Scrip's Complete Guide to the World Generic Drugs Market

Scrip's Complete Guide to the World Generic Drugs Market

Essential for understanding today's complex generic drugs market

R&D-based companies actually stand to lose more through generic market penetration than generic companies stand to gain. In order to compete in this market and maximise commercial potential of their respective products, it is important that both sides are fully informed about current developments and their effects.

An authoritative, comprehensive analysis - presented in two volumes

Scrip's Complete Guide to the World Generic Drugs Market will enable you to:

Gain an in-depth view of the global generics market
Identify current trends and analyse exactly how these affect your business
Assess which market forces influence generic product penetration
Ensure you fully maximise the commercial potential of your product
Create your own life-cycle management strategies based on informed analysis and up-to-date market data

Volume One - Generic Companies, Products and Markets presents a comprehensive evaluation of the generics market in 32 countries affected by the trade. It includes a market overview, assessing generic products by therapeutic category and providing data on product opportunities up to 2002. There are also detailed profiles of over 30 generics producers.

Volume Two - Successful Business Strategies for R&D-based and Generic Companies provides you with information on global healthcare trends, the global intellectual property environment, GATT/TRIPs, the exhaustion of IP rights, the impact of parallel trade and the role of special interest groups.

The case studies and analysis presented in this volume will help you to understand where opportunities arise in your business process and what action can be taken to enhance the commercial potential of your products.

Price: Both Volumes: £995/$1,995/¥239,000
Ref: BS985E
Published: February 1999
Pages: 400 (both volumes)
For more information, single volume prices and to order, please contact the Scrip Reports Customer Helpdesk on Tel: +44 181 332 8965/66 or Fax: +44 181 332 8992

CONTENTS
LIST OF TABLES AND FIGURES
LIST OF FIGURES
EXECUTIVE SUMMARY
GLOSSARY AND ABBREVIATIONS

CHAPTER 1 MARKET OVERVIEW
1.1 The global pharmaceutical marketplace
1.2 The generics market
1.3 Industry drivers
1.4 Generics industry trends
1.5 Major generics markets
1.6 Market trends and developments
1.7 Future prospects

CHAPTER 2 GENERIC PRODUCTS
2.1 Therapeutic categories
2.2 Leading generic products
2.3 Future opportunities

CHAPTER 3 NORTH AMERICAN GENERICS MARKETS
3.1 Canada
3.1.1 Provision of healthcare
3.1.2 Government policy
3.1.3 Generic prescribing practice
3.1.4 Pricing and reimbursement
3.1.5 Regulation
3.1.6 The pharmaceutical market
3.1.7 Generics market size
3.1.8 Generic companies
3.1.9 Therapeutic categories
3.1.10 Industry associations
3.1.11 Regional business news
3.1.12 Future prospects
3.2 The United States
3.2.1 Provision of healthcare
3.2.2 Government policy
3.2.3 Generic prescribing practice
3.2.4 Pricing and reimbursement
3.2.5 Regulation
3.2.6 The pharmaceutical market
3.2.7 Generics market size
3.2.8 Generic companies
3.2.9 Therapeutic categories
3.2.10 Industry associations
3.2.11 Regional business news
3.2.12 Future prospects

