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Economy Statistics 2011 The Pharmaceutical Industry in Germany

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Page 1: The Pharmaceutical Industry in Germany - vfa · subject to economic fluctuations as much as other necessities. As a result, the pharmaceutical industry is one of those economic areas

Economy

Statistics 2011The Pharmaceutical Industry in Germany

Page 2: The Pharmaceutical Industry in Germany - vfa · subject to economic fluctuations as much as other necessities. As a result, the pharmaceutical industry is one of those economic areas

The vfa is the trade association of the research-based phar-maceutical companies in Germany. It represents the interests of 44 globally leading pharmaceutical companies and their more than 100 subsidiaries and affiliated companies in the areas of health, research and economic policy. The vfa member companies make up about two thirds of the German pharma-ceutical market and employ approximately 90,000 people in Germany. More than 17,000 are engaged in research and development.

Page 3: The Pharmaceutical Industry in Germany - vfa · subject to economic fluctuations as much as other necessities. As a result, the pharmaceutical industry is one of those economic areas

Foreword

2010 was a critical year for research-based pharmaceutical companies: a price moratorium and an increased mandatory discount (from 6 percent to 16 percent) since the middle of the year as well as the law (AMNOG), in effect since the start of 2011, which reorganised the pharmaceutical market and includes an early benefits analysis, dictated discussions over the past year and pose new and unexpected challenges for companies. That the effects of these changes are not yet reflect-ed in key economic indicators is mainly due to newly increased export volumes: 62 percent of pharmaceuticals produced in Germany are currently sold in other markets. Thus, Germany continued to be a leading market over the past year, at least for Europe.

However, new molecular entities showed a downward trend in 2010: only 26 innovative pharmaceuticals were launched on the German market, as opposed to 36 in the previous year. As part of AMNOG, lawmakers have established a new procedure starting this year that would, if employed purely as a cost con-tainment instrument, create additional heavy burdens on the German pharmaceutical industry.

This would hurt an industry that, as much as any other, stands for innovation and medical progress (this hinders even the pharmaceutical projects of vfa members which would reach market maturity by 2015)! Instead of measures governing the health care sector, which unilaterally burden individual market actors, in future, Germany needs collaboration among all those involved in the health care sector in order to jointly develop smart, forward-thinking ideas. Research-based pharmaceutical compa-nies are ready for dialogue and cooperation. Statistics for 2011 once again provide a good argument for such collaboration.

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

The Pharmaceutical Industry and InnovationNew Molecular Identities in Germany 20 New Molecular Identities and Their Applications in 2010 21Pharmaceutical Projects by vfa Member Companies Promising Success by 2015 22Marketing Authorizations for Orphan Drugs in the European Union 23Development Costs for a New Pharmaceutical 24R&D Expenditures of the vfa Member Companies 25Research Intensity: A Comparison 26R&D Expenditures in Europe, Japan and the USA 27Patent Applications for Genetically Manufactured Pharmaceuticals 28Expenditures for Research and Development 29

Contents

Page 5: The Pharmaceutical Industry in Germany - vfa · subject to economic fluctuations as much as other necessities. As a result, the pharmaceutical industry is one of those economic areas

The Pharmaceutical Industry and the Health Care SectorLife Expectancy Trends in Germany 32Increasing Therapeutic Benefit of Innovative Pharmaceuticals 33Improved Substances Save Money 34Health Care Expenditures and National Product 35Health Care Spending Trends 36Health Care Spending Trends in Europe, Japan and the USA 37Pharmaceutical Expenditures in Europe, Japan and the USA 38The Financing of the Statutory Health Insurance System (SHI) 39Expenditures in the Statutory Health Insurance System in 2010 40

The Pharmaceutical MarketThe Global Pharmaceutical Market 44Development of the Largest Pharmaceutical Markets 45Per-capita Sales of Pharmaceuticals 46New Molecular Entities in Germany 47Number of Pharmaceuticals in Germany 48From Manufacturers to Patients: Distribution and Financing of Pharmaceuticals in the 2010 Pharmacy Market 49Sales and Packages Sold Through Pharmacies in 2010 50Parallel Imports 51Sales of Genetically Manufactured Pharmaceuticals 52Sales Distribution in the SHI Pharmaceutical Market in 2010 53Manufacturer Sales in the SHI Pharmaceutical Market 542010 Sales Growth: Driven by what Components? 55Changes in 2010 Sales Based on Health Disorders 56Reference Prices in the SHI Market 57Generic Drugs in the SHI Pharmaceutical Market 58

Appendix

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Page 7: The Pharmaceutical Industry in Germany - vfa · subject to economic fluctuations as much as other necessities. As a result, the pharmaceutical industry is one of those economic areas

The Pharmaceutical Industry and the Economy

“With a net added value of almost EUR 120,000 per employee, the pharmaceutical industry is among the most productive sectors in the German economy.”

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6 Economy

Pharmaceutical products worth EUR 27 billion were produced in Germany in 2010, an increase of 2.3 percent compared with the previous year. However, the production growth in 2010 is not reflected in the companies’ correspond-ing revenue statements. Government intervention (e.g. legally mandated dis-counts, price freezes) has actually caused manufacturing revenue to decrease by 2.1 percent.

