Infectious Disease Molecular Diagnostics Market Size, Share & Trends Analysis Report By Product (Instruments, Reagents), By Technology (PCR, ISH, INAAT), By End-use, By Application, By Region, And Segment Forecasts, 2021 - 2028

Report Overview 

The global infectious disease molecular diagnostics market size was valued at USD 32.4 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 3.0% from 2020 to 2028. The growth can be attributed to the growing use of molecular diagnostics in infection detection, the rising geriatric population, and the increasing demand for point-of-care molecular diagnostics. The outbreak of COVID-19 is anticipated to act as a key driver.

The global geriatric population is increasing. Over 727.0 million people globally were categorized in the age group 65 and above. The geriatric population is more susceptible to COVID-19 owing to multimorbidity, decreased immune function, and physiological changes associated with aging. According to CDC in 2021, 80% of COVID-19 related deaths were among people aged over 65. Thus, this group has to be tested continuously to avoid severe infections, which creates growth opportunities for molecular diagnostic tests in regions such as Russia, Japan, and the U.S. that have the highest elderly people globally.

The infectious disease molecular diagnostics test menus cannot afford to be static or superficial due to the diverse nature of infectious diseases and the building resistance of causative agents. For instance, the coronavirus outbreak in China was declared a global health emergency by the WHO in January 2020. RT-PCRs and sequencing tools were used in the identification and characterization of the virus.

An increase in external funding to conduct clinical studies in infectious disease molecular diagnostics is expected to drive the market. Funding plays a significant role in the product development process. For instance, in October 2019, Sense Biodetection Limited received an investment of USD 16.85 million for POC molecular diagnostic development with an initial focus on infectious diseases such as influenza diagnostics.

Product Insights

The reagents segment dominated the market for infectious disease molecular diagnostics and accounted for the largest revenue share of 66.7% in 2020 attributable to the introduction and commercialization of new reagents and the high uptake rate when compared to instruments. Novel reagent launches have risen exponentially due to increased demand for PCR reagents. For instance, in March 2021, PCR Biosystems announced the launch of its IsoFast Bst Polymerase reagents that support sensitive, robust, and rapid amplification of RNA & DNA, which enables faster testing procedures.

The instrument segment is projected to grow at a lucrative rate over the forecast period. Acquisition of companies for portfolio expansion in the instrument segment is becoming a key strategy adopted by major players. For instance, in March 2021, Roche announced the acquisition of multiplex molecular diagnostics company GenMark Diagnostics for USD 1.8 billion. This aids the infectious disease molecular diagnostics portfolio expansion strategy of Roche ensuring continuous revenue generation in the coming years by improving patient care.

Technology Insights

The PCR segment dominated the market for infectious disease molecular diagnostics and accounted for the largest revenue share of 90.4% in 2020. This growth can be attributed to its conventional use in the diagnosis of infectious diseases and advancements in the technology to detect novel infectious diseases.  Increasing use of high-throughput PCR technology to detect coronavirus is expected to drive segment growth.

In January 2021, QuantuMDx Group invested USD 15.0 million for expediting the production of Q-POC, which is a SARS-CoV-2 molecular diagnostics test that can detect influenza A & B and SARS-CoV-2. This investment by the company displays unmet diagnostic needs that are getting fulfilled with such investments, thereby propelling segment growth at a lucrative rate.

Apart from conventional culture growth methods, the most recent change in DNA amplification techniques has led to the introduction and development of Transcription-mediated Amplification (TMA). Proprietary work for the development of this technology has been undertaken by Gen-Probe, which is now a part of Hologic, Inc. The use of TMA has improved the diagnosis of infectious organisms such as Chlamydia trachomatis and Neisseria gonorrhoeae.

Application Insights

The Human Papillomavirus (HPV) segment is projected to witness a lucrative CAGR of 9.9% over the forecast period. This is attributable to the increased incidence rate of the disease. Since the infection leads to cervical cancer, the interest of major players in the detection of the disease with advanced molecular diagnostics is high. Major players like Roche (Cobas HPV Test) and Abbott (Real-Time High-Risk HPV Assay) have assays directed toward the detection of HPV.

Increased focus on drug-resistant infections due to their rising prevalence is supporting the lucrative market share of the segment. In addition, 57.0% of patients were reported to have colonized MDR bacteria during post-acute care admission. Prolonged hospitalizations are also a source of MDR bacterial infections. The rate of getting a novel resistant gram-negative bacillus was 13.6% per 1,000 patient days of hospitalization. 

End-use Insights

The diagnostic laboratories segment dominated the market for infectious disease molecular diagnostics and accounted for the largest revenue share of 76.4% in 2020 owing to high procedure volumes and market penetration. The rising number of initiatives undertaken by the government for the provision of various services, such as diagnostic test reimbursements, is another major factor anticipated to drive the market for infectious disease molecular diagnostics.

