Introduction

DNA-based testing is moving into a new phase. Transformational technologies are allowing complex genetic (specific gene) and genomic (large numbers of genes) tests to move from research-only labs into medical and clinical labs that perform tests for individual patients to identify genes associated with specific medical conditions. Progress in this young industry is happening fast and furious. New discoveries about the genetic basis of disease are being made every day. And even though DNA-based tests have a relatively small impact on how medicine is practiced today, each new and encouraging development is a step closer to a day when healthcare can be tailored or personalized to an individual's genetic makeup.

This report examines the U.S. market for DNA-based test products that are commercially available today, or will be soon, to screen for disease, confirm a diagnosis in someone with disease symptoms or even determine if you carry a gene that predisposes you to disease - before it causes symptoms. Particular emphasis is given to adult genetic tests that predict risk of disease and predict the best treatment regimens for diagnosed disease.

Even as DNA-based diagnostic tests gain in popularity, matters of genetic privacy and ethics, as well as issues of reimbursement and regulation, are still being debated. The report also evaluates these potential obstacles to DNA-based tests becoming standard medical practice where they can be offered through a physician or directly to the public.

Research Objectives and Targets

·	Brief history of DNA-based testing and market development
·	Broad look at the market players, distribution structure, and regulatory paths to commercializing DNA test products in the United States
·	Analysis of U.S. market structure and size, by major product segments: predisposition, diagnostic and predictive pharmacodiagnostic tests for cancers, infectious diseases and other chronic diseases
·	Analysis of product development trends and technology advances in multiplexed diagnostic systems and next-generation ultrahigh-throughput sequencers
·	Status of regulations and policies related to genetic privacy, genetic testing insurance coverage and DNA counseling
·	Future market potential through 2012 - including market drivers and obstacles
·	Activities and strategy of 10 notable companies that serve this market and their relevant test products

Targeted Product Segment

General Health Screen (non-disease-specific)

Disease Screening

Predisposition/ Risk Assessment (Chronic Disease)

Risk Assessment (Cancer)

Carrier Screens (Inherited Disease)

Disease Diagnostic

Treatment: Pharmacodiagnostics

Prognosis (mostly Cancer)

Source: Fuji-Keizai USA


Note: Targeted adult genetic tests are in blue. Prenatal and infant/child testing is outside the scope of our research.


TABLE OF CONTENTS
INTRODUCTION

Research Objectives and Targets
Research Methodology

SECTION A: MARKET CONDITION

1. Market Overview
  1.1 Market 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


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