M&A in pharma
Explores the merits of mega-deal in contrast to a more measured portfolio growth strategy
European Generic Drug Markets
Growth to 2007
| Publication Date | November 2002 |
| ISBN | 095411213X |
| Pages | 110 |
| Tables | n/a |
| Figures | n/a |
PDF £250 $470 Single user |
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The generic drug sector in Europe is poised for significant market growth over the next 5 years. Already generics account for 50% of all prescriptions and this is forecast to reach 75% by 2007.
Cost-containment pressures on healthcare services and organisations will lead to increased adoption of generic substitution and prescribing practices in many EU Member States boosting volume and value for the industry. Other factors such as patent expiry of leading drugs and EU enlargement are intrinsic in the growth and expansion of the EU generics sector to 2007.
Countries such as Germany and the UK continue to dominate the European generics sector, but Southern Mediterranean countries such as Spain and Italy who have had low value and volume generic markets are forecast to increase rapidly mainly as a result of government cost-containment pressures. The Dutch and Scandinavian markets are also expected to show sustained growth in line with growth of total markets and positive disposition towards generics.
Contents
Marketing Brochure
View the marketing brochure (pdf)
Executive Summary
1. The European Generics Market
2. United Kingdom
3. Germany
4. France
5. The Netherlands
6. Belgium
7. Scandinavia (Denmark, Norway, Sweden)
8. Spain
9. Other European Generics Markets
10. Future Market Trends And Opportunities
11. Generics In Central And Eastern Europe
12. Strategies For Research-Based Companies And Generics Manufacturers
Bibliography
Glossary Of Abbreviations And Acronyms
LIST OF TABLES
LIST OF FIGURES
Marketing Brochure
View the marketing brochure (pdf)
Executive Summary
1. The European Generics Market
Summary - the European market for generic drugs
Introduction to the European generics industry
Government cost-containment and the evolution of the EU generics sector
Generic substitution
Barriers to the generics industry
Factors stimulating growth in the European generics market
Measures needed to stimulate generic medicines
The generics market in Europe
Generic therapeutic categories
Future generic blockbusters
Generic market territories
Regulatory issues ? ten-year rule, MRP, bioequivalence
Ten-year rule
The Mutual Recognition Procedure (MRP)
Bioequivalence
Eurogenerics
Recent regulatory issues
Roche-Bolar ? the European perspective
Bolar provisions outside the EU
Proposed changes to expedite the Mutual Recognition Procedure
Recommendations from the generics industry
Data Exclusivity versus Bolar provision: a fair trade off?
Recent European Commission proposals on data exclusivity include:
Recent generics regulatory legislation in the US
Intellectual property, patents and Supplementary Protection Certificates
Intellectual property
Patents
Recent patent litigation ? the case of AstraZeneca?s Losec (Omeprazole)
Schering-Plough ? Claritin(loratadine) franchise
Supplementary Protection Certificates (SPCs)
EU enlargement
Multinationals and generics subsidiaries
Pricing and patents develop an active generic market
Pricing
Expansion in the generics industry
Impact of patent expiries of the generics market
Parallel trade in generics
Introduction to the European generics industry
Government cost-containment and the evolution of the EU generics sector
Generic substitution
Barriers to the generics industry
Factors stimulating growth in the European generics market
Measures needed to stimulate generic medicines
The generics market in Europe
Generic therapeutic categories
Future generic blockbusters
Generic market territories
Regulatory issues ? ten-year rule, MRP, bioequivalence
Ten-year rule
The Mutual Recognition Procedure (MRP)
Bioequivalence
Eurogenerics
Recent regulatory issues
Roche-Bolar ? the European perspective
Bolar provisions outside the EU
Proposed changes to expedite the Mutual Recognition Procedure
Recommendations from the generics industry
Data Exclusivity versus Bolar provision: a fair trade off?
Recent European Commission proposals on data exclusivity include:
Recent generics regulatory legislation in the US
Intellectual property, patents and Supplementary Protection Certificates
Intellectual property
Patents
Recent patent litigation ? the case of AstraZeneca?s Losec (Omeprazole)
Schering-Plough ? Claritin(loratadine) franchise
Supplementary Protection Certificates (SPCs)
EU enlargement
Multinationals and generics subsidiaries
Pricing and patents develop an active generic market
Pricing
Expansion in the generics industry
Impact of patent expiries of the generics market
Parallel trade in generics
2. United Kingdom
The UK generics market
Strengths of UK generics sector
Generic prescribing trends in the UK
Generic pricing issues
Recent Pricing issues
The UK Government perspective ? setting maximum generic prices
Unfounded generic price increases in the UK - A case of serious fraud?
