Infectious Disease Molecular Diagnostics Market Size, Share, and Trends 2024 to 2034

Infectious Disease Molecular Diagnostics Market Size to Reach USD 63.37 Bn by 2034

The global infectious disease molecular diagnostics market size was USD 44.58 billion in 2023, calculated at USD 46.03 billion in 2024 and is expected to reach around USD 63.37 billion by 2034, expanding at a CAGR of 3.25% from 2024 to 2034. The North America infectious disease molecular diagnostics market size reached USD 17.39 billion in 2023. It helps in the identification and detection of infectious agents like parasites, fungi, bacteria, and viruses.

The global molecular diagnostics market size accounted for USD 44.68 billion in 2024 and is expected to be worth around USD 61.29 billion by 2033.

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Infectious Disease Molecular Diagnostics Market Key Takeaways

• North America dominated the infectious disease molecular diagnostics market with the largest revenue share of 39% in 2023.
• Asia Pacific is estimated to be the fastest-growing during the forecast period of 2024-2033.
• By product, the reagents segment has held a major revenue share of 71% in 2023.
• By product, the instruments segment is estimated to be the fastest-growing during the forecast period.
• By technology, the PCR segment has captured more than 93% of revenue share in 2023.
• By application, the human papillomavirus (HPV) segment dominated the market in 2023.
• By application, the drug-resistant disease segment is significantly growing during the forecast period.
• By end-use, the diagnostic laboratories segment has contributed more than 79% of revenue share in 2023.
• By end-use, the clinics segment is expected to be the fastest-growing during the forecast period.

U.S. Infectious Disease Molecular Diagnostics Market Size and Growth 2024 to 2034

The U.S. infectious disease molecular diagnostics market size was exhibited at USD 12.17 billion in 2023 and is projected to be worth around USD 17.65 billion by 2034, poised to grow at a CAGR of 3.43% from 2024 to 2034.

North America dominated the infectious disease molecular diagnostics market in 2023. Rising investment in diagnostics and increasing regulatory support help to the growth of the market. Increasing cancer cases and infectious diseases in the United States leads to the growth of the growth of the market.

• In May 2022, in the United States, a completely automated, high-production infectious disease molecular diagnostics was launched by a leading global medical technology company, Becton, Dickinson and Company.

Asia Pacific is estimated to be the fastest-growing during the forecast period of 2024-2033. The rising prevalence of infectious diseases, increasing investments, high-end medical treatments, rising awareness among people, government healthcare benefits, etc., help the growth of the infectious disease molecular diagnostics market in the Asia Pacific region.

• In May 2022, in Gurugram, Haryana, India, the GeneStore Company’s Centre of Excellence for Proteomics and Molecular Diagnostics was launched by GeneStore’s Founder, Anubhav Anusha. This facility is useful for the manufacturing and development of RT-PCR kits for the manufacturing of RT-PCR kits for infectious diseases like Hepatitis C, Dengue, HIV, Japanese Encephalitis Virus, Tuberculosis, etc., that contribute to the high public health burden in India.
• In February 2023, to scale up diagnostics space for infectious diseases and to improve India’s preparedness for current and future pandemics, a program was launched by the Center for Cellular and Molecular Platforms (C-CAMP).

Market Overview

The infectious disease molecular diagnostics market deals with research institutes, diagnostics laboratories, clinics, and laboratories for the applications of infectious diseases, drug-resistance diseases, sepsis, sexually transmitted infections, HPV, gastrointestinal tract infections, meningitis, tuberculosis, respiratory diseases, etc. Infectious disease molecular diagnostics devices include specialized platforms or instruments designed for the identification and detection of infectious agents like parasites, fungi, bacteria, and viruses by molecular methods. Molecular diagnostics technology offers an effective solution for infectious disease diagnostics because it is flexible, agile, and fast. Health systems that regularly use molecular diagnostics will obtain economies of scale, quickly reply to new threats, and maximize limited expertise. These factors help to the growth of the market.

Infectious Disease Molecular Diagnostics Market Growth Factors

• The benefits of infectious disease molecular diagnostics methods include platforms and specialized instruments designed for the identification and detection of infectious agents like parasites, fungi, bacteria, and viruses.
• The applications of infectious disease molecular diagnostics include the identification and detection of diseases like infectious diseases, drug-resistance diseases, sepsis, sexually transmitted infections, etc.
• These are also helpful for the diagnosis of diseases like HPV, gastrointestinal tract infections, meningitis, tuberculosis, respiratory diseases, etc. These factors help to the growth of the infectious disease molecular diagnostics market.

Market Scope

Market Dynamics

Driver

Rising prevalence of cancer and infectious diseases

The rising prevalence of cancer and infectious diseases can help the growth of the market. Infectious disease molecular diagnostics are important for infectious diseases and cancers in less resource settings. In settings with a wide range of possible etiologies and limited resources, infectious disease molecular diagnostics technologies offer an effective solution for cancer and infectious disease diagnostics because they are flexible, agile, fast, sustained, and workable. These factors help to the growth of the infectious disease molecular diagnostics market.

Restraint

Limitations of infectious disease molecular diagnostics

Limitations of infectious disease molecular diagnostics include infection caused by new or rare pathogens, narrow detection spectrum of pathogens, low sensitivity, and long detection cycles. It also includes difficulties in validating orphan testing; it may produce false positive or false negative results, which can hamper the growth of the market. High costs of molecular diagnostics tests have limited access to low and middle-income nations and high costs of consumables, equipment, and reagents. These factors may restrict the growth of the infectious disease molecular diagnostics market.

Opportunity

Future scope of infectious disease molecular diagnostics

Rapid molecular testing, reimbursement concerns of syndromic panels, clinical metagenomics, and next-generation sequencing can be opportunities in the future for infectious disease molecular diagnostics. With increasing infectious diseases, there is a need for new therapeutics and resistance mechanisms. These factors help to the growth of the infectious disease molecular diagnostics market.

Product Insights

The reagents segment dominated the infectious disease molecular diagnostics market in 2023. In infectious disease molecular diagnostics, PCR reagents are highly used. It also includes assays such as fluorescence in situ hybridization or PCR-ELISA, INAAT, INAAT, sequencing, mass spectrometry, etc. These reagents help to detect a molecule that may be in low concentrations that is a risk in the sample or marker of disease taken from a patient. Reagents provide reliability, sensitivity, and specificity in target analytes detection. Control reagents ensure the validity and accuracy of diagnostics assays by acting as quality control materials, positive & negative controls, and calibrators. These factors help to the growth of the reagents segments and contribute to the growth of the infectious disease molecular diagnostics market.

The instruments segment is estimated to be the fastest-growing during the forecast period. Instruments used in infectious disease molecular diagnostics include PCR, in-situ hybridization, INAAT, chips & microarrays, mass spectroscopy, mass spectrometry, sequencing, transcription-mediated amplification, etc. PCR instrument is used to detect the etiologic agents of diseases from clinical samples, and there is no need for culture. It is useful in fastidious microorganisms’ detection or rapid detection of unculturable microorganisms. Sequencing analysis of amplified microbial DNA enables better characterization and identification of pathogens. These factors help the growth of the instruments segment and contribute to the growth of the infectious disease molecular diagnostics market.

Technology Insights

The PCR segment dominated the infectious disease molecular diagnostics market in 2023. PCR technology is the most well-developed molecular diagnostics technique and has a high range of already fulfilled, potential clinical applications of the PCR technique, including antimicrobial resistance profiling, early detection of biothreats, surveillance, evolution of emerging new infections, and specific or broad-spectrum pathogen detection. These factors help to the growth of the PCR segment and contribute to the growth of the market.

