64
Statistics 2010 The Pharmaceutical Industry in Germany
Statistics2010The 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 Stable2010 – 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.
The Pharmaceutical Industry and the EconomyThe Innovative Fields of the Pharmaceutical Industry 5Production of Pharmaceutical Products in Germany 6Production in Europe, Japan and the USA 7Economic Stability 8Added Value 9Export Ratio of the Pharmaceutical Companies in Germany 10Employees of the vfa Member Companies 11Capital Spending 12Capital Spending of the vfa Member Companies 13Price Trends 14Price Changes: A Comparison 15Pharmaceutical Prices: A European Comparison 16Price Structure in Europe 17
The Pharmaceutical Industry and Innovation New Molecular Entities in Germany 2009 19New Molecular Entities and Their Applications 2009 20Pharmaceutical Projects by vfa Member Companies Promising Success by 2013 21Marketing Authorizations for Orphan Drugs in the European Union 22Development Costs for a New Pharmaceutical 23R&D Expenditures of the vfa Member Companies 24Research Intensity: A Comparison 25R&D Expenditures in Europe, Japan and the USA 26Patent Applications for Genetically Manufactured Pharmaceuticals 27
Contents
2
The Pharmaceutical Industry and the Health Care SectorLife Expectancy Trends in Germany 29Increasing Therapeutic Benefit of Innovative Pharmaceuticals 30Improved Substances Save Money 31Health Care Expenditures and National Product 32Health Care Spending Trends 33Health Care Spending Trends in Europe, Japan and the USA 34Pharmaceutical Expenditures in Europe, Japan and the USA 35The Financing of the Statutory Health Insurance System (SHI) 36Expenditures in the Statutory Health Insurance System 2009 37
The Pharmaceutical Market The Global Pharmaceutical Market 39Development of the Largest Pharmaceutical Markets 40Per-capita Sales of Pharmaceuticals 41New Molecular Entities in Germany 42Number of Pharmaceuticals in Germany 43From Manufacturers to Patients:Distribution and Financing of Pharmaceuticals in the 2009 Pharmacy Market 44Sales and Packages Sold Through Pharmacies in 2009 45Parallel Imports 46Sales of Genetically Manufactured Pharmaceuticals 47Sales Distribution in the SHI Pharmaceutical Market in 2009 48Manufacturer Sales in the SHI Pharmaceutical Market 492009 Sales Growth: Driven by what Components? 50Changes in 2009 Sales Based on Health Disorders 51Reference Prices in the SHI Market 52Generic Drugs in the SHI Pharmaceutical Market 53
Appendix
3
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.
The Innovative Fields of the Pharmaceutical Industry
0 20 40 60 80 100
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
Successful Innovators
Provisional data Source: ZEW
Only ongoing/discontinued innovation activities
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.
5Economy
2009: provisional data; for detailed data, see Appendix, page 55Source: Federal Statistical Office, vfa
1995 1997 1999 2001 2003 2005 2007 200916
–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
1995 1997 1999 2001 2003 2005 2007 2009
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.
6 Economy
Production in Europe, Japan and the USA
1990: EUR 136 billion
Japan, UK: 2007 Source: The OECD, EFPIA, Pharmaceutical associations of the European countries, and the vfa
Other 8%Switzerland 4%
United Kingdom 7%
Italy 8%
France 9%
Germany 9%23% Japan
32% USA
2008: EUR 358 billion
Other 14%
Switzerland 6%
Ireland 5%
United Kingdom 6%
Italy 6%
France 10%Germany 8% 11% Japan
34% USA
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.
7Economy
Economic StabilityIndex of orders received, adjusted seasonally, 2005 = 100
Source: Federal Statistical Office
1992 1994 1996 1998 2000 2002 2004 2006 2008 2010
60
70
80
90
100
110
120
130
Pharmaceutical productsChemical industry Manufacturing industry
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.
8 Economy
Added Value Net added value per employee in 2007 in EUR 1,000
Source: Federal Statistical Office
Pharmaceutical industry
Chemical industry¹
106.6
97.0
Electrical engineering² 68.3
Mechanical engineering 68.1
Manufacturing industry (total)
64.1
Construction 43.9
0 20 6040 80 100
¹ incl. pharmaceutical industry ² Office machinery, computing equipment, electrical engineering
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.
9Economy
60
50
40
30
20
10
0
Export Ratio of the Pharmaceutical Companies in GermanyForeign sales as a percent of total sales
2009: provisional data; for detailed data, see Appendix, page 56Source: Federal Statistical Office
2007 2009
30.5
35.4
43.245.5
47.950.0
47.449.7
54.2 53.356.0
57.860.8 61.4
1995 1997 1999 2001 2003 2005
31.9
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.
10 Economy
2009
2008
87.1
17.5
87.7
2007 95.1
2005 91.9
2000 78.4
1995 73.2
17.3
17.2
15.9
14.1
14.5
0 20 6040 80 100
Employees of the vfa Member CompaniesNumber in thousands
2009: provisional dataSource: vfa
Employees (total)
R&D employees
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.
11Economy
As of 2008 Source: Federal Statistical Office
¹ not incl. pharmaceutical industry ² Office machinery, computing equipment, electrical engineering
Capital Spending as a percent of sales
Pharmaceutical industry
Chemical industry¹
4.4
3.9
Mechanical engineering 3.6
Motor vehicle industry 3.5
Manufacturing industry (total)
3.4
Electrical engineering² 2.9
0 1 32 4
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.
12 Economy
2009 1.32
2008 1.35
2007 1.46
2005 1.27
2000 1.04
1996 0.89
0 0.5 1.51.0
Capital Spending of the vfa Member Companiesin EUR billion
2009: provisional dataSource: 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.
13Economy
Price Trends 2000 = 100
For detailed data, see Appendix, page 57Source: Federal Statistical Office, WIdO
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
85
90
95
100
105
110
115
120
SHI pharmaceuticals Private consumption (total)
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.
14 Economy
Price Changes: A ComparisonPrice increase from 2006 to 2009 in percent
Source: Federal Statistical Office, BMG, WIdO
SHI pharmaceuticals
Income subject to SHI contributions per SHI member
–2.7
+3.6
Retail sector +4.6
Private consumption (total)
+5.3
–6 –4 0–2 42 6
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.
15Economy
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 1st half of 2009; currency exchange rates from 2008Source: 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.
16 Economy
Pricing Structure in Europe
0 20 40 60 80 100
Shares in percent
Sweden
Portugal
Switzerland
France
Spain
Greece
Finland
Netherlands
Austria
Italy
Denmark
Germany
Ireland
Norway
Belgium
83
71
67
67
65
63
61
60
60
60
59
57
57
57
57
3
7
6
2
5
5
3
7
6
6
4
4
10
8
9
5
2
7
4
8
14
6
9
10
21
25
20
6
15
17
25
24
26
24
23
27
25
24
16
15
33
15
29
Manufacturers Wholesalers Pharmacies Taxes and discounts
Prescribed or reimbursed pharmaceuticals; Ireland: only oral dosage forms; as of 2007Sources: 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.
17Economy
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.
Market Launches of New Molecular Entities in Germany 2009Number (excluding biosimilars)
Source: Pharmazeutische Zeitung, vfa
282929
2009
14
2523
34
25
21
26
36
44
36
31
27 27
17
36
23
3028
1989 1991 1993 1995 1997 1999 2001 2003 2005 2007
37
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.
19Innovation
New Molecular Entities and their Applications 2009
Source: vfa
1 Contraception Respiratory diseases 1
Sexual disorders 1
Cardiovascular diseases 2
Nervous system disorders 2
6 Infections
Hematological disorders 4
7 Metabolic diseases
7 Cancer
Immune disorders 6
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.
20 Innovation
Source: vfa
Pharmaceutical Projects by vfa Member Companies Promising Success by 2013Distribution in various medical areas; overall number of projects: 442
¹ Each individual project accounts for 1% or less² Alzheimer’s disease, Parkinson’s disease³ Depression, schizophrenia, bipolar disorder, etc. 4 Rheumatoid arthritis, asthma, multiple sclerosis, Crohn’s disease, psoriasis, etc.
31% Cancer
Other medical areas¹ 10%
Chronic obstructive pulmonary disease 2%
Diabetes type 2 4%
Osteoporosis 1%
Psychiatric disorders³ 6%
Neurodegenerative diseases² 2%
Other nervous system disorders 4%
Inflammatory diseases4 10%14% Infectious diseases
13% Cardiovascular diseases
Pain 3%
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.
