Polymerase Chain Reaction (PCR) Global Market is estimated to be worth $21.4 billion in 2020
Polymerase chain reaction (PCR) is a basic molecular technique used for efficient and rapid amplification of specific DNA or RNA template in an exponential manner. This technique has a broad range of applications, not only in basic research but also in the areas of clinical diagnosis (infectious & non –infectious), forensics, agriculture, biomedical research, food testing, environmental testing, and others. The evolution of PCR technologies such as second-generation (Real-time PCR) and third-generation (digital PCR), development of various PCR techniques by modifying the basic protocol (multiplex PCR, reverse transcriptase PCR, Nested PCR, Alle specific PCR, Hot star PCR), development of advanced reagents and assay kits with the incorporation of advanced technologies for simplifying the workflow to obtain results in a shorter period and also the integration microfluidics and other technologies for the development of miniaturized PCR has further increased the advantages of PCR and made this as one of valuable molecular technique in clinical diagnosis and research.
According to IQ4I analysis, the Polymerase chain reaction (PCR) global market is valued at $21,408.8 million in 2020. As there is a rapid surge in the demand for PCR-based diagnostic kits during 2020 due to COVID-19, the PCR global market increased by XX% compared to 2019. The rising incidence of infectious and non-infectious diseases, increase in demand for early disease detection, diagnosis & treatment, growing focus towards the development of personalized medicine, increasing advancements in PCR technologies and increasing demand for point of care testing are driving the PCR market growth. However, lack of skilled personnel to use advanced PCR Instruments and data analysis software, high cost of advanced instruments, presence of alternative molecular, immunology and diagnostic imaging technologies, and stringent regulations are expected to hamper the market growth.
The PCR global market is categorized into various market segments based on the products, applications, end-users and geography. Based on the products, the PCR market is segmented into instruments, reagents & consumables and software & services. Among these, the Reagents & consumables segment accounted for the largest revenue in 2020 due to an increase in the utilization of reagents and assay kits in clinical diagnosis and research. For instance, the COVID-19 pandemic has drastically increased the demand for RT-PCR-based diagnostic assay kits and reagents. In Reagents & consumables sub-segments, Reagent kits or master mixes and assay kits are accounted for the highest revenue of in 2020 due to the increase in demand for assay kits in COVID-19 diagnosis. The enzymes segment is expected to grow at a high single digit CAGR from 2020 to 2027 due to increasing utilization of enzymes in basic research and development of an advanced version of DNA polymerase compatible of most of the PCR reactions. The demand for PCR instruments has substantially grown in the past three decades with the development of a large number of models with various characteristics to accommodate all the needs of research as well as a clinical diagnosis so that users can choose among many available options in PCR systems. The design of PCR machines varies with sample holding capacity, throughput, portability & footprint and working mechanism. Among the instruments sub-segments, Real-Time PCR is accounted for the largest share in 2020 due to the increase in demand for Real-time PCR instruments in clinical diagnosis of infectious diseases especially in COVID-19 diagnosis & non-infectious diseases, research and industrial application and development of advanced standalone and integrated multiplex real-time PCR instruments. The Digital PCR segment is expected to grow at a mid teen CAGR from 2020 to 2027 due to potential applications of digital PCR instruments in disease research mainly in cancer, detecting, profiling, and quantifying drug resistant infections, growing focus towards the development of digital PCR based diagnostic solutions and entering of companies into the market with integrated digital PCR solutions. For instance, Qiagen recently entered the digital PCR market with a differentiated QIAcuity Digital PCR System, a fully integrated (partitioning, thermocycling, and imaging into a single fully automated instrument) nanoplate-based digital PCR system.
The PCR global market based on application is categorized into clinical diagnostics, industrial applications, and others (blood screening and HLA typing). Among these applications, Clinical diagnostics is accounted for the highest revenue in 2020 due to an increase in the incidence of infectious and non-infectious diseases and an increase in demand for PCR-based early diagnostic solutions. Industrial applications are expected to grow at a mid single digit CAGR from 2020 to 2027 due to the increasing application of real-time PCR and advanced digital PCR in biomedical research, agriculture, environmental monitoring and food testing. In Clinical diagnostics sub-segments, infectious diseases are accounted for the highest revenue in 2020 due to an increase in the incidence of infectious diseases, particularly in COVID-19 and an increase in demand for RT-PCR based solutions in COVID-19 diagnosis. For instance, FDA has approved close to 192 RT-PCR COVID-19 tests through Emergency use authorization as of May 2021. The non-infectious diseases segment is expected to grow at a double digit CAGR from 2020 to 2027 due to increase in incidence and prevalence of non-infectious diseases like cancer, growing focus towards the development of PCR based companion diagnostic solutions and increasing application of digital PCR in cancer research due to its high precession and specificity to detect the rare mutation. In the Infectious diseases sub-segment, COVID-19 diagnosis is accounted for the highest revenue in 2020 due to an increase in the incidence of COVID-19 and an increase in demand for PCR-based early diagnosis solutions. According to IQ4I analysis, total number of diagnostic tests performed for COVID-19 globally is estimated to be 1,514 million in 2020. Among them, XX million are PCR based diagnosis tests.
The PCR global market based on geography is segmented into North America, Europe, Asia-Pacific and the Rest of the world (RoW). North America accounted for the highest revenue in 2020. The factors such as increasing R&D and health care expenditure, increase in the incidence of infectious diseases particularly COVID-19 and non-infectious diseases with increased demand for early detection, diagnosis & treatment, increasing funding from the government for the disease research, development of diagnostic and therapeutic solutions, growing focus towards personalized medicine and a growing number of startup companies engaged in developing advanced digital PCR systems & portable PCR solutions to use in research & diagnostics are driving the market.
