Molecular Diagnostics Market, by Product Type (Reagents & Kits and Instruments), By Application (Oncology, Genetic Testing, Microbiology, STDs, Blood Screening, Virology, Tissue Typing, Prenatal Diagnosis, and Others), By End User (Hospitals, Diagnostic Laboratories, Academic and Research Labs, and Other) - Global Industry Insights, and Forecast to 2025

  • Published On : Apr 2018 |
  • Pages : 176 Pages |
  • Format :  

Molecular Diagnostics Market - Global Industry Insights

Molecular diagnostics tests are used for detecting disturbance between specific sequences in DNA or RNA, which may be associated with disease. The disturbance between a single nucleotide polymorphism (SNP), deletions, rearrangements, insertions, and others factors lead to various diseases. Disease that are diagnosed by using molecular diagnostic test includes infectious diseases, oncology, virology, and STDs.

Increasing incidence and prevalence of infectious disease and cancer is expected to be a major factor for growth of the market over the forecast period. For instance, according to the Centers for Disease Control and Prevention (CDC), in 2015, around 5,251 deaths were reported due to influenza infection in the U.S. Furthermore, according to a National Cancer Institute, 2016, an estimated 16.8 million new cases of cancer were diagnosed in the U.S. with an estimated 595,690 deaths from the disease. The number of people with cancer is expected to rise to 19 million by 2024.

Molecular diagnostics also helps in providing precision medicine, due to capability of detecting specific disease. Therefore, various governments are focusing on initiatives in precision medicine, which is expected to foster growth of the molecular diagnostics market in the near future. For instance, in 2015, the U.S. government launched Precision Medicine Initiative (PMI), to increase awareness regarding advancement in the precision medicine field. 

The molecular diagnostics market is estimated to be valued at US$8,623.2 Mn in 2017 and is expected to witness a robust CAGR of 11.5% during the forecast period (2017-2025).

Molecular Diagnostics Market Share, By Product Type (%)

molecular diagnostics market

Source: Coherent Market Insights (2018)

Growth in biomarker identification is expected to foster growth of the molecular diagnostics market

Application of biomarkers in molecular diagnostic is increasing, due to advantages of biomarkers such as aiding in early detection of specific diseases. For instance, biomarkers are used in detection of ABO haemolytic diseases in new born, Huntington's disease and hereditary haemochromatosis, and cystic fibrosis. Biomarkers are also used in detection of disorders related to chromosome structure such as Turner syndrome, Down syndrome, patau syndrome, and Edwards’s syndrome. Furthermore, biomarker also have wide application in therapeutic areas, which includes neurological diseases, metabolic disorders, immune deregulation, and oncology.

Increasing research and development for identification of biomarkers have led to development of new molecular diagnostic tests, which is expected to foster growth of the molecular diagnostics market. For instance, in February 2018, FDA granted marketing authorization to Banyan Biomarkes, Inc. for the first diagnostic blood test, for traumatic brain injury, Banyan BTI. Such innovations for various disease indication is expected to drive growth of the molecular diagnostics market in the near future.

Regional insights

North America accounts for the largest share in the global molecular diagnostics market and this is attributed to increasing adoption of precision medicine and growing prevalence of cancer. According to a National Cancer Institute, 2016, an estimated 16.8 million new cases of cancer were diagnosed in the U.S., with around 595,690 deaths from the disease. The number of people with cancer is expected to rise to 19 million by 2024, in turn increasing the demand of the molecular diagnostics market in the near future.

Furthermore, the U.S. government, in 2015, launched Precision Medicine Initiative that aimed to revolutionize the treatment to improve health, as precision medicine provides an innovative approach that takes into account an individual’s differences in genes and offers tailored treatment. Precision Medicine Initiative have led to development of novel products and several new treatments are tailored for specific characteristic such as, person’s genetic makeup or genetic profile of an individual tumor that helps to transform the way of treatment. The Precision Medicine Initiative was valued at US$ 215 million in 2016 that could accelerate biomedical research and provide clinicians with new tools to select the innovative therapies tailored according to individual needs that, in turn favors, growth of the market of molecular diagnostic.

