The Pharmaceutical Industry in Europe Key data - Download as PowerPoint

Document Sample
The Pharmaceutical Industry in Europe Key data - Download as PowerPoint Powered By Docstoc
					The Pharmaceutical Industry in Europe
             Key data

  INDUSTRY (EFPIA Total) (*)                            1990            2000     2004         2005

  Production                                          60,220         121,471   160,769   170,000 (e)
  Exports                                             23,180          90,935   165,003   178,000 (e)
  Imports                                              16,113         68,841   132,853   144,000 (e)
  Trade balance                                        7,067          22,094    32,150   34,000 (e)
  R&D expenditure                                      7,766          17,849    21,106    21,700 (e)
  Employment (units)                                500,879         538,317    612,114   615,000 (e)
  R&D employment (units)                              75,760          88,524   102,222   103,000 (e)
  Pharmaceutical market value at ex-                  43,005          86,812   120,007   127,500 (e)
  factory prices


  Values in € million unless otherwise stated
  (*) Data relate to EU-25, Norway and Switzerland since 2004
  Source: EFPIA member associations (official figures) – (e): EFPIA estimate
          Eurostat (EU-25 trade data 1995-2005)
  Pharmaceutical production in Europe
        1980-2005 (€ million)
                   180000                                                     170000
                                                                        160769
                   160000

                   140000
                                                               121471
                   120000

                   100000
                                                       87799

                    80000
                                              60220
                    60000
                                      39821
                    40000
                             20336
                    20000

                         0
                              1980    1985     1990     1995    2000     2004      2005


Source: EFPIA member associations (official figures) – Data 2005: EFPIA estimate
Pharmaceutical employment in Europe
            1985-2005
                    700000

                                                                                         612114   615000

                    600000                                               577028 575071
                                                                552901
                                                       538317
                                       500879 506052
                    500000
                              439090


                    400000



                    300000



                    200000



                    100000



                          0
                              1985     1990 1995       2000 2001 2002           2003 2004         2005

 Note: as of 2004 data include Malta, Poland and Slovenia
 Source: EFPIA member associations (official figures) – Data 2005: EFPIA estimate
  Employment in pharmaceutical R&D
       in Europe (1985-2005)
                          120000

                                                                          102222 103000
                          100000
                                                                 88524
                                                       82282
                           80000              75760

                                    63000
                           60000



                           40000



                           20000



                                0
                                     1985      1990     1995      2000     2003      2004


Cyprus, Czech Rep., Estonia, Greece, Hungary, Latvia, Lithuania, Malta, Poland, Portugal Slovakia: data not available
Source: EFPIA member associations – Data 2005: EFPIA estimate
Pharmaceutical R&D expenditure in Europe
                                               € million

                           25000

                                                                                 21700
                                                                         21106

                           20000
                                                                 17849



                           15000

                                                         11484

                           10000
                                                  7766


                                           4310
                            5000
                                   2331


                               0
                                   1980    1985   1990    1995   2000    2004      2005


Source: EFPIA Member Associations (official figures) – Data 2005: EFPIA estimate
European total pharmaceutical exports, imports
    & trade balance 1985-2005 (€ million)
  200000
                                                                           178000 (e)
  180000
                                                                165003

  160000
                                                                                 144000 (e)
  140000                                                            132853


  120000
                                                                                               Total exports
  100000                                           90935                                       Total imports
                                                                                               Trade surplus
   80000                                                68841

   60000
                                       44188
   40000                                                                 32150     34000 (e)
                                           31018
                          23180                            22094
            14854             16113            13170
   20000         9724
                                7067
                   5130
        0
              1985          1990         1995          2000        2004          2005


   Note: All data based on SITC 54; Data 2005: EFPIA estimate
   Source: Eurostat (1995-2005); Norway, Switzerland: EFPIA Member Associations (official figures)
EU Trade balance – High technology sectors
            (€ million) – 2004
                      30000
                               23003

                      20000
                                12165

                      10000                 7324    SITC 54 Pharmaceutical
                                                    products

                                                    SITC 71 Pow er generating
                          0                         machinery and equipment

                                                    SITC 75 Office machines
                                            -5058   and computers
                      -10000                        SITC 76 Telecommunication,
                                                    sound, TV, video

                                                    SITC 77 Electrical
                      -20000       -18086           machinery

                                                    SITC 87 Professional,
                                                    scientific, controlling
                      -30000                        material



