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

• 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

CHAPTER TWO: INTRODUCTION

• 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

CHAPTER FOUR: INDUSTRY AND REGULATORY TRENDS

• 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)

CHAPTER SIX: CONSORTIA, GOVERNMENT INVOLVEMENT, DEALS

• Figure 6-1: Domains of Genomes Sequenced by Year (Archaea, Bacteria, Eukaryota)
  
  
  
  
  
• Major Sequencing Centers, Jan 2008
  
  
  
  
  
• Figure 6-5: Top Funding Agencies, DNA Sequencing, 2008
  
  
  
  
  
• 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)

CHAPTER SEVEN: MARKET DATA AND COMPETITIVE ANALYSIS

• 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

CHAPTER NINE: CHALLENGES AND STRATEGIC RECOMMENDATIONS

• Figure 9-1: Estimated Decrease in Screening Price

COMPANION DIAGNOSTICS MARKETS