Overview


According to FutureWise analysis the market for Molecular Diagnostics in 2023 is US$ 15.6 billion, and is expected to reach US$ 37.59 billion by 2031 at a CAGR of 11.62%.

Molecular diagnostics is a field of medical testing that focuses on the identification and analysis of molecules at the molecular level, including nucleic acids and proteins. It involves using advanced laboratory techniques to identify and measure specific biomarkers that are indicative of disease or other health conditions. Molecular diagnostics can be used for a variety of purposes, including the detection of infectious diseases, genetic disorders, and cancers. By analyzing the specific molecular characteristics of a patient's sample, molecular diagnostics can provide a more accurate and precise diagnosis compared to traditional methods.

There are several different types of molecular diagnostic tests available, including next-generation sequencing (NGS), PCR, and fluorescent in situ hybridization (FISH). Each of these techniques uses different methods to identify and measure specific molecules, depending on the type of analysis required. Molecular diagnostics is becoming increasingly important in the field of individualized medicine, which aims to tailor medical treatment to an individual's specific genetic makeup and other molecular characteristics. By analyzing a patient's molecular profile, doctors can identify the most effective treatment options and avoid treatments that may not be effective or may cause harmful side effects.

FutureWise Market Research has published a report that provides an insightful analysis of Molecular Diagnostics Market trends that are affecting the overall market growth. This report will provide a detailed analysis of market share, regional insights, and competitor analysis that includes stature of key manufacturers operational in this industry. By the end of the forecast period FutureWise research analysts projects that Molecular Diagnostics Market will experience a significant growth.

According to the analysis done, this report will help understand the information referring to the total valuation held by this industry. Additionally, this report will help in understanding the growth opportunities held by various segments of this market, further assist in making better strategic and expansion decisions by key stakeholders of an organization.

  • F. Hoffmann-La Roche Ltd.
  • Hologic, Inc. 
  • BioMérieux SA 
  • Abbott Laboratories 
  • Qiagen
  • Thermo Fisher Scientific Inc. 
  • Siemens Healthineers AG 
  • Danaher Corporation 
  • Myriad Genetics Inc. 
  • Illumina Inc. 
  • Agilent Technologies Inc. 
  •  Becton, Dickinson and Company 
  • DiaSorin S.p.A 
  • Grifols S.A. 
  • Quidel Corporation
  • Genetic Signatures 
  • MDxHealth, Inc. 
  • Exact Sciences Corporation 
  • Biocartis NV 
  • TBG Diagnostics Ltd. 

(Note: The list of the major players will be updated with the latest market scenario and trends)

Recent developments by key players in Molecular Diagnostics Market:

In October 2022, a CE-IVD marked panel called the TaqPath Enteric Bacterial Select Panel was introduced by Thermo Fisher Scientific to quickly identify common gastrointestinal bacteria.

The molecular diagnostics industry is expanding at a fast pace, driven by advancements in genomics and proteomics, as well as increasing demand for personalized medicine. One of the major driving forces of the molecular diagnostics market is the increasing prevalence of infectious diseases and genetic disorders. With the rise of global travel and urbanization, the spread of infectious diseases has become more common, making accurate and timely diagnosis critical for effective treatment. In addition, advances in genetic testing have made it possible to detect genetic mutations associated with inherited disorders, allowing for early intervention and personalized treatment. Another factor propelling the growth of the molecular diagnostics market is the increasing availability of affordable and portable testing devices. These tools are designed to offer accurate and rapid diagnosis in a variety of settings, including hospitals, clinics, and even at home. This has increased the demand for point-of-care testing, which allows for faster and more efficient diagnosis and can reduce healthcare costs.

However, there are also some challenges facing the molecular diagnostics market. One major challenge is the lack of reimbursement for molecular diagnostic tests in many countries. This can limit the adoption of molecular diagnostics, especially in low- and middle-income countries. Another challenge is the high cost of molecular diagnostic tests, which can make them inaccessible to many patients. This is particularly true for NGS tests, which can be very expensive.

