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DNA Diagnostics: Technologies and Global Markets

Price:
USD $4,850.00
ISBN/SKU #:
GB-BIO063A
Research Group:
BCC
Date of Publication:
June 2008
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Summary

The 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. 

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.

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. This report  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.

This study will be of interest to technology and business professionals in the pharmaceutical, health care, genomics and biotechnology industries. Business development professionals, market analysts, consultants, and investors working in medical biotechnology will also find this report valuable. 

This Report:

  • By the end of 2008, the global DNA diagnostics market is expected to be valued at $10.6 billion. The total market is projected to grow at a compound annual growth rate (CAGR) of 13.7% to reach $20.1 billion in 2013.
  • PCR-based diagnostic assays should claim the largest share of the market in 2008 and be worth $5.4 billion. The segment will reach $9.5 billion in 2013, for a CAGR of 11.9%.
  • The fastest growing segment of the DNA diagnostics market is the LOAC market, which is expected to reach $890 million in 2008 and $2.1 billion in 2013, for a CAGR of 18.7%.

TABLE OF CONTENTS

Chapter- 1: 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


Chapter- 2: 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- 3: OVERVIEW

INTRODUCTION TO GENOMIC DIAGNOSTICS
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- 4: REGULATORY FACTORS

SUCCESSES AND LIMITATIONS OF GENETIC TESTING
REGULATORY POLICIES
FOOD AND DRUG ADMINISTRATION: NEW GUIDELINES
INTERNAL STANDARDS FOR DNA DIAGNOSTICS
INSURANCE
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 3 GLOBAL DNA DIAGNOSTICS MARKET, BY PRODUCT SHARE, 2013 (%)


Chapter- 5: 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
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)
MICROFLUIDIC DEVICES
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- 6: 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 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
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
Presymptomatic Testing


Chapter- 7: 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
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


Chapter- 8: 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)


Chapter- 9: COMPANY PROFILES

454 LIFE SCIENCES
ABBOTT DIAGNOSTICS
ADVANDX
AFFYMETRIX, INC.
AGILENT TECHNOLOGIES INC.
AMBION INC.
APPLIED BIOSYSTEMS GROUP
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
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.

 

 


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Number of Pages: 150

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