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Brochure More information from http://www.researchandmarkets.com/reports/2860766/ Testing Services Markets, SNP Analysis, DNA Sequencing, Retail Clinics, Companion Diagnostics Description: A perfect supplemental information resource for customers who have already purchased The Worldwide Market for In Vitro Diagnostic Tests, 6th Edition, The IVD Market Research Supplement bundle studies and quantifies in greater detail some of the important areas that will have a transforming impact on the diagnostic industry: Companies are now performing diagnostic tests as a service rather than simply selling kit to laboratories. Are companies seeking profit, or a 'back-door' around FDA regulations? And does it have growth potential as a strategy. DNA sequencing and SNPs are essential for genetic testing, clearly the future of diagnostics. What companies/products are dominating these areas, and what growth can be expected? Retail clinics present an interesting venue for diagnostics to be sold; but there is confusion in the marketplace about how many stores will open and what their impact will be. Companion diagnostics, or theranostics has generated a lot of publicity- but what are the obstacles that need to be overcome for the concept to work in the marketplace? These questions have been tackled by Kalorama analysts in five reports. While the topics are touched on in the 6th Edition, this bundle of reports, representing over 1,000 pages of market research, takes a more detailed look. Test Services Commercialization SNP Analysis Retail Clinics (contains POC and Immunoassay retail clinic sales information) Companion Diagnostics DNA Sequencing Equipment and Services A bundle of five Kalorama Information reports, this resource, representing over 1,000 pages of information on cutting-edge topics critical to the future of diagnostics, is available at a significant discount over the cost of the five reports individually. The cost of these reports, purchased seperately with a single user license would be over $16,000. This resource is available to all buyers but the Kalorama editors believe this will be especially useful to previous buyers of the The Worldwide Market for In Vitro Diagnostic Tests, 6th Edition, (which is not included in this product, and would be purchased separately.) The reports are grouped together into one electronic version, with a seperate table of contents for each market report. As with all Kalorama Information products, these five reports were created by professional analysts with industry experience and were the result of both secondary (research into annual reports, medical literature, trade press) and most importantly primary research (interviews with experts and executives) to obtain real market insights. In several of these areas, SNPs, Retail Clinics and Test Services for instance, Kalorama has been the first to publish meaningful research on the topics. Contents: DIAGNOSTIC TEST SERVICE COMMERCIALIZATION: A ROADMAP TO DIAGNOSTICS IN THE 21ST CENTURY CHAPTER ONE: EXECUTIVE SUMMARY Scope and Methodology Market Trends Clinical Chemistry Coagulation tests Flow Cytometry Histology/Cytology Infectious Diseases Keys to Success CHAPTER TWO: INTRODUCTION Background The U.S. Versus Europe ASRs Hospital Outreach and National Reference Lab Services Lab Outreach Testing Independent Laboratories Status quo and Future Tests in Development Serendepity or Strategy? CHAPTER THREE: MARKET OVERVIEW/ SUPPLY ANALYSIS Background Market Analysis, revenue estimates 2007 - 2012 Testing Markets ISC and ISH Market and Growth Market Share Lab Launches and Acquisitions Market Leaders Evaluation of Lab Tests Uniqueness Need Reimbursed Incumbent Recognized Peer Reviewed Competition from FDA Cleared Products Cost Competitive Technologies Pathwork BRCA analysis Mammastatin Limited Use of Molecular Testing for Colon Cancer. TDT Ovarian Cancer Testing Future Leaders? HIV Testing Mental Illness Test Services on the Horizon CHAPTER FOUR: MARKET TRENDS/ DEMAND ANALYSIS The Commercialization of Multiplexed and Complex Analyses Opportunity Pricing and margins are attractive Demand for Esoteric Tests CHAPTER FIVE: MARKET BARRIERS FOR TEST SERVICES Regulatory affairs Can the FDA Regulate New test Modalities? IVDMIAs Pending LDT Legislation Reimbursement Imperative Physician Uptake Connectivity, a Force to Consider The In Vivo - In Vitro Diagnostic Paradigm Social media and Internet-Based Services CHAPTER SIX: TESTS AND COMPANIES TO WATCH 23andMe, Inc. Key Comment Details Affymetrix Key Comment Details Agendia B.V. Key Comment Details ARUP Laboratories Key Comment Athena Diagnostics, Inc. Key Comment Details Atherotech Key Comment Details AviaraDx (formerly Arcturus Biosciences Key Comment Details Biomedical Diagnostics, LLC/Abviva, Inc. Key Comment Details Biophysical Corporation Key Comment Details Caris MPI Key Comment Clarient Inc. (formerly ChromaVision Key Comment Detail Clinical Data, Inc Key Comment Details CombiMatrix Molecular Diagnostics (CMDX Key Comment Details Consumer Genetic Key Comment Details Corgenix Medical Corporatio Key Comment Details Correlogic Systems, Inc deCode Genetics Inc. Details DiagnoCure Key Comment Details DNA Direct, Inc. Key Comment Details EXACT Sciences Corporation Key Comment Details Exiqon A/S Key Comment Details Focus Diagnostics, Inc. Key Comment Details Genelex Corporation Key Comment Details Genomic Health Key Comment Details Genoptix, Inc. Key Comment Details Genzyme Corporation Details InterGenetics, Inc. Key Comment Details Knome, Inc. Key Comment Details Lab21 Healthcare Key Comment Laboratory Corporation of America Holdings (LabCorp) Key Comment Details LipoScience, Inc. Key Comment Details Mayo Medical Laboratories Key Comment Details Monogram Biosciences, Inc. (formerly ViroLogic) Key Comment Details Myriad Genetics, Inc. Key Comment Details NeuroMark Key Comment Details Nuvera Biosciences Key Comment Details Nymox Pharmaceuticals Details Oncolab, Inc. Key Comment Details Panacea Pharmaceuticals, Inc. Key Comment Details Pathway Diagnostics Corporation Key Comment Details Pathwork Diagnostics (formerly Predicant Biosciences) Key Comment Details Perceptronix Medical Inc. Key Comment Details Power3 Medical Products, Inc. Key Comment Details Precision Therapeutics, Inc. Key Comment Details Prometheus Laboratories Inc. Key Comment Details Psynomics Incorporated Key Comment Details Quest Diagnostics Incorporated Key Comment Details Rational Therapeutics Key Comment Details Rosetta Genomics Ltd. Key Comment Details Signature Genomic Laboratories, LLC Key Comment Details Smart Genetics Key Comment Details Specialty Laboratories Key Comment Details SpectraCell Laboratories, Inc. Key Comment Details Targeted Diagnostics & Therapeutics, Inc. (TDT) Key Comment Details XDx Inc. Key Comment Details CHAPTER SEVEN: CONCLUSION Is There a Market for Test Services? Strategies for Successful Market Entry TABLE OF EXHIBITS CHAPTER ONE: EXECUTIVE SUMMARY Figure 1-1: Sales of 7 Key IVD Segments (Clinical Chemistry, Immunoassays, Radioimmunassays, Coagulation, Histology/Cytology, Nucelic Acid Assays, Flow Cytometry) vs. Their Esoteric Components, 2007 Figure 1-2: Growth Rate 7 IVD Segments (Clinical Chemistry, Immunoassays, Radioimmunassays, Coagulation, Histology/Cytology, Nucelic Acid Assays, Flow Cytometry) vs. Their Esoteric Components , 2007 Figure 1-3: Esoteric Test Service Revenues, Reference Labs and CLIA-registered Company Test Service Offerings, 2007 and 2012 CHAPTER TWO INTRODUCTION Figure 2-1: Explosion of Test Capabilities 20th and 21st Century CHAPTER THREE: MARKET OVERVIEW AND SUPPLY ANALYSIS Table 3-1: Worldwide Esoteric Test Reagent Sales by Product Market, 2007 Figure 3-1: Esoteric Sales Across IVD Segments (Clinical Chemistry, Immunoassays, Radioimmunassays, Coagulation, Histology/Cytology, Nucelic Acid Assays, Flow Cytometry), 2007 Table 3-2: Worldwide Test Servcies Market Table 3-3: Esoteric and Genomic Service Test Sales, Selected Companies (Company, Location, Area, 20052008 sales, % of Change) Table 3-4: Selected CLIA- Registered Company Lab Tests Evaluated Selected CLIA- mRegistered Company Lab Tests Evaluated (Uniqueness, Need, Reimbursement, Incumbent Presence, Recognizable Technology, Peer Reviewed) Table 3-5: Selected CLIA-Registered Lab Test Services, 2007 CHAPTER FOUR: MARKET TRENDS AND DEMAND ANALYSIS Table 4-1: Number of People Who Get Chronic Diseases Every Year SNP GENOTYPING AND ANALYSIS MARKETS