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Expanding Applications of Personalized Medicine: Use of Biomarkers in Prognostic, Predictive and Pharmacogenetic Tests in a Targeted Approach

Published by: Business Insights

Published: Aug. 1, 2009 - 141 Pages


Table of Contents


Expanding applications of personalized medicine
Executive Summary
Overview
Breast cancer
Colorectal cancer
Lung cancer
Other diseases
Future outlook
Chapter 1 Overview
Summary
Introduction
The rise of personalized medicine
Population and disease-based biobanks
Healthcare costs and R&D productivity
Applications
Predictive tests
Prognostic tests
Pharmacogenetic tests
Regulation
US
EU
Regulators response to emerging genomics-based diagnostics
Chapter 2 Breast cancer
Summary
Introduction
Prognostic tests
MammaPrint
Oncotype DX
Uptake of tests
Other prognostic tests
Predictive tests
Hormonal therapies
Taxanes/anthracyclines
Biologicals
Triple negative breast cancer
Other novel biomarkers
Chapter 3 Colorectal cancer
Summary
Introduction
Prognostic tests
Predictive tests
Cetuximab
Panitumumab
Other predictive tests
Chapter 4 Lung cancer
Summary
Introduction
Predictive tests
Gefitinib
Erlotinib
Other predictive tests
Novel therapies
Chapter 5 Other diseases
Summary
Prostate cancer
Ovarian cancer
Malignant melanoma
Non-cancer indications
Cardiovascular diseases
CNS diseases
Chapter 6 Future outlook
Summary
Introduction
Drug development
Clinical trial enrichment
Retrospective study of biomarkers
The importance of tissue collection
Coverage and reimbursement
Conclusion
Appendix
Methodology
Glossary
List of Figures
Figure 1.1: Cancer cases versus five-year survival, US
Figure 1.2: Projected health expenditure, 2009-2018, US
Figure 1.3: New drug approvals and R&D spending, 1996-2008, US
Figure 1.4: Applications of personalized medicine
Figure 2.5: Oncotype DX sales ($m), 2004-2008, US
Figure 2.6: Comparison of Oncotype DX and MammaPrint
Figure 2.7: Simplified schematic of treatment selection in breast cancer
Figure 3.8: Development of KRAS as a predictive marker of cetuximab efficacy
Figure 6.9: Targeted versus non-targeted drug approvals, 1998-2008, US
Figure 6.10: Clinical trials using predictive biomarkers, 2005-2009
Figure 6.11: Drivers and resistors to personalized medicine
List of Tables
Table 1.1: Estimated US cancer cases, by site, 2009
Table 1.2: Drugs with target specific indications
Table 1.3: US drug labels with pharmacogenomic information
Table 2.4: Prognostic breast cancer assays
Table 2.5: Predictive breast cancer assays
Table 2.6: Selected ongoing breast cancer trials
Table 3.7: Selected ongoing colorectal cancer clinical trials
Table 4.8: Selected ongoing lung cancer clinical trials
Table 5.9: Selected ongoing miscellaneous clinical trials

Abstract

Introduction

Against a background of increasing commercial pressures the need to find new markets and exploit them has never been greater. At the same time changes in prevailing healthcare thinking with respect to the role of nutrition means that better nutritional care of patients is increasingly on the agenda of governments and healthcare professionals alike. Add to that the rise in diseases (often associated with aging populations) that can be managed effectively with better nutrition and a burgeoning market segment is being created.

At present this area is not well addressed; clinical nutrition products tend to focus on enteral feeding and functional foods neither target this area presently nor are their benefits specific enough to allow them to do so. But regulatory guidelines are encouraging healthcare professionals to close the gap that exists between the recognition that improved nutrition can aid disease management and recovery and actual practice . Increasingly this means that they can be marketed to with products that help in this goal.

Key findings
  • Nutritional management is a burgeoning market segment which is currently under-targeted. Few products specifically target this area and crucially consumers’ needs and wants are often overlooked and are not reflected in product design.
  • There is a clear need to promote the role that nutritional management can play in order to close the gap between healthcare professionals’ views about the benefits of improved nutritional care of patients and actually prescribing this improved care.
  • Hypertension is easily the leading disease area for companies to target. This is due both the sheer number of sufferers of this disease in Western countries, but also because of the clear links to diets and the role that foods can play in helping manage this disease.
Key features of this report
  • Provides a unique framework that defines a hot growth area of the market which is currently largely overlooked by food companies and clinical nutrition players alike.
  • Identifies, sizes and forecasts the patient populations for key diseases in which nutritional management can play a key role in aiding recovery or provide ongoing disease management.
  • Shows which new ingredients and products, by disease, are most likely to play a role in nutritional management in the future through reviews of the latest scientific research.
Use this report to
  • Understand exactly where opportunities exist for either current products within your portfolio or where new product development could help to open up a new market segment for your company.
  • Develop initial marketing plans and strategies based upon the unique forecast data on the number of disease sufferers and identify areas requiring further research to develop product specific insights.
  • Identify the key areas to target for your company based upon the relative importance of different disease
Discover
  • What exactly is nutritional management and how does this differ to both clinical nutrition and functional foods which are available in retail channels?
  • What are the most important disease areas, by country, where nutritional management can play a role in aiding patients to recover from and manage disease?
  • Which latest products and ingredients are showing the most potential for providing nutritional management benefits in each of the most important disease areas?
  • Will retail functional foods start to encroach on this area and will the latest health claims regulation process in Europe actually encourage this to happen?


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