Molecular Diagnostics Markets

Molecular Diagnostics Markets

The technologies that constitute molecular diagnostics--like first-generation amplification, DNA probes, fluorescent in situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors, and molecular labels--are influencing the discovery of therapeutic molecules, the screening and diagnosis of patients, and the optimization of drug therapy.

In the past few years, this rapidly evolving field has seen several fascinating developments. This TriMark Publications report describes the specific market segment of the in vitro diagnostics market known as molecular diagnostics and includes all of the generally accepted clinical analytical activities in use today.

It examines the prevalent clinical-measurement devices, as well as their reagents and supplies as utilized in hospitals, clinics, large reference laboratories and doctor’s offices. Diagnostic tests marketed primarily as over-the-counter are generally not included in this report, although there is inevitably some overlap. The main objectives of this analysis are: 1) identifying viable technology drivers through a comprehensive look at platform technologies for molecular diagnostics, including probe-based nucleic acid assays, microarrays and sequencing; 2) obtaining a complete understanding of the chief molecular diagnostics tests--i.e., predictive, screening, prognostic, monitoring, pharmacogenomic and theranostic--from their basic principles to their applications; 3) discovering feasible market opportunities by identifying high-growth applications in different clinical diagnostic areas and by focusing on expanding markets, such as communicable diseases, cardiology and oncology; and 4) focusing on global industry development through an in-depth analysis of the major world markets for molecular diagnostics, including growth forecasts. 
 

