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Molecular Diagnostics: Technologies and Global Markets

Molecular Diagnostics: Technologies and Global Markets

Report Scope:

This study examines the global market for assays used to detect specific nucleic acid sequences in medical and life science applications. The goal of all DNA-based diagnostic assays is similar, but 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. Government regulations, major collaborations, recent patents and factors affecting the industry from a global perspective are examined. New directions for DNA diagnostic technologies and emerging applications in clinical diagnostics are also examined.

Key molecular diagnostic technologies and products are analyzed to determine present and future market status, and growth is forecast from 2021 to 2026. In-depth discussion of strategic alliances, industry structures, competitive dynamics, patents and market driving forces are also provided.

Report Includes:

- 60 tables
- An overview of the global market and technologies for molecular diagnostics
- Estimation of the market size and analyses of global market trends, with data from 2019 to 2021 and projections of compound annual growth rates (CAGRs) through 2026
- Characterization and quantification of market potential for molecular diagnostic technologies by technology, application and region
- Information about food and drug administration guidelines and internal standards for DNA diagnostics, and coverage of novel therapeutic products and their approvals
- Discussion on related issues, government regulations, and reimbursement through insurance, patient confidentiality and other legal ramifications
- Identification of market drivers, restraints and other forces impacting the global market and evaluation of current market trends, market size and forecast
- Market share analysis of the key companies of the industry and coverage of events like mergers & acquisitions, joint ventures, collaborations or partnerships, and other key market strategies
- Company profiles of major players, including Abbott, Becton, Dickinson and Company, General Electric, Siemens Healthcare GmbH and Thermo Fisher Scientific Inc.
Table of Contents

Chapter 1 Introduction
Study Goals and Objectives
Reasons for Doing the Study
Intended Audience
What's New in This Update?
Scope of Report
Methodology
Information Sources
Geographical Breakdown
Analyst's Credentials
BCC Custom Research
Related BCC Research Reports
Chapter 2 Summary and Highlights
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 Impact of the COVID-19 Pandemic
Introduction
Impact of COVID-19 on Market
Changes in Consumption Trends for Health-Related Products
Chapter 5 Market Dynamics
Market Drivers
High Incidences of Infectious Diseases
Increasing Incidences of Chronic Disease
Increasing Research and Development Budget
Increasing Healthcare Expenditures
Restraints and Challenges
Stringent Regulatory Framework
High R&D and Marketing Costs
Opportunities
Point-of Care Tests that Minimize Dependency on Lab Testing
Discovery of New Biomarkers and Advances in Molecular Techniques
Chapter 6 Market Breakdown by Technology
Microarrays
Description
Microfluidic Devices
Market Size and Forecast
PCR
Market Size and Forecast
In Situ Hybridization
Labeling Techniques
In Situ Hybridization Applications
Fiber Fish
Her2 Fish Testing
Market Size and Forecast
Others
Trend Toward Single-Cell Measurements
Market Size and Forecast
Chapter 7 Molecular Diagnostics by Application
Infectious Diseases
Market Size and Forecast
Oncology
Leukemias
Chronic Myeloid Leukemia
Genetic Marker of Chronic Myeloid Leukemia
Market Size and Forecast
Pre- and Post-Natal Screening
Carrier Screening
Prenatal Diagnostic Testing
Amniocentesis
Chorionic Villus Sampling
Genetic Counseling
Preimplantation Diagnosis
Newborn Screening
Market Size and Forecast
Identity and Paternity
Paternity Testing
Technology
Accreditation
Legal Issues
Veterinary Identity Testing
Market Size and Forecast
Others
Market Size and Forecast
Chapter 8 Market Breakdown by Region
Global Molecular Diagnostic Market by Region
North America
U.S.
Canada
Europe
Germany
U.K.
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Rest of Asia-Pacific
Rest of the World
Chapter 9 Regulations and Finance
Overview
Europe
U.S.
Japan
Insurance
Food and Drug Administration Guidelines
Internal Standards for DNA Diagnostics
Minimum Information about a Microarray
Experiment: MIAME 2.0
Microarray Quality Control Project
Clinical Laboratory Improvement Amendments
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 10 Patents
Chapter 11 Competitive Landscape
Overview
Chapter 12 Company Profiles
ABBOTT
AGILENT TECHNOLOGIES INC.
ALMAC GROUP
BECTON, DICKINSON AND CO.
BIOMERIEUX SA
BIO-RAD LABORATORIES INC.
CARDINAL HEALTH
DANAHER CORP.
ELITECH GROUP
GENERAL ELECTRIC
HOLOGIC INC.
ILLUMINA INC.
MYRIAD GENETICS
GRIFOLS (NOVARTIS MOLECULAR DIAGNOSTICS)
PHILIPS HEALTHCARE
QIAGEN N.V.
QUEST DIAGNOSTICS
ROCHE HOLDING AG (F. HOFFMANN-LA ROCHE LTD.)
SIEMENS HEALTHCARE
THERMO FISHER SCIENTIFIC INC.

