U.S. DNA-Based Diagnostic and Test Market

Table of Contents

INTRODUCTION

• Research Objectives and Targets
• Research Methodology

SECTION A: MARKET CONDITION

1. Market Overview

• 1.1Market History
  • Table1-1: Important Industry Development
• 1.2 Market Structure and Character
  • CLIA Regulations and Genetic Tests
  • "Two Path" System of FDA Regulation
• 1.3 Major Players and Character
• 1.4 Major Players' Products (Name, Targeted Diagnostic, Price, Product Feature)
  • Comments/Notes

2. Market Trends (2006-2008)

• 2.1 Market Size (Total)
  • Table2-1: DNA Test Makers, Product Revenues
  • Graph2-1: Market Size: DNA-based Diagnostics (All Product Segments)
  • Table2-2: Total U.S. Market Size: High and Low Estimates
  • Graph2-2: Total U.S. Market Size: High and Low Estimates
• 2.2 Market Size by Product Segment
  • Diagnostic Testing Product Segments (DNA-Based Diagnostics)
  • Table2-3: Target, Healthy Adult (Pre-symptomatic), Potentially Sick Person (Prone to Disease), Sick Person (Diagnosed with Disease)
  • Table2-4: Surveyed Companies and Their Product Segment
  • Predisposition Tests and Primary Screening for Risk
  • Predictive Diagnostic Tests
  • Predictive Treatment Tests (Pharmacodiagnostics)
  • Prognosis Diagnosis (DNA-based Recurrence Risk Scores)
  • Table2-5: Market Size and Growth Rate, by Product Segment
  • Graph2-3: Market Size by Product Segment (10 Companies Surveyed)

3. Market Share by Product Segment

• Graph3-1: Market Share (%) 2006 and 2008

4. Distribution Structure

• 4.1 Basic Distribution Pattern
• 4.2 Sales (%) by Channel
  • Graph4-1: Sales by Channel
• 4.3 Sales Agent Intervention and Influence
  • Physician Customers
  • Laboratory Customers
  • Graph4-2: Laboratory Share (%) of DNA Testing in the U.S.
  • Clinical Labs as Distribution Partners
• 4.4 Distribution Character in B-to-C Business
  • Who Buys a Do-It-Yourself DNA Test?
  • B-to-C Model Based on Genetic Counseling Services

5. New Product Development Trends

• 5.1 Development Trends by Product Segment
  • Infectious Disease: Low-Cost, High-Volume Testing
  • Predictive Medicine: Primary Adult Screening and Secondary Prevention
  • Onco-Molecular: Testing for Human Cancers
  • Pharmacodiagnostics: Predicting Drug Response
• 5.2 Hot New Products (13 Products)

6. Technology Character in DNA Diagnostic Product Development

• 6.1 Trends of Development/Supported Technology
• 6.2 Development Speed and Improvement Points in the Above-Mentioned Technology
• Table6-1: Comparison of Faster (Ultrahigh-Throughput) Personal DNA Sequencers (Maker, Name of System, Process, Read length, Throughput, Machine Price, Est. Cost to Sequence One Person' s Genome)

7. Future of Market

• 7.1 Market Potentiality
  • Table7-1: Market Positioning 2010 to 2012
  • Graph7-1: Market Positioning 2010 to 2012
  • Developments and Drivers
  • Table7-2: Factors Affecting Market Expansion or Obstruction

8. Issues and Strategy for the DNA-Based Diagnostic and Test Business

• 8.1 Management of Individual Information (Privacy)
  • Limited Federal Policy on Genetic Privacy
  • State Laws on "Genetic Exceptionalism"
  • Informed Consent
  • Laboratory Industry Best Practices
• 8.2 Organization of Ethics Committee, etc.
  • Federal Oversight Agencies and Their Responsibilities
  • Medical Community Guidelines on Ethics
  • Corporate Ethics and Compliance Committees
  • Major Ethical Issues
  • Fairness, privacy in the use of genetic information
  • Clinical practice issues and evidence-based guidelines
  • Patents and commercialization of products
  • Ethics of consumer-directed marketing
  • Social issues
• 8.3 Current Status of DNA Counseling
• 8.4 Policy and Proposal by Insurance Industry
  • Table8-1: Condition, Who' s Covered, Approved Tests

SECTION B: 10 NOTABLE COMPANIES: ACTIVITIES & STRATEGIES

• 1~10 Notable Company (10 companies)
• Common Research Items:
• 1) Company In-Brief (Name of Company, Revenue (Most recent data), Location, Established Year, Special Note)
• 2) Revenue by Business Segment (DNA-based Diagnostic and Test, Drugs, Medical Equipments, etc.)
• 3) Revenue Forecast by Product: Type of DNA-based Diagnostic and Test (2006-2008
  • 3)-1 Revenue Trends by Product Segment
  • 3)-2 Most Important Product for Sales and Marketing Spending - and Key Reason for Spending on Product
• 4) Distribution Policy
  • 4)-1 Basic Distribution Flow
  • 4)-2 Status of Usage of Sales Agents, Wholesalers, etc.
• 5) R&D Activity
  • 5)-1 Expenditure
  • 5)-2 Most Important R&D Area for Capital Spending - and Key Reason for Spending
• 6) Technology Trends
  • 6)-1 Technology Used in DNA-based Diagnostic and Test
  • 6)-2 Patents Status
• 7) New Product Development Activity
  • 7)-1 Product Character
  • 7)-2 Product Development Areas where Company Invests More Money and Resources
• 8) Profitability
  • 8)-1 Revenue Contribution of DNA-based Diagnostic and Test Business
  • 8)-2 Profitability (%) of the Above-mentioned Business
• 9) Current Rules for the Business Operation
  • 9)-1 Management of Privacy
  • 9)-2 Company Policy on Ethics
  • 9)-3 Status of Usage of DNA Counseling
• 10) Opinion - Future DNA Diagnostic and Test Market Outlook
  • 10)-1 Product Segment where Company Can Expect Brighter Future
  • 10)-2 Market Expansion and Obstruction Factors (Positive Indications, Negative Indications)
  • 10)-3 Business Potentiality of B-to-C Segment

APPENDIX B: Additional Companies Active in DNA-based Diagnostics and Personalized Medicine