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Multiplexed Diagnostics 2010 Market Report

  • ID: 1727433
  • Report
  • May 2011
  • 572 Pages
  • Select Biosciences Ltd
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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. In addition, the report comes with one hour of consulting (in the form of a conference call) with one of the authors, Dr. Steven Bodovitz, Principal of BioPerspectives, or Dr. Jutta Bachmann, CEO of Bachmann Consulting.
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Chapter 1: Executive Summary
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
Marketing/ Educating Physicians
Competitive Environment
Future Prediction of the Market

Chapter 2: Introduction to Diagnostics
Diagnostics Terminology

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
Philosophical Question
Survey Question
Multivariate Test Successes

Chapter 5: Biomarkers
Discovery of Biomarkers
Policy Issues for New Biomarkers
DNA Sequencing Looms Large
Genome-Wide Association Studies
List of Successes
Genetic Testing
Survey Questions
Copy Number Variation
Protein Biomarkers
Survey Question
Metabolic Biomarkers
Survey Question

Chapter 6: Regulatory Hurdles
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
Survey Questions
Medical Device Regulation
In Vitro Diagnostics - Definitions
In Vitro Diagnostics - EU Directive 98/79/EC
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
IVD Reimbursement - Gene Expression Tests
Great Britain
Health Systems Comparison

Chapter 8: Market Drivers
Unmet Needs
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
More Tests
Intellectual Property
Educating Physicians
Survey Question
Survey Question
Survey Question
Differentiation Amidst Complexity
Survey Questions

Chapter 9: Market Model
Introduction and Methodology
Factors for Success
Summary Scenarios
Survey Questions
Selected Financial Information
Financial Reports
Company Projections
Market Model

Chapter 10: Competitive Environment
Survey Questions
Survey Question

Chapter 11: Multiplexed Diagnostics on the Market
Allergies, Celiac Disease
Allergies, Common
Allergies, Indoor Allergens
Autoimmune, Systemic Rheumatic Diseases
Autoimmune, Vasculitis
Blood, Coagulation
Blood, Clotting Disorders
Blood, Thrombophilia
Blood, Warfarin Metabolism
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, 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
Drug Metabolism
Drugs of Abuse
Genetic, Alpha-1 Antitrypsin Deficiency
Genetic, Ashkenazi-Specific Diseases
Genetic, Cardiac
Genetic, Cystic Fibrosis
Genetic, Multiple Diseases
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
Psychiatric, Autism
Psychiatric, Bipolar Disorder
Psychiatric, Depression
Typing, Blood
Typing, HLA
Typing, RhD

Chapter 12: Multiplexed Diagnostics in Development
Autoimmune Disease, Lupus
Blood, Thrombophilia
Blood, Thrombocytopenia
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, Coronary Heart Disease
Cardiac, Heart Failure
Cardiac, Hemochromatosis
Cardiac, Peripheral Artery Disease
Companion Diagnostics
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
First Survey Participants
Second Survey Participants
Secondary Sources
Market Model
Appendix 2: IVDMIA Draft Guidance
Draft Guidance
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Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown