The Pharmaceutical Industry in Europe Key data INDUSTRY (EFPIA Total) (*) 1990 2000 2002 2003 Production 63,127 121,311 158,647 170,000 (e) Exports 23,180 89,443 144,022 170,000 (e) Imports 16,113 62,810 108,063 130,000 (e) Trade balance 7,067 26,633 35,959 40,000 (e) R&D expenditure 7,941 17,661 20,164 21,100 (e) Employment (units) 500,762 540,106 588,091 588,000 (e) R&D employment (units) 76,287 87,625 100,503 100,500 (e) Pharmaceutical market value at ex-factory prices 43,005 86,696 104,180 111,500 (e) Values in € million unless otherwise stated (*) Excluding Turkey Source: EFPIA member associations (official figures) – (e): EFPIA estimate
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The Pharmaceutical Industry in Europe Key data INDUSTRY (EFPIA Total) (*)1990200020022003 Production63,127121,311158,647170,000 (e) Exports23,18089,443144,022170,000.
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Breakdown of the world pharmaceutical market – 2003
sales
49,2%
27,8%
11,3%
8,0%3,7%
North America (USA,Canada)
Europe
Japan
Africa, Asia(excl.Japan) & Austr.
Latin America
Breakdown of the world pharmaceutical market
1990 - 2003
North America (USA, Canada)31,1%
Europe37,8%
Latin America5,7%
Africa, Asia & Australasia
25,4%
Total pharmaceutical market value 1990:135,900 million Euros173,000 million Dollars
Total pharmaceutical market value 2003:412,290 million Euros466,300 million Dollars
Source: IMS World Review 2004
North America (USA, Canada)
49,2%
Europe27,8%
Africa, Asia & Australasia
19,3%
Latin America3,7%
Total pharmacy market (at ex-factory prices)
Average annual growth rate 1992-2002
Source: EFPIA member associations, PhRMA, JPMA
Europe(weightedaverage)
USAJ apan
7,0
11,8
4,04,6
9,3
3,8
0,0
2,0
4,0
6,0
8,0
10,0
12,0
At constant prices(Adjusted for inflation)
At current prices
New Molecular Entities 1989-2003
Source: SCRIP Publications - EFPIA calculations (according to nationality of mother company)
9389
62
44
74 73
62
53
28
4 6 4
0
10
20
30
40
50
60
70
80
90
100
1989-1993 1994-1998 1999-2003
Europe
USA
Japan
Others
Pharmaceutical R&D expenditure in Europe, USA and Japan, 1990-
2003
€ million, 2002 constant exchange rates
Data 2003: estimate EFPIA & PhRMASource: EFPIA member associations, PhRMA, JPMA
7941
11423
17661
2016422584
27167
43695436 6317
8177
21100 (e)
7191
12552
28964 (e)
n.a.0
5000
10000
15000
20000
25000
30000
35000
1990 1995 2000 2002 2003
Europe
USA
Japan
Pharmaceutical R&D expenditure in Europe, USA and Japan, 1990-
2003
Million of national currency units*
* National currency units: Europe: € million; USA: $ million; Japan: ¥ milliion x 100Data 2003: estimate EFPIA & PhRMASource: EFPIA member associations, PhRMA, JPMA
7941
17661
20164
6803
21364
25700
51616422
74629657
11423
21100 (e)
11874
27400 (e)
n.a.0
5000
10000
15000
20000
25000
30000
1990 1995 2000 2002 2003
Europe
USA
Japan
73% 69%59%
26%26%
34%
1% 5% 7%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
1990 1995 1999
Year
Rest of the World
USA
EU
Source: EFPIA, 2000
Location of R&D spending by EU companies1990-1999
BiopharmaceuticalsEurope versus USA (2002)
Europe USATurnover (€ million)
8,733 31,994
R&D expenditure (€ million)
5,274 17,201
Net loss (€ million)
2,921 9,913
Number of public companies (units)
102 318
Number of employees (units)
33,304 142,900Source: Ernst & Young, ‘Beyond Borders, The Global Biotechnology Report 2003’ (data relate to publicly traded companies)
Share of Global Biotechnology Revenues
Publicly traded companies (2002)
Note: Global revenues of € million 43,730 (USA: 31,994; Europe: 8,733; Canada: 1,550; Asia/Pacific: 1,453)Source: Ernst & Young, ‘Beyond Borders, The Global Biotechnology Report 2003’
73,2%
20,0%
3,5%
3,3%
USA
Europe
Canada
Asia/Pacific
Share of Global Biotechnology R&D Expenses Publicly traded companies
(2002)
Note: Global R&D expenses of € million 23,269 (USA: 17,201; Europe: 5,274; Canada: 586; Asia/Pacific: 208)Source: Ernst & Young, ‘Beyond Borders, The Global Biotechnology Report 2003’
73,9%
22,7%
2,5%
0,9%
USA
Europe
Canada
Asia/Pacific
Source: CMR International
Number of new molecular entities (NMEs) and biotechnology products first launched worldwide 1990-
2003
17 6 2 5 7 6 5
10 94
112 4
35
4437
38 35 3430
41 27 32
2820
26 22
0
10
20
30
40
50
60
Year
To
tal N
ME
's
Biotechnology products