Leading UK generics companies
Major players
Norton/IVAX
APS-Berk
Cox Pharmaceuticals
Impact of parallel trade
Impact of patent expiries
Distribution methods
Direct pharmacy sales
Wholesale distribution
Short line wholesalers
Regulatory environment
Intellectual property and patent law
Strengths of UK generics sector
Generic prescribing trends in the UK
Generic pricing issues
Recent Pricing issues
The UK Government perspective ? setting maximum generic prices
Unfounded generic price increases in the UK - A case of serious fraud?
Leading UK generics companies
Major players
Norton/IVAX
APS-Berk
Cox Pharmaceuticals
Impact of parallel trade
Impact of patent expiries
Distribution methods
Direct pharmacy sales
Wholesale distribution
Short line wholesalers
Regulatory environment
Intellectual property and patent law
3. Germany
Cost-containment measures
Penalties for doctors
Prescribing trends
Generic prescribing
Therapeutic focus
Pricing in Germany
Reference pricing
Generic pricing ? effects of competition
Impact of patent expiries
Factors affecting pricing of generics in the future
Changes to the reference pricing system
Positive list
Physician prescribing budget
Increased contributions to Statutory Health Insurers
Distribution
Impact of parallel trade
Regulatory environment
Intellectual property and patent law
Leading generics players in Germany
Ratiopharm
Hexal
Stada
Penalties for doctors
Prescribing trends
Generic prescribing
Therapeutic focus
Pricing in Germany
Reference pricing
Generic pricing ? effects of competition
Impact of patent expiries
Factors affecting pricing of generics in the future
Changes to the reference pricing system
Positive list
Physician prescribing budget
Increased contributions to Statutory Health Insurers
Distribution
Impact of parallel trade
Regulatory environment
Intellectual property and patent law
Leading generics players in Germany
Ratiopharm
Hexal
Stada
4. France
The French generics market
Generic substitution
The R?pertoire
Pharmacists and generic substitution
Encouraging generic use among doctors
Consumer barriers to substitution
Recent market trends
The French pricing system
Distribution
Regulatory environment
Intellectual property
Impact of parallel trade
Generics companies in France
The market leader
Merck G?n?riques
Generic substitution
The R?pertoire
Pharmacists and generic substitution
Encouraging generic use among doctors
Consumer barriers to substitution
Recent market trends
The French pricing system
Distribution
Regulatory environment
Intellectual property
Impact of parallel trade
Generics companies in France
The market leader
Merck G?n?riques
5. The Netherlands
The Dutch generics market
Generic prescribing trends
Leading generic companies in The Netherlands
Pricing system
Patent expiry
Regulatory environment
Intellectual property
Impact of parallel trade
Generic prescribing trends
Leading generic companies in The Netherlands
Pricing system
Patent expiry
Regulatory environment
Intellectual property
Impact of parallel trade
6. Belgium
The Belgian generics market
Leading generics companies in Belgium
Pricing system
Distribution
Regulatory environment
Intellectual property
Impact of parallel trade
Leading generics companies in Belgium
Pricing system
Distribution
Regulatory environment
Intellectual property
Impact of parallel trade
7. Scandinavia (Denmark, Norway, Sweden)
The Scandinavian generic drugs market
Denmark
Pricing in Denmark
Denmark and the Euro
Parallel trade in Denmark
Finland
Norway
Pricing in Norway
Parallel trade in Norway
Sweden
Pricing in Sweden
Reference pricing
Parallel trade in Sweden
Denmark
Pricing in Denmark
Denmark and the Euro
Parallel trade in Denmark
Finland
Norway
Pricing in Norway
Parallel trade in Norway
Sweden
Pricing in Sweden
Reference pricing
Parallel trade in Sweden
8. Spain
The Spanish generics market
Pricing in Spain
The pricing system in Spain
Government cost-containment pressure
Measures to encourage doctors
Measures to encourage pharmacists through generic substitution
Impact of patent expiries
Distribution
Regulatory environment
Intellectual property
Impact of parallel trade
Generic companies in Spain
Pricing in Spain
The pricing system in Spain
Government cost-containment pressure
Measures to encourage doctors
Measures to encourage pharmacists through generic substitution
Impact of patent expiries
Distribution
Regulatory environment
Intellectual property
Impact of parallel trade
Generic companies in Spain