Key players in the market are involved in new product launches to cater to increasing demand for molecular diagnostic. For instance, in August 2016 Abbott Laboratories introduced Alinity, a next generation system, used for immunoassay, clinical chemistry, point-of-care, hematology, blood and plasma screening, and molecular diagnostics. Some of the other key players in the global molecular diagnostics market include Hologic,Inc., Grifols, S.A., Abbott Laboratories, Qiagen N.V., F. Hoffmann-La Roche Ltd., Siemens Healthineers, Becton, Dickinson and Company, and Beckman Coulter, Inc.

Molecular diagnostics is used for detection in various applications such as oncology, genetic testing, microbiology, STDs, blood screening, virology, tissue typing, and prenatal diagnostics. Molecular diagnostics are laboratory tests, conducted to identify a disease by analyzing DNA, RNA or proteins in humans. Furthermore, the reagent and kits for molecular diagnostics kits vary according to the application, as the kits consists of probes that are directed against specific sequence of viruses, bacteria, and parasites. Increasing use of biomarker specific testing kits is expected to foster growth of the molecular diagnostics market, as these tests are useful prior to initiation of any therapy or treatment.

Market Dynamics

The global molecular diagnostics market is projected to witness significant growth over the forecast period, owing to rapid advancements in technology for development of novel biomarkers. For instance, in June 2017, Qiagen N.V. expanded its biomarker content portfolio by adding new biomarkers for microsatellite instability (MSI) and Mismatch repair (MMR) in its NGS panels. This extension in the product portfolio was done to cater to growing demand for molecular diagnostics for immuno-oncology therapies.

Furthermore, precision medicine aids in treatment of diseases and prevention based on individual’s genes, lifestyle, and environment. This helps to offer proper treatment, which has led to high demand for precision medicine, in turn, favoring growth of the market.

However, stringent regulation by FDA to regulate molecular diagnostic tests is expected to be major factor restraining growth of the market. The FDA regulates molecular diagnostic tests in various ways, including in some instances, wherein, certain tests require regulatory pathways as complex as Class III medical devices.

Key features of the study:

  • This report provides in-depth analysis of the molecular diagnostics market size (US$ Million) and Cumulative Annual Growth Rate (CAGR (%)) for the forecast period: 2017 – 2025, considering 2016 as the base year
  • It elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrix for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategy adopted by the leading players
  • It profiles leading players in the global molecular diagnostics market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments, and strategies
  • Key companies covered as a part of this study include Abbott Laboratories, Hologic,Inc., Grifols, S.A., Qiagen N.V., F. Hoffmann-La Roche Ltd., Siemens Healthineers, Becton, Dickinson and Company, and Beckman Coulter, Inc.
  • Insights from this report would allow marketers and management authorities of companies to make informed decision with respect to their future product launch, governmental initiatives, technological up-gradation, market expansion, and marketing tactics.
  • The global molecular diagnostics market report caters to various stakeholders in this industry, including investors, product manufacturers, distributors and suppliers for molecular diagnostics market, research and consulting firms, new entrants, and financial analysts.

Detailed Segmentation:

  • Global Molecular Diagnostics Market, By Product Type:
    • Reagents & Kits (Consumables)
    • Instruments
  • Global Molecular Diagnostics Market, By Application
    • Oncology
    • Genetic Testing
    • Microbiology
    • STDs
    • Blood Screening
    • Virology
    • Tissue Typing
    • Prenatal Diagnosis
    • Others
  • Global Molecular Diagnostics Market, By End User:
    • Hospitals
    • Diagnostic Laboratories
    • Academic and Research Labs
    • Others
  • Global Molecular Diagnostics Market, By Region:
    • North America
      • North America Molecular Diagnostics Market, By Product Type
        • Reagents & Kits (Consumables)
        • Instruments
      • North America Molecular Diagnostics Market, By Application
        • Oncology
        • Genetic Testing
        • Microbiology
        • STDs
        • Blood Screening
        • Virology
        • Tissue Typing
        • Prenatal Diagnosis
        • Others
      • North America Molecular Diagnostics Market, By End User
        • Hospitals
        • Diagnostic Laboratories
        • Academic and Research Labs
        • Other
      • North America Molecular Diagnostics Market, By Country
        • U.S.
        • Canada
    • Europe
      • Europe Molecular Diagnostics Market, By Product Type
        • Reagents & Kits (Consumables)
        • Instruments
      • Europe Molecular Diagnostics Market, By Application
        • Oncology
        • Genetic Testing
        • Microbiology
        • STDs
        • Blood Screening
        • Virology
        • Tissue Typing
        • Prenatal Diagnosis
        • Others
      • Europe Molecular Diagnostics Market, By End User
        • Hospitals
        • Diagnostic Laboratories
        • Academic and Research Labs
        • Other
      • Europe Molecular Diagnostics Market, By Country
        • U.K.
        • Germany
        • Italy
        • France
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • Asia Pacific Molecular Diagnostics Market, By Product Type
        • Reagents & Kits (Consumables)
        • Instruments
      • Asia Pacific Molecular Diagnostics Market, By Application
        • Oncology
        • Genetic Testing
        • Microbiology
        • STDs
        • Blood Screening
        • Virology
        • Tissue Typing
        • Prenatal Diagnosis
        • Others
      • Asia Pacific Molecular Diagnostics Market, By End User
        • Hospitals
        • Diagnostic Laboratories
        • Academic and Research Labs
        • Other
      • Asia Pacific Molecular Diagnostics Market, By Country
        • China
        • India
        • Japan
        • ASEAN
        • Australia
        • South Korea
        • Rest of Asia Pacific
    • Latin America
      • Latin America Molecular Diagnostics Market, By Product Type
        • Reagents & Kits (Consumables)
        • Instruments
      • Latin America Molecular Diagnostics Market, By Application
        • Oncology
        • Genetic Testing
        • Microbiology
        • STDs
        • Blood Screening
        • Virology
        • Tissue Typing
        • Prenatal Diagnosis
        • Others
      • Latin America Molecular Diagnostics Market, By End User
        • Hospitals
        • Diagnostic Laboratories
        • Academic and Research Labs
        • Other
      • Latin America Molecular Diagnostics Market, By Country
        • Brazil
        • Mexico
        • Rest of Latin America
    • Middle East
      • Middle East Molecular Diagnostics Market, By Product Type
        • Reagents & Kits (Consumables)
        • Instruments
      • Middle East Molecular Diagnostics Market, By Application
        • Oncology
        • Genetic Testing
        • Microbiology
        • STDs
        • Blood Screening
        • Virology
        • Tissue Typing
        • Prenatal Diagnosis
        • Others
      • Middle East Molecular Diagnostics Market, By End User
        • Hospitals
        • Diagnostic Laboratories
        • Academic and Research Labs
        • Other
      • Middle East Molecular Diagnostics Market, By Country
        • GCC
        • Israel
        • Rest of Middle East
    •  Africa
      • Africa Molecular Diagnostics Market, By Product Type
        • Reagents & Kits (Consumables)
        • Instruments
      • Africa Molecular Diagnostics Market, By Application
        • Oncology
        • Genetic Testing
        • Microbiology
        • STDs
        • Blood Screening
        • Virology
        • Tissue Typing
        • Prenatal Diagnosis
        • Others
      • Africa Molecular Diagnostics Market, By End User
        • Hospitals
        • Diagnostic Laboratories
        • Academic and Research Labs
        • Other
      • Africa Molecular Diagnostics Market, By Country
        • North Africa
        • Central Africa
        • South Africa
  • Company Profiles
    • Abbott Laboratories *
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Recent Highlights
      • Strategies
    • Hologic, Inc.
    • Grifols, S.A.
    • Qiagen N.V.
    • F. Hoffmann-La Roche Ltd.
    • Siemens Healthineers
    • Becton, Dickinson and Company
    • Beckman Coulter, Inc.

