Infectious Disease Diagnostics Market

Market Overview

The global infectious disease diagnostics market was valued at USD 41.79 billion in 2022. It is expected to reach USD 57.91 billion by 2031, growing at a CAGR of 3.69% during the forecast period (2023–2031).

Infectious illness, a diagnosis is a laboratory test performed to identify infectious diseases with the assistance of trained technicians and medical professionals. It is a diagnostic process where the infectious disease's causing organism is described and located. The sample of urine, blood, mucus or other bodily fluids is examined using various diagnostic techniques and tools to reveal details about the causative organism.

Diagnostic procedures are essential for identifying diseases and enhancing global health. Traditional methods for diagnosing infectious diseases need to be more accurate and time-consuming. As a result of this shortcoming, quick, precise, and portable point-of-care testing kits have begun to appear in the market for infectious disease diagnostics. POC testing offers immediate results and enables quicker identification of infectious diseases to present close to the patient's location. Multiple scientists are now developing multiplex point-of-care diagnostic devices.

Market Dynamics

Market Drivers

• Rising Prevalence of Infectious Diseases

The prevalence of infectious diseases is rising, which is causing a greater emphasis to be placed on their diagnosis and treatment. The Centers for Disease Control and Prevention (CDC) estimates that in 2020, approximately 7,174 new tuberculosis cases were discovered in the United States, translating to a rate of 2.2 per 100,000 people. As a result, the high prevalence of tuberculosis drives up the demand for diagnosis, which drives the market for diagnosing infectious diseases. In addition, the CDC reported in a February 2022 article that each year in the United States, Salmonella bacteria causes about 1.35 million infections, 26,500 hospitalizations, and 420 fatalities. Every year, many infectious diseases strain the nation's healthcare system. As a result, the market under study could benefit from an unprecedented demand for diagnostic products and services.

Furthermore, between 2019 and 2020, there will be a 24% increase in central line bloodstream infections (CLABSI) and a 35% increase in ventilator-associated events (VAE), according to the CDC's 2020 National and State Healthcare-Associated Infections Progress Report. The Intensive Care Unit (ICU) saw the greatest increase in these infections, followed by the wards. These infections are acquired in hospitals, and given that hospital admission rates are expected to rise during the forecast period, the market is anticipated to grow profitably.

• Studies in the Diagnostic of Infectious Diseases

On-time and accurate diagnosis depends significantly on the global effort to prevent and treat infectious diseases. Despite advancements in diagnostic technology, there is a pressing need for tests that are easy to use, identify the microbe infecting the patient, determine whether it is drug-resistant, and provide results faster than current tests. As a result, the Infectious Diseases Society of America (IDSA) is committed to advancing diagnostics. This includes offering suggestions to support the development of new tests, their application to patient care, and their research and development.

Furthermore, according to the Ministry of Science and Technology of the Government of India, infectious diseases, such as high HIV/AIDS, tuberculosis, malaria, and other neglected diseases, continue to plague India despite its fast-paced economic development and expanding technological capabilities. To this end, the Department's Infectious Disease Biology Program solicits a wide range of projects on bacterial, viral, parasitic, and fungal diseases, spanning the spectrum from the basic biology of human pathogens and their interactions with human hosts to translational and clinical research toward the development of new and improved diagnostics, medications, and vaccines for infectious diseases. The growing body of research on diagnostics for infectious diseases will aid the market's growth.

Market Restraints

• Increasing Healthcare Costs constrain the Use of Novel Diagnostic Techniques

Recent advances in medical technology have made it possible to treat diseases once thought incurable. However, the cost of their care is so high that a person from the middle class could never afford it. Healthcare has come a long way, but most developing nations still cannot afford it. High-quality diagnostic methods for infectious diseases are generally available in industrialized nations, but they are neither practical nor affordable in developing countries with high disease burdens. In addition, many labs in underprivileged areas may lack the elaborate equipment to perform rigorous commercial tests. Poor rural clinics or laboratories operating in high-pressure political situations may face unique challenges. This is a factor that could slow the market's expansion.

Market Opportunities

• Decentralized Diagnostics and Sample Collection

Decentralized diagnostics have increased the effectiveness and accessibility of healthcare. Decentralized diagnostics and sample collection are becoming increasingly popular to improve healthcare's effectiveness, efficiency, and accessibility globally. A number of factors influence this trend toward remote sample collection and testing, including patient convenience, which improves patient experience and compliance with diagnostic testing; increasingly sensitive and accurate diagnostic tools and reagents requiring smaller sample volumes, which eliminates the need for phlebotomy and large volume blood draws for specific tests; increased utilization of telemedicine and other virtual care models, which lowers the number of in-person diagnostic testing procedures. As a result, this offers market participants chances to produce brand-new, cutting-edge goods.