                      -40000
                                  -40611


                      -50000

   Source: Eurostat
Shares of top 5 sectors in total R&D investment
by top 942 companies by main world region
in 2004
              90,0%

              80,0%
                                                         0,7%                                            0,4%
              70,0%               2,3%
                                  9,9%                   24,3%                  13,8%                   23,0%
              60,0%
                                                                                 2,0%
              50,0%                                                                                      6,2%
                                                                                12,0%
                                 26,0%
              40,0%                                      26,1%
                                                                                                        27,5%
              30,0%                                                             22,6%
                                 17,3%                   7,9%
              20,0%

              10,0%                                      17,3%                  18,5%                   18,5%
                                 14,1%
                0,0%
                                   EU                    Japan                    USA              Rest of World

                                 IT Harware                                 Pharmaceuticals & Biotechnology
                                 Automobiles & Parts                        Electronics & electrical
                                 Software & Computer

Note: Data relate to the top 942 companies with registered offices in the EU (242 companies), Japan (198 companies), the USA (398 companies) and
      the Rest of the World (104 companies), ranked by size of their R&D investment level (over € 32.7 million)
Source: The 2005 EU industrial R&D investment scoreboard, European Commission
Sector R&D investment as % of all sectors
      EU top 700 companies - 2004
                              Others (1 secto rs)
                                       6                                 4,2
                                Fo o d pro ducers        1,0
                          M edia & Entertainment         1,2
                     P erso nal care & ho useho ld       1,2
                                        Oil & Gas         1,4
                           Diversified industrials         1,9
                                           Health              2,1
                   Teleco mmunicatio n Services                2,1
                        Engineering & M achinery                 2,9
                          A ero space & Defence                      3,8
                                      Chemicals                            5,1
                 So ftware & Co mputer Services                                    6,4
               Electro nic & Electrical Equipment                                                 11,2
            P harmaceuticals and B io techno lo gy                                                                       18,2
                                     IT Hardware                                                                          18,6
                           A uto mo biles & P arts                                                                         19,0
                                                     0    2          4         6         8   10   12     14   16    18      20

Note: Sector of economic activities according to the Financial Times Stock Exchange (FTSE) index classification
      Data relate to the top 700 companies with registered offices in the EU ranked by the size of their R&D investments (over € 4.1 million)
Source: The 2005 EU industrial R&D investment scoreboard, European Commission, DG Research
 R&D/Sales ratio for industrial sectors (%)
      EU top 700 companies - 2004
                              Others (1 secto rs)
                                       6                       1,4
                                        Oil & Gas        0,3
                   Teleco mmunication Services                 1,5
                                Fo o d producers                1,8
                           Diversified industrials                   2,4
                        Engineering & M achinery                     2,5
                          M edia & entertainment                     2,7
                     Perso nal care & househo ld                      2,9
                                      Chemicals                          3,7
                           Auto mo biles & Parts                               4,3
                          Aerospace & Defence                                   4,9
                Electronic & Electrical Equipment                                    5,6
                                           Health                                          6,8
                                     IT Hardware                                                 8,6
                  Software & Co mputer Services                                                         10,7
             Pharmaceuticals and Biotechno logy                                                                     15,3
                                                     0         2           4         6       8     10     12   14   16      18

Note: Sector of economic activities according to the Financial Times Stock Exchange (FTSE) index classification
      Data relate to the top 700 companies with registered offices in the EU ranked by the size of their R&D investments (over € 4.1 million)
Source: The 2005 EU industrial R&D investment scoreboard, European Commission, DG Research
Breakdown of the world pharmaceutical
        market – 2005 sales


                        4,2%
               8,2%
                                                                 North America (USA,
                                                                 Canada)
       10,7%                                                     Europe

                                                 47,0%           Japan

                                                                 Africa, Asia
                                                                 (excl.Japan) & Austr.
                                                                 Latin America
           30,0%




 Source: IMS MIDAS, MAT February 2006 (totals do not add due to rounding)
    Pharmacy Market Growth Rate
                                             2005 (%)

                                         8
            8
                                                                                            7
                               6                                                  6
            6
                                                   5
                    4
            4

            2
                                                              0
            0

            -2
                                                                       -3
            -4
                 USA      Canada    Germany    France     Italy      UK       Spain     Japan


