Basic facts about the EU pharma market

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1 Basic facts about the EU pharma market I. Market volume 1

2 Distribution of turnover for prescription medicines by originator companies in 2007 for USA, EU and Rest of the world Health spending across EU Member States Wide variety, differences in national health systems 6% of GDP in Poland, 11% of GDP in France Considerably lower in EU than in US (15%) Total size of pharmaceutical market in EU 138 bn ex factory basis, 214 bn retail-level almost one third of global turnover of pharmaceutical market 430 annual spending for every European citizen Five biggest EU markets make up 73% of total EU market Pharmaceutical Sector Inquiry, para

3 Annual sales of prescription and non-prescription medicines (ex-factory and retail prices) per Member State (2007) Different companies Different expenditures Originator companies 17% of turnover on R&D 23% of turnover on marketing 21% of turnover on manufacturing Generic companies 7% of turnover on R&D 13% of turnover on marketing 51% of turnover on manufacturing Pharmaceutical Sector Inquiry, p.48 3

4 II. Originators Facts of the top ten originator companies on EU market Prescription medicine constitute on average 80% of the turnover of originator companies 59 bn is the total turnover of all ten companies in the EU Turnover of prescription medicines in the USA is significantly higher than in Europe half of the companies listed are of European origin In 2007 the ten leading pharmaceutical companies generated on average almost 30% of their total global turnover in the EU Pharmaceutical Sector Inquiry, para. 63 4

5 Largest originator companies in the EU by turnover in prescription medicines (2007) Company Rank Turnover EU Turnover USA Turnover global Share EU/global Sanofi-Aventis 1 11,064,138 9,474,424 28,051,716 39% Glaxo-Smith-Kline 2 8,189,486 13,513,760 28,032,381 29% Pfizer* 3 8,004,675 15,589,595 32,433,183 25% Hoffmann La Roche 4 6,981,780 9,009,986 22,391,735 31% Astra-Zeneca 5 6,260,463 8,400,802 19,819,190 31% Novartis 6 5,463,289 6,473,219 17,530,229 31% Wyeth* 7 3,332,506 6,159,070 11,590,479 29% Johnson&Johnson 8 3,309,067 11,385,274 18,027,103 18% Eli Lilly 9 3,201,487 7,016,469 12,869,539 25% Abbott 10 2,845,826 5,695,479 10,878,652 26% Total 58,652,717 92,718, ,696,207 29% On 26 January 2009 Pfizer and Wyeth announced the conclusion of a merger agreement creating the largest pharmaceutical company in the world. The Swiss-based company Hoffmann LaRoche has also announced the takeover of the complete American biotech company Genentech. These transactions will slightly modifiy the above ranking. Top selling prescription medicines in the EU 27 (2007) 5

6 II. Generics Turnover of generic companies in the USA, EU and the rest of the world as a % of global turnover (2007) 6

7 Largest generic companies in the EU by turnover in prescription medicines (2007) Company Rank Turnover EU Turnover USA Turnover global Teva 1 3,388,421 1,449,732 5,763,037 Sandoz 2 2,041,182 1,318,915 5,406,935* Ratiopharm 3 1,021,388 n/a 1,383,599 Stada 4 900,000-1,000,000 6,519 1,570,490* Mylan 5 800, ,000¹ 1,259,525 1,435,811² Actavis 6 496, ,905 1,544,154* Zentiva 7 341, ,646 Gedeon Richter 8 314,676 14,64 607,067 Pliva 9 282, ,67 564,772 Ranbaxy , ,579* 1,181,651* Total 9,940,683 4,780, ,16 Notes: * = global turnover for prescription medicines was not provided by the companies so the figures used refer to medicines in general. = these figures were originally calculated in US$. The conventional foreign exchange rate used to translate Sandoz initial US$ denominated figures into was US$ 1 = = for prescription medicine only excluding the contribution from the Anti-Infective business and/or OTC activities in some markets. 1 = EU turnover of Merck Generics for prescription is between 800 million and 900 million for 2007 which includes, from the acquisition of Merck Generics Group by Mylan, the EU turnover for the fourth quarter publicly disclosed and amounting to million (US$ million). 2 =Turnover (total sales), in thousand, globally but excluding Merck Generics. Five top selling generic INNs in the EU27 (2007) Rank INN Therapeutic class (ATC1 st level) EU 27 turnover Global turnover 1 OMEPRAZOLE alimentary tract and metabolism 557, ,072 2 SIMVASTATIN cardiovascular system 391, ,629 3 FENTANYL nervous system 108, ,663 4 METOPROLOL cardiovascular system 98, ,107 5 ALENDRONIC ACID musculo-skeletal 80,025 83,952 Total 1,235,694 2,029,424 7

8 Generic market shares in Europe (based on IMS data) Note: Generic market shares in Figure 11 may differ from findings by other sources, e.g. EGA, due to the fact that the definition of generic products may include different product categories in the various countries. Global share of cost factors among generic companies as a percentage of annual turnover (prescription medicines, 2007) Manufacturing costs Marketing and promotion costs R&D costs General administration and overhaed costs Distribution costs Other annual costs 51% 13% 7% 6% 3% 1% 8

9 III. Generic entry Market effects in case of generic entry Generic entry in 50% of medicines within first year after loss of exclusivity (LoE) Price drop generic price on average 25% lower than originator prior LoE two years after entry, prices of generic medicines are between 40% and 50% below originator price prior to LoE Market share of generic companies 30% after first year, 45% after two years Pharmaceutical Sector Inquiry, p. 94 9

10 Originator and generic prices in the first year (sample: E75 list, LoE in ; all INNs with entry; weighted by INN; month 0 = entry; index = 1 for price six months before LoE) (partially based on IMS data). Originator and generic prices in the first two years (sample: E75 list, all INNs with entry; weighted by INN; month 0 = entry; index = 1 for price six months before LoE) (partially based on IMS data). 10

11 Originator and generic prices for products with generic entry (sample: E75 list, all INNs with entry; weighted by INN; month 0 = entry; index = 1 for price six months before LoE) (partially based on IMS data) Factors with influence on generic entry Volume of the market at the point of LoE Regulatory environment Existence of compulsory generic substitution for pharmacists Mandatory discounts or price caps for generics Policies encouraging doctors to prescribe INNs instead of a specific brand Number of generic companies that enter Pharmaceutical Sector Inquiry, para. 189, 190, 197,

12 Share of INNs which expired followed by generic entry within one year, by MS (head count), for the periods and (partially based on IMS data). Evolution of the effective protection period counted from first launch to first generic product in the period

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