Worldwide Diagnostics Market Research Bundle (Worldwide Market for In Vitro Diagnostic Tests 6th Ed., SNP Genotyping and Analysis Markets, Companion Diagnostics Markets)

• Introduction
• Scope and Methodology
• Size and Growth of the Market
• Market Trends - a ten year review

• Background
• Lab Medicine Disciplines And Applications, new report design
• Market Analysis of IVD Market Segments
• Age of the giants and smaller colossuses
• Licenses and distribution agreements
• Point of View

• Background
• The global community strives for regulatory harmonization
• World Segments of the IVD Market and IVD Market Evolution
• The United States of America - a free market in disguise - holding its own
• Europe - economic crisis drives reorganizations
• China - the WTO powerhouse
• The lure of emerging markets
• IVD Market Growth - segments and technologies
• Traditional IVDs
• Emerging Tests and Technologies

• Background
• HIV Testing, a 25 year phenomenon
• Diabetes innovation
• Miniaturization And Chip Progress
• Non-Invasive Techniques And Alternative Samples
• Commercialization Issues : Patents and market innovation
• Direct to consumer marketing
• Patient Management and Outcomes-Based Medicine
• Economics of New Tests and Technologies - the old don't disappear
• Post Genomics and Pharmacogenomics - reality check
• Growing Globalization of Public Health Crises - SARS, West Nile, Biowar impact
Regulatory and Reimbursement Issues And Novel Devices

• Overview of POC Tests
• Leading Innovations
• Cost Pressures and Perceived Barriers for POC Tests
• Institutional Users of POC Tests
• The Commercial Outlook for POC Tests
• Companies to Watch

• Overview
• Market Analysis : Leading Suppliers and Growth Potential
• Lab Automation and Work Station Consolidation
• Decentralization Imperative
• The Commercial Outlook for the Core Lab
• Companies to Watch

• Overview of Immunoassays
• Market Analysis : Leading Suppliers and Growth Potential
• Immunoassay Test Segments - Mature and Emerging
• Point-of-care OTC and Professional Use
• The Commercial Outlook for Immunoassays
• Companies to watch

• Overview of Molecular Assays
• Molecular Testing Innovation -- Technology and Players
• PCR patents and innovation
• Expectations for decentralized testing
• The Commercial Outlook for Molecular Tests
• Companies to watch

• Overview of Hematology
• Market Analysis : Leading Suppliers and Growth Potential
• Decentralized Hematology Testing
• The Commercial Outlook for Hematology Tests
• Companies to Watch

• Overview of Coagulation / Immunohematology Tests
• Genetic markers of hypercoagulation disorders
• Decentrealized Coagulation testing - OTC and Professional Use
• Market Analysis : Leading Suppliers and Growth Potential
The Commercial Market for Coagulation Tests Companies to Watch

• Overview of Microbiology / Virology Tests
• Market Analysis : Leading Suppliers and Growth Potential
• Antimicrobial Resistance - a moving target
• Tradition is Challenged by Molecular Techniques
• Rapid Microbiology Screening
• Emerging Organisms and the Globalization of Infectious Diseases
• The Commercial Outlook for Microbiology / Virology Tests
• Companies to Watch

• Overview of Blood Banking
• Market Analysis : Leading Suppliers and Growth Potential
• Nucleic Acid Testing Continues to Grow
• The Commercial Outlook for Blood Banking
• Companies to Watch

• Overview of Histology / Cytology
• Market Analysis : Leading Suppliers and Growth Potential
• Genomic Medicine Fuels Automated Techniques and FISH
• Flow Cytometry on the FLOW
• The Commercial Outlook for Histology and Cytology Tests
• Companies to Watch

SNP GENOTYPING AND ANALYSIS

• What is a SNP?
• Applications
• The Market
• Competitive Analysis
• Challenges
• Scope and Methodology

• Background
• SNP Analysis Methods
  • Amplification
  • Allele discrimination / assay reaction mechanism
  • Single Nucleotide Addition; Pyrosequencing
  • Assay Format
  • Detection Method
• Scope and Methodology
• Definitions
  • DNA Microarray
  • Genome-Wide Association
  • Linkage Analysis
  • Mass Spectrometry
  • Single-Nucleotide Polymorphism (SNP)

• Life Science Research
• Pharmacogenetics / Pharmacogenomics
  • Case Study #1 -- SNPs in Gene for P-glycoprotein Affect Antidepressant Response
  • Case Study #2 - Celera Studying SNPs Associated With Heart Disease
  • Case Study #3 - Synonymous SNPs Alter mRNA Splicing with Obesity
  • Case Study #4 - University of Ottawa Heart Institute (UOHI) Coronary Artery
  • Disease Research

• Industry Trends
  • Consolidation Occurring in Array and Life Science Markets
  • FDA Involvement Making Drug Industry More Comfortable
  • Acceptance of SNP Analysis, Pharmacogenetics Reached Tipping Point
  • Core Labs Becoming Established Paradigm
• Technology Trends
  • Increased Multiplexing Expands Applications
  • End-Users Attracted to Larger-Scale SNP Platforms
  • Complexity of Biological Systems Requires Multiple Techniques
  • Miniaturization of Equipment and Instruments
• Regulatory Trends
  • Introduction
  • Critical Path Initiative
  • March 2005 - “Guidance for Industry - Pharmacogenomic Data Submissions”
  • April 2005 - “Drug-Diagnostic Co-Development Concept Paper”
  • March 2006 - Critical Path Opportunities List
  • November 2006 - “Recommendations for the Generation and Submission of
  • Genomic Data”
  • August 2007 - “Pharmacogenomic Data Submissions — Companion Guidance”
  • August 2007 - FDA Updates Labeling of Warfarin (Coumadin)
  • December 2007 - EGAPP Reviews Use of CYP450 Genetic Testing For SSRIs

• Affymetrix
  • Overview of Affymetrix Products
  • Hardware
• Applied Biosystems
  • Overview of Applied Biosystems Products
  • Assays and Reagent
  • Instruments
• Beckman Coulter
• CombiMatrix
• Febit
• GE Healthcare
• Illumina
  • Hardware
  • Microarrays
• LI-COR Biosciences (Lincoln, NE)
• Roche Applied Science
• Sequenom
• Services
  • Agencourt Biosciences
  • DNAPrint Genomics
  • Polymorphic DNA Technologies
• Software
  • Applied Biosystems
  • Premier Biosoft
• Public Tools

• Consortia, Collaborative Projects
  • The Cancer Genome Atlas (TCGA) Pilot Project
  • Cancer Sequencing Project
  • Critical Path Institute
  • DNA Polymorphism Discovery Resource
  • Genetic Association Information Network (GAIN)
  • Genotype-To-Phenotype Database (GEN2PHEN)
• International HapMap Project
  • Introduction & Background
  • Rationale for HapMap Approach
  • Process for Producing HapMap
  • Populations Included in HapMap
  • Measures Taken to Protect Donors’ Privacy
• Laboratories and Technologies Involved in HapMap
• Practical Use of the HapMap Data
  • MicroArray Quality Control (MAQC) Project
• NIH Roadmap
  • NIH Roadmap for Medical Research
  • Pharmacogenetics Research Network (PGRN)
• NIH Involvement, Funding for SNPs and Sequencing
• Funding for Sequencing Projects Affecting SNP Market
  • Continued Rapid Growth in Sequence Production
  • Funding and Consortia for Sequencing
• NHGRI Funds Large-Scale Sequencing Centers, 2006
• Competitive Activity

• Historical
  • Illumina as Bellwether for SNP Analysis Market
  • Applied Biosystems as Bellwether for RT-PCR Products
• Forecast
  • Assumptions
  • SNP Revenues by Region
  • SNP Revenues by Product
• Competitive Analysis

• Affymetrix
• Applied Biosystems
• Illumina

• Challenges
  • Cheaper Sequencing Creates Competition for SNP Analysis Platforms
  • Market Is Dominated by a Small Number of Suppliers
  • Issues Arise With Use of Public Databases
  • Data Management Requirements Limit Large-Scale Technologies
  • Diagnostic Market Holds Obstacles For New Innovations
  • Backlash Against Rush Into Genetic Testing, DTC Marketing
  • Standard Processes for SNP Experiments Still Not Established
  • Shortcomings in Sample Preparation and Handling Hinder Success
  • Privacy Concerns Pose Threat to Broad Technology Adoption
• Strategic Recommendations

