디지털 PCR 시장 : 유형별, 제품별, 용도별, 최종사용자별, 지역별, 기회, 예측(2018-2032년)

Global digital PCR market is projected to witness a CAGR of 9.01% during the forecast period 2025-2032, growing from USD 8.96 billion in 2024 to USD 17.87 billion in 2032. The market demand for digital PCR is anticipated to thrive drastically in the forecast years due to the rise in the prevalence of infectious diseases and cancer driving demand for precise diagnostics, with dPCR offering high sensitivity.

Digital PCR (dPCR) is a highly sensitive and precise technique in molecular biology for detecting and quantifying DNA or RNA. The global digital PCR (dPCR) market is expected to grow significantly due to the increasing demands for accurate and sensitive diagnostic technologies in clinical and research domains. The increasing prevalence of infectious diseases and cancer and growing awareness for personalized medicine further drive the market. Technological advancements, such as enhancements in automation and integration of microfluidics, ensure the efficiency and accessibility of dPCR systems, fostering their adoption. For instance, in June 2024, QIAGEN N.V. introduced 35 new digital PCR microbial DNA detection assays for its QIAcuity platform, enhancing research into infectious diseases. Available on the GeneGlobe platform, the assays detect pathogens responsible for tropical diseases, sexually transmitted infections (STIs), and urinary tract infections (UTIs), expanding QIAGEN's microbial detection portfolio to over 680 targets.

Increasing applications in oncology, detection of infectious diseases, and genetic analysis, combined with increasing investments in genomics research, further growth in the market could be driven by key strategies such as making dPCR systems cost-effective and portable, are strengthening the dynamics in the market.

Increasing Prevalence of Infectious Diseases and Cancer

The growing incidence of infectious diseases and cancer acts as a significant growth driver for the global digital PCR (dPCR) market. The increasing burden of infectious diseases, including COVID-19, HIV, and hepatitis, worldwide increases the demand for highly sensitive and accurate diagnostic tools like dPCR. Low-level pathogen detection and viral load monitoring capability enhance the utility of dPCR in diagnosing and tracking infectious diseases. The rise of cancer cases in the world increases the demand for better diagnostic technologies capable of identifying genetic mutations as well as monitoring minimal residual disease. Thus, its precision in DNA and RNA quantification makes dPCR an essential tool in oncology, propelling the market's expansion. For instance, in November 2024, QIAGEN N.V. launched two new tools for designing and ordering custom solutions for microbial analysis of bacterial, fungal, and viral targets. These tools enable assay customization for both the QIAcuity digital PCR system and third-party NGS systems. Expanding on over 700 existing microbial assays, the tools enhance nanoplate digital PCR for diverse applications, including wastewater testing, food production, and human pathogen analysis, offering high accuracy and precision without the need for a standard curve.

Technological Advancements in Digital PCR

Technological advancements in digital PCR are the major driving factor for the global market, as innovations are constantly improved, enhancing the sensitivity and efficiency of the technology in the process. The newest technologies in automation, microfluidics, and nanotechnology transformed dPCR systems into highly scalable and fast products, thereby reaching an even wider laboratory and health services market. Integrating artificial intelligence (AI) and machine learning into dPCR data analysis further drives its revolution for faster and more precise results. In addition, progress in portability enables devices to be even more compact and user-friendly, expanding the application of dPCR at the point of care. These technological advancements and the low costs of dPCR systems and reagents fuel market growth. For instance, in June 2024, Stilla Technologies SAS expanded its Nio digital PCR line with two new configurations, namely, Nio E (48 samples per run) and Nio (192 samples per run), complementing the flagship Nio+ (384 samples). The Nio family ensures seamless assay transfer across models. Stilla's Nio+, an all-in-one digital PCR instrument, also won the Red Dot Design 2024 award for innovation and design excellence.

