디지털 PCR 시장 - 세계 및 지역 분석 : 유형, 용도, 최종 사용자 및 국가별 분석 및 예측(2024-2034년)

Introduction of Digital PCR

The global digital PCR market, initially valued at $678.1 million in 2023, is poised for substantial growth, projected to surge to $3,351.0 million by 2034, marking a remarkable compound annual growth rate (CAGR) of 15.75% over the period from 2024 to 2034. The market has been experiencing significant double-digit growth, primarily fueled by the rising adoption of personalized medicine to screen and diagnose genetic disorders. This approach tailors medical treatment to the unique characteristics of each patient, with digital PCR (dPCR) playing a crucial role by enabling the detection and quantification of rare genetic mutations linked to various cancers. Additionally, the growing prevalence of infectious diseases is driving the demand for dPCR as healthcare providers seek rapid and accurate diagnostic solutions. Technological advancements have also contributed to market expansion, with innovations such as droplet digital PCR, nanoplate technology, and microfluidic platforms enhancing the capabilities of digital PCR.

Market Introduction

The digital PCR (dPCR) market is currently experiencing significant growth, fueled by cutting-edge technology and strategic collaborations that improve diagnostic capabilities. For instance, the partnership between Bio-Rad Laboratories and Oncocyte Corporation is crucial for developing solutions for transplant monitoring, highlighting dPCR's role in personalized medicine. Additionally, major companies such as Thermo Fisher Scientific have been accelerating the use of dPCR in oncology and infectious disease diagnostics, i.e., their recent launch of the AutoRun dPCR Suite, which is designed to enhance laboratory efficiency. The increasing acknowledgment of dPCR's ability to detect low-abundance mutations is further driving its importance for tailored treatment approaches. With ongoing innovations and supportive regulations, the dPCR market is poised for substantial expansion, ultimately leading to better patient outcomes through advanced molecular diagnostics.

Industrial Impact

The digital PCR (dPCR) market has significantly shaped the landscape of molecular diagnostics, driven by key players such as Bio-Rad Laboratories, Thermo Fisher Scientific, and QIAGEN. These companies leverage innovative technologies to provide highly sensitive and precise solutions for applications in oncology, infectious diseases, and genetic testing. dPCR systems, known for their exceptional accuracy in quantifying nucleic acids, facilitate the detection of low-abundance mutations, which is crucial for personalized treatment strategies.

The industrial impact of dPCR extends beyond diagnostics, i.e., it plays a vital role in drug development and clinical trials by providing reliable data on patient responses and treatment efficacy. This is particularly evident in oncology, where dPCR helps identify specific biomarkers that guide targeted therapies. Additionally, the integration of dPCR into public health initiatives enhances disease monitoring and outbreak response capabilities.

As dPCR technologies continue to evolve and regulatory support increases, the market's influence on research and clinical practices is profound. By driving advancements in precision medicine and enabling deeper insights into genetic conditions, the dPCR market is at the forefront of transforming healthcare and improving patient outcomes worldwide.

Market Segmentation:

Segmentation 1: by Product

• Systems
• Consumables (Kits, Assay, and Reagents)
• Software and Services

Consumable Segment to Dominate the Digital PCR Market (by Product)

Based on product, the global digital PCR market was led by the consumables segment, which held a 60.30% share in 2023. This substantial market share indicates the high demand for digital PCR consumables, including kits, assays, and reagents. The dominance of the consumable segment underscores the critical role of high-quality reagents and kits in digital PCR processes, facilitating reliable results and enhancing the overall effectiveness of genetic testing. This emphasis on consumables is essential for achieving accurate diagnoses and advancing personalized healthcare solutions, as they provide the necessary tools for precisely detecting and quantifying genetic variations.

