• Chemicals
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• Regulatory
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• Therapeutic

M&A in pharma

Explores the merits of mega-deal in contrast to a more measured portfolio growth strategy

The new edition of this best-selling report offers insight into the manufacturing process, strategy, issues and drivers from an expert author.

Manufacturing in the Global Pharmaceuticals Industry - Key drivers, company strategies and regulations (3rd ed) is the only report available that covers this crucial area of the pharmaceutical industry in such depth. The concentration in recent years on creating organisations that are market or customer-led, or research-driven has taken the focus away from the manufacturing process, although it is clear that the most successful organisations integrate all these activities to remain market leaders.

Global pharmaceutical manufacturing is in a state of flux. There is excess capacity in manufacturing facilities for finished dosage forms and a shortfall for biotechnology manufacturing. The situation in APIs is not so clear-cut, and the trend for multinationals to grow through M & A has led to the need to rationalise facilities. Meanwhile, local companies from emerging markets wishing to expand into new markets and exporting must be able to satisfy ever more stringent quality standards.

This report tackles the challenges of manufacturing in a global marketplace by providing unique insight into the strategies a successful company will adopt. By using examples, case studies and scenarios to aid clarification of the more technical aspects of the manufacturing process, you can be assured your desisions are made with full understanding of the key issues.

This timely third edition will enable you to:

• Assess the pros and cons of outsourcing manufacturing functions and develop key strategies to effectively measure supplier and contractor performance
  
• Understand and prepare for the latest regulations applicable to manufacturing and their variations globally
  
• Develop strategies to effectively manage contractor relationships
  
• Understand the definitions used in validation, and how extra investment in validation will improve performance
  
• Build competencies for manufacturing that meet the objectives of: speed of delivery, reduction in product cost, overall quality, optimisation of capital spend, maintenance of customer inventory, minimisation of regulatory impact, optimisation in the number of manfacturing sites, maintenance of strategic sourcing for disaster management planning
  
• Understand the 'New Paradigm' in international manufacturing and how it relates to the pharmaceutical industry.

Use this report help with:

• Planning a global manfacturing strategy
• Regulations and quality assurance issues
• The 'New Paradigm' in manufacturing
• The key drivers and changes in today's manufacturing environment
• Making the right investment decision

Executive Summary

Chapter 1: Key Issues Facing the Pharmaceutical Industry
Structure of the industry
Global product portfolio
The need to change the way the industry works
Historical development of manufacturing
Conclusion

Chapter 2: Pharmaceutical Manufacturing versus Sales Worldwide, in Europe and in Japan
World market
Western Europe
Japan

Chapter 3: Pharmaceutical Manufacturing versus Sales in Central and Eastern Europe
Armenia
Georgia
Kazakhstan
Russia
Turkey
Ukraine

Chapter 4: Pharmaceutical Manufacturing versus Sales in the Americas
North America
Latin America

Chapter 5: Pharmaceutical Manufacturing versus Sales in the Rest of the World
Africa
Australasia
Far East
India
Middle East

Chapter 6: Strategic Options for Pharmaceutical Manufacture
In-house manufacture
Partnerships
Contracting out
Outsourcing
Licensing out
Selling off the product
Selling off the company
Acquisitions
Strategic options for companies in emerging markets
Facility for rent
Conclusion

Chapter 7: The Impact of e-Business on the Pharmaceutical Industry
Product registration
Manufacturing information sources
Purchasing
Documentation control
Sales and marketing
Electronic communities
Conclusion

Chapter 8: Outsourcing Pharmaceutical Manufacturing
Why outsource?
Outsourcing providers (the contract takers)
Prerequisites for successful outsourcing
Researching the outsourcing market
Conclusion

Chapter 9: Key Issues Facing Pharmaceutical Manufacturing
Drivers for manufacturing strategy
Current manufacturing base
Internal factors
Economic factors
Political factors
Geographical factors
Disaster management
Biotechnology manufacturing
Conclusion

Chapter 10: Quality Management in Pharmaceutical Manufacturing
Quality assurance
Good manufacturing practice
Quality control
Electronic records and electronic signatures
GMP for starting materials
GMP guidelines and enforcement around the world
Australia
Japan
Latin America
Central and Eastern Europe and the Former Soviet Union (FSU)
Central Asian Republics and the Caucasus
New EU Member States
Russia
Ukraine
Middle East and Africa
Asia
Singapore
The role of the World Health Organization
GMP and the multinationals
Harmonisation of standards
Mutual recognition between the EU and North America
Mutual recognition between the EU and third countries
ICH
Other harmonisation programmes
Conclusion

Chapter 11: Certification of Factories to GMP Compliance
Determining the appropriate standard
Factory inspection - the Food and Drug WHO certification scheme
WHO prequalification scheme
ISO 9000
Quality Systems Inspection Technique
Conclusion