Droplet Digital PCR Segment to Dominate Digital PCR Market

The digital PCR market's droplet digital PCR segment will be the highest contributor due to its increased sensitivity and accuracy and the absolute quantification of nucleic acids. It is particularly useful for highly precise detection of low-abundance targets in applications such as oncology, infectious disease diagnostics, and genetic research through partitioning samples into thousands of individual droplets. The increasing adoption of liquid biopsy, minimal residual disease detection, and monitoring of the response to therapies in oncology further add to market domination. Also, this technology is boosted by ongoing advances in droplet generation and detection technology, including user-friendly automated ddPCR platforms, contributing to overall market growth.

For instance, in April 2024, Bio-Rad Laboratories, Inc. launched the ddPLEX ESR1 Mutation Detection Kit, an ultrasensitive multiplexed digital PCR assay for the oncology market. The assay enables simultaneous detection and quantification of seven ESR1 mutations with 0.01% sensitivity. Designed for Bio-Rad's QX600 Droplet Digital PCR System, it supports circulating tumor DNA (ctDNA) and formalin-fixed paraffin-embedded (FFPE) tissue samples, enhancing mutation detection for translational research, therapy selection, and disease monitoring.

North America Dominates the Digital PCR Market

North America dominates the global digital PCR market, holding the largest market share for several significant reasons. Mainly due to its well-developed healthcare infrastructure, advanced research capabilities, and major investments in genomics and molecular diagnostics. The growing incidence of infectious diseases and cancer in North America and the increasing interest in personalized medicine led to a growing demand for precise and sensitive diagnostic tools such as digital PCR. In addition, the widespread adoption of innovative technologies during the initial years and advancement in automation and data analysis in North America also continue to propel the North American digital PCR market. For instance, in March 2024, F. Hoffmann-La Roche AG announced the U.S. Food and Drug Administration (FDA) approval of the cobas Malaria test for use on the cobas 6800/8800 Systems, enhancing blood safety by screening for malaria in blood, organ, and tissue donors. The test provides highly sensitive detection of Plasmodium parasites, helping to remove infected units from the blood supply and improving both safety and availability. This marks the first FDA-approved malaria blood screening test, advancing malaria detection and safeguarding the global blood supply.

Future Market Scenario (2025-2032F)

The future market scenario of the digital PCR (dPCR) market seems to be very promising due to certain technical achievements and the expansion of applications in various industries. The market is expected to experience reliable growth caused by the increase in the demand for accurate, sensitive, and non-invasive diagnostic tools, diseases, and individualized medicine infectious tests in tumors. Integrating artificial intelligence (AI) and machine learning in data analytics and innovations in microfluidics, automation, and portable devices will further enhance the capabilities and accessibility of dPCR technology. Furthermore, increasing adoption of liquid biopsy in cancer diagnostics and increasing use of dPCR in minimal residual disease detection and genetic profiling will drive market expansion.

For instance, in February 2024, Bio-Rad Laboratories, Inc., launched the Vericheck ddPCR Replication Competent Lentivirus Kit and Vericheck ddPCR replication competent adeno-associated virus (AAV) kit, offering rapid, cost-effective solutions for the quantification of replication-competent lentivirus (RCL) and adeno-associated virus (RCAAV). These kits support the safe production of cell and gene therapies by providing highly sensitive and specific detection of viral replication genes, ensuring safety throughout the production process.

Key Players Landscape and Outlook

The global digital PCR market is segmented into instruments, reagents, and services. Major manufacturers lead the instrument segment, while the services segment is fragmented. Recent developments include innovations in automation, product launches, and increased applications in oncology and infectious diseases. Strategic mergers and acquisitions are driving growth.

For instance, in May 2024, QIAGEN announced a cooperative research and development agreement (CRADA) with the U.S. Federal Bureau of Investigation (FBI) to develop a novel digital PCR (dPCR) test for QIAcuity devices, enhancing DNA quantification in forensic samples. The assay will enable simultaneous, absolute quantification of nuclear and mitochondrial DNA, male DNA, and quality markers, improving the accuracy and efficiency of forensic analysis. This advancement, offering higher tolerance to inhibitors and minimal DNA detection, enhances next-generation sequencing (NGS) analysis, especially in challenging samples like aged bones or hair, which is crucial for identifying human remains.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. Global Digital PCR Market Outlook, 2018-2032F

• 4.1. Market Size Analysis & Forecast
  • 4.1.1. By Value
• 4.2. Market Share Analysis & Forecast
  • 4.2.1. By Type
    • 4.2.1.1. Droplet Digital PCR
    • 4.2.1.2. Chip-based Digital PCR
    • 4.2.1.3. Others
  • 4.2.2. By Product
    • 4.2.2.1. Instruments
    • 4.2.2.2. Reagents and Consumables
    • 4.2.2.3. Consumables and Services
  • 4.2.3. By Application
    • 4.2.3.1. Research Applications
    • 4.2.3.2. Clinical Applications
      • 4.2.3.2.1. Infectious Disease Testing
      • 4.2.3.2.2. Oncology Screening
      • 4.2.3.2.3. Transplant Testing
      • 4.2.3.2.4. Others
    • 4.2.3.3. Forensic Applications
    • 4.2.3.4. Other Application
  • 4.2.4. By End-user
    • 4.2.4.1. Hospitals and Clinics
    • 4.2.4.2. Pharmaceutical and Biotechnology Industries
    • 4.2.4.3. Forensic and Diagnostic Laboratories
    • 4.2.4.4. CROs and CDMOs
    • 4.2.4.5. Others
  • 4.2.5. By Region
    • 4.2.5.1. North America
    • 4.2.5.2. Europe
    • 4.2.5.3. Asia-Pacific
    • 4.2.5.4. South America
    • 4.2.5.5. Middle East and Africa
  • 4.2.6. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2024)
• 4.3. Market Map Analysis, 2024
  • 4.3.1. By Type
  • 4.3.2. By Product
  • 4.3.3. By Application
  • 4.3.4. By End-user
  • 4.3.5. By Region

5. North America Digital PCR Market Outlook, 2018-2032F*

• 5.1. Market Size Analysis & Forecast
  • 5.1.1. By Value
• 5.2. Market Share Analysis & Forecast
  • 5.2.1. By Type
    • 5.2.1.1. Droplet Digital PCR
    • 5.2.1.2. Chip-based Digital PCR
    • 5.2.1.3. Others
  • 5.2.2. By Product
    • 5.2.2.1. Instruments
    • 5.2.2.2. Reagents and Consumables
    • 5.2.2.3. Consumables and Services
  • 5.2.3. By Application
    • 5.2.3.1. Research Applications
    • 5.2.3.2. Clinical Applications
      • 5.2.3.2.1. Infectious Disease Testing
      • 5.2.3.2.2. Oncology Screening
      • 5.2.3.2.3. Transplant Testing
      • 5.2.3.2.4. Others
    • 5.2.3.3. Forensic Applications
    • 5.2.3.4. Other Application
  • 5.2.4. By End-user
    • 5.2.4.1. Hospitals and Clinics
    • 5.2.4.2. Pharmaceutical and Biotechnology Industries
    • 5.2.4.3. Forensic and Diagnostic Laboratories
    • 5.2.4.4. CROs and CDMOs
    • 5.2.4.5. Others
  • 5.2.5. By Country Share
    • 5.2.5.1. United States
    • 5.2.5.2. Canada
    • 5.2.5.3. Mexico
• 5.3. Country Market Assessment
  • 5.3.1. United States Digital PCR Market Outlook, 2018-2032F*
    • 5.3.1.1. Market Size Analysis & Forecast
      • 5.3.1.1.1. By Value
    • 5.3.1.2. Market Share Analysis & Forecast
      • 5.3.1.2.1. By Type
        • 5.3.1.2.1.1. Droplet Digital PCR
        • 5.3.1.2.1.2. Chip-based Digital PCR
        • 5.3.1.2.1.3. Others
      • 5.3.1.2.2. By Product
        • 5.3.1.2.2.1. Instruments
        • 5.3.1.2.2.2. Reagents and Consumables
        • 5.3.1.2.2.3. Consumables and Services
      • 5.3.1.2.3. By Application
        • 5.3.1.2.3.1. Research Applications
        • 5.3.1.2.3.2. Clinical Applications
        • 5.3.1.2.3.2.1. Infectious Disease Testing
        • 5.3.1.2.3.2.2. Oncology Screening
        • 5.3.1.2.3.2.3. Transplant Testing
        • 5.3.1.2.3.2.4. Others
        • 5.3.1.2.3.3. Forensic Applications
        • 5.3.1.2.3.4. Other Application
      • 5.3.1.2.4. By End-user
        • 5.3.1.2.4.1. Hospitals and Clinics
        • 5.3.1.2.4.2. Pharmaceutical and Biotechnology Industries
        • 5.3.1.2.4.3. Forensic and Diagnostic Laboratories
        • 5.3.1.2.4.4. CROs and CDMOs
        • 5.3.1.2.4.5. Others
  • 5.3.2. Canada
  • 5.3.3. Mexico

All segments will be provided for all regions and countries covered

6. Europe Digital PCR Market Outlook, 2018-2032F

• 6.1. Germany
• 6.2. France
• 6.3. Italy
• 6.4. United Kingdom
• 6.5. Russia
• 6.6. Netherlands
• 6.7. Spain
• 6.8. Poland

7. Asia-Pacific Digital PCR Market Outlook, 2018-2032F

• 7.1. India
• 7.2. China
• 7.3. Japan
• 7.4. Australia
• 7.5. Vietnam
• 7.6. South Korea
• 7.7. Indonesia
• 7.8. Philippines

8. South America Digital PCR Market Outlook, 2018-2032F

• 8.1. Brazil
• 8.2. Argentina

9. Middle East and Africa Digital PCR Market Outlook, 2018-2032F

• 9.1. Saudi Arabia
• 9.2. UAE
• 9.3. South Africa
• 9.4. Israel

10. Demand Supply Analysis

11. Trade Analysis

12. Value Chain Analysis

13. Porter's Five Forces Analysis

14. PESTLE Analysis

15. Pricing Analysis

16. Market Dynamics

• 16.1. Market Drivers
• 16.2. Market Challenges

17. Market Trends and Developments

18. Regulatory Framework and Innovation

• 18.1. Regulatory Approvals
• 18.2. Clinical Trials

19. Patent Landscape

20. Case Studies

21. Competitive Landscape

• 21.1. Competition Matrix of Top 5 Market Leaders
• 21.2. SWOT Analysis for Top 5 Players
• 21.3. Key Players Landscape for Top 10 Market Players
  • 21.3.1. Thermo Fisher Scientific Inc.
    • 21.3.1.1. Company Details
    • 21.3.1.2. Key Management Personnel
    • 21.3.1.3. Products and Services
    • 21.3.1.4. Financials (As Reported)
    • 21.3.1.5. Key Market Focus and Geographical Presence
    • 21.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisitions
  • 21.3.2. Danaher Corporation
  • 21.3.3. QIAGEN N.V.
  • 21.3.4. F. Hoffmann-La Roche AG
  • 21.3.5. Merck KGaA
  • 21.3.6. Precigenome LLC
  • 21.3.7. Bio-Rad Laboratories, Inc.
  • 21.3.8. Standard BioTools Inc.
  • 21.3.9. JN Medsys Pte, Ltd
  • 21.3.10. Stilla Technologies SAS

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

22. Strategic Recommendations

23. About Us and Disclaimer