Global Digital PCR Market - 2022-2029

Market Overview

Digital PCR Market size is estimated to reach high at a CAGR of 7.4 % during the forecast period (2022-2029).

The end-point PCR technique, digital PCR, is utilized for accurate quantification and studying small sequences compared to related large sequences. PCR stands for a polymerase chain reaction. It amplifies the DNA or RNA segments multiple times. Finds genetic changes or infections in any individual.

Market Dynamics

The global digital PCR market will expand due to several factors. Some of them are rising technological advancements, novel product launches, growing infectious disease incidents, and a surge in R&D activities by biopharma companies.

The increase in technological advancements and research & development by various biopharmaceutical companies is expected to drive market growth.

The surge in research and development activities by various major key players is a major factor in driving the market. PCR diagnoses various illnesses, such as infectious diseases and genetic changes. It can diagnose the disease in its earliest stage, and even if only minute amounts of antibodies or cancer cells are present, it can detect it by amplifying the DNA or RNA multiple times. Nucleic acid measurement is accurate and sensitive, thanks to digital PCR (dPCR). Traditional PCR uses agarose gel electrophoresis to detect the amplified product, making it a semi-quantitative end-point examination. The three main subtypes of digital PCR (dPCR) are beaming, droplet, and chip-based digital PCR.

One of the significant possibilities in the worldwide PCR market is the growth of R&D spending for d-PCR molecular diagnostics. To facilitate effective diagnosis, several biotechnologies and life sciences, businesses are collaborating on developing diagnostic tests and the therapeutic use of d-PCR in several illness indications to provide effective treatment.

Introducing new products by major companies and technological breakthroughs in PCR technologies fuel the market's expansion. For instance, some market participants have created unique d-PCR products that can recognize various diseases or detect various genetic abnormalities. For instance, in Mar 2021, Thermo Fisher announced United States Food and Drug Administration had completed the listing for QuantStudio 5, a real-time PCR and launched it in the market. It helps labs and developers fulfill the demands of testing.

Major key players develop the latest products or models with novel technological innovations and advancements. Most of the products receiving approval are driving the market's growth. For instance, in 2020, Thermo Fisher created several PCR kits and tests for diagnostic and research to fight the COVID-19 outbreak. They released AcroMetrix Coronavirus 2019 (COVID-19) RNA Control after receiving the US FDA's emergency use authorization (EUA) for the SARS CoV 2 multiplex real-time PCR test.

Technical limitations associated with the market are expected to hamper the market growth.

Costly equipment and PCR's technological limitations are predicted to impede market expansion. A classic d-PCR method is accompanied by a variety of technical limitations, including the need for assay procedure optimization and validation, the measurement of signals all through the exponential growth phase of the PCR amplification, difficulties in target detection caused by the existence of reaction modulators, and the inability to identify biomolecules due to the poor efficiency of the DNA sequence template. Additionally, the usage of carcinogenic chemicals, chemical binding of d-PCR reagent to dsDNA and inability to evaluate DNA quality are some of the procedural restrictions that prevent using these reagents in genomic research.

COVID-19 Impact Analysis

The COVID-19 outbreak severely impacted the healthcare industry. The PCR market has experienced a boom, and the diagnosis sector was most severely affected. Real-time and digital PCR are in high demand since they are used for drug research and diagnostic purposes. It is becoming increasingly important for industry entities to test COVID-19 by creating droplet digital PCR kits. The regulatory agencies have given these tests their full support to limit the COVID-19 pandemic's effects.

Since digital PCR techniques are utilized to diagnose COVID-19 infection, the COVID-19 epidemic is projected to affect the global PCR market's growth positively. The market is expanding because various infectious diseases are becoming more common.

Segment Analysis

The droplet digital PCR segment is expected to hold the largest market share in the global digital PCR market.

The technology segment is further sub-segmented into digital droplet PCR, beaming digital PCR and chip-based digital PCR. Digital droplet PCR is expected to hold the largest market share due to the increasing number of product launches and various novel technological advances. Nucleic acid analysis can be done with extreme sensitivity, accuracy and exactness because of the development of digital PCR. It is also helpful for monitoring low-abundance targets, allelic variations (SNPs), targets with complicated backgrounds, and tiny changes in target levels that real-time PCR cannot pick up on. The use of this technology in in-vitro testing has now been authorized.

