Content
Foreword
Introduction
1: A brief history of the pharmaceutical industry
Traditional treatments
The Dark Ages
The role of pharmacists in the origins of the drug industry
The second strand
The antibiotic triumph
The young drug industry goes west into early merger mania
The American way
The biotech revolution
Japan and the Far East
Dramatic differences
Conclusion
2: The pharmaceutical industry's vital statistics
A major industry?
The largest drug companies
R&D expenditure
The top 10 pharmaceutical markets
Employees
The blockbusters
The rise of generic industry
Production
Industry organisations
Drug companies other interests
3: Market dynamics
The drive towards globalisation
Stock market pressures
Health service factors
The structure of healthcare systems
Controlling escalating healthcare expenditure
Pharmaco-economics and the fourth hurdle
Orphan drugs
Patient advocacy
The influence of nongovernmental organisations
4: Drug discovery
What is illness?
Unmet clinical needs
The aims of drug discovery
Identifying a lead compound
Testing and safety
The ethics of using animals in research
New developments
The Human Genome Project
Informatics
Therapeutic innovation develops new markets
The problem with specialisation
5: Clinical development
The cost of clinical development
Prelaunch development
Paediatric trials
Phase I
Phase II
Phase III
Study design
The ethics of clinical trials
Postlaunch clinical trials
Safety assessment of marketed medicines
Health economics
Transparency
Developing line extensions
The importance of the delivery device
Clinical trials outsourcing
6: Manufacturing
Keeping to standard
Good Manufacturing Practice
Quality management
Personnel
Premises and equipment
Documentation
Labelling
Quality control
Complaints and product recall
The global base and rationalisation
7: Launch and marketing
The product life cycle
Pricing
Marketing strategies
New approaches
Direct-to-consumer advertising
The role of public relations
Parallel imports
E-commerce
8: Regulation
Regulatory approval processes
US registration procedures
The European system
The Japanese system
Postmarketing regulation
The patent system
Transnational organisations
The International Conference of Harmonisation
The European Union
The WTO and Gatt
9: What makes a company successful?
Enhancing creativity
Knowledge management systems
The biotech problem
Alliances: bridging the innovation gap
Switching to over-the-counter drugs
How a company develops
What makes a successful company?
10: A glimpse of the future
The pressure grows...
Will the trend towards mega-mergers continue?
Companies need to think globally
The AIDS pandemic
Engage the public
Market trends
Disease trends
A secure future
Glossary and abbreviations
References
Internet resources
List of Tables
Table 1.1: Standardised death rates per thousand of the population
Table 2.1: The largest 15 global companies in all sectors
Table 2.2 Pharmaceutical companies in the Fortune global 500
Table 2.3: The top 20 pharmaceutical companies
Table 2.4: Leading drug companies by region: Japan
Table 2.5: Leading drug companies by region: US
Table 2.6: Leading drug companies by region: Europe
Table 2.7: Trends in UK R&D expenditure
Table 2.8: Leading drug companies R&D expenditure: Japan
Table 2.9: Leading drug companies R&D expenditure: US
Table 2.10: Leading drug companies R&D expenditure: Europe
Table 2.11: Estimated product pipelines for top 40 companies worldwide in 1997, by nationality
Table 2.12 The top 10 pharmaceutical markets 1998
Table 2.13: Per capita sales of pharmaceuticals in major markets 1999
Table 2.14: Proportion of Bayer's sales and earnings by region 1999
Table 2.15: Size of leading pharmaceutical companies sales forces
Table 2.16: Top 30 companies ranked by number of employees
Table 2.17: Drugs with sales of more than $1bn during 1998
Table 2.18: European generic market 1997
Table 2.19: World pharmaceutical production in 1997
Table 3.1: Main cost containment methods used in Europe
Table 5.1: Out of pocket costs of clinical development in various therapeutic groups (1997, US data)
Table 5.2: The attrition rate for clinical development
Table 5.3: Discrepancy between objective and subjective outcome measures
Table 5.4: Number and indications of drugs in development for children during 2000
Table 6.1: Definitions of clean air in pharmaceutical manufacturing
Table 7.1: Important sources of patient information
Table 7.2: Usage of and growth in e-commerce
Table 8.1: Average delays in the launch of new drugs
Table 8.2: Pharmaceutical market distortion within the free trade European Union in 1998
Table 9.1: Leading public biotechnology therapeutic and hybrid companies marketed medicines and products in development 2000
Table 9.2: Products in development in the pipelines of European public biotechnology companies 1999
Table 9.3: Ranking of patentees by number of biotechnology patents and products
Table 9.4: The growth in the UK's over-the-counter market
Table 9.5: Over-the-counter model profit and loss profile
Table 10.1: Patent status of the world's best selling medicines 1998
Table 10.2: Changes in the world pharmaceutical market 1998-2002
Table 10.3: US annual expenditure on disease treatment
Table 10.4: Major chronic conditions in the US
Table 10.5: Number of drugs in development for age-related diseases
List of Figures
Figure 3.1: Hierarchical healthcare
Figure 3.2: The reach of patient power
Figure 3.3: Sources of patient information
Figure 7.1: A pharmaceutical product's life cycle
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