CHAPTER 4 WESTERN EUROPEAN GENERICS MARKETS
4.1 The European Union registration system
4.1.1 Centralised procedure
4.1.2 Mutual recognition
4.2 Austria
4.2.1 Provision of healthcare
4.2.2 Government policy
4.2.3 Generic prescribing practice
4.2.4 Pricing and reimbursement
4.2.5 Regulation
4.2.6 The pharmaceutical market
4.2.7 Generics market size
4.2.8 Therapeutic categories
4.2.9 Generic companies
4.2.10 Industry associations
4.2.11 Future prospects
4.3 Belgium
4.3.1 Provision of healthcare
4.3.2 Government policy
4.3.3 Generic prescribing practice
4.3.4 Pricing and reimbursement
4.3.5 Regulation
4.3.6 The pharmaceutical market
4.3.7 Generics market size
4.3.8 Generic companies
4.3.9 Industry associations
4.3.10 Regional business news
4.3.11 Future prospects
4.4 Denmark
4.4.1 Provision of healthcare
4.4.2 Government policy
4.4.3 Generic prescribing practice
4.4.4 Pricing and reimbursement
4.4.5 Regulation
4.4.6 The pharmaceutical market
4.4.7 Generics market size
4.4.8 Therapeutic categories
4.4.9 Generic companies
4.4.10 Industry associations
4.4.11 Regional business news
4.4.12 Future prospects
4.5 France
4.5.1 Provision of healthcare
4.5.2 Government policy
4.5.3 Generic prescribing practice
4.5.4 Pricing and reimbursement
4.5.5 Regulation
4.5.6 The pharmaceutical market
4.5.7 Generics market size
4.5.8 Therapeutic categories
4.5.9 Generic companies
4.5.10 Industry associations
4.5.11 Regional business news
4.5.12 Future prospects
4.6 Germany
4.6.1 Provision of healthcare
4.6.2 Government policy
4.6.3 Generic prescribing practice
4.6.4 Pricing and reimbursement
4.6.5 Regulation
4.6.6 The pharmaceutical market
4.6.7 Generics market size
4.6.8 Therapeutic categories
4.6.9 Generic companies
4.6.10 Industry associations
4.6.11 Regional business news
4.6.12 Future prospects
4.7 Greece
4.7.1 Provision of healthcare
4.7.2 Government policy
4.7.3 Pricing and reimbursement
4.7.4 Regulation
4.7.5 The pharmaceutical market
4.7.6 Generic companies
4.7.7 Industry associations
4.7.8 Future prospects
4.8 Italy
4.8.1 Provision of healthcare
4.8.2 Government policy
4.8.3 Generic prescribing practice
4.8.4 Pricing and reimbursement
4.8.5 Regulation
4.8.6 The pharmaceutical market
4.8.7 Generics market size
4.8.8 Therapeutic categories
4.8.9 Generic companies
4.8.10 Industry associations
4.8.11 Regional business news
4.8.12 Future prospects
4.9 The Netherlands
4.9.1 Provision of healthcare
4.9.2 Government policy
4.9.3 Generic prescribing practice
4.9.4 Pricing and reimbursement
4.9.5 Regulation
4.9.6 The pharmaceutical market
4.9.7 Generics market size
4.9.8 Generic companies
4.9.9 Industry associations
4.9.10 Regional business news
4.9.11 Future prospects
4.10 Portugal
4.10.1 Provision of healthcare
4.10.2 Government policy
4.10.3 Generic prescribing practice
4.10.4 Pricing and reimbursement
4.10.5 Regulation
4.10.6 The pharmaceutical market
4.10.7 Generics market size
4.10.8 Therapeutic categories
4.10.9 Generic companies
4.10.10 Industry associations
4.10.11 Future prospects
4.11 Spain
4.11.1 Provision of healthcare
4.11.2 Government policy
4.11.3 Generic prescribing practice
4.11.4 Pricing and reimbursement
4.11.5 Regulation
4.11.6 The pharmaceutical market
4.11.7 Generics market size
4.11.8 Therapeutic categories
4.11.9 Generic companies
4.11.10 Industry associations
4.11.11 Future prospects
4.12 Sweden
4.12.1 Provision of healthcare
4.12.2 Government policy
4.12.3 Generic prescribing practice
4.12.4 Pricing and reimbursement
4.12.5 Regulation
4.12.6 The pharmaceutical market
4.12.7 Generics market size
4.12.8 Therapeutic categories
4.12.9 Generic companies
4.12.10 Industry associations
4.12.11 Future prospects
4.13 Switzerland
4.13.1 Provision of healthcare
4.13.2 Government policy
4.13.3 Pricing and reimbursement
4.13.4 Regulation
4.13.5 The pharmaceutical market
4.13.6 Generics market size
4.13.7 Generic companies
4.13.8 Therapeutic categories
4.13.9 Industry associations
4.13.10 Regional news
4.13.10 Future prospects
4.14 United Kingdom
4.14.1 Provision of healthcare
4.14.2 Government policy
4.14.3 Generic prescribing practice
4.14.4 Pricing and reimbursement
4.14.5 Regulation
4.14.6 The pharmaceutical market
4.14.7 Generics market size
4.14.8 Therapeutic categories
4.14.9 Generic companies
4.14.10 Regional business news
4.14.11 Industry associations
4.14.12 Future prospects

