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Multiplexed Diagnostics 2010 Market Report

Select Biosciences Limited
May 1, 2010
572 Pages - SKU: SBS2690164

Abstract Table of Contents Related Reports

The multiplexed diagnostics market has grown rapidly and generated sales of approximately $2.4 billon in 2009, but is now balanced on multiple tipping points. Will the FDA finally release the updated IVDMIA guidelines? If so, will the FDA close the CLIA loophole and/or will the FDA require 510(k) approvals for all multivariate diagnostics? Will Genomic Health and Agendia be able to maintain high prices for their flagship tests amidst growing competition? How many new tests will reach the market in 2010? Does the inability of Genomic Health’s new colon cancer diagnostic to predict response to chemotherapy indicate ongoing challenges in developing new multivariate diagnostics or is this an isolated example? Will growing competition lead to market confusion? In situations with similar tests, how will physicians and payers decide? Will they want to see more prospective clinical trials? Will prospective clinical trials be more attractive due to the experience of XDx? As multiplexed diagnostics become more established, will physicians and payers begin to actively seek these new tests to increase the efficiency of healthcare? Will changes in healthcare policies, especially in the US, be a net positive because of the expanded use of tests (for aging and expanding populations) or a net negative because of cost controls? Will new multiplexing technologies, such as MagPix from Luminex and BeadXpress from Illumina, create another shift in the market or are diagnostics laboratories becoming entrenched with current methods? Will new biomarkers, such as microRNA and methylated DNA, be more powerful than gene expression levels? For genetic tests, how far will multiplexing go? Is Counsyl’s combination of 100 genetic tests only the beginning? If so, will the increasing complexity of genetic tests usher in the era of diagnostic DNA sequencing?

On the whole, the multiplexed diagnostics market is expected to tip in favor of continued rapid growth, reaching almost $5.8 billion in 2015, according to a new report, Multiplexed Diagnostics 2010, published by Select Biosciences and written by BioPerspectives and Bachmann Consulting. This report explains the unmet needs, trends, regulations, reimbursement, competition, technologies and business strategies. This 572-page report includes a survey of more than 400 respondents, interviews with 12 experts, a detailed database of more than 190 commercial multiplexed diagnostics and a two-tiered quantitative worldwide market model.