By Product

  • Reagents & kits
  • Instruments
    •   Tabletop Instruments
    •   Portable & PoC Instruments
  • Services & Software

By Technology

  • Polymerase Chain Reaction (PCR)
  • Isothermal Nucleic Acid Amplification Technology (INAAT)
  • DNA Sequencing & Next-Generation Sequencing (NGS)
  •  In Situ Hybridization (ISH)
  • DNA Microarrays
  • Other technologies

By Application

  • Infectious Disease Diagnostics
    •  COVID-19
    •  Hepatitis
    •   HIV
    •   CT/NG
    •   HAI
    •   HPV
    •   Tuberculosis
    •  Influenza
    •   Other Infectious Diseases
  • Oncology Testing
    •   Breast Cancer
    •   Colorectal Cancer
    •   Lung Cancer
    •   Prostate Cancer
    •   Other Cancers
  • Genetic Tests
  • Other Applications

By End User

  • Diagnostic Laboratories
  • Hospitals and Clinics
  • Other End Users

By Region

  • North America
  • Europe
  •  Asia-Pacific
  • Latin America
  • Middle East and Africa

This market research report also emphasis on factors affecting the growth rate in various regions listed above. A deep-down analysis of region will also be provided in the final version of this market which is based on conclusion of primary interviews and secondary data point gathered during the process.

By region, the market is segmented into North America, Latin America, Europe, Asia-Pacific, and Middle East & Africa. North America registered the highest share in the market in 2022. Large bacterial and viral epidemic outbreaks, the rising need for point-of-care diagnostics, quickly advancing technology, and the consistent presence of leading market players in the region are some of the factors boosting the market growth in this region. The field of molecular diagnostics has significantly changed how diseases are diagnosed, allowing for quick identification and precise treatment of individuals who are severely ill. Traditional diagnostic techniques are being replaced by molecular diagnostics as a result of rising per capita health expenditures, improvements in the healthcare system, and an increase in the incidence of infectious illnesses and cancer in the United States. For instance, the ACS "Cancer Facts & Figures 2022" estimates that there were around 1,918,030 new cancer cases in the United States in 2022. Because of the high prevalence of cancer in this region, molecular diagnostics are expected to become more widely used to diagnose cancer, leading to market growth


  • Tier 1 players- established companies in the market with a major market share
  • Tier 2 players
  • Emerging players which are growing rapidly
  • New Entrants

  • Growth prospects
  • SWOT analysis
  • Key trends
  • Key data-points affecting market growth

  • To provide with an exhaustive analysis on the Molecular Diagnostics Market By Product, By Technology, By Application, By End User and By Region.
  •  [To cater comprehensive information on factors impacting market growth (drivers, restraints, opportunities, and industry-specific restraints)
  • To evaluate and forecast micro-markets and the overall market
  • To predict the market size, in key regions— North America, Europe, Asia Pacific, Latin America and Middle East and Africa.
  •  To record and evaluate competitive landscape mapping- Product launches, technological advancements, mergers and expansions

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Table of Contents


  • 1.   Market Introduction
    •   1. Objectives of the Study
        2. Market Definition
        3. Market Scope
         3.1 . Years Considered for the Study
         3.2 . Market Covered
        4. Currency
        5. Limitations
        6. Stakeholders
  • 2.   Research Methodology
    •   1. Research Data
         1.1 . Secondary Data
          1.1.1 . Key Data from Secondary Sources
         1.2 . Primary Data
          1.2.1. Key Data from Primary Sources
        2. Market Size Estimation
        3. Market Breakdown and Data Triangulation
        4. Assumptions for the Study
  • 3.   Executive Summary
    •   1. Market Outlook
        2. Segment Outlook
        3. Competitive Insights
  • 4.   Molecular Diagnostics Market Variables, Trends and Scope

    •        1. Market Lineage Outlook
        2. Penetration and Growth Prospect Mapping
        3. Industry Value Chain Analysis
        4. Cost Analysis Breakdown
        5. Technology Overview
        6. Regulatory Framework
         6.1. Reimbursement Framework
         6.2. Standards and Compliances

