The global infectious respiratory disease diagnostics market was valued at USD 63.81 billion in 2021 and it is predicted to surpass around USD 43.76 billion by 2030 with a CAGR of -4.1% from 2022 to 2030.
The decline in market size is majorly attributed to the decline in COVID-19 testing. However, the market without the impact of COVID-19 is expected to grow over the forecast years. The growth can be attributed to an increase in the prevalence of infectious respiratory diseases and initiatives taken by governments & nonprofit organizations to introduce novel & innovative products to address the increasing demand. For instance, the global investment in tuberculosis R&D reached USD 915 million, and around USD 401 million was spent by the U.S. government on TB research in 2020.
During the forecast period, the global industry is expected to be driven by the rising incidence of infectious respiratory disorders, such as tuberculosis, RSV, and influenza. According to the UN, pneumonia affects around 4.2 million people every year. Key players are developing innovative techniques to improve production for meeting the growing demand in diagnostics and consumables for the diagnosis of infectious diseases. For instance, OPT Industries Inc. has introduced InstaSwab by utilizing the 3D printing system to address supply shortages of sample collection kits due to the COVID-19 pandemic. These swabs are made of woven lattices to absorb and release more fluid than conventional swabs. Companies are advancing their diagnosis products by using new techniques to gain target-specific and accurate results.
Canon Inc. announced the development of a built-in AEC assistance for digital X-rays in March 2021. The X-ray image sensor enables users to perform picture production and real-time detection of images corresponding to emitted X-rays. Furthermore, in May 2021, the University of California developed an ultrasensitive molecular test to identify the presence of SARS-CoV-2 and influenza A antigens using chip technology. In addition, companies are also launching multiplex tests for the simultaneous diagnosis of RSV, influenza, and COVID-19 respiratory diseases. RT-PCR tests are considered the gold standard for the diagnosis of COVID-19 in patients. However, high prices associated with molecular tests are one of the major factors impeding this market.
The lack of comparable products is another reason for hiked prices. This problem is further compounded by the significant variations in prices for different applications of each molecular diagnostic product. Companies are adopting strategies, such as new product launches and partnerships, to increase the penetration of infectious respiratory disease diagnostics products. For instance, in August 2021, Thermo Fisher Scientific Inc. received EUA for the introduction of two COVID-19 diagnostic products, TaqPath COVID-19 RNase P Combo Kit and TaqPath COVID-19 Fast PCR Combo Kit, in the U.S. market.
Scope of The Report
|Market Size in 2021|
|Revenue Forecast by 2030|
|Growth rate from 2022 to 2030||CAGR of%|
|Forecast Period||2022 to 2030|
|Segmentation||Product type, sample type, technology, application, end-use, region
Product Type Insights
On the basis of product types, the global industry has been further categorized into instruments, consumables, and services. The consumables segment dominated the global industry in 2021 and accounted for the maximum share of more than 65.15% of the overall revenue. The segment is anticipated to maintain its dominance over the forecast period owing to the increased testing volumes. The segment is also anticipated to exhibit the fastest growth rate during the forecast period. The consumables segment includes reagents and reagent kits that are used for performing in vitro diagnostic tests for respiratory diseases.
In September 2021, the U.S. FDA authorized around 261 molecular diagnostics products, 88 serological diagnostics tests, and 34 antigen diagnostics tests for the diagnosis of COVID-19. The instrument was the second-largest revenue-generating segment in 2021 owing to the introduction of innovative products to aid physicians in diagnosing COVID-19 patients. For instance, in March 2021, Vyaire Medical, Inc. introduced AioCare for diagnosing respiratory diseases in European Union, Middle East countries, and Australia. The product is a mobile spirometry system that provides accurate results as hospital-grade spirometers and enables the physician to monitor patients with advanced digital connectivity at home.
Sample Type Insights
On the basis of sample types, the global industry has been further categorized into saliva, Nasopharyngeal Swabs (NPS), anterior nasal region, blood, and others. The nasopharyngeal swabs sample type segment dominated the global industry in 2021 with a revenue share of more than 60.51% owing to a wide application scope in conducting various tests including rapid antigen detection tests, direct fluorescent antibodies, Polymerase Chain Reaction (PCR), and others coupled with increased demand. In response to the COVID-19 pandemic, multiple companies have drastically increased their swab manufacturing capacities.
The saliva sample type segment is estimated to witness a lucrative growth rate over the forecast period. This growth is owing to the increasing use of samples in testing coupled with an urgent need for noninvasive tests. In a study published in May 2020, researchers established the sensitivity and specificity of the saliva sample test, which were found to be around 84.2% and 98.9%, respectively. As a result, industry players started developing and commercializing no-swabs saliva-based tests. For instance, in March 2021, BATM Advanced Communications Ltd. introduced an RT-PCR kit that utilizes Salivette for the self-collection of samples for COVID-19 diagnosis.