2010: provisional data; for detailed data, see Appendix, page 62Source: Federal Statistical Office, vfa

1994 1996 1998 2000 2002 2004 2006 2008 201016

–3

–1

9

11

1

3

5

7

18

20

22

24

26

28

Production of Pharmaceutical Products in Germany

in EUR billion

Change over previous year in percent

1994 1996 1998 2000 2002 2004 2006 2008 2010

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7Economy

In an international comparison, Germany has barely been able to maintain its position as a production location for pharmaceutical products. Overall, 8 percent of pharmaceutical production from Europe, Japan and the USA, worth EUR 350 billion in 2009, came from Germany. In 1990 this share was 9 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 Euro-pean countries in particular, such as Ireland and Switzerland, have expanded their pharmaceutical production.

Production in Europe, Japan and the USA

Japan: 2008Source: The OECD, EFPIA, Pharmaceutical associations of the European countries, and the vfa

2009: EUR 348 billion

Other 14%

Switzerland 7%

Ireland 6%

United Kingdom 5%

Italy 7%

Germany 8%

France 7%

12% Japan

34% USA

1990: EUR 136 billion

Other 8%Switzerland 4%

United Kingdom 7%

Italy 8%

France 9%

Germany 9%23% Japan

32% USA

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8 Economy

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 pharmaceutical industry.

Economic StabilityIndex of orders received, adjusted seasonally, 2005 = 100

Source: Federal Statistical Office

1991 1993 1995 1997 1999 2001 2003 2005 2007 20112009

60

70

80

90

100

110

120

130

Pharmaceutical productsChemical industry Manufacturing industry

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9Economy

With a net added value of over EUR 120,000 per employee in 2008, the pharmaceutical industry one of the best performing and most productive industries in Germany.

100

Added ValueNet added value per employee in 2008 in EUR 1,000

Source: Federal Statistical Office

Pharmaceutical industry

Chemical industry

119.3

90.1

Mechanical engineering 67.5

Electrical engineering 64.5

Manufacturing industry (total)

60.8

Motor vehicle industry 60.3

Construction 47.7

0 20 6040 80 120

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10 Economy

70

60

50

40

30

20

10

0

Export Ratio of Pharmaceutical Companies in GermanyForeign sales as a percent of total sales

2010: provisional data; for detailed data, see Appendix, page 63Source: Federal Statistical Office

2010

31

48

53

63

1995 2000 2005

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 more than doubled in the last 15 years.The latest international statistics show Germany, together with Switzerland, as the world’s third largest production location (after the USA and Japan).

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11Economy

Employee numbers in vfa member companies hardly changed in 2010 in comparison to the previous year. Despite this limited fluctuation, there is an unmistakable long-term trend towards more employment in research and development. 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.

2010

2009

85,250

17,136

85,832

2005 91,922

2000 78,378

1995 73,158

17,332

15,943

14,145

14,467

0 20 6040 80 100

Employees of the vfa Member CompaniesNumber in thousands

From 2009: Only limited comparisons can be made with values from the previous year (statistical adjustment)2010: provisional data Source: vfa

Employees (total)

R&D employees

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12 Economy

As of 2009Source: Federal Statistical Office

Capital Spendingas a percent of sales

Chemical industry

Pharmaceutical industry

4.3

3.9

Motor vehicle industry 3.5

Manufacturing industry (total)

3.3

Electrical engineering 3.3

Mechanical engineering 3.1

0 1 32 4 5

With capital spending at a 3.9 percent share of sales, the pharmaceutical industry is one of 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 Eco-nomic Research. These indirect production and investment effects increase the industry’s added value by roughly another 90 percent. In particular, industry sectors that provide higher added value and employment volume, such as research and development services, are pulled along by the pharma-ceutical industry. Each job in one of our companies creates another job in another industry.

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13Economy

Investment volumes of vfa companies decreased slightly in 2010 in comparison to the previous year, but remained on par with values from recent years.

2010 1.20

2009 1.38

2005 1.27

2000 1.04

1996 0.89

0 0.5 1.51.0

Capital Spending of the vfa Member Companiesin EUR billion

From 2009: Only limited comparisons can be made with values from the previous year (statistical adjustment)2010: provisional dataSource: vfa

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14 Economy

Price Trends2000 = 100

For detailed data, see Appendix, page 64Source: Federal Statistical Office, WIdO

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

85

90

95

100

105

110

115

120

SHI pharmaceuticalsPrivate consumption (total)

Until 2003 prices for pharmaceuticals had barely changed, after which they have significantly decreased. Pharmaceuticals are now 10 percent cheaper than they were in 2000. In contrast, overall prices for consumer goods and services have increased by over 17 percent since 2000.

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15Economy

Pharmaceuticals are no more expensive in Germany than in many other industrialized nations, as was confirmed by the most recent study commis-sioned by the Norwegian Ministry of Health and Care Services. The study examined the drug prices of the 200 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.

Ireland

Belgium

158

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

Pharmaceutical Prices: A European ComparisonGermany = 100

As of the 1st half of 2009; currency exchange rates from 2008Source: Institute for Research in Economics and Business Administration (SNF), Bergen 2010

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16 Economy

Value-added Tax on Pharmaceuticals: A European Comparison

As of January 2011Source: vfa

25% Denmark, Norway20% Bulgaria19% Germany12% Latvia10% Italy, Austria, Slovakia, Czech Republic9% Estonia, Finland, Romania8.5% Slovenia8% Poland6.5% Greece6% Belgium, Netherlands, Portugal5% Hungary4% Spain3% Luxembourg2.5% Switzerland2.1% France0% Ireland, Lithuania, Malta, Sweden, United Kingdom, Cyprus No data

In most European countries, the tax burden for pharmaceuticals has been reduced or waived entirely. Pharmaceuticals in Germany are subject to the full value-added tax rate.

