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Statistics

2010
The Pharmaceutical Industry in Germany
The vfa is the trade association of the research-based
pharmaceutical companies in Germany. It represents the
interests of 46 globally leading pharmaceutical companies
and their more than 100 subsidiaries and affiliated compa-
nies in the areas of health, research and economic policy.
The vfa member companies make up about two thirds of the
German pharmaceutical market and employ approximately
90,000 people in Germany. More than 17,500 are engaged
in research and development.
2009 – The Industry Remained Stable
2010 – Politics Prescribes a Crisis

Research-based pharmaceutical companies proved to be a stable


anchor during the economic crisis in 2009. No significant losses
were recorded, either in the production of pharmaceutical
products or in employment levels. The companies’ commitment
to research and development was in fact again extended.
Research-based pharmaceutical companies are investing more
in medical progress in Germany than ever before: a total of
EUR 5.22 billion. 17,500 of our staff were employed in this area,
demonstrating Germany’s high potential as a research location.
The pharmaceutical industry is thus regarded as Germany’s
leading innovative industry. 37 new substances were launched
on the German market in 2009, the highest number since
1997. The new medications enable vital treatments to succeed,
treatments for rheumatism and some types of cancer, for
example.
It is therefore all the more regrettable that politics is hindering
the development of this crucial future industry by imposing
increasing numbers of new regulations and compulsory measures.
Instead of the hoped-for reforms to competition, government-
controlled cost containment measures with retroactive price
freezes and compulsory discounts extending over several years
have been imposed, exposing the industry to considerable
location disadvantages in the global competition for invest-
ment. It is feared that this will negatively impact the industry
in coming years. So although it has so far succeeded in avoiding
the crisis thanks to the commitment of its highly-qualified
employees and high level of innovative potential, short-sighted
political measures have retroactively prescribed a crisis for
the pharmaceutical industry.
2

Contents

The Pharmaceutical Industry and the Economy


The Innovative Fields of the Pharmaceutical Industry 5
Production of Pharmaceutical Products in Germany 6
Production in Europe, Japan and the USA 7
Economic Stability 8
Added Value 9
Export Ratio of the Pharmaceutical Companies in Germany 10
Employees of the vfa Member Companies 11
Capital Spending 12
Capital Spending of the vfa Member Companies 13
Price Trends 14
Price Changes: A Comparison 15
Pharmaceutical Prices: A European Comparison 16
Price Structure in Europe 17

The Pharmaceutical Industry and Innovation


New Molecular Entities in Germany 2009 19
New Molecular Entities and Their Applications 2009 20
Pharmaceutical Projects by vfa Member Companies
Promising Success by 2013 21
Marketing Authorizations for Orphan Drugs
in the European Union 22
Development Costs for a New Pharmaceutical 23
R&D Expenditures of the vfa Member Companies 24
Research Intensity: A Comparison 25
R&D Expenditures in Europe, Japan and the USA 26
Patent Applications for Genetically Manufactured
Pharmaceuticals 27
3

The Pharmaceutical Industry and the Health Care Sector


Life Expectancy Trends in Germany 29
Increasing Therapeutic Benefit of Innovative
Pharmaceuticals 30
Improved Substances Save Money 31
Health Care Expenditures and National Product 32
Health Care Spending Trends 33
Health Care Spending Trends in Europe, Japan and the USA 34
Pharmaceutical Expenditures in Europe, Japan and the USA 35
The Financing of the Statutory Health Insurance System (SHI) 36
Expenditures in the Statutory Health Insurance
System 2009 37

The Pharmaceutical Market


The Global Pharmaceutical Market 39
Development of the Largest Pharmaceutical Markets 40
Per-capita Sales of Pharmaceuticals 41
New Molecular Entities in Germany 42
Number of Pharmaceuticals in Germany 43
From Manufacturers to Patients:
Distribution and Financing of Pharmaceuticals
in the 2009 Pharmacy Market 44
Sales and Packages Sold Through Pharmacies in 2009 45
Parallel Imports 46
Sales of Genetically Manufactured Pharmaceuticals 47
Sales Distribution in the SHI Pharmaceutical
Market in 2009 48
Manufacturer Sales in the SHI Pharmaceutical Market 49
2009 Sales Growth: Driven by what Components? 50
Changes in 2009 Sales Based on Health Disorders 51
Reference Prices in the SHI Market 52
Generic Drugs in the SHI Pharmaceutical Market 53

Appendix
The Pharmaceutical Industry
and the Economy

In 2009 as well, research-based pharmaceutical companies


have proven to be a stable anchor of the German economy.
A slight decline of 2.8 percent in production had little impact
on employment levels. In the area of research and develop-
ment, the number of employees has in fact again increased,
and its gross added value proves that the industry is one of
the most productive in the German economy. The companies
have also maintained the previous year’s investment levels
despite the crisis and continue to be reliable customers of the
domestic capital goods industry. Their export ratio also
increased, with 61.4 percent of total sales now earned from
exports. In comparison with other industries, pharmaceutical
companies are leaders in the areas of product and process
innovations.
Economy 5

The Innovative Fields of the Pharmaceutical Industry


Share of companies with successful product and process innovations
(2008, in percent)

Chemistry/pharmaceuticals
Electronics industry
Telecommunications
Automotive industry
Mechanical engineering
Rubber/plastics
Financial services
Furniture/sport. goods/toys/med. tech.
Technical/R&D services
Media services
Metal production/processing
Energy/mining/oil
Water/waste disposal/recycling
Corporate services
Total
0 20 40 60 80 100
Successful Innovators Only ongoing/discontinued innovation activities

Provisional data
Source: ZEW

89 percent of companies in the chemical and pharmaceutical


industry, i.e. nine out of ten, were innovative in 2008, achieving
innovations in products or processes; and most (83 percent)
did so successfully. In 6 percent of companies the innovation
is not (yet) complete. As in previous years, the chemical and
pharmaceutical industry achieved the highest innovation rate
of all German industries.
6 Economy

Production of Pharmaceutical Products in Germany

in EUR billion
28
26
24
22
20
18
16
1995 1997 1999 2001 2003 2005 2007 2009

Change over previous year in percent


11
9
7
5
3
1
–1
–3
1995 1997 1999 2001 2003 2005 2007 2009

2009: provisional data; for detailed data, see Appendix, page 55


Source: Federal Statistical Office, vfa

Pharmaceutical products worth EUR 26.4 billion were produced


in Germany in 2009, a decline of 2.8 percent compared with
the previous year. The global financial and economic crisis has
therefore also left its mark on the German pharmaceutical
industry, although other industries have suffered much heavier
impact. Overall industrial production declined by 16 percent.
The business activities of pharmaceutical manufacturers are
normally influenced much less by the economic situation than
by government intervention to regulate the health care sector.
This is forecast to again be the case in 2010.
Economy 7