Segmentation 2: by Application

• Clinical and Research Application
• Environmental Application
• Other Application

Clinical and Research Application Segment to Dominate the Digital PCR Market (by Application)

Based on application, the global digital PCR testing market was led by the clinical and research application segment, which held an 86.48% share in 2023. The prominence of clinical and research applications underscores the critical role of digital PCR (dPCR) in enhancing diagnostic accuracy and advancing scientific inquiry. With its high precision and sensitivity, dPCR is essential across various fields, including oncology, infectious diseases, rare diseases, reproductive genetics, and transplant diagnostics. This technology facilitates the effective quantification of nucleic acids, enabling early cancer detection and personalized treatment strategies. Additionally, dPCR provides accurate pathogen detection for infectious diseases and identifies genetic mutations associated with rare conditions. dPCR has become increasingly vital for delivering effective, personalized healthcare solutions by improving prenatal and postnatal screening and transplant monitoring.

Segmentation 3: by End User

• Academic and Research Institutes
• Hospitals and Clinics
• Diagnostic Centers
• Pharmaceutical and Biopharmaceutical Companies
• Other End User

Academic and Research Institute Segment to Dominate the Digital PCR Market (by End User)

Based on end user, the global digital PCR market was led by the academic and research institute segment, which held a 33.77% share in 2023. The dominance of academic and research institutes in the digital PCR (dPCR) market is underscored by their engagement in advanced research applications that require the high sensitivity and precision dPCR offers. These institutions leverage this technology for various studies, including genetic research, cancer investigations, and pathogen detection, driving significant advancements in genomics and molecular biology. By utilizing dPCR to explore new genetic variants and understand complex biological processes, academic settings remain at the forefront of scientific innovation. Additionally, partnerships with leading companies provide access to specialized dPCR systems and assays tailored to their research needs, enhancing the quality of studies and experiments. Moreover, with an increasing emphasis on personalized medicine and public health, these institutes contribute significantly to developing and validating innovative diagnostic tools, solidifying their dominance in the market.

Segmentation 4: by Region

• North America
  • U.S.
  • Canada
• Europe
  • U.K.
  • Germany
  • France
  • Italy
  • Spain
  • Rest-of-Europe
• Asia-Pacific
  • China
  • Japan
  • South Korea
  • Australia
  • Rest-of-Asia-Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest-of-Latin America
• Middle East and Africa
  • K.S.A.
  • Egypt
  • Rest-of-Middle East and Africa

The digital PCR market in the North America region is expected to witness a significant growth rate of 16.04% during the forecast period. This notable growth can be attributed to several key factors. The increasing emphasis on personalized medicine has been driving demand for precise and sensitive diagnostic tools. Additionally, substantial investments in research and development from the public and private sectors have fostered innovation in dPCR technologies. Furthermore, government initiatives focused on enhancing healthcare infrastructure and supporting research have significantly fueled the expansion of the dPCR market. However, the Asia-Pacific region is expected to reach $695.5 million in 2034 from $124.8 million in 2023, at a CAGR of 17.02% during the forecast period 2024-2034.

Recent Developments in the Digital PCR Market

• In September 2024, QIAGEN N.V. launched 100 new assays for its digital PCR (dPCR) platform, QIAcuity. These assays are intended for research in cancer, inherited genetic disorders, infectious disease monitoring, and food and environmental assessments.
• In June 2024, QIAGEN N.V. launched its new Custom Assay Design Tool for digital PCR (dPCR), specifically designed for copy number variation (CNV) analysis on the QIAcuity platform.
• In June 2024, Stilla Technologies launched two new digital PCR system configurations that have been added to the Nio product line, launched in November 2023 with the introduction of the flagship Nio+ instrument. The two new configurations are designed to deliver digital PCR solutions with a throughput that is fully tailored to the user's requirements.
• In April 2024, Bio-Rad Laboratories, Inc. collaborated with Oncocyte Corporation to develop and commercialize transplant monitoring products utilizing Bio-Rad's Droplet Digital PCR (ddPCR) instruments and reagents. As part of the agreement, Bio-Rad will participate in a private placement of Oncocyte's equity and has obtained exclusive commercial rights in specific markets to market Oncocyte's assay for transplant monitoring research with Bio-Rad's QX600 ddPCR System.
• In March 2023, Thermo Fisher Scientific launched its latest digital PCR research solution: the Applied Biosystems QuantStudio Absolute Q AutoRun dPCR Suite. This is the only digital PCR system on the market that facilitates lab automation while minimizing overhead costs, all without compromising consistency, flexibility, and user-friendliness.