Application Insights

The human papillomavirus (HPV) segment dominated the infectious disease molecular diagnostics market in 2023.  The infectious disease molecular diagnostics method is used for the identification of several different types of high-risk HPV that may lead to better diagnosis and treatment plans for patients. In the prevention of cervical cancer, infectious disease molecular diagnostics play an important role in the detection of HPV. These factors help the growth of the human papillomavirus (HPV) segment and contribute to the growth of the infectious disease molecular diagnostics market.

The drug-resistant disease segment is expected to grow significantly during the forecast period. In the drug-resistant disease, infectious disease molecular diagnostics play an important role. The drug-resistant TB is a high risk to worldwide TB control. Rapid infectious disease molecular diagnostic tests are important for improved treatment outcomes, enhanced retention in care, shortened time to treatment initiation, and earlier diagnosis. These factors help the growth of the drug-resistant disease segment and contribute to the growth of the infectious disease molecular diagnostics market.

End-use Insights

The diagnostic laboratories segment dominated the infectious disease molecular diagnostics market in 2023. The benefits of diagnostics laboratories include satisfaction with the services provided, reduced requirements for re-testing by saving money and time, confidence in personnel performing tests, and the surety of genuine reports from accurately calibrated testing. These factors help to the growth of the diagnostic laboratories segment and contribute to the growth of the market.

The clinics segment is estimated to be the fastest-growing during the forecast period. The benefits of clinics include effective disease management, being ideal for effective care, having experienced staff, being less expensive, providing immediate assistance, etc. These factors help the growth of the clinics segment and contribute to the growth of the infectious disease molecular diagnostics market.

Infectious Disease Molecular Diagnostics Market Companies

• Sysmex Corporation
• Siemens Healtineers AG
• Qiagen
• Grifols S.A.
• Illumina, Inc.
• Hologic, Inc. (Gen-Probe)
• Becton, Dickinson and Company
• Agilent Technologies, Inc.
• Bio-Rad Laboratories, Inc.
• F. Hoffmann-La Roche Ltd
• bioMerieux SA
• Danaher Corporation
• Abbott

Recent Developments

• In February 2023, Thermo Fischer Scientific launched PCR kits for the detection of infectious diseases in India. These kits are used for patient care, disease diagnosis and screening, monitoring of disease progression, therapeutic response, and genetic risk factor identification. 
• In February 2024, a share purchase agreement to acquire molecular diagnostics innovator ELITech Group was announced by Bruker Corporation.

Segments Covered in the Report

By Product

• Instruments
• Reagents
• Services

By End-use

• Hospitals
• Clinics
• Diagnostics Laboratories
• Research Institutes

By Technology

• Polymerase chain reaction (PCR)
  • PCR, by Type
    • Multiplex PCR
    • Other PCR
  • PCR, by Product
    • Instruments
    • Reagents
    • Services
• In Situ Hybridization
  • Instruments
  • Reagents
  • Services
• Isothermal Nucleic Acid Amplification Technology (INAAT)
  • Instruments
  • Reagents
  • Services
• Chips and Microarrays
  • Instruments
  • Reagents
  • Services
• Mass Spectrometry
  • Instruments
  • Reagents
  • Services
• Sequencing
  • Instruments
  • Reagents
  • Services
• Transcription Mediated Amplification
  • Instruments
  • Reagents
  • Services
• Others
  • Instruments
  • Reagents
  • Services

By Application

• Respiratory Diseases
• Tuberculosis
• Meningitis
• Gastrointestinal Tract Infections
• HPV
• Sexually Transmitted Infections
• Sepsis
• Drug Resistance Diseases
• Other Infectious Diseases

Respiratory Diseases

• Respiratory Diseases, By Product
  • Instruments
  • Reagents
  • Services
• Respiratory Diseases, By End Use
  • Hospitals
  • Clinics
  • Diagnostics Laboratories
  • Research Institutes
• Respiratory Diseases, By Technology
  • Polymerase chain reaction (PCR)
  • In Situ Hybridization
  • Isothermal Nucleic Acid Amplification Technology (INAAT)
  • Chips and Microarrays
  • Mass Spectrometry
  • Sequencing
  • Transcription Mediated Amplification
  • Others