Production in Europe, Japan and the USA

1990: EUR 136 billion


Other 8%
Switzerland 4%
United Kingdom 7% 32% USA

Italy 8%

France 9%

Germany 9%
23% Japan

2008: EUR 358 billion

Other 14%

34% USA
Ireland 5%

Italy 6%

Switzerland 6%

United Kingdom 6%

Germany 8% 11% Japan


France 10%

Japan, UK: 2007


Source: The OECD, EFPIA, Pharmaceutical associations of the European countries, and the vfa

In an international comparison, Germany has only barely


been able to maintain its position as a production location for
pharmaceutical products. Eight percent of overall pharma-
ceutical production from Europe, Japan and the USA, worth
EUR 358 billion in 2008, came from Germany. In 1990 this
share was nine percent. Compared with Japan and the USA,
countries of the Euro zone have benefited in the past five years
from the strength of their currency. Medium-sized European
countries such as Ireland, Austria, Belgium and Switzerland
(as a non-Euro country) have especially expanded their
pharmaceutical production.
8 Economy

Economic Stability
Index of orders received, adjusted seasonally, 2005 = 100

130

120

110

100

90

80

70

60

1992 1994 1996 1998 2000 2002 2004 2006 2008 2010

Manufacturing industry Chemical industry Pharmaceutical products

Source: Federal Statistical Office

The supply of pharmaceuticals is a basic human need and is


therefore not subject to economic fluctuations as much as
other necessities. As a result, the pharmaceutical industry is
one of those economic areas that lends continuity to economic
development. One of the most important economic indicators,
the index of orders received, shows that the economic cycles
of recent years, especially 1993 to 1995, 1996 to 1998, 1999
to 2001 and the 2006/07 boom barely impacted the pharma-
ceutical industry. The current financial and economic crisis
has also not hit the pharmaceutical industry very hard.
Economy 9

Added Value
Net added value per employee in 2007 in EUR 1,000

Pharmaceutical industry 106.6

Chemical industry ¹ 97.0

Electrical engineering ² 68.3

Mechanical engineering 68.1

Manufacturing industry 64.1


(total)
Construction 43.9

0 20 40 60 80 100

¹ incl. pharmaceutical industry


² Office machinery, computing equipment, electrical engineering

Source: Federal Statistical Office

With a net added value of over EUR 100,000 per employee in


2007, the pharmaceutical industry is among the best performing
and most productive industries in Germany.
10 Economy

Export Ratio of the Pharmaceutical Companies in Germany


Foreign sales as a percent of total sales

60.8 61.4
60 57.8
56.0
54.2 53.3
50.0 49.7
50 47.9 47.4
45.5
43.2

40
35.4
31.9
30.5
30

20

10

0
1995 1997 1999 2001 2003 2005 2007 2009

2009: provisional data; for detailed data, see Appendix, page 56


Source: Federal Statistical Office

Due to various types of regulations, the domestic pharmaceutical


market has lost its significance for German pharmaceutical
manufacturers in the long term. In contrast, international sales
have become more and more important. The export ratio has
increased from around 30 percent in 1995 to over 60 percent.
In a ranking of production locations, Germany still ranks fourth
after the USA, Japan and France.
Economy 11

Employees of the vfa Member Companies


Number in thousands

2009 87.1
17.5

2008 87.7
17.3

2007 95.1
17.2

2005 91.9
15.9

2000 78.4
14.1

1995 73.2
14.5
Employees (total)
0 20 40 60 80 100 R&D employees

2009: provisional data


Source: vfa

Employee numbers in vfa member companies stabilized again


in 2009 after a noticeable decline in 2008.
In contrast, the number of employees engaged in research and
development again increased slightly. This shows Germany’s
excellent potential as a research location. Research-based
pharmaceutical companies rely in particular on the qualified
workers they find in Germany.
12 Economy

Capital Spending
as a percent of sales

Pharmaceutical industry 4.4

Chemical industry¹ 3.9

Mechanical engineering 3.6

Motor vehicle industry 3.5

Manufacturing industry 3.4


(total)
Electrical engineering² 2.9

0 1 2 3 4

¹ not incl. pharmaceutical industry


² Office machinery, computing equipment, electrical engineering

As of 2008
Source: Federal Statistical Office

With capital spending at a 4.4 percent share of sales, the


pharmaceutical industry is among the industries in Germany
with above-average capital spending. This triggers considerable
additional production and employment in other industries, as
was shown in a study by the German Institute for Economic
Research. These indirect production and investment effects
increase the industry’s added value by roughly another 90
percent. In particular, industry sectors that provide great
added value and employment volume, such as research and
development services, are pulled along by the pharmaceutical
industry. Each job in one of our companies creates another
job in another industry.
Economy 13

Capital Spending of the vfa Member Companies


in EUR billion

2009 1.32

2008 1.35

2007 1.46

2005 1.27

2000 1.04

1996 0.89

0 0.5 1.0 1.5

2009: provisional data


Source: vfa

Research-based pharmaceutical companies in the vfa have


proven to be a stabilizing factor during the economic crisis.
Investments in long-term tangible assets declined only slightly
compared with the previous year (from EUR 1.35 to 1.32 billion)
while investments in R&D facilities actually increased slightly.
The share of investments as a proportion of sales is above the
industry average (most current comparative figures for 2008:
3.7 percent compared with 3.4 percent).
In the current crisis, research-based pharmaceutical companies
have been shown to be reliable customers of the domestic
capital goods industry. As a study by the German Institute for
Economic Research in Berlin (DIW) has shown, pharmaceutical
production creates additional as well as almost equivalently
high added value in related industries and service sectors.
14 Economy

Price Trends
2000 = 100

120

115

110

105

100

95

90

85

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009

Private consumption (total) SHI pharmaceuticals

For detailed data, see Appendix, page 57


Source: Federal Statistical Office, WIdO

Until 2003 prices for pharmaceuticals had barely changed, yet


they have significantly decreased over the past seven years.
Pharmaceuticals are now 10 percent cheaper than they were in
2000. In contrast, consumer goods and services prices overall
have increased by over 15 percent since 2000.
Economy 15

Price Changes: A Comparison


Price increase from 2006 to 2009 in percent

SHI pharmaceuticals –2.7

Income subject to +3.6


SHI contributions
per SHI member

Retail sector +4.6

Private consumption +5.3


(total)

–6 –4 –2 0 2 4 6

Source: Federal Statistical Office, BMG, WIdO

The prices of pharmaceuticals provided to patients insured


through statutory health insurance decreased by 2.7 percent
over the past three years. In contrast, retail prices increased
by 4.6 percent, and prices for private consumption were up
5.3 percent. The income of SHI members that is subject to
contributions increased by 3.6 percent.
16 Economy

Pharmaceutical Prices: A European Comparison


Germany = 100

Ireland 158

Belgium 149

Germany 100

United Kingdom 98

Denmark 98

Austria 97

Sweden 91

Netherlands 88

Finland 84

Norway 78

0 20 40 60 80 100 120 140 160

As of 1st half of 2009; currency exchange rates from 2008


Source: Institute for Research in Economics and Business Administration (SNF), Bergen 2010

