The dPCR and qPCR market size is expected to grow from US$ 8,976.99 million in 2022 to US$ 18,230.74 million by 2030; it is estimated to record a CAGR of 9.3% during 2022-2030.
The dPCR and qPCR market growth is attributed to the increasing incidence of genetic and infectious diseases, rising investments and funds for gene synthesis, and technological advancements in PCR technologies.
In recent years, molecular methods such as PCR have evolved as diagnostic technology. The method enables healthcare professionals to diagnose a wide range of infectious diseases accurately and is considered an indispensable research and diagnostic tool. PCR allows the generation of millions of DNA copies from one single strand of DNA. It also allows early diagnosis of disease and hence plays an essential role in disease control. PCR gives reproducible results that are comparable between different laboratories and hence are accepted worldwide. As PCR techniques are being widely accepted and utilized in emerging countries. According to the World Health Organization Report on the Establishment of PCR Laboratory in Developing Countries 2016, WHO is providing necessary technical assistance to establish PCR laboratories in all 11 member states of the WHO South East Asia countries. The laboratories will help in providing high-quality medical care. These PCR laboratories have adopted different PCR technologies such as Reverse transcriptase PCR (RT-PCR), Multiplex PCR, Real-time PCR, In-situ PCR, Digital PCR (dPCR), and others depending on their need. Due to its simple, rapid, and highly specific screening of diseases and its increasing application in clinical microbiology, virology, parasitology, biotechnology, and allied fields, the dPCR and qPCR market in developing countries is expected to experience lucrative opportunities during the forecast period.
Droplet Digital PCR (ddPCR) is a new technique for performing digital PCR. It utilizes water-oil emulsion droplet technology. A sample to be tested is fractionated into around 20,000 droplets, and then amplification of the target DNA strand is carried out in each droplet. The ddPCR then digitally measures the nucleic acid targets in the individual droplet. Thus, the technique gives high precision and absolute quantification of target DNA molecules and enables wide application in diagnosis and research. In qPCR, DNA quantification is obtained from the cycle threshold (CT). External calibrators are required, and imperfect amplification affects absolute quantitation. Droplet Digital PCR (ddPCR) directly counts the target DNA without the calibration curve. Thus, with the advent of ddPCR, scientists will be able to explore complex genetic landscapes, discover and validate new disease associations, and define a new era of molecular diagnostics. Thus, the development of ddPCR would become a major trend in the dPCR and qPCR market in the future.
Application-Based Insights
Based on application, the dPCR and qPCR market is segmented into research application, clinical application, and forensic application. In 2022, the clinical application segment held the largest share of the market and is anticipated to register the highest CAGR during 2022–2030. Molecular biology techniques have revolutionized disease diagnosis and are now a crucial part of laboratory diagnostics. The dPCR and qPCR techniques are now being used in the diagnosis of many diseases, including diabetes, infectious diseases, cancer, and others. For instance, real-time PCR technology RIDA GENE kits are developed for the diagnosis of gastrointestinal infections, hospital-acquired infections (HAI), respiratory infections, sexually transmitted infections, and other parameters. As these molecular methods allow early, sensitive, and specific diagnosis, the clinical application segment is expected to witness growth over the forecast period.
Real-time PCR technologies have been used to detect mutation in genes, which helps in the diagnosis of cancer. dPCR also enables precise detection of tumor markers in cell-free DNA (cfDNA) samples like sputum, urine, cerebrospinal fluid, plasma, and others. dPCR is more effective in detecting single-nucleotide polymorphism among the wild-type sequences. For example, dPCR is commonly used to detect mutation in epidermal growth factor receptor (EGFR), KRAS, and ESR1.
Furthermore, technological advancements are offering molecular markers for diagnosing and treating cancer. In April 2023, Thermo Fisher Scientific introduced 37 CE-IVD-marked real-time PCR assay kits for its QuantStudio Dx series of instruments to detect numerous infectious diseases.
End User-Based Insights
Based on end user, the dPCR and qPCR market is segmented into hospitals and diagnostic centers, pharmaceutical and biotechnology companies, research laboratories and academic institutes, forensic laboratories, and clinical research organizations. In 2022, the hospitals and diagnostic centers segment held the largest share of the market and is anticipated to register the highest CAGR during 2022–2030.
Hospitals and diagnostic centers contribute a significant market share to the dPCR and qPCR market. Hospitals are the primary centers for a patient seeking highly advanced treatment under the guidance of much-trained personnel. dPCR and qPCR offer advantages such as high sensitivity and specificity, allowing early and accurate detection of pathogens, including bacteria, viruses, and fungi.
In addition, hospitals offer advanced diagnosis and treatment options for patients to treat acute and chronic conditions, and the adoption of PCR techniques is much higher in hospitals and diagnostic centers as they provide healthcare facilities with specialized scientific equipment. Moreover, the continued expansion of healthcare infrastructure across emerging countries, the high incidences of infectious diseases, and the growing number of hospital admissions has created a need for rapid and sensitive diagnostic tools. Additionally, growing demand for early and efficient disease diagnosis and treatment, the increasing number of dPCR product launches for diagnostic applications, the advantages offered by dPCR in disease diagnosis (as compared to other PCR technologies), and growing awareness among public associated with the benefits offered by both these technologies for clinical and disease diagnosis fuel the market growth.
Furthermore, diagnostic laboratories are well-equipped with hi-tech equipment that enables easy workflow and management of various samples to be tested. For instance, Thermo Fisher Scientific, Inc. offers multiple variants of its PCR, including QuantStudio 5, QuantStudio 6 Flex, QuantStudio 7, QuantStudio 12k, QuantStudio 3D, and QuantStudio Absolute Q AutoRun dPCR Suite. Similarly, several companies, such as Bio-Rad Laboratories, Inc., Fluidigm Corporation, Eppendorf, and Agilent Technologies, Inc., offer PCR devices to hospitals and diagnostic centers based on their capacity and requirements.
Centers for Disease Control and Prevention, Medical Research Future Fund, and the World Health Organization (WHO) are among the primary and secondary sources referred to while preparing the dPCR and qPCR market report.