Tuberculosis

• Tuberculosis, By Product
  • Instruments
  • Reagents
  • Services
• Tuberculosis, By End Use
  • Hospitals
  • Clinics
  • Diagnostics Laboratories
  • Research Institutes
• Tuberculosis, By Technology
  • Polymerase chain reaction (PCR)
  • In Situ Hybridization
  • Isothermal Nucleic Acid Amplification Technology (INAAT)
  • Chips and Microarrays
  • Mass Spectrometry
  • Sequencing
  • Transcription Mediated Amplification
  • Others

Meningitis

• Meningitis, By Product
  • Instruments
  • Reagents
  • Services
• Meningitis, By End Use
  • Hospitals
  • Clinics
  • Diagnostics Laboratories
  • Research Institutes
• Meningitis, By Technology
  • Polymerase chain reaction (PCR)
  • In Situ Hybridization
  • Isothermal Nucleic Acid Amplification Technology (INAAT)
  • Chips and Microarrays
  • Mass Spectrometry
  • Sequencing
  • Transcription Mediated Amplification
  • Others

Gastrointestinal Tract Infections

• Gastrointestinal Tract Infections, By Product
  • Instruments
  • Reagents
  • Services
• Gastrointestinal Tract Infections, By End Use
  • Hospitals
  • Clinics
  • Diagnostics Laboratories
  • Research Institutes
• Gastrointestinal Tract Infections, By Technology
  • Polymerase chain reaction (PCR)
  • In Situ Hybridization
  • Isothermal Nucleic Acid Amplification Technology (INAAT)
  • Chips and Microarrays
  • Mass Spectrometry
  • Sequencing
  • Transcription Mediated Amplification
  • Others
• HPV
  • HPV, By Product
  • Instruments
  • Reagents
  • Services
• HPV, By End Use
  • Hospitals
  • Clinics
  • Diagnostics Laboratories
  • Research Institutes
• HPV, By Technology
  • Polymerase chain reaction (PCR)
  • In Situ Hybridization
  • Isothermal Nucleic Acid Amplification Technology (INAAT)
  • Chips and Microarrays
  • Mass Spectrometry
  • Sequencing
  • Transcription Mediated Amplification
  • Others

Sexually Transmitted Infections

• Sexually Transmitted Infections By Product
  • Instruments
  • Reagents
  • Services
• Sexually Transmitted Infections, By End Use
  • Hospitals
  • Clinics
  • Diagnostics Laboratories
  • Research Institutes
• Sexually Transmitted Infections, By Technology
  • Polymerase chain reaction (PCR)
  • In Situ Hybridization
  • Isothermal Nucleic Acid Amplification Technology (INAAT)
  • Chips and Microarrays
  • Mass Spectrometry
  • Sequencing
  • Transcription Mediated Amplification
  • Others

Sepsis

• Sepsis, By Product
  • Instruments
  • Reagents
  • Services
• Sepsis, By End Use
  • Hospitals
  • Clinics
  • Diagnostics Laboratories
  • Research Institutes
• Sepsis, By Technology
  • Polymerase chain reaction (PCR)
  • In Situ Hybridization
  • Isothermal Nucleic Acid Amplification Technology (INAAT)
  • Chips and Microarrays
  • Mass Spectrometry
  • Sequencing
  • Transcription Mediated Amplification
  • Others

Drug Resistance Disease

• Drug Resistance Disease, By Product
  • Instruments
  • Reagents
  • Services
• Drug Resistance Disease, By End Use
  • Hospitals
  • Clinics
  • Diagnostics Laboratories
  • Research Institutes
• Drug Resistance Disease, By Technology
  • Polymerase chain reaction (PCR)
  • In Situ Hybridization
  • Isothermal Nucleic Acid Amplification Technology (INAAT)
  • Chips and Microarrays
  • Mass Spectrometry
  • Sequencing
  • Transcription Mediated Amplification
  • Others

By Geography

• North America
• Asia Pacific
• Europe
• Latin America
• Middle East & Africa