CHAPTER 5 CENTRAL AND EASTERN EUROPEAN GENERICS MARKETS
5.1 Baltic States
5.1.1 Provision of healthcare
5.1.2 Pricing and reimbursement
5.1.3 Regulation
5.1.4 The pharmaceutical market
5.1.5 Generics market size
5.1.6 Generic companies
5.1.7 Regional business news
5.1.8 Future prospects
5.2 Czech Republic
5.2.1 Provision of healthcare
5.2.2 Government policy
5.2.3 Generic prescribing practice
5.2.4 Pricing and reimbursement
5.2.5 Regulation
5.2.6 The pharmaceutical market
5.2.7 Generics market size
5.2.8 Generic companies
5.2.9 Industry associations
5.2.10 Future prospects
5.3 Hungary
5.3.1 Provision of healthcare
5.3.2 Government policy
5.3.3 Generic prescribing practice
5.3.4 Pricing and reimbursement
5.3.5 Regulation
5.3.6 The pharmaceutical market
5.3.7 Generics market size
5.3.8 Generic companies
5.3.9 Industry associations
5.3.10 Future prospects
5.4 Poland
5.4.1 Provision of healthcare
5.4.2 Government policy
5.4.3 Generic prescribing practice
5.4.4 Pricing and reimbursement
5.4.5 Regulation
5.4.6 The pharmaceutical market
5.4.7 Generics market size
5.4.8 Generic companies
5.4.10 Industry associations
5.4.11 Future prospects
5.5 Russia
5.5.1 Provision of healthcare
5.5.2 Government policy
5.5.3 Generic prescribing practice
5.5.4 Pricing and reimbursement
5.5.5 Regulation
5.5.6 The pharmaceutical market
5.5.7 Generics market size
5.5.8 Generic companies
5.5.9 Industry associations
5.5.10 Regional business news
5.5.11 Future prospects

