DNA Diagnostics: Technologies and Global Markets

SUMMARY

Highlights

This report:

• Decribes the major technologies for analyzing DNA in a clinic setting, including DNA microarrays, PCR-based assays, ISH diagnostics, and LOAC diagnostics
• Offers the current global market status for DNA diagnostics, with trends and forecasts for growth over the next 5 years
• Analyzes differential applications within the categories of diagnostic technologies
• Discusses government regulatory provisions that govern activities in the industry
• Includes company profiles.

INTRODUCTION

STUDY GOALS AND OBJECTIVES

BCC's goal in conducting this study is to determine the current status of the DNA diagnostics industry and to assess its growth potential over a 5-year period from 2008 to 2013. We are particularly interested in the markets for DNA microarrays, PCR-based assays, fluorescent in situ hybridization, and biochips.

In addition, we are interested in the market for DNA assays for specific clinical applications. For each, we examine the technology, development process, market penetration and the projected market for each diagnostic assay through 2013.

Our key objective is to present a comprehensive analysis of the current market and its future direction.

REASONS FOR DOING THE STUDY

DNA-based assays continue to move from research settings into the clinic and as such they represent one of the fastest growing segments of diagnostics. We are interested in the innovations in microarrays, PCR assays, biochips and other common technologies for DNA detection as they are modified for routine clinical use.

As nucleic acid testing becomes routine, a number of related issues have come to the fore including government regulation, reimbursement through insurance, patient confidentiality and other legal ramifications. These developments and their impact on the DNA diagnostics business are also covered in this report.

SCOPE OF REPORT

This study examines the global market for assays used to detect specific nucleic acid sequences in medical and life sciences applications. While the goal of all DNA-based diagnostic assays is similar, several different technologies can be employed. BCC analyzes each technology in detail and determines major players, current market status and presents forecasts of growth over the next 5 years. Scientific challenges and advances, including the latest trends, are emphasized.

We examine government regulations, major collaborations, recent patents and factors affecting the industry worldwide. In addition, we examine new directions for DNA diagnostic technologies and emerging applications in clinical diagnostics.

TABLE OF CONTENTS

Chapter- 1: SUMMARY

• SUMMARY TABLE GLOBAL MARKET FOR CLINICAL DNA DIAGNOSTICS, BY SEGMENT, THROUGH 2013 ($ MILLIONS)
• SUMMARY FIGURE GLOBAL MARKET FOR CLINICAL DNA DIAGNOSTICS, BY SEGMENT, 2008-2013 ($ MILLIONS)

Chapter- 2: OVERVIEW

• INTRODUCTION TO GENOMIC DIAGNOSTICS
• INTRODUCTION TO GENOMIC … (CONTINUED)
• INTRODUCTION TO GENOMIC … (CONTINUED)
• EXPRESSION PROFILING AND DISEASE
• EXPRESSION PROFILING AND INFECTIOUS DISEASE
• DNA SEQUENCING FOR GENOTYPING AND DIAGNOSIS
• CLINICAL PHARMACOLOGY
• MUTATION DETECTION AND GENOTYPING FOR SPECIFIC GENES
• IDENTIFICATION OF NEW DISEASE GENES

Chapter-3: REGULATORY FACTORS

• SUCCESSES AND LIMITATIONS OF GENETIC TESTING
• REGULATORY POLICIES
• FOOD AND DRUG ADMINISTRATION: NEW GUIDELINES
• INTERNAL STANDARDS FOR DNA DIAGNOSTICS
• INSURANCE
• INSURANCE (CONTINUED)
• MARKETING DIRECTLY TO CONSUMERS
• MARKET FOR CLINICAL DNA DIAGNOSTICS, BY PRODUCT
• TABLE 1 GLOBAL MARKET FORECAST FOR DNA DIAGNOSTICS PRODUCTS, THROUGH 2013 ($ MILLIONS)
• FIGURE 1 GLOBAL MARKET FORECAST FOR DNA DIAGNOSTICS PRODUCTS, 2005-2013 ($ MILLIONS)
• FIGURE 2 GLOBAL DNA DIAGNOSTICS MARKET, BY PRODUCT SHARE, 2008 (%)
• FIGURE 2 (CONTINUED)
• FIGURE 3 GLOBAL DNA DIAGNOSTICS MARKET, BY PRODUCT SHARE, 2013 (%)