“*” marked represents similar segmentation in other categories in the respective section.

Table of Contents

  1. Research Objective and assumption
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Purview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet Product Type
      • Market Snippet By Application
      • Market Snippet By End-User
      • Market Snippet By Region
    • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Epidemiology
    • Key Developments
    • Reimbursement
    • PEST Analysis
  4. Global Molecular Diagnostics Market, Product Type, 2015 - 2025 (USD Million)
    • Introduction
      • Market Share Analysis, 2017 and 2025 (%)
      • Y-O-Y Growth Analysis, 2016 - 2025
      • Segment Trends
    • Reagents & Kits
      • Introduction
      • Market Size and Forecast, and Y-O-Y Growth, 2015 - 2025, (USD Million)
    • Instruments
      • Introduction
      • Market Size and Forecast, and Y-O-Y Growth, 2015 - 2025, (USD Million)
  5. Global Molecular Diagnostics Market, By Application, 2015 - 2025 (USD Million)
    • Introduction
      • Market Share Analysis, 2017 and 2025 (%)
      • Y-O-Y Growth Analysis, 2016 - 2025
      • Segment Trends
    • Oncology
      • Introduction
      • Market Share Analysis, 2017 and 2025 (%)
      • Y-O-Y Growth Analysis, 2016 - 2025
    • Genetic Testing
      • Introduction
      • Market Size and Forecast, and Y-O-Y Growth, 2015 - 2025, (USD Million)
    • STDs
      • Introduction
      • Market Size and Forecast, and Y-O-Y Growth, 2015 - 2025, (USD Million)
    • Microbiology
      • Introduction
      • Market Size and Forecast, and Y-O-Y Growth, 2015 - 2025, (USD Million)
    • Blood Screening
      • Introduction
      • Market Size and Forecast, and Y-O-Y Growth, 2015 - 2025, (USD Million)
    • Virology
      • Introduction
      • Market Size and Forecast, and Y-O-Y Growth, 2015 - 2025, (USD Million)
    • Tissue Typing
      • Introduction
      • Market Size and Forecast, and Y-O-Y Growth, 2015 - 2025, (USD Million)
    • Prenatal Diagnosis
      • Introduction
      • Market Size and Forecast, and Y-O-Y Growth, 2015 - 2025, (USD Million)
    • Others
      • Introduction
      • Market Size and Forecast, and Y-O-Y Growth, 2015 - 2025, (USD Million)
  6. Global Molecular Diagnostics Market, By End-User, 2015 - 2025 (USD Million)
    • Introduction
      • Market Share Analysis, 2017 and 2025 (%)
      • Y-O-Y Growth Analysis, 2016 - 2025
      • Segment Trends
    • Hospitals
      • Introduction
      • Market Size and Forecast, and Y-O-Y Growth, 2015 - 2025, (USD Million)
    • Diagnostic Laboratories
      • Introduction
      • Market Size and Forecast, and Y-O-Y Growth, 2015 - 2025, (USD Million)
    • Academic and Research Labs
      • Introduction
      • Market Size and Forecast, and Y-O-Y Growth, 2015 - 2025, (USD Million)
    • Others
      • Introduction
      • Market Size and Forecast, and Y-O-Y Growth, 2015 - 2025, (USD Million)
  7. Global Molecular Diagnostics Market, By Regions, 2015 - 2025 (USD Million)
    • Introduction
      • Market Share Analysis, By Product Type, 2017 and 2025 (%)
      • Market Share Analysis, By Application, 2017 and 2025 (%)
      • Market Share Analysis, By End User, 2017 and 2025 (%)
      • Market Share Analysis, By Region, 2017 and 2025 (%)
      • Y-O-Y Growth Analysis, For Regions, 2015 - 2025
    • North America
      • Market Size and Forecast, By Product Type, 2017 and 2025 (%)
      • Market Size and Forecast, By Application, 2017 and 2025 (%)
      • Market Size and Forecast, By End User, 2017 and 2025 (%)
      • Market Size and Forecast, By Country, 2017 and 2025 (%)
        • U.S.
        • Canada
    • Europe
      • Market Size and Forecast, By Product Type, 2017 and 2025 (%)
