Table of Contents
DIAGNOSTIC TEST SERVICE COMMERCIALIZATION: A ROADMAP TO DIAGNOSTICS IN THE 21ST CENTURY
CHAPTER ONE: EXECUTIVE SUMMARY
CHAPTER TWO: INTRODUCTION
- Hospital Outreach and National Reference Lab Services
CHAPTER THREE: MARKET OVERVIEW/ SUPPLY ANALYSIS
- Market Analysis, revenue estimates 2007 – 2012
- Lab Launches and Acquisitions
- Competition from FDA Cleared Products
- Limited Use of Molecular Testing for Colon Cancer.
- 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
- Can the FDA Regulate New test Modalities?
- 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
- AviaraDx (formerly Arcturus Biosciences
- Biomedical Diagnostics, LLC/Abviva, Inc.
- Clarient Inc. (formerly ChromaVision
- CombiMatrix Molecular Diagnostics (CMDX
- Corgenix Medical Corporatio
- EXACT Sciences Corporation
- Laboratory Corporation of America Holdings (LabCorp)
- Mayo Medical Laboratories
- Monogram Biosciences, Inc. (formerly ViroLogic)
- Panacea Pharmaceuticals, Inc.
- Pathway Diagnostics Corporation
- Pathwork Diagnostics (formerly Predicant Biosciences)
- Perceptronix Medical Inc.
- Power3 Medical Products, Inc.
- Precision Therapeutics, Inc.
- Prometheus Laboratories Inc.
- Quest Diagnostics Incorporated
- Signature Genomic Laboratories, LLC
- SpectraCell Laboratories, Inc.
- Targeted Diagnostics & Therapeutics, Inc. (TDT)
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, 2005-2008 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
CHAPTER TWO: INTRODUCTION
- Allele discrimination / assay reaction mechanism
- Single Nucleotide Addition; Pyrosequencing
- Single-Nucleotide Polymorphism (SNP)
CHAPTER THREE: APPLICATIONS
- 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
CHAPTER FOUR: INDUSTRY AND REGULATORY 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
- Increased Multiplexing Expands Applications
- End-Users Attracted to Larger-Scale SNP Platforms
- Complexity of Biological Systems Requires Multiple Techniques
- Miniaturization of Equipment and Instruments
- 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
- 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
- Overview of Affymetrix Products
- Overview of Applied Biosystems Products
- LI-COR Biosciences (Lincoln, NE)
- Polymorphic DNA Technologies
CHAPTER SIX: CONSORTIA, GOVERNMENT INVOLVEMENT, DEALS
- Consortia, Collaborative Projects
- The Cancer Genome Atlas (TCGA) Pilot Project
- Cancer Sequencing Project
- 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 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
CHAPTER SEVEN: MARKET DATA AND COMPETITIVE ANALYSIS
- Illumina as Bellwether for SNP Analysis Market
- Applied Biosystems as Bellwether for RT-PCR Products
CHAPTER EIGHT: CORPORATE PROFILES
CHAPTER NINE: CHALLENGES AND STRATEGIC RECOMMENDATIONS
- 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
- Potential Benefits of Companion Diagnostics
- Pitfalls of Personalized Medicine
- Market Factors and Estimates
- Drivers For Companion Diagnostics
- Possible Tactic: Royalty Model
CHAPTER TWO: OVERVIEW OF COMPANION DIAGNOSTICS
- Privacy and Public Perception
- Biomarkers and Companion Diagnostics
CHAPTER THREE: APPLICATIONS OF COMPANION DIAGNOSTICS
- Pharmacogenetics and Pharmacogenomics
- UAMS Multiple Myeloma Project
- Acute Lymphoblastic Leukemia
- Applications of Genome More Challenging Than Expected
- RAS polymorphisms With Drug Effectiveness
- Psychiatry and Pharmacogenetics/Pharmacogenomics
- A Balancing Act Between the Players
CHAPTER FOUR: MAJOR WORLD MARKET FACTORS AND DATA FOR COMPANION DIAGNOSTICS
- Estimating Market Potential
- The Needs of Pharma and of Diagnostic Companies
- Questions Determining Companion Diagnostics Growth
- A Partial Change in Attitude
- Cancer Market Potential Estimate
- Ideal Market Potential – Cancer, Heart Disease, Psychiatric
- Source: Kalorama Information
- Challenges Unique to Companion Diagnostics
- Fear of Learning About Diseases
- Avoiding Pitfalls of Market Calculation
- Companion Diagnostics Not Linked to Molecular Diagnostics
- Considering Time of Cooperative Development
- Market Realities to Consider
- Possible Tactic: Royalty Model
CHAPTER FIVE: COMPANY SUMMARIES
- Abbott (Molecular) Diagnostics Subsidiary of Abbott Laboratories
- Agilent Technologies, Inc
- Althea Technologies, Inc.
- Lipomics Technologies, Inc.
CHAPTER SIX: CONCLUSIONS AND STATEGIC 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)
