DUBLIN, May 13, 2016 /PRNewswire/ --
Research and Markets has announced the addition of the "Molecular Diagnostics in Infectious Disease Testing" report to their offering.
This report describes the specific segment of the in vitro diagnostics market known as molecular diagnostics testing for infectious disease. In the current medical diagnostics market, molecular diagnostics in infectious disease testing offers one of the most promising areas for growth and innovation. The confluence of breakthroughs in genomics and proteomics - along with the development of microarray devices to measure analytes in the blood - has led to this revolutionary market development.
Specifically, molecular diagnostics offers the power of advanced analytical techniques to diagnose infectious diseases. Whereas before, the detection of many infectious agents was slow and expensive due to reliance upon culturing methods, researchers are now at the cusp of overcoming such limitations via the use of nucleic acid-mediated molecular diagnostics testing. The purpose of this report is to describe the emerging field of molecular diagnostics in infectious disease testing. The infectious disease space is the most dominant and profitable sector of molecular diagnostics.
Topics covered in this study include:
- The existing and emerging technologies in the field - The U.S. and global market size for molecular diagnostic products - The profiles of companies that are focusing on the molecular diagnostic sector.
The research examines drivers and restraints for sales growth, market share and technical trends. In addition, an in-depth analysis of the competitive situation of prominent market venders is provided with five-year sales forecasts.
Key Topics Covered:
1.1 Statement of Report
1.2 About This Report
1.3 Scope of the Report
1.6 Executive Summary
2. Introduction to Molecular Diagnostics for Infectious Disease Testing
2.1 Molecular Diagnostics Testing and Opportunities in the Infectious Disease Sector
2.2 The Infectious Disease Problem
2.3 Impact of the Human Genome Project on Molecular Diagnostics
2.4 Opportunities for Molecular and Clinical Diagnostics
2.5 Development of Molecular Diagnostics Testing Markets
2.6 Target-Based Gene Amplification
2.7 PCR Reagents for Clinical Diagnostics
3. Infectious Disease Diagnostics Molecular Testing Market
3.1 Market Overview
3.2 NAT Molecular Diagnostics Market
3.3 Infectious Disease Molecular Diagnostic Testing Markets
3.4 Blood Screening
4. Molecular Diagnostic Testing Technology for Infectious Disease Testing
4.1 Infectious Disease Diagnostic Tests
4.2 Use of Molecular Tests in Infectious Disease
4.3 Cost of Molecular Diagnostic Testing
4.4 Use of Multiplex PCR Tests
4.5 Next-Generation Sequencing
4.6 Patient Flow Software
4.7 Digital PCR
4.9 Ion Proton System for Gene Sequencing
4.10 xMap Technology (Luminex)
5.1 Technology and Market Trends
5.2 M&A Activity5.3 Partnerships
5.4 Competitive Analysis5.5 Intellectual Property Rights
5.6 Opportunities and Strategic Recommendations
5.7 Business Models and Requirements for a Successful Molecular Diagnostics Infectious Disease Products Industry
6. Reimbursement and Billing Landscape for Molecular Diagnostics Testing for Infectious Disease
6.2 Trends in Reimbursement Practice
6.3 Trends in Patient Care and Reimbursement
6.4 Revenue Threats
6.5 Billing Rules
7. Regulatory Requirements
7.1 Food and Drug Administration
7.2 CLIA Regulations7.3 Clinical Laboratory Improvement Act
7.4 State Licensing for Service Laboratories
7.6 FDA Draft Guidance on In Vitro Companion Diagnostic Devices
7.7 510(k) Clearance
7.8 Pre-Market Approval
7.9 Analyte Specific Reagents
7.10 What Regulatory Guidance is Needed for Companion Biomarkers?
7.11 U.S. Patent and Trademark Office
7.12 IRB Approval in Clinical Trials
7.13 CE Marking and the European In Vitro Diagnostic Device Directive
7.14 De Novo Classification
7.15 Research Use Only Reagents
7.16 FDA Recommendations on MRSA and SA Testing
7.17 FDA Guidance on Molecular Diagnostic Instruments with Combined Functions
8. Business Decisions using Molecular Diagnostic Tests in Infectious Disease Testing
8.1 What are Key Opportunities in Infectious Disease Testing Development and Commercialization?
8.2 What are the Current Obstacles for Molecular Diagnostic Infectious Disease Testing Implementation?
8.3 How do Business Strategies, Such as Those Relating to Acquisition, Drive Molecular Diagnostic Strategies?
8.4 How might Novel Infectious Disease Molecular Diagnostic Test Development Lead to Acquisition Strategies and their Implications for Deal Making?
8.5 How can Molecular Diagnostic Tests Increase Value in an Associated Drug Marketing Plan?
8.6 Which Types of Infectious Disease Molecular Diagnostic Testing should be Developed by Diagnostic Companies at Various Stages in the Development Pipeline?
8.7 How can Regulatory Oversight Drive Approval and Adoption of New Technologies?
8.8 What are the Noteworthy Deals?
8.9 Who are the Acquirers?
8.10 Who are the Target Companies?
8.11 How will Platform Technology Companies Enter the Space?
8.12 Will Pharma Integrate with Diagnostics?
8.13 How do Platform Technology Companies Position Themselves for Diagnostics Development?
8.14 Evaluate How Partnering and M&As will Alter the Competitive Landscape
8.15 Predict How FDA Regulations will Impact New Diagnostic Tests
8.16 How can Big Pharma and Diagnostic Companies Co-Develop Biomarkers in a Model for Regulatory Acceptance?
8.17 How to Maximize Business Development Through Biomarker Strategies?
8.18 What is the Best Type of Business Model for Developing Genetic Biomarkers for Infectious Disease?
8.19 How Best have Genetic Biomarkers Provided the Most Benefit in Infectious Disease Testing?
8.20 What are the Most Innovative Methods in Development of Molecular Diagnostic Biomarkers?
8.21 What are the Best Values for Genetic Biomarkers in Drug Development and in Diagnostics?
9. Economics of Anti-Microbial Drug Resistance: The Persistent Need for Antibacterials9.1 Resistance and Antibiotic Usage9.2 Infection Control Programs
10. Company Profiles
10.1 Abbott Laboratories
10.4 Arcxis Biotechnologies
10.5 Asuragen, Inc.
10.6 AutoGenomics, Inc.
10.7 Becton, Dickinson and Company
10.10 BioHelix Corporation (now part of Quidel)
10.13 EraGen Biosciences
10.14 GenMark Diagnostics, Inc.
10.15 Genomix Biotech
10.16 Gen-Probe, Inc. (now known as Hologic Gen-Probe)
10.17 Genomica S.A.U.
10.18 Great Basin Corporation
10.19 Illumina, Inc.
10.20 Life Technologies (Thermo Fisher Scientific)
10.21 Luminex Corp.
10.24 Myriad Genetics, Inc.
10.26 NorDiag ASA (The DiaSorin Group)
10.27 Qiagen N.V.
10.29 Roche Diagnostics (Roche Ltd.)
10.32 Siemens AG
10.36 Veredus Laboratories
10.37 Veridex, LLC(Janssen Diagnostics, LLC)
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