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Molecular Diagnostics: Technologies and Global Markets

Published By :

BCC Research

Published Date : Sep 2017

Category :

Biotechnology

No. of Pages : 172 Pages

Report Highlights
The global molecular diagnostics market was valued at nearly $10.6 billion in 2016. The market is projected to grow at a compound annual growth rate (CAGR) of 14.3% from 2017 through 2022 to reach $12.2 billion by 2017 and $23.8 billion by 2022.

Report Includes:
An overview of the global market for molecular diagnostics
Analyses of global market trends, with data from 2016, estimates for 2017, and projections of compound annual growth rates (CAGRs) through 2022
Discussion of related issues, such as government regulations, reimbursement through insurance, patient confidentiality, and other legal ramifications
Identification of scientific challenges and advances, including the latest trends in the market
A relevant patent analysis
Comprehensive company profiles of major players in the field
Report Scope
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. BCC Research analyzes each technology in detail, determines major players and current market status and presents forecasts of growth over the next five years. Scientific challenges and advances including the latest trends are emphasized. We examine government regulations, major collaborations, recent patents and factors affecting the industry globally. In addition, we examine new directions for DNA diagnostic technologies and emerging applications in clinical diagnostics.

Table of Contents
Chapter 1: Introduction
Study Goals and Objectives
Reasons for Doing the Study
Scope of Report
Intended Audience
Methodology and Information Sources
Geographic Breakdown
Analyst's Credentials
Related BCC Research Reports
Chapter 2: Summary and Highlights
Forecasts
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: Regulations and Finance
Overview
Insurance
Food and Drug Administration Guidelines
Internal Standards for DNA Diagnostics
Minimum Information about a Microarray
Experiment - Miame 2.0
Microarray Quality Control (MAQC) Project
Clinical Laboratory Improvement Amendments (CLIA)
Personalized Medicines and Companion Diagnostics
FDA Guidelines for In Vitro Companion Diagnostics
Definition and Use of an IVD Companion Diagnostic Device
Review and Approval of IVD Companion Diagnostic Devices and Therapeutic Products
Novel Therapeutic Products
Approval of a Therapeutic Product without an Approved IVD Companion Diagnostic Device
General Policies
FDA Approved Companion Diagnostics
Nucleic Acid Based Tests
Pharmacogenomics Research Network
Chapter 5: Commercial Market Trends
Market Conditions
Healthcare, Hospitals, Doctors, Greater Regulation and Need for Insurance Reimbursement
New Requirements for Success
Sales and Marketing
Medical Affairs
Regulatory Compliance
Reimbursement
Alliances and Mergers
Chapter 6: Market for Molecular Diagnostics by Technology
Overview
Description
Revenues and Forecasts
Manufacturers
Microarray, Lab-on-a-Chip/Biochips
Description
Microfluidic Devices
Revenues and Forecasts
Manufacturers and Products
PCR
Description
Revenues and Forecasts
Manufacturers and Products
In Situ Hybridization (ISH)
Description
Labeling Techniques
Applications of In Situ Hybridization
Fiber Fish
Her2 Fish Testing
Revenues and Forecasts
Emerging and Other Diagnostic Technologies
Description
The Trend toward Single-Cell Measurements
Revenues and Forecasts
Chapter 7: Market for Molecular Diagnostics by Application and Products
Overview
Description
Revenues and Forecasts
Pre-/Postnatal Genetic Screening
Description
Carrier Screening
Prenatal Diagnostic Testing
Amniocentesis
Chorionic Villus Sampling
Genetic Counseling
Preimplantation Diagnosis
Newborn Screening
Revenues and Forecasts
Infectious Disease Diagnostics
Description
Revenues and Forecasts
Oncology Diagnostics
Description
Leukemias
Chronic Myeloid Leukemia
Genetic Marker of Chronic Myeloid Leukemia
Revenues and Forecasts
Identity Diagnostics, Forensics and Paternity
Description
Paternity Testing
Technology
Accreditation
Legal Issues
Veterinary Identity Testing
Revenues and Forecasts
Pharmacogenomics/Other Applications
Description
Revenues and Forecasts
Chapter 8: Geographic Forecasts
PCR
Microarray
ISH
Emerging and Other Markets
Chapter 9: Patent Analysis
PCR
ISH
Microarrays
Microfluidics and Biochips
Chapter 10: Company Profiles
About BCC Research
About BCC Research
BCC Library Access
BCC Custom Research

