Pharmacogenomics for Clinical Use and in Drug Development

Pharmacogenomics for Clinical Use and in Drug Development published by Trimark Publications in June, 2009. This report consists of 244 Pages and the price starts from US $ 3400.

Introduction

Abstract

Pharmacogenomics, the science of individualizing drug therapy based on the genetic makeup of individual patients, offers an unusual opportunity for future market growth. Applying pharmacogenomics would allow doctors to treat specific segments of the population based on their particular responses to a drug. The knowledge of the likely effectiveness of a drug in a patient makes the drug more reliable, and fewer drugs would have to be taken off the market due to adverse reactions in some, but not all, of the patients to whom they were administered. Additionally, reducing the occurrence of adverse effects to a drug effectually reduces the cost of patient care overall. This TriMark Publications study examines the market for diagnostic tests based on this science and the clinical measurement methods, the reagents and supplies being utilized in clinical medicine and the pharmaceutical industry. This report presents an overview of the latest information regarding emerging new products and industry trends and will not only quantify, but also, qualify the pharmacogenomic market segments as an area of research, product development and investment opportunity. Forecasts of the pharmacogenomic market and an analysis of products in the worldwide diagnostics market will provide a basis for understanding the significance of past developments and the immense possibilities of the future.

Table of Contents

1. Overview

• 1.1 Statement of Report
• 1.2 Objectives of this Report
• 1.3 Scope of the Study
• 1.4 Methodology
• 1.5 Executive Summary

2. Introduction

• 2.1 Pharmacogenomic Testing Overview
  • 2.1.1 Clinical Applications
  • 2.1.2 Technologies for Pharmacogenomic Diagnostic Tools
  • 2.1.3 Drug and Diagnostic Combinations
  • 2.1.4 Economic Impact of Healthcare Costs
• 2.2 Genetic Variation among Individuals
  • 2.2.1 Population Genomics
  • 2.2.2 SNPs and Haplotypes
  • 2.2.3 HapMap
    • 2.2.3.1 The International HapMap Project
    • 2.2.3.2 HapMap Participants and Funding Sources
• 2.3 Drug Metabolism
  • 2.3.1 Adverse Drug Reactions (ADRs)
  • 2.3.2 Drug-Test Combinations
• 2.4 Impact of Pharmacogenomics
  • 2.4.1 How Will Gene Variation Be Used in Predicting Drug Response?
  • 2.4.2 How Will Drug Development and Testing Benefit from Pharmacogenomics?
  • 2.4.3 Advantages of Pharmacogenomics
  • 2.4.4 The Diagnostics-Therapeutics Fusion
  • 2.4.5 Potential Challenges
  • 2.4.6 Poor Metabolizer Phenotype Testing
  • 2.4.7 Drug Repositioning
• 2.5 Pharmacogenomic Tests
  • 2.5.1 CYP2D6
  • 2.5.2 CYP2C19 and CYP2C9
  • 2.5.3 CYP3A4 and CYP3A5 Genotyping
  • 2.5.4 CYP1A2 and CYP2B6
  • 2.5.5 NAT2, DPD, and UGT1A1
• 2.6 HercepTest
• 2.7 Drivers of Pharmacogenomic Testing
• 2.8 Pharmacogenomics and Drug Discovery
  • 2.8.1 Business Implications of Pharmacogenomics in Drug Discovery
  • 2.8.2 Impact of Pharmacogenomics on Drug Sales
  • 2.8.3 Pressure to Optimize Drug Discovery Drives Use of Pharmacogenomics

3. Pharmacogenomic Testing Market: Size, Growth and Share

• 3.1 Global Pharmacogenomic Testing Markets by Technology Segments
  • 3.1.1 Market Structure
  • 3.1.2 Market Drivers in the Pharmacogenomic Diagnostics Testing Sector
  • 3.1.3 Market Restraints in Pharmacogenomic Diagnostic Testing Segment
  • 3.1.4 Principal Market Segments for Genomics Testing
    • 3.1.4.1 Diagnostic Testing
    • 3.1.4.2 Pharmacogenomic Testing
    • 3.1.4.3 SNP Identification
  • 3.1.5 Key Players in the Pharmacogenomic Diagnostics Testing Segment
  • 3.1.6 Pharmacogenomic Testing Sector Analysis
• 3.2 U.S. Pharmacogenomic Testing Market
  • 3.2.1 Market Overview
  • 3.2.2 Diagnostic Testing Categories
• 3.3 European Pharmacogenomic Diagnostic Testing Market
• 3.4 Japanese Diagnostic Testing Market