Demand - Drivers, Challenges, and Opportunities

Market Drivers:

Growing Demand for Precision Medicine: The growing demand for precision medicine has been significantly driving the adoption of digital PCR (dPCR) due to its capacity for accurate genetic profiling. As healthcare increasingly focuses on tailored treatments, dPCR's high sensitivity allows for the precise quantification of low-abundance mutations, which is essential for identifying specific patient needs. This technology supports targeted therapies by providing reliable diagnostics to monitor treatment efficacy and detect resistance mutations. Furthermore, dPCR facilitates the early detection of genetic disorders and cancers, enabling timely interventions that are vital for personalized care. The emphasis on individualized treatment also spurs innovation in dPCR technologies, expanding their applications in clinical and research settings and enhancing their overall relevance in modern healthcare.

Market Challenges:

High Cost of Platforms Associated with Digital PCR: The high costs associated with digital PCR (dPCR) platforms significantly hinder market growth in several ways. The substantial initial investment required for dPCR systems can deter smaller laboratories and healthcare facilities, especially in developing regions with tight budgets, slowing adoption rates. Additionally, healthcare systems often prioritize essential services and established technologies over newer, more expensive dPCR options, leading providers to rely on traditional PCR methods. This financial barrier also affects research institutions, where funding agencies may be reluctant to support projects involving costly technologies, limiting innovation. Overall, these high costs restrict broader adoption and hinder the expansion of the dPCR market.

Market Opportunities:

Growing Adoption of Digital PCR Solutions for Therapeutic Drug Development and Comprehensive Treatment Strategies: The growing adoption of digital PCR (dPCR)-based solutions for developing therapeutic drugs and comprehensive treatment plans offers significant growth opportunities in the dPCR market. As pharmaceutical and biotechnology industries shift toward personalized medicine, dPCR's exceptional sensitivity and precision enable the identification of biomarkers critical for therapeutic development. This technology enhances the monitoring of disease progression and treatment responses, facilitating tailored therapeutic strategies. Moreover, regulatory agencies increasingly value robust molecular diagnostics in clinical trials, further driving demand for dPCR solutions. With rising chronic diseases and ongoing advancements in dPCR methodologies, the market is set for substantial expansion, fueled by data-driven approaches in drug development and personalized healthcare.

How can this report add value to an organization?

Product/Innovation Strategy: The global digital PCR market has been extensively segmented based on various categories, such as product, application, end user, and region. This can help readers understand which segments account for the largest share and which are well-positioned to grow in the coming years.

Growth/Marketing Strategy: Mergers, acquisitions, and product launches accounted for the maximum number of key developments, i.e., nearly 50.61% of the total developments in the global digital PCR market were between January 2019 and September 2024.

Competitive Strategy: The global digital PCR market has numerous established players with product portfolios. Key players in the global digital PCR market analyzed and profiled in the study involve established players offering products for digital PCR.

Methodology

Key Considerations and Assumptions in Market Engineering and Validation

• The base year considered for the calculation of the market size is 2023. A historical year analysis has been done for the period FY2019-FY2022. The market size has been estimated for FY2023 and projected for the period FY2024-FY2034.
• The scope of this report has been carefully derived based on interactions with experts in different companies across the world. This report provides a market study of upstream and downstream products of the digital PCR market.
• The market contribution of digital PCR is anticipated to be launched in the future and has been calculated based on the historical analysis of the solutions.
• The company's revenue has been referenced from their annual reports for FY2022 and FY2023. For private companies, revenues have been estimated based on factors such as inputs obtained from primary research, funding history, market collaborations, and operational history.
• The market has been mapped based on the available digital PCR solutions. All the key companies with significant offerings in this field have been considered and profiled in this report.

Primary Research:

The primary sources involve industry experts in digital PCR, including the market players offering products and services. Resources such as CEOs, vice presidents, marketing directors, and technology and innovation directors have been interviewed to obtain and verify both qualitative and quantitative aspects of this research study.