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17Economy

With a manufacturer’s share of 56 percent of the retail price, Germany is located in the bottom segment of the European ranking. Together with legally mandated manufacturer and pharmacy discounts, the tax rate in Germany amounts to 25 percent of the retail price, making it the highest in Europe. In most other European countries the tax burden on pharmaceuticals is reduced or waived entirely.

Pricing Structure in Europe

0 20 40 60 80 100

Shares in percent

Sweden

Ireland

Portugal

France

Switzerland

Spain

Greece

Denmark

Austria

Finland

Netherlands

Italy

Belgium

Germany

80

76

71

68

67

65

63

61

60

60

60

60

56

56

17

17

17

25

25

26

24

13

25

24

27

24

29

15

5

5

2

4

8

21

9

13

6

10

6

25

3

7

7

2

6

5

5

5

6

3

7

6

9

4

Manufacturers Wholesalers Pharmacies Taxes and discounts

Prescribed or reimbursed pharmaceuticals; Ireland: only oral dosage forms; as of 2009 (Netherlands 2008)Sources: EFPIA, Pharmaceutical associations of European countries, vfa

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19Economy

The Pharmaceutical Industryand Innovation

“We currently have over 350 projects under development in our labs to address more than 100 illnesses, with each project having the chance to reach market maturity by 2015.”

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20 Innovation

Market Launches of New Molecular Entities in Germany Number (excluding biosimilars)

Source: vfa

282929

14

2523

34

25

21

26

36

44

36

31

27 27

17

36

23

3028

1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008

36

2010

26

26 pharmaceuticals based on new NMEs (new substances known internation-ally as New Molecular Entities) were launched in the German market in 2010. 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 marketing authorization as soon as possible in all key countries. This is the only way to balance the costs for research and development of an NME, which globally amount to USD 800 million on average, within its limited patent term.

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21Innovation

In 2010, research-based pharmaceutical companies once again facilitated important progress in medicine by creating new drugs, e.g. for the treatment of osteoporosis, cardiac arrhythmia and several types of cancer. With six medications, rare illnesses, such as idiopathic thrombocytopenic purpura (ITP), can be treated.Research-based pharmaceutical companies launched a total of 26 new molecular entities this year, as well as another 13 drugs based on existing active ingredients, which are delivered in a new dosage form. For instance, with a drug to combat prostate cancer, only two applications are needed per year instead of the previous four. An additional medication to counter high blood pressure is now available as oral solution suitable for children.

New Molecular Entities and their Applications in 2010

Source: vfa

Gastrointestinal diseases 1Haematological disorders (excluding cancer) 1

Allergies 1

Bone diseases 3

Fertility disorders 1

Metabolic diseases 2

3 Cancer

Infectious diseases 2

3 Cardiovascular diseases

3 Diagnostic imaging

3 Nervous system disorders

Urological diseases 1

Respiratory illnesses 2

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22 Innovation

Research-based pharmaceutical companies are working on the challenges of the future: 359 projects for medications to treat over 100 illnesses are currently in the final stages of development by vfa member companies. Each has the prospect of reaching market maturity by 2015. Infectious diseases (11 percent), cardiovascular disorders (11 percent) and inflammatory diseas-es, such as rheumatoid arthritis, asthma and multiple sclerosis, also share the focus of our researchers.

Source: vfa

Pharmaceutical Projects by vfa Member Companies Promising Success by 2015Distribution in various medical areas; overall number of projects: 359

¹ Each individual project accounts for 1% or less ² Excluding cancer³ Depression, schizophrenia, bipolar disorder, etc.4 Alzheimer’s disease, Parkinson’s disease, etc.5 Rheumatoid arthritis, asthma, multiple sclerosis, Crohn’s disease, psoriasis, etc.

32% Cancer

Other medical areas¹ 13%

Chronic obstructive pulmonary disease 1%

Diabetes type 2 4%

Osteoporosis 2%

Psychiatric disorders³ 4%

Female-specific illnesses² 1%

Other nervous system disorders 2%

Inflammatory diseases5 12%11% Infectious diseases

11% Cardiovascular disorders

Pain 4%

Neurodegenerative diseases4 3%

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23Innovation

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 for a maximum of 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 70 Orphan Drugs have now received marketing authorization in the EU.

NumberMarketing Authorizations for Orphan Drugs in the European Union

Source: vfa

¹ Expected marketing authorizations (as of September 2011)

0

1996

3

1997

1

1998

1

1999

1

2000

3

2001

European Orphan DrugRegulation effectivefrom 2000 onward

4

2002

5

2003

6

2004

4

2005

9

2006

13

2007

6

2008

9

4

2009

2010 2011

3

4

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24 Innovation

In 2005, between USD 970 million and USD 1.6 billion was required for the research and development of a new drug with a new molecular 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, tolera-bility and quality during the marketing authorization process have increased steadily. A further reason for the high increase in costs lies in the growing complexity 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.

