• Background
  
  
  • Potential Benefits of Companion Diagnostics
    
  • Pitfalls of Personalized Medicine
    
  • Scope and Methodology
    
  • Market Factors and Estimates
    
  • Drivers For Companion Diagnostics
    
  • Assumptions
    
  • Important Trends
    
  • Possible Tactic: Royalty Model

CHAPTER TWO: OVERVIEW OF COMPANION DIAGNOSTICS

• Personalized Medicine
  
• Potential Benefits
  
• Privacy and Public Perception
  
• Biomarkers and Companion Diagnostics
  
  
  • Types of Biomarkers

CHAPTER THREE: APPLICATIONS OF COMPANION
DIAGNOSTICS

• Pharmacogenetics and Pharmacogenomics
  
• Historical Basis
  
• Current Techniques
  
• Requirements
  
• Cost-effectiveness
  
• Applications
  
  
  • The Cytochrome System
    
  • Cancer
    
  • Amgen
    
  • UAMS Multiple Myeloma Project
    
  • DakoAssay 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
  
• Is Herceptin a Paradigm?
  
• A Balancing Act Between the Players

CHAPTER FOUR: MAJOR WORLD MARKET FACTORS AND
DATA FOR COMPANION DIAGNOSTICS

• Estimating Market Potential
  
• Associated Testing
  
• The Needs of Pharma and of Diagnostic Companies
  
• Questions Determining Companion Diagnostics Growth
  
• A Partial Change in Attitude
  
• Intellectual Property
  
• Cancer Market Potential Estimate
  
• Ideal Market Potential - Cancer, Heart Disease, Psychiatric
  
• Source: Kalorama Information
  
• Challenges Unique to Companion Diagnostics
  
• Privacy Concerns
  
• Fear of Learning About Diseases
  
• Use of Remnant Samples
  
• Avoiding Pitfalls of Market Calculation
  
• Companion Diagnostics 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
  
• Abbott (Molecular) Diagnostics Subsidiary of Abbott Laboratories
  
• Affymetrix, Inc.
  
• Agilent Technologies, Inc
  
• Althea Technologies, Inc.
  
• Curidium Medica plc
  
• Dako
  
• Gen Probe
  
• Genzyme Corporation
  
• Ipsogen SAS
  
• Lipomics Technologies, Inc.
  
• Osmetech plc
  
• Perlegen Sciences
  
• Provista Life Sciences
  
• Qiagen NV
  
• Singulex, Inc.
  
• Theranostics Health
  
• Ventana Medical Systems

CHAPTER SIX: CONCLUSIONS AND STATEGIC IMPLICATIONS

• First Conclusion
  
• Implications:
  
  
• Second Conclusion
  
• Implications:
  
• Third Conclusion
  
• Implications:
  
• Fourth Conclusion
  
• Implications:
  
• Fifth Conclusion
  
• Implications:
  
• Sixth Conclusion
  
• Implications:
  Seventh Conclusion
  Implications:
  
• Eighth Conclusion
  
• Implications:
  
• Ninth Conclusion
  
• Implications:
  
• Tenth Conclusion
  
• Implications:

APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS

CHAPTER ONE: EXECUTIVE SUMMARY

• Table 1-1: Market Projections for Companion Diagnostics*
  in the United States: 2008 - 2018

  
  

• Figure 1-1: Market Projection Trends for Companion Diagnostics
  in the United States: 2008 - 2018

CHAPTER THREE: APPLICATIONS OF COMPANION DIAGNOSTICS

• Table 3-1 Companion Diagnostics Groups

  
  

• Table 3-3: Frequency of Recessive Traits

  
  

• Table 3-4: Existing Cancer Drugs Complimentary to Companion Diagnostics

  
  

• Table 3-5: Recent Activities in Companion Diagnostics

CHAPTER FOUR: MAJOR WORLD MARKET FACTORS AND
DATA FOR COMPANION DIAGNOSTICS

• Table 4-1: The Ideal Potential Companion Diagnostics Markets for
  Cancer Therapeutics: 2008

  
  

• Figure 4-1: The Ideal Potential Companion Diagnostics Markets
  for Cancer Therapeutics: 2008

  
  

• Table 4-2: The Ideal Potential Companion Diagnostics Markets for
  Therapeutics Addressing the Top Four, High-Profile Cancers: 2008

  
  

• Figure 4-2: The Ideal Potential Companion Diagnostics Markets for
  Therapeutics Addressing the Top Four, High-Profile Cancers: 2008

  
  

• Figure 4-3: The Ideal Companion Diagnostics 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 Companion Diagnostics* in
  the United States: 2008 - 2018

  
  

• Figure 4-1: Market Projection Trends for Companion Diagnostics*
  in the United States: 2008 - 2018

CHAPTER SIX: CONCLUSIONS AND STATEGIC IMPLICATIONS

• Table 6-1: Hypothetical Cancer Therapy Outcome Based on Associated Genes

Abstract

Essentially the co-development of testing products to enhance the value and efficacy of a therapeutic, companion diagnostics is widely seen as an important growth strategy in both the diagnostic and pharmaceutical industries. It is envisioned as a pathway to personalized medicine, where the right therapeutic is selected for the right patient. Personalized medicine is one of the key trends in healthcare, and it's no surprise that there is great enthusiasm in many quarters of the in vitro industry, pharmaceutical companies and the investment community about companion diagnostics. But will the concept work in the fashion that the industry is envisioning? Who will succeed and with what strategy? How much can companies expect to earn in this field? What strategies should companies adopt to thrive in this market?

In this report, Kalorama Information analyst Kenneth Krul, PhD. brings a real-world view to the concept of companion diagnostics and the likely scenario given market conditions. He addresses the myriad challenges that diagnostic and pharmaceutical companies will face in this endeavor. He outlines strategies that will be more successful. His analysis includes:

• A Complete Explanation of Companion Diagnostics
• Realistic Market Forecasts for the Companion Diagnostics to 2018
• A Glossary of Terms Used in this Industry
• Review of Collaborations Between Pharma and Diagnostic Companies
• Possible Pitfalls the Companion Diagnostic Concept will Face.
• Companies Best Poised to Profit From This Market
• 10 Strategic Conclusions about the Market and Implications for Marketers
• The Key Therapeutic Areas Where Companion Diagnostics Could Succeed.
• The Best Approaches for Companion Diagnostics Marketing

The following companies and their efforts in companion diagnostics are profiled in this report:

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