The key data points taken from the primary sources include:

• Validation and triangulation of all the numbers and graphs
• Validation of the report's segmentation and key qualitative findings
• Understanding the competitive landscape and business model
• Current and proposed production values of a product by market players
• Validation of the numbers of the different segments of the market in focus
• Percentage split of individual markets for regional analysis

Secondary Research

Open Sources

• Certified publications, articles from recognized authors, white papers, directories, and major databases, among others
• Annual reports, SEC filings, and investor presentations of the leading market players
• Company websites and detailed study of their product portfolio
• Gold standard magazines, journals, white papers, press releases, and news articles
• Paid databases

The key data points taken from the secondary sources include:

• Segmentations and percentage shares
• Data for market value
• Key industry trends of the top players of the market
• Qualitative insights into various aspects of the market, key trends, and emerging areas of innovation
• Quantitative data for mathematical and statistical calculations

Key Market Players and Competition Synopsis

The companies that are profiled have been selected based on inputs gathered from primary experts, who have analyzed company coverage, product portfolio, and market penetration.

Some prominent names established in this market are:

• Bio-Rad Laboratories, Inc.
• Thermo Fisher Scientific Inc.
• QIAGEN N.V.
• F. Hoffmann-La Roche Ltd
• Standard BioTools Inc.
• Merck KGaA
• Stilla Technologies Inc.
• SAGA Diagnostics AB
• RevoSketch Inc.
• JN Medsys
• JETA Molecular BV.
• Sysmex Corporation

Table of Contents

Executive Summary

Scope and Definition

1 Markets

• 1.1 Market Overview
  • 1.1.1 Workflow of Digital PCR
  • 1.1.2 Comparison of qPCR and dPCR
• 1.2 Trends: Current and Future Impact Assessment
  • 1.2.1 Integration with Next-Generation Sequencing (NGS)
  • 1.2.2 Increased Real-time Monitoring and Point-of-care Applications of Digital PCR
  • 1.2.3 Increasing Product Launches in d-PCR Ecosystem
• 1.3 Supply Chain Overview
• 1.4 Research and Development Review
  • 1.4.1 Patent Filing Trend (by Region)
  • 1.4.2 Patent Filing Trend (by Country)
  • 1.4.3 Patent Filing Trend (by Year)
• 1.5 Ongoing Digital PCR Clinical Trials
• 1.6 Regulatory Landscape
  • 1.6.1 U.S.
  • 1.6.2 European Union
  • 1.6.3 Asia Pacific
    • 1.6.3.1 Japan
    • 1.6.3.2 China
• 1.7 Market Dynamics Overview
  • 1.7.1 Market Drivers
    • 1.7.1.1 Increasing Adoption of Personalized Medicine for Screening and Diagnostics of Genetic Disorders such as Rare Diseases and Cancer
    • 1.7.1.2 Increasing Incidence of Infectious Diseases
    • 1.7.1.3 Technological Advancement in dPCR to Enhance Market Growth
  • 1.7.2 Market Restraints
    • 1.7.2.1 High Cost of Platforms Associated with Digital-PCR
    • 1.7.2.2 Shortage of Skilled Professionals and Trained Laboratory Technicians
  • 1.7.3 Market Opportunities
    • 1.7.3.1 Increased Use of Digital-PCR-Based Solutions for the Development of Therapeutics Drugs and Comprehensive Treatment Plan
    • 1.7.3.2 Growing Adoption of dPCR in Emerging Markets

2 Global Digital PCR Market, by Product, $Million, 2023-2034

• 2.1 Overview
• 2.2 Systems
  • 2.2.1 Droplet Digital PCR Systems
  • 2.2.2 Chip-Based Digital PCR Systems
• 2.3 Consumables (Kits, Assays, and Reagents)
• 2.4 Software and Services