2001

Development Costs for a New Pharmaceuticalin USD million

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); “The current state of innovationin the pharmaceutical industry” (Report for the European Commission, June 2008)

800

1999

2005

1997

1993

1991

0 200 600400 800 1,000 1,200 1,400 1,600

610

970 to 1,600

802

429

359

231

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25Innovation

Research-based pharmaceutical companies in Germany again intensified and expanded their research and development (R&D) activities involving new pharmaceuticals in 2010. R&D expenditure amounted to around EUR 5.2 billion, which corresponds to over EUR 14 million a day. A slightly lower proportion of sales, 13.4 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. The research-based pharmaceutical companies make a disproportionately high contribution in the effort to meet the EU states’ declared goal of expending at least 3 percent of their gross national products on research and development. In Germany, this figure was 2.8 percent for 2009.

R&D Expenditures of vfa Member Companiesin EUR billion

From 2009: Only limited comparisons can be made with values from the previous year (statistical adjustment)2010: Provisional dataSource: vfa

2010 5.19

2009 5.23

2005 4.16

2000 3.08

1996 2.45

1.38

1.34

1.16

0.95

0.94

0 1 32 4 5

R&D expenditures

Share of humanresources costs

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26 Innovation

The research and development of new drugs is extremely cost and labour intensive. The research intensity of vfa member companies remained at a high level in 2010. A comparably higher share of sales, 13.4 percent, was invested in R&D activities than in the previous year. The proportion of R&D employees of all vfa company employees remained at 20 percent, which means one in five employees works in this area. The R&D intensity of vfa companies thus remains significantly higher overall than that of other companies conducting R&D in Germany, which achieve a sales rate of 4.4 percent and an employee rate of 9.3 percent.

13% vfa companies

Research Intensity: A Comparison

Share of R&D expenditures in sales in percent

Share of R&D employees in overall employees in percent

9% companies conducting R&D (total)

4% companies conducting R&D (total)

Source: Stifterverband für die deutsche Wissenschaft (2009), vfa (2010)

20% vfa companies

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27Innovation

The R&D expenditure of pharmaceutical companies in Europe, Japan and the USA increased to almost USD 90 billion in 2009. This corresponds to a growth of 62 percent since 2000 (disregarding exchange rate fluctuations). In 2008 and 2009, R&D expenditures in the USA declined for the first time. On account of this and currency losses, the US share, which was still almost 50 percent in 2000, has now decreased to 40 percent.

in USD billion Shares (2009)

41% USA

9% Germany

Japan 15%

R&D Expenditures in Europe, Japan and the USA

2009: Provisional dataSource: EFPIA, PhRMA, vfa

44.8

67.8

76.0

86.9

2000 2005 2006 2008

84.0

2007

86.4

2009

Europe excl. Germany 35%

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28 Innovation

10,384 patents were registered for pharmaceuticals in Germany in 2010. 1,228 applications (12 percent) were for genetically manufactured drugs. At the outset of the millennium, the proportion of these applications was 20 percent. Patent applications from the USA in particular have significantly decreased. Patent applications from Germany have also declined in absolute figures (2000: 183 applications, 2010: 112). The number of patent applications from Japan and countries such as Switzerland, Sweden and Canada has grown considerably.

Other 18%

France 5%

United Kingdom 6%

Germany 11%

Japan 5%

55% USA

Patent Applications for Genetically Manufactured Pharmaceuticals

Published patent applications effective in Germany, IPC main classification and sub-classification (A61K);For detailed data, see Appendix, page 64Source: German Patent Office

2000: 1,615 patents

2010: 1,228 patents

Other 32%

United Kingdom 4%France 5%

Germany 9% 14% Japan

36% USA

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29Innovation

The research and development of new drugs is extremely cost and labour intensive. The research-based pharmaceutical companies belong to the most research-intensive sectors of the economy.

2 64 8 10 140 12

As of 2009Source: Stifterverband, Federal Statistical Office, vfa

Expenditures for Research and Development in percent of sales

Research-based pharmaceutical companies

Data processing, electronic and optical products

13.4

9.9

Motor vehicle industry 5.2

Chemical Industry 3.0

Manufacturing industry (total)

2.9

Mechanical engineering 2.7

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31Economy

The Pharmaceutical Industry and the Health Care Sector

“Life expectancy in Germany rises 2 to 3 months each year – and innovative medications are no small reason why.”

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32 Health Care System

Thanks in part to new pharmaceuticals, average life expectancy in Germany has increased by four years for women and five years for men over the past 20 years. For example, several drugs specifically designed to target tumours 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 leukaemia 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 even treated at all.

Women

Men

Life Expectancy Trends in Germanyin years

Source: Federal Statistical Office

2007/09

2002/04

82.5

77.3

81.6

1997/99 80.6

1992/94 79.7

1987/89 78.9

75.9

74.4

73.4

72.4

60 65 7570 80 85

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33Health Care System

Of the 145 molecular entities that received marketing authorization in Germany for the first time over the last five years, 104 (72 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 20 years.

