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The World Market for Molecular Diagnostics Potential and Reality, What's Hot and What's Not


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  • 1. Get more info on this report!The World Market for Molecular Diagnostics: Potential and Reality, Whats Hotand Whats NotMarch 1, 2011This report The World Market for Molecular Diagnostics: Potential and Reality, WhatsHot and Whats Not estimates the market for molecular diagnostics and provides arealistic look at the role of molecular testing and its future in various market segments.Analyst Shara Rosen, R.T. MBA, reviews the competitors in the market and their latestmoves.There have been many predictions made about a molecular revolution in diagnostics.Indeed some of those changes are now taking place, while other predictions have notturned out to be true. How can companies sort out what is effective and what is not inthis market? For over a decade, Kalorama Informations lead diagnostics analyst SharaRosen, R.T., MBA has reviewed the molecular diagnostics market. A lot has changed,and a lot has stayed the same. There is intense competition but also opportunities forentrants in some areas. This report The World Market for Molecular Diagnostics:Potential and Reality, Whats Hot and Whats Not provides current market data forbusiness planning but also goes beyond the numbers to fully assess what is going on inthe market.What are the important developments in the market? Who are the small innovators inthis industry and how are the big players reacting to them? Which developments are"hot" and which trends have not caught on? In this report, Rosen provides answers tothese questions.The Rewards, Pitfalls and Competition of This High Potential MarketAs we enter the second decade of the 21st century the investment in molecular biology,in bioinformatics, in disease management research and the unraveling of the humangenome is bearing fruit. Almost every day the discovery of new molecular markers forcancer, cardiac disease, diabetes, arthritis, neurological diseases and psychiatricconditions are announced.
  • 2. Far from being a cheerleader of what is clearly a growth market, The World Market forMolecular Diagnostics -Potential and Reality, Whats Hot and Whats Not provides adetailed examination of molecular testing today. Among the data points the reportprovides are the following: Current Market Size and Forecast for Molecular Segments (Infectious Disease, Blood Screening, Histology, Oncology, Prenatal, Coagulation, Tissue Typing, Inherited Diseases, Pharmacodiagnostics and Other) Infectious Disease Molecular Sales by Disease (Hepatitis, HIV, GC/Chlamydia, HAI, Respiratory, Organism ID, Mycobacteria/TB, others) Revenues of Top Molecular Diagnostic Companies Recent Mergers and Acquisitions Revenue of Test Service Companies Geographic Breakout of Molecular Diagnostics Market by Region (North America, Europe, Asia, ROW) Sample Prep Market, 2010 and 2015 Breakout of Molecular Histology/Cytology Market (in situ hybridization, HPV, Tissue Microarrays), 2010 and 2015 Important CLIA Lab Developments, 2008-2010More and more laboratories offer complex panels of tests that help physicians evaluatedisease risk and make therapeutic decisions. Government and private healthcarepayors have recognized the value of new molecular tools and have agreed to pay forthem.This renewed interest in IVDs in general and more particularly in molecular diagnosticshas lead to the commercialization of a number of technological tools that make moresensitive and specific tests possible. Some of these technological innovations include:cost-effective, multiplexed testing platforms coupled with high-powered softwarecapabilities. In addition analyses using saliva, urine, and blood instead of biopsiedtissue make for more patient-friendly test systems.Extensive Company ProfilesKalorama provides profiles of over 110 companies participating in the market. All ofthese companies have different strategies and compete in different areas, andKalorama acknowledges this by separating the companies in a triage system based onwhere they stand in the molecular in vitro diagnostics market. "The Majors" -companies who are the top IVD companies and participate in multiple IVD markets. "The Participants"- Molecular diagnostic companies who are by now established in the market. "The Stars"- Those companies that have shown better than average results "Newcomers"- Companies who have novel or interesting approaches to keep an eye on
  • 3. "High Potentials"- Companies that could show explosive growth but also could fall based on market developments "Specialists" in various areas (microbiology, histology, quality control, sample prep)A Realistic Look at The Need-To-Know TrendsMolecular diagnostics is a complicated market that requires a thorough analysis tounderstand. Many reports make bold predictions which later are proved incorrect bymarket events. In this report, Kalorama Information provides revenues and marketforecasts, but also looks deeply at some of the trends in the market and what mightimpact results in the future. The report summarizes what is working and what is notworking in the past few years. Shara Rosen, RT, MBA, looks at these trends, includingHot Trends, and Lukewarm Trends, including New Platforms Making Their Mark Based on based on Miniaturization and Biochips The Growing Significance of Quality Control Products and Innovations in this area. The Sequence Begins: Innovations in DNA Sequencing, Key Players and its Future in Clinical Medicine Pharmacodiagnostics and Where it Stands in 2011. The Latest Growth Numbers of LDTs, regulatory activity, and their impact on the Market. The $1000 Genome - If and When Miniaturization and Multiplexing The Ongoing Saga of Patents Healthcare Reform and Reimbursement Trends Integrated Sample Preparation and System Automation - A Growing Number of Competitors Developments in Mass Spectroscopy Screening for Wellness The Latest on Consumer TestsMarket size and forecasts in the report are for manufacturers revenues. Secondary andprimary resources, including: trade publications, annual report and interviews with keyexecutives in molecular diagnostics were used for this study.Table of ContentsCHAPTER ONE: EXECUTIVE SUMMARY Introduction Scope and Methodology Size and Growth of the Market Market TrendsCHAPTER TWO: INTRODUCTION Background - Developments since 2000
  • 4. New Platforms Quality Control Products Building a strong future - hot, hot, hot The sequence begins Personalizing Risk and Therapies LDTs reign The $1000 Genome - If and When Luke warm Trends Miniaturization and Multiplexed Assays Integrated Sample Preparation and System Automation Mass Spectroscopy Screening for WellnessCHAPTER THREE: THE COMMERCIALIZATION CONUNDRUM Background Reimbursement of Novel Tests Regulatory Issues and Molecular Assays Commercializing Molecular Diagnostics - Physician Acceptance U.S. Health Care Reform and Molecular TestingCHAPTER FOUR: MARKET ANALYSIS Background Worldwide opportunities for molecular tests The United States Europe Japan China India Molecular diagnostics and target markets The market for molecular assays in cancer management Liquid Biopsies - CTCs Tumor Markers Sequencing Chromosome Analysis The market for molecular Assays in hematology The market for molecular Assays in coagulation The market for molecular Assays in histopathology/cytology Overview The Pap Smear & HPV testing FISH Goes Digital, Multiplexed and Quantitative Tissue Microarrays Pharmacodiagnostic Test ApplicationsCHAPTER FIVE: CONCLUSIONS AND STRATEGIC IMPLICATIONS - 2015 ANDBEYOND Conclusion One
  • 5. Implication Conclusion Two Implication Conclusion Three Implication Conclusion Four Implication Conclusion Five Implication Conclusion Six Implication Conclusion Seven Implication Conclusion Eight ImplicationCHAPTER SIX: MAJOR COMPANIES AND VENDORS TO WATCH Background Acquisitions, Alliances and Collaborations in Molecular Diagnostics Company Triage The Majors Abbott Diagnostics Recent Revenue History ) Key Comment Molecular Histology Molecular Diagnostics Microbiology Molecular Sample Prep Alere (formerly Inverness Medical Innovations) Recent Revenue History Key Comment Becton, Dickinson and Company (BD) Recent Revenue History Key Comment Histology Microbiology Expanding Molecular Testing Capabilities. Beckman Coulter Inc. Recent Revenue History Key Comment Research Markets bioMérieux Inc. Marcy Letoile, France www.bioMé Recent Revenue History Key Comment Molecular Gen-Probe Inc. Recent Revenue History
  • 6. Key Comment GTI acquisition Transplant/HLA testing Infectious Diseases Blood Bank Oncology Hologic, Inc. Recent Revenue History Key Comment Histology Instrumentation Laboratory (IL) Recent Revenue History Key Comment QIAGEN N.V. Recent Revenue History Key Comment Histology Infectious Diseases Oncology Roche Diagnostics Recent Revneue History Key Comment Histology H1N1/ Applied Sciences PCR Infectious Diseases Blood Bank Personalized Medicine - Companion Tests Research Siemens Healthcare Diagnostics Recent Revenue Key Comment Sysmex Corporation Recent Revenue History: Key Comment Thermo Fisher Scientific Inc. Recent Revenue History Key CommentTHE PARTICIPANTS Affymetrix, Inc. Recent Revenue History Key Comment Agendia BV Recent Revenue History Key Comment Agilent Technologies Inc.
  • 7. Recent Revenue History Key Comment Asuragen, Inc. Recent Revenue History Key Comment AviaraDx (biomerieux) Ambry Genetics Recent Revenue History Key Comment Bio-Reference Laboratories, Inc. (BRLI) Recent Revenue History Key Comment Caliper Life Sciences, Inc. Recent Revenue History Key Comment China Medical Technologies, Inc. Recent Revenue History Key Comment Clarient Inc. (formerly ChromaVision) Recent Revenue History Key Comment deCode genetics ehf Recent Revenue History Key Comment and others...THE STARS AdvanDx, Inc. Recent Revenue History Key Comment Celera Diagnostics Recent Revenue History Key Comment Berkeley HeartLab (BHL) Product Development Cepheid Key Comment Instrumentation DxS Ltd. Recent Revenue history Key Comment and others...NEWCOMERS Akonni Biosystems Inc. Applied BioCode, Inc. Arrayit Diagnostics Inc.
  • 8. Exiqon A/S and others...HIGH POTENTIAL COMPANIES AdnaGen AG Allegro Diagnostics and others...HISTOLOGY SPECIALISTS Advanced Cell Diagnostics Perceptronix Medical Inc. (PMI Labs)MICROBIOLOGY SPECIALISTS Adnavance Technologies Inc. CapitalBio Corporation Cooperative Diagnostics, LLC and others...QUALITY CONTROL SPECIALISTS AcroMetrix Bio-Rad Laboratories Inc. ParagonDx LLC (formerly Gentris Diagnostics Inc.)SAMPLE PREP SPECIALISTS Arcxis Biotechnologies Argylla Technologies LLC Biomatrica, Inc. and others... LIST OF EXHIBITSCHAPTER ONE: EXECUTIVE SUMMARY Table 1-2: Worldwide Molecular Test Sales, 2010-2015 (Infectious Disease, Blood Screening, Histology, Oncology, Prenatal, Coagulation, Tissue Typing, Inherited Diseases, Pharmacodiagnostics and Other) Figure 1-1: Market Share of Molecular Diagnostics Market, 2010CHAPTER TWO: INTRODUCTION Table 2-1: Selected Novel Nucleic Acid Testing Platforms, 2008-2010 Table 2-2: Selected Molecular QC Products, 2008-2010 Table 2-3: Selected innovations in sequencing Table 2-4: Selected Drug/Test Pharmacodiagnostic Combinations Table 2-5: Selected collaborations between IVD and pharmaceutical companies Table 2-7: Selected Advanced Sample Preparation Devices, 2008-2010CHAPTER THREE: THE COMMERCIALIZATION CONUNDRUM
  • 9. Table 3-1: Selected Drug PGx Targets in the U.S. Table 3-2: Selected Drugs that Require PGx Testing in Europe Table 3-3: U.S. Patents for Selected Molecular Test PlatformsCHAPTER FOUR: MARKET ANALYSIS Table 4-1: Worldwide Molecular Test Sales, 2010-2015 Table 4-2: Selected LDT Service Provider Revenues, 2007-2010 Table 4-3: Market Penetration of Clinical Molecular Diagnostics, by geographic area, 2010-2015 Table 4-4: Selected Company Sponsored Accredited Labs Table 4-5: Selected Molecular Tumor Marker Test Innovations, 2008-2010 Table 4-6: Selected Companies Involved in Chromosomal Analysis of Cancer Cells Table 4-7: Selected Molecular Tests for Coagulation Testing, 2008-2010 Table 4-8: Worldwide Molecular Histology/Cytology Sales, 2010-2015 (in situ hybridization, HPV, Tissue Microarrays) 118 Table 4-9: Selected HPV Tests, 2008-2010 Table 4-10: Selected Molecular Histology Innovations, 2008-2010 Table 4-11: Selected tissue microarray products, 2008-2010 Table 4-12: Molecular Test Sales, Infectious Diseases, 2010-2015 (Hepatitis, HIV, GC/Chlamydia, HAI, Respiratory, Organism ID, Mycobacteria/TB, others) 130 Table 4-13: Selected Infectious Disease Molecular Test Innovations, 2009-2010 Table 4-14: Selected molecular tests for prenatal analysis, 2008-2010 Table 4-15: Most Frequently Requested Genetic Tests Table 4-16: Selected Molecular Tests for Inherited Diseases, 2008-2010 Table 4-17: Selected PGx Test Innovations, 2008-2010CHAPTER SIX: MAJOR COMPANIES AND VENDORS TO WATCH Table 6-1: Selected Molecular Company Acquisitions, 2008-2010 Table 6-2: Selected Molecular Company Collaborations, 2008-2010 Table 6-3: Selected Molecular Company Distribution Agreements, 2008-2010 Table 6-4: Selected Molecular Company Licensing Agreements, 2008-2010 Table 6-6: Selected CLIA Lab Developments, 2008-2010Available immediately for Online Download at
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