医薬品ブランド最適化ガイドブック：ライフサイクルマネジメント戦略

Abstract

Increase the effectiveness of your LCM Strategies:

With pipelines diminishing and generics becoming more aggressive, pharmaceutical companies must maximize their brands' value and time on the market. Strategic and well-orchestrated lifecycle management efforts are crucial to maintaining a brand' s long-term health.

Cutting Edge Information' s report A Guidebook to Pharma Brand Optimization analyzes the inner-workings of lifecycle management strategy, development and implementation processes. This study provides companies with the tools to improve their lifecycle management efforts by exploring top pharmaceutical companies' LCM structures, processes, best practices, strategies and tactical approaches. The report makes its case with metrics and techniques for launching effective lifecycle management efforts.

• Structure and Funding - Learn how pharmaceutical companies are establishing dedicated lifecycle management teams to spearhead efforts. Benchmark functional involvement and funding support.
• LCM Processes, Challenges and Measurements - Examine top companies' lifecycle management LCM objectives and goals. Analyze the processes companies take to launch comprehensive LCM strategies as well as many common challenges they must overcome to be successful.
• Drug Time Periods - Explore the strategies that companies should be considering at three major points in a drug' s lifecycle - pre-launch, peak and mature time periods. Within each time period are LCM tactic profiles that analyze the individual tactics in detail including resources, timeframes and real-world case studies.
• Individual LCM Brand Profiles - Uncover the resource support that individual brands receive for their lifecycle management efforts annually during pre-launch, peak and mature time periods.

Use this study to win additional resource support for your lifecycle management efforts. Examine the brand profiles and case studies to learn from real-world company examples.

Table of Contents

Executive Summary

• Profiled Companies
• Study Methodology
• Lifecycle Management: Five Principles for Success

LCM Structure, Processes and Challenges

• Establishing Best Practices in LCM Structure and Funding
• LCM Processes and Challenges

Pre-Launch time Period

• Divestitures
• New Formulations/Delivery Systems
• Strategic Alliances/Licensing
• Publications Strategy
• Contracting with Large Volume Purchasers

Peak Time Period

• Strategic Pricing
• New Dosing Frequency
• New Dosing Strength
• New Indication
• New Indication
• CRM/Disease Management
• Repurposing

Mature time Period

• Pediatric Indications
• New Combinations
• Next Generation Product
• Patent Litigation
• Branded Generics
• Rx-to-OTC
• Removal from Market

Individual Brand LCM Profiles

• Brand 1
• Brand 2
• Brand 3
• Brand 4
• Brand 5
• Brand 6
• Brand 7

CHARTS AND GRAPHICS

Executive Summary

• Figure Ex. 1: Study Context: Therapeutic Areas Explored in Chapter 5
• Figure Ex. 2: Dedicated Lifecycle Management Team

LCM Structure. Processes and Challenges

• Figure 1.1: Companies' LCM Structures

Establishing Best Practices in LCM Structure and Funding

• Figure 1.2: Dedicated Lifecycle Management Team
• Figure 1.3: Dedicated Lifecycle Management Team Reports to Which Department
• Figure 1.4: Departments Responsible for LCM when No Dedicated Team Exists
• Figure 1.5: Company F' s LCM Structure
• Figure 1.6: Responsible for Spearheading LCM
• Figure 1.7: Other Functions Involved in LCM During Various Time Periods
• Figure 1.8: LCM Budgets Tied to Individual Brands
• Figure 1.9: Funding of LCM Budgets
• Figure 1.1O: Lifecycle Management Ratings

LCM Processes and Challenges

• Figure 1.11: Important Factors to Have a Successful LCM Effort
• Figure 1.12: Areas with Greatest Room for Improvement
• Figure 1.13: Importance of Criteria in Assessing LCM Tactics
• Figure 1.14: LCM Success Measurements

Pre-Launch time Period

• Figure 2.1: Pre-Launch LCM Tactical Timeline
• Figure 2.2: Pre-Launch LCM Strategy Investment Levels
• Figure 2.3: Average Time to Implement Pre-Launch LCM Strategies
• Figure 2.4: Pre-Launch LCM Strategy Time to Implement vs. Return on Investment
• Figure 2.5: Pre-Launch LCM Strategy Return on Investment

