Pharmaceutical Lifecycle Management Strategy

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Perfect your pharmaceutical lifecycle management (LCM) strategy to maximize sales throughout the product lifecycle and retain market share as patent expiry approaches. First, strengthen internal communication and improve portfolio management by combining cross-functional committees and dedicated teams. Then, analyze benchmarks and strategy case studies to choose the right LCM tactic at the right time. This report focuses on 15 LCM strategies across two main categories: market enhancement and line extension. Charts include peak global sales and number of competitors for companies using each tactic; companies’ primary LCM goals for using the tactic; and the timelines, costs and ROI involved in using the tactic. Finally, this report examines teams’ leading LCM challenges and keys to success. Real-company examples explore the most critical element of LCM success, strong leadership, and provide insights on how to use that leadership to drive LCM initiatives.

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Report Details

Publication Date: September 2014
Pages: 196
Chapters: 4
Metrics: 500+
Charts/Graphics: 152

Top Reasons to Buy This Report on Pharmaceutical Lifecycle Management

Reinforce the Need for Cross-Functional Communications: As a new patent cliff nears and pipelines empty, drug companies need to develop or strengthen team structure to better manage their existing portfolios. Executives interviewed for this study are all in agreement that pharmaceutical lifecycle management warrants a dedicated team. Companies that are on the right track to managing drug lifecycles have also begun to add cross-functional or ad hoc committees to assist these dedicated teams. In total, 86% of life science companies have both a dedicated LCM team and a cross-functional LCM committee. This report examines the communication strategies that pharmaceutical lifecycle management teams use and shows which functions are involved in committee decisions and at what points during the product’s lifecycle they contribute to the LCM strategy.

Mix Market Enhancement and Line Extension Tactics to Maximize Product Value: Within lifecycle management planning, companies deal with patent expiry mainly in two ways: either maximize a product’s market impact before patent expiry (market enhancement) or delay a product’s patent expiry altogether (line extension). The traditional LCM method is to delay a product’s patent expiry by creating more products and indications that carry on the brand name; however, this strategy may not actually delay the initial product’s patent.  Market enhancement strategies enable companies to increase their customer base and add value to their existing products by developing relationships with patients and healthcare providers. As a result, market enhancement tactics help companies to earn consumer trust and maximize profits before patent expiry. Learn from this study how superior pharmaceutical lifecycle management teams choose one set of strategies over another. Additionally, use this study’s ROI benchmarks to determine an ideal mix of tactics that create a robust LCM strategy.

You may also be interested in CEIConnect: The Lifesciences Industry’s On-Demand Research Resource as well as our individual portfolio management research reports.

Excerpt from Pharmaceutical Lifecycle Management

Pharma companies and their drugs face numerous challenges in the brief window between launch and patent expiration. These challenges include earlier generic threats, increasing branded drug competition and payers’ demands to see real and meaningful value. Companies are forced to reevaluate their lifecycle management (LCM) strategies to maximize products still under patent protection. Paired with declining pipelines, LCM becomes even more essential. The patent cliff of 2012 saw major blockbuster drugs lose patent protection, and the upcoming patent cliff of 2015 will prove almost as painful.

With seven blockbuster drugs above the $1 billion mark, hopefully these companies have long been planning their LCM strategies. A natural barrier will protect Sanofi’s Lantus because of the difficulty in duplicating biologics. However, other drugs stand to lose sales almost immediately. An increased focus on LCM will help companies maximize product sales now and better prepare a counter-generic strategy in the future. Proactive planning is a key element to any LCM strategy, as timing during exclusivity windows is crucial. An extra day of patent protection could mean millions of dollars for a blockbuster drug.

