U.S. Digital PCR Market Size, Share & Industry Analysis, By Type (Droplet Digital PCR, Chip-based Digital PCR, and Others), By Product (Instruments, and Reagents & Consumables), By Indication (Infectious Diseases, Oncology, Genetic Disorders, and Others), By End-user (Hospital & Clinics, Pharmaceutical & Biotechnology Industries, Diagnostic Centers, and Academic & Research Organizations), and Country Forecast, 2024-2032

The U.S. Digital PCR market size was worth USD 239.5 million in 2023 and is projected to grow at a CAGR of 23.2% during the forecast period. 

The rise in the prevalence of infectious diseases, cancer, and genetic disorders among the U.S. population and the growing adoption of digital PCR technology by clinical laboratories are some key factors projected to drive the market growth during the forecast period. Moreover, rising technological advancements in digital devices are expected to contribute to the growth of the market.

• In October 2021, Stilla launched Naica, a digital polymerase chain reaction (PCR) system with six fluorescent channels. The Naica system supports cell & gene therapy research, cancer and liquid biopsy studies, and the detection of infectious diseases in wastewater and food.

The impact of the COVID-19 pandemic resulted in considerably high market growth in 2020 due to the increasing demand for effective diagnostics of COVID-19 and the rising adoption of these devices in diagnostic centers and research institutes.

LATEST TRENDS

High Adoption of Devices across Healthcare Systems 

The potential advantages of digital tests over traditional PCR tests, such as highly sensitive tests and absolute quantification, has to led to high adoption of these tests and instruments across several healthcare systems in the U.S. Moreover, the increasing awareness of advanced technologies, such as chip-based technology in the country, further drives U.S. digital PCR market growth.

• According to research statistics published by the SDI report in December 2022, the adoption of dPCR among the 248 scientists surveyed in the U.S. labs was over 40.0%.

Thus increasing adoption of these systems to diagnose various diseases across the country is propelling the market growth.

DRIVING FACTORS

Rise in Introduction of Technologically Advanced dPCR Devices to Enhance Market Growth

The growing demand for innovative PCR devices across healthcare systems and increasing R&D initiatives by major industry players have led to the introduction of various technologies offering more significant benefits.

The introduction of innovative devices based on various techniques, such as a droplet, chip-based, and crystal digital polymerase chain reactions, by key market players is anticipated to increase its adoption, further augmenting the market growth.

• In September 2021, Thermo Fisher Scientific Inc. launched the first fully integrated dPCR system designed to provide highly accurate and consistent results within 90 minutes.

Such technological advancements in digital polymerase chain reactions are expected to grow the market during the forecast timeframe, 2023-2030.

RESTRAINING FACTORS

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Limitations to the Use of Devices to Restrain Market Growth

Certain limitations associated with digital PCR, such as the high initial cost of devices and the high risk of sample contamination, compared to alternatives, such as real-time polymerase chain reaction, are factors limiting the adoption of these devices.

• For instance, in August 2022, according to the Frontiers Media S.A. article, limitations of digital PCR, such as the high price of the analysis instrument and its poor versatility of reagents as compared to NGS, has led to its limited adoption across general biochemistry laboratories.

Such limitations associated with using these digital devices and the presence of other economic alternative tests can restrain the U.S. market growth in the coming years.

SEGMENTATION

By Type Analysis 

By type, the market is divided into droplet digital PCR, chip-based digital PCR, and others.

In 2022, the droplet digital PCR segment held the highest market share, attributed to the increasing emphasis of market players on developing and commercializing droplet dPCR for infectious disease diagnosis. Moreover, the rising adoption of droplet PCR across U.S. healthcare systems is expected to boost segment growth.

• In April 2023, Bio-Rad Laboratories, Inc. launched its new QX600 Droplet System. Maintaining its ddPCR technology, this device utilizes the same droplet generation and processing protocols as the QX200 system and enables easy adoption of its advanced multiplexing capabilities.