Source: IMS Retail Drug Monitor, 12 months to December 2005
Note: US: including sales through mail order channels; Japan: including hospital sales; Average growth rate for
Europe (top five markets): + 4%
Breakdown of the world pharmaceutical market
                                                     1990 - 2005


                                                                 Africa, Asia &   Latin America
                      Latin America                               Australasia          4,2%
                                           North America (USA,
                           5,7%                                      18,8%
  Africa, Asia &                                 Canada)                                               North America (USA,
   Australasia                                    31,1%                                                      Canada)
      25,4%
                                                                                                              47,0%




                                                                         Europe
                                                                         30,0%
                                  Europe
                                  37,8%




                   Total pharmaceutical market value 1990:               Total pharmaceutical market value 2005:
                         135,900 million Euros                                 454,867 million Euros
                         173,000 million Dollars                               565,900 million Dollars




                   Source: IMS MIDAS, MAT February 2006
Total pharmacy market (at ex-factory prices)
        Average annual growth rate 1994-2004



          14,0                             12,5
          12,0
          10,0                        10,0
                               7,0
           8,0
           6,0                                                  At constant prices
                       4,8                                      (Adjusted for inflation)
           4,0                                            2,9
           2,0                                      2,9         At current prices
            0,0
                    Europe
                                     USA
                  (w eighted                      Japan
                   average)




 Source: EFPIA member associations, PhRMA, JPMA
Total pharmacy market (at ex-factory prices)
         Average annual growth rate 1994-2004




 Source: EFPIA member associations, PhRMA, JPMA
Total pharmacy market (at ex-factory prices)
    Average real annual growth rate 1994-2004




 Source: EFPIA member associations, PhRMA, JPMA
     Global corporate performance
              (worldwide)
              RANK                   1990                        2005
                 1             Merck & Co (US)                Pfizer (US)
                 2               Glaxo (UK)             GlaxoSmithKline (UK)
                 3         Bristol-Myers Squibb (US)       Sanofi-Aventis (F)
                 4                Bayer (DE)                 Novartis (CH)
                 5               Hoechst (DE)           Johnson & Jonhson (US)
                 6           Eastman Kodak (US)          AstraZeneca (SE/UK)
                 7             Ciba-Geigy (CH)             Merck & Co (US)
                 8         SmithKline Beecham (UK)            Roche (CH)
                 9               Sandoz (CH)                 Abbott (US)
                10         American Home Prod. (US)    Bristol-Myers Squibb (US)
                11                Takeda (J)                  Wyeth (US)
                12               Eli Lilly (US)              Eli Lilly (US)
                13               Abbott (US)                 Amgen (US)
                14           Warner-Lambert (US)       Boehringer Ingelheim (DE)
                15                Pfizer (US)                 Takeda (J)

Source: IMS Health MIDAS December 2005
      Leading products (worldwide)
RANK            1987                   1992             1997             2005
  1          Zantac (UK)           Zantac (UK)       Losec (SE)       Lipitor (US)
  2         Tagamet (UK)           Renitec (US)      Zocor (US)        Plavix (F)
  3          Adalat (DE)           Voltaren (CH)    Prozac (US)      Nexium (UK)
  4         Capoten (US)           Lopirin (US)     Zantac (UK)      Seretide (UK)
  5        Tenormin (UK)           Mevacor (US)     Norvasc (US)      Zocor (US)
  6         Renitec (US)            Adalat (DE)     Renitec (US)     Norvasc (US)
  7        Naprosyn (US)           Tagamet (UK)    Augmentin (UK)    Zyprexa (US)
  8         Voltaren (CH)          Zovirax (UK)      Zoloft (US)     Risperdal (US)
  9         Feldene (US)           Ciproxin (DE)    Seroxat (UK)     Ogastro (US/J)
 10           Kefral (J)          Cardizem (US)     Ciproxin (US)    Effexor (US)
 11         Cardizen (US)         Augmentin (UK)     Klacid (US)
 12         Ventolin (UK)           Prozac (US)     Adalat (DE)
 13          Ceclor (US)          Procardia (US)    Voltaren (CH)
 14         Amoxil (UK)           Naprosyn (US)     Claritine (US)
 15           Krestin (J)           Ceclor (US)     Epogen (US)

Source: IMS MIDAS December 2005
  Pharmaceutical R&D expenditure in
 Europe, USA and Japan, 1990-2005
             € million, current exchange rates
         30000


                                                                               25277
         25000                                                  23758
                                                 23121
                                                                            21700
                                                             21106