4. Pharmacogenomic Disease Markers

• 4.1 SNPs
  • 4.1.1 SNP Identification Market
  • 4.1.2 Overview of SNP Identification
  • 4.1.3 Strategies for SNP Identification
  • 4.1.4 Candidate Gene Selection
  • 4.1.5 Whole-Genome Linkage Disequilibrium Mapping
  • 4.1.6 SNP Databases
  • 4.1.7 Computational Tools for SNP Identification
  • 4.1.8 SNPbrowser, Applied Biosystems
  • 4.1.9 Progeny Suite, Progeny Software, LLC
  • 4.1.10 Sentrix Array Matrix, Illumina
  • 4.1.11 Third Wave Technologies (a Hologic Company)
• 4.2 Predictive Pharmacogenomics
  • 4.2.1 Cancer Testing
  • 4.2.2 Breast Cancer
  • 4.2.3 Melanoma
  • 4.2.4 Colon Cancer
  • 4.2.5 Predictive Cancer Testing Market Size
  • 4.2.6 Prostate Cancer
  • 4.2.7 Lung Cancer
  • 4.2.8 Acute Myelocytic Leukemia (AML)
  • 4.2.9 Cystic Fibrosis
  • 4.2.10 Genetic Test for Cardiac Ion Channel Mutations (Cardiac Channelopathies)
  • 4.2.11 Cardiac Transplants
  • 4.2.12 Thiopurine S-methyltransferase (TPMT) Genetic Test
  • 4.2.13 CARING Study
  • 4.2.14 Vilazodone
  • 4.2.15 STRENGTH Trials (Statin Response Examined by Genetic HAP Markers)
  • 4.2.16 HIV and AIDS
  • 4.2.17 Herceptin and Tykerb
  • 4.2.18 Asthma
  • 4.2.19 Hepatitis C Viral Load
• 4.3 Examining the Impact of Pharmacogenomics in Specific Disease Application
  • 4.3.1 The Impact of Pharmacogenomics in Bipolar and Other Psychiatric Disorders
  • 4.3.2 Pharmacogenomics in Warfarin Treatment
  • 4.3.3 Pharmacogenomics and Breast Cancer Treatment
  • 4.3.4 Pharmacogenomics of Depression
    • 4.3.4.1 Tricyclic Antidepressants
    • 4.3.4.2 Serotonin Re-uptake Inhibitors
    • 4.3.4.3 Mirtazapine and Venlafaxine
    • 4.3.4.4 Nefazodone, Moclobemide, Reboxetine and Trazodone
  • 4.3.5 Pharmacogenomics of Cardiovascular Disease
    • 4.3.5.1 Beta-blockers
    • 4.3.5.2 Angiotensin II Type 1 Receptor Antagonists and AT1 Receptor Antagonists (Sartans)
  • 4.3.6 Pharmacogenomics of Thromboembolic Disorders
    • 4.3.6.1 Warfarin
    • 4.3.6.2 Acenocoumarol
    • 4.3.6.3 Phenprocoumon
• 4.4 Gene Chips to Detect Cytochrome Variations
  • 4.4.1 AmpliChip CYP450-Roche Diagnostics
  • 4.4.2 GeneChip System-Affymetrix
  • 4.4.3 NanoChip Molecular Biology Workstation-Nanogen, Inc.

5. Pharmacogenomic Testing: Development Issues

• 5.1 Adoption of Pharmacogenomic Testing
  • 5.1.1 Pharmacogenomics Gatekeepers
    • 5.1.1.1 Industry
      • 5.1.1.1.1 Use of Pharmacogenomics in Drug Development
      • 5.1.1.1.2 Co-development of Pharmacogenomics Diagnostics and Drugs
    • 5.1.1.2 FDA as a Gatekeeper of Pharmacogenomics
• 5.2 Factors Influencing the Integration of Pharmacogenomics into Clinical Trials
• 5.3 Moderators of Growth
  • 5.3.1 Classification of Extensive vs. Poor Metabolizer
  • 5.3.2 Genetic Testing
  • 5.3.3 Cost-Benefit of Pharmacogenomic Testing
  • 5.3.4 Workforce Issues
  • 5.3.5 Reimbursement
  • 5.3.6 New CPT Test Codes and Payment Amounts
  • 5.3.7 CMS and Other Third-party Payers
    • 5.3.7.1 Reimbursement Challenges to Pharmacogenomic Testing
    • 5.3.7.2 CMS Regulatory Responsibilities
    • 5.3.7.3 Costs Associated with Pharmacogenomic Testing
• 5.4 Clinical Guidelines and Pharmacogenomic Testing
• 5.5 Good Laboratory Practice (GLP)
• 5.6 Quality Assurance Issues
  • 5.6.1 Criteria Required to Establish a Genomic Test for Clinical Use
  • 5.6.2 Microarrays in Clinical Diagnostic Use
• 5.7 Pre-therapeutic Pharmacogenomic Testing
• 5.8 Regulatory Requirements
• 5.9 Screening
• 5.10 Cost of Phenotyping vs. Genotyping
• 5.11 Pharmacogenomic Tests: New Product Development
• 5.12 Underutilization of Pharmacogenomic Tests