Table of Contents

8             Executive Summary

12           Study Methodology

13           Study Definitions

15           Lifecycle Management Strategy: Five Principles for Success

22           Streamline LCM Decision Making through Dedicated Teams and Cross-Functional Committees

23           Create A Dedicated Force to Manage LCM Strategy

29           Leverage Cross-Functional Committees to Coordinate LCM Decision Making

44           Measuring LCM Strategy ROI

49           Optimize Product Value with Market Enhancement Strategies

49           Increasing Consumer Base and Profits With Market Enhancement Strategies

119         Align Market Enhancement Strategies with Brand Goals

126         Expand Product Lines and Maintain End-of-Life Sales with Line Extension Tactics

130         Create New Product Lines to Meet Patient Needs and Extend Exclusivity

183         Tailor Line Extension Tactics to Drug Characteristics and LCM Goals

188         Overcoming Challenges in Implementing LCM Strategy

CHARTS AND GRAPHICS

8             Executive Summary

8              Table E.1: 2015 Patent Cliff

9              Figure E.1: Traditional Drug Lifecycle Curve

15           Lifecycle Management Strategy: Five Principles for Success

15           Figure E.2: Drug Lifecycle Curve: Line Extension and Market Enhancement

17           Figure E.3: Percentage of Companies with a Dedicated LCM Team and Cross-Functional LCM Committee

19           Figure E.4: Publications Strategy Cost and ROI

20          Figure E.5: Estimated Return on Investment: Next-Gen Drug

21           Figure E.6: Rankings of Elements Essential to a Successful LCM Strategy

22           Streamline LCM Decision Making through Dedicated Teams and Cross-Functional Committees

23           Create a Dedicated Force to Manage LCM Strategy

23           Figure 1.1: Function Responsible for Lifecycle Management Strategy

24           Figure 1.2: Function Responsible for Lifecycle Management Strategy, by Company Size

26           Figure 1.3: LCM Function Staffing, by Level of Executive

27           Table 1.1: Other FTEs Involved in LCM Strategy

28           Table 1.2: LCM Department Head Reporting Line

29           Leverage Cross-Functional Committees to Coordinate LCM Decision Making

29           Figure 1.4: Percentage of Companies with a Dedicated LCM Team and Cross-Functional LCM Committee

32           Figure 1.5: Functions Contributing to LCM Committee

33           Figure 1.6: Functions Contributing to LCM Committee, by Company Size

35           Figure 1.7: Function Involvement in LCM Strategy: Brand Team

35           Figure 1.8: Function Involvement in LCM Strategy: Marketing

36           Figure 1.9: Function Involvement in LCM Strategy: R&D

36           Figure 1.10: Function Involvement in LCM Strategy: Medical Affairs

37           Figure 1.11: Function Involvement in LCM Strategy: Market Research/Competitive Intelligence

37           Figure 1.12: Function Involvement in LCM Strategy: Business Development

38           Figure 1.13: Function Involvement in LCM Strategy: Strategic Planning

38           Figure 1.14: Function Involvement in LCM Strategy: New Product Planning

39           Figure 1.15: Function Involvement in LCM Strategy: Legal/Regulatory

39           Figure 1.16: Function Involvement in LCM Strategy: Sales

40           Figure 1.17: Function Involvement in LCM Strategy: Market Access

41           Figure 1.18: Number of Committee Meetings per Drug Lifecycle Stage

42           Figure 1.19: Number of Committee Meetings per Drug Lifecycle Stage, by Company Size

43           Table 1.3: Other Roles Handling LCM Strategy

44           Measuring LCM Strategy ROI

45           Figure 1.20: Tools Used to Measure ROI of LCM Strategy, by ROI Tool

46           Figure 1.21: Tools Used to Measure ROI of LCM Strategy, by Company Size

47           Optimize Product Value with Market Enhancement Strategies

48           Figure 2.1: Drug Lifecycle Curve: Market Enhancement

49           Figure 2.2: Prevalence of LCM Strategies: Market Enhancement

49           Increasing Consumer Base and Profits with Market Enhancement Strategies

51            Figure 2.3: Peak Global Sales and Number of Competitors for Companies Using Strategic Pricing

52           Figure 2.4: Primary LCM Goals of Companies Using Strategic Pricing

53           Figure 2.5: Primary LCM Goals of Companies Using Strategic Pricing, by Company Size

54           Figure 2.6: Strategic Pricing Timeline from Planning to Execution

55           Figure 2.7: Amount of Time Spent from Strategy Planning to Execution: Strategic Pricing

56           Figure 2.8: Estimated Cost of Strategy Implementation: Strategic Pricing

57           Figure 2.9: Estimated Return on Investment: Strategic Pricing

58           Figure 2.10: Strategic Pricing Case Study: Company 33

59           Figure 2.11: Peak Global Sales and Number of Competitors for Companies Using Authorized Generics

60           Figure 2.12: Primary LCM Goals of Companies Using Authorized Generics

61           Figure 2.13: Primary LCM Goals of Companies Using Authorized Generics, by Company Size

62           Figure 2.14: Authorized Generics Timeline from Strategy Planning to Execution

63           Figure 2.15: Amount of Time Spent from Strategy Planning to Execution: Authorized Generics

64           Figure 2.16: Estimated Cost of Strategy Implementation: Authorized Generics

65           Figure 2.17: Estimated Return on Investment: Authorized Generics

67           Figure 2.18: Authorized Generics Case Study: Company 30

68           Figure 2.19: Authorized Generics Case Study: Company 3

69           Figure 2.20: Peak Global Sales and Number of Competitors for Companies Using Strategic Alliances/Partnerships