  • 5.   Market Overview
    •   1. Market Dynamics
         1.1. Market Driver Analysis
          1.1.1. Increasing focus of Molecular Diagnostics Market Companies on Brand Protection
          1.1.2. Untapped Opportunities in Emerging Regions
         1.2. Market Restraint Analysis
          1.2.1. High Cost Associated with Implementation of Predictive Analysis
         1.3. Industry Challenges
          1.3.1. Presence of Ambiguous Regulatory Framework
  • 6.   Molecular Diagnostics Market Analysis Tools
    •   1. Industry Analysis - Porter’s
         1.1. Supplier Power
         1.2. Buyer Power
         1.3. Substitution Threat
         1.4. Threat from New Entrants
         1.5. Competitive Rivalry
        2. Pestel Analysis
         2.1. Political Landscape
         2.2. Environmental Landscape
         2.3. Social Landscape
         2.4. Technology Landscape
         2.5. Legal Landscape
        3. Major Deals And Strategic Alliances Analysis
         3.1. Joint Ventures
         3.2. Mergers and Acquisitions
         3.3. Licensing and Partnership
         3.4. Technology Collaborations
         3.5. Strategic Divestments
        4. Market Entry Strategies
        5. Case Studies
  • 7.   Molecular Diagnostics Market, By Product Historical Analysis and Forecast 2023-2031 (USD Million)

    •   1. Reagents and kits
        2. Instruments
         2.1. Tabletop Instruments
         2.2. Portable nand PoC Instruments
        3. Services and Software

  • 8.   Molecular Diagnostics Market, By Technology Historical Analysis and Forecast 2023-2031 (USD Million)

    •   1. Polymerase Chain Reaction (PCR)
        2. Isothermal Nucleic Acid Amplification Technology (INAAT)
        3. DNA Sequencing and Next-Generation Sequencing (NGS)
        4. In Situ Hybridization (ISH)
        5. DNA Microarrays
        6. Other technologies

  • 9.   Molecular Diagnostics Market, By Application Historical Analysis and Forecast 2023-2031 (USD Million)

    •   1. Infectious Disease Diagnostics
         1.1. COVID-19
         1.2. Hepatitis
         1.3. HIV
         1.4. CT/NG
         1.5. HAI
         1.6. HPV
         1.7. Tuberculosis
         1.8. Influenza
         1.9. Other Infectious Diseases
        2. Oncology Testing
         2.1. Breast Cancer
         2.2. Colorectal Cancer
         2.3. Lung Cancer
         2.4. Prostate Cancer
         2.5. Other Cancers
        3. Genetic Tests
        4. Other Applications

  • 10.   Molecular Diagnostics Market, By End User Historical Analysis and Forecast 2023-2031 (USD Million)

    •   1. Diagnostic Laboratories
        2. Hospitals and Clinics
        3. Other End Users

  • 11.   North America Molecular Diagnostics Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. U.S.A
         2.2. Canada
         2.3. Mexico
        3. Market Size (USD Million) Forecast for North America 2023-2031

  • 12.   Latin America Molecular Diagnostics Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Brazil
         2.2. Venezuela
         2.3. Argentina
         2.4. Rest of Latin America
        3. Market Size (USD Million) Forecast for Latin America 2023-2031

  • 13.   Europe Molecular Diagnostics Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Germany
         2.2. U.K
         2.3. France
         2.4. Italy
         2.5. Spain
         2.6. Russia
         2.7. Poland
         2.8. Rest of Europe
        3. Market Size (USD Million) Forecast for Europe 2023-2031

  • 14.   Asia Pacific Molecular Diagnostics Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Japan
         2.2. China
         2.3. India
         2.4. Australia and New Zealand
         2.5. ASEAN
         2.6. Rest of Asia Pacific
        3. Market Size (USD Million) Forecast for Asia Pacific 2023-2031

  • 15.   Middle East and Africa Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. GCC
         2.2. Israel
         2.3. South Africa
         2.4. Rest of MEA
        3. Market Size (USD Million) Forecast for MEA 2023-2031

  • 16.   Market Share Analysis and Competitive Landscape
    •   1. Global Landscape - Key Players, Revenue and Presence
        2. Global Share Analysis - Key Players (Tier 1, Tier 2, Tier 3)
        3. Global Emerging Companies
        4. North America - Market Share Analysis and Key Regional Players
        5. Europe - Market Share Analysis and Key Regional Players
        6. Asia Pacific - Market Share Analysis and Key Regional Players
        7. Global Key Player - Growth Matrix
  • 17.   Company Profiles (Competition Dashboard, Competitors Deep Dive, Products Offered and Financial Layouts)