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

Increasing Therapeutic Benefit of Innovative Pharmaceuticals

Quelle: Source: Arzneimittelverordnungs-Report 2010, Fricke

44

53

64

72

1991–1995 1996–2000 2001–2005 2006–2010

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34 Health Care System

Active ingredients whose molecular structure resembles substances that have already been released often yield various therapeutic benefits. This is why many of these products are on the World Health Organization’s “essen-tial 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 2010 (p. 185) show that drugs with a novel active ingredient or therapeutic princi-ple cost on average EUR 7.16 per daily dose, while substances associated with improved pharmacological qualities of previously known therapeutic principles cost 31 percent less on average, thus offering a greater benefit at a lower price. Even less expensive are analogue preparations that closely resemble substances already on the market. They cost only around one-fifth of the amount for a drug with a novel active ingredient or therapeutic principle.

Improved Substances Save MoneyCosts per daily dose of patented products in the 2009 SHI market in EUR

Source: Arzneimittelverordnungs-Report 2010

Pharmaceuticals with novel activeingredients/therapeutic principles

Pharmaceuticals with improvedqualities of known therapeutic principles

7.16

4.94

Pharmaceuticals with smalldifferences to previously releasedactive ingredients

1.61

–31%

–78%

0 53 621 4 7 8

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35Health Care System

The global financial and economic crisis has left its mark on the national economy. A much higher share of gross domestic product was spent on health care in 2009 than in previous years. The reason was not an explosion of costs, but rather a decline in gross domestic product, which fell by around 5 percent in 2009. In reality, health care expenses have 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. With the economic rebound of 2010, the share of health care expenses has again declined.

Health Care Expenditures and National ProductShare of gross domestic product in percent

2010: provisional estimate; for detailed data, see Appendix, page 65Source: Federal Statistical Office, vfa

1992 1995 1998 2001 2004 2007 2010

2

0

4

6

8

10

12

Pharmaceuticalexpenditures

SHI serviceexpenditures

Health carespending in total

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36 Health Care System

In recent years, costs incurred in the pharmaceutical sector have not grown as steadily as overall health care costs.

10

Health Care Spending TrendsIncreased expenditures 2005 to 2009 in percent

Source: Federal Statistical Office

Early detection of diseases

Other medical needs

36.6

20.7

Office-based doctor’s care 18.5

Health care spendingin total

15.7

Pharmaceuticals 14.9

Overall health protection 3.3

Nursing care/therapeutic services

14.0

3020 400

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37Health Care System

In an international comparison, Germany – after the USA, Switzerland 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.

0 2 6 8 104 12 14 16

Health Care Spending in Europe, Japan and the USAas percent of GDP

2008: Japan, Switzerland estimated; United Kingdom: different methodologySource: OECD

USA

France

16.0

13.4

11.2

Switzerland 10.7

Germany 10.6

Italy 9.1

Japan 8.1

10.1

10.1

10.4

7.7

7.3

United Kingdom

8.7

6.7

Spain 9.0

7.3

18

2008

1998

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38 Health Care System

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.

Pharmaceutical Expenditures in Europe, Japan and the USAas percent of total health care expenditures

2008: Japan, Switzerland estimatedSource: OECD

Spain

Japan

20.5

21.0

20.1

Italy 18.4

France 16.4

Germany 15.1

18.9

21.5

15.5

13.6

Switzerland 10.3

10.4

USA 11.9

10.0

0 105 15 20

2008

1998

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39Health Care System

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 prod-uct (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 percent (1992) to 15.5 percent (as of 1/1/2011).

Employee wages as percent of GDP

SHI contribution rate in percent

1992 1995 1998 2001 2004 2007 2010

1992 1995 1998 2001 2004 2007 201048

12

11

13

14

15

50

52

54

56

The Financing of the Statutory Health Insurance System (SHI)

Since 1 July 2009 a standard contribution rate has applied; additional contributions not considered; for detailed data, see Appendix, page 66Source: Federal Statistical Office, BMG

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40 Health Care System

A third of SHI expenditures, EUR 58.8 billion of a total of EUR 180.7 billion, is spent on hospital treatment. Together, expenditures on care by doctors (EUR 33.0 billion; 18 percent) and pharmaceuticals (EUR 32.0 billion; 18 percent) make up another third, with EUR 9.5 billion (6 percent) spent on administrative costs. Just 4 percent of overall SHI expenditures (EUR 6.7 billion) went to the manu-facturers of patented pharmaceuticals.

321

in EUR billion (percent)

Changes over 2009 in percent

Expenditures in the Statutory Health Insurance System in 2010

Provisional data; data includes additional payments by patients; for detailed data, see Appendix, page 67Source: BMG

Total expenditures 2.9

Hospital care 4.5

Office-based doctor’s care 2.1

Pharmaceuticals 1.0

Remedies/medical devices 3.0

Administrative costs, etc. 4.2

Other services 2.4

54

Other services 19%

Remedies/medical devices 6%

Pharmaceuticals 18%

33% Hospital care

18% Office-based doctor’s care

Administrative costs, etc. 6%

0

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43Economy

The Pharmaceutical Market

“The share of biopharmaceuticals in the entire German pharmaceuticals market is already 17 percent.”

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44 Pharmaceutical Market

Global pharmaceutical sales have almost quadrupled since 1992. The USA, with around 36 percent, is still the world’s largest single market, followed by Europe and Japan. However, this “big three” share has decreased. The rest of the world combined accounts for around one quarter of sales, perhaps even a bit more considering the unreliability of certain data in many countries. The Latin American and Asian markets are developing most strongly. In 2010, growth in these countries was on average around 14 percent, while growth rates in established markets remained under 3 percent.