CHAPTER 6 ASIAN GENERICS MARKETS
6.1 China
6.1.1 Provision of healthcare
6.1.2 Government policy
6.1.3 Generic prescribing practice
6.1.4 Pricing and reimbursement
6.1.5 Regulation
6.1.6 The pharmaceutical market
6.1.7 Therapeutic categories
6.1.8 Generic companies
6.1.9 Industry associations
6.1.10 Future prospects
6.2 India
6.2.1 Provision of healthcare
6.2.2 Government policy
6.2.3 Generic prescribing practice
6.2.4 Pricing and reimbursement
6.2.5 Regulation
6.2.6 The pharmaceutical market
6.2.7 Generics market size
6.2.8 Therapeutic categories
6.2.9 Generic companies
6.2.10 Industry associations
6.2.11 Future prospects
6.3 Indonesia
6.3.1 Provision of healthcare
6.3.2 Government policy
6.3.3 Generic prescribing practice
6.3.4 Pricing and reimbursement
6.3.5 Regulation
6.3.6 The pharmaceutical market
6.3.7 Generics market size
6.3.8 Generic companies
6.3.9 Industry associations
6.3.10 Future prospects
6.4 Japan
6.4.1 Provision of healthcare
6.4.2 Government policy
6.4.3 Generic prescribing practice
6.4.4 Pricing and reimbursement
6.4.5 Regulation
6.4.6 The pharmaceutical market
6.4.7 Generics market size
6.4.8 Therapeutic categories
6.4.9 Generic companies
6.4.10 Industry associations
6.4.11 Regional business news
6.4.12 Future prospects
6.5 Malaysia
6.5.1 Provision of healthcare
6.5.2 Government policy
6.5.3 Generic prescribing practice
6.5.4 Pricing and reimbursement
6.5.5 Regulation
6.5.6 The pharmaceutical market
6.5.7 Generics market size
6.5.8 Therapeutic categories
6.5.9 Generic companies
6.5.10 Industry associations
6.5.11 Future prospects
6.6 Philippines
6.6.1 Provision of healthcare
6.6.2 Government policy
6.6.3 Generic prescribing practice
6.6.4 Pricing and reimbursement
6.6.5 Regulation
6.6.6 The pharmaceutical market
6.6.7 Generics market size
6.6.8 Generic companies
6.6.9 Industry associations
6.6.10 Future prospects
6.7 Thailand
6.7.1 Provision of healthcare
6.7.2 Government policy
6.7.3 Generic prescribing practice
6.7.4 Pricing and reimbursement
6.7.5 Regulation
6.7.6 The pharmaceutical market
6.7.7 Generics market size
6.7.8 Generic companies
6.7.9 Future prospects

CHAPTER 7 LATIN AMERICAN GENERICS MARKETS
7.1 Argentina
7.1.1 Provision of healthcare
7.1.2 Government policy
7.1.3 Generic prescribing practice
7.1.4 Pricing and reimbursement
7.1.5 Regulation
7.1.6 The pharmaceutical market
7.1.7 Generics market size
7.1.8 Generic companies
7.1.9 Industry associations
7.1.10 Regional business news
7.1.11 Future prospects
7.2 Brazil
7.2.1 Provision of healthcare
7.2.2 Government policy
7.2.4 Generic prescribing practice
7.2.3 Pricing and reimbursement
7.2.5 Regulation
7.2.6 The pharmaceutical market
7.2.7 Generics market size
7.2.8 Generic companies
7.2.9 Industry associations
7.2.10 Future prospects
7.3 Mexico
7.3.1 Provision of healthcare
7.3.2 Government policy
7.3.3 Generic prescribing practice
7.3.4 Pricing and reimbursement
7.3.5 Regulation
7.3.6 The pharmaceutical market
7.3.7 Generics market size
7.3.8 Generic companies
7.3.9 Industry associations
7.3.10 Future prospects

CHAPTER 8 AUSTRALASIAN GENERICS MARKETS
8.1 Australia
8.1.1 Provision of healthcare
8.1.2 Government policy
8.1.3 Generic prescribing practice
8.1.4 Pricing and reimbursement
8.1.5 Regulation
8.1.6 The pharmaceutical market
8.1.7 Generics market size
8.1.8 Generic companies
8.1.9 Industry associations
8.1.10 Regional business news
8.1.11 Future prospects
8.2 New Zealand
8.2.1 Provision of healthcare
8.2.2 Government policy
8.2.3 Generic prescribing practice
8.2.4 Pricing and reimbursement
8.2.5 Regulation
8.2.6 The pharmaceutical market
8.2.7 Generics market size
8.2.8 Therapeutic categories
8.2.9 Generic companies
8.2.10 Industry associations
8.2.11 Future prospects