3 Global Digital PCR Maret, by Application, $Million, 2023-2034

• 3.1 Overview
• 3.2 Clinical and Research Application
  • 3.2.1 Oncology
    • 3.2.1.1 Solid Tumor
    • 3.2.1.2 Hematological Malignancies
  • 3.2.2 Infectious Diseases
    • 3.2.2.1 Respiratory Infections
    • 3.2.2.2 Gastrointestinal Infections
    • 3.2.2.3 Other Infections
  • 3.2.3 Rare Diseases
    • 3.2.3.1 Inherited Trait Type
    • 3.2.3.2 Acquired Trait Type
  • 3.2.4 Reproductive Genetics
    • 3.2.4.1 Prenatal Diseases
    • 3.2.4.2 Postnatal Diseases
  • 3.2.5 Transplant Diagnostics
  • 3.2.6 Other Clinical and Research Applications
• 3.3 Environmental Applications
• 3.4 Other Applications

4 Global Digital PCR Market, by End User, $Million, 2023-2034

• 4.1 Overview
• 4.2 Academic and Research Institutes
• 4.3 Hospitals and Clinics
• 4.4 Diagnostic Centers
• 4.5 Pharmaceutical and Biopharmaceutical Companies
• 4.6 Other End Users

5 Regions

• 5.1 Regional Summary
• 5.2 Drivers and Restraints
• 5.3 North America
  • 5.3.1 Regional Overview
  • 5.3.2 Driving Factors for Market Growth
  • 5.3.3 Factors Challenging the Market
  • 5.3.4 By Application
  • 5.3.5 By End User
  • 5.3.6 U.S.
  • 5.3.7 Canada
• 5.4 Europe
  • 5.4.1 Regional Overview
  • 5.4.2 Driving Factors for Market Growth
  • 5.4.3 Factors Challenging the Market
  • 5.4.4 By Application
  • 5.4.5 By End User
  • 5.4.6 France
  • 5.4.7 Germany
  • 5.4.8 U.K.
  • 5.4.9 Spain
  • 5.4.10 Italy
  • 5.4.11 Rest-of-Europe
• 5.5 Asia-Pacific
  • 5.5.1 Regional Overview
  • 5.5.2 Driving Factors for Market Growth
  • 5.5.3 Factors Challenging the Market
  • 5.5.4 Application
  • 5.5.5 By End User
  • 5.5.6 China
  • 5.5.7 Australia
  • 5.5.8 South Korea
  • 5.5.9 Japan
  • 5.5.10 Rest-of-Asia-Pacific
• 5.6 Latin America
  • 5.6.1 Regional Overview
  • 5.6.2 Driving Factors for Market Growth
  • 5.6.3 Factors Challenging the Market
  • 5.6.4 By Application
  • 5.6.5 By End User
  • 5.6.6 Brazil
  • 5.6.7 Mexico
  • 5.6.8 Rest-of-Latin America
• 5.7 Middle East and Africa
  • 5.7.1 Regional Overview
  • 5.7.2 Driving Factors for Market Growth
  • 5.7.3 Factors Challenging the Market
  • 5.7.4 By Application
  • 5.7.5 By End User
  • 5.7.6 K.S.A.
  • 5.7.7 Egypt
  • 5.7.8 Rest-of-Middle East and Africa

