Molecular Diagnostics Market

Global Molecular Diagnostics Industry Analysis, Size, Share, Growth, Trends, and Forecast 2023-2031 - (By Product Type Coverage, By Application Coverage, By End User Coverage, By Geographic Coverage and By Company)

Published Date: Jul 2024 | Format: | No. of Pages: 153

Industry: Medical Devices


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Global Molecular Diagnostics Market Forecast

  • The approximately US$23.2 Bn molecular diagnostics market 2023 poised to reach US$37.1 Bn by the end of 2031
  • Global molecular diagnostics market size likely to expand at 6.2% CAGR between 2023 and 2031

Molecular Diagnostics Market Snapshot, 2018-2030

Quick Report Digest

  1. Improvements in new technologies to pave the way for the identification of several antibiotic-resistant determinants and accomplish microbial surveillance and epidemiology on a genetic level.
  2. Emergence of nucleic-based methods such as CRISPR-Cas diagnostic platform, and a shift toward personalised medicine.
  3. Molecular diagnostics enable the identification of specific biomarkers or genetic signatures associated with diseases, allowing for early detection, disease monitoring, and the selection of targeted therapies, aligning with the principles of personalised medicine.

A Look Back and a Look Forward - Comparative Analysis

Historically, the molecular diagnostics market has shown rapid growth due to advancements in technology, increasing prevalence of infectious diseases and chronic illnesses, rising demand for personalised medicine, and improvements in healthcare infrastructure globally.

Molecular diagnostics offer precise and quick analysis of genetic content, aiding in disease diagnosis, prognosis, and selection of appropriate therapies. Also, Continuous innovation in technologies like PCR (Polymerase Chain Reaction), next-generation sequencing (NGS), microarrays, and other molecular techniques has expanded the scope and accuracy of molecular diagnostics.

Molecular Diagnostics Market, US$ Bn, 2018-2030

Key Growth Determinants

Growing Prevalence of Infectious Diseases

Timely diagnosis through molecular techniques allows for early initiation of appropriate treatments and preventive measures. This helps in preventing disease transmission, managing outbreaks, and optimising treatment strategies, thereby reducing the disease burden.

The human immunodeficiency virus (HIV) causes AIDS, a chronic communicable disease.

According to WHO in 2021, roughly 38.4 million people worldwide were still living with HIV, and 0.65 million died from HIV-related causes. As the condition progresses, the infection may be asymptomatic or cause flu-like symptoms such as fever, headache, rash, and sore throat, followed by more pronounced symptoms such as swollen lymph nodes, weight loss, fever, diarrhoea, and cough. HIV gradually affects immune cell function, which frequently leads to difficulties from numerous infections and tumors.

Moreover, according to the WHO, in 2022, 1.3 million people died from tuberculosis (including 167 000 HIV patients). Ending the TB epidemic by 2030 is one of the United Nations Sustainable Development Goals (SDGs) for health.

According to Nature Reviews Microbiology Journal, as molecular technologies are nimble, rapid, and versatile, they are an effective answer for infectious disease diagnostics in situations with limited resources and a large range of probable aetiologies. Health-care systems that use molecular diagnostics on a regular basis will gain economies of scale, maximise limited expertise, and respond quickly to new threats.

Major Growth Barriers

Prohibitive Costs of Equipment and Reagents

State-of-the-art molecular diagnostic equipment and reagents can be expensive, making it challenging for labs to invest in the latest technology while remaining financially sustainable. The upfront cost of purchasing molecular diagnostic equipment is often substantial, deterring smaller laboratories or facilities with limited budgets from investing in this technology. Additionally, the cost of setting up infrastructure and specialised facilities adds to the financial burden.

Reagents used in molecular diagnostics, such as PCR kits, DNA probes, and enzymes, can be costly. Regular replenishment of these consumables contributes to ongoing operational expenses, making it financially challenging for laboratories, especially in resource-constrained settings.

Beyond the initial purchase, maintaining and servicing the equipment involves additional expenses. Calibration, repairs, and upgrades further add to the overall cost of ownership.

Key Trends and Opportunities to Look at

Emerging Molecular Diagnostics Market Penetration

Emerging markets, often found in developing economies, have a considerable untapped potential for molecular diagnostics. These regions typically exhibit rapid economic growth, urbanisation, and improving healthcare infrastructure, presenting a ripe environment for the adoption of advanced medical technologies.

According to the Global Fund News, the Truenat® technology, which enables Real-Time PCR testing at the point-of-care in all laboratories, in the field, and in proximity to patients, is brought to healthcare professionals globally by Molbio Diagnostics, an Indian company. This quick, portable technology allows for early and accurate diagnosis and the start of the appropriate therapy at the first point of contact. Its menu of Truenat® assays is extensive and continuously expanding, and it covers over 30 infectious illnesses, including COVID-19, HIV, HCV, HBV, HPV, and influenza.

