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Pharmacodiagnostics and Personalized Medicine 2009 (Markets,
Challenges, Forecasts and Key Players)
April 1, 2009
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

2. 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.
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

3. 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

4. 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

5. 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
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