SNP Genotyping and Analysis Markets and the Future of Personalized Medicine


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SNP Genotyping and Analysis Markets and the Future of Personalized Medicine

  1. 1.    Get more info on this report!SNP Genotyping and Analysis Markets and the Future of Personalized MedicineFebruary 1, 2010Because SNPs are the most common type of genetic variation between human beings,these specific single base pair mutations can be ideal for the task of hunting forcorrelations between genotype and behavior or quality exhibited by a living organism.For this reason, SNP analysis represents one of many possible pathways topersonalzied medicine. The use of SNP analysis has spread into numerous areas inrecent years. But diagnostics and pharmacogenomics are the most promisingapplications, and Kalorama has followed developments in SNP analysis closely.Kalorama Informations analyst Justin Saeks has taken a detailed look into the marketfor DNA Sequencing Equipment, as well as Gene Expression Profiling Systems. Now, inhis report SNP Genotyping and Analysis Markets he looks at SNP analysis instruments,reagents, and related software and services, providing information critical to having anunderstanding of the business behind this new technology: • Overview of SNPs, their Applications and Key SNP Analysis Methods • Current Market Size and Estimates of Future Growth • Impact of the GWAS First Round on the Market • Estimates of Revenues by Region (North America, Europe and ROW) and By Product Type (Consumable, Instruments, Software) • Complete List of SNP-Related Deals Made Between Companies Since 2002 • Exhaustive Review of Products on the Market • Market Share of Major Companies in SNP Analysis • Discussion of GOLD Database Projects, Government Involvement and Funding • Corporate Profiles • Regulatory, Technology and Industry Trends as well as; • Twelve Challenges the Market Faces and Eight Strategic Recommendations for Companies in the SNP Analysis MarketWhile the market is expected to create opportunities for growth, the SNP Genotypingand Analysis market is not without its challenges. The report tackles the followingtrends:
  2. 2. • Rapid Rate of Product Introductions • Increased Multiplexing Creates Improved Products • End-Users Attracted to Larger-Scale SNP Platforms • Accelerating Discoveries Create Volatile Market • Diagnostic Market Holds Obstacles For New Innovations • Complexity of Biological Systems Requires Multiple Techniques • Miniaturization of Equipment and InstrumentsAs with all Kalorama Information publications, SNP Genotyping and Analysis Markets isthe result of a primary research effort. An analyst with experience following the biotechinstrument industry researching all available sources and contacting industry expertsand end users to obtain real market insights. Strategic Planners, Marketing Directors,Business Development Executives are among the individuals who will benefit from thisresource.Table of ContentsCHAPTER ONE: EXECUTIVE SUMMARY • Introduction • Market • TrendsCHAPTER TWO: OVERVIEW • SNP Analysis Methods o Amplification o Allele Discrimination / Assay Reaction Mechanism Allele-Specific Hybridization Allele-Specific Invasive Cleavage Allele-Specific Ligation Allele-Specific Primer Extension Allele-Specific Single Base Extension (Single Base Primer Extension) Single Nucleotide Addition; Pyrosequencing Assay Format o Detection Method • Definitions o DNA Microarray o Genome-Wide Association o Linkage Analysis o Mass Spectrometry o Single-Nucleotide Polymorphism (SNP) • Applications o Life Science Research o Pharmacogenetics / Pharmacogenomics