CHAPTER 9 COMPANY PROFILES
9.1 Alpharma
9.1.1 Activities
9.1.2 International presence
9.1.3 Products
9.1.4 Recent developments
9.1.5 Organisation
9.2 Andrx
9.2.1 Activities
9.2.2 International presence
9.2.3 Products
9.2.4 Recent developments
9.2.5 Organisation
9.3 Apotex
9.3.1 Activities
9.3.2 International presence
9.3.3 Products
9.3.4 Organisation
9.4 Apothecon
9.4.1 Activities
9.4.2 Products
9.4.3 Recent developments
9.4.4 Organisation
9.5 Barr Laboratories
9.5.1 Activities
9.5.2 Products
9.5.3 Recent developments
9.5.4 Organisation
9.6 BASF Generics
9.6.1 Activities
9.6.2 International presence
9.6.3 Products
9.6.4 Organisation
9.7 Biovail Corp
9.7.1 Activities
9.7.2 International presence
9.7.3 Products
9.7.4 Recent developments
9.7.5 Organisation
9.8 Cipla Ltd
9.8.1 Activities
9.8.2 International presence
9.8.3 Products
9.8.4 Organisation
9.9 Copley Pharmaceutical Inc
9.9.1 Activities
9.9.2 Products
9.9.3 Organisation
9.10 Draxis Health
9.10.1 Activities
9.10.2 Products
9.10.3 Recent developments
9.10.4 Organisation
9.11 Dr Reddy's Laboratories
9.11.1 Activities
9.11.2 International presence
9.11.3 Products
9.12 Duramed Pharmaceuticals Inc
9.12.1 Activities
9.12.2 Products
9.12.4 Organisation
9.13 Faulding Oral Pharmaceuticals
9.13.1 Activities
9.13.2 International presence
9.13.3 Products
9.13.4 Organisation
9.14 Gedeon Richter
9.14.1 Activities
9.14.2 International presence
9.14.3 Products
9.14.4 Recent developments
9.15 Hexal AG
9.15.1 Activities
9.15.2 International presence
9.15.3 Products
9.15.4 Recent developments
9.15.5 Organisation
9.16 ICN Pharmaceuticals
9.16.1 Activities
9.16.2 International presence
9.16.3 Products
9.16.4 Organisation
9.17 IVX BioScience (IVAX Corporation)
9.17.1 Activities
9.17.2 International presence
9.17.3 Products
9.17.4 Organisation
9.18 Krka
9.18.1 Activities
9.18.2 International presence
9.18.3 Products
9.18.4 Organisation
9.19 Lek
9.19.1 Activities
9.19.2 International presence
9.19.3 Products
9.19.4 Organisation
9.20 Merck KGaA
9.20.1 Activities
9.20.2 International presence
9.20.3 Products
9.21 Mylan Laboratories
9.21.1 Activities
9.21.2 Products
9.21.3 Recent developments
9.21.4 Organisation
9.22 Novartis Generics
9.22.1 Activities
9.22.2 International presence
9.22.3 Products
9.22.4 Recent developments
9.22.5 Organisation
9.23 Novopharm Ltd
9.23.1 Activities
9.23.2 International presence
9.23.3 Products
9.23.4 Organisation
9.24 Pliva
9.24.1 Activities
9.24.2 International presence
9.24.3 Products
9.24.4 Organisation
9.25 Ranbaxy Laboratories
9.25.1 Activities
9.25.2 International presence
9.25.3 Products
9.25.4 Organisation
9.26 Ratiopharm GmbH
9.26.1 Activities
9.26.2 International presence
9.26.3 Products
9.26.4 Recent developments
9.26.5 Organisation
9.27 Schein Pharmaceutical Inc
9.27.1 Activities
9.27.2 International presence
9.27.3 Products
9.27.4 Recent developments
9.27.5 Organisation
9.28 STADA Arzneimittel AG
9.28.1 Activities
9.28.2 International presence
9.28.3 Products
9.28.4 Organisation
9.29 Teva Pharmaceutical Industries Ltd
9.29.1 Activities
9.29.2 International presence
9.29.3 Products
9.29.4 Recent developments
9.29.5 Organisation
9.30 Watson Pharmaceuticals Inc
9.30.1 Activities
9.30.2 International presence
9.30.3 Products
9.30.4 Recent developments
9.30.5 Organisation
9.31 Wockhardt Ltd
9.31.1 Activities
9.31.2 International presence
9.31.3 Products
9.31.4 Organisation