Chapter-4: MARKET FOR CLINICAL DNA DIAGNOSTICS BY TECHNOLOGY, THROUGH 2013

• MICROARRAY DIAGNOSTICS
• TABLE 2 GLOBAL MARKET FORECAST FOR DNA MICROARRAY PRODUCTS IN CLINICAL DIAGNOSTICS, THROUGH 2013 ($ MILLIONS)
• FIGURE 4 GLOBAL MARKET FORECAST FOR DNA MICROARRAY PRODUCTS IN CLINICAL DIAGNOSTICS, 2005-2013 ($ MILLIONS)
• PLANAR DNA MICROARRAYS
• TABLE 3 MAJOR SUPPLIERS OF PLANAR DNA MICROARRAYS
• BEAD MICROARRAYS
• TABLE 4 MAJOR SUPPLIERS OF BEAD MICROARRAYS
• ELECTRONIC MICROARRAYS
• EMERGING TECHNOLOGY: NANOPARTICLE ARRAYS
• Verigene (Nanosphere, Chicago, IL)
• Nanoplex Technologies (Mountain View, CA)
• PCR-BASED DIAGNOSTICS
• TABLE 5 GLOBAL MARKET FORECAST FOR PCR-BASED PRODUCTS IN CLINICAL DIAGNOSTICS, THROUGH 2013 ($ MILLIONS)
• FIGURE 5 GLOBAL MARKET FORECAST FOR ISH PRODUCTS IN CLINICAL DIAGNOSTICS, 2005-2013 ($ MILLIONS)
• TABLE 6 MAJOR SUPPLIERS OF PCR-BASED ASSAYS
• PCR-BASED TECHNOLOGIES FOR DIAGNOSTICS
• LightCycler (Roche Molecular Systems, Pleasanton, CA)
• TaqMan DNA probes (Applied Biosystems, Foster City, CA)
• Invader (Third Wave Technologies, Madison, WI)
• Tag-It Mutation Assay (Tm Bioscience)
• ReadIt Depolymerization Assay (Promega, Madison, WI)
• IN SITU HYBRIDIZATION DIAGNOSTICS
• TABLE 7 GLOBAL MARKET FORECAST FOR ISH PRODUCTS IN CLINICAL DIAGNOSTICS, THROUGH 2013 ($ MILLIONS)
• FIGURE 6 GLOBAL MARKET FORECAST FOR ISH PRODUCTS IN CLINICAL DIAGNOSTICS, 2005-2013 ($ MILLIONS)
• INTRODUCTION TO ISH PRODUCTS
• INTRODUCTION TO ISH PRODUCTS (CONTINUED)
• TECHNOLOGY
• FIBER FISH
• HER-2 FISH TESTING
• IMMUNOHISTOCHEMISTRY
• TABLE 8 COMPARISON OF FISH AND IHC PRODUCTS FOR DIAGNOSTIC TESTING
• EMERGING TECHNOLOGIES IN IN SITU HYBRIDIZATION
• BIOCHIPS/LAB-ON-A-CHIP
• THE MARKET FOR LAB-ON-A-CHIP PRODUCTS
• TABLE 9 GLOBAL MARKET FORECAST FOR LOAC PRODUCTS IN CLINICAL DIAGNOSTICS, THROUGH 2013 ($ MILLIONS)
• FIGURE 7 GLOBAL MARKET FORECAST FOR LOAC PRODUCTS IN CLINICAL DIAGNOSTICS, 2005-2013 ($ MILLIONS)
• The Market for Lab-on-a-… (Continued)
• MICROFLUIDIC DEVICES
• Microfluidic Devices (Continued)
• EMERGING DIAGNOSTIC ASSAYS
• THE TREND TOWARDS SINGLE CELL MEASUREMENTS
• Genetic Typing of Single Cells
• Single Cell Sequencing
• Copy Number Variations in Single Cells
• Combined Immunotyping and Single Cell Expression Analysis
• DIAGNOSING THE EPIGENOME

Chapter-5: MARKETS BY APPLICATION

• OVERALL MARKET FOR DNA DIAGNOSTICS BY APPLICATION
• TABLE 10 GLOBAL DNA DIAGNOSTICS MARKET BY APPLICATION, THROUGH 2013 ($ MILLIONS)
• FIGURE 8 GLOBAL DNA DIAGNOSTICS MARKET BY APPLICATION, 2005-2013 ($ MILLIONS)
• FIGURE 9 GLOBAL DNA DIAGNOSTICS MARKET BY APPLICATION, 2008 (%)
• FIGURE 10 GLOBAL DNA DIAGNOSTICS MARKET FORECAST BY APPLICATION, 2013 ($ MILLIONS)
• PRENATAL AND NEWBORN GENETIC SCREENING
• TABLE 11 GLOBAL MARKET FORECAST FOR PRENATAL AND NEWBORN DNA SCREENING BY PRODUCT, THROUGH 2013 ($ MILLIONS)
• FIGURE 11 GLOBAL MARKET FORECAST FOR PRENATAL AND NEWBORN DNA SCREENING BY PRODUCT, 2005-2013 ($ MILLIONS)
• CARRIER SCREENING
• Prenatal Diagnostic Testing
• Amniocentesis
• Chorionic Villus Sampling (CVS)
• Genetic Counseling
• PREIMPLANTATION DIAGNOSIS,
• NEWBORN SCREENING
• TABLE 12 NEWBORN SCREENING RECOMMENDED BY THE AMERICAN COLLEGE OF MEDICAL GENETICS
• TABLE 12 (CONTINUED)
• TABLE 13 STATES WITH MANDATED NEWBORN SCREENING FOR AT LEAST 20 OF THE RECOMMENDED ACMG DISORDERS
• Prenatal and Post-Natal Genetic Testing: An Example
• INFECTIOUS DISEASE DIAGNOSTICS
• TABLE 14 GLOBAL MARKET FORECAST FOR INFECTIOUS DISEASE DNA DIAGNOSTICS BY PRODUCT, THROUGH 2013 ($ MILLIONS)
• FIGURE 12 GLOBAL MARKET FORECAST FOR INFECTIOUS DISEASE DNA DIAGNOSTICS BY PRODUCT, 2005-2013 ($ MILLIONS)
• HIV/AIDS
• TABLE 15 MAJOR SUPPLIERS OF HIV GENOTYPIC RESISTANCE TESTS
• PRODUCTS
• Monogram Biosciences (formerly ViroLogic)
• PhenoSense GT
• PhenoSense HIV
• GeneSeq HIV
• PhenoSense Entry
• Replication Capacity (RC)
• PHARMACOGENOMICS AND HIV THERAPY
• ONCOLOGY DIAGNOSTICS AND HISTOPATHOLOGY
• TABLE 16 GLOBAL MARKET FORECAST FOR ONCOLOGY DNA DIAGNOSTICS BY PRODUCT, THROUGH 2013 ($ MILLIONS)
• FIGURE 13 GLOBAL MARKET FORECAST FOR ONCOLOGY DNA DIAGNOSTICS BY PRODUCT, 2005-2013 ($ MILLIONS)
• Leukemias
• Chronic Myeloid Leukemia (CML)
• Genetic Marker of CML
• Gleevec
• IDENTITY DIAGNOSTICS, PATERNITY AND FORENSICS
• TABLE 17 GLOBAL MARKET FORECAST FOR IDENTITY AND PATERNITY DNA DIAGNOSTICS BY PRODUCT, THROUGH 2013 ($ MILLIONS)
• FIGURE 14 GLOBAL MARKET FORECAST FOR IDENTITY AND PATERNITY DNA DIAGNOSTICS BY PRODUCT, 2005-2013 ($ MILLIONS
• PATERNITY TESTING
• Technology
• Pricing and Target Consumers
• Accreditation
• Legal Issues
• International News
• International News (Continued)
• TABLE 18 MAJOR PLAYERS IN PATERNITY TEST SERVICES
• Veterinary Identity Testing
• OTHER APPLICATIONS
• TABLE 19 GLOBAL MARKET FORECAST FOR DNA DIAGNOSTICS IN OTHER CLINICAL APPLICATIONS, BY PRODUCT, THROUGH 2013 ($ MILLIONS)
• FIGURE 15 GLOBAL MARKET FORECAST FOR DNA DIAGNOSTICS IN OTHER APPLICATIONS BY PRODUCT, 2005-2013 ($ MILLIONS)
• PHARMACOGENOMICS DIAGNOSTIC TESTING
• DRUG METABOLISM
• P450 ISOZYMES AND PHARMACEUTICALS
• TABLE 20 DRUG METABOLISM AND CYTOCHROME P450 ISOZYMES
• P450 Isozyme CYP3A
• P450 Isozyme CYP2D6
• P450 Isozyme CYP2C9
• P450 Isozyme 2C19
• P450 Isozyme 1A2
• P450 DIAGNOSTIC TESTING
• TABLE 21 MAJOR SUPPLIERS OF CYTOCHROME P450 TESTING
• FOR RESEARCH PURPOSES
• TABLE 21 (CONTINUED)
• Presymptomatic Testing