The clinics' segment is expected to witness the fastest growth rate over the forecast period. This is attributable to high-quality healthcare and convenience. Moreover, the patient visits to the clinics for preventive care to which infectious disease testing is a crucial part for the segment growth, the presence of high-quality molecular diagnostics to identify infections thereby becomes a significant factor for patients in choosing clinics. Moreover, the cost-effectiveness of molecular diagnostics further supports the revenue generation capabilities of clinics.

Regional Insights

North America dominated the market for infectious disease molecular diagnostics and accounted for the largest revenue share of 34.9% in 2020. This is attributed to growing regulatory support and increasing investment in diagnostics is anticipated to fuel growth. The increasing need for molecular testing to detect infectious diseases, for early detection of infections in patients with underlying medical conditions such as diabetes, and the rising number of drug-resistant infections are factors projected to accelerate the growth of the market for infectious disease molecular diagnostics.

In Asia Pacific, the market for infectious disease molecular diagnostics is expected to grow fast over the forecast period due to rising investments and an increasingly high prevalence of infectious diseases. Positive changes, such as healthcare benefits being provided by governments, increased awareness among the population, and the urge to avail of high-end medical treatment is also expected to drive the market for infectious disease molecular diagnostics in the region. The COVID-19 pandemic has put immense strain on molecular diagnostics in this region, due to high incidence and densely populated areas. Nearly half of the global population resides in this region, led by China and India. 

Key Companies & Market Share Insights

The market for infectious disease molecular diagnostics is competitive. Subsequently, manufacturers are compelled to design innovative products in terms of speed, accuracy, specificity, precision, and other parameters to gain a competitive edge. For instance, in December 2020, Bruker Corporation announced the launch of a winter four-plex PCR panel called FluoroType that can detect RSV, Flu, and SARS-CoV-2.

The internal substitution rate is rising steadily attributable to the launch of new products. For instance, in February 2021, BD announced the launch of its Influenza A+B and SARS-CoV-2 in a single test with a CE mark. The product received a EUA from FDA in the same month. The ability of the product to test for both Flu and COVID-19 gives it a competitive advantage over its rivals. Some of the prominent players in the infectious disease molecular diagnostics market include:

• Abbott

• Danaher Corporation

• bioMérieux SA

• F. Hoffmann-La Roche Ltd

• Bio-Rad Laboratories, Inc.

• Agilent Technologies, Inc.

• Becton, Dickinson and Company

• Hologic, Inc. (Gen-Probe)

• Illumina, Inc.

• Grifols S.A.

• Qiagen

• Siemens Healthineers AG

• Sysmex Corporation

Infectious Disease Molecular Diagnostics Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2028. For the purpose of this study, Grand View Research has segmented the global infectious disease molecular diagnostics market report on the basis of the product, technology, end-use, application, and region:

• Product Outlook (Revenue, USD Million, 2017 - 2028)

  • Instruments

  • Reagents

  • Services

• End-use Outlook (Revenue, USD Million, 2017 - 2028)

  • Hospitals

  • Clinics

  • Diagnostics Laboratories

  • Research Institutes

• Technology Outlook (Revenue, USD Million, 2017 - 2028)

  • 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

• Application Outlook (Revenue, USD Million, 2017 - 2028)

  • Respiratory Diseases

  • Tuberculosis

  • Meningitis

  • Gastrointestinal Tract Infections

  • HPV

  • Sexually Transmitted Infections

  • Sepsis

  • Drug Resistance Diseases

  • Other Infectious Diseases

• Respiratory Diseases Outlook (Revenue, USD Million, 2017 - 2028)

  • Respiratory Diseases, By Product (Revenue, USD Million, 2017 - 2028)

    • Instruments

    • Reagents

    • Services

  • Respiratory Diseases, By End Use (Revenue, USD Million, 2017 - 2028)

    • Hospitals

    • Clinics

    • Diagnostics Laboratories

    • Research Institutes

  • Respiratory Diseases, By Technology, (Revenue, USD Million, 2017 - 2028) (Number of Tests Performed from 2017 - 2028 in Million)

    • Polymerase chain reaction (PCR)

    • In Situ Hybridization

    • Isothermal Nucleic Acid Amplification Technology (INAAT)

    • Chips and Microarrays

    • Mass Spectrometry

    • Sequencing

    • Transcription Mediated Amplification

    • Others

• Tuberculosis Outlook (Revenue, USD Million, 2017 - 2028)

  • Tuberculosis, By Product (Revenue, USD Million, 2017 - 2028)

    • Instruments

    • Reagents

    • Services

  • Tuberculosis, By End Use (Revenue, USD Million, 2017 - 2028)