21Innovation
NumberMarketing Authorizations for Orphan Drugs in the European Union
0
1996
3
1997
1
1998
1
1999
1
2000
3
2001
European Orphan Drug Regulation effective from 2000 onward
4
2002
5
2003
6
2004
4
2005
9
2006
13
2007
6
2008
9
2009
Source: vfa
¹ expected marketing authorizations (as of July 2010)
8¹
2010
3
5
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.
22 Innovation
2001
Development Costs for a New Pharmaceutical in 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)
800
1999 610
1997 430
1993 360
1991 230
0 200 600400 800
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.
23Innovation
R&D Expenditures of vfa Member Companiesin EUR billion
2009: provisional dataSource: vfa
2009
2008
5.22
1.32
5.00
2007 4.53
2005 4.16
2000 3.08
1996 2.45
1.29
1.27
1.16
0.95
0.94
0 1 32 4 5
R&D expenditures
Share of human resources costs
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.
24 Innovation
14% 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
8% companies conducting R&D (total)
4% companies conducting R&D (total)
Source: Stifterverband für die deutsche Wissenschaft (2007), vfa (2009)
20% vfa companies
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).
25Innovation
in USD billion Shares (2008)
41% USA
8% Germany
Japan 14%
Europe excl. Germany 37%
R&D Expenditures in Europe, Japan and the USA
2008: provisional dataSource: EFPIA, PhRMA, vfa
44.8
67.8
76.0
87.1
2000 2005 2006 2008
84.2
2007
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.
26 Innovation
Other 18%
France 6%
United Kingdom 5%
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 57 Source: German Patent Office
2000: 1,615 patents
2009: 1,028 patents
Other 28%
United Kingdom 4%
France 6%
Germany 11% 14% Japan
37% USA
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.
27Innovation
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.
Women
Men
Life Expectancy Trends in Germany in years
Source: Federal Statistical Office
2006/08
2001/03
82.4
77.2
81.3
1996/98 80.3
1991/93 79.5
1986/88 78.7
75.6
74.0
73.1
72.2
60 65 7570 80 85
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.
29Health Care System
Share of new molecular entities rated as an innovative pharmaceutical or significant therapeutic improvement (in percent)
Increasing Therapeutic Benefit of Innovative Pharmaceuticals
Source: Arzneimittelverordnungs-Report 2009, Fricke
44
53
64
74
1991–1995 1996–2000 2001–2005 2006–2009
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.
30 Health Care System
Improved Substances Save MoneyCosts of patented products per daily dose in the 2008 SHI market in EUR
Source: Arzneimittelverordnungs-Report 2009
Pharmaceuticals with novel active ingredient/therapeutic principle
Pharmaceuticals with improved qualities of known therapeutic principles
7.25
4.24
Pharmaceuticals with small differences to previously released active ingredients
1.41
–42%
–81%
0 53 621 4 7 8
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.
31Health Care System
Health Care Expenditures and National Product Share of gross domestic product in percent
2009: provisional estimate; for detailed data, see Appendix, page 58 Source: Federal Statistical Office, vfa
1993 1995 1997 1999 2001 2003 2005 2007 2009
2
0
4
6
8
10
12
Pharmaceutical expenditures
SHI service expenditures
Health care spending in total
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.
32 Health Care System
Health Care Spending TrendsIncreased expenditures 1992 to 2008 in percent
Source: Federal Statistical Office
Office-based doctor’s care
Health care spending in total
59.6
66.7
Pharmaceuticals 70.1
Administration 72.9
Prevention/health protection
75.6
Other medical needs 90.3
Nursing care/therapeutic services
89.9
0 20 6040 10080
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.
33Health Care System
Health Care Spending in Europe, Japan and the USAas percent of GDP
2007: Japan, Switzerland estimated; United Kingdom: different methodologySource: OECD
USA
France
16.0 13.4
11.0
Switzerland 10.8
Germany 10.6
Italy 8.7
Japan 8.1
10.2
10.0
10.4
7.7
7.0
United Kingdom
8.4
6.6
Spain 8.5
7.3
0 3 96 12 15
2007
1997
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.