The Global Pharmaceutical Market

Sales at manufacturer prices in the pharmacy marketSource: IMS Health, vfa

in USD billion Shares (2010)

36% USA

Other 23%

Japan 12%

Europe 29%

365

788819

2000 2005 2008 2009 2010

605

856

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45Pharmaceutical Market

With a volume of around USD 35 billion in 2010, 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 2010, 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 around 70 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.

2001 2002 2003 2004 2005 2006 2007 2009 20102008

110

100

120

130

140

150

160

180

170USA

FranceGermany

Italy

United Kingdom

Spain

Japan

Development of the Largest Pharmaceutical Markets2001 = 100

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

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46 Pharmaceutical Market

Germany ranks in the middle of a European comparison of per-capita pharmaceutical sales.

Belgium

Denmark

Switzerland

744

702

Norway

France

Finland

Italy

609

Sweden 499

Germany

487

Netherlands

452

Spain

430

United Kingdom

396

Portugal 298

370

483

591

699

0 400200 600 800

Per Capita Sales of Pharmaceuticals2009 in USD

Sales figures in pharmacy consumer prices; Italy 2009 estimatedSource: OECD

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47Pharmaceutical Market

Germany ranks lower than other European countries in terms of innovation. In 2010, only 5.1 percent of expenditures in Germany was spent on inno-vations launched during the previous 5 years. This market share pales in comparison to shares in other European countries, which can be as high as 18 percent.

New Molecular Entities in GermanyMarket share of new molecular entities launched in the past five years in percent

Source: InsightHealth, vfa

7.4

6.5

5.6

6.5

2004 2005 2006 2007 2008 2009 2010

6.3

4.65.1

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48 Pharmaceutical Market

The number of pharmaceuticals is declining significantly. The ‘Rote Liste’ (Red List), a well known German drugs directory, currently lists 8,280 prod-ucts, 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 separately, 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.

Number of Pharmaceuticals in Germany

Source: Rote Liste

Shares (2011)

81% Chemically defined pharmaceuticals

4% OtherHomeopathics 7%

Pharmaceuticals from botanical sources 8%

Number

9,615

8,500

2000 2005 2010 2011

8,933

8,280

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49Pharmaceutical Market

In 2010, pharmaceutical companies provided drugs for human use worth EUR 25.6 billion (at manufacturer prices) via pharmacies for outpatient treatment. Adding wholesale and pharmacy mark-ups as well as sales tax gives a market volume of EUR 43.2 billion at retail prices.9 percent of this amount was for self-medication, 12 percent for private prescriptions outside of statutory health insurance and 79 percent for SHI prescriptions. These were financed through copayments by insured patients (5 percent), manufacturer and pharmacy discounts (11 percent) and by the health insurance funds themselves (84 percent).

Manufacturer sales(at manufacturer prices)

From Manufacturers to Patients: Distribution and Financing of Pharmaceuticalsin the 2010 Pharmacy Marketin EUR billion

Trade mark-ups

Sales tax

Pharmacy marketat retail pricesSelf-medicationwith OTC drugsPrivate prescriptions

SHI prescriptions

Insured patients’copayments

Manufacturer andtrade discountsExpenditures of thehealth insurance funds

25.6

10.7

6.9

4.0

5.3

1.7

3.7

33.9

28.5

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

Distribution

Financing

43.2

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50 Pharmaceutical Market

Sales in the German pharmacy market increased slightly in 2010, the same as in the previous year. After deducting legally mandated discounts and indi-vidual contractual rebates, net sales reached EUR 25.6 billion, 3.7 percent more than in the previous year. However, net sales were actually much lower due to these discounts. The discounts, about EUR 1.8 billion the previous year, rose to about 2.8 in 2010 and are expected to reach around EUR 3.8 billion in 2011. The number of packages sold reached a volume of 1.55 billion in 2010, a decrease of 3.0 percent compared with the previous year. While total sales of unrestricted over-the-counter drugs from pharmacies fell sharply (–4.2 percent), sales of prescription-only drugs declined by only 2.6 percent, with sales of unrestricted over-the-counter drugs maintaining the same sales rate as in the previous year.

Sales and Packages Sold through Pharmacies in 2010

Sales at pharmaceutical manufacturer prices (discounts not taken into account)Source: InsightHealth, vfa

Sales: EUR 25.6 billion (+3.7% over the previous year)

unrestricted over-the-counter drugs 6%

pharmacy-only drugs 11%

83% prescription drugs

Packages: 1.55 billion (–3.0% over the previous year)

unrestricted over-the-counter drugs 12%

pharmacy-only drugs 42%

46% prescription drugs

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51Pharmaceutical Market

The market share of pharmaceutical parallel imports in the pharmacy market, less than 1.8 percent in 1998, increased to 11.8 percent in 2010. This was due in large part to targeted government support. The introduction of a mini-mum 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 considerable loss of sales in the domestic market. Importers generated sales worth EUR 3.03 billion in 2009.

Parallel Imports

Sales at pharmaceutical manufacturer prices; for detailed data, see Appendix, page 68Sources: IMS Health, InsightHealth, vfa

2

–20

–40

0

60

40

20

4

6

8

12

10

2000 2001 2003 2005 2007 20092002 2004 2006 20102008

Market share in percent

Growth rates (in percent) Parallel imports Overall market

2000 2001 2003 2005 2007 20092002 2004 2006 20102008

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52 Pharmaceutical Market

In 2010, pharmaceuticals with genetically manufactured substances (bio-pharmaceuticals) generated sales of nearly EUR 5.2 billion (total sales in pharmacies and hospitals at manufacturer prices). The biopharmaceutical share of the entire pharmaceuticals market increased from 16 percent to 17 percent. After adjustment for mandatory discounts, sales of biopharma-ceuticals rose 8 percent compared to 2009, reaching EUR 4.9 billion. Certain biopharmaceutical subsectors far exceeded the 17 percent share of the entire pharmaceuticals market. Biopharmaceuticals for treating immunological disorders claimed a nearly three-quarters share (74 percent), while those for treating metabolic disorders (e.g. diabetes) and oncological diseases (e.g. breast and colon cancer, leukaemia) accounted for roughly one third (35 percent, 32 percent). Biopharmaceuticals for non-oncological haematology (haemophilia, anaemia) reached almost a one-quarter share (23 percent).

Sales of Genetically Manufactured Pharmaceuticals

¹ Total sales at pharmaceutical manufacturer prices² Excl. haematological oncology³ Incl. gastroenterology, dermatology, urology, etc.Source: IMS, BCG analysis

Share of biopharmaceuticals in the entire German pharmaceutical market (2010)

Share of biopharmaceuticals in the entire German pharmaceutical market (Sales 2010¹)

CNS

Metabolism

Infections

Oncology

Immunology

Other³

Hematology²

Chemical and otheractive ingredients 83%

17% Biopharmaceuticals

12%

35%

11%

32%

74%

23%

2%

0 20 40 60 80 100

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53Pharmaceutical Market

Gross sales of proprietary medical products in the SHI market (at pharmacy retail prices incl. VAT without rebate deductions) were worth EUR 31.9 billion in 2010.Value-added tax accounts for EUR 5 billion (16 percent) of this total (tax rate: 19 percent).The discounts that pharmaceutical manufacturers must grant to statutory health insurers were substantially increased as part of the 2010 amendment to the law governing health insurance. To this must be added rebates from contracts outlined in Section 130a par. 8 of Germany’s Social Security Code (SGB). The entire volume of manufacturer rebates reached EUR 2.8 billion in 2010.Government mandated pharmacy discounts amounted to an additional EUR 1 billion, although they were not yet legally binding in 2010.

Sales Distribution in the SHI Pharmaceutical Market in 2010

Sales at pharmacy retail pricesSources: InsightHealth, BMG, ABDA, vfa

11.6% Discounts and rebates

15.2% Pharmacies

3.5% Wholesale

16.0% Tax

Manufacturers 53.8%

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54 Pharmaceutical Market

Several tightenings of discount regulations have caused legally mandated manufacturer discounts to triple 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 2.7 billion (14 percent of gross sales at manufacturer prices).Net sales in 2010 were EUR 17.2 billion, a decline of 0.9 percent compared with the previous year.

Manufacturer Sales in the SHI Pharmaceutical Marketin EUR billion at manufacturer prices

Source: InsightHealth, vfa

2009 17.3

2008 16.8

2007 16.0

2006 15.4

2005 15.4

19.1

18.1

17.1

16.4

15.9

1.8

1.3

2010 17.2 19.92.7

1.1

1.0

0.5

Net sales

Manufacturer discount

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55Pharmaceutical Market

The very slight sales increase in the SHI market in 2010 was driven by opposing components, whose effect was partly to increase and partly to decrease sales. Consumption (increase in prescribed daily doses) and innovative pharmaceu-ticals have created an additional demand of around EUR 900 and EUR 480 million respectively. In contrast, “technical” savings, e.g. the selection of more cost-effective drugs, including those with active ingredients whose patents have expired, have resulted in total savings of EUR 430 million. Increased discounts led to a reduction of around EUR 800 million.As before, the dominant factors in the dynamics of the pharmaceutical market are medical and therapeutic needs, which have steadily declined in recent years.

–1,000 800600400 1,000200–800 –600 –400 –200

2010 Sales Growth: Driven by what Components?Changes in sales in EUR billion

Source: IGES

Overall

Consumption

+93

+899

Innovation +482

Technical savings

–433

Price –775

0

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56 Pharmaceutical Market

Expenditure increases were recorded mainly for the treatment of serious and chronic diseases, especially for rheumatic diseases, diabetes, chronic obstructive pulmonary disease and HIV.Expenditure decreases were recorded in disease categories where generic drugs could be prescribed more cost-effectively (medications to treat acid-related disorders) or where there has been a decrease in consumption (anti-biotics, erythropoietin with renal anaemia). In addition, there was a signifi-cant reduction in the demand for vaccines, especially for the flu (influenza).

Changes in 2010 Sales Based on Health DisordersChanges in sales in EUR million

¹ and other immune system disordersDisorders of more than +/– EUR 35 millionSource: IGES

+153

+56Non-insulin-dependent diabetes mellitus

+45

Parkinson’s disease

Tick-borne encephalitis (vaccine)

HIV (antiretrovirals)

–36

+46

+40

+35

–38

Acid-related disorders –136

Lipid reducers

Diabetes tests

Neuroleptic drugs, antipsychotics

Asthma, COPD

Renal anaemia (erythropoietin)

Rheumatoid arthritis ¹

Influenza (vaccine)

–42

–61

0 100–100–150 –50 50 150

+37

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57Pharmaceutical Market

Over the past three years, indirect price regulation based on reference prices has continued to expand significantly. In 2009 and 2010, 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 has declined first and fore-most due to reductions in reference prices.Since 2005, new categories of reference prices can also include patented active ingredients. This imposes newer and significant burdens, especially on research-based pharmaceutical manufacturers.Since 1 January 2011, 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 5.2 billion in 2011.