Also, collaborating with local institutions for technology transfer and capacity building initiatives can contribute to the local workforce's skill development, fostering the adoption and utilisation of molecular diagnostic technologies. For instance, thorough product introductions, partnerships, and facility expansions, Thermo Fisher Scientific mobilised its resources to fuel intriguing potential in cell and gene therapy, companion diagnostics, liquid biopsy, direct-to-consumer, and more.

Molecular Diagnostics Market, DROs

How Does the Regulatory Scenario Shape this Industry?

Medical devices are an important part of health care service delivery, and developments in new technologies can improve their ability to diagnose and treat illness.

The FDA regulates molecular diagnostic tests in a variety of ways, with some requiring complex regulatory processes as Class III medical devices and the majority being approved as 510k devices or lab developed tests (LDTs). Based on the author's vast experience with such tests, this session will address the existing regulatory procedures for genetic and protein biomarker-based diagnostic tests, as well as practical recommendations for navigating regulatory approval.

The FDA classifies medical devices, including IVD products, into Class I, II, or III according to the level of regulatory control that is necessary to reasonably assure safety and effectiveness. The classification of an IVD (or other medical device) determines the appropriate premarket process.

Fairfield’s Ranking Board

Top Segments

Reagents to be at the Forefront as are Essential for Testing Procedures

Reagents are the core components used in various testing procedures within molecular diagnostics. These include DNA and RNA extraction, amplification, labeling, purification, and detection. For instance, in Polymerase Chain Reaction (PCR) tests, reagents such as DNA polymerases, primers, nucleotides, and buffers are essential for DNA amplification.

High-quality reagents are vital for ensuring the precision and accuracy of molecular diagnostic tests. They help minimise false positives or negatives and contribute to the reliability of test results.

Growing Need for Rapid and Accurate Diagnosis Drives Techniques Like PCR, and NAAT

Molecular diagnostics enable rapid and accurate detection of infectious agents such as bacteria, viruses, fungi, and parasites. Techniques like PCR (Polymerase Chain Reaction), and nucleic acid amplification tests (NAATs) allow for the detection of specific genetic material of pathogens, facilitating quicker diagnosis compared to traditional culture-based methods.

Molecular diagnostics help in monitoring antimicrobial resistance by identifying specific genetic markers associated with drug resistance in infectious agents. This assists healthcare providers in prescribing appropriate and effective treatments, thereby combating antibiotic resistance.

Hospitals and Clinics Record the Most Extensive Adoption for Better Patient Care and Management

Hospitals and clinics utilise molecular diagnostics extensively for disease detection, screening, and monitoring. These facilities rely on molecular tests to identify genetic mutations, infectious agents, and biomarkers associated with various diseases like cancer, infectious diseases, genetic disorders, and more.

Molecular diagnostics aid in personalised medicine by providing detailed genetic information about a patient's condition. This allows clinicians to tailor treatment plans according to individual genetic profiles, enhancing the efficacy of therapies and reducing adverse reactions.

Regional Frontrunners

Primacy of North America Prevails on the Back of Rising Prevalence of Chronic Diseases

Continuous innovations in molecular diagnostic technologies, such as PCR, NGS, microarrays, and digital PCR, have enhanced testing accuracy, efficiency, and speed.

North America, being a hub for technological innovation, experiences rapid adoption of these advancements. The rising incidence of chronic diseases like cancer, cardiovascular disorders, diabetes, and genetic disorders in North America has increased the demand for precise and early diagnostic methods. Molecular diagnostics provide accurate disease detection, enabling early intervention and personalised treatment strategies.

Molecular Diagnostics Market Regional Outlook, 2018-2030

The Personalised Medicine Boom Drives Market in Europe

Molecular diagnostics enable personalised and precision medicine by analysing genetic variations in patients. The focus on tailored treatments based on individual genetic profiles is driving the demand for molecular tests and contributing to market growth.

Moreover, hospitals, clinics, and laboratories across Europe are increasingly adopting molecular diagnostic tools for routine patient care, disease screening, and management, furthering Molecular Diagnostics Market demand.

North America Molecular Diagnostics Market, by Application, 2018 - 2031, US$ Bn

Fairfield’s Competitive Landscape Analysis

Established companies such as Roche Diagnostics, Abbott Laboratories, Siemens Healthineers, Thermo Fisher Scientific, and bioMérieux were prominent players, each having a significant market presence due to their diverse product portfolios and established brand recognition.

Numerous smaller companies and start-ups were actively involved in the development of novel molecular diagnostic technologies, focusing on niche areas, point-of-care testing, and innovative testing platforms. Some of these emerging companies aimed to disrupt the market with novel approaches and cost-effective solutions.

Who are the Leaders in Global Molecular Diagnostics Market Space?