Pharmaceuticals are no more expensive in Germany than


in many other industrialized nations, as was confirmed by a
recent study by a Norwegian research institute. The study
examined the drug prices of around 200 of the most frequently
sold molecular entities in 10 European countries. The results
place Germany in the midrange of the countries compared,
on par with the United Kingdom, Denmark and Austria.
Economy 17

Pricing Structure in Europe


Shares in percent

Sweden 83 3 15
Portugal 71 7 17 5
Switzerland 67 6 25 2
France 67 2 24 7
Spain 65 5 26 4
Greece 63 5 24 8
Finland 61 3 23 14
Netherlands 60 7 27 6
Austria 60 6 25 9
Italy 60 6 24 10
Denmark 59 4 16 21
Germany 57 4 15 25
Ireland 57 10 33
Norway 57 8 15 20
Belgium 57 9 29 6

0 20 40 60 80 100
Manufacturers Wholesalers Pharmacies Taxes and discounts

Prescribed or reimbursed pharmaceuticals; Ireland: only oral dosage forms; as of 2007


Sources: EFPIA, Pharmaceutical associations of European countries, vfa

With a manufacturer’s share of 57 percent of the retail price,


Germany is located in the bottom segment of the European
ranking. Pharmaceuticals are subject to the full value-added tax
rate in Germany. Together with legally mandated manufacturer
and pharmacy discounts, the tax rate in Germany amounts to
24 percent of the retail price, making it the highest in Europe.
In most other European countries the tax burden on pharma-
ceuticals is reduced or waived entirely.
The Pharmaceutical Industry
and Innovation

Even in the crisis year of 2009, research-based pharma-


ceutical companies further increased their investment in
research and development in Germany to its current amount
of EUR 5.22 billion, or more than EUR 14 million a day!
Few other industries are as research-intensive. Around
20 percent of these companies’ employees work in the area
of research and development, many more than the average
of R&D-based companies. 37 new substances were launched
onto the market, the highest number since 1997, providing
for important medical progress, such as improvements
in the treatment of rheumatism and some types of cancer.
Germany remains a valued research location worldwide:
We are number 1 in Europe in terms of the number of clinical
trials and are surpassed only by the USA on a global level.
Innovation 19

Market Launches of New Molecular Entities in Germany 2009


Number (excluding biosimilars)

44

36 36 36 37
34
31
29 29 30
28 28
27 27
25 25 26
23 23
21

17
14

1989 1991 1993 1995 1997 1999 2001 2003 2005 2007 2009

Source: Pharmazeutische Zeitung, vfa

37 pharmaceuticals based on new NMEs (new substances known


internationally as New Molecular Entities) were launched in
the German market in 2009 – the highest number since 1997.
Because of the global research process, the number of such
substances launched in Germany is closely connected to the
international development of pharmaceuticals. Unless they are
of merely regional importance, most new NMEs receive market-
ing authorization as soon as possible in all key countries. This
is the only way to balance the costs for research and develop-
ment of an NME, which globally amount to USD 800 million on
average, within its limited patent term.
20 Innovation

New Molecular Entities and their Applications 2009

Sexual disorders 1 1 Contraception


Respiratory diseases 1
7 Cancer
Nervous system disorders 2

Cardiovascular diseases 2

Hematological
disorders 4
7 Metabolic diseases

Immune disorders 6

6 Infections

Source: vfa

In 2009 research-based pharmaceutical companies once again


facilitated important progress in medicine by creating new
drugs, e.g. for the treatment of rheumatism and some types
of cancer. For the first time, the five new vaccines launched
included one against Japanese encephalitis. These five drugs
will be used to treat rare diseases such as phenylketonuria
and Muckle-Wells syndrome.
Research-based pharmaceutical companies launched a total
of 37 new molecular entities this year, the highest number
since 1997, as well as another 19 drugs based on existing active
ingredients, which are delivered in a new dosage form. In the
form of a nasal spray, a powerful pain reliever can now offer
relief within just a few minutes and an HIV medication is now
available as a drinking solution suitable for administering
to children.
Innovation 21

Pharmaceutical Projects by vfa Member Companies Promising Success by 2013


Distribution in various medical areas; overall number of projects: 442

Other medical areas ¹ 10%

Other nervous system disorders 4%


Neurodegenerative diseases ² 2% 31% Cancer

Psychiatric disorders ³ 6%

Pain 3%

Diabetes type 2 4%
Osteoporosis 1%

Inflammatory diseases 4 10%


14% Infectious diseases

Chronic obstructive pulmonary disease 2%


13% Cardiovascular diseases

¹ Each individual project accounts for 1% or less


² Alzheimer’s disease, Parkinson’s disease
³ Depression, schizophrenia, bipolar disorder, etc.
4
Rheumatoid arthritis, asthma, multiple sclerosis, Crohn’s disease, psoriasis, etc.

Source: vfa

The vfa member companies are working on thousands of drugs.


Pharmaceutical projects for medications to treat some 110
diseases have progressed so far that they could lead to market-
ing authorization by the end of 2013. Most of these projects
target cancer (31 percent), cardiovascular diseases (13 percent)
and infectious diseases (14 percent) but a particularly large
number of drugs are also being developed against inflammatory
diseases such as rheumatoid arthritis and type 2 diabetes
(adult-onset diabetes).
A total of 97 percent of the projects are concerned with severe
diseases, some of them life-threatening; only three percent
address less serious physical disorders such as incontinence
or menopausal discomfort.
22 Innovation

Marketing Authorizations for Orphan Drugs in the European Union


Number

13
European Orphan Drug
Regulation effective
from 2000 onward

9 9

5
6 6
5
4 4
3 3
3
1 1 1
0
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

¹ expected marketing authorizations (as of July 2010)

Source: vfa

Since the start of 2000, companies have been able to apply


for “Orphan Drug” status for a drug being developed in Europe
if it is for treating a disease affecting no more than one in
2,000 EU citizens. With this status comes lower marketing
authorization fees, free scientific consulting and exclusive
marketing rights, usually for ten years.
Whereas on average only one drug for treating a rare disease
(Orphan Drug) received marketing authorization every year
before the regulation came into force, the figure is now much
higher. A total of 60 Orphan Drugs have now received market-
ing authorization in the EU and over 700 more are being
developed (as of July 2010). The Orphan Drug Regulation
is therefore a good example of how meaningful political regu-
latory activity can boost pharmaceutical research in areas
society deems important.
Innovation 23

Development Costs for a New Pharmaceutical


in USD million

2001 800

1999 610

1997 430

1993 360

1991 230

0 200 400 600 800

Sources: Di Masi J.et al., Tufts University (1991); Office of Technology Assessment (1993); Myers and Howe (1997);
Office of Health Economics & Lehman Brothers (1999); Tufts University (2001)

In 2001, an average of USD 800 million was required for


the research and development of a new drug with a new molec-
ular entity. More than half of these costs are spent on clinical
development, especially the logistically expensive, multinational
phase-III studies. The requirements involved in proving a new
drug’s safety, efficacy, tolerability and quality during the market-
ing authorization process have increased steadily. A further
reason for the high increase in costs lies in the growing complex-
ity of the diseases treated. Examples include multiple sclerosis
and Parkinson’s disease, for which researchers must take into
account many physical processes simultaneously to identify
possibilities for risk-free pharmaceutical therapy.
24 Innovation

R&D Expenditures of vfa Member Companies


in EUR billion

2009 5.22
1.32

2008 5.00
1.29

2007 4.53
1.27

2005 4.16
1.16

2000 3.08
0.95

1996 2.45
0.94 R&D expenditures
Share of human
0 1 2 3 4 5 resources costs

2009: provisional data


Source: vfa

Research-based pharmaceutical companies in Germany again


intensified and expanded their research and development
(R&D) activities involving new pharmaceuticals in 2009. R&D
expenditure increased to EUR 5.2 billion, which corresponds to
over EUR 14 million a day. As a result, not just volume but also
research intensity increased, despite the global financial and
economic crisis. At 4.4 percent, R&D expenditure grew more
strongly than sales (3.6 percent). A higher proportion of sales,
13.7 percent, was invested in R&D activities than in the
previous year.
Although pharmaceutical products make up only 2.4 percent
of the German industry’s sales, research-based pharmaceutical
companies contributed more than 10 percent of R&D spending
in 2009.
Innovation 25

Research Intensity: A Comparison

Share of R&D expenditures in sales in percent

14% vfa companies 4% companies conducting R&D (total)

Share of R&D employees in overall employees in percent

20% vfa companies 8% companies conducting R&D (total)

Source: Stifterverband für die deutsche Wissenschaft (2007), vfa (2009)

The research and development of new drugs is highly cost


and labor intensive.
The research intensity of vfa member companies continued
to grow in 2009. A higher share of sales, 13.7 percent, was
invested in R&D activities than in the previous year (13.6
percent). The proportion of R&D employees of all vfa company
employees increased to 20 percent (from 19.7 percent in
the previous year), which means one in five employees now
works in this area.
The R&D intensity of vfa companies thus remains much higher
than that of other companies conducting R&D in Germany
overall, which achieve a sales rate of 3.9 percent and an
employee rate of 7.9 percent (2007, most recent available
data).
26 Innovation

R&D Expenditures in Europe, Japan and the USA

in USD billion Shares (2008)

87.1 Japan 14%


84.2

76.0 41% USA


Europe excl.
67.8
Germany 37%

8% Germany

44.8

2000 2005 2006 2007 2008

2008: provisional data


Source: EFPIA, PhRMA, vfa

The R&D expenditure of pharmaceutical companies in Europe,


Japan and the USA increased to almost USD 90 billion in 2008.
Calculated in local currency, R&D expenditures in the USA and
Japan have risen more strongly than in Europe. 40 percent of
global R&D outlays continue to be made in the USA.
Innovation 27

Patent Applications for Genetically Manufactured Pharmaceuticals

2000: 1,615 patents

Other 18%

Japan 5%
55% USA
United Kingdom 5%

France 6%

Germany 11%

2009: 1,028 patents

Other 28%
37% USA

United Kingdom 4%
France 6%
Germany 11% 14% Japan

Published patent applications effective in Germany, IPC main classification and sub-classification (A61K);
For detailed data, see Appendix, page 57
Source: German Patent Office

10,289 patents were registered for pharmaceuticals in Germany


in 2009. 1,028 applications (10 percent) were for genetically
manufactured drugs. At the outset of the millennium, the pro-
portion of these applications was 20 percent. Patent appli-
cations from the USA in particular have decreased. Patent
applications from Germany have declined in absolute figures
(2000: 183 applications, 2009: 111), but have been able to
maintain their share of the total number. The number of patent
applications from Japan and countries such as Switzerland,
Sweden and Canada has grown considerably.
The Pharmaceutical Industry
and the Health Care Sector

Germany spent a much larger share of gross domestic


product on health care in 2009 than in previous years.
The reason for this is not an explosion in costs, but an
approximately 5 percent decrease in gross domestic
product compared with the previous year. Health care
costs also increased slightly overall. The amount spent
by SHI on pharmaceuticals increased by 5.2 percent,
and expenditures on hospital treatment by 6.4 percent
and on doctors’ services by 6.6 percent. Just 4 percent
of total SHI expenditures, EUR 170.8 billion, went to
manufacturers of patented pharmaceuticals in 2009.
Health Care System 29

Life Expectancy Trends in Germany


in years

2006/08 82.4
77.2

2001/03 81.3
75.6

1996/98 80.3
74.0

1991/93 79.5
73.1

1986/88 78.7
72.2
Women
60 65 70 75 80 85 Men

Source: Federal Statistical Office

Thanks in part to new pharmaceuticals, average life expectancy


in Germany increased by four years for women and five years
for men over the past 20 years. For example, several drugs
specifically targeting tumors have helped to make the average
lifespan much longer for many patients diagnosed with cancer
and to prevent a relapse in many cases, particularly in cases of
breast, colon and renal cancer and some types of leukemia and
lymphoma. Disease prevention has also improved, due to new
vaccines against rotaviruses, pneumococci and meningococci.
Doctors can now better protect patients with diabetes or high
blood pressure from life-threatening secondary diseases. It is
also thanks to such medications that increasing numbers of
rare diseases can be better treated or treated at all.
30 Health Care System

Increasing Therapeutic Benefit of Innovative Pharmaceuticals


Share of new molecular entities rated as an innovative pharmaceutical or
significant therapeutic improvement (in percent)

74

64

53

44

1991–1995 1996–2000 2001–2005 2006–2009

Source: Arzneimittelverordnungs-Report 2009, Fricke

Of the 122 molecular entities that received marketing authori-


zation in Germany for the first time over the last four years,
90 (74 percent) were rated as innovations or therapeutically
relevant improvements – even by critical experts. The share of
new molecular entities that can be considered innovative in
this respect has continuously increased over the past 19 years.
Health Care System 31

Improved Substances Save Money


Costs of patented products per daily dose in the 2008 SHI market in EUR

Pharmaceuticals with novel active 7.25


ingredient/therapeutic principle

Pharmaceuticals with improved 4.24 –42%


qualities of known therapeutic
principles
Pharmaceuticals with small 1.41 –81%
differences to previously released
active ingredients

