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US PMP Overview
                                         October 2008

                                         Accenture Research
                                         Jaydeep Adhikari, Dawn M. Melberg, Mikael Stenstrand
                                                          1
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      Agenda                                                                                               Agenda




                                         • US Overview
                                           – Summary Conclusions
                                           – Geography & Political Structure
                                           – Key Economic Indicators
                                           – Demographics
                                         • US PMP Overview
                                         • Key PMP Players
                                         • US PMP Outlook
                                         • Appendix




                                                      2
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      The US Pharmaceutical and Medical Products industries are facing many
      challenges due in part to domestic scrutiny and reforms and global issues
      impacting all the major geographic markets                                                                   US Overview:
                                                                                                                Summary Conclusions


      Summary
                                                US PMP overview


   • US national healthcare spending will increase                • The US prescription drug market is currently
     by 7.3% in 2008, reaching a total of US $2.1
                                                                    experiencing a slowdown, in large part due to
     trillion
                                                                    increased utilization of generic drugs and weak
   • Currently at 16 percent of gross domestic
                                                                    performances from newly launched products
     product (GDP), U.S. health spending is double
     the median of industrialized countries and is                • The generics segment is growing rapidly as a
     expected to consistently outpace GDP over the
                                                                    result of the cost-containment measures
     coming decade, accounting for 20 percent of
                                                                    implemented by health insurers
     GDP by 2015
   • The elderly population (65+) is projected to                 • The market for OTC drugs is showing stronger
     exceed 20% of the total US population by                       growth than in many years, mainly as a result of
     2050, placing a tremendous strain on public
                                                                    increased Rx-to-OTC switching and the decision
     services and programs
                                                                    by a number of health insurers to reimburse
   • Public and private healthcare payers have
                                                                    certain OTC products
     begun to implement cost-saving mechanisms –
     eg. Increased premiums and co-payments,                      • In 2005 Medicare represented 2% of the
     tiered health plans and generic drug preference
                                                                    prescription drug market, that share is expected to
   • In 2008, the federal health insurance Medicare
                                                                    jump to 28% in 2008
     expanded its scope to include outpatient care,
     including prescription drug subsidies. This
     represents a large shift in the way prescription
     drugs are paid for in the United States


                                                           3
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      Agenda                                                                                               Agenda




                                         • US Overview
                                           – Summary Conclusions
                                           – Geography & Political Structure
                                           – Key Economic Indicators
                                           – Demographics
                                         • US PMP Overview
                                         • Key PMP Players
                                         • US PMP Outlook
                                         • Appendix




                                                      4
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      US – Geographic Summary                                                                  US Overview:
                                                                                        Geography & Political Structure


    Geography

                                                                Capital City: Washington, DC
                                                                Main Language (s): English
                                                                Continent/Region: North
                                                                America
                                                                Population: 300 million
                                                                Monetary Unit: US Dollar $
                                                                Main Export (s): Capital goods
                                                                including transistors, aircraft,
                                                                motor vehicle parts, computers
                                                                and telecommunication devices;
                                                                Consumer goods including
                                                                automobiles and medicines;
                                                                Industrial supplies including
                                                                organic chemicals




  Source: Lonelyplanet; US Census Bureau; CIA Factbook
                                                         5
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      The United States is a constitution-based federal republic consisting
      of 50 states with significant legislative authority                                                                    US Overview:
                                                                                                                      Geography & Political Structure




                                The United States

                                                                             • The United States’ is a federalist system with a
                                                                               national government and fifty sovereign states.
                                                                             • Any power not delegated to the federal
                                                                               government in the U.S. Constitution, nor
                                                                               prohibited by it to the states, are reserved to the
                                                                               states
                                                                             • Both the national government and each state
                                                                               government are divided into executive,
                                                                               legislative, and judicial branches
                                                                             • In the United States, federal and state
                                                                               government funding of health care needs of its
                                                                               citizens is limited to Medicare and Medicaid
                                                                               insurance programs for the eligible senior, very
                                                                               poor or disabled persons
                                                                             • Individual states have significant leeway in
                                                                               regard to healthcare legislation including access
                                                                               and funding
                                                                             • State budgets have been heavily impacted by
                                                                               escalating healthcare costs as federal funding
                                                                               declines and costs for healthcare services and
                                                                               medications increase


Source: Plano ISD Instructional Center; CIA Factbook; Legislationline;
                                                                         6
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      Agenda                                                                                               Agenda




                                         • US Overview
                                           – Summary Conclusions
                                           – Geography & Political Structure
                                           – Key Economic Indicators
                                           – Demographics
                                         • US PMP Overview
                                         • Key PMP Players
                                         • US PMP Outlook
                                         • Appendix




                                                      7
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     The United States is the largest economy in the world
     Key facts of the United States economy and consumers
                                                      GDP , GDP growth                                                                                          Private consumption, population
                          6%                                                                                                                      5%
                                                                                   Germany         2008est.                                                                                           USA                   2008
                          5%




                                                                                                                          Private consumption
                                                                                                                                                                                        USA
                                     World average
       GDP real growth*




                                                                                                                                                  3%
                                                                                   GDP*           $12.36 bn                                                                                           Population            300m
                          4%




                                                                                                                               growth ***
                                      UK                                           GDP real             3.5%                                                                                          Private            $16,260
                                                                                                                                                        Spain
                                                                                                                                                  1%                     France UK
                                                                                   growth**                                                                                                           consumption
                                                                    USA
                          3%
                                           France
                                Spain                                                                                                                                                                 per capita
                                                                                   GDP p.c.         $41,800
                          2%                                                                                                                     -1% $0         $5,000     $10,000 $15,000 $20,000
                                                                                                                                                                                       Germany
                                     Germany
                          1%
                                                                                                                                                 -3%
                                                                                            Bubble size = GDP
                          0%                                                                per capita
                                                                                                                                                                                                         Bubble size = 2008 Population
                               0             5000           10000          15000                                                                 -5%
                                                                                            *official exchange rate
                                                                                                                                                       Private consumption p.c. (2008)
                                                     GDP ($bn)                              **2004/2005


                                                                                                                                                              Consumer price index (2000=100)
                                            GDP per capita index (2000=100)
                                                                                                        CAGR                                    120                                                                     CAGR
                                                                               Country                 2000/08
                               125                                                                                                                                                                     Country         2000/08
                                                                                                                                                115
                                                                                    Spain                                                                                                              Spain
                               120                                                                        3.2%                                                                                                            3.2%
                                                                                    UK                                                                                                                 UK
                                                                                                          2.5%
                               115                                                                                                              110                                                                       2.3%
                                                                                    France                                                                                                             France
                                                                                                          1.9%
                               110                                                                                                                                                                                        1.9%
                                                                                                                                                105
                                                                                    Germany                                                                                                            Germany
                                                                                                          1.6%                                                                                                            1.6%
                               105
                                                                                    United States                                                                                                      United States
                                                                                                          3.8%                                  100                                                                       2.5%
                               100
                               95                                                                                                                95
                                       2002 2004 2006 2008 2010 2012                                                                                   2002   2004       2006   2008    2010   2012

                                                             Sources: OECD Factbook, 2006; Pharmaceutical Markets Fact Book 2005, OECD Main Economic Indicators; U.S. Department of Labor, Bureau of Labor
                                                             Statistics, World Economic Outlook Database 2006 and The Economist Intelligence Unit Ltd, 2005
                                                                                                                      8
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      Agenda                                                                                               Agenda




                                         • US Overview
                                           – Summary Conclusions
                                           – Geography & Political Structure
                                           – Key Economic Indicators
                                           – Demographics
                                         • US PMP Overview
                                         • Key PMP Players
                                         • US PMP Outlook
                                         • Appendix




                                                      9
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      The United States has one of the largest birth rates of OECD countries with
      the population projected to almost double between 2005 and 2050                                                                              Germany Overview:
                                                                                                                                                     Demographics




                                 Birth rate*, 2008                                                     Expected US population (million), 2005-2050


     United States                                             2.04

           France                                                                            450
                                                           1.89

