Molecular Diagnostic for Infectious Diseases Market Report | Global Forecasts to 2030

The molecular diagnostic for infectious diseases market was valued at US$ 6,883.03 million in 2022 and is projected to reach US$ 17,614.44 million by 2030. It is estimated to register a CAGR of 12.5% during 2022–2030.

Market Insights and Analyst View:

The molecular diagnostic for infectious diseases market size is flourishing with the increasing cases of infectious diseases among humans and animals. Various emerging infectious diseases such as HIV, SARS, and dengue fever are fueling the need to develop diagnostic techniques for early treatment of these diseases. The increase in the use of point-of-care diagnostics for infectious diseases is driving the growth of the market. The rise in the demand for home healthcare encourages manufacturers to commercialize user-friendly portable products, and the emergence of smartphone-oriented healthcare solutions, digital technologies, and embedded vision-based solutions further influence the point-of-care testing (POCT) market. Additionally, the significance of POC diagnostics in environmental monitoring and public health, the number of CLIA-waived POC tests, the increase in technological advancement, and the surge in healthcare expenditure positively affect demand for POCT.     

Growth Drivers and Challenges:

Diagnostic technologies that can detect emerging infectious animal diseases at an early stage are essential for reducing economic losses associated with outbreaks of such diseases. Polymerase chain reaction (PCR) remains the most widely used molecular assay globally for detecting animal pathogens. Diagnostic methods of this type are easy to use, cost-effective, highly sensitive, and specific, with the ability to detect at a high volume.

Point-of-care diagnostics (POCDs) are simple, rapid, and portable diagnostic devices that can detect the disease status at the field level. In recent years, real-time PCR (qPCR) has been transitioned into a POCD platform. These fully automated platforms combine nucleic acid extraction, thermal cycling, and on-site reporting results. For instance, MiniLab from Enigma Diagnostics is a molecular diagnostic platform of 10–35 kg that is carried at the field level and used for validating African swine fever virus, avian influenza virus, classical swine fever virus, and foot-and-mouth disease virus for research purposes. The genesig detection kits of Primerdesign Ltd, UK, supplies lyophilized qPCR assay kits for the diagnosis of 62 bovine, 42 equine, 47 porcine, 60 avian, 40 canine, and 26 feline pathogens for research purposes. Similarly, Boster offers Bosterbio qPCR kits to detect up to 48 individual or pooled samples. It is used for gene expression profiling, target DNA quantification, microbial detection, viral or bacterial pathogen load determination, and evaluation of primer pair performance for probe-based qPCR.

Thus, molecular diagnostics methods such as PCR and qPCR to diagnose bacterial, viral, fungal, and parasitic infections in animals can replace conventional methods such as serological, microscopic, and culture-based techniques.

The outcomes of molecular testing rely on sampling and testing processes and the technician’s skill sets. A few test procedures may also take a longer time to produce results. At times, test kits may show false positive or negative results. Thus, uncertainties associated with molecular tests hamper their adoption, especially in diagnostics and treatment of life-threatening infectious diseases. The limited awareness of point-of-care tests also hinders the market growth. In addition, the cost of molecular testing for indications such as viral infections, and the shortage of supplies hamper the molecular diagnostics for infectious diseases market growth.  

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Molecular Diagnostic for Infectious Diseases Market: Strategic Insights

Molecular Diagnostic for Infectious Diseases Market

• 
  CAGR (2022 - 2030)

  12.5%
• Market Size 2022
  US$ 6.88 Billion
• Market Size 2030
  US$ 17.61 Billion

Market Dynamics

GROWTH DRIVERS

• Surging Prevalence of Infectious Disease Globally
• Rising Application of Molecular Diagnostics in Veterinary Infectious Diseases

FUTURE TRENDS

• Diagnostics for Infectious Diseases in Personalized Medicine

OPPORTUNITIES

• Advancement in Molecular Diagnostics Technologies

Key Players

• F. Hoffmann-La Roche Ltd
• Abbott
• Thermo Fisher Scientific Inc
• bioMérieux SA
• Danaher
• Digene and International Murex Technologies
• Hologic
• Siemens Healthcare Private Limited
• Bruker Corporation
• Molzym

Regional Overview

• North America
• Europe
• Asia-Pacific
• South and Central America
• Middle East and Africa

Market Segmentation

Type

• Point-of-Care Testing and Laboratory Testing

End User

• Point-of-Care Testing

Application

• Point-of-Care Testing

Disease Type

• Point-of-Care Testing

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Report Segmentation and Scope:

The molecular diagnostic for infectious diseases market is divided on the basis of type, disease type, infection type, application, and end user. Based on type, the market is classified into point-of-care testing and laboratory testing. The molecular diagnostic for infectious diseases market, by end user, is bifurcated into point-of-care testing and laboratory testing. Point-of-care testing is further bifurcated into human testing and vet testing. Similarly, laboratory testing is further bifurcated into human testing and vet testing. The molecular diagnostic for infectious diseases market, by application, is bifurcated into point-of-care testing and laboratory testing. Point-of-care testing is further segmented into detection of a single pathogen, detection of two or more pathogens, evaluation of emerging novel infections, surveillance and early detection of biothreat agents and diseases-related biomarkers, and antimicrobial resistance profiling. Laboratory testing is further segmented into patient stratification, drug regimen selection, toxicity avoidance, therapeutic monitoring, and detection of predisposition to disease. The molecular diagnostic for infectious diseases market, by disease type, is bifurcated into point-of-care testing and laboratory testing. Point-of-care testing is further segmented into detection of a sepsis, prosthetic joint infection, endocarditis, STDs, mononucleosis, group A streptococcus (GAS), and others. Laboratory testing is further segmented into sepsis, prosthetic joint infection, endocarditis, STDs, chlamydia, gastrointestinal infection, tuberculosis, H1N1 virus, and others. The molecular diagnostic for infectious diseases market, by infection type, is bifurcated into point-of-care testing and laboratory testing. Point-of-care testing is further segmented into bacteria, viral, fungi, and others. Laboratory testing is further segmented into bacteria, viral, fungi, and others. Based on geography, the market is divided into North America (the US, Canada, and Mexico), Europe (the UK, Germany, France, Italy, Spain, Luxembourg, Austria, Belgium, the Netherlands, and the Rest of Europe), Asia Pacific (China, Japan, India, South Korea, Indonesia, Malaysia, and the Rest of Asia Pacific), the Middle East & Africa (the UAE, Saudi Arabia, South Africa, and the Rest of Middle East & Africa), and South & Central America (Brazil and the Rest of South & Central America).

Segmental Analysis:

Based on type, the molecular diagnostic for infectious diseases market is segmented into point-of-care testing and laboratory testing. In 2022, the laboratory testing segment held a larger share of the market. The point-of-care testing segment is expected to grow at a faster rate during 2022–2030. The identification and differentiation of microorganisms principally rely on microbial morphology and growth variables. Molecular diagnostics are an effective, efficient, and precise tool for detecting and monitoring infectious diseases such as HIV and HPV. PCR-based systems that detect the etiologic agents of disease directly from clinical samples have been useful in rapidly detecting unculturable or fastidious microorganisms. In addition, sequence analysis of amplified microbial DNA allows for identifying and characterizing pathogens. Isothermal nucleic acid amplification technology (INAAT) has opened new avenues of microbial detection and better characterization such that growth is no longer required for microbial identification. The use of molecular diagnostics for infectious diseases in research institutes is increasing.

Key players are updating their product portfolio for PCR and other instruments with increased R&D initiatives for developing novel kits to target emerging diseases. In December 2021, Roche launched infectious disease tests for use on the cobas 5800 System in countries that accept the CE Mark. The launch of the cobas omni Utility Channel enables laboratory professionals to flexibily run CE-IVD assays and design their laboratory-developed tests (LDTs).

Molecular Diagnostic for Infectious Diseases Market, by Type – 2022 and 2030

Access Data

Based on application, the molecular diagnostic for infectious diseases market is bifurcated into point-of-care testing and laboratory testing. Point-of-care testing is further segmented into detection of a single pathogen, detection of two or more pathogens, evaluation of emerging novel infections, surveillance and early detection of biothreat agents and diseases-related biomarkers, and antimicrobial resistance profiling. Laboratory testing is further segmented into patient stratification, drug regimen selection, toxicity avoidance, therapeutic monitoring, and detection of predisposition to disease. According to an article published in the National Library of Medicine, it is estimated that ~10 million people yearly die due to antimicrobial resistance (AMR). In AMR, certain bacteria develop resistance to antibiotics that are given to treat bacterial infections. To detect AMR, WHO has planned to emphasize effective, fast, and low-cost diagnostic technologies for guiding the appropriate use of antibiotics in humans and animal medicine. This plan is proposed to improve the accuracy and speed of diagnosis of AMR using POC testing techniques. Increasing focus on developing and using POC testing tools for accurate diagnosis of AMR is fueling the market for the segment.

Multiplex POC testing is used in critical care to detect two or more pathogens. In critical care, multiplex POC tests provide higher accuracy for actionable decision making, due to which the patient can receive pathogen-specific treatment. ID NOW, cobas Liat influenza A/B/RSV assay, and GeneXpert Xpress Flu/RSV are the three products clinically approved and available for detecting pathogens. The availability of multiplex POC testing for detecting pathogens is fueling the market for the segment.

Regional Analysis:

Based on geography, the molecular diagnostic for infectious diseases market is divided into North America, Europe, Asia Pacific, the Middle East & Africa, and South & Central America. North America is the largest contributor to the growth of the market, and Asia Pacific is expected to be the fastest-growing market in the coming years. The increasing acceptance of technologically advanced products, a rise in research and development activities, the presence of large healthcare businesses, and the growing use of molecular diagnostics kits for infectious disease diagnosis are among the key factors propelling the growth of the molecular diagnostics for infectious diseases market in North America. The molecular diagnostics for infectious diseases market growth in the US is primarily driven by the increasing prevalence of infectious disease, rising geriatric population, and multiple product launches by key players. Aging is a prominent risk factor for renal diseases. According to a study published by the Population Reference Bureau in 2020, the population of individuals aged 65 and above was 55 million in the US in 2020, and the number is expected to hike up to 95 million by 2060. Regulatory agencies in the US are devising favorable policies for the development of point-of-care (POC) products for the diagnosis and treatment of various indications. For instance, in March 2021, the US Food Drug Administration (FDA) authorized Binx Health IO CT/NG Assay for community-based clinics, urgent care settings, and outpatient healthcare facilities; it is the first POC testing products for diagnosing chlamydial and gonorrheal infections. In May 2022, Becton and Dickinson (BD), one of the leading global medical technology companies, announced the launch of its new, fully automated, high-throughput molecular diagnostics platform for infectious diseases for the market in the US. The new BD COR MX instrument was launched as an analytical instrument option for the BD COR platform, with 510(k) clearance from the FDA. The BD CTGCTV2 molecular assay, the first test available on the new system, is a single test that detects the three most prevalent non-viral sexually transmitted infections (STIs)—Neisseria gonorrhoeae (GC), Chlamydia trachomatis (CT), and Trichomonas vaginalis (TV).

Industry Developments and Future Opportunities: 

Various initiatives by key players operating in the Molecular Diagnostic for Infectious Diseases Market are listed below:

1. In April 2023, Bruker introduced new mycobacteria and fungi IVD solutions for MALDI Biotyper, and a Novel LiquidArray Gastrointestinal Syndromic Panel. With the introduction of new IVD workflows, kits, software, and reference libraries for mycobacteria and fungi, the company further expanded the applications of the established MALDI Biotyper platform. This creates additional value for all current and future customers. The new LiquidArray Gastrointestinal is a next-generation syndromic panel with amazing pathogen coverage. It is ideal for laboratories interested in a broad screening approach to detect most pathogens in one run.
2. In February 2023, Thermo Fisher Scientific launched PCR kits for infectious disease detection in India. Thermo Fisher Scientific announced that its Applied Biosystems TaqPath PCR kits for infectious diseases such as multi-drug-resistant tuberculosis (MTB MDR), M. tuberculosis complex (MTB), hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), and for genetic analysis (HLA B27) have received licensing rights by the Central Drugs Standard Control Organisation (CDSCO) and will be manufactured in India in association with Mylab Discovery Solutions. 

Competitive Landscape and Key Companies:

A few of the prominent players operating in the infectious disease molecular diagnostics market are F.Hoffmann-La Roche Ltd, Abbott Laboratories, Thermo Fisher Scientific Inc, bioMerieux SA, Danaher Corp, Hologic Inc, Siemens Healthineers AG, Bruker Corp, Molzym GmbH & Co KG, and DiaSorin SpA. These companies focus on new product launches and geographic expansions to meet the growing consumer demand worldwide and increase their product range in specialty portfolios. Their global presence allows them to serve a large set of customers, subsequently allowing them to expand their market share.

Molecular Diagnostic for Infectious Diseases Market Report Scope