Digital PCR Market

The digital PCR market in terms of revenue was worth of USD 414.2 Million in 2021 and is expected to reach USD 967.5 Million in 2028, growing at a CAGR of 13.0% from 2021 to 2028. Digitalization has pushed significant innovations in PCR technology. Digital PCR, which involves absolute quantification of nucleic acid target sequences, is the next generation of PCR technology. High tolerance to biological, sample prep inhibitors and advanced performance for applications necessitating higher sensitivity and accuracy of the digital PCR has gained huge potential across the world. 

Sykes et al. first proposed the concept of digital PCR in 1992, when they realized that combining limiting dilution, end-point PCR, and Poisson statistics might produce an absolute estimate of nucleic acid concentration. Digital PCR was widely used across the world for different applications due to its mind-blowing beneficial aspects. Whereas the digital PCR market has taken massive impetus since the advent of the Covid-19 pandemic. Covid-19 has created a disruptive picture across the world and affected almost 494,278,684 people of which around 6,184,261 caused death. To improve the frightening environment created by Covid-19, precise diagnostic testing is incredibly essential. Hence, the use of digital PCR is extensively used to accurately qualify the presence of SARS-CoV-2 and substantially lessens the risks of death. Due to the unique causal pathogen, incompletely known clinical sequelae, and restricted testing resources, the COVID-19 pandemic produced by the SARS-CoV-2 virus stimulates a variety of diagnostic techniques. Digital PCR technique provides higher sensitivity, precision, and specificity than traditional qPCR technology, making it ideal for detecting uncommon gene mutations, modest copy number variation, and absolute nucleic acid measurement. This is the reason why the inclination of many consumers toward digital PCR is drastically escalating. As a new technology, digital PCR technology has been broadly used in numerous fields such as microbiological detection, precision medicine, and food safety.  

The droplet digital PCR is achieving the highest demand in PCR technology. One of the key reasons for this segment's ascendancy in the global polymerase chain reaction (PCR) market is the clinically established potential advantages of droplet dPCR in the diagnosis of infectious disorders, such as viral, bacterial, and parasitic infections. Masses of advantages of this technology have promoted several major players to invest in the droplet digital technologies. For example, in November 2019,  

Bio-Rad Laboratories, Inc. launched the QX ONE Droplet Digital PCR System that enables an absolute measurement of target DNA molecules with greater accuracy, precision, and sensitivity. Apart from this, other players are also investing in droplet digital PCR across the world. Therefore, the preference toward droplet digital PCR has significantly shifted which has further contributed to the enormous revenue for the market. 

The future of the digital PCR market appears promising in the upcoming years across the world owing to new innovations and investments in it. Manifold digital PCR engineering companies are anticipated to implement go-to-market strategies, mergers & acquisitions, and new product launches to remain competitive and meet the escalating demand for medical drones. Bio-Rad Laboratories, Inc., Thermo Fisher Scientific, Merck KGaA, QIAGEN, and many more are hugely contributing to producing different types of digital PCR systems, their consumables, reagents, and software. For instance, the company innovating the next generation of digital PCR solutions for life science research and molecular diagnostics, Stilla Technologies launched its 6-Color Digital PCR Access Program which permits initial access to the industry’s first Digital PCR system introducing six fluorescent channels for offering the highest multiplexing and detection capacity accessible on the market. Similarly, Thermo Fisher Scientific has established the Applied Biosystem QuantStudio Absolute Q-Digital PCR System, the first completely integrated digital PCR (dPCR) system constructed to deliver highly precise and reliable results within 90 minutes. Apart from these, other market players are also intensively poring their millions of amounts of money in the digital PCR market. As a result, it is safe to say that digital PCR will play a larger role in the future.  

Analyst Comment, “With more advanced technology and developed technological advancements among many market players will result in promising growth for the digital PCR market”. 

Global Digital PCR Market Segmentation- 

By Product Type  

• Digital PCR Equipment 
• Consumables and Reagents 
• Software and Services  

By Technology  

• Droplet Digital PCR 
• Beaming Digital PCR  

By Application  

• Clinical Diagnostics 

• Forensics 
• Research 
• Others  

By Market Players 

• Bio-Rad Laboratories, Inc. 

• Thermo Fisher Scientific 
• JN Medsys 
• Merck KGaA 
• Stilla 
• QIAGEN 

• Fluidigm Corporation 
• Others 

Trends: - 

Following are some major trending Points of Digital PCR 

Digital PCR (DPCR) enables accurate, highly sensitive authentication of nucleic acids. Conventional PCR is a final-point analysis that is semi-quantitative because the amplified product is detected by agarose gel electrophoresis. Droplet Digital ™ PCR system, beaming PCR systems, and many more are some of the trendier technologies using across world. Apart from these, following are some of the most popular application areas for digital PCR covering various fields of biology. 

1. Liquid Biopsy

Liquid biopsies are non-invasive tests that can detect DNA sheds from cancer cells (circulating tumor cells, CTC) or blood tumors (circulating tumor DNA, CTDNA). They are increasingly being used to detect and monitor cancer. Unlike tumor tissue biopsy, liquid biopsy represents the least risk to an individual and can be repeated over time for the purpose of diagnosing and quantifying the disease and monitoring its progression. Several studies have shown that dPCR can be used for fluid biopsies, usually with greater sensitivity than other techniques. 

