasma volume has more than doubled since 2005, whereas recovered plasma volume remains stable at still higher level.

cost components: materials, labour, indemnities (distribution, donor restoration..), overhead expenses. Share of costs: plasma processing industry: more than 50% production, 5% marketing. Conventional pharma industry: 5% production, 30% marketing. Point of reference for costs per litre: USD 150-200 (2 Bio. dollars total)

specialty products: wound healing, fibrinogen, factor IX, prothrombin, API, inhibitors (low revenue, new gain methods and therapies needed, new markets and indications). 3 products cover 95% of the plasma gain: coagulation factor (VIII), albumin and immune globulin. use of recombinant products as alternatives to coagulation factors: for hemophilia A/B, recombinants are prophylactical and less immunogenic, for various therapeutic areas