                                                                                                                                                           420
      Netherlands                                     1.75

                                                                                                                                                 392
  United Kingdom                                      1.71                                   400

          Sweden                                      1.71                                                                            364
          Belgium                                   1.61                                     350                           336
                                                                  OECD average (1.56)
       Switzerland                             1.41
                                                                                                                309
                                                                                                      296
           Austria                            1.39                                           300
            Japan                             1.38

         Germany                             1.34
                                                                                             250
              Italy                          1.29

             Spain                           1.29
                                                                                             200
                                                                                                     2005      2010       2020       2030       2040       2050
                      0                  1                 2                 3

 Note: Birth rate equivalent to number of children born to women aged 15 to 49               Source: US Census Bureau, 2004
 Source: OECD Factbook 2008: Economic, Environmental and Social Statistics
                                                                                        10
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      US citizens have historically lived longer than the OECD average however in
      2003 the US life expectancy dipped just below the OECD average. Life
      expectancy at birth continues to increase for both men and women                                                       Germany Overview:
                                                                                                                               Demographics




                      Life expectancy at birth (years)                             US life expectancy at birth by sex (years)



    80                                                                       85
                                                                 77.8
                                                         77.5
    78                                                                                                                       80.1
                                                                                                       78.8
                                                                             80
                                         75.4
    76
                                                74.9
                                                                                                                                    74.8
                                                                                  74.6
                                                                             75
    74
                                                                                                              72
    72
                                                                             70
               70.8
                       70.3
                                                                                         67
    70
                                                                             65
    68

                                                                             60
    66
                                                                                    1970                 1990                   2010
                  1970                     1990                2010

                                                                                                    Females        Males
                            United States       OECD Average


  Source: US CDC, 2008
                                                                        11
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     The population in the US is ageing, which is illustrated by the fact that people
     aged 65 and above are projected to represent 16% of the US population by
     2020, compared to 12% in 2000                                                                                    US Overview:
                                                                                                                      Demographics


     The expected development of the age structure in the US, 2000-2020

                      Age structure (2000)                                                 Age structure (2020)

               Population aged 65 and over: 12%                                   Population aged 65 and over: 16%
    People ‘000
                                                                      People ‘000
   60,000
                                                                     60,000


   50,000                                                            50,000


   40,000                                                            40,000


                                                                     30,000
   30,000


                                                                     20,000
   20,000


                                                                     10,000
   10,000


                                                                           0
        0
                                                                                 0-4      19-May    20-44    45-64     65-84    85+
              0-4    19-May    20-44     45-64   65-84   85+

                                                                                                     Male    Female
                                 Male   Female

                                                                    Source: US Census Bureau, Population Projections
  Source: US Census Bureau, Population Projections
                                                               12
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      Agenda                                                                                               Agenda




                                         • US Overview
                                         • US PMP Overview
                                           – PMP Expenditures
                                           – Regulatory System
                                           – Pharmaceuticals Overview
                                           – Medical Products Overview
                                           – Distributor Overview
                                         • Key PMP Players
                                         • US PMP Outlook
                                         • Appendix


                                                      13
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      The United States spends more on healthcare than any other OECD country
      both in terms of GDP and per capita – the US has not managed to contain
      costs                                                                                                                                US PMP Overview:
                                                                                                                                           PMP Expenditures




                 Healthcare spend as a % of GDP, 2008                                              Healthcare spend per capita (USD*)

                                                                                                                                           CAGR 1999-2008
                                                           CAGR 1999-2008
                                                                                           USA                                         5,711      7.1%
                                                                   3.8%
             USA                                      15.2%
                                                                                    Switzerland                               3,776               5.8%
                                                                   2.3%
    Switzerland                               11.5%
                                                                                       Germany                         3,001                      4.0%
                                                                   1.2%
       Germany                                11.1%
                                                                                    Netherlands                        2,987                      8.9%
                                                                   2.1%
          France                            10.1%
                                                                                         France                       2,902                       5.9%
                                                                   3.9%
    Netherlands                           9.8%
                                                                                       Belgium                        2,828                       7.6%
                                                                   2.9%
         Sweden                          9.4%
                                                                                        Sweden                       2,704                        6.3%
                                                                   2.5%
        Belgium                          9.4%
                                                                                         Ireland                    2,496                         11.3%
             Italy                                                 2.2%
                                       8.4%
                                                                                 United Kingdom                    2,389                          8.9%
United Kingdom                        8.0%                         2.7%
                                                                                        Austria                    2,306                          3.0%
           Spain                     7.7%                          0.7%
                                                                                           Italy                                                  5.1%
                                                                                                                   2,266
         Austria                     7.5%                          -0.3%
                                                                                                                                                  6.2%
                                                                                          Spain              1,853
          Ireland                    7.3%                          4.2%

                                                                                                                                      6,000 USD
                                                                                                   0       2,000           4,000
                 0.0%       5.0%      10.0%      15.0%     20.0%
Note: Healthcare spend per capita expressed at international dollar rate
Source: WHO Statistical Information System (WHOSIS), May 2008
                                                                            14
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      Pharmaceutical spending in the US is lower than the OECD average
      however per capita spending is significantly higher than OECD peers                                                                          US PMP Overview:
                                                                                                                                                   PMP Expenditures




                                                                                              Pharmaceuticals expenditure per capita, 2008 (USD)
   Pharmaceutical spend as a % of total healthcare spend, 2008



        Italy                                                    22.1%                       USA                                                         728


       Spain                                                     21.8%                    France                                                 606


     France                                                 20.9%                            Italy                                   498


      Japan                                              18.4%                          Germany                                436

                                                          OECD average (17.5%)
   Germany                                       14.6%                                      Spain                            401


        USA                                 12.9%                                     Switzerland                            398


    Sweden                                  12.6%                                          Japan                             393                 OECD average (380)


Netherlands                               11.4%                                          Sweden                        340


Switzerland                              10.5%                                        Netherlands                      340


            0.0%       5.0%      10.0%      15.0%    20.0%        25.0%                              0     200          400                600             800

Source: Health at a Glance, OECD 2005
                                                                                 15
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      The US spends less on medical technology as a percent of total healthcare
      spend than the OECD, but maintains the highest rate of spend on a per capita
      basis                                                                                                                                            US PMP Overview:
                                                                                                                                                       PMP Expenditures




                Medical Technology spend as a % of                                                Medical Technology expenditure per capita, 2008
                   total healthcare spend, 2008                                                                       (EUR)


   Germany                                                     8.6%                           USA                                                             278


Netherlands                                       6.5%                                    Germany                                                    230


     France                                       6.5%                                  Switzerland                                        188

                                                         European average (6.4%)
                                                                                        Netherland
       Spain                                     6.1%                                                                                154
                                                                                            s

        Italy                                   5.8%                                        France                                150


                                                                                                                                                 European average (124)
        USA                                5.1%                                            Sweden                           120


    Sweden                                 5.1%                                                Italy                     107


         UK                               4.8%                                                  UK                     97


Switzerland                              4.5%                                                Spain                73


            0.0%       2.0%       4.0%     6.0%         8.0%     10.0%                                 0   50      100         150         200        250      300

Source: Medical Technology Brief, Eucomed 2008
                                                                                   16
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      Hospital and physician services represent the largest share of total US
      healthcare expenditures                                                                                                             US PMP Overview:
                                                                                                                                          PMP Expenditures



               Distribution of US Healthcare Expenditures, 2008
                                                                                                • National healthcare expenditures are expected
                                                                                                  to reach a total of $2.1 trillion in 2008, growing
    100%
                                                                                                  at a much faster rate than the overall economy
                                                        10%         Other
                                                                                                • While the largest portion of US health
     90%                 22%
                                                                                                  expenditures is paid for by private funds, the US
                                                        14%         Administrative
     80%
                                                                                                  government is projected to spend approximately
                                                         2%
                          7%                                        Nursing home care
                                                                                                  $740 billion on healthcare in 2006, representing
     70%
                          7%                            14%         Pharmaceuticals               34% of total national spending
     60%                 11%                                                                    • Hospital care and physician services account for
                                                                                                  more than 50% of total healthcare expenditures
     50%
                                                                    Hospital care
                                                        29%                                     • Total hospital spending growth is projected to be
     40%
                                                                                                  7.9 percent in 2005, more than 1.5 percentage
                         31%
                                                                                                  points higher than GDP growth
     30%
                                                                                                • Advances in medical technology, growth and
     20%                                                                                          aging in the population and the propensity of
                                                                    Physician/Clinical
                                                        31%
                                                                    services                      baby boomers to frequently use healthcare
                         22%
     10%
                                                                                                  services are all factors contributing to the
                                                                                                  increased use of hospital and physician
       0%
                                                                                                  services
              Private healthcare spend        Total healthcare spend


