Report: Genetics Bundle TOC

Bioinformatics Markets

1. Overview

1.1 Statement of Report
1.2 About this Report
1.3 Scope of this Report
1.4 Methodology
1.5 Executive Summary

2. Introduction

2.1 Global Bioinformatics Products Industry
2.2 Computers and Biology
2.3 Bioinformatics and the Internet
2.4 Company Evaluation Overview
2.5 Market Outlook
2.6 Competitive Structure
2.7 Applications of Bioinformatics
- 2.7.1 Medicine
- 2.7.2 Microbial Genomics
- 2.7.3 Agriculture
2.8 R&D
- 2.8.1 Allocation of R&D
- 2.8.2 Traditional Drug Discovery Process
- 2.8.3 Drug Discovery and Bioinformatics
- 2.8.4 Collaborative Agreements
2.9 The Human Genome Project (HGP)
- 2.9.1 Goals of the Human Genome Project
- 2.9.2 Benefits of the Human Genome Project
2.10 Barriers to Entry
2.11 Proteomics and Databases
- 2.11.1 Protein Database Standards
- 2.11.2 Future Trends

3. The U.S. Bioinformatics Market

3.1 Overview
3.2 Market Restraints and Drivers
- 3.2.1 Market Restraints
- 3.2.2 Market Drivers

4. Genomics

4.1 The Biotechnology Industry
4.2 The Development of a Genomics Market
- 4.2.1 Market Drivers
- 4.2.2 Market Restraints
- 4.2.3 Market Size and Growth Projections
- 4.2.4 The U.S. Genomics Market
4.3 Biochips and DNA Microarrays
- 4.3.1 Key Challenges
- 4.3.2 Freeware
- 4.3.3 New Tools
4.4 Bioinformatics
4.5 Disease Targets
4.6 Functional Genomics
4.7 Gene Sequencing
4.8 Gene Sequence Variation Detection
4.9 Comparative Genomics
4.10 Genome Database Arrays
4.11 High-throughput Genomics
- 4.11.1 High-throughput Technology
- 4.11.2 Lab on a Chip
4.12 Pharmacogenomics
4.13 Probe Arrays
- 4.13.1 Gene Expression Monitoring Arrays
- 4.13.2 DNA Analysis Arrays
4.14 Proteomics
4.15 Sequencing
4.16 Single Nucleotide Polymorphisms (SNPs)
4.17 Structural Genomics
4.18 Photolithography
4.19 Instrumentation

5. The Bioinformatics Industry

5.1 Definition and Role of Bioinformatics
- 5.1.1 Bioinformatics Sector Overview
- 5.1.2 The Future Status of Bioinformatics
- 5.1.3 Barriers to Growth
5.2 Types of Data and Bioinformatics Applications
- 5.2.1 Validated Core Modeling Technology
- 5.2.2 Broad Applicability
- 5.2.3 Data Management Compliant with Industry Standards
- 5.2.4 Open Architecture
- 5.2.5 Ease of Use
- 5.2.6 Increased Access
5.3 Functions of Bioinformatics Software
- 5.3.1 Data Management
- 5.3.2 Data Transformation
- 5.3.3 Data Collaboration
- 5.3.4 Interface for Online Data Sources
5.4 Target Markets for Informatics Software
5.5 Steps Involved in Bringing a Drug to Market
5.6 Costs Incurred in Developing a New Drug
5.7 Industry Drivers and Challenges
5.8 Industry Risks
5.9 Products of Bioinformatics
5.10 Bioinformatics Processes
5.11 Informatics Tools and Functionalities
- 5.11.1 Sequence to Structure
- 5.11.2 Lead Identification and Optimization
- 5.11.3 Development and Formulation
- 5.11.4 Improving Materials and Processes
- 5.11.5 Other Materials-Based Industries
5.12 Role of Bioinformatics in the Biotechnology Value Chain
5.13 Bioinformatics Market Segment
- 5.13.1 Databases
- 5.13.2 Hardware
- 5.13.3 Software
- 5.13.4 Bioinformatics Services
5.14 Bioinformatics Market Size
- 5.14.1 Sales and R&D
- 5.14.2 IT Budget
- 5.14.3 Projected Bioinformatics Market Size
5.15 Global Market Perspective

6. Bioinformatics Business

6.1 Bioinformatics Business Models
- 6.1.1 Changing Business Models
- 6.1.2 Competition for Pure Play Informatics Companies
- 6.1.3 Non-Profit Organizations
- 6.1.4 In-House Bioinformatics Solutions
- 6.1.5 Large IT Companies
6.2 Bioinformatics Target Disciplines
- 6.2.1 Comparative Genomics
- 6.2.2 Pharmacogenomics
- 6.2.3 Functional Genomics
- 6.2.4 Proteomics
- 6.2.5 Structural Genomics
- 6.2.6 Image Informatics
- 6.2.7 Clinical Trial Informatics
- 6.2.8 Cheminformatics
6.3 Bioinformatics Architecture
6.4 Bioinformatics Applications
- 6.4.1 Data Search Tools
- 6.4.2 Data Visualization Tools
- 6.4.3 Data Mining and Clustering
- 6.4.4 Enterprise Solutions
- 6.4.5 Data Warehousing
6.5 Evaluation of Bioinformatics Solutions
- 6.5.1 Requirements of Study
- 6.5.2 Shortlisting the Options
- 6.5.3 Scoring Patterns
- 6.5.4 Performance
- 6.5.5 Data Storage
- 6.5.6 Data Management in Drug Discovery
- 6.5.7 Key Issues in Bioinformatics Data Storage
6.6 Convergence of Industries
6.7 Proteins as a Driver
6.8 Current Bioinformatics Research
6.9 New Bioinformatics Modeling Algorithms
6.10 3D Modeling
6.11 Patenting Bioinformatics Algorithms

7. Recent Industry Activity

7.1 Collaborations and Acquisitions
7.2 Product Development and Launches

8. Corporate Profiles

8.1 Abbott Laboratories
8.2 Abgenix
8.3 Ablynx
8.4 Accelrys
8.5 Affimed Therapeutics
8.6 Affitech
8.7 Affymetrix
8.8 Agencourt Bioscience Corporation
8.9 Agensys
8.10 Agilent Technologies
8.11 Alexion Pharmaceuticals
8.12 AlgoNomics
8.13 ALLEZ Software
8.14 Amgen
8.15 Antisoma
8.16 Applied Biosystems
8.17 Arana Therapeutics
8.18 Ariadne Genomics
8.19 Array Genetics
8.20 Astellas Pharma
8.21 AstraZeneca
8.22 Automated Handling Systems
8.23 Avesthagen, Limited
8.24 Bioalma
8.25 BIOBASE Biological Databases
8.26 BioCarta
8.27 Biodatabases (AMITA Corporation)
8.28 BioDiscovery
8.29 Biogen Idec
8.30 BioInformatics
8.31 BioInformatics Services
8.32 BioInformatics Solutions
8.33 Biomax Informatics
8.34 BioServe Technologies
8.35 Biosiris
8.36 BioSoftSolutions
8.37 Biotique Systems
8.38 BioInvent International
8.39 Biosite Discovery
8.40 BioWa
8.41 BioWisdom
8.42 Bio-Xtal
8.43 Boehringer Ingelheim
8.44 Cambridge Antibody Technology Group
8.45 Capital Genomix
8.46 Celera Group
8.47 Cellectis
8.48 Cellomics
8.49 CeuticalSoft
8.50 Chemical Computing Group
8.51 Cimarron Software
8.52 CLONDIAG Chip Technologies
8.53 CodonCode Corporation
8.54 CompuDrug International
8.55 Compugen USA
8.56 Corimbia
8.57 Crucell
8.58 CSIRO Bioinformatics
8.59 CuraGen Corporation
8.60 CyberGene
8.61 Cytogen
8.62 Data Unlimited International
8.63 deCODE Genetics
8.64 Decodon
8.65 Deltagen
8.66 Digilab
8.67 DNA Software
8.68 DNAPrint Genomics
8.69 DNA Star
8.70 DxS
8.71 Dyax Corp.
8.72 Eisai
8.73 Elan Corporation
8.74 Electric Genetics Corporation
8.75 Elusys Therapeutics
8.76 Entagen
8.77 Entelos
8.78 Enzon Pharmaceuticals
8.79 Epigenomics
8.80 ePitope Informatics
8.81 EraGen Biosciences
8.82 European Bioinformatics Institute (EBI) Industry Programme
8.83 Evolutionary BioInformatics
8.84 Genamics
8.85 GeneData
8.86 Gene Logic
8.87 Genentech
8.88 Geneva Bioinformatics (GeneBio)
8.89 Genmab
8.90 GenOdyssee
8.91 Genolyze
8.92 Genomatica
8.93 GenomeQuest
8.94 Genomic Solutions
8.95 Genomining
8.96 Genovac
8.97 Genzyme
8.98 Geospiza
8.99 GlaxoSmithKline
8.100 Glycominds
8.101 Health Discovery Corporation
8.102 Hitachi Corporate Technology Group
8.103 IBM Life Sciences
8.104 ImClone Systems
8.105 ImmunoGen
8.106 Immunomedics
8.107 Improved Outcomes Software
8.108 INCOGEN
8.109 Incyte Corporation
8.110 Informagen
8.111 Ingenuity Systems
8.112 InNexus Biotechnology
8.113 Insilicos
8.114 Intrexon Corporation
8.115 Invitrogen Corporation
8.116 IO Informatics
8.117 Johnson & Johnson
8.118 LabVantage Solutions
8.119 Lexigen
8.120 Lifespan Biosciences
8.121 Lion Bioscience
8.122 MathEcology
8.123 Matrix Science
8.124 Medarex
8.125 Medicel
8.126 MedImmune
8.127 Merus
8.128 METabolic Explorer
8.129 Metahelix Life Sciences
8.130 Metalife
8.131 Micromet
8.132 Millennium Pharmaceuticals
8.133 Molecular Connections
8.134 Molecular Networks
8.135 Molecularware
8.136 MorphoSys
8.137 Nexus Genomics
8.138 Nonlinear Dynamics
8.139 Novartis
8.140 Ocimum Biosolutions
8.141 OmniViz
8.142 Partek
8.143 PDL BioPharma
8.144 Perlegen Sciences
8.145 Philogen
8.146 Philotec
8.147 Prokaria
8.148 Quantiom Bioinformatics
8.149 Relevant Software
8.150 Roche
8.151 Rosetta Inpharmatics
8.152 Sanofi-Aventis
8.153 SBI Science
8.154 Seascape Learning
8.155 Seattle Genetics
8.156 Scil Proteins
8.157 Simulations Plus
8.158 Spotfire
8.159 Strand Life Sciences
8.160 Sun Microsystems
8.161 Symphogen
8.162 Syngene
8.163 Tahoe Informatics
8.164 Tanox
8.165 3rd Millennium
8.166 ThromboGenics
8.167 Thomson Reuters
8.168 TIB MOLBIOL
8.169 Trion Pharma
8.170 Tripos
8.171 UBI Life Sciences
8.172 Viventia Biotech
8.173 VizX Labs
8.174 Wyeth
8.175 Xcellerex
8.176 Xencor
8.177 Xoma
8.178 Xpogen

