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December 2024
The global digital PCR market size was evaluated at US$ 6.54 billion in 2023 and is expected to attain around US$ 17.45 billion by 2034, growing at a CAGR of 9.33% from 2024 to 2034. The market is growing because digital PCR (dPCR) has many advantages, such as better accuracy, reproducibility, sensitivity, and inhibitor tolerance, as well as unique applications, including genetic code variation (CNV) analysis and gene expression analysis.
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The digital polymerase chain reaction (dPCR) is considered the third generation of polymerase chain reaction (PCR) because it allows direct, precise, and accurate measurement of the target sequences, so the digital PCR market is growing rapidly. dPCR has proven to be particularly important for accurate diagnosis and measurement of the composition of nucleic acids, demonstrating its advantages in cancer diagnosis, prediction of relapse, and minimal disease maintenance, often combined with next-generation splicing. Digital polymerase chain reaction (dPCR) in cancer research is a novel technology.
The development of electronic digital polymerase chain reaction (dPCR) instruments has led to the expansion of the digital PCR market. Unlike traditional PCR, dPCR uses a water-oil emulsion system to disperse the sample into thousands of nanoliter-sized droplets, resulting in non-uniformity. This method requires small sample and reagent volumes, thus reducing cost and resource usage, making it particularly suitable for high-throughput applications. In any case, dPCR's ability to reduce error rates and address issues such as PCR inhibitors and changes in optimization further increases its repeated appeal. These factors and their clinical, environmental, and agricultural performance make dPCR a more accurate and convenient alternative to PCR methods, encouraging economic development.
Artificial intelligence is being used to prove several steps in the digital polymerase chain reaction process. AI is being deployed to predict the outcomes of dPCR experiments during the experiment design stage, with machine learning algorithms being used to suggest more effective optimal primers and reaction conditions. AI-based tools are also deployed to increase throughput screening processes, especially large data sets, more efficiently. Researchers have used MATLAB environment scripts to generate artificial digital PCR images and match the dPCR results.
This was done by generating images using a set of parameters, including targets, background fluorescence distribution, intensity, etc., and then generating chip images based on layout design or pattern recognition algorithms. The images are then used to train the image processing algorithms based on other customizable parameters. Artificial intelligence is also being employed to improve the detection and quantification of nucleic acids. Integrating these new technologies into crdPCR is likely to lead to further breakthroughs in next-generation PCR targeting absolute micro-analysis.
Recent advances in droplet digital PCR (ddPCR) technology, represented by the Bio-Rad QX600 droplet digital PCR system, create significant opportunities for commercial digital PCR. The QX600 platform can use up to 6 fluorophores simultaneously to measure up to 12 targets in a single well, enabling increased throughput and data collection. This capability is essential for many high-impact applications, including oncology research, gene expression analysis, next-generation sequencing (NGS) orthogonal assay, and cell and gene therapy biomarker discovery. Additionally, the platform’s accuracy and sensitivity enhance resource utilization by aiding in collecting critical samples such as circulating tumor DNA (ctDNA). While ddPCR technology continues to offer the highest demand, throughput, and specificity, it drives digital PCR development and innovation, opening new doors for clinical and commercial expansion, particularly in oncology, genetic research, and environmental testing, driving growth and innovation within the digital PCR market.
Despite the advantages of droplet digital PCR (dPCR), several operational challenges and operational constraints have restrained the digital PCR market growth. Droplet content and shape variations can negatively impact the strength and reproducibility of ddPCR results, compromising reliability. The ddPCR system has many instruments, such as generators, thermocyclers, and droplet readers, that take up much lab space and require human training to operate properly. This process is time-consuming and cumbersome, involving multiple dispensing and transfer steps, increasing the risk of contamination and human error. In addition, the data quality can be affected by leakage coalescence or drift, which is often caused by thermal oscillations during amplification. These challenges and potential sources of error can limit the widespread use of ddPCR technology and hinder its commercial expansion.
According to regional insights, North America is dominated in the digital PCR market, accounting for over 40% of the global medical market. The medical device market in North America is experiencing significant growth and development due to key macroeconomic factors such as consumer preference for new products and technology, shift to healthcare solutions, special local conditions such as elderly and critical illnesses, and good governance health regulations and policies. The global medical technology industry is valued at over $567 billion annually.
Asia Pacific is expected to witness significant growth in the digital PCR market during the forecast period as medical devices play a significant role amidst the increasing demand for medical services in this region. The diversity in the region requires companies to identify each country. These include large markets like Japan and Australia, populous countries like China and India, and emerging markets like Malaysia and Thailand. The digitization of medical devices continues as OEMs digitize their equipment and operations. This digital revolution has not only forced medical technologists to use digital information to improve outcomes for doctors and patients but has also contributed to the emergence of new business models and related technologies.
By type, the droplet dPCR segment held the highest market share due to the ddPCR technology increasing the efficiency by using lower sample and reagent volumes and reducing the overall cost while maintaining high accessibility and sensitivity compared to other PCR methods. The chip-based segment is projected to expand at a moderate CAGR during the forecast timeframe as it is rapidly partitioning. Use small amounts of samples and reagents. Multiple events can be accommodated in a single instrument.
Based on product, the instruments segment accounted for the largest global digital PCR market share because it helps control the temperature required for the denaturation, annealing, and extension steps of the PCR process, thereby achieving positive results for DNA or RNA. The reagents and consumables segment is expected to grow at the highest CAGR during the forecast period.
Based on indication, the genetic disorders segment dominated the market and is expected to expand at a moderate CAGR during the forecast timeframe due to the increasing interest in dPCR based on Quantitative tools, especially in preclinical studies, which are used to detect genetics and precise measurements. The oncology segment is projected to expand at a substantial CAGR during the forecast timeframe, where dPCR enables rapid and accurate detection of oncogenic somatic mutations and CNVs, thereby helping translate and replicate statistical analysis to provide information about the changes leading to cancer.
Based on end-users, the academic and research organizations segment held the largest market share due to the use of PCR in education, clinical research, and experimental design in diagnostic facilities. Academic and research organizations use digital polymerase chain reaction (dPCR) for various applications. At the same time, the clinical laboratories segment is projected to expand at the highest CAGR during the forecast timeframe as dPCR has entered the clinical arena and has applications in oncology, microbiology and epidemiology, genetics, and prenatal/newborn screening.
On the basis of application, the clinical segment led the market in 2023. The rising demand for accurate and precise alongside reliable nucleic testing in healthcare sector has promoted the expansion of the segment. The wide use of advanced clinical diagnostics in the clinical sector is observed to sustain the segment as a largest shareholder in the market. Moreover, as the research sector expands, the research segment is seen to grow rapidly.
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December 2024
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