DNA-based diagnostics are established in laboratory medicine with many of the top tests run for infectious disease. The U.S. market for DNA-based infectious disease tests is today a $1.1 billion industry. Nucleic acid testing (NAT) is used to screen blood supplies; DNA-based tests are rapidly emerging as an oncology standard as well; and newer tests are more slowly developing as a way to treat other non-infectious diseases such as chronic diseases and diseases of aging. However, they still operate largely outside of core medical practice today - which is the doctor's office and hospital lab. Evidence that DNA-based testing can appreciably improve the quality of healthcare is still murky, but policymakers and scientific researchers believe that DNA-based diagnostics (also called genomics-based molecular diagnostics) will change the way medicine is practiced in the coming decades.

This Fuji-Keizai USA report examines the key players and issues in commercializing DNA-based diagnostics in the United States. It covers the market for testing products for infectious diseases, human cancers and pharmacogenomics, and the instrumentation needed to perform the tests. It analyzes U.S. market structure and size by major product segments. It covers distribution structure; development trends and technology advances; regulations and policies for genetic privacy, insurance coverage and DNA counseling; and a future market outlook through 2012 - including market drivers and obstacles.

The report contains profiles of 15 companies including U.S.-based public and private companies: Abbott Molecular Diagnostics, Celera, Genomic Health, Myriad Genetics, Gen-Probe and Life Technologies (formerly Applied Biosystems). For key players such as Siemens Healthcare, BioMerieux and Qiagen, whose core business operates in non-U.S. regions, we cover their U.S.-oriented activities and product portfolios. Others covered: Novartis V&D, Becton Dickinson, Interleukin Genetics, Hologic/Third Wave Technologies, and Decode. Most of the market-leading companies cater to the traditional medical channel and regulatory path, although companies having great success with largely unregulated laboratory-developed tests also factor into this report. Newer companies selling personal genomic scans directly to consumers are growing in number but are not the primary focus here, although they are covered briefly in the section C ( 27 companies).


Table of Contents

Section A: Market Condition

1. Market Overview
  1.1 Market History
      Table 1-1 Important Industry Developments
  1.2 Market Structure and Character
    1.2.1 U.S. Regulatory Structure
    1.2.2 Regulatory Update
  1.3 Major Players and Character
      Table 1-2 Market Participants and Their Multiple Business Models
  1.4 Major Players' Products (Product Name, Targeted Diagnostic, Price, Product Feature)

2. Market Trends, 2008-2010
  2.1 Market Size and Forecast: Test Products & Equipment Markets
      Table 2-1 Revenue by 15 Surveyed Companies, 2008-2010
      Table 2-2 Maker (15) Share, 2008-2010
      Table 2-3 Estimates of Current U.S. Market Size
  2.2 Equipment & Test Product Market Trends
      Table 2-4 Equipment Market Forecast, by Product Type, 2008-2010
      Table 2-5 Test Product Market Size, by Test Product Segment
      Table 2-6 Diagnostic Testing Product Segments
      Table 2-7 Market Size Human Gene Tests, by Type of Test

3. Market Share by Product Segment of Surveyed Companies
  3.1Market Share Overview 2008 vs. 2010
      Table 3-1 Market Share Overview 2008 vs. 2010
  3.2 Maker Shares, by Type of Test Product
    3.2.1Blood Screens
      Table 3-2 Maker Share
    3.2.2 Infectious Diseases (Viral)
      Table 3-3 Maker Share
    3.2.3 Infectious Diseases (Bacterial)
      Table 3-4 Maker Share
    3.2.4 Human Gene Tests
      Table 3-5 Maker Share
  3.3 Maker Share, by Equipment
    3.3.1 RT-PCR
      Table 3-6 Maker Share
    3.3.2 DNA Amplification and Detection
      Table 3-7 Maker Share
    3.3.3 Microarrays
      Table 3-8 Maker Share

4. Distribution Structure
  4.1 Basic Distribution Pattern
    4.1.1 The Customer Continuum
    4.1.2 Direct Sales to Clinical Labs - Genetic Tests as "Medical Devices"
    4.1.3 Direct Sales to Physicians - Genetic Tests as "Laboratory Service"
  4.2 Sales (%) by Channel
  4.3 Sales Agent Intervention and Influence
    4.3.1 Physician Customers
    4.3.2 Laboratory Customers
    4.3.3 Clinical Labs as Distribution Partners
  4.4 Distribution Character in B-to-C Business

5. New Product Development Trends
  5.1 Development Trends by Product Segment
  5.2 Hot New Products

6. Technology Character in DNA Diagnostic Product Development
  6.1 Trends of Development/Supported Technology
    6.1.1 Multiplex Testing and Genomic Hybridization
    6.1.2 Multiplexed (Multi-Analyte) Platforms
    6.1.3 More Choices in Gene Amplification
  6.2 Development Speed and Improvement Points in Sequencing Technology
      Table 6-1 Comparison of Faster (Ultrahigh-Throughput) DNA Sequencers:
                      Commercially Available Systems
      Table 6-2 New Sequencing Platforms Under Development

7. Future of Market
  7.1 Market Potentiality and Roadmap
      Table 7-1 Market Positioning 2010 to 2012: Major Categories of Test Products
      Table 7-2 Market Positioning 2010 to 2012: DNA-based Diagnostic Tests & Key Equipment
  7.2. Roadmap: Development and Drivers, 2009, 2010/11, Beyond 2012

8. Issues and Strategy for the DNA-Based Diagnostic and Test Business
  8.1 Management of Individual Information (Privacy)
  8.2 Organization of Ethics Committee, etc.
  8.3 Current Status of DNA Counseling
  8.4 Policy and Proposal by Insurance Industry

Section B: Company Case Studies (15 Companies)

Common research Item
   1) Company In-Brief
    -Revenue
    -Location
    -Established Year
    -Special Note
   2) Revenue by Business Segment (DNA-based Diagnostics and Tests, Drugs, Medical Equipment, etc.)
   3) Product Revenue Forecasts, 2007-2009
     -Equipment Revenue
     -Product Revenue, by Segment
   4) Most Important Product for Sales and Marketing Spending - and Key Reason for Spending on Product
   5) Distribution Policy
     - Basic Distribution Flow
     - Status of Usage of Sales Agents, Wholesalers, etc.
   6) R&D Activity
     - Expenditure
     - Most Important R&D Area for Capital Spending - and Key Reason for Spending
   7) Technology Trends
     - Technology Used in DNA-based Diagnostic and Test
     - Patents Status
   8) New Product Development Activity
     - Product Character
     - Product Development Areas where Company Invests More Money and People Resources
   9) Profitability
     - Revenue Contribution of DNA-based Diagnostic and Test Business
     - Profitability (%) of the Above-mentioned Business
   10) Business Policies
     - Management of Privacy
     - Company Policy on Ethics
     - Status of Usage of DNA Counseling
   11) Market Trends (Roadmap): Future DNA Diagnostic and Test Market Outlook
     - Product Segment where Company Can Expect Brighter Future
     - Market Expansion and Obstruction Factors
     - Business Potentiality of B-to-C Segment
1. Abbott Molecular Diagnostics
2. Becton Dickinson (BD) Diagnostics
3. BioMerieux USA/BioTheranostics
4. Celera Corp.
5. Decode Genetics
6. Qiagen North America/Digene
7. Genomic Health
8. Gen-Probe
9. Interleukin Genetics
10. Life Technologies (formerly Applied Biosystems & Invitrogen)
11. Myriad Genetics
12. Novartis V&D
13. Roche (Molecular Diagnostics & Applied Science divisions)
14. Siemens Healthcare Diagnostics (formerly Bayer Diagnostics)
15. Hologic Molecular (formerly Third Wave Technologies)

Section C: Additional Companies in DNA-based Diagnostics, by Market Segment

Common Research Item
    -Location/Contact Information
    -URL
    -Private or Public
    -Revenue
    -Current Product or
    -Developing Product & Application
    -Technology, R&D and Commercialization
    -Strategic Alliance and Partner

1. Consumer Genomics
  1.1 ~ 1.5 Total 5 Companies
2. DNA-Based Test Makers
  2.1 ~ 2.8 Total 8 Companies
3. Instrumentation and Tools
  3.1 ~3.14 Total 14 Companies

    

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