9. Other European Generics Markets
Austria
Greece
Italy
Parallel export trade in Italy
Portugal
Greece
Italy
Parallel export trade in Italy
Portugal
10. Future Market Trends And Opportunities
Factors facilitating generic growth to 2007
Individual countries
Future generic opportunities
Patent expiry
Parallel trade in generics
Biogenerics
Recent EU registration and regulation issues
Individual countries
Future generic opportunities
Patent expiry
Parallel trade in generics
Biogenerics
Recent EU registration and regulation issues
11. Generics In Central And Eastern Europe
EU Enlargement
Hungary
Poland
Former Yugoslavia
Iceland
Turkey
Hungary
Poland
Former Yugoslavia
Iceland
Turkey
12. Strategies For Research-Based Companies And Generics Manufacturers
Strategies for research-based companies
Litigation
Reformulation
New isomeric forms
Changing the manufacturing process
Releasing your own generic
Strategies for generics manufacturers
Exploiting patent rights
Intellectual property protection
R&D
Protecting the manufacturing process
Recognising and evaluating the rights protecting a commercial product
Opposition to the Bolar exemption
Litigation
Reformulation
New isomeric forms
Changing the manufacturing process
Releasing your own generic
Strategies for generics manufacturers
Exploiting patent rights
Intellectual property protection
R&D
Protecting the manufacturing process
Recognising and evaluating the rights protecting a commercial product
Opposition to the Bolar exemption
Bibliography
Glossary Of Abbreviations And Acronyms
LIST OF TABLES
Table 1.1 Measures employed by governments and healthcare systems to save on pharmaceutical spending.
Table 1.2 Barriers to the generics drugs industry
Table 1.3 Key drivers of growth in the European generics sector
Table 1.4 Measures needed to stimulate the use of generic medicines
Table 1.5 Major western European generic pharmaceutical markets, 2001-2007
Table 1.6 EC data exclusivity times as at mid-2000
Table 1.7 EGA position in response to research-based industry?s claims on patent protection and data exclusivity
Table 1.8 Comparative prices of a basket of pharmaceuticals
Table 1.9 Price differentials between brand names and generics in Europe
Table 1.10 Patent expiries of leading drugs in Europe to 2004
Table1.11 Leading patented drugs, patent expiry dates and sales revenue, 2000-2005
Table 2.1 Estimations of UK generics market by value, 2001-2007
Table 2.2 UK rates of generic prescribing, 1987-2001
Table 2.3 Generic prescribing and dispensing rates in the UK, 2000-2001
Table 3.1 Estimates of Germany?s generic market by value, 2001-2007
Table 3.2 German Sick Fund Drug Spending Trends, 1994-1999
Table 3.3 German prescribing rates for generically available substances (1998)
Table 3.4 A basket of drug prices in Germany, 1999-2000
Table 4.1 Estimates of the generic market in France by value, 2001-2007
Table 4.2 European average prices in 2000
Table 4.3 Leading generic molecules listed in August 2000 R?pertoire
Table 4.4 Increase use of branded generics and decline of brands, 1998-2000
Table 4.5 European per capita drug consumption (1997)
Table 4.6 Revenue for leading French generic companies in 2001
Table 5.1 Estimates of the generic market in The Netherlands by value, 2001-2007
Table 5.2 Dutch generic prescribing rates 1998
Table 5.3 Leading Dutch generic firms, 1999
Table 6.1 Estimated generics market in Belgium, 2001-2007
Table 7.1 The Danish generics market, 2001-2007
Table 7.2 The Finnish generics market, 2001-2007
Table 7.3 The Norwegian generics market, 2001-2007
Table 7.4 The Swedish generics market, 2001-2007
Figure 7.1 Total generics market for Scandinavia, 2001-2007, US$bn
Table 8.1 Spanish generic market estimations, 2001-2007
Table 8.2 European average prices, 2000
Table 8.3 Average price per prescription in Spain, 1997-2000
Table 8.4 Cost-containment measures introduced at government level in Spain since 1997
Table 8.5 Examples of Spanish generic companies
Table 9.1 The generics market in Austria, 2001-2007
Table 9.2 The generics market in Greece, 2001-2007
Table 9.3 The generics market in Italy, 2001-2007
Table 9.4 The generic companies in Italy
Table 10.1 Growth of the generic market in various European countries
Table 10.2 Major European patent expiries, 2000 to 2010
Table 10.3 Biopharmaceuticals expected to come off patent by 2007
Table 10.4 Main EGA objections to EC proposals on improving the registration system for generics