1. Overview

1.1 Statement of Report

1.2 About This Report

1.3 Scope of the Report

1.4 Objectives

1.5 Methodology

1.6 Executive Summary

2. Introduction to Molecular Diagnostics and PCR Technology

2.1 Science Overview: Introduction to Genomics and Its Opportunity

2.2 Impact of the Human Genome Project on Molecular Diagnostics

2.3 Considerations for Molecular and Clinical Diagnosis

2.4 Molecular Diagnosis in the Post-Genomic Era

2.5 Advances in Molecular Diagnostics Technologies

2.6 Genetic Variability and Disease

2.7 Major Technology Platforms

2.7.1 Gene-based Amplification Technologies

2.7.2 Detection of Amplified Gene Products

2.7.3 Target-Based Gene Amplification

2.7.3.1 Polymerase Chain Reaction

2.7.3.2 Real-time PCR

2.7.3.3 Nucleic Acid Sequence-Based Amplification

2.7.4 Probe-Based Amplification

2.7.4.1 Ligase Chain Reaction

2.7.4.2 Strand Displacement Amplification

2.7.4.3 Qß-replicase Amplified Probe Assay

2.7.5 Signal-Based Amplification

2.7.5.1 Branched DNA (bDNA)

2.7.6 Other Gene Amplification Technologies

2.7.6.1 Immuno-PCR

2.7.6.2 Bio-Barcode Assay

3. Nucleic Acid Test Applications

3.1 Blood Testing and Infectious Diseases

3.1.1 Molecular Diagnostics Market

3.1.1.1 Methods for DNA Detection and Gene Sequencing

3.1.1.2 Products and Applications

3.1.1.3 Oncology

3.1.2 SNPs and Genes: Medical Utility (Clinical Applications)

3.1.2.1 Clinical Application Initiatives

3.1.2.2 A Sampling of Clinical Application Collaborations

3.1.2.3 Collaborative Relationships

3.2 Diagnostic Testing Using DNA

3.2.1 HIV

3.2.2 Hepatitis Serologic Markers and Nucleic Acid Testing

3.2.2.1 Hepatitis A Virus (HAV)

3.2.2.2 Hepatitis B Virus (HBV)

3.2.2.3 Hepatitis C Virus (HCV)

3.2.2.4 Hepatitis D Virus (HDV)

3.2.2.5 Hepatitis E Virus (HEV)

3.2.2.6 HBV/HCV Viral Load and Drug Resistance

3.2.3 Severe Acute Respiratory Syndrome (SARS)

3.2.3.1 New Approach to Diagnosing Avian Influenza

3.2.3.2 Microarray or DNA Chip-Based Tests

3.2.4 Cancer Detection Using PCR

3.2.4.1 Lung Cancer

3.2.4.2 Oral Cancer

3.2.4.3 Prostate Cancer

3.2.4.4 Chronic Myelogenous Leukemia

3.2.4.5 Malignant Gliomas

3.2.4.6 Colorectal Cancer

3.2.4.7 Breast Cancer

3.2.4.8 Bladder Cancer

3.2.5 Microbiology Testing

3.2.5.1 Chlamydia

3.2.5.2 Gonorrhea

3.2.5.3 Tuberculosis

3.2.5.4 Group B Streptococcus

3.2.5.5 Pathogenic Enteric Bacteria

3.2.5.6 Bordetella pertussis

3.2.5.7 Legionella Pneumophila

3.2.5.8 Peridontal Bacteria

3.2.5.9 Pneumocystis Carinii

3.2.5.10 Methicillin-resistant Staphylococcus Aureus

3.2.6 Blood Screening

3.3 SNPs in Clinical Diagnostics

3.3.1 Functional Genomics

3.3.2 Paternity Testing

3.4 Industrial Testing and Food Diagnostics

3.4.1 The Market

3.4.2 Detection of H. pylori by PCR

3.4.3 Detection of E. coli 0157

3.4.4 Detection of Enteric Viruses

3.5 Forensics Market

3.5.1 Isolation of DNA for PCR Profiling

3.5.2 Analysis by PCR-Based DNA Typing

3.5.3 Rapid Isolation of DNA for RFLP and PCR

3.5.4 DNA for PCR-STR Typing

3.6 Bioterrorism and Molecular Diagnostics

3.6.1 Introduction

3.6.1.1 Current Biological Threat Detection Systems

3.6.1.2 Use of DNA Microarrays and Biochips for Gene Expression Profiles in BWA

3.6.1.3 Advantages and Disadvantages of Host Gene Expression Profiling as a Biothreat Detection System

3.6.2 Biological Warfare Agents

3.6.2.1 Anthrax

3.6.2.2 Botulinum Toxin

3.6.2.3 Ricin

3.6.2.4 IVD Industry and Bioterrorism Preparedness

