Molecular Diagnostics Markets
The technologies that constitute molecular diagnostics-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.
By Purchasing This Report You Will Have:·
- An improved understanding of the current state and future of the molecular diagnostics market.·
- The latest information on the leading companies engaged in research and development and products in the pipeline.
- The leading perspective of recent imaging developments and revelations.
- Knowledge of the molecular diagnostics market as an area of growth, research and investment.
This Report Will Cover the Following Molecular Diagnostics Technologies:
- Nucleic acid test applications.
- Blood testing and infectious diseases
- Diagnostic testing using DNA
- Cancer detection using PCR
- Microbiology testing
- Blood screening
- SNPs in clinical diagnostics
- Industrial testing and food diagnostics
- Forensics market
- Bioterrorism and molecular diagnostics
- Cystic fibrosis testing
- HLA sequencing-based typing kits
- Cytogenetic testing
- Developments in biochips for clinical applications
- Pharmacogenomics.
Analysis includes the use of charts and graphs measuring product growth and trends within the marketplace. In addition, a discussion of research into the molecular diagnostics arena provides the reader with a deeper understanding of the possibilities for future treatment and avenues for possible research and development budgets. Company-specific information, including sales figures, product pipeline status and research and development trends is provided throughout the report.
The report will:
- Assess the molecular diagnostics market drivers and bottlenecks, from the perspective of the medical and scientific communities.
- Discuss the potential benefits of the molecular diagnostics market for various sectors of the medical and scientific community.
- Establish the current total market size and future growth of the molecular diagnostics market and analyze the current size and growth of various segments
- Provide current and forecasted market shares by company
- Discuss profit/business opportunities by imaging segment
- Provide strategic recommendations for near-term business opportunities
- Assess current commercial uses of the molecular diagnostics market
- Assess the molecular diagnostics business models.
This report answers the following questions
- What are the near-term business opportunities in the molecular diagnostics market?
- What are the current and forecasted sizes of the molecular diagnostics market?
- What are the business models currently used by companies in molecular diagnostics?
- How will manufacturers, researchers, physicians, patients and payers influence the molecular diagnostics market?
- What are the drivers and bottlenecks influencing the molecular diagnostics market?· What are the technologies used in the molecular diagnostics sector?
- Who holds the proprietary rights to molecular diagnostics market technology?
- What are current applications of this technology?
- What regulatory processes must molecular diagnostics undergo in the United States (U.S.), Japan and Europe?
- How will new molecular diagnostics change treatment and payment paradigms?
- How will molecular diagnostics reduce healthcare expenditures?
Table of Contents
- 1. Overview9
- 1.1Statement of Report9
- 1.2 About This Report9
- 1.3 Scope of the Report9