  3. 3. o Agriculture / Breeding • Case Studies o Case Study #1 - SNPs in Gene for P-glycoprotein Affect Antidepressant Response o Case Study #2 - Celera Studying SNPs Associated With Heart Disease o Case Study #3 - Synonymous SNPs Alter mRNA Splicing with Obesity o Case Study #4 - University of Ottawa Heart Institute (UOHI) Coronary Artery Disease Research o Case Study #5 - Development of Miniaturized Integrated SNP Genotyping MicrosystemsCHAPTER THREE: INDUSTRY, TECHNOLOGY, REGULATORY TRENDS • Industry Trends o Period of Limbo While Funding and Content Materialize o Consolidation Occurring in Array and Life Science Markets o Drug and Diagnostics Industries More Comfortable o Broad Acceptance of SNP Analysis’ Value o Core Labs Becoming Established Paradigm • Technology Trends • Rapid Rate of Product Introductions • Increased Multiplexing Creates Improved Products • End-Users Attracted to Larger-Scale SNP Platforms • Complexity of Biological Systems Requires Multiple Techniques • Miniaturization of Equipment and Instruments • Regulatory Trends o Introduction o March 2004 - Critical Path Initiative o March 2005 - “Guidance for Industry - Pharmacogenomic Data Submissions” o March 2006 - Critical Path Opportunities o November 2006 - “Recommendations for the Generation and Submission of Genomic Data” o August 2007 - Pharmacogenomic Data Submissions — Companion Guidance o December 2007 - EGAPP Reviews Use of CYP450 Genetic Testing For SSRIs o NIH Limits Access to Data from GWASCHAPTER FOUR: PRODUCTS • Affymetrix o Overview o Systems Axiom Genotyping Solution GeneChip Scanner 3000 7G
  4. 4. GeneChip Scanner 3000 7G Plus Targeted Genotyping System GeneTitan Multi-Channel (MC) Instrument Array Station o Microarrays and Reagents GeneChip Human Mapping 10K Array Xba 142 2.0 (GeneChip Mapping 10K 2.0 Array) GeneChip Human Mapping 100K Set Genome-Wide Human SNP Array 5.0 Genome-Wide Human SNP Array 6.0 Axiom Genome-Wide Human Array Plates, Reagent Kits DMET Plus Premier Pack o GeneChip Universal Tag Arrays and Related Kits Human 20K cSNP Kit Human Immune-Inflammation 9K SNP Kit Human MALD 3K SNP Kit Bovine Mapping 10K SNP Kit Bovine Mapping 25K SNP Kit Rat Mapping 5K SNP Kit• Applied Biosystems (Life Technologies) o Overview o SNP Genotyping Systems and Kits SNaPshot Multiplex System SNPlex Genotyping System o TaqMan Genotyping Assays Applied Biosystems’ TaqMan Genotyping Assay Strategy TaqMan Sample-to-SNP Kits VariantSEQr Resequencing System TaqMan OpenArray Genotyping System o RT-PCR 7900HT Fast Real-Time PCR System o Sequencers 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 3• Beckman Coulter o CEQ 8000; CEQ 8800 o GenomeLab SNPstream Genotyping Series• CombiMatrix o CustomArray Synthesizer o Geniom RT Analyzer• GE Healthcare
  5. 5. o Overview o Reagents and Kits o SNP Genotyping Kits o Sequencers MegaBACE 500 MegaBACE 750 MegaBACE 1000 MegaBACE 1500 MegaBACE 4000 • Illumina o Overview iScan iScan SQ BeadXpress Reader Illumina Genome Analyzer IIx o Microarrays Human1M-Duo BeadChip Human1M-Quad BeadChip • LI-COR Biosciences o 4300 • Roche Applied Science o LightCycler 480 System o HybProbe; SimpleProbe • Sequenom o iPLEX GOLD Assay o MassARRAY System o MassARRAY Compact 96 o Selected SNP Genotyping Products & TechnologiesCHAPTER FIVE: CONSORTIA, FUNDING, LITIGATION AND DEALS • Consortia, Initiatives o The Cancer Genome Atlas (TCGA) Project o Cancer Sequencing Project o Critical Path Institute (C-Path) o DNA Polymorphism Discovery Resource o Genetic Association Information Network (GAIN) o Genotype-To-Phenotype Database (GEN2PHEN) • International HapMap Project o Introduction & Background o Rationale for HapMap Approach o Process for Producing HapMap o Populations Included in HapMap o Laboratories and Technologies Involved in HapMap o Practical Use of the HapMap Data o MicroArray Quality Control (MAQC) Project
  6. 6. • NIH Roadmap o NIH Roadmap for Medical Research o Pharmacogenetics Research Network (PGRN) o Wellcome Trust Case-Control Consortium (WTCCC) o WTCCC2 o Other Related Initiatives and Consortia o NIH Involvement, Funding for SNPs and Sequencing o Funding for Sequencing Projects Affecting SNP Market o Continued Rapid Growth in Sequence Production • Funding and Consortia for Sequencing o NHGRI Funds Large-Scale Sequencing Centers, 2006 • Deals • Intellectual Property and Litigation o Patent Interference Between Life Technologies and Pacific Biosciences o Helicos Appeals European Patent Office Decision on Illumina Patent o Applied Biosystems and Illumina Claims and Counter-claims Both Unsuccessful o Fluidigm and Applied