INDEX OF FIGURES

Figure 4.1: Representation of Biotechnology Market, Geographically, 2008
Figure 5.1: Informatics Applications along the Drug-Discovery Value Chain
Figure 5.2: Functions of Bioinformatics Software in Research
Figure 5.3: EMBL Database Growth, 1995-2008
Figure 5.4: The Steps Involved in Bringing a Drug to Market
Figure 5.5: The Breakdown of Total Costs in New Drug Development, 2007
Figure 5.6: The Role of Bioinformatics in the Biotechnology Value Chain
Figure 5.7: Worldwide Pharmaceutical Sales and R&D Expenditures, 2000-2013
Figure 5.8: Worldwide Growth in IT Budget, 2000-2013
Figure 5.9: Worldwide Bioinformatics Market, 2000-2013
Figure 6.1: Steps of a Proteomics Experiment
Figure 6.2: Bioinformatics Architecture

INDEX OF TABLES

Table 2.1: Leading Biotechnology Companies
Table 2.2: Total of Domestic U.S. R&D, 2006-2013
Table 2.3: Global Biotechnology Market, 2007
Table 2.4: SIB Informatics Databases
Table 4.1: The U.S. Biotechnology Industry Size and Revenue, 2000-2007
Table 4.2: Global Biotechnology Industry Major Segments
Table 4.3: Genomics Sector Market Size, 2006-2013
Table 4.4: Total Biochip Market, 2007-2013
Table 4.5: Selected Competitors in the Biochip Market
Table 4.6: Biochip Microarray Products
Table 4.7: Bioinformatics Tools
Table 4.8: Functional Genomics Companies Building Advanced Integrated Platforms and Substantial Databases
Table 4.9: Companies Using New Genomic Tools
Table 4.10: Non-DNA-Based Chip Suppliers
Table 4.11: Robotics or "Lab-on-a-Chip" Market Sector
Table 4.12: Key High-throughput and Systemic Approaches in Genomic Analysis
Table 4.13: Pharmacogenomics Segment Players
Table 4.14: The Worldwide Market for Pharmacogenomics, 2006-2013
Table 4.15: Competitors in the SNP Genotyping Segment
Table 4.16: Scanning and Detection Technology Suppliers
Table 5.1: Data Sources and Bioinformatic Investigations
Table 5.2: Drivers and Challenges of the Bioinformatics Industry
Table 5.3: Bioinformatics Activities, Sub-Activities and Key Players
Table 5.4: Bioinformatics Market Size, 2006-2013
Table 5.5: Cheminformatics Market Size, 2006-2013
Table 5.6: In-silico Informatics Market Size, 2006-2013
Table 5.7: Bioinformatics Hardware and Systems Market Size, 2006-2013
Table 6.1: Alliances between IT/Telecom and Biotechnology Firms
Table 6.2: Types of Intellectual Property Protection for Bioinformatics Tools

DNA Sequencing and PCR Markets.

1. Overview

1.1 Statement of Report
1.2 About This Report
1.3 Scope of the Report
1.4 Methodology
1.5 Executive Summary

2. Introduction to DNA Sequencing and Amplification and PCR Technology

2.1 Science Overview: Introduction to DNA
- 2.1.1 DNA Sequencing and PCR Applications Space
- 2.1.2 Proteomics
- 2.1.3 Products for the Genomics Market
2.2 The Impact of the Human Genome Project on Molecular Biology
2.3 Impact of DNA Sequencing Techniques on Biotechnology, Pharmaceutical and Healthcare Industries
2.4 Molecular Diagnostics in the Post-genomic Era-The Role of SNPs
2.5 Advances in Molecular Diagnostic Technologies
2.6 The Use of PCR Technology
2.7 Genetic Variability and Disease

3. Market Analysis of PCR and DNA Sequencing Product Market

3.1 Overview of the Sequencing and Amplification Market
- 3.1.1 Highlights of DNA Sequencing Market
- 3.1.2 Genomic Analysis Market Development
- 3.1.3 Leading U.S. and Canadian Companies Offering Sequencing Technology Platforms
- 3.1.4 Competition
- 3.1.5 Markets for DNA Sequencing
- 3.1.6 Market Opportunity
- 3.1.7 Market Dynamics
- 3.1.8 Overview of Current DNA Sequencing Technology Platforms and Players
- 3.1.9 Limitations of Current Sequencing Technologies
- 3.1.10 Overview of the Life Science Marketplace
- 3.1.11 Research Laboratories
  - 3.1.11.1 Market Share
3.2 Paradigm Shift in Drug Discovery and Development
- 3.2.1 Systems Biology and the Need for More Effective Tools
- 3.2.2 Molecular Medicine and the New Therapeutics
- 3.2.3 Pharmacogenomics Using Genotyping and Phenotyping Clinical Biomarkers
- 3.2.4 The Market
3.3 Detection of Amplified DNA
- 3.3.1 Nucleic Acid Amplification Methods
- 3.3.2 Amplification of Refractory Mutation System (ARMS)
3.4 DNA Reagent Applications Market Share and Key Players
- 3.4.1 Product Description
  - 3.4.1.1 Pricing
3.5 PCR/DNA Testing Market Analysis
- 3.5.1 Nucleic Acid-Amplification and Detection Systems: How Big a Market?
- 3.5.2 Market Size 2004-2010 and Growth Projections in DNA Amplification Instrumentation
  - 3.5.2.1 U.S. Market
  - 3.5.2.2 European Market
- 3.5.3 Market Share of Key Players in DNA Amplification
3.6 The Drivers of the Biotech Industry
- 3.6.1 Isolation of DNA for PCR Profiling
- 3.6.2 Analysis by PCR-Based DNA Typing
- 3.6.3 Rapid Isolation of DNA for RFLP and PCR
- 3.6.4 DNA for PCR-STR Typing
3.7 Biotechnology Instrumentation Outlook
- 3.7.1 Products for the Genomics Market
- 3.7.2 Genetic Analysis Products

4. Use of PCR and DNA Amplification Products

4.1 PCR Components
- 4.1.1 Primers for PCR
- 4.1.2 Equipment for PCR
4.2 Sources of DNA for PCR
4.3 PCR Primer Sequence
4.4 Thermostable DNA Polymerases
4.5 PCR Protocols
4.6 Microfluidic Automated DNA Analysis Using PCR

5. Technical Trends in PCR

5.1 Practical Applications of PCR
- 5.1.1 Overview
5.2 Quality Control Issues in PCR
5.3 Determining Length of cDNA Product
- 5.3.1 Direct Signal Amplification Using the Invader Assay
- 5.3.2 Biosensor Technologies
  - 5.3.2.1 DNA Hybridization Biosensor Chips
  - 5.3.2.2 PNA-Based Biosensors
5.4 Novel Nucleic Acid Amplification Techniques
5.5 Microplate Readers
5.6 Genotyping Methods
- 5.6.1 Use of DNA Sequencers
  - 5.6.1.1 Capillary-Based Sequencers
  - 5.6.1.2 Pyrosequencing
- 5.6.2 Use of Microarrays
5.7 RiboMaker Detection System
5.8 RNA Isolation Kits
5.9 Nucleic Acid Sample Prep Platforms
5.10 DNA Microarrays
- 5.10.1 The Technique
- 5.10.2 The Market
- 5.10.3 Gene Expression Monitoring Arrays
5.11 Emerging Markets of DNA Arrays
5.12 Alternatives to PCR Amplification
- 5.12.1 Locked Nucleic Acids (LNAs)
- 5.12.2 Multiplexed Nuclease-Protection Assay and ArrayPlate