Regional Analysis

North America Dominates the Global Market

By region, the global infectious disease diagnostics market is segmented into North America, Europe, Asia-Pacific, the Middle East and Africa, and South America.

North America is the most significant contributor to the global infectious disease diagnostics market and is expected to grow at a CAGR of 3.82% during the forecast period. The US infectious disease diagnostics market is predicted to grow significantly during the study period due to the increased prevalence of infectious diseases, rapid technology improvements, improved healthcare, and rising need for point-of-care testing. According to data released by HIV.gov in June 2021, 34,800 new HIV infections occurred in 2019 at a rate of 12.6, making up approximately 1.2 million people living with the disease in the United States (per 100,000 people). This suggests that the country has a high incidence of HIV, increasing demand for its diagnostic products, which will drive the market under study. The need for and use of infectious diagnostics has increased along with the incidence of infectious diseases.

Europe is expected to grow at a CAGR of 4.06% during the forecast period. The market for infectious diseases in Germany is expected to grow during the study period as a result of factors like rising infectious disease rates, product launches, expanding strategic initiatives by significant market players, and the government. According to a study published in November 2019 titled "Good Practices in the Long-Term Care of People Living With HIV: Learning From Country Experiences Germany And Romania," an estimated 86,000 HIV-positive people live in Germany, with 20% of them residing in Berlin. The country's high incidence of HIV increases the need for its diagnostics, driving the market under study. In addition, according to the report above, Germany's government has implemented a novel community-based testing strategy known as "Checkpoints" to increase diagnostics production and lower the infectious disease-related mortality rate. These initiatives will also accelerate market expansion.

Asia-Pacific is expected to grow significantly over the forecast period. The rise in infectious diseases like HIV, hepatitis, hospital-acquired infections, rising product launches, increasing investments, and significant strategic initiatives are all expected to contribute to the Chinese infectious disease market expansion during the forecast period. Nearly 1.71 million cases of infectious diseases were reported on the mainland in December 2019, according to the National Health Commission 2020. There were about 288,739 cases of infectious diseases of class B. 94% of these cases were caused by viral hepatitis, TB, syphilis, scarlet fever, and gonorrhea. As a result, China's molecular diagnostics market is anticipated to expand over the forecast period. Furthermore, QuantiFERON-TB Gold Plus (QFT-Plus) was given the go-ahead by China's National Medical Products Administration (NMPA) in February 2022 for the diagnosis of tuberculosis (TB), including active TB infections. This test provides precise TB infection detection, even in those with compromised immune systems. As a result, the market will be driven by introducing products nationwide that can provide accurate and significant diagnoses.

Six nations comprise the Gulf Cooperation Council (GCC): Oman, Saudi Arabia, Kuwait, Bahrain, Qatar, and the United Arab Emirates (UAE). The studied market will grow due to factors including the rising incidence of infectious diseases in these nations, rising investments, increased product launches, and strategic initiatives taken by market participants and the government. According to a study entitled "Epidemiology of tuberculosis among different occupational groups in Makkah region, Saudi Arabia," published in June 2021, the incidence rate of tuberculosis in the Makkah region was 9 per 100,000 workers and 31 per 100,000 people in the general population. This demonstrates that tuberculosis prevalence in the nation was extremely high, increasing the demand for diagnostics and driving the market.

The Brazilian market for infectious disease diagnostics is predicted to expand profitably over the forecast period due to the rising frequency of infectious diseases, the increasing number of product launches, and strategic activities made by the leading market players and the government. According to the study "A time series analysis of detection and mortality of hepatitis C in Brazil, 2008-2018," released in January 2022, 271,624 newly diagnosed hepatitis C cases were identified. This implies a very high prevalence of hepatitis C in the country, which is projected to increase the demand for hepatitis diagnostics.

Segmental Analysis

The global infectious disease diagnostics market is segmented by application, product, and technology.

Based on The Application

The global infectious disease diagnostics market is bifurcated into hepatitis, human immunodeficiency virus (HIV), chlamydia trachomatis genital infection and gonorrhea (CT/NG), hospital-acquired infections, human papillomavirus (HPV), tuberculosis (TB), and influenza.

The hospital-acquired infections segment is the highest contributor to the market and is expected to grow at a CAGR of 5.33% during the forecast period. Nosocomially acquired infections that are not present or incubating at the time of admission to a hospital are known as hospital-acquired infections (HAI). Hospitals may contain an infection or toxin that can cause these infections. These infections include bloodstream infections linked to central lines, urinary tract infections related to catheters, surgical site infections, pneumonia linked to ventilators, pneumonia acquired in hospitals, and infections with Clostridium difficile. Furthermore, according to the World Ageing Report 2019, there were 703 million people in the world who were 65 or older in 2019. By 2050, this number is expected to double to 1.5 billion. The elderly population is particularly vulnerable to infectious diseases because they frequently visit hospitals and have weakened immune systems. The incidence of HAI is therefore anticipated to increase due to the growing geriatric population, driving the market.

The hepatitis segment is expanding due to elements like rising hepatitis cases, initiatives by public and private organizations, and product launches. One of the drivers of the market's expansion is the government's expanding initiatives. For instance, a framework for eliminating viral hepatitis as a threat to public health in the United States by 2030 is provided by the Viral Hepatitis National Strategic Plan for the United States: A Roadmap to Elimination 2021–2025 (Viral Hepatitis Plan or Plan), which was published on January 7, 2021. The three most prevalent hepatitis viruses, hepatitis A, hepatitis B, and hepatitis C, that have the greatest effect on the country's health are the focus of the viral hepatitis plan.

Based on the Product

The global infectious disease diagnostics market is bifurcated into assays, kits, and reagents, instruments, and services and software.

The assays, kits, and reagents segment owns the highest market share and is expected to grow at a CAGR of 3.95% during the forecast period. The chemical, biological, or immunological components, solutions, or preparations included in the assays, kits, and reagents segment of the market under study are those that the manufacturer intends to use in the diagnosis procedure. Due to the high cost of many diagnostic platforms, manufacturers frequently lease technology rather than selling it outright to consumers. In these agreements, the lease is linked to agreements for the long-term purchase of related reagents or assays for the equipment. Due to the significant need for reagents to meet the rising demand for diagnostics around the world for the diagnosis of COVID-19 infection, COVID-19 is anticipated to contribute significantly to the studied segment's growth.

Diagnostic tools are medical equipment used to conduct tests to find diseases and infections by looking at samples of bodily materials like urine, blood, tissues, and stool. For the examination of specimens, including blood and tissue donations derived from human bodies, the instruments include control material, apparatus, pieces of equipment, devices, or systems that are used either individually or in combination. The rising incidence of communicable and non-communicable diseases and the expansion of microbiology and point-of-care testing research and development are the primary drivers of the demand for diagnostic tools.

Based on the Technology

The global infectious disease diagnostics market is bifurcated into Polymerase Chain Reaction (PCR), Isothermal Nucleic Acid Amplification Technology (INAAT), immunodiagnostics, DNA microarray, clinical microbiology, and DNA sequencing and Next-Generation Sequencing (NGS).

The immunodiagnostics segment is the highest contributor to the market and is expected to grow at a CAGR of 3.79% during the forecast period. A primary method of diagnosis known as "immunodiagnostics" relies on an antigen-antibody response. The results of immunodiagnostic tests, which employ antibodies as reagents, are frequently used to support diagnoses across various scientific fields. Simple manual techniques and fully automated systems with sophisticated integrated detection are among the various test types. Due to the rising incidence of infectious diseases and the organic and inorganic strategies employed by numerous market players, the immunodiagnostics segment is anticipated to expand significantly over the forecast period. According to World Health Organization (WHO) statistics for 2020, 1.4 million people worldwide passed away from tuberculosis (TB) in 2019.

A Polymerase Chain Reaction (PCR) technique amplifies target DNA and produces thousands to millions of copies of a specific DNA segment. Clinical diagnosis, criminal forensics, and biomedical research are just a few diverse fields in which PCR techniques are used in clinical and research labs. The main drivers of the market under study are growing diagnostics applications, growing product launches, technological advancements, and applications, along with initiatives from both public and private players. High-throughput PCR systems and microfluidics-based PCR devices for point-of-care (POC) applications are the two main areas of PCR utilization in bioscience, according to an article titled "PCR past, present, and future," published in August 2020. The market will grow due to the rising demand for point-of-care diagnostics worldwide.

Recent Developments

January 2023- Precigen, Inc. announced positive Phase 1 dose escalation and expansion cohort data as of the January 12, 2023 cutoff for the investigational, potential first-in-class PRGN-2012 off-the-shelf (OTS) AdenoVerse™ immunotherapy in patients with recurrent respiratory papillomatosis (RRP).

January 2023- Memo Therapeutics AG, an innovator in the field of antibody discovery and development, announced positive safety and tolerability data from a Phase I clinical trial with AntiBKV, an antibody targeting BK polyomavirus (“BKV”) infection in renal transplant patients, meeting its primary endpoint.