Reports, MRG Multimedia Research Group, Inc.

U.S. DNA-Based Diagnostic and Test Market

Market Trends, New Product Trends, Technology Trends,
Distribution Structure and 10 Notable Companies

Published by Fuji-Keizai and MRG, Inc.
January 2008, 136 pages

Hard Copy Print Edition $1,800 USD
PDF Single-Departmental License $2,800 USD
PDF Corporate-Wide License $4,800 USD
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To order click here or contact Rob Smith at rsmith@mrgco.com

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
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)
2.2	Market Size by Product Segment Diagnostic Testing Product Segments (DNA-Based Diagnostics) Predisposition Tests and Primary Screening for Risk Predictive Diagnostic Tests Predictive Treatment Tests (Pharmacodiagnostics) Prognosis Diagnosis (DNA-based Recurrence Risk Scores)

3	Market Share by Product Segment

4	Distribution Structure
4.1	Basic Distribution Pattern
4.2	Sales (%) by Channel
4.3	Sales Agent Intervention and Influence Physician Customers Laboratory Customers 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

7	Future of Market
7.1	Market Potentiality Developments and Drivers

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

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

Table of Graphs

Graph 2-1:	Market Size: DNA-based Diagnostics (All Product Segments)
Graph 2-2:	Total U.S. Market Size: High and Low Estimates
Graph 2-3:	Market Size by Product Segment (10 Companies Surveyed)
Graph 3-1:	Market Share (%) 2006 and 2008
Graph 4-1:	Sales by Channel
Graph 4-2:	Laboratory Share (%) of DNA Testing in the U.S. Clinical Labs as Distribution Partners
Graph 7-1:	Market Positioning 2010 to 2012

Table of Tables

Table 1-1:	Important Industry Development
Table 2-1:	DNA Test Makers, Product Revenues
Table 2-2:	Total U.S. Market Size: High and Low Estimates
Table 2-3:	Target, Healthy Adult (Pre-symptomatic), Potentially Sick Person (Prone to Disease), Sick Person (Diagnosed with Disease)
Table 2-4:	Surveyed Companies and Their Product Segment
Table 2-5:	Market Size and Growth Rate, by Product Segment
Table 6-1:	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)
Table 7-1:	Market Positioning 2010 to 2012
Table 7-2:	Factors Affecting Market Expansion or Obstruction
Table 8-1:	Condition, Who's Covered, Approved Tests

U.S. DNA-Based Diagnostic and Test Market — January 2008 is 136 pages and is available in a printed English language edition for $1,800 USD, a PDF single-departmental license for $2,800 USD, and a PDF corporate-wide license for $4,800 USD. For more information or to order the report, contact Rob Smith at 408-453-5553 or rsmith@mrgco.com.

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