+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)

Molecular Diagnostics: Technologies and Global Markets

  • ID: 4404586
  • Report
  • April 2022
  • Region: Global
  • 204 Pages
  • BCC Research
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. The publisher 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
Frequently Asked Questions about the Global Molecular Diagnostics Market

What is the estimated value of the Global Molecular Diagnostics Market?

The Global Molecular Diagnostics Market was estimated to be valued at $17.6 Billion in 2021.

What is the growth rate of the Global Molecular Diagnostics Market?

The growth rate of the Global Molecular Diagnostics Market is 19.3%, with an estimated value of $42.6 Billion by 2026.

What is the forecasted size of the Global Molecular Diagnostics Market?

The Global Molecular Diagnostics Market is estimated to be worth $42.6 Billion by 2026.

Who are the key companies in the Global Molecular Diagnostics Market?

Key companies in the Global Molecular Diagnostics Market include Abbott, Agilent Technologies Inc., Almac Group, Becton, Dickinson and Co., Bio, Rad Laboratories Inc., Biomerieux Sa, Cardinal Health and Elitech Group.

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
  • Custom Research
  • Related 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
List of Figures
Summary Figure A: Global Molecular Diagnostic Market, by Region, 2019-2026
Summary Figure B: Global Molecular Diagnostic Market Shares, by Region, 2020
Figure 1: Incidences of Diagnosed Infectious Disease, by Country, 2019
Figure 2: Distribution of Malaria Cases, by Country, 2018
Figure 3: Global Projections for Deaths from the Top Three Chronic Diseases, 2005-2030
Figure 4: Increased Incidence of Cancer, 2012 and 2030
Figure 5: Global Distribution of Deaths from Chronic Diseases, 2018
Figure 6: Flow of Funding for Disease Research, 2014-2018
Figure 7: Global Funding in Tuberculosis Research and Development, by Institutions, 2019
Figure 8: Rising Trends in Healthcare Spending, by Institution, 2015-2040
Figure 9: Global Molecular Diagnostic Market Shares, by Technology, 2020
Figure 10: Global Molecular Diagnostic Market, by Technology, 2019-2026
Figure 11: Global Microarray Market, 2019-2026
Figure 12: Global PCR Market, 2019-2026
Figure 13: Global ISH Market, 2019-2026
Figure 14: Global Others Market, 2019-2026
Figure 15: Global Molecular Diagnostic Market Shares, by Application, 2020
Figure 16: Global Molecular Diagnostic Market, by Application, 2019-2026
Figure 17: Global Infectious Disease Market, 2019-2026
Figure 18: Global Oncology Market, 2019-2026
Figure 19: Global Pre- and Post-Natal Screening Market, 2019-2026
Figure 20: Global Identity and Paternity Market, 2019-2026
Figure 21: Global Others Market, 2019-2026
Figure 22: Global Molecular Diagnostic Market Shares, by Region, 2020
Figure 23: North American Molecular Diagnostic Market Shares, by Technology, 2020
Figure 24: North American Molecular Diagnostic Market Shares, by Application, 2020
Figure 25: North American Molecular Diagnostic Market Shares, by Country, 2020
Figure 26: U.S. Molecular Diagnostic Market, 2019-2026
Figure 27: Canadian Molecular Diagnostic Market, 2019-2026
Figure 28: European Molecular Diagnostic Market Shares, by Technology, 2020
Figure 29: European Molecular Diagnostic Market Shares, by Application, 2020
Figure 30: European Molecular Diagnostic Market Shares, by Country, 2020
Figure 31: German Molecular Diagnostic Market, 2019-2026
Figure 32: U.K. Molecular Diagnostic Market, 2019-2026
Figure 33: French Molecular Diagnostic Market, 2019-2026
Figure 34: Italy New Disease Cases, 2020
Figure 35: Italian Molecular Diagnostic Market, 2019-2026
Figure 36: Spain Share of New Cases, 2020
Figure 37: Spanish Molecular Diagnostic Market, 2019-2026
Figure 38: Rest of European Molecular Diagnostic Market, 2019-2026
Figure 39: Asia-Pacific Molecular Diagnostic Market Shares, by Technology, 2020
Figure 40: Asia-Pacific Molecular Diagnostic Market Shares, by Application, 2020
Figure 41: Asia-Pacific Molecular Diagnostic Market Shares, by Country, 2020
Figure 42: China New Cancer Cases, 2020
Figure 43: China New Cancer Cases Share, 2020
Figure 44: Chinese Molecular Diagnostic Market, 2019-2026
Figure 45: Japanese Molecular Diagnostic Market, 2019-2026
Figure 46: Indian Molecular Diagnostic Market, 2019-2026
Figure 47: Rest of Asia-Pacific Molecular Diagnostic Market, 2019-2026
Figure 48: Africa New Cancer Cases, 2020
Figure 49: Rest of the World Molecular Diagnostic Market Shares, by Technology, 2020
Figure 50: Rest of the World Molecular Diagnostic Market Shares, by Application, 2020
Figure 51: U.S. Process for Marketing a Medical Device
Figure 52: Growth in Clinical Laboratory Sites and Disease Testing, 2012-2015
Figure 53: Global Molecular Diagnostic Market Shares, by Manufacturer, 2020
Figure 54: Abbott: Revenue Share, by Region or Country,
Figure 55: Abbott: Revenue Share, by Business Segment
Figure 56: Becton, Dickinson and Company: Annual Revenue, 2018-2020
Figure 57: Becton, Dickinson and Company: Revenue Share, by Region, 2020
Figure 58: Becton, Dickinson and Company: Revenue Share, by Business Segment, 2020
Figure 59: Danaher Corp.: Annual Revenue, 2018-2020
Figure 60: Danaher Corp.: Revenue Share, by Geography, 2020
Figure 61: Danaher Corp.: Revenue Share, by Segment, 2020
Figure 62: General Electric: Revenue Share, by Business Segment, 2020
Figure 63: General Electric Healthcare: Revenue Share, by Region, 2020
Figure 64: F. Hoffmann-La Roche Ltd.: Revenue Share, by Segment, 2019
Figure 65: F. Hoffmann-La Roche Ltd.: Revenue Share, by Region or Country, 2019
Figure 66: Siemens Healthcare GmbH: Revenue Share, by Business Segment, 2019
Figure 67: Siemens Healthcare GmbH: Revenue Share, by Region, 2019
Figure 68: Thermo Fisher Scientific: Annual Revenue, 2019 and 2020
Figure 69: Thermo Fisher Scientific: Revenue Share, by Region, 2020
Figure 70: Thermo Fisher Scientific: Revenue Share, by Segment, 2020