6. Business Trends in the Industry

• 6.1 Pharmacogenomic Initiatives within Pharmaceutical Companies
• 6.2 Pharmacogenomic Testing Growth Factors
• 6.3 Acquisition, License Agreements, Internal Development and Partnerships
• 6.4 Product Testing Depth in Pharmacogenomic Testing
• 6.5 Government Regulation
  • 6.5.1 U.S. Regulations
  • 6.5.2 U.K. Regulations
  • 6.5.3 E.U. Regulations
  • 6.5.4 Japanese Regulations
• 6.6 Increased Market Penetration in Pharmacogenomic Testing
• 6.7 Legal Issues
  • 6.7.1 Federal Policy History
  • 6.7.2 State Policy History
  • 6.7.3 Federal Anti-Discrimination Laws and How They Apply to Genetics
  • 6.7.3.1 The Genetic Information Nondiscrimination Act of 2008 (GINA)
  • 6.7.4 Prescription Drug User Fee Act (PDUFA)
  • 6.7.5 Liability Concerns for Pharmacogenomics Drug and Diagnostic Developers
• 6.8 Barriers to Growth
• 6.9 Drivers of Growth
• 6.10 Product Launches and Developments
• 6.11 Investment Parameters for Diagnostic Companies
• 6.12 Key Elements of the Pharmaceutical Value Chain
• 6.13 An Evaluation of Successful Pharmacogenomic Business Models
• 6.14 Ethical Considerations for Pharmacogenomic Applications
• 6.15 Drug Repositioning Services
• 6.16 Patent Protection of Pharmacogenomic Technology
• 6.17 FDA Product Submission and Review Process
• 6.18 FDA Pipeline for Pharmacogenomic Tests
• 6.19 Adaptive Clinical Trial Design

7. Important Technology Trends in Pharmacogenomics

• 7.1 Trends in Pharmacogenomic Testing
  • 7.1.1 Toxicogenomics
• 7.2 Drug Metabolism
• 7.3 Personalized Medicine: the Genomic and Proteomic Approach
• 7.4 Biomarkers
  • 7.4.1 Cancer
    • 7.4.1.1 Leukemia: Gleevec and Dasatinib (BMS-354825)
    • 7.4.1.2 Gefitinib (Iressa)
    • 7.4.1.3 Colorectal Cancer
• 7.5 Cardiovascular Drugs
  • 7.5.1 Arrhythmia
  • 7.5.2 Hypertension
  • 7.5.3 Hyperlipidemia
  • 7.5.4 Myocardial Infarction
  • 7.5.5 Heart Failure
• 7.6 Future Developments
  • 7.6.1 GSK' s Pharmacogenomic Program
  • 7.6.2 Roche' s Biomarker Strategy
  • 7.6.3 Hypertension Markets
  • 7.6.4 Expression Data to Integrate Pharmacology and Chemistry Data
  • 7.6.5 Metabolomics
  • 7.6.6 Theranostics

8. Overview and Conclusions

• 8.1 The Unrealized Promise of Pharmacogenomics
• 8.2 The New Drug Pipeline
• 8.3 Pharmacogenomics and Regulation
• 8.4 Pharmacogenomics and Reimbursement
• 8.5 Key Considerations for Realizing the Promise of Pharmacogenomics
• 8.6 Development of Easy to Use Point of Care Pharmacogenomic Tests
• 8.7 Development of Pharmacogenomic Tests during Drug Development
• 8.8 Pharmacogenomics' Impact on Commercial Strategies
• 8.9 Pharmacogenomics' Impact on the Blockbuster Model of Drug Development
• 8.10 Pharmacogenomics' Impact on Clinical Trials
• 8.11 Pharmacogenomic Business Models
• 8.12 Structure of Pharmacogenomic Deals and Alliances
• 8.13 Challenges to Pharmacogenomics

