Polymerase chain reaction (PCR) has become one of the important platforms in the healthcare sector. In terms of innovation and demand, the PCR kit market is experiencing significant growth. One of the major factors driving the market is the expiry of key PCR patents, which enables emerging companies to enter the arena. Such new and emerging companies are actively engaged in the development of innovative technologies and expansion of the market into various end-use segments.
The PCR kit market size was valued at USD 2,350.5 million in 2019 and is expected to grow with a CAGR of 8.0% during the forecast period.
Leading market players in the polymerase chain reaction market are involved in the launch of advanced and novel PCR instruments and consumables that enable quick and easy amplification of nucleic acids, which can be used effectively in the diagnosis of various chronic diseases. For instance, in October 2017, Diatech Pharmacogenetics, an Italian market leader in the development of diagnostic kits, launched ‘easyPGX,’ easy to use and ready to use in-vitro diagnostic real-time PCR product line, comprising of reagents that are delivered in 8-preloaded strips. The company also launched ‘Helix’ a polymerase chain reaction kit for the extraction of circulating free DNA from plasma, which is increasingly being adopted for detecting circulating DNA fragments released in the blood plasma in cancer and chronic infectious disease.
In September 2015, Bio-Rad Laboratories introduced droplet digital PCR (ddPCR) Supermix for Residual DNA Quantification, which delivers maximum PCR efficiency, specificity, and sensitivity in molecular diagnostics. This has also offered a highly precise method for DNA measurement. In November 2016, Chai Biotechnologies Inc. launched Open qPCR, the real-time PCR Thermocycler, which is designed to use for genetic genotyping, pathogen detection, and relative DNA quantification. In addition, Bio-Rad Laboratories, in April 2015, launched Precision Blue Real-Time PCR Dye, compatible with Bio-Rad’s universal qPCR supermixes and can be used with all Bio-Rad’s CFx real-time PCR systems
Several market players engage in collaborations to expand their geographic reach and increase the customer base. For instance, in March 2018, Akonni Biosystems Inc., a molecular diagnostic company in the U.S., and Righton diagnostics signed a commercial agreement, which allows Righton to market Akonni'sTruDiagnosis and TruTip Nucleic Acid Purification Kits in China. In January 2018, Thermo Fisher Scientific and Illumina, Inc. signed a collaboration agreement to increase the consumer base. Furthermore, in December 2017, Genome Diagnostics (GenDx) signed a global reseller agreement with Thermo Fisher Scientific, according to which Thermo Fisher Scientific has assigned GenDx as a non-exclusive reseller ofQuantStudio real-time PCR instrument. According to the agreement, GenDx will market the QuantStudio real-time PCR in the Netherlands and other European countries.
The polymerase chain reaction has numerous applications and is increasingly being used in the clinical diagnosis of infectious diseases, paternity testing, nucleic acid amplification, DNA fingerprinting, detection and diagnosis of cancer and other genetic diseases, and molecular quality control and development of personalized medicines. As per the Centers for Disease Control and Prevention (CDC), in the U.S., around 5,251 deaths were reported due to influenza infection in 2015. As per the World Health Organization (WHO) estimates, about 32,000 deaths were reported due to tuberculosis, and approximately 323,000 new cases of TB were registered in the European region in 2015.
As per the National Ambulatory Medical Care Survey: 2015, more than 16.8 million patient’s visits to physician clinics were reported for the treatment of infectious and parasitic diseases. In 2016, around 555,318 new cases of cancer were reported in the Middle East, as per the WHO, and the region is expected to witness the highest relative increase of cancer cases in the world accounting to 961,098 cases by 2030. In addition, according to the Cancer Atlas, 2017, about 2.1 million new cancer cases and 600,000 cancer deaths are reported every year in Latin America and the Caribbean.
The quantitative PCR segment accounted for the largest market share in 2018 in terms of revenue. Quantitative PCR (qPCR), also known as Real-time PCR, can calculate PCR amplification simultaneously with the progress of polymerase chain reaction. Quantitative PCR does not require post-amplification processing, which reduces the turnaround time of the diagnostic process and the risk of contamination of amplified DNA or RNA. Consistently, rising demand in areas such as genetic testing and analysis, gene expression analysis, and genotyping coupled with an increasing focus on the development of Point of Care (PoC) diagnostic platforms drive the segment growth.
The digital PCR segment is expected to register robust growth during the forecast period, owing to its precise estimation of nucleic acids and proteins in the next-generation sequencing technique. Digital PCR is a relatively newer technology for DNA amplification and quantification, which uses molecular counting protocol. Digital PCR is primarily used in allele’s differentiation, detection of viral infection load in infectious diseases, detection of cancer genes, and detection of fetal DNA in circulating blood. The key advantage offered by digital PCR is that it is insensitive to reaction efficiency and does not require preparation of standard curves. However, high instrument costs and technical limitations of Digital PCR restrict the segment growth.
The consumables and reagent segment held the largest market share in 2019. The segment is expected to witness a strong growth rate as compared to other segments due to the launch of new PCR test kits. For instance, in October 2017, Bio-Rad laboratories received certification for iQ-Check (Real-Time PCR Kit) as the official method of analysis for Salmonella species detection in the food processing industry by AOAC INTERNATIONAL, independent standards developing organization. The validation of this kit has resulted in increasing demand for the kits in a wide range of industrial applications in the food industry.
The software segment is predicted to exhibit the fastest growth during the forecast period as software helps in improving the efficiency of digital PCR data management. Recently, Bio-Rad laboratories launched CFX Maestro™ Software for Real-Time PCR Data Analysis, which integrates statistical analysis, data visualization, and publication-ready graphics production in one platform.
Most of the market players in the PCR kits market are actively involved in responding to the current coronavirus outbreak. Thermo Fischer Scientific, Roche diagnostics, and Bio-Rad laboratories are working with government agencies and researchers to ensure priority access to instruments, consumables supplies, and other products to address the outbreak, particularly in the analysis of the virus, diagnosis and personal protection. Recently, the Ortho Clinical Diagnostics laboratories launched an immunodiagnostic PCR kit to detect antibodies (including IgG and IgM) in response to SARS-CoV-2 that can be used to detect immune response to the coronavirus.
North America dominates the PCR kit market in on account of high healthcare spending, increasing adoption of new PCR kits, availability of R&D grants, and large scale & commercialization of the kits. Moreover, the strong presence of dominant market players and diagnostic laboratories, coupled with increasing demand for rapid diagnostic tests, drive the growth of the PCR kits market.
Asia-Pacific is projected to create substantial revenue opportunities due to the investments in the research and development sector in the emerging economies like India, China, and Japan. Rising patient pool due to the high prevalence of chronic and infectious diseases along with increasing awareness among patients about early diagnosis drives the market growth. Recently, the Indian government allowed two private companies MyLab and Altona Diagnostics, to supply COVID-19 test PCR kits to both the government as well as private diagnostic laboratories In addition, two South Korean firms Seegene and SD Biosensor, received approval to supply RT-PCR based COVID-19 diagnostic kits in India. The Indian government has also approved 12 rapid antibody test kits for COVID-19 diagnosis.
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In January 2019, QIAGEN N.V. acquired FORMULATRIX’s digital PCR assets in a deal valued at USD 260 million. The acquisition has augmented the company’s ability to launch new digital PCR platforms in 2020 by incorporating FORMULATRIX’s advanced Digital PCR technology.
In January 2019, Abbott signed an eight-year partnership agreement with the Japanese Red Cross Society (JRC) to develop PCR kits for serological testing and quality control, including instruments and reagents and consumables used for blood and plasma screening in Japan.