Table 12.1 R&D companies and their subsidiaries involved with generics
Table 1.2 Barriers to the generics drugs industry
Table 1.3 Key drivers of growth in the European generics sector
Table 1.4 Measures needed to stimulate the use of generic medicines
Table 1.5 Major western European generic pharmaceutical markets, 2001-2007
Table 1.6 EC data exclusivity times as at mid-2000
Table 1.7 EGA position in response to research-based industry?s claims on patent protection and data exclusivity
Table 1.8 Comparative prices of a basket of pharmaceuticals
Table 1.9 Price differentials between brand names and generics in Europe
Table 1.10 Patent expiries of leading drugs in Europe to 2004
Table1.11 Leading patented drugs, patent expiry dates and sales revenue, 2000-2005
Table 2.1 Estimations of UK generics market by value, 2001-2007
Table 2.2 UK rates of generic prescribing, 1987-2001
Table 2.3 Generic prescribing and dispensing rates in the UK, 2000-2001
Table 3.1 Estimates of Germany?s generic market by value, 2001-2007
Table 3.2 German Sick Fund Drug Spending Trends, 1994-1999
Table 3.3 German prescribing rates for generically available substances (1998)
Table 3.4 A basket of drug prices in Germany, 1999-2000
Table 4.1 Estimates of the generic market in France by value, 2001-2007
Table 4.2 European average prices in 2000
Table 4.3 Leading generic molecules listed in August 2000 R?pertoire
Table 4.4 Increase use of branded generics and decline of brands, 1998-2000
Table 4.5 European per capita drug consumption (1997)
Table 4.6 Revenue for leading French generic companies in 2001
Table 5.1 Estimates of the generic market in The Netherlands by value, 2001-2007
Table 5.2 Dutch generic prescribing rates 1998
Table 5.3 Leading Dutch generic firms, 1999
Table 6.1 Estimated generics market in Belgium, 2001-2007
Table 7.1 The Danish generics market, 2001-2007
Table 7.2 The Finnish generics market, 2001-2007
Table 7.3 The Norwegian generics market, 2001-2007
Table 7.4 The Swedish generics market, 2001-2007
Figure 7.1 Total generics market for Scandinavia, 2001-2007, US$bn
Table 8.1 Spanish generic market estimations, 2001-2007
Table 8.2 European average prices, 2000
Table 8.3 Average price per prescription in Spain, 1997-2000
Table 8.4 Cost-containment measures introduced at government level in Spain since 1997
Table 8.5 Examples of Spanish generic companies
Table 9.1 The generics market in Austria, 2001-2007
Table 9.2 The generics market in Greece, 2001-2007
Table 9.3 The generics market in Italy, 2001-2007
Table 9.4 The generic companies in Italy
Table 10.1 Growth of the generic market in various European countries
Table 10.2 Major European patent expiries, 2000 to 2010
Table 10.3 Biopharmaceuticals expected to come off patent by 2007
Table 10.4 Main EGA objections to EC proposals on improving the registration system for generics
Table 12.1 R&D companies and their subsidiaries involved with generics
LIST OF FIGURES
Figure 1.1 Benefits of generic drugs
Figure 1.2 Key national factors stimulating generics growth in Europe
Figure 1.3 Penetration of generics in the EU by value and volume, 2001
Figure 1.4 Estimated market share by value of the European generics industry, 2002
Figure 1.5 Convergence of Eastern and Western generics manufacturers during EU enlargement
Figure 1.6 Prices of a basket of products at pharmacy level
Figure 2.1 Estimated market share by volume of leading UK generics companies, 2002
Figure 3.1 Leading German generics companies, 1999 (based on value DM million)
Figure 3.2 Top 10 generics companies by sales value, 1999
Figure 4.1 Market share of French generic companies by value, 2001
Figure 5.1 Estimated market share of leading generics firms in The Netherlands, 2000
Figure 1.2 Key national factors stimulating generics growth in Europe
Figure 1.3 Penetration of generics in the EU by value and volume, 2001
Figure 1.4 Estimated market share by value of the European generics industry, 2002
Figure 1.5 Convergence of Eastern and Western generics manufacturers during EU enlargement
Figure 1.6 Prices of a basket of products at pharmacy level
Figure 2.1 Estimated market share by volume of leading UK generics companies, 2002
Figure 3.1 Leading German generics companies, 1999 (based on value DM million)
Figure 3.2 Top 10 generics companies by sales value, 1999
Figure 4.1 Market share of French generic companies by value, 2001
Figure 5.1 Estimated market share of leading generics firms in The Netherlands, 2000