Molecular Diagnostics Market

Market Study on Molecular Diagnostics: With the Advent in Modern Tools, Genomic Technologies, and Diagnosis of Infectious Diseases, PMR Foresees Various Opportunities for Arising on the Horizon

Report ID: PMRREP2784

Number of Pages: 225

Format: PPT*, PDF, EXCEL

Industry: Healthcare

Published Date: March-2024

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Molecular Diagnostics Market Outlook

The global market for molecular diagnostics is forecast to expand at a CAGR of 6.2% and thereby increase from a value of US$23.2 Bn in 2024, to US$35.6 Bn by the end of 2031.


Key Insights

Market Size (2024)

US$23.2 Bn

Projected Market Value (2031F)

US$35.6 Bn

Global Market Growth Rate (CAGR 2024 to 2031)


Historical Market Growth Rate (CAGR 2019 to 2023)


Revenue Share of Top Four Countries (2023A)


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Market Introduction and Definition

Molecular diagnostics involves the analysis of biological markers at the molecular level to detect specific genetic sequences or mutations associated with various diseases. This field has witnessed significant advancements, and the market has grown steadily due to the increasing prevalence of infectious diseases, genetic disorders, and cancer.

The growth prospects of the Molecular Diagnostic industry can vary depending on factors such as economic development, infrastructure projects, urbanization rates, and construction activity. Form strategic partnerships and collaborations with research institutions, healthcare providers, and technology firms to access expertise, resources, and novel technologies.

Moreover, according to the 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. Healthcare systems that use molecular diagnostics regularly will gain economies of scale, maximize limited expertise, and respond quickly to new threats.

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Market Growth Drivers

Expanding Role of Companion Diagnostics Across Therapeutic Fields

A subset of molecular diagnostics is called companion diagnostics. Companion diagnostics and molecular diagnostics are intertwined, and comprehension of molecular diagnostics facilitates comprehension of companion diagnostics.

The increased use of targeted medications in oncology and other areas has increased the need for companion diagnostic testing. Using a multi-analyte approach, next-generation sequencing (NGS) provides comprehensive biomarker information, making it an ideal means of integrating precision medicine into everyday clinical practice.

The FDA and other regulatory agencies support the creation and application of companion diagnostics. To guarantee safe and efficient use, the approval of companion diagnostics may be required for the prescription medications in question.

Companion diagnostics are not limited to cancer treatments. They're extending to other therapeutic areas like infectious diseases, cardiovascular conditions, and neurological disorders, broadening the potential market for related diagnostic tools.

Market Research Methodology

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Market Restraints

High Cost of Both Equipment and Reagents

Modern molecular diagnostic tools and supplies can be costly; thus, it might be difficult for labs to make the most technological investments without going over budget. Large molecular diagnostic equipment purchases can be expensive up front, which discourages smaller labs or establishments with tighter finances from acquiring this technology. The establishment expenses of specialist facilities and infrastructure also contribute to the financial strain.

Molecular diagnostics reagents, including enzymes, PCR kits, and DNA probes, can be expensive. It is expensive for laboratories to regularly restock these consumables since it adds to continuing operating costs, particularly in environments with limited resources.

The equipment requires additional costs for upkeep and servicing after the initial purchase. Upgrades, maintenance, and calibration raise the total cost of ownership even more.

Skilful Workforce Training

Operating molecular diagnostic equipment frequently involves specific knowledge and abilities in molecular biology, genetics, biochemistry, and related subjects. Qualified workers may be required to operate and maintain these advanced instruments effectively.

Training people to use molecular diagnostic equipment and interpret results necessitates the purchase of training programs, workshops, and educational resources. High training expenses might be prohibitively expensive, especially for smaller healthcare organizations or laboratories with restricted finances.


Increasing Government Support, and Favorable Regulations

In the past, real-time PCR (RT PCR) was thought to be a largely specialized technology used by a small number of labs nationwide. COVID-19 placed pressure on the diagnostics industry to rapidly grow to the point where over 3000 testing laboratories in India alone perform molecular testing. The prevalence of RT PCR, viral amplification, and genome sequencing is about to revolutionize the field of molecular diagnosis.

The legislative stances of the US, and the EU regarding laboratory-developed tests (LDTs) and in-house tests differ, offering molecular diagnostic companies a rare chance to take advantage of this difference and drive innovation in both markets. The secret is to carefully craft molecular diagnostic products so that they comply with local laws and regulations.