70           Figure 2.21: Primary LCM Goals of Companies Using Strategic Alliances/Partnerships

71           Figure 2.22: Primary LCM Goals of Companies Using Strategic Alliances/Partnerships, by Company Size

72           Figure 2.23: Strategic Alliance/Partnerships Timeline from Planning to Execution

73           Figure 2.24: Amount of Time Spent from Strategy Planning to Execution: Strategic Alliance/Partnerships

74           Figure 2.25: Estimated Cost of Strategy Implementation: Strategic Alliance/Partnerships

75           Figure 2.26: Estimated Return on Investment: Strategic Alliance/Partnerships

76           Figure 2.27: Strategic Alliances Case Study: Company 3

77           Figure 2.28: Peak Global Sales and Number of Competitors for Companies Using Customer Retention Programs

78           Figure 2.29: Primary LCM Goals of Companies Using Customer Retention Programs

79           Figure 2.30: Primary LCM Goals of Companies Using Customer Retention Programs, by Company Size

80           Figure 2.31: Customer Retention Programs Timeline from Strategy Planning to Execution

81           Figure 2.32: Amount of Time Spent from Strategy Planning to Execution: Customer Retention Programs

82           Figure 2.33: Estimated Cost of Strategy Implementation: Customer Retention Programs

83           Figure 2.34: Estimated Return on Investment: Customer Retention Programs

84           Figure 2.35: Customer Retention Programs Case Study: Company 8

86           Figure 2.36: Customer Retention Programs Case Study: Company 10

87           Figure 2.37: Primary LCM Goals of Companies Using Contracting with Large Volume Purchasers

88           Figure 2.38: Primary LCM Goals of Companies Using Contracting with Large Volume Purchasers, by Company Size

89           Figure 2.39: Contracting with Large Volume Purchasers Timeline from Strategy Planning to Execution

90           Figure 2.40: Amount of Time Spent from Strategy Planning to Execution: Contracting with Large Volume Purchasers