  • Hoffman - La Roche Ltd.
  • Becton, Dickinson and Company
  • Bio-Rad Laboratories In
  • Merck KgaA
  • Thermo Fisher Scientific Inc.
  • Agilent Technologies, Inc.
  • Illumina, Inc.
  • Qiagen N.V.
  • Hologic Inc.
  • Siemens Healthineers AG
  • Seegene, Inc.
  • DiaSorin S.p.A
  • Grifols, S.A.
  • bioMérieux
  • QuidelOrtho Corporation
  • RapidBio
  • Abbott Laboratories
  • Danaher Corporation

Significant Industry Developments

Partnership & Acquisition

  • In October 2023, Roche announced the US Food and Drug Administration (FDA) approved the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify metastatic breast cancer patients with low HER2 expression for whom Enhertu (fam-trastuzumab deruxtecan-nxki) may be considered as a targeted treatment.
  • In November 2023, Thermo Fisher Scientific Inc. and Flagship Pioneering, the bio platform innovation company, announced the formation of a strategic partnership to develop and commercially scale multi-product platforms on an accelerated basis. The newly formed strategic partnership is an expansion of the long-standing supply relationship between Thermo Fisher and Flagship, which extends to Flagship’s ecosystem of companies and leverages the expertise of both organisations including the areas of life science tools, diagnostics, and services.

An Expert’s Eye

Demand and Future Growth

The outbreaks of infectious diseases, especially the COVID-19 pandemic, highlighted the crucial role of molecular diagnostics in rapid and accurate disease detection, contributing significantly to market growth.

Molecular diagnostics extended beyond clinical diagnostics into genomics, pharmacogenomics, and biomarker discovery, broadening the market's scope. Hospitals, clinics, and laboratories increasingly adopted molecular diagnostic tools for routine patient care, enhancing Molecular Diagnostics Market demand.

Supply Side of the Market

The trend toward developing and refining liquid biopsy techniques continues to grow, driven by ongoing research, technological advancements, and the promise of enhancing diagnostic accuracy, enabling earlier interventions, and improving patient outcomes. As these techniques evolve, they hold immense potential to transform disease management paradigms and further establish molecular diagnostics as a cornerstone of modern healthcare.

The significance of liquid biopsy lies in its ability to provide real-time and dynamic information about the tumor's genetic makeup and molecular changes. This allows for the early detection of cancers, monitoring of treatment response, identification of potential drug resistance, and tracking disease progression or recurrence. Liquid biopsy techniques are particularly instrumental in scenarios where obtaining tissue biopsies is challenging or impractical.

Liquid biopsy research is also a revolutionary in the treatment of glioblastoma (GB), a very aggressive central nervous system tumor with a poor prognosis. The only validated predictive and prognostic biomarker for GB is O6-methylguanine-DNA methyltransferase (MGMT) methylation (mMGMT), which is associated with improved response to treatment and longer survival. However, the mMGMT status monitoring techniques used to this point have proven inadequate. Small extracellular vesicles, or sEVs, have the potential to transform clinical diagnoses through liquid biopsy.

Global Molecular Diagnostics Market is Segmented as Below:

Product Type:

  • Instruments
    • Polymerase Chain Reaction (PCR) Systems
    • Hybridization (In-Situ Hybridization & Fish) Systems
    • DNA Sequencing and Next-Generation Sequencing Platforms
    • Microarrays
  • Reagent
    • Antibodies
    • DNA Template
    • DNA Polymerase
    • Oligonucleotide Primers
    • Deoxyribonucleotide Triphosphate (dNTPs)
    • Buffer
  • Assay Kits
  • Consumables

Application:

  • Infectious Disease
  • Diabetes
  • Cardiology
  • Oncology
  • Nephrology
  • Autoimmune Disease
  • Dermatology
  • Wound Care
  • Others

End User:

  • Hospitals & Clinics
  • Diagnostics Laboratories
  • Academic and Research Institutes
  • Biopharmaceutical Companies

By Geographic Coverage:

  • North America 
    • United States
    • Canada
  • Europe 
    • Germany
    • U.K.
    • France
    • Italy
    • Spain
    • Russia
    • Rest of Europe 
  • Asia Pacific 
    • Japan
    • China
    • India
    • South Korea
    • Southeast Asia
    • Australia
    • Rest of Asia Pacific
  • Latin America 
    • Brazil 
    • Mexico 
    • Rest of Latin America 
  • Middle East & Africa  
    • GCC 
    • South Africa
    • Egypt
    • Rest of the Middle East & and Africa

1. Executive Summary
    1.1. Global Molecular Diagnostics Market Snapshot
    1.2. Future Projections
    1.3. Key Market Trends
    1.4. Regional Snapshot, by Value and Volume, 2022
    1.5. Analyst Recommendations

2. Market Overview
    2.1. Market Definitions and Segmentations
    2.2. Market Dynamics
        2.2.1. Drivers
        2.2.2. Restraints
        2.2.3. Market Opportunities
    2.3. Value Chain Analysis
    2.4. Porter’s Five Forces Analysis
    2.5. COVID-19 Impact Analysis
        2.5.1. Supply
        2.5.2. Demand
    2.6. Economic Overview
        2.6.1. World Economic Projections
    2.7. PESTLE Analysis

3. Global Molecular Diagnostics Market Outlook, 2018 - 2031
    3.1. Global Molecular Diagnostics Market Outlook, by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
        3.1.1. Key Highlights
            3.1.1.1. Instruments
                3.1.1.1.1. Polymerase Chain Reaction (PCR) Systems
                3.1.1.1.2. Hybridization (In-Situ Hybridization & Fish) Systems
                3.1.1.1.3. DNA Sequencing and Next-Generation Sequencing Platforms
                3.1.1.1.4. Microarrays
            3.1.1.2. Reagent
                3.1.1.2.1. Antibodies
                3.1.1.2.2. DNA Template
                3.1.1.2.3. DNA Polymerase
                3.1.1.2.4. Oligonucleotide Primers
                3.1.1.2.5. Deoxyribonucleotide Triphosphate (dNTPs)
                3.1.1.2.6. Buffer
            3.1.1.3. Assay Kits
            3.1.1.4. Consumables
    3.2. Global Molecular Diagnostics Market Outlook, by Disease Area, Value (US$ Mn) and 2018 - 2031
        3.2.1. Key Highlights
            3.2.1.1. Infectious Disease
            3.2.1.2. Diabetes
            3.2.1.3. Cardiology
            3.2.1.4. Oncology
            3.2.1.5. Nephrology
            3.2.1.6. Autoimmune Disease
            3.2.1.7. Dermatology
            3.2.1.8. Wound Care
            3.2.1.9. Others
    3.3. Global Molecular Diagnostics Market Outlook, by End User, Value (US$ Mn), 2018 - 2031
        3.3.1. Key Highlights
            3.3.1.1. Hospitals & Clinics
            3.3.1.2. Diagnostics Laboratories
            3.3.1.3. Academic and Research Institutes
            3.3.1.4. Biopharmaceutical Companies
    3.4. Global Molecular Diagnostics Market Outlook, by Region, Value (US$ Mn) and Volume (Units), 2018 - 2031
        3.4.1. Key Highlights
            3.4.1.1. North America
            3.4.1.2. Europe
            3.4.1.3. Asia Pacific
            3.4.1.4. Latin America
            3.4.1.5. Middle East & Africa

4. North America Molecular Diagnostics Market Outlook, 2018 - 2031
    4.1. North America Molecular Diagnostics Market Outlook, by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
        4.1.1. Key Highlights
            4.1.1.1. Instruments
                4.1.1.1.1. Polymerase Chain Reaction (PCR) Systems
                4.1.1.1.2. Hybridization (In-Situ Hybridization & Fish) Systems
                4.1.1.1.3. DNA Sequencing and Next-Generation Sequencing Platforms
                4.1.1.1.4. Microarrays
            4.1.1.2. Reagent
                4.1.1.2.1. Antibodies
                4.1.1.2.2. DNA Template
                4.1.1.2.3. DNA Polymerase
                4.1.1.2.4. Oligonucleotide Primers
                4.1.1.2.5. Deoxyribonucleotide Triphosphate (dNTPs)
                4.1.1.2.6. Buffer
            4.1.1.3. Assay Kits
            4.1.1.4. Consumables
    4.2. North America Molecular Diagnostics Market Outlook, by Disease Area, Value (US$ Mn) and 2018 - 2031
        4.2.1. Key Highlights
            4.2.1.1. Infectious Disease
            4.2.1.2. Diabetes
            4.2.1.3. Cardiology
            4.2.1.4. Oncology
            4.2.1.5. Nephrology
            4.2.1.6. Autoimmune Disease
            4.2.1.7. Dermatology
            4.2.1.8. Wound Care
            4.2.1.9. Others
    4.3. North America Molecular Diagnostics Market Outlook, by End User, Value (US$ Mn), 2018 - 2031
        4.3.1. Key Highlights
            4.3.1.1. Hospitals & Clinics
            4.3.1.2. Diagnostics Laboratories
            4.3.1.3. Academic and Research Institutes
            4.3.1.4. Biopharmaceutical Companies
        4.3.2. BPS Analysis/Market Attractiveness Analysis
    4.4. North America Molecular Diagnostics Market Outlook, by Country, Value (US$ Mn) and Volume (Units), 2018 - 2031
        4.4.1. Key Highlights
            4.4.1.1. U.S. Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            4.4.1.2. U.S. Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            4.4.1.3. U.S. Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
            4.4.1.4. Canada Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            4.4.1.5. Canada Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            4.4.1.6. Canada Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
        4.4.2. BPS Analysis/Market Attractiveness Analysis