List of Table

List of Tables
Summary Table: Global Market for Molecular Diagnostics, by Technology, Through 2022 ($ Millions)
Table 1: Minimum Information About a Microarray Experiment - MIAME 2.0
Table 2: Microarray Quality Control (MAQC) Project
Table 3: U.S. Laboratories CLIA-Certified for Molecular Diagnostics and Number of Disease Tests
Table 4: Genetic Testing Procedures Performed in U.S. by Type, 2015
Table 5: FDA-approved In Vitro Companion Diagnostic Devices as of June 1, 2017
Table 6: Nucleic Acid-based Tests Cleared or Approved by the Center for Devices and Radiological Health, as of June 1, 2017
Table 7: Nucleic Acid-based Tests Cleared or Approved by the Center for Devices and Radiological Health as of June 1, 2017
Table 8: Diagnostics Manufacturer Mergers and Acquisitions, 2004-2017
Table 9: Global Market for Molecular Diagnostics by Technology, Through 2022 ($ Millions)
Table 10: Global Market Share for Molecular Diagnostics by Technology, 2017 (%)
Table 11: Global Market Share for Molecular Diagnostics by Manufacturer, 2017 (%)
Table 12: Global Microarray Market for Molecular Diagnostics, by Application, through 2022 ($ Millions)
Table 13: Global Microarray Market Share for Molecular Diagnostics, by Application, 2017 (%)
Table 14: Major Suppliers of Planar DNA Microarrays
Table 15: Major Suppliers of Bead Microarrays
Table 16: Global PCR Market for Molecular Diagnostics, by Application, Through 2022 ($ Millions)
Table 17: Global PCR Market Share for Molecular Diagnostics, by Application, 2017 (%)
Table 18: Global PCR Market Share, by Manufacturer, 2017 (%)
Table 19: Global ISH Market for Molecular Diagnostics by Application, Through 2022 ($ Millions)
Table 20: Global ISH Market Share for Molecular Diagnostics, by Application, 2017 (%)
Table 21: Global Emerging/Other Molecular Diagnostics Market, by Application, Through 2022 ($ Millions)
Table 22: Global Emerging/Other Molecular Diagnostics Market Share, by Application, 2017 (%)
Table 23: Global Market for Molecular Diagnostics, by Application, Through 2022 ($ Millions)
Table 24: Global Market Share for Molecular Diagnostics, by Application, 2017 (%)
Table 25: Global Pre/Postnatal Screening Market for Molecular Diagnostics, by Technology, Through 2022 ($ Millions)
Table 26: Global Pre/Postnatal Screening Market Share for Molecular Diagnostics, by Technology, 2017
Table 27: Global Infectious Diseases Market for Molecular Diagnostics, by Technology, Through 2022 Millions)
Table 28: Global Infectious Disease Screening Market Share for Molecular Diagnostics, by Technology, 2017 (%)
Table 29: Global Oncology Market for Molecular Diagnostics, by Technology, Through 2022 ($ Millions)
Table 30: Global Oncology Market Share for Molecular Diagnostics, by Technology, 2017 (%)
Table 31: Global Identity Testing Market for Molecular Diagnostics, by Technology, Through 2022 ($ Millions)
Table 32: Global Identity Testing Market Share for Molecular Diagnostics, by Technology, 2017 (%)
Table 33: Global Pharmacogenomics and Other Market Share for Molecular Diagnostics by Technology, Through 2022 ($ Millions)
Table 34: Global Pharmacogenomics and Other Market Share for Molecular Diagnostics by Technology, 2017 (%)
Table 35: Global PCR Molecular Diagnostics Market, by Region, Through 2022 ($ Millions)
Table 36: Global Microarray Molecular Diagnostics Market, by Region, Through 2022 ($ Millions)
Table 37: Global ISH Molecular Diagnostics Market, by Region, Through 2022 ($ Millions)
Table 38: Global Emerging and Other Molecular Diagnostics Markets, by Region, Through 2022 ($ Millions)
Table 39: Selected PCR Patents Granted from January 2015 to June 2017
Table 40: Selected ISH Patents Granted from January 2015 to June 2017
Table 41: Selected Microarray Patents Granted from January 2015 to June 2017
Table 42: Selected Biochip Patents Granted from January 2015 To June 2017
Table 43: Selected Microfluidics Patents Granted from January 2015 to June 2017
Table 44: List of Companies Acquired, 2014-2017

List of Chart

List of Figures
Summary Figure: Global Market for Molecular Diagnostics, 2016-2022 ($ Millions)
Figure 1: Growth in Clinical Laboratory Sites and Disease Testing, 2012-2015 (Number)
Figure 2: Global Market Share for Molecular Diagnostics by Technology, 2017 (%)
Figure 3: Global Market Share for Molecular Diagnostics by Manufacturer, 2017 (%)
Figure 4: Global Microarray Market Share for Molecular Diagnostics, by Application, 2017 (%)
Figure 5: Global PCR Market Share for Molecular Diagnostics, by Application, 2017 (%)
Figure 6: Global ISH Market Share for Molecular Diagnostics, by Application, 2017 (%)
Figure 7: Global Market Share for Molecular Diagnostics, by Application, 2017 (%)
Figure 8: Global Pre/Postnatal Screening Market Share or Molecular Diagnostics, by Technology, 2017 (%)
Figure 9: Global Infectious Disease Screening Market Share for Molecular Diagnostics, by Technology, 2017 (%)
Figure 10: Global Oncology Market Share for Molecular Diagnostics, by Technology, 2017 (%)
Figure 11: Global Identity Testing Market Share for Molecular Diagnostics, by Technology, 2017 (%)

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