Worldwide Diagnostics Market Research Bundle (Worldwide Market for In Vitro Diagnostic Tests 6th Ed., SNP Genotyping and Analysis Markets, Companion Diagnostics Markets)
The purpose of the Kalorama Key Topics Bundles is to allow companies to stretch their market research budget by providing multiple related reports, each available for sale on their own, together in one offering at a significant value.
This Worldwide Diagnostics Market Research Bundle represents three of our most innovative and best-selling topics related to the Diagnostic Industry today: We’ve included the following reports, each of them relevant to understanding the diagnostic market in 2008:
- The complete text of Shara Rosen’s Worldwide Market for In Vitro Diagnostic Tests, the 6th Edition. This report covers every area of invitro diagnostics and details trends including intense consolidation and molecular testing that are shaping this industry.
- Dr. Kenneth Krul’s Companion Diagnostics Markets which provides a realistic assessment of the concept of developing tests for a specific therapeutic to increase its effectiveness and revenue.
- Kalorama biotech analyst Justin Saeks's SNP Genotyping and Analysis Markets, a thorough market round-up of this most promising part of genetic testing.
The reports are provided as separate reports with separate tables of contents, combined in one PDF file. Combined, these report provide more than 1400 pages of market estimates and forecasts, company profiles, product reviews, and analysis of trends and issues in the industry. Any company seriously competing in the diagnostic market today should consider this essential resource.
THE WORLDWIDE MARKET FOR IN VITRO DIAGNOSTIC TESTS, 6TH ED.
Table of Contents 1 Executive Summary
- Introduction
- Scope and Methodology
- Size and Growth of the Market
- Market Trends - a ten year review
2 Introduction
- 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
3 Overview Of Global In Vitro Diagnostic Markets
- 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
4 Trends and Innovation
- 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
5 Point-of-Care Test Platforms
- 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
6 The Core Lab: ClinicalChemistry/Immunoassays/Hematology/Coagulation/Urinalysis/Microbiology
- 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
7 Immunoassays
- 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
8 Molecular Assay Platforms
- 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
9 Hematology
- Overview of Hematology
- Market Analysis : Leading Suppliers and Growth Potential
- Decentralized Hematology Testing
- The Commercial Outlook for Hematology Tests
- Companies to Watch
10 Coagulation
- 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
11 Microbiology and Virology
- 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
12 Blood Banking Services
- 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
13 Histology and Cytology
- 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
TABLE OF CONTENTSCHAPTER 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 EXHIBITSCHAPTER 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
TABLE OF CONTENTS
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
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 EXHIBITSCHAPTER ONE: EXECUTIVE SUMMARY
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 for Therapeutics 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
