Pharmacodiagnostics and Personalized Medicine 2009 (Markets, Challenges, Forecasts and Key Players)

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY BACKGROUND

• Potential Benefits of Pharmacodiagnostics
• Pittfalls of Personalized Medicine
• Market Considerations
• Drivers
• Impact of Current Economy
• Likely Market Potential
• Assumptions
• Need for Greater Payoff
• Higher Reimbursement
• Royalty Model
• Best Case Market
• Important Considerations
• Increase in Risk
• ' Shotgun' Effect?
• Privacy and Personalized Medicine
• Scope and Methodology

CHAPTER TWO: OVERVIEW OF PHARMACODIAGNOSTICS PERSONALIZED MEDICINE

• Potential Benefits
• Privacy and Public Perception
• Biomarkers and Pharmacodiagnostics
• Types of Biomarkers

CHAPTER THREE: APPLYING PHARMACODIAGNOSTICS

• Pharmacogentics and Pharmacogenomics
• Historical Basis
• Current Techniques
• Requirements
• Cost-effectiveness
• Applications
• The Cytochrome System
• Cancer
• Recent Activities in Pharmacodiagnostics
• Amgen
• UAMS Multiple Myeloma Project
• DAKO Assay for TOP2A
• GE and Eli Lilly
• Epigenomics and Abbott
• Celera and Merk
• bioMerieiux and Ipsen
• Acute Lymphoblastic Leukemia
• Regulatory Agencies
• Applications of Genome More Challenging Than Expected
• Cardiovascular Disease
• RAS polymorphisms With Drug Effectiveness
• Pgp
• Thiazide diuretics
• 825T allele
• HIT
• Statins
• Psychiatry and Pharmacogenetics/Pharmacogenomics
• Drug Development Rescue
• Is Herceptin a Paradigm?
• A Balancing Act between the Players

CHAPTER FOUR: ESTIMATED MARKET POTENTIAL FOR PHARMACODIAGNOSTICS

• On Estimating Market Potential
• Associated Testing
• The Needs of Pharma and of Diagnostic Companies
• Questions Determining Pharmacodiagnostics Growing
• A Partial Change in Attitude
• Economic Impact
• New Approaches
• Industry Collaborations
• Intellectual Property
• Cancer Market Potential Estimate
• Ideal Market Potential - Cancer, Heart Disease, Psychiatric
• Challenges Unique to Pharmacodiagnostics
• Privacy Concerns
• Fear of Learning about Diseases
• Use of Remnant Samples
• Avoiding Pitfalls of Market Calculation
• Pharmacodiagnostics Not Linked to Molecular Diagnostics
• Demonic and SNP Analysis
• Considering Time of Cooperative Development
• Market Realities to Consider
• Possible Tactic: Royalty Model

CHAPTER FIVE: COMPANY SUMMARIES

• OVERVIEW

CHAPTER SIX: CONCLUSIONS AND STATEGIC IMPLICATIONS

• Payoffs
• Who Leads and Who Follows?
• Risk
• Genome Cost Critical
• ' Shotgun' Effect?
• Possibility of Price Increases
• Orphan Drug Markets
• Privacy Issue to Watch

TABLE OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

• Table 1-1: Likely Market Potential for Pharmacodiagnostics in the United States: 2009 - 2013
• Figure 1-1: Likely Market Potential for Pharmacodiagnostics in the United States: 2009 - 2013
• Figue 1-2: Best Case Market Potential: Potential for Pharmacodiagnostics in the United States: 2009 - 2013

CHAPTER THREE: APPLYING PHARMACODIAGNOSTICS

• Table 3-1: Pharmacodiagnostics Groups
• Table 3-2: Examples of Inherited or Acquired Variations in Enzymes and Receptors Affecting Drug Response and Toxicity
• Table 3-3: Frequency of Recessive Traits
• Table 3-4: Existing Cancer Drugs Complimentary to Pharmacodiagnostics
• Table 3-5: Genes Believed to Affect Cardiovascular Drug Metabolism (Drug/Drug Class, Associated Gene)

CHAPTER FOUR: ESTIMATED MARKET POTENTIAL FOR PHARMACODIAGNOSTICS

• Table 4-1: Markets for Cancer Pharmacodiagnostics if All Patients Tested, by Cancer Site (Oral, Digestive System, Respiratory System, Bones, Soft Tissue, Skin, Breast, Genital, Urinary, Eye, Brain, Endocrine, Lymphoma, Myeloma, Leukemia, Others)
• Figure 4-2: Markets for Cancer Pharmacodiagnostics if All Patients Tested, by Cancer Site (Oral, Digestive System, Respiratory System, Bones, Soft Tissue, Skin, Breast, Genital, Urinary, Eye, Brain, Endocrine, Lymphoma, Myeloma, Leukemia, Others)
• Table 4-2: The Ideal Potential Pharmacodiagnostics Markets for Therapeutics Addressing Four High-Profile Cancers: 2008
• Figure 4-3: The Ideal Potential Pharmacodiagnostics Markets for Therapeutics Addressing the Top Four, High-Profile Cancers: 2008
• Figure 4-1 Market If All Cancer Patients Tested Compared to Current Cancer Diagnostics
• Figure 4-3: The Ideal Pharmacodiagnostics Market (Ideal vs. Likely to Benefit)
• Figure 4-4: Subset of Ideal Market Likely to Benefit from Pharmaceutical Intervention (Likely to Benfit vs. Realistic Market)
• Table 4-3: Market Projections for Pharmacodiagnostics in the United States: 2008 - 2018 (Realistic, Likely Potential, Hi Reimbursement, Absolute Best Case) millions
• Figure 4-5: Market Projection Trends for Pharmacodiagnostics* in the United States: 2008 - 2018