DIRECTORY
REFERENCES AND FURTHER READING

LIST OF TABLES AND FIGURES
Table 1.1 Most important generic acquisitions, 1997-1998
Table 1.2 World's leading 15 generic players, 1997
Table 1.3 Leading generics markets, 1997
Table 1.4 Regional generics market trends, 1997-1998

Table 2.1 Leading therapeutic classes in developed generics markets, 1997
Table 2.2 Leading 25 generics in the US, ranked by prescription volume, 1997
Table 2.3 Leading generic products in Germany ranked by volume, 1996
Table 2.4 Leading 15 product opportunities in the US, 2000-2002

Table 3.1 Sales of top 15 therapeutic categories in Canada at ex-factory prices, 1997

Table 4.1 Sales of leading therapeutic classes in the Danish pharmacy market at pharmacy purchase prices, 1997
Table 4.2 Sales of leading generic companies in Denmark, 1995-1997 (Dkr million)
Table 4.3 Development of the share of generics in the German health insurance market, 1989-1997
Table 4.4 Generics with greatest savings potential in Germany, 1996
Table 4.5 Leading therapeutic classes in Italy, 1997
Table 4.6 Examples of price cuts following the Medicines Price Control Act, 1996
Table 4.7 Swedish pharmaceutical sales by main therapeutic class, 1997
Table 4.8 Generics as a proportion of UK NHS net ingredient costs, 1993-1997
Table 4.9 Generic prescribing by therapeutic class, 1997
Table 4.10 Leading therapeutic classes in terms of NHS prescriptions and costs, 1997

Table 5.1 International presence in the Hungarian pharmaceutical industry, 1998
Table 5.2 Sales of leading domestic and importing pharmaceutical companies in Russia at ex-factory/import prices, 1997

Table 6.1 Leading therapeutic categories in India, 1995
Table 6.2 Reimbursement listing of generics in Japan, 1996-1998
Table 6.3 Leading therapeutic categories in Japan, 1995-1996

Table 8.1 Pharmac expenditure by leading therapeutic groups at public purchase price, excluding GST, 1996-1998

Table 9.1 Alpharma's financial data, 1997
Table 9.2 Andrx's financial data, 1997
Table 9.3 Apotex's financial data, 1996
Table 9.4 Barr's financial data, 1998
Table 9.5 BASF's financial data, 1998
Table 9.6 Biovail's financial data, 1998
Table 9.7 Cipla's financial data, 1998
Table 9.8 Cipla's leading therapeutic categories, 1997
Table 9.9 Copley's financial data, 1997
Table 9.10 Draxis' financial data, 1997
Table 9.11 Dr Reddy's Laboratories' financial data, 1998
Table 9.12 Duramed's financial data, 1997
Table 9.13 Faulding Oral Pharmaceutical's financial data, 1998
Table 9.14 Gedeon Richter's financial data, 1998
Table 9.15 Richter's sales by region, 1998
Table 9.16 Hexal's financial data, 1996
Table 9.17 ICN's financial data, 1997
Table 9.18 IVAX's financial data, 1997
Table 9.19 Krka's financial data, 1997
Table 9.20 Krka's sales by region, 1996
Table 9.21 Krka's sales by therapeutic class (% of total), 1996
Table 9.22 Lek's financial data, 1997
Table 9.23 Lek's sales by region, 1997
Table 9.24 Merck KGaA's financial data, 1997
Table 9.25 Mylan's financial data, 1998
Table 9.26 Novartis Generics' financial data, 1997
Table 9.27 Novartis's generic sales by therapeutic class, 1996
Table 9.28 Employees at Novartis generic units, 1997
Table 9.29 Novopharm's financial data, 1997
Table 9.30 Pliva's financial data, 1997
Table 9.31 Pliva's sales by region, 1996
Table 9.32 Pliva's sales by therapeutic class, 1995
Table 9.33 Ranbaxy's financial data, 1998
Table 9.34 Ratiopharm's financial data, 1996
Table 9.35 Schein's financial data, 1997
Table 9.36 STADA's financial data, 1997
Table 9.37 Teva's financial data, 1997
Table 9.38 Teva's sales by region, 1997
Table 9.39 Watson's financial data, 1997
Table 9.40 Wockhardt's financial data, 1998

LIST OF FIGURES
Figure 1.1 Process of change in the generics market

Figure 3.1 Leading 20 therapeutic classes in the US, 1997

Figure 4.1 French pharmaceutical sales by therapeutic class, 1997 (% of total value)
Figure 4.2 French pharmaceutical sales by therapeutic class, 1997 (% of total volume)
Figure 4.3 Leading generic companies in France, November 1997

Figure 7.1 Leading companies in Argentina, 1997
Figure 7.2 Pharmaceutical sales in Mexico at ex-manufacturer prices, 1993-1997

EXECUTIVE SUMMARY
The generics industry has experienced a turnaround once more during the past two years. Life has become more difficult: generic companies have weathered a trough in sales, with fewer new product opportunities, stronger price competition, and a regulatory backlash in some markets.

The three clear trends to emerge from this report are firstly that the mature generics markets are undergoing industry consolidation, allowing the development of stronger, sometimes international players. Secondly, new generics markets are emerging as a result of a combination of government cost-containment measures and the presence of these stronger competitors to move the process forward (eg in France). The third trend is the entry of generics into the markets where 'copy drugs' predominate, but where product patent protection will start to become effective after 2000. These will be the generics markets of the longer term future.

The four main drivers of the generics market are:

Expiry of patents
Government cost-containment policies
Relatively high prices and scope for price competition
Strong company commitment to the generic business

Industry consolidation through mergers and acquisitions is resulting in players with the liquidity to invest in rationalisation of manufacturing, and in new product development. These competitors are more fully integrated, and will be able to harness economies of scale to act globally. Leading generic companies are looking to develop expertise in areas where products are difficult to replicate, such as controlled-release and biotechnology-based generics, and at niche markets for new branded drugs. This will contribute to higher margins in future.

At the same time, the multinational R&D-based players are largely taking one of two strategies: either they are becoming more committed to generics (eg Novartis, Merck KGaA), or they are retreating from the sector (eg Hoechst Marion Roussel, Bayer).

The outlook for the world generics market is optimistic, particularly since cost-containment issues are becoming increasingly pressing. It is estimated that products with sales of about $15 billion are coming off-patent in the world's leading generics markets during the years until 2002. These include the blockbusters omeprazole, enalapril and fluoxetine.

Report structure and methodology

This report aims to provide a reference tool for all those interested in world markets for generic drugs. It summarises the existing situation, highlights current trends, and looks at future developments in a standardised format. For ease of use, it is divided into the following sections:

1. Market overview. Chapter 1 assesses the global generics market, and discusses industry drivers, major generics markets, market trends, and future prospects.

2. Generic products. Chapter 2 briefly evaluates important generic therapeutic classes, and the outlook for generic products.

3. North American generics markets. Chapter 3 covers Canada and the US.

4. Western European generics markets. Chapter 4 begins with a summary of the European registration system, which applies to all the countries reviewed (Austria, Belgium, Denmark, France, Germany, Greece, Italy, the Netherlands, Portugal, Spain, Sweden, Switzerland and the UK).

5. Central and Eastern European generics markets. Chapter 5 covers the Baltic States, the Czech Republic, Hungary, Poland and Russia.

