Multiplexed Diagnostics 2008 Market Report

Table of Contents

Chapter 1: Executive Summary

• The Wild West of Medicine
• Opportunities and Strategies
• The Opportunity is Significant
  • Rapidly Advancing Technology
  • Barriers Broken Down
  • Major Unmet Needs
  • New Biomarkers
• Strategy is Critical
  • Compensation
  • Competition
  • Regulation
  • Education
• Summary of Market Drivers
• Market Model

Chapter 2: Introduction to Multiplexing

• Why Multiplex?
• Independent Tests Versus Multivariate
• Multivariate Tests
  • The Potential Versus the Reality
  • Successes and Challenges
• Technologies for Multiplexing
  • Introduction
  • Platforms
  • Platforms - Luminex

Chapter 3: Regulatory Hurdles

• To Regulate or Not To Regulate
• United States (FDA)
  • Draft Guidance for IVDMIA
  • Retrospective Versus Prospective
  • Current Guidelines Are Hazy
  • The FDA May Not Be Up to the Task
• Europe
  • IVD
• Potential Pitfalls

Chapter 4: Market Drivers

• The Wild West of Medicine
• Unmet Needs
  • Diagnosis
  • Responses to Treatment
• Discovery of New Biomarkers
• Genome-Wide Association Studies
  • Introduction and Successes
  • Limitations
• Copy Number Variation
• Protein Biomarkers
• Metabolic Biomarkers
• The Next Generation
  • MicroRNAs
  • Comparative Genomics By Sequence Analysis
  • Integration of Different Types of Data
  • Tissue Availability
  • Tissue Specificity
• General Screening Versus Proprietary Markers
• New Development Has Widespread Support
• Not Everyone Is Convinced of the Value
• Insurance Is A Problem
• Education
• Business Models
  • Insurance Versus Direct Payment
  • Getting Reimbursement Is Difficult
• Competitive Environment
  • Competition Reigns
  • Differentiation Amidst Complexity
• Looking Into the Future

Chapter 5: Market Survey

• Methodology
• Participants
• Question 1
  • Total
  • By Category
• Question 2
  • Total
  • By Category
• Question 3
  • Total
  • By Category
• Question 4
  • Total
  • By Category
• Question 5
  • Total
  • By Category
• Question 6
  • Total
  • By Category
• Question 7
  • Total
  • By Category
• Question 8
  • Total
  • By Category
• Question 9
  • Total
  • By Category
• Question 10
  • Total
  • By Category
• Question 11
  • Total
  • By Category
• Question 12
  • Total
  • By Category
• Question 13
  • Total
  • By Category
• By Open Response
• Question 14
  • Total
  • By Category

Chapter 6: Market Model

• Introduction and Methodology
• Summary of Market Drivers
• Market Model

Chapter 7: Multiplexed Diagnostics on the Market

• Introduction
• Allergies
• Autoimmune
• Blood
• Cancer
• Cardiac
• Drug Metabolism
• Drugs of Abuse
• Genetic
• Infectious Disease
• Metabolic
• Neurologic
• Ophthalmic
• Prenatal
• Psychiatric
• Typing

Chapter 8: Multiplexed Diagnostics In Development

• Introduction
• Autoimmune
• Blood
• Cancer
• Cardiac
• Genetic
• Infectious Disease
• Metabolic
• Neurologic
• Psychiatric