34 Health Care System
Pharmaceutical Expenditures in Europe, Japan and the USAas percent of total health care expenditures
2007: Japan, Switzerland estimatedSource: OECD
Spain
Japan
21.0
20.8
19.6
Italy 19.3
France 16.3
Germany 15.1
20.6
21.2
15.0
13.1
Switzerland 10.3
10.5
USA 12.0
9.5
0 105 15 20
2007
1997
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.
35Health Care System
Employee wages as percent of GDP
SHI contribution rate in percent
1993 1995 1997 1999 2001 2003 2005 2007 2009
1993 1995 1997 1999 2001 2003 2005 2007 200948
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 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.
36 Health Care System
42
in EUR billion (percent)
Changes over 2008 in percent
Expenditures in the Statutory Health Insurance System 2009
Provisional data; for detailed data, see Appendix, page 60 Source: BMG
Total service expenditures 6.3
Hospital care 6.4
Office-based doctor’s care 6.6
Pharmaceuticals 5.2
Remedies/medical devices 5.7
Administrative costs, etc. 5.8
Other services 1.1
0 6 8
Other services 21%
Remedies and medical devices 6%
Pharmaceuticals 18%
33% Hospital care
16% Office-based doctor’s care
Administrative costs etc. 6%
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.
37Health Care System
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.
The Global Pharmaceutical Market
Sales at manufacturer prices in the pharmacy market Source: IMS Health, vfa
in USD billion Shares (2009)
37% USA
Other 21%
Japan 11%
Europe 31%
365
781808
2000 2007 2008 2009
717
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.
39Pharmaceutical Market
2001 2002 2003 2004 2005 2006 2007 20092008
110
100
120
130
140
150
160
180
170
USA
France Germany
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
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.
40 Pharmaceutical Market
USA
Japan
687
556
Canada 426
Switzerland 370
France 349
Germany 337
Spain 301
Italy 214
United Kingdom
181
0 400200 600 800
Per Capita Sales of Pharmaceuticals2009 in USD (adjusted for purchasing power)
Sales in the pharmacy market at manufacturer prices; Switzerland 2008Source: 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.
41Pharmaceutical Market
New Molecular Entities in GermanyMarket share of new molecular entities launched in the past five years in percent
Source: InsightHealth, vfa
7.7
6.5
5.45.9
2004 2005 2006 2007 2008 2009
6.2
4.4
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.
42 Pharmaceutical Market
Number of Pharmaceuticals in Germany
Source: Rote Liste
Shares (2010)
80% Chemically defined pharmaceuticals
4% OtherHomeopathics 8%
Pharmaceuticals from botanical sources 8%
in USD billion
9,615
8,500
2000 2005 2010
8,933
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.
43Pharmaceutical Market
Manufacturer sales (at manufacturer prices)
From Manufacturers to Patients: Distribution and Financing of Pharmaceuticals in the 2009 Pharmacy Market in EUR billion
Trade mark-ups
Sales tax
Pharmacy market at retail pricesSelf-medication with OTC drugsPrivate prescriptions
SHI prescriptions
Insured patients’ copayments
Manufacturers’ and trade discounts Expenditures of the health insurance funds
24.7
10.8
6.7
4.0
5.2
1.6
2.9
42.2
33.1
28.6
Simplified representation of the most important cash and service flows (with approximate values)Source: vfa
Distribution
Financing
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).
44 Pharmaceutical Market
Sales and Packages Sold through Pharmacies in 2009
Sales at pharmaceutical manufacturer prices (discounts not taken into account)Source: InsightHealth, vfa
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%
pharmacy-only drugs 42%
46% prescription drugs
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).
45Pharmaceutical Market
Parallel Imports
Sales at pharmaceutical manufacturer prices; for detailed data, see Appendix, page 59Sources: IMS Health, InsightHealth, vfa
2
–20
–40
0
60
40
20
4
6
8
12
10
2000 2001 2002 2003 2004 2005 20072006 20092008
2000 2001 2002 2003 2004 2005 20072006 20092008
Market share in percent
Growth rates (in percent) Parallel imports Overall market
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.