3.6.2.4.1 Brucellosis

3.6.2.4.2 Cholera

3.6.2.5 Rapid Lateral Flow Immunoassays

3.6.2.6 Biosensors

3.6.2.6.1 Antibody and Synthetic Receptor-Based Sensors

3.6.2.6.2 DNA Sensors

3.6.2.6.3 Reagentless Sensors

3.6.3 Anthrax in Clinical Samples

3.6.3.1 Overview of Anthrax and Its Infectivity

3.6.3.2 Rapid Tests

3.6.3.2.1 PCR Tests

3.7 Cystic Fibrosis Testing

3.8 HLA Sequencing-Based Typing Kits

3.9 Cytogenetic Testing

3.9.1 Hereditary Hemochromatosis

3.9.2 Apolipoprotein E (ApoE) Genotyping

3.9.3 Fragile X Syndrome

3.9.4 Methylenetetrahydrofolate Reductase (MTHFR) Carrier Testing

3.10 Developments in Biochips for Clinical Applications

3.10.1 Roche AmpliChip Microarray

3.10.2 Breast Cancer DNA Chips

3.10.3 eSensor DNA Detection System

3.11 Pharmacogenomics

3.11.1 Coumadin

3.12 Thrombic Disorders

4. Trends in Molecular Diagnostics

4.1 Pharmacogenomics

4.1.1 The Market

4.1.1.1 Oncology

4.1.1.2 Toxicogenomics

4.1.2 Market Influences and Forecast

4.2 DNA Microarrays

4.2.1 Techniques

4.2.2 The Market

4.2.3 Identification of Sequence SNPs

4.2.4 Determining Gene Expression Levels

4.2.4.1 Hybridization Tests

4.2.4.2 Oligonucleotide Probes

4.2.5 Molecular Diagnostics Entry into Point-of-Care Testing

4.3 Emerging Markets of DNA Arrays

4.3.1 Pharmacogenomics

4.3.2 Adoption of Amplified Screening Technology

4.3.3 Advances in Automated Testing

4.3.4 Increased Focus on Safety of Blood Supply

4.3.5 Development of Emerging Markets for NAT Technology

4.3.6 Cancer

4.3.7 Human Leukocyte Antigen Typing

4.3.8 Neonatal Screening

4.4 Drivers and Restraints

4.5 Market Forecast

4.6 Business Trends in the Industry

4.6.1 Molecular Diagnostics Industry Trends

4.6.1.1 Adoption of Amplified Screening Technology

4.6.1.2 Advances in Automated Testing

4.6.1.3 Responsiveness to Newly Emerging Threats

4.6.1.4 Increased Focus on Safety of Blood Supply

4.6.1.5 Growth in Viral Load Testing

4.6.1.6 Development of Emerging Markets for NAT Technology

4.6.1.7 Improvements in Detection Technologies

4.6.2 Pharmaceutical Industry Trends

4.6.3 Acquisitions, License Agreements and Partnerships

4.6.4 Ethical, Legal and Social Issues Related to the Use of Genetic Information

4.6.5 Regulatory Issues

4.6.6 Reimbursement Issues

4.6.6.1 Cystic Fibrosis

4.6.6.2 Viral Load Testing

4.6.6.3 NMP22

5. Molecular Diagnostics Automated Instrumentation Approved for Market by the FDA

5.1 Gene Expression Profiling

5.2 Proteomic Multiplex Assays

5.3 Solution-Phase Multiplexing

5.4 RNA Interference (RNAi)

5.4.1 Role of RNAi in Drug Target Validation

5.4.2 Other Companies Involved in the RNAi Market

5.5 DNA Tags

6. Market Trends and Forecasts

6.1 Market Dynamics

6.1.1 Technological Perspective on Molecular Diagnostics

6.1.2 Molecular Diagnostics Market Opportunities

6.1.3 Market Forces

6.1.3.1 Adoption of Amplified Screening Technology

6.1.3.2 Advances in Automated Testing

6.1.3.3 Responsiveness to Newly Emerging Threats

6.1.3.4 Increased Focus on Safety of Blood Supply

6.1.3.5 Growth in Viral Load Testing

6.1.3.6 Development of Emerging Markets for NAT Technology

6.1.3.7 Improvements in Detection Technologies

6.2 Future Considerations for Molecular Diagnosis

6.3 Role of Genomics in Transforming Pharmaceutical R&D

6.4 Cancer Markers

6.5 Cytology Markers

6.6 RNA Detection

6.7 Diagnosis of Inherited Disease

6.8 Ethical Considerations

6.9 NAT and Personalized Medicine

