qPCR Instruments Market

Market Overview

The global qPCR instruments market size was valued at USD 1,373.05 million in 2022. It is estimated to reach USD 4,224.15 million by 2031, growing at a CAGR of 13.3% during the forecast period (2023–2031).

A machine that amplifies and detects DNA is known as a quantitative or real-time PCR instrument. It enables the quantitative PCR procedure by combining the capabilities of a thermal cycler with a fluorimeter. Thermal control, fluorimetry, and sample throughput are the main performance parameters of quantitative PCR instruments. Two commercial models of the first quantitative PCR machine were made available in 1996 after being first reported in 1993. By the year 2009, a total of 18 models were available from seven distinct manufacturers.

Key performance factors for quantitative PCR devices include speed, accuracy, and uniform heat control. It has been shown that PCR may complete 30 cycles in less than 10 minutes. The advantages of rapid cycling include a shorter time to result, higher system throughput, and greater reaction specificity. Fluorescence measurements are used by quantitative PCR equipment to track the status of PCR and the characteristics of amplified products. Relevant performance features include the variety of fluorescent labels that may be observed, the accuracy of the measurements, and the capacity to distinguish between signals from various labels.

Highlights

• GeneXpert dominates the instruments segment
• North America is the highest shareholder in the global market

Market Dynamics

Global qPCR Instruments Market Drivers

Increasing Number of CROs and Forensic and Research Laboratories

Clinical Research Organizations (CROs) are growing globally, and biotechnology and pharmaceutical companies are increasingly outsourcing their drug development programs for cost benefits. With the help of qPCR technologies, several academic researchers and CROs have started genomics-based research to develop innovative strategies in disease management. This is a consequence of the increased availability of government funding for conducting research based on genomics. For instance 2018, Genomics Medicine Ireland (GMI) received USD 425.80 million for conducting genomics research in Ireland, which allowed research efforts to scale up to over 60 disease areas.

Additionally, an increase in public and private funding to increase the capacity of forensic laboratories is expected to fuel market growth. For instance, the National Institute of Justice, between 2004 and 2011, awarded USD 542 million to local and state DNA laboratories. Federal funding has helped local and state laboratories increase their capacity and allow them to keep pace with the increasing demand. Likewise, there is the Coverdell Forensic Science Improvement Grant Program. These initiatives allow organizations to improve laboratory automation and procure better laboratory equipment. The demand for specialized instruments in this industry, like qPCR, is expected to increase due to changes in the legal system.

Increasing Adoption of qPCR Technologies

Conventional PCR methods are time-consuming and often provide low accuracy of results. In addition, they are labor-intensive and manual interference can cause contamination of output. Rapid diagnostic methods are sensitive, precise, and usually automated. Automation can save up to half the time required for the procedure and yield accurate results. Increasing adoption of qPCR technologies is expected to propel this market.

qPCR techniques are gaining popularity due to their accuracy, automation, precision, real-time quantification, and sensitivity. The versatility of qPCR's input nucleic acids in research applications makes it an effective and useful technology. It has diverse applications in areas such as oncology and genetic disease research, stem cell research, pathogen detection, research of infectious diseases, pharmacogenomics, pharmaceutical analytics, agricultural biotechnology, and plant sciences research. The forensics field also makes heavy use of this technology.

Global qPCR Instruments Market Restraint

High Prices of qPCR Instruments

qPCR instruments render accurate and effective results and have indispensable applications in disease diagnostics. However, the high cost of molecular tests is one of the main factors restraining this market. The lack of comparable products is another factor contributing to price increases. This issue is worsened by the reality that prices for each molecular diagnostic product vary significantly depending on the application. For instance, Thermo Fisher Scientific's 7900 HT qPCR system ranges from USD 20,000 to USD 30,000. Therefore, the high cost of qPCR devices is expected to restrain the market.

Global qPCR Instruments Market Opportunities

Technological Advancement in PCR

Recent years have seen sensitivity, accuracy, efficiency, and cost-effectiveness technological breakthroughs in PCR. The top companies on the market are focusing on delivering cutting-edge PCR test instruments. For instance, In July 2017, Bio-Rad Laboratories released droplet digital PCR Genome Edit Detection Assays to evaluate the efficacy of CRISPR-Cas9 or any other genome using Bio-droplet Rad's digital PCR technology. This technology has gained popularity recently.