Divestitures

• Figure 2.6: Divestitures Dashboard
• Figure 2.7: Planning for Divestitures Begins
• Figure 2.8: Implementation for Divestitures Begins
• Figure 2.9: Effectiveness of LCM Tactic: Divestitures

New Formulations/Delivery Systems

• Figure 2.10: New Formulations/ Delivery Systems Dashboard
• Figure 2.11: Planning for New Formulations/ Delivery Systems Begins
• Figure 2.12: Implementation for New Formulations/Delivery Systems Begins
• Figure 2.13: Effectiveness of LCM Tactic, New Formulations/Delivery systems

Strategic Alliances/Licensing

• Figure 2.14: Strategic Alliances/Licensing Dashboard
• Figure 2.15: Planning for Strategic Alliances/Licensing Begins
• Figure 2.16: Implementation for Strategic Alliances/Licensing Begins
• Figure 2.17: Effectiveness of LCM Tactic: Strategic Alliances/Licensing

Publications Strategy

• Figure 2.18: Publications Strategy Dashboard
• Figure 2.19: Planning for Publications Strategy Begins
• Figure 2.20: Implementation for Publications Strategy Begins
• Figure 2.21: Effectiveness of LCM Tactic, Publications Strategy

Contracting with Large Volume Purchasers

• Figure 2.22: Contracting with Large Volume Purchasers Dashboard
• Figure 2.23: Planning for Contracting with Large Volume Purchasers Begins
• Figure 2.24: Implementation for Contracting with Large Volume Purchasers Begins
• Figure 2.25: Effectiveness of LCM Tactic: Contracting with Large Volume Purchasers

Peak Time Period

• Figure 3.1: Peak (Launch until two years prior to US Patent expiration) LCM Tactical Tiemline
• Figure 3.2: Peak LCM Strategy Investment Levels
• Figure 3.3: Average me to Implement Peak LCM Strategies
• Figure 3.4: Peak LCM Strategy Time to Implement vs. Return on Investment
• Figure 3.5: Peak LCM Strategy Recturn on Investment

Strategic Pricing

• Figure 3.6: Strategic Pricing Dashboard
• Figure 3.7: Planning for Strategic Pricing Begins
• Figure 3.8: Implementation for Strategic Pricing Begins
• Figure 3.9: Effectiveness of LCM Tactic, Strategic Pricing

New Dosing Frequency

• Figure 3.1O: New Dosing Frequency Dashboard
• Figure 3.11: Planning for New Dosing Frequency Begins
• Figure 3.12: Implementation for New Dosing Frequency Begins
• Figure 3.13: Effectiveness of LCM Tactic, New Dosing Frequency

New Dosing Strength

• Figure 3.14: New Dosing Strength Dashboard
• Figure 3.15: Planning for New Dosing Strength Begins
• Figure 3.16: Implementation for New Dosing Strength Begins
• Figure 3.17: Effectiveness of LCM Tactic: New Dosing Strength

New Indication

• Figure 3.18: New Indication Dashboard
• Figure 3.19: Planning for New Indications Begins
• Figure 3.20: Implementation for New Indications Begins
• Figure 3.21: Effectiveness of LCM Tactic: New Indications

CRM/Disease Management

• Figure 3.22: CRM/ Disease Management Dashboard
• Figure 3.23: Planning for CRM/ Disease Management Begins
• Figure 3.24: Implementation for CRM/Disease Management Begins
• Figure 3.25: Effectiveness of LCM Tactic : CRM/Disease Management

Market Repositioning

• Figure 3.26: Market Repositioning Dashboard
• Figure 3.27: Planning for Market Repositioning Begins
• Figure 3.28: Implementation for Market Repositioning Begins
• Figure 3.29: Effectiveness of LCM Tactic :Market Repositioning
• Figure 3.30: Repurposing Dashboard
• Figure 3.31: Planning for Repurposing Begins
• Figure 3.32: Implementation for Repurposing Begins
• Figure 3.33: Effectiveness of LCM Tactic:Repurposing

Mature time Period

• Figure 4.1: Mature (Two years prior to US Patent expiration and beyond) LCM Tactical Timeline
• Figure 4.2: Mature LCM Strategy Investment Levels
• Figure 4.3: Average Time to Implement Mature LCM Strategies
• Figure 4.4: Mature LCM Strategy Time to Implement vs.Return on Investment
• Figure 4.5: Mature LCM Strategy Return on Investment

