Digital PCR and qPCR Market: Growth, Size, Share, and Trends

Market Growth Outlook Summary

The global digital PCR market growth forecasted to transform from $10.0 billion in 2024 to $14.8 billion by 2029, driven by a CAGR of 8.1%. Growth in the digital PCR (dPCR) and real-time PCR (qPCR) 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, the role of PCR in biomarker discovery,  and increased use of dPCR and qPCR technologies for point of care (POC) diagnostics. However, challenges such as time consuming methodology involving in sample handling and post-PCR analysis, and lack of accuracy & standardization in protocol may hinder the market's growth.

Digital PCR Market Trends

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Attractive Opportunities in the Digital PCR Market

Global Digital PCR Market Dynamics

DRIVER: Increased use of dPCR and qPCR technologies for point of care (POC) diagnostics

dPCR and qPCR technologies offer high sensitivity, specificity, and rapid results, making them ideal for POC applications where timely and accurate diagnostics are crucial. The ability to perform on-the-spot testing in various settings, such as clinics, hospitals, and remote locations, enhances disease management and patient outcomes. The demand for POC diagnostics has surged, especially in the wake of global health crises like the COVID-19 pandemic, highlighting the need for decentralized testing solutions. The PoC testing market has grown significantly over the last few years due to the increasing adoption of PoC testing products in home care settings and hospitals. The convenience of these tools has greatly driven their adoption, particularly given the rising prevalence of infectious diseases, technological advancements in PoC testing products, the growing patient awareness of PoC testing, the shortage of technicians to conduct conventional lab tests, and the rising number of Clinical Laboratory Improvement Amendment (CLIA) approvals for PoC tests.

RESTRAINT: Unfavorable reimbursement scenario for diagnostic companies

Insurance coverage for PCR tests varies widely by region and by provider. Inconsistent policies can lead to out-of-pocket expenses for patients, making them less likely to opt for these advanced diagnostic tests. Insurers may cover only certain types of PCR tests or only under specific conditions, restricting the use of dPCR and qPCR for broader diagnostic applications. Even when PCR tests are covered, the reimbursement rates may be low. This can result in healthcare providers being reluctant to offer these tests due to the financial burden of not covering the costs of the tests and associated procedures. Low reimbursement rates can discourage investment in new PCR technologies and the development of innovative applications, as companies may not see a sufficient return on investment. For instance, In March 2023, the Centers for Medicare & Medicaid Services’ (CMS), through its local contractors (known as Medicare Administrative Contractors or MACs) issued revised billing instructions for blood test for organ transplant in response to improper billing and overutilization. Billing instructions help health care providers understand when and how to bill Medicare for a covered service. Moreover, in February 2024 the MACs updated these instructions to clarify that these tests remain available to patients when medically necessary and ordered by a physician. furthermore CMS’s Medicare Administrative Contractors (MACs) have removed and replaced the March 2023, billing article. The new article restores the table of solid organ allograft rejection tests for indications that meet the coverage criteria, as requested by interested parties, and removes explanatory language that may have confused physicians and patients.

OPPORTUNITY: Growing significance of RT-PCR based companion diagnostics in drug development process

RT-PCR based companion diagnostics play a crucial role in personalized medicine by enabling the identification of specific genetic mutations, gene expressions, or biomarkers that influence a patient's response to a particular drug. This allows for the development of targeted therapies tailored to individual patients, improving treatment efficacy and minimizing adverse effects. Companion diagnostics using RT-PCR can identify predictive biomarkers that indicate how well a patient will respond to a specific treatment. This helps in selecting the right patients for clinical trials and ensures that only those likely to benefit from the therapy are included, thereby increasing the success rates of clinical trials. RT-PCR can also detect biomarkers associated with adverse drug reactions, aiding in the exclusion of patients who may experience severe side effects, enhancing patient safety, and improving overall treatment outcomes. Regulatory agencies such as the FDA often require companion diagnostics for the approval of targeted therapies. RT-PCR based diagnostics provide robust and reproducible results that meet regulatory standards, facilitating the approval process for new drugs. in 2019, QIAGEN Manchester Ltd., has received US FDA approval for therascreen FGFR RGQ RT-PCR Kit for the detection of Urothelial Cancer – Tissue.

CHALLENGE: Availability of alternative technologies for disease diagnosis

The availability of alternative technologies for disease diagnosis poses a significant challenge for the qPCR and dPCR markets. Advanced diagnostic methods such as next-generation sequencing (NGS), CRISPR-based diagnostics, and immunoassays offer different advantages like higher throughput, broader detection capabilities, and often lower costs. These technologies can provide comprehensive genetic profiling, rapid results, and cost-effective solutions, making them attractive alternatives to PCR-based methods. As these alternative technologies continue to advance and become more accessible, they could potentially reduce the demand for qPCR and dPCR, impacting market growth and prompting PCR technology providers to innovate and demonstrate the unique value of their solutions in a competitive diagnostic landscape.Techniques like ELISA (enzyme-linked immunosorbent assay) are well-established for detecting proteins and other biomarkers associated with diseases. They offer an alternative diagnostic approach that doesn’t require nucleic acid amplification, which can be quicker and less resource-intensive for certain applications. Some alternative technologies can be more cost-effective compared to qPCR and dPCR, especially when considering the cost of reagents, equipment, and the need for skilled personnel.

Global Digital PCR Market Ecosystem Analysis

The digital PCR (dPCR) and real-time PCR (qPCR) market ecosystem comprises raw material suppliers, digital PCR (dPCR) and real-time PCR (qPCR) product manufacturers, and end users such as hospitals and diagnostic laboratories, academic and research institutes, pharmaceutical and biotechnology companies, CROs and CDMOs, forensic laboratories, and others

The droplet digital PCR instrument segment of the digital PCR industry under DPCR instrument dominated digital PCR market in 2023.

Based on instrument, the digital PCR market is segmented into droplet digital PCR, chip-based digital PCR and Beaming digital PCR. In 2023, droplet digital PCR segment dominated the market. Droplet digital PCR (dDPCis) is the modified form of real-time PCR, which utilizes a water-oil emulsion droplet system. Each water droplet separates template DNA molecules into individual PCR reactions. As a result, thousands of independent amplification events can occur within a single sample. The growth of the ddPCR instruments market will primarily be driven by the procedural benefits of ddPCR, like high accuracy and time efficiency. In addition, ddPCR is more tolerant to common inhibitors present in the matrices used in the viral vector process. The ddPCR segment is experiencing significant growth due to its precise nucleic acid quantification capabilities, expanding oncology and liquid biopsy diagnostics applications, and increasing demand for high-sensitivity genetic analysis in clinical & research settings.

The gene expression segment under research application segment dominated the digital PCR industry in 2023.

Based on research application, the digital PCR market is segmented into single cell analysis, stem cell research, gene expression and other research application. In 2023, the gene expression segment accounted for the largest share of the digital PCR (dPCR) and real-time PCR (qPCR) market. The primary driving factors for the use of qPCR in gene expression studies are the need for precise and sensitive quantification of gene expression and the increasing importance of personalized medicine and biomarker discovery. qPCR's high sensitivity and specificity make it an ideal tool for these applications.

North America was the largest regional market for the digital PCR industry in 2023.

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The global digital PCR market is segmented into six major regions—North America, Europe, the Asia Pacific, Latin America, Middle East and Africa. North America was the largest segment in 2023 in the digital PCR (dPCR) and real-time PCR (qPCR) market, followed by Europe and the Asia Pacific. Factors such as the presence of key market players such as Danaher Corporation (US) and Thermo Fisher Scientific Inc. (US) in the region, rising demand for qPCR and dPCR product for early and accurate disease diagnosis due to increasing patient population suffering from life-threatening disease.

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 Offering

• QPCR
  • QPCR Product
    • QPCR Reagents and Consumables
    • QPCR Instruments
  • QPCR Software
  • QPCR Service
• DPCR
  • DPCR Products
    • DPCR Reagents and Consumables
    • DPCR Instruments
      • Droplet Digital PCR
      • Chip-based PCR
      • Beaming Digital PCR
  • DPCR Software
  • DPCR Service

By Application

• QPCR Application
  • Clinical Applications
    • Infectious Disease Testing
    • Oncology Testing
    • Blood Screening
    • Transplant Diagnostics
    • Other Clinical Applications
  • Research Applications
    • Single Cell Analysis
    • Stem Cell Research
    • Gene Expression
    • Other Research Application
  • Forensic Applications
  • Environmental Applications
  • Other Applications
• DPCR Applications
  • Clinical Applications
    • Infectious Disease Testing
    • Oncology Testing
    • Blood Screening
    • Transplant Diagnostics
    • Other Clinical Applications
  • Research Applications
    • Single Cell Analysis
    • Stem Cell Research
    • Gene Expression
    • Other Research Application
  • 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

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia Pacific (APAC)
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific (RoAPAC)
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America (RoLATAM)
• Middle East
  • GCC
    • Saudi Arabia
    • UAE
    • Rest of GCC
  • Rest of Middle East
• Africa

Recent Developments of Digital PCR Market

• In May 2024, Qiagen N.V. entered into a cooperative R&D agreement (CRADA) with the US Federal Bureau of Investigation (FBI) to develop a novel test for its QIAcuity digital PCR devices that will boost forensics by improving the quantification of DNA in human samples.
• In March 2024, F. Hoffmann-La Roche Ltd, has received the US Food and Drug approval for its cobas Malaria test for use on the cobas 6800/8800 systems.

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