Furthermore, by adopting R&D initiatives to create kits to reduce the frequency of new diseases or signing agreements with other kit-producing companies, leading players are updating various tests for their qPCR devices. Examples include Roche Diagnostics' introduction of the cobas HPV test in cobas 4800 and Becton, Dickinson, and the Company's BD GeneOhm MRSA ACP assay, used with Cepheid's SmartCycler. These elements create opportunities for market expansion.

Regional Analysis

Based on region, the global qPCR instruments market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global qPCR instruments market shareholder and is anticipated to exhibit a CAGR of 15.51% during the forecast period. North America held the most prominent market share in the global qPCR market, owing to key market players, developed diagnostic infrastructure, and increasing research-based grants in the region. A growing emphasis on personalized medicine, increasing collaborations and externalizations with academic research institutes, and rapid adoption of healthcare IT and software to manage PCR with its growing automation rates are additional factors anticipated to propel the region's market further. In contrast to other regions, North America has a higher diagnostic capability, as seen by the sheer quantity of instruments deployed there. However, it lessens the opportunity for the installation of new instruments. Growing regulatory support and increasing investments in biotechnology and biopharmaceutical industries are anticipated to accelerate the market further. Similarly, the growing incidence of diseases like cancer, cystic fibrosis, hemophilia, and heart diseases, is anticipated to drive the demand for applications, including gene therapy, propelling the demand for qPCR instruments.

Europe is predicted to exhibit a CAGR of 12.5% over the forecast period. The market is anticipated to be driven by an increase in research funding and the existence of important market players locally. Due to growing investments, the number of biopharmaceutical corporations is increasing in Europe. For instance, in 2017, investments raised by the biopharma industry reached USD 20 billion, demonstrating an increase of 28% to USD 27.5 billion in 2019. In addition, several key global players conduct their biopharmaceutical R&D in Europe. qPCR plays a crucial role in biopharmaceutical research due to the involvement of genes and biological sources.

Additionally, the market is accelerating due to new players' increasing investments and strategic activities. For instance, Discovery Laboratories and Deerfield Management Company worked together in January 2020 to identify a gene therapy CDMO with USD 1.1 billion in funding. Furthermore, Europe is the second-largest market for qPCR instruments in terms of revenue share, which can be attributed to the presence of developed economies such as Germany, Turkey, the UK, France, and Italy. For instance, countries like Italy have an advanced R&D infrastructure, which is anticipated to contribute significantly to the qPCR instrument market's growth.

Latin America includes nations such as Mexico, Argentina, and Brazil. A surge in the frequency of breast cancer and rapid economic development, especially in Mexico, are major factors expected to propel the regional market. Although this region has high unmet patient needs, capitalizing on market opportunities is difficult due to the lack of appropriate healthcare infrastructure. However, technological advancements are expected to contribute to market growth. In addition, increased government spending, the presence of skilled healthcare professionals, a rise in the focus of multinational companies to capture the untapped markets, and an increase in patient awareness about innovative and novel therapies such as gene therapy are expected to drive the market over the forecast period. Latin America's market is also expected to witness a surge in laboratories providing diagnostics to fulfill the growing demand. These laboratories are anticipated to propel the demand for qPCR instruments.

In the Middle East and Africa, the growing demand for effective and cost-efficient novel technologies is among the major reason driving the qPCR instrument market. The rate of diagnosis of cancer is low in the region. Delays in treatment and diagnosis can lead to lower survival rates. This creates an unmet need for affordable and novel treatments and predictive analytical tools, such as qPCR, in the region, which is expected to expedite the market. Due to the increasing use of novel therapies in the region, growing interest in gene therapy companies is projected to accelerate the market. For instance, in January 2021, Orchard Therapeutics announced a collaboration with GEN and GenPharm Services to improve its reach in the Middle Eastern market. In addition, economic development witnessed in emerging markets, such as South Africa, and high unmet healthcare needs are primary drivers for this market. There is a high prevalence of communicable and infectious diseases in this region. However, ethical reasons, poor infrastructure, and affordability might hamper market growth.