6. Corporate Directory

6.1 Abbott Laboratories
6.2 Affymetrix
6.3 Agilent Technologies
6.4 AgriGen Biotech Pty
6.5 GE Healthcare
6.6 Applera Applied Biosystems
6.7 Avesthagen Gengraine Technologies, Pvt.
6.8 Bayer Corporation
6.9 BD Biosciences
6.10 Beckman Coulter
6.11 BGI Life Tech
6.12 bioMerieux
6.13 Bioneer
6.14 Bio-Rad Laboratories
6.15 BioTrove
6.16 Caliper LifeSciences
6.17 Cepheid
6.18 Cogenics (A subsidiary of Clinical Data)
6.19 CombiMatrix Corporation
6.20 Commonwealth Biotechnologies
6.21 Complete Genomics
6.22 CuraGen Corporation
6.23 Cytocell
6.24 Dako A/S
6.25 DiaDexus
6.26 DNA LandMarks
6.27 DNAVision
6.28 Enzo Biochem
6.29 Epicentre
6.30 Eppendorf AG
6.31 Eurofins Medigenomix
6.32 Exiqon
6.33 Febit Biomed
6.34 Geneart AG
6.35 GeneticTechnologies Limited
6.36 GeneWorks
6.37 Genisphere
6.38 Genizon BioSciences
6.39 Genovoxx
6.40 Gen-Probe
6.41 Genset
6.42 Genta
6.43 Genzyme
6.44 GVK BIO
6.45 Hamilton Thorne Biosciences
6.46 Helicos BioSciences Corporation
6.47 High Throughput Genomics
6.48 Hokkaido System Science
6.49 Hy Laboratories
6.50 Illumina
6.51 Incyte Corporation
6.52 Integrated DNA Technologies
6.53 Invitrogen
6.54 Inqaba Biotechnical Industries
6.55 Johnson & Johnson
6.56 Kreatech Holding BV
6.57 LI-COR
6.58 Sygnis Pharma AG
6.59 Lucigen
6.60 Luminex Corporation
6.61 Meridian Biosciences
6.62 Microchip Biotechnologies
6.63 Microsynth AG
6.64 MilleGen SA
6.65 Millennium Pharmaceuticals
6.66 MWG Biotech AG
6.67 Myriad Genetics
6.68 Nanogen
6.69 Nanosys
6.70 Nymox
6.71 Ocimum Biosolutions
6.72 Orchid Cellmark
6.73 Ostex
6.74 Pacific Biosciences
6.75 PamGene
6.76 Perlegen Sciences
6.77 PPD
6.78 PPGx
6.79 PrimmBiotech
6.80 Promega
6.81 Biotage
6.82 QIAGEN
6.83 Quidel
6.84 Research Biolabs Pte
6.85 Roche Diagnostics
6.86 Shanghai Sangon Biological Engineering Technology & Services Co.
6.87 Saturn Biotech
6.88 Sequenom
6.89 Sequetech
6.90 Shimadzu Biotech
6.91 Siemens AG
6.92 Tepnel Life Sciences
6.93 Third Wave Technologies
6.94 Visible Genetics
6.95 VisiGen Biotechnologies
6.96 Vysis
6.97 Wellcome Trust Sanger Institute
6.98 ZS Genetics

7. Market Trends and Forecasts

7.1 Market Dynamics
7.2 Future Considerations for Molecular Diagnostics
7.3 How Genomics is Transforming Pharmaceutical R&D
7.4 Cancer Markers
7.5 NAT and Personalized Medicine
7.6 Three Growth Areas of Molecular Diagnostics
7.7 RNA Detection
7.8 Ramification Amplification Method
7.9 Invader Assays/Third Wave Technologies
7.10 Molecular Beacons

8. Major Product Innovations/Launches in DNA Sequencing Industry

8.1 Major Product Innovations/Launches in DNA Sequencing Industry
8.2 Major Activities in DNA Sequencing Industry

LIST OF FIGURES

Figure 2.1: Segment of Double-Stranded DNA Showing the Base-Pair Relationship
Figure 3.1: Global Market for DNA Sequencing
Figure 4.1: Cepheid' s I-CORE Module

LIST OF TABLES

Table 3.1: Global Market for DNA Sequencing
Table 3.2: DNA Sequencing Market Players
Table 3.3: Major DNA Product Companies in Europe
Table 3.4: Major DNA Product Companies in Asia and Australia
Table 3.5: Major DNA Product Companies in Japan
Table 3.6: Major DNA Product Companies in Rest of the World
Table 3.7: Market Revenue and Market Share of DNA Sequencing Market Players
Table 3.8: Thermal Cyclers Marketed by Applied Biosystems
Table 3.9: Applied Biosystems' Real-Time PCR Systems
Table 3.10: Applied Biosystems Genetic Analysis Instruments
Table 3.11: Gene Expression Assays Offered by Applied Biosystems
Table 3.12: SNP Genotyping Assays Offered by Applied Biosystems
Table 3.13: Comparison of Established Genomic Analysis Technologies
Table 3.14: Life Science Techniques Frequently Used
Table 3.15: The Most Commonly Used Reagents Used by Life Science Researchers
Table 3.16: The Most Commonly Used Instruments and Apparatus in Life Science Research
Table 3.17: The Most Widely Reported Categories of Software in Life Science Research
Table 3.18: Reagents and Equipment Sales for Use in DNA Sequencing Worldwide
Table 3.19: Global Market for Tools and Consumables Used in Drug Discovery and Development, Clinical Diagnostics and Biomedical Research
Table 3.20: Key Bioassay Technologies in the Life Sciences Industry
Table 3.21: Nucleic Acid Amplification Methods
Table 3.22: Properties of Various Acid Amplification Techniques
Table 3.23: Amplification Reagent Product Description
Table 3.24: Standard Prep Pricing
Table 3.25: Small Target Prep Pricing
Table 3.26: Hybridization Pricing
Table 3.27: Analysis Pricing
Table 3.28: U.S. Market Size 2004-2010 in DNA Amplification Instrumentation
Table 3.29: Market Share of Key Players in DNA Amplification Thermostable Enzymes
Table 3.30: Leading Manufacturers of Thermal Cyclers and Market Share
Table 4.1: ThermoFisherMolecular Biology Thermal Cyclers
Table 4.2: PCR Systems and Thermocyclers
Table 5.1: RiboMaker"! Assays to be Introduced for Cancer and Pathogen Detection
Table 8.1: The Key Bioassay Technologies in the Life Sciences Industry

Gene Expression Reagents Markets.

1. Overview

1.1 Objectives of the Report
1.2 Methodology
1.3 Scope of the Report
1.4 Executive Summary

2. Gene Expression

2.1 The Genomics Revolution
2.2 Basic Principles of Gene Expression
- 2.3.1 Quantitative Real-Time PCR (qRT-PCR)
- 2.3.2 PCR Labeling Chemistries
- 2.3.3 TaqManR Probes
- 2.3.4 SYBRR Green
2.4 Microarray Technology
2.5 Microarray Target Preparation and Hybridization
2.6 RNA Sample Preparation and Assessment

3. Gene Expression Reagents

3.1 Kit Format vs. Home-Brew Assays
3.2 Whole Product Solutions
3.3 Emerging Technologies

4. Market Environment

4.1 Institutional and Government Budgeting
4.2 Worldwide Investment in Genomics Technologies and Research
4.3 Industry Consolidation and Acquisitions

5. Market Drivers

5.1 Improved Assay Performance
5.2 Cost Effective Systems
5.3 Automation
5.4 Bioinformatics Solutions

6. Worldwide Market for Gene Expression Reagents

6.1 Life Science Research
6.2 Drug Discovery and Development, Molecular Diagnostics
6.3 Commercial Production
6.4 Gene Expression Market Size
- 6.4.1 Real-Time PCR Revenue
- 6.4.2 Commercial Microarray Revenue
- 6.4.3 RNA Sample Preparation Revenue
6.5 Gene Expression Reagent Market by Region
6.6 Users of Gene Expression Products
- 6.6.1 Core Laboratories
- 6.6.2 Consortia
- 6.6.3 Pharmaceutical and Biotechnology Companies
6.7 Affiliation
6.8 Job Function and Decision Makers