6.10 Five Molecular Diagnostics Growth Areas

6.11 Specific Commercial Nucleic Acid Probes

6.12 Novel Amplification Techniques in the Market

6.13 Ramification Amplification Method (RAM)

6.14 Invader Assays/Third Wave Technologies

6.15 Molecular Beacons

6.16 HLA Sequencing-Based Typing Kits

6.17 Prenatal Diagnosis

6.18 Newborn Screening

6.19 NAT and Preventive Medicine: NAT-Based Assays

6.20 Prenatal and Pre-implantation Diagnosis

6.21 FISH-Based Tests on Fetal Cells

6.22 Companion Therapeutic/Diagnostic Approach

6.23 Sample Preparation Market

7. Corporate Directory

7.1 Abbott Laboratories

7.2 Affymetrix

7.3 Agendia

7.4 Agilent Technologies

7.5 Ambion

7.6 Applied Biosystems Group

7.7 Beckman Coulter

7.8 BioGenex

7.9 bioMérieux

7.10 Bio-Rad Laboratories

7.11 Biotage

7.12 Biotest

7.13 Caliper Life Sciences

7.14 Celera Group

7.15 Cellomics

7.16 Cepheid

7.17 Chiron (Novartis)

7.18 Ciphergen Biosystems

7.19 CuraGen

7.20 Cytocell Technologies

7.21 Dako A/S (formerly DakoCytomation A/S)

7.22 DiaDexus

7.23 Digene

7.24 Enzo Biochem

7.25 Epigenomics

7.26 EraGen Biosciences

7.27 Eurogentec

7.28 Exiqon

7.29 Gene Link

7.30 Gene Logic

7.31 GeneOhm Sciences

7.32 Genisphere

7.33 Gen-Probe

7.34 Genzyme

7.35 Hamilton Thorne Biosciences

7.36 ID Biomedical

7.37 Illumina

7.38 Incyte

7.39 Innogenetics

7.40 Interleukin Genetics

7.41 Invitrogen

7.42 Kreatech Biotechnology

7.43 LabCorp

7.44 LI-COR Biosciences

7.45 Matritech

7.46 Meridian Bioscience

7.47 Monogram Biosciences

7.48 Motorola

7.49 MWG Biotech

7.50 Myriad Genetics

7.51 Nanogen

7.52 Nanosys

7.53 NimbleGen Systems

7.54 Nuvelo

7.55 Nymox Pharmaceutical

7.56 Orchid BioSciences

7.57 Orchid Cellmark

7.58 Organon International

7.59 Ortho-Clinical Diagnostics

7.60 Ostex International

7.61 PerSeptive Biosystems

7.62 PharMingen

7.63 PPD

7.64 PPGx (DNA Sciences Laboratories)

7.65 Prodesse

7.66 Professional Genetics Laboratory

7.67 Promega

7.68 QIAGEN

7.69 Quantum Biotechnologies

7.70 Response Biomedical

7.71 Roche Diagnostics

7.72 Siemens

7.73 Sequenom

7.74 SurModics

7.75 Tepnel Life Sciences

7.76 Third Wave Technologies

7.77 Tm Bioscience

7.78 Visible Genetics

7.79 VisiGen Biotechnologies

7.80 Vysis

7.81 Alternative Sequencing Companies

7.81.1 Callida Genomics, Inc.

7.81.2 Mobious Genomics, Ltd.

7.81.3 Perlegen Sciences, Inc.

7.81.4 Solexa, Ltd.

7.81.5 U.S. Genomics, Inc.

8. Market Overview

8.1 Snapshot of Molecular Diagnostics Industry Structure

8.2 Global Molecular Diagnostics Testing Market

8.3 U.S. Molecular Diagnostics Testing Market

8.4 European Molecular Diagnostics Market

8.5 Japanese Molecular Diagnostics Testing Market

8.6 Overview of the European Molecular Diagnostics Country Markets

8.6.1 France

8.6.2 Germany

8.6.3 The United Kingdom

8.6.4 Italy

8.6.5 Spain

Appendix 1: Biowarfare Agents

LIST OF FIGURES

Figure 2.1: Segment of Double-Stranded DNA Showing the Base-Pair Relationship

Figure 3.1: Applications of Molecular Diagnostics Technology Platforms

Figure 3.2: Overall Structure of Nucleic Acid Testing Market

Figure 3.3: Applications of Key Players and Market Share in Molecular

Diagnostics Testing Markets

Figure 3.4: Serologic and Clinical Course of Acute HBV Infection

Figure 3.5: Primary Causes of Chronic Liver Disease

Figure 3.6: Combination Therapy in Typical HCV Infection

Figure 3.7: Time Course of Markers in Typical HCV Infection

