Pharmacogenomics For Clinical Use And In Drug Development --- Aarkstore Enterprise

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 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 8

1.1 Statement of Report 8

1.2 Objectives of this Report 8

1.3 Scope of the Study 9

1.4 Methodology 10

1.5 Executive Summary 11

2. Introduction 17

2.1 Pharmacogenomic Testing Overview 17

2.1.1 Clinical Applications 18

2.1.2 Technologies for Pharmacogenomic Diagnostic Tools 19

2.1.3 Drug and Diagnostic Combinations 22

2.1.4 Economic Impact of Healthcare Costs 23

2.2 Genetic Variation among Individuals 33

2.2.1 Population Genomics 33

2.2.2 SNPs and Haplotypes 33

2.2.3 HapMap 35

2.2.3.1 The International HapMap Project 35

2.2.3.2 HapMap Participants and Funding Sources 36

2.3 Drug Metabolism 37

2.3.1 Adverse Drug Reactions (ADRs) 37

2.3.2 Drug-Test Combinations 39

2.4 Impact of Pharmacogenomics 39

2.4.1 How Will Gene Variation Be Used in Predicting Drug Response? 40

2.4.2 How Will Drug Development and Testing Benefit from Pharmacogenomics? 40

2.4.3 Advantages of Pharmacogenomics 40

2.4.4 The DiagnosticsTherapeutics Fusion 41

2.4.5 Potential Challenges 42

2.4.6 Poor Metabolizer Phenotype Testing 44

2.4.7 Drug Repositioning 45

2.5 Pharmacogenomic Tests 46

2.5.1 CYP2D6 46

2.5.2 CYP2C19 and CYP2C9 49

2.5.3 CYP3A4 and CYP3A5 Genotyping 52

2.5.4 CYP1A2 and CYP2B6 54

2.5.5 NAT2, DPD, and UGT1A1 55

2.6 HercepTest 56

2.7 Drivers of Pharmacogenomic Testing 56

2.8 Pharmacogenomics and Drug Discovery 57

2.8.1 Business Implications of Pharmacogenomics in Drug Discovery 58

2.8.2 Impact of Pharmacogenomics on Drug Sales 59

2.8.3 Pressure to Optimize Drug Discovery Drives Use of Pharmacogenomics 60

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