Pediatric Indications

• Figure 4.6: Pediatric Indications Dashboard
• Figure 4.7: Planning for Pediatric Indications Begins
• Figure 4.8: Implementation for Pediatric Indications Begins
• Figure 4.9: Effectiveness of LCM Tactic :Pediatric Indications

New Combinations

• Figure 4.1O: New Combinations Dashboard
• Figure 4.11: Planning for New Combinations Begins
• Figure 4.12: Implementation for New Combinations Begins
• Figure 4.13: Effectiveness of LCM Tactic : New Combinations

Next Generation Product

• Figure 4.14: Next Generation Product Dashboard
• Figure 4.15: Planning for Next Generation Product Begins
• Figure 4.16: Implementation for Next Generation Product Begins
• Figure 4.17: Effectiveness of LCM Tactic:Next Generation Product

Patent Litigation

• Figure 4.18: Patent Litigation Dashboard
• Figure 4.19: Altace Timeline: Litigation, Settlement, Patent Invalidation, Launch
• Figure 4.20: Planning for Patent Litigation Begins
• Figure 4.21: Implementation for Patent Litigation Begins
• Figure 4.22: Effectiveness of LCM Tactic :Patent Litigation

Branded Generics

• Figure 4.23: Branded Generics Dashboard
• Figure 4.24: Planning for Branded Generics Begins
• Figure 4.25: Implementation for Branded Generics Begins
• Figure 4.26: Effectiveness of LCM Tactic :Branded Generics
• Figure 4.27: Zoloft Timeline: Litigation, Settlement, Generic Launch

Rx-to-OTC

• Figure 4.28: Rx-to OTC Dashboard
• Table 4.1: FDA Rx-to-OTC Switch List
• Figure 4.29: Planning for Rx-to-OTC Begins
• Figure 4.30: Implementation for Rx-to-OTC Begins
• Figure 4.31: Effectiveness of LCM Tactic :Rx-to-OTC

Removal from Market

• Figure 4.32: Removal from Market Dashboard
• Figure 4.33: Planning for Removal from Market Begins
• Figure 4.34: Implementation for Removal from Market Begins
• Figure 4.35: Effectiveness of LCM Tactic: Removal from Market

Individual Brand LCM Profiles

Brand 1

• Brand 1 : Figure 1: Brand1 : Ovewiew
• Brand 1 : Figure 2: Brand1 Competitive Outlook
• Brand 1 : Figure 3: Greatest Threats to Brand1
• Brand 1 : Figure 4: Brand1' s Tactical Approach
• Brand 1 : Figure 5: Brand1' s LCM Tactic Timelines
• Brand 1 : Figure 6: Brand 1: Annual LCM Strategy Investments
• Brand 1 : Figure 7: Brand 1: LCM Strategy Annual Investments by Time Period
• Brand 1 : Figure 8: Brand1' s LCM Headcount Support
• Brand 1 : Figure 9: Percentage of Brand1' s Marketing Budget Allocated to LCM
• Brand 1 : Figure 1O: Brand 1: LCM Strategy Investments, Returns and Returns on Investment Percentages
• Brand 1 : Figure 11: Brand11: LCM Strategies' Average Returns Per Dollar Invested

Brand 2

• Brand 2: Figure 1: Brand 2 Overview
• Brand 2: Figure 2: Brand 2 Competitive Outlook
• Brand 2: Figure 3: Greatest Threats to Brand2
• Brand 2: Figure 4: Brand 2' s Tactical Approach
• Brand 2: Figure 5: Brand 2' s LCM Tactic Timelines
• Brand 2: Figure 6: Brand 2: Annual LCM Strategy Investments
• Brand 2: Figure 7: Brand 2: LCM Strategy Annual Investments by Time Period
• Brand 2: Figure 8: Brand 2' s LCM Headcount Support
• Brand 2: Figure 9: Percentage of Brand 2' s Marketing Budget Allocated to LCM
• Brand 2: Figure 1O: Brand 2: LCM Strategy Investments, Returns and Returns on Investment Percentages
• Brand 2: Figure 11: Brand 2: LCM Strategies' Average Returns Per Dollar Invested