Figure 3.8: Bacillus anthracis

Figure 8.1: Molecular Diagnostics Market Segmentation

Figure 8.2: Molecular Diagnostics Market Segmentation by Technology

Figure 8.3: Breakout of the Molecular Diagnostics Marketplace

Figure 8.4: U.S. Molecular Diagnostics Market Segments 2007

LIST OF TABLES

Table 3.1: Global Market for Molecular Diagnostics Testing, 2000 to 2012

Table 3.2: U.S. Market for Molecular Diagnostics Testing, 2004 to 2012

Table 3.3: Global Market for Nucleic Acid Testing, 2000 to 2012

Table 3.4: Summary of Molecular Diagnostics Testing

Table 3.5: Share of Molecular Diagnostics Testing by Testing Type

Table 3.6: Key Players and Market Share in Molecular Diagnostics Testing Market

Table 3.7: Annual U.S. Market for DNA Probe Diagnostics, 1998 to 2012

Table 3.8: Annual Global Market for DNA Probe Diagnostics, 1998 to 2009

Table 3.9: Estimated Market Share of Major Competitors in U.S. DNA/PCR Kit Research Market

Table 3.10: Estimated Market Share of Major Competitors in U.S. DNA/PCR Kit Diagnostics Market

Table 3.11: Roche PCR Licenses

Table 3.12: DNA Probe Market Segments in the U.S.

Table 3.13: Companies Marketing Products Using DNA Probes

Table 3.14: Companies Marketing Multiple Products in Molecular Diagnostics Sector

Table 3.15: Global Sales of DNA Probe Kits, 1998 to 2005

Table 3.16: Companies Marketing DNA Detection Platforms

Table 3.17: Companies Marketing Genotyping Technologies

Table 3.18: Companies Marketing Clinical Genotyping Technologies

Table 3.19: Summary of Assays for HIV Viral Load Testing

Table 3.20: Global Market for HIV Diagnostic Testing, 2000 to 2012

Table 3.21: U.S. Market for HIV Diagnostic Testing, 2000 to 2012

Table 3.22: Serologic Diagnosis of HBV Infections*

Table 3.23: Unusual HBV Serologic Profiles Requiring Further Evaluation

Table 3.24: Recommendations for HBV Diagnostic Testing

Table 3.25: Lower Detection Limits of HBV DNA Assays

Table 3.26: Recommendations for HCV Diagnostic Testing

Table 3.27: Important HCV Statistics

Table 3.28: Global Market for HAV Diagnostic Testing, 2000 to 2008

Table 3.29: U.S. Market for HAV Diagnostic Testing, 2000 to 2008

Table 3.30: Global Market for HBV Diagnostic Testing, 2000 to 2008

Table 3.31: U.S. Market for HBV Diagnostic Testing, 2000 to 2008

Table 3.32: Global Market for HCV Diagnostic Testing, 2000 to 2008

Table 3.33: U.S. Market for HCV Diagnostic Testing, 2000 to 2008

Table 3.34: Global Market for SARS Diagnostics Testing, 2002 to 2008

Table 3.35: U.S. Market for SARS Diagnostics Testing, 2002 to 2008

Table 3.36: Global Market for Molecular Diagnostics Cancer Testing, 2000 to 2008

Table 3.37: Annual Volume of NAT Infectious Disease Testing, 2000 to 2008

Table 3.39: Global Market Dollar Volume of NAT STD Testing, 2000 to 2008

Table 3.39: U.S. Market Dollar Volume of NAT STD Testing, 2000 to 2009

Table 3.40: U.S. Market Share of NAT STD Testing

Table 3.41: Global Market for Chlamydia Diagnostic Testing, 2000 to 2009

Table 3.42: U.S. Market for Chlamydia Diagnostic Testing, 2000 to 2009

Table 3.43: Global Market for Gonorrhea Diagnostic Testing, 2000 to 2008

Table 3.44: Global Market for TB Diagnostic Testing, 2000 to 2008

Table 3.45: Global Market for DNA Group B Streptococcus Diagnostic Testing, 2000 to 2009

Table 3.46: U.S. Market for Group B Streptococcus Diagnostic Testing, 2000 to 2009

Table 3.47: Gen-Probe Clinical Diagnostic Products for the Detection of Non-Viral Micro-organisms

