The Pharmaceutical Industry in Europe Key data

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Dec 5, 2012 (4 years and 8 months ago)

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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

European total pharmaceutical exports, imports
& trade balance 1980
-
2003 (


million)

Note:

Data 2003: EFPIA estimate


Data based on SITC 54


Source:

EFPIA Member Associations (official figures)


23180
44053
89443
144022
170000
14854
108063
62810
30453
16113
9724
130000
40000
35959
26633
13600
7067
5130
0
20000
40000
60000
80000
100000
120000
140000
160000
180000
1985
1990
1995
2000
2002
2003
Total exports
Total imports
Trade surplus
EU Trade balance


High technology sectors
(


million
)


2002

Source: Eurostat, SITC 54

25234
6129
-33236
5467
-9131
-1437
-40000
-30000
-20000
-10000
0
10000
20000
30000
SITC 54 Pharmaceutical
products
SITC 71 Power generating
machinery and equipment
SITC 75 Office machines
and computers
SITC 76 Telecommunication,
sound, TV, video
SITC 77 Electrical
machinery
SITC 87 Professional,
scientific, controlling
material
Source: IMS World Review 2004

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%
Europe
37,8%
Latin America
5,7%
Africa, Asia &
Australasia
25,4%
Total pharmaceutical market value
1990:


135,900 million Euros


173,000 million Dollars


Total pharmaceutical market value
2003:


412,290 million Euros


466,300 million Dollars




Source: IMS World Review 2004

North America (USA,
Canada)
49,2%
Europe
27,8%
Africa, Asia &
Australasia
19,3%
Latin America
3,7%
Total pharmacy market (at ex
-
factory prices)


Average annual growth rate 1992
-
2002

Source: EFPIA member associations, PhRMA, JPMA

Europe
(weighted
average)
USA
Japan
7,0
11,8
4,0
4,6
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)


93
89
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
P
harmaceutical R&D expenditure in
Europe, USA and Japan, 1990
-
2003





million, 2002 constant exchange rates

Data 2003: estimate EFPIA & PhRMA

Source: EFPIA member associations, PhRMA, JPMA

7941
11423
17661
20164
22584
27167
4369
5436
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
P
harmaceutical 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 100

Data 2003: estimate EFPIA & PhRMA

Source: EFPIA member associations, PhRMA, JPMA

7941
17661
20164
6803
21364
25700
5161
6422
7462
9657
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 companies


1990
-
1999

Biopharmaceuticals


Europe versus USA (2002)

Europe

USA

Turnover (


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

142,900

Source: 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


1
7
6
2
5
7
6
5
10
9
4
11
2
4
35
44
37
38
35
34
30
41
27
32
28
20
26
22
0
10
20
30
40
50
60
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
Year
Total NME's
Biotechnology products
R&D as a percentage of sales



1985
-
2003

Source: EFPIA Member Associations (official figures)


(e): EFPIA estimate

15,6
18,5
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&D

1999
-
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; Swiss


Federal Statistical Office (Switzerland)

2,40
2,17
2,80
2,98
0,84
1,99
1,84
2,63
4,27
0,96
0,84
1,62
1,94
1,07
1,17
0,67
2,49
2,20
3,49
1,94
0,00
0,50
1,00
1,50
2,00
2,50
3,00
3,50
4,00
4,50
United States
Japan
Acceding countries (10)
EU-15
U.K.
Switzerland
Sweden
Spain
Portugal
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 of

new medicines launched during the period 199
8

-

200
2

Source: IMS,
2003

Product life cycle in US and
Europe

Time

Sales

Europe

US

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
0
2
4
6
8
10
12
14
16
18
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 only

Source: IMS Health

216
952
82
1274
90
214
3058
434
340
0
500
1000
1500
2000
2500
3000
3500
Bulgaria
Czech Republic
Estonia
Hungary
Latvia
Lithuania
Poland
Slovakia
Slovenia
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 Reimbursement

Application 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)

Increasing

overall delay

P&R

Pricing

Reimbursement

Publication

180 days

90 days



In Belgium
-

until January 2002, the transparency commission process had to be conducted before a company could apply for reimb
ursement

of a given product. In France, only ambulatory care products have been included in this analysis. In Italy and Sweden the p
ric
ing and/or reimbursement

procedure can start as soon as CPMP opinion is available (for centrally approved medicines). This analysis does not reflect

th
e impact of recent reforms

in Italy. In Spain anecdotal evidence suggests that delays have increased recently. In Switzerland a more comprehensive stud
y c
oncerning 191 files

shows an average delay over 180 days. Finland has a two
-
tier reimbursement system, with a slower process for treatments of chro
nic diseases

(reimbursed at 75%) and serious or life
-
threatening diseases, and a faster one for acute diseases. Delays shown in this study d
o not reflect this

distinction, and actual pricing and reimbursement delays are typically longer for medicines in the 75%/100% reimbursement cat
ego
ries