TBPP_Economics and Trends in the Plasma Industry

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

immunoglobulin: in 2013 yield of 4 g/L, sufficient to supply the demand, increase in demand (North America, Europe, Asia). Albumin: in 2013 yield of 20 g/L, sufficient to supply the demand, demand increase of 3% - 7%. Factor VIII: still some growth (2.1%), therapy of hemophilia completely undertreated: not all countries can afford the products = too expensive.

2011: 59% North America, 19.5% Europe, 2016: 56.4% North America, 20,1% Europe (increase in Europe, decrease in North America). Baxter, CSL and Grifols = leader of the industry with 65% market share and hold key technologies + patents. With further expanding market, more revenue in the future.

founded in 1916, HQ: parkville, Australia. Total number of employees: 16'000, revenue 2016: 6,129 Mio., public ownership, revenue by therapy: 46% immunoglobulins, 30% critical care (albumin), FVIII 19%. By region: 46% North America, 27% Europe, 11% Asia.

non-profit decreasing from 19.5% to 6.7%, CSL growing from 5.1% to 24.9%. Global revenue still growing in the future. China offers high growth potential for all product categories