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.

Northbrook, IL 60062 -- (SBWire) -- 07/13/2023 --Digital PCR (dPCR) and Real-time PCR (qPCR) Market in terms of revenue was estimated to be worth $8.5 billion in 2023 and is poised to reach $12.4 billion by 2028, growing at a CAGR of 7.8% from 2023 to 2028 according to a new report by MarketsandMarkets™. The growth of this market is due 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, increasing investments, and funds.
The dPCR and qPCR industry is expected to experience significant growth in the near future. This is due to the increasing demand for precise, accurate, and efficient detection of nucleic acids for various applications, such as gene expression analysis, disease diagnosis, and food safety testing. Furthermore, the development of highly sensitive and specific instruments, reagents, and assays for dPCR and qPCR are expected to drive the market growth. Additionally, the introduction of next-generation sequencing (NGS) methods, such as single-cell sequencing, is expected to further fuel the growth of the dPCR and qPCR industry. Moreover, the increasing demand for personalized medicine and rapid diagnostics is expected to create numerous opportunities for the dPCR and qPCR industry.

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Drivers:

1. Rising incidence and prevalence of target infectious diseases and genetic disorders
2. Continuous advancements in PCR technologies
3. Growing importance of PCR in biomarker discovery

Restraints:

1. High device costs associated with dPCR
2. Technical limitations of qPCR and dPCR

Opportunities:

1. Growing market penetration in emerging countries

Challenges:

1. Time-consuming methodology involving sample handling and post-PCR analysis
2. Lack of accuracy & standardization in protocols

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qPCR and dPCR reagents and consumables accounted for the largest share of global dPCR and qPCR market
Based on products & services, the qPCR market is categorized into reagents and consumables, instruments and software & services. The qPCR reagents and consumables segment is expected to command the largest share of the qPCR products & services market in 2023. The dPCR and qPCR products are increasingly used by researchers and healthcare professionals due to the ongoing automation and miniaturization of qPCR/dPCR instruments, the commercialization of advanced software, and the availability of customized laboratory reagents. 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 expected to drive the growth of the reagents and consumables market.
Clinical application segment accounted for the largest share of qPCR market

Based on application, the qPCR and dPCR market is categorized into clinical applications (Infectious Disease Testing, Oncology Testing, Blood Screening, Transplant Diagnostics and Other Clinical Applications), research applications, environmental applications, forensic applications and other applications. The clinical applications segment is estimated to dominate the Dpcr & qPCR applications market in 2022. The clinical applications segment is estimated to dominate the qPCR applications market 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.

The clinical applications segment is expected to account for the largest share of the digital PCR (dPCR) market in 2022. The technological benefits offered by dPCR over qPCR & traditional PCR (such as high flexibility, increased device sensitivity, better precision, and absolute quantification of target molecule), the growing adoption of dPCR among hospitals & diagnostic centers, and the increasing global burden of cancer & AIDS are key factors that will drive the market for clinical applications during the study period. The key factors driving the market growth of clinical applications segment 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.

The hospitals and diagnostic laboratories is the largest and fastest growing end user segment of the qPCR & dpcr market

On the basis of end user, the dPCR and qPCR 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, the hospitals and diagnostic centers segment accounted for the largest share of the real-time PCR (qPCR) market. This can be attributed to the increasing market availability of qPCR reagents for clinical diagnostic applications, the ongoing expansion of healthcare infrastructure across emerging countries, the high prevalence of target diseases, and growing awareness among end users related to the benefits offered by qPCR for clinical diagnosis.

In 2022, the hospitals and diagnostic centers segment accounted for the largest share of the dPCR market. This can be attributed to the growing demand for early and efficient disease diagnosis and treatment, the increasing number of dPCR product launches for diagnostic applications, the benefits offered by dPCR in disease diagnosis (as compared to other PCR technologies), and the growing public awareness related to the benefits offered by dPCR in disease diagnosis.

North America accounted for the largest share of the dPCR and qPCR market

On the basis of region, In 2022, North America accounted for the largest share of the digital PCR (dPCR) and real-time PCR (qPCR) market, followed by Europe. The North American digital PCR (dPCR) and real-time PCR (qPCR) market is driven by the 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.

Digital PCR (dPCR) and Real-time PCR (qPCR) Market Dynamics:

Key Market Players:

The prominent players operating in the dPCR and qPCR market are Thermo Fisher Scientific (US), Danaher Corporation (US), and F. Hoffmann-La Roche, Ltd. (Switzerland).

Report Link: Digital PCR (dPCR) and Real-time PCR (qPCR) Market

Recent Developments:

- 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.

Table of Contents :

1 INTRODUCTION (Page No. - 53)

1.1 STUDY OBJECTIVES
1.2 MARKET DEFINITION
1.3 STUDY SCOPE
1.4 CURRENCY

2 RESEARCH METHODOLOGY (Page No. - 57)

2.1 RESEARCH APPROACH
FIGURE 1 DIGITAL PCR MARKET: RESEARCH DESIGN
2.1.1 SECONDARY RESEARCH
2.1.2 PRIMARY RESEARCH
2.2 MARKET SIZE ESTIMATION
2.3 GROWTH FORECAST
2.4 MARKET BREAKDOWN AND DATA TRIANGULATION
2.5 RESEARCH ASSUMPTIONS

3 EXECUTIVE SUMMARY (Page No. - 69)

4 PREMIUM INSIGHTS (Page No. - 77)

4.1 GLOBAL DIGITAL PCR MARKET OVERVIEW

FIGURE 16 RISING INCIDENCE AND PREVALENCE OF TARGET INFECTIOUS DISEASES & GENETIC DISORDERS EXPECTED TO DRIVE MARKET GROWTH

4.2 ASIA PACIFIC: DPCR AND QPCR MARKET OVERVIEW (2022)
4.3 GEOGRAPHICAL SNAPSHOT OF DIGITAL PCR (DPCR) AND REAL-TIME PCR (QPCR) MARKET
FIGURE 18 CHINA TO WITNESS HIGHEST GROWTH DURING FORECAST PERIOD

5 MARKET OVERVIEW (Page No. - 80)

5.1 INTRODUCTION
5.2 MARKET DYNAMICS