The global real-time PCR (qPCR), endpoint PCR, and dPCR market size was valued at USD 4,125.93 million in 2022. It is estimated to reach USD 7,976.86 million by 2031, growing at a CAGR of 7.6% during the forecast period (2023–2031).
Real-time PCR, also known as quantitative PCR, is a well-established technology that has become the method of choice for the sensitive and rapid quantification of nucleic acid in various biological samples. Real-time PCR, or quantitative PCR, is a well-established technology that has become the method of choice for the sensitive and rapid quantification of nucleic acid in various biological samples.
Endpoint PCR, or conventional PCR, involves amplifying a PCR reaction mixture in a tube using a thermocycler until all needed cycles have been run. Gel electrophoresis is used to analyze a fraction of the tube's contents, and the results are stained with ethidium bromide. Digital PCR is a highly precise method for sensitively detecting and quantifying nucleic acids. Each sample is divided into thousands of distinct reactions. After that, each partition is examined for the presence or absence of a fluorescent signal before the sample's absolute molecule count is calculated following endpoint PCR cycling. dPCR does not require a standard curve for quantification.
Rising Incidence of Chronic Diseases, Infectious Diseases, and Genetic Disorders
The rising prevalence of chronic and contagious illnesses and genetic disorders, such as Alzheimer's disease, Turner syndrome, and Parkinson's disease, is expected to boost the market demand during the forecast period. According to CDC, chronic diseases, such as cancer, diabetes, and chronic kidney diseases, and respiratory diseases, account for 7 in 10 fatalities in the U.S. every year. Rapid detection of infectious diseases with PCR facilitates timely intervention and appropriate treatment. In addition, the SARS-CoV-2 epidemic is fueling a surge in demand for qPCR equipment. The rise in cases is expected to increase the number of preventive screenings, facilitating market growth.
Furthermore, the increasing prevalence of genetic disorders is driving the market growth. According to a report published by CDC in 2016, congenital heart defects were the most common congenital disabilities in the U.S., affecting approximately 1% of births yearly. The frequency of breast cancer and ovarian cancer is increasing at a rapid rate in many regions. Therefore, the high incidence of various diseases is boosting the growth of the qPCR & dPCR market.
Increasing Demand for Prenatal Genetic Testing Procedures
Increasing demand for prenatal genetic testing procedures, owing to growing awareness about genetic disorders such as cystic fibrosis, hemophilia, and thalassemia, is expected to propel the market growth. In the early stages of pregnancy, fetal DNA in the mother's blood or the amniotic fluid can be analyzed to detect genetic defects before birth using qPCR and dPCR techniques. Possible genetic aberrations and defective fetuses can also be treated during early pregnancy.
Furthermore, an increase in the number of cases of chromosomal abnormalities is expected to fuel the market's growth in the future. For instance, sickle cell disease impacts 1 in 365 births of African American origin. Increasing healthcare expenditure and the growing need for high accuracy and safety is also expected to propel the market growth.
Stringent Regulatory Policies
Good manufacturing practice, Good Laboratory Practice, and Clinical Laboratory Improvement Amendments (CLIA) regulations govern Real-time PCR (qPCR)-based assays. The assays used must be validated and documented according to the guidelines of ICH recommended for adoption by regulatory bodies of the U.S., Japan, and the EU. Developed diagnostic assays are validated in compliance with the College of American Pathologists/CLIA requirements. Despite technological advancements in Real-time PCR (qPCR) technologies, their regulatory approval processes may take several years, restraining the market growth.
Technological Advancements in PCR
PCR has witnessed technological advancements in sensitivity, accuracy, efficiency, and cost-effectiveness over the past few years. The market's leading companies are concentrating on releasing innovative and cutting-edge PCR test equipment. For instance, in July 2017, Bio-Rad Laboratories launched Droplet Digital PCR Genome Edit Detection Assays to quantify the efficiency of CRISPR-Cas9 or any other genome using Bio-Rad's Droplet Digital PCR technology. This technology has gained prominence over the past years.
Furthermore, major players are updating a range of tests for their qPCR instruments by implementing R&D initiatives to develop kits to control the incidence of emerging diseases or by entering into agreements with other kit-producing firms. The examples include the introduction of the cobas HPV test in cobas 4800 by Roche Diagnostics and the BD GeneOhm MRSA ACP assay by Becton, Dickinson, and Company, which is used with SmartCycler by Cepheid. Such factors create opportunities for market expansion.
The global real-time PCR (qPCR), endpoint PCR, and dPCR market is segmented by technology, product, and application.
Based on technology, the global market is segmented into quantitative, endpoint PCR, and digital.
The quantitative PCR segment owns the highest market share and is predicted to exhibit a CAGR of 7.1% during the forecast period. Quantitative PCR is also referred to as real-time PCR. It is more accurate, precise, and time-saving. qPCR has wide applications in quantifying gene expression, pathogen detection, copy number variation, microarray verification, viral quantification, SNP genotyping, and microRNA analysis. The market for quantitative PCR is expected to witness lucrative growth owing to rapid technological advancements in devices. High gene expression analysis and genotyping usage as a validation tool are also expected to drive segment growth.