0 1 2 3 4 5 6 7 8

Source: Arzneimittelverordnungs-Report 2009

Active ingredients whose molecular structure resembles sub-


stances that have already been released often yield various
therapeutic benefits, such as improved pharmacokinetics or
fewer side effects. This is why many of these products are on
the World Health Organization’s “essential drug list”, while the
original product is not listed. Molecular variations also promote
price competition between the patented substances of a given
substance class.
The latest data from the Arzneiverordnungs-Report in 2009
(p. 170) show that drugs with a novel active ingredient or thera-
peutic principle cost on average EUR 7.25 per daily dose, while
substances associated with improved pharmacological qualities
of previously known therapeutic principles cost 42 percent less
on average, thus offering a greater benefit at a lower price.
32 Health Care System

Health Care Expenditures and National Product


Share of gross domestic product in percent

12
Health care
spending in total
10

SHI service
expenditures
6

2 Pharmaceutical
expenditures

0
1993 1995 1997 1999 2001 2003 2005 2007 2009

2009: provisional estimate; for detailed data, see Appendix, page 58


Source: Federal Statistical Office, vfa

The global financial and economic crisis left its mark on the
national economy in 2009. Although final figures are not yet
available, a much higher share of gross domestic product will
have been spent on health care than in previous years.
The reason is not an explosion of costs, but rather a decline
in gross domestic product, which fell by around 5 percent in
2009. In contrast, health care expenses for both statutory
health insurers and private consumers increased moderately,
as they have in previous years. Since these expenditures also
stabilize domestic demand, they have contributed significantly
to cushioning the impact of the crisis on the national economy.
Health Care System 33

Health Care Spending Trends


Increased expenditures 1992 to 2008 in percent

Office-based doctor’s care 59.6

Health care spending 66.7


in total
Pharmaceuticals 70.1

Administration 72.9

Prevention/ 75.6
health protection
Nursing care/ 89.9
therapeutic services
Other medical needs 90.3

0 20 40 60 80 100

Source: Federal Statistical Office

This long-term comparison between 1992 and 2008 (last


available data) shows that costs incurred in the pharmaceutical
sector have increased only slightly more than overall health
care costs.
34 Health Care System

Health Care Spending in Europe, Japan and the USA


as percent of GDP

USA 16.0
13.4
France 11.0
10.2
Switzerland 10.8
10.0
Germany 10.6
10.4
Italy 8.7
7.7
Spain 8.5
7.3
United 8.4
Kingdom 6.6
Japan 8.1
7.0 2007
0 3 6 9 12 15 1997

2007: Japan, Switzerland estimated; United Kingdom: different methodology


Source: OECD

In an international comparison, Germany (after the USA, Switzer-


land and France) spends the fourth-largest proportion of its gross
domestic product on health care services. In contrast to these
other countries, Germany’s share has barely increased over the
past ten years.
Health Care System 35

Pharmaceutical Expenditures in Europe, Japan and the USA


as percent of total health care expenditures

Spain 21.0
20.8
Japan 19.6
20.6
Italy 19.3
21.2
France 16.3
15.0
Germany 15.1
13.1
USA 12.0
9.5
Switzerland 10.3
10.5
2007
0 5 10 15 20 1997

2007: Japan, Switzerland estimated


Source: OECD

Levels of pharmaceutical costs in Germany, which spends


15.1 percent of total health care expenditures on medications,
remain well below those of most European countries and Japan.
36 Health Care System

The Financing of the Statutory Health Insurance System (SHI)

Employee wages as percent of GDP


56

54

52

50

48
1993 1995 1997 1999 2001 2003 2005 2007 2009

SHI contribution rate in percent


15

14

13

12

11
1993 1995 1997 1999 2001 2003 2005 2007 2009

Since 1 July 2009 a standard contribution rate of 14.9 percent has applied; for detailed data, see Appendix, page 59
Source: Federal Statistical Office, BMG

For years, statutory health insurers (SHI) have been faced


with the problem of increasing expenditures and decreasing
revenues. One important reason for the striking increase
in SHI contribution rates is the weaker growth in employee
wages, which form the most important basis for financing
SHI. Between 1992 and 2007, employee wages as a share of
gross domestic product (GDP) decreased from almost 60 to
less than 49 percent. Only in 2009 did income from business
and investments fall more steeply than employee wages,
leading to an increase in the share of GDP for these wages.
Average SHI contribution rates increased over the same
period from 12.7 to over 15 percent.
Health Care System 37

Expenditures in the Statutory Health Insurance System 2009

in EUR billion (percent)

Administrative costs etc. 6%

Other services 21% 33% Hospital care

Remedies and
medical devices 6%

Pharmaceuticals 18% 16% Office-based doctor’s care

Changes over 2008 in percent

Total service expenditures 6.3


Hospital care 6.4
Office-based doctor’s care 6.6
Pharmaceuticals 5.2
Remedies/medical devices 5.7
Other services 1.1
Administrative costs, etc. 5.8

0 2 4 6 8

Provisional data; for detailed data, see Appendix, page 60


Source: BMG

A third of SHI expenditures, EUR 56.1 billion of a total of


EUR 170.8 billion, is spent on hospital treatment. Together,
expenditures on care by doctors (EUR 27.8 billion; 16 percent)
and pharmaceuticals (EUR 30.7 billion; 18 percent) make up
another third, with EUR 9 billion (6 percent) spent on adminis-
trative costs. Due to the increase in value-added tax, effective
from 1/1/2007, expenditures in some service areas (notably
pharmaceuticals) showed an above-average increase. Spend-
ing on preventive medicine was also much higher. Just four
percent of overall SHI expenditures (EUR 6.7 billion) went to
the manufacturers of patented pharmaceuticals.
The Pharmaceutical Market

The global pharmaceutical market grew slightly in the past


year to its current level of USD 808 billion. The USA is still
the world’s biggest single market by a substantial margin.
The Latin American and Asian markets grew most strongly,
while Europe remained stable. China, one of the most
dynamic markets, may soon surpass Germany and France
to become the world’s third largest market (behind the
USA and Japan). Compared with other countries, Germany’s
per-capita expenditure is in the average range, although
it ranks lower than other European countries in terms of
innovation. In 2009, only 4.4 percent of overall pharma-
ceutical costs were spent on innovations launched on the
market in the past 5 years.
Pharmaceutical Market 39

The Global Pharmaceutical Market

in USD billion Shares (2009)


808
781
Other 21%
717 37% USA

Japan 11%

Europe 31%

365

2000 2007 2008 2009

Sales at manufacturer prices in the pharmacy market


Source: IMS Health, vfa

Global pharmaceutical sales more than doubled from 2000


to 2009. The USA, with around 37 percent, is still the world’s
biggest single market. Growth in this market, which was above
average until the first years of the new millennium, has tended
to approximate the moderate dynamic of European markets
in the past three years. Latin American and Asian markets have
grown most strongly.
Europe’s share of the world market declined in 2009 to 31
percent (from 32 percent in the previous year), due mainly
to the euro’s weaker exchange rate against the U.S. dollar.
Germany’s global market share also fell very slightly in 2009
from 4.5 to 4.3 percent. In real terms, assuming a constant
exchange rate, Germany’s share of the world market decreased
from 5.0 to 3.5 percent over the past decade.
40 Pharmaceutical Market

Development of the Largest Pharmaceutical Markets


2001 = 100

180
Spain
170

USA
160

150

140
United Kingdom
Germany
130
France
Japan
120

110 Italy

100
2001 2002 2003 2004 2005 2006 2007 2008 2009

Sales increases adjusted for exchange rate fluctuations; sales in Germany adjusted for manufacturer discounts
from 2003 onward
Source: IMS Health, vfa

With a volume of around USD 35 billion in 2009, Germany is


the third largest market for pharmaceuticals in an international
comparison and at the same time one of the markets showing
moderate growth. From 2001 to 2009, sales in the German
pharmacy market increased by around 30 percent, an average
annual increase of 3.4 percent, while the US and Spanish
pharmacy markets grew by more than 60 percent in the same
period. Growth in the upcoming Asian and Latin American
markets is even stronger. China, one of the most dynamic
markets, may soon overtake Germany and France to become
the third largest market.
Pharmaceutical Market 41

Per Capita Sales of Pharmaceuticals


2009 in USD (adjusted for purchasing power)

USA 687

Japan 556

Canada 426

Switzerland 370

France 349

Germany 337

Spain 301

Italy 214

United 181
Kingdom
0 200 400 600 800

Sales in the pharmacy market at manufacturer prices; Switzerland 2008


Source: IMS Health, OECD, vfa

Germany ranks in the middle of an international comparison of


per-capita sales (sales in the pharmacy market at manufacturer
prices). Compared with other European countries, Germany
lies behind France and Switzerland. In non-European industrial
nations such as the USA, Japan and Canada, per capita sales
are higher than those in Germany.
42 Pharmaceutical Market

New Molecular Entities in Germany


Market share of new molecular entities launched in the past five years in percent

7.7

6.5
6.2
5.9
5.4

4.4

2004 2005 2006 2007 2008 2009

Source: InsightHealth, vfa

Germany ranks lower than other European countries in terms


of innovation. In 2009, only 4.4 percent of expenditures
in Germany was spent on innovations launched during the
previous 5 years. This market share is well below the rates
of previous years and pales in comparison to shares in other
European countries, which can be as high as 18 percent.
Pharmaceutical Market 43

Number of Pharmaceuticals in Germany

in USD billion Shares (2010)

9,615 4% Other
Homeopathics 8%
8,933
8,500 Pharmaceuticals from
botanical sources 8%

80% Chemically
defined pharmaceuticals

2000 2005 2010

Source: Rote Liste

The number of pharmaceuticals is declining significantly. The


‘Rote Liste’, a well known German drugs directory, currently lists
8,500 products, many of which are only rarely used. According
to evaluations made by statutory health insurers, 90 percent
of doctors’ prescriptions are issued for just 2,000 medications.
The number of pharmaceuticals available is often represented
imprecisely. For example, if not only the individual product,
but also every dosage form and concentration is counted sepa-
rately, a figure of more than 40,000 pharmaceuticals can be
reached. However, this method of counting is not customary in
other countries and is therefore inappropriate for the purpose
of comparison.
44 Pharmaceutical Market

From Manufacturers to Patients: Distribution and Financing of Pharmaceuticals


in the 2009 Pharmacy Market
in EUR billion

Manufacturer sales 24.7


(at manufacturer prices)
Trade mark-ups 10.8

Sales tax 6.7

Pharmacy market 42.2


at retail prices
Self-medication 4.0
with OTC drugs
Private prescriptions 5.2

SHI prescriptions 33.1

Insured patients’ 1.6


copayments
Manufacturers’ and 2.9
trade discounts
Expenditures of the 28.6 Distribution
health insurance funds Financing

Simplified representation of the most important cash and service flows (with approximate values)
Source: vfa

In 2009, pharmaceutical companies provided drugs for


human use worth EUR 24.7 billion (at manufacturer prices)
via pharmacies for outpatient treatment. Adding wholesale
and pharmacy mark-ups and sales tax gives a market volume
of EUR 42.2 billion at retail prices.
10 percent of this amount was for self-medication, 12 percent
for private prescriptions outside of statutory health insurance,
and 78 percent for SHI prescriptions. These were financed
through copayments by insured patients (5 percent), manu-
facturer and pharmacy discounts (8.6 percent) and by the
health insurance funds themselves (86.4 percent).
Pharmaceutical Market 45

Sales and Packages Sold through Pharmacies in 2009

Sales: EUR 24.7 billion (+3.7% over the previous year)


unrestricted over-the-
counter drugs 6%
pharmacy-only drugs 12%

82% prescription drugs

Packages: 1.6 billion (–0.5% over the previous year)


unrestricted over-the-
counter drugs 12%

46% prescription drugs

pharmacy-only drugs 42%

Sales at pharmaceutical manufacturer prices (discounts not taken into account)


Source: InsightHealth, vfa

Sales in the German pharmacy market increased slightly in


2009, as they did in the previous year. After deducting legally
mandated discounts and individual contractual rebates, net
sales reached EUR 24.7 billion, 3.7 percent more than in the
previous year. However, net sales were actually much lower
due to these discounts. The exact amount of these discounts
is currently unknown but is estimated at up to EUR 2 billion.
The number of packages sold reached a volume of 1.6 billion
in 2009, a decrease of 0.5 percent compared with the previous
year. Sales of prescription-only drugs increased slightly
(+0.2 percent), while total sales of pharmacy-only and unre-
stricted over-the-counter drugs from pharmacies declined
(–1.1 percent).
46 Pharmaceutical Market

Parallel Imports

Market share in percent


12

10

2
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Growth rates (in percent) Parallel imports Overall market
60

40

20

–20

–40
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009

Sales at pharmaceutical manufacturer prices; for detailed data, see Appendix, page 59
Sources: IMS Health, InsightHealth, vfa

The market share of pharmaceutical parallel imports in the


pharmacy market, less than 2 percent in 1998, increased to
almost 11 percent in 2009. This was due in large part to targeted
government support. The introduction of a minimum price
difference for imported products compared to original products
from 2004 interrupted this development only temporarily.
Parallel imports focus mainly on patented innovations, so
research-based pharmaceutical companies suffer a consider-
able loss of sales in the domestic market. Importers generated
sales worth EUR 2.66 billion in 2008.
Pharmaceutical Market 47

Sales of Genetically Manufactured Pharmaceuticals

Share of biopharmaceuticals in the total German pharmaceutical market (2009)

16% Biopharmaceuticals

Chemical and other


active ingredients 84%

Sales¹ of biopharmaceuticals in Germany in EUR million (2009)

Total sales 4,673


Metabolism 1,204
Immunology 1,124
Oncology 753
CNS 659
Infections 362
Hematology ² 350
Other³ 221

¹ Total sales at pharmaceutical manufacturer prices


² Excl. hematological oncology
³ Incl. gastroenterology, dermatology, urology, etc.
Source: IMS, BCG analysis