By Product Analysis 

Based on product, the market is segmented into instruments and reagents & consumables.

The instruments segment accounted for the largest market share in 2022 due to the increasing initiatives of the market players for the launch of new systems and rising applications of these devices in the market.

• In August 2023, F. Hoffmann-La Roche AG launched the Digital LightCycler System to fight against cancer and other diseases. This device is a next-generation dPCR, that helps clinical researchers better predict genetic disease, cancer, or infection.

By Indication Analysis 

Based on indication, the market is segmented into infectious diseases, oncology, genetic disorders, and others.

The genetic disorders segment dominated the market in 2022 due to the rising number of genetic tests among the U.S. population and the increasing adoption of these devices to identify gene alterations due to their high sensitivity and specificity in detection.

• According to an article published by NCBI in 2023, as per Genetic Testing Registry data, about 129,624 genetic tests were performed in the U.S. in November 2022.

By End-user Analysis

The market is segmented into hospitals & clinics, pharmaceutical & biotechnology industries, diagnostic centers, and academic & research organizations based on end-user.

The academic & research organizations segment held the largest market share owing to research organizations' rising emphasis on producing technologically advanced devices across several applications such as oncology, genetic diseases, and others.

Furthermore, the high demand for these devices among the research institutes, and the rise launch of new dPCR assays and solutions by key players in the country, further drove the market growth.

• In February 2023, Thermo Fisher Scientific Inc. announced the launch of its new digital PCR research solution, the Applied Biosystems QuantStudio Absolute Q AutoRun dPCR suite.

KEY INDUSTRY PLAYERS

Strong Focus of Industry players on Organic Strategies to strengthen their Market Position

The key companies operating in the market are Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., and Qiagen.

Bio-Rad Laboratories, Inc., dominated the market with the highest U.S. digital PCR market share. The company’s market dominance was due to a robust focus on inorganic strategies such as collaborations with new dPCR manufacturers for production and expansion of its existing product portfolio globally. These factors are further propelling the company's growth in the market.

• In August 2022, Bio-Rad Laboratories, Inc. announced the acquisition of Curiosity Diagnostics, Sp. Z. O. o., a Poland-based developer of innovative technology solutions for the medical diagnostic and healthcare markets.

Similarly, other prominent players in the U.S. market include Stilla, Sysmex Corporation, and Standard BioTools Inc. (Fluidigm Corporation). These companies are focusing on strategic initiatives for the expansion of distribution channels across the country, further boosting U.S. market growth during the forecast period.

• In March 2023, Stilla and AtilaBiosystems entered into an agreement to market co-labeled digital PCR kits.

LIST OF KEY COMPANIES PROFILED:

• QIAGEN (Germany)


• Thermo Fisher Scientific Inc. (U.S.)


• Bio-Rad Laboratories, Inc. (U.S.)


• Stilla (France)


• Sysmex Corporation (Japan)


• Standard BioTools Inc. (U.S.)


• Biocompare (U.S.)


• Precigenome LLC. (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• In July 2022, Qiagen announced a series of enhancements through collaborations for its QIAcuity series of dPCR instruments designed to drive greater use among customers, particularly those involved in the biopharma industry.


• In January 2022- QIAGEN and Atila BioSystems announced their collaboration to provide Non-invasive Prenatal Testing (NIPT) solutions to QIAGEN’s devices franchise. This collaboration would expand QIAGEN’s device solutions in the future.

REPORT COVERAGE

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The research report provides a detailed competitive landscape and market dynamics. It focuses on key aspects such as the prevalence of chronic disease, regulatory scenarios by key countries/regions, and an overview of dPCR consumables in the market. Furthermore, the report provides information on key industry developments and detailed product mapping of consumables supplied by key companies. In addition, the report includes insights related to technological advancements in the devices and the impact of COVID-19 on the market.

Report Scope & Segmentation