Chapter-6: PATENT ANALYSIS

• PATENTS BY TECHNOLOGY
• TABLE 22 DNA DIAGNOSTICS, ISSUED PATENTS BY TECHNOLOGY, JANUARY 2005-JANUARY 2008
• FIGURE 16 DNA DIAGNOSTICS, ISSUED PATENTS BY TECHNOLOGY, JANUARY 2005-JANUARY 2008 (%)
• PATENTS BY REGION
• TABLE 23 DNA DIAGNOSTICS, ISSUED PATENTS BY REGION, JANUARY 2005-JANUARY 2008
• TABLE 23 (CONTINUED)
• PATENTS BY MEDICAL APPLICATION
• TABLE 24 DNA DIAGNOSTICS, ISSUED PATENTS BY PRIMARY APPLICATION, JANUARY 2005-JANUARY 2008
• FIGURE 17 DNA DIAGNOSTICS, ISSUED PATENTS BY PRIMARY APPLICATION, JANUARY 2005-JANUARY 2008 (%)
• SIGNIFICANT PATENT NEWS
• KEY PATENT ACTIVITY IN PCR
• KEY PATENT ACTIVITY IN BREAST CANCER TYPING
• RECENT KEY PATENTS IN DNA DIAGNOSTICS
• Recent Key Patents in DNA … (Continued)
• Recent Key Patents in DNA … (Continued)
• Recent Key Patents in DNA … (Continued)

Chapter-6: INDUSTRY STRUCTURE

• TABLE 25 MARKET SHARE OF COMPANIES INVOLVED IN MICROARRAY DIAGNOSTICS, 2008 ($ MILLIONS)
• TABLE 26 MARKET SHARE OF COMPANIES INVOLVED IN PCR DIAGNOSTICS, 2008 ($ MILLIONS)
• TABLE 27 MARKET SHARE OF COMPANIES INVOLVED IN ISH DIAGNOSTICS, 2008 ($ MILLIONS)
• TABLE 28 MARKET SHARE OF COMPANIES INVOLVED IN LAB-ON-A-CHIP DIAGNOSTICS, 2008 ($ MILLIONS)
• INDUSTRY STRUCTURE (CONTINUED)

Chapter-8: COMPANY PROFILES

• 454 LIFE SCIENCES
• ABBOTT DIAGNOSTICS
• ADVANDX
• AFFYMETRIX, INC.
• AGILENT TECHNOLOGIES INC.
• AMBION INC.
• APPLIED BIOSYSTEMS GROUP
• APPLIED BIOSYSTEMS GROUP (CONTINUED)
• APPLIED IMAGING CORP.
• AUTOGENOMICS, INC.
• BAYER DIAGNOSTICS
• BECKMAN COULTER, INC.
• BECTON DICKINSON
• BIOMERIEUX SA
• BIOMICRO SYSTEMS, INC.
• BIO-RAD LABORATORIES
• CALIPER LIFE SCIENCES, INC.
• CALLIDA GENOMICS INC./HYSEQ
• CELERA DIAGNOSTICS
• CEPHEID
• CHEMICON INTERNATIONAL, INC., DIVISION OF SEROLOGICALS CORP.
• CHIRON CORP.
• CLINICAL DATA, INC
• CURAGEN CORP
• DECODE GENETICS
• DIGENE CORP.
• DNA DIAGNOSTICS CENTER
• EUROGENTEC
• EXACT SCIENCES CORP.
• FOCUS DIAGNOSTICS
• GE HEALTHCARE
• GEN-PROBE INCORPORATED
• GEN-PROBE INCORPORATED (CONTINUED)
• ILLUMINA
• INVITROGEN DYNAL AS
• LABORATORY CORPORATION OF AMERICA (LABCORP)
• LUMINEX CORP
• MICRONICS
• MONOGRAM BIOSCIENCES, INC.
• MYRIAD GENETICS
• NANOGEN INC.
• ORCHID BIOSCIENCES
• OXFORD GENE TECHNOLOGY IP LTD.
• PRODESSE INC.
• PYROSEQUENCING/BIOTAGE AB
• QIAGEN N.V.
• QUEST DIAGNOSTICS
• ROCHE (F. HOFFMANN-LA ROCHE LTD)
• SEQUENOM INC.
• STRATAGENE CORP. / HYCOR BIOMEDICAL INC.
• SORENSON GENOMICS, INC.
• THERMO FISHER SCIENTIFIC, INC.
• THIRD WAVE TECHNOLOGIES, INC.
• TRANSGENOMIC INC.
• U.S. GENOMICS
• VIROLOGIC, INC.
• WYETH-AYERST, INC.
• WYETH-AYERST, INC. (CONTINUED)