- 1.4 Methodology10
- 1.5 Executive Summary10
- 2. Introduction to Molecular Diagnostics and PCR Technology14
- 2.1 Science Overview: Introduction to Genomics and Its Opportunity14
- 2.2 Impact of the Human Genome Project on Molecular Diagnostics16
- 2.3 Considerations for Molecular and Clinical Diagnosis16
- 2.4 Molecular Diagnosis in the Post-Genomic Era18
- 2.5 Advances in Molecular Diagnostics Technologies19
- 2.6 Genetic Variability and Disease21
- 2.7 Major Technology Platforms21
- 3. Nucleic Acid Test Applications22
- 3.1 Blood Testing and Infectious Diseases23
- 3.1.1Molecular Diagnostics Market23
- 3.1.1.1 Methods for DNA Detection and Gene Sequencing34
- 3.1.1.2 Products and Applications36
- 3.1.1.3 Oncology37
- 3.1.2 SNPs and Genes: Medical Utility (Clinical Applications)37
- 3.1.2.1 Clinical Application Initiatives39
- 3.1.2.2 Clinical Application Collaborations40
- 3.1.2.3 Collaborative Relationships42
- 3.1.1Molecular Diagnostics Market23
- 3.2 Diagnostic Testing Using DNA44
- 3.2.1 HIV46
- 3.2.2 Hepatitis Serologic Markers and Nucleic Acid Testing47
- 3.2.2.1 Hepatitis A Virus (HAV)48
- 3.2.2.2 Hepatitis B Virus (HBV)48
- 3.2.2.3 Hepatitis C Virus (HCV)52
- 3.2.2.4 Hepatitis D Virus (HDV)56
- 3.2.2.5 Hepatitis E Virus (HEV)56
- 3.2.2.6 HBV/HCV Viral Load and Drug Resistance57
- 3.2.3 Severe Acute Respiratory Syndrome (SARS)59
- 3.2.3.1 New Approach to Diagnosing Avian Influenza61
- 3.2.3.2 Microarray or DNA Chip-Based Tests63
- 3.2.4 Cancer Detection Using PCR63
- 3.2.4.1 Lung Cancer64
- 3.2.4.2 Oral Cancer65
- 3.2.4.3 Prostate Cancer65
- 3.2.4.4 Chronic Myelogenous Leukemia65
- 3.2.4.5 Malignant Gliomas65
- 3.2.4.6 Colorectal Cancer65
- 3.2.4.7 Breast Cancer66
- 3.2.4.8 Bladder Cancer66
- 3.2.5 Microbiology Testing66
- 3.2.5.1 Chlamydia66
- 3.2.5.2 Gonorrhea66
- 3.2.5.3 Tuberculosis67
- 3.2.5.4 Group B Streptococcus70
- 3.2.5.5 Pathogenic Enteric Bacteria72
- 3.2.5.6 Bordetella Pertussis72
- 3.2.5.7 Legionella Pneumophila72
- 3.2.5.8 Peridontal Bacteria73
- 3.2.5.9 Pneumocystis Carinii73
- 3.2.5.10 Staphylococcus Aureus73
- 3.2.6 Blood Screening73
- 3.3 SNPs in Clinical Diagnostics79
- 3.3.1 The Market83
- 3.3.2 Paternity Testing84
- 3.4 Industrial Testing and Food Diagnostics84
- 3.4.1 The Market84
- 3.4.2 Detection of H. pylori by PCR87
- 3.4.3 Detection of E. coli 015788
- 3.4.4 Detection of Enteric Viruses88
- 3.5 Forensics Market88
- 3.5.1 Isolation of DNA for PCR Profiling90
- 3.5.2 Analysis by PCR-Based DNA Typing90
- 3.5.3 Rapid Isolation of DNA for RFLP and PCR90
- 3.5.4 DNA for PCR-STR Typing91
- 3.6 Bioterrorism and Molecular Diagnostics91
- 3.6.1 Introduction91
- 3.6.1.1 Current Biological Threat Detection Systems93
- 3.6.1.2 Use of DNA Microarrays and Biochips for Gene Expression Profiles in BWA94
- 3.6.1.3 Advantages and Disadvantages of Host Gene Expression Profiling as a Biothreat Detection System95
- 3.6.2 Biological Warfare Agents97
- 3.6.2.1 Anthrax97
- 3.6.2.2 Botulinum Toxin98
- 3.6.2.3 Ricin99
- 3.6.2.4 IVD Industry and Bioterrorism Preparedness99
- 3.6.2.4.1Brucellosis99
- 3.6.2.4.2Cholera100
- 3.6.2.5 Rapid Lateral Flow Immunoassays100
- 3.6.2.6Biosensors102
- 3.6.2.6.1Antibody and Synthetic Receptor-Based Sensors102
- 3.6.2.6.2DNA Sensors103
- 3.6.2.6.3Reagentless Sensors104
- 3.6.3 Anthrax in Clinical Samples105
- 3.6.3.1 Overview of Anthrax and Its Infectivity105
- 3.6.3.2 Rapid Tests107
- 3.6.3.2.1PCR Tests107
- 3.6.1 Introduction91
- 3.7 Cystic Fibrosis Testing108
- 3.8 HLA Sequencing-Based Typing Kits110
- 3.9 Cytogenetic Testing112
- 3.9.1 Hereditary Hemochromatosis114
- 3.9.2 Apolipoprotein E (ApoE) Genotyping114
- 3.9.3 Fragile X Syndrome115
- 3.9.4 Methylenetetrahydrofolate Reductase (MTHFR) Carrier Testing116
- 3.10 Developments in Biochips for Clinical Applications117
- 3.10.1 Roche AmpliChip Microarray117
- 3.10.2 Breast Cancer DNA Chips118
- 3.10.3 eSensor DNA Detection System118
- 3.11 Pharmacogenomics119
- 3.1 Blood Testing and Infectious Diseases23
- 4. Trends in Molecular Diagnostics121
- 4.1 Pharmacogenomics121
- 4.1.1 The Market121
- 4.1.1.1Oncology121
- 4.1.1.2 Toxicogenomics121
- 4.1.2 Market Influences and Forecast122
- 4.1.1 The Market121
- 4.2 DNA Microarrays122
- 4.2.1 Techniques127
- 4.2.2 The Market127
- 4.2.3 Identification of Sequence SNPs128
- 4.2.4 Determining Gene Expression Levels128
- 4.2.4.1 Hybridization Tests128
- 4.2.4.2 Oligonucleotide Probes129
- 4.2.5 Molecular Diagnostics Entry into Point-of-Care Testing129
- 4.3 Emerging Markets of DNA Arrays129
- 4.3.1 Pharmacogenomics129
- 4.3.2 Adoption of Amplified Screening Technology130
- 4.3.3 Advances in Automated Testing130
- 4.3.4 Increased Focus on Safety of Blood Supply131
- 4.3.5 Development of Emerging Markets for NAT Technology131
- 4.3.6 Cancer131
- 4.3.7 Human Leukocyte Antigen Typing131
- 4.3.8 Neonatal Screening131
- 4.4Drivers and Restraints132
- 4.5 Market Forecast133
- 4.6 Business Trends in the Industry134
- 4.6.1 Molecular Diagnostics Industry Trends134
- 4.6.1.1 Adoption of Amplified Screening Technology134
- 4.6.1.2 Advances in Automated Testing134
- 4.6.1.3 Responsiveness to Newly Emerging Threats134
- 4.6.1.4 Increased Focus on Safety of Blood Supply134
- 4.6.1.5 Growth in Viral Load Testing135
- 4.6.1.6 Development of Emerging Markets for NAT Technology135
- 4.6.1.7 Improvements in Detection Technologies135
- 4.6.2 Pharmaceuticals Industry Trends136
- 4.6.3 Acquisitions, License Agreements and Partnerships136
- 4.6.4 Ethical, Legal and Social Issues Related to the Use of Genetic Information138
- 4.6.5 Regulatory Issues138
- 4.6.1 Molecular Diagnostics Industry Trends134
- 4.1 Pharmacogenomics121
- 5. New Products Under Development140
- 5.1 Gene Expression Profiling140
- 5.2 Proteomic Multiplex Assays140
- 5.3 Solution-Phase Multiplexing140
- 5.4 RNA Interference (RNAi)140
- 5.4.1 Role of RNAi in Drug Target Validation142
- 5.4.2 Other Companies Involved in the RNAi Market142
- 5.5 DNA Tags143
- 6. Market Trends and Forecasts144
- 6.1 Market Dynamics144
- 6.1.1 Technological Perspective on Molecular Diagnostics144
- 6.1.2 Molecular Diagnostics Market Opportunities144
- 6.1.3 Market Forces145
- 6.1.3.1 Adoption of Amplified Screening Technology146
- 6.1.3.2 Advances in Automated Testing146
- 6.1.3.3 Responsiveness to Newly Emerging Threats147
- 6.1.3.4 Increased Focus on Safety of Blood Supply147
- 6.1.3.5 Growth in Viral Load Testing147
- 6.1.3.6 Development of Emerging Markets for NAT Technology147
- 6.1.3.7 Improvements in Detection Technologies148
- 6.2 Future Considerations for Molecular Diagnosis148
- 6.3 Role of Genomics in Transforming Pharmaceutical R&D149
- 6.4 Cancer Markers149
- 6.5 Cytology Markers150
- 6.6 RNA Detection150
- 6.7 Diagnosis of Inherited Disease150
- 6.8 Ethical Considerations151
- 6.9 NAT and Personalized Medicine152
- 6.10 Five Molecular Diagnostics Growth Areas152
- 6.11 Specific Commercial Nucleic Acid Probes152
- 6.12 Novel Amplification Techniques on the Market153
- 6.13 Ramification Amplification Method (RAM)154
- 6.14 Invader Assays/Third Wave Technologies155
- 6.15 Molecular Beacons156
- 6.16 HLA Sequencing-Based Typing Kits157
- 6.17 Prenatal Diagnosis157
- 6.18 Newborn Screening158
- 6.19 NAT and Preventive Medicine: NAT-Based Assays159
- 6.20 Prenatal and Preimplantation Diagnosis159
- 6.21 FISH-Based Tests on Fetal Cells159
- 6.22 Companion Therapeutic/Diagnostic Approach159
- 6.1 Market Dynamics144
- 7. Corporate Directory161
- 7.1Abbott Laboratories161
- 7.2Affymetrix165
- 7.3Agilent Technologies175
- 7.4Ambion175
- 7.5Applied Biosystems Group176
- 7.6Bayer179
- 7.7Beckman Coulter181
- 7.8BioMérieux184
- 7.9Bio-Rad Laboratories184
- 7.10Biotage185
- 7.11Biotest185
- 7.12Caliper Life Sciences186
- 7.13Cellomics188
- 7.14Cepheid188
- 7.15Chiron189
- 7.16Ciphergen Biosystems190
- 7.17CuraGen191
- 7.18Cytocell Technologies197
- 7.19Dako A/S (formerly DakoCytomation A/S)197
- 7.20DiaDexus198
- 7.21Digene200
- 7.22Enzo Biochem202
- 7.23Epigenomics202
- 7.24Epoch Biosciences202
- 7.25EraGen Biosciences203
- 7.26Eurogentec203
- 7.27Exiqon203
- 7.28Gene Link204
- 7.29Gene Logic204
- 7.30GeneOhm Sciences206
- 7.31Genisphere206
- 7.32Gen-Probe207
- 7.33Genzyme208
- 7.34Hamilton Thorne Biosciences210
- 7.35ID Biomedical210
- 7.36Illumina211
- 7.37Incyte213
- 7.38Innogenetics214
- 7.39BioGenex215
- 7.40Interleukin Genetics216
- 7.41Invitrogen218
- 7.42Kreatech Biotechnology219
- 7.43LabCorp219
- 7.44LI-COR Biosciences219
- 7.45Matritech220
- 7.46Meridian Bioscience221
- 7.47Monogram Biosciences223
- 7.48Motorola224
- 7.49MWG Biotech225
- 7.50Myriad Genetics225
- 7.51Nanogen226
- 7.52Nanosys228
- 7.53NimbleGen Systems229
- 7.54Nuvelo230
- 7.55Nymox Pharmaceutical231
- 7.56Orchid BioSciences232
- 7.57Orchid Cellmark233
- 7.58Organon International236
- 7.59Ortho-Clinical Diagnostics236
- 7.60Ostex International238
- 7.61PerSeptive Biosystems238
- 7.62PharMingen238
- 7.63PPD238
- 7.64PPGx (DNA Sciences Laboratories)238
- 7.65Prodesse239
- 7.66Professional Genetics Laboratory239
- 7.67Promega239
- 7.68QIAGEN239
- 7.69Quantum Biotechnologies242
- 7.70Quidel242
- 7.71Response Biomedical244
- 7.72Roche Diagnostics244
- 7.73Sequenom247
- 7.74SurModics249
- 7.75Tepnel Life Sciences249
- 7.76Thermo Electron249
- 7.77Third Wave Technologies250
- 7.78Tm Bioscience251
- 7.79Visible Genetics251
- 7.80Vysis251
- 7.81VisiGen Biotechnologies252
- 7.9Alternative Sequencing Companies252
- 7.9.1Callida Genomics Inc.252
- 7.9.2Mobious Genomics Ltd.252
- 7.9.3Perlegen Sciences Inc.252
- 7.9.4Solexa Ltd.252
- 7.9.5U.S. Genomics Inc.253
- 8. Market Overview254
- 8.1 Global Molecular Diagnostics Testing Market255
- 8.2 U.S. Molecular Diagnostics Testing Market255
- 8.3 Japanese Molecular Diagnostics Testing Market256
- 8.4Rest-of-World (ROW) Molecular Diagnostics Testing Market256
- 8.5 Overview of the Asian Healthcare Market257
- 8.5.1 Singapore257
- 8.5.2 Malaysia257
- 8.5.3 Thailand257
- 8.5.4 Indonesia258
- 8.5.5 Philippines258
- 8.5.6 South Korea258
- 8.5.7 India258
- 8.5.8 Hong Kong259
- 8.5.9 Taiwan259
- 8.5.10 China260
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