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2015: Strategic Considerations for the U.S. Pharmaceutical Industry
Publication Date February 2005
Publisher Cambridge Healthtech Advisors
Product Type Strategic Report
Pages 177
ISBN Number not applicable
Product Code CHA013
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Summary
The obstacles to success in the industry over the next ten years are numerous and complicated. 2015: Strategic Considerations for the U.S. Pharmaceutical Industry maps out the competitive, scientific, and regulatory hurdles ahead, and offers insightful and creative business strategies to navigate through the challenges, capitalize on the opportunities, and adapt to change.
This report offers a thorough analysis of current trends and issues that are challenging high-level decision making, including the following:
• The main issues that companies face as a result of globalization.
• The need to align products and markets, and differentiate products.
• Key issues in forming development partnerships.
• Convergence strategies—finding new combinations of formerly distinct market segments for a company’s pharmaceuticals, therapeutic devices, and diagnostic processes or equipment.
• Outstanding needs in new product development & commercialization.
• Managing the regulatory environment and drug approval process.
2015: Strategic Considerations for the US Pharmaceutical Industry builds on this analysis by constructing 4 bold scenarios based on the interaction between these fundamental drivers of change —customized therapeutics versus blockbuster drugs, and free market versus price control. Using these two drivers and their variables, the report details developments in the following four areas:
• Socio-economic
• Technology
• Market and regulatory
• Distribution
The scenarios are based on direct input from industry insiders through in-depth interviews as well as extensive secondary research of the US market. This analysis provides insight into the issues that will shape the industry and prompts managers to begin preparing for long-term changes.
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Content
Chapter 1. Methodology and Executive Summary
1.1. Methodology
-Data Sources
-Process for Conclusions and Report Content
1.2. Executive Summary
Chapter 2. Adapting to Change
2.1. Adapting to Change: Overview
2.2. Responding to Trends
-Increased Globalization
-Evolving Regulatory Enviro nment
-Industry Consolidation
-Innovation and Speed to Market
-Limitations of Blockbuster Model
-The Changing Consumer
2.3. Tracking Changes: Major Players
-Large Pharmaceutical Companies
-HMOs
-Contract Research Organizations
-Biotechnology Companies
-Service Providers
2.4. Importance of Preparing for the Future: Summary
Chapter 3. Factors Driving Change
3.1. Macro-Environment
-Population Demographics
-Economic Factors
-Globalization
-Bio-Terrorism Threat
-Public Policy
3.2. Micro-Environment
-Drug Discovery
-Drug Delivery
-Drug Manufacturing
-Drug Distribution
-FDA and CMS
-Generics
-Healthcare Services
Chapter 4. Current Industry Issues
4.1 . Competitive Landscape
4.2. New Product Introduction
-R&D
-Regulatory Process
-Managing Clinical Trials and Information
-Commercialization
-Distribution Strategies
4.3. Intellectual Property
4.4. Role of Pharmacies and PBMs
4.5. Partnerships
4.6. Mergers and Acquisitions
Chapter 5. Winning Strategies: Addressing Industry Issues
5.1. Overview: Winning in a Competitive Environment
5.2. Aligning Company, Products, Markets, and Customers
-Organizational Design
-Product Pipeline Management
-Product Offerings
-New Product Introduction
-Marketing
-Public Relations
5.3. Leveraging the New Roles of Pharmacies and PBMs
5.4. Effective IP Management
5.5. Stressing Innovation
5.6. Managing the Regulatory Environment
-Drug Approval Processes
-Manufacturing Practices
-Marketing
-Pricing
5.7. Managing Costs
5.8. Optimizing Alliances
Chapter 6. Pharmaceutical Indu stry 2015: Scenario Analysis
6.1. Scenario Analysis: Success in a Changing Environment
6.2. Scenario 1: Customized Therapeutics and Free Market Innovation Rewarded
-Socio-Economic Developments
-Technology Developments
-Market and Regulatory Developments
-Distribution Developments
6.3. Scenario 2: Blockbuster and Free Market
-A Broken Model
-Socio-Economic Developments
-Technology Developments
-Market and Regulatory Developments
-Distribution Developments
6.4. Scenario 3: Blockbuster and Price Control
-Volume is King
-Socio-Economic Developments
-Technology Developments
-Market and Regulatory Developments
-Distribution Developments
6.5. Scenario 4: Customized Therapeutics and Price Control
-Slow Improvements
-Socio-Economic Developments
-Technology Developments
-Market and Regulatory Developments
-Distribution Developments
6.6. Being Prepared for 2015
References
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