7. Key Applications

7.1 BioMarker Identification and Pharmacogenomics
7.2 Toxicogenomics
7.3 Molecular Diagnostics

8. Vendor and Product Selection

8.1 Product Adoption
8.2 Drivers for Product Switching

9. Leading Vendors

10. Marketing Strategies

10.1 e-Marketing and e-Commerce
10.2 Catalog
10.3 On-Site Cabinet Programs

11. Pricing Strategies

11.1 Price Elasticity
11.2 Strategies

12. Distribution Channels

13. Competitive Situation

14. Opportunities

15. Market Strategy Profiles, Leading and Selected Vendors

15.1 Applied Biosystems
- 15.1.1 Applera Corporation-Corporate History and Structure
- 15.1.2 Molecular Biology Technology and Products
- 15.1.3 Acquisitions, Partnerships and Collaborations, 2006
- 15.1.4 Product Portfolio Summary
- 15.1.5 Real-Time PCR/Genomics Products and Consumables
- 15.1.6 Real-Time PCR/Genomics New Product Introductions, 2006
- 15.1.7 End-Users
- 15.1.8 Distribution Channels
- 15.1.9 Competition-Gene Expression Products
- 15.1.10 Competitive Analysis
- 15.1.11 Business Model
15.2 Affymetrix
- 15.2.1 Corporate History and Structure
- 15.2.2 Technology
- 15.2.3 Partnerships and Collaborations
- 15.2.4 Product Portfolio Summary
- 15.2.5 Complementary Services
- 15.2.6 New Product Introductions
- 15.2.7 End-Users
- 15.2.8 Distribution Channels
- 15.2.9 Competition
- 15.2.10 Competitive Analysis
- 15.2.11 Business Model
15.3 Invitrogen
- 15.3.1 Corporate History and Structure
- 15.3.2 Technology
- 15.3.3 Acquisitions
- 15.3.4 Partnerships and Collaborations
- 15.3.5 Product Profile Summary
- 15.3.6 Gene Expression Product Portfolio
- 15.3.7 New Product Introductions
- 15.3.8 End-Users
- 15.3.9 Distribution Channels
- 15.3.10 Competition
- 15.3.11 Competitive Analysis
- 15.3.12 Business Model
15.4 Qiagen
- 15.4.1 Corporate History and Structure
- 15.4.2 Technology
- 15.4.3 Acquisitions, Partnerships and Collaborations
- 15.4.4 Collaborations and Partnerships
- 15.4.5 Product Portfolio Summary
- 15.4.6 Complementary Services
- 15.4.7 New Product Introductions
- 15.4.8 End-Users
- 15.4.9 Distribution Channels
- 15.4.10 Competition
- 15.4.11 Competitive Analysis
- 15.4.12 Business Model
15.5 GE Healthcare (Formerly Amersham Biosciences)
- 15.5.1 Corporate History and Structure
- 15.5.2 Technology
- 15.5.3 Product Portfolio Summary
- 15.5.4 Complementary Services
- 15.5.5 Genomics New Product Introductions
- 15.5.6 Amersham Biosciences End-Users
- 15.5.7 Distribution Channels
- 15.5.8 Competition
- 15.5.9 Competitive Analysis
- 15.5.10 Business Model
15.6 Stratagene
- 15.6.1 Corporate History and Structure
- 15.6.2 Technology
- 15.6.3 Acquisitions, Collaborations, Alliances and Partnerships
- 15.6.4 Product Portfolio Summary-Research Products Division
- 15.6.5 New Product Introductions
- 15.6.6 Complementary Services
- 15.6.7 End-Users
- 15.6.8 Distribution Channels
- 15.6.9 Competition
- 15.6.10 Competitive Analysis
- 15.6.11 Business Model

Appendix I: Leading Vendor' s Gene Expression Products

Appendix II: Gene Expression Product Groups

Appendix III: Companies Offering Gene Expression Products

LIST OF FIGURES

Figure 2.1: Gene Expression Process
Figure 2.2: qRT-PCR Workflow
Figure 2.3: Microarray Workflow
Figure 6.1: Gene Expression Market by Region
Figure 6.2: Researchers Using Gene Expression Technologies Worldwide, 2005
Figure 6.3: Distribution of Laboratory Workers by Organization in North America
Figure 6.4: Laboratory Job Function
Figure 6.5: Product Selection and Purchasing Decision Makers

LIST OF TABLES

Table 5.1: Microarray Analysis Cost per Sample
Table 5.2: Cost of qRT-PCR Research Reagents and Systems
Table 6.1: Five-Year Forecast-Gene Expression Reagents, Instruments
Table 6.2: RNA Sample Preparation Revenue
Table 6.3: Forecasted Annual Revenue-qRT-PCR, 2005-2010
Table 6.4: Forecasted Annual Revenue-Commercial Microarrays, Reagents, Instruments, 2005-2010
Table 6.5: Forecasted Annual Revenue-Gene Expression Reagents, Instruments, 2005-2010
Table 6.6: Forecasted Annual Revenue-RNA Sample Preparation, 2005-2010
Table 6.7: Projected Revenue Growth of Microarrays and Related Products
Table 6.8: Major Players' Distribution of Revenue by Region, 2005
Table 6.9: Decision Makers Profile
Table 9.1: Major Vendors-Gene Expression Reagents and RNA Sample Preparation
Table 9.2: Vendors' Key Statistics, 2005
Table 9.3: Vendors' Technology and Products
Table 11.1: RNA Sample Preparation-Vendors Prices
Table 11.2: qPCR Kits-Vendor' s Prices
Table 11.3: Reverse Transcriptase-Vendor' s Prices
Table 12.1: Distribution Channels
Table 15.1: Applied Biosystems Revenue, 2005
Table 15.2: Affymetrix Revenue, 2005
Table 15.3: Invitrogen Revenue, 2005
Table 15.4: Qiagen Revenue, 2005
Table 15.5: GE Healthcare Revenue, 2005
Table 15.6: Stratagene Revenue, 2005

Genomics World Markets

1. Introduction

1.1 Statement of Report
1.2 Objectives and Goals of Study
1.3 Methodology
1.4 Executive Summary
- 1.4.1 Market Drivers
- 1.4.2 Market Restraints
- 1.4.3 Market Size and Growth Projections
1.5 What Is a Gene?
1.6 Gene Expression
1.7 Genetic Variability
1.8 The Human Genome Project (HGP)
1.9 Gene Databases
1.10 Sequencing and Resequencing
1.11 RNA Interference (RNAi)
1.12 DNA Tags

2. Genomics Technology and Industry

2.1 The Development of a Genomics Market
- 2.1.1 Market Size and Growth Projections
- 2.1.2 The U.S. Genomics Market
2.2 DNA Microarray Technology
- 2.2.1 Biochips
- 2.2.2 Photolithography
- 2.2.3 Instrumentation for DNA Microarray Analysis
- 2.2.4 Lab-on-a-Chip
- 2.2.5 DNA Microarrays
2.3 Applications of DNA Microarrays
- 2.3.1 DNA Sequence Analysis
- 2.3.2 Gene Expression Analysis
- 2.3.3 Effect of DNA Sequence and Gene Expression Monitoring on the Genomics Market
2.4 Bioinformatics
2.5 Functional Genomics
- 2.5.1 Gene Knockdown
- 2.5.2 Protein-Protein Interactions
- 2.5.3 Bioinformatics
- 2.5.4 Strategies of Functional Genomics Companies
- 2.5.5 Frontiers in Functional Genomics
2.6 Comparative Genomics
2.7 Pharmacogenomics
2.8 Proteomics
2.9 Structural Genomics
2.10 Disease Targets
- 2.10.1 Paradigm Shift in Drug Development: The Evolution of Targeted Therapies
- 2.10.2 Personalized Warfarin Therapy

3. How Genomics Is Revolutionizing Healthcare

3.1 Pharmaceutical Applications
3.2 Diagnostics
3.3 Toxicogenomics
3.4 The Market for DNA Microarrays
3.5 DNA Chip Technology Competition
3.6 Expression Profiling
3.7 Gene Sequencing-Advantages of Chip Array Technology
3.8 Applied Markets for Genomics
3.9 Genomics and the Pharmaceutical Companies
3.10 Cancer Markets
3.11 Agricultural Markets
- 3.11.1 Plant Genomics
- 3.11.2 Food Processing
- 3.11.3 Animal Husbandry

4. Proprietary Applications and Patents

4.1 What is Patentable?
4.2 Patents and Litigation

5. Business Analysis

5.1 Facilitation and Capitalization of the Convergence of Gene Expression Analysis and Proteomics
5.2 Competition
5.3 Market Opportunities for Functional Genomics
- 5.3.1 Metabolic Profiling
- 5.3.2 Anti-Fungal Targets
- 5.3.3 Nutrition
- 5.3.4 Crop Production
5.4 The Highly-Competitive Nature of the Genomics Industry
- 5.4.1 First-Generation Biotech
- 5.4.2 Second-Generation Genomics Companies
- 5.4.3 Next-Generation DNA Sequencing Companies
5.5 Strategic Alliances