    •   1. F. Hoffmann-La Roche Ltd.
         1.1. Company Overview
         1.2. Product Portfolio
         1.3. SWOT Analysis
         1.4. Financial Overview
         1.5. Strategic Overview
        2. Hologic, Inc.
         2.1. Company Overview
         2.2. Product Portfolio
         2.3. SWOT Analysis
         2.4. Financial Overview
         2.5. Strategic Overview
        3. BioMérieux SA
         3.1. Company Overview
         3.2. Product Portfolio
         3.3. SWOT Analysis
         3.4. Financial Overview
         3.5. Strategic Overview
        4. Abbott Laboratories
         4.1. Company Overview
         4.2. Product Portfolio
         4.3. SWOT Analysis
         4.4. Financial Overview
         4.5. Strategic Overview
        5. Qiagen
         5.1. Company Overview
         5.2. Product Portfolio
         5.3. SWOT Analysis
         5.4. Financial Overview
         5.5. Strategic Overview
        6. Thermo Fisher Scientific Inc.
         6.1. Company Overview
         6.2. Product Portfolio
         6.3. SWOT Analysis
         6.4. Financial Overview
         6.5. Strategic Overview
        7. Siemens Healthineers AG
         7.1. Company Overview
         7.2. Product Portfolio
         7.3. SWOT Analysis
         7.4. Financial Overview
         7.5. Strategic Overview
        8. Danaher Corporation
         8.1. Company Overview
         8.2. Product Portfolio
         8.3. SWOT Analysis
         8.4. Financial Overview
         8.5. Strategic Overview
        9. Myriad Genetics Inc.
         9.1. Company Overview
         9.2. Product Portfolio
         9.3. SWOT Analysis
         9.4. Financial Overview
         9.5. Strategic Overview
        10. Illumina Inc.
         10.1.Company Overview
         10.2.Product Portfolio
         10.3.SWOT Analysis
         10.4.Financial Overview
         10.5.Strategic Overview
        11. Agilent Technologies Inc.
         11.1.Company Overview
         11.2.Product Portfolio
         11.3.SWOT Analysis
         11.4.Financial Overview
         11.5.Strategic Overview
        12. Becton, Dickinson and Company
         12.1.Company Overview
         12.2.Product Portfolio
         12.3.SWOT Analysis
         12.4.Financial Overview
         12.5.Strategic Overview
        13. DiaSorin S.p.A
         13.1.Company Overview
         13.2.Product Portfolio
         13.3.SWOT Analysis
         13.4.Financial Overview
         13.5.Strategic Overview
        14. Grifols S.A.
         14.1.Company Overview
         14.2.Product Portfolio
         14.3.SWOT Analysis
         14.4.Financial Overview
         14.5.Strategic Overview
        15. Quidel Corporation
         15.1.Company Overview
         15.2.Product Portfolio
         15.3.SWOT Analysis
         15.4.Financial Overview
         15.5.Strategic Overview
        16. Genetic Signatures
         16.1.Company Overview
         16.2.Product Portfolio
         16.3.SWOT Analysis
         16.4.Financial Overview
         16.5.Strategic Overview
        17. MDxHealth, Inc.
         1.Company Overview
         2.Product Portfolio
         3.SWOT Analysis
         4.Financial Overview
         5.Strategic Overview
        18. Exact Sciences Corporation
         18.1.Company Overview
         18.2.Product Portfolio
         18.3.SWOT Analysis
         18.4.Financial Overview
         18.5.Strategic Overview
        19.Biocartis NV
         19.1.Company Overview
         19.2.Product Portfolio
         19.3.SWOT Analysis
         19.4.Financial Overview
         19.5.Strategic Overview
        20. TBG Diagnostics Ltd.
         20.1.Company Overview
         20.2.Product Portfolio
         20.3.SWOT Analysis
         20.4.Financial Overview
         20.5.Strategic Overview

  • 18.   Pre and Post COVID-19 Impact
    •   1. Positive influence on the healthcare industry
        2. The financial disruption of the manufacturing sector
        3. Impact of COVID-19 on emerging companies
        4. Significant mandates in the healthcare regulations initiated by administrations
        5. The overall economic slowdown of the developing and developed nations
  • 19.   FutureWise SME Key Takeaway Points for Client

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