Businesses can highlight FDA-compliant testing for the US market to demonstrate their compliance with strict regulations. In the EU, they can also present themselves as collaborators that support improved internal testing capacities by providing additional and creative molecular diagnostic solutions. By using this tactical strategy, businesses may take advantage of the different regulatory frameworks in each area, maximizing their market share and product offers.

Market Segmentation

Which Product Types are Expected to be at the Forefront of Adoption?

Reagents likely to be the Primary Product Category as Demand for Diagnostic Testing Soars

Reagents are the primary components utilized in molecular diagnostic testing methods. These include extraction of DNA and RNA, amplification, tagging, purification, and detection. Reagents such as DNA polymerases, primers, nucleotides, and buffers, for example, are required for DNA amplification in Polymerase Chain Reaction (PCR) testing.

Reagents of high quality are critical for assuring the precision and accuracy of molecular diagnostic procedures. They add to the reliability of test results by reducing false positives and negatives.

Which Category is Most Focused in Molecular Diagnostics by Disease Area?

Infectious Diseases Account for the Largest Market Share Owing to Point-of-Care Testing

The focus on disease areas in molecular diagnostics can evolve based on scientific advancements, emerging health threats, and the availability of new technologies. The rapid and precise identification of infectious agents, including bacteria, viruses, fungi, and parasites, is made possible by molecular diagnostics.

In contrast to conventional culture-based procedures, techniques such as PCR (Polymerase Chain Reaction), and nucleic acid amplification tests (NAATs) enable the detection of specific genetic material of diseases, aiding faster diagnosis. By identifying genetic markers linked to drug resistance in infectious organisms, molecular diagnostics aids in the monitoring of antimicrobial resistance. This helps medical professionals prescribe suitable and efficient therapies, which help fight antibiotic resistance.

Which is the Leading End User Segment?

Hospitals Continue to Take the Lead on the Back of Advanced Treatment Facilities, and Specialized Expertise

Molecular diagnostics is widely used in hospitals and clinics for illness monitoring, screening, and detection. To find genetic mutations, infectious agents, and biomarkers linked to a range of illnesses, including cancer, infectious diseases, genetic abnormalities, and more, these institutions rely on molecular testing.

Molecular diagnostics provide comprehensive genetic information on a patient's diseases, which helps with tailored medicine. This increases the effectiveness of treatments and lowers side effects by enabling doctors to customize treatment regimens based on each patient's unique genetic profile.

Top Regional Markets

North America Continues to Leverage the Early Mover’s Advantage

The accuracy, efficiency, and speed of molecular diagnostic tests have been improved by ongoing advancements in technologies like digital PCR, microarrays, polymerase chain reaction (PGR), and next-generation sequencing (NGS). North America, a center of technical innovation, adopts these developments quickly.

Accurate and early diagnostic methods are becoming more and more necessary in North America due to the rising occurrence of chronic diseases such as cancer, cardiovascular disorders, diabetes, and genetic abnormalities. Precise illness detection made possible by molecular diagnostics allows for early intervention and individualized treatment plans.

Asia Pacific's Mounting Healthcare Needs Complement Market Expansion

The Asia Pacific area is home to a sizable and diverse population, and several of its nations have high rates of chronic illnesses like diabetes and cancer as well as infectious diseases like hepatitis and tuberculosis. Because of this, there is a need for sophisticated molecular diagnostics for the early diagnosis, observation, and treatment of many illnesses.

In the Asia-Pacific region, there is a growing need for point-of-care molecular diagnostics, particularly in isolated or underdeveloped locations. Producers that can offer lightweight, easily navigable diagnostic instruments would be able to meet the wide range of healthcare requirements in the area.

Analyst’s Viewpoint

The COVID-19 pandemic, along with other infectious disease outbreaks, has underscored the crucial role played by molecular diagnostics in the early and precise diagnosis of illnesses. This heightened awareness of the significance of molecular diagnostics has resulted in a substantial expansion of the market. Molecular diagnostics, originally associated primarily with clinical diagnostics, has broadened its scope to include applications in genomics, pharmacogenomics, and biomarker discovery.

Moreover, molecular diagnostics has contributed substantially to biomarker discovery, identifying specific molecules indicative of various diseases. This has implications for early disease detection, monitoring treatment efficacy, and predicting patient outcomes. The report suggests that the increased recognition of the benefits of molecular diagnostics has led to its wider integration into healthcare systems. Hospitals, clinics, and laboratories are increasingly incorporating molecular diagnostic technologies into routine patient care, further driving market demand.