• Figure-1-1: SNP Analysis Market 2007-2013
• Figure 1-2: Growth Rate in SNP Analysis Revenues 2008-2013

• Table 2-1 Adelle-Specific Invasive Cleavage
• Table 2-2 Adelle-Specific Ligation
• Table 2-1 Allele-Specific Primer Extension
• Table 2-4 Single Base Primer Extension

• Table 4-1: Critical Path Opportunities List

• Figure 5-1: Taq Man Assay
• Figure 5-2: SOLID System Average Throughput Progress
• Figure 5-3: SNPstream Method
• Figure 5-4: Roche SimpleProbe System
• Figure 5-5: Roche HybProbe System
• Table 5-1 Products in the SNP Analysis Market
• Table 5-2 Public SNP Tools and Resources (Tool, Website)

• Table 6-1: Number of Individuals in Each Subset (Population Group, Full Set, Subsets)
• Figure 6-1: Domains of Genomes Sequenced by Year (Archaea, Bacteria, Eukaryota)
• Table 6-2: Composition of the DNA Polymorphism Discovery Resource (Population Group, Proportion of Admixture, Number of Individuals, Number of Genomes by Continent)
• Table 6-3: Companies’ Technologies Used in First Phase of HapMap (Company, Percent of Genome)
• Table 6-4: Companies’ Technologies Used in First Phase of HapMap (Group, Technology, % of Genome)
• Figure 6-4: Major Sequencing Centers and Percent of Sequencing Projects (WORLD, GENOSCOPE, BMC, Sanger, WashU, BROAD, JCVI, JGI), Jan 2008
• Figure 6-5: Top Funding Agencies, DNA Sequencing, 2008($M)
• Figure 6-4: Major Sequencing Centers and Percent of Sequencing Projects (WORLD, GENOSCOPE, BMC, Sanger, WashU, BROAD, JCVI, JGI), Jan 2008
• Figure 6-5: Top Funding Agencies, DNA Sequencing, 2008 ($M)
• Figure 6-6: Human Genome Project Funding, DOE& NIH ’90-‘03
• Figure 6-7: Areas Funding Genome Sequencing, Jan 2008 (Medical, Evolutionary, Agricultural, Environmental, Biotechnology)
• Table 6-5: Large-Scale Sequencing Centers, NHGRI Funding, 2004-2006
• Figure 6-8: Top Genome Sequencing Countries, Jan. 2008 (# projects)
• Figure 6-9: SNP Analysis Related Deals (Companies, Date, Details of Deal)
• Figure 6-10: SNP: NHGRI Funded Large-Scale Sequencing Ctrs, ‘07
• Table 6-6: SNP Analysis-Related Deals (Companies, Date, Details of Deal)

• Figure 7-1: Illumina Quarterly Revenues, 2001-2007 ($M)
• Figure 7-2: Applied Biosystems Revenues in Real Time PCR/Applied Genomics
• Table-7-1: Forecasted Revenues in the SNP Analysis Market
• Figure-7-3: Forecasted Revenues in the SNP Analysis Market
• Table 7-2: Growth Rate in SNP Analysis Tools Market, 2008-2013
• Figure 7-4: Growth Rate in SNP Analysis Tools Market, 2008-2013
• Figure 7-5: SNP Analysis Revenues by Region (North America, Europe, Rest of World)
• Table 7-3: SNP Analysis Revenues by Region (North America, Europe, Rest of World)
• Figure 7-6 SNP Market by Product Segment (Instruments, Consumables, Software & Services)
• Table 7-4: SNP Market by Segment (Instruments, Consumables, Software & Services)
• Table 7-5: Revenues Among the Top Companies in SNP Analysis (Illumina, Affymetrix, Applied Biosystems, Other)
• Figure 7-7: SNP Analysis Market Share, 2007

CHAPTER EIGHT: CORPORATE PROFILES

• Figure 8-1: Affymetrix’ Revenues by Product Type, 2004 - 2007
• Figure 8-2: Illumina BeadStation Installed Base, 2004-2006

• Figure 9-1: Estimated Decrease in Screening Price

COMPANION DIAGNOSTICS MARKETS