PCR For Respiratory Infection Diagnostic Market Size, Trends and Growth Analysis by 2027

The market for PCR diagnostics in respiratory infections is projected to reach a valuation of US$ 8279.32 million by 2028, up from US$ 4146.02 million in 2021, reflecting a compound annual growth rate (CAGR) of 10.4% from 2021 to 2028.

Several global factors are propelling the growth of the PCR diagnostics market for respiratory infections. The increasing prevalence of Chronic Respiratory Diseases (CRDs) and advancements in PCR testing technologies are significantly enhancing the capabilities of medical devices. The application of PCR testing for diagnosing various respiratory infections, along with ongoing innovations in PCR technology, is further driving market expansion. However, the presence of alternative diagnostic assays poses a challenge to market growth.

In recent years, the demand for PCR testing to identify infectious diseases has surged dramatically. Technological advancements have facilitated point-of-care testing through PCR, which has further increased the demand for these diagnostics. The COVID-19 pandemic has notably amplified this demand. Since the onset of the pandemic, the reverse transcription-polymerase chain reaction (RT-PCR) test has become the preferred method for diagnosing and analyzing the genetic material of SARS-CoV-2 RNA. The RT-PCR technique is widely recognized as the gold standard for detecting SARS-CoV-2 RNA due to its high sensitivity.

In May 2021, Lucira Health introduced the first and only FDA Emergency Use Authorization (EUA) approved single-use molecular test available for over-the-counter purchase in the United States. Viral diagnostic assays have dominated the testing landscape in the U.S. In October 2020, Eurofins launched the EmpowerDX SARS-CoV-2 RT-PCR test, which allows for home sampling in Europe. This product was commercialized following its EUA from the FDA and is available in countries like Germany and Spain through online distribution channels. Eurofins plans to expand the availability of this product to the UK, France, Belgium, the Netherlands, and Sweden upon receiving the necessary regulatory approvals.

Additionally, Eurofins developed a similar version of the EmpowerDX SARS-CoV-2 RT-PCR test through its subsidiary, Eurofins Viracor, in March 2020. This COVID-19 PCR test was designed to detect the VUI-2020-12/01 strain, which was noted for its rapid spread in the UK. In December 2020, Bruker Corporation announced the FluoroType SARS-CoV-2/Flu/RSV winter four-plex PCR panel, which enables the sensitive and simultaneous detection of SARS-CoV-2 alongside influenza A and B viruses and respiratory syncytial virus (RSV). This panel is CE-IVD labeled according to the European IVD Directive (98/79/EC) and is validated for use with nasopharyngeal swabs, oropharyngeal swabs, and saliva samples. The kit includes all necessary reagents to produce 96 PCR result panels within two hours post nucleic acid extraction. Given the rising demand for PCR testing, numerous market players are launching PCR products and engaging in strategic developments globally.

The global PCR diagnostics market for respiratory infections is categorized by service, type, product type, infection type, and end user. By type, the market is divided into real-time PCR (qPCR), multiplex PCR, and others. The real-time PCR (qPCR) segment held the largest market share in 2021 and is expected to exhibit the highest CAGR during the forecast period. In terms of product type, the market is segmented into reagents and kits, instruments, and others. The reagents and kits segment also held the largest market share in 2021 and is projected to grow at the highest CAGR in the coming years.

Regarding infection type, the PCR diagnostics market is divided into bacterial infections, viral infections, and fungal and other pathogens. The viral infections segment dominated the market in 2021 and is anticipated to register the highest CAGR during the forecast period. By end user, the market is segmented into hospitals, physician clinics, clinical laboratories, academic and research institutions, biotech and pharmaceutical companies, and others. In 2020, clinical laboratories represented the largest market share and are expected to experience the highest CAGR in the future.

Key primary and secondary sources referenced in this report include the Food and Drug Administration (FDA), the World Health Organization (WHO), and the European Respiratory Society (ERS), among others.