CHAPTER ONE: EXECUTIVE SUMMARY What is a SNP? Applications The Market Competitive Analysis Challenges Scope and Methodology CHAPTER TWO: INTRODUCTION 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) CHAPTER THREE: APPLICATIONS 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 CHAPTER FOUR: INDUSTRY AND REGULATORY TRENDS 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 CHAPTER FIVE: PRODUCTS 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 CHAPTER SIX: CONSORTIA, GOVERNMENT INVOLVEMENT, DEALS 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 CHAPTER SEVEN: MARKET DATA AND COMPETITIVE ANALYSIS 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 CHAPTER EIGHT: CORPORATE PROFILES Affymetrix Applied Biosystems Illumina CHAPTER NINE: CHALLENGES AND STRATEGIC RECOMMENDATIONS 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 TABLE OF EXHIBITS CHAPTER ONE: EXECUTIVE SUMMARY 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 CHAPTER FIVE: PRODUCTS 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 (A REALISTIC ASSESSMENT OF THE OPPORTUNITIES, CHALLENGES, KEY PLAYERS AND IMPORTANT TRENDS IN PERSONALIZED MEDICINE) CHAPTER ONE: EXECUTIVE SUMMARY Background Potential Benefits of Companion Diagnostics Pitfalls of Personalized Medicine Scope and Methodology Market Factors and Estimates Drivers For Companion Diagnostics Assumptions Important Trends Possible Tactic: Royalty Model CHAPTER TWO: OVERVIEW OF COMPANION DIAGNOSTICS Personalized Medicine Potential Benefits Privacy and Public Perception Biomarkers and Companion Diagnostics Types of Biomarkers CHAPTER THREE: APPLICATIONS OF COMPANION DIAGNOSTICS Pharmacogenetics and Pharmacogenomics Historical Basis Current Techniques Requirements Cost-effectiveness Applications The Cytochrome System Cancer Amgen UAMS Multiple Myeloma Project DakoAssay for TOP2A GE and Eli Lilly Epigenomics and Abbott Celera and Merk bioMerieiux and Ipsen Acute Lymphoblastic Leukemia Regulatory Agencies Applications of Genome More Challenging Than Expected Cardiovascular Disease RAS polymorphisms With Drug Effectiveness Pgp Thiazide diuretics 825T allele HIT Statins Psychiatry and Pharmacogenetics/Pharmacogenomics Is Herceptin a Paradigm? A Balancing Act Between the Players CHAPTER FOUR: MAJOR WORLD MARKET FACTORS AND DATA FOR COMPANION DIAGNOSTICS Estimating Market Potential Associated Testing The Needs of Pharma and of Diagnostic Companies Questions Determining Companion Diagnostics Growth A Partial Change in Attitude Intellectual Property Cancer Market Potential Estimate Ideal Market Potential - Cancer, Heart Disease, Psychiatric Source: Kalorama Information Challenges Unique to Companion Diagnostics Privacy Concerns Fear of Learning About Diseases Use of Remnant Samples Avoiding Pitfalls of Market Calculation Companion Diagnostics Not Linked to Molecular Diagnostics Demonic and SNP Analysis Considering Time of Cooperative Development Market Realities to Consider Possible Tactic: Royalty Model CHAPTER FIVE: COMPANY SUMMARIES Overview Abbott (Molecular) Diagnostics Subsidiary of Abbott Laboratories Affymetrix, Inc. Agilent Technologies, Inc Althea Technologies, Inc. Curidium Medica plc Dako Gen Probe Genzyme Corporation Ipsogen SAS Lipomics Technologies, Inc. Osmetech plc Perlegen Sciences Provista Life Sciences Qiagen NV Singulex, Inc. Theranostics Health Ventana Medical Systems CHAPTER SIX: CONCLUSIONS AND STATEGIC IMPLICATIONS First Conclusion Implications: Second Conclusion Implications: Third Conclusion Implications: Fourth Conclusion Implications: Fifth Conclusion Implications: Sixth Conclusion Implications: Seventh Conclusion Implications: Eighth Conclusion Implications: Ninth Conclusion Implications: Tenth Conclusion Implications: APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS TABLE OF EXHIBITS CHAPTER ONE: EXECUTIVE SUMMARY Table 1-1: Market Projections for Companion Diagnostics* in the United States: 2008 - 2018 Figure 1-1: Market Projection Trends for Companion Diagnostics in the United States: 2008 - 2018 CHAPTER THREE: APPLICATIONS OF COMPANION DIAGNOSTICS Table 3-1 Companion Diagnostics Groups Table 3-3: Frequency of Recessive Traits Table 3-4: Existing Cancer Drugs Complimentary to Companion Diagnostics Table 3-5: Recent Activities in Companion Diagnostics CHAPTER FOUR: MAJOR WORLD MARKET FACTORS AND DATA FOR COMPANION DIAGNOSTICS Table 4-1: The Ideal Potential Companion Diagnostics Markets for Cancer Therapeutics: 2008 Figure 4-1: The Ideal Potential Companion Diagnostics Markets for Cancer Therapeutics: 2008 Table 4-2: The Ideal Potential Companion Diagnostics Markets for Therapeutics Addressing the Top Four, High-Profile Cancers: 2008 Figure 4-2: The Ideal Potential Companion Diagnostics Markets forTherapeutics Addressing the Top Four, High-Profile Cancers: 2008 Figure 4-3: The Ideal Companion Diagnostics Market (Ideal vs. Likely to Benefit) Figure 4-4 Subset of Ideal Market Likely to Benefit From Pharmaceutical Intervention (Likely to Benfit vs. Realistic Market) Table 4-3: Market Projections for Companion Diagnostics* in the United States: 2008 - 2018 Figure 4-1: Market Projection Trends for Companion Diagnostics* in the United States: 2008 - 2018 CHAPTER SIX: CONCLUSIONS AND STATEGIC IMPLICATIONS Table 6-1: Hypothetical Cancer Therapy Outcome Based on Associated Genes RETAIL CLINICS, THE EMERGING MARKET FOR CONVENIENCE AND IN-STORE HEALTHCARE CHAPTER ONE: Executive Summary Healthcare Reform The Emergence of Retail Clinics Establishing a Retail Clinic Service Providers Suppliers Clinical Chemistry and Immunoassays Vaccines Indirect Revenues Types of Retail Outlets Offering Clinics Drug Stores Supermarkets and Food Stores Mass Merchandisers Other Outlets Issues And Trends Competition with Primary Care Providers Regulation Development of Standards Expansion of Services Labor Shortages Scope and Methodology CHAPTER TWO: Introduction The U.S. Healthcare System Today Overview Public Health Care Private Health Care The Need For Alternatives High Cost of Care Inconsistent Quality of Care Delays to Treatment Advertising and Promotion Insurance Consumer Response Growth Drivers Economic Pressures on Consumers Consumer Responsibility for Health Care Benefits of Prevention Challenges Standards of Care Patient Flow Medical Community Response Reaction from Managed Care Organizations Ability to Meet Financial Expectations Establishing A Retail Clinic Alliances CHAPTER THREE: Service Providers The Industry Convenience Clinic Sales Forecasts The Market Competitive Positions of Key Players CHAPTER FOUR: OPPORTUNITIES FOR DIAGNOSTIC AND PHARMACEUTICAL COMPNIES Point of Care Tests The Industry Competitive Positions of Key Players Convenience Clinic Sales Forecasts Clinical Chemistry and Immunoassays The Industry Competitive Positions of Key Players Convenience Clinic Sales Forecasts Vaccines The Industry Competitive Positions of Key Players Convenience Clinic Sales Forecasts CHAPTER FIVE: Retail Outlets Drug Stores The Industry Competitive Positions of Key Players Convenience Clinic Sales Forecasts Food Stores The Industry Competitive Positions of Key Players Convenience Clinic Sales Forecasts Mass Merchandisers The Industry Competitive Positions of Key Players Convenience Clinic Sales Forecasts Other Outlets The Industry Competitive Positions of Key Players Convenience Clinic Sales Forecasts CHAPTER SIX: Total Market Growth of Retail Clinics Opportunities for Suppliers Increased Revenue for Retailers CHAPTER SEVEN: Issues and Trends Competition With Primary Care Providers Regulation Overview Regulation of Convenience Clinics Pending Legislation Development of Standards Expansion of Services Labor Shortages CHAPTER EIGHT: Company Profiles Atlanticare Aurora Quick Care Checkups Early Solutions Clinic MedBasics Minute Clinic My Healthy Access Quick Health Now Medical Centers Rediclinic SmartCare Family Medical Centers Solantic Take Care Health Systems Target Clinic Medical Associates The Little Clinic APPENDIX TABLE OF EXHIBITS CHAPTER ONE: EXECUTIVE SUMMARY Figure 1-1: Estimated Number of U.S. Convenience Clinics, 2007 - 2011 Figure-1-2: Locations of Retail Clinics, 2007 Figure 1-3: Indirect Revenue to Drug Stores, Supermarkets, Mass Merchandising Outlets and Others with Retail Clinics CHAPTER TWO: INTRODUCTION Figure 2-1: National Health Expenditures (NHE) and NHE as a Percent of GDP, 1980 - 2011 Figure 2-2: Premium Increases vs. Increases in Workers Earnings and Prices, 1989 - 2005 Figure 2-3: Unnecessary Deaths