Pharmaceutical Product Lifecycle Management 2010-2020
The pharmaceutical industry currently faces marked challenges in its long-standing business model. Product lifecycle management (PLM) is being used to maximise the revenue-generating potential of pharmaceuticals, especially in their maturity, but also earlier on. In our new report - Pharmaceutical Product Lifecycle Management 2010-2020 - we examine the PLM strategies that pharmaceutical companies are using. Those measures range from reformulations, new combinations of drugs and expanded indication ranges, to the use of alliances, licensing, mergers and acquisitions.
In our report we consider the advantages and drawbacks of lifecycle management techniques, as well as approaches such as litigating to protect patents and reducing drug development times. We analyse and discuss conditions within the pharma industry, covering commercial, technological, regulatory and legal aspects. Our study considers where the main opportunities and successes will lie from 2010 onwards. Our research shows that optimised product lifecycle management will be of crucial importance to the pharmaceutical industry from 2010 to 2020. But which techniques will best tackle the decline in revenues and growth prevalent in the sector? Our study tackles such questions, providing the information that you require.
Furthermore, our new report profiles twenty leading drugs that are approaching the 'patent cliff' within the next ten years. For those drugs, we investigate and analyse the lifecycle management strategies that companies are using to maximise commercial life and revenue generation. Those leading products include Lipitor, Plavix, Seretide and Seroquel. By analysing approaches the industry is taking, and evaluating the commercial potential for various PLM methods, we provide incisive analysis of pharma PLM activities for this decade.
Comprehensive analysis of pharmaceutical product lifecycle management
Pharmaceutical Product Lifecycle Management 2010-2020 examines that aspect of the pharmaceutical industry and market through a comprehensive review of information sources. We use primary and secondary research. This report provides forward-looking sales analysis, discussions of commercial and technological developments and analysis of market drivers and restraints, including multiple SWOT analyses. There are wide-ranging tables and figures included, as well as a full interview with an authority on the industry. The result is a comprehensive market- and industry-centred study, with detailed analyses and opinion to benefit your work.
Why you should buy Pharmaceutical Product Lifecycle Management 2010-2020
Our report gives you the following benefits in particular:
In our report we consider the advantages and drawbacks of lifecycle management techniques, as well as approaches such as litigating to protect patents and reducing drug development times. We analyse and discuss conditions within the pharma industry, covering commercial, technological, regulatory and legal aspects. Our study considers where the main opportunities and successes will lie from 2010 onwards. Our research shows that optimised product lifecycle management will be of crucial importance to the pharmaceutical industry from 2010 to 2020. But which techniques will best tackle the decline in revenues and growth prevalent in the sector? Our study tackles such questions, providing the information that you require.
Furthermore, our new report profiles twenty leading drugs that are approaching the 'patent cliff' within the next ten years. For those drugs, we investigate and analyse the lifecycle management strategies that companies are using to maximise commercial life and revenue generation. Those leading products include Lipitor, Plavix, Seretide and Seroquel. By analysing approaches the industry is taking, and evaluating the commercial potential for various PLM methods, we provide incisive analysis of pharma PLM activities for this decade.
Comprehensive analysis of pharmaceutical product lifecycle management
Pharmaceutical Product Lifecycle Management 2010-2020 examines that aspect of the pharmaceutical industry and market through a comprehensive review of information sources. We use primary and secondary research. This report provides forward-looking sales analysis, discussions of commercial and technological developments and analysis of market drivers and restraints, including multiple SWOT analyses. There are wide-ranging tables and figures included, as well as a full interview with an authority on the industry. The result is a comprehensive market- and industry-centred study, with detailed analyses and opinion to benefit your work.
Why you should buy Pharmaceutical Product Lifecycle Management 2010-2020
Our report gives you the following benefits in particular:
- You will receive a comprehensive analysis of the prospects for product lifecycle management from 2010 to 2020, including predicted corporate directions, sales analyses and other important data
- You will discover commercial prospects for leading drugs, finding out how companies are protecting their brands through PLM
- You will find out where the pharmaceutical industry and market are heading – technologically and commercially – from 2010 onwards with regards to PLM
- You will discover the prospects for leading companies and their market strategies, with comparisons and predictions of where success will lie from 2010 onwards
- You will identify key industry trends and best practice in PLM
- You will discover the drivers, restraints, competition and opportunities influencing the various aspects of product lifecycle management for pharmaceuticals.
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
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
LIST OF TABLES
Table 2.1 Top Ten Pharmaceutical Products, 2009
Table 4.1 Twenty Leading Prescription Drugs Approaching Patent Expiry from 2010 Onwards
Table 5.1 SWOT Analysis for New Indications, 2010-2020
Table 5.2 SWOT Analysis for Drug Reformulations, 2010-2020
Table 5.3 SWOT Analysis for Combination Drugs, 2010-2020
Table 5.4 SWOT Analysis for OTC Switching, 2010-2020
Table 5.5 SWOT Analysis for Branded Generics, 2010-2020
Table 5.6 SWOT Analysis for M&A Activity, 2010-2020
Table 5.7 SWOT Analysis for Alliances, 2010-2020
Table 5.8 SWOT Analysis for Pricing Activities, 2010-2020
Table 5.9 SWOT Analysis for Patent Protection Strategies, 2010-2020
Table 5.10 SWOT Analysis for Developing New Markets, 2010-2020
Table 5.11 SWOT Analysis for Increasing and Refocusing R&D Expenditure, 2010-2020
Table 5.12 SWOT Analysis for Reducing Drug Development Times, 2010-2020
Table 5.13 SWOT Analysis for Early-Stage Lifecycle Management Activities, 2010-2020
Table 5.14 SWOT Analysis for Branding and Rebranding Activities, 2010-2020
Table 5.15 SWOT Analysis for the PLM Concept, 2010-2020
Table 2.1 Top Ten Pharmaceutical Products, 2009
Table 4.1 Twenty Leading Prescription Drugs Approaching Patent Expiry from 2010 Onwards
Table 5.1 SWOT Analysis for New Indications, 2010-2020
Table 5.2 SWOT Analysis for Drug Reformulations, 2010-2020
Table 5.3 SWOT Analysis for Combination Drugs, 2010-2020
Table 5.4 SWOT Analysis for OTC Switching, 2010-2020
Table 5.5 SWOT Analysis for Branded Generics, 2010-2020
Table 5.6 SWOT Analysis for M&A Activity, 2010-2020
Table 5.7 SWOT Analysis for Alliances, 2010-2020
Table 5.8 SWOT Analysis for Pricing Activities, 2010-2020
Table 5.9 SWOT Analysis for Patent Protection Strategies, 2010-2020
Table 5.10 SWOT Analysis for Developing New Markets, 2010-2020
Table 5.11 SWOT Analysis for Increasing and Refocusing R&D Expenditure, 2010-2020
Table 5.12 SWOT Analysis for Reducing Drug Development Times, 2010-2020
Table 5.13 SWOT Analysis for Early-Stage Lifecycle Management Activities, 2010-2020
Table 5.14 SWOT Analysis for Branding and Rebranding Activities, 2010-2020
Table 5.15 SWOT Analysis for the PLM Concept, 2010-2020
LIST OF FIGURES
Figure 2.1 Numbers of NCEs Approved by the US FDA, 2002-2009
Figure 2.2 Potential for Revenue Erosion Resulting from Patent Expiries, 2009-2014
Figure 3.1 Prescription and Generic Drug Sales: World Market Shares by Volume, 2009
Figure 3.2 Prescription and Generic Drug Sales: World Market Shares by Revenue, 2009
COMPANIES LISTED
Abbott Laboratories
Accord Healthcare
Acino Holding AG
Almirall
Alphapharm
Andrx Corporation
Apotex
Aspen
Astellas Pharma
AstraZeneca
Aurobindo Pharma
Bausch & Lomb
Bayer Pharmaceuticals
Bentley Pharmaceuticals
Biovail Corporation
Boehringer Ingelheim
Bolar Pharmaceuticals
Brand Institute
Bristol-Myers Squibb
Caraco Pharmaceutical Laboratories
Changzhou Pharmaceuticals Factory
Chiesi
China Pharma Holdings
Choong-Wae Pharma Corporation
Cipla
Cobalt
Consilient Health
Daiichi Sankyo
Dr. Reddy's Laboratories
Eisai Pharmaceuticals
Elan Pharmaceuticals
Eli Lilly
Esteve
European Free Trade Association (EFTA)
European Medicines Agency (EMA, EMEA)
European Patent Office
Fokusin
Food and Drugs Administration (US FDA)
Forest Pharmaceuticals
Fujisawa Pharma
Gedeon Richter
Genpharm
GlaxoSmithKline
Glenmark Pharmaceuticals
Handa Pharmaceuticals
Hexal
IMPAX Laboratories
Insight Strategy Advisors
Ipsen
Iscover
Jiansu Hengrui Medicine
Johnson & Johnson
Kern Pharma
Krka Pharmaceuticals
Laboratorios Alter
Laboratorios Belmac
Laboratorios Cinfa
Laboratorios Davur
Laboratorios Rimafar
Lundbeck
Lupin Pharmaceuticals
Matrix Laboratories
Menarini
Merck & Co.
Ministry of Health, Labour and Welfare (MHLW, Japan)
Mitsubishi Tanabe Pharma
MSN Laboratories
Mutual Pharmaceuticals
Mylan
National Institute for Clinical Excellence (NICE, UK)
Norton Healthcare
Novartis
Novopharm
Par Pharmaceuticals
Pfizer
Pharmacia
Pharmascience
Ranbaxy Laboratories
Ratiopharm
Roche
Sandoz
Sanofi-Aventis
Schering-Plough
Schwarz Pharma
Shionogi & Co.
Sigma-Tau Pharmaceuticals
Stada Arzneimittel
Sun Pharmaceuticals
Synthon Chemicals
Takeda Pharmaceuticals
Teikoku Pharma USA
Teva Pharmaceutical Industries
UCB
URL Pharma
URL/Mutual Pharmaceuticals
Ventana Medical Systems
Watson Pharmaceuticals
World Health Organization (WHO)
World Trade Organization (WTO)
Wyeth
Figure 2.1 Numbers of NCEs Approved by the US FDA, 2002-2009
Figure 2.2 Potential for Revenue Erosion Resulting from Patent Expiries, 2009-2014
Figure 3.1 Prescription and Generic Drug Sales: World Market Shares by Volume, 2009
Figure 3.2 Prescription and Generic Drug Sales: World Market Shares by Revenue, 2009
COMPANIES LISTED
Abbott Laboratories
Accord Healthcare
Acino Holding AG
Almirall
Alphapharm
Andrx Corporation
Apotex
Aspen
Astellas Pharma
AstraZeneca
Aurobindo Pharma
Bausch & Lomb
Bayer Pharmaceuticals
Bentley Pharmaceuticals
Biovail Corporation
Boehringer Ingelheim
Bolar Pharmaceuticals
Brand Institute
Bristol-Myers Squibb
Caraco Pharmaceutical Laboratories
Changzhou Pharmaceuticals Factory
Chiesi
China Pharma Holdings
Choong-Wae Pharma Corporation
Cipla
Cobalt
Consilient Health
Daiichi Sankyo
Dr. Reddy's Laboratories
Eisai Pharmaceuticals
Elan Pharmaceuticals
Eli Lilly
Esteve
European Free Trade Association (EFTA)
European Medicines Agency (EMA, EMEA)
European Patent Office
Fokusin
Food and Drugs Administration (US FDA)
Forest Pharmaceuticals
Fujisawa Pharma
Gedeon Richter
Genpharm
GlaxoSmithKline
Glenmark Pharmaceuticals
Handa Pharmaceuticals
Hexal
IMPAX Laboratories
Insight Strategy Advisors
Ipsen
Iscover
Jiansu Hengrui Medicine
Johnson & Johnson
Kern Pharma
Krka Pharmaceuticals
Laboratorios Alter
Laboratorios Belmac
Laboratorios Cinfa
Laboratorios Davur
Laboratorios Rimafar
Lundbeck
Lupin Pharmaceuticals
Matrix Laboratories
Menarini
Merck & Co.
Ministry of Health, Labour and Welfare (MHLW, Japan)
Mitsubishi Tanabe Pharma
MSN Laboratories
Mutual Pharmaceuticals
Mylan
National Institute for Clinical Excellence (NICE, UK)
Norton Healthcare
Novartis
Novopharm
Par Pharmaceuticals
Pfizer
Pharmacia
Pharmascience
Ranbaxy Laboratories
Ratiopharm
Roche
Sandoz
Sanofi-Aventis
Schering-Plough
Schwarz Pharma
Shionogi & Co.
Sigma-Tau Pharmaceuticals
Stada Arzneimittel
Sun Pharmaceuticals
Synthon Chemicals
Takeda Pharmaceuticals
Teikoku Pharma USA
Teva Pharmaceutical Industries
UCB
URL Pharma
URL/Mutual Pharmaceuticals
Ventana Medical Systems
Watson Pharmaceuticals
World Health Organization (WHO)
World Trade Organization (WTO)
Wyeth