Executive Summary

Medical device companies, both industry giants and startups, are significantly investing in research and development (R&D) to develop innovative diagnosticproducts that can manage a host ofmedical conditions, including obesity, sleep apnea, diabetes,chronicobstructive pulmonary disease (COPD), asthmaand cardiac diseases, aswell as disability rehabilitation and the monitoring of progressive nervous systemdisorders, such as Parkinson’s disease.

The increasing prevalence of diseases requiring round-the-clockmonitoring is an important driverof the market, and it is expected to significantly contribute to the industry’s double-digit growth, especially considering the increase in the global geriatric population. Technological advancements are also promoting the adoption of many diagnostic products.

Companies Mentioned

  • Abbott
  • Agilent Technologies Inc.
  • Almac Group
  • Becton, Dickinson and Co.
  • Bio-Rad Laboratories Inc.
  • Biomerieux Sa
  • Cardinal Health
  • Danaher Corp.
  • Elitech Group
  • General Electric
  • Grifols (Novartis Molecular Diagnostics)
  • Hologic Inc.
  • Illumina Inc.
  • Myriad Genetics
  • Philips Healthcare
  • Qiagen N.V.
  • Quest Diagnostics
  • Roche Holding AG (F. Hoffmann-La Roche Ltd.)
  • Siemens Healthcare
  • Thermo Fisher Scientific Inc.