91           Figure 2.41: Estimated Cost of Strategy Implementation: Contracting with Large Volume Purchasers

92           Figure 2.42: Contracting with Large Volume Purchasers Case Study: Company 35

93           Figure 2.43: Peak Global Sales and Number of Competitors for Companies Using Publications

94           Figure 2.44: Primary LCM Goals of Companies Using Publications

95           Figure 2.45: Primary LCM Goals of Companies Using Publications, by Company Size

96           Figure 2.46: Publications Timeline from Strategy Planning to Execution

97           Figure 2.47: Amount of Time Spent from Strategy Planning to Execution: Publications

98           Figure 2.48: Estimated Cost of Strategy Implementation: Publications

99           Figure 2.49: Estimated Return on Investment: Publications

101         Figure 2.50: Publications Strategy Case Study: Company 31

102         Figure 2.51: Publications Strategy Case Study: Company 10

104         Figure 2.52: Peak Global Sales and Number of Competitors for Companies Using Pediatric Exclusivity

105         Figure 2.53: Primary LCM Goals of Companies Using Pediatric Exclusivity

106         Figure 2.54: Primary LCM Goals of Companies Using Pediatric Exclusivity, by Company Size

107         Figure 2.55: Pediatric Exclusivity Timeline from Strategy Planning to Execution

108         Figure 2.56: Amount of Time Spent from Strategy Planning to Execution: Pediatric Exclusivity

109         Figure 2.57: Estimated Cost of Strategy Implementation: Pediatric Exclusivity

110         Figure 2.58: Estimated Return on Investment: Pediatric Exclusivity

112         Figure 2.59: Pediatric Exclusivity Case Study: Company 32

114         Figure 2.60: Pediatric Exclusivity Case Study: Company 31

116         Figure 2.61: Patent Litigation Case Study: Company 2

118         Figure 2.62: Divestiture Case Study: Company 54

119         Align Market Enhancement Strategies with Brand Goals

121         Figure 2.63: Choosing Market Enhancement Goals, by Company Size

122         Figure 2.64: Brands’ Market Enhancement Goals, by Peak Global Sales

123         Figure 2.65: Choosing Market Enhancement Goals, by Level of Generic Competition

124         Figure 2.66: Choosing LCM Strategies: Market Enhancement

126         Expand Product Lines and Maintain End-of-Life Sales with Line Extension Tactics

127         Figure 3.1: Drug Lifecycle Curve: Line Extension

129         Figure 3.2: FDA New Drug Application Approvals, 2013

130         Figure 3.3: Prevalence of LCM Strategies: Line Extension

130         Create New Product Lines to Meet Patient Needs and Extend Exclusivity

132         Figure 3.4: Peak Global Sales and Number of Competitors for Companies Using New Formulations

133         Figure 3.5: Primary LCM Goals of Companies Using New Formulations

134         Figure 3.6: Primary LCM Goals of Companies Using New Formulations, by Company Size

135         Figure 3.7: New Formulation Timeline from Strategy Planning to Execution

136         Figure 3.8: Amount of Time Spent from Planning to Execution: New Formulations

137         Figure 3.9: Estimated Cost of Strategy Implementation: New Formulations

138         Figure 3.10: Estimated Return on Investment: New Formulations

140         Figure 3.11: New Formulation Case Study: Company 8

141         Figure 3.12: New Formulation Case Study: Company 36

143         Figure 3.13: Peak Global Sales and Number of Competitors for Companies Using New Indications

144         Figure 3.14: Primary LCM Goals of Companies Using New Indications

145         Figure 3.15: Primary LCM Goals of Companies Using New Indications, by Company Size

146         Figure 3.16: New Indication Timeline from Strategy Planning to Execution

147         Figure 3.17: Amount of Time Spent from Planning to Execution: New Indications

148         Figure 3.18: Estimated Cost of Strategy Implementation: New Indications

149         Figure 3.19: Estimated Return on Investment: New Indications

150         Figure 3.20: New Indication Case Study: Company 31

151         Figure 3.21: New Indication Case Study: Company 52

153         Figure 3.22: Peak Global Sales and Number of Competitors for Companies Using New Dosages

154         Figure 3.23: Primary LCM Goals of Companies Using New Dosages

155         Figure 3.24: Primary LCM Goals of Companies Using New Dosages, by Company Size

156         Figure 3.25: New Dosage Timeline from Strategy Planning to Execution

157         Figure 3.26: Amount of Time Spent from Planning to Execution: New Dosage

158         Figure 3.27: Estimated Cost of Strategy Implementation: New Dosage

159         Figure 3.28: Estimated Return on Investment: New Dosage

160         Figure 3.29: New Dosage Case Study: Company 7

161         Figure 3.30: New Dosage Case Study: Company 10

163         Figure 3.31: Peak Global Sales and Number of Competitors for Companies Using Combination Drugs

164         Figure 3.32: Primary LCM Goals of Companies Using Combination Drugs

165         Figure 3.33: Primary LCM Goals of Companies Using Combination Drugs, by Company Size

166         Figure 3.34: Combination Drug Timeline from Strategy Planning to Execution

167         Figure 3.35: Amount of Time Spent from Strategy Planning to Execution: Combination Drug

168         Figure 3.36: Estimated Cost of Strategy Implementation: Combination Drug

169         Figure 3.37: Estimated Cost of Strategy Implementation: Combination Drug

170         Figure 3.38: New Combination Case Study: Company 3

171         Figure 3.39: New Combination Case Study: Company 52

172         Figure 3.40: Peak Global Sales and Number of Competitors for Companies Using Next-Gen Drugs

173         Figure 3.41: Primary LCM Goals of Companies Using Next-Gen Drugs

174         Figure 3.42: Primary LCM Goals of Companies Using Next-Gen Drugs, by Company Size

175         Figure 3.43: Next-Gen Drug Timeline from Strategy Planning to Execution

176         Figure 3.44: Amount of Time Spent from Strategy Planning to Execution: Next-Gen Drug

177         Figure 3.45: Estimated Cost of Strategy Implementation: Next-Gen Drug

178         Figure 3.46: Estimated Return on Investment: Next-Gen Drug

179         Figure 3.47: Next-Generation Drug Case Study: Company 2

180         Figure 3.48: Next-Generation Drug Case Study: Company 7

181         Figure 3.49: Primary LCM Goals of Companies Using OTC Drugs

182         Figure 3.50: OTC Drug Case Study: Company 40

183         Tailor Line Extension Tactics to Drug Characteristics and LCM Goals

184         Figure 3.51: Choosing Line Extension Goals, by Company Size

185         Figure 3.52: Brands’ Line Extension Goals, by Peak Global Sales

186         Figure 3.53: Choosing Line Extension Goals, by Level of Generic Competition

187         Figure 3.54: Choosing LCM Strategies: Line Extension

188         Overcoming Challenges in Implementing LCM Strategy

189         Figure 4.1: LCM Strategy Effectiveness in Preserving Revenue

190         Figure 4.2: Rankings of Challenges of LCM Strategies, by Company Size

191         Figure 4.3: Rankings of Challenges of LCM Strategies, by Company Size

193         Figure 4.4: Rankings of Elements Most Essential to a Successful LCM Strategy

194         Figure 4.5: Rankings of Elements Most Essential to a Successful LCM Strategy, by Company Size