  Note: Other spend includes dental services, home healthcare, durable medical products, etc.
  Source: 2008 Medical Cost Reference Guide, Blue Cross Blue Shield Association
                                                                                   17
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      Pharmaceutical spend as a percent of total healthcare expenditures
      has slowed to single digit growth over the past several years                                                               US PMP Overview:
                                                                                                                                  PMP Expenditures




    Total Pharmaceutical Spend and % of Total Healthcare*
                                                                                       •   Prescription drug expenditures reached $224 billion in
                                                                                           2005, representing 11.5% of total national healthcare
                                                                                           expenditures
                       $600                                                   16%
                                                                                       •   Prescription drug spending has slowed over the past
                                                                              14%          few years, growing at a rate of 8.2% in 2005 as
                       $500
                                                                                           opposed to the double digit growth of the mid nineties
                                                                              12%          through 2003
       (in billions)




                       $400                                                            •   Slower growth rates are in part attributed to a
                                                                              10%
                                                                                           slowdown in drug usage prompted by increased
                                                                                           consumer out-of-pocket expenditures and recent
                       $300                                                   8%
                                                                                           concerns over drug safety
                                                                                       •   The industry outlook is characterized by conflicting
                                                                              6%
                       $200                                                                factors which will both accelerate and slow growth –
                                                                                           The former include practice patterns that involve
                                                                              4%
                                                                                           prescribing existing drugs to a larger segment of the
                       $100
                                                                              2%           population and high-cost specialty drugs designed to
                                                                                           treat rare conditions; growth constraints include
                        $0                                                    0%           projected growth in the use of generics and increased
                                                                                           cost sharing in the form of rising co-payments and
                                                                                           additional deductibles or both



  Note: 2005-2014 projected
  Source: 2008 Medical Cost Reference Guide, Blue Cross Blue Shield Association
                                                                                  18
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      Pharmaceuticals are primarily financed by private insurance in the US,
      however with the introduction of Medicare Part D legislation in 2006 there is
      expected to be a significant increase in federal funding                                                                  US PMP Overview:
                                                                                                                                PMP Expenditures




     Prescription drug spend, by source, $bn, 2000-2010                           • Currently, the private sector represents the largest
                                                                                    share of prescription drug purchasing with a
                                                                                    projected share of over 80% in 2006
                                                                                  • A shift is underway in prescription drug funding with
     400
                                                                                    private insurers attempting to reduce drug
     350                                                                            expenditures through higher co-pays and increased
                                                                                    use of generic substitutes
     300
                                                                                  • The federal government’s share of prescription
     250
                                                                                    drug spending is expected to increase significantly
                                                                                    with the passage of Medicare Part D legislation
     200
                                                                                    which provides previously unavailable outpatient
     150
                                                                                    drug coverage to Medicare members
     100                                                                          • Under Medicare Part D, Medicare beneficiaries will
                                                                                    be able to join a private health plan for out-patient
      50
                                                                                    coverage, or sign up to a stand-alone Medicare
        0                                                                           prescription drug scheme
              2000      2005        2006      2008      2009          2010
                                                                                  • The Medicare share of prescription drug spending
                                                                                    is expected to increase from 2% in 2005 to 27% in
                     Total            Out-of-Pocket   Total Private
                                                                                    2006
                     Total Public     Medicare        Medicaid



Source: US Centers for Medicare and Medicaid Services, 2008
                                                                             19
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      US managed care companies are increasingly demanding higher co-
      payments for prescription drugs                                                                                         US PMP Overview:
                                                                                                                              PMP Expenditures


                        Prescription drug co-payments demanded by HMOs (% of all prescriptions covered)

         Prescription Co-Payments                         2004                          2008         2012 [Projected]

         Generic
                         $5                                46                            24                   23

                         $10                               40                            52                   51

                         $15                                 -                           6                    9

         Brand Formulary
                         $10                               28                            10                   7

                         $15                               30                            15                   14

                         $20                               26                            35                   31

                         $30                                -                            7                    13

         Brand Non-Formulary
                         $10                                9                            4                    2

                         $25                               21                            5                    6

                         $30                               22                            11                   10

                        >$30                               24                            38                   40

Source: Global Insights Report: United States (Healthcare and Pharma). October, 2008.
                                                                                  20
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     In the United States, the manufacturer receives 76.5% of the reimbursed drug
     price (excluding taxes), which is among the highest of European peers. In
                                                                                                                                                              Germany PMP Overview:
     contrast, US pharmacies get a lower margin than their European counterparts                                                                                PMP Expenditures



              Share of final drug price (excluding taxes) in selected countries, per type of player, percentage 2008

                                                                                                                                                 Taxes
            Sweden                                           82                                           2           16      0
       United States                                   76.5                                        3.4           20.1         0
             Norway                                    75.3                                        4.9           19.8
           Denmark                                    74.7                                                       20.3                           26.6
         Switzerland                                  73.5                                    0               26.5             2
            Portugal                                 71.6                                      8.4                20               5.3
             France                                  70.5                                3.2                  26.3                 5.3
             Finland                              68.6                                  3.5                27.9                          16.3
        Netherlands                              68.1                                       10.6                21.3               6.4
                Italy                             67                                    6.6                   26.4                   9.9
               Spain                            65.6                                   7.3                    27.1             4.2
              Ireland                            64                                    11                      25             0
           Germany                               64                               4.7                     31.4                           16.3
            Belgium                           59.6                               9.6                      30.9                     6.4
                 UK                                           87.5                                                4        8.5 0

                        0             20                    40              60                       80                      100                       120        140

                                                            Manufacturers   Wholesalers              Pharmacies              Taxes
Source: Statistics 2008 VFA (The German Association of Research-Based Pharmaceutical Companies)
                                                                              21
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      Agenda                                                                                               Agenda




                                         • US Overview
                                         • US PMP Overview
                                           – PMP Expenditures
                                           – Regulatory System
                                           – Pharmaceuticals Overview
                                           – Medical Products Overview
                                           – Distributor Overview
                                         • Key PMP Players
                                         • US PMP Outlook
                                         • Appendix

                                                      22
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      The US Food & Drug Administration (FDA) is the primary regulator of the
      pharmaceutical and medical products industries in the US                                                                                            US PMP Overview:
                                                                                                                                                          Regulatory System


                                                                                                                               •All drugs must be accepted by the FDA
                                                                                                                               prior to being marketed and sold in the US

                                                                                                                               •The FDA requires that pharmaceutical
                                                                                                                               manufacturers perform extensive testing to
                                                      US FDA
                                                                                                                               prove that their products are safe and
                                                                                                                               effective before it will sanction commercial
                                                                                                                               sale

                                                                                                                               •New drugs must pass through a three
      Enforces US food
                                                                                                                               stage process of Clinical Trials before
         & drug laws
                                                                                                                               receiving final approval from the FDA

                                                                                                                               •The FDA estimates that, of 20 drugs
                                                                             Regulates the Introduction
                                                                                                                               entering clinical trial testing, an average of
                                                                                   of New Drugs
                      Monitors the manufacture,
                                                                                                                               13 to 14 will successfully complete phase I
                        Transport & storage of
                                                                                                                               – of those only 9 will finish phase II and
                      food, drugs and cosmetics
                                                                                                                               only 1 or 2 will pass phase III

                                                                                                                               •Due to recent concerns over drug safety,
                                                                                   Clinical Trials
                                                                                                                               The FDA is working on improving ways to
                                                                                                                               track the safety of drugs already
                                                                  Phase I             Phase II             Phase III           on the market; Tightening label
                                                                                                                               requirements and planning to expand the
                                                                                                                               duties of advisory committees are two
                                                                                                      New Drug Application
                                                                                                                               measures currently underway to achieve
                                                                                                            (NDA)
                                                                                                                               more effective post-market surveillance
  Source: Pharmaceutical Industry Survey. Standard & Poor’s. May 25, 2006.