Brand 3

• Brand 3: Figure 1: Brand3 Overview
• Brand 3: Figure 2: Brand3 Competitive Outlook
• Brand 3: Figure 3: Brand3 Greatest Threats to Brand3
• Brand 3: Figure 4: Brand3' s Tactical Approach
• Brand 3: Figure 5: Brand3' s LCM Tactic Timelines
• Brand 3: Figure 6: Brand3: Annual LCM Strategy Investments
• Brand 3: Figure 7: Brand3: LCM Strategy Annual Investments by Time Period
• Brand 3: Figure 8: Brand3' s LCM Headcount Support
• Brand 3: Figure 9: LCM Strategy Investments, Returns and Return on Investment Percentages
• Brand 3: Figure 1O: Brand 3: LCM Strategies' Average Retuns Per Dollar Invested

Brand 4

• Brand4: Figure 1 : Brand 4 Overview
• Brand4: Figure 2 : Brand4 Competitive Outlook
• Brand4: Figure 3 : Brand Greatest Threats to Brand 4
• Brand4: Figure 3:Greatest Threats to Brand4
• Brand4: Figure 4: Brand 4' s Tactical Approach
• Brand4: Figure 5: Brand 4' s LCM Tactic Timelines
• Brand4: Figure 6: Brand 4: Annual LCM Strategy Investments
• Brand4: Figure 7: Brand 4: LCM Strategy Annual Investments by Time Period
• Brand4: Figure 8: Brand 4' s LCM Headcount Support
• Brand4: Figure 9: Percentage of Brand 4' s Marketing Budget Allocated to LCM
• Brand4: Figure 1O: Brand 4: LCM Strategy Investments, Returns and Returns on Investment Percentages
• Brand4: Figure 11: Brand 4: LCM Strategies' Average Returns Per Dollar Invested

Brand 5

• Brand 5: Figure 1:Brand5 Overview
• Brand 5: Figure 2:Brand5 Competitive Outlook
• Brand 5: Figure 3: Greatest Threats to Brand 5
• Brand 5: Figure 4: Brand 5' s Tactical Approach
• Brand 5: Figure 5: Brand5' s LCM Tactic Timelines
• Brand 5: Figure 6: Brand 5: Annual LCM Strategy Investments
• Brand 5: Figure 7: Brand 5: LCM Strategy Annual Investments by Time Period
• Brand 5: Figure 8: Brand 5' s LCM Headcount Support
• Brand 5: Figure 9: Percentage of Brand 5' s Marketing Budget Allocated to LCM
• Brand 5: Figure 1O: Brand 5: LCM Strategy Investments, Returns and Returns on Investment Percentages
• Brand 5: Figure 11:Brand 5: LCM Strategies' Average Returns Per Dollar Invested

Brand 6

• Brand 6 : Figure 1:Brand6 Overview
• Brand 6 : Figure 2:Brand6 Competitive Outlook
• Brand 6 : Figure 3: Greatest Threats to Brand 6
• Brand 6 : Figure 4: Brand 6' s Tactical Approach
• Brand 6 : Figure 5: Brand6' s LCM Tactic Timelines
• Brand 6 : Figure 6: Brand 6: Annual LCM Strategy Investments
• Brand 6 : Figure 7: Brand6 : LCM Strategy Annual Investments by Time Period
• Brand 6 : Figure 8: Brand6' s LCM Headcount Support
• Brand 6 : Figure 9: Percentage of Brand6 Fs Marketing Budget Allocated to LCM
• Brand 6 : Figure 1O:Brand6 : LCM Strategy Investments,Returns and Returns on Investment Percentages
• Brand 6 : Figure 11:Brand6 : LCM Strategies' Average Returns Per Dollar Invested

Brand 7

• Brand 7: Figure 1: Brand 7 Overview
• Brand 7: Figure 2: Brand7 Competitive Outlook
• Brand 7: Figure 3: Greatest Threats to Brand 7
• Brand 7: Figure 4: Brand 7' s Tactical Approach
• Brand 7: Figure 5: Brand7' s LCM Tactic Timelines
• Brand 7: Figure 6: Brand 7: Annual LCM Strategy Investments
• Brand 7: Figure 7: Brand7 : LCM Strategy Annual Investments by Time Period
• Brand 7: Figure 8: Brand 7' s LCM Headcount Support
• Brand 7: Figure 9: Percentage of Brand7' s Marketing Budget Allocated to LCM
• Brand 7: Figure 1O: Brand7 : LCM Strategy Investments,Returns and Returns on Investment Percentages
• Brand 7: Figure 11: Brand7 :LCM Strategies' Average Returns Per Dollar Invested