5. Europe Molecular Diagnostics Market Outlook, 2018 - 2031
    5.1. Europe Molecular Diagnostics Market Outlook, by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
        5.1.1. Key Highlights
            5.1.1.1. Instruments
                5.1.1.1.1. Polymerase Chain Reaction (PCR) Systems
                5.1.1.1.2. Hybridization (In-Situ Hybridization & Fish) Systems
                5.1.1.1.3. DNA Sequencing and Next-Generation Sequencing Platforms
                5.1.1.1.4. Microarrays
            5.1.1.2. Reagent
                5.1.1.2.1. Antibodies
                5.1.1.2.2. DNA Template
                5.1.1.2.3. DNA Polymerase
                5.1.1.2.4. Oligonucleotide Primers
                5.1.1.2.5. Deoxyribonucleotide Triphosphate (dNTPs)
                5.1.1.2.6. Buffer
            5.1.1.3. Assay Kits
            5.1.1.4. Consumables
    5.2. Europe Molecular Diagnostics Market Outlook, by Disease Area, Value (US$ Mn) and 2018 - 2031
        5.2.1. Key Highlights
            5.2.1.1. Infectious Disease
            5.2.1.2. Diabetes
            5.2.1.3. Cardiology
            5.2.1.4. Oncology
            5.2.1.5. Nephrology
            5.2.1.6. Autoimmune Disease
            5.2.1.7. Dermatology
            5.2.1.8. Wound Care
            5.2.1.9. Others
    5.3. Europe Molecular Diagnostics Market Outlook, by End User, Value (US$ Mn), 2018 - 2031
        5.3.1. Key Highlights
            5.3.1.1. Hospitals & Clinics
            5.3.1.2. Diagnostics Laboratories
            5.3.1.3. Academic and Research Institutes
            5.3.1.4. Biopharmaceutical Companies
        5.3.2. BPS Analysis/Market Attractiveness Analysis
    5.4. Europe Molecular Diagnostics Market Outlook, by Country, Value (US$ Mn) and Volume (Units), 2018 - 2031
        5.4.1. Key Highlights
            5.4.1.1. Germany Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            5.4.1.2. Germany Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            5.4.1.3. Germany Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
            5.4.1.4. U.K. Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            5.4.1.5. U.K. Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            5.4.1.6. U.K. Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
            5.4.1.7. France Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            5.4.1.8. France Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            5.4.1.9. France Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
            5.4.1.10. Italy Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            5.4.1.11. Italy Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            5.4.1.12. Italy Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
            5.4.1.13. Spain Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            5.4.1.14. Spain Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            5.4.1.15. Spain Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
            5.4.1.16. Russia Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            5.4.1.17. Russia Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            5.4.1.18. Russia Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
            5.4.1.19. Rest of Europe Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            5.4.1.20. Rest of Europe Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            5.4.1.21. Rest of Europe Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
        5.4.2. BPS Analysis/Market Attractiveness Analysis

6. Asia Pacific Molecular Diagnostics Market Outlook, 2018 - 2031
    6.1. Asia Pacific Molecular Diagnostics Market Outlook, by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
        6.1.1. Key Highlights
            6.1.1.1. Instruments
                6.1.1.1.1. Polymerase Chain Reaction (PCR) Systems
                6.1.1.1.2. Hybridization (In-Situ Hybridization & Fish) Systems
                6.1.1.1.3. DNA Sequencing and Next-Generation Sequencing Platforms
                6.1.1.1.4. Microarrays
            6.1.1.2. Reagent
                6.1.1.2.1. Antibodies
                6.1.1.2.2. DNA Template
                6.1.1.2.3. DNA Polymerase
                6.1.1.2.4. Oligonucleotide Primers
                6.1.1.2.5. Deoxyribonucleotide Triphosphate (dNTPs)
                6.1.1.2.6. Buffer
            6.1.1.3. Assay Kits
            6.1.1.4. Consumables
    6.2. Asia Pacific Molecular Diagnostics Market Outlook, by Disease Area, Value (US$ Mn) and 2018 - 2031
        6.2.1. Key Highlights
            6.2.1.1. Infectious Disease
            6.2.1.2. Diabetes
            6.2.1.3. Cardiology
            6.2.1.4. Oncology
            6.2.1.5. Nephrology
            6.2.1.6. Autoimmune Disease
            6.2.1.7. Dermatology
            6.2.1.8. Wound Care
            6.2.1.9. Others
    6.3. Asia Pacific Molecular Diagnostics Market Outlook, by End User, Value (US$ Mn), 2018 - 2031
        6.3.1. Key Highlights
            6.3.1.1. Hospitals & Clinics
            6.3.1.2. Diagnostics Laboratories
            6.3.1.3. Academic and Research Institutes
            6.3.1.4. Biopharmaceutical Companies
        6.3.2. BPS Analysis/Market Attractiveness Analysis
    6.4. Asia Pacific Molecular Diagnostics Market Outlook, by Country, Value (US$ Mn) and Volume (Units), 2018 - 2031
        6.4.1. Key Highlights
            6.4.1.1. China Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            6.4.1.2. China Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            6.4.1.3. China Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
            6.4.1.4. Japan Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            6.4.1.5. Japan Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            6.4.1.6. Japan Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
            6.4.1.7. South Korea Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            6.4.1.8. South Korea Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            6.4.1.9. South Korea Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
            6.4.1.10. India Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            6.4.1.11. India Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            6.4.1.12. India Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
            6.4.1.13. Southeast Asia Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            6.4.1.14. Southeast Asia Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            6.4.1.15. Southeast Asia Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
            6.4.1.16. Russia Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            6.4.1.17. Russia Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            6.4.1.18. Russia Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
            6.4.1.19. Rest of Asia Pacific Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            6.4.1.20. Rest of Asia Pacific Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            6.4.1.21. Rest of Asia Pacific Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
        6.4.2. BPS Analysis/Market Attractiveness Analysis

7. Latin America Molecular Diagnostics Market Outlook, 2018 - 2031
    7.1. Latin America Molecular Diagnostics Market Outlook, by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
        7.1.1. Key Highlights
            7.1.1.1. Instruments
                7.1.1.1.1. Polymerase Chain Reaction (PCR) Systems
                7.1.1.1.2. Hybridization (In-Situ Hybridization & Fish) Systems
                7.1.1.1.3. DNA Sequencing and Next-Generation Sequencing Platforms
                7.1.1.1.4. Microarrays
            7.1.1.2. Reagent
                7.1.1.2.1. Antibodies
                7.1.1.2.2. DNA Template
                7.1.1.2.3. DNA Polymerase
                7.1.1.2.4. Oligonucleotide Primers
                7.1.1.2.5. Deoxyribonucleotide Triphosphate (dNTPs)
                7.1.1.2.6. Buffer
            7.1.1.3. Assay Kits
            7.1.1.4. Consumables
    7.2. Latin America Molecular Diagnostics Market Outlook, by Disease Area, Value (US$ Mn) and 2018 - 2031
        7.2.1. Key Highlights
            7.2.1.1. Infectious Disease
            7.2.1.2. Diabetes
            7.2.1.3. Cardiology
            7.2.1.4. Oncology
            7.2.1.5. Nephrology
            7.2.1.6. Autoimmune Disease
            7.2.1.7. Dermatology
            7.2.1.8. Wound Care
            7.2.1.9. Others
    7.3. Latin America Molecular Diagnostics Market Outlook, by End User, Value (US$ Mn), 2018 - 2031
        7.3.1. Key Highlights
            7.3.1.1. Hospitals & Clinics
            7.3.1.2. Diagnostics Laboratories
            7.3.1.3. Academic and Research Institutes
            7.3.1.4. Biopharmaceutical Companies
        7.3.2. BPS Analysis/Market Attractiveness Analysis
    7.4. Latin America Molecular Diagnostics Market Outlook, by Country, Value (US$ Mn) and Volume (Units), 2018 - 2031
        7.4.1. Key Highlights
            7.4.1.1. Brazil Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            7.4.1.2. Brazil Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            7.4.1.3. Brazil Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
            7.4.1.4. Mexico Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            7.4.1.5. Mexico Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            7.4.1.6. Mexico Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
            7.4.1.7. Rest of Latin America Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            7.4.1.8. Rest of Latin America Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            7.4.1.9. Rest of Latin America Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
        7.4.2. BPS Analysis/Market Attractiveness Analysis

8. Middle East & Africa Molecular Diagnostics Market Outlook, 2018 - 2031
    8.1. Middle East & Africa Molecular Diagnostics Market Outlook, by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
        8.1.1. Key Highlights
            8.1.1.1. Instruments
                8.1.1.1.1. Polymerase Chain Reaction (PCR) Systems
                8.1.1.1.2. Hybridization (In-Situ Hybridization & Fish) Systems
                8.1.1.1.3. DNA Sequencing and Next-Generation Sequencing Platforms
                8.1.1.1.4. Microarrays
            8.1.1.2. Reagent
                8.1.1.2.1. Antibodies
                8.1.1.2.2. DNA Template
                8.1.1.2.3. DNA Polymerase
                8.1.1.2.4. Oligonucleotide Primers
                8.1.1.2.5. Deoxyribonucleotide Triphosphate (dNTPs)
                8.1.1.2.6. Buffer
            8.1.1.3. Assay Kits
            8.1.1.4. Consumables
    8.2. Middle East & Africa Molecular Diagnostics Market Outlook, by Disease Area, Value (US$ Mn) and 2018 - 2031
        8.2.1. Key Highlights
            8.2.1.1. Infectious Disease
            8.2.1.2. Diabetes
            8.2.1.3. Cardiology
            8.2.1.4. Oncology
            8.2.1.5. Nephrology
            8.2.1.6. Autoimmune Disease
            8.2.1.7. Dermatology
            8.2.1.8. Wound Care
            8.2.1.9. Others
    8.3. Middle East & Africa Molecular Diagnostics Market Outlook, by End User, Value (US$ Mn), 2018 - 2031
        8.3.1. Key Highlights
            8.3.1.1. Hospitals & Clinics
            8.3.1.2. Diagnostics Laboratories
            8.3.1.3. Academic and Research Institutes
            8.3.1.4. Biopharmaceutical Companies
        8.3.2. BPS Analysis/Market Attractiveness Analysis
    8.4. Middle East & Africa Molecular Diagnostics Market Outlook, by Country, Value (US$ Mn) and Volume (Units), 2018 - 2031
        8.4.1. Key Highlights
            8.4.1.1. GCC Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            8.4.1.2. GCC Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            8.4.1.3. GCC Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
            8.4.1.4. South Africa Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            8.4.1.5. South Africa Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            8.4.1.6. South Africa Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
            8.4.1.7. Egypt Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            8.4.1.8. Egypt Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            8.4.1.9. Egypt Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
            8.4.1.10. Rest of Middle East & Africa Molecular Diagnostics Market by Product Type, Value (US$ Mn) and Volume (Units), 2018 - 2031
            8.4.1.11. Rest of Middle East & Africa Molecular Diagnostics Market by Disease Area, Value (US$ Mn) and Volume (Units), 2018 - 2031
            8.4.1.12. Rest of Middle East & Africa Molecular Diagnostics Market by End User, Value (US$ Mn) and Volume (Units), 2018 - 2031
        8.4.2. BPS Analysis/Market Attractiveness Analysis

9. Competitive Landscape
    9.1. Manufacturer vs by Disease Area Heatmap
    9.2. Company Market Share Analysis, 2022
    9.3. Competitive Dashboard
    9.4. Company Profiles
        9.4.1. F. Hoffman - La Roche Ltd.
            9.4.1.1. Company Overview
            9.4.1.2. Product Portfolio
            9.4.1.3. Financial Overview
            9.4.1.4. Business Strategies and Development
        9.4.2. Becton, Dickinson, and Company
            9.4.2.1. Company Overview
            9.4.2.2. Product Portfolio
            9.4.2.3. Financial Overview
            9.4.2.4. Business Strategies and Development
        9.4.3. Bio-Rad Laboratories In
            9.4.3.1. Company Overview
            9.4.3.2. Product Portfolio
            9.4.3.3. Financial Overview
            9.4.3.4. Business Strategies and Development
        9.4.4. Merck KgaA
            9.4.4.1. Company Overview
            9.4.4.2. Product Portfolio
            9.4.4.3. Financial Overview
            9.4.4.4. Business Strategies and Development
        9.4.5. Thermo Fisher Scientific Inc
            9.4.5.1. Company Overview
            9.4.5.2. Product Portfolio
            9.4.5.3. Financial Overview
            9.4.5.4. Business Strategies and Development
        9.4.6. Agilent Technologies, Inc.
            9.4.6.1. Company Overview
            9.4.6.2. Product Portfolio
            9.4.6.3. Financial Overview
            9.4.6.4. Business Strategies and Development
        9.4.7. Illumina, Inc.
            9.4.7.1. Company Overview
            9.4.7.2. Product Portfolio
            9.4.7.3. Financial Overview
            9.4.7.4. Business Strategies and Development
        9.4.8. Qiagen N.V.
            9.4.8.1. Company Overview
            9.4.8.2. Product Portfolio
            9.4.8.3. Financial Overview
            9.4.8.4. Business Strategies and Development
        9.4.9. Hologic Inc.
            9.4.9.1. Company Overview
            9.4.9.2. Product Portfolio
            9.4.9.3. Financial Overview
            9.4.9.4. Business Strategies and Development
        9.4.10. Siemens Healthineers AG
            9.4.10.1. Company Overview
            9.4.10.2. Product Portfolio
            9.4.10.3. Financial Overview
            9.4.10.4. Business Strategies and Development
        9.4.11. Seegene, Inc.
            9.4.11.1. Company Overview
            9.4.11.2. Product Portfolio
            9.4.11.3. Financial Overview
            9.4.11.4. Business Strategies and Development
        9.4.12. DiaSorin S.p.A
            9.4.12.1. Company Overview
            9.4.12.2. Product Portfolio
            9.4.12.3. Financial Overview
            9.4.12.4. Business Strategies and Development
        9.4.13. Grifols, S.A.
            9.4.13.1. Company Overview
            9.4.13.2. Product Portfolio
            9.4.13.3. Financial Overview
            9.4.13.4. Business Strategies and Development
        9.4.14. BioMérieux
            9.4.14.1. Company Overview
            9.4.14.2. Product Portfolio
            9.4.14.3. Financial Overview
            9.4.14.4. Business Strategies and Development
        9.4.15. QuidelOrtho Corporation
            9.4.15.1. Company Overview
            9.4.15.2. Product Portfolio
            9.4.15.3. Financial Overview
            9.4.15.4. Business Strategies and Development
        9.4.16. RapidBio
            9.4.16.1. Company Overview
            9.4.16.2. Product Portfolio
            9.4.16.3. Financial Overview
            9.4.16.4. Business Strategies and Development
        9.4.17. Abbott Laboratories
            9.4.17.1. Company Overview
            9.4.17.2. Product Portfolio
            9.4.17.3. Financial Overview
            9.4.17.4. Business Strategies and Development
        9.4.18. Danaher Corporation
            9.4.18.1. Company Overview
            9.4.18.2. Product Portfolio
            9.4.18.3. Financial Overview
            9.4.18.4. Business Strategies and Development

10. Appendix
    10.1. Research Methodology
    10.2. Report Assumptions
    10.3. Acronyms and Abbreviations

BASE YEAR

HISTORICAL DATA

FORECAST PERIOD

UNITS

2022

 

2019 - 2022

2023 - 2031

Value: US$ Billion

 

REPORT FEATURES

DETAILS

By Product Type

  • Instruments
    • Polymerase Chain Reaction (PCR) Systems
    • Hybridization (In-Situ Hybridization & Fish) Systems
    • DNA Sequencing and Next-Generation Sequencing Platforms
    • Microarrays
  • Reagent
    • Antibodies
    • DNA Template
    • DNA Polymerase
    • Oligonucleotide Primers
    • Deoxyribonucleotide Triphosphate (dNTPs)
    • Buffer
  • Assay Kits
  • Consumables

By Application

  • Infectious Disease
  • Diabetes
  • Cardiology
  • Oncology
  • Nephrology
  • Autoimmune Disease
  • Dermatology
  • Wound Care
  • Others

By End User

  • Hospitals & Clinics
  • Diagnostics Laboratories
  • Academic and Research Institutes
  • Biopharmaceutical Companies

Geographic Coverage

  • North America
  • United States
  • Canada
  • Europe
  • Germany
  • Italy
  • France
  • U.K.
  • Spain
  • Russia
  • Rest of Europe
  • Asia Pacific
  • China
  • Japan
  • South Korea
  • Southeast Asia
  • India
  • Australia
  • Rest of Asia Pacific
  • Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
  • Middle East and Africa
  • GCC Countries
  • South Africa
  • Egypt
  • Rest of Middle East and Africa

Leading Companies

  • F. Hoffman - La Roche Ltd. 
  • Becton Dickinson And Co.
  • Bio-Rad Laboratories In
  • Merck KgaA
  • Thermo Fisher Scientific Inc
  • Agilent Technologies, Inc.
  • Illumina, Inc.
  • Qiagen N.V.
  • Hologic Inc.
  • Siemens Healthineers AG
  • Seegene, Inc.
  • DiaSorin S.p.A
  • Grifols, S.A.
  • bioMérieux
  • QuidelOrtho Corporation
  • RapidBio
  • Abbott Laboratories
  • Danaher Corporation

Report Highlights 

Key Market Indicators, Market Estimates and Forecast (Value), Market Dynamics, Regulatory Guidelines, Technological Advancements, COVID-19 Impact Analysis, Product Insights, Disease Area Insights, Regional and Country Insights, Competitive Landscape, Company Profiles.

FAQs : Molecular Diagnostics Market

Global molecular diagnostics market is anticipated to reach US$37.2 billion in 2031.

North America leads the global molecular diagnostics market in terms of value. The region will continue to lead its way through the forecast period to reach a value of US$ 13,700.4 Million by 2031.

Reagents product type is anticipated to dominate the global molecular diagnostics market with a CAGR of 6.3% during 2024-2031, while instruments are expected to grow at a faster CAGR of 7.0% during 2024-2031.

Infectious disease dominates the market throughout, followed by the diabetes application segment, and is expected to exhibit a strong revenue growth rate during the forecast period (2024-2031) with a CAGR of around 5.6%.

Hospitals and clinics hold the largest share with a value expected to reach more than US$16,100.4 Mn, while the hair sample segment is anticipated to grow at a faster CAGR of 5.5% during 2024-2031.

Our Research Methodology

Considering the volatility of business today, traditional approaches to strategizing a game plan can be unfruitful if not detrimental. True ambiguity is no way to determine a forecast. A myriad of predetermined factors must be accounted for such as the degree of risk involved, the magnitude of circumstances, as well as conditions or consequences that are not known or unpredictable. To circumvent binary views that cast uncertainty, the application of market research intelligence to strategically posture, move, and enable actionable outcomes is necessary.

View Methodology
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