Chapter 12: Designing and Building a Manufacturing Facility
Obtaining the correct environmental standards
Classification systems
Product types, dosage forms and related technologies
Packaging
Other dosage forms and technologies
API manufacturing
Trends in facility design
Greenfield site development versus refurbishment
Getting the design right from the start
Conclusion

Chapter 13: Validation in Manufacturing
Definitions
Design qualification
Design qualification
Installation qualification
Operational qualification
Determining validation requirements
Carrying out and completing OQ
Performance qualification
Performance testing
Process validation
Retrospective validation
Cleaning validation
Analytical validation
Validation - a cost-benefit analysis
Conclusion

Chapter 14: The New Paradigm
Twenty-first-century pharmaceutical manufacturing
New terminology
ICH and the 'New Paradigm'
Mandatory versus optional activities

Chapter 15: The Future for Pharmaceutical Manufacturing
Trends
The shape of the manufacturing industry
Conclusion

Glossary

Bibliography and Sources


LIST OF FIGURES
Figure 12.1 Horizontal flow I
Figure 12.2 Horizontal flow II
Figure 12.3 Vertical flow

LIST OF TABLES
Table 1.1 Worldwide leading pharmaceutical companies
Table 1.2 Cumulative market share of 50 pharmaceutical companies, 1989, 1999 and 2007
Table 1.3 Leading therapy classes by global pharmaceutical sales, 2007
Table 1.4 Leading products by global pharmaceutical sales, 2007 (2001)
Table 1.5 The fall in market exclusivity over time
Table 1.6 R&D spend by the 10 leading companies, 2006
Table 2.1 World market growth, 2000-2007
Table 2.2 Global pharmaceutical sales by market, 2001
Table 2.3 Global pharmaceutical sales by market, 2007
Table 2.4 Top 10 markets for retail sales, March 2007-February 2008
Table 2.5 International pharmaceutical trade in Western Europe, 2006 ($bn)
Table 2.6 Austria - pharmaceutical trade balance ($bn)
Table 2.7 Domestic sales versus imports in France
Table 2.8 Domestic sales versus exports in France
Table 2.9 Changes in the size of the French market in recent years
Table 2.10 Changes in German pharmaceutical sales ($bn)
Table 2.11 Trade balance in pharmaceuticals, Greece ($bn)
Table 2.12 Changes in the Irish export market in recent years
Table 2.13 Trade balance in pharmaceuticals, the Netherlands ($bn)
Table 2.14 Changes in the Japanese share of the global market
Table 2.15 Changes in Japanese trade
Table 3.1 Estimated pharmaceutical market, Russia and FSU countries, 2004
Table 3.2 Pharmaceutical market, Kazakhstan ($m)
Table 3.3 Pharmaceutical market, Russia, 1997-2005
Table 3.4 Pharmaceutical market, Turkey, 1997-2007
Table 3.5 Ukrainian pharmaceutical suppliers
Table 4.1 Share of global pharmaceutical sales, North America
Table 4.2 The US market as a percentage of global pharmaceutical sales
Table 4.3 The Argentinean market by value and volume
Table 4.4 Argentinean trade in pharmaceuticals ($m)
Table 4.5 Argentinean production versus imports ($bn)
Table 5.1 Market growth, China, 1991-2007
Table 5.2 Market growth, selected markets, 2003-2007
Table 6.1 Advantages and disadvantages of options for pharmaceutical manufacturing
Table 9.1 Summary of key manufacturing issues facing pharmaceutical companies in general
Table 12.1 Facility construction costs in Western Europe
Table 12.2 Air classification system for the manufacture of sterile products
Table 12.3 Comparison of classes of environmental standards
Table 12.4 ISO 14644 Cleanrooms and Associated Controlled Environments
Table 12.5 Area classifications for sterile production
Table 12.6 Cost elements in a construction project
Table 12.7 Typical URS questionnaire
Table 13.1 Comparison of validation terminology
Table 13.2 Resource investment in validation
Table 13.3 Benefits of validation

Dr Kate McCormick, of Heathside Information Services Ltd, UK, is a manufacturing consultant with extensive strategic and operational management experience in the international pharmaceutical industry. Kate has 10 years of line management and 20 years of internal and external consulting experience, and has worked with multinationals, SMEs, non-governmental organisations and national drug regulatory authorities in more than 50 countries.

Kate is a published author, editor of GMP Review, European Education Advisor for ISPE and a regular speaker at international conferences. She gained a degree in biochemistry and a doctorate in microbiology, both at London University, together with a Masters in Business Administration from Cranfield University. She is registered as a senior GMP expert within the EU and is eligible to act as a QP under the terms of the EU directive.