46 Pharmaceutical Market
Sales of Genetically Manufactured Pharmaceuticals
¹ Total sales at pharmaceutical manufacturer prices ² Excl. hematological oncology ³ Incl. gastroenterology, dermatology, urology, etc.Source: IMS, BCG analysis
Share of biopharmaceuticals in the total German pharmaceutical market (2009)
Sales¹ of biopharmaceuticals in Germany in EUR million (2009)
Total sales
Metabolism 1,204
Immunology 1,124
Oncology 753
CNS 659
Hematology² 350
Other³ 221
Infections 362
Chemical and other active ingredients 84%
16% Biopharmaceuticals
4,673
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.
47Pharmaceutical Market
Sales Distribution in the SHI Pharmaceutical Market in 2009
Sales at pharmacy retail pricesSources: InsightHealth, BMG, vfa
Manufacturers 56.1%
9.2% Discounts and rebates
15.2% Pharmacies
3.5% Wholesale
16.0% Tax
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.
48 Pharmaceutical Market
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
1.1
1.0
0.5
Net sales
Manufacturer discount
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.
49Pharmaceutical Market
2009 Sales Growth: Driven by what Components?Changes in sales in EUR billion
Source: IGES
Overall
Consumption
+1.3
+1.1
Innovation +0.4
Technical Savings
–0.4
Price +0.2
0–0.5 1.0 1.50.5
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.
50 Pharmaceutical Market
Changes in 2009 Sales Based on Health DisordersChanges in sales in EUR million
¹ and other immune system disorders ² drugs affecting the renin-angiotensin system Disorders of more than +/– EUR 60 million Source: IGES
Rheumatoid Arthritis¹
Cardiovascular diseases²
+203
+154
+140
Asthma, COPD +121
Painkillers
Diabetes tests +62
+123
+105
+93
+62
Human papillomavirus (vaccine) –130
Tick-borne encephalitis (vaccine)
Neuroleptic drugs, antipsychotics
Multiple sclerosis
Cancer
HIV infections
Non-insulin-dependent diabetes mellitus
Acid-related disorders
–90
–97
0 100–100–150 –50 20050 150
+99
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.
51Pharmaceutical Market
Reference Prices in the SHI MarketShares in percent
2000: as of July 1st; 2007, 2008: annual averages; 2009: January to NovemberSource: SHI, vfa
2009
2008
75.2
41.3
74.8
2007 75.0
2000 64.6
43.6
47.1
46.5
0 20 40 8060
Prescriptions
Sales
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.
52 Pharmaceutical Market
1995 1997 1999 2001 2003 2005 2007 2009
50
55
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 60 Source: Arzneiverordnungs-Report 2009 (up to 2008); projections: vfa (2009)
Sales
Prescriptions
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.
53Pharmaceutical Market
Appendix
The Production of Pharmaceutical Products in Germany
Production of pharm. Change over previousYear 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 dataSource: Federal Statistical Office, vfa
55Appendix
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
56 Appendix
Price Trends2000 = 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
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
Source: Federal Statistical Office, WIdO
Published patent applications effective in Germany, IPC main classification and sub-classification (A61K) Source: German Patent Office
57Appendix
Health Care Expenditures and Gross National ProductShare of Gross Domestic Product in percent
Health care SHI service PharmaceuticalYear 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 estimateSource: Federal Statistical Office, vfa
58 Appendix
Gross domestic Employee Employee SHI contributionYear 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
Market share Overall market Parallel importsYear 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
The Financing of the Statutory Health Insurance System (SHI) in EUR billion
A standard contribution rate of 14.9 percent has applied since 1 July 2009Source: Federal Statistical Office, BMG
Parallel Imports
Sales at pharmaceutical company pricesSource: IMS Health, InsightHealth, vfa
59Appendix
Generic Drugs in the SHI Pharmaceutical MarketShares 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)
Expenditures in the Statutory Health Insurance Systemin 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 dataSource: BMG
60 Appendix
Imprint
Published byVerband Forschender Arzneimittelhersteller e.V.(German Association of Research-based Pharmaceutical Companies)Hausvogteiplatz 1310117 Berlin, Germany
DiagramsAdler & Schmidt Kommunikations-Design, Berlin
PrinterRuksaldruck
UpdatedJuly 2010
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