         20000
                                              17849

                                                                                             Europe
         15000                                                                               USA
                               11484                                                         Japan

         10000                    9078
                 7766                                 7499
                                                                     6744
                    5342               5221
          5000
                        2810

                                                                                      n.a.
            0
                    1990          1995           2000           2004           2005


Data 2005: estimate EFPIA & PhRMA
Source: EFPIA member associations, PhRMA, JPMA
     Pharmaceutical R&D Expenditure
   Yearly growth rate (Europe vs USA)

            14,00
                                            12,50
                           11,89
            12,00


            10,00                       9,27
                       8,19                                  8,05
             8,00
        %                                                           Europe
                                                                    USA
             6,00

                                                      4,02
             4,00


             2,00


             0,00
                     1990-1995       1996-2000      2001-2005



Source: EFPIA member associations, PhRMA, JPMA
Breakdown of Worldwide Phramaceutical R&D
         Expenditure 1990-2004
            100%

                                                    15,5%          13,1%
             90%       17,7%         20,2%

             80%

             70%
                       33,6%                                       46,0%
                                     35,2%          47,7%
             60%
                                                                                  Japan
             50%                                                                  USA
             40%                                                                  Europe

             30%
                       48,8%
                                     44,5%
             20%                                                   40,9%
                                                    36,8%

             10%

              0%
                       1990           1995           2000          2004



 Note: R&D expenditure in Europe, USA & Japan used as proxy for worldwide expenditure
 Source: EFPIA member associations, PhRMA, JPMA
Breakdown of Worldwide Phramaceutical R&D
            Expenditure 2004

                                                2004                                    Belgium
                                                                                        Denmark
                               2,2%
                                                                                        France
                             4,8%     3,0%
                                         1,4%          7,6%
                                                7,7%                                    Germany
                                                        0,2%
                     3,1
                    1 %
                                                        1,9%
                                                                                        Ireland
                                                         1,3%                           Italy
                                                         1,6%                           Spain
                                                       9,3%
                                                                                        Sweden
                                                                                        U.K.
                                                                                        USA
                           46,0%
                                                                                        Japan
                                                                                        Switzerland
                                                                                        Other UE

 Note: R&D expenditure in Europe, USA & Japan used as proxy for worldwide expenditure
 Source: EFPIA member associations, PhRMA, JPMA
  Pharmaceutical R&D expenditure in
 Europe, USA and Japan, 1990-2005
               Million of national currency units*
           35000
                                                                                31444
                                                                 29556
           30000



           25000
                                                  21364                      21700
                                                              21106

           20000                                                                        Europe
                                               17849
                                                                                        USA
           15000                                                                        Japan
                                     11874
                                11484

           10000                                                      9067
                    7766                               7462
                       6803             6422
                         5161
            5000



               0
                      1990           1995         2000           2004           2005


* National currency units: Europe: € million; USA: $ million; Japan: ¥ million x 100
Data 2005: estimate EFPIA & PhRMA
Source: EFPIA member associations, PhRMA, JPMA
New Molecular Entities 1986-2005
      120
              104
      100                                          94
                                                        83
                                78
       80                                 73
                      70                                                                  Europe
                                                                           61             USA
       60                            54
                 51                                                   51
                                                                                          Japan
                                                                                          Others
       40                                                    31
                                                                                23
       20                  13                                                        14
                                               6                  3
         0
              1986-1990 1991-1995 1996-2000 2001-2005

Source: SCRIP Publications - EFPIA calculations (according to nationality of mother company)
                               Biopharmaceuticals
                      Europe versus USA (2005)

                                                    Europe                                  USA

    Turnover (€ million)                              7,862                               38,413

    R&D expenditure
                                                      2,630                               12,844
    (€ million)

    Net loss (€ million)                              1,562                                1,711

    Number of public
                                                        122                                  329
    companies (units)
    Number of
                                                     33,340                             137,400*
    employees (units)

* 2004 data
Source: Ernst & Young, ‘Beyond Borders, The Global Biotechnology Report, 2006’ (data relate to publicly traded companies)
  Share of Global Biotechnology Revenues
             Publicly traded companies (2005)

                                   4,8%
                              4,0%

                       15,5%
                                                                                     USA
                                                                                     Europe
                                                                                     Canada
                                                                                     Asia/Pacific