6. Asian generics markets. Chapter 6 covers China, India, Indonesia, Japan, Malaysia, the Philippines and Thailand.

7. Latin American generics markets. Chapter 7 covers Argentina, Brazil and Mexico.

8. Australasian generics markets. Chapter 8 covers Australia and New Zealand.

9. Generic company profiles (Chapter 9). A selection of companies has been chosen, which represents the leading generic competitors, as well as some of the companies of growing importance to the generics sector. These companies include suppliers of technology (eg specialists in drug delivery systems), as well as bulk and finished products (eg Indian and Central European players).

10. Directory. A comprehensive listing is included of names, addresses and contact details for companies and industry associations included in the report.

The national market sections describe the local context of the generics market under the following headings: provision of healthcare; government policy; generic prescribing practice; pricing and reimbursement; regulation; the pharmaceutical market; generics market size; generic companies; therapeutic categories; industry associations; regional business news; and future prospects. Also included under 'regulation' is a brief description of the current patent situation.

The company profiles have a standardised format, dealing with the company's financial data, activities, international presence, products, recent developments, organisation, and senior executives. Information contained in the company profiles is derived from company annual reports, brochures, press releases, press articles, websites and, in some cases, personal contact.

Where a source has not been cited it may be assumed that it is the author of the report, who gathered the information from a variety of sources.

Definition of generics

Evaluation and quantification of international generics markets is confused by differing definitions of generics between countries. Generally this report defines generics in the following ways:

'True' generics are competing versions of off-patent brands, which usually are bioequivalent, or at least are marketed as generics, and offer a price differential to the branded version. However, not all generics are available off-patent, as originator companies sometimes license a generic version prior to patent expiry. Also, companies may settle litigation by an agreement to let the generic competitor market the generic, although prima facie patent protection still exists (eg as occurred with rantidine)

Unbranded generics are sold by the name of the molecule, or international non-proprietary name (INN) only

Branded generics are sold either by the generic supplier's brand name, or by molecule name linked to the supplier's name, or an abbreviation

'Copy' products are competing versions of brands, which are not necessarily sold at lower prices than the original
Generic sales are difficult to measure as a result of problems in defining generics and difficulty in tracking unbranded products, which is further exacerbated by the varying routes through which some generics reach the market. They can be supplied via a wholesaler, or delivered direct to the pharmacy, clinic or dispensing doctor. Another difficulty in measuring the size of generic sales occurs because parallel imports tend to get mixed up with generic sales when estimates are given in Europe. Therefore the statistics provided in this report should be regarded as a guide to the actual situation. Where useful, differing estimates have been given to reflect the range of opinion concerning the size of generics markets.

Definition of terms

A definition of some of the other terms used in the report include:

Full generic substitution: A generic can be substituted for a brand. Substitution systems differ, but there is usually a means for the prescribing doctor to prevent substitution by writing or marking the prescription (eg in the US). In some countries authorisation from the doctor is required to substitute (eg in Germany). Patient agreement to receive a substituted product can also be necessary.

Soft generic substitution: A generic product can be substituted for an identical generic version.
Generic prescribing: Doctors prescribe by standardised generic name, and the pharmacist can dispense any generic or branded version of the product.

Copayment: Copayments are the share of the cost of a drug paid for by the patient when the drug is reimbursed by a third party payer, whether social security, health service, or health insurance company. A variety of copayment systems are used: copayments can be in the form of flat fees, or can represent a percentage proportion of the cost, and are often adjusted to reflect the perceived value of different types of treatment.

Reference pricing: There are two types of pricing system commonly referred to as reference pricing:

Price comparisons between countries, using average prices for specific drugs in other countries or groups of countries to determine price ceilings in a pharmaceutical market

The use of government social security schemes of a calculation of average market prices for molecules, or groups of molecules, to establish 'reference prices' or upper price limits for which drugs will be reimbursed. Patients usually have to pay the full cost above the reimbursement limit

Trade dress: The shape, colour and form of a pharmaceutical product.