Segmental Analysis

The global qPCR instruments market is segmented into instruments.

Based on instruments, the global qPCR instruments market is divided into 7500, QuantStudio Dx Real-Time PCR Instrument, QuantStudio 5 Real-Time PCR System, ViiA 7 Dx, StepOne/ StepOne Plus, LightCycler 2.0/ 96/ 480/ 1536, Cobas 4800, CFX96, SmartCycler, GeneXpert, Rotor-Gene Q 5Plex HRM System, Rotor-Gene Q, BioFire FilmArray Systems, and BMS Mic System. 

The GeneXpert segment is the most significant contributor to the market and is estimated to exhibit a CAGR of 9.81% over the forecast period. GenXpert systems are fully automated and integrated, on-demand molecular diagnostic systems. They offer accurate testing available around-the-clock, flexible workflows, and user-friendly designs. They provide a variety of testing using a single, scalable, and consolidated workstation. The systems are available in 1, 2, 4, 16, 48, and 80-module configurations. GeneXpert I, GeneXpert II, GeneXpert IV, and GeneXpert XVI are various systems available under the GeneXpert family.

In addition, GeneXpert infinity systems are mostly automated molecular diagnostic systems. They provide a menu of tests that can be operated on a single system, in real-time, and in a moderately complex environment by a single user. Features include high adjustability, touchscreen, increased accumulator capacity, expanded test shuttle, expanded conveyor and loading zone, and self-containment; it also has a quieter, faster, and more robust robotic gantry. Likewise, GeneXpert Infinity 48s and GeneXpert Infinity 80 are the two GeneXpert Infinity Systems.

The 7500 system for real-time PCR is powerful and provides dye versatility for superior performance in laboratories. The enhanced sensitivity of the instrument can be attributed to its innovative optical system. A range of dyes is available on the color-coordinated platform. Data viewing is made simple with the inclusion of user-friendly software. This instrument is USD 8,999 in price. In January 2021, the University of Oregon started using its research capabilities to conduct extensive SARS-CoV-2 testing. Oregon University announced the use of 7500 qPCR for the swab-based testing workflow. In addition, companies such as L7 Informatics are working to improve the integration of instruments such as the 7500 in the laboratory. Research conducted by NCBI in 2018 mentioned that the 7500 platform provided comparable quantitative PCR results to other instruments, including the LC480 platform. The high-quality performance of the instrument, along with the increased interest of researchers, is expected to drive the market.

Life Technologies Corporation launched Quantstudio DX in November 2012. The instrument has CE-Mark approval for its use in European countries. It follows the In Vitro Diagnostic Medical Devices Directive (98/79/EC) requirements and can be used as IVD. The system is available in 384 and 96 well plate formats. It can be used in pathogen diagnosis, number analysis copy, SNP analysis, genotyping analysis, and mutation detection. Researchers can also use the instrument as Quantstudio supports research functions. The use of Quantstudio DX in research and diagnostics is anticipated to act as a driver for this segment.

The Rotor-Gene Q platform by Qiagen is automated and designed for clinical laboratories. It is available in 72 and 100-well formats. It gives fast results and can multiplex six targets. High throughput is an advantage of the system, but expensive consumables and closed systems are disadvantages. The instrument was approved for Influenza A/B Assay by the U.S. FDA in April 2012, post which the product gained popularity globally. In March 2020, Qiagen announced the recall of its Rotor-Gene Q PCR Platform owing to false results given by the instrument. The recall was ordered to reduce the risk of misdiagnosis; however, with the growing incidence of COVID-19 cases, the recall was expected to impact the market adversely.

Recent Developments

• May 2022- Anitoa Systems, an American startup, developed a portable RT-PCR molecular test to detect dengue virus infections. Maverick qPCR, a family of four- to six-channel small-footprint real-time PCR instruments, is utilized in the new test.
• September 2022- Thermo Fisher Scientific validated the Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System* for compliance with the In Vitro Medical Devices Regulation (IVDR). The modernized system now incorporates a new, complementary Applied Biosystems Diomni Software ecosystem to enable clinical laboratories and test developers to utilize flexible qPCR testing on-site.