Chapter 1: Executive Summary: Medicalomics; Multiplexed Technologies; Multiplexed Diagnostics Categories; Why Multiplex Independent Measurements?; Why Multivariate Signatures?; Current State of the Market; Previous Tipping Point - First-Movers; Current Tipping Points; New Biomarkers; New Technologies; DNA Sequencing; Data Standardization; FDA Guidelines; EU Regulatory Guidelines; Prospective Clinical Trials; Building a Platform for Independent Measurements; Building a Platform for Multivariate Diagnostics; Pricing; Healthcare; Reimbursement; Marketing/ Educating Physicians; Competitive Environment; Future Prediction of the Market
Chapter 2: Introduction to Diagnostics: Diagnostics Terminology; Basic; Intermediate
Chapter 3: Introduction to Multiplexing: Why Multiplex?; Independent Tests Versus Multivariate; Technologies for Multiplexing; General Platforms; Survey Question; Specific Platforms; Specific Platforms in Development; Survey Questions
Chapter 4: Multivariate Diagnostics: Fundamental Principles I; Fundamental Principles II; Survey Question; Multivariate Strategies; Minimal; Sophisticated; Complex; Philosophical Question; Survey Question; Multivariate Test Successes
Chapter 5: Biomarkers: Introduction; Discovery of Biomarkers; Policy Issues for New Biomarkers; DNA Sequencing Looms Large; Genome-Wide Association Studies; Introduction; List of Successes; Limitations; Genetic Testing; Survey Questions; Copy Number Variation; MicroRNA; Protein Biomarkers; Survey Question; Metabolic Biomarkers; Survey Question
Chapter 6: Regulatory Hurdles: Introduction; Problems With Lack of Regulation; Regulatory Basics and the CLIA Loophole; Lack of Resources for the FDA; New FDA Guidelines for 510(k) Due in 2011; The FDA Is Not The Only Control in Place; General Solution: Standardization; Specific Solution: An Independent Agency; Specific Solution: The NIH Steps In; United States (FDA); Retrospective Versus Prospective; Survey Question; IVDMIA; Survey Questions; Europe; Medical Device Regulation; In Vitro Diagnostics - Definitions; In Vitro Diagnostics - EU Directive 98/79/EC; CE-Marking; EU Projects to Improve In Vitro Diagnostics; Position Paper; CHMP/ Pharmacogenomics Biomarkers; Europe - US; Regulatory Processes for Companion Diagnostics; Europe - US - Japan; Regulatory Processes
Chapter 7: Reimbursement Challenges: Regulation Versus Reimbursement in the US; US Payers; Advice for Gaining Reimbursement; The Business Model Challenge; Case Study of Oncotype DX; Case Study of GeneSearch; AHRQ Assessment; Medicare Advisory Panel Assessment; Europe Overview; Germany; Overview; IVD Reimbursement - Gene Expression Tests; France; Overview; Great Britain; Overview; Health Systems Comparison
Chapter 8: Market Drivers: Unmet Needs; Diagnosis; Response to Treatment; New Diagnostics Offer Better Healthcare; Improving Healthcare Efficiency; The Challenge of Proving the Value; Focus on Multivariate Tests; Survey Question; Focus on Tests with Independent Measurements; Survey Question; Healthcare Reform in the US; Healthcare in Europe; Pharmacogenomics; Demographics; More Tests; Intellectual Property; Educating Physicians; Survey Question; Marketing; Survey Question; Pricing; Survey Question; Differentiation Amidst Complexity; Survey Questions
Chapter 9: Market Model: Introduction and Methodology; Factors for Success; Summary Scenarios; Pessimistic; Optimistic; Survey Questions; Selected Financial Information; Financial Reports; Company Projections; Market Model; Chapter 10: Competitive Environment; Introduction; Survey Questions; Acquisitions; Survey Question
Chapter 11: Multiplexed Diagnostics on the Market: Introduction; Allergies, Celiac Disease; Allergies, Common; Allergies, Indoor Allergens; Autoimmune; Autoimmune, Systemic Rheumatic Diseases; Autoimmune, Vasculitis; Blood, Coagulation; Blood, Clotting Disorders; Blood, Thrombophilia; Blood, Warfarin Metabolism; Cancer; Cancer, Breast; Cancer, Colon; Cancer, Colorectal; Cancer, Leukemia; Cancer, Lung; Cancer, Melanoma; Cancer, Ovarian; Cancer, Pancreas; Cancer, Paradontium; Cancer, Prostate; Cancer, Tissue of Unknown Origin; Cardiac; Cardiac, Atrial Fibrillation; Cardiac, AVRC; Cardiac, Channelopathies; Cardiac, Cholesterol; Cardiac, Coronary Heart Disease; Cardiac, Heart Failure; Cardiac, Myocardial Infarction; Cardiac, Shortness of Breath; Cardiac, Vascular Oxidation; Cytogenetic Abnormalities; Detoxification; Drug Metabolism; Drugs of Abuse; Genetic, Alpha-1 Antitrypsin Deficiency; Genetic, Ashkenazi-Specific Diseases; Genetic, Cardiac; Genetic, Cystic Fibrosis; Genetic, Multiple Diseases; Inflammation; Immune System; Infectious Disease; Infectious Disease, Bacteria; Infectious Disease, Borrelia; Infectious Disease, Candida; Infectious Disease, Chlamydia; Infectious Disease, Clostridium difficile; Infectious Disease, CMV; Infectious Disease, EBV; Infectious Disease, Enteroccocci; Infectious Disease, Enterovirus; Infectious Disease, FSME; Infectious Disease, Fungi/Sepsis; Infectious Disease, Gastrointestinal; Infectious Disease, HCV; Infectious Disease, Healthcare-Associated; Infectious Disease, Herpes Virus; Infectious Disease, HIV; Infectious Disease, HPV; Infectious Disease, Influenza; Infectious Disease, Meningitis; Infectious Disease, Metapneumovirus; Infectious Disease, MRSA; Infectious Disease, Mycobacteria; Infectious Disease, Mycoplasma; Infectious Disease, Neisseria; Infectious Disease, Parainfluenza; Infectious Disease, Parasite; Infectious Disease, Pneumobacter; Infectious Disease, Pneumonia; Infectious Disease, Respiratory; Infectious Disease, S. aureus and enterococci; Infectious Disease, Sepsis; Infectious Disease, Sexually Transmitted; Infectious Disease, Staphylococcus; Infectious Disease, Streptococcus; Infectious Disease, Syphilis; Infectious Disease, Urinary Tract; Infectious Disease, VRE; Infectious Disease, Whooping Cough; Liver Disease, Fibrosis; Metabolic, Diabetes; Metabolic, Estrogen; Metabolic, Weight Loss; Neurologic, Alzheimer’s; Neurologic, Schizophrena; Opthalmic, Glaucoma; Organ Rejection; Osteoporosis; Psychiatric, Autism; Psychiatric, Bipolar Disorder; Psychiatric, Depression; Typing, Blood; Typing, HLA; Typing, RhD
Chapter 12: Multiplexed Diagnostics in Development: Introduction; Arthritis; Autoimmune Disease, Lupus; Blood, Thrombophilia; Blood, Thrombocytopenia; Cancer; Cancer, Bladder; Cancer, Blood; Cancer, Breast; Cancer, Cervical; Cancer, Colon; Cancer, Colorectal; Cancer, Head and Neck; Cancer, Kidney; Cancer, Leukemia; Cancer, Lung; Cancer, Lymphoma; Cancer, Melanoma; Cancer, Ovarian; Cancer, Pancreas; Cancer, Prostate; Cancer, Renal Carcinoma; Cancer, Small Round Blue Cell Tumors; Cancer, Tissue of Unknown Origin; Cardiac; Cardiac, Coronary Heart Disease; Cardiac, Heart Failure; Cardiac, Hemochromatosis; Cardiac, Peripheral Artery Disease; Companion Diagnostics; Genetic; Genetic, Down Syndrome; Genetic, Prenatal Testing; Infectious Disease, General Identification; Infectious Disease, HBV; Infectious Disease, HCV; Infectious Disease, Herpes; Infectious Disease, HIV; Infectious Disease, HPV; Infectious Diseases, Influenza; Infectious Disease, Respiratory; Infectious Disease, Sepsis; Infectious Disease, Viral; Liver Disease, Fibrosis; Metabolic, Diabetes; Metabolic, Drug Resistance; Metabolic, Liver Fat; Neurologic, ALS; Neurologic, Alzheimer’s Disease; Neurologic, Depression; Neurologic, Neurodegeneration; Neurologic, Schizophrenia; Neurologic, Traumatic Brain Injury; Neurologic, Suicide Risk from Antidepressants; Typing, Chimerism; Unspecified Diseases; Appendix 1: Methodology; Key Opinion Leaders; Internet Survey; Introduction; First Survey Participants; Second Survey Participants; Secondary Sources; Market Model
Appendix 2: IVDMIA Draft Guidance: Draft Guidance

Multiplexed Diagnostics 2010 Market Report

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