Digital PCR Market

The global size of digital PCR market in terms of revenue was estimated to be worth USD 8.5 billion in 2023 and is poised to reach USD 12.4 billion by 2028, growing at a CAGR of 7.8% from 2023 to 2028. The research study consists of an industry trend analysis, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market.

The growth of this market can be attributed to factors such as the rising incidence and prevalence of target infectious diseases and genetic disorders, continuous advancements in PCR technologies and growing importance of PCR in biomarker discovery.

Attractive Opportunities in the dPCR and qPCR Market

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Digital PCR Market Dynamics

Driver: Rising incidence and prevalence of target infectious diseases and genetic disorders is likely to upsurge the market growth

The demand for genomic analysis techniques was expected to grow steadily during the last decade. This was expected to result in the increased use of these techniques (microbial identification and detection of genetic mutations) in the diagnosis of major infectious diseases (such as HIV, tuberculosis, malaria, hepatitis, and Staph-related diseases) and genetic disorders (such as cancer and fragile X syndrome). The rising prevalence of target diseases globally, coupled with the proven efficacy of PCR analysis in diagnosing and estimating disease-causing microbes, is likely to boost the use of clinical diagnostic tests (including qPCR and dPCR analysis) and support market growth. The eastern and southern African regions have an HIV prevalence of close to 6.7%, which roughly translates to 21 million people. With the advent of modern dPCR technologies, mutations within the HIV virus can be encountered, owing to which four in five cases of HIV patients are aware of their disease, which has increased substantially.

Restraint: Technical limitations of dPCR and qPCR can potentially to hamper the market growth

A typical qPCR/dPCR method is associated with several technical limitations, such as signal measurement during the exponential phase of the PCR reaction, the need for optimization and validation of assay procedures, hindrances in target detection due to the presence of reaction inhibitors, and the failure to detect target molecules due to the low quality of the nucleotide template. In addition, qPCR and dPCR reagents have several procedural limitations that directly affect their adoption in genomic research— chemical binding of the reagent to dsDNA (SYBR Green dye), inability to assess DNA quality (AluQuant), and the use of carcinogenic chemicals (Yield gel). This can potentially hamper market growth to a certain extent.

Opportunity: Growing market penetration in emerging countries offers significant growth opportunities for market players

Emerging markets are expected to offer significant growth opportunities, led by the rising incidence of infectious and chronic diseases, as well as increasing R&D initiatives to develop innovative genomic techniques such as PCR. Growth will be supported by the expansion of healthcare infrastructure, an increase in healthcare expenditure, and reduced procedural costs for qPCR-based and dPCR-based disease diagnosis in emerging countries. Emerging countries are witnessing rapid modernization in their healthcare facilities and expansion of their healthcare infrastructure. This factor contributes to the growing demand for clinical diagnostic procedures among diagnostic laboratories, which has resulted in increased sales of clinical PCR products.

Reagents and consumables segment dominated the digital PCR industry in 2022.

Based on product & service, the digital PCR market is broadly segmented into reagents and consumables; instruments; and software and services. In 2022, reagents and consumables accounted for the dominant share of the dPCR and qPCR market. This segment is also expected to witness the highest growth during the forecast period. The increasing adoption of MIQE guidelines across the globe is also driving the use of qPCR/dPCR reagents among researchers. Expanding applications of qPCR (owing to its technological benefits over traditional PCR, such as real-time analysis and reduced analysis time), are also expected to drive the growth of the qPCR reagents and consumables market.

The clinical applications segment of digital PCR industry is expected to grow at the highest CAGR during the forecast period.

On the basis of application, the digital PCR market is segmented into clinical, research, forensic, environmental, and other applications. The clinical applications segment is further sub-segmented into infectious disease testing, oncology testing, blood screening, transplant diagnostics, and other clinical applications. The clinical applications segment will witness the highest growth during the forecast period. The key factors driving the market growth include the growing usage of qPCR in disease diagnosis, rising incidence of infectious and genetic diseases, and growing public emphasis on early & effective disease diagnosis & treatment.

Hospitals and diagnostic laboratories end user segment held the largest share of the digital PCR industry in 2022.

Based on end user, the digital PCR market is segmented into hospitals and diagnostic laboratories, academic and research institutes, pharmaceutical and biotechnology companies, CROS and CDMOS, forensic laboratories and other end users. In 2022, Hospitals and Diagnostic laboratories segment dominated this market owing to growing demand for early and efficient disease diagnosis and treatment and the benefits offered by dPCR in disease diagnosis (as compared to other PCR technologies) are some factors driving the growth of the dPCR market for hospitals and diagnostic laboratories.

North America dominated the global digital PCR industry in 2022.

Geographically, the digital PCR market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. In 2022, North America accounted for the largest share in dPCR and qPCR market, followed by Europe and the Asia Pacific. The large share of the North American market is attributed to increased adoption of innovative and novel genomic analysis products (including advanced qPCR and dPCR products), availability of R&D funding for genomics research (coupled with the robust research infrastructure in the region), expanding use of PCR techniques in clinical diagnostics and forensics, and the early commercialization of qPCR/dPCR products in North America as compared to other regions. Asia pacific accounted for the largest growth in the market during the forecast period.

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Key players in the digital PCR market are Danaher Corporation (US), F. Hoffmann-La Roche Ltd. (Switzerland), Thermo Fisher Scientific Inc. (US), Abbott Laboratories (US) and QIAGEN (Germany).

Scope of the Digital PCR Industry

This report categorizes the digital PCR market to forecast revenue and analyze trends in each of the following submarkets:

By Product & Service

• qPCR Products & Services
  • qPCR Reagents and Consumables
  • qPCR Instruments
  • qPCR Software and Services
• dPCR Products & Services
  • dPCR Instruments
    • Droplet PCR
    • Chip-based PCR
    • BEAMing Digital PCR
  • dPCR Reagents and Consumables
  • dPCR Software and Services

By Application

• Clinical Applications
  • Infectious Disease Testing
  • Oncology Testing
  • Blood Screening
  • Transplant Diagnostics
  • Other Clinical Applications
• Research Applications
• Forensic Applications
• Environmental Applications
• Other Applications
• dPCR Applications
• Clinical Applications
  • Infectious Disease Testing
  • Oncology Testing
  • Blood Screening
  • Transplant Diagnostics
  • Other Clinical Applications
• Research Applications
• Forensic Applications
• Environmental Applications
• Other Applications

By End User

• qPCR End Users
• Hospitals and Diagnostic Laboratories
• Academic and Research Institutes
• Pharmaceutical and Biotechnology Companies
• CROs and CDMOs
• Forensic Laboratories
• Other End Users
• dPCR End Users
• Hospitals and Diagnostic Laboratories
• Academic and Research Institutes
• Pharmaceutical and Biotechnology Companies
• CROs and CDMOs
• Forensic Laboratories
• Other End Users

Recent Developments of Digital PCR Industry

• In October 2022, Roche received FDA clearance for the COVID-19 PCR test for use on cobas 6800/8800 systems. The cobas SARS-CoV-2 Qualitative test is one of the first COVID-19 PCR tests performed on an automated, high-throughput platform to receive FDA 510(k) clearance.
• In August 2022, Roche launched the Digital LightCycler System, Roche’s first digital polymerase chain reaction (PCR) system that will help clinical researchers better understand the nature of a patient’s cancer, genetic disease, or infection.
• In May 2022, QIAGEN (Netherlands) acquired BLIRT S.A. (Poland) which produces kits for the isolation of DNA and RNA, as well as reagents for reverse transcription and real-time PCR.
• In September 2021, Thermo Fisher Scientific launched the Applied Biosystems QuantStudio Absolute Q Digital PCR System, the first fully integrated digital PCR (dPCR) system designed to provide highly accurate and consistent results within 90 minutes.
• In June 2020, Cepheid Inc. received US FDA EUA for the Xpert Xpress SARS-CoV-2/Flu/RSV test.

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