Resulting From Variations in Health Care Quality Figure 2-4: HEDIS Scores by Quality of Health Care Plan, 2006 Figure 2-5: Change in Out of Pocket Health Care Expenses for Medicaid Recipients, 1997 - 2002 Figure 2-6: Out of Pocket Health Care Expenses for Disabled and Non-Disabled Medicaid Recipients, 1997 vs. 2002 Figure 2-7: Proportion of Adults Under Age 65 With Chronic Conditions, 2003 Table 2-2: U.S. Health Care Coverage by State, 2007 Table 2-3: Cost Savings From Medical Tourism, 2007 Table 2-4: Estimated Number of U.S. Convenience Clinics, Expansion of U.S. Convenience Clinics by Major Chain (Aurora, QuickCare, Healthy Access, Minute Clinic, Quick Health, Solantis, Target Clinical, CheckUps, MedBasics, Now Medical Centers, RediClinic Others, Take Care Clinics, the Little Clinic) 2007 to 2011 Figure 2-8: Expansion of U.S. Convenience Clinics by Major Chain (Aurora QuickCare, Healthy Access, Minute Clinic, Quick Health, Solantis, Target Clinical, CheckUps, MedBasics, Now Medical Centers, RediClinic Others, Take Care Clinics, the Little Clinic) 2007 to 2011 Table 2-5: Characteristics of Retail Outlets, 2007 (Drug Stores, Food Stores, Mass Merchandizing Outlets) Table 2-6: Benefits and Drawbacks of Convenience Clinic Funding Approaches, 2007 92 Table 3-1: The U.S. Market for Retail Clinic Services, 2001-2011 CHAPTER THREE: SERVICE PROVIDERS Figure 3-1: Growth of U.S. Retail Clinic Services, 2001-2011 Table 3-2, Leading Service Providers’ Revenues and Market Share Figure 3-2: Market Shares of Leading Retail Clinic Service Provider, 2006 CHAPTER FOUR: OPPORTUNITIES FOR DIAGNOSTIC AND PHARMACEUTICAL COMPNIES Table 4-1: Sales to Retail Clinics by Supplier Segment, 2001-2011 (POC Tests, Clinical Chemistry & Immuno- assays, Vaccines) Figure 4-1: Growth of Retail Clinic Supplier Sales by Type of Supplies, 2001-2011 (POC Tests, Clinical Chemistry & Immuno-assays, Vaccines) Table 4-2: U.S. Professional POC Test Sales, 2001-2011 Table 4-3: Leading POC Test Makers’ U.S. Revenues and Markert Share, 2006 Table 4-4: U.S. Professional POC Test Sales to Retail Clinics, 2001-2011 Table 4-5: U.S. Clinical Chemistry and Immunoassay Sales, 2001-2011 Table 4-6: Leading Clinical Chemistry and Immunoassay Suppliers’ Revenues and Market Share, 2006 Table 4-8: Diseases for which Vaccines are Available in the U.S., 2007 Table 4-9: U.S. Market for Preventative Vaccines, 2001-2011 Table 4-10: Leading Vaccine Manufacturers’ U.S. Revenues and Market Share, 2007 Table 4-11: U.S. Vaccine Sales to Convenience Clinics, 2001-2011 CHAPTER FIVE: RETAIL OUTLETS Table 5-1: Number of Retail Clinics by Type of Retail Outlet (Drug Stores, Supermarkets, Mass Merchandising Outlets, Other), 2001-2011 Figure 5-2: Proportion of Rents Collected From Retail Clinics by Type of Retail Outlet, 2001-2011 (Drug Stores, Supermarkets, Mass Merchandising Outlets, Others) Table 5-3: Indirect Income Generated by Retail Clinics by Type of Retail Outlet, 2001-2011, (Drug Stores, Supermarkets, Mass Merchandising Outlets, Others) Figure 5-3: Proportion of Indirect Income Generated by Retail Clinics by Type of Retail Outlet, 2001-2011 (Drug Stores, Supermarkets, Mass Merchandising Outlets, Others) Table 5-4: Selected Retail Outlet Relationships with Convenience Clinics, 2007 Table 5-5: U.S. Drug Store Sales, 2001-2011 Table 5-6 Leading U.S. Drug Stores’ Revenues and Market Share, 2006 Table 5-7: U.S. Drug Store Direct Retail Clinic Revenues, 2001-2011 (No. of Stores, Sq. Ft Per Store, Cost Per Sq. Ft.) Table 5-8: U.S. Drug Store Indirect Retail Clinic Revenues, 2001-2011 (Number of Clinics, Patients/Clinic/Day, Incremental Sales per Patient, Total Indirect Revenue) Figure 5-4: Direct vs. Indirect Revenues to Drug Stores From Retail Clinics, 2001-2011 Table 5-9: U.S. Food Store Sales, 2001-2011 Table 5-10: Leading Food Stores Revenues and Market Share, 2006 Table 5-11: U.S. Food Stores Direct Retail Clinic Revenues, 2001-2011 (No. of Stores, Sq. Ft Per Store, Cost Per Sq. Ft.) Table 5-12: U.S. Food Store Indirect Retail Clinic Revenues, 2001-2011 (Number of Clinics, Patients/Clinic/Day, Incremental Sales per Patient, Total Indirect Revenue) Figure 5-5: Direct vs. Indirect Revenues to Food Stores from Retail Clinics, 2001-2011 Table 5-13: U.S. Mass