Market Overview

Digital PCR (dPCR) is a quantitative PCR practice that facilitates a sensitive and reproducible method of operation to measure the amount of DNA or RNA. dPCR does not rely on a sample goal quantification calibration curve.

The global digital PCR market was valued at USD 441.28 million in 2019 and is expected to grow at a CAGR of 17.8% during the forecast period.

Rising Incidences of Target Infectious Diseases and Genetic Disorders

Rising incidences of infectious diseases and genetic disorders have bolstered the demand for better and faster diagnostic tests, thereby driving the digital PCR market growth. As per the World Health Organization, in 2018, cancer was among the leading causes of deaths worldwide, responsible for 9.6 million deaths. This has encouraged the overall pace of market research and development, pulling in support in the form of investments, funds, and grants. The demand for genomic analysis technique has snowballed in the past few years, owing to its growing usage as microbial identification and detection of genetic mutations in the diagnosis of critical infectious diseases such as HIV, tuberculosis, malaria, hepatitis, and staph-related diseases, and genetic disorders such as cancer and syndrome.

According to the data published by WHO in 2019, as of 2018, around 219 million patients suffered from malaria across the globe, with 92% of cases registered in WHO Africa alone. In 2017, nearly 6.4 million new TB cases were registered worldwide. Also, according to UNAIDS data, in 2017, roughly 36.9 million people were suffering from HIV-AIDS globally, with an average mortality of 0.9 million.

Thriving Medical Technology

Advances in medical technology and the emerging cutting-edge therapeutic devices will aid in market expansion. These groundbreaking devices include crystal dPCR, digital PCR based on a beam dPCR chip, and digital PCR droplet. Moreover, the shift by health care professionals to chip-based dPCR from droplet dPCR is expected to improve the demand in the coming years. The technologies have vast applications both in basic and diagnostic research. They were widely used in areas such as human genetic testing, forensic science, pathogen detection, and testing of infectious diseases. On the other hand, its widespread application amongst other industries, such as food microbiology and veterinary medicine, is estimated to accelerate the market further.

Segmental Overview

Application of Digital PCR in Pathogen Detection and Diagnosis

Digital PCR is the refinement of traditional PCR that can be utilized to directly quantify and clonally amplify nucleic acids. As a result, it finds broad use in testing microbial resistance, non-invasive prenatal diagnosis, and the treatment of cancer. It is also used to treat diseases such as Down's syndrome and inherited cancer. It offers benefits in pathogen identification and quantitation by providing high sensitivity and faster detection by eliminating the need for DNA templates to be pre-enriched. Thus, the rising use of dPCR in pathogen detection and diagnosis of disease is anticipated to push market growth during the forecast period.

Digital PCR helps in delivering a complete measure of target nucleic acid molecules compared to the relative measure achieved from the real-time PCR. dPCR is used for identifying minor amounts of deoxyribonucleic acid DNA and ribonucleic acid targets such as chromosomal translocations, point mutation, alternatively spliced messenger ribonucleic acid, and DNA methylate. This absolute DNA quantification enables for sensitivity, reproducibility, and precision, further promoting researchers to quantify minute differences and precisely measure minor variants. These benefits are significantly boosting the adoption rate of dPCR over conventional and other PCR methods. Moreover, continuous efforts by PCR manufacturers to develop new systems to use in molecular testing is expected to further boost the growth of the dPCR market.

A Myriad of Advantages of DdPCR

Droplet Digital PCR (DdPCR) is a process working under the principle of water-oil emulsion droplet technology used to conduct optical PCRs. A sample is divided into 20,000 droplets, and the template molecules are multiplied by PCR in each droplet. DdPCR equipment uses similar reagents and workflows to most typical TaqMan probe-based assays. Besides the above-mentioned advantages of the ddPCR, the key factor that boosts the segment’s growth is the increasing incidences of cancer, infectious diseases, etc., and growing the funding and developments of the biotechnology industry. Furthermore, technological advances, coupled with new product launches by prominent players, are fostering the segmental growth. For instance, in August 2018, Merck KGaA launched the BioReliance Droplet Dpcr Technology for cell and gene therapy development. The ddPCR technique provides a precise measure of DNA molecules through each drop. Additionally, massive partitioning of samples is a crucial element of the ddPCR technique, which increases the demand for this technology, thereby driving the segment’s growth.