Table 3.48: Global Market for Blood-Screening Diagnostic Testing, 2000 to 2008

Table 3.49: U.S. Market for Blood-Screening Diagnostic Testing, 2000 to 2008

Table 3.50: Leading Players in SNP Genotyping

Table 3.51: Global Market for SNP Genotyping, 2000 to 2011

Table 3.52: DNA-Analysis Market Competitors

Table 3.53: Leading Companies in Medical Utility of SNPs

Table 3.54: Competitors in the Field of Identity Genomics Testing

Table 3.55: U.S. Market for Food-Screening Diagnostic Testing Using Molecular Diagnostics Techniques, 2000 to 2008

Table 3.56: Methods for Detection of Salmonella in Food Using Molecular Diagnostics Methods

Table 3.57: U.S. Market for Forensic Diagnostics Testing, 2000 to 2010

Table 3.58: U.S. Market for Biological Threat Detection Testing, 2000 to 2010

Table 3.59: Biotest Reagents

Table 3.60: Variation of CF Carrier Risks by Ethnic Group

Table 3.61: Reasons for CF Testing

Table 3.62: Variation of CF Detection Rates by Ethnic Background

Table 3.63: Global Market for CF Diagnostic Testing, 2000 to 2008

Table 3.64: U.S. Market for CF Diagnostic Testing, 2000 to 2008

Table 3.65: Commercial CF-Screening Products

Table 3.66: Emerging CF-Screening Products

Table 3.67: CF Screening Technology Summary

Table 3.68: U.S. Market for HLA Type Testing, 2000 to 2008

Table 3.69: Competitors in HLA Testing

Table 3.70: U.S. Market for NAT Genetic-Disease Testing, 2000 to 2008

Table 3.71: Non-U.S. Market for NAT Genetic-Disease Testing, 2000 to 2008

Table 3.72: U.S. Market for NAT Cytogenetic-Disease Testing, 2000 to 2008

Table 3.73: Non-U.S. Market for NAT Cytogenetic-Disease Testing, 2000 to 2008

Table 3.74: Carrier Rates of Common HFE Mutations in Caucasians

Table 3.75: Results and Diagnosis for Fragile X Syndrome

Table 3.76: Principal Competitors in Pharmacogenetics R&D for Personalized Medicine

Table 3.77: Principal Competitors in Pharmacogenetics Patient Testing

Table 4.1: DNA-Sequencing Market Players

Table 4.2: Global Market for DNA Chips, 2000 to 2007

Table 4.3: Top Ten Companies for Molecular Diagnostics Patents

Table 6.1: Companies Licensed to Sell Custom Molecular Beacon Probes

Table 6.2: U.S. Sample Preparation Market, 2005 to 2012

Table 7.1: Products Marketed by Abbott in the Diagnostics Market

Table 7.2: Summary of Selected Affymetrix Expression-Profiling Customers

Table 7.3: PACE Product Sales as a Percentage of Total Company Revenue, 2000 to 2005

Table 7.4: Innogenetics HLA Products for Genetic Testing and Transplantation

Table 7.5: Nanogen Product Sales, 2000 to 2006

Table 7.6: Rarely-Expressed Genes as Therapeutic Product Candidates

Table 7.7: Roche Diagnostics Key Products

Table 7.8: Sales by Region

Table 7.9: Sales by Business Area

Table 7.10: Product Line Sales 2005

Table 7.11: Growth Drivers

Table 8.1: Number of Molecular Diagnostics Tests in the U.S., 2000 to 2008

Table 8.2: Global Molecular Diagnostics Testing Revenues, 2000 to 2012

Table 8.3: Global Distribution of Molecular Diagnostics Testing

Table 8.4: U.S. Molecular Diagnostics Testing Market, 2004 to 2012

Table 8.5: European Molecular Diagnostics Testing Market, 2005 to 2012

Table 8.6: Japanese Molecular Diagnostics Testing Market, 2005 to 2012