                                                                                            23
© 2008 Accenture. All rights reserved.                                                                                       Adhikari,Dawn & Melberg - accenture H&LS consultant
Accenture Research
                                                                                                                          Accenture Research



      Unlike its European counterparts, the US pharmaceutical industry is
      characterized by no direct pricing controls                                                                                                         US PMP Overview:
                                                                                                                                                          Regulatory System



                                                                                                        •   Currently, US drug pricing is primarily affected by:
                                                                                                            • Free market dynamics: Includes the relative efficacy and
                                                                                                                safety profile of a drug versus its rivals, the size of its
                                                                                                                market, the competition it faces, and its development costs
                                                                                                            • Discount and rebate programs resulting from leverage
                                                                                                                exacted by large buying groups: Large-scale buyers (such
                                                                                                                as hospital chains and other institutional customers) usually
                                                                                                                pay well below list price, because their huge volume
                                                                                                                purchases enable them to negotiate heavy discounts.
                                                                                                                Government organizations, such as the Department of
                                                                                                                Defense, the Department of Veterans Affairs, and Medicaid,
                                                                                                                for example, typically negotiate some of the steepest
                                                                                                                discounts for drugs.
                                                                                                            • Patient assistance programs: Programs run by
                                                                                                                pharmaceutical companies to provide free medications to
                                                                                                                people who cannot afford to buy their medicine
                                                                                                            • Generic competition: When some easy-to-manufacture
                                                                                                                blockbuster drugs go off-patent, half a dozen or more
                                                                                                                generic competitors may enter the market simultaneously at
                                                                                                                prices that are 50% to 80% or more below brand

                                                                                                        •   Because US drug prices tend to be an average of 16-18%
                                                                                                            higher than in European countries, there have been an
                                                                                                            increasing number of calls for the US to adopt more direct
                                                                                                            pricing controls
  Source: Pricing & Reimbursement in the US. Datamonitor. June, 2008; Pharmaceutical Industry Survey.
  Standard & Poor’s. May 25, 2008.
                                                                                                  24
© 2008 Accenture. All rights reserved.                                                                                       Adhikari,Dawn & Melberg - accenture H&LS consultant
Accenture Research
                                                                     Accenture Research




      Agenda                                                                                               Agenda




                                         • US Overview
                                         • US PMP Overview
                                           – PMP Expenditures
                                           – Regulatory System
                                           – Pharmaceuticals Overview
                                           – Medical Products Overview
                                           – Distributor Overview
                                         • Key PMP Players
                                         • US PMP Outlook
                                         • Appendix


                                                      25
© 2008 Accenture. All rights reserved.                                   Adhikari,Dawn & Melberg - accenture H&LS consultant
Accenture Research
                                                                                                          Accenture Research


      For a long time, the market-based nature of the US Pharmaceuticals market
      has enabled it to grow faster than the Pharmaceuticals market in any other
      major developed country                                                                                                              US PMP Overview:
                                                                                                                                        Pharmaceuticals Overview


       Growth of the largest Pharmaceutical markets, 2004-2010
                              [projected]
                                                                                        • The Pharmaceutical market in the US has been
                                                                                          growing faster than in any other major developed
   Index 1998=100
   220                                                                                    country over the last decade
                                                                                        • While tight price controls from central governments
                                                                      USA                 has limited growth in many other OECD-countries,
   200
                                                                                          the US market is still characterized by free market
                                                                                          pricing and a large number of independent buyers,
                                                                                          leading to higher prices in general
   180
                                                                      Spain
                                                                                        • In addition, the strong development of the US
                                                                                          economy, the introduction of new
                                                                      UK
   160                                                                                    products/treatments and an aging population have
                                                                                          driven growth in volume consumption. For instance,
                                                                      Italy               in 2010 an estimated 51% of the population took
   140                                                                France              prescription drugs on a daily basis and 27% took
                                                                                          three or more drugs daily
                                                                      Germany
                                                                      Japan
   120



   100
      2004      2005      2006      2007      2008      2009      2010

Sources: Statistics 2008, VFA (The German Association of Research-Based Pharmaceutical Companies); Health Care Costs Survey, USA Today/Kaiser Family
Foundation/Harvard School of Public Health, 2008
                                                                              26
© 2008 Accenture. All rights reserved.                                                                        Adhikari,Dawn & Melberg - accenture H&LS consultant
Accenture Research
                                                                                                           Accenture Research


      Over the last few years value growth has stagnated, mainly as a result of
      increasing competition from generic drugs, but also due to falling
      productivity among manufacturers                                                                                                      US PMP Overview:
                                                                                                                                         Pharmaceuticals Overview



         Prescription Pharmaceutical sales (at wholesale
         prices) and annual growth rates, 2005-2008($bn)                             •   Between 2005 and 2008 the US prescription drugs market grew
                                                                                         from $194 bn to $252bn, recording a Compound Annual
                                                                                         Growth Rate (CAGR) of 9.1%
     $ bn
                                                                                     •   Yet, the annual growth rate fell every year during the same
   300                                                               14.0%
                                                                                         period to reach a low 5.4% in 2008
                  13.0%
                                                                                     •   This decelerating growth in terms of value is underpinned by
                                                                     12.0%               several factors, of which a few stand out:
                                  11.3%
                                                                                         – Lower number of approvals for New Chemical Entities
                                               10.4%                                         (NCEs)
                                                          252        10.0%
                                                                                         – Fewer and lower-performing product launches
   250
                                            239
                                                                                         – The increasing use of generic drugs, which in turn is driven
                                                                     8.0%
                                                                                             mainly by two different facts:
                                                                                             • The implementation of greater cost-sharing measures by
                               216
                                                                                                 most health insurers
                                                                     6.0%
                                                              5.4%
                                                                                             • The fact that many major drugs lost their patent
              194
   200
                                                                                                 protection over the last few years
                                                                     4.0%
                                                                                         – The withdrawal (for safety reasons) of a number of major
                                                                                             products
                                                                     2.0%                – A large number of switches by prescription drugs to OTC
                                                                                             status
                                                                                     •   At the same time it should be noted that in terms of volume the
   150                                                               0.0%
                                                                                         market continues to expand
              2005            2006          2007          2008

                                     Size    Growth



Sources: IMS Health press release 22 Feb 2008; PharmaHandbook 2008, VOI Consulting 2008, United States Healthcare and Pharma, Global Insight, Oct 2008
                                                                               27
© 2008 Accenture. All rights reserved.                                                                        Adhikari,Dawn & Melberg - accenture H&LS consultant
Accenture Research
                                                                                                                                                                                        Accenture Research




     Pharma sales by therapeutic category                                                                                                                                                                                                                  US PMP Overview:
                                                                                                                                                                                                                                                        Pharmaceuticals Overview



                                               Pharmaceutical Retail Sales by Therapeutic Category, 2008 (USD m)

                                                                                                                                                                                                                                                           577       25,098
          Contracting < -ve growth 2005-2008                                                                                                                                                                                    389
                                                                                                                                                                                                               522
                                                                                                                                                                                             661                                                           2%        100%
                                                                                                                                                                                                                                2%
                                                                                                                                                                                 694
          Underperforming market <6%2003-2008                                                                                                                                                                  2%
                                                                                                                                                          1,102                              3%                                                            N/A        0.5%
                                                                                                                                                                                                                                3%
                                                                                                                                                                                  3%
                                                                                                                                       1,321                                                                   3%
                                                                                                                                                           4%                                2%
          Out performing Market >6% growth 2003-2008*                                                                   1,387                                                    -9%
                                                                                                                                        5%                12%
                                                                                                              1,858      6%             -7%
                                                                                                               7%
                                                                                          1,902                          8%
                                                                                                               -3%
                                                                                           8%
                                                                         1,995
                                                                                           3%
                                                                          8%
                                                   3,836
                                                                         16%
                                                   15%
                                                    -2%
                                     3,839
                                     15%
                                      8%
    Sales ($m)          5,015
    Share of total      20%
    Growth (03-04)       -9%
                                                                        Erythropoietins




                                                                                                                                                                                             Bisphosphonates
                                                Antipsychotics, other




                                                                                                                                                                                                                                                             Other
                                                                                                                                                                                Monoclonal




                                                                                                                                                                                                                                 Anti-platelets, Oral




                                                                                                                                                                                                                                                                       Total
                     Statins




                                                                                          Seizure Disorders




                                                                                                                                       Calcium Blockers




                                                                                                                                                                                                               Ace Inhibitors
                                                                                                              SSRI
                                Proton Pump




                                                                                                                                                           Insulin Sensitizer
                                                                                                                      Angiotensin II




                                                                                                                                                                                Antibodies
                                                                                                                       Antagonists
                                  Inhibitors




Source: PharmaHandbook 2008, VOI Consulting                                                                               * IMS reported 6% growth in retail sales 12m to May-08 $26.8B
                                                                                                                              28
© 2008 Accenture. All rights reserved.                                                                                                                         Adhikari,Dawn & Melberg - accenture H&LS consultant
Accenture Research
                                                                                                    Accenture Research


      Pfizer’s cholesterol reducer Lipitor is by far the best-selling drug on the US
      market. At the same time, a number of biotech products, such as Amgen’s
      Aranesp and Enbrel, are rapidly becoming major growth engines                                                                US PMP Overview:
                                                                                                                                Pharmaceuticals Overview



                                           Leading prescription drugs, 2008, at wholesaler prices

                                         Company                      Class                         Sales (USD bn) Change (2005-2008)

         Lipitor                         Pfizer                       Statin                        8.4                +8%

         Zocor                           Merck & Co                   Statin                        4.4                -5%

         Nexium                          AstraZeneca                  Proton pump inhibitor         4.4                +15%

         Prevacid                        TAP (Takeda/Abbott)          Proton pump inhibitor         3.8                -2%

         Advair Diskus                   GlaxoSmithKline              Beta 2 agonist                3.6                +22%

         Plavix                          Bristol-Myers Squibb         Platelet ADP antagonist       3.5                +15%

         Zoloft                          Pfizer                       SSRI                          3.1                -2%

         Epogen                          Amgen                        Erythropoietin                3.0                -1%

         Procrit                         Johnson & Johnson            Erythropoietin                3.0                -9%

         Aranesp                         Amgen                        Erythropoietin                2.8                +46%

         Enbrel                          Amgen                        TNFa inhibitor                2.7                +36%

        Note: Biotech products shaded


Source: IMS National Sales Perspectives, 1/2008 IMS Health
                                                                          29
© 2008 Accenture. All rights reserved.                                                                Adhikari,Dawn & Melberg - accenture H&LS consultant
Accenture Research
                                                                                           Accenture Research

      The US prescription drug market is still dominated by US-headquartered
      companies. However, weak performances by companies like Pfizer and Merck
      & Co has recently paved the way for some of the larger European companies
                                                                                                                           US PMP Overview:
      to increase their market share                                                                                    Pharmaceuticals Overview




      Leading Pharma companies, by US prescription drug sales, 2008
                                                                                 • Pfizer has dominated the US prescription drugs
                                                                                   market for many years and has maintained its
                                                                                   market share mainly by acquisitions. Examples
                                   Sales    Change      Market Ranking
                                                                                   include the acquisition of Warner-Lambert in
                                   (USD bn) (2004-2008) share in 2000
                                                                                   2000 and of Pharmacia in 2003
      Pfizer                       27.2       -12%            10.8%     1        • In the last few years, however, Pfizer’s market
                                                                                   share has dropped, mainly due to falling
      GlaxoSmithKline              19.9       +6%             7.9%      2
                                                                                   productivity, patent expiries and the withdrawal
                                                                                   of some marketed products, such as the COX-2
      Johnson & Johnson            16.0       -4%             6.3%      6
                                                                                   inhibitor Bextra in 2005
      Merck & Co                   15.2       0               6.0%      3
                                                                                 • Two other major US companies, Merck and
                                                                                   Bristol-Myers Squibb have also lost market
      AstraZeneca                  12.3       +10%            5.1%      5
                                                                                   share recently. In Merck’s case the withdrawal
                                                                                   of one of its best-selling products, the COX-2
      Novartis                     12.3       +11%            4.9%      -
                                                                                   inhibitor Vioxx in September 2004 marked the
      Amgen                        11.9       +23%            4.7%      -          beginning of a tough time for the company
                                                                                 • This has paved the way both for European
      Sanofi-Aventis               11.0       +9%             4.4%      -
                                                                                   companies like Novartis and Sanofi-Aventis,
                                                                                   and for biotech companies like Amgen, who
      Eli Lilly                    8.7        +6%             3.4%      8
                                                                                   have all increased their market share over the
      Bristol-Myers Squibb 8.4                -10%            3.3%      4          last few years. In the case of Novartis, sales of
                                                                                   generic drugs within its Sandoz division has
                                                                                   contributed to sales growth
Source: IMS National Sales Perspectives, 1/2008, IMS Health; IMS 2000
                                                                            30
© 2008 Accenture. All rights reserved.                                                        Adhikari,Dawn & Melberg - accenture H&LS consultant
US PMP Overview: Healthcare Spending & Reform
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US PMP Overview: Healthcare Spending & Reform
US PMP Overview: Healthcare Spending & Reform
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US PMP Overview: Healthcare Spending & Reform
US PMP Overview: Healthcare Spending & Reform
US PMP Overview: Healthcare Spending & Reform
US PMP Overview: Healthcare Spending & Reform
US PMP Overview: Healthcare Spending & Reform
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US PMP Overview: Healthcare Spending & Reform
US PMP Overview: Healthcare Spending & Reform
US PMP Overview: Healthcare Spending & Reform
US PMP Overview: Healthcare Spending & Reform
US PMP Overview: Healthcare Spending & Reform
US PMP Overview: Healthcare Spending & Reform
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US PMP Overview: Healthcare Spending & Reform
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US PMP Overview: Healthcare Spending & Reform
US PMP Overview: Healthcare Spending & Reform
US PMP Overview: Healthcare Spending & Reform
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US PMP Overview: Healthcare Spending & Reform
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US PMP Overview: Healthcare Spending & Reform
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US PMP Overview: Healthcare Spending & Reform

  • 1. US PMP Overview October 2008 Accenture Research Jaydeep Adhikari, Dawn M. Melberg, Mikael Stenstrand 1 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 2. Accenture Research Accenture Research Agenda Agenda • US Overview – Summary Conclusions – Geography & Political Structure – Key Economic Indicators – Demographics • US PMP Overview • Key PMP Players • US PMP Outlook • Appendix 2 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 3. Accenture Research Accenture Research The US Pharmaceutical and Medical Products industries are facing many challenges due in part to domestic scrutiny and reforms and global issues impacting all the major geographic markets US Overview: Summary Conclusions Summary US PMP overview • US national healthcare spending will increase • The US prescription drug market is currently by 7.3% in 2008, reaching a total of US $2.1 experiencing a slowdown, in large part due to trillion increased utilization of generic drugs and weak • Currently at 16 percent of gross domestic performances from newly launched products product (GDP), U.S. health spending is double the median of industrialized countries and is • The generics segment is growing rapidly as a expected to consistently outpace GDP over the result of the cost-containment measures coming decade, accounting for 20 percent of implemented by health insurers GDP by 2015 • The elderly population (65+) is projected to • The market for OTC drugs is showing stronger exceed 20% of the total US population by growth than in many years, mainly as a result of 2050, placing a tremendous strain on public increased Rx-to-OTC switching and the decision services and programs by a number of health insurers to reimburse • Public and private healthcare payers have certain OTC products begun to implement cost-saving mechanisms – eg. Increased premiums and co-payments, • In 2005 Medicare represented 2% of the tiered health plans and generic drug preference prescription drug market, that share is expected to • In 2008, the federal health insurance Medicare jump to 28% in 2008 expanded its scope to include outpatient care, including prescription drug subsidies. This represents a large shift in the way prescription drugs are paid for in the United States 3 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 4. Accenture Research Accenture Research Agenda Agenda • US Overview – Summary Conclusions – Geography & Political Structure – Key Economic Indicators – Demographics • US PMP Overview • Key PMP Players • US PMP Outlook • Appendix 4 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 5. Accenture Research Accenture Research US – Geographic Summary US Overview: Geography & Political Structure Geography Capital City: Washington, DC Main Language (s): English Continent/Region: North America Population: 300 million Monetary Unit: US Dollar $ Main Export (s): Capital goods including transistors, aircraft, motor vehicle parts, computers and telecommunication devices; Consumer goods including automobiles and medicines; Industrial supplies including organic chemicals Source: Lonelyplanet; US Census Bureau; CIA Factbook 5 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 6. Accenture Research Accenture Research The United States is a constitution-based federal republic consisting of 50 states with significant legislative authority US Overview: Geography & Political Structure The United States • The United States’ is a federalist system with a national government and fifty sovereign states. • Any power not delegated to the federal government in the U.S. Constitution, nor prohibited by it to the states, are reserved to the states • Both the national government and each state government are divided into executive, legislative, and judicial branches • In the United States, federal and state government funding of health care needs of its citizens is limited to Medicare and Medicaid insurance programs for the eligible senior, very poor or disabled persons • Individual states have significant leeway in regard to healthcare legislation including access and funding • State budgets have been heavily impacted by escalating healthcare costs as federal funding declines and costs for healthcare services and medications increase Source: Plano ISD Instructional Center; CIA Factbook; Legislationline; 6 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 7. Accenture Research Accenture Research Agenda Agenda • US Overview – Summary Conclusions – Geography & Political Structure – Key Economic Indicators – Demographics • US PMP Overview • Key PMP Players • US PMP Outlook • Appendix 7 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 8. Accenture Research Accenture Research The United States is the largest economy in the world Key facts of the United States economy and consumers GDP , GDP growth Private consumption, population 6% 5% Germany 2008est. USA 2008 5% Private consumption USA World average GDP real growth* 3% GDP* $12.36 bn Population 300m 4% growth *** UK GDP real 3.5% Private $16,260 Spain 1% France UK growth** consumption USA 3% France Spain per capita GDP p.c. $41,800 2% -1% $0 $5,000 $10,000 $15,000 $20,000 Germany Germany 1% -3% Bubble size = GDP 0% per capita Bubble size = 2008 Population 0 5000 10000 15000 -5% *official exchange rate Private consumption p.c. (2008) GDP ($bn) **2004/2005 Consumer price index (2000=100) GDP per capita index (2000=100) CAGR 120 CAGR Country 2000/08 125 Country 2000/08 115 Spain Spain 120 3.2% 3.2% UK UK 2.5% 115 110 2.3% France France 1.9% 110 1.9% 105 Germany Germany 1.6% 1.6% 105 United States United States 3.8% 100 2.5% 100 95 95 2002 2004 2006 2008 2010 2012 2002 2004 2006 2008 2010 2012 Sources: OECD Factbook, 2006; Pharmaceutical Markets Fact Book 2005, OECD Main Economic Indicators; U.S. Department of Labor, Bureau of Labor Statistics, World Economic Outlook Database 2006 and The Economist Intelligence Unit Ltd, 2005 8 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 9. Accenture Research Accenture Research Agenda Agenda • US Overview – Summary Conclusions – Geography & Political Structure – Key Economic Indicators – Demographics • US PMP Overview • Key PMP Players • US PMP Outlook • Appendix 9 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 10. Accenture Research Accenture Research The United States has one of the largest birth rates of OECD countries with the population projected to almost double between 2005 and 2050 Germany Overview: Demographics Birth rate*, 2008 Expected US population (million), 2005-2050 United States 2.04 France 450 1.89 420 Netherlands 1.75 392 United Kingdom 1.71 400 Sweden 1.71 364 Belgium 1.61 350 336 OECD average (1.56) Switzerland 1.41 309 296 Austria 1.39 300 Japan 1.38 Germany 1.34 250 Italy 1.29 Spain 1.29 200 2005 2010 2020 2030 2040 2050 0 1 2 3 Note: Birth rate equivalent to number of children born to women aged 15 to 49 Source: US Census Bureau, 2004 Source: OECD Factbook 2008: Economic, Environmental and Social Statistics 10 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 11. Accenture Research Accenture Research US citizens have historically lived longer than the OECD average however in 2003 the US life expectancy dipped just below the OECD average. Life expectancy at birth continues to increase for both men and women Germany Overview: Demographics Life expectancy at birth (years) US life expectancy at birth by sex (years) 80 85 77.8 77.5 78 80.1 78.8 80 75.4 76 74.9 74.8 74.6 75 74 72 72 70 70.8 70.3 67 70 65 68 60 66 1970 1990 2010 1970 1990 2010 Females Males United States OECD Average Source: US CDC, 2008 11 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 12. Accenture Research Accenture Research The population in the US is ageing, which is illustrated by the fact that people aged 65 and above are projected to represent 16% of the US population by 2020, compared to 12% in 2000 US Overview: Demographics The expected development of the age structure in the US, 2000-2020 Age structure (2000) Age structure (2020) Population aged 65 and over: 12% Population aged 65 and over: 16% People ‘000 People ‘000 60,000 60,000 50,000 50,000 40,000 40,000 30,000 30,000 20,000 20,000 10,000 10,000 0 0 0-4 19-May 20-44 45-64 65-84 85+ 0-4 19-May 20-44 45-64 65-84 85+ Male Female Male Female Source: US Census Bureau, Population Projections Source: US Census Bureau, Population Projections 12 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 13. Accenture Research Accenture Research Agenda Agenda • US Overview • US PMP Overview – PMP Expenditures – Regulatory System – Pharmaceuticals Overview – Medical Products Overview – Distributor Overview • Key PMP Players • US PMP Outlook • Appendix 13 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 14. Accenture Research Accenture Research The United States spends more on healthcare than any other OECD country both in terms of GDP and per capita – the US has not managed to contain costs US PMP Overview: PMP Expenditures Healthcare spend as a % of GDP, 2008 Healthcare spend per capita (USD*) CAGR 1999-2008 CAGR 1999-2008 USA 5,711 7.1% 3.8% USA 15.2% Switzerland 3,776 5.8% 2.3% Switzerland 11.5% Germany 3,001 4.0% 1.2% Germany 11.1% Netherlands 2,987 8.9% 2.1% France 10.1% France 2,902 5.9% 