List of Tables
Summary Table : Global Molecular Diagnostic Market, by Region, Through 2026
Table 1 : Global HIV Data, 2000-2020
Table 2 : Global Leading Causes of Disease, 2004 and 2030
Table 3 : National Institutes of Health Funding Estimates for Various Conditions and Diseases, 2014–2019
Table 4 : Global Molecular Diagnostic Market, by Technology, Through 2026
Table 5 : Global Molecular Diagnostic Market, by Application, Through 2026
Table 6 : Global Molecular Diagnostic Market, by Region, Through 2026
Table 7 : North American Molecular Diagnostic Market, by Technology, Through 2026
Table 8 : North American Molecular Diagnostic Market, by Application, Through 2026
Table 9 : North American Molecular Diagnostic Market, by Country, Through 2026
Table 10 : U.S. Estimated Number of New Cancer Cases, 2021
Table 11 : European Molecular Diagnostic Market, by Technology, Through 2026
Table 12 : European Molecular Diagnostic Market, by Application, Through 2026
Table 13 : European Molecular Diagnostic Market, by Country, Through 2026
Table 14 : Asia-Pacific Molecular Diagnostic Market, by Technology, Through 2026
Table 15 : Asia-Pacific Molecular Diagnostic Market, by Application, Through 2026
Table 16 : Asia-Pacific Molecular Diagnostic Market, by Country, Through 2026
Table 17 : Rest of the World Molecular Diagnostic Market, by Technology, Through 2026
Table 18 : Rest of the World Molecular Diagnostic Market, by Application, Through 2026
Table 19 : Class I and Class II Exempt Devices
Table 20 : Minimum Information About a Microarray Experiment: MIAME 2.0
Table 21 : Microarray Quality Control Project
Table 22 : U.S. Laboratories CLIA-Certified for Molecular Diagnostics and Number of Disease Tests
Table 23 : U.S. Genetic Testing Procedures, by Type, 2015
Table 24 : FDA-Approved In Vitro Companion Diagnostic Devices, June 1, 2017
Table 25 : Nucleic Acid-Based Tests Cleared or Approved by the Center for Devices and Radiological Health, June 1, 2017
Table 26 : Nucleic Acid-Based Tests Cleared or Approved by the Center for Devices and Radiological Health, June 1, 2017
Table 27 : Selected Molecular Diagnostics, 2020-2021
Table 28 : Global Molecular Diagnostic Market Shares, by Manufacturer, 2020
Table 29 : Abbott: Financials, 2016-2020
Table 30 : Abbott: Product Portfolio, by Business Segment
Table 31 : Abbott: Point of Care Diagnostic Products
Table 32 : Abbott: Recent Developments, October 2017-September 2021
Table 33 : Agilent Technologies Inc.: Product Portfolio
Table 34 : Almac Group: Product Portfolio
Table 35 : Becton, Dickinson and Company: Product Portfolio
Table 36 : bioMérieux S.A.: Product Portfolio
Table 37 : BioRad Laboratories: Product Portfolio
Table 38 : Cardinal Health Inc.: Product Portfolio
Table 39 : Danaher Corp.: Product Portfolio
Table 40 : ELITech Group: Product Portfolio
Table 41 : General Electric: Financial Performance, 2019 and 2020
Table 42 : General Electric Healthcare: Molecular Diagnostics Products
Table 43 : Hologic Inc.: Product Portfolio
Table 44 : Illumina Inc.: Product Portfolio
Table 45 : Myriad Genetics: Product Portfolio
Table 46 : Novartis Molecular Diagnostics: Product Portfolio
Table 47 : Philips Healthcare: Product Portfolio
Table 48 : Qiagen N.V.: Product Portfolio
Table 49 : Quest Diagnostics: Product Portfolio
Table 50 : F. Hoffmann-La Roche Ltd.: Financials, 2019
Table 51 : F. Hoffmann-La Roche Ltd.: Revenue, by Diagnostic Segment, 2016-2018
Table 52 : F. Hoffmann-La Roche Ltd.: Product Portfolio
Table 53 : F. Hoffmann-La Roche Ltd.: Recent Developments, June 2017-April 2020
Table 54 : Siemens Healthcare GmbH: Product Segments
Table 55 : Siemens Healthcare GmbH: Molecular Diagnostics Products
Table 56 : Siemens Healthcare GmbH: Financials, 2019
Table 57 : Siemens Healthcare GmbH: Key Developments
Table 58 : Thermo Fisher Scientific: Product Portfolio
Table 59 : Thermo Fisher Scientific: Key Developments, 2021

Report Title: Molecular Diagnostics: Technologies and Global Markets


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