May 12, 2008 22:26 ET

Focus on the Pharmacogenomic Testing Markets

LONDON, UNITED KINGDOM--(Marketwire - May 12, 2008) - announces that a new market research report related to the Medical devices industry is available in its catalogue.

Pharmacogenomic Testing Markets

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.

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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
2.1.1 Clinical Applications
2.1.2 Demand for Pharmacogenomic Diagnostic Tools Worldwide
2.1.3 Key Factors that Contributed to the Growth of Pharmacogenomic Demand
2.1.4 Clinical Applications
2.1.5 Drug and Diagnostic Combinations
2.1.6 Economic Impact of Healthcare Costs
2.2 Individual Genetic Differences
2.2.1 Population Genomics
2.2.2 SNPs and Haplotypes
2.2.3 HapMap The International HapMap Project HapMap Participants and Funding Sources
2.2.4 Metabolism
2.3 Drug Treatment Outcomes
2.3.1 Contribution of Cytochrome P450s
2.3.2 Adverse Drug Reactions (ADRs)
2.3.3 Drug-Test Combinations
2.4 Role 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 Importance of Testing for the PM Phenotype
2.4.7 Drug Repositioning
2.5 Top Pharmacogenomic Tests
2.5.1 CYP2D6
2.5.2 CYP2C19 and CYP2C9
2.5.3 CYP3A4 and CYP3A5 Genotyping
2.6 Barriers to Pharmacogenomic Testing
2.7 Drivers of Pharmacogenomic Testing

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 Diagnostic Testing Pharmacogenomic Testing 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 LD Mapping
4.1.6 SNP Databases
4.1.7 Computational Tools for SNP Identification
4.1.8 SNPbrowser, Applied Biosystems
4.1.9 ChromosomeBrowser(tm), Orchid Cellmark
4.1.10 Sentrix(r) Array Matrix, Illumina
4.1.11 Celera Discovery System(tm), Celera Genomics, Appelera Corporation
4.1.12 Third Wave Technologies
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 Cystic Fibrosis
4.2.6 Genetic Test for Cardiac Ion Channel Mutations (Cardiac Channelopathies)
4.2.7 Thiopurine S-methyltransferase (TPMT) Genetic Test
4.2.8 CARING Study
4.2.9 Vilazodone
4.2.10 STRENGTH Trials (Statin Response Examined by Genetic HAP Markers)
4.2.11 Predictive Cancer Testing Market Size
4.2.12 HIV and AIDS
4.2.13 Cardiac Transplants
4.2.14 Prostate Cancer
4.2.15 Herceptin and Tykerb
4.2.16 Asthma
4.2.17 Lung Cancer
4.2.18 Hepatitis C Viral Load
4.2.19 Acute Myelocytic Leukemia (AML)
4.3 Examining the Role of Pharmacogenomics in Specific Disease Application
4.3.1 The Role of Pharmacogenomics in Bipolar and Other Psychiatric Disorders
4.3.2 Pharmacogenomics in Warfarin Treatment
4.3.3 Pharmacogenomics and Breast Cancer Treatment
4.4 Gene Chips to Detect Cytochrome Variations
4.4.1 AmpliChip CYP450-Roche Diagnostics
4.4.2 GeneChip System 3000Dx-Affymetrix
4.4.3 NanoChip(r) Molecular Biology Workstation-Nanogen, Inc.

5. Pharmacogenomic Testing: Development Issues
5.1 Adoption of Pharmacogenomic Testing
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
5.4 Clinical Guidelines and Pharmacogenomic Testing
5.5 Good Laboratory Practice
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

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
6.8 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 Pharmacogenomic Applications of Ethical Considerations
6.15 Drug Repositioning Services
6.16 Patent Protection of Pharmacogenomic Technology
6.17 FDA Pipeline for Pharmacogenomic Tests

7. Important Technology Trends in Pharmacogenomics
7.1 Trends in Pharmacogenomic Testing
7.1.1 Toxicogenomics
7.2 Drug Metabolism
7.3 Personalized Medicine for Cardiovascular Disorders: Genomic and Proteomic
7.4 Biomarkers
7.4.1 Cancer Leukemia: Gleevec and Dasatinib (BMS-354825) Colorectal Cancer Cardiovascular Drugs Arrhythmia Hypertension Hyperlipidemia Myocardial Infarction
7.5 Future Developments
7.5.1 GSK's Pharmacogenomic Program
7.5.2 Roche's Biomarker Strategy
7.5.3 Hypertension Markets
7.5.4 Expression Data to Integrate Pharmacology and Chemistry Data
7.5.5 Metabonomics

8. Company Profiles
8.1 Abbott Diagnostics
8.2 Affymetrix
8.3 Ambion (Asuragen)
8.4 Applera Corporation
8.5 AstraZeneca
8.6 Bayer Healthcare
8.7 Bristol-Myers Squibb
8.8 Celera Diagnostics (Appelera Corporation)
8.9 Clinical Data
8.10 CuraGen Corporation
8.11 Dako (formerly DakoCytomation)
8.12 deCODE Genetics
8.13 DNAPrint Genomics
8.14 DxS
8.15 EraGen Biosciences
8.16 EXACT Sciences
8.17 Expression Analysis
8.18 FivePrime Therapeutics
8.19 GE Healthcare
8.20 Genaissance Pharmaceuticals (now Clinical Data)
8.21 Gene Logic (Ore Pharmaceuticals)
8.22 Genentech
8.23 Genomic Health
8.24 Gentris
8.25 Genzyme
8.26 GlaxoSmithKline
8.27 Human Genome Sciences
8.28 Iconix Pharmaceuticals, Inc.
8.29 Illumina
8.30 Incyte, Inc.
8.31 Interleukin Genetics
8.32 Johnson & Johnson
8.33 Luminex Corp.
8.34 Merck & Co.
8.35 Merck KGaA (now Merck Serano)
8.36 Merck Serano
8.37 Millennium Pharmaceuticals
8.38 Myriad Genetics, Inc.
8.39 Nanogen
8.40 Nanosphere
8.41 Nitromed
8.42 Nuvelo, Inc.
8.43 Orchid Cellmark
8.44 Prediction Sciences
8.45 PharmaSeq
8.46 PPGx (now Clinical Data)
8.47 Prometheus Laboratories
8.48 Roche Diagnostics
8.49 Sequenom
8.50 Third Wave Technologies
8.51 Tm Bioscience Corp. (now Luminex)
8.52 Vertex Pharmaceuticals
8.53 Warnex
8.54 Wyeth


Figure 2.1: Relative Contribution of Human CYP450s in Drug Metabolism.


Table 2.1: Clinical Applications of Diagnostic Pharmacogenomic Testing
Table 2.2: Groups Participating in the International HapMap Project
Table 2.3: Drugs Pulled from the Market that Might Have Benefited from Pharmacogenomic Analysis
Table 2.4: Currently-Marketed Drugs that Might Benefit from Pharmacogenomic Analysis
Table 2.5: Major Cytochrome P450 Isozymes
Table 2.6: Examples of Test-Drug Combinations
Table 2.7: Factors that Determine a Successful Pharmacogenomic Test
Table 2.8: Pharmacogenomics' Influence on Drug Sales
Table 2.9: Pharmacogenomics' Effect on Maximizing R&D Productivity
Table 2.10: Prevalence of Metabolically-Active Enzymes
Table 2.11: Role of Pharmacogenomics in Phases II-III Drug Trials
Table 2.12: Pharmacogenomic Drug Development Tests
Table 2.13: AACC Top Ten List of PGx Tests
Table 2.14: CYP2D6
Table 2.15: CYP2D6 Drugs
Table 2.16: Response to Tricyclic Antidepressants
Table 2.17: CYP2C19
Table 2.18: CYP2C9
Table 2.19: Barriers to Pharmacogenomic Testing
Table 2.20: Drivers of Pharmacogenomic Testing
Table 2.21: Users of Pharmacogenomics
Table 2.22: Markets for Pharmacogenomic Testing
Table 3.1: Worldwide Pharmacogenomic Market Size by Technology Segments, 2001-2011
Table 3.2: Total Pharmacogenomic Testing Market Size, 2001-2011
Table 3.3: Diagnostic Pharmacogenomic Testing Market Size, 2001-2011
Table 3.4: Benefits of Pharmacogenomic Diagnostics in Patient Care
Table 3.5: Genotyping Pharmacogenomic Testing Market Size, 2001-2011
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, 2001-2011
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' Withdrawals 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 Consortium Members
Table 4.3: Developmental Atherosclerosis Drugs
Table 4.4: Myriad Genetics Predictive Medicine Sales, 2001-2005
Table 4.5: DNA-based Predictive Medicine Product Sales for Cancer, 2006-2010
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: Monogram Bioscience, Inc. Products for HIV Testing
Table 4.9: Asthma Therapeutic Drug Pipeline
Table 4.10: Psychiatric Case Studies-Organized Pharmacokinetically
Table 6.1: U.S. Prescription Drug Expenditures, 2000-2012
Table 6.2: U.S. Pharmaceutical Market Size and Growth Rate, 1996-2006
Table 6.3: Top Ten Pharmaceutical Companies by U.S. Prescription Sales, 2006
Table 6.4: Top Categories of U.S. Prescription Drug Spending Percentage Total Sales, 2006
Table 6.5: Therapeutic Classes by U.S. Prescription Sales, 2006
Table 6.6: Number of NME Approvals and Mean Approval Times, 1984-2007
Table 6.7: Global Market for Tools and Consumables Used in Drug Discovery and Development, 1999-2010
Table 6.8: Drug Sales Therapeutic Categories as a Percentage of the World Market, 2002 and 2006

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