3.9% Netherlands 9.8% Belgium 2,828 7.6% 2.9% Sweden 9.4% Sweden 2,704 6.3% 2.5% Belgium 9.4% Ireland 2,496 11.3% Italy 2.2% 8.4% United Kingdom 2,389 8.9% United Kingdom 8.0% 2.7% Austria 2,306 3.0% Spain 7.7% 0.7% Italy 5.1% 2,266 Austria 7.5% -0.3% 6.2% Spain 1,853 Ireland 7.3% 4.2% 6,000 USD 0 2,000 4,000 0.0% 5.0% 10.0% 15.0% 20.0% Note: Healthcare spend per capita expressed at international dollar rate Source: WHO Statistical Information System (WHOSIS), May 2008 14 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 15. Accenture Research Accenture Research Pharmaceutical spending in the US is lower than the OECD average however per capita spending is significantly higher than OECD peers US PMP Overview: PMP Expenditures Pharmaceuticals expenditure per capita, 2008 (USD) Pharmaceutical spend as a % of total healthcare spend, 2008 Italy 22.1% USA 728 Spain 21.8% France 606 France 20.9% Italy 498 Japan 18.4% Germany 436 OECD average (17.5%) Germany 14.6% Spain 401 USA 12.9% Switzerland 398 Sweden 12.6% Japan 393 OECD average (380) Netherlands 11.4% Sweden 340 Switzerland 10.5% Netherlands 340 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 0 200 400 600 800 Source: Health at a Glance, OECD 2005 15 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 16. Accenture Research Accenture Research The US spends less on medical technology as a percent of total healthcare spend than the OECD, but maintains the highest rate of spend on a per capita basis US PMP Overview: PMP Expenditures Medical Technology spend as a % of Medical Technology expenditure per capita, 2008 total healthcare spend, 2008 (EUR) Germany 8.6% USA 278 Netherlands 6.5% Germany 230 France 6.5% Switzerland 188 European average (6.4%) Netherland Spain 6.1% 154 s Italy 5.8% France 150 European average (124) USA 5.1% Sweden 120 Sweden 5.1% Italy 107 UK 4.8% UK 97 Switzerland 4.5% Spain 73 0.0% 2.0% 4.0% 6.0% 8.0% 10.0% 0 50 100 150 200 250 300 Source: Medical Technology Brief, Eucomed 2008 16 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 17. Accenture Research Accenture Research Hospital and physician services represent the largest share of total US healthcare expenditures US PMP Overview: PMP Expenditures Distribution of US Healthcare Expenditures, 2008 • National healthcare expenditures are expected to reach a total of $2.1 trillion in 2008, growing 100% at a much faster rate than the overall economy 10% Other • While the largest portion of US health 90% 22% expenditures is paid for by private funds, the US 14% Administrative 80% government is projected to spend approximately 2% 7% Nursing home care $740 billion on healthcare in 2006, representing 70% 7% 14% Pharmaceuticals 34% of total national spending 60% 11% • Hospital care and physician services account for more than 50% of total healthcare expenditures 50% Hospital care 29% • Total hospital spending growth is projected to be 40% 7.9 percent in 2005, more than 1.5 percentage 31% points higher than GDP growth 30% • Advances in medical technology, growth and 20% aging in the population and the propensity of Physician/Clinical 31% services baby boomers to frequently use healthcare 22% 10% services are all factors contributing to the increased use of hospital and physician 0% services Private healthcare spend Total healthcare spend Note: Other spend includes dental services, home healthcare, durable medical products, etc. Source: 2008 Medical Cost Reference Guide, Blue Cross Blue Shield Association 17 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 18. Accenture Research Accenture Research Pharmaceutical spend as a percent of total healthcare expenditures has slowed to single digit growth over the past several years US PMP Overview: PMP Expenditures Total Pharmaceutical Spend and % of Total Healthcare* • Prescription drug expenditures reached $224 billion in 2005, representing 11.5% of total national healthcare expenditures $600 16% • Prescription drug spending has slowed over the past 14% few years, growing at a rate of 8.2% in 2005 as $500 opposed to the double digit growth of the mid nineties 12% through 2003 (in billions) $400 • Slower growth rates are in part attributed to a 10% slowdown in drug usage prompted by increased consumer out-of-pocket expenditures and recent $300 8% concerns over drug safety • The industry outlook is characterized by conflicting 6% $200 factors which will both accelerate and slow growth – The former include practice patterns that involve 4% prescribing existing drugs to a larger segment of the $100 2% population and high-cost specialty drugs designed to treat rare conditions; growth constraints include $0 0% projected growth in the use of generics and increased cost sharing in the form of rising co-payments and additional deductibles or both Note: 2005-2014 projected Source: 2008 Medical Cost Reference Guide, Blue Cross Blue Shield Association 18 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 19. Accenture Research Accenture Research Pharmaceuticals are primarily financed by private insurance in the US, however with the introduction of Medicare Part D legislation in 2006 there is expected to be a significant increase in federal funding US PMP Overview: PMP Expenditures Prescription drug spend, by source, $bn, 2000-2010 • Currently, the private sector represents the largest share of prescription drug purchasing with a projected share of over 80% in 2006 • A shift is underway in prescription drug funding with 400 private insurers attempting to reduce drug 350 expenditures through higher co-pays and increased use of generic substitutes 300 • The federal government’s share of prescription 250 drug spending is expected to increase significantly with the passage of Medicare Part D legislation 200 which provides previously unavailable outpatient 150 drug coverage to Medicare members 100 • Under Medicare Part D, Medicare beneficiaries will be able to join a private health plan for out-patient 50 coverage, or sign up to a stand-alone Medicare 0 prescription drug scheme 2000 2005 2006 2008 2009 2010 • The Medicare share of prescription drug spending is expected to increase from 2% in 2005 to 27% in Total Out-of-Pocket Total Private 2006 Total Public Medicare Medicaid Source: US Centers for Medicare and Medicaid Services, 2008 19 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 20. Accenture Research Accenture Research US managed care companies are increasingly demanding higher co- payments for prescription drugs US PMP Overview: PMP Expenditures Prescription drug co-payments demanded by HMOs (% of all prescriptions covered) Prescription Co-Payments 2004 2008 2012 [Projected] Generic $5 46 24 23 $10 40 52 51 $15 - 6 9 Brand Formulary $10 28 10 7 $15 30 15 14 $20 26 35 31 $30 - 7 13 Brand Non-Formulary $10 9 4 2 $25 21 5 6 $30 22 11 10 >$30 24 38 40 Source: Global Insights Report: United States (Healthcare and Pharma). October, 2008. 20 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 21. Accenture Research Accenture Research In the United States, the manufacturer receives 76.5% of the reimbursed drug price (excluding taxes), which is among the highest of European peers. In Germany PMP Overview: contrast, US pharmacies get a lower margin than their European counterparts PMP Expenditures Share of final drug price (excluding taxes) in selected countries, per type of player, percentage 2008 Taxes Sweden 82 2 16 0 United States 76.5 3.4 20.1 0 Norway 75.3 4.9 19.8 Denmark 74.7 20.3 26.6 Switzerland 73.5 0 26.5 2 Portugal 71.6 8.4 20 5.3 France 70.5 3.2 26.3 5.3 Finland 68.6 3.5 27.9 16.3 Netherlands 68.1 10.6 21.3 6.4 Italy 67 6.6 26.4 9.9 Spain 65.6 7.3 27.1 4.2 Ireland 64 11 25 0 Germany 64 4.7 31.4 16.3 Belgium 59.6 9.6 30.9 6.4 UK 87.5 4 8.5 0 0 20 40 60 80 100 120 140 Manufacturers Wholesalers Pharmacies Taxes Source: Statistics 2008 VFA (The German Association of Research-Based Pharmaceutical Companies) 21 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 22. Accenture Research Accenture Research Agenda Agenda • US Overview • US PMP Overview – PMP Expenditures – Regulatory System – Pharmaceuticals Overview – Medical Products Overview – Distributor Overview • Key PMP Players • US PMP Outlook • Appendix 22 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 23. Accenture Research Accenture Research The US Food & Drug Administration (FDA) is the primary regulator of the pharmaceutical and medical products industries in the US US PMP Overview: Regulatory System •All drugs must be accepted by the FDA prior to being marketed and sold in the US •The FDA requires that pharmaceutical manufacturers perform extensive testing to US FDA prove that their products are safe and effective before it will sanction commercial sale •New drugs must pass through a three Enforces US food stage process of Clinical Trials before & drug laws receiving final approval from the FDA •The FDA estimates that, of 20 drugs Regulates the Introduction entering clinical trial testing, an average of of New Drugs Monitors the manufacture, 13 to 14 will successfully complete phase I Transport & storage of – of those only 9 will finish phase II and food, drugs and cosmetics only 1 or 2 will pass phase III •Due to recent concerns over drug safety, Clinical Trials The FDA is working on improving ways to track the safety of drugs already Phase I Phase II Phase III on the market; Tightening label requirements and planning to expand the duties of advisory committees are two New Drug Application measures currently underway to achieve (NDA) more effective post-market surveillance Source: Pharmaceutical Industry Survey. Standard & Poor’s. May 25, 2006. 