6 Markets - Competitive Benchmarking & Company Profiles

• 6.1 Competitive Landscape
  • 6.1.1 Mergers and Acquisitions
  • 6.1.2 Synergistic Activities
  • 6.1.3 Product Launch and Approval Activities
  • 6.1.4 Expansion, Funding, and Other Activities
• 6.2 Market Share Analysis
• 6.3 Company Profile
  • 6.3.1 Bio-Rad Laboratories, Inc.
    • 6.3.1.1 Overview
    • 6.3.1.2 Top Products/Product Portfolio
    • 6.3.1.3 Top Competitors
    • 6.3.1.4 Target Customers
    • 6.3.1.5 Key Personnel
    • 6.3.1.6 Analyst View
  • 6.3.2 Thermo Fisher Scientific Inc.
    • 6.3.2.1 Overview
    • 6.3.2.2 Top Products/Product Portfolio
    • 6.3.2.3 Top Competitors
    • 6.3.2.4 Target Customers
    • 6.3.2.5 Key Personnel
    • 6.3.2.6 Analyst View
  • 6.3.3 QIAGEN N.V.
    • 6.3.3.1 Overview
    • 6.3.3.2 Top Products/Product Portfolio
    • 6.3.3.3 Top Competitors
    • 6.3.3.4 Target Customers
    • 6.3.3.5 Key Personnel
    • 6.3.3.6 Analyst View
  • 6.3.4 F. Hoffmann-La Roche Ltd
    • 6.3.4.1 Overview
    • 6.3.4.2 Top Products/Product Portfolio
    • 6.3.4.3 Top Competitors
    • 6.3.4.4 Target Customers
    • 6.3.4.5 Key Personnel
    • 6.3.4.6 Analyst View
  • 6.3.5 Standard BioTools Inc.
    • 6.3.5.1 Overview
    • 6.3.5.2 Top Products/Product Portfolio
    • 6.3.5.3 Top Competitors
    • 6.3.5.4 Target Customers
    • 6.3.5.5 Key Personnel
    • 6.3.5.6 Analyst View
  • 6.3.6 Merck KGaA
    • 6.3.6.1 Overview
    • 6.3.6.2 Top Products/Product Portfolio
    • 6.3.6.3 Top Competitors
    • 6.3.6.4 Target Customers
    • 6.3.6.5 Key Personnel
    • 6.3.6.6 Analyst View
  • 6.3.7 Stilla Technologies Inc.
    • 6.3.7.1 Overview
    • 6.3.7.2 Top Products/Product Portfolio
    • 6.3.7.3 Top Competitors
    • 6.3.7.4 Target Customers
    • 6.3.7.5 Key Personnel
    • 6.3.7.6 Analyst View
  • 6.3.8 SAGA Diagnostics AB
    • 6.3.8.1 Overview
    • 6.3.8.2 Top Products/Product Portfolio
    • 6.3.8.3 Top Competitors
    • 6.3.8.4 Target Customers
    • 6.3.8.5 Key Personnel
    • 6.3.8.6 Analyst View
  • 6.3.9 Naveris, Inc.
    • 6.3.9.1 Overview
    • 6.3.9.2 Top Products/Product Portfolio
    • 6.3.9.3 Top Competitors
    • 6.3.9.4 Target Customers
    • 6.3.9.5 Key Personnel
    • 6.3.9.6 Analyst View
  • 6.3.10 Genetron Holdings Limited
    • 6.3.10.1 Overview
    • 6.3.10.2 Top Products/Product Portfolio
    • 6.3.10.3 Top Competitors
    • 6.3.10.4 Target Customers
    • 6.3.10.5 Key Personnel
    • 6.3.10.6 Analyst View
  • 6.3.11 RevoSketch Inc.
    • 6.3.11.1 Overview
    • 6.3.11.2 Top Products/Product Portfolio
    • 6.3.11.3 Top Competitors
    • 6.3.11.4 Target Customers
    • 6.3.11.5 Key Personnel
    • 6.3.11.6 Analyst View
  • 6.3.12 JN Medsys
    • 6.3.12.1 Overview
    • 6.3.12.2 Top Products/Product Portfolio
    • 6.3.12.3 Top Competitors
    • 6.3.12.4 Target Customers
    • 6.3.12.5 Key Personnel
    • 6.3.12.6 Analyst View
  • 6.3.13 JETA Molecular BV.
    • 6.3.13.1 Overview
    • 6.3.13.2 Top Products/Product Portfolio
    • 6.3.13.3 Top Competitors
    • 6.3.13.4 Target Customers
    • 6.3.13.5 Key Personnel
    • 6.3.13.6 Analyst View
  • 6.3.14 Sysmex Corporation.
    • 6.3.14.1 Overview
    • 6.3.14.2 Top Products/Product Portfolio
    • 6.3.14.3 Top Competitors
    • 6.3.14.4 Target Customers
    • 6.3.14.5 Key Personnel
    • 6.3.14.6 Analyst View

7 Research Methodology

• 7.1 Data Sources
  • 7.1.1 Primary Data Sources
  • 7.1.2 Secondary Data Sources
  • 7.1.3 Data Triangulation
• 7.2 Market Estimation and Forecast