Technological advancements are expanding the PCR market, particularly in the development of portable PCR. As there is an increasing demand for the development of miniaturized PCR mainly for point of care applications, the development of novel methods for thermocycling such as infrared mediated non-contact thermocycling and novel plasmonic photothermal thermalcycling (Nano-PCR) will further boost the development of miniaturized PCR (Portable PCR systems). Also, the development of an advanced crystal digital PCR system by combing existing chip-based and droplet-based methods, integration of AI features to instruments for data analysis and addition of remote reaction capabilities to instruments will further increase the PCR utilization in clinical diagnosis and research. For instance, in March 2021, Qiagen launched QIAsphere cloud-based platform for its PCR based syndromic testing platform QIAstat-Dx to monitor their instrument and test status remotely and provide notifications across their personal devices, such as smartphones, desktop PCs and smartwatches.
Due to advantages associated with PCR-based diagnostics, government or private ventures are funding to develop novel rapid PCR assays or systems, develop advanced digital PCR systems and expansion of manufacturing & production capacity of PCR assays. Also, the recently emerged COVID-19 pandemics have gained further attention from the government or private ventures to fund PCR as RT-PCR techniques are considered as golden standard for COVID-19 diagnosis. According to IQ4I research, during the period April 2019-2021(June), approximately $XX million was invested by various venture and government agencies in PCR. Among the total funding, around 43.4% of total funding or $XX million of funding is for PCR-based COVID-19 diagnosis. At the same time, the development of PCR-based point of care testing also gained more attention during the COVID-19 pandemic, as there is need for robust, effective testing solutions that help workers to get on with their work as quickly, safely, and efficiently as possible. Thus, government agencies and private ventures are funded for startup companies for the development and commercialization of point of the care system and assays for COVID-19 diagnosis. According to IQ4I analysis, around $XX million or 53.4% of total COVID-19 funding is for the development of point of care diagnosis during the period of 2020-2021 (June). For instance, in March 2021, QuantuMDx received funding of $15.0 million to support manufacturing and commercial scale-up of its Q-POC rapid, PCR-based point-of-care diagnostic system which detects SARS-CoV-2.
In COVID-19 pandemics, as there is an increased demand for RT-PCR-based assay for early clinical diagnosis, a number of companies have developed the RT-PCR assay and received regulatory approval for use in diagnosis. Companies are constantly focused in innovating RT-PCR testing strategies to gain more attention by modifying sample collection methods, sample preparation methods, detection methods, developing point of care assay, and automation to further improve the efficiency and timeliness of the RT-PCR assay. For instance, some of the companies are developing Direct RT-PCR kits for COVID-19 diagnosis to remove lengthy RNA extraction steps, which will help to perform more diagnostic tests, reduces the cost, labor and time required to carry out very sensitive PCR tests. For instance, in July 2021, Menarini Diagnostics launched its CE Marked CoronaMelt VAR Real time PCR kit for SARS CoV-2 detection and variant screening. The test combines SARS CoV-2 viral detection with concurrent genotyping of Alpha, Beta and Gamma variants (UK, South African and Brazilian). Similarly, in March 2021, Novacyt launched CE approved SNPsig VariPLEX PCR assay panel able to detect the four COVID-19 variants such as UK (20I/501Y.V1), South Africa (20H/501Y.V2), Brazil (20J/501Y.V3) and California (20C/S.452R), and mutations N501Y and E484K in a single kit. In March 2021, Roche launched real-time PCR-based Cobas SARS-CoV-2 Variant Set 1 assay to detect and differentiate mutations found in variants that originated in the UK (B.1.1.7), South Africa (B.1.351), and Brazil (P.1). This research assay helps in tracking mutation prevalence and to assess any potential impact on diagnostics, vaccines and therapeutics, providing crucial insight for healthcare systems in making appropriate measures to combat COVID-19.
The PCR market is fragmented, the top 6 players occupy XX% of the market share and the remaining 56.0% of the market is occupied by other players. Companies are adopting various organic and inorganic strategies to expand their market in a competitive market. To gain market share, companies are constantly focusing on developing innovative technologies and differentiated products. For instance, in October 2020, Bio-Rad Laboratories, Inc. launched CFX Opus 96 and CFX Opus 384 Real-time PCR Systems along with BR.io, cloud-based instrument connectivity, data management, and analysis platform to use in research and genomic testing as well as in pathogen detection and infectious disease testing. Companies are collaborating with pharma or biotech companies to develop PCR-based companion diagnosis tests. For instance, in May 2021, Qiagen collaborated with Mirati Therapeutics Inc. to develop PCR-based tissue-based KRAS companion diagnostic to identify cancer patients with cancers KRASG12C mutation who may benefit from treatment with adagrasib, Mirati’s investigational, highly selective and potent oral small molecule inhibitor of KRASG12C. In response to COVID-19, the top companies have developed innovative multiplex PCR assays and direct PCR kits inorder to grab the opportunities in the current PCR market.
The key players in the PCR global market include Abbott Laboratories, Inc. (U.S.), F.Hoffmann-La Roche Ltd (Switzerland), Biomerieux SA (France), Becton Dickinson and Company (U.S.), Bio-Rad Laboratories (U.S.), Danaher Corporation (U.S.), Merck KGAA (Germany), PerkinElmer, Inc. (U.S.), Qiagen N.V. (Netherlands) and Thermo Fisher Scientific, Inc. (U.S.).