      • Market Size and Forecast, By Application, 2017 and 2025 (%)
      • Market Size and Forecast, By End User, 2017 and 2025 (%)
      • Market Size and Forecast, By Country, 2017 and 2025 (%)
        • U.K.
        • Germany
        • Italy
        • France
        • Russia
        • Others
    • Asia Pacific
      • Market Size and Forecast, By Product Type, 2017 and 2025 (%)
      • Market Size and Forecast, By Application, 2017 and 2025 (%)
      • Market Size and Forecast, By End User, 2017 and 2025 (%)
      • Market Size and Forecast, By Country, 2017 and 2025 (%)
        • China
        • India
        • Japan
        • ASEAN
        • Australia
        • South Korea
        • Others
    • Latin America
      • Market Size and Forecast, By Product Type, 2017 and 2025 (%)
      • Market Size and Forecast, By Application, 2017 and 2025 (%)
      • Market Size and Forecast, By End User, 2017 and 2025 (%)
      • Market Size and Forecast, By Country, 2017 and 2025 (%)
        • Brazil
        • Argentina
        • Mexico
        • Others
    • Middle East
      • Market Size and Forecast, By Product Type, 2017 and 2025 (%)
      • Market Size and Forecast, By Application, 2017 and 2025 (%)
      • Market Size and Forecast, By End User, 2017 and 2025 (%)
      • Market Size and Forecast, By Country, 2017 and 2025 (%)
        • GCC Countries
        • Israel
        • Rest of Middle East
    • Africa
      • Market Size and Forecast, By Product Type, 2017 and 2025 (%)
      • Market Size and Forecast, By Application, 2017 and 2025 (%)
      • Market Size and Forecast, By End User, 2017 and 2025 (%)
      • Market Size and Forecast, By Country, 2017 and 2025 (%)
        • North Africa
        • Central Africa
        • South Africa
  8. Competitive Landscape
    • Heat Map Analysis
    • Company Profiles
      • Abbott Laboratories
        • Company Overview
        • Product Description
        • Financial Performance
        • Recent Developments
        • Strategies
      • Hologic, Inc.
        • Company Overview
        • Product Description
        • Financial Performance
        • Recent Developments
        • Strategies
      • Grifols, S.A.
        • Company Overview
        • Product Description
        • Financial Performance
        • Recent Developments
        • Strategies
      • Qiagen, N.V.
        • Company Overview
        • Product Description
        • Financial Performance
        • Recent Developments
        • Strategies
      • F. Hoffmann-La Roche Ltd.
        • Company Overview
        • Product Description
        • Financial Performance
        • Recent Developments
        • Strategies
      • Siemens Healthineers
        • Company Overview
        • Product Description
        • Financial Performance
        • Recent Developments
        • Strategies
      • Becton, Dickinson and Company
        • Company Overview
        • Product Description
        • Financial Performance
        • Recent Developments
        • Strategies
      • Beckman Coulter, Inc.
        • Company Overview
        • Product Description
        • Financial Performance
        • Recent Developments
        • Strategies
    • Analyst Views
  9. Section
    • References
    • Research Methodology
    • About us and Sales Contact

*Browse 37 market data tables and 35 figures on “Molecular Diagnostics Market” - Global forecast to 2025”

Research Methodology

Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.


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Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.

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Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization:

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users

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