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32 Plasma KCE Reports 120 NAT technology for viral DNA detection has dramatically reduced this window period. Negative results from the subsequent application of NAT technology to the plasma pool for a range of viruses (HCV, HIV, Parvo B19, HBV, etc.) provide assurance that the initial viral load in the plasma pool is zero or very low. 2.2.2 The worldwide supply of plasma products 2.2.2.1 Corporate structure of the market of plasma products Restructuring of the sector of plasma products Considering the increasing and vital needs of plasma products in most western countries, and simultaneously the uncertain level of donation, purchasers of plasma products – ie hospitals, and more generally health care institutions – can feel in an inferior position towards the plasma fractionation industry. The evolution of medical practices and also the political pressure of patient associations on health authorities do not leave them much room for manoeuvre. Therefore it is important to analyze the recent evolution of this industry to have a clear idea on the purchasers’ actual negotiation power. MAIN SPECIFICITIES OF THIS INDUSTRY SINCE THE NINETIES: FUSIONS AND MARKET CONSOLIDATION In 1996, the number of global stakeholders in the nineties was relatively high: almost 40 companies (or non profit organisations) were identified worldwide in the plasma fractionation industry. Following several merger waves, only 20 companies still exist today. Among these 20 companies some of them do not play a noticeable role on the global market because of their size or because of regulatory barriers that still isolate their domestic market from the international market. Hence, only a very small number of companies can be considered as real “global players” in terms of economic weight: and market share. CURRENT SITUATION (2003-2005) Worldwide, only five private companies still play an important role (>5%) on the global market. Non profit organizations are also important stakeholders; however some of them enjoy a monopoly, based on a specific national regulation. Table 10: Global firms on the plasma product industry 2003 2005 Baxter 18.4% 19.5% State ruled or on Profit 23.1% 16.5% Organisations CSL-Behring 15.8% 17.1% Talecris / Bayer 14.2% 13.8% Octapharma 5.7% 7.1% Grifols 7.6% 6.1% CSL/ZLB / Bioplasma 6% 1.6% Other 9.1% 18.2% Total 100% 100%
KCE Reports 120 Plasma 33 GEOGRAPHICAL DIMENSION OF THIS INDUSTRY: Table 11: Geographical dimension of the plasma product industry ‘MM US$ Oceania Africa South Middle Asia- Europe North World America East Pacific America Total Baxter 13.22 8.77 174.12 26.31 74.81 557.20 1230 2084.4 CSL-Behring 116.54 13.08 72.4 39.2 191.54 539.98 929.74 1902.47 Talecris 0 5.12 19.3 15.37 55.58 128.65 925.79 1149.81 Octapharma 24.5 32.25 98.78 96.75 23.07 382.98 205.75 864.08 Grifols 0 1.53 40.59 4.60 16.66 413.59 270.65 747.63 Leaving aside non profit or public organisations (the strategy of which is largely connected with specific national regulations), private companies’ strategies is obviously guided by financial prospects and expected profits on each geographical area. In that respect, the North-American area remains the most attractive geographical area for plasma fractionation firms. Therefore, European buyers are apt to compete with American ones, and a harsh competition could arise at any time between them with two possible consequences: punctual supply shortage and/or sharp increase in the prices of plasma-derived products. Capital structure: Four profiles identified As far as capital structure is concerned, one must notice that four profiles of capital structure have emerged, generally due to specific and deliberate corporate strategies. In other cases, (public institutions or other structures commissioned by public authorities) capital structure is closely connected with the monopoly status of the institution or specific national regulations. PROFILE 1: PRIVATE OWNED FIRMS (OCTAPHARMA AND GRIFOLS) These two firms are relatively close situations from this point of view: Octapharma is as a private-owned firm, and so is Grifols. In both cases, other stakeholders (especially banks) can play an important role in capital structure. However, private and family stakeholders remain the key investors in both cases and key stakeholders often remain deeply connected with the national or even regional economy (Switzerland / Catalonia). PROFILE 2: NATIONAL STATE-CONTROLLED FIRMS OR INSTITUTIONS (LFB) In several western countries, fractionation firms enjoy a monopoly as defined by a specific regulation (generally for historical or cultural reasons). In this case, the firm is either owned or controlled by public stakeholders, ie governmental institutions or institutions commissioned by the government. LFB in France is a traditional example: it enjoys a monopoly in plasma fractionation based on a French specific regulation. Before 2005, LFB used to be a public-law institution. Since then, it has been transformed into a private law holding company (legally a Ltd company) divided into two subsidiary companies: one focusing on Biotechnology, one focusing on Plasma fractionation. The capital of both subsidiary companies is state-controlled. Key members of the Board of Administration are government’s representatives (Ministry of Finance, Ministry of Health). PROFILE 3: FOREIGN-OWNED FIRMS (CSL-BEHRING) CSL-Behring is a very specific case: it was originally a German firm, CSL Behring became a subsidiary of CSL Limited, a biopharmaceutical company headquartered in Melbourne, Australia. From a financial point of view, about 90% of the shares are now controlled by Australian stakeholders. Therefore, even if CSL-Behring’s main facilities and RD centres are still located in Europe, it is under the control of foreign-based institutions.
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