Market Report Source

Overview

During the last fifteen years tremendous advances have been made in deciphering the genetic coding of a variety of species from invertebrates, vertebrates and finally man through the formal initiation of the Human Genome Project in October 2000 and its completion in 2003. This information has helped to increase our understanding of how genetics has a pivotal role in the predisposition of many diseased states, the progression of a course of a disease, as well as a patient’s response to a drug, or lack of it. Now in the 21st Century there is a growing trend towards the development of personalized medicine – the right drug for the right individual.

Table of Contents

Executive Summary
Pharmacogenomics defined
Application & implementation of PGx by the industry
Pharmacogenomic strategies, alliances & licensing opportunities
Pharmacogenomic regulation & implementation
Reimbursement – coverage, coding & payment
Future challenges and opportunities

Chapter 1 Pharmacogenomics defined
Summary
Introduction
What is pharmacogenomics & pharmacogenetics?
Why is pharmacogenomics important?
Rising R&D costs
Long development times
High risk drug development
Current pharmacogenomic environment
PGx testing for targeted therapies
PGx diagnostics to improve safety
Conclusions

Chapter 2 Implementation of PGx by the industry
Summary
Introduction
Current applications
Efficacy studies
Safety and toxicity studies
Dosing studies
Implications
Target identification
Pre-clinical development
Clinical development
Phase 4 development
Conclusions

Chapter 3 Pharmacogenomic strategies, alliances and licensing opportunities
Summary
Introduction
Pharmaceutical strategies to PGx
AstraZeneca
Bayer Schering Pharma
Eli Lilly
GlaxoSmithKline
Pfizer
Roche
Conclusions- Pharma PGx strategies
Biotech strategies to PGx
Amgen
Genentech
Millennium Pharmaceuticals
Conclusions- Biotech PGx strategies
Diagnostic strategies to PGx
Clinical Data
Dako
Diaceutics
Genomic Health
Genzyme Genetics
Monogram Biosciences
Conclusions- Diagnostic PGx strategies
Interactions between stakeholders
Consortia
Intellectual property
IP conclusions
Conclusions

Chapter 4 Adoption of pharmacogenomics by regulators
Summary
Introduction
Regulators: US, Europe and Japan
USA
Europe
Japan
Global PGx harmonization: ICH
In vitro diagnostics
The US
Europe
PGx guidance on IVD devices
Conclusions

Chapter 5 PGx and Health Economics
Summary
Introduction
Reimbursement criteria
Coverage
Coding
Payment
Reimbursement drivers
Reimbursement in the US
Reimbursement in Europe
Eligibility of coverage
Medical support for PGx coverage
Dx coding
Payment and pricing
Case study 1: DPD testing
Cost-effectiveness of PGx
Commercially viable PGx testing
Case Study 2: HLA B*5701 testing
Industry incentives
Conclusions

Chapter 6 Future challenges and opportunities
Summary
Introduction
Challenges
Opportunities
Market trends
Market sales
Conclusions

Chapter 7 Appendix
Acknowledgements
Acronyms
Bibliography
Glossary
Index

List of Figures
Figure 1.1: A genomic timeline
Figure 1.2: The concept of pharmacogenetics
Figure 1.3: Costs, time and success rates associated with drug development
Figure 1.4: R&D costs savings following the application of pharmacogenetics
Figure 1.5: R&D time savings following the application of genomics technologies in drug discovery
Figure 2.6: Applications of PGx/biomarkers in drug development timelines
Figure 2.7: Applications of new technologies to develop new medicines
Figure 2.8: Response rates to current medicines
Figure 2.9: Factors affecting efficacy and outcome of drug treatment
Figure 2.10: Response rates to Iressa
Figure 2.11: US Reported Adverse Drug Reactions (1995-2001)
Figure 2.12: Relationship of drugs, disease, genes and gene products
Figure 2.13: Roche AmpliChip CYP450 array technology
Figure 2.14: Dose response curves to A) penicillin and B) 6MP
Figure 2.15: Warfarin mode of action, metabolism and inter-individual variation
Figure 3.16: Pharmacodynamic biomarkers for dose-selection
Figure 3.17: PGx and biomarkers to aid decision making
Figure 3.18: Bayer’s high tech research platform
Figure 3.19: Obesity patients stratified according drug response and weight loss/weight gain
Figure 3.20: Pfizer- Applying PGx
Figure 3.21: Genotyping an integral part of diagnosis and treatment
Figure 3.22: Roche –Pharmaceuticals’ and diagnostics’ approach
Figure 3.23: Amgen – PGx approach in R&D and Drug Therapy
Figure 3.24: Genentech – development history of Herceptin/HercepTest
Figure 3.25: Genentech – multiple targeted cancer therapy
Figure 3.26: Millennium – molecular classifiers of Velcade response
Figure 3.27: Millennium – Survival classifiers stratifies risk groups
Figure 3.28: Diaceutics Library – Rationale for its CMR model
Figure 3.29: Genomic Health Product Pipeline 2008-2009
Figure 3.30: Genzyme Genetics Product Pipeline 2008-2009
Figure 3.31: Monogram Biosciences molecular diagnostics approach
Figure 4.32: The organization of the Interdisciplinary Pharmacogenomic Review Group (IPRG)
Figure 4.33: FDA’s voluntary PGx submission pathway
Figure 4.34: The organization of the EMEA
Figure 5.35: CMS a dominant third-party payor A) 2002A and B) 2008E
Figure 5.36: Roche – US & EU approval & reimbursement of new tests
Figure 6.37: Market trends and drivers for the industry
Figure 6.38: Challenges in PGx
Figure 6.39: Opportunities in PGx
Figure 6.40: Key stakeholder in PGx
Figure 6.41: Future PGx Landscape
Figure 6.42: Future PGx Landscape
Figure 6.43: PGx Sales Forecasts 2005-2015

List of Tables
Table 1.1: PGx – Gene Association Studies
Table 1.2: Targeted Oncology Products and PGx based tests
Table 1.3: PGx tests to aide prescription and reduce the risk of ADRs
Table 2.4: Patient stratification for Herceptin trials
Table 2.5: Drug withdrawals 1996-2004
Table 2.6: PharmGKB Knowledge Base annotated PGx genes
Table 2.7: Warfarin dosage versus genetic variant
Table 2.8: Disease-associated alleles underlie complex disease phenotypes
Table 3.9: SNP Coverage per candidate gene
Table 3.10: Recent strategic alliances and collaborations in PGx
Table 3.11: PGx driven consortia
Table 5.12: PGx Dx value based pricing
Table 5.13: Types of economic evaluations in health care
Table 5.14: Assessment of the potential cost-effectiveness of PGx interventions
Table 5.15: Potential cost-effective PGx applications