Product Lifecycle Management, 2006

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Publication Date: 2006-05-18

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The global pharmaceutical market with sales of approximately $550 billion is about to enter a pivotal period in its history. The industry has been used to double digit growth rates but growth has now dropped to below 10% for the first time. In addition to this whole swathes of lucrative high revenue earning drugs are going to lose patent. Ordinarily, the industry would have been able to cope with this after all patent loss is a normal part of the industrial process. But this time the industry faces serious problems, pipelines are notoriously thin. The industry is going to have huge difficulties in replacing those drugs going off patent and the high levels of revenue that they earn. The industry is going to have incorporate the new culture of Product Lifecycle Management (PLM) if it is to salvage some of those lost revenues.

Visiongain's s new report Product Lifecycle Management, 2006 offers an in depth view of this new work strategy. PLM may not be able to save the industry but in times of low growth, patent loss, generic competition and a dearth of new high earning products it is a one of the few viable options. Visiongain's Product Lifecycle Management, 2006 explains this new method of business and assesses each major aspect of PLM and how they may improve industrial performance. Visiongain's Product Lifecycle Management, 2006 has to be an essential part of any pharmaceutical company's outlook.

Why you should buy this report:

The level of imminent patent loss is unprecedented in the history of the pharmaceutical industry
Generic companies can expect at least a 50% share of the patent expired market
Key product lifecycle management strategies are examined, recent examples considered and the advantages and disadvantages of each assessed
Leading drugs in the principal R&D based company pipelines are assessed
The key aspects of the patent system are outlined
This report considers the latest financial and anecdotal information to enable the most appropriate choice of product lifecycle management strategy to be assessed.

1. Executive Summary

1.1 Product Lifecycle Management (PLM) Gains Increasing Prominence
1.2 Aims, Scope and Format of the Report
1.3 Research Methodology

2. Introduction

2.1 Old Strategies, New Concept

3 Patent Expiry: The Pharmaceutical Industry is Going to Lose Billions of Dollars
- 3.1 Leading Drugs are Facing Patent Expiry
- 3.2 The Years 2006-2008 Are Pivotal for Patent and Revenue Loss

4. The Current Pharmaceutical Business Model and Why It Is Failing

4.1 The World Pharmaceutical Market Will See Low Future Growth
4.2 The Drug Development Cycle Is Extending
4.3 Pricing - A Revenue Generating Strategy That Is Increasingly Out of Pharma's Control
4.4 Challenges to the Current Pharma Business Model
4.5 Niche Market Drugs - A New Model for Success?
- 4.5.1 Biotech Drugs May Offset Some Degree of Patent Loss
- 4.5.2 Pharmacogenomic Drugs Will Not Save the Market
4.6 M&A - Current Strategy to Overcome Low Drug Revenues
4.7 Threats from Developing Countries
4.6 A New Pharmaceutical Business Model Must Include PLM Strategies

5. The Rise of the Generic

5.1 Cheap Generic Drugs Are Very Attractive to Healthcare Systems
5.2 The World Generics Market Will Maintain High Growth Through to 2011
5.3 Loss of Major Patents Will Drive the Generic Market at the Expense of the Branded Market
5.4 The CNS and Cholesterol Drugs Will Lead the Generics Market
5.5 High Prices for Branded Drugs Drives the Generic Market - The US Leads the World
5.6 The Expanding Generic Market Will Be a Driver of PLM

6. The Collapse of a Pharmaceutical Market Due to Generic Competition

6.1 The Antidepressant Market as a Case Study
6.2 The Weakness of the Antidepressant Market Is that it Is Dominated By Only Two Drugs
6.3 Patent Issues and Generic encroachment
6.4 Marketing Restraints Should Encourage Brand Antidepressants
6.5 New Indications and Off-label Use as a PLM Strategy Can Extend an Antidepressant's Lifetime
6.6 New Formulations Will Provide a Small Amount of Protection from Generics
6.7 Pricing
6.8 Paxil/Seroxat - PLM Strategies That Failed
6.9 Prozac - An Example of a More Successful PLM
6.10 The Antidepressant Market Suggests a Future Trend for All Pharmaceutical Markets

