Digital PCR Market Size, Share & Trends Analysis Report By Product (Instruments, Reagents & Consumables), By Technology (Droplet Digital PCR, Chip-based Digital PCR), By Application (Research, Clinical Diagnostics, Pharmaceutical & Biotechnology Industries, Academic Organizations), By Indication (Infectious Diseases, Oncology, Genetic Disorders, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2022-2030

Digital PCR Market Size

The global digital PCR market size was valued at USD 555 million in 2021 and is projected to reach USD 1236 million by 2030, growing at a CAGR of 9.3% during the forecast period (2022-2030).

The digital polymerase chain reaction (dPCR) is a new method for detecting and quantifying nucleic acids that offer a sensitive and repeatable way to determine the amount of DNA or RNA in a sample. dPCR has a lot of promise in research (both basic and applied research), clinical diagnostics, forensics, and other fields. Copy number variation, rare sequence detection, mutation detection, miRNA analysis, gene expression analysis, and next-generation sequencing sample quantification are all applications for dPCR systems.

Due to the rising prevalence of infectious diseases and increased awareness and acceptance of personalized medicines, the global digital PCR market is expected to grow significantly in the near future. Furthermore, technological advancements are expected to boost market growth during the forecast period.

Digital PCR Market Growth Factors

Rise in prevalence of infectious diseases and cancer, along with the increased awareness and acceptance of personalized medicines

The alarming rise in the incidence of cancer and infectious diseases is a major factor driving the global market forward. Cancer, for example, is one of the leading causes of death worldwide. According to the World Health Organization, the number of new cancer cases reached 18.4 million in 2020, with 9.7 million deaths. 

Due to an increase in the number of patients suffering from chronic diseases, the demand for digital PCR technologies for early disease diagnosis is expected to rise. According to WHO and UNAIDS estimates, 38 million people globally were infected with HIV by the end of 2020. As a result, the rising demand for digital PCR technologies to detect these diseases at an early stage has a positive impact on market growth.

Increased awareness and acceptance of personalized medicines

The number of personalized treatments had increased dramatically since 2008, when only five personalized medicines were available, according to the Personalized Medicine Coalition (PMC). Because of the increased awareness and acceptance of personalized medicines, there are now over 145 personalized therapies available in the market. Furthermore, as the FDA rapidly approves more tests and treatments that can provide more effective and efficient healthcare, the number of personalized medicines is increasing. Furthermore, diagnostic tests aid in determining the best course of treatment for each patient.

Technological advancements

Major players in the industry are boosting the market's growth by making advanced products available to healthcare professionals for the detection of various types of infectious diseases, cancer, blood screening, and other applications, thanks to advancements in digital PCR technologies. As a result, rapid technological advancement is a major driving force behind the global digital PCR market expansion over the forecast period.

Key Market Restraints

High costs associated with the digital PCR devices and the reimbursement issues

Despite the fact that the digital PCR device has numerous advantages in research applications, its high price prevents customers from purchasing it. A manual digital PCR device costs between USD 65,000 to USD 70,000, while an automated digital PCR device costs USD 100,000. When compared to competing for technology, this is a disadvantage because real-time PCR costs between USD 20,000 to USD 30,000. Although the dPCR technique is improving, real-time PCR is in high demand in applications such as genotyping and gene expression analysis because it is less expensive than digital PCR. As a result, the market's global growth is stifled by the high cost of digital PCR and causing a steep decline in the market.

Digital PCR tests can be used to diagnose a wide range of illnesses. The cost of using digital PCR technologies for diagnostic tests, on the other hand, is high, and as a result, patients avoid such tests. Furthermore, many countries do not cover the costs of these tests. These rates would result in a 20–75% reduction in reimbursement for key molecular tests like inherited disease, molecular cytogenetics, and cancer testing if they were implemented. As a result, the lack of reimbursement facilities limits the growth of the digital PCR market.

