Pharmacodiagnostics are considered the pathway to what has been termed "personalized medicine," the use of molecular analysis to achieve optimum medical outcomes in the management of a patient’s disease or predisposition to disease. As such, personalized medicine promises to bring about a new standard of healthcare, with the possiblity to increase profits, speed clinical trials, achieve better clinical results and satisfy patients. But how can companies earn revenue in this undertaking? What are the likely challenges for pharma companies and IVD companies? Will the current eocnomy impact this emerging market?

This report, Pharmacodiagnostics and Personalized Medicine (Markets, Challenges, Forecasts and Key Players) presents a realistic look at the promise and pitfalls of personalized medicine, with important data useful for business planning and marketing efforts, including:

• Current Market Size for U.S. Pharmacodiagnostics
• Forecasted Likely and 'Best Case' Revenue Projections to 2018.
• An Overview of the Concept, Past Successes and Failures.
• Potential Pitfalls for PM Strategies
• Forecasts for Pharmacodiagnostics in the U.S. Cancer Treatment Markets (by type.)
• Possible Cardiological and Psychiatric Treatment Markets
• 8 Strategic Conclusions And Implications For Entrants in this Market
• Profiles of Key Players in Pharmacodiagnostics

Personalized Medicine has given the diagnostics field a huge boost in terms of publicity/public attention, revenue potential, and investment interest. Still questions exist as to how extensive such testing will be and how soon we will see its growth in clinical applications. There are many hurdles to be overcome, but researchers are confident they can be. For a thorough understanding of the impact that personalized medicine could have on pharmaceutical and diagnostic companies, this report reviews these important factors: including the key challenges new entrants need to overcome to establish a revenue stream, genome costs, the likely 'Shotgun Effect' on Pharmaceutical product lines, the challenge of overcoming privacy concerns in the wake of the GINA legislation, competing cultures between diagnostic and pharmaceutical companies, and other factors. There are numerous companies participating in this market and the number is growing. As part of its unique analysis, the following companies are profiled:

• Abbott Diagnostics
• Affymetrix, Inc.
• Agilent
• Althea Technologies
• Curidium Medica, PLC.
• Dako
• Gen Probe
• Genzyme Corporation
• Ipsogen
• Lipomics
• Osmetech
• Perlegen Sciences
• Provista Life Sciences
• Qiagen
• Singulex
• Theranostics Health
• Ventana Medical Systems

Because of its size and influence, this report (necessarily, Kalorama believes), focuses on the U.S. market.

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