Market Report Source

Overview

Combination pharmaceutical products, or fixed-dose combinations (FDC’s), offer benefits to many drug classes due to the additive nature of therapeutic effect and the reduced level of side-effects associated with their use. Their core advantage however is an improvement in convenience that stems from reducing prescription numbers and their associated administrative costs. Although fixed-dose combination drugs have historically attracted disapproval from physicians, who typically prefer to determine the components and ratios of drug applications at their own discretion, a widespread acknowledgement and acceptance of these therapies has now been established. This is largely due to their effectiveness in areas such as HIV and asthma, but the successful positioning of combination products remains difficult in therapeutic areas where combination therapies only provide marginally incremental benefits.

Launching Combination Products is a new report published by Business Insights that provides detailed strategic guidance for the preparation and successful execution of combination product launches. This report performs a comprehensive examination of current competitive pressures, best practices and future developments in key therapeutic areas including cardiovascular, respiratory, HIV and women’s health. Detailed case studies also provide unique insights into the brand extension and franchise development strategies of leading companies and help to identify the key success factors behind recent combination product launches. Discover potential growth opportunities for your brands, identify future combination launches and use case studies to understand the most effective launch strategies across key therapeutic areas with this new report.

Some Key Findings from this Report

• Key cardiovascular combination product launch strategies are focused upon developing franchises within individual indications. Seven of these projects are currently in late-stage development, while three are poised to expand into other risk factors such as diabetes.
• Major diabetes combination product launch strategies are concentrated in franchise development across multiple indications, two of which are currently in late-stage development. However, oral diabetes drugs will continue their expansion with brand extensions.
• Single pill, fixed dose combinations will be introduced to the HIV market as dosing regimens for new therapies become established and replace current market leading combinations. Presently however, the market is still characterized by significant pill burdens.
• The success of combination products is largely dependant upon the implementation of effective branding, pricing and positioning objectives. Although such issues are the primary concern of the product manager, this responsibility should be shared amongst associated product managers, therapy area heads, R&D leads, corporate planning and pricing managers, and sales and marketing.

Top Five Reasons to Order Your Copy Today

• Understand the competitive environment for combination product launches with this report’s detailed analysis of recent, leading and launches in key therapy areas including cardiovascular, respiratory, HIV and women’s health.
• Benchmark the successful strategies of leading companies using report’s case studies that detail a range of combination product tactics applied across a variety of drugs.
• Formulate effective therapy area-specific combination product launch strategies with this report’s analysis of high value opportunities across a number of therapy areas.
• Assess the differences between brand extensions and franchise developments and understand the strategic rationale that will determine which implementation is most effective for your company.
• Develop defensive counter-strategies against combination products with this report’s examination of impending launches and explore repositioning initiatives offered by combination strategies.

Key Issues Examined in this Report

• Patient compliance. Fixed dose combinations provide essential convenience for patients, most notably for chronic diseases involving high pill burdens. However, improved patient compliance is more evident in some treatment settings than in others.
• Cardiovascular risk factor combinations. Combinations in late stage development are attempting targeting a number of cardiovascular risk factors, such as hypertension, dyslipidemia and diabetes. Their potential impact on this broad therapeutic category remains unknown.
• Cancer combinations. The use of multiple drug ‘combinations’ in the treatment of cancer is well established, most prominently with monoclonal antibody and chemotherapies. However, fixed dose combinations are difficult to establish when drugs from different classes are combined into different formulations.
• HIV combinations. There are currently no leading combination therapies in late stage development for HIV, and it will take time for new therapies to be integrated into established treatment paradigms.

Your Questions Answered

• What are the key issues influencing combination products and successful therapy area launches?
• How do combination brand strategies vary by therapy area?
• What are the therapeutic and commercial drivers for developing fixed-dose combination products?
• What are the differences between brand extension and franchise development strategies?
• To what extent have established combination product launches affected key therapy areas?
• What impact will future combination product launches have upon key therapy areas?
• What are the leading combination product opportunities within key therapy areas?

Table of Contents

Executive Summary
An introduction to combination products
Combination product strategies in the cardiovascular market
Combination product strategies in the respiratory market
Combination product strategies in the diabetes market
Combination product strategies in the HIV market
Combination product strategies in the women’s health market
Combination product strategies in other therapeutic markets
Brand extension and franchise development strategies

Chapter 1 An introduction to combination
products
Summary
Introduction
Therapeutic value
Combining therapies
Improved convenience
Commercial value
Brand extension
Franchise development
Leading combination products
Key products
Key therapeutic categories
Key combination product strategies

Chapter 2 Strategies for cardiovascular
products
Summary
Introduction
Leading combination products
Recent combination product launches
Exforge
Future combination product developments
Simcor
Avandia/simvastatin
Key combination product launch strategies

Chapter 3 Strategies for respiratory
products
Summary
Introduction
Leading combination products
Recent combination product launches
Symbicort
Future combination product developments
Singulair/Claritin
Flutiform
Key combination product launch strategies

Chapter 4 Strategies for diabetes products
Summary
Introduction
Leading combination products
Recent combination product launches
Janumet
Duetact
Future combination product developments
Avandia/simvastatin
Synordia
Key combination product launch strategies

Chapter 5 Strategies for HIV products
Summary
Introduction
Leading combination products
Recent combination product launches
Atripla
Future combination product developments
Key combination product launch strategies

Chapter 6 Strategies for women’s health
products
Summary
Introduction
Leading combination products
Recent combination product launches
Lybrel
Angeliq
Future combination product developments
Aprela
DUB-OC
Key combination product launch strategies

Chapter 7 Strategies for other therapeutic
areas
Summary
Introduction
Leading combination products
Anti-infectives
Recent combination product launches
Combigan
Ziana
Pylera
Future combination product developments
Oncology
CNS and pain
Key combination product launch strategies

Chapter 8 Brand extension and franchise
development strategies
Summary
Introduction
Case studies
Diovan, Diovan HCT/Co–Diovan and Exforge
Avandia, Avandamet and Avandaryl
Advair/Seretide
Case study: Kaletra
Case study: Vytorin
Key success factors
Branding
Pricing
Positioning

Chapter 9 Appendix
Sources
Product sales data
Regulatory data
Specific sources

List of Figures
Figure 1.1: Number of combination products by therapy area, 2006
Figure 1.2: Key combination product strategies
Figure 2.3: Key cardiovascular combination product strategies
Figure 3.4: Key respiratory combination product strategies
Figure 4.5: Key diabetes combination product strategies
Figure 6.6: Key women’s health combination product strategies
Figure 8.7: Diovan, Diovan HCT/Co-Diovan sales, 2002-2006
Figure 8.8: Avandia, Avandamet and Avandaryl sales, 2002-2006
Figure 8.9: Advair/Seretide, Flovent/Flixotide and Serevent sales, 2002-2006
Figure 8.10: Kaletra sales, 2002-2006
Figure 8.11: Vytorin, Zetia and Zocor sales, 2002-2006

List of Tables
Table 1.1: Leading brand extension combination products, 2006
Table 1.2: Leading brand extension combination products, 2006
Table 1.3: Leading franchise development combination products, 2006
Table 2.4: Leading brand extension combination products in the cardiovascular market, 2004-2006
Table 2.5: Leading franchise development combination products in the cardiovascular market, 2004-2006
Table 2.6: Recently approved combination products in the cardiovascular market, 2005-2007
Table 2.7: Future combination products in development for the cardiovascular market, 2007
Table 3.8: Leading brand extension combination products in the respiratory market, 2004-2006
Table 3.9: Leading franchise development combination products in the respiratory market, 2004-2006
Table 3.10: Recently approved combination products in the respiratory market, 2005-2007
Table 3.11: Future combination products in development for the respiratory market, 2007
Table 4.12: Leading brand extension combination products in the diabetes market, 2004-2006
Table 4.13: Recently approved combination products in the diabetes market, 2005-2007
Table 4.14: Future combination products in development for the diabetes market, 2007
Table 5.15: Leading franchise development combination products in the HIV market, 2004-200660
Table 5.16: Recently approved combination products in the HIV market, 2005-2007
Table 6.17: Leading brand extension combination products in the women’s health market, 2004-2006
Table 6.18: Leading franchise development combination products in the women’s health market, 2004-2006
Table 6.19: Recently approved combination products in the women’s health market, 2005-2007
Table 6.20: Future combination products in development for the women’s health market, 2007
Table 7.21: Leading brand extension combination products in other therapeutic markets, 2004-2006
Table 7.22: Leading franchise development combination products in other therapeutic markets, 2004-2006
Table 7.23: Recently approved combination products in other therapeutic markets, 2005-2007
Table 7.24: Future combination products in development for other therapeutic markets, 2007