The droplet digital PCR divides the sample of DNA into 20,000 droplets using water-emulsion droplet technology. Every particular droplet then experiences PCR replication of the template and quantifying the positive droplets provides accurate target estimation. Absolute quantification, high precision and high sensitivity can be seen in droplet digital PCR so that it will be more helpful and accurate for analysis. For instance, in 2020, Bio-Rad announced that the droplet digital PCR SARS-CoV-2 test kit got emergency use permission from the United States Food and Drug Administration for COVID testing.

Geographical Analysis

The North American region holds the largest market share in the global digital PCR market.

In 2021 North America reserve an extensive share in the digital PCR market, and it is estimated that it is also going to overshadow the global market in the coming years owing to the upsurge in widespread presence of chronic diseases, the existence of key players for the progress of digital PCR devices, and prevalent foundation and substructure in the region. The growing technological advancement for developing digital PCR products shall stimulate the market. Favorable reimbursement policies and better healthcare facilities shall fuel market growth.

Most of the key players in this region are Thermo Fisher Scientific, Bio-Rad Laboratories Inc., Becton, Dickinson and Company and F. Hoffmann-La Roche, Ltd. All of them are launching various innovative and novel products. Various acquisitions and merges are also taking place, fueling the market's growth in this region and making North America the largest shareholder.

Competitive Landscape

The global digital PCR market is highly competitive with several international and local markets. Product diversification, revenue generation, and opportunities intensify the market competition. Thermo Fisher Scientific, Bio-Rad Laboratories Inc., and F. Hoffmann-La Roche, Ltd. are the three key players operating in the global digital PCR market. Other well-known players are Agilent Technologies, Abbott Laboratories, Becton Dickinson and Company, Danaher Corporation, Eppendorf, Merck, Promega Corporation, Takara Bio, Enzo Life Sciences, Meridian Bioscience, Bioneer, QIAGEN N.V, ELITech Group, Genetron Holdings Limited.

The companies are entering into collaborations, strategic partnerships, acquisitions and mergers to increase the demand for digital PCR and their global expansion. Companies are also using new product launches, product development, market expansion and technical advancement strategies to hold their market position. For instance,

• In Sep 2022, Thermo Fisher certified it's Applied Biosystems QuantStudio 7 Pro Dx, a real-time PCR, as it fulfills all the requirements by novel in-vitro medical devices regulation. Now it includes the biosystem Diomni Software ecosystem to grant labs and developers of tests to support the flexible PCR testing.

• In Sep 2022, Qiagen announced novel additions in their NeuMoDx assay portfolio for the viruses associated with organ transplants. Its latest assays got CE-In Vitro Diagnostic mark for European Union and various other countries. The novel assays are for identifying and quantifying human herpes virus 6 and Epstein-Barr virus.

• In May 2022, Qiagen launched the therascreen EGFR Plus RGQ PCR kit. It is the novel test kit for in-vitro diagnostic analysis for EGFR mutation as it detects all the activating EGFR mutations and resistance EGFR mutations. This device provides better detection limits, automatic sample extraction and analysis of results.

• In Sep 2020, Qiagen announced its partnership with NeuMoDx. Both will work on manufacturing and commercializing automated, fully integrated PCR devices.

Key Companies to Watch

Thermo Fisher Scientific:

Overview: Thermo Fisher Scientific is a healthcare distributor company that serves science. They manufacture and market reagents, scientific instruments & equipment, consumables and software services. It was established in 1956 and is based in Waltham, Massachusetts, United States.

Product Portfolio:

QuantStudio^*6 and 7 Pro Real-Time PCR Systems - These are PCR systems that are very flexible as they reinforce various kinds of applications and favorable conditions. The smartness of these systems is created to minimize contamination by making them run hands-free. Mobile phones can be used to schedule and even monitor the run. The QuantStudio 6 and 7 Pro systems contain 96-well blocks that comprise a technology known as VeriFlex that is used for specific temperature control. All these blocks are prorated into secluded zones, due to which there are separate cycling surrounding inside the one and same run that is ideal for optimization.

Key Developments: In Feb 2022, Therma Fisher launched its rapid Renvo PCR test to fight COVID-19. It is a novel solution in-air product that is included in its portfolio of pathogen surveillance. This test is done on the air samples collected by the aerosol sense sampler.

The digital PCR market report would provide access to an approx. 45+ market data table, 40+ figures and 180 pages.