R&D as a percentage of sales
1985-2003
Source: EFPIA Member Associations (official figures) – (e): EFPIA estimate
15,618,5 19,3 20,4 19,4 18,9 (e)
0
5
10
15
20
25
1985 1990 1995 2000 2002 2003
%
6,046 5,995
6,198
6,416
6,994
5500
6500
1999 2000 2001 2002 2003
Number of Drugs in active R&DNumber of Drugs in active R&D
1999-20031999-2003
Source: SCRIP, May 2003
EU / US ‘Global’ Environment
USA• Basic patent (20 years)• Patent Term Restoration – max 5
years, 1984• Biotech Patent, 1983• Orphan Drug Act, 1984• Same levels of IPRs across all
States• Bayh-Dole Act + National
Institutes for Health• Economic environment (direct
access to a large unified market; competitive market pricing)
EUROPE• Basic patent (20 years)• SPC – max 5 years, 1992• Biotech Patent 2000-yet to be
applied in 8 MS• Orphan Drug Reg., 2000• Lower IPRs in some EU MS (+
EU enlargement)• European Framework Research
Programme• Economic environment (no
direct market access; price controls; free movement of goods)
R&D Expenditure as a percentage of GDP
(2002)
Note: Greece, Italy, Japan, The Netherlands, Switzerland: 2000 data; Belgium, Denmark, Germany, Ireland, Portugal, Spain, Sweden, Acceding countries: 2001 data
Source: EUROSTAT & DG Research, ‘Statistics on Science and Technology in Europe: data 1991-2002’, February 2004; SwissFederal Statistical Office (Switzerland)
2,402,17
2,802,98
0,841,99
1,842,63
4,270,96
0,841,62
1,94
1,071,17
0,672,49
2,203,49
1,94
0,00 0,50 1,00 1,50 2,00 2,50 3,00 3,50 4,00 4,50
United States
J apan
Acceding countries (10)
EU-15
U.K.
Switzerland
Sweden
Spain
P ortugal
Norway
Netherlands
Italy
Ireland
Greece
Germany
France
Finland
Denmark
Belgium
Austria
%
70 %USA
18 % Europe
4 %Japan
8 % ROW
Innovation – Market penetration
Geographical breakdown (by main markets) of sales ofnew medicines launched during the period 1998 - 2002
Source: IMS, 2003
Product life cycle in US and Europe
Time
Sales EuropeUS
Delay in Market Access
Utilisation and Price Level
Generic competition
Source: GSK
European policies do not reward innovation but neutralise generic competition
Share of Parallel Imports in Pharmacy Market Sales (%) -
2002
12,2
7,1
10,5
6,3
10,2
17,6
02468
1012141618
DK DE NL N S UK
%
Note: Denmark, Germany, The Netherlands, Norway, Sweden, UK: Data 2002 Norway: share of total market sales (estimate)
Source: EFPIA Member Associations
Total market sales (at ex-factory prices) in EU acceding countries (2002 – €
Million)
Note: Bulgaria, Estonia, Latvia, Lithuania: pharmacy sales onlySource: IMS Health
216
952
82
1274
90214
3058
434340
0
500
1000
1500
2000
2500
3000
3500
EU Acceding & Candidate Countries
GDP per capita (PPS) - € 2002
Source: Eurostat, Statistics in Focus 47/2003
5500
17700
11400
5900
9500
11700
9400
8500
13600
10000
14400
17400
5900
8000
24000
0 5000 10000 15000 20000 25000 30000
EU15
Acceding/candidate countries (13)
Turkey
Slovenia
Slovakia
Romania
Poland
Malta
Lithuania
Latvia
Hungary
Estonia
Czech Republic
Cyprus
Bulgaria
Delays From Pricing And/Or ReimbursementApplication To Reimbursement
0 100 200 300 400 500 600 700 800
Belgium
Greece
Portugal
France
Austria
Finland
Italy
Norway
Spain
Netherlands
Switzerland
Sweden
Denmark
Ireland
Germany
UK
(Days)
Increasingoverall delay
P&R
Pricing Reimbursement
Publication
180 days90 days
•In Belgium - until January 2002, the transparency commission process had to be conducted before a company could apply for reimbursementof a given product. In France, only ambulatory care products have been included in this analysis. In Italy and Sweden the pricing and/or reimbursementprocedure can start as soon as CPMP opinion is available (for centrally approved medicines). This analysis does not reflect the impact of recent reformsin Italy. In Spain anecdotal evidence suggests that delays have increased recently. In Switzerland a more comprehensive study concerning 191 filesshows an average delay over 180 days. Finland has a two-tier reimbursement system, with a slower process for treatments of chronic diseases(reimbursed at 75%) and serious or life-threatening diseases, and a faster one for acute diseases. Delays shown in this study do not reflect thisdistinction, and actual pricing and reimbursement delays are typically longer for medicines in the 75%/100% reimbursement categories