DNA Diagnostics: Technologies and Global Markets

• Publication date: June 2008

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 c...

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.  
 

Global Medical Devices Industry

INTRODUCTION

STUDY GOALS AND OBJECTIVES

REASONS FOR DOING THE STUDY

SCOPE OF REPORT

INTENDED AUDIENCE

METHODOLOGY AND INFORMATION SOURCES

ANALYST CREDENTIALS

BCC ONLINE SERVICES

DISCLAIMER

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)

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

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 (%)

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

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

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)

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-ONA-CHIP DIAGNOSTICS, 2008 ($ MILLIONS)

INDUSTRY STRUCTURE (CONTINUED)

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)

LIST OF TABLES

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

TABLE 1 GLOBAL MARKET FORECAST FOR DNA DIAGNOSTICS PRODUCTS, THROUGH 2013 ($ MILLIONS)

TABLE 2 GLOBAL MARKET FORECAST FOR DNA MICROARRAY PRODUCTS IN CLINICAL DIAGNOSTICS, THROUGH 2013 ($ MILLIONS)

TABLE 3 MAJOR SUPPLIERS OF PLANAR DNA MICROARRAYS

TABLE 4 MAJOR SUPPLIERS OF BEAD MICROARRAYS

TABLE 5 GLOBAL MARKET FORECAST FOR PCR-BASED PRODUCTS IN CLINICAL DIAGNOSTICS, THROUGH 2013 ($ MILLIONS)

TABLE 6 MAJOR SUPPLIERS OF PCR-BASED ASSAYS

TABLE 7 GLOBAL MARKET FORECAST FOR ISH PRODUCTS IN CLINICAL DIAGNOSTICS, THROUGH 2013 ($ MILLIONS)

TABLE 8 COMPARISON OF FISH AND IHC PRODUCTS FOR DIAGNOSTIC TESTING

TABLE 9 GLOBAL MARKET FORECAST FOR LOAC PRODUCTS IN CLINICAL DIAGNOSTICS, THROUGH 2013 ($ MILLIONS)

TABLE 10 GLOBAL DNA DIAGNOSTICS MARKET BY APPLICATION, THROUGH 2013 ($ MILLIONS)

TABLE 11 GLOBAL MARKET FORECAST FOR PRENATAL AND NEWBORN DNA SCREENING BY PRODUCT, THROUGH 2013 ($ MILLIONS)

TABLE 12 NEWBORN SCREENING RECOMMENDED BY THE AMERICAN COLLEGE OF MEDICAL GENETICS

TABLE 13 STATES WITH MANDATED NEWBORN SCREENING FOR AT LEAST 20 OF THE RECOMMENDED ACMG DISORDERS

TABLE 14 GLOBAL MARKET FORECAST FOR INFECTIOUS DISEASE DNA DIAGNOSTICS BY PRODUCT, THROUGH 2013 ($ MILLIONS)

TABLE 15 MAJOR SUPPLIERS OF HIV GENOTYPIC RESISTANCE TESTS

TABLE 16 GLOBAL MARKET FORECAST FOR ONCOLOGY DNA DIAGNOSTICS BY PRODUCT, THROUGH 2013 ($ MILLIONS)

TABLE 17 GLOBAL MARKET FORECAST FOR IDENTITY AND PATERNITY DNA DIAGNOSTICS BY PRODUCT, THROUGH 2013 ($ MILLIONS)

TABLE 18 MAJOR PLAYERS IN PATERNITY TEST SERVICES

TABLE 19 GLOBAL MARKET FORECAST FOR DNA DIAGNOSTICS IN OTHER CLINICAL APPLICATIONS, BY PRODUCT, THROUGH 2013 ($ MILLIONS)

TABLE 20 DRUG METABOLISM AND CYTOCHROME P450 ISOZYMES

TABLE 21 MAJOR SUPPLIERS OF CYTOCHROME P450 TESTING

FOR RESEARCH PURPOSES

TABLE 22 DNA DIAGNOSTICS, ISSUED PATENTS BY TECHNOLOGY, JANUARY 2005-JANUARY 2008

TABLE 23 DNA DIAGNOSTICS, ISSUED PATENTS BY REGION, JANUARY 2005-JANUARY 2008

TABLE 24 DNA DIAGNOSTICS, ISSUED PATENTS BY PRIMARY APPLICATION, JANUARY 2005-JANUARY 2008

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-ACHIP DIAGNOSTICS, 2008 ($ MILLIONS)

LIST OF FIGURES

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

FIGURE 1 GLOBAL MARKET FORECAST FOR DNA DIAGNOSTICS PRODUCTS, 2005-2013 ($ MILLIONS)

FIGURE 2 GLOBAL DNA DIAGNOSTICS MARKET, BY PRODUCT SHARE, 2008 (%)

FIGURE 3 GLOBAL DNA DIAGNOSTICS MARKET, BY PRODUCT SHARE, 2013 (%)

FIGURE 4 GLOBAL MARKET FORECAST FOR DNA MICROARRAY PRODUCTS IN CLINICAL DIAGNOSTICS, 2005-2013 ($ MILLIONS)

FIGURE 5 GLOBAL MARKET FORECAST FOR ISH PRODUCTS IN CLINICAL DIAGNOSTICS, 2005-2013 ($ MILLIONS)

FIGURE 6 GLOBAL MARKET FORECAST FOR ISH PRODUCTS IN CLINICAL DIAGNOSTICS, 2005-2013 ($ MILLIONS)

FIGURE 7 GLOBAL MARKET FORECAST FOR LOAC PRODUCTS IN CLINICAL DIAGNOSTICS, 2005-2013 ($ 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)

FIGURE 11 GLOBAL MARKET FORECAST FOR PRENATAL AND NEWBORN DNA SCREENING BY PRODUCT, 2005-2013 (MILLIONS)

FIGURE 12 GLOBAL MARKET FORECAST FOR INFECTIOUS DISEASE DNA DIAGNOSTICS BY PRODUCT, 2005-2013 ($ MILLIONS)

FIGURE 13 GLOBAL MARKET FORECAST FOR ONCOLOGY DNA DIAGNOSTICS BY PRODUCT, 2005-2013 ($ MILLIONS)

FIGURE 14 GLOBAL MARKET FORECAST FOR IDENTITY AND PATERNITY DNA DIAGNOSTICS BY PRODUCT, 2005-2013

($ MILLIONS

FIGURE 15 GLOBAL MARKET FORECAST FOR DNA DIAGNOSTICS IN OTHER APPLICATIONS BY PRODUCT, 2005-2013 ($ MILLIONS

FIGURE 16 DNA DIAGNOSTICS, ISSUED PATENTS BY TECHNOLOGY, JANUARY 2005-JANUARY 2008 ($ MILLIONS)

FIGURE 17 DNA DIAGNOSTICS, ISSUED PATENTS BY PRIMARY APPLICATION, JANUARY 2005-JANUARY 2008 (%)