    • Hospitals

    • Clinics

    • Diagnostics Laboratories

    • Research Institutes

  • Tuberculosis, By Technology, (Revenue, USD Million, 2017 - 2028) (Number of Tests Performed from 2017 - 2028 in Million)

    • Polymerase chain reaction (PCR)

    • In Situ Hybridization

    • Isothermal Nucleic Acid Amplification Technology (INAAT)

    • Chips and Microarrays

    • Mass Spectrometry

    • Sequencing

    • Transcription Mediated Amplification

    • Others

• Meningitis Outlook (Revenue, USD Million, 2017 - 2028)

  • Meningitis, By Product (Revenue, USD Million, 2017 - 2028)

    • Instruments

    • Reagents

    • Services

  • Meningitis, By End Use (Revenue, USD Million, 2017 - 2028)

    • Hospitals

    • Clinics

    • Diagnostics Laboratories

    • Research Institutes

  • Meningitis, By Technology, (Revenue, USD Million, 2017 - 2028) (Number of Tests Performed from 2017 - 2028 in Million)

    • 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 Outlook (Revenue, USD Million, 2017 - 2028)

  • Gastrointestinal Tract Infections, By Product (Revenue, USD Million, 2017 - 2028)

    • Instruments

    • Reagents

    • Services

  • Gastrointestinal Tract Infections, By End Use (Revenue, USD Million, 2017 - 2028)

    • Hospitals

    • Clinics

    • Diagnostics Laboratories

    • Research Institutes

  • Gastrointestinal Tract Infections, By Technology, (Revenue, USD Million, 2017 - 2028) (Number of Tests Performed from 2017 - 2028 in Million)

    • Polymerase chain reaction (PCR)

    • In Situ Hybridization

    • Isothermal Nucleic Acid Amplification Technology (INAAT)

    • Chips and Microarrays

    • Mass Spectrometry

    • Sequencing

    • Transcription Mediated Amplification

    • Others

• HPV Outlook (Revenue, USD Million, 2017 - 2028)

  • HPV, By Product (Revenue, USD Million, 2017 - 2028)

    • Instruments

    • Reagents

    • Services

  • HPV, By End Use (Revenue, USD Million, 2017 - 2028)

    • Hospitals

    • Clinics

    • Diagnostics Laboratories

    • Research Institutes

  • HPV, By Technology, (Revenue, USD Million, 2017 - 2028) (Number of Tests Performed from 2017 - 2028 in Million)

    • 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 Outlook (Revenue, USD Million, 2017 - 2028)

  • Sexually Transmitted Infections, By Product (Revenue, USD Million, 2017 - 2028)

    • Instruments

    • Reagents

    • Services

  • Sexually Transmitted Infections, By End Use (Revenue, USD Million, 2017 - 2028)

    • Hospitals

    • Clinics

    • Diagnostics Laboratories

    • Research Institutes

  • Sexually Transmitted Infections, By Technology, (Revenue, USD Million, 2017 - 2028) (Number of Tests Performed from 2017 - 2028 in Million)

    • Polymerase chain reaction (PCR)

    • In Situ Hybridization

    • Isothermal Nucleic Acid Amplification Technology (INAAT)

    • Chips and Microarrays

    • Mass Spectrometry

    • Sequencing

    • Transcription Mediated Amplification

    • Others

• Sepsis Outlook (Revenue, USD Million, 2017 - 2028)

  • Sepsis, By Product (Revenue, USD Million, 2017 - 2028)

    • Instruments

    • Reagents

    • Services

  • Sepsis, By End Use (Revenue, USD Million, 2017 - 2028)

    • Hospitals

    • Clinics

    • Diagnostics Laboratories

    • Research Institutes

  • Sepsis, By Technology, (Revenue, USD Million, 2017 - 2028) (Number of Tests Performed from 20217 - 2028 in Million)

    • 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 Outlook (Revenue, USD Million, 2017 - 2028)

  • Drug Resistance Disease, By Product (Revenue, USD Million, 2017 - 2028)

    • Instruments

    • Reagents

    • Services

  • Drug Resistance Disease, By End Use (Revenue, USD Million, 2017 - 2028)

    • Hospitals

    • Clinics

    • Diagnostics Laboratories

    • Research Institutes

  • Drug Resistance Disease, By Technology, (Revenue, USD Million, 2017 - 2028) (Number of Tests Performed from 2017 - 2028 in Million)

    • Polymerase chain reaction (PCR)

    • In Situ Hybridization

    • Isothermal Nucleic Acid Amplification Technology (INAAT)

    • Chips and Microarrays

    • Mass Spectrometry

    • Sequencing

    • Transcription Mediated Amplification

    • Others

• Regional Outlook (Revenue, USD Million, 2017 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE