Infectious Respiratory Disease Diagnostics Market

Market Overview

The global infectious respiratory disease diagnostics market size was valued at USD 24 billion in 2022. It is estimated to reach USD 38.86 billion by 2031, growing at a CAGR of 5.5% during the forecast period (2023–2031). Factors like the high prevalence of infectious respiratory diseases globally and technological advancement in respiratory disease testing drive market growth.

Infectious Ailments of the Respiratory System Diagnostics is a broad term encompassing various procedures and technologies that medical experts utilize to identify and diagnose respiratory diseases brought on by viruses, bacteria, or other pathogens. These conditions include the influenza virus, COVID-19, pneumonia, TB, and various other infections of the respiratory tract. Appropriate therapy, patient management, and infection control measures need to have an accurate diagnosis and be made promptly. Molecular tests, serology, the detection of antigens, and imaging techniques, including X-rays and CT scans, are some imaging methods that may be utilized during diagnostic procedures.

Molecular tests, such as polymerase chain reaction (PCR), are frequently employed because they are extremely sensitive and specific. These tests are commonly used to detect the genetic material of the pathogens. The antibodies created by the immune system as a response to the infection can be identified through serological testing. Radiological imaging helps visualize lung problems. Diagnostic tests for infectious respiratory diseases that are both quick and accurate play an important part in limiting outbreaks, guiding suitable medications, and reducing the spread of infections that have the potential to be severe and are highly contagious.

Market Dynamics

Global Infectious Respiratory Disease Diagnostics Market Drivers

High Prevalence of Infectious Respiratory Diseases Globally

In diagnosing infectious diseases, molecular diagnostics are essential since they provide answers promptly and with a high degree of precision. It is projected that the rising prevalence of infectious respiratory diseases such as tuberculosis, influenza, and COVID-19 will be the main factor driving market expansion over the period covered by the estimate. This estimate was carried out to determine the size of the market. The World Health Organization (WHO) identifies tuberculosis as one of the top 10 major causes of death across the globe, as it is responsible for 1.4 million deaths.

Additionally, it is projected that the growing frequency of sexually transmitted illnesses (STIs), such as HIV and HPV, will supply the industry with a sizeable pool of potential clients. People who have HIV are particularly vulnerable to other diseases, such as tuberculosis, which is usually considered the primary cause of death among HIV-affected individuals. This is because HIV makes people extremely susceptible to other infections.

Technological Advancement in Respiratory Disease Testing

Rapid technology improvements will significantly impact this market by enabling accurate findings, portability, and cost-effectiveness. To get precise and accurate results, businesses are improving their goods. Key players are increasing the number of tests they offer that use qPCR devices, either by partnering with other kit manufacturers, investing in R&D to create diagnostic kits that can detect developing disorders, or both. The infectious respiratory disease diagnostics market is likely driven by Cepheid's introduction of the Xpert assay to test for tuberculosis on its GeneXpert platform. This will fill unmet needs in sub-Saharan Africa, East Asia, and Latin America.

It is projected that the market will be stimulated by the release of novel products for the diagnosis and progression of the disease. During the first and second waves of the pandemic, lung CT scans, contrast-enhanced ultrasonography, and similar technology were widely employed to evaluate COVID-19 patients. Launches of SARS-CoV-2 diagnostics are ongoing to serve markets with particular regulatory requirements.

Global Infectious Respiratory Disease Diagnostics Market Restraint

High Prices of Diagnostic Products

To diagnose infectious respiratory diseases, molecular diagnostics provide precise and efficient results. The gold standard for diagnosing COVID-19 in patients is the RT-PCR test. However, one of the main barriers to this sector is the high cost of molecular testing. Another factor driving up pricing is the absence of comparable goods. The huge price fluctuations for each molecular diagnostic product's various uses further exacerbate this issue.

The healthcare authorities have taken action to lessen the burden of the high cost on manufacturers. The U.S. FDA's EUA approval for COVID-19 tests is anticipated to lower development costs and quicken the process to enhance the tests' availability at more testing locations. Therefore, it is projected that a decline in development costs will boost testing accessibility for consumers and healthcare professionals.

Global Infectious Respiratory Disease Diagnostics Market Opportunities

Increasing Focus on Introducing Multiplex PCR

It is common for an increase in respiratory illnesses such as RSV, pneumonia, and influenza during the winter months. The major businesses in this industry are pouring money into research and development and marketing individual diagnostic tests for each illness. Multiplex polymerase chain reaction (PCR) is a form of polymerase chain reaction (PCR) technology that involves the addition of numerous primers to the PCR biochemical mixture. The traditional polymerase chain reaction (PCR) technology can be changed to produce multiplex PCR, a variety of technology.

As a result, it is possible to target a large number of genes simultaneously, reducing the time and money necessary to carry out conventional PCR. Multiplex PCR is gradually replacing the traditional PCR approach in several significant applications. These applications include the identification of pathogens, the genotyping and analysis of mutations based on single-nucleotide polymorphisms, and the detection and analysis of connections between genes. Multiplex PCR was first developed in the 1990s.

Regional Analysis

Based on region, the global infectious respiratory disease diagnostics market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global infectious respiratory disease diagnostics market shareholder and is estimated to exhibit a CAGR of 3.3% over the forecast period. Due to their excellent accuracy, sensitivity, and specificity, diagnostic products are most popular in North America. Market expansion is anticipated to be fuelled by the rising demand for tests for conditions including tuberculosis, RSV, influenza A and B, and COVID-19. Thanks to strategic alliances between testing kit makers and in vitro diagnostics businesses, North America is a lucrative market for infectious respiratory illness diagnostics. Market expansion is anticipated to be fueled by government programs and reimbursement regulations like the New Technology Add-on Payment (NTAP) program. The CDC's Antimicrobial Stewardship Project is designed to hasten the creation and adoption of quick diagnostic techniques. The recent new coronavirus pandemic is likely to benefit market growth, and the market is anticipated to be driven by the number of tests performed in North America.

Europe is anticipated to exhibit a CAGR of 3.7% over the forecast period. The expansion of this region's market can be ascribed to a rise in the prevalence of infectious diseases, developments in related technologies, and aggressive actions taken by the government. When educating the general public about the possible advantages of receiving an early diagnosis of infectious diseases, government agencies' roles are paramount. The region is experiencing an increase in the number of people getting tested for infectious diseases, which is expected to be a primary driver of market expansion. The area has the highest testing rate because European people get tested even with moderate symptoms. However, countries such as Spain, Britain, and France test only ill persons since they struggle to meet the demand for testing kits.

The Asia-Pacific market is expanding due to more pro-health measures, improved technologies, and consumer awareness. Growing infectious disease prevalence, the need for diagnostic products, and an expanding population base contribute to market expansion. Healthcare reimbursement programs for diagnostic testing exist in Asia Pacific nations like Taiwan, Australia, Korea, and China. The main growth drivers are initiatives in scientific research, a growing economy, and significant unfulfilled requirements. Due to improved healthcare regulatory environments, international players are drawn to invest and take advantage of opportunities in high-growth countries. Regional market expansion is also fuelled by favorable changes such as government healthcare benefits, raised awareness, and demand for top-notch medical care.

Latin America will expand at a healthy rate, thanks to government steps in the region regarding regulating industries and reimbursing the costs of conducting laboratory tests. Recently, Argentina proposed to change its healthcare system, in which they stated that the government ought to assume control of the private payers to improve the system. This may result in the tests becoming more reasonably priced for the general population, increasing the demand for IVD instruments and reagents. Private investment in the healthcare sector may be hampered because of this action, which may result in a reduction in the rate at which advancements in healthcare are made.

Middle East and African (MEA) nations with thriving economies include Saudi Arabia, the UAE, and South Africa. The high prevalence of infectious respiratory disorders like tuberculosis, pneumonia, whooping cough, and others fuels this region's market. Economic development and significant unmet healthcare requirements are primary market growth drivers, as seen in developing nations like South Africa. Due to the significant untapped potential and the critical need for early disease detection, the industry is expected to grow. In this area, infectious and contagious diseases are very common.

Segmental Analysis

The global infectious respiratory disease diagnostics market is bifurcated into product type, sample type, technology, application, and end-use.

Based on the product type, the global infectious respiratory disease diagnostics market is bifurcated into instruments, consumables, and services. 

The consumables segment dominates the global market and is projected to exhibit a CAGR of 4.1% over the forecast period. Consumables are expected to grow significantly in the next years due to the substantial demand for testing materials and increased manufacturing capacity. However, there was a supply shortage of consumables due to the government's lockdown and the increased demand produced by COVID-19 worldwide. Both of these factors contributed to the situation. It is projected that the launch of innovative techniques for validating and monitoring diagnostic tests employed for COVID-19 will drive the expansion of the market. In addition, initiatives that focus on the early diagnosis of tuberculosis are contributing to the market's growth.

Based on sample type, the global infectious respiratory disease diagnostics market is segmented into saliva, nasopharyngeal swabs (NPS), anterior nasal swabs, blood, and others. 

The nasopharyngeal swabs (NPS) segment dominates the global market and is predicted to exhibit a CAGR of 3.0% during the forecast period. Nasopharyngeal swabs are used to collect samples for a variety of diagnostic procedures. These procedures include but are not limited to quick antigen detection tests, direct fluorescent antibody testing, and polymerase chain reaction, amongst others. Swab samples are acquired in a variety of ways. These tests are performed to produce a diagnosis regarding a wide variety of illnesses, including COVID-19, RSV, and tuberculosis, amongst others. The purpose of carrying out these tests is to make an accurate diagnosis. Several different producers, such as COPAN ITALIA Spa and Noble Bio, are currently offering their cotton swabs for sale in the United States market. These businesses stand to make very significant profits from participating in this market.

Based on technology, the global infectious respiratory disease diagnostics market is bifurcated into immunoassay, molecular diagnostics, microbiology, and other technologies. 

The molecular diagnostics segment owns the highest market share and is predicted to exhibit a CAGR of 2.2% over the forecast period. Numerous technologies, including PCR, Isothermal Nucleic Acid Amplification Technology (INAAT), and Next-generation Sequencing (NGS), are used in molecular diagnostics. The most well-known and dependable gold standard technology for amplifying DNA to undertake molecular diagnostics is polymerase chain reaction (PCR). The market is anticipated to be driven by the rising usage of high-throughput PCR technology to identify respiratory viruses. Businesses are developing multiplex tests that can be used to diagnose various illnesses with just one swab because influenza, RSV, and COVID-19 illnesses share symptoms.

Although PCR typically requires large equipment, the increased research in the field has led to advancements like postage stamp-sized plasm fluidic chips. Companies introducing cutting-edge technology to get beyond molecular diagnostics' limitations, like storage and cold chain logistics, are anticipated to accelerate market growth. DNA sequencing procedures and the newly developed NGS technologies, such as sequencing platforms and RNA sequencing, are examples of sequencing technologies for the molecular diagnostics market. Early detection of viral illness outbreaks may benefit from using NGS to surveillance and identify emerging infectious disease strains like SARS-CoV-2.

Based on application, the global infectious respiratory disease diagnostics market is bifurcated into COVID-19, influenza, respiratory syncytial virus (RSV), tuberculosis, streptococcus testing, and other respiratory disease testing. 

The COVID-19 segment owns the highest market share and is predicted to exhibit a CAGR of 7.3% over the forecast period. There were 220,904,838 confirmed cases of COVID-19, as indicated by the dashboard maintained by the WHO. There is a strong demand for diagnostic tools because of the illness load, which has led to the regulatory authorities increasing the number of COVID-19 tests approved for emergency use. To assist in managing and preventing COVID-19 during the pandemic crisis, approval is required for the emergency use of tests for research purposes.

Both healthcare professionals and the government require this approval. Increasing technical breakthroughs that enable automated and high-throughput testing would promote market expansion. The collection of samples no longer needs to be done by qualified persons, and the turnaround time has been cut significantly thanks to the introduction of testing kits sold directly to consumers by key businesses. The demand for diagnostics for COVID-19 testing is expected to decrease throughout the forecast period due to the growing number of vaccinations being administered worldwide.

Based on end-use, the global infectious respiratory disease diagnostics market is divided into hospitals, diagnostic laboratories, physician offices, and other end users. 

The hospitals segment is the most significant contributor to the market and is estimated to exhibit a CAGR of 2.7% over the forecast period. The controlled treatment and round-the-clock monitoring needed for respiratory infections like COVID-19, Respiratory Syncytial Virus (RSV), and influenza can only be provided in a hospital setting, encouraging hospitalization. Growing healthcare costs and an increase in illness burden could encourage sector growth. According to The Pulse, hospitals do almost 60% of all imaging procedures in the United States.

The demand for CT and X-ray scanning of patients with severe COVID-19 symptoms has increased due to the COVID-19 outbreak. This is a key element influencing segment growth. However, due to their fear of catching COVID-19 infection, people are hesitant to visit hospitals for disease testing. Companies are concentrating on presenting their products by targeting hospital laboratories since the pandemic has improved due to an expanded vaccine effort. For instance, using a desktop immunoassay analyzer, biome Rieux SA aims to reach hospital laboratories with its interferon-gamma release assay. Therefore, such programs encourage segment expansion.

Recent Developments

• May 2022- Quantum Group Limited, a UK-based developer of transformational point-of-care diagnostics, launched its new respiratory panel test Q-POC SARS-CoV-2, Flu A/B & RSV Assay. With the launch of the Q-POC respiratory panel test, the company is expanding its multiplex capabilities and providing customers with rapid, point-of-care testing.