On the basis of technologies, the global industry has been segmented into immunoassay, molecular diagnostics, microbiology, and other technologies. The molecular diagnostics segment dominated the global industry in 2021 and accounted for the maximum share of more than 64.45% of the overall revenue. This high share can be attributed to the increased requirements of RT-PCR tests for the diagnosis of COVID-19, RSV, influenza, and others. PCR is the most conventional and trusted gold standard technology for amplification of DNA material to perform molecular diagnosis.
The companies are introducing multiplex tests that can be used for the diagnosis of infectious respiratory diseases using a single swab. For instance, in December 2020, GENETWORx, LLC launched a breakthrough test that can detect three respiratory viruses (SARS-COV-2, RSV, & Influenza A & B) in a single sample. The immunoassays segment is estimated to exhibit the fastest growth rate over the forecast period owing to the factors, such as technological advancements and the commercialization of innovative products. In April 2021, Bio-Rad Laboratories, Inc. launched a blood-based immunoassay kit to detect IgM, IgA, and IgG antibodies for diagnosis of COVID-19 patients. This immunoassay kit launch is expected to accelerate the diagnosis of COVID-19, thereby, driving the overall industry growth.
The COVID-19 segment dominated the global industry in 2021 with a revenue share of more than 90.95% owing to a high incidence of COVID-19, increased product approvals, and a rise in R&D. However, the increasing vaccination rates are expected to reduce the severity of the disease and the testing rates are expected to decline during the forecast period. Key players are introducing direct-to-consumer testing kits that eliminate the requirement of trained personnel for sample collection and shorten the turnaround time. The tuberculosis segment is estimated to witness a considerable growth rate during the forecast period. This is owing to increased government focus and R&D funding for the development of diagnostics.
According to the WHO, in 2020, globally, 10 million people suffered from TB and approximately 86% of all new cases of TB were reported in the 30 high disease burden countries. Two-thirds of new cases were registered in Indonesia, Philippines, India, China, Nigeria, Bangladesh, South Africa, and Pakistan. The increasing number of launches of highly sensitive and flexible molecular tests for the diagnosis of TB is expected to fuel segment growth. For instance, in October 2021, QIAGEN launched CE-IVD-certified QuantiFERON & QlAreach test that can diagnose TB in 20 minutes with a one-day patient visit. Such test launches accelerate the disease diagnosis and help address unmet diagnosis needs of patients in developing and low-middle income countries.
The diagnostic laboratories end-use segment dominated the global industry in 2021 and accounted for the maximum share of more than 42.03% of the overall revenue. According to the CDC's August 2020 report, around 79.6 million tests were conducted in public health laboratories. Moreover, laboratories are entering into strategic initiatives with various organizations to offer COVID-19 testing to combat the rising incidence of the disease. For instance, in March 2020, Bio-Rad Laboratories, Inc., partnered with Assurance Scientific Laboratories in Birmingham & Alabama, and other laboratories to provide its real-time qPCR products, such as Reliance One-Step Multiplex RT-qPCR Supermix, CFX RT-PCR Detection Systems, and CFX384 Touch Real-Time PCR Detection System for COVID-19 screening.
The physician offices end-use segment is estimated to witness a significant growth rate over the forecast period owing to increased preference of patients and increased focus of manufacturers on the development of PoC diagnostics. The introduction of novel assays that provide quick PoC results is anticipated to boost segment growth. For instance, in April 2021, Chembio Diagnostics, Inc., introduced a rapid PoC COVID-19/Flu A&B test, which is suitable for differentiating patients with influenza or COVID-19 in a shorter turnaround time in traditional & decentralized settings.
Asia Pacific dominated the global industry in 2021 and accounted for the largest share of more than 34.11% of the overall revenue. North America accounted for the second-largest share of the global industry in 2021. This was attributed to the high testing rates, proactive government measures, improvements in healthcare infrastructure, technological advancements, and the presence of major players in the North America region. Favorable government initiatives and reimbursement policies are likely to drive the region’s growth. However, the shortage of supply of materials during the COVID-19 pandemic, such as reagents, required to perform diagnostic tests may impede the industry growth to some extent.
According to the Academy Society for Microbiology, around 47.5% of laboratories in the U.S. reported a shortage of reagents used for the diagnosis of pneumonia, followed by tuberculosis with 29.4% of laboratories. Europe is estimated to witness a significant growth rate over the forecast period. The region’s growth can be attributed to the rising prevalence of respiratory indications and increasing testing rates. According to the European Center for Disease Prevention and Control (ECDC), in 2022, around 90,644 new cases of influenza were reported across Europe, out of this, approximately 98% and 2% were type A and type B viruses.