Abstract
Multiplexed diagnostics are the wild west of medicine. Technology is established, regulation is limited and the number of new biomarkers exploding. First-movers are grabbing biomarker territories, combining independent measurements for efficiency and mining molecules for multivariate panels. All the while demand is high for improving diagnoses and predicting responses to treatment. The challenges, however, are uncertain reimbursement, unclear business models and ever-intensifying competition. On balance, though, the market is prosperous and is estimated to be more than $1.5 billion in 2007 and is projected to grow to more than $6 billion by 2013.
Successful navigation of this difficult terrain requires a detailed understanding of the market. Multiplexed Diagnostics 2008 explains the unmet needs, trends, regulations, competition, technologies and business strategies. The 260-page report includes a survey of more than 200 respondents, a detailed database of more than 135 commercial multiplexed diagnostics and a quantitative market model. In addition, the report comes with one hour of consulting (in the form of a conference call) with the lead author, Steven Bodovitz, Principal of BioPerspectives.
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- Draft Guidance for IVDMIA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