Pharmaceuticals with genetically manufactured substances


(biopharmaceuticals) generated sales of EUR 4.7 billion (total
sales in pharmacies and hospitals at manufacturer prices). The
increase in the sales rates of biopharmaceuticals has slowed
in recent years, from 12 percent in 2006 and 28 percent in
2007 to over 9 percent in 2008 and 5 percent in 2009. The
proportion of biopharmaceuticals in the total pharmaceutical
market remained stable in 2009 at 16 percent.
Biopharmaceuticals for treating metabolic diseases and immu-
nological agents each make up around a quarter of biopharma-
ceutical sales, followed by cancer and CNS drugs, with shares
of 16 percent and 14 percent respectively. Anti-infectives and
hematological products each make up shares of approx. 7 percent.
48 Pharmaceutical Market

Sales Distribution in the SHI Pharmaceutical Market in 2009

16.0% Tax

9.2% Discounts and rebates

Manufacturers 56.1%
15.2% Pharmacies

3.5% Wholesale

Sales at pharmacy retail prices


Sources: InsightHealth, BMG, vfa

Gross sales of proprietary medical products in the SHI market


(at pharmacy retail prices incl. VAT without rebate deductions)
were worth EUR 30.9 billion in 2009. Through the Contribution
Rate Safeguarding Act, the SHI Modernization Act and the Eco-
nomic Optimization of Pharmaceutical Care Act, the discounts
that pharmaceutical manufacturers, wholesalers and retailers
must grant to statutory health insurers have been changed
several times between 2002 and 2008. To this must be added
rebates from contracts outlined in Section 130a par. 8 of
Germany’s Social Security Code (SGB).
The increase in value-added tax to 19 percent from 1/1/2007
also raised the share of tax in gross sales to 16 percent.
Pharmaceutical Market 49

Manufacturer Sales in the SHI Pharmaceutical Market


in EUR billion at manufacturer prices

2009 17.3 1.8 19.1

2008 16.8 1.3 18.1

2007 16.0 1.1 17.1

2006 15.4 1.0 16.4

2005 15.4 0.5 15.9

Net sales
Manufacturer discount

Source: InsightHealth, vfa

Several tightenings of discount regulations have caused


legally mandated manufacturer discounts to more than double
since 2005. Discounts, which have increased substantially
in recent years, based on individual agreements between
health insurance funds and manufacturers pursuant to Section
130a par. 8 of Germany’s Social Security Code, must also
be taken into account. The total of these discounts is now
estimated at over EUR 1.8 billion (almost 10 percent of gross
sales at manufacturer prices).
Net sales in 2009 were EUR 17.3 billion, an increase of just
2.8 percent compared with the previous year.
50 Pharmaceutical Market

2009 Sales Growth: Driven by what Components?


Changes in sales in EUR billion

Overall +1.3

Consumption +1.1

Innovation +0.4

Technical –0.4
Savings
Price +0.2

–0.5 0 0.5 1.0 1.5

Source: IGES

The EUR 1.3 billion sales increase in the SHI market in 2009
was driven by opposing components whose effect was partly
to increase and partly to decrease sales. Consumption (increase
in prescribed daily doses) and innovative pharmaceuticals
have created an additional demand of around EUR 1.1 and
EUR 0.4 billion respectively. In contrast, “technical” savings,
e.g. the selection of more cost-effective drugs, including those
with active ingredients whose patents expired in 2009, or
larger packages, have resulted in total savings of EUR 0.4 billion.
Increased prices boosted sales by EUR 0.2 billion.
As in the past four years, the dominant factors in the dynamics of
the pharmaceutical market are medical and therapeutic needs.
Pharmaceutical Market 51

Changes in 2009 Sales Based on Health Disorders


Changes in sales in EUR million

Rheumatoid Arthritis¹ +203


Neuroleptic drugs, antipsychotics +154
Cardiovascular diseases² +140
Multiple sclerosis +123
Asthma, COPD +121
Cancer +105
Painkillers +99
HIV infections +93
Diabetes tests +62
Non-insulin-dependent diabetes mellitus +62
Tick-borne encephalitis (vaccine) –90
Acid-related disorders –97
Human papillomavirus (vaccine) –130

–150 –100 –50 0 50 100 150 200

¹ and other immune system disorders


² drugs affecting the renin-angiotensin system
Disorders of more than +/– EUR 60 million
Source: IGES

Sales increases were recorded mainly for the treatment of


serious and chronic diseases, especially mental illness and
rheumatic and cardiovascular diseases. Decreasing sales
were recorded for categories of diseases for which classes
of active ingredients used could be prescribed more cost-
effectively due to expired patents or price reductions. To
this must be added a normalization in the usage frequency
of two vaccines, which underwent increased demand in
2008 due to vaccination recommendations.
52 Pharmaceutical Market

Reference Prices in the SHI Market


Shares in percent

2009 75.2
41.3

2008 74.8
43.6

2007 75.0
47.1

2000 64.6
46.5
Prescriptions
0 20 40 60 80 Sales

2000: as of July 1st; 2007, 2008: annual averages; 2009: January to November
Source: SHI, vfa

Over the past three years, indirect price regulation based on


reference prices has continued to be expanded significantly. In
2009, around three quarters of all pharmaceuticals prescribed
in Germany were subject to this regulation. This share is the
highest since reference prices were introduced. The share of
pharmaceutical sales subject to reference prices is declining
due to reductions in reference prices.
Since 2005, new categories of reference prices can also
include patented active ingredients. This imposes a consider-
able additional burden, especially on research-based pharma-
ceutical manufacturers.
Since January 1st, 2010, over 30,000 proprietary medical
products have been subject to reference prices. As a result,
the statutory health insurance funds should save at least
EUR 4.3 billion in 2010.
Pharmaceutical Market 53

Generic Drugs in the SHI Market


Shares in the market eligible for generic drugs (in percent)

90

Prescriptions
85

80
Sales
75

70

65

60

55

50
1995 1997 1999 2001 2003 2005 2007 2009

For detailed data, see Appendix, page 60


Source: Arzneiverordnungs-Report 2009 (up to 2008); projections: vfa (2009)

When patents expire, the imitation products of other manu-


facturers (generic drugs) can be authorized for marketing along-
side the original pharmaceuticals. In Germany, 80 percent of
SHI prescriptions, at 45 percent almost half of total market
sales, are generated in this so-called ‘generics-eligible market’.
Over the past twelve years, Germany has evolved into the
world’s most generics-friendly country. Original products often
lose almost their entire market share to generic drugs within a
few months after a patent expires. An average of over 85 percent
of prescriptions and around 77 percent of sales in the generics-
eligible market were generated by imitation products in 2009.
Appendix
Appendix 55

The Production of Pharmaceutical Products in Germany


Production of pharm. Change over previous
Year products in EUR billion year in percent
2009 26.381 –2.8
2008 27.136 3.5
2007 26.219 10.6
2006 23.700 4.6
2005 22.654 8.4
2004 20.893 0.8
2003 20.720 0.2
2002 20.672 2.3
2001 20.200 9.2
2000 18.500 2.8
1999 18.000 1.1
1998 17.812 2.5
1997 17.380 –0.4
1996 17.442 4.8
1995 16.641 –0.9
1994 16.800 6.4
2009: provisional data
Source: Federal Statistical Office, vfa
56 Appendix

Pharmaceutical Product Sales of Manufacturers


Domestic Foreign Export ratio
Year sales sales Total in percent
2009 14.6 23.2 37.8 61.4
2008 15.2 23.6 38.8 60.8
2007 17.4 23.8 41.3 57.8
2006 16.8 21.3 38.1 56.0
2005 16.7 19.1 35.9 53.3
2004 14.3 16.9 31.3 54.2
2003 14.3 14.2 28.5 49.7
2002 14.3 12.9 27.1 47.4
2001 15.7 15.7 31.4 50.0
2000 15.9 14.6 30.6 47.9
1999 15.9 13.3 29.2 45.5
1998 15.5 11.8 27.3 43.2
1997 13.4 7.4 20.8 35.4
1996 12.9 6.0 18.9 31.9
1995 12.7 5.6 18.3 30.5

2009: provisional data; distinction according to technical company segments


Source: Federal Statistical Office, vfa
Appendix 57

Price Trends
2000 = 100
Year Private consumption SHI pharmaceuticals
2009 115.4 89.9
2008 115.0 89.5
2007 112.1 90.9
2006 109.6 92.4
2005 107.9 94.7
2004 106.3 95.3
2003 104.5 99.8
2002 103.5 100.3
2001 101.9 100.9
2000 100.0 100.0
1999 98.6 99.5
1998 98.1 98.8
1997 97.1 98.5
1996 95.3 99.1
1995 94.0 99.0
Source: Federal Statistical Office, WIdO

Patent Applications for Genetically Manufactured


Pharmaceuticals
Country of origin 1990 2000 2005 2006 2007 2008 2009
USA 192 891 597 517 468 482 380
Germany 49 183 157 146 102 109 111
Japan 66 82 162 198 173 150 147
United Kingdom 29 90 78 64 42 52 42
France 25 84 81 57 52 78 64
Other 71 285 300 319 276 361 284
Total 432 1,615 1,375 1,301 1,113 1,232 1,028
Published patent applications effective in Germany, IPC main classification and
sub-classification (A61K)
Source: German Patent Office
58 Appendix

Health Care Expenditures and Gross National Product


Share of Gross Domestic Product in percent
Health care SHI service Pharmaceutical
Year spending in total expenditures expenditures
2009 11.37 6.67 1.86
2008 10.55 6.05 1.73
2007 10.41 5.94 1.72
2006 10.55 5.97 1.71
2005 10.68 6.02 1.76
2004 10.58 5.94 1.61
2003 10.81 6.29 1.70
2002 10.64 6.27 1.67
2001 10.44 6.18 1.62
2000 10.30 6.10 1.53
1999 10.30 6.12 1.52
1998 10.23 6.11 1.52
1997 10.23 6.18 1.47
1996 10.39 6.44 1.48
1995 10.09 6.33 1.43
1994 9.79 6.24 1.41
1993 9.58 6.04 1.41
1992 9.57 6.20 1.54
2009: provisional estimate
Source: Federal Statistical Office, vfa
Appendix 59

The Financing of the Statutory Health Insurance System (SHI)


in EUR billion
Gross domestic Employee Employee SHI contribution
Year product (GDP) wages wages in % rate in %
2009 2,407.2 1,223.9 50.84 15.20
2008 2,495.8 1,225.1 49.08 14.90
2007 2,428.2 1,180.9 48.63 14.80
2006 2,321.5 1,149.5 49.52 14.22
2005 2,241.0 1,129.9 50.42 14.17
2004 2,207.2 1,134.5 51.40 14.23
2003 2,161.5 1,131.1 52.33 14.31
2002 2,143.2 1,128.7 52.66 13.96
2001 2,113.2 1,120.6 53.03 13.54
2000 2,062.5 1,100.0 53.33 13.57
1999 2,012.0 1,059.5 52.66 13.60
1998 1,965.4 1,032.3 52.52 13.62
1997 1,915.6 1,010.7 52.76 13.58
1996 1,876.2 1,006.6 53.65 13.48
1995 1,848.5 997.0 53.94 13.15
1994 1,780.8 961.9 54.02 13.17
1993 1,694.4 938.7 55.40 13.22
1992 1,646.6 917.2 55.70 12.71
A standard contribution rate of 14.9 percent has applied since 1 July 2009
Source: Federal Statistical Office, BMG

Parallel Imports
Market share Overall market Parallel imports
Year in percent growth rates in percent growth rates in percent
2009 10.8 3.7 23.9
2008 9.0 4.3 5.7
2007 8.9 4.4 20.2
2006 7.7 –0.4 36.6
2005 5.6 5.9 28.1
2004 4.7 0.2 –29.1
2003 6.6 11.1 2.6
2002 7.2 6.5 65.4
2001 4.6 9.3 60.7
2000 3.1 5.9 52.2
Sales at pharmaceutical company prices
Source: IMS Health, InsightHealth, vfa
60 Appendix

Expenditures in the Statutory Health Insurance System


in EUR billion
Area 2000 2005 2008 2009
Total spending without RBFE 133.8 143.6 160.8 170.8
Total expenditures on
health care services 125.9 134.8 151.1 160.6
Hospital care 44.5 49.0 52.6 56.1
Office-based doctors’ care 21.5 21.6 24.3 27.8
Pharmaceuticals 20.1 25.4 29.2 30.7
Remedies/medical devices 9.4 8.2 9.0 9.5
Other services 30.4 30.6 36.0 36.4
Administrative expenses, etc. 7.9 8.8 9.6 10.2

RBFE: risk-based fiscal equalization; 2009: provisional data


Source: BMG

Generic Drugs in the SHI Pharmaceutical Market


Shares in the market eligible for generic drugs (in percent)
Year Prescriptions Sales
2009 85.9 77.1
2008 85.1 76.3
2007 82.1 75.2
2006 76.7 74.0
2005 74.2 68.3
2004 74.1 70.1
2003 75.0 67.3
2002 74.7 68.2
2001 72.2 65.2
2000 71.0 63.7
1999 68.2 59.4
1998 65.7 55.9
1997 65.0 54.2
1996 63.1 51.2
1995 62.1 50.0
Source: Arzneiverordnungs-Report 2009 (up to 2008); projections: vfa (2009)
Imprint
Published by
Verband Forschender Arzneimittelhersteller e.V.
(German Association of Research-based
Pharmaceutical Companies)
Hausvogteiplatz 13
10117 Berlin, Germany

Diagrams
Adler & Schmidt Kommunikations-Design, Berlin

Printer
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Updated
July 2010

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