1. Executive Summary
1.1 Product Lifecycle Management Review
1.2 Overview of PLM in the Pharmaceutical Industry
1.3 Overview of Report Contents
1.4 Research and Analysis Methods
2. PLM: An Introduction
2.1 What is Product Lifecycle Management (PLM)?
2.2 Why the Pharmaceutical Industry Needs PLM
2.2.1 R&D Pipeline Challenges
2.2.2 Patent Expiry a Serious Challenge
2.2.3 The Rise of Generic Competition Worldwide
2.2.4 Governmental Policies, Regulatory Hurdles, Pricing Pressures and Other Concerns
2.3 PLM versus Other Strategies
2.4 PLM Options for the Pharmaceutical Industry
2.4.1 New Indications
2.4.2 Reformulations
2.4.3 Combination Drugs
2.4.4 OTC Switching (Rx-to-OTC)
2.4.5 Branded Generics
2.4.6 M&A Activity
2.4.7 Alliances
2.4.8 Pricing
2.4.9 Patent Protection Strategies
2.4.10 Developing New Markets for Products
2.4.11 Increasing and Refocusing R&D Expenditure
2.4.12 Reducing Drug Development Time
2.4.13 Early-Stage Lifecycle Management
2.4.14 Branding and Rebranding
2.4.15 Choosing a Strategy
3. The Pharmaceutical Industry: Countering Patent Expiry
3.1 Patent Law and the Pharmaceutical Industry
3.1.1 Requirements for a Patent
3.1.2 The FDA
3.1.3 Types of Exclusivity
3.1.4 NCE Exclusivity
3.1.5 Indication Exclusivity
3.1.6 New Formulation Exclusivity
3.1.7 Orphan Drug Exclusivity
3.1.8 Paediatric Exclusivity
3.1.9 Generic First-to-File Exclusivity
3.1.10 European Medicines Agency Policy
3.1.11 Supplementary Protection Certificates
3.1.12 Japanese Regulations
3.2 The Generic Drug Market
3.2.1 Regulations for Generic Drugs
3.2.2 Healthcare Providers
3.2.3 The Expansion of the Generics Market
3.3 R&D Pipeline Challenges for Pharmaceutical Companies this Decade
3.4 Regulation s
3.5 Conclusions
4. PLM Strategies for Products Facing Patent Expiry
4.1 Leading Drugs and their Commercial Prospects from 2010
4.2 Lipitor (Pfizer)
4.2.1 Pfizer's PLM Strategies for Lipitor
4.2.2 Caduet (Pfizer)
4.3 Plavix (Sanofi-Aventis/Bristol-Myers Squibb)
4.3.1 Clinical Trials Underway For New Plavix Indications
4.3.2 Resisting Competition from Generic Clopidogrel
4.4 Seretide (GlaxoSmithKline)
4.4.1 Reformulations and New Delivery Systems
4.5 Seroquel (AstraZeneca)
4.5.1 Seroquel XR and Seroquel SR
4.5.2 Legal Battles over Seroquel
4.6 Crestor (AstraZeneca)
4.6.1 Crestor in Combinations
4.6.2 New Indications for Crestor
4.7 Zyprexa (Eli Lilly)
4.7.1 Eli Lilly's PLM Strategies for Zyprexa
4.8 Singulair (Merck)
4.8.1 Singulair: an OTC Possibility
4.9 Actos (Takeda Pharmaceuticals)
4.9.1 Actos: PLM Activities
4.10 Aricept (Eisai/Pfizer)
4.10.1 Challenges with New Indications
4.11 Diovan (Novartis)
4.11.1 Diovan for Cardiovascular Disease
4.12 Taxotere (Sanofi-Aventis)
4.13 Lexapro (Forest)
4.13.1 Attempts to Widen Lexapro's Indications – What Implications?
4.14 Symbicort (AstraZeneca)
4.14.1 Symbicort: PLM Activities
4.15 Alna/Harnal (Astellas/Boehringer Ingelheim)
4.16 Cozaar (Merck)
4.17 Zometa (Novartis)
4.18 Levaquin (Johnson & Johnson)
4.19 Xalatan (Pfizer)
4.20 Avandia (GlaxoSmithKline)
4.21 Aprovel (Sanofi/Bristol-Myers Squibb)
4.22 Concluding Remarks
5. PLM Activities 2015-2020
5.1 New Indications: SWOT Analysis
5.2 Reformulations: SWOT Analysis
5.3 Combination Drugs: SWOT Analysis
5.4 OTC Switching: SWOT Analysis
5.5 Branded Generics: SWOT Analysis
5.6 M&A Activities: SWOT Analysis
5.7 Alliances: SWOT Analysis
5.8 Pricing Activities: SWOT Analysis
5.9 Patent Protection Strategies: SWOT Analysis
5.10 Developing New Markets: SWOT Analysis
5.11 Increasing and Refocusing R&D Expenditure: SWOT Analysis
5.12 Reducing Drug Development Times: SWOT Analysis
5.13 Early-Stage Lifecycle Management: SWOT Analysis
5.14 Branding and Rebranding: SWOT Analysis
5.15 PLM Concept: SWOT Analysis
6. Expert Opinion
6.1 The Importance of the Emerging Markets
6.2 The Changing Patient Demographic in Emerging Markets
6.3 Pricing and Reimbursement in the Emerging Markets
6.4 Pharmaceutical Industry Strategies in the Emerging Markets
6.5 Intellectual Property Issues in the Emerging Markets
6.6 Growth Variation in Emerging Markets
6.7 Therapeutic Areas and Other New Opportunities in Emerging Markets
7. Conclusions
7.1 PLM Helping Companies to Mitigate Pressures on the Industry
7.2 Emerging Markets, M&A and Branded Generics Will Become Increasingly Important from 2010 Onwards
7.3 PLM Crucial to the Future of the Pharmaceutical Industry and Market
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