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Product Lifecycle Management, 2006


Publication Date   May 2006
Publisher   Visiongain
Product Type   Strategic Report
Pages   153
ISBN Number   not applicable
Product Code   VIS030
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Price £1,499.00

approximately: $2,969 | €1,905

Summary


Please Note: Reports are sold based on the user licenses indicated. The reports will be accessible in Flash format via an online reading room on the publisher website, allowing viewing and printing capabilities only. Within one to two business days after placing the order, the client will receive an email with information on accessing their purchase.

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.

This new report entitled 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.

List of companies mentioned in this report:

  • 3i
  • Abbott Laboratories
  • Alphapharm
  • Apotex
  • Arrow International
  • Artemis Pharmaceuticals
  • AstraZeneca
  • Astellas
  • Avance Pharma
  • Azko Nobel
  • Baxter International
  • Bayer
  • Biosystems International
  • Boehringer Ingelheim
  • Bristol-Myers Squibb
  • Dr Reddy's
  • Eli Lilly
  • Forest Laboratories
  • Fujisawa Pharmaceutical
  • Galenea
  • GSK
  • Hoechst
  • ImQuest Pharmaceuticals
  • Inspire Pharmaceuticals
  • Isis Pharmaceuticals
  • IVAX
  • Johnson & Johnson
  • King Pharmaceuticals
  • Kyorin Pharmaceutical
  • Lequio Pharma
  • Lundbeck
  • Merck KGaA
  • Merck & Co
  • Millenia Hope Biopharma
  • Mitsibushi Pharma
  • Mylan
  • Nastech
  • Novartis
  • Novavax
  • Pacific GMP
  • Par Pharmaceutical
  • Pfizer
  • Pharmacia
  • Roche
  • Rosetta Genomics
  • Sanofi-Aventis
  • Schering-Plough
  • Schwarz Pharma
  • Sepracor Pharmaceuticals
  • Samjin Pharmaceutical
  • Spectrun Pharmaceuticals
  • Tap Holdings
  • Teva
  • UCB
  • Warner-Lambert
  • Wyeth
  • Yuhan
  • Zenith Laboratories

Content


  • 1. Executive Summary
    • 1.1 Product Lifecycle Management (PLM0 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
    • 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 ($m), 2003-2010
    • Table 9.8 Leading Pharmaceutical Companies' R&D Expenditure, 2004
    • Table 9.9 Inter-company Alliances, March 2006
    • Table 9.10 Country Pharmaceutical Expenditure ($) Per Person
    • Table 10.1 SWOT for PLM Strategies, 2006
    • Table 10.2 SWOT for The PLM Concept, 2006
  • List of Figures
    • 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 (%) For Antidepressant 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 Antidepressants, 2006
    • 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