Market Opportunities

Increased funding for r&d activities in the digital PCR tests

As the incidence of infectious disease and cancer has increased, so has the demand for diagnostic techniques that can aid in early detection. As a result, funding for R&D activities that could aid in the early detection of these diseases has increased. Furthermore, major corporations invest in the advancement of molecular diagnostics with dPCR, anticipating the field's growth and demand. Increased funding for R&D activities that include the use of dPCR for various purposes is expected to increase the use of this technology and open up new opportunities for global market expansion during the forecast period.

Regional Insights

North America had the biggest share of the market and is expected to grow steadily over the next few years. This is because of its well-developed healthcare industry, the presence of leading molecular diagnostics companies that invest in launching new products, and the rise in the number of patients using personalized medicines. The digital PCR market in North America grew because there were more older people, more infectious diseases were being diagnosed, and there were better healthcare facilities. With all this, the region is expected to grow at a CAGR of 8.3% during the forecast period.

In 2020, Europe had the second-largest share of the global market, and it is expected to keep growing steadily during the forecast period. This is because diseases like COVID-19 and other infectious diseases are becoming more common in Europe. This is because biotech companies are putting more money into research and development (R&D) to make better products that will sell more, which is why the European region is said to grow to USD 419 million by 2030 at a CAGR of 9.3%. 

As there are more people in the Asia-Pacific region with chronic diseases like cancer, HIV, and hepatitis, and because healthcare facilities are getting better, molecular diagnostics companies can make a lot of money there. With the emerging economies spending a lot on their healthcare facilities, the Asia-Pacific region is said to grow at a rapid pace.

Technology Insights

The market is further classified into Droplet Digital PCR and Chip-based Digital PCR, where Droplet Digital PCR dominates the market. Digital PCR is done with a technology called digital droplet PCR, which is based on water-oil emulsion droplet technology. A sample of DNA is broken up into 20,000 droplets, and PCR is used to multiply the same DNA in each droplet. This system can be used to find mutations, copy number variations (CNV) and rare sequences, analyze gene expression, analyze miRNA, and count the number of samples for next-generation sequencing. 

The ddPCR method is based on massive sample partitioning. Based on the ddPCR method, the system gives an accurate count of the number of DNA molecules in each drop. This method can be very helpful in the study of cancer. Also, this technology has the biggest share of the dPCR market because it is accurate, sensitive, and easy to use over and over again, which is why it is predicted to grow at a CAGR of 9.3%.

Chip-based digital PCR technology uses silicon chips with thousands of intertwining valves and channels to perform rtPCR on a large scale in nanoliter volumes. The chip can test up to 48 or 96 samples at once with the same number of assays, giving a lot of results from just one reaction.

Chip-based digital PCR is becoming more popular every day because it reduces the chance of cross-contamination, and droplets always flow in the same direction. This kind of new technology is likely to be used to diagnose more diseases in the future. Also, the market is growing because there are more cases of infectious diseases and more people with cancer.

Also, healthcare providers are slowly moving away from droplet digital PCR and toward chip-based digital PCR, which is expected to help the market grow in the coming year.

Application Insights

The market is classified into two applications, research and clinical diagnostics, out of which the clinical diagnostics segment dominates the market. Because digital PCR is sensitive and specific, it is a useful and powerful tool for research. It can be used for basic research, translational medicine, and applied biology, among other things. Gene research, forensics, medicine, stem cell research, oncology, and environmental microbiology are some of the ways that research can be used, which is why the said segment contributes to a significant market share.

In the clinical section, there are tests for genetics, infectious diseases, cancer, transplantation, and other things that use nucleic acid amplification. Due to the rise of molecular diagnostics and disease-specific treatments, which are used in many hospitals and clinics around the world, the market for clinical diagnostics is growing all the time, and this segment is contributing with a major market share and is expected to grow at a CAGR of 8.3%.

Recent Developments

• In January 2022, Bio-Rad Laboratories, Inc. introduced its growth strategy and acceleration of financial targets at the investor day.
• In April 2022, Fluidigm Corporation launched the Hyperion+ Imaging system, a new standard in high-plex spatial imaging.
• In January 2022, JN Medsys developed a PCR test kit that can specifically identify the Omicron variant with high accuracy.