Supply-side Dynamics

As a result of continuous research, technology developments, and the potential to improve patient outcomes, allow early interventions, and increase diagnostic accuracy, there is an increasing trend toward the development and refinement of liquid biopsy procedures. As these methods advance, they have the potential to completely change the way that illness management is thought of and solidify molecular diagnostics as a mainstay of contemporary healthcare.

Liquid biopsy is important because it can give dynamic, real-time information regarding the molecular changes and genetic composition of the tumor. This makes it possible to track the progression or recurrence of disease, identify possible medication resistance, assess therapy response, and spot malignancies early. When it is difficult or impracticable to acquire tissue biopsies, liquid biopsy procedures are especially helpful.

Research on liquid biopsy is also significant in the treatment of glioblastoma (GB), a tumor of the central nervous system that is particularly aggressive and has a dismal prognosis. O6-methylguanine-DNA methyltransferase (MGMT) methylation (mMGMT), which is linked to a better response to treatment and a longer survival time, is the only validated predictive and prognostic biomarker for GB. However thus far, the methods of mMGMT status monitoring that have been used have not been sufficient. Via liquid biopsy, small extracellular vesicles, or sEVs, have the power to revolutionize clinical diagnosis.

Competitive Intelligence and Business Strategy

Prominent organizations, including Roche Diagnostics, Abbott Laboratories, Siemens Healthineers, Thermo Fisher Scientific, and bioMérieux are at the vanguard of this sector, each having a significant market presence due to their diverse product portfolios and established brand recognition.  

In the rapidly evolving field of molecular diagnostics, competitive intelligence is integral to shaping effective business strategies. Understanding the market landscape, including competitor offerings, technological advancements, and regulatory dynamics, is crucial for companies operating in this space. Businesses need to continuously assess the competitive environment to identify emerging trends and potential disruptions, ensuring they stay ahead of market shifts.

A comprehensive analysis of competitor strengths and weaknesses, coupled with insights into customer needs, allows companies to refine their product development and marketing strategies. Strategic collaborations and partnerships with key players in the industry can provide access to complementary technologies and expanded market reach.

Key Recent Developments


July 2023, llumina Inc. and Pillar Biosciences Inc., the pioneers of Decision Medicine™, announced a strategic partnership to make Pillar's suite of oncology assays commercially available globally as part of the Illumina portfolio of oncology products.

FDA Approval

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.

Molecular Diagnostics Market Report Scope



Forecast Period

2024 to 2031

Historical Data Available for

2019 to 2023

Market Analysis

US$ Million for Value

Key Regions Covered

  • North America
  • Europe
  • East Asia
  • South Asia & Oceania
  • Latin America
  • Middle East & Africa

Key Countries Covered

  • U.S.
  • Canada
  • Germany
  • France
  • U.K.
  • Spain
  • Russia
  • Türkiye
  • China
  • Japan
  • South Korea
  • India
  • Southeast Asia
  • ANZ
  • Brazil
  • Mexico
  • GCC Countries
  • Egypt
  • South Africa  

Key Market Segments Covered

  • Product Type
  • Application
  • End User
  • Region

Key Companies Profiled

  • Becton, Dickinson and Company
  • Bio-Rad Laboratories In
  • Merck KgaA
  • Thermo Fisher Scientific Inc
  • Agilent Technologies, Inc.
  • F. Hoffman - La Roche Ltd.
  • 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 Coverage

  • Market Forecast
  • Company Share Analysis
  • Competition Intelligence
  • DROT Analysis
  • Market Dynamics and Challenges
  • Strategic Growth Initiatives  

Customization & Pricing

Available upon request

Molecular Diagnostics Market Research Segmentation

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 Disease Area:

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

By End-use:

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

By Region:

  • North America
  • Europe
  • East Asia
  • South Asia & Oceania
  • Latin America
  • Middle East & Africa

For report customisation and delivery information contact our sales representative.

Companies Covered in This Report

  • Becton, Dickinson and Company
  • Bio-Rad Laboratories In
  • Merck KgaA
  • Thermo Fisher Scientific Inc
  • Agilent Technologies, Inc.
  • F. Hoffman - La Roche Ltd.
  • 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

Frequently Asked Questions

The market is anticipated to grow at a CAGR of 6.2% during the projected period.

The global molecular diagnostics market size was around US$23.2 billion in 2023.

The US held the largest market share in 2023.

Some of the prominent players in the market are F. Hoffmann la Roche, Thermo Fisher Scientific Inc., Abbott Laboratories, and Siemens Healthineers.

The reagents segment is expected to grow at the fastest CAGR during the forecast period.

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