7. Patents and The Pharmaceutical Industry

7.1 Patents Are Legal Monopolies
7.2 Harmonisation of Patent Life
7.3 Patents Must Be Specific
- 7.3.1 Five Year NCE Exclusivity
- 7.3.2 New Indication Exclusivity
- 7.3.3 New Formulation Exclusivity
- 7.3.4 Orphan Drug Exclusivity
- 7.3.5 Pediatric Exclusivity
- 7.3.6 Generic First-to-file Exclusivity
7.4 The FDA is Key to Pharmaceutical Success
7.5 EMEA Allows Multi-country Patent Filing
- 7.5.1 EU Regulations and SPCs
- 7.5.2 Market Exclusivity
- 7.5.3 The 8+2+1 Rule - Moving Towards Standardisation
7.6 MHLW Allows Tight Control of the Japanese Market
7.7 Biogenerics Wait For Approval
7.8 The Bolar Trial Outcome - Branded Companies Gain Advantage
7.9 The Hatch Waxman Act - Generic Companies Fight Back
7.10 Patents Vital Sustaining Effect on the Pharmaceutical Market

8. Introduction to Product Lifecycle Management

8.1 Strategies for Branded Manufacturers
8.2 The Development of New Indications Is Vital
8.3 Reformulations Account For More Than 50% of All NDAs
8.4 Combination Drugs Are Likely to Become an Important Part of PLM and May Generate High Revenues
8.5 OTC Switching Is Growing
8.6 US Authorised Generics Increase Competition
8.7 Determining Strategy Choice

9. Lifecycle Management Involves Increasing Revenue Across the Lifetime of a Drug

9.1 Increasing R&D Investment - Is it R&D Pharma's Black Hole?
9.2 Reducing Drug Development Time
9.3 Early Stage Lifecycle Management
9.4 Re-branding - Will it Work?
9.5 New Markets - Gaining Presence in Fast-growing Markets
9.6 New Indications - Biology Controlled PLM
- 9.6.1 Additional Revenues from Extra Drug Indications May Not Be Substantial
9.7 Patent Protection Strategies
9.8 Combination Therapies
9.9 New Formulations Delivering Added Therapeutic Value
- 9.9.1 New Formulations Are the Most Popular Lifecycle Management Strategy
- 9.9.2 Advantages of Reformulation
- 9.9.3 Examples of Drug Reformulations and Delivery
- 9.9.4 Disadvantages of Drug Reformulation
- 9.9.5 Reformulation: The Leading Lifecycle Management Strategy
9.10 Celexa and Lexapro - Individual Isomers Make More Revenue than Racemic Mixtures
9.11 Prilosec and Nexium Are Racemic and Single Isomer Drugs Respectively
9.12 Prescription to OTC Switching
9.13 Authorised Generics - The Most Aggressive PLM Strategy
9.14 M&A - An Impressive but Unsustainable PLM Strategy
9.15 Alliances - The Foundation For Many Successful Programmes
- 9.15.1 Merck & Co.: A Case Study in Alliances
9.16 Pricing - A Key Factor in Determining Revenue
9.17 Combination and Drug Reformulation Are PLM Strategies That Offer the Most Reward
9.18 Conclusion: PLM Is a Company-wide Change in Business Culture Which Is Necessary to Maintain Profitability

10. SWOT Analysis for Product Lifecycle Management

10.1 SWOT for PLM Strategies

10.2 SWOT for PLM Concept Itself
10.3 PLM Implementation is Key to Its Success
10.4 Increased PLM In The Future

11. Conclusion

List of Tables and Figures

Table 3.1 High Profile, Blockbuster Products Losing US Patent Protection/Market Exclusivity in 2006

Table 3.2 Leading Drugs Patent Expiry Dates, 2004-2009

Table 3.3 Drugs Losing Patent Protection in 2005 and 2006

Table 4.1 Increasing R&D Spend With Flat NME Approval for Three Selected Years, 1988, 2002 and 2004

Table 5.1 US Price Comparison of Leading Generic Drugs and Their Branded Equivalents