Higher Adoption of dPCR Devices by Diagnostic Centers

The emergence of diagnostic centers is attracting a large patient pool suffering from infectious disorders, genetic disorders, and other conditions. The burgeoning incidences of target organisms coupled with the effectiveness of dPCR assays in the diagnosis and evaluation of pathogenic microorganisms have prompted the use of clinical diagnostic tests, thereby increasing the demand for diagnostic centers. The rising number of diagnostic centers and favorable reimbursement policies provided are also key factors supporting segment growth.

Regional Overview

Presence of Key Players and Improving Healthcare Infrastructure Drives the North America Digital PCR Market Growth 

North America is expected to dominate the digital PCR market. The region’s growth can be attributed to advances in technology and higher research and development expenditure. Market development is also attributed to factors such as the presence of key players, the region's increasing incidences of chronic diseases, and the improving healthcare infrastructure. Moreover, beneficial government initiatives and a spike in the proportion of research partnerships will further support the market growth. The U.S. has the maximum share in this region due to favorable healthcare policies, high patient numbers, and a developed healthcare market.

Asia-Pacific’s Awareness for Early Disease Diagnosis

The Asia-Pacific digital PCR market will grow at the fastest pace during the forecast period due to the high prevalence of chronic and infectious diseases coupled with growing awareness among patients about early diagnosis of these diseases. Moreover, advancements in PCR technology and the continuous development of PCR-based research activities support the regional market growth. Furthermore, the transition from underdeveloped areas and plant-based drugs to genomic-based drugs will further augment the digital PCR market growth. In addition, factors driving the market growth are improved healthcare infrastructure, a surge in public and private investments in research and development, and technological advances in China and India. China, India, and Japan are presumed to become potential markets with evolving medical diagnostic infrastructure and high economic development.

Competitive Landscape

Significant players in the industry have strived to deploy aggressive management strategies to cement their position in the market. The key strategies undertaken by market players include new product launches, collaborations, and agreements with institutes, as well as mergers and acquisitions. The key players operating in the global digital PCR market are Bio-Rad Laboratories, Inc., Thermo Fisher Scientific, RainDance Technologies Inc., Fluidigm Corporation, JN Medsys, QIAGEN, Merck KGaA, Stilla, and Avance Biosciences.

Recent Development

• In November 2019, Bio-Rad Laboratories, Inc. launched QX ONE Droplet Digital PCR System, that offers an absolute measurement of target DNA molecules with improved accuracy, sensitivity and precision
• In February 2019, Bio-Rad received the U.S. FDA’s approval for QXDx AutoDG ddPCR System and the QXDx BCR-ABL %IS Kit.
• In January 2019, Qiagen announced the plans for the development of a range of next-generation systems for digital PCR in the life sciences industry.
• In January 2019, QIAGEN N.V. acquired FORMULATRIX’s digital PCR assets in a deal valued to the tune of USD 260 million. The acquisition will aid the firm in launching new digital PCR platforms in 2020 by incorporating FORMULATRIX’s innovative dPCR technology.

Digital PCR Market: Segmentation

By Product

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

By Technology

• Droplet Digital PCR (ddPCR)
• BEAMing Digital PCR

By Application

• Clinical Diagnostics
• Research
• Forensics

By End-Use

• Clinical Diagnostic Laboratories
• Pharmaceuticals and Biotechnology Industries
• University and Government Organizations

By Region

• North America
• Europe
• Asia-Pacific
• Central, South America, and the Caribbean
• The Middle East and Africa