Pharmaceutical lifecycle management (LCM) is the process of managing the entire lifecycle of a product including its research, design and manufacture, service and disposal. LCM is a well-established tool to maximize sales throughout the product lifecycle and acts as a competitive edge to provide greater profitability and retain market share as the patent expiry or market exclusivity rights of products approaches. LCM planning will continue to be at the forefront of the pharmaceutical industry’s efforts to address declining R&D productivity, stricter reimbursement demands and increasing generic and branded competition.
Pharmaceutical industry continues to face a variety of threats and challenges. These are not new challenges, as they are mostly the result of a wide variety of economic, operational and commercial issues that in many cases have been overlooked, accumulating over decades and increasingly gaining momentum.
Companies in the pharmaceutical industry invest significant capital and resources into preserving the patent life and the subsequent profits of products which take several years to produce.
The potential rapid revenue losses that innovator companies in the pharmaceutical industry can experience due to generic competition calls for the incorporation of sophisticated strategies that allow for maximizing a product’s lifetime value.
Important challenges include pricing pressures, rising development costs, stringent regulatory and reimbursement policies, declining R&D productivity and drug patent cliffs (the immediate decline in sales after the patent expiration). These issues, particularly the productivity gap, leave pharmaceutical companies exposed to generic and biosimilar competition, which can erode a significant percentage of their sales and market share within a short period of time. Companies risk losing up to 90% of the revenue of some of their biggest products to generic and biosimilar competition.
The report “Pharmaceutical Lifecycle Management Strategies in 2017” provides a comprehensive assessment of product lifecycle (LCM) management strategies that are being implemented by pharmaceutical companies around the world.
In depth, this report enables the following:
- Helps to investigate a wide range of commercial, developmental, legal and regulatory strategies.
- Provides deep analysis into the rationale for implementing LCM strategies, as well as the challenges, risks and commercial opportunities.
- To understand the key challenges that the pharmaceutical industry has been facing in recent years.
- What is driving the need for effective LCM strategies in the pharmaceutical industry?
- What are the most common LCM strategies being implemented?
- What are the business opportunities and commercial rewards arising from the implementation of LCM strategies?
- What are the key factors that impact the choice of LCM strategy?
- What strategies have Big Pharma companies implemented in recent years to preserve revenues and market share?
Key Reasons to Purchase
This report will allow you to:
- Gain insights into the rationale for implementing LCM strategies, alongside their key challenges, risks and potential benefits.
- Understand the key challenges that the pharmaceutical industry has been facing in recent years
- Assess real-world examples of successful strategies implemented in the past, and the key factors that determined their success.
- Obtain information on strategies for products currently in development.
2. Executive Summary
3. Introduction to Pharmaceutical Lifecycle Management Strategies
3.1 The Pharmaceutical Product Lifecycle Curve
3.2 Key Objectives of Life Cycle Management Strategies in the
3.3 What is Driving the Need for Effective Lifecycle Management
Strategies in the Pharmaceutical Industry?
3.4 Classification and Benefits of Different Lifecycle Management
Strategies for Pharma
3.5 Business Opportunities Created by LCM Strategies
3.6 Factors Impacting Choice of Lifecycle Strategies
4. Pharmaceutical Lifecycle Management – Commercial Strategies
4.1 Rx-to-OTC Switch as an LCM Strategy
4.1.1 RX-to-OTC Switch Case Studies
4.2 Geographical Expansion
4.3 Contract Research Organizations Helping Overcome Industry Challenges
4.3.1 Benefits from Partnering with Contract Development and
Manufacturing Organizations (CDMOs)
4.3.2 Strategic Partnerships with CROs: Case studies
4.4 Pricing and Reimbursement Strategies for LCM in Pharma
4.4.1 Key Factors and Strategies to Consider when Making Pricing
4.4.2 Common Pricing Strategies in Pharma
4.4.3 A Systematic Value Development Plan to Achieve Optimum
4.5 Customer Retention Programs as LCM Strategies for Pharma
4.5.1 Role of Medical Publications in LCM Optimization
4.6 Asset Transactions as an LCM Tactic
4.6.1 Strategic Divestitures by Type and Recent Examples
5. Regulatory and Legal Strategies
5.1 Data Exclusivity
5.2 Orphan Drug Exclusivity
5.3 Pediatric exclusivity
6. Developmental Strategies
6.1 Introduction and Classification of Developmental Strategies
6.2 Indication Expansion
6.2.1 Key Consideration When Planning for Indication Expansion
6.2.2 Indication Expansion Case Study
6.3.1 Next-Generation Products: Introduction and Key Strategic
6.3.2 Types of Next-Generation Products
126.96.36.199 Chiral Switching
6.3.3 Next-Generation Products: Case Study
6.3.4 New Modes of Drug Delivery
188.8.131.52 Dosage Form: Case study
184.108.40.206 Route of Administration: Case Study
220.127.116.11 Drug delivery technologies: Case Study
6.4 Combination Drugs
6.4.1 Combination Drugs: Case Study
7. Successful LCM Strategies Employed by Big Pharma: Case Studies
7.5 Roche & GSK
7.7 Unsuccessful Implementation of LCM Strategies: Case Study
8. Patent Expiry Dates of Bestselling Pharmaceuticals 2005–2016
9. Life Cycle Management Strategies of Pipeline Products 2017
9.2 Merck & Co
9.3 Johnson & Johnson