Endpoint PCR is a conventional method that monitors the reaction at the end. It is generally used in cloning and genotyping applications that have been replaced with qPCR and dPCR-based testing due to the associated limitations of the endpoint PCR, such as time and resource consumption. However, it is currently being utilized for food safety purposes. For instance, an article published in 2016 suggests that the tests were used for testing animal species, including cattle, swine, poultry, and fish, in meat and dairy products. Moreover, the presence of companies such as Promega Corporation, QIAGEN, and Canvax Biotech contributes to the market growth by offering products in their portfolio. Its use in pathogen testing is also expected to drive the market.
Based on product, the global market is bifurcated into consumables and reagents, instruments, software, and services.
The consumables and reagents segment dominates the global market and is predicted to exhibit a CAGR of 7.9% over the forecast period. Real-time PCR (qPCR) consumables vary in numerous parameters. Well-surface characteristics, material properties, quality, and well/skirt dimensions play the most important role. Consumables and reagents influence the overall performance of an assay. They help create standardized workflows that can support researchers in various fields, such as food testing, detection of cancer and infectious diseases, and forensics. In addition, the global burden of diseases has increased in the previous few years, and the current pandemic has contributed to the demand for consumables and reagents, which is responsible for the dominance of this segment.
Various Real-time PCR (qPCR) instruments include QuantStudio 3 and 5 Real-Time PCR Systems and 7500 Fast and 7500 Real-Time PCR System by Thermo Fisher Scientific, Inc.; QuantStudio 3D Digital PCR System and CFX96 by Bio-Rad Laboratories, Inc.; SmartCycler by Cepheid, Rotor-Gene Q by QIAGEN, LightCycler 2.0, Cobas 4800, and Light Cycler 480 by Roche Molecular Systems, Inc. The advantages offered by these instruments include specificity, sensitivity, and automation during the development of point-of-care diagnostics. Further, robust machine structure, user-friendly software, and excellent support services will drive market growth.
Based on application, the global market is divided into clinical, research, forensic, and others.
The research segment is the most significant contributor to the market and is estimated to exhibit a CAGR of 7.2% over the forecast period. Real-time PCR (qPCR) has applications in various research areas: stem cell research, Southern blotting, DNA cloning and sequencing, and recombinant DNA technology. Many research laboratories and academic institutes use Real-time PCR (qPCR) technology, as they have wide applications in stem cell research, oncology, clinical microbiology, and pathogen testing. Efficiency and accuracy are the factors responsible for the increasing adoption of these techniques.
qPCR and dPCR are ideal methods for clinical applications, owing to reduced sample volume requirements and the availability of automated processes. qPCR and dPCR have applications in clinical virology, oncology, microbiology, etc. These techniques are also used to monitor response to various treatments, such as antiviral treatment, and assess predisposition to diseases. Hospitals or diagnostic centers use PCR devices for genetic testing and detecting various illnesses like cancer and infectious diseases.
Based on region, the global market are bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.
North America is the most significant global real-time PCR (qPCR), endpoint PCR, and dPCR market shareholder and is predicted to exhibit a CAGR of 6.4% during the forecast period. The rising prevalence of chronic and genetic disorders and infectious diseases, increasing demand for rapid diagnostic tests, and the surging geriatric population are some of the major factors responsible for the largest revenue generated by North America. The increase in investments for gene-based research and the presence of major market participants such as Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., and Agilent Technologies are also among key factors positively impacting the market's growth. Furthermore, technological advancements, such as microfluidic PCR in droplets, on-chip, off-chip thermocycling, and on-chip integration, are high-impact rendering drivers. The current pandemic has also increased demand for qPCR and dPCR products, coupled with favorable regulatory guidelines for launching COVID-19-related products. In addition, product advancements in the field of qPCR, such as QuantStudio 5 real-time PCR system, which is used for human identification in forensic laboratories, are expected to propel market growth.
Europe is estimated to exhibit a CAGR of 6.7% over the forecast period. The rising prevalence of cardiovascular and genetic disorders and growing investments in genomics and proteomics are predicted to drive regional market growth. Government funding, a rise in the number of genetic counseling programs being conducted by governments, and an increase in investments in the healthcare sector are some of the high-impact rendering drivers of the qPCR and dPCR market in Europe. Furthermore, the outbreak of SARS-COV-2 has increased the demand for testing assays in the region. This, coupled with favorable regulatory policies, is anticipated to aid manufacturers in developing and launching COVID-19-related products in the region, driving market growth soon. However, the European economic crisis and the presence of uneven reimbursement policies may restrain the growth of this market in Europe.
Asia-Pacific is envisaged to be the fastest-growing region over the forecast period. A few of the significant drivers for expanding this region's market include the high unmet clinical needs, undiscovered market potential, and rising healthcare costs. Moreover, a huge target population pool boosts the market growth. Technological advancements and the rising prevalence of various target diseases also increase the demand for qPCR and dPCR. Furthermore, the rising demand for healthcare products and government initiatives to improve the population's health will drive market growth over the forecast period.
In Latin America, technological advancements are estimated to contribute to the market expansion. Increasing government spending, the presence of skilled healthcare professionals, the rising focus of multinational pharmaceutical companies, and increased patient awareness are expected to drive market growth over the forecast period. Cancer is the second most frequent cause of mortality in Latin America. Currently, 118 research groups in Latin America are working on cancer genomics projects. In 2016, 272 articles were published on genomics by authors affiliated with Latin American institutions. Despite recent advancements in cancer genomics and its applications in Latin America, the region lacks research projects on the development of combined genomics, hindering growth opportunities.
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