Infectious Disease Diagnostics Market Assessment, By Product [Reagents, Kits, and Consumables, Instruments, Software], By Sample Type [Blood and Components, Urine, Other], By Setting [Laboratory Testing, Point-of-Care Testing], By Type of Testing [Molecul

Infectious Disease Diagnostics Market Assessment, By Product [Reagents, Kits, and Consumables, Instruments, Software], By Sample Type [Blood and Components, Urine, Other], By Setting [Laboratory Testing, Point-of-Care Testing], By Type of Testing [Molecular Tests, Serological Tests, Antigen Tests, Culture Tests, Blood Tests, Imaging Tests], By Indication [Bacterial Infections, Viral Infections, CNS Infections, Cardiovascular Infections, Fungal Infections, GI Infections, Sexually Transmitted Diseases, Other], By End-user [Diagnostic Laboratories, Academic And Medical Institutes, Hospitals, Ambulatory Clinics, Home Healthcare, Other], By Region, Opportunities and Forecast, 2017-2031F

Global infectious disease diagnostics market is projected to witness a CAGR of 6.17% during the forecast period 2024-2031, growing from USD 27.78 billion in 2023 to USD 44.85 billion in 2031F. Infectious disease diagnostics involve the identification of the causative agent of an infectious disease, such as bacteria, viruses, fungi, or parasites, in a patient with a compatible clinical illness. The process is essential for determining the most effective treatment. Diagnostic methods include laboratory tests, such as blood, urine, and tissue samples, as well as imaging scans to reveal evidence of the microbe causing the disease. The detection of the pathogen can be done through cultivation, isolation in cell culture, and identification biochemically, antigenically, or genetically. Additionally, specific immune responses and molecular technologies are used for accurate diagnosis, especially in low-resource settings.

The infectious disease diagnostics market is expected to thrive under the influence of factors like growing prevalence of infectious diseases, availability of a diverse range of diagnostic tests, and the increasing preference for point-of-care diagnostic testing techniques. The development of innovative disease diagnosis and monitoring technologies by key players in the industry is greatly contributing to the expansion of the market. Increasing investments for improving disease model analysis, and the strategic activities of key players is also contributing to the market growth.

However, the growth of infectious disease diagnostics market may be hindered by a lack of awareness of novel diagnostic solutions, absence of compiled regulatory guidelines, and lower positivity rates due to inferior laboratory conditions. Market players are actively involved in strategic product launches and business tactics to expand the market.

In February 2023, Thermo Fisher Scientific recently announced the release of Applied Biosystems TaqPath PCR kits designed specifically for diagnosing infectious diseases. These kits are effective in detecting diseases such as Multi-Drug Resistant Tuberculosis (MDR-TB), M. Tuberculosis complex (MTB), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human Immunodeficiency Virus (HIV). Moreover, they can be used for genetic analysis (HLA B27). The Central Drugs Standard Control Organization (CDSCO) has approved these kits, and they will be produced in India in partnership with Mylab Discovery Solutions, a leading healthcare company.

Growing Prevalence of Infectious Diseases

Infectious diseases have been on the rise in the 21st century, with outbreaks such as COVID-19, SARS, and swine flu with a devastating impact on lives and livelihoods globally. Factors contributing to the emergence and spread of infectious diseases include ecological, environmental, or demographic factors that place people in increased contact with a previously unfamiliar microbe, as well as increasing prevalence of these factors. The growing prevalence of infectious diseases is directly proportional to the demand for infectious disease diagnostic solutions, further expanding the market. Infectious diseases are one of the leading causes of death globally and a suitable treatment plan be effectively utilized through efficient diagnostics.

According to the World Economic Forum, annually, infectious diseases, such as malaria, HIV, and tuberculosis, are the cause of death for over 2.8 million people, and more than 1.7 billion people require treatment for at least one neglected tropical disease, globally. In addition, epidemic-prone infectious diseases such as COVID-19 and Ebola are anticipated to claim thousands to millions of lives before control and preventive measures can be effective.

Availability of a Diverse Range of Diagnostic Tests

A diverse range of diagnostic tests is available for infectious diseases, including laboratory tests, rapid diagnostic tests, serological testing, and polymerase chain reaction (PCR) testing. These tests can detect antibodies, antigens, and specific microorganisms to aid in the diagnosis of infectious diseases. Laboratory tests use samples of blood, urine, sputum, or other fluids to identify microorganisms through staining, culturing, or molecular methods. Rapid diagnostic tests, which are available in various formats and platforms, provide rapid results to inform clinical decision-making and enable point-of-care management. Serological testing looks for antibodies to verify previous exposure, while PCR testing detects the genetic material of microorganisms. These diverse testing methods play a crucial role in accurate and timely diagnosis of infectious diseases. The diverse range is anticipated to contribute to the expansion of the market. Market players offer a variety of rapid diagnostic kits for different diseases.

In July 2023, EMPE Diagnostics launched mfloDx MDR-TB test kit for rapid diagnosis of tuberculosis and antibiotic resistance. The mfloDx MDR-TB test kit, developed in Genome Valley, provides clear yes/no results in a fraction of the time compared to traditional methods. It's recognized by the World Health Organization and approved by the Central Drugs Standard Control Organization, poised to change tuberculosis diagnostics globally.

Dominance of Laboratory Testing Segment While Fast Growth for PoC Testing

The laboratory testing segment is expected to lead the market with a larger value share throughout the assessment period due to its widespread application areas and efficacy percentage. Clinical laboratory tests encompass a wide range of services, such as complete blood count, basic metabolic panel, genetic testing, and clinical chemistry. While point-of-care testing is anticipated to grow at a higher CAGR owing to the rising rate of adoption of such technologies in diagnostics and the increasing availability of rapid diagnostics test kits. The growth in point-of-care testing is driven by factors like the increased demand for at-home testing and the development of innovative services, including personalized medication selection and dosing based on genetic testing. Market participants are dedicated to expanding their point-of-care portfolio through the launch of new rapid test kits.

For instance, in June 2023, Agdia, Inc. launched a new rapid and field-deployable RNA-based assay to detect Blueberry scorch virus (BlScV). The test has outperformed all commercially available serological (ELISA) tests and matches the performance of the most well-established PCR methods presently in use. The rapid diagnostic kit is called AmplifyRP XRT for BlScV.

Molecular Tests to Dominate the Market

The molecular tests segment is anticipated to dominate the infectious disease diagnostics market. Molecular diagnostics, including techniques such as DNA microarray analysis, is one of the fastest-growing areas in infectious disease identification. Molecular diagnostics is a modern solution for detecting parasitic, bacterial, and viral infections. Unlike traditional testing methods, these tests are more advanced and overcome the drawbacks of manually prepared media, longer turnaround duration, and poor sensitivity. They are highly accurate and reliable, making them an essential tool in the field of medical diagnosis.

For instance, in November 2023, Roche launched the LightCycler PRO System which uses the reliable technology of the LightCycler Systems that preceded it. The new system offers better performance and is more user-friendly, while bridging the gap between translational research and in-vitro diagnostics. The LightCycler PRO System is a great addition to Roche's molecular PCR testing portfolio, which includes solutions for various healthcare professionals. These solutions cater to those performing research as well as those testing patients for cancer, infectious diseases, and other public health challenges.

Asia-Pacific to be the Fastest Growing Region

Asia-Pacific is experiencing a growing incidence of infectious diseases. It is due to factors such as poverty, overpopulation, inadequate preventive health systems, and increasing population. The region is a hotspot for emerging infectious diseases, with new variants of cholera and dengue being reported. Despite impressive improvements in health and healthcare infrastructure, infectious diseases remain the major cause of death in the region. The share of deaths due to infectious diseases is increasing in the Asia-Pacific. In the region, Southeast Asia has a higher growth rate due to climatic and economic reasons for the widespread of infectious diseases.

According to the 'Health at a Glance: Asia-Pacific 2022' report published by WHO in 2023, Southeast Asia accounted for the largest number of tuberculosis cases globally in 2020, about 43% of the total cases. Among the countries and territories most affected by tuberculosis in 2020 were India (26.0% of tuberculosis cases globally), China (8.5%), Indonesia (8.4%), the Philippines (6.0%), Pakistan (5.8%), and Bangladesh (3.6%).

Future Market Scenario (2024 – 2031F)

The diagnostic industry is witnessing growing regulatory approvals for infectious disease diagnostic solutions, which are expected to be marketed in near future, further boosting the market. For instance, the Biomedical Advanced Research and Development Authority (BARDA) has supported a diverse portfolio of medical solutions and these products have received a total of 86 FDA approvals, licensures, or clearances. Similarly, the Infectious Diseases Society of America (IDSA) has highlighted the need for new incentives and regulatory changes to spur R&D for new antibiotics and flexible regulations to allow innovative test development to keep pace with emerging infectious diseases. The increasing regulatory approved products for infectious disease diagnosis are anticipated to land the market in future and bring a healthy competition among key players. The FDA has approved a number of diagnostic devices and authorized the emergency use of uncleared devices for infectious diseases, including influenza and respiratory syncytial virus.

In February 2023, The U.S. Food and Drug Administration granted emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test. This test is capable of detecting and differentiating influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test is a single-use kit that can be used at home. The test provides results from self-collected nasal swab samples in around 30 minutes.

Key Players Landscape and Outlook

These companies have a strong market presence with a vast product portfolio to offer in the field of diagnostics and research. With the growing infectious disease scenario, these players have strengthened their offerings through collaborations, mergers and acquisitions, and other market tactics.

In April 2023, Biosynex SA announced that it had completed its acquisition of Chembio Diagnostics, Inc. The combination of the two companies' technologies and product portfolios, and the combination of market opportunities, will be important growth drivers for the combined entity. Additionally, significant operational synergies are expected in procurement, research and diagnostics logistics, and production.

In July 2023, Novacyt announced its acquisition of Yourgene Health for approximately EUR 16.7 million (USD 21.2 million) in cash. Yourgene Health, located in Manchester, the United Kingdom, offers a range of molecular diagnostic tests for prenatal screening, male infertility, thrombosis risk, and cystic fibrosis. In addition, the company provides genomic medicine services to healthcare, research, and biopharmaceutical clients.