                                                          75,7%




Note: Global revenues of € 50,765 million (USA: 38,413; Europe: 7,862; Canada: 2,077; Asia/Pacific: 2,413)
Source: Ernst & Young, ‘Beyond Borders, The Global Biotechnology Report, 2006’
Share of Global Biotechnology R&D Expenses
             Publicly traded companies (2005)

                                     1,5%
                                  4,2%
                         16,0%

                                                                                    USA
                                                                                    Europe
                                                                                    Canada
                                                                                    Asia/Pacific


                                                         78,3%




Note: Global R&D expenses of € 16,410 million (USA: 12,844; Europe: 2,630; Canada: 685; Asia/Pacific: 251)
Source: Ernst & Young, ‘Beyond Borders, The Global Biotechnology Report, 2006’
 Number of new molecular entities (NMEs) and biotechnology
      products first launched worldwide 1990-2004

                    60                                                       Biotechnology products

                    50


                    40
      Total NME's




                    30        44
                                   37                       41          32
                                                  34               27
                                        38   35
                    20                                 30                         20
                         35                                                  28
                                                                                       26   22   18
                    10
                                                                   10   9         11
                              7    6         5    7    6     5                                   6
                                        2                                    4         2    4
                     0   1
                      90

                      91

                      92

                      93

                      94

                      95

                      96

                      97

                      98

                      99

                      00

                      01

                      02

                      03

                      04
                    19

                    19

                    19

                    19

                    19

                    19

                    19

                    19

                    19

                    19

                    20

                    20

                    20

                    20

                    20
                                                            Year


Source: CMR International
                                                                                                              1


             ROUTE OF A NEW SUBSTANCE FROM
              DISCOVERY TO PATIENT’S ACCESS




     1 medicinal product


 0                  5 years                10 years                15 years     20 years            SPC
                                                                              Patent expiry (supplementary
      10 years of research                                                                 protection certificate)
                                                                                              max. + 5 years
                                             2 to 3 years of administrative
Source : « Recherche & Vie », LIM (AGIM)               procedures
Estimated full cost of bringing a new chemical or
 biological entity to market (million of 2000 €)


             1000

               800

               600
                                                                                          868
               400

               200                                             344
                                    149
                   0
                                1975                       1987                       2000

   Note:   Data have been expressed in € million, 2000 euros

   Source: J.A. Di Masi, R.W. Hansen, and H.G. Grabowski, ‘The Price of Innovation: New Estimates of Drug Development Costs’,
   Journal of Health Economics 22(2003): 151-185
                             R&D: Scientific Risk
                                       Discovery and Development of a Successful NCE                                      Phases
                          15
                          14
                          13 Introduction/Registration                   1                Post-Marketing Surveillance         IV
                          12
                          11                                             2                                                    III
                          10
                           9                                            2-5                   Clinical Tests (Humans)
                                                                                                                              II
                  Years




                           8 Development
                           7                                           5-10                                                    I
                           6                                                                Preclinical Tests (Animals)
                           5                                          10-20
                           4
                           3
                           2
                           1 Basic Research
                           0                                     3,000-10,000
                                                              Quantity of Substances




Source: Based on PhRMA analysis, updated for data per Tufts Center for the Study of Drug Development (CSDD) database.
Allocation of R&D investments by function
           100%

            90%
                                     25,90%
            80%

            70%                       6,70%                         Pre-human/Pre-clinical
                                     10,20%                         Clinical trials (Phase I)
            60%
                                                                    Clinical trials (Phase II)
            50%                                                     Clinical trials (Phase III)
                                     26,20%                         Approval
            40%
                                                                    Pharmacovigilance (IV)
            30%                                                     Uncategorized
                                      9,20%
            20%
                                     13,20%
            10%
                                      8,60%
              0%
                                         1

Source: PhRMA, Annual Membership Survey 2006 (percentages calculated from 2004 data)
     R&D as a percentage of sales
                                 1985-2005
          25


          20



          15

     %
          10                            19,3        20,3
                             18,5                              18,6     18,3 (e)
                  15,6
            5


            0
                  1985       1990       1995        2000       2003          2004




Source: EFPIA Member Associations (official figures) – (e): EFPIA estimate
R&D Expenditure as a percentage of GDP (2004)
         Austria                                                  2,26
         Belgium                                           1,93
          Cyprus        0,37
     Czech Rep.                              1,28
        Denmark                                                          2,61
         Estonia                     0,91
         Finland                                                                         3,51
          France                                                2,16
        Germany                                                        2,49
         Greece               0,58
         Hungary                     0,89
          Ireland                        1,20
             Italy                      1,14
           Latvia        0,42
        Lithuania               0,76
  %Luxembourg                                         1,75
           M alta      0,29
     Netherlands                                      1,77
         Norway                                       1,75
         Poland            0,58
        Portugal               0,78
        Slovakia          0,53
        Slovenia                                    1,61
           Spain                       1,07
         Sweden                                                                             3,74
      Switzerland                                                        2,57
             U.K.                                      1,79
           EU-25                                         1,90
           China                             1,31
           Japan                                                                  3,15
    United States                                                        2,59

                0,00                  0,50                 1,00                 1,50            2,00   2,50   3,00   3,50   4,00

  Note: Switzerland: 2001 data; China, Italy, Japan, Portugal, USA: 2003 data
  Source: EUROSTAT, Statistics in Focus, Science and Technology, 6/2006, ‘R&D expenditure in Europe’, First preliminary data; EUROSTAT
    EU / US ‘Global’ Environment
USA                             EUROPE
• Basic patent (20 years)       • Basic patent (20 years)
• Patent Term Restoration –     • SPC – max 5 years, 1992
  max 5 years, 1984
• Biotech Patent, 1983           • Biotech Patent 2000-yet to be
                                   applied in some MS
•   Orphan Drug Act, 1984        • Orphan Drug Reg., 2000
•   Same levels of IPRs across   • Lower IPRs in some EU MS (+
    all States                     EU enlargement)
•   Bayh-Dole Act + National     • European Framework
    Institutes for Health          Research Programme
•   Economic environment (direct • Economic environment (no
    access to a large unified      direct market access; price
    market; competitive market     controls; parallel trade)
    pricing)
      EU/US ‘Healthcare’ Environment

USA                                       EUROPE
•   A less regulated health system and    •   National health services depending
    no monopsony                              on the restrictive requirements of
                                              public budgets (welfare,
•   Difference between payer and              Maastricht, etc)
    supplier of health care services
                                          •   No difference between payer/buyer
•   Scientific and economic system            and regulator of health care
    which is flexible and ready for           services
    changes and renewals (universities,
    small enterprises and high-tech       •   Rigid economic environment
    laboratories, integration between         marked by fragmented legislation
    schools and enterprises, etc)             and policies (lack of a single
                                              economic European market)
•   Financial and fiscal incentives for
    scientific and technological          •   Limited incentives to scientific and
    innovation (access to credits and         technological innovation (financial,
    capital, incentives, flexibility at       credit and fiscal incentives)
    work, company aids, etc)
  Product life cycle in US and Europe
        Main target of savings
        For EU governments
                                                             US
Sales                                                        Europe

                                                  Govt budget wasted as
                                                  result of lack of generic
                                                  competition




                                                               Time
                       European policies do not reward innovation but
Delay in Market Access
                       neutralise generic competition: prices of generics
                       are much lower in the US than in Europe.
      Innovation – Market penetration
Geographical breakdown (by main markets) of sales of
new medicines launched during the period 2001-2005




                         66 %                                                   24 %   4%                           6%
                         USA                                                   Europe Japan                         ROW



Note: New medicines cover all new active ingredients marketed for the first time on the world market during the period 2001-2005
Source: IMS Health MIDAS MAT December 2005
  Innovation – market penetration
                               Geographical breakdown (by main markets)
                               of sales of new medicines launched


                                                         1995 - 2000
         57% USA                 25% EUR     5%    13%
                                             JPN   ROW




                                                         2001 - 2005
      66% USA                    24% EUR     4%    6%
                                             JPN   ROW
Source: IMS Health MIDAS MAT December 2005
        Impact of Cost Containment
           Policies on Industry
                         Estimated costs                         In % of total
                         Euro million                            market value
     2003                      4,104                                   4.5%
     2004                             5,745                                    6.0%
     2005                             6,486 (p)                                6.4% (e)

EFPIA Calculations – (p): provisional - (e): estimate
Data relate to the 7 largest EU markets (Belgium, France, Germany, Italy, Netherlands, Spain, U.K.)
Total market value in 2003: Euro 90,342 million (Source: IMS)
Total market value in 2004: Euro 95,762 million (p)
   Share of Parallel Imports in
Pharmacy Market Sales (%) - 2004
      18,0                                                                              17,0
      16,0       14,8
      14,0                                           12,8
                                                                            12,1
      12,0
      10,0
  %
        8,0                                                       7,4
        6,0                               5,3
        4,0
                              2,0
        2,0
        0,0
               Denmark     Finland     Germany       The       Norway     Sweden        UK
                                                 Netherlands



  Note: Paralle trade was estimated to amount to € 4,200 million (value at ex-factory prices) in 2004.
  Source: EFPIA Member Associations
     Pricing – International referencing
Austria       Average of EU price
Belgium       Notification of prices of the product applied in other EU countries
Denmark       Average of prices of 13 EEA countries (Austria, Belgium, Finland, France, Germany,
              Iceland, Ireland, Italy, Liechtenstein, Netherlands, Norway, Sweden, UK)
Finland       Notification of prices of the product applied in all EU-15 countries, Norway & Switzerland
France        Reference to prices applied in four countries (Germany, Italy, Spain, U.K.)
Germany
Greece        Average price of the three lowest EU prices calculated as follows: the two lowest
              prices among EU-15 + Switzerland and the lowest of the ten new EU Member States
Ireland       Average of prices in five countries (Denmark, France, Germany, Netherlands, UK) or
              UK price
Italy         Notification of prices of the product applied in other EU countries
Netherlands   Average of prices in four countries (Belgium, France, Germany, U.K.)
Norway        Average of the 3 lowest prices of 9 EEA countries (Austria, Belgium, Denmark,
              Finland, Germany, Ireland, Netherlands, Sweden, UK)
Portugal      Lowest price in three reference countries (France, Italy, Spain)
Spain         Notification of the price of the product in other EU countries
Sweden
Switzerland   Average of prices in four countries (Denmark, Germany, Netherlands, U.K.)
UK
Average time delay between marketing authorisation and
effective market access – all products (MA 31/12/2000 to
31/12/2004)

                        Combined EMEA and Non-EMEA approved molecules          *For Poland, the
          Poland                                                               true delay could not
         Belgium                                                               be calculated as no
         Slovakia                                                              new innovative
          Austria                                                              products have been
          France                                                               reimbursed for
          Greece                                                               almost seven years
          Norway
            Italy
   Czech Republic
         Portugal
           Spain
     Netherlands
          Finland
         Hungary
          Ireland
         Sweden
      Switzerland
          Estonia
          Cyprus
        Denmark
        Germany
              UK
              US

                    0   100     200    300     400     500    600        700
                                      Number of days
         Blue bars represent time period (30 June 2000 – 30 June 2004)
         Source: IMS, May 2005
 Diffusion of Medicines in Europe
         Current situation
• Market authorization does not mean access for the
  patient
• There are huge differences between a possible
  optimal treatment and the treatment in reality
• There are also huge differences in the provision of
  innovative medicines between European countries


      Many patients do not receive
       "up-to-date" therapies with
             new medicines
 Percentage of eligible patients
       receiving statins
   60%
                                                                              56%
   50%

   40%
                                                                     36%
   30%                                                 29%
                                         26%
                           23%
   20%       17%
   10%

    0%
              Italy          UK           Ger.         Switz.         Neth.   USA

Source: Diffusion of Medicines in Europe, Oliver Schöffsky, December 2002
Breakdown of total health expenditure
in Europe - 2003


                 15,6%



                                            40,3%
                                                             In-patient care (hospital)
                                                             Out-patient care
                                                             Pharmaceutical products


              44,1%




 Source: OECD Health Data 2005, Statistics and Indicators for 30 countries, October 2005
 EFPIA calculations (non-weighted average for 19 EU & EFTA countries)
       The case of introducing inhaled
    corticosteroid in asthma management

£35.000
                                                                     An audit carried out among 50
£30.000                                                          patients with severe asthma attending a
                                                                 specialist asthma clinic in Leeds showed
£25.000                            Cost of hospital admissions   that, after six months, adding inhaled
                                   Cost of steroids              corticosteroid in the disease treatment
£20.000
                                                                 led to an increase in steroid costs from
£15.000           £28,427                                        £1,374 to £6,91. However, the costs of
                                                                 hospital admissions fell from £28,427 to
£10.000                                         £6,146
                                                                 £6,146 with a combined effect of
 £5.000
                                                                 reducing healthcare costs by £16,744 or
                                                £6,911           56%.
    £0             £1,374
                   Before                        After



      Source: The Value of Medicines (Asthma), ABPI