Table 5.2 Leading Generic Drugs in the US by Revenue ($m), 2005

Table 5.3 World Generic Market Revenues ($bn), 2004-2011

Table 5.4 Number of Drugs Losing US Patent Protection, 2004-2009

Table 5.5 World Generic Revenue ($bn) and Market Share (%) By Country, 2004

Table 5.6 World Generic Market Growth Rate (%) by Country, 2004

Table 5.7 Generic Market Share By Value and Volume, 2005

Table 6.1 Revenue ($m) for the World Antidepressants, 2003-2010

Table 6.2 Patents For The Leading Branded Antidepressants

Table 6.3 Revenue ($m) and Growth Rate (%) For US Generic Antidepressants, 2004

Table 6.5 Prices of Branded and Generic Antidepressants, 2006

Table 6.4 Approved Indications For Leading Antidepressants

Table 6.6 Paxil/Seroxat Revenues ($m), 2003-2010

Table 6.7 Prozac Revenues ($m), 2003-2010

Table 9.1 R&D Investment For The Top Ten Pharmaceutical Companies, 2004

Table 9.2 Comparison Revenues ($m) Between Primary and Secondary Indications of the Same Drug, 2005

Table 9.3 Additional Indications and Revenues ($m) for the Leading Cholesterol Drugs, 2005

Table 9.4 Celexa Revenues ($m), 2003-2010.

Table 9.5 Lexapro Revenues ($m), 2003-2010

Table 9.6 Nexium and Prilosec/Losec Revenues ($m), 2000-2005

Table 9.7 Paxil/Seroxat Revenues ($m), 2003-2010

Table 9.8 Leading Pharmaceutical Companiesâ€™ R&D Expenditure, 2004

Table 9.9 Inter-company Alliances, March 2006

Table 9.10 Country Pharmaceutical Expenditure ($) Per Person

Table 10.1 SWOT for PLM Strategies, 2006

Table 10.2 SWOT for The PLM Concept, 2006

Figure 1.1 Increasing R&D Investment With Decreasing NME Approval

Figure 3.1 Revenue Loss ($bn) Due to Drug Patent Loss, 2004-2009

Figure 3.2 Accumulated Revenue Loss ($bn) Due to Drug Patent Loss

Figure 4.1 NME Development Costs ($m), 1976-2005

Figure 5.1 US Price Comparison of Leading Generic Drugs and Their Branded Equivalents

Figure 5.2 Growth in the World Generics Market, 2004-2011

Figure 5.3 Estimated Percentage of Generic Drug Revenue By Therapeutic Area

Figure 5.4 Revenue ($bn) and Market Share (%) By Country For The Global Generic Pharmaceutical Market, 2004

Figure 6.1 Revenue ($m) For The World Antidepressant Market, 2003-2010

Figure 6.2 Comparison of Revenue ($m) for Antidepressant Drugs, 2004 and 2010

Figure 6.3 World Market Share (%) ForAntidepressant Drugs, 2004

Figure 6.4 World Market Share (%) For Antidepressant Drugs, 2010

Figure 6.5 Prices of Branded Antidepressants, 2006

Figure 6.6 Prices of Branded and Generic, 2006 Antidepressants

Figure 6.7 World Revenues ($m) for Paxil/Seroxat, 2003-2010

Figure 6.8 World Revenues ($m) for Prozac, 2003-2010

Figure 9.1 R&D Investment and NME Approval, 1980-2004

Figure 9.2 Increasing R&D Investment, 1980-2004

Figure 9.3 NME Development Costs ($m), 1975-2005

Figure 9.4 R&D Expenditure (% of Total Revenue), 2004

Figure 9.5 Stages of Drug Development Time, 2006

Figure 9.6 World Revenues ($m) for Lexapro and Celexa, 2003-2010

Figure 9.7 Nexium and Prilosec/Losec Revenues ($m), 2000-2005

Figure 9.8 World Revenues ($m) for Paxil/Seroxat, 2003-2010

Figure 9.9 Merck's Key Partnerships, 1999-2005

Figure 9.10 Percentage of Merck's Revenue Generated From Alliance Projects, 2004

Figure 9.11 Internal and Licensed Candidates Entering Merck Pipeline, 2001-2005

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