This technique can be used not only to detect different cancers, but also to detect cancer changes, detect tumor heterogeneity, find biomarkers, as well as detect response to treatment damage. The range of diseases that can be detected by liquid biopsy is rapidly expanding. Some examples include early detection of type 1 diabetes, infection detection and monitoring, organ transplants, and non-invasive pregnancy tests. 

1. Rare Sequence Detection

The increasing search sensitivity to low-abundance targets will have far-reaching consequences. These are ranging from earlier and more accurate detection of cellular changes in research and clinical settings to the development of a wide range of non-invasive trials. Additionally, digital PCR allows for increased performance in the detection and quantification of rare sequences because the target quantification is independent of the number of amplification cycles. Furthermore, when searching for related sequences (SNPs, allelic variants, edited RNA), segmentation reduces competition with more abundant background (wild type) species. The extended use of digital PCR to detect rare sequences includes: 

• Detection of cancer below the level identified by current tests 
• Observing new mutations and duplications in cancer as they arise 
• Investigation of viral loads such as HIV that can be detected by current tests 

• Non-invasive testing of body fluids for infectious diseases and cancer, including cell-free DNA (cfDNA). 
• Non-invasive antenatal testing using cfDNA 
• Detection of transplant rejection in transmitted DNA 

1. Copy Number Variation (CNV)

It is estimated that more than 10% of human genomes are made up of CNVs with sequences larger than 1 kb, and about 30% of the reference human genomes have CNVs with sequences larger than 100 bp. Some regions may have multiple copies per cell. Many are associated with CNV diseases. Digital PCR can provide accurate CNV dimensions in single wells. The precision and sensitivity of ddPCR technology allow the system to easily distinguish small changes: the same change between four and five copies can be determined using only one well. In addition, the accuracy of digital PCR is less sensitive to changes in amplification efficiency, a major cause of error in qPCR measurements. 

1. Gene Expression

The enhanced accuracy of digital PCR can provide higher resolution in many aspects of gene expression measurement. Digital PCR also provides a greater sensitivity when quantifying rare targets, or RNA from very limited material. 

Digital PCR is used for the analysis of gene expression at both the DNA and RNA levels in the following areas: 

• Detection and measurement of genomic DNA methylation 
• Increased sensitivity in transcriptional analyses with absolute quantification 

• Detection of rare mRNAs and miRNAs with rapid turnover including those in complex matrices such as blood 
• Detection of as few as 2 targets per well using EvaGreen with the QX200™ Droplet Digital PCR System. This allows users to perform gene expression analysis without TaqMan probes. 

1. Single-Cell Analysis

Single-cell analysis can be used to study differences in cellular processes, such as different cell profiles in tissue, differences in cell populations, and differentiation or response to stimuli. Digital PCR, with its increased sensitivity and perfect authentication, can overcome some of the hurdles in single-cell analysis. Preliminary studies showing the potential of digital PCR in the single-cell analysis include the characteristics of hematopoietic progenitor cells. In addition to using digital PCR to study gene expression in individual cells, ddPCR technology can be used to create single-cell libraries for further analysis by techniques such as next-generation sequences.  

The following characteristics of digital PCR make it a sensitive and robust tool for single-cell analysis: 

• Precise detection and amplification of targets at low template levels 
• No requirement for a standard curve or housekeeping genes 
• Reduced sensitivity to PCR-inhibiting components in crude cell lysates 
• Simultaneous detection of 4 targets through multiplexing 
• Can be combined with other techniques such as next-generation sequencing 

1. Pathogen Detection and Microbiome Analysis

Digital PCR is perhaps the most widely used form of microbiology to date. Some areas of pathogen detection in which digital PCR is used: 

• Detection and monitoring of viral loads below the current test parameters 
• Pathogen detection both pre- and post-allotransplantation 
• Detection and monitoring of microbial drug resistance and heteroresistance 

• Discovery of pathogens in food 

Analysis of microbiomes can be difficult and labor intensive due to the large number of species and subspecies in most biomes and their ever-changing nature. High sensitivity, the ability to raise rare targets in complex backgrounds, and reduced sensitivity to PCR inhibitors such as humic acid are all features of digital PCR that can improve microbiome analysis.  

1. Next-Generation Sequencing (NGS)

Digital PCR can enhance the efficiency and accuracy of NGS, saving both money and time. Digital PCR can increase the accuracy of library authentication, enable accurate balancing of libraries, and provide validation of NGS findings. Bio-Rad's Droplet Digital PCR (ddPCR) system is particularly suitable for integration into NGS workflows to increase sequence efficiency. Using Poson statistical analysis, the ratio of positive to negative drops achieves the absolute magnitude of the initial number of copies of the target sequence. 

Integration of digital PCR into an NGS workflow can occur at several steps: 

• Amplification of target libraries, ensuring better representation of low abundance species 
• Accurate quantification of NGS libraries 
• Validation of sequencing results 

Through our research, BrandEssence Research Analysts have covered some of the most important and most popular application areas for the digital PCR market.