Merchandiser Sales, 2001-2011 Table 5-14: Leading Mass Merchandisers Revenues and Market Share, 2006 Table 5-15: U.S. Mass Merchandiser Retail Clinic Revenues (No. of Stores, Sq. Ft Per Store, Cost Per Sq. Ft.) Table 5-16: U.S. Mass Merchandiser Indirect Retail Clinic Revenues, 2001-2011 (Number of Clinics, Patients/Clinic/Day, Incremental Sales per Patient, Total Indirect Revenue) Table 5-17: U.S. Other Retail Sales, 2001-2011 Table 5-18: Leading Other Outlets Revenues and Market Share, 2006 Table 5-19: US Other Outlets Direct Retail Clinics Revenues (No. of Stores, Sq. Ft Per Store, Cost Per Sq. Ft.) Table 5-20: U.S. Other Outlets Indirect Retail Clinic Revenues (Number of Clinics, Patients/Clinic/Day, Incremental Sales per Patient, Total Indirect Revenue) CHAPTER SIX: MARKET SUMMARY Table 6-1: Retail Clinic Service Revenues, 2001-2011 Table 6-2: Sales to Retail Clinics by Suppliers 2001-2011 Figure 6-1: Revenues from Retail Clinics (Direct Rents/Indirect Revenues) CHAPTER SEVEN: ISSUES AND TRENDS Table 7-1: Selected U.S. Federal and State Health Care Oversight Bodies, 2007 DNA SEQUENCING EQUIPMENT AND SERVICES MARKETS CHAPTER ONE: EXECUTIVE SUMMARY DNA Sequencing Applications Types of Samples Market Trends Scope and Methodology CHAPTER TWO: INTRODUCTION Background DNA Sequencing Applications Types of Samples DNA Sequencing Strategies DNA Sequencing Chemistries and Techniques Sanger Sequencing Single Nucleotide Addition; Pyrosequencing Cyclic Reversible Terminators CHAPTER THREE: SEQUENCER MARKET TRENDS AND FUNDING TRENDS Market Trends Market Fragmenting Into Multiple Applications, Products Synergies Appearing Between Companies’ Products Microbes and Metagenomics Gaining Importance Various Disruptive Technologies Rapidly Appearing On Market Miniaturization of Sanger and CE Technology Paired-End Techniques, Increasing Read-Lengths Expanding Applications Development of Multiplexing Approaches Extends Market SNP and Other Experiments Moving to Sequencing for Higher Detail Continued Rapid Growth in Sequence Production Funding Trends Funding and Consortia for Sequencing The Cancer Genome Atlas Pilot Project Cancer Sequencing Project FUGE - Functional Genomics in Norway NSF / USDA Microbial Genome Sequencing Program OTHER FUNDING CHAPTER FOUR: DNA SEQUENCER PRODUCTS 454 Life Sciences (Branford, CT) / Roche Genome Sequencer 20 Genome Sequencer FLX Applied Biosystems (Foster City, CA) ABI Prism 310 Genetic Analyzer ABI Prism 3100-Avant Genetic Analyzer Applied Biosystems 3100 Genetic Analyzer Applied Biosystems 3130 Genetic Analyzer Applied Biosystems 3130xl Genetic Analyzer Applied Biosystems 3730 DNA Analyzer Applied Biosystems 3730xl DNA Analyzer SOLiD (early access) Beckman Coulter CEQ 8000; CEQ 8800 GE Healthcare MegaBACE 500 MegaBACE 750 MegaBACE 1000 MegaBACE 1500 MegaBACE 4000 Illumina / Solexa Illumina Genome Analyzer LI-COR Biosciences (Lincoln, NE) 4300 CHAPTER FIVE: MARKET DATA Revenues and Forecast CHAPTER SIX: COMPETITIVE ANALYSIS Features and Strengths of Next-Generation Sequencers 454 Life Sciences - Strengths / Advantages 454 Life Sciences - Weaknesses / Disadvantages Applied Biosystems SOLiD - Strength / Advantages Applied Biosystems SOLiD - Weaknesses / Disadvantages Illumina Genome Analyzer - Strength / Advantages Illumina Genome Analyzer - Weaknesses / Disadvantages CHAPTER SEVEN: INTELLECTUAL PROPERTY AND LITIGATION Affymetrix Wins Patent Infringement Case Against Illumina Applied Biosystems and Amersham plc (GE Healthcare) Settle Sequencing Patent Litigation Applied Biosystems Sues Solexa and Former Chief Patent Counsel Beckman Coulter and Applied Biosystems Settle Outstanding Legal Disputes Cepheid and Idaho Technology Settle Dispute Over PCR Patents Enzo Biochem Disputes CalTech Sequencing Patents Huang v. CalTech CHAPTER EIGHT: DEALS CHAPTER NINE: CORPORATE PROFILES 454 Life Sciences (Branford, CT) / Roche Applied Biosystems (Foster City, CA) Beckman Coulter (Fullerton, CA) GE Healthcare Life Sciences (Little Chalfont, UK) Helicos Biosciences (Cambridge, MA) Illumina / Solexa Intelligent Bio-Systems (Waltham, MA) LI-COR Biosciences (Lincoln, NE) NABsys (Providence, RI) CHAPTER TEN: TECHNOLOGIES UNDER DEVELOPMENT NHGRI Funds Next Generation of Sequencing Technologies 454 Life Sciences Corp “Massively Parallel High Throughput, Low Cost Sequencing” “454 Life Sciences Massively Parallel System DNA Sequencing” Agencourt Personal Genomics [Applied Biosystems] “Bead-based Polony Sequencing” Arizona State University, Tempe “Multiplexed Reactive Sequencing of DNA” Baylor College of Medicine, Human Genome Sequencing Ctr “Ultrafast SBS Method for Large-Scale Human Resequencing” Columbia University “An Integrated System for DNA Sequencing by Synthesis” Harvard University, Rowland Institute; moved to Boston Univ “Ultra-fast Nanopore Readout Platform for Designed DNA's” LI-COR Inc “Single-Molecule DNA Sequencing Using Charge-Switch dNTPs” Microchip Biotechnologies Inc “Microbead INtegrated DNA Sequencer (MINDS) System” Stanford University “High-Throughput, Single-Molecule DNA Sequencing” Stanford Genome Technology Center “Pyrosequencing Array for DNA Sequencing” University of Gainesville, Florida “DNA Sequencing Using Nanopores” “Polymerases for Sequencing by Synthesis” Second Group of Grants, $1000 Genome Arizona State University, Tempe “Molecular Reading Head for Single-Molecule DNA Sequencing” Oak Ridge National Laboratory “Experimental R&D for Rapid Sequencing Nanotechnology” “Computational R&D for Rapid Sequencing Nanotechnology” Stanford University “Single Molecule Nucleic Acid Detection with Nanopipettes” University of British Columbia, Vancouver “Nanopores for Trans-Membrane Bio-Molecule Detection” University of Maine, Orono “High-speed Nanopore Gene Sequencing” University of North Carolina, Chapel Hill “Nanotechnology for the Structural Interrogation of DNA” NHGRI Expands Effort to Revolutionize Sequencing Technologies Agencourt Personal Genomics [Applied Biosystems] “Bead-Based Polony Sequencing (Supplemental)” Network Biosystems “$100,000 Genome Using Integrated Microfluidic CE” The State University of New York, Stony Brook (SUNY) “Ultra High Throughput DNA Sequencing System Based on 2D Monolith Multi-Capillary Arrays and Nanoliter Reaction Volume” Columbia University “Modulating Nucleotide Size in DNA for Detection by Nanopore” Duke University “Droplet-Based Digital Microfluidic Genome Sequencing” Harvard University “Electronic Sequencing in Nanopores” Nanofluidics “Real-Time Multiplex Single-Molecule DNA Sequencing” New York University “Haplotype Sequencing Via Single Molecule Hybridization” Oxford University and The Scripps Research Institute “Single-Molecule DNA Sequencing with Engineered Nanopores” University of California, San Diego “Massively Parallel Cloning and Sequencing of DNA” University of Illinois at Urbana-Champaign “Sequencing a DNA Molecule Using a Synthetic Nanopore” VisiGen Biotechnologies “Real-Time DNA Sequencing” “NHGRI Aims to Make DNA Sequencing Faster, More Cost Effective”, October 2006 “Fabrication of Universal DNA Nanoarrays for Sequencing by Hybridization” Boston University “High-Throughput DNA Sequencing Using Design Polymers and Nanopore Arrays” Case Western Reserve University “Large-Scale Nanopore Arrays for DNA Sequencing” General Electric Global Research “Closed Complex Single Molecule Sequencing” Helicos Biosciences “High Accuracy Single Molecule DNA Sequencing by Synthesis” Lehigh University “Force Spectroscopy Platform for Label Free Genome Sequencing” University of California, San Diego “Genome Sequencing by Ligation Using Nano-Arrays of Single DNA Molecules” University of North Carolina, Chapel Hill “Nanoscale Fluidic Technologies for Rapidly Sequencing Single DNA Molecules” University of Washington, Seattle “Engineering MspA for Nanopore Sequencing” Baylor College of Medicine, HGSC “Ultrafast SBS Method for Large-Scale Human Resequencing” Intelligent Bio-Systems “High-Throughput DNA Sequencing by Synthesis Platform” Other Microfluidics and Lab-on-a-Chips CHAPTER ELEVEN: CHALLENGES AND STRATEGIC RECOMMENDATIONS Market Challenges Saturation, Technology Advances Threaten Market Growth Next-Generation Vendors Contending With 454’s Head-Start Rapid Changes, Multiple Variables Creating Unpredictable Market Labs Hesitant to Invest in Unproven Technologies Segments Resisting Change Where Long Read-Lengths Key New Technologies Create Data Management Issues Recent Acquisitions Make Tougher Environment for New Entrants Strategic Recommendations Increase Products’ Value Through Software Tools Explore Demand in Expanding Industry Segments Address Niche Markets Resulting From Fragmentation Increase Value by Combining with Complementary Content Establish Early Connections With End-Users Balance Risks by Diversifying Applications Move Towards Diagnostic Environment Requires Partnering TABLE OF EXHIBITS CHAPTER ONE: EXECUTIVE SUMMARY Table 1-1: DNA Sequencer Equipment Revenues 1999-2006 Figure 1-1: Trending in the DNA Sequencer Equipment Market 2006-2012 CHAPTER THREE: SEQUENCER MARKET TRENDS AND FUNDING TRENDS Figure 3-1: Distribution of Archaeal and Bacterial Genome Projects, Q1 2007 (JGI, TIGR, J Venter, World) Figure 3-2: Phylogenetic Distribution of Bacterial Genome Projects, Q1 '07 Figure 3-3: Number of Completely Sequenced Genomes (Published vs Unpublished) 1999 through Q1 2007 Figure 3-4: Distribution of Number of Projects Among Major Sequencing Centers Q1 2007 Figure 3-5: Funding by the Top Agencies in DNA Sequencing Figure 3-6: U.S. Funding for the Human Genome Project DOE vs NIH 1990-2003 Figure 3-7: Distribution of the Number of Bacterial Sequencing Projects by Area of Focus (Agriculture/Food, Biomedical, Biotech, Environmental, Evolutionary) Table 3-1: FUGE Funding Recipients Table 3-2 Large-Scale Sequencing Centers NHGRI Funding, 2007 Figure 3-8: NHGRI Funding of Large-Scale Sequencing Centers by Organization 2004-2006 (cumulative) Figure 3-9: NHGRI Funding of Large-Scale Sequencing Centers by Organization 2007 Figure 3-10: Broad Institute Organizational Structure Table 3-3: NSF Plant Genome Research Project Recent Funding Awards (Title Start Date, Expiration Date, PI, Organizatino, Funding Amount) Table 3-4: NSF / USDA Microbial Genome Sequencing Program Recent Funding Awards (Title, Start Date, Expiration Date, PI, Organization, Funding Amount) CHAPTER FOUR: DNA SEQUENCER PRODUCTS Table 4-1: Key Products and Technologies Currently on the Market by Company (Company, Product/ Technology, Comments) CHAPTER FIVE: MARKET DATA Table 5-1: DNA Sequencer Equipment Revenues 1999-2006 Table 5-2: DNA Sequencer Equipment Revenues 2006-2012 Figure 5-1 DNA Sequencer Market, Market Share by Industry, 2006 Figure 5-2: Trending in the DNA Sequencer Equipment Market 1999-2006 Figure 5-3: ABI’s Quarterly Overall Sequencing Revenues 2001 to 2006 Figure 5-4: ABI’s Quarterly Overall Sequencing Revenues Q3 2005 to Q4 2006 Figure 5-5: Estimated Forecasted Price of Sequencing a Genome 1990-2030 Figure 5-6: Trending in the DNA Sequencer Equipment Market, 2006-2012 CHAPTER SIX: COMPETITIVE ANALYSIS Table 6-1: Revenues and Market Shares of Leading DNA Sequencer System Suppliers, 2006 (Company, Market Share, Revenues, Trend) Figure 6-1: Market Shares, DNA Sequencer Systems, 2006 Table 6-2: Comparison of Next-Generation Sequencer System Features (Reads, Read Length, Number of Samples at Once, BP Output, Cost Comparison with Sanger/ CE, Consumable Cost per Run) CHAPTER SEVEN: INTELLECTUAL PROPERTY AND LITIGATION Table 7-1: Selected Sequencing-Related Patents Assigned or Licensed to Applied Biosystems (Assignee, Title, Patent #) CHAPTER EIGHT: DEALS Table 8-1: Notable Deals in Recent Years (Companies, Date, Details) CHAPTER TEN: TECHNOLOGIES UNDER DEVELOPMENT Table 10-1: First Set of NHGRI “$100,000 Genome” Grant Awardees October 2004 (Awardee, Title, Amount, Term) Table 10-2: First Set of NHGRI “$1,000 Genome” Grant Awardees October 2004 (Awardee, Title, Amount, Term) Table 10-3: Second Set of NHGRI “$100,000 Genome” Grant Awardees August 2005 (Awardee, Title, Amount, Term) Table 10-4: Second Set of NHGRI “$1,000 Genome” Grant Awardees August 2005 (Awardee, Title, Amount, Term) Table 10-5: Latest Set of NHGRI “$1,000 Genome” Grant Awardees October 2006 (Awardee, Title, Amount, Term) Table 10-6: Latest Set of NHGRI “$100,000 Genome” Grant Awardees October 2006 (Awardee, Title, Amount, Term) Table 10-7: Selected Group s Workingon Microfluidics for DNA Sequencing Applications (Number of Channels, Read Length, Time) Ordering: Order Online - http://www.researchandmarkets.com/reports/2860766/ Order by Fax - using the form below Order by Post - print the order form below and send to Research 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