9. Company Profiles

• 9.1 Abbott Laboratories
• 9.2 Affymetrix
• 9.3 Agilent Technologies, Inc.
• 9.4 Ambry Genetics
• 9.5 ARCA Biopharma, Inc.
• 9.6 Asper Biotech
• 9.7 AstraZeneca
• 9.8 Bayer
• 9.9 BioTrove, Inc.
• 9.10 Bristol-Myers Squibb
• 9.11 Celera Group
• 9.12 Clinical Data
• 9.13 CombinatoRx, Inc.
• 9.14 Complement Genomics Ltd.
• 9.15 Covance Inc.
• 9.16 CuraGen Corporation
• 9.17 Cypress Bioscience, Inc.
• 9.18 Dako (formerly DakoCytomation)
• 9.19 deCODE Genetics
• 9.20 DNAPrint Genomics
• 9.21 DxS
• 9.22 EraGen Biosciences
• 9.23 EXACT Sciences
• 9.24 Expression Analysis
• 9.25 FivePrime Therapeutics
• 9.26 GE Healthcare
• 9.27 Gene Express, Inc.
• 9.28 GeneGO Inc.
• 9.29 Genelex Corporation
• 9.30 Genentech
• 9.31 Genizon Biosciences Inc.
• 9.32 Genomic Health
• 9.33 Gentris
• 9.34 Genzyme
• 9.35 GlaxoSmithKline
• 9.36 g-Nostics Ltd.
• 9.37 Hologic
• 9.38 Human Genome Sciences
• 9.39 Illumina
• 9.40 Incyte, Inc.
• 9.41 InterGenetics Inc.
• 9.42 Interleukin Genetics
• 9.43 Iris BioTechnologies Inc.
• 9.44 Johnson & Johnson
• 9.45 Lab21
• 9.46 Life Technologies Corporation
• 9.47 Luminex Corp.
• 9.48 MediBIC Group
• 9.49 Melior Discovery Inc.
• 9.50 Merck & Co.
• 9.51 Merck Serano
• 9.52 Millennium Pharmaceuticals
• 9.53 Monogram Biosciences, Inc.
• 9.54 Myriad Genetics, Inc.
• 9.55 Nanogen
• 9.56 Nanosphere
• 9.57 Nitromed
• 9.58 Ocimum Biosolutions
• 9.59 Orchid Cellmark
• 9.60 Ore Pharmaceuticals
• 9.61 PharmaSeq
• 9.62 Prediction Sciences
• 9.63 Predictive Biosciences
• 9.64 Prometheus Laboratories
• 9.65 Progeny Software, LLC
• 9.66 Roche Diagnostics
• 9.67 Response Genetics, Inc.
• 9.68 Sequenom
• 9.69 SimuGen Ltd.
• 9.70 Sosei Group Corporation
• 9.71 Transgenomic, Inc.
• 9.72 TrimGen Corp.
• 9.73 Tripos International
• 9.74 Vertex Pharmaceuticals
• 9.75 VIA Pharmaceuticals, Inc.
• 9.76 Warnex
• 9.77 Wyeth
• 9.78 XDx, Inc.

INDEX OF FIGURES

• Figure 2.1: Roche AmpliChip
• Figure 2.2: FDA Approval Rates for NME Drug Applications vs. R&D Expenditures, 1998-2008
• Figure 2.3: Steps Involved in Bringing a Drug to Market
• Figure 2.4: CYP2C9
• Figure 6.1: Total Spending on Healthcare in the U.S., 1960-2008
• Figure 6.2: The Healthcare Dollar, 2008