Reference Prices in the SHI MarketShares in percent

2010: January to OctoberSource: GKV, vfa

2000 64.6

46.5

0 20 40 8060

Prescriptions

Sales

2009

2008

75.2

41.2

74.8

43.6

75.2

2010 75.1

38.5

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58 Pharmaceutical Market

When patents expire, the imitation products of other manufacturers (generic drugs) can be authorized for marketing alongside the original pharmaceuti-cals. In Germany, 80 percent of SHI prescriptions, and almost half of total market sales at 45 percent, are generated in this so-called ‘generics-eligible market’.Over the past twelve years, Germany has evolved into the world’s most gener-ics-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 86.5 percent of prescriptions and around 78.4 percent of sales in the generics-eligible market were generated by imitation products in 2010.

50

1996 1998 2000 2002 2004 2006 2008 2010

55

45

60

65

70

75

80

85

90

Generic Drugs in the SHI MarketShares in the market eligible for generic drugs (in percent)

For detailed data, see Appendix, page 68Source: Arzneiverordnungs-Report 2010 (up to 2009); projections: vfa (2010)

Sales

Prescriptions

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Appendix

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62 Appendix

The Production of Pharmaceutical Products in Germany in EUR billion

Production of Change over previous Year pharmaceutical products year in percent

2010 26.981 2.3

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

2010: provisional dataSource: Federal Statistical Office, vfa

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63Appendix

Pharmaceutical Product Sales of Manufacturers in EUR billion

Export ratio Year Domestic sales Foreign sales Total in percent

2010 14.3 23.8 38.1 62.5

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

2010: provisional data; distinction according to technical company segmentsSource: Federal Statistical Office, vfa

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64 Appendix

Price Trends 2000 = 100

Year Private consumption SHI pharmaceuticals

2010 116.7 89.8

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 2008 2009 2010

USA 192 891 597 482 380 443

Germany 49 183 157 109 111 112

Japan 66 82 162 150 147 175

United Kingdom 29 90 78 52 42 43

France 25 84 81 78 64 65

Other 71 285 300 361 284 390

Total 432 1,615 1,375 1,232 1,028 1,228

Published patent applications effective in Germany, IPC main classification andsub-classification (A61K)Source: German Patent Office

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65Appendix

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

2010 11.47 6.61 1.83

2009 11.61 6.70 1.89

2008 10.66 6.09 1.74

2007 10.47 5.94 1.72

2006 10.60 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

2010: provisional estimateSource: Federal Statistical Office, vfa

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66 Appendix

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 %

2010 2,498.8 1,257.8 50.34 14.90

2009 2,397.1 1,225.9 51.14 15.20

2008 2,481.2 1,223.3 49.30 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% has applied since 1 July 2009Source: Federal Statistical Office, BMG

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67Appendix

Expenditures in the Statutory Health Insurance System in EUR billion

Area 2000 2005 2008 2009 2010

Total spending without RBFE 133.8 143.6 160.8 170.8 175.7

with additional payments by patients – – – 175.6 180.7

Total expenditures on health care services 125.9 134.8 151.1 160.6 165.1

with additional payments by patients – – – 175.6 180.7

data below includes additional payments in each case:

Hospital care – – – 56.3 58.8

Office-based doctors’ care – – – 32.4 33.0

Pharmaceuticals – – – 31.7 32.0

Remedies/medical devices – – – 10.8 11.1

Other services – – – 44.5 45.8

Administrative expenses, etc. 7.9 8.8 9.6 10.2 10.6

RBFE: risk-based fiscal equalization; data from 2009 includes additional payments by patients; 2010: provisional dataSource: BMG

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68 Appendix

Parallel Imports

Market share Overall market Parallel imports Year in percent growth rate in percent growth rate in percent

2010 11.8 3.7 12.2

2009 10.9 3.8 25.7

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

Source: Insight Health, vfa

Generic Drugs in the SHI Pharmaceutical Market Shares in the market eligible for generic drugs (in percent)

Year Prescriptions Sales

2010 86.5 78.4

2009 86.2 77.9

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 2010 (up to 2009), projections vfa (2010)

Page 71: The Pharmaceutical Industry in Germany - vfa · subject to economic fluctuations as much as other necessities. As a result, the pharmaceutical industry is one of those economic areas

3Economy

Imprint

Published byVerband Forschender Arzneimittelhersteller e.V.(German Association of Research-based Pharmaceutical Companies)Hausvogteiplatz 1310117 Berlin, Germany

DiagramsAdler & Schmidt Kommunikations-Design, Berlin

Photo creditsTitle Fotoliap. 4 Corbisp. 18 vfa/Martin Joppenp. 30 Fotoliap. 42 Getty Imagesp. 60 Fotolia

UpdatedDecember 2011

For additional vfa publications, please visit:www.vfa.de/publikationen

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