6. Genomics Company Profiles

6.1 Affymetrix, Inc.
6.2 Agendia
6.3 Agilent Technologies, Inc.
6.4 Applied Biosystems Group
6.5 Bayer, AG
6.6 Biotage
6.7 Caliper Life Sciences
6.8 Celera Group
6.9 Cepheid
6.10 CLC bio
6.11 Clinical Data, Inc.
6.12 CuraGen Corporation
6.13 Cytocell Ltd.
6.14 diaDexus, Inc.
6.15 Enzo Biochem, Inc.
6.16 Exiqon A/S
6.17 GE Healthcare
6.18 Gene Link, Inc.
6.19 Gene Logic, Inc.
6.20 Genentech, Inc.
6.21 Genisphere, Inc.
6.22 Genomatix Software, Inc.
6.23 Genomic Solutions, Inc.
6.24 Gen-Probe, Inc.
6.25 Harvard Bioscience, Inc.
6.26 Helicos Biosciences Corporation
6.27 Human Genome Sciences, Inc.
6.28 Illumina, Inc.
6.29 Interleukin Genetics
6.30 LI-COR Biosciences
6.31 Luminex Corporation
6.32 Millennium Pharmaceuticals, Inc.
6.33 Monogram Biosciences, Inc.
6.34 Motorola, Inc.
6.35 MWG Biotech AG
6.36 Myriad Genetics, Inc.
6.37 Nanogen, Inc.
6.38 Nuvelo, Inc.
6.39 Orchid Cellmark
6.40 Pacific Biosciences, Inc.
6.41 QIAGEN, Inc.
6.42 Roche Diagnostics
6.43 Sequenom, Inc.
6.44 Third Wave Technologies, Inc.
6.45 Verenium Corporation
6.46 Visigen Technologies, Inc.
6.47 Brief Profiles of Companies Marketing Personalized Genomics Products
6.47.1 23andMe, Inc.
6.47.2 deCODE Genetics, Inc.
6.47.3 Navigenics, Inc.
6.48 Brief Profiles of Other Selected Genomics Firms
6.48.1 Aber Genomic Computing
6.48.2 Spotfire, Inc.

7. Genomics Challenges and Growth Factors

7.1 Market Drivers
- 7.1.1 Product Pipeline: Need for More Drug Candidates
- 7.1.2 Need for Increased Research and Development Productivity
7.2 A Genomics Market Bottleneck-Bioinformatics
7.3 Strategic Recommendations-Market Opportunities
- 7.3.1 More Comprehensive Tools Are Needed
- 7.3.2 Resolving Bottlenecks in Functional Genomics Market
7.4 Key Trends of Recent Mergers and Acquisition Deals
7.5 Chemogenomics
7.6 Pharmacogenomics
7.7 Biomarkers
7.8 Additional Genomics Market Opportunities

8. Bioinformatics

8.1 Types of Data and Bioinformatics Applications
- 8.1.1 Validated Core Modeling Technology
- 8.1.2 Broad Applicability
- 8.1.3 Data Management Compliant with Industry Standards
- 8.1.4 Open Architecture
- 8.1.5 Ease of Use
- 8.1.6 Increased Access
8.2 Functions of Informatics Software
- 8.2.1 Data Management
- 8.2.2 Transformation of Data into Knowledge
- 8.2.3 Collaboration Among Researchers
- 8.2.4 Interface for Online Data Sources
8.3 Target Markets for Informatics Software
- 8.3.1 Pharmaceutical Companies
- 8.3.2 Biotechnology Companies
- 8.3.3 Academic and Government Research Institutions
- 8.3.4 Agricultural, Environmental and Industrial Biotechnology Companies
8.4 Products of Bioinformatics
- 8.4.1 Sequences and Structure of Genes and Proteins
- 8.4.2 3-D Molecular Structures
- 8.4.3 Genome Structures and Functions
- 8.4.4 Bibliographic Data
8.5 Bioinformatics Processes
8.6 Informatics Tools and Functionalities
- 8.6.1 Sequence to Structure
- 8.6.2 Lead Identification and Optimization
- 8.6.3 Development and Formulation
- 8.6.4 Improving Materials and Processes in the Chemicals Industry
- 8.6.5 Other Materials-Based Industries
8.7 Role of Bioinformatics in the Value Chain
8.8 Bioinformatics Market Segments
- 8.8.1 Database
- 8.8.2 Hardware
- 8.8.3 Software
- 8.8.4 Bioinformatics Services
8.9 Bioinformatics Business Models
- 8.9.1 Changing Business Models
- 8.9.2 Selected Business Strategies

Glossary

INDEX OF FIGURES

Figure 2.1: Major Areas of Functional Genomics and Their Relationship to Bioinformatics and Industry
Figure 8.1: Role of Bioinformatics in the Biotechnology Value Chain

INDEX OF TABLES

Table 2.1: Genomics Sector Global Market Size, 2001 to 2010
Table 2.2: Companies Marketing DNA Microarray Software
Table 2.3: Selected Competitors in the DNA Microarray Market
Table 2.4: Companies Offering DNA Sequencing Products
Table 2.5: Competitors in the SNP-Genotyping Segment
Table 2.6: Companies that Market MAQC-tested Gene Expression Microarrays
Table 2.7: Worldwide Market for Bioinformatics, 2005 to 2010
Table 2.8: Selected Companies Marketing New Functional Genomics Tools
Table 3.1: Genomics Pharmaceutical Market Sector Leaders and Promising Newcomers
Table 3.2: Summary of Assays for HIV Viral Load Testing
Table 3.3: Global Market for HIV Diagnostic Testing, 2000 to 2012
Table 3.4: Summary of Molecular Diagnostics Testing
Table 3.5: Global Market for Molecular Diagnostics Testing, 2000 to 2012
Table 3.6: U.S. Market for Molecular Diagnostics Testing, 2004 to 2012
Table 3.7: Applied Markets for Genomics
Table 3.8: Competitors in the Field of Identity Genomics Testing
Table 3.9: Opportunities for Molecular-Targeting Therapeutics for Cancer
Table 3.10: Emerging Companies in the Anti-Cancer Sector
Table 8.1: Data Source and Bioinformatic Investigations
Table 8.2: Bioinformatics Activities, Subactivities and Key Players

Microarray Markets

1. Overview

1.1 Statement of Report
1.2 About This Report
1.3 Scope of the Report
1.4 Objectives
1.5 Methodology
1.6 Executive Summary

2. Overview of Microarrays

2.1 History of Microarrays
2.2 Genomics and Proteomics
- 2.2.1 Genetic Variability and Disease
2.3 General Theory of Microarrays
2.4 DNA Microarrays
2.5 Protein Microarrays
2.6 Tissue Microarrays

3. DNA Microarrays

3.1 Advantages and Drivers
3.2 Limitations and Barriers to Commercialization
3.3 DNA Microarray Technology Platforms
- 3.3.1 Reasons Why Researchers Utilize DNA Microarrays
- 3.3.2 Factors for Difficulties Applying DNA Microarrays Technology
3.4 Key Attributes of DNA Microarray Software
3.5 Applications
3.6 Future Directions for DNA Microarray Technology
- 3.6.1 High-Throughput Array Technology
- 3.6.2 Emerging Microarray Trends
- 3.6.3 Emerging Microarray Applications
- 3.6.4 Key Points for Developing Microarray Based Applications
3.7 Competitive Landscape for DNA Microarrays

4. Protein Microarrays

4.1 Critical Factors for Microarray Content
4.2 Key Findings on Use of Microarrays
4.3 Advantages and Drivers
4.4 Limitations and Barriers to Commercialization
4.5 Key Experimental Parameters of Protein Microarray Technology for Current and Future Users
4.6 Reasons Why Researchers Utilize Protein Microarrays
4.7 Factors for Adoption of Protein Microarrays Technology
4.8 Top Suppliers of Protein Microarray Slides and Products
4.9 Factors that Influence Sale Decisions
4.10 Future Innovations in Protein Microarray Technology

5. Current DNA Microarrays

5.1 Key Players
- 5.2.1 Microarray-Based Commercial Genotyping Activity
- 5.2.2 Location Analysis
5.3 Future Innovations in DNA Microarray Technology

6. Current Protein Microarrays

6.1 Protein Profiling Microarrays-Antibody Arrays
6.2 Protein Profiling Microarrays-Reverse Phase Microarrays
6.3 Multiplex Sandwich Microarrays-Planar
6.4 Multiplex Sandwich Immunoassays-Bead Based
6.5 Microarrays for Protein Function Studies
6.6 High Growth Applications
- 6.6.1 Cytokine Arrays
- 6.6.2 Whole Proteome Arrays
- 6.6.3 Microarray-Based Commercial Genotyping Activity
  - 6.6.3.1 Microarray-Based Genotyping Applications
  - 6.6.3.2 Microbial Applications
  - 6.6.3.3 The Market for Microbial Genotyping Products
  - 6.6.3.4 Comparative Genomic Hybridization (CGH)
- 6.6.4 ChIP-on-Chip Analysis

7. Technology

7.1 Production of Microarrays
7.2 2-D Versus 3-D Technology
7.3 Substrates and Surface Chemistries
7.4 Detection Methods
7.5 Instruments
7.6 Data Management and Informatics in Gene Expression

8. Applications

8.1 DNA Microarrays in Gene Expression
8.2 DNA Microarrays in SNP Analysis
8.3 DNA Microarrays in Cancer
8.4 Protein Expression
- 8.4.1 Cytokine Applications
- 8.4.2 Protein Function
- 8.4.3 Protein-Protein Interactions
8.5 Target /Biomarker Discovery
8.6 Drug Discovery and Development (Gene and Protein Microarrays)
8.7 Clinical Diagnostics (Gene and Protein Microarrays)
8.8 RNA Microarrays
8.9 Oligo Microarrays
8.10 Yeast Microarrays
8.11 Antibody Arrays
8.12 Arrays for Toxicogenomics

9. The Commercial Opportunity for Microarrays

9.1 Market Drivers for Microarrays
9.2 Market Restraints for Microarrays
9.3 Key Players
9.4 Market Size, Strategic Trends and Competitive Landscape for Protein Arrays
9.5 Marketing and Distribution
9.6 Protein Arrays Market Analysis
9.7 Genes Associated with Major Diseases
9.8 Software and Data Analysis
- 9.8.1 Supplier of DNA Microarray Analysis Software
- 9.8.2 Satisfaction with Software Features
- 9.8.3 Satisfaction with Software
- 9.8.4 Supplier Factors in Software Purchase Decision
- 9.8.5 Suppliers' Role in Improving Data Sharing for DNA Microarrays

10. Company Profiles

10.1 Manufacturers

LIST OF FIGURES

Figure 6.1: Cytokines and Growth Factors: Sources of Microarrays for Cytokine Research
Figure 8.1: Microbial Genotyping: Applications for DNA Microarrays
Figure 8.2: Source of Variation in Microarray Data
Figure 8.3: Toxicogenomics: DNA Microarrays

LIST OF TABLES

Table 3.1: Microarray Product Revenue: Arrays, Reagents and Instruments, 2005 and 2010
Table 3.2: Microarray Market Drivers
Table 3.3: Microarray Market Barriers
Table 3.4: Unit Pricing of DNA Microarrays, 2000-2010
Table 3.5: Steps in the Design and Implementation of a DNA Microarray Experiment
Table 3.6: Microarray Applications
Table 3.7: List of DNA Array Manufacturers
Table 4.1: Critical Factors for Microarray Content
Table 4.2: Top Three Suppliers of Treated Protein Microarray Surfaces for Self-Printing
Table 4.3: Top Suppliers of Commercially Available Protein Microarrays
Table 4.4: Top Suppliers of Protein Microarray Readers
Table 5.1: Affymetrix Sales of Probe Arrays, 2000-2007
Table 5.2: Affymetrix Total Product Sales, 1999-2007
Table 5.3: Affymetrix Instrument Sales, 2000-2007
Table 6.1: Microarray Genetic Testing
Table 6.2: ChIP-on-Chip Microarray Market Size Projections, 2005-2011
Table 8.1: Applications of Biochips by Class
Table 8.2: Diagnostics Microarray Market Size Projections, 2005-2011
Table 8.3: HTS Microarray Market Size Projections, 2005-2011
Table 8.4: Pharmacogenomics Microarray Market Size Projections, 2005-2011
Table 8.5: Toxicology Screening Microarray Market Size Projections, 2005-2011
Table 8.6: Expression Profiling Microarray Market Size Projections, 2005-2011
Table 9.1: Market Share of Microarray Products, 2006
Table 9.2: Affymetrix Product Sales
Table 9.3: Leading Microarray Companies
Table 9.4: Worldwide Microarray Market Size, 2004-2012
Table 9.5: Microarray Market Share by Technology Type
Table 9.6: DNA Microarray U.S. Market Size, 2005-2011
Table 9.7: DNA Microarray Worldwide Market Size, 2002-2011
Table 9.8: Biochip Market by Usage, 2003 and 2007

Personalized Medicine

1. Overview

1.1 Statement of Report
1.2 Scope of this Report
1.3 Methodology
1.4 Executive Summary

2. The Case for Pharmacogenomics and Personalized Medicine: Biology, Approaches, Pipeline and Regulatory Trends

2.1 Scope of this Section
2.2 Introduction to Pharmacogenomics/Personalized Medicine
2.3 The Compelling Case for Personalized Medicine
2.4 The Process of Drug Metabolism and Implications for Pharmacogenomics/Personalized Medicine
2.5 Examples of Personalized Medicine
- 2.5.1 Herceptin
- 2.5.2 Ziagen
- 2.5.3 Iressa
- 2.5.4 Erbitux
2.6 Personalized Medicine Product Pipeline
2.7 The Personalized Medicine Coalition
2.8 Regulatory Trends and Guidelines in the Personalized Medicine Space
2.9 FDA Approved Agendia' s MammaPrintR Diagnostic-The First IVDMIA to be Approved
2.10 A Changing Regulatory Landscape for Personalized Medicine
2.11 Patenting Personalized Medicine
- 2.11.1 U.S. Supreme Court Dismisses LabCorp Appeal
2.12 The Leading Edge of Personalized Medicine: Specific Examples of Clinical Situations Where Personalized Medicine is Appropriate and Being Used
- 2.12.1 EGFR Assay
- 2.12.2 Individualized Warfarin Therapy
- 2.12.3 UGT1A1 Molecular Assay for Camptosar
- 2.12.4 Response to Gleevec in Gastrointestinal Stromal Tumors
- 2.12.5 LabCorp, ARCA Personalized Medicine Deal for Cardiovascular Diseases
- 2.12.6 Osmetech Licenses Epidauros Biotechnologie AG CYP2D6 Biomarker to Push into Pharmacogenomics

3. Pharmacogenomics/Personalized Medicine: Qualitative and Quantitative Market Analysis

3.1 Scope of this Section
3.2 Market Analysis of Molecular Diagnostics as it Relates to Pharmacogenomics/Personalized Medicine
3.3 Snapshot of Diagnostics Industry Structure
3.4 The Case for Theranostics (Therapeutic/Companion Diagnostic)
3.5 Classification of Diagnostics by Risk
3.6 Personalized Medicine Market Analysis-Market Survey Data Characterizing the Qualitative and Quantitative Industry Parameters
3.7 Segmentation of the Personalized Medicine Marketplace
3.8 Timeline for Impact of Various Segments in Personalized Medicine
3.9 Challenges for Personalized Therapeutics Development
3.10 Molecular Diagnostics Technology Platforms and Their Impact on Personalized Medicine
3.11 Macro Trends in Personalized Medicine
3.12 Personalized Medicine: Industry SWOT Analysis

4. Company Profiles

4.1 Abbott Molecular, Inc./Vysis
4.2 Affymetrix, Inc.
4.3 Agendia
4.4 Celera Diagnostics
4.5 Cepheid
4.6 Clinical Data, Inc.
4.7 Dakocytomation
4.8 deCODE Genetics
4.9 DNA Direct, Inc.
4.10 DxS Ltd.
4.11 Exact Sciences Corp.
4.12 Exagen Diagnostics, Inc.
4.13 Gen-Probe
4.14 Genelex Corp.
4.15 Gene Logic, Inc.
4.16 Genentech, Inc.
4.17 Genomic Health, Inc.
4.18 Genzyme Genetics
4.19 Illumina
4.20 Luminex Corporation/Tm Biosciences
4.21 Monogram Biosciences
4.22 Myriad Genetics, Inc.
4.23 Nanogen
4.24 Osmetech plc
4.25 Perlegen Sciences, Inc.
4.26 PGxl Laboratories
4.27 Prometheus Laboratories, Inc.
4.28 Roche Diagnostics
4.29 Siemens Medical Solutions Diagnostics
4.30 Target Discovery, Inc.
4.31 Third Wave Technologies
4.32 Ventana Medical Systems
4.33 XDx, Inc.

Appendix 1: Qualitative Market Responses

LIST OF FIGURES

Figure 2.1: Phase I and II Processes of Drug Metabolism
Figure 2.2: Human Phase I Enzymes
Figure 2.3: Human Phase II Enzymes
Figure 2.4: Hepatic Distribution of Human CYP450
Figure 2.5: Relative Contribution of CYP450 Enzymes to Drug Metabolism
Figure 2.6: Genetic Components Determine Drug Metabolism
Figure 3.1: From Genetic Content to Personalized Medicine
Figure 3.2: The Lopsided Remuneration for Diagnostics
Figure 3.3: Breakout of the Molecular Diagnostics Marketplace
Figure 3.4: Molecular Diagnostics Market Segmentation
Figure 3.5: Molecular Diagnostics Market Segmentation by Technology
Figure 3.6: Market Survey Respondent Demographics
Figure 3.7: Breakout of the Respondent Pool by Affiliation
Figure 3.8: Segmentation of the Personalized Medicine Market
Figure 3.9: Personalized Medicine Market Drivers
Figure 3.10: Challenges in the Personalized Medicine Space

LIST OF TABLES

Table 2.1: Personalized Medicine at the Nexus Point
Table 2.2: Percentage of Non-Responders in Various Drug Classes
Table 2.3: High Profile Drug Withdrawals from the Marketplace
Table 2.4: Drug Metabolism Drives Drug Efficacy/Toxicity
Table 2.5: Population Frequency of the Various Cytochromes
Table 2.6: List of Personalized Medicine Tests
Table 2.7: Personalized Medicine Product Pipeline
Table 2.8: Marketed Personalized Therapies, 2006
Table 2.9: Current Targets, Drugs and Disease Areas Classified by their Clinical Applications
Table 3.1: Areas in Personalized Medicine-Timeline of Impact
Table 3.2: Impact of Personalized Medicine on Various Therapeutic Areas
Table 3.3: Hurdles in Personalized Medicine Development in Various Therapeutic Areas
Table 3.4: Various Molecular Diagnostics Technologies: Timeline for Impact
Table 3.5: Various Molecular Diagnostics Technologies: Impact on Different Therapeutic Areas in Personalized Medicine
Table 3.6: Various Molecular Diagnostics Technologies: Technical Challenges in the Deployment for Personalized Medicine
Table 3.7: Market Opportunities in Personalized Medicine
Table 3.8: Challenges for Market Adoption of the Various Personalized Medicine Tests
Table 3.9: Personalized Medicine Industry SWOT

Pharmacogenomics for Clinical Use and in Drug Development

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

RNA Interference Markets

1. Overview

1.1 Objectives
1.2 Scope
1.3 Methodology
1.4 Executive Summary

2. RNA Interference (RNAi)

2.1 Introduction
2.2 Overview of RNA Interference
- 2.2.1 Classes of Endogenous Small RNAs: siRNA, rasiRNA and miRNA
- 2.2.2 Mechanism of RNAi In Vivo
2.3 Glossary
2.4 What Areas of Research Does RNAi Impact?
- 2.4.1 RNAi Technology in Life Sciences Research, Drug Discovery and Development
- 2.4.2 RNAi Technology in Agriculture

3. Technology Trends in RNAi Space

3.1 Overview
3.2 End-User Segmentation
3.3 Technologies for Inducing RNAi
- 3.3.1 Methods for Detecting Gene Silencing
- 3.3.2 Comparison of Strategies for Target Validation
- 3.3.3 Libraries of siRNAs/shRNAs to Knock Down Genes En Masse
3.4 miRNA-Based RNAi: The Leading Edge of RNAi Space
- 3.4.1 Biological Function of miRNAs
- 3.4.2 Role of miRNAs in Disease
- 3.4.3 miRNA-based Diagnostics
- 3.4.4 miRNA-based Therapeutics
3.5 Market Shifts in RNAi Space: Where Is It Headed?
- 3.5.1 Intellectual Property and Patent Issues
- 3.5.2 Patents Covering the Molecular Characteristics of the RNAi Agent
- 3.5.3 Funding in RNAi Space: Grants, Venture Capital and IPOs
- 3.5.4 Partnerships, Alliances, Mergers and Acquisitions
3.6 SWOT Analysis of Technologies and Vendors in RNAi Space

4. RNAi Market Analysis

4.1 Overview
4.2 Market Data Collection and Respondent Pool
- 4.2.1 Respondent Pool Characteristics
4.3 RNAi Technologies / Products in Research Applications
4.4 RNAi Technologies/Products: Market Shares (Quantitative)
4.5 Quantitative Metrics of RNAi Usage: Market Opportunity and Growth
- 4.5.1 Growth of Various Segments in RNAi Space
- 4.5.2 Product Formats and Representation in RNAi Marketplace
4.6 RNAi Marketplace: Challenges, Unmet Needs and Drivers
- 4.6.1 Unmet Needs in RNAi Space
- 4.6.2 RNAi Market: Qualitative Growth Drivers

5. The RNAi Landscape

5.1 Overview
5.2 Market Segmentation of RNAi and Segment Characteristics
5.3 Quantitative Market Opportunities in RNAi Space
- 5.3.1 Opportunities in miRNA Space
- 5.3.2 Opportunities in siRNA/shRNA Space
5.4 RNAi Product Offerings and Associated Business Models
5.5 Challenges for RNAi Therapeutic Development

6. RNAi-Based Therapeutics: The Emerging Industry Landscape

6.1 Factors Contributing to the Success of RNAi Therapeutics
6.2 Advantages and Disadvantages of siRNA-based Drugs
6.3 Opportunities and Challenges with RNAi-based Therapeutics
6.4 The Gene Therapy Precedent
6.5 The Antisense Precedent
6.6 Interferon Response
6.7 Delivery of RNAi-based Therapeutics
6.8 Off-Target Effects
6.9 Overwhelming the Endogenous RNAi System-Affecting the microRNA Pathway
6.10 RNAi-based Therapeutics
- 6.10.1 Cancer
- 6.10.2 Cardiac Disease
- 6.10.3 Immunologic Disease
- 6.10.4 Infectious Disease
- 6.10.5 Inflammation
- 6.10.6 Lifestyle Therapeutics
- 6.10.7 Metabolic Disease
- 6.10.8 Neurologic Disease
- 6.10.9 Ophthalmic Disease
- 6.10.10 Renal Disease
- 6.10.11 Respiratory Disease

7. Company Profiles-U.S.

7.1 Alfacell Corporation
7.2 Allele Biotechnology and Pharmaceuticals, Inc.
7.3 Alnylam Pharmaceuticals
7.4 Ambion
7.5 Asuragen, Inc.
7.6 Avalon Pharmaceuticals, Inc.
7.7 B-Bridge International, Inc.
7.8 Bio-Rad Laboratories
7.9 Calando Pharmaceuticals, Inc.
7.10 Cepheid
7.11 Cequent
7.12 Clontech Laboratories, Inc.
7.13 CombiMatrix Corporation
7.14 Cyntellect, Inc.
7.15 CytRx Corp.
7.16 Dharmacon
7.17 Dicerna
7.18 Galenea Corporation
7.19 GeneCopoeia, Inc.
7.20 GeneThera, Inc.
7.21 Genlantis
7.22 GenoSensor
7.23 GRL, Inc.
7.24 IDT
7.25 Imgenex Corporation
7.26 Ingenuity Systems
7.27 Intradigm Corporation
7.28 Invitrogen
7.29 InvivoGen
7.30 Isis Pharmaceuticals, LLC
7.31 LC Sciences
7.32 Lentigen Corporation
7.33 MDRNA
7.34 Merck & Co., Inc.
7.35 Mirus Bio Corporation (Acquired by Roche)
7.36 Monsanto
7.37 Nastech Pharmaceutical Company, Inc.
7.38 New England BioLabs
7.39 Nucleonics, Inc.
7.40 Open Biosystems, Inc.
7.41 OPKO Health, Inc.
7.42 OriGene
7.43 Panomics, Inc.
7.44 PhaseRx
7.45 Promega Corp.
7.46 Quark Pharmaceuticals, Inc.
7.47 RXi Pharmaceuticals Corporation
7.48 Senetek PLC
7.49 Sigma-Aldrich
7.50 Sirna Therapeutics
7.51 Sirnaomics, Inc.
7.52 SomaGenics, Inc.
7.53 System Biosciences
7.54 Tacere Therapeutics
7.55 Targeted Genetics Corporation
7.56 Third Wave Technologies
7.57 Traversa

8. Company Profiles-Europe

8.1 Actigenics SA
8.2 Amaxa
8.3 AstraZeneca PLC
8.4 Cenix Bioscience GmbH
8.5 deVGen N.V.
8.6 DNAVision
8.7 Exiqon
8.8 Genovis
8.9 genOway
8.10 imaGenes GmbH
8.11 MWG Biotech AG
8.12 OZ Biosciences
8.13 Prosensa Holding
8.14 QIAGEN
8.15 RNAx GmbH (Germany)
8.16 Roche
8.17 Rosetta Genomics, Ltd.
8.18 Santaris Pharma A/S
8.19 Silence Therapeutics PLC
8.20 TaconicArtemis GmbH
8.21 TRANSAT

9. Company Profiles-Asia-Pacific

9.1 alphaGEN Co., Ltd.
9.2 Benitec, Ltd.
9.3 Bioneer
9.4 CytoPathfinder, Inc.
9.5 Genesis Research & Development Corp.
9.6 GeneDesign, Inc.
9.7 GNI Pharmaceutical Corporation
9.8 Koken Co., Ltd.
9.9 NanoCarrier Co., Ltd.
9.10 Oncolys Biopharma, Inc.
9.11 RealGene Bio-Technologies, Inc.
9.12 Samchully Pharmaceuticals
9.13 Samyang Corp.
9.14 Shanghai Biochip
9.15 Shanghai GenePharma Co.
9.16 Shanghai Genomics, Inc.
9.17 Transgene Biotek, Ltd.

10. Company Profiles-Rest of the World

10.1 Benitec, Ltd.
10.2 Tekmira

INDEX OF TABLES

Table 2.1: Advantages/Disadvantages of siRNAs and shRNAs as Inducers of RNAi in Mammalian Cells
Table 2.2: Prevalence of siRNA-mediated RNAi in Disease Models, as Reported in Scientific Literature
Table 2.3: RNAi-based Therapeutics in Clinical Trials
Table 2.4: Suppliers of Enabling Technologies and Tools in RNAi Space
Table 2.5: Suppliers of siRNA/shRNA Products (by Product/Service Class)
Table 3.1: Currently-Utilized Technologies for Inducing RNAi-Mediated Knockdown
Table 3.2: Comparison of mRNA Detection Technologies
Table 3.3: Strategies for Target Validation by Pharma/Biotech: RNAi and Others
Table 3.4: Comparison of Formats for Library-Based Gene Knockdown
Table 3.5: Characteristics of Various Publicly-Available Mouse and Human RNAi Libraries
Table 3.6: Disease-Related miRNAs
Table 3.7: Publicly-Available Computational Programs for Identifying miRNA Sequences/Targets
Table 3.8: Seminal Patents in RNAi
Table 3.9: Venture Capital Raised by Selected Companies in the RNAi Space
Table 3.10: List of Public Biotech Companies in RNAi Space
Table 3.11: SWOT Analysis of siRNA Oligonucleotides
Table 3.12: Transfection Reagents (Lipid-Mediated Delivery)
Table 3.13: shRNA Plasmid Constructs
Table 3.14: shRNA Pooled Libraries or Arrayed Collections (Retroviral/Lentiviral Delivery)
Table 5.1: RNAi Market Segmentation and Research Settings
Table 5.2: Segment 1: Basic Life Science Research Utilizing RNAi Tools and Technologies
Table 5.3: Segment 2: RNAi for Drug Discovery and Development
Table 5.4: Segment 3: RNAi Research for Development of RNAi Therapeutics
Table 5.5: Segment 4: RNAi Fee-for-Service Business
Table 5.6: Grants Awarded and Research Spending in miRNA Space, 2005 to 2008
Table 5.7: RNAi Opportunity and Market Size: Quantitative Model, 2006 to 2009
Table 5.8: Challenges for RNAi Therapeutic Development
Table 5.9: Technology Platforms used in RNAi Research
Table 6.1 : Similarities Between Antisense Oligonucleotides and siRNAs
Table 6.2: Disadvantages of siRNA Versus Antisense Oligonucleotides
Table 6.3: Delivery Vectors for siRNA and Hairpin-Encoding DNA for In Vivo Experiments.
Table 6.4: Delivery Systems for siRNA and Hairpin-Encoding DNA for In Vivo Experiments.
Table 6.5: Delivery Systems for RNAi-based Therapeutics
Table 6.6: Diseases for RNAi Therapeutics
Table 6.7: RNAi-Based Therapeutics Pipeline-Broken Out by Disease/Therapeutic Area
Table 6.8: RNAi-Based Therapeutics Pipeline-Broken Out by Stage of Development
Table 6.9: Most Common Types of Cancer
Table 6.10: RNAi Therapeutics for Cancer in Phase I
Table 6.11: RNAi Therapeutics for Cancer in IND
Table 6.12: RNAi Therapeutics for Cardiac Disease in IND
Table 6.13: RNAi Therapeutics for Cardiac Disease in Pre-clinical/Research
Table 6.14: RNAi Therapeutics for Immunologic Disease in Pre-clinical / Research
Table 6.15: RNAi Therapeutics for Infectious Disease in Phase II
Table 6.16: RNAi Therapeutics for Infectious Disease in Phase I
Table 6.17: RNAi Therapeutics for Infectious Disease in IND
Table 6.18: RNAi Therapeutics for Infectious Disease in Pre-clinical/Research
Table 6.19: RNAi Therapeutics for Inflammatory Disease in Pre-clinical/Research
Table 6.20: RNAi Therapeutics for Life Style Therapies in IND
Table 6.21: RNAi Therapeutics for Metabolic Disease in Pre-clinical/Research
Table 6.22: RNAi Therapeutics for Neurologic Disease in Pre-clinical/Research
Table 6.23: RNAi Therapeutics for Ophthalmic Disease in Phase III
Table 6.24: RNAi Therapeutics for Ophthalmic Disease in Phase II
Table 6.25: RNAi Therapeutics for Ophthalmic Disease in Phase I
Table 6.26: RNAi Therapeutics for Ophthalmic Disease in Pre-clinical/Research
Table 6.27: RNAi Therapeutics for Renal Disease in Phase I
Table 6.28: RNAi Therapeutics for Respiratory Disease in Pre-clinical/Research
Table 7.1: Nucleonics Products and Programs Ongoing/Pipeline
Table 7.2: Quark' s Product Pipeline
Table 8.1: Santaris' Product Pipeline
Table 8.2: Silence Therapeutics' Product Pipeline

INDEX OF FIGURES

Figure 2.1: The miRNA Processing Pathway
Figure 2.2: Growth of Scientific Publications Addressing miRNAs, 2001 to 2008
Figure 2.3: Mechanisms of Small RNA-induced Gene Regulation
Figure 2.4: Types of RNAi Compounds
Figure 2.5: Breakdown of Scientific Publications Related to RNAi by Geographic Region, 2007 to 2008
Figure 3.1: End-User Segmentation of RNAi Space
Figure 3.2: RNAi Patents Filed Globally, by Geographical Origin
Figure 3.3: Selected Deals in RNAi Space
Figure 4.1: Geographical Breakdown of RNAi End-User Survey Respondents
Figure 4.2: Affiliation of RNAi End-User Survey Respondents
Figure 4.3: Utilization of RNAi Technologies/Products by Respondent Pool
Figure 4.4: RNAi Utilization Period: Breakdown of Respondent Pool
Figure 4.5: Research Applications Using RNAi Technologies/Products
Figure 4.6: Types of RNAi Technologies Currently Utilized
Figure 4.7: RNAi Technologies Most Commonly Utilized Currently by End-Users
Figure 4.8: Types of RNAi Technologies: Expected Use in Six to 18 Months
Figure 4.9: Evolution of Market Shares of RNAi-Inducing Technologies
Figure 4.10: Number of Experiments Involving RNAi Conducted per Week
Figure 4.11: Range of Research Dollars Spent Monthly on RNAi Research
Figure 4.12: RNAi Experiment Throughput Correlated with Type of RNAi Technology Used
Figure 4.13: Current RNAi Market Share by Segments
Figure 4.14: Growth/Decline Rate of RNAi Marketplace Segments (Six to 18 Months)
Figure 4.15: Product Formats Utilization for RNAi Research (Current and Six to 18 Months)
Figure 4.16: Companies Offering Product Formats for Currently-Used RNAi Products
Figure 4.17: RNAi Product Offerings/Formats Use (Projections-Six to 18 Months)
Figure 4.18: Percentage Change of RNAi Product Offerings/Formats (Six to 18 Months)
Figure 4.19: Key Challenges Faced by End-Users in RNAi Space
Figure 4.20: Unmet Needs in RNAi Space Ranked by Importance to End-Users
Figure 5.1: Growth and Evolution of miRNA Space
Figure 5.2: Elements of RNAi Value Chain
Figure 5.3: Growth and Evolution of RNAi (siRNA/shRNA) Space
Figure 5.4: Market Revenues Based on Components of siRNA Experimental Paradigm

Genetics Bundle

Table of Contents

Bioinformatics Markets

1. Overview

2. Introduction

3. The U.S. Bioinformatics Market

4. Genomics

5. The Bioinformatics Industry

6. Bioinformatics Business

7. Recent Industry Activity

8. Corporate Profiles

INDEX OF FIGURES

INDEX OF TABLES

DNA Sequencing and PCR Markets.

1. Overview

2. Introduction to DNA Sequencing and Amplification and PCR Technology

3. Market Analysis of PCR and DNA Sequencing Product Market

4. Use of PCR and DNA Amplification Products

5. Technical Trends in PCR

6. Corporate Directory

7. Market Trends and Forecasts

8. Major Product Innovations/Launches in DNA Sequencing Industry

LIST OF FIGURES

LIST OF TABLES

Gene Expression Reagents Markets.

1. Overview

2. Gene Expression

3. Gene Expression Reagents

4. Market Environment

5. Market Drivers

6. Worldwide Market for Gene Expression Reagents

7. Key Applications

8. Vendor and Product Selection

9. Leading Vendors

10. Marketing Strategies

11. Pricing Strategies

12. Distribution Channels

13. Competitive Situation

14. Opportunities

15. Market Strategy Profiles, Leading and Selected Vendors

LIST OF FIGURES

LIST OF TABLES

Genomics World Markets

1. Introduction

2. Genomics Technology and Industry

3. How Genomics Is Revolutionizing Healthcare

4. Proprietary Applications and Patents

5. Business Analysis

6. Genomics Company Profiles

7. Genomics Challenges and Growth Factors

8. Bioinformatics

INDEX OF FIGURES

INDEX OF TABLES

Microarray Markets

1. Overview

2. Overview of Microarrays

3. DNA Microarrays

4. Protein Microarrays

5. Current DNA Microarrays

6. Current Protein Microarrays

7. Technology

8. Applications

9. The Commercial Opportunity for Microarrays

10. Company Profiles

LIST OF FIGURES

LIST OF TABLES

Personalized Medicine

1. Overview

2. The Case for Pharmacogenomics and Personalized Medicine: Biology, Approaches, Pipeline and Regulatory Trends

3. Pharmacogenomics/Personalized Medicine: Qualitative and Quantitative Market Analysis

4. Company Profiles

LIST OF FIGURES

LIST OF TABLES

Pharmacogenomics for Clinical Use and in Drug Development

1. Overview

2. Introduction

3. Pharmacogenomic Testing Market: Size, Growth and Share

4. Pharmacogenomic Disease Markers

5. Pharmacogenomic Testing: Development Issues

6. Business Trends in the Industry