INDEX OF TABLES

• Table 1.1: The Success of Pharmacogenomics: Drugs that Utilize Companion Tests, 2008
• Table 2.1: The Difference between Pharmacogenomics and Pharmacogenetics
• Table 2.2: Clinical Applications of Diagnostic Pharmacogenomic Testing
• Table 2.3: Comparison of New Molecular Entity Outcomes for FDA and EMEA (Jan 2006 - October 2008)
• Table 2.4: Timeline for Development of Companion Diagnostics
• Table 2.5: Valid Genomic Biomarkers in the Context of FDA-Approved Drug Labels
• Table 2.6: Potential Benefits of Biomarkers as Companion Diagnostics in Drug Development
• Table 2.7: Groups Participating in the International HapMap Project
• Table 2.8: High-Profile Drug Withdrawals from the Marketplace
• Table 2.9: Response Rates of Patients to a Major Drug for Selected Therapeutic Areas
• Table 2.10 Factors That Determine a Successful Pharmacogenomic Test
• Table 2.11: Pharmacogenomics' Influence on Drug Sales
• Table 2.12: Pharmacogenomics' Effect on Maximizing R&D Productivity
• Table 2.13: Prevalence of Metabolically-Active Enzymes
• Table 2.14: Pharmacogenomics in Phase II and Phase III Trials
• Table 2.15: Drug Testing
• Table 2.16: Factors Affecting Variability in Individual Response to Drug Therapy
• Table 2.17: CYP2D6 Characteristics
• Table 2.18: CYP2D6 Metabolism of Drug Types
• Table 2.19: CYP2C19
• Table 2.20: CYP2C19 Metabolism of Drug Types
• Table 2.21: CYP2C9 Characteristics
• Table 2.22: CYP2C9 Metabolism of Drug Types
• Table 2.23: CYP3A4/5/7 Metabolism of Drug Types
• Table 2.24: CYP1A2 Metabolism of Drug Types
• Table 2.25: CYP2B6 Metabolism of Drug Types
• Table 2.26: Drivers of Pharmacogenomic Testing
• Table 2.27: Markets for Pharmacogenomic Testing
• Table 3.1: Worldwide Pharmacogenomic Market Size by Technology Segments, 2004-2012
• Table 3.2: Total Pharmacogenomic Testing Market Size, 2001-2012
• Table 3.3: Diagnostic Pharmacogenomic Testing Market Size, 2001-2012
• Table 3.4: Benefits of Pharmacogenomic Diagnostics in Patient Care
• Table 3.5: Genotyping Pharmacogenomic Testing Market Size, 2001-2012
• Table 3.6: Benefits of Pharmacogenomics in Clinical Trials and Drug Development
• Table 3.7: Five Key Action Points for Pharmaceutical Companies
• Table 3.8: Global SNP Identification Tools Market Size, 2004-2012
• Table 3.9: Pharmacogenomic Testing Market Structure
• Table 3.10: P450 Isozymes and Pharmaceuticals
• Table 3.11: List of Companies that Market Pharmacogenomic Tests
• Table 3.12: Key Collaborations in the Pharmacogenomics Industry
• Table 3.13: Prominent Drugs Withdrawn from the Market
• Table 3.14: Key Elements in the Drug Development Process
• Table 3.15: Major Suppliers of PCR-based Assays and PCR-based Technologies
• Table 4.1: Methods for Performing NAT
• Table 4.2: SNP Databases
• Table 4.3: Myriad Genetics Predictive Medicine Sales, 2001-2008
• Table 4.4: DNA-based Predictive Medicine Product Sales for Cancer, 2006-2010
• Table 4.5: Developmental Atherosclerosis Drugs
• Table 4.6: Summary of Assays for HIV Viral Load Testing
• Table 4.7: U.S. Market Share of HIV Testing Kits
• Table 4.8: Global HIV Statistics, 2007
• Table 4.9: List of Approved HIV/AIDS Rapid Test Kits, 2009
• Table 4.10: Monogram Bioscience, Inc. Products for HIV Testing
• Table 4.11: CCR-5 Receptor Agonists in Development, 2009
• Table 4.12: Asthma Therapeutic Drug Pipeline
• Table 4.13: Psychiatric Case Studies, Organized Pharmacokinetically
• Table 4.14: Antidepressant Drugs Decreased Clearance with DME CYP2D6
• Table 4.15: Antidepressant Drugs with No Effect Clearance with DME CYP2D6
• Table 5.1: Examples of Gene-Drug Pharmacogenomic Relationships
• Table 5.2: Estimated Cost and Time for Typing of the BRCA1 Gene by Direct Sequencing vs. SNP Array
• Table 5.3: Average Cost of Resistance Testing, 2007
• Table 6.1: U.S. Prescription Drug Expenditures, 2003-2015
• Table 6.2: U.S. Pharmaceutical Market, 1996-2009
• Table 6.3: Top Ten Global Pharmaceutical Companies by Global Sales, 2007
• Table 6.4: Pharmaceutical Companies Ranked by Total R&D Expenditures, 2007
• Table 6.5: Leading Therapy Classes for R&D, 2008
• Table 6.6: Leading Therapy Classes by Global Pharmaceutical Sales (Audited Market), 2007
• Table 6.7: Number of NME Approvals and Mean Approval Times, 1984-2008
• Table 6.8: Global Market for Tools and Consumables Used in Drug Discovery and Development, 1999-2010
• Table 6.9: Leading Therapeutic Classes by U.S. Sales, 2006 and 2007
• Table 6.10: Top Ten Therapeutic Classes by U.S. Dispensed Prescriptions, 2006 and 2007
• Table 6.11: Top Ten Brand Drugs by U.S. Retail, 2007
• Table 7.1: Select Companies Developing Cancer Diagnostics Available as Analyte Specific Reagents (ASRS)
• Table 7.2: Emerging Fields in Biological Science with the Potential to Impact Personalized Medicine

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