23 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 24. Accenture Research Accenture Research Unlike its European counterparts, the US pharmaceutical industry is characterized by no direct pricing controls US PMP Overview: Regulatory System • Currently, US drug pricing is primarily affected by: • Free market dynamics: Includes the relative efficacy and safety profile of a drug versus its rivals, the size of its market, the competition it faces, and its development costs • Discount and rebate programs resulting from leverage exacted by large buying groups: Large-scale buyers (such as hospital chains and other institutional customers) usually pay well below list price, because their huge volume purchases enable them to negotiate heavy discounts. Government organizations, such as the Department of Defense, the Department of Veterans Affairs, and Medicaid, for example, typically negotiate some of the steepest discounts for drugs. • Patient assistance programs: Programs run by pharmaceutical companies to provide free medications to people who cannot afford to buy their medicine • Generic competition: When some easy-to-manufacture blockbuster drugs go off-patent, half a dozen or more generic competitors may enter the market simultaneously at prices that are 50% to 80% or more below brand • Because US drug prices tend to be an average of 16-18% higher than in European countries, there have been an increasing number of calls for the US to adopt more direct pricing controls Source: Pricing & Reimbursement in the US. Datamonitor. June, 2008; Pharmaceutical Industry Survey. Standard & Poor’s. May 25, 2008. 24 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 25. Accenture Research Accenture Research Agenda Agenda • US Overview • US PMP Overview – PMP Expenditures – Regulatory System – Pharmaceuticals Overview – Medical Products Overview – Distributor Overview • Key PMP Players • US PMP Outlook • Appendix 25 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 26. Accenture Research Accenture Research For a long time, the market-based nature of the US Pharmaceuticals market has enabled it to grow faster than the Pharmaceuticals market in any other major developed country US PMP Overview: Pharmaceuticals Overview Growth of the largest Pharmaceutical markets, 2004-2010 [projected] • The Pharmaceutical market in the US has been growing faster than in any other major developed Index 1998=100 220 country over the last decade • While tight price controls from central governments USA has limited growth in many other OECD-countries, 200 the US market is still characterized by free market pricing and a large number of independent buyers, leading to higher prices in general 180 Spain • In addition, the strong development of the US economy, the introduction of new UK 160 products/treatments and an aging population have driven growth in volume consumption. For instance, Italy in 2010 an estimated 51% of the population took 140 France prescription drugs on a daily basis and 27% took three or more drugs daily Germany Japan 120 100 2004 2005 2006 2007 2008 2009 2010 Sources: Statistics 2008, VFA (The German Association of Research-Based Pharmaceutical Companies); Health Care Costs Survey, USA Today/Kaiser Family Foundation/Harvard School of Public Health, 2008 26 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 27. Accenture Research Accenture Research Over the last few years value growth has stagnated, mainly as a result of increasing competition from generic drugs, but also due to falling productivity among manufacturers US PMP Overview: Pharmaceuticals Overview Prescription Pharmaceutical sales (at wholesale prices) and annual growth rates, 2005-2008($bn) • Between 2005 and 2008 the US prescription drugs market grew from $194 bn to $252bn, recording a Compound Annual Growth Rate (CAGR) of 9.1% $ bn • Yet, the annual growth rate fell every year during the same 300 14.0% period to reach a low 5.4% in 2008 13.0% • This decelerating growth in terms of value is underpinned by 12.0% several factors, of which a few stand out: 11.3% – Lower number of approvals for New Chemical Entities 10.4% (NCEs) 252 10.0% – Fewer and lower-performing product launches 250 239 – The increasing use of generic drugs, which in turn is driven 8.0% mainly by two different facts: • The implementation of greater cost-sharing measures by 216 most health insurers 6.0% 5.4% • The fact that many major drugs lost their patent 194 200 protection over the last few years 4.0% – The withdrawal (for safety reasons) of a number of major products 2.0% – A large number of switches by prescription drugs to OTC status • At the same time it should be noted that in terms of volume the 150 0.0% market continues to expand 2005 2006 2007 2008 Size Growth Sources: IMS Health press release 22 Feb 2008; PharmaHandbook 2008, VOI Consulting 2008, United States Healthcare and Pharma, Global Insight, Oct 2008 27 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 28. Accenture Research Accenture Research Pharma sales by therapeutic category US PMP Overview: Pharmaceuticals Overview Pharmaceutical Retail Sales by Therapeutic Category, 2008 (USD m) 577 25,098 Contracting < -ve growth 2005-2008 389 522 661 2% 100% 2% 694 Underperforming market <6%2003-2008 2% 1,102 3% N/A 0.5% 3% 3% 1,321 3% 4% 2% Out performing Market >6% growth 2003-2008* 1,387 -9% 5% 12% 1,858 6% -7% 7% 1,902 8% -3% 8% 1,995 3% 8% 3,836 16% 15% -2% 3,839 15% 8% Sales ($m) 5,015 Share of total 20% Growth (03-04) -9% Erythropoietins Bisphosphonates Antipsychotics, other Other Monoclonal Anti-platelets, Oral Total Statins Seizure Disorders Calcium Blockers Ace Inhibitors SSRI Proton Pump Insulin Sensitizer Angiotensin II Antibodies Antagonists Inhibitors Source: PharmaHandbook 2008, VOI Consulting * IMS reported 6% growth in retail sales 12m to May-08 $26.8B 28 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 29. Accenture Research Accenture Research Pfizer’s cholesterol reducer Lipitor is by far the best-selling drug on the US market. At the same time, a number of biotech products, such as Amgen’s Aranesp and Enbrel, are rapidly becoming major growth engines US PMP Overview: Pharmaceuticals Overview Leading prescription drugs, 2008, at wholesaler prices Company Class Sales (USD bn) Change (2005-2008) Lipitor Pfizer Statin 8.4 +8% Zocor Merck & Co Statin 4.4 -5% Nexium AstraZeneca Proton pump inhibitor 4.4 +15% Prevacid TAP (Takeda/Abbott) Proton pump inhibitor 3.8 -2% Advair Diskus GlaxoSmithKline Beta 2 agonist 3.6 +22% Plavix Bristol-Myers Squibb Platelet ADP antagonist 3.5 +15% Zoloft Pfizer SSRI 3.1 -2% Epogen Amgen Erythropoietin 3.0 -1% Procrit Johnson & Johnson Erythropoietin 3.0 -9% Aranesp Amgen Erythropoietin 2.8 +46% Enbrel Amgen TNFa inhibitor 2.7 +36% Note: Biotech products shaded Source: IMS National Sales Perspectives, 1/2008 IMS Health 29 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant
  • 30. Accenture Research Accenture Research The US prescription drug market is still dominated by US-headquartered companies. However, weak performances by companies like Pfizer and Merck & Co has recently paved the way for some of the larger European companies US PMP Overview: to increase their market share Pharmaceuticals Overview Leading Pharma companies, by US prescription drug sales, 2008 • Pfizer has dominated the US prescription drugs market for many years and has maintained its market share mainly by acquisitions. Examples Sales Change Market Ranking include the acquisition of Warner-Lambert in (USD bn) (2004-2008) share in 2000 2000 and of Pharmacia in 2003 Pfizer 27.2 -12% 10.8% 1 • In the last few years, however, Pfizer’s market share has dropped, mainly due to falling GlaxoSmithKline 19.9 +6% 7.9% 2 productivity, patent expiries and the withdrawal of some marketed products, such as the COX-2 Johnson & Johnson 16.0 -4% 6.3% 6 inhibitor Bextra in 2005 Merck & Co 15.2 0 6.0% 3 • Two other major US companies, Merck and Bristol-Myers Squibb have also lost market AstraZeneca 12.3 +10% 5.1% 5 share recently. In Merck’s case the withdrawal of one of its best-selling products, the COX-2 Novartis 12.3 +11% 4.9% - inhibitor Vioxx in September 2004 marked the Amgen 11.9 +23% 4.7% - beginning of a tough time for the company • This has paved the way both for European Sanofi-Aventis 11.0 +9% 4.4% - companies like Novartis and Sanofi-Aventis, and for biotech companies like Amgen, who Eli Lilly 8.7 +6% 3.4% 8 have all increased their market share over the Bristol-Myers Squibb 8.4 -10% 3.3% 4 last few years. In the case of Novartis, sales of generic drugs within its Sandoz division has contributed to sales growth Source: IMS National Sales Perspectives, 1/2008, IMS Health; IMS 2000 30 © 2008 Accenture. All rights reserved. Adhikari,Dawn & Melberg - accenture H&LS consultant