Biosystems Agree to End Case o Beckman Coulter and Applied Biosystems Settle Outstanding Legal Disputes o Cepheid and Idaho Technology Settle Dispute Over PCR Patents o Enzo Biochem Disputes CalTech Sequencing Patents o Huang v. CalTech o Applied Biosystems and Amersham plc (GE Healthcare) o Settle Sequencing Patent LitigationCHAPTER SIX: MARKET ANALYSIS • Historical • Illumina as Bellwether for SNP Analysis Market • Applied Biosystems as Bellwether for RT-PCR Products • Forecast • Assumptions and Scope • Consumer SNP • Product Revenue • Competitive AnalysisCHAPTER SEVEN: CORPORATE PROFILES • Affymetrix • Applied Biosystems (ABI) (Life Technologies) • IlluminaCHAPTER EIGHT: CHALLENGES AND STRATEGIC RECOMMENDATIONS • Challenges
  7. 7. o Challenge #1 o Challenge #2 o Challenge #3 o Challenge #4 o Challenge #5 o Challenge #6 o Challenge #7 o Challenge #8 o Challenge #9 o Challenge #10 o Challenge #11 o Challenge #12 • Strategic Recommendations o Recommendation #1 o Recommendation #2 o Recommendation #3 o Recommendation #4 o Recommendation #5 o Recommendation #6 o Recommendation #7 o Recommendation #8 TABLE OF EXHIBITSEXECUTIVE SUMMARY • Figure 1-1: SNP Analysis MarketCHAPTER THREE: INDUSTRY, TECHNOLOGY, REGULATORY TRENDS • Table 3-1 Critical Path Opportunities ListCHAPTER FOUR: PRODUCTS • Table 4-1: Axiom Genome-Wide Array Planes SNP Content • Figure 4-1: TaqMan Assay Strategy • Figure 4-2: Beckman Coulter’s SNPstream Assay Strategy • Table 4-2 Selected SNP Products and Technologies. • Figure 4-3 Simple ProbeSequenomCHAPTER FIVE: CONSORTIA, FUNDING, LITIGATION AND DEALS • Table 5-1: Number of Individuals in Each Subset • Table 5-2: Composition of the DNA Polymorphism Discovery Resources
  8. 8. • Figure 5-1: Companies’ Technologies Used in First Phase of HapMap • Table 5-3: Technologies Used in Phase 1 of HapMap • Table 5-4: SNP and Sequencing Related Initiatives and Consortia, 2009 • Table 5-5: Completely Sequenced Genomes in GOLD, Jan 2009 • Figure 5-2 Domains of Completely Sequenced Genomes in GOLD by Year, 1999-2008 and by Category (Archae, Bacteria, Eukaryota) • Figure 5-3 Number of Genome Projects by Inst., 95- Q1 09 Cumulative • Figure 5-4 Domains of Sequenced Genomes in GOLD, Jan 2009 • Table 5-6 Number of Genome Projects by Institution • Figure 5-5 Funding of Genome Projects, 2007-2009 ($M) • Table 5-7: Funding Sources of Genome Projects • Figure 5-6 Human Genome Project Funding, DOE & NIH 90-03 • Table 5-7: Countries Leading Projects, 95-Q109 • Table 5-8: SNP Projects by Category • Table 5-9: Relevance of Non-Bacterial Sequencing Projects, 95 - Q1 09, Cum. • Figure 5-7: Disease/Conditions Associated with Projects • Figure 5-8: NHGRI Budget by Year incl. ARRA, 2006-2010 ($M) • Table 5-10: 2010 Est. NHGRI Budget by Mechanism • Figure 5-9 2010 Est. NHGRI Budget by Mechanism • Figure 5-10 NHGRI Funded Large-Scale Sequencing Ctrs 07-08 • Table 5-11 SNP Related Deals, 2009 • Table 5-12: SNP Related PatentsCHAPTER SIX: MARKET ANALYSIS • Figure 6-1: Illumina Total Quarterly Revenues, 2003-2009 ($M) • Figure 6-2: Applied Biosystems RT-PCR / Applied Genomics Revenues, 2001- 2008 ($M) • Table 6-1: SNP Analysis Tools Market, 2008-2014 ($M) • Figure 6-3: SNP Analysis Tools Market Revenues, 2008-2014 ($M) • Table 6-4: Growth Rate for SNP Analysis Tools • Figure 6-4: SNP Analysis Tools Market Growth Rate, 2008-2014 • Figure 6-5: SNP Tools Market by Region (North America, Europe, Japan, ROW) • Table 6-5: SNP Tools Market by Product (Consumable, System, Software/Service) • Figure 6-6: SNP Market by Product, 2008 (Systems, Services/Software, Consumables) • Table 6-6: SNP Analysis Market Shares, 2008 ($M) • Figure 6-7: SNP Analysis Tools Market Shares, 2008 ($M)CHAPTER SEVEN: CORPORATE PROFILES • Figure 7-1: Affymetrix Revenues by Product Type, 2005 - 2009 • Figure 7-2: Affymetrix Consumables Revenues by DNA v RNA
  9. 9. • Figure 7-3: Illumina Revenues 2008-2009 by quarterCHAPTER EIGHT: CHALLENGES AND STRATEGIC RECOMMENDATIONS • Figure 8-1: Cheaper Sequencing Impacts SNP